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BEEspoke Data 42

FIELD OF THE INVENTION The invention relates to casino games with the objective to inspire more players to make a side wager or continue to play a casino game. The inspiration comes from the possible occurrence of a random event during the play of the game so the event pays off not only the individual player and possibly the other bystander players. BACKGROUND OF THE INVENTION There is a continuing need to add excitement to casino offerings. One manner in which this has been done is through the use of optional side wagers to an underlying game. In particular, side wagers to Blackjack have become plentiful in recent years. A desired quality of any Blackjack side bet is that it be optional. In this way, players who do not want to make the side bet are not required to do so. Players not making the side wager instead play a normal Blackjack game. From a casino point of view, making the side bet optional is also desirable, for there is then very little risk in introducing it. If the side bet is unsuccessful (no one wants to wager on it), the Blackjack table reverts back to its classic play by default. Optional Blackjack side wagers include Over/Under 13, Super 7s, Top of the Deck, Royal Match (Boylan et al., U.S. Pat. No. 5,098,107) and Bust-Out wagers. Too, a separate jackpot wager achieved through a predetermined arrangement of cards has been proposed (Jones et al., U.S. Pat. No. 4,861,041). The Top of the Deck wager includes a side bet on if the player and/or dealer will receive a natural (a two-card total of 21). It has no “play” value, per se, in that the outcome of the wager is decided merely on the basis of the first two cards dealt to the player and/or dealer. Top of the Deck suffers with restrictive rules as to when players can make the bet (only immediately after a shuffle). Thus, players can make the wager typically only once every few hands. The Over/Under 13 wager is a side bet on whether the player's first two cards will total over or total below 13. It is made at the start of a new hand. There is no decision for the player once the bet has been made. The Royal Match wager is a side bet on whether the player's first two cards will be of the same suit. It is made at the start of a new hand but is also another completely passive bet. The Super 7s wager has a bet on if the player will receive one or more Sevens in his/her hand. It too is made at the start of a new hand and it is almost completely passive as the player has a decision to make roughly once in every 170 hands. But in all other cases (the vast majority), there is nothing to do. Indeed, any jackpots paid on a predetermined arrangement of rare cards (cf. U.S. Pat. No. 4,861,041 mentioned above) succumb to this problem. Vancura (U.S. Pat. No. 5,673,917) describes a side wager that allows players to wager on the number of hits that they and/or the dealer will ultimately take. The resolution of the main Blackjack wager can proceed as usual. Unlike the aforementioned Blackjack side wagers, players are actively in control of their fortunes and can play hands as they wish. Boylan et al. (U.S. Pat. No. 5,863,041) describe a side wager to Pai Gow poker in which an “envy bet” is taught. The “envy bet” is a side wager of a minimum amount and allows the player to also be paid, should another player receive a hand of predetermined rank. The game of Spanish 21 (Lofink, U.S. Pat. Nos. 5,615,888 and 5,806,846) modifies Blackjack and includes a bonus on the main wager. There is an opportunity of several players winning if someone gets special predetermined cards. In Spanish 21, the player receiving the predetermined cards wins in addition to all other players. Rainbow Blackjack, (Grassa, U.S. Pat. Nos. 5,390,934 and 5,494,296) wherein the rules of play are the same but each player is assigned a color and players are allowed to wager on each other's colors, is another try that is reminiscent of back-lining, where others can wager with a particular player. While the above casino games are each unique, none of them have the desirable feature of allowing a bystander player (one who wagers on the base game but not necessarily on any side bet) to receive an award based on the outcome of a side wager. Furthermore, none of these games afford one player an award based upon another player losing a wager. There is therefore the need for side wagers that are exciting, easy-to-play, encourages play, and allows players to formulate their own strategy. There is the need to add excitement to wagering players not currently “in the game” to minimize boredom. There is the need for a casino game that allows a bystander player to receive an award based on the outcome of another player's side wager. There is the need for a casino game in which one player may win based upon another player losing. BRIEF SUMMARY OF THE INVENTION Described herein is a casino game that allows a bystander player to receive an award based on the outcome of another player's side wager. In a preferred embodiment, one player may win based upon another player losing. A preferred method uses a side wager associated with the conventional game of casino Blackjack. The preferred game is played on the standard Blackjack table with an extra area for making each player to side wager adjacent to the area delineated for making the main wager. There is a video screen for play of the bonus game, in a preferred embodiment including the MONOPOLY® game. In principle, wagers may be made with money, gaming chips, credits, or their video or mechanical equivalent and preferably the bonus game is played in a bonus round by a player that has achieved entry thereto during play of a base game of cards. More particularly, the entry into the bonus game requires that the players make a side bet on the occurrence of a predetermined outcome of the base game and the outcome indeed happen. The game has a method of paying off according to Blackjack rules modified to include a bonus round with incentives for all Blackjack players. The rest of the rules for the base game of Blackjack are normal remaining exactly as before. Indeed, the resolution of the main wager may proceed in exactly the same fashion as in ordinary play. In this way, the invention conforms to the subtle yet common variations in rules and/or conditions that exist between casinos. In the preferred embodiment, the introduction of side betting of bystanders does not cause the overall “optimal” Blackjack strategy to change whatsoever. Unlike the existing Blackjack side bets where the player has little, if anything, to do, this invention affords the player considerable interest in the outcome of the bonus game. Playing Blackjack with the classical “basic strategy” (a set of rules meant to optimize the player's expectation taking into account only information from the present player and dealer hands) does not guarantee winning on the side bet. The outcome of the side bet is exciting but subject to chance due to random selection. In another embodiment, players may make the side wager on the dealer's hand, in addition to their own. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top view illustration shown in perspective of a layout for the preferred embodiment of the equipment. FIG. 2 is a flow chart showing some steps in the method of play of the preferred game. FIG. 3 is a schematic diagram of the electronic equipment of the MONOPOLY® Blackjack version of the current invention. DETAILED DESCRIPTION OF THE INVENTION A detailed specification of the preferred game 10 of MONOPOLY® Blackjack includes a place 11 for side wagers for each of the players. When used herein, the trademarks, MONOPOLY® and Mr. MONOPOLY® are those belonging to Hasbro, Inc. The MONOPOLY® BLACKJACK card game includes a side wager in Blackjack to participate in the bonus game. Upon a player achieving a qualifying hand, the icon, Mr. MONOPOLY®, offers the qualifying player the choice of a fixed prize or the chance to play “the MONOPOLY® game” by “going to the board.” In this manner, the qualifying player with the qualifying hand has an active choice in how the bonus game proceeds. If the player with the qualifying hand chooses to play the MONOPOLY® game, play begins on a MONOPOLY® board 12 (preferably a video screen) with movement thereabout by a token 14 . The award is based on the square 13 randomly selected. For traditional squares 13 , the qualifying player receives odds on his/her wager. But if the qualifying player lands in the square 13 designated, “Jail”, he/she wins nothing but instead a “Good Samaritan” or “bystanders' bonus” is granted to all other Blackjack side bettors. The terms, “Good Samaritan” or “bystanders” are used throughout this disclosure to cover the other players that are not the qualifying player that is playing directly for the bonus. In a preferred embodiment this betting bystanders' bonus is awarded to all Blackjack players, whether or not they have made the side wager for the bonus game. Alternatively, the bystanders' bonus could be paid only when the qualifying player gets a randomly selected bonus move that does not pay him/her. In another alternate embodiment, the “bystanders' bonus” is awarded only to those players who have made a side wager. Game Specifics Rules of Play for Blackjack Style Game To begin play, each player makes a wager on one of two optional side wagers on the qualifying hand: either “Red Blackjack” or “Black Blackjack.” In FIG. 1 place 11 is shown as a rectangle but any indication of whereat to bet is within this disclosure including two areas for making each side bet wagers or two coin acceptors. Each wager pays 10 to 1 for a Blackjack that is not the correct color. For example, a player betting on “Red Blackjack” receives 10 to 1 for a mixed color Blackjack consisting of, for example, a red ace and black king, etc. A player betting on “Red Blackjack” also receives 10 to 1 for a Black Blackjack consisting of, for example, a black ace and a black ten, etc. When the side wagering player is dealt a Blackjack or a two card total of 21 that is, a qualifying hand, e.g. the monochromatically correct color-combination, he/she is said to have qualified to play the bonus game. There is about a 1 in 84 chance of qualifying for each color side wager, hence roughly a 1 in 42 chance for a bettor that wagers on both “Red Blackjack” and “Black Blackjack”. The MONOPOLY® BLACKJACK bonus game begins and the player is offered the choice of one of the following: (a) a sure award of fixed odds, or (b) the option to play “the MONOPOLY® game.” Taking fixed odds ends the bonus game. The player is paid according to the fixed odds. This may be referred to as a “sure thing” since there is no risk involved in making this decision. Instead, if the player is so inclined, the player may elect to play the MONOPOLY® game, which is then invoked on board 12 shown in FIGS. 1 and 3. During the game, a single square 13 is selected randomly (by a method to be explained later) to determine the outcome of the bonus game. Standard squares 13 pay the player associated odds on his/her wager. Special squares 13 , for example (“Go To Jail”, “Jail”) pay the player nothing, but all other (non qualifying hand) players are paid a “Good Samaritan” or “bystanders' bonus” of fixed odds. Thus, an incentive to play at this table (as opposed to a standard Blackjack table) is afforded to all the other players (whether making the side wager or not in the preferred embodiment) side-betting bystanders who did not qualify and thus are not actively playing in the bonus round. Algorithmic Flow (Only Side Wager is Portrayed) 1) Player wagers on MONOPOLY® BLACKJACK base game 10 and has a side bet at place 11 . 2) If player does not receive a Blackjack, side wager is taken, return to step #1. 3) If player receives a Blackjack but not the correct color type, he/she is paid 10 to 1 for each such side wager. If player does not have a Blackjack of the correct type, return to step #1. 4) If player receives a Blackjack of the correct type, dealer initiates bonus sequence via control panel. On the video screen showing board 12 a 3-dimensional Mr. MONOPOLY® icon welcomes the winning player to “MONOPOLY® Blackjack” as the bonus round. That icon explains that the winning player has a choice by saying, “Welcome! Choose either sure 20 to 1 odds or play the MONOPOLY® game.” 5) If player selects fixed pay, he/she is paid accordingly. The dealer enters the player's choice via a control panel 14 . Return to step #1. 6) If player selects to play the MONOPOLY® game, the dealer enters that choice via the control panel 14 . The screen then changes to show a MONOPOLY® game board having a path of squares 13 for play. An animation of a locomotive begins circling the path of squares 13 at high speed starting from the lower-right “Go” square 13 . A plunger 15 shown in FIG. 1 connects to a switch 16 in FIG. 3 is automatically armed by the dealer's entry of the player's choice. Upon the locomotive crossing each square 13 , that square 13 is highlighted. 7) Upon the bonus round player pressing the plunger, an accompanying sound effect, e.g. train brakes applied, is presented to signal the plunger 15 application. The train concurrently begins to decelerate, and the “odds” values associated with each square 13 (corresponding to current highlighted square 13 beneath the train location) immediately is shown in the center of the game board 18 and designated as, “Title Deeds”. After at least one-half but not more than one and one-half revolutions, the locomotive randomly comes to rest on, the MONOPOLY® game; a specific property in a particular square 13 and that position of rest is purely a chance event. This property of that square 13 is announced and that determines the outcome of the bonus round of the MONOPOLY® game. 8) Should the locomotive have come to rest on a standard (non-Go To Jail, non-Jail) property, the Mr. MONOPOLY® icon announces the property. The player is paid appropriate odds associated with the square 13 for the property landed upon. Return to step #1. 9) If the locomotive came to rest on the squares 13 labeled “Chance” or “Community Chest”, the Mr. MONOPOLY® icon announces the square 13 . Additional animation then depicts appropriate cards shuffling and top-card is revealed (e.g., “2 nd Prize in Beauty Contest”) and the Mr. MONOPOLY® icon then announces the event. Player is paid appropriate odds according to that randomly selected event. Return to step #1. 10) Should the locomotive have come to rest on the square 13 marked, “Go To Jail” or “Jail”, animation is depicted of a jail cell closing on the Mr. MONOPOLY® icon, while stating, “Good Samaritan bonus! Pay all other MONOPOLY® Blackjack players 7 to 1 odds!” Return to step #1. Associated odds for squares 13 , shown schematically in FIG. 3, have in a preferred embodiment the values attainable during play of board 12 for pay off to the player: Go 75 to 1 Purple 1 1 to 1 CC 42 to 1 Purple 2 14 to 1 Income Tax 15 to 1 Azure 1 14 to 1 Chance 42 to 1 Azure 2 14 to 1 Azure 3 15 to In Jail Zero Note, the Good Samaritans' or betting bystanders' Bonus of 7 to 1 is paid on all other bettors' wagers. Magenta 1 18 to 1 Magenta 2 18 to 1 Electric Co. 12 to 1 Magenta 3 20 to 1 RR2 2 5 to 1 Orange 1 25 to 1 Orange 2 25 to 1 CC 42 to 1 Orange 3 30 to 1 Free Parking 50 to 1 Red 1 35 to 1 Chance 42 to 1 Red 2 35 to 1 Red 3 40 to 1 RR 3 25 to 1 Yellow 1 45 to 1 Yellow 2 45 to 1 Water Works 12 to 1 Yellow 3 50 to 1 Go to Jail Zero Note, the Good Samaritans' or betting bystanders' Bonus of 7 to 1 is paid for all other side bettors' wagers Green 1 75 to 1 Green 2 75 to 1 CC 42 to 1 Green 3 100 to 1 RR4 25 to 1 Chance 42 to 1 Blue 1 150 to 1 Luxury Tax 15 to 1 Blue 2 200 to 1 The list of chance events determined randomly appear in the middle 18 of the board 12 by simulated draw of a card from a deck: Tax Refund Arrives 20 to 1 Favorite Roulette # Pays Off 35 to 1 2 nd Prize Beauty Contest 40 to 1 1 st Place Blackjack Tourney 50 to 1 Stock Market Boom 65 to 1 List of community chest events and is shown in the middle 18 of the board 12 by simulation: Slot Machine Jackpot 20 to 1 Visit Las Vegas 25 to 1 X-Mas Fund Matures 40 to 1 Bank Error in Your Favor 50 to 1 Lottery Winner 75 to 1 With the rules and conditions as given previously, the house advantage is a function of how many other side wagers are made concurrently. This is due to the “Good Samaritan” or “bystanders' bonus” feature, which all players receive when someone lands in jail. For a table 10 in which all positions wager on the base game, each individual side wager has a house advantage of 7.38%. For a table 10 with only a player wagering on the base game and side wager, the house advantage is 12.78%. All other cases fall in between these bounds. It is an advantage of this invention that as the number of players increases, the house advantage per player decreases. The invention thus has a stabilizing effect on overall revenue. Hardware Description In FIGS. 1 and 3 a 17″ or 18″ LCD flat-screen full-color panel is shown for board 12 mounted on the card table 10 and is visible to all players and dealer. Remote radio frequency switch 16 is accessible to the player in the shape of the small plunger 15 with a thematic “top hat” shell, see FIG. 1 . Dealer control pad 14 is used to control the play of the bonus game after arming the remote radio frequency switch 16 . Associated computer hardware 19 in FIG. 3 connected to the remote radio frequency switch 16 and the control pad 14 for game functionality is shown schematically and can be positioned remotely. While the preferred embodiment includes a MONOPOLY® bonus game 10 , those skilled artisans will appreciate that the side betting bystander's bonus can be included in any form of random selection bonus game. Blackjack as a base game is shown and described as the preferred embodiment. That is not to say that other table card games such as Caribbean Stud® poker, Let It Ride card game, Pai Gow poker, etc. could not be adapted to this invention by one skilled in the art. Also non-side-betting bystanders are afforded a chance to win in the preferred embodiment but that is not essential. An alternate game might require a side bet to participate in the bonus. The bonuses are fixed amounts in the example but one or more could be linked to a progressive jackpot. Note also that while the foregoing has been presented in terms of an optional side wager, the invention can also be utilized as a primary wager. In this case, all other players wagering simultaneously may be considered the “side wagering bystander players.” In particular, the novel feature of paying others when the qualifying hand player loses can still be used in the embodiment wherein the invention is a primary wager. In the claims that follow the term, “payment” is credits or money as this is a casino game and may results from a win of fixed odds or a jackpot including a progressive.

A method and equipment for playing a base and bonus games with side betting. A video board is used for bonus play if a predetermined arrangement of cards results in the base game. Side wagers allow bettors to win of the bonus with random selection. If a player gets the predetermined arrangement then chooses a sure win or playing an additional game. By chance that player can win a multiple of the side wager or may win nothing while other players win instead. Blackjack played with money, gaming chips, and/or credits pit players against a dealer at a table whereat cards are dealt and awards to one or more players are given for resolution of the bonus. Methods include each player placing a main eager to play, and a side wager optionally to play the bonus game.

TECHNICAL FIELD This application relates in general to light emitting polymer displays, and in specific to light emitting polymers used as wearable displays. BACKGROUND Prior art attempts at providing surface areas with patterns, decorations, colors, advertisements, information, and the like onto all manner of surfaces have been generally confined to printing (paint, transfer process, etc.) or integration (weaving and/or coloring raw batches of composite materials, etc.). In accordance with these methodologies, the prior art teaches the marking, coloring, or printing of walls, fabrics, plastics, metals, infrastructures, and other manners of manufactured items. However, all of the above prior art methodologies are subject to the same inflexibility. Specifically, once a surface of any one of the multitude of disparate objects is prepared with colors, patterns, or markings, any changes required thereon may range from the impossible (such as in the case of fabrics, where color is dyed on or woven in), to the time consuming (such as repainting walls, metals, or transportation infrastructures, such as roadway markings, etc.) Accordingly, the prior art technology relating to the field of surface area marking has certain drawbacks. Recent attempts to overcome the particular disadvantages of the prior art, such as the ones described above, include a wide range of solutions, ranging from the use of light emitting diode (LED) screens on changeable surfaces (e.g., highway signs reflecting the updating of highway information) to items such as reversible jackets or velcro patches, which are offered as a remedy to the inflexibility of the coloring or marking of textiles or fabric. Nevertheless, such solutions provide at best only moderate flexibility with respect to the ability to change the surface colorings or markings, particularly with respect to non-paintable, flexible surfaces such as fabric. Moreover, the prior art teachings have yet to offer a solution which is widely applicable to all manner of surface changeability, including flexible surfaces like fabric. Therefore, there is a need in the art of surface area marking for a system that permits easy changeability of surface coloration or marking across the wide range of materials having markable surfaces. Furthermore, there is a particular need for such a solution to apply to surfaces which are flexible and not easily changeable, such as fabric. SUMMARY OF THE INVENTION These and other objects, features and technical advantages are achieved by a system and method by which light emitting polymers (LEPs) are applied to a variety of surfaces, both flexible and inflexible, in order to provide versatile, easily changeable surface markings and/or coloration. A system and method are disclosed which further provide for displaying both still and moving images (e.g., movies) on such surface. Additionally, other information received/generated by an application may be displayed on such surface. For example, a received e-mail or a desired map generated by a mapping application may be displayed on the surface. In a most preferred embodiment, the surface on which the LEPs are utilized to display a desired image/color/information is a fabric surface. For instance, in a most preferred embodiment, LEPs are implemented within an article of clothing that a user may wear. Specifically, LEPs are a class of polymers which exhibit electrical properties beyond the purely insulating characteristics of simple plastics and provide a light weight combined with physical strength, yet are able to offer structural flexibility in the areas of application/manufacture, as well as versatility in usage thereafter. More specifically, LEPs are conjugated polymers which may be molded, extruded woven, deposited (e.g., through electrochemical or spin coating means) or even may be printed on a surface, all while providing metallic and semiconductor characteristics. These characteristics stem from the very structure of the class of polymers which possess a delocalized pi-electron system along the polymer backbone such that the delocalized pi-electron system. This confers semiconducting properties to the polymer and gives it the ability to support positive and negative charge carriers. It is the nature of the characteristics described as such which offer materials fashioned thereof with many classical transistor-like properties. Accordingly, LEPs are generally suitable to application of a variety of surface areas in neo-transistor structural order. Application in certain structural order may be fashioned even on difficult surfaces, such as fabrics, which ideally would have flexible substrate surfaces, and are then spun coated from LEP material, into distinct layers. In a preferred embodiment, the composition of these layers would ideally be doped semiconducting conjugated polymers such as polyaniline and polypyrrole which lead to the presence of states in the band gap, and at sufficient dopant concentrations, permit the band gap to virtually disappear, thereby allowing the polymer to act as a metal with high conductivity. Although, any suitable composition now known or later developed may be implemented, and any such implementation is intended to be within the scope of the present invention. For instance, any suitable composition for a sufficiently flexible LEP display that may be implemented with fabric, such as an article of clothing, is intended to be within the scope of the present invention. By providing material composed of the LEP elements of a preferred embodiment, versatile, flexible fabrics are provided which would permit a user to change the color, pattern, or design of a garment, for example, constructed of such fabric. For instance, the mere touch of a control button may dictate transmission of coloration or markings in say, an array of transition-like modules, which, according to embedded code (as known in the art of video display coding) may implement, pixel by pixel, the resulting appearance throughout the specified areas in a garment. Structured as such, a preferred embodiment of the present invention contemplates provision of a given wearer of a LEP garment the ability to change the appearance of an article of clothing, such as a jacket. For example, in a preferred embodiment, a user may change a jacket from bearing the design of the New York Yankees to that of the logo of the New York Giants, or alternatively, to change the color, text, or other pattern on any given garment. Furthermore, in a preferred embodiment, the display on a garment need not be still images. For example, movies, videos, cartoons, “screen savers,” or any other type of moving images may be displayed on the fabric. Furthermore, provision of LEPs in such a manner extends well beyond garments. As examples, the contemplated provision of flexibly-backed LEP elements also provides for application to walls, signs, carpets, road surfaces, automobile surfaces (interior and/or exterior), airplane surfaces (interior and/or exterior), safety devices, message boards, etcetera. Of course, it will be recognized that flexibly-backed LEPs as disclosed herein may be utilized in an unlimited number of applications, and the scope of the present invention is intended to encompass all such applications. Such surfaces may simply be augmented by the covering of desired surfaces with the described flexibly-backed LEP material or may even be originally provided with the above-described LEP elements spin coated or otherwise deposited on a given manufactured surface area. For example, a surface may be implemented as a movie screen to display a movie, as opposed to a movie projector being utilized to project a movie onto the display surface. Thus, the requirement of expensive movie projector equipment for displaying movies may be eliminated. Accordingly, it is a technical advantage of the present invention to provide versatility and ease of LEPs for changing surface coloration and marking. It is a further technical advantage of the present invention to apply the advantages of LEPs to problematic surfaces such as fabric, such that a user would be able to increase the versatility and appearance of any given fabric, such as a garment. The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims. BRIEF DESCRIPTION OF THE DRAWING For a more complete understanding of the present invention, and the advantages thereof, reference is now made to the following descriptions taken on conjunction with the accompanying drawing, in which: FIG. 1 depicts a cross section of a preferred embodiment of LEP layers deposited on a flexible substrate; and FIG. 2 depicts a preferred embodiment garment fashioned from a fabric having a changeable surface area. DETAILED DESCRIPTION For ease of explanation, the below description focuses primarily on a preferred embodiment for implementing LEPs to accomplish a fabric (e.g., a wearable) display. However, the below description of a preferred embodiment is intended to render the disclosure enabling for many other applications of such LEPs (e.g., utilizing LEPs with any other type of flexible surface), which are intended to be within the scope of the present invention. It should also be understood that a preferred technique for implementing such an LEP is disclosed below to render the disclosure enabling and satisfy the best mode requirement, although other techniques that are now known or later developed may be utilized in implementing such an LEP on a flexible surface such as fabric, and any such implementation is intended to be within the scope of the present invention. The actual thickness of the LEP elements are principally determined by the particular embodiment required for appearance purposes. Thus, by way of example, in the case of an article of clothing or garment which has a changeable surface area for providing a video, map, or variable team logo display, an active matrix display of LEPs would be optimal. Such an embodiment would ideally be provided with a spin coating deposition of an approximately 1000 Å layer having hole mobilities of between 0.1 and 1 cm 2 V −1 s −1 with fields of 5 or 10 5 v/cm in order to achieve needed switching speeds. The preferred material will be PPV, which might have intrinsic conductivities on the order of 10 −12 (Ohm cm) −1 . More specifically, the use of polypyrrole and polyaniline is expressly contemplated for a preferred embodiment given their relatively superior stability. However, the particular use of one or the other is dependent on the processing for the given application. Generally, polypyrrole is not directly processable and is deposited in film form by electrochemical means, while polyaniline is generally made soluble through the use of soluble counter-ions that associate with the dopant ions on the polymer backbone, all of which provide conductivity levels between 10 −2 and 10 2 (Ohm cm) −1 . Turning attention to FIG. 1, shown is a cross section depiction of the layered deposition of LEP materials on a flexible substrate 34 of a preferred embodiment. As mentioned, the application of the contemplated conjugated polymers is structured in order to provide a configuration which utilizes transistor-type principles the novel medium of a flexible substrate coated with the particular advantages of the below-described non-metallic materials. In particular, a preferred embodiment of the present invention contemplates use of a heterostructure that allows carrier confinement at the polymer/polymer interface in order to increase the likelihood of electron/hole capture so as to form an exciton that can radiatively recombine. In a most preferred embodiment, the electron/hole injection barriers will be similar through the provision of an injection electrode material and through the modification of the polymer material to be electron withdrawing so as to provide for a higher or lower electron affinity. More specifically, a preferred embodiment provides for a cyano group which is electron withdrawing and is capable of pushing down the barrier to electron injection. Accordingly, cyanoPPV (CN-PPV) layer 28 therefore acts as an electron transport layer. Because the bandgap of the CN-PPV layer 28 is lower than the PPV layer 30 , recombination takes place in this layer thereby increasing efficiency at ranges of over 1%. Because heterostructures can be designed using polymer material and given that organic synthesis allows additional degrees of freedom in tuning bandgap and work function of semiconductors, the polymer materials of a preferred embodiment are capable of a performance level comparable with inorganic LEDs and further have the fast switching speeds typical of LEDs. LEPs further provide the added capabilities of large area patterning at low cost because the light emitting device can be patterned simply by pixellation of the metal (unlike inorganic LEDs which require a highly doped semiconductor layer for ohmic contact). Hence, large area pixilated displays made from one sheet are possible, with added features such as flexibility. Preferred embodiments include their use as backlights for instrumentation panels or for ultra-thin transflective LCDs fixed on flexible garments. However, in an especially preferred embodiment, the system will comprise the use of simple patterning, such as dot matrix alphanumeric displays. Specifically, the configuration of a preferred embodiment of an efficient light emitting structure on a flexible background for use on textiles and other manufactured items is as follows (with continued reference to FIG. 1 ): (1) flexible substrate layer 34 , which may be a plastic flexible layer (preferably a polymer) which allows passage of light 36 ; (2) a transparent electrode layer 32 ; (3) PPV layer 30 ; (4) CN-PPV layer 28 ; and (5) a bit size electrode 26 , which contains −ve contacts 22 , 24 which are opposed to +ve contact 20 located on transparent electrode 32 . Thusly provided for, a preferred embodiment of the present invention affords greater versatility in changing the coloration or marking of surface areas, while providing the versatility of a flexible substrate which permits the resulting array of LEP units to be draped or contoured to a multitude of surfaces as needed. Although the present invention also contemplates the use of the described array and structure in environments where flexibility is not required, a preferred embodiment, as depicted in FIG. 2, includes application as a fabric which may be fashioned into garments which will provide for the uses described herein. For example, an array of LEP units 14 may be provided on a jacket. As shown, the LEP display 14 may display a particular image, such as the New York Yankees logo. However, according to a preferred embodiment of the present invention, a user may change the display to a different color and/or different logo. For instance, a user may change the display 14 to a logo for the St. Louis Cardinals. As a further example, display 14 may provide “New York Yankees—World Champions 1998.” A user may alter the display 14 to read “New York Yankees—World Champions 1999.” Thus, a user may alter the display 14 to allow the jacket to be more versatile and to remain up to date with changing fashion and/or changing information. In a preferred embodiment, the jacket may include a power supply 10 (e.g., batteries, such as Ni—MH batteries), which may be integrated within the shoulder pad, for example, of a jacket. Of course, various power supplies may be implemented, and such power supplies may be arranged in any desirable manner for a particular application of a preferred embodiment. Additionally, in a preferred embodiment, a control system 12 (e.g., a computer) may be provided to allow a user to control display 14 . Control system 12 may vary with complexity, depending on the amount of control/versatility desired and the requirements for integrating such a control system within a particular application (e.g., the size requirements). For instance, a control system 12 may be integrated within a pocket of the jacket, so as to be inconspicuous. Control system 12 may include one or more buttons, which when activated may alter the display 14 . For example, depressing such a button(s) may scroll the display 14 through images/colors pre-stored within the control system 12 . Of course, control system 12 may, in various embodiments, include any amount of functionality for allowing a user to interact with such control system. For example, in some embodiments, a partial or full keyboard may be provided for control system 12 to allow a user to interact with the control system 12 (e.g., to edit/change a display 14 ). Additionally, the on-board control system 12 may include a connector that allows the control system 12 to be coupled to an off-board system (e.g., a PC), whereby a user may utilize such an off-board system to control display 14 . For example, a user may couple the control system 12 of a jacket to a PC (e.g., via a serial port or USB port) and then edit/change the display 14 , as desired, utilizing the PC's input devices (e.g., keyboard, mouse, etc.). Various applications may be executed by control system 12 to display information on a display 14 . For example, a mapping application may be executing to allow a map to be displayed on a wearable display 14 . For instance, a user may utilize a mapping application to map out the directions for a desired destination, and the directions may be displayed on display 14 to aid the user in navigating to the desired destination. In one embodiment, control system 12 may provide a mechanism (e.g., a button) which when activated displays the map (or other desired information) on display 14 , and the control system 12 may provide a further mechanism (e.g., the same or different button) which when activated displays another image on display 14 . Thus, the user may alternate display 14 between a New York Yankees logo, for example, and a map illustrating directions to a desired location. Thus, when the user arrives at the desired location, he may simply choose to have the New York Yankees logo displayed. As another example, a wrist band or other article of clothing may include a display 14 , and control system 12 may allow a user to store reference information to be displayed on display 14 . For instance, a quarterback of a football team may store various formations and plays within control system 12 and recall such information on the display 14 during a game. Alternatively, a user may store an outline and/or notes for a presentation, and the user may display such outline and/or notes for reference when giving the presentation. Of course a user may store various other reference information, including but not limited to shopping lists, to-do lists, or other information that may be displayed on display 14 . As a further application, in one embodiment control system 12 may allow a user to receive a message (e.g., an e-mail and/or page) via control system 12 and display the received message on display 14 . It should be understood that in a most preferred embodiment, LEPs are implemented on an article of clothing, including but not limited to shirts, ties, jackets, coats, pants, shorts, underwear, socks, shoes, dresses, blouses, skirts, gloves, scarfs, wrist bands, head bands, and hats/caps. However, it should be understood that a preferred embodiment may be implemented for any fabric, not just an article of clothing. As examples, fabric for furniture, carpet, rugs, drapes, curtains, towels, sheets, blankets, other linens, pillows, and/or other fabric commonly found in a room may be so implemented to allow for versatile interior designing. As yet a further example, handbags, purses, briefcases, luggage, golf bags, bowling ball bags, and gym bags may be implemented having LEPs. It should also be understood that a preferred embodiment of the present invention may be implemented using the technique described above, with reference to FIG. 1 . However, alternative embodiments may be implemented using any other now known or later discovered technique for implementing LEPs on a flexible surface (e.g., fabric), and the scope of the present invention is intended to encompass any such implementation. Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.

The present invention pertains to the provision of Light Emitting Polymer structure, which increases the versatility of the coloring and marking of surface areas of manufactured items, particularly fabric and garments.

GOVERNMENT RIGHTS NOTICE [0001] This invention was made with government support under grant No. R24EY12893-01, awarded by the National Institutes of Health. The government has certain rights in the invention. FIELD OF THE INVENTION [0002] The present invention is generally directed to neural stimulation and more specifically to an improved method of neural stimulation for improved persistence. BACKGROUND OF THE INVENTION [0003] In 1755 LeRoy passed the discharge of a Leyden jar through the orbit of a man who was blind from cataract and the patient saw “flames passing rapidly downwards.” Ever since, there has been a fascination with electrically elicited visual perception. The general concept of electrical stimulation of retinal cells to produce these flashes of light or phosphenes has been known for quite some time. Based on these general principles, some early attempts at devising a prosthesis for aiding the visually impaired have included attaching electrodes to the head or eyelids of patients. While some of these early attempts met with some limited success, these early prosthetic devices were large, bulky and could not produce adequate simulated vision to truly aid the visually impaired. [0004] In the early 1930's, Foerster investigated the effect of electrically stimulating the exposed occipital pole of one cerebral hemisphere. He found that, when a point at the extreme occipital pole was stimulated, the patient perceived a small spot of light directly in front and motionless (a phosphene). Subsequently, Brindley and Lewin (1968) thoroughly studied electrical stimulation of the human occipital (visual) cortex. By varying the stimulation parameters, these investigators described in detail the location of the phosphenes produced relative to the specific region of the occipital cortex stimulated. These experiments demonstrated: (1) the consistent shape and position of phosphenes; (2) that increased stimulation pulse duration made phosphenes brighter; and (3) that there was no detectable interaction between neighboring electrodes which were as close as 2.4 mm apart. [0005] As intraocular surgical techniques have advanced, it has become possible to apply stimulation on small groups and even on individual retinal cells to generate focused phosphenes through devices implanted within the eye itself. This has sparked renewed interest in developing methods and apparati to aid the visually impaired. Specifically, great effort has been expended in the area of intraocular retinal prosthesis devices in an effort to restore vision in cases where blindness is caused by photoreceptor degenerative retinal diseases such as retinitis pigmentosa and age related macular degeneration which affect millions of people worldwide. [0006] Neural tissue can be artificially stimulated and activated by prosthetic devices that pass pulses of electrical current through electrodes on such a device. The passage of current causes changes in electrical potentials across retinal neuronal cell membranes, which can initiate retinal neuronal action potentials, which are the means of information transfer in the nervous system. [0007] Based on this mechanism, it is possible to input information into the nervous system by coding the sensory information as a sequence of electrical pulses which are relayed to the nervous system via the prosthetic device. In this way, it is possible to provide artificial sensations including vision. [0008] Some forms of blindness involve selective loss of the light sensitive transducers of the retina. Other retinal neurons remain viable, however, and may be activated in the manner described above by placement of a prosthetic electrode device on the inner (toward the vitreous) retinal surface (epiretinal). This placement must be mechanically stable, minimize the distance between the device electrodes and the retinal neurons, and avoid undue compression of the retinal neurons. [0009] In 1986, Bullara (U.S. Pat. No. 4,573,481) patented an electrode assembly for surgical implantation on a nerve. The matrix was silicone with embedded iridium electrodes. The assembly fit around a nerve to stimulate it. [0010] Dawson and Radtke stimulated a cat's retina by direct electrical stimulation of the retinal ganglion cell layer. These experimenters placed nine and then fourteen electrodes upon the inner retinal layer (i.e., primarily the ganglion cell layer) of two cats. Their experiments suggested that electrical stimulation of the retina with 30 to 100 uA current resulted in visual cortical responses. These experiments were carried out with needle-shaped electrodes that penetrated the surface of the retina (see also U.S. Pat. No. 4,628,933 to Michelson). [0011] The Michelson '933 apparatus includes an array of photosensitive devices on its surface that are connected to a plurality of electrodes positioned on the opposite surface of the device to stimulate the retina. These electrodes are disposed to form an array similar to a “bed of nails” having conductors which impinge directly on the retina to stimulate the retinal cells. U.S. Pat. No. 4,837,049 to Byers describes spike electrodes for neural stimulation. Each spike electrode pierces neural tissue for better electrical contact. U.S. Pat. No. 5,215,088 to Norman describes an array of spike electrodes for cortical stimulation. Each spike pierces cortical tissue for better electrical contact. [0012] The art of implanting an intraocular prosthetic device to electrically stimulate the retina was advanced with the introduction of retinal tacks in retinal surgery. De Juan, et al. at Duke University Eye Center inserted retinal tacks into retinas in an effort to reattach retinas that had detached from the underlying choroid, which is the source of blood supply for the outer retina and thus the photoreceptors. See, e.g., E. de Juan, et al., 99 Am. J. Ophthalmol. 272 (1985). These retinal tacks have proved to be biocompatible and remain embedded in the retina, and choroid/sclera, effectively pinning the retina against the choroid and the posterior aspects of the globe. Retinal tacks are one way to attach a retinal electrode array to the retina. U.S. Pat. No. 5,109,844 to de Juan describes a flat electrode array placed against the retina for visual stimulation. U.S. Pat. No. 5,935,155 to Humayun describes a retinal prosthesis for use with the flat retinal array described in de Juan. [0013] It is known that neurons respond best to change in stimuli. The retina, if continuously stimulated in a consistent manner, will slowly become less and less sensitive to the stimulus. This causes the perception of a constant visual image to gradually disappear. Those with normal vision are unable to perceive this effect because the eye constantly moves, motions called jitter or microsaccades. A normal retina has a resolution of approximately four million light transducer cells (rods and cones), hence it requires a minute movement to change the light intensity cast upon a given light transducer. [0014] A retinal prosthesis, according to the present invention, has two disadvantages. First, the resolution of an electrode array applied to the retina, is significantly lower than the resolution of a healthy retina, requiring a greater movement to move an image from one electrode to the next electrode, as compared to one cone to the next cone. Further, a head mounted camera does not have the natural jitter or microsaccades of an eye. Therefore it is necessary to achieve the required change in another manner. [0015] It is also known that some neural processing is done within the retina. Hence, a continuously stimulated cone will not result in a continuous signal to the brain. Ganglion and bipolar cells pass along this change in information more readily than constant information. In a diseased retina, rods and cone can not be stimulated, since they are dead. Electrically stimulating cells further along the neural pathway, bypasses some of the neural processing. This processing must be simulated electronically to gain normal brain stimulation. [0016] The ability to perceive a constant image or image persistence is necessary to the design of a visual prosthesis. SUMMARY OF THE INVENTION [0017] The present invention is a method of improving the persistence of electrical neural stimulation, and specifically a method of improving the persistence of an image supplied to the retina, or visual cortex, through a visual prosthesis. A continuously stimulated retina, or other neural tissue, will adapt or desensitize after a time period in the range of 20 to 150 seconds. However, an interruption of the stimulation on the order of a few milliseconds will restore the retinal sensitivity without the user perceiving the interruption, or with the user barely perceiving the interruption. [0018] The novel features of the invention are set forth with particularity in the appended claims. The invention will be best understood from the following description when read in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0019] FIG. 1 is a perspective view of the implanted portion of the preferred retinal prosthesis. [0020] FIG. 2 is a side view of the implanted portion of the preferred retinal prosthesis showing the fan tail in more detail. [0021] FIG. 3 depicts a flow chart showing the processing in the preferred embodiment. [0022] FIG. 4 depicts a typical perceptual pattern for a single electrode. [0023] FIG. 5 depicts a stimulation waveform train including interruption. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0024] The following description is of the best mode presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention. The scope of the invention should be determined with reference to the claims. [0025] FIG. 1 shows a perspective view of the implanted portion of the preferred retinal prosthesis. An electrode array 10 is mounted by a retinal tack or similar means to the epiretinal surface. The electrode array 10 is electrically coupled by a cable 12 which pierces the sclera and is electrically coupled to an electronics package 14 , external to the sclera. [0026] The electronics package 14 is electrically coupled to a secondary inductive coil 16 . Preferably the secondary inductive coil 16 is made from wound wire. Alternatively, the secondary inductive coil may be made from a thin film polymer sandwich with wire traces deposited between layers of thin film polymer. The electronics package 14 and secondary inductive coil 16 are held together by a molded body 18 . The molded body 18 may also include suture tabs 20 . The molded body narrows to form a strap 22 which surrounds the sclera and holds the molded body 18 , secondary inductive coil 16 , and electronics package 14 in place. The molded body 18 , suture tabs 20 and strap 22 are preferably an integrated unit made of silicone elastomer. Silicone elastomer can be formed in a pre-curved shape to match the curvature of a typical sclera. However, silicone remains flexible enough to accommodate implantation and to adapt to variations in the curvature of an individual sclera. The secondary inductive coil 16 and molded body 18 are preferably oval shaped. A strap can better support an oval shaped coil. [0027] It should be noted that the entire implant is attached to and supported by the sclera. An eye moves constantly. The eye moves to scan a scene and also has a jitter motion to improve acuity. Even though such motion is useless in the blind, it often continues long after a person has lost their sight. It is an advantage of the present design, that the entire implanted portion of the prosthesis is attached to and supported by the sclera. By placing the device under the rectus muscles with the electronics package in an area of fatty issue between the rectus muscles, eye motion does not cause any flexing which might fatigue, and eventually damage, the device. [0028] FIG. 2 shows a side view of the implanted portion of the retinal prosthesis, in particular, emphasizing the fan tail 24 . When implanting the retinal prosthesis, it is necessary to pass the strap 22 under the eye muscles to surround the sclera. The secondary inductive coil 16 and molded body 18 must also follow the strap under the lateral rectus muscle on the side of the sclera. The implanted portion of the retinal prosthesis is very delicate. It is easy to tear the molded body 18 or break wires in the secondary inductive coil 16 . In order to allow the molded body 18 to slide smoothly under the lateral rectus muscle, the molded body is shaped in the form of a fan tail 24 on the end opposite the electronics package 14 . [0029] FIG. 3 is a flow chart showing the basic operation of the periodic interruption scheme. The process must cycle through each electrode so that each electrode is interrupted, but not all electrodes are interrupted simultaneously. Hence the system begins with an initialization loop storing the current time in an array of values for each electrode. Time must be tracked for each electrode independently, so the array of time values, time(N) stores time values for each electrode. The electrode counter N is set to zero 29 . The current time (time) is loaded into the array at time(N) 30 , and N is incremented 31 . As long as N is less than the total number of electrodes, X the loop repeats 32 . The electrode counter, N is set to zero again in step 33 . Next the system tests for data on electrode N. If no data, or sub-threshold data, causes electrode N to cease stimulation 34 , there is no need to interrupt, and the current time is reset in time(N) 35 , and N is incremented to address the next electrode 38 . Interruption in the data occurs naturally on a regular basis such as scanning across a dark corner in a room. In the total number of electrodes (X) has not been exceeded 39 , the process continues on the next electrode 34 . If the total number has been exceeded, 39 the electrode counter is reset 33 . If there is data, an interruption may be needed. In the preferred embodiment, the longest continuous stimulation is three seconds. Step 34 compares the current time with the stored time(N) plus three seconds. If three seconds have not elapsed, N is incremented in step 38 and the system checks for data on the next electrode 34 . [0030] When an electrode has stimulated continuously for more than 3 seconds 36 , time(N) is reset and stimulation for that electrode is interrupted 42 . 33 milliseconds are counted out 44 and stimulation resumes 46 . This process continues until each electrode has been interrupted 50 . The system compares N to X, the total number of electrodes and once all electrodes have been interrupted, at which point N is reset to zero in step 30 . [0031] While a simple raster pattern is the simplest method of selecting electrodes it does not achieve the best response. It is preferable to not interrupt adjacent electrodes near the same time. A pattern that jumps around the electrode array will achieve a better result. Ideally, a pseudorandom generator constantly varies the interruption pattern. This, however, requires a lot of processing power. Establishing a pseudorandom pattern in advance and repeating the pattern will achieve good results and require less processing power. [0032] Depending on the time values selected (interruption time and time between interruptions) and the total number of electrodes, it may be necessary to interrupt more than one electrode at a time. In the preferred embodiment, there is a thee second stimulation period and a thirty three millisecond interruption period, or a ratio of about one hundred to one. Hence, nearly one hundred electrodes can be interrupted sequentially within a stimulation period, with a small allowance for processing time. If the array has more than one hundred electrodes, more than one electrode will need to be interrupted simultaneously. However, the smallest number of electrodes interrupted simultaneously will result in the least likelihood of the user noticing the interruption. If more than one electrode is to be interrupted at a time, it would be advantageous to organize the electrodes by zone, interrupting only one electrode at a time in each zone, thus reducing the likelihood that adjacent electrodes will be interrupted simultaneously. [0033] Referring to FIG. 4 , a typical perceptual response to a constant stimulus begins to decay immediately. A stimulus creates a percept 50 that gradually decays 52 until the precept disappears, 54 . An interruption of the stimulus, 56 brings the precept back to a full response 58 and decay begins again. Hence, the more often stimulation is interrupted, the more natural the perceived response will be. However, the more often stimulation is interrupted, the more likely a user is to notice the interruption. This is especially true if multiple electrodes are interrupted at the same time. Since, each individual's ability to perceive the interruptions varies, as well as each individual's persistence response decay varies, it is advantageous to have both periods, stimulation and interruption, programmable to achieve optimal performance. It may even be advantageous to have these values programmable on an electrode by electrode basis if there is sufficient processing power to support such a scheme. [0034] The persistence, or decay parameter, is dependent on the individual neural response and by the frequency of stimulation. Generally, higher frequency stimulation generates longer persistence, and greater effect from a given interruption period. Hence, it is highly advantageous to have the stimulation period and interruption period programmable on an individual basis. [0035] While a complete interruption is ideal for resetting the neural response, there are possible alternate embodiments. Any significant change in neural stimulation will tend to reset the neural response. A reduction in signal below threshold will reset the neural response, although a longer time period is required to obtain the desired result. Even a sudden spike in the signal will reset the neural response in some cases. [0036] FIG. 5 depicts a typical pulse sequence stimulation pattern according to the preferred embodiment. The retina is stimulated by biphasic square wave pulses. In the example, a sixty hertz signal with a 33 millisecond interruption is shown. The signal includes cathodic phases 60 and anodic phases 62 , with a brief inter-phase interruption 64 between each phases and each pulse, creating a signal envelope 66 . The 3 millisecond interruption 68 is an interruption of the signal envelope 66 , and should not be confused with the inter-phase interruption 64 . [0037] Accordingly, what has been shown is an improved method of making a neural prosthesis and improved method of stimulating neural tissue. While the invention has been described by means of specific embodiments and applications thereof, it is understood that numerous modifications and variations could be made thereto by those skilled in the art without departing from the spirit and scope of the invention. In particular, the preferred embodiment describes a retinal prosthesis for artificial vision. It should be obvious to one skilled in the art that the invention has broad applicability to other types of neural stimulation. It is therefore to be understood that within the scope of the claims, the invention may be practiced otherwise than as specifically described herein.

The present invention is a method of improving the persistence of electrical neural stimulation, and specifically a method of improving the persistence of an image supplied to a retina, or visual cortex, through a visual prosthesis. A continuously stimulated retina, or other neural tissue, will desensitize after a time period in the range of 20 to 150 seconds. However, an interruption of the stimulation on the order of a few milliseconds will restore the retinal sensitivity without the user perceiving the interruption, or with the user barely perceiving the interruption.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to new sialic acid derivatives and more specifically to sialic acid derivatives having active ester groups in the molecules, biochemical half life extenders of biologically active substances, sialic acid derivatives bonding these sialic acid derivatives with amino compounds, and intermediate compounds used for synthesis of the sialic acid derivatives. 2. Related Art Statement Neuraminic acid derivatives including N-acetylneuraminic acid, that is, sialic acid derivatives, are known to exist widely in the animal world or on the cell surface of several bacteria such as sialo complexes, more specifically, glycoproteins, glycolipids, oligosaccharides, and polysaccharides. The above-mentioned sialic acid derivatives are compounds which have recently become highly valuable in medical and pharmaceutical fields, in the treatment of nervous functions, cancer, inflammation, immunity, virus infection, differentiation, and hormone receptor, and are attractng keen attention as particularly active molecules located on the cell surface. Various theories have been set forth about the role played by sialic acid derivatives in the aforementioned sialo complex, but there are many things that have not yet been clarified, and are still a matter of conjecture. The inventors have studied sialic acid derivatives for many years and succeeded in synthesizing sialic acid derivatives which exhibit conspicuous biological activity (Japanese Patent Application No.62-295641). Recently, the inventors discovered a new sialic acid derivative that exhibits conspicuous biological activity and in the subject matter of this invention. SUMMARY OF THE INVENTION Therefore, an object of the present invention is to provide a new sialic acid derivative which exhibits high reactivity with various amino compounds. Another object of the present invention is to provide biological half-life extenders of various biologically active substances using the said sialic acid derivative. Still another object of the present invention is to provide a new sialic acid derivative which bonds the said sialic acid derivative to various amino compounds including amino acids and amines through amide bonding. A further object of the present invention is to provide a new sialic acid derivative which is useful as the intermediate for synthesis of the inventive sialic acid derivative. The above and other objects, features, and advantages of the present invention will become more apparent from the following detailed description and embodiments. The sialic acid derivative of the present invention has active ester groups expressed by the formula [I]. ##STR2## where R 1 denotes hydrogen or an acetyl group, R 2 denote hydrogen or a lower alkyl group, R 3 C 2 H 4 , C 3 H 6 or C 2 H 2 , R 4 denotes an hydroxyl group, the residue left after removing hydrogen from the alcohol portion of an active ester or alkyloxycarbonyloxy group, Ac denotes an acetyl group, Ph denotes a phenyl group, and X denotes oxygen or sulfur. In the said sialic acid derivative, the residue R 4 left after removing hydrogen from the alcohol portion of the active ester includes N-hydroxysuccinimide, N-hydroxy-5-norbornene-2, 3-dicarboximide, N-hydroxyphthalimide, N-hydroxybenzotriazole, p-nitrophenol, 2, 4-dinitrophenol, 2, 4, 5trichlorophenol, or pentachlorophenol. r The alkyloxycarbonyloxy group (R 4 ) is introduced by allowing carboxylic acid to react with alkyl or aryl halogenoformates in the presence of bases, wherein the alkyl group includes methyl group, ethyl group, n butyl group, isobutyl group, and the aryl group includes the phenyl group, and benzyl group. The sialic acid derivative containing the ester group is prepared by the following method using N-acetyl neuraminic acid having the following formula as starting material. ##STR3## where Ac denotes a acetyl group. The same applies to the following. At first, the methyl ester substance is produced at a high yield by letting N-acetylneuraminic acid react with methanol in the presence of an ion-exchange resin Dowex 50 w (H + ). Then, the methyl-ester compound is allowed to react with excess acetyl chloride (CH 3 COCl), then with ethanol while cooling, to give the chlor substance at a high yield. Then, this chlor substance is allowed to react with anhydrous sodium salt of p nitrophenol in the anhydrous dimethylformamide to give p-nitrophenylglycoside at a high yield. The p-nitrophenylglycoside is a known compound described in "Carbohydrate Research, 162 (1987) 294-297" and details of the synthesis method will be discussed in Embodiment 1 herein. The chlor substance is allowed to react with anhydrous sodium salt of p-nitrothiophenol in the anhydrous dimethylformamide to give p-nitrophenylthioglycoside (Embodiment 2). Then, to the aforementioned p-nitrophenylglycoside, hydrogen is added in the presence of 5% Pd/C in the methanol to give p-aminophenylglycoside (Embodiment 3). Adding hydrogen to the p-nitrophenylthioglycoside in the presence of 5% Pd/C in methanol expedites the reductive alkylation reaction and N, N'-dimethylaminophenyl-thioglycoside is obtained (Embodiment 4). On the other hand, adding hydrogen to the p-nitrophenylthioglycoside in the acetic acid in the presence of 5% Pd/C give p-aminophenylthioglycoside (Embodiment 5). Next, the said p-aminophenylglycoside is allowed to react with slightly excess succinic anhydride in anhydrous tetrahydrofuran to give an amido-carboxylic acid compound (Embodiment 6). The p-aminophenylthioglycoside is allowed to react with slightly excess succinic anhydride in anhydrous tetrahydrofuran to give an amido carboxylic acid compound (Embodiment 8). Alternatively, the above mentioned p-aminophenylglycoside is allowed to react with maleic anhydride in anhydrous tetrahydrofuran to give an unsaturated amido carboxylic acid compound (Embodiment 7). Next, the amido carboxylic acid compound is allowed to react with sodium methoxide in anhydrous methanol, and is then neutralized by Dowex 50 w (H + ) to give deacetylated substance (Embodiment 9). Because the sialic acid derivatives of this invention shown by the aforementioned formula [I] contain the active ester group, they exhibit high reactivity to other compounds containing functional groups that can react with ester groups, such as amino compounds. The sialic acid derivative of this invention containing active ester groups is an extremely useful compound as a raw material or intermediate to synthesize various sialic acid derivatives. Another sialic acid derivative of this invention has the formula [II] as follows: ##STR4## where R 1 is hydrogen or an acetyl group, R 2 hydrogen or a lower alkyl group, R 3 is selected from C 2 H 4 , C 3 H 6 or C 2 H 2 , Ac is a acetyl group, m is 1-60, Ph phenyl group, X is oxygen or sulfur, and Y is the residue left from removing m number of amino groups from amino compounds. The amino compounds include amine of lower class and amino acids. The sialic acid derivative can be prepared from amino compounds and sialic acid derivatives containing the aforementioned active ester group by the use of the active ester process and the mixed acid anhydride process. The active ester process produces N-oxysuccinimide ester mixing the amido-carboxylic acid compound with DSC (N, N'-disuccinimidyl carbonate) in anhydrous acetonitrile (Embodiment 10). In this reaction, adding anhydrous pyridine at more than an equivalent mole ratio causes the N-oxysuccinimide ester to transfer to the p-succinimidophenylglycoside of intramolecular ring closure (Embodiment 11). The amido carboxylic acid compound is allowed to react in anhydrous tetrahydrofuran in the presence of WSC (1 ethyl-3-(3-dimethylaminopropyl)-carbodiimide) the condensing agent to give the p-nitrophenyl ester (Embodiment 12). The said ester is not isolated and is allowed to react by adding amino acid methyl ester in the solution to give an amide, the sialic acid derivative of this invention (Embodiment 13-1). Alternatively, in the mixed acid anhydride process, the amido-carboxylic compound is allowed to react with isobutylchloroformate in anhydrous tetrahydrofuran to give a mixed acid anhydride, Then, the mixed acid anhydride is allowed to react with amino acid methyl ester to give the amide of this invention (Embodiment 13-2). Incidentally, the use of this mixed acid anhydride process can produce the amide from the deacetyl of the amido carboxylic acid compounds under similar reaction conditions (Embodiment 15). For other processes, there is a method to produce a peracetylated substance by allowing the amide to react with acetic anhydride in anhydrous pyridine (Embodiment 13-3). As reaction species other than the amino acid ester, hydrazine is allowed to react with the N-hydroxysuccinimide ester isolated or in solution in anhydrous acetonitrile to give an acid hydrazide (Embodiment 14). The sialic acid derivatives of this invention having the aforementioned formula [II] are compounds consisting of sialic acid derivatives represented by the aforementioned formula [I] and amino compounds. For example, when an amino acid is administered to animals or human bodies as nutrient, or when insulin, growth hormone, interferon, and immunogen are administered as medicine, it is predicted that administration of these medicines as the sialic acid derivative of formula [II] will prevent or delay biological reactions of a biologically active substance by the presence of sialic acid. This will produce the beneficial effects of increasing the durability of biologically active substances in the body or displaying desired medicinal effects with a small amount of administration. The sialic acid derivative represented by the said formula [I] is an extremely useful compound as an extender of the biological half-life of various biologically active substances. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In the examples, embodiments of the sialic acid derivative according to the present invention will now be described in detail. However, the present invention is not limited by these embodiments. [Embodiment 1] Synthesis of methyl (4-nitrophenyl 5-acetamido 4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero D galacto-2-nonulopyranosido)onate (1) N-acetylneuraminic acid was allowed to react in methanol in the presence of Dowex 50 w (H + ) at the room temperature for six hours to give methyl ester substance (yield=80%). ##STR5## (2) After the methyl ester was allowed to react with excess acetyl chloride for one day, ethanol was added with cooling (-30 ° C.), and it was allowed to stand for 10 days to give the following chlor substance (yield=83%). ##STR6## (3) 10.26 g of the anhydrous sodium salt of p-nitrophenol and 6.0 g of the chlor substance obtained in Step 2 (methyl 5-acetamide 4, 7, 8, 9-tetra-O-acetyl-2 chloro-3,5 dideoxy-α-D-glycero-D-galacto-nonulopyranosonate) were dissolved in 120 ml of anhydrous dimethylformamide, and were allowed to react with stirring for 24 hours under moisture-proof conditions. Then, the solvent was removed from the solution under reduced pressure, xylene was added, and solvent was repeatedly removed. Ethyl acetate was added to the residue obtained and stirred, and the residue was extracted thoroughly with ethyl acetate. The solvent was removed from the extract liquid and the residue was purified with silica gel column chromatography (Wakogel C-300). At first, p-nitrophenol was eluted from the residue with ether, and after removal, it was eluted with ethyl acetate to give a fractional solution containing the object. The solvent was removed from the fractional solution and an oily substance (crude yield point=6.87 g, crude yield=95.4%, melting point=95°-98 ° C.) was obtained. TLC: Rf=0.41 (Kieselgel 60 F 254 , Merck product, acetate) Rf=0.44 (Kieselgel 60 F 254 , Merck product, CHCl 3 MeOH=20/1) ##STR7## Reference (1) In Volker Eschenfelder and Reinhard Brossmer, Carbohydrate Research 162 (1987) 294-297, the aforementioned synthesis method is described, but the yield is as poor as 57% (melting point=104°-108° (dec.) (ether/hexane). Physical Properties of the product 1 H-N (CDCl 3 , TMS) 1 932 (3H, s, --NHCOCH 3 ), 2.055;2.061;2.119;2.193 (all 3H, all s, --OCOCH 3 X 4), 2.304 (1H, t, J=12.8 Hz, H 3ax ), 2.744 (1H, dd, J=13.2 Hz, 4.8 Hz, H 3eq ), 3.663 (3H, s, 2'COOCH 3 ), 4.986 (1H, ddd, J=12.1, 10.3, 4.8 Hz, H-4), 7.153 (2H, d, J=9.2 Hz, phenyl-H) 8.189 (2H, d, J=9.2 Hz, phenyl-H). IRνKBr/maxcm -1 : 1740, 1660, 1520, 1340, 1220, Embodiment 2 Synthesis of methyl (4-nitrophenyl 5-acetamido-4, 7, 8, 9 tetra-O-acetyl-2, 3, 5-trideoxy-2-thio-α-D-glycero-D-galacto-2-nonulopyranosido)onate: The anhydrous sodium salt of p-nitrothiophenol was prepared from 19.6 ml of methanol solution of 1.67 g of p-nitrothiophenol, 0.5 mol of sodium methoxide, and 1.0 g of the chlor substance obtained in Embodiment 1 (2) (methyl 5-acetamide-4, 7, 8, 9 tetra-O-acetyl-2-chloro-3, 5-dideoxy-β-D-glycero-D-galacto-1-nonulopyranosonate) was dissolved in 15 ml of anhydrous dimethylformamide and allowed to react with stirring for 6 hours at room temperature under moisture-proof conditions and a nitrogen atmosphere. Then, after solvent was removed under reduced pressure, xylene was added and solvent was repeatedly removed. The residue obtained was purified with silica gel column chromatography (Wakogel C-300, ethyl acetate) twice and solvent was again removed from the fractional solution, and finally 0.52 g white powder was obtained (yield=42.4%, melting point=94°-96° C.). TLC: Rf=0.44 (Kieselgel 60 F 254 , Merck product, ethyl acetate) ##STR8## Physical properties of the product C 26 H 32 O 14 N 2 S FAB-MS m/z : 629 (M + +1) 1 H-NMR ppm/500 MHz (CDCl 3 , TMS) 1.891 (3H, s, --NHCOCH 3 ), 2.041;2.061;2.063;2.165 (all 3H, all s,--OCOCH 3 X 4), 2.869 (1H, dd, J=12.8, 4.8 Hz, H 3eq ), 3.611 (3H, s, 2-COOCH 3 ), 4.883 (1H, ddd, J=12.1, 10.3, 4.8 Hz, H-4), 7.655 (2H, d, J=8.8 Hz, phenyl-H), 8.192 (2H, d, J=8.8 Hz, phenyl-H). IRνKBr/max cm -1 : 3250, 1750, 1650, 1550, 1520, 1350, Embodiment 3 Synthesis of methyl (4-aminophenyl 5 acetamido 4, 7, 8, 9-tetra-0-acetyl-3, 5-dideoxy-α-D-glycero-D galacto-2-nonulopyranosido)onate: V 6 87 g of methyl (4-nitrophenyl 5-acetamido-4,7,8, 9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosido)onate) obtained in the aforementioned Embodiment 1 (3) were dissolved in 50 ml of methanol. After a slight amount of 5% palladium/carbon was added with a spatula, it was reduced with hydrogen with stirring at room temperature. Then after allowing reaction to proceed for 2 days, the reagents were removed by filtering. Solvent was removed from the filtrate and 4.91 g of an oily substance (yield=71.63%) was obtained. It was further purified by the use of silica gel column chromatography (Wakogel C-300, CHCl 3 /MeOH=40/1) and white powdery crystals (melting point: 95°-99 ° C.) was obtained as TLC one spot purified product as shown below. TLC: Rf=0.29 (Kieselgel 60 F 254 , Merck product, ethyl acetate) Rf=0.35 (Kieselgel 60 F 254 , Merck product, CHCl 13 /MeOH=20/1) ##STR9## Physical properties of the product C 26 H 34 O 13 N 2 FAB-MS m/z : 583 (M + +1) 1 H-NMR pp/m500 MHz (CDCl 3 , TMS) 1.896 (3H, s, --NHCOCH 3 ), 2.028;2.055;2.115;2.139 (all 3H, all s,--OCOCH 3 X 4), 2.676 (1H, dd, J=12.8, 4.8 Hz, H 3 eq), 3.671 (3H, s, 2-COOCH 3 ), 4.936 (1H, J=12.1, 10.3, 4.8 Hz, H-4), 6.569 (2H, d, J=8.8 Hz, phenyl-H), 6.886 (2H, d, J=8.8 Hz, phenyl-H). IRνKBr/max cm -1 : 3450, 3370, 1740, 1660, 1540, Embodiment 4 Synthesis of methyl (4-dimethylaminophenyl 5-acetamido-4, 7, 8, 9-tetra-O-acetyl-2, 3, 5-trideoxy-2-thio-α-D-glycero-D-galacto-2-nonulopyranosido)onate: 0.25 g of [methyl (4-nitrophenyl 5 acetamido-4, 7, 8, 9-tetra-0-acetyl-2, 3, 5-trideoxy-2-thio-α-D glycero-D galacto-2-nonulopyranoside)onate) obtained in the aforementioned Embodiment 2 were dissolved in 10 ml of methanol. After a slight amount of 5% palladium/carbon was added with a spatula, it was reduced with hydrogen with stirring at room temperature for one day. Then reagents were removed by filtering. The solvent was removed from the filtrate and the residue was purified with silica gel column chromatography (Wakogel C-300, CHCl 3 /MeOH=40/1). Solvent was removed from the fractional solution containing the product and 100 mg of white powdery crystals were obtained (yield=40%, melting point=83°-85 ° C.). TLC: Rf=0.50 (Kieselgel 60 F 254 , Merck product, chloroform/methanol=20/1) ##STR10## Physical properties of the product C 28 H 38 O 12 N 2 S FAB-MS m/z : 627 (M + +1) 1 H-NMR ppm/500 MHz (CDCl 3 , TMS) 1.853 (3H, s, --NHCOCH 3 ), 1.970 (1H, t, J=12.8 Hz, H 3ax ), 2.011;2.054;2.133 (3H;6H;3H, all s, --OCOCH 3 X 4), 2.742 (1H, dd, J=12.8, 4.8 Hz, H 3eq ), 2.987 (6H, s, ##STR11## 3.636 (3H, s, 2 COOCH 3 ), 4.829 (1H, ddd, J=11.7, 10.3, 4.8 Hz, H-4), 6.614 (2H, d, J=8.8 Hz, phenyl-H), 7.330 (2H, d, J=8.8 Hz, phenyl-H). IRνKBr/max cm -1 : 3360, 1740, Embodiment 5 Synthesis of methyl (4-aminophenyl 5 acetamido-4, 7, 8, 9-tetra-0-acetyl-2, 3, 5-trideoxy-2-thio-α-D-glycero D galacto-2-nonulopyranosido)onate: 0.10 g of methyl (4-nitrophenyl 5-acetamido-4, 7, 8, 9-tetra-0-acetyl-2, 3, 5-trideoxy-2 thio-α-D-glycero-D galacto-2-nonulopyranosido)onate) obtained in the aforementioned Embodiment 2 were dissolved in 5 ml of acetic acid. After a slight amount of 5% palladium/carbon was added with a spatula, it was reduced with hydrogen with stirring at room temperature. Then reagents were removed by filtering. Solvent was removed from the filtrate and the residue was purified with silica gel column chromatography (Wakogel C-300, CHCl 3/ MeOH=40/1). Therein, the solution of the residue was neutralized with triethylamine, then developed. Solvent was removed from the fractional solvent containing the product and 67 mg of white powdery crystals were obtained (yield=70%, melting point=100°14 102 ° C.). TLC: Rf=0.29 (Kieselgel 60 F 254 , Merck product, chloroform/methanol=20/1) ##STR12## Physical properties of the product C 26 H 34 O 12 N 2 S FAB-MS m/z : 599 (M + +1) 1H-NMR ppm/500 MHz (CDCl 3 , TMS) 1.858 (3H, s, --NHCOCH 3 ), 1.978 (1H, t, J=12.5 Hz, H 3ax ), 2.016;2.054;2.060 2.138 (all 3H, all s, --OCOCH 3 X 4), 4.144 (1H, dd, J=12.8, 4.8 Hz, H 3eq ), 3.618 (3H, s, 2 COOCH 3 ), 603 (1H, d, J=8.8 Hz, phenyl-H), 266 (1H, d, J=8.8 Hz, phenyl-H), IRνKBr/max cm -1 3470, 3380, 1740, Embodiment 6 Synthesis of 4'-[(methyl 5-acetamido 4, 7, 8, 9-tetra-0-acetyl-3, 5-dideoxy-α-D glycero-D-galacto-2-nonylopyranosylonate) oxy] succinanilic acid: 4.91 g of [methyl (4-aminophenyl 5-acetamido-4, 7, 8, 9-tetra-0-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosido)onate] obtained in the aforementioned Embodiment 3 and 1.26 g of succinic anhydride were dissolved in 100 ml of anhydrous tetrahydrofuran and allowed to react for one day with stirring at room tempcrature. After the disappearance of raw materials was confirmed with a TLC, reaction solvent was removed under reduced pressure and the residue was purified with gel filtration chromatography (LH-20, MeOH) and the fractional solution not containing succinic anhydride was obtained. The residue obtained by removing solvent from the fractional solution was recrystallized with acetate, and 4.81 g of the product was obtained (total up to the third crystal, yield=83.7%, melting point=130°-131 ° C.). TLC Rf=0.13 (Kieselgel 60 F 254 , Merck product, CHCl 3/ MeOH=20/1) Rf=0.42 (Kieselgel 60 F 254 , Merck product, CHCl 3/ MeOH=10/3) ##STR13## Physical properties of the product C 30 H 38 O 16 N 2 FAB-MS m/z : 683 (M + +1) H-NMR ppm/500 MHz (CDCl 3 , TMS) 1.890 (3H, s, --NHCOCH 3 ), 2.041;2.051;2.121 2.126 (all 3H, all s, --OCOCH 3 X 4), 2.186 (1H, t, J=12.5 Hz, H 3ax ), 2.655-2.710 (3H, m, --CH 2 CH 2 -+H 3eq )), 2.777 (3H, t, J=6.6 Hz, --CH 2 CH 2 --), 3.643 (3H, s, -COOCH 3 ), 4.964 (2H, ddd, J=12.1, 10.3, 4.8 Hz, H-4), 7.011 (2H, d, J=9.2 Hz, phenyl-H), 7.418 (2H, d, J=9.2 Hz, phenyl-H). IRνKBR/max cm -1 3350, 1740, 1660, 1540, Embodiment 7 Synthesis of 4'-[(methyl (5-acetamido 4,7,8,9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonate)oxy] maleanilic acid 100 g of [methyl (4 aminophenyl 5-acetamido-4, 7, 8, 9-tetra-0-acetyl-3, 5 dideoxy-α-D-glycero-D-galacto-2 nonulopyranosido)onate] obtained in the aforementioned Embodiment 3 and 24 mg of maleic anhydride were dissolved in 3 ml of anhydrous tetrahydrofuran and stirred at room temperature. The reactions took place immediately. After the disappearance of raw materials was confirmed with a TLC, reaction solvent was removed under reduced prsesure. The residue was purified with gel filtration chromatography (LH-20, MeOH) and the fractional solution containing the product was obtained. From this fractional solution, solvent was removed and 74.8 mg of pale yellow powdery crystals were obtained (yield=67.4% melting point=121°-123° C.). TLC: Rf=0.33 (Kieselgel 60 F 254 , Merck product, CHCl 3/ MeO=10/3) ##STR14## Physical properties of the product C 30 H 36 O 16 N 2 FAB-MS m/z: 681 (M + +1) 1 H-NMR ppm/500 MHz (CDCl 3 , TMS) 1.929 (3H, s, NHCOCH 3 ), 2.047;2.095;2.140 2.145 (all 3H, all s, --OCOCH 3 X 2.243 (1H, t, J=12.8 Hz, H 3ax ), 2.715 (1H, dd, J=12.8, 4.4 Hz, H 3eq ), 3.654 (3H, s, 2--COOCH 3 ), 4.955 (1H, ddd, J=12.1, 10.6, 4.4 Hz, H 4), 6.455 (1H, d, J=12.8 Hz, olefin H), 6.499 (1H, d, J=12.8 Hz, olefin H), 7.048 (2H, d, J=8.8 Hz, phenyl-H), 7.543 (2H, d, J=8.8 Hz, phenyl-H), IRνKBr/max cm -1 3350, 1750, 1770, 1550, Embodiment 8 Synthesis of 4'-[methyl (5-acetamido 4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonate) thio] succinanilic acid 0.1 g of [methyl (4 aminophenyl 5-acetamide-4, 7, 8, -tetra-0-acetyl 3, 5 dideoxy-α-D-glycero D galacto-2 nonulopyranosido)onate] obtained in the aforementioned Embodiment 5 and 20 mg of succinic anhydride were dissolved in 3 ml of anhydrous tetrahydrofuran and were allowed to react with stirring for one day at room temperature. After the disappearance of raw materials was confirmed with a TLC, reaction solvent was removed under reduced pressure conditions. The residue was purified with gel filtration chromatography (LH-20, MeOH) and a fractional solution containing the product was obtained. From this fractional solution, solvent was removed and 9.4 mg of white powdery crystals were obtained (yield=82%, melting point=119°-121 ° C.). TLC: Rf=0.40 (Kieselgel 60 F 254 , Merck product, CHCl 3/ MeOH=10/3) ##STR15## Physical properties of the product C 30 H 38 O 15 N 2 S FAB-MS m/z : 699 (M + +1) 1H-NMR 500MHz (CDCl 3 , TMS) 1.844 (3H, s, --NHCOCH 3 ), 2 019;2.038;2.059;2.127 (all 3H, all s, --OCOCH 3 X 4), 2.65-2.80(5H, m, --CH 2 CH 2 --+H 3eq ), 3.585 (3H, s, 2 COOCH 3 ), 4.837 (1H, ddd, J=11.4, 10.3, 4.8 Hz, H-4), 7.414 (2H, d, J=8.4 Hz, phenyl-H), 7.534 (2H, d, J=8.4 Hz, phenyl-H), IRνKBr/max cm -1 3340, 1740, 1220, Embodiment 9 Synthesis of 4'-[(methyl 5-acetamido-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonate)oxy] succinanilic acid and its sodium salts 222 mg of 4'-[(methyl 5-acetamido-4, 7, 8, 9-tetra-0-acetyl 3, 5 dideoxy-α-D-glycero-D-galacto 2-nonulopyranosylonate)oxy]succinanilic acid obtained in the aforementioned Embodiment 6 were dissolved in 20 ml of anhydrous methanol and 386 mg of 28% methanol solution of sodium methoxide were added at room temperature and allowed to react with stirring for two hours. Then, while cooling, 0.8 g of Dowex 50 w (H + ) were added and stirred to be made slightly acidic to pH 4. The ion exchange resin was removed by filtering. Solvent was removed from the filtrate liquid, and a amorphous substance was obtained. The residue obtained was purified with C 18 -column chromatography (YMC.GEL ODS 60Å 60/200 mesh). The residue was eluted first with water, then with methanol, and water was added to the methanol fractional solution containing the object, freeze-dried to give 100 mg of white powdery crystals of free-acid type carboxylic acid (yield=60%, melting point=132 -135° C.). The sodium salts were similarly isolated when the amount of the aforementioned Dowex 50 w (H + ) was less than a half. TLC: Rf=0.40 (Kieselgel 60 F 254 , Merck product, CHCl 3/ MeOH=6/3/0.5) ##STR16## Physical properties of the product (COOH substance) Element analysis C 22 H 30 O 12 N 2 FAB-MS m/z : 515 (M + +1) 1H-NMR ppm/500 MHz (D20, TSP) 2.030 (1H, t, J=12.5 Hz, H 3ax ), 2.039 (3H, s, --NHCOCH 3 ), 2.67-2.69(4H, m, --CH 2 --CH 2 --), 2.880 (1H, dd, J=12.8, 4.8 Hz, H 3eq ), 7.150 (1H, d, J=8.8 Hz, phenyl-H), 7.386 (1H, d, J=8.8 Hz, phenyl-H), IRνKBr/max cm -1 3400, 1730, 1660, 1550, Embodiment 10 Synthesis of [4'-(3- (N-succinimidyloxycarbonyl)propionamido) phenyl 5-acetamido-4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-αD-glycero D galacto 2 nonulopyranosido]onate: 100 mg of 4'-[(methyl 5-acetamido-4, 7, 8, 9-tetra-O-acetyl 3, 5-dideoxy-α-D glycero-D-galacto 2 nonulopyranosylonate)oxy]succinanilic acid obtained in the aforementioned Embodiment 6 and 38 mg of N, N'-disuccinimidyl carbonate were dissolved in 10 ml of anhydrous acetonitrile and 11.7 μl of anhydrous pyridine were added and allowed to react with stirring at room temperature. After disappearance of raw material was confirmed with a TLC, the reaction solvent was removed under reduced pressure condition. The residue obtained was purified with silica gel column chromatography (Wakogel C=300, toluene/acetone=1/1). The residue of the obtained fractional solution was further purified with a gel filtration chromatography (LH-20, toluene/acetone =1/1) and 91 mg of white powdery crystal was obtained (yield=80%, melting point=115°-117 ° C.). TLC: Rf=0.27 (Kieselgel 60 F 254 , Merck product, toluene/acetone=1/1) ##STR17## Physical properties of the product C 34 H 41 O 18 N 3 FAB-MS m/z : 780 (M + +1) 1 H-NMR ppm/500 MHz (CDCl 3 , TMS) 1.902 (3H, s, --NHCOCH 3 ), 2.036;2.051;2.118;2.133 (all 3H, all s, --OCOCH 3 X 4), 2.183 (1H, t, J=12.8 Hz, H 3ax ), 2.699 (1H, dd, J=12.8, 4.8 Hz, H 3eq ), 2.759 (2H, t, J=7.0 Hz, --CH 2 --CH 2 --), 3.056 (2H, t, J=7.0 Hz, --CH 2 CH 2 --), 2.844 (4H, s, H of succinimidyl group), 3.658 (3H, t, 2-COOCH 3 ), 4.944 (1H, ddd, J=12.5, 10.3, 4.8 Hz, H-4), 7.022 (2H, d, J=8 Hz, phenyl-H), 7.413 (1H, d, J=8 Hz, phenyl-H), IRνKBr/max cm -1 3360, 1740, 1670, 1540, Embodiment 11 Synthesis of [4 succinimidophenyl 5-acetamido-4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-αD glycero-D-galacto-2-nonulopyranosido]onate 120 mg of 4 -[(methyl 5-acetamido-4, 7, 8, tetra O-acetyl-3, 5 dideoxy-α-D-glycero D galacto-2-nonulopyranosylonate)oxy] succinanilic acid obtained in the aforementioned Embodiment 6 and 247 mg of N, N'-disuccinimidyl carbonate and 340 mg of anhydrous pyridine were dissolved in 20 ml of anhydrous acetonitrile and allowed to react at room temperature for one day. After the reaction solvent was removed, the residue obtained was purified with silica gel column chromatography (C=300, toluene/acetone=1/1). The solvent was removed from the obtained fractional solution containing the product and white powdery crystals were obtained. The residue of the obtained fractional solution was further purified with a gel filtration chromatography (LH-20, ethyl acetate) and 24 mg of white powdery crystal was obtained (yield=20%, melting point=110°-114 ° C.). TLC: Rf=0.35 (Kieselgel 60 F 254 , Merck product, toluene/acetone=1/1) Rf=0.26 (Kieselgel 60 F 254 , Merck product, ethyl acetate) ##STR18## Physical properties of the product C 30 H 36 O 15 N 2 FAB-MS m/z: 665 (M + +1) 1 H NMR ppm/500 MHz (CDCl 3 , TMS) 1.913 (3H, s, --NHCOCH 3 ), 2.047;2.049;2.121;2.153 (all 3H, all s, --OCOCH 3 X 2.250 (1H, t, J=12.8 Hz, H 3ax ), 2.711 (1H, dd, J=12.8, 4.8 Hz, H 3eq ), 2.875 (4H, s, H of succinimido group), 3.687 (3H, s, 2--COOCH 3 ), 4.971 (1H, ddd, J=12.1, 10.6, 4.8 Hz, H-4), 7.140 (2H, d, J=8.8 Hz, phenyl-H), 7.203 (1H, d, J=8.8 Hz, phenyl-H), IRνKBr/max cm -1 3460, 3360, 1750, 1710, Embodiment 12 Synthesis of [4-(3-p-nitrophenyloxycarbonylpropionamide) phenyl 5 acetamido-4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosido]onate: 52 mg of 4'-[(methyl 5-acetamido-4, 7, 8, 9-tetra 0 acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonato)oxy] succinanilic acid obtained in the aforementioned Embodiment 6, 24.1 mg of p-nitrophenol, and 14.5 mg of WSC (1-ethyl-3-(3-dimethylaminopropyl)-carbodiimide hydrochloride] were dissolved in 1 ml of tetrahydrofuran and allowed to react at 0 ° C. with stirring. After disappearance of raw material was confirmed with a TLC, reaction solvent was removed and the residue obtained was purified with silica gel column chromatography (Wakogel C=300, toluene/acetone=1/1) to give the fractional solution containing the object. The solvent was removed from the obtained fractional solution and 20 mg of white powdery crystals were obtained (yield=32.7 melting point=106°-108 ° C.). TLC: Rf=0.38 (Kieselgel 60 F 254 , Merck product, ethyl acetate) Rf=0.42 (Kieselgel 60 F 254 , Merck product, toluene/acetone=1/1). ##STR19## Physical properties of the product C 36 H 41 O 18 N 3 FAB-MS m/z : 804 (M + +1) 1 H NMR ppm/500 MHz (CDCl 3 , TMS) 1.908 (3H, s, --NHCOCH 3 ), 2.038;2.047;2.126;2.132 (all 3H, all s, --OCOCH 3 X 4), 2.191 (1H, t, J=12.8 Hz, H 3ax ), 2.708 (1H, dd, J=12.8, 4.4 Hz, H 3eq ), 2.779 (2H, t, J=6.6 Hz, --CH 2 --CH 2 --), 3.019 (2H, t, J=6.6 Hz, --CH 2 --CH 2 --), 3.656 (3H, t, 2--COOCH 3 ), 4.947 (1H, ddd, J=12.1, 10.3, 4.4 Hz, H-4), 7.031 (2H, d, J=8.8 Hz, H of nitrophenyl group), 7.313 (2H, d, J=8.8 Hz, aromatic ring H of anilic acid), 7.409 (2H, d, J=8.8 Hz, aromatic ring-H of anilic acid), 8.265 (2H, d, J=8.8 Hz, nitrophenyl group). IRνKBr/max cm -1 3350, 1740, 1660, 1520, 1340, Embodiment 13 Synthesis of N-(4'-[(methyl 5-acetamido-4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonate)oxy] succinaniloyl)glycine methyl ester [13-1] The first method (active ester process) 100 mg of 4'-[(methyl 5-acetamido-4, 7, 8, 9 tetra-O-acetyl-3, 5 dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonate) oxy] succinanilic acid obtained in the aforementioned Embodiment 6, 38 mg of N,N'-disuccinimidyl carbonate, and 11.7 μl of anhydrous pyridine were dissolved in 10 ml of anhydrous acetonitrile and allowed to react at room temperature for 2 hours. After disappearance of raw material was confirmed with a TLC, the acetontrile solution consisting of 18.4 mg of glycine methyl ester hydrochloride and 20.4 μl of triethylamine was added to the mixture of the above-mentioned active ester, and the solution was allowed to react with stirring for one day. After disappearance of the active ester with a TLC, the reaction solvent was removed and the residue obtained was purified with silica gel column chromatography (Wakogel C=300, CHCl 3 /MeOH=20/1), then further with gel filtration chromatography (LH-20, MeOH) to give a fractional solution containing the product. Solvent was removed from the obtained fractional solution and 50 mg of white powdery crystals were obtained (yield=45.5%, melting point =102°-105 ° C.). TLC: Rf=0.22 (Kieselgel 60 F 254 , Merck product, toluene/acetone=1/1) ##STR20## Physical properties of the product C 33 H 43 O 17 N 3 FAB MS m/z : 754 (M + +1) 1 H-NMR ppm/500 MHz (CDCl 3 , TMS) 1.898 (3H, s, --NHCOCH 3 ), 2.034;2.054;2.118;2.133 (all 3H, all s, --OCOCH 3 X 4), 2.175 (1H, t, J=12.5 Hz, H 3ax ), 2.65°-2.71 (5H, m, --CH 2 --CH 2 - +H 3eq ), 3.648 (3H, s, 2 --COOCH 3 ), 3.749 (3H, s, --NHCH 2 COOCH 3 ), 4.946 (1H, ddd, J=12.5, 10.3, 4.8 Hz, H-4), 7.012 (2H, d, J=9.2 Hz, phenyl H), 7.417 (1H, d, J=9.2 Hz, phenyl-H), IRνKBr/max cm -1 3300, 1750, 1660, 1550, [13-2] The second method (mixed acid anhydride process) 107.4 mg of 4'[(methyl 5-acetamido 4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonate)oxy] succinanilic acid obtained in the aforementioned Embodiment 6, and 20.4 μl of triethylamine were dissolved in 2 ml of anhydrous tetrahydrofuran, and with cooling to -12 ° C. and stirring, 18.9 μl of isobutylchloroformate were added and allowed to react for 10 minutes. Then, 1 ml of anhydrous chloroform solution dissolving 18.3 mg of glycine methyl ester hydrochloride and 20.4 μl of triethylamine was added to the mixture of the above-mentioned mixed acid anhydride solution. After stirring, the solution was allowed to react at 0 ° C. for 1 hour, then at room temperature with stirring for one day. After reaction solvent was removed, the residue obtained was purified with silica gel column chromatography (Wakogel C=300, CHCl 3 /MeOH=20/1) to give a fractional solution containing the product. Solvent was removed from the obtained fractional solution and 36.3 mg of white powdery crystals were obtained (yield=30.6%). TLC: Rf=0.22 (Kieselgel 60 F 254 , Merck product, toluene/acetone=1/1) Rf=0.34 (Kieselgel 60 F 254 , Merck product, chloroform/methanol=20/2) 1H-NMR, IR data agreed with that obtained with the aforementioned first method (active ester process). Even when solvents used in the above-mentioned reactions (tetrahydrofuran, chloroform) were replaced with dimethylformamide, a similar product was obtained. [13-3] The third method 37 4 mg of 4'[(methyl 5 acetamido 3, 5 dideoxy-α-D-glycero-D galacto-2-nonulopyranosylonate) oxy] succinaniloyl) glycine methyl ester and 0.8 ml of acetic anhydride were dissolved in 0.8 ml of anhydrous pyridine and allowed to react at room temperature for one day with stirring. The reaction solvent was removed and the residue obtained was purified with silica gel column chromatography (Wakogel C=300, CHCl 1 /MeOH=20/1) to give fractional solution containing the product. Solvent was removed from the obtained fractional solution and 28.8 mg of white powdery crystals (yield=59.8%) were obtained. TLC Rf=0.22 (Kieselgel 60 F 254 , Merck product, toluene/acetone=1/1) Rf=0.34 (Kieselgel 60 F 254 , Merck product, chloroform/methanol=20/1) 1H-NM data completely agreed with that obtained with the aforementioned first method (active ester process). Embodiment 14 Synthesis of 4'-[(methyl 5-acetamido-4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonate)oxy] succinanilohylhydrazide 100 mg of 4'-[(methyl 5-acetamido-4, 7, 8, 9 tetra-O-acetyl-3, 5 dideoxy-α-D-glycero D galacto-2-nonulopyranosylonate)oxy] succinanilic acid obtained in the aforementioned Embodiment 6, 38 mg of N, N'-disuccinimidyl carbonate, and 11.7 μl of anhydrous pyridine were dissolved in 10 ml of anhydrous acetonitrile and allowed to react at room temperature for 8 hours. After disappearance of raw material was confirmed with a TLC, while cooling, 10 μl of anhydrous hydrazine was added and allowed to react for one day. The reaction solvent was removed and the residue obtained was purified with gel filtration chromatography (LH-20, MeOH), then further with silica gel chromatography (Wakogel C-300, CHCl 1 /MeOH=10/1) to give a fractional solution containing the product. Solvent was removed from the obtained fractional solution and 40.5 mg of white powdery crystal (yield=40%, melting point=110°-113 ° C.) were obtained. Rf=0.52 (Kieselgel 60 F 254 , Merck product, ethyl acetate/methanol=5/3) Rf=0.20 (Kieselgel 60 F 254 , Merck product, chloroform/methanol=10/1) ##STR21## Physical properties of the product Element analysis C 30 H 40 O 15 N 4 FAB-MS m/z: 697 (M + +1) 1 H-NMR ppm/500 MHz (CDCl 3 , TMS) 1.811 (3H, s, --NHCOCH 3 ), 1.972;2.031;2.055 (6H;3H;3H, all s, --OCOCH 3 X 4), 2.108 (1H, t, J=12.5 Hz, H 3ax ), 2.492 (4H, m, --CH 2 --CH 2 --), 2.622 (3H, m, --CH 2 --CH 2 -- +H 3eq ), 3.544 (3H, s, 2 --COOCH 3 ), 4.876 (1H, m, H-4), 6.921 (2H, d, J=8.8 Hz, phenyl-H), 7.355 (2H, d, J=8.8 Hz, phenyl-H), IVνKBr/max cm -1 3300, 1740, 1660, 1540, Embodiment 15 Synthesis of N-4'-[methyl (5-acetamido-3,5-dideoxy-α-D-glycero-D-galacto 2 nonulopyranosylonate)oxy] succinaniloyl) glycine methyl ester 98 mg of 4,-[(methyl 5-acetamido 3, 5 dideoxy-α-D glycero-D-galacto-2-nonulopyranosylonate)oxy] succinanilic acid obtained in the aforementioned Embodiment 9 and 27.1 μl of triethylamine were dissolved in 1 ml of anhydrous dimethylformamide and 25 ml of iso-butylchloroformate were added with stirring and cooling (15 ° C.), then allowed to react for 10 minutes. Then, 1 ml of anhydrous dimethylformamide solution dissolving 24.4 mg of glycine methyl ester hydrochloride salt and 27.1 μl of triethylamine was added to the above-mentioned acid anhydride solution. After stirring, the solution was allowed to react at 0 ° C. for 1 hour, then at room temperature with stirring for one day. After the reaction solvent was removed under reduced pressure conditions, the residue obrtained was purified with C 18 -column chromatography (YMC.GEL ODS 60 Å 60/200 mesh). The solution was eluted first with water, then with water/methanol=1/1 solution, and the fractional solution containing the product was freeze-dryed to give 50 mg of white powdery crystals (yield=45%, melting point=111°-113 ° C.). TLC: Rf=0.46 (Kieselgel 60 F 254 , Merck product, CHCl 3 /MeOH/ACOH=6/3/0.5) ##STR22## Physical properties of the product C 25 H 35 O 13 N 3 FAB MS m/z : 586 (M + +1) 1 H-NMR ppm/500 MHz (D20, TSP) 2.040 (1H, t, J=12.5 Hz, H 3ax ), 2.051 (3H, s, --NHCOCH 3 ), 2.68-2.74 (4H m --CH 2 --CH 2 --) 2.890 (1H, dd, J=12.8, 4.4 Hz, H 3eq ), 3.726 (3H, s, 2--COOCH 3 ), 3.763 (3H, s, --NHCH 2 COOCH 3 ), 7.164 H, d, J=8.8 Hz, phenyl-H), 7.397 (2H, d, J=8.8 Hz, phenyl H), IRνKBr/max cm -1 3350, 1740, 1650, 1550, Embodiment 16 Synthesis of N 4'-[methyl (5-acetamido-4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonate)oxy] succinaniloyl) glycine 100 mg of 4'-[(methyl 5-acetamido-4, 7, 8, 9-tetra-O-acetyl-3, 5-dideoxy-α-D-glycero-D-galacto-2-nonulopyranosylonate) oxy] succinanilic acid obtained in the aforementioned Embodiment 6 and 20.4 μl of triethylamine were dissolved in 2 ml of anhydrous tetrahydrofuran, and 18.9 μl of isobutylchloroformate were added with stirring and cooling (-15 ° C.), then allowed to react for 10 minutes. Then, the above mentioned acid anhydride solution was added to 1 ml of tetrahydrofuran-water (1:1) solution dissolving 11 mg of glycine and 0.4 μl of triethylamine with cooling (0 ° C.) and stirring. The solution was allowed to react at 0 ° C. for hour, then at room temperature with stirring for one day. After the reaction solvent was removed under reduced pressure conditions, the residue obtained was freeze-dried. The methanol solution of the residue obtained was made acidic with Dowex 50 w (H + ), then solvent was removed. The residue was purified with silica gel column chromatography (Wakogel C 300, acetate/methanol=5/3) to give the fractional solution containing the product. Solvent was removed from the fractional solution and 54 mg of white powdery crystals were obtained (yield=50%, melting point=105°-108 ° C.). TLC: Rf=0.15 (Kieselgel 60 F 254 , Merck product, acetate/methanol=5/3) ##STR23## Physical properties of the product C 32 H 41 O 17 N 3 FAB-MS m/z 740 (M + +1) 1 H-NMR ppm/500 MHz (CDCl 3 , TMS) 1.880 (3H, s, --NHCOCH 3 ), 024;2.085;2.117 (all s, --OCOCH 3 X 4), 3.605 (3H, s, 2--COOCH 3 ), 3.61 (2H, broad s, -NH-CH 2 --COOH), 4.93 (1H, m, H 4), 6.962 (2H, d, J=8.1 Hz, phenyl H), 7.412 (2H, d, J=8.1 Hz, phenyl-H), IRνKBr/max cm -1 3350, 1740, 1660, 1540,

Sialic acid derivative with active ester groups expressed with the formula [I] ##STR1## Where R 1 denotes hydrogen or an acetyl group, R 2 denotes hydrogen or a lower alkyl group, R 3 denotes C 2 H 4, C 3 H 6 or C 2 H 2, R 4 denotes an hydroxyl group, the residue left after removing hydrogen from the alcohol portion of the active ester or alkyloxycarbonyloxy group, AC denotes an acetyl group, Ph denotes an phenyl group, and X denotes oxygen or sulfur. This sialic acid derivative has high reactivity because it has active ester groups in the molecules and can be used as a raw material or intermediate for synthesis of various sialic acid derivatives.

BACKGROUND OF THE INVENTION 1. Technical Field The present invention relates to lighting systems for use with roller skates and/or skateboards. In particular, it relates to indirect lighting systems which illuminate the floor under a roller skate or skateboard. 2. Background Art Currently, a wide variety of wheeled amusement devices, such as skates and skateboards are used by young and old alike. In particular, roller skates have found wide use both indoor and outdoors in roller skating rings and for general use on streets and sidewalks. Use of roller skates has led to some difficulty when used in poorly lit places such as darkened roller rinks or when used outdoors in the night. In areas such as indoor roller rinks the use of low level lighting generally does not lead to safety problems, but it can detract from the aesthetics of the activity. On the other hand, in outdoor use the absence of adequate lighting quite often does result in the exposure of the skater to danger from automobiles. Attempts have been made to provide some lighting capability to footwear and other devices used by pedestrians such as athletic shoes, roller skates, or skateboards. In the case of athletic shoes, one of the methods used to enhance the visibility of the wearer has been to place lights in the heel and around the periphery of the athletic shoes. The lights used by this type of device are normally triggered by a switch in the heel of the shoe that automatically activates a light each time the user takes a step. The lights are ordinarily LEDs and are powered by a battery contained with the shoe. This type of lighting system has both ornamental value, and in addition, provides some safety value since the lights can improve the visibility of a pedestrian at night so long as the pedestrian is moving. Of course, if the pedestrian is standing still, the lights are normally off. A disadvantage of the device is that the light assembly is visible even when not in use. Other known lighting methods use devices similar in structure to a flashlight which attaches to a shoe. These devices are typically used to illuminate the path in front of pedestrians while walking in the dark. An additional benefit is that the lights can make the user more noticeable by a driver from a distance. Another type of device which has used lighting systems is the skateboard. It is known, for example, to put head light and tail light arrangements on skateboards both for forward illumination purposes and rear lighting. These devices can be configured as small flash light assemblies which mount on the underside of the skateboard. Likewise, rail bars are known which arrange LEDs around the periphery of the skateboard. Typically, these types of systems have switch and battery assemblies mounted on the underside of the skateboard. Another device commonly used is roller skates. Attempts to provide lighting systems for this type of device have usually involved the attachment of a flash light device to provide a head light, or tail light function to roller skates. This type of lighting system typically attaches to the tow brake on the front of a roller skate or the underside of the skate at the rear. There have been known tow brakes that have led lighting arrangements built in to the tow brake on the front of the skate. Another approach used in conjunction with roller skates has been to provide lighting in or on the wheels themselves. One such method includes making the light an integral part of the wheel. A second approach is to add on a device to the side of the wheel. This allows lights to be provided to pre-existing skates. However, in both of these configurations as well as the configuration that uses the tow brake, the lighting assemblies detract from the appearance of the roller skates and may also interfere with the use of the roller skates due to the size of the lighting assemblies. These configurations are suitable for the older type of roller skates whose wheels are configured in a square pattern with wheels in each of four corners. These wheels tend to be large and wide. However, with the advent of the new roller skate design commonly known as in-line skates, the addition of lighting assemblies has increasingly detracted from the appearance of the skates and increasingly interferes with the use of the skates. This because in-line skates are configured similarly to ice skates rather than the conventional roller skates. The wheels are to small to hold batteries and of course the orientation of the lights into the wheels would still only provide direct lighting. The disadvantage of this wheel structure is that it would not have the ability to provide indirect lighting which for aesthetic reasons may be much more desirable. Likewise, the increased performance available from in-line skates may be hampered since the skater may not be able to tilt as far to the side if lights are mounted underneath. In addition to the problems associated with the ability to incorporate lighting into in-line skates, there is also an additional problem associated with the ability to conveniently alter colors. The ability to changes colors is desirable since the choice of color may vary depending on the nature of the use. For example, if a skater is outdoors near automobile traffic the skater may wish to have a specific color such as red. In dark indoor environments such as a skating ring with dimmer lights another color may be more desirable. Battery usage is another problem associated with many lighting systems used for roller skates. A typical lighting arrangements such as incandescent bulbs tend to consume considerable power, as do LEDs. Further LEDs often do not have the luminance necessary to effectively provide lighting capabilities indirectly. Therefore, arrangements which use LED lamps typically are implemented in direct lighting systems where the viewer looks directly at the lamps. Due to the rapid draining effect these devices have on their batteries, either large, heavy and inconvenient batteries must be used which may last for a more extended period, or lighter weaker batteries which drain faster must be used. The prior art has failed to provide a single system which is capable of being inconspicuous when not in use, which provides for convenient change of color by the user, which provides indirect lighting, which has the ability to relocate the lighting on the skate or on a skateboard, and which has the inability to provide very low power systems which can operate for extended periods on a light weight battery. SUMMARY OF THE INVENTION The present invention overcomes the foregoing problems and disadvantages of the prior art with a system that provides indirect lighting by mounting a lighting assembly under the shoe and providing a light directed down from the bottom of the shoe section of the skate to the floor under the user. The color of the lighting system can be altered by placing a color filter in front of the lamp. In an alternative embodiment the incandescent lamps used in the first embodiment are replaced by electroluminescent lamps (EL lamps). EL lamps used in this embodiment tend to be very flat and are not noticeable to observers when the skate is in use and the lamps are turned off because they are positioned flat against the bottom of the skate or skateboard. The color of the EL lamp can be altered via a film color filter placed on top of the EL lamp or by selecting a particular color EL lamp. When the lamps are activated, they illuminate the floor beneath the skate but are not directly seen. The third embodiment provides flat EL lamp panels which removably attach to the sides of the skates such that they can be used not only for aesthetic reasons but also to provide an effective safety measure. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows prior art in-line skates. FIG. 2 shows the prior skate of FIG. 1 with the lamp kit of the present invention installed. FIG. 3 shows a bottom view of the lamp kit of FIG. 2 installed on the prior art in-line skate. FIG. 4 shows a close up of the lamp kit of the present invention with a removable color filter for changing colors. FIG. 5 shows the device of FIG. 2 from a front view illustrating a preferred location of the lamp kit. FIG. 6 shows a bottom view of an alternative embodiment which uses electroluminescent lamps in place of the incandescent lamps of the forgoing embodiments. FIG. 7 shows the side view of the electroluminescent strips as shown in FIG. 6. FIG. 8 is a bottom of the embodiment of FIG. 6 showing an electroluminescent lamp with multiple portions. FIG. 9 illustrates a side mounted electroluminescent lamp system which is used as a safety warning when the skater is outdoors. FIG. 10 illustrates a side view of an alternative embodiment in which the electroluminescent lamp kit is used on a skateboard. FIG. 11 illustrates a top view of an alternative embodiment in which the electroluminescent lamp kit is used on a skateboard. DESCRIPTION OF THE PREFERRED EMBODIMENT In FIG. 1 a prior art in-line skate 100 is illustrated. In this configuration, the in-line skate 100 consists of an upper boot section 102 into which the user places his foot (hereinafter called the boot). A wheel rail 104 is attached to the bottom of boot 102. Four wheels 106 are attached to wheel rail 104 by axles 108. Aperture 110 is an open area between boot 102 and wheel rail 104. In the preferred embodiment, described below, the in-line skate 100 configuration shown in FIG. 1 is used to illustrate the invention. However, those skilled in the art will recognize that other configurations, such as a conventional square wheel configuration with wheels at each corner, can advantageously use the invention as well. FIG. 2 is a side view which illustrates the prior art in-line skate 100 as shown in FIG. 1 with the additional feature of an indirect light generator attached to the underside of the boot 102. In this view, a light shield 202 surrounds the other components of the light generator and prevents direct viewing of light from a lateral direction. However, the light shield 202 does not prevent light from being projected down from the boot 102 to the floor, thereby allowing a bed of light to flood the floor beneath in-line skate 100. A more detailed discussion of the methods used to create the indirect lighting is discussed more fully below in regard to the other figures. Light shield 202 is preferably constructed from a lightweight material such as plastic, etc. A flexible or semi-flexible material is preferred in order to mitigate damage from impacts which can happen during normal use of in-line skate 100. While the preferred embodiment envisions a light shield 202 which completely blocks light, those skilled in the art will recognize that light shield 202 can also be constructed from material which allows some light to penetrate through for direct lateral viewing. In the case where the material in light shield 202 is colored, light shield 202 acts as a color filter to produce a side light having a particular color. Light shield 202 is preferably removably attached to permit replacement with light shields 202 of any desired color. Attachment and removal methods for covers, shields, and like devices are well known in the art and can be accomplished by any suitable method such as a snap-on connectors, screws, etc. Providing for easy removal and replacement of the light shield 202 allows users to conveniently change the appearance of the in-line skate 100. FIG. 3 is a bottom view of the embodiment of FIG. 2. In this figure, light shield 202 is shown surrounding the components used to generate the indirect lighting. Lamps 302 are connected to sockets 304 which are in turn attached to power supply 308 via wires 306. Power to lamps 302 is controlled by switch 310. In the preferred embodiment, power supply 308 is typically a conventional battery. The lamps 302 are shielded from external view during use of in-line skate 100 by the light shield 202 which extends around the periphery. The light shield 202 is illustrated in FIGS. 2 and 3 as extending farther to the front and rear of boot 102 than aperture 110. By so doing, the area covered by the bed of light will be extended such that a larger bed of light floods the floor beneath in-line skate 100. The lamps 302 can themselves have a particular color to create a particular visual effect. In the alternative, a color filter 402 (shown in FIG. 4) can be attached to the indirect light generator (which is comprised of lamps 302, sockets 304, wires 306, power supply 308, switch 310, and light shield 202) which results in the same effect. Preferably, the color filter 402 is a substantially flat, replaceable panel which attaches to the light generator and lies in the light path from the components of the light generator not already screened by light shield 202. Those skilled in the art will recognize that various changes can be made to the design of the indirect light generator. For example, the light shield 202 and the color filter 402 can be a single unit. Likewise, a variety of attachment means, well known in the art, can be used to attach the components of the indirect light generator to the in-line skate 100. For ease of illustration, switch 310 is illustrated as a simple on/off switch. However, alternative embodiments can be easily implemented which provide more flexibility. For example, switching means can be attached which provide for flashing of the lamps 302 under control of a timer. Likewise, if the lamps 302 each have a different color, color control switching means can be used to selectably switch the different colored lamps 302 on and off to produce any desired effect. The type of switching and/or control mechanisms necessary to switch lamps 302 on and off as well as the controls necessary to selectably activate individual lamps 302 are well known in the art and can easily be implemented by hardware and/or software as an integrated circuit, prom, eprom, etc. Further, the incandescent lamps 302 used in FIGS. 2 and 3 can be implemented as neon lights, or LEDs. The number of lamps 302 used is not critical and may vary so long as the battery selected for power supply 308 is capable of illuminating the number of lamps 302 used for a particular design. The battery used by this embodiment is a commonly used 9 volt DC battery. Those skilled in the art will recognize that any suitable substitute for the battery can be used. For example, the power can be produced by attaching a small generator to one or more of the wheels (production of power in this manner is known in the art). Likewise the switch can be any suitable switch for this type of power supply. Finally, FIGS. 2 and 3 have illustrated how an add-on lighting kit can be retrofitted to an existing skate by fitting the components of the indirect light generator within the aperture 110 of the wheel rail 104 where possible. However, if an indirect lighting generator is designed to be manufactured as part of the in-line skate 100, then the various components such as wheel rail 104 can be easily designed to conceal the components of the indirect lighting generator for a more pleasing appearance. FIG. 4 shows the embodiment of FIGS. 2 and 3 with the color filter 402 in place. Those skilled in the art will recognize that any suitable attachment means can be used to attach color filter 402. In the preferred embodiment, a quick disconnect attachment is used for color filter 402 to allow easy change of colors. Referring to FIG. 5, this figure shows a front (toe) view of the in-line skate 100, including boot 102, wheel rail 104, wheel 106, axle 108, light shield 202 and boot laces 502. This view illustrates the appearance of in-line skate 100 with light shield 202 attached. In this embodiment, wheel rail 104 is shown dividing light shield 202. However, the size of light shield 202 is not critical and may extend past the ends of wheel rail 104 such that light shield 202 appears to be a single unit. As can be seen, during normal use, light shield 202 blocks lateral viewing of the light produced by lamps 302. light shield 202 is shown as not protruding all the way to the edge of the boot. The reason for this is that light shield 202 should not interfere with the skaters use of the in-line skate 100 such as when turning. In addition, another advantage of the inward position of light shield 202 is that by locating light shield 202 inward from the edge of the boot 102 the ability of an observer to notice it is decreased. FIG. 6 illustrates an alternative embodiment of the invention. This figure shows a bottom view of the in-line skate 100. The lamps used by this embodiment are electroluminescent lamps 604. These electroluminescent lamps 604 are powered by AC power output by DC inverter 602 via wires 606. DC inverter 602 in turn receives its power from DC battery 308 under control of switch 310. A principle advantage of this embodiment is that electroluminescent lamps 604 can be attached flat against the bottom surface of boot 102 such that they are not noticeable to a viewer from a lateral direction and do not require a light shield 202. Further, electroluminescent lamps 604 can be designed to cover as much of the boot 102 surface as desired. In kit form, the electroluminescent lamps 604 can be attached to existing in-line skates 100 via conventional attachment means such as adhesive or double stick tape. Further, by using removable attachment means, such as double stick tape, hook and loop material, or the like, electroluminescent lamps 604 of one color can be replaced with electroluminescent lamps 604 of another color, thereby allowing a user to conveniently change the color of the light projected onto the floor beneath the in-line skate 100. Those skilled in the art will recognize that the color projected by the electroluminescent lamp 604 can also be changed by placing a translucent color filter, such as a film, over the light emitting surface of the electroluminescent lamp 604. When designed as an integral part of an in-line skate 100 rather than as an add-on kit, the indirect light generator can be made such that it is not visible to a lateral viewer. For example, the battery 308, DC inverter 602, and switch 310 can be concealed within wheel rail 104. Likewise, electroluminescent lamps 604 and wires 606 can be recessed into the lower surface of boot 102 such that they are not directly visible from a lateral vantage point as is the case during normal use. Regarding FIG. 7, this figure shows a side view of an add-on kit form of the embodiment discussed in FIG. 6. As can be seen, the electroluminescent lamps 604 provide a very low profile. As a result, light shield 202 is not required for this embodiment. In the add-on kit form, the outer edge of electroluminescent lamp 604 may be coated with a paint or other light blocking film to prevent direct lateral viewing of emitted light. Of course, in the case of an in-line skate 100 with an integral indirect lighting system, the electroluminescent lamps 604 can be recessed into the bottom surface of the boot 102 such that no treatment of the edge of the electroluminescent lamp 604 is necessary. These electroluminescent lamps 604 can be sized to fit substantially the entire bottom of the boot 102 or any other convenient size for the user. The battery power system is shown in the same place it was with earlier embodiments with the switch assembly also mounted in the rail with the battery. This also allows convenient access by the user and allows and inconspicuous placement. Those skilled in the art will recognize that electroluminescent (EL) lamps 604 are well known in the art and commercially available from a variety of sources. For example, suitable EL lamps and matching DC inverters can be obtained from several manufacturers such as BKL, Inc. a corporation in King of Prussia, Pa. USA. EL lamps typically produce a specific color when illuminated by an AC signal. For portable usage, such as with a roller skate or skateboard, a battery makes a suitable power source for the DC inverter. Commercially available DC to AC inverters typically have an input voltage of 1.5 to 28 volts DC. Typical output ranges of DC inverters are 25 to 180 volts AC, and output frequencies range from 100 Hz to 5000 Hz. Output of EL lamps are matched to a specific DC inverter to achieve maximum desired effect and maximum efficiency. Typically, DC inverters are selected based on the size of the EL lamp, brightness desired, and lamp-life considerations. The higher the output voltage and/or frequency of the DC inverter, the brighter the lamp. EL lamps and DC inverters are well known in the art. But as a practical matter, the selection of the DC inverter, the type of battery, and the particular EL lamp chosen will be based on practical considerations such as the amount of surface area available to mount the EL lamp on, and the color and amount of brightness desired. Selection will also depend on the intended use, such as outdoors, where luminance may be more important for safety reasons, and indoor use where the color selected may have greater importance. Therefore, the selection of a particular size DC inverter and EL lamp surface area will typically be a design choice. The following table illustrates a typical manufacturer's EL lamp performance based on applied voltage and frequency and their effect on luminance: ______________________________________ Volt. Freq. Lum. Lum.Type Color (VAC) (Hz) (Ft-L) (Cd/M2______________________________________Low Power White 40 2000 5.3 18.2Long LifeLow Power White 90 650 25.0 85.7Long LifeLow Power White 120 400 31.0 106.2Long LifeLow Power Aviation 40 2000 8.5 29.1Long Life GreenLow Power Aviation 90 650 32.0 109.6Long Life GreenLow Power Aviation 120 60 8.0 27.4Long Life GreenLow Power Aviation 120 400 36.0 123.3Long Life GreenLow Power Blue Green 120 400 29.0 99.4Long LifeLow Power Yellow 120 400 36.0 123.3Long Life GreenHigh Power White 120 400 26.0 89.1Short LifeHigh Power Aviation 40 2000 4.5 15.4Short Life GreenHigh Power Aviation 120 400 28.0 95.9Short Life GreenHigh Power Blue Green 120 400 28.0 95.9Short LifeHigh Power Green 40 2000 6.0 20.6Short LifeHigh Power Green 120 400 28.0 95.9Short Life______________________________________ FIG. 8 shows an alternative embodiment of the invention shown in FIGS. 6 and 7. In this embodiment, electroluminescent lamps 604 are divided into separate portions 802 and 804. As was the case above, battery 308 provided power under control of switch 310. The DC power provided by battery 308 is input to DC inverter 602 which in turn outputs high voltage AC power to illuminate electroluminescent lamps 802, 804. The difference in this embodiment is that the power output by DC inverter 602 is selectably applied to one or more of electroluminescent lamps 802, 804 by lamp controller 806 by actuating switches (not shown) on lamp controller 806. By so doing, the user can take advantage of several features. For example, if electroluminescent lamps 802 and 804 emit different colors, then the user can conveniently change the color of the indirect light which illuminates the floor under the in-line skate 100. Likewise, lamp controller 806 can be equipped with a timer or with a programmable device such as a prom, eprom, etc to vary emitted colors automatically. Alternatively, if electroluminescent lamps 802, 804 are the same color, the lamp controller 806 can be used to selectably vary the number of electroluminescent lamps 802, 804 activated at any point in time, thereby varying the intensity of the indirect light under the in-line skate 100. Of course, combinations of color and light intensity can be simultaneously achieved either through manual switching or automatic programmed control by lamp controller 806. FIG. 9 illustrates an alternative embodiment in which an electroluminescent lamp 904 is used to produce directly visible light on the side of boot 102. Power is provided via wires 904 connected to DC inverter 602. Of course, when manufactured as an integral unit rather than as an add-on kit, the wires 904 can be imbedded into the boot 102 wall such that they are invisible. Likewise, the location, color, and number of electroluminescent lamps 902 can vary as well as the pattern of illumination which can be optionally varied by lamp controller 806. While the indirect lighting produced by the previous embodiments provided enhanced aesthetic value, the advantage of placing the electroluminescent lamps 902 on the upper portion of the boot 102 is increased safety. When using the in-line skates 100 outdoors and at night, electroluminescent lamps 902 can provide a much larger area of illumination which was heretofore impossible with previous lighting technologies. By increasing the relative area of illumination, the skater is much more visible to drivers in dark outdoor areas, thereby providing enhanced warning to the vehicle driver of the presence of a skater. FIG. 10 shows an alternative embodiment in which the electroluminescent lamp 1004 is used to provide safety illumination substantially along the side edge of a skateboard. As was the case above, battery 308 provided DC voltage to a DC inverter 602 which in turn outputs high voltage AC via wires 1008 to electroluminescent lamp 1004. The skateboard 1000 is constructed from board 1006 and wheel assemblies 1002. The same kit which was used to add indirect lighting to the in-line skates 100, discussed above, can be used with skateboard 1000 as shown in FIG. 10 or used to provide indirect lighting in the same manner as was done above with in-line skate 100. FIG. 11 illustrates a top view of another embodiment in which the electroluminescent lamps 1102 are used to illuminate large areas of the surface of a skateboard 1000. For ease of illustration, the power supply, wiring, and other hardware, are not illustrated to better illustrate the placement of the electroluminescent lamps 1102. The electroluminescent lamps 1102 can be attached to the upper or lower surfaces of the skateboard 1000. Likewise the same type of color and intensity manipulation can be used with this embodiment as was used with the previously discussed embodiments. While the invention has been described with respect to a preferred embodiment thereof, it will be understood by those skilled in the art that various changes in detail my be made therein without departing from the spirit, scope, and teaching of the invention. For example, the EL lamps can be made as an integral part of the skate or as a removable lamp which allows the user to conveniently change colors. The size of the lamp can vary. The location or the DC battery and DC inverter does not have to be located under the boot as shown in the drawings and can be located in any convenient location, and may even be imbedded in the wall of the boot for aesthetic reasons. Accordingly, the invention herein disclosed is to be limited only as specified in the following claims.

A lighting kit that provides indirect lighting for roller skates or skateboards by mounting a lighting assembly under the shoe section of the skate or underside of the skateboard and providing a light directed down from the bottom of the shoe section of the skate or underside of the skateboard to the floor under the user. The color of the lighting system can be altered by placing a color filter in front of the lamp. In an alternative embodiment the conventional lamps used in the first embodiment are replaced by electroluminescent (EL) lamps. The EL lamps provide a flat structure which is relatively unnoticeable to observers when the skate is in use and the lamps turned off because they are positioned flat against the bottom of the skate or skateboard. When the lamps are activated, they illuminate the floor beneath the skate but are not directly seen. The third embodiment provides flat EL lamp panels which removably attach to the sides of the skates or skateboards such that they can be used not only for aesthetic reasons but also to provide an effective safety measure. The kit can be manufactured with the skate or skateboard as an integral component.

TECHNICAL FIELD OF THE INVENTION The present invention relates to a cornea mapping apparatus and, in particular, to an optical coherence tomography corneal mapping apparatus. BACKGROUND OF THE INVENTION As is well known, refractive surgery is a surgical procedure that has, as its primary objective, correction of an ametropia by making incisions in a cornea to change the refractive power of the cornea. Surgical manipulation of corneal shape requires an accurate and precise method of measuring anterior corneal curvature from apex to limbus. At present, measurement of curvature of the center of the cornea is commonly made using a keratometer and, for more precise measurements of corneal topography, it is common to utilize photokeratoscopy or videokeratoscopy. Current corneal topography measurement apparatus are mostly Placido-disc-based videokeratoscopes. In such an apparatus, a series of concentric rings are configured on a cone-shaped housing so that an image reflected from the cornea is virtually flat in space. Then, the configuration of the rings is analyzed to determine the corneal topography. A prior art apparatus of this type has been described in an article entitled "New Equipment and Methods for Determining The Contour of the Human Cornea" by M. G. Townsley, Contacto, 11(4), 1967, pp. 72-81. Such videokeratoscopes have the following disadvantages: (a) due to the small radius of the cornea (˜8 mm), a limited number of rings can be resolved on the cornea (normally, the contour which can be measured is restricted to an area which ranges from 0.8 to 11 mm in diameter on the cornea); (b) no information can be obtained between the rings; and (c) due to use of rings, in-line measurement is very difficult when used in conjunction with an ophthalmologic surgical microscope. An article entitled "Accuracy and Precision of Keratometry, Photokeratoscopy, and Corneal Modeling on Calibrated Steel; Balls" by S. B. Hannush, S. L. Crawford, G. O. Waring III, M. C. Gemmill, M. J. Lynn, and A. Nizam in Arch. Ophthalmol, Vol. 107, August 1989, pp. 1235-1239 provides a comparison of these prior art methods and apparatus. Another corneal topography measurement apparatus has been developed recently by PAR Microsystem Co. The apparatus utilizes raster photogrammetry to measure a corneal topography. In this apparatus, a grid pattern is projected onto the cornea. The grid pattern is then viewed and imaged from an offset angle. Finally, corneal elevation at each of the discrete points in the grid pattern are calculated using the image of the projected grid pattern, and information relating to its geometry. This apparatus is described in an article entitled "Intraoperative raster photogrammetry--the PAR Corneal Topography System" by M. W. Berlin, J. Cataract Refract Surg, Vol. 19, Supplement, 1993, pp. 188-192. Corneal topography measurements suffer in this apparatus because only a limited number of points in the image of the projected grid pattern can be resolved by the image optics. As is further known, since a posterior corneal surface contributes about -14% of total corneal refractive power, in some cases, an anterior corneal topography, by itself, does not provide sufficient information for use in a refractive surgical procedure. For that reason, it becomes even more important to obtain corneal topography measurements with a precision that cannot be provided by current corneal topography measurement apparatus. Recently, a new ophthalmic measurement apparatus, an optical coherence tomography ("OCT") apparatus, has been disclosed which has advantages over the above-described prior art ophthalmic measurement apparatus. An OCT apparatus uses a short coherence light source for range measurements based on the principle of white light interferometry. OCT has been proposed recently for use in several ophthalmologic applications. For example, such proposals have been made in a preprint of an article which has been submitted for publication entitled "Micron-Resolution Imaging of the Anterior Eye in Vivo with Optical Coherence Tomography" by J. A. Izatt, M. R. Hee, E. A. Swanson, C. P. Lin, D. Huang, J. S. Schuman, C. A. Puliafito, and J. G. Fujimoto, 1994, pp. 1-24 ("Izatt et al. reference"). The preprint discloses an OCT apparatus which utilizes optical fiber technology and a superluminescent laser diode source, which OCT apparatus is interfaced with a slitlamp biomicroscope for imaging intraocular structures with a spatial resolution of 10-20 μm. The preprint discloses the use of the OCT apparatus to provide direct, micron-resolution measurements of (a) ocular profile dimensions, optical scattering, and structure in the cornea; (b) the anterior angle region; (c) the iris; and (d) the crystalline lens. The preprint further discloses the use of the OCT apparatus to measure: (a) anterior chamber depth, defined as a distance, along the visual axis, from the posterior corneal surface to the lens anterior capsule; (b) radius of curvature of the posterior and anterior surfaces of the cornea; (c) corneal refractive power; and (d) corneal dimensions such as thickness. The preprint still further discloses that the OCT apparatus, using an inexpensive diode laser source and a fiber optic implementation, is compatible with existing ophthalmic instrumentation. Finally, the preprint makes the following suggestions for potential clinical applications of OCT: (a) providing cross-sectional images of the entire anterior chamber for use in elucidating pathologies of the cornea, anterior angle region, and iris and for use in identifying and monitoring intraocular masses or tumors; (b) measuring anterior chamber depth, corneal curvature, and corneal refractive power; and (c) providing high resolution images showing corneal thickness variations and the distribution of scattering in corneal stroma for quantitative analysis of corneal pathologies. There are two major disadvantages of the above-described OCT apparatus. The first major disadvantage of the above-described device is that the described data acquisition time of several seconds is too long for in vivo measurements of the cornea because saccadic movement of the eye would disturb in vivo measurements. In fact, in practice, in order to preclude disturbance by saccadic movement, data acquisition times smaller than 0.1 seconds are required. The second major disadvantage of the above-described device is that the signal-to-noise ratio of an OCT signal is determined by shot noise of back scattered light, which shot noise depends on the average number of detected photons. The number of detected photons can be increased by using a brighter OCT beam or by utilizing a longer integration time per sampling point. Either of these methods are problematic. For example, the maximum permissible power of the OCT beam at the cornea of the human eye is limited and regulated by ANSI standards. Second, utilizing a longer integration time per sampling point implies a longer acquisition time for a given number of sampling points and exacerbates the data acquisition problem discussed above. In light of the above, there is a need in the art for a corneal mapping apparatus which solves the above-identified problems and provides rapid data acquisition and low noise for reconstructing a three-dimensional structure of a cornea. SUMMARY OF THE INVENTION An embodiment of the present invention comprises an optical coherence tomography ("OCT") corneal mapping apparatus which solves the above-identified problems in the art by providing rapid data acquisition and low noise for reconstructing a three-dimensional structure of a cornea. In particular, an embodiment of a first aspect of the present invention is an OCT corneal mapping apparatus which comprises: (a) an OCT apparatus which is comprised of means for altering a reference beam path; (b) raster scanning means for raster scanning sampling optical output from the OCT apparatus; (c) curved mirror means for transferring the sampling optical output from the raster scanning means to an eye and for transferring the sampling optical output reflected from the eye back to the OCT apparatus through the raster scanning means; and (d) analyzing means, coupled to the raster scanning means, the altering means, and reference and sampling interaction output from the OCT apparatus for causing: (i) the raster scanning means to move the sampling optical output to points in a raster; (ii) the altering means to alter the length of the reference beam path over a predetermined amount at each of the points; and (iii) determination of the corneal mapping from the reference and sampling interaction output at the points in the raster. An embodiment of a second aspect of the present invention is an OCT corneal mapping apparatus which comprises: (a) an OCT apparatus which is comprised of means for altering the length of a reference beam path; (b) raster scanning means for raster scanning sampling optical output from the OCT apparatus over an eye and for transferring the sampling optical output reflected from the eye back to the OCT apparatus; and (c) analyzing means, coupled to the raster scanning means, the altering means, and reference and sampling interaction output from the OCT apparatus for causing: (i) the raster scanning means to move the sampling optical output to points in a raster; (ii) the altering means to alter the length of the reference beam path over a predetermined amount at each of the points; (iii) the altering means to alter the length of the reference beam path in response to reference and sampling interaction output obtained at one or more points; and (iv) determination of the corneal mapping from the reference and sampling interaction output at the points in the raster. BRIEF DESCRIPTION OF THE FIGURE FIG. 1 shows, in pictorial form, a first embodiment of the present invention which comprises an optical coherence tomography ("OCT") corneal mapping apparatus; FIG. 2 shows, in pictorial form, a fiber optic embodiment of an OCT apparatus utilized to fabricate the first embodiment shown in FIG. 1; FIG. 3 shows, in pictorial form, a helical mirror utilized to fabricate the OCT apparatus shown in FIG. 1; FIG. 4 shows, in graphical form, optical path length as a function of time provided by the helical mirror shown in FIG. 3; FIG. 5 shows, in pictorial form, a second embodiment of the present invention which comprises an OCT corneal mapping apparatus; and FIG. 6 shows, in pictorial form, a corneal mapping OCT scan pattern. Components which are the same in the various figures have been designated by the same numerals for ease of understanding. DETAILED DESCRIPTION In accordance with the present invention, the data acquisition time of an inventive corneal mapping apparatus is reduced by reducing the sampled volume so that the volume of the cornea which is scanned is small compared to other parts of the anterior chamber of the eye which do not belong to the cornea. FIG. 1 shows, in pictorial form, a first embodiment of the present invention which comprises optical coherence tomography ("OCT") corneal mapping apparatus 100. As shown in FIG. 1, OCT corneal mapping apparatus 100 comprises OCT interferometer 1. An OCT sample beam is output from OCT interferometer 1 in single mode fiber 250. The OCT sample beam output from single mode fiber 250 is collimated by collimator lens 3 and is deflected by mirror 4 to impinge upon scanner mirror 5. The OCT sample beam is then reflected by scanner mirror 5 toward scanner mirror 6 and is reflected, in turn, by scanner mirror 6 toward curved mirror 7. The OCT sample beam is then reflected by curved mirror 7 onto eye 8. FIG. 2 shows, in pictorial form, a fiber optic embodiment of OCT interferometer 1. As shown in FIG. 2, OCT interferometer 1 comprises CW radiation source 220, for example, a superluminescent laser diode having an output centered substantially at 850 nm. Output from radiation source 220 is coupled into optical fiber 230 and is separated into two beams by 50/50 coupler 240. The output from 50/50 coupler 240 is coupled into optical fibers 250 and 270, respectively. The output from fiber 270 is imaged by lens 280 onto helical reference mirror 290 and the output from fiber 250 is directed to impinge upon eye 8 as was described above. Then, radiation reflected from eye 8 is coupled back into fiber 250 and superimposed by 50/50 coupler 240 with radiation reflected from helical reference mirror 290 and coupled back into fiber 270. Superimposed radiation output from 50/50 coupler 240 is coupled into fiber 265. As is known, there is interference between radiation reflected from the object (eye 8) and radiation reflected from helical reference mirror 290 if the optical path difference is smaller than the coherence length of radiation source 220. As shown in FIG. 3, helical reference mirror 290 is rotated with a substantially constant velocity by means which are well known to those of ordinary skill in the art (not shown) and, as a result, the interference is detected as a periodic variation of a detector signal produced by photodetector 275, the periodic variation having a frequency equal to the frequency of rotation of helical reference mirror 290. The helical surface of helical reference mirror 290 is described by the formula: z=hφ/2 where h is the step height of the helical surface and φ is the azimuthal rotating angle. As is known, the reference arm length of OCT interferometer 1 is changed periodically when helical reference mirror 290 is rotated. FIG. 4 shows, in graphical form, the optical path length variation as a function of time produced by rotating helical reference mirror 290. In accordance with the present invention, the height h of the helical surface is chosen so that the depth scan provided by the optical path length variation of the reference arm of OCT interferometer 1 is in the order of the thickness of the cornea. This reduces the scan volume and, thereby, reduces the data acquisition time required for a corneal mapping. In accordance with the present invention, the use of a helical reference mirror is advantageous because it can be rotated very fast and, thereby, a short data acquisition time can be achieved. As shown in FIG. 2: (a) the output from photodetector 275 is applied as input to demodulator 285 to be demodulated; (b) the demodulated output from demodulator 285 is applied as input to analog-to-digital converter 295 (A/D 295) to be convened to a digital signal; and (c) the digital signal output from A/D 295 is applied as input to computer 210 for analysis. In accordance with the present invention, the interference signal output from photodetector 275 vanishes as soon as the optical path difference between radiation reflected from the object (eye 8) and radiation reflected from helical reference mirror 290 becomes larger than the coherence length of source 220. Referring back to FIG. 1, to provide transverse scanning of the OCT beam, scanner mirrors 5 and 6 are orthogonally mounted, scanner mirrors which are mounted on a pair of galvanometers (not shown) for scanning. The pair of scanning galvanometers and a motor which rotates helical reference mirror 290 are operated under the control of computer 210 in a manner which is well known to those of ordinary skill in the art. This provides information to computer 210 which enables it to determine three-dimensional coordinates from the geometry of the apparatus; scanner mirrors 5 and 6 providing a raster scan and helical reference mirror 290 providing a depth scan. In accordance with the present invention, and as shown in FIG. 1, the radius of mirror 7 is chosen so that the principal ray of the scanned beam always goes through the center of curvature 15 of the cornea of eye 8. As the OCT sample beam output from fiber 250 is tranversely scanned by scanner mirrors 5 and 6, the optical path length from 50/50 coupler 240 to dotted curve 71 in front of eye 8 is constant for all positions of scanner mirror 6. Further, this constant optical path length is equal to the optical distance between 50/50 coupler 240 and helical reference mirror 290 for home position 291, i.e., the high point of helical reference mirror 290. In addition, dotted curve 72 describes a curve of equal optical path length for home position 292, i.e., the low point of helical mirror 290. At each transverse position provided by scanner mirrors 5 and 6, helical reference mirror 290 is caused to rotate by 360 degrees to provide a depth scan over a distance of 2h, i.e., the distance between dotted curves 71 and 72. During a depth scan, the OCT signal received by computer 210 provides data which is used to locate the structure of the cornea at the respective transverse position. As one can readily appreciate from this, in accordance with the present invention, the data acquisition time has been shortened by use of a helical mirror and by reducing the depth scan to a distance equal to 2h. In accordance with the present invention, 2h is adjusted to be the minimum distance required to span the corneal thickness. In accordance with the present invention, eye 8 is monitored using CCD camera 115 which is placed at a position which is conjugate to the iris of eye 8. As shown in FIG. 1, infrared light from infrared source 80 illuminates eye 8. Infrared source 80 is obtained, for example, by filtering an incandescent lamp with an infrared filter. The infrared light illuminated iris of eye 8 is imaged onto CCD 115 by lens 135 through notch filter 20 in curved mirror 7. In accordance with the present invention, notch filter 20 reflects radiation at wavelengths of the OCT sample beam, for example, wavelengths substantially equal to 850 nm, with a reflectivity of about 90% (transmissivity of about 10%) and transmits the infrared light which illuminates eye 8. The reflectivity of the remainder of curved mirror 7 to radiation at wavelengths of the OCT sample beam is also about 90%. The image produced by CCD camera 115 shows eye 8 and a scan trace of the OCT sample beam on the iris and on the vertex of the cornea. The image of the scan trace of the OCT sample beam results from radiation reflected by eye 8 which is transmitted through notch filter 20. A scan trace can be imaged even though transmission of the reflected OCT sample beam is small since CCD camera 115 is very sensitive to radiation at wavelengths in the region of 850 nm. FIG. 6 shows, in pictorial form, a scan pattern produced by OCT corneal mapping apparatus 100. FIG. 6 shows OCT sample beam scan traces 300-350, iris 360, and pupil 370. Because reflection from pupil 370 is very low, the CCD image shows pupil 370 to be dark and to be surrounded by a bright iris 360. Further, the image of OCT sample beam scan traces 300-350 exhibit a dark portion where the scan traces pass though an area corresponding to pupil 370 (except for the vertex of the cornea) and a bright portion when they pass through an area corresponding to iris 360. As a result, one can manually reposition apparatus 100 so that the OCT sample beam scan traces pass through the center of pupil 370. In addition, the image produced by CCD camera 115 can be analyzed by computer 210 to determine the center of pupil 370 by edge detection and the position of the scan traces be adjusted in response thereto. In response to data acquired during the depth scans, computer 210 identifies various portions of the cornea at a transverse scan point by detecting various signal-strength maxima. In accordance with the present invention, scanner mirrors 5 and 6, in accordance with instructions from computer 210, provide a raster, i.e., transverse, OCT scan of the cornea and OCT interferometer 1, in accordance with instructions from computer 210 to helical reference mirror 290, provides a depth OCT scan of the cornea. The results are analyzed by computer unit 210 to obtain corneal topography measurements such as: (a) anterior corneal surface contours, (b) posterior corneal surface contours, and (c) the thickness of the cornea. These data can be used, for example, for on-line monitoring of corneal refractive power during a refractive surgical procedure or for fitting contact lens and so forth. In one embodiment of this first aspect of the present invention, thresholds are input to computer 210 for the purpose of identifying signal maxima corresponding to predetermined surfaces of the cornea. Then, computer 210 makes a correspondence between signals having levels above the maxima with the predetermined surfaces and captures the spatial coordinates of the surfaces in space from the position of the OCT sample beam in the raster scan and the depth coordinates of the surfaces from the position of helical reference mirror 290 in the depth scan. These values in space are stored in computer 210. The thickness of the cornea can be determined from the spatial difference between signal peaks produced by the posterior and anterior corneal surface during a depth scan and the well known optical properties of the cornea, such as, for example, index of refraction. When the raster scan is completed, computer 210 performs a fit of the spatial coordinates of the surfaces to provide posterior and anterior corneal surface contours. Then, the surface contours are utilized to provide a measure of the curvature of the posterior and anterior surfaces of the cornea and, from them, a measure of corneal refractive power. FIG. 5 shows, in pictorial form, a second embodiment of the present invention which comprises OCT corneal mapping apparatus 500. As shown in FIG. 5, OCT corneal mapping apparatus 500 comprises CW radiation source 220, for example, a superluminescent laser diode having an output centered substantially at 850 nm. Output from radiation source 220 is directed toward beamsplitter 540. Beamsplitter 540 splits the output into reference beam 541 which is directed toward retroreflector 550 and sample beam 542 which is directed toward a scanner apparatus, which scanner apparatus is comprised of orthogonally mounted, galvanometer driven scanner mirrors 565 and 566 which are mounted on a pair of galvanometers (not shown). Scanner motors 565 and 566 are operated under the control of computer 210 in a manner which is well known to those of ordinary skill in the art. The raster scanner formed of scanner mirrors 565 and 566 is located in the back focal plane of scanner lens 31. This provides a telecentric optical configuration wherein the principal rays of scanned sample beam 542, in the various scan positions, are parallel. Further, this telecentric optical configuration guarantees that the scan length on the cornea is independent of the cornea in the z direction, i.e., along the direction shown by arrow 1000 in FIG. 5. However, the "surface of equal path length" for a raster scan is a plane which is indicated by dotted curve 571 in FIG. 5. This is disadvantageous in that plane 571 is not adapted to the geometry of the cornea and results in scan volumes and data acquisition times which are larger than are required to determine a corneal mapping. In accordance with the present invention, the scan volumes are decreased by changing the path length of reference beam 541 at various positions of the raster scan. This is done by moving retroreflector 550 to change the path length of reference beam 541 as a function of scan angle of OCT sample beam 542. As shown in FIG. 5, retroreflector 550 is moved by galvanoscanner 532. For example, wand 535 is affixed to galvanoscanner 532 and to retroreflector 550. Whenever galvanoscanner 532 is activated (in a manner which will be described below), wand 535 is rotated and retroreflector 550 is moved along a direction indicated by arrow 1010. Since the required movement of galvanoscanner 532 is small, subsequent movement of retroreflector 550 is substantially along a straight line. As a result, and in accordance with a preferred embodiment of the second aspect of the present invention, the motion of galvanoscanner 532 changes the plane indicated by dotted curve 571 into a spherical surface having a radius substantially equal to the radius of the cornea, which radius is in the order of 8 mm. As further shown in FIG. 5, reference beam 541 is directed from retroreflector 550 toward helical reference mirror 290. At each transverse position provided by scanner mirrors 565 and 566, helical mirror 290 is rotated by 360 degrees to provide a depth scan over a distance of 2h in the manner discussed above with respect to embodiment 100 shown in FIG. 1. Helical reference mirror 290 is rotated with a substantially constant velocity by means which are well known to those of ordinary skill in the art (not shown). Reference beam 541 is reflected from helical reference mirror 290 and is superimposed, by beamsplitter 540, with radiation from sample beam 542 which is reflected by eye 8. The superimposed radiation is detected by photodetector 275. The output from photodetector 275 is demodulated by demodulator 285, the demodulated output from demodulator 285 is converted to a digital signal by analog-to-digital converter 295 (A/D 295), and the output from A/D 295 is applied as input to computer 210 for analysis. During a transverse scan of sample beam 542 by scanner mirrors 565 and 566, helical mirror 290 rotates a predetermined number of times, for example, n. The pair of scanning galvanometers which drive scanner mirrors 565 and 566 and a motor which rotates helical reference mirror 290 are operated under the control of computer 210 in a manner which is well known to those of ordinary skill in the art. In accordance with a preferred embodiment of the present invention, OCT data are collected synchronously by computer 210 so that, for example, n depth scans provided by n rotations of helical reference mirror 290 occur during one transverse scan. The OCT signals received by computer 210 from detector 275 are preferably analyzed in real time. The coordinates of various corneal structures are determined by analysis of peaks of the OCT signal received by computer 210 in the manner described above with respect to OCT corneal mapping apparatus 100. As has been described above, a depth scan is made at predetermined points in the raster or transverse scan. During the depth scan at a point in the transverse scan, particular signal peaks locate particular corneal structures and the depths of the particular corneal structures at the point in the transverse scan depends on the path length difference between reference beam 541 and sample beam 542. However, the path length difference changes as a function of scan angle because of the curved shape of the cornea. In accordance with the second aspect of the present invention, during a transverse scan, computer 210 determines the depth of a particular corneal structure at a first point in the transverse scan, for example, the anterior surface of the cornea, by detecting a signal peak. Next, computer 210 compares the depth of the anterior surface at the first point with the depth of the anterior surface at a predecessor point along the transverse scan. The difference in depth of the anterior surface at the two adjacent points along the transverse scan is used to move retroreflector 550 so that it tracks the curved shape of the cornea. This tracking is done by having computer 210 apply the negative of the difference in depth of the anterior surface at the two adjacent points as an input signal to galvanoscanner 532 through filter 555. In response to this signal, galvanoscanner 532 moves retroreflector 550 so that it causes the depth scan to follow the surface of the cornea. As a result, an effect is produced wherein the surface of constant path length difference, i.e., dotted curve 571, adapts automatically to the surface of the cornea under investigation. In this manner, and in accordance with the present invention, the data acquisition time of the depth scan is shortened. Filter 555 is used to avoid oscillation of galvanoscanner 532 and may be fabricated as a PI-controller which is well known to those of ordinary skill in the art. Lastly, as shown in FIG. 5, eye 8 is monitored with CCD camera 115 in a manner similar to that shown for embodiment 100 of FIG. 1. In particular, eye 8 is illuminated with infrared light from infrared source 80 which is obtained, for example, by filtering an incandescent lamp with an infrared filter. The infrared light reflected from eye 8 is imaged onto CCD 115 by lens 537 through notch filter 575. In accordance with the present invention, notch filter 575 reflects the infrared light which illuminates the eye and transmits wavelengths of the OCT beam, for example, wavelengths substantially equal to 850 nm. Those skilled in the art will recognize that the foregoing description has been presented for the sake of illustration and description only. As such, it is not intended to be exhaustive or to limit the invention to the precise form disclosed. For example, modifications and variations are possible in light of the above teaching which are considered to be within the spirit of the present invention. Thus, it is to be understood that the claims appended hereto are intended to cover all such modification and variations which fall within the true scope and spirit of the invention.

Optical coherence tomography ("OCT") corneal mapping apparatus includes an OCT apparatus having a rotating helical mirror for altering a reference beam path in the OCT apparatus; a raster scanner for raster scanning sampling optical output from the OCT apparatus; a curved mirror for transferring the sampling optical output from the raster scanner to an eye and for transferring sampling optical output reflected from the eye back to the OCT apparatus through the raster scanner; and an analyzer, coupled to the raster scanner, the rotating helical mirror, and reference and sampling interaction output from the OCT apparatus. The analyzer causes the raster scanner to scan the sampling optical output to points in a raster; causes the rotating mirror to alter the length of the reference beam path over a predetermined amount at each of the points in the raster; and provides the corneal mapping from the reference and sampling interaction output at the points in the raster.

[0001] This application is a Continuation in Part Application to U.S. patent application Ser. No. 13/183,020 filed on Jul. 14, 2011, which claims the benefit of U.S. Provisional Application No. 61/364,128 filed on Jul. 14, 2010, both of which are fully incorporated herein by reference. FIELD OF INVENTION [0002] The invention pertains to methods, apparatus, and systems for performing endoscopic ligament release surgery, such as carpal tunnel release, plantar fasciotomy, gastroc release, cubital tunnel release, and tarsal tunnel release surgery, and similar surgical procedures on anatomic members. BACKGROUND [0003] Carpal tunnel syndrome occurs when the median nerve is squeezed where it passes through the carpal tunnel, thereby causing insanguination of the nerve, which leads to numbness, a cold feeling, and/or pain in the hand and fingers. The carpal tunnel is an anatomic passageway at the base of the wrist through which the median nerve and the flexor tendons for the fingers of the hand pass. It is defined by the carpal bones of the hand and the transverse carpal ligament. Carpal tunnel syndrome is commonly caused by highly repetitive hand motions over a number of years. For instance, carpal tunnel syndrome is common in certain professionals such as secretaries and other professionals who type on a keyboard regularly, carpenters, dentists or anyone who performs the same hand motions repeatedly and regularly. [0004] The current standard of care for alleviating carpal tunnel syndrome is to incise the transverse carpal ligament to open up the carpal tunnel and release the pressure on the median nerve. With few exceptions, most people can manage daily activities with a severed transverse carpal ligament with almost no adverse effects. [0005] The particular current procedure for carpal tunnel release is an endoscopic or arthroscopic procedure in which an incision is made in the wrist proximal of the carpal tunnel. An endoscope with a camera is inserted into the incision and through the carpal tunnel to allow the surgeon to visualize the carpal tunnel, and, particularly, the transverse carpal ligament, and then a knife is inserted alongside the endoscope to cut the transverse carpal ligament. SUMMARY OF INVENTION [0006] The invention pertains to a method, apparatus, and system for cutting anatomic members, such as ligaments, in surgical procedures such as carpal tunnel release, plantar fasciotomy, gastroc release, cubital tunnel release, and tarsal tunnel release. The apparatus includes a retrograde knife and a guide tool for guiding the knife and a scope during surgery. Relevant features include a knife stop for preventing the knife from inadvertently raising out of the knife channel, indicators showing the proper orientation for the guide tool, a self dilating tip and channel design on the guide tool, a cover piece and/or pivotable panel system for preventing ligaments and other anatomy from getting caught in the guide tool, a pivot pin and groove system for stabilizing the knife and also assuring that the knife blade is not inadvertently raised out of the channel, and a use indicator for preventing re-use of a single use device. BRIEF DESCRIPTION OF THE DRAWINGS [0007] FIG. 1 is a diagram illustrating use of one particular endoscopic carpal tunnel release apparatus and method in accordance with the prior art. [0008] FIG. 2 is a perspective view of a guide in accordance with one particular embodiment of the invention. [0009] FIG. 3 is a close up view of the distal end of the guide of FIG. 2 . [0010] FIG. 4A is a perspective view of a guide in accordance with a second embodiment of the invention viewed from a first perspective. [0011] FIG. 4B is a perspective view the guide in accordance with the second embodiment of the invention viewed from a second perspective. [0012] FIG. 4C depicts a mode of the device in a view similar to that of 4 A showing a shorter version without the extending handle portions at the proximal end. [0013] FIG. 4D depicts a mode of the device in a view similar to that of 4 B showing a shorter version without the extending handle portions at the proximal end. [0014] FIG. 5 is a perspective view of the distal portion of a guide in accordance with a third embodiment of the invention. [0015] FIG. 6A is a perspective view of a guide in a first condition in accordance with a fourth embodiment of the invention. [0016] FIG. 6B is a perspective view of the guide of the fourth embodiment in a second condition. [0017] FIG. 7A is a cross sectional side view of the longitudinal member of a guide in a first condition in accordance with a fifth embodiment of the invention. [0018] FIG. 7B is a cross sectional side view of a distal longitudinal member of a guide in a second condition in accordance with the fifth embodiment of the invention. [0019] FIGS. 8A and 8B show a cover member and guide, respectively, in accordance with a sixth embodiment of the invention. [0020] FIG. 9A is a transverse cross-section of a guide in accordance with a seventh embodiment of the invention. [0021] FIG. 9B is a side view of a knife in accordance with the seventh embodiment of the invention [0022] FIG. 9C is a top view of the guide and knife of FIGS. 10A and 10B assembled. [0023] FIG. 10A is a perspective view of a knife prior to sterilization in accordance with an eighth embodiment of the invention. [0024] FIG. 10B is a close up perspective view of the proximal end of the knife in accordance with the eighth embodiment. DETAILED DESCRIPTION OF THE EMBODIMENTS [0025] Referring to FIG. 1 , one system available on the market today is the SEG-Way system offered by Core Essence Orthopedics, Inc. of Fort Washington, Pa., USA. The SEG-Way system comprises, among other things, a guide 10 and a retrograde knife 12 . As seen in FIG. 1 , the guide 10 compromises a longitudinal member 14 , containing a channel 16 . The channel 16 is for receiving the endoscope 20 and the knife 12 side-by-side. A key feature of the SEG-Way system is that the endoscope and knife are entirely independently manipulable. The guide further comprises a transverse member 19 at its proximal end comprising two wings 21 and 22 extending in opposition transverse directions from the proximal end 23 of the longitudinal member 14 . The wings 21 , 22 provide a place for the surgeon to hold the guide as well as some stability against rotation about the longitudinal axis 24 of the longitudinal member because the wings essentially rest upon the forearm 26 of the person after the guide has been inserted through the incision 25 . [0026] In use, the incision 25 is made in the wrist proximal to the carpal tunnel 27 and the longitudinal member 14 of the guide 10 is advanced distally into and through the carpal tunnel, thereby dilating the carpal tunnel. Once the guide 10 is fully inserted and through the carpal tunnel 27 , the endoscope 20 is advanced through the first channel 16 to allow the surgeon to see the carpal tunnel, and particularly, the transverse carpal ligament 30 . Then, the knife 12 is advanced distally within the channel 16 . As can be seen in FIG. 1 , the knife comprises a handle 34 and a distal segment 36 disposed at an angle 38 to each other and has a hooked, retrograde blade 29 at the distal end of the distal segment 36 that faces proximally and cuts when the knife is pulled back in the proximal direction. The angled junction 38 between the handle 34 and the distal segment 36 of the knife 12 generally defines a pivot point about which the knife will be rotated after insertion and prior to cutting. More particularly, the knife 12 is inserted into the channel 16 with the distal segment 36 lying flat in the channel 16 and flush against the bottom of the channel with the blade 29 concealed inside the channel 16 until it is past the transverse carpal ligament so as not to contact any anatomy. This inherently means that the handle segment 34 will be angled upwardly. Then, the surgeon pushes down on the handle to cause the distal segment, and particularly, the retrograde blade to rise up out of the channel 16 so that it can engage the distal edge 30 a of the transverse carpal ligament 30 and cut it by drawing the knife 12 back in the proximal direction. [0027] FIG. 2 is a perspective view looking substantially from the proximal end of a guide member in accordance with a first embodiment of the present invention. FIG. 3 is a close up view of the distal end of the guide member of FIG. 2 . The guide 100 comprises a longitudinal member 101 and a transverse member 102 . The transverse member comprising two wings 103 and 105 extended laterally from the proximal end 104 of the longitudinal member 101 . The longitudinal member 101 defines two channels 107 and 109 separated by a partition, such as a ridge 106 in a surface of the longitudinal member for accepting a scope, such as an endoscope or arthroscope, and a knife, respectively. [0028] One issue of which surgeons must be aware when using carpal tunnel release surgical systems of the type shown in FIGS. 1 and 2 is the fact that the cutting tip of the knife should remain concealed within the knife channel 109 so as not to accidentally engage anatomy when the knife is being inserted distally through the carpal tunnel. This, of course, is achieved by holding the knife handle at an angle to the longitudinal axis 108 so that the distal segment of the knife lays flat on the bottom surface 113 of the channel 109 as described above in connection with FIG. 1 . However, if the knife is advanced distally far enough into the channel to engage the endwall or distal wall 115 of the channel 109 , if that wall is at an obtuse angle to the longitudinal axis 108 of the guide, the wall may divert some of the distally directed advancing force on the knife upwardly, thereby deflecting the distal end of the knife, i.e., the blade to exit the safe area inside the channel 109 and possibly cut anatomy inadvertently. [0029] Thus, in accordance with this embodiment of the invention, the end wall 115 of the channel 109 forms an angle 118 with the bottom 113 of the channel 109 that is substantial enough that any distally-directed advancing force on the knife is not easily redirected upwardly so as to cause the distal end of the knife to rise up out of the channel 109 . This angle 118 may be a right angle (90°). However, it can be an acute angle so that engagement of the end of the knife with the wall 115 actually applies a downward force on the distal end of the knife. Generally, no downward motion of the distal end of the knife will actually occur because the distal segment of the knife already should be flush against the bottom 113 of the channel 109 . However, if the surgeon is holding the knife at an incorrect angle so that the distal end of the knife is not flush against the bottom of the channel, the engagement with the end wall 115 may actually help by pushing the distal end of the knife down into the channel until it is flush with the bottom surface 113 . [0030] In other embodiments, the angle may even be slightly greater than 90°. Specifically, since there will be some friction between the knife and the wall 115 such that contact between the end of the knife and the wall under reasonably expected loads still would not result in the knife sliding upward along the end wall 115 and rising out of the channel. [0031] Additionally, the ridge 106 between the endoscope channel 107 and the knife channel 109 helps prevent the endoscope and knife from inadvertently interfering with each other. Specifically, in prior devices having a single channel for containing both the endoscope and the knife, the scope and knife would often cross over into each other's spaces within the single channel, sometimes causing difficulty in individually advancing, withdrawing, tilting, turning, or otherwise moving the endoscope and/or knife. The present design with two channels 107 , 109 separated by a ridge 106 essentially keep each of the endoscope and knife from crossing over into the channel of the other instrument and interfering with it. [0032] FIGS. 4A and 4B are right-side and left-side perspective views of a second embodiment of the guide 200 illustrating another feature. Particularly, with respect to the human body, medical personnel generally adhere to certain semantic conventions for clarity. For instance, the term “medial” is generally used to describe a direction towards the center of the body, and the term “lateral” is generally used to describe a direction away from the center of the body. However, with respect to the hands, this language is not sufficiently definite because a person can hold one's hand in different orientations, e.g., with the palm facing towards the sky or with the palm facing towards the ground. Accordingly, the terms medial and lateral are indefinite with respect to hands. Hence, with respect to the hand, the terms “ulnar” and “radial” often are used instead. Ulnar refers to the direction from the center of the hand towards the ulnar nerve. The ulnar nerve runs along the length of the hand on the pinky side of the hand. Accordingly, the ulnar direction is the direction transverse the length of the hand facing from the center of the hand towards the pinky as illustrated by arrow 13 in FIG. 1 . Radial, of course, is the opposite direction, as illustrated by arrow 15 in FIG. 1 . [0033] FIGS. 4C and 4D are right-side and left-side perspective views of the device in similar configuration to that of FIGS. 4A and 4B but showing a shorter version without the two wing type projections at the proximal end in a mode which might be employed on other parts of the body such as the feet. [0034] When performing endoscopic carpal tunnel release surgery using a guide such as any of guides 10 , 100 , and 200 , it is desirable to have the camera on the radial side and the knife on the ulnar side because the guide is inserted to the ulnar side of the medial nerve. This places the endoscope against the medial nerve, which is preferred because it separates the medial nerve from the knife for extra safety in avoiding accidental nicking of the medial nerve with the knife. Accordingly, it is desirable to provide different guides for the right hand and the left hand. Therefore, to help avoid confusion, the two guides should be clearly marked, such as with an L and an R for the left-hand and right-hand guides, respectively. FIGS. 4A and 4B , for instance, illustrate the left hand guide and, it can be seen that there is a prominent L printed on one of the transverse wings. [0035] Nevertheless, there still tends to be confusion during surgery as to the proper choice and orientation of the guide. Accordingly, in addition to clearly marking the guide as left or right, each guide member is also marked to indicate which side of the guide 200 should be facing towards the radial direction and the ulnar direction. This may be accomplished, for instance, by printing the words “radial” 202 and/or “ulnar” 204 on the sidewall of the channels as shown in FIGS. 4A and 4B . [0036] FIG. 5 is a perspective view of the distal end of a guide 300 according to a third embodiment. Particularly, as previously described, the distal tip of the guide leads the guide into and through the carpal tunnel. The carpal tunnel is rather tightly packed with flexor tendons and the median nerve. Accordingly, tip 301 is shaped to better assist in dilating the carpal tunnel and spreading the various flexor tendons and radial nerve to create room for the guide to pass through the carpal tunnel. [0037] More specifically, the distal tip 301 of the guide 300 is prow shaped in order to ease the insertion of the distal tip of the guide into the carpal tunnel and to assist in the dilation of the carpal tunnel and the spreading of the flexor tendons and the medial nerve to allow the longitudinal member 302 of the guide to pass through the carpal tunnel. As can be seen, the distal tip is shaped like the prow of a boat. Particularly, it is pointy without being sharp and it is curved upward slightly. [0038] FIGS. 6A and 6B illustrate an alternative embodiment of the longitudinal portion 401 of a guide 400 designed to even further ease insertion of the longitudinal portion 401 of the guide into the carpal tunnel and to more efficiently dilate the tunnel. In accordance with this embodiment, the longitudinal portion 401 of the guide 400 actually comprises two longitudinal members 404 , 406 that are collapsible and expandable in the transverse dimension 402 relative to each other. In this manner, the longitudinal portion 401 of the guide 400 can be initially inserted into and through the carpal tunnel while in the collapsed condition shown in FIG. 6A in order to ease insertion by virtue of having a smaller profile in the transverse dimension (the ulnar/medial direction) and be expandable to the expanded condition shown in FIG. 6B to further dilate the carpal tunnel and provide the necessary room for the endoscope and knife within the longitudinal portion 401 . In the exemplary embodiment illustrated in FIGS. 6A and 6B , the first longitudinal member 404 defines the endoscope channel 408 and the second longitudinal member 406 defines the knife channel 405 . The second longitudinal member 406 is a transversely translatable L-shaped member. In the closed position, the bottom leg 407 of the L-shaped second longitudinal member 406 slides into a groove (not shown) under the endoscope channel 408 of the first longitudinal member 404 so that the vertical leg 409 of the L-shaped second longitudinal member 406 butts up against the ulnar-side wall 411 of the endoscope channel 408 . This essentially collapses the knife channel 405 to nothing and reduces the cross-section of the guide portion 404 . The longitudinal portion 404 of the guide 400 can be initially inserted into and through the carpal tunnel in the collapsed condition shown in FIG. 6A . Then, after initial insertion and, perhaps, after waiting a designated period of time to allow the carpal tunnel to dilate and adjust to accommodate the collapsed longitudinal portion 401 , the L-shaped second longitudinal member 406 can then be slid transversely outwardly into the expanded condition illustrated in FIG. 6B , with the bottom leg 407 of the L-shaped member 406 sliding out from under the first longitudinal member 404 to open the knife channel 405 . [0039] The mechanism for permitting the longitudinal member to be collapsible and expandable may take many forms. One such mechanism comprises transverse grooves in the bottom leg 407 of the L-shaped member 406 that mate with pegs protruding from underneath the endoscope channel 408 . The transverse grooves can slide laterally relative to the pegs. The transverse grooves may have detents at two positions to provide a higher resistance to transverse sliding when in the fully collapsed position and the fully opened position. The movement between the collapsed position and open position can be actuated by any number of mechanisms. For instance, a turnbuckle-type screw runs through a longitudinal channel underneath the endoscope channel 408 , the proximal half of the screw being right-hand threaded and the distal half of the screw being left-hand threaded. Each half of the screw bears a matingly threaded wedge-shaped nut that sits within a mating cut out in the bottom leg 407 of the L-shaped member 406 . The proximal end of the screw protrudes from the proximal end of the longitudinal member and has a thumb wheel to allow the surgeon to turn it by hand. Instead of a thumb wheel, the screw may have a contoured head that mates with an instrument, such as a screwdriver, to turn the screw. When the screw is turned in one direction, the mating threads in the wedges and on the screw cause the wedges 437 , 438 to move toward each other; causing the edges of the wedges to travel along the adjacent edges of the cutouts, thus pushing the L-shaped member 406 transversely outward. [0040] This exposes (or creates) the knife channel 405 , which is defined by the inner surface 409 a of upper leg 409 of the L-shaped second longitudinal member 406 , the upper surface 407 a of the bottom leg 407 of the L-shaped second longitudinal member 406 , and the ulnar-side outer surface 411 a of the first longitudinal member 404 . The endoscope and knife can then be advanced into their respective channels 408 and 405 and the procedure performed. After the procedure is performed and the knife and endoscope are withdrawn from their channels, the screw may be turned in the opposition direction. The force of the wedge pushing the L-shaped second longitudinal member transversely outward is thus released and the surrounding forces of the flexor tendons, median nerve, and other anatomy in the carpal tunnel on the outer surface 409 b of upper leg 405 of the L-shaped member 406 will push the L-shaped member 406 back to the collapsed position shown in FIG. 6A . The guide 400 may then be withdrawn while in this collapsed state. If desired, the edges of the wedge nuts can be provided with pegs that fit within further grooves in the adjacent edges of the triangular cutouts so that the pegs cannot escape from the grooves, but can only travel within the grooves. In this manner, turning the screw in the opposite direction will actually draw the L-shaped member back inwardly in and of itself without the need to rely on any external forces from the tendons and/or medial nerve in the carpal tunnel. [0041] FIGS. 7A and 7B illustrate a fifth embodiment of a guide 500 . Particularly, FIGS. 7A and 7B are transverse cross-sectional slices of the longitudinal member 501 of the guide 500 in accordance with this embodiment. FIG. 7A illustrates the closed position and FIG. 7B illustrates the open position. In this embodiment, the outer walls 545 , 547 of the endoscope and knife channels 507 , 509 bear panels 551 , 553 that are rotatable on pins 555 , 557 between a first position as illustrated in FIG. 7A and a second position as illustrated in FIG. 7B . [0042] Initially and throughout most of the procedure, the panels remain in the first position and simply form part of the walls 545 , 547 of the two channels 507 , 509 . However, after the ligament has been cut and the guide 500 is to be withdrawn from the carpal tunnel, the panels 551 , 553 may be flipped into the closed position illustrated in FIG. 7B to help prevent pieces of the cut ligament or other anatomy from falling into the channels 507 , 509 . [0043] Particularly, it is not uncommon for pieces of the cut ligament to hang down into the channels of the longitudinal member 501 of the guide 500 and potentially be pulled by the guide 500 as it is withdrawn, which would cause unnecessary pain and possible damage to the patient. In accordance with this embodiment, the panels 551 , 553 can be rotated into the second position shown in FIG. 7B . As can be seen in FIG. 7B , in this position, the panels 551 , 553 block off a significant portion of the channels 507 , 509 . As they are rotated up, the panels would tend to push out any ligament that has fallen into the channel. Furthermore, as the guide 500 is withdrawn from the carpal tunnel, the panels will substantially prevent ligament strands and other anatomy from falling into the channel and potentially getting caught in the channels. [0044] In the illustrated embodiment, the panels 551 , 553 do not fully close off the channels 507 , 509 . This is acceptable because the ligaments tend to get caught on the edges of the channels rather than in the middles of the channels. However, if desired, the panels 551 , 553 can be made wide enough to meet each other in the second position to completely close off all of the channels. Preferably, the panels 551 , 553 run the entire length of the channels, but shorter lengths that leave a small portion of the channels exposed at either the proximal or distal end of the channels would be acceptable. [0045] The mechanism for rotating the panels between the first and second positions can take many forms. In the illustrated embodiment, the panels are fixedly mounted on longitudinal pins 555 , 557 that run in holes 561 , 563 the full length of the channels 507 , 509 . The proximal ends of those pins 555 , 557 protrude from the proximal end of the longitudinal member and bear thumb wheels for allowing the surgeon to rotate the pins 555 , 557 . The panels 551 , 553 can be fixable in any position, not just the first and second positions. For instance, at least the proximal ends of the pins can be threaded and nuts 565 , 567 can be provided near the proximal end of each pin and so that the nuts can be rotated on the pins as desired to abut the proximal end of the longitudinal member 501 and thereby lock the pins/panels in any desired orientation. [0046] The panels 551 , 553 also may be rotated and locked in the second positions to close off the channels during initial insertion of the guide 500 into and through the carpal tunnel. Particularly, although less common, it is possible for the transverse carpal ligament, flexor tendons, medial nerve or other anatomy to get caught in one of the channels 507 , 509 during insertion too. Accordingly, it may be desirable to flip up the panels during both insertion and withdrawal of the guide from the carpal tunnel or other anatomical passageway. [0047] FIGS. 8A and 8B illustrate aspects of a sixth embodiment of the invention having some of the same advantages as the fifth embodiment described above in connection with FIGS. 7A and 7B . [0048] More particularly, in this embodiment, a cover piece 680 illustrated in FIG. 8A is provided to completely cover the channels 607 , 609 in the longitudinal member 601 of the guide 600 (illustrated in FIG. 8B ) during insertion into and/or withdrawal. In this embodiment, the cover 607 piece comprises two members 681 , 683 , one shaped to exactly fill the endoscope channel 607 and the other shaped to exactly fill the knife channel 609 . The two members 681 , 683 are joined to each other through a proximal end piece 685 . The cover piece is inserted simply by pushing it distally into the longitudinal member from the proximal end openings 607 a , 609 a of the channels 607 , 609 . The cover piece 680 fully fills both channels 607 , 609 . [0049] In use, the cover piece 680 is inserted into the longitudinal member 601 prior to insertion of the guide 600 into the carpal tunnel. The cover piece 680 serves the purpose of closing off the channels, thereby preventing ligaments and other fibers from getting caught in the channels as the guide is advanced into and through the carpal tunnel. Once the guide 600 is inserted, the cover member 680 can be withdrawn proximally to expose the channels 607 , 609 so that the endoscope and knife can be inserted into their respective channels. If desired, after the procedure is performed, the cover member 680 may be reinserted into the channels 607 , 609 prior to withdrawing the guide 600 from the carpal tunnel in order to again close off the channels and prevent ligament strands and other fibers from getting caught in the channels as the guide is pulled out. [0050] FIGS. 9A, 9B, and 9C illustrate a seventh embodiment of the invention. FIG. 9A is a transverse cross-section view through the guide of this embodiment. FIG. 9B is a side view of the knife in accordance with the seventh embodiment. FIG. 9C is a top view of the knife in accordance with the seventh embodiment. In this embodiment, two pin grooves 711 , 712 are provided in the knife channel 709 of the longitudinal member 701 of the guide 700 , the pin grooves 711 , 712 are open to the proximal end of the guide. Mating pins 713 , 714 for sliding in the grooves 711 , 712 are provided on the body of the retrograde knife 770 . Hence, the height of the pin grooves 711 , 712 within the knife channel 709 and the position of the pins 713 , 714 on the knife 770 are selected so that, when the knife is inserted into the channel with the longitudinal dimension of the distal portion 771 of the knife 770 parallel to the channel 709 and concealed within the channel 709 , the pins 713 , 714 meet the grooves 711 , 712 and can ride within the grooves in the longitudinal direction, thereby allowing the knife 770 to slide freely in the knife channel 709 in the longitudinal direction, but fixing the height of the knife in the channel at the location of the pins. The mating grooves 711 , 712 and pins 713 , 714 provide a defined position about which the knife can be pivoted to raise the retrograde blade out of the channel for cutting the ligament. More particularly, the height of the pivot point is fixed by the height of the grooves 711 , 712 . However, while the pivot pins 713 , 714 define the precise axis about which the knife can be pivoted, the longitudinal position of those pins within the grooves is freely and fully adjustable within the grooves. [0051] The combination of the pivot pins 713 , 714 and the pivot grooves 711 , 712 also provides increased stability to the knife 770 during distal advancement of the knife into the channel 709 insofar as the height of the knife is vertically fixed in the channel at the point where the pivot pins are positioned on the knife. As long as the surgeon maintains a neutral or upward force on the handle 772 of the knife, the distal segment 771 of the knife will remain entirely in the knife channel 709 . On the other hand, in the absence of the pivot pins and grooves, the surgeon would need to be much more careful when inserting the knife to assure that the entire distal segment 771 of the knife 770 remained in the channel 709 . Even further, the pivot pins/grooves combination also provides greater knife stability against roll (see arrow 747 ) about the longitudinal axis 749 of the distal segment 771 of the knife 770 . [0052] The pivot pins 713 , 714 should be positioned on the knife 770 at an axis around which it is most desirable to pivot the knife. This will usually be at or very near the point 781 defining the base of the angle between the handle portion 772 of the knife and the distal portion 771 of the knife. The diameter of the pivot pins 713 , 714 should be very close to the height, h, of the pivot pin grooves 711 , 712 so that there is very little vertical play between the pivot pins and the pivot pin grooves, but should allow the pins to slide freely in the grooves. The grooves may run the entire length of the knife channel so that the knife can be advanced into the channel to any desired distance. However, in accordance with another embodiment, the groove may have a defined length, I, from the proximal end of the knife channel 709 so that the knife 770 cannot advance distally past the point where the pins 713 , 714 on the knife hit the ends of the grooves 711 , 712 . This length, for instance, may be selected to prevent the distal end 773 of the knife from hitting the distal wall of the knife channel 709 . This would be another potential mechanism for preventing the end of the knife from hitting the end wall of the channel and potentially being damaged and/or accidentally riding up the end wall 710 and out of the channel 709 inadvertently, as discussed above in connection with the embodiment of FIGS. 2 and 3 . [0053] Although the various features disclosed herein have been described in connection with different embodiments of a guide, it should be understood that any and all of the features of each embodiment may be combined in the same instrument in virtually any permutation. [0054] In accordance with another aspect of the invention and with reference to FIGS. 10A and 10B , a portion 802 of the knife 800 , preferably on the handle 801 is composed of a material different than the rest of the knife, which material cannot survive an autoclaving process intact. FIGS. 10A and 10B show the knife prior to sterilization. This is a desirable feature because it will provide an easily identifiable visual cue that the knife has been autoclaved. More particularly, in accordance with at least one embodiment, the entire system, including the guide, knife, and any other related instruments, such as a ligament rasp or a probe, are single-use surgical instruments, i.e., they can only be used once and then should be discarded. However, it is not uncommon for either medical staff or medical equipment resellers to inadvertently or even intentionally attempt to re-use or re-sell medical equipment that is intended only for a single use. In order to reuse any surgical instrument, it must be sterilized after the first use, which usually involves an autoclaving process. Accordingly, providing a portion 802 of the knife that is made of a material that cannot survive autoclaving, can provide a easy visual reference that the device has been previously used, and therefore should not be used again. In the embodiment illustrated in FIGS. 10A and 10B , the portion is a circular medallion 802 near the proximal end of the handle 801 . The knife 800 generally will be made of a biocompatible metal, such as titanium or nitinol. The medallion, however, may be made of a polymer that will melt or otherwise degrade when subjected to a conventional autoclaving process (or any other process that might be used to re-sterilize a medical instrument). [0055] In one embodiment, the medallion may run through the entire width, w, of the handle so that, after autoclaving, a hole will be left in the handle. However, in another embodiment, the button may only comprise a surface layer of material which, when destroyed reveals an underlying non-degradable material, such as the same material that the rest of the knife is made of, bearing a warning indicator indicating that the device has been used and should be not re-used, such as the words “Warning, this instrument has been used and should be discarded” or simply “Discard”. [0056] Having thus described a few particular embodiments of the invention, various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements as are made obvious by this disclosure are intended to be part of this description though not expressly stated herein, and are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description is by way of example only, and not limiting. The invention is limited only as defined in the following claims and equivalents thereto.

A method, apparatus, and system for cutting anatomic members, such as ligaments, in surgical procedures such as carpal tunnel release, plantar fasciotomy, gastroc release, cubital tunnel release, and tarsal tunnel release is disclosed. The apparatus includes a guide tool for guiding a knife and a scope during surgery which may be employed with a translating knife. Relevant features include a knife stop for preventing the knife from inadvertently raising out of the knife channel, indicia viewable to show the proper orientation for the guide tool, a self dilating tip and channel design on the guide tool, a cover piece and/or pivotable panel system for preventing ligaments and other anatomy from getting caught in the guide tool, a pivot pin and groove system for stabilizing the knife and also assuring that the knife blade is not inadvertently raised out of the channel, and a use indicator employable to prevent re-use of the device.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is directed to a device for expelling air or gas from a sealed container through which liquid is pumped. 2. Description of the Related Art One example of a device which includes a sealed container through which liquid is pumped is an canister-type aquarium filter. While application of the present invention is not limited to use with canister-type aquarium filters, such filters will be used to illustrate the problem in the art solved by the present invention. As described in U.S. Pat. No. 4,601,821 to Sherman et al. entitled "Freestanding Aquarium Filter," canister-type aquarium filters include a canister containing filter media, a pump, a first hose connecting the aquarium to the canister, and a second hose connecting the pump to the aquarium. The canister also includes a removable cover which allows access to the filter media within the canister. Typically, canister-type aquarium filters operate in the following manner. First, the pump is energized and water flows out of the pump housing, through the second hose, and into the aquarium. As water flows out of the canister, the water level within the canister decreases. The decrease in water level creates a vacuum within the canister. As used herein, the term "vacuum" refers to an area of reduced pressure. The vacuum within the canister causes water in the aquarium to be drawn into the canister through the first hose. The vacuum increases until the flow of water drawn into the canister equals the flow of water pumped out of canister. The water drawn into the canister passes through a filter media and then is drawn into the pump. One of the major problems associated with devices which draw fluid into a sealed container is a buildup of gas within the container. In the case of canister-type aquarium filters, the presence of air within the canister often results in water noise which in turn leads to user dissatisfaction. Moreover, in those filters with the pump mounted at the top of the canister, the accumulation of gas within the canister may cause a phenomenon commonly referred to as "air lock" or "vapor lock." An "air lock" occurs when gas accumulates in the pump housing or at the entrance to the pump housing and the impeller is unable to expel the gas. Eventually, the accumulated gas will prevent water from entering the pump housing and, accordingly, the pump (and filter) will malfunction. The buildup of gas within the container may be the result of air bubbles and other dissolved gasses present in the fluid. As a variety of devices are used to aerate the water in an aquarium, air bubbles and dissolved gasses are especially prevalent in the water drawn into canister-type aquarium filters. Once inside the canister, the bubbles expand due to the vacuum within the canister and aggregate on the filter media to form larger bubbles. The larger bubbles eventually release from the aggregating surfaces and rise to the top of the canister. Additionally, the buildup of gas within the container may be caused by gas leaking into the container at the seal between the cover and the canister. Such leaks are caused by the vacuum within the canister which draws gas into the canister. The vacuum is greatest when the container is located near or above the level of the reservoir from which the fluid is drawn. Accordingly, gas leaks into the container will be especially prevalent when the container is located at or above the reservoir level. SUMMARY OF THE INVENTION It is an object of the present invention to provide an air expelling device obviating, for practical purposes, the above mentioned limitations. In accordance with the present invention, these and other objectives are achieved by providing an apparatus which traps gas in a predetermined location within the canister and draws the trapped gas into the pump. The gas may then be pumped out of the canister. In one aspect of the invention, a diffuser cup may be arranged above the filter cartridge. As gas rises to the surface of the liquid with the container, it may be trapped by the diffuser cup. Alternatively, the cover of the container may provide an area that accumulates gas which has risen to the surface of the liquid within the container. In another aspect of the invention, a device may be provided which generates a vacuum in the area adjacent the pump inlet. This vacuum is greater than the vacuum within other portions of the container and may be used to draw the gas which has risen to the surface of the container into the area adjacent the pump inlet. The gas may then be pumped out of the container. As a result, the amount of gas within the container may be maintained at a level below that which will result in water noise and "vapor lock." BRIEF DESCRIPTION OF THE DRAWINGS A detailed description of the preferred embodiment of the invention will be made with reference to the accompanying drawings. FIG. 1 is a sectional view of a canister-type filter in accordance with a preferred embodiment of the present invention. FIG. 2 is a sectional view of the embodiment illustrated in FIG. 1 rotated 90 degrees. FIG. 3 is an perspective view of a diffuser cup in accordance the preferred embodiment of the present invention. FIG. 4 is another perspective view of the diffuser cup illustrated in FIG. 3. FIG. 5 is still another perspective view of the diffuser cup illustrated in FIG. 3. FIG. 6 is a perspective view of a discharge tube in accordance the preferred embodiment of the present invention. FIG. 7 is another perspective view of the discharge tube illustrated in FIG. 6. FIG. 8 is a side view of the discharge tube illustrated in FIG. 6. FIG. 9 is a perspective view of a portion of the discharge tube illustrated in FIG. 7. FIG. 10 is a sectional view of a second preferred embodiment of the present invention. FIG. 11 is a sectional view of a third preferred embodiment of the present invention. FIG. 12 is a perspective view of a cover in accordance with a third preferred embodiment of the present invention. FIG. 13 is a perspective view of a portion of the cover illustrated in FIG. 12 DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The following is a detailed description of the best presently known mode of carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The scope of the invention is defined by the appended claims. Moreover, the present invention may be used in conjunction with any number of devices which draw fluid into a sealed container. For illustrative purposes only, three variations of canister-type aquarium filters will be used to demonstrate the features and advantages of the present invention. As illustrated for example in FIGS. 1 and 2, one such variant of canister-type aquarium filter (the subject of a commonly owned and contemporaneously filed application (our docket PD-2148) entitled "Hang on Tank Canister Filter" the subject matter of which is incorporated herein by reference) includes a canister 10, a filter cartridge 12, and a removable cover 14. A clamp wire 16 secures the cover 14 on the canister 10. The cover may include an inlet port (not visible) and an outlet port 15. The filter unit also includes a perforated tube 96, a pump 40, and a discharge tube 74. The pump 40 includes an impeller housing 46 and an impeller 52. The filter cartridge 12 includes a filter media and is supported by a plate 68. As indicated by the arrows in FIG. 1, water enters the aquarium filter from the aquarium 69 through the inlet port and flows downwardly to the filter cartridge 12. Next, the water flows through the filter cartridge 12 and the perforated tube 96 and then into an open space 100 between the perforated tube 96 and the discharge tube 74. Finally, the water flows into the bottom of the impeller housing 46, is acted on by the impeller 52, flows upwardly through the discharge tube 74 and exits the filter unit via the outlet port 15. In accordance with the first preferred embodiment, and as illustrated for example in FIGS. 1 and 2, a diffuser cup 120 may be arranged above the filter cartridge 12. The underside of the diffuser cup defines a gas accumulation space 121. Before initiating operation of the filter, the canister 10 is first filled with water such that nearly all of the water is contained below the diffuser cup 120. When the pump 40 is started, the water level in the canister 10 drops a certain amount, which, in the illustrated embodiment, is approximately 3/8-1/2". The drop in water level is immediately evident below the diffuser cup 120. As the air that originally occupied the space between the diffuser cup 120 and the canister cover 14 is displaced into the canister, air bubbles rise to the water surface, causing the water level below the diffuser cup 120 to drop another 3/16-1/4. As illustrated for example in FIGS. 3-5, the diffuser cup 120 may include a number of diffusing channels 122. As the pump 40 is operated, water enters the canister 10 and flows over the top of the diffuser cup 120 and into each of the diffusing channels 122 (FIG. 2). The channels 122 direct the water downwardly towards the filter cartridge 12 so that debris circulates past the filter cartridge 12 and gas is directed down into the canister 10 in the form of bubbles. As discussed above, the bubbles eventually rise to the surface of the water. The interior of the diffuser cup 120 traps most of the gas that rises to the surface. The diffuser cup 120 also supports the top portion of the discharge tube 74 such that the discharge tube remains coaxial with the impeller housing 46. Referring to the numbered elements in the embodiment illustrated for example in FIGS. 1, 2 and 6-9, the portion of the discharge tube 74 arranged adjacent the impeller housing 46 may include curved ribs 124a and 124b. Additionally, the discharge tube 74 may further include flanges 76 and 92. The flange 76 and a gasket 77 provide a substantially airtight seal at the top of the filter cartridge 12. The flange 92 and a gasket 93 minimize gas seepage from beneath the diffuser cup 120. A trough 126 extends along the discharge tube 74 from a point between flanges 76 and 92 to the narrowest portion of the gap defined by curved ribs 124a and 124b (FIGS. 6 and 7). The trough 126 contains a tube or conduit 130 which extends from the region under the diffuser cup 120 through a hole 129 in the flange 76 to the region adjacent the impeller housing 46. The tube 130 may be secured to the trough 126 by inserting the tube through a hole in a rib 75 (illustrated for example in FIG. 2) or by other suitable means such as epoxy, hot melt gluing, an elastomer ring, a plastic retaining clip or heat shrink tubing. In accordance with the first preferred embodiment and as best seen in FIG. 2, water flowing in the space 100 between perforated tube 96 and discharge tube 74 is forced to flow into a constricted area 132 defined between the curved ribs 124a and 124b. Because the curved ribs 124a and 124b constrict the flow of water towards the impeller housing 46, the water accelerates as it flows through the area defined by the curved ribs 124a and 124b. The high velocity water creates a reduced pressure at the narrowest point 134 between the curved ribs as a result of the venturi effect. As such, a vacuum is created in the area adjacent plate 68 which is greater than the general, overall vacuum produced in the canister 10. The force of the vacuum at the narrowest point 134 draws water from the gas accumulation space 121 into the tube 130. The water is then drawn into the impeller housing 46 and pumped into the discharge tube 74. As the amount of gas trapped by the diffuser cup 120 increases, the water level below the diffuser cup drops. When the water level has dropped to a level that is slightly above the top of the tube 130, a vortex is formed at the inlet of the tube. Gas trapped under the diffuser cup 120 is then drawn through the center of the vortex and into the tube 130 by the vacuum created adjacent the plate 68. The gas drawn through the tube 130 is discharged into the water stream entering the region below the plate 68. Due to the turbulence of the water in the region below the plate 68, gas bubbles will be ingested into the impeller housing 46 and subsequently pumped into the discharge tube 74 and out of the canister 10. In this manner, the buildup of air within the canister is effectively prevented, assuring proper operation of the filter. As illustrated in FIG. 10, a second variant of canister-type filter (the '821 patent is one example of such a species of filter) includes a canister 114, a filter cartridge 16, a perforated tube 16a and a pump 31. The pump 31 includes a pump housing 32. The pump housing 32 includes an inlet 32a. The filter also includes a cover 18 having a central extension 18d, an inlet port 190 and an outlet port (not visible). The outlet port is connected to an outlet tube 192. As indicated by the arrows in FIG. 10, water flows into the canister 114 through inlet port 190, through the filter cartridge 16 and the perforated tube 16a, and then into the open space 110. Water in the open space 110 enters the pump housing 32 at the inlet 32a and is pumped to the outlet port. To prepare the filter for operation, the canister 10 is first filled with water to a level 1 to 2-3/4" from the top of the canister before starting the motor in the subject filter (if the canister is filled to the top, water will be forced out of the canister when the cover is installed). Prior to operating the filter the first time, the hoses from and to the aquarium typically contain air. Once the filter pump 31 is started, the air contained within the inlet hose is drawn into the canister, adding to the air present in the canister. It is preferred that the filter be stopped and allowed to "burp", that is, allow the air to rise out of the canister to be expelled through the inlet hose and tubes while water is drawn through the outlet tube and hose into the canister. However, air will likely still be present to some degree in the canister 10 after "burping" the filter and restarting. In accordance with the second preferred embodiment, and as illustrated for example in FIG. 10, the cover 18 may include a diffuser 18c and an elevated area 150. As the filter pump 31 is operated, water enters the canister 114, flows over the diffuser 18c and is directed down to the filter cartridge 16. Debris circulates past the filter cartridge 16 and gas is directed down into the canister 114 in the form of bubbles. As discussed above, the gas bubbles will eventually rise to the surface of the water within the canister 114. The elevated area 150 provides a gas accumulation space which traps the gas that has risen to the surface of the water. To reduce or contain the accumulation of gases in the canister 114, a venturi tube 160 may be positioned within the top portion of the inlet port 32a. The venturi tube 160 includes an inside surface 162 which defines a diameter. The diameter gradually decreases up to a transition point 164. Thereafter, the diameter of the inside surface 162 increases until the diameter is approximately equal to the inside diameter of the inlet port 32a. The venturi tube 160 also includes a step 168 and thin ribs 166 which extend inwardly from the inside surface 162. A tube 170 may be tightly held by the thin ribs 166 and supported by the step 168. The tube 170 extends from the transition point 164 to a point 171 beyond the top of filter cartridge 16. Referring to the numbered elements in the embodiment illustrated for example in FIG. 10, the cover 18 may also include a central extension 18d which extends into the perforated tube 16a. When the cover 18 is placed onto the canister 114, a conical surface 172 guides the tube 170 into a hole in the central extension 18d. A gasket 18e provide a seal at the top of the filter cartridge 16. Finally, the cover may include ribs 178 and 180. The ribs 178 and 180 may in turn define slots 174 and 176 which allow gas and water to pass from the elevated area 150 to the area above the central extension 18d. In accordance with the second preferred embodiment, water flowing in the space 110 is directed through the venturi tube 160. The venturi tube 160 is designed such that a vacuum will be created at the transition point 164 which is greater than the vacuum within the canister 114. The force of the vacuum draws water from the elevated area 150 into the tube 170. The water is then drawn into the impeller housing 32 and pumped to the outlet port. As the amount of gas trapped within the elevated area 150 increases, the water level within the elevated area decreases. When the water level has decreased to a level that is slightly above the top of the tube 170, a vortex is formed at the inlet of the tube. Gas trapped within the elevated area 150 is then drawn through the center of the vortex and into the tube 170 by the vacuum created at the transition point 164. The gas drawn through the tube 170 is discharged from the tube at the transition point 164 of the venturi tube 160. The water flowing through the venturi 160 will carry the gas into the pump housing 32. The gas will then be pumped to the outlet port by pump 31. In the two above-described embodiments, the gas expelling device will expel gas if the container or canister is not completely filled with water before starting the pump. In which case, air or gas is drawn down the collection tube (130 or 170, respectively) as soon as the pump is started, and will continue to expel air or gas until the water level in the gas accumulation area is above the entrance to the tube as described above. As illustrated in FIG. 11, a third species of canister-type filter includes a canister 200 and a cover 210. The canister 200 contains filter media. The cover 210 includes an inlet port 212 and an outlet port 214 (FIG. 12). Water from within the canister 200 is pumped to the outlet port by a pump 241 which includes a pump housing 242. The pump housing includes an inlet housing 232. In accordance with the third preferred embodiment, and as illustrated for example in FIGS. 11-13, a media container cover 216 may be arranged below the cover 210. The media container cover 216 and the cover 210 define an open area 220. A venturi tube 230 is positioned within the inlet housing 232. The venturi tube 230 includes an inside surface 234 which defines a diameter. The diameter gradually decreases up to a transition point 236. Thereafter, the diameter of the inside surface 234 increases until it is approximately equal to the inside diameter of the inlet housing 232. The inlet housing 232 may include a gas bleed passage or conduit 240 and projections 238a and 238b. During assembly, the projections 238a and 238b of the inlet housing 232 are respectively aligned with depressions 244a and 244b formed in the cover 210. The inlet housing 232 is then inserted into the pump housing 242. Next, the inlet housing 232 is rotated until the projections 238a and 238b stop against locating ribs (not visible) and the gas bleed passage 240 aligns with a passage 246. The passage 246 is formed by a depression in the cover 210 and a plate 248. In accordance with the third preferred embodiment, the media container cover 216 directs water entering inlet port 212 towards the inside wall of the canister 200 and down into the canister 200. Gas bubbles will accumulate in the open area 220 defined by the cover 210 and the media container cover 216. After passing through the filter media, the water is directed through the venturi tube 230. The venturi tube 230 is designed such that a vacuum will be produced at the transition point 236 that is greater than the vacuum within the canister 200. If gas is present in the open area 220, the gas will be drawn through passage 246 and into the gas bleed passage 240. The gas will then be discharged at the transition point 236 in the venturi tube 230. Water will then carry the gas into the pump housing 242, and from the pump 241 to the outlet port 214. In yet another embodiment, a canister filter has an inlet port at the bottom of the canister rather than through the canister cover. In this filter, the canister is simply filled with layers of filter media and then filled with water before installing the canister cover. Typically, one then suctions the outlet tube to remove air from the canister in order for the pump to prime. In operation, the filter typically accumulates air in the canister at the water surface below the canister cover. In accordance with the present invention, the air is expelled by adding a venturi tube similar to that of the third preferred embodiment. However, rather than providing a passageway to a specific gas accumulation area removed from the venturi tube, the venturi tube simply has a side hole or conduit in the venturi tube at the transition diameter. In operation, when the water level drops to a point slightly above the side hole, air will be ingested into the venturi. Thus, neither a specific area to trap the accumulating air nor a lengthy passageway is required. Although the present invention has been described in terms of the preferred embodiments above, numerous modifications or additions to the above-described preferred embodiment would be readily apparent to one skilled in the art. It is intended that the scope of the present invention extends to all such modifications or additions and that the scope of the present invention is limited solely by the claims set forth below.

An apparatus for expelling gas from within a sealed container. The apparatus may include a device for collecting gas in a predetermined area within the container as well as a device for drawing the gas out of the predetermined area and for directing the gas into the inlet of a pump. The apparatus eliminates problems related to the buildup of gas within the container such as water noise and vapor lock.

BACKGROUND OF THE INVENTION (a) Field of the Invention This invention relates to an apparatus for the insufflation of gas into a body cavity, more particularly, of the kind in which the dynamic pressure of the gas flow conducted to the body cavity and the static intra-abdominal pressure in the body cavity are detected with at least one measuring transducer of which the electrical output signal for detecting the pressure is converted by difference formation with a compensation signal, which substantially takes into account the resistance to flow of an instrument for conducting the gas into the body cavity, into a difference signal which corresponds to the static intra-abdominal pressure and with this signal a control circuit for the adjustment of the desired pressure value in the body cavity is controlled. (b) Description of the Prior Art A special problem with the insufflation of gas into a body cavity, for example during a surgical operation, consists in generating with the gas flow a constant intra-abdominal pressure within physiologically acceptable limits and in measuring this pressure accurately. In the case of modern apparatus of the aforementioned kind, the supply of the gas into the body cavity and the measurement of the static intra-abdominal pressure is effected utilizing a single tube or pipe. Thus, for example, DE-PS No. 30 00 218 discloses an insufflation apparatus in which, in an internal operation, gas is insufflated through a supply pipe, after that the gas flow is switched off and then the pressure through the same pipe is measured. This method involving intermittent gas inflow and pressure measurement by way of a supply pipe leads perforce to a regular interruption of the gas flow and can lead to exceeding the desired value, to be preselected, of the intra-abdominal pressure, namely when a gas flow phase starts just before the desired pressure value is reached. Equally, in the device disclosed in EP-OS No. 0 169 972, merely one pipe is provided for the gas flow and the pressure measurement. In this specification it is proposed, after a single compensation, undertaken at the start of the entire insufflation procedure, of the system resistance, which is dictated mainly by the instrument projecting into the body cavity, for example a Veress needle, constantly to ascertain the static intra-abdominal pressure by the substraction of the system resistance pressure from the total pressure and to indicate same to the doctor. This proposal has however, the disadvantage that a change in resistance, caused for example by a change of instrument, a retrocession of the flow as a result of low pressure difference between inlet and outlet or by kinking of the hose is not taken into account during the continuance of the insufflation procedure. SUMMARY OF THE INVENTION Accordingly, the main object of the present invention is to provide an apparatus for the insufflation of gas into a body cavity in which there is constant measuring of the intra-abdominal pressure and monitoring of possible variations in the pressure system up and measuring throughout the entire insufflation procedure. To this end, and from one aspect, the present invention consists in apparatus for the insufflation of gas into a body cavity, in which the dynamic pressure of the gas flow conducted to the body cavity and the static intra-abdominal pressure in the body cavity are detected with at least one measuring transducer of which an electrical output signal of a measuring transducer for detecting the pressure is converted by difference formation with a compensation signal, which substantially taken into account the resistance to flow of an instrument for conducting the gas into the body cavity, into a difference signal which corresponds to the static intra-abdominal pressure and with this signal a control circuit for the adjustment of the desired pressure value in the body cavity is controlled, characterised in that the compensation signal in each case, at the start of the insufflation, is generated from the output signal of the relevant measuring transducer and is stored in a first store and in that upon gas flows, the stored compensation signal is fed to the one input and the output signal of the measuring transducer is fed to the other input of a first operation amplifier for the formation of the difference signal, whilst the store at the input side is electrically separated from the measuring transducer by way of a first switch. In accordance with this aspect of the invention compensation of the system resistance by means of an electronics system which can recognise variations in the pipe system is initiated also at the points in time at which these variations take place. In this respect, the invention has the advantage that, upon operation of an insufflation apparatus, there are various points in time at which the apparatus is brought from the flow "off" state into the "on" state, for example upon the switching-on of the apparatus, upon the keeping constant of the desired pressure in the body cavity, which takes place through short insufflation surges, or upon variations of the resistance to flow as a result of instrument change or flow fluctuations. At these points in time, counter-connected to the measuring circuit is a compensation signal which has previously been ascertained in a compensation circuit and which takes into account substantially the resistance to flow of the instrument conducting the gas into the body cavity immediately prior to the change from the "off" state into the flow "on" state. This compensation signal remains counter-connected to the measuring circuit during the entire flow "on" phase. Accordingly, by means of the invention the result is achieved that at all times the actual internal pressure in the body cavity can be brought to the knowledge of the operating personnel on a display and this pressure is decisive for regulating the apparatus to a desired pressure. Preferably, the store is a capacitor which is connected by way of an impedance transformer having high input resistance and low output resistance to the said one input of the first operational amplifier. In a preferred embodiment of the invention, the output signal which corresponds to the desired intra-abdominal pressure and which is generated by the measuring transducer is, with the gas flow shut off, stored by way of a closed second switch in a second store and is conducted to the one input of a second operational amplifier. With the switching-on of the gas flow, the second switch opens for a short time and the dynamic output signal of the measuring transducer is imparted to the other input of the second operational amplifier which from the two input signals by difference formation generates the compensation signal which is then stored in the first store. Advantageously, the first store, upon each switching-on of the gas flow, is cleared and is then loaded with the compensation signal actualized in view of the desired pressure value. From another aspect, the present invention consists in apparatus for the insufflation of gas into a body cavity, in which the flow of the gas conducted to the body cavity is detected with a measuring transducer which can be compensated to a zero position and with the resulting output signal of the measuring tranducer a control circuit is controlled in order to regulate the gas flow to a desired value with an adjusting member located in the gas pipe, characterised in that a no-load signal which occurs when the measuring transducer is unloaded at the input side is fed to the one input of an operational amplifier which forms a difference signal from the amounts of this no-load signal and of a compensation signal fed to its other input, in that the output signal of the said one operational amplifier is amplified with a further operational amplifier and, with the output signal thereof by way of a time member, an electrical store (C3) is loaded which communicates permanently with the said other input of the one operational amplifier and in that the store is separable from the output of this operational amplifier by opening of a contact. Thus in accordance with this aspect of the invention, that part which regulates the amount of gas flow to the instrument conducting the gas into the body cavity, i.e. the flow regulating circuit, is advantageously so designed that tendencies of measuring transducers, which are used to convert a pressure into an electrical signal, to vary their output value upon non-loading by temperature changes within the apparatus as a result of the development of heat or also ageing are compensated for by a constant zero-point equalisation. For this, a special compensation circuit is provided in the flow regulating circuit, which has the advantage that the gas flow can at all times be regulated exactly and irrespectively of the thermal offset characteristic or ageing -dictated variations of the measuring transducer. Preferably, the time member is an RC-member having a capacitor which serves as a store. In a preferred embodiment, the contact is connected into the connection between the said further operational amplifier and the store. BRIEF DESCRIPTION OF THE DRAWINGS In order that the invention may be more readily understood some embodiments thereof will now be described, by way of example, with reference to the accompanying drawings, in which FIG. 1 shows a diagrammatic circuit arrangement of an apparatus for the insufflation of gas into a body cavity and constructed in accordance with the invention with the upper part of the drawing showing a flow regulating circuit and the lower part of the drawings showing a pressure regulating circuit; FIG. 2 shows a compensation circuit for the zero-point equalisation of a pressure measuring transducer, as is used in accordance with an advantageous further development in the flow regulating circuit of FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1 of the drawings, gas is conducted out of a pressure container (not shown) by way of a gas inlet into the gas pipe 1 of the apparatus. After passage through a flow regulating circuit of the insufflator, the gas passes out of a gas outlet 11 and through an instrument 12 for example a Veress needle which conducts the gas into a body cavity 13. The flow regulating circuit comprises a differential-pressure measuring transducer 2 which is connected to the gas pipe 1 and the output signal of which is conducted to an input of an operational amplifier (OP) 3. The output signal of the amplifier 3 is fed as actual-value signal to an electronic regulator 4 which compares the actual-value signal with a desired-value signal preselected by an adjuster 8. Upon deviation of the actual value from the desired value of the gas flow, the electronic regulator 4 is operative by means of an analog adjusting member 9 to bring the gas flow back to the desired value. This can be achieved by means of a throttle which is acted upon by the adjusting member 9 to narrow or widen the passage of the gas flow 1. The now constant gas flow passes through a valve 10 to the gas outlet 11. Between the output of the amplifier (OP) 3 and its second input a compensation circuit 6, to be more fully described, may be provided, which ensures zero-point equalisation of the amplifier (OP) 3 when the measuring transducer 2 is not loaded. The pressure prevailing at the outlet end of the gas pipe 1 is detected in the pressure regulating circuit by a pressure measuring transducer 14 which converts the detected pressure into a corresponding electrical signal. An operational amplifier (OP) 15 connected subsequently to the measuring transducer 14 conducts the measuring signal to the one input of an operational amplifier (OP) 16, the output of which is connected to a pressure display or indicator (not shown) and to an electronic evaluator 18. This electronic evaluator 18 compares the instantaneous actual-value signal at the output of the (OP) 16 with a desired-value signal which is to be selected by means of an adjuster 17. Electronic evaluator 18 is connected to the valve 10 which is controlled, as a function of the result of the comparison between the desired-and actual-value signal in the electronic evaluator 18, in such a way that the gas flow in the gas pipe 1 is switched when the desired pressure is reached in the body cavity, that is to say upon equality between the actual-value-signal and the desired-value-signal in the electronic evaluator 18. In operation the apparatus changes over at various points in time from the flow "off" state into the flow "on" state, for instance upon the switching-on, upon keeping-constant of the desired pressure in the body cavity 13, which takes place through short insufflation surges, or upon variations of the resistance to flow of the pressure system as a result of a change of the instrument 12 or flow fluctuations. An electronic control 19 coupled to the electronic evaluator 18 recognises and controls these "off"-"on" states. Two monostable flip flops MF1 and MF2 are connected subsequently to it at 20. Upon the change-over from the flow "off" state of the apparatus into the flow "on" state, in the electronic control 19, a rising pulse edge is generated, which for its part triggers the subsequently-connected monostable flip flops MF1 and MF2. Connected subsequently to the flip flop MF1 are two relays R1 and R2, which are activated for the duration of the pulse on the flip flop MF1. The relays R1 and R2 open or close respectively two switches r1 or r2 respectively in a compensation circuit, to be hereinafter described. The pulse which is generated by MF2 and the pulse duration of which is considerably shorter than that of the pulse in MF1, drives or switches a subsequently-connected transistor T1, the function of which will be hereinafter described. The output signal of the (OP) 15 is fed, besides to the direct feed wire to the (OP) 16, at the same time to the said compensation circuit. On the one hand it is conducted directly onto one input of an operational amplified (OP) 22, on the other hand it is switchable by way of a switch r1, controlled by the relay R1, onto an operational amplifier (OP) 21 connected to an impedance transformer and having high input resistance and slight output resistance and also a capacitor C1 connected between the input of the (OP) 21 and earth. The output of the (OP) 21 is connected to the second input of the (OP) 22. (OP) 22 amplifies the voltage difference, the peak value of which is obtained by way of the subsequently connected operational amplifier (OP) 23 with diode at the output thereof. The output of the (OP) 23 with diode is on the one hand connected to the said transistor T1, on the other hand it is switchable by way of a switch r2, controlled by the relay R2, onto an operational amplifier (OP) 24 connected as an impedance transformer as well as onto a capacitor C2 connected between the input of the (OP) 24 and earth. The output of the (OP) 24 is amplified in the subsequently connected operational amplifier (OP) 25 and is conducted by way of a switch r3, which is opened in the flow "off" state of the apparatus and is closed in the flow "on" state, onto the other input of the (OP) 16. In detail the pressure measurement with the described circuit arrangement functions as follows. If the gas flow is switched off, then in the outlet end of the gas pipe 1 the static intra-abdominal pressure obtains, which is totally unaffected by a flow pressure. This value is brought in the form of a corresponding voltage by way of (OP) 15 and (OP) 16 to the pressure display or indicator and at the same time onto the compensation circuit, in which respect the value is conducted by way of the switch r1, closed in this operating state, onto the capacitor C1 and is stored there. The value is conducted by way of (OP) 21 onto the input of the (OP) 22, the second input of which is connected directly to the measuring voltage. Since at the input side at the (OP) 22 both values are the same, no further signal processing is effected in this phase. If now the gas flow is switched on again, for instance if the actual value of the static intra-abdominal pressure is less than the desired value, the switches r1 and r2 are, in this switch-on phase, opened or respectively closed briefly by the relays R1 and R2 controlled by the flip flop MF1. At the same time, through the pulse, generated by the flip flop MF2, by way of T1 and the now closed switch r2 the capacitor C2 is short-circuited, so that a voltage value stored in C2 upon a previous switching-on of the gas flow is cleared. With the switching-on, the switch r3 is closed. In this phase there obtains at the measuring transducer 14 the static intra-abdominal pressure as well as the dynamic pressure of the gas flow, the value of which it is essential to compensate for. The voltage value, increased by reason of the increased pressure value, at (OP) 16 is conducted to (OP) 22. Since, in this phase, the switch r1 is opened, the voltage previously obtaining at C1, which was applied upon flow "off" state and represents the value of the static intra-abdomindal pressure, is conducted by way of (OP) 21 furthermore onto the second input of (OP) 22. Accordingly, the voltage at the output of the (OP) 22 represents only the dynamic part of the overall pressure present at the transducer and thus the insufflation pressure. The peak value of the output voltage of the (OP) 22 is obtained by way of (OP) 23 and diode. With this peak value the capacitor C 2 is charged by way of the switch r2 closed in this phase. It is conducted by way of (OP) 24 and (OP) 25 and closed switch r3 as offset onto the second input of the (OP) 16, at the output of which now merely the voltage value representing the static part of the total pressure appears and is displayed. The duration of this transition phase lies in the millisecond region. After that the relays R1 and R2 are again inactive, that is to say switch r1 is again closed and switch r2 again opened. The voltage value stored at the capacitor C2 is conducted furthermore up till the end of the insufflation phase as offset onto (OP) 16. The value corresponds exactly to the superelevation which the connected instrument 12 causes. Measured values which now lie amountwise higher than this value can be caused only by an external pressure. Here this is the intra-abdominal pressure in the body cavity 13 and thus the pressure which is decisive for the regulation of the apparatus to the set desired pressure. An advantageous further development of the flow regulation consists, as mentioned above, in the incorporation of a compensation circuit 6. This compensation circuit serves for the zero balancing of the measuring transducer 2 in the unloaded state. If the measuring transducer 2 is unloaded, in the normal case a voltage of zero volts should occur at its output. This can, however, be different by reason of temperature changes within the apparatus as a result of the development of heat or also caused by ageing. In the circuit in accordance with FIG. 2, a voltage generated by a measuring transformer 2 is conducted onto one input of operational amplifier (OP) 3. The output of (OP) 3 is conducted onto an amplifier circuit with operational amplifier (OP) 26, which has a high amplification. The output signal of (OP) 26 is switchable by way of a contact K, which is always closed whenever the measuring transducer 2 is unloaded, by way of a time member RC onto an electrical store (in FIG. 2) (C3). In the further course, the signal is returned by way of an operational amplifier (OP) 27, which is connected as an impedance transformer, to the second input of the (OP) 3. The compensation is activated with the closing of the contact, thus always when the measuring transducer 2 is unloaded. This is the case when the set desired value of the intra-abdominal pressure is reached and the gas flow is switched off, since there is this case also no longer a pressure drop, and the same upon the switching-on of the apparatus. The mode of operation of the circuit is made clear with the aid of an example. Let us assume that the measuring transducer 2 is unloaded and the contact accordingly closed. At the output of the measuring transducer 2 there stands a voltage of +1 volt, at the point B a voltage of :0.2 volt. Let us assume that the amplification factor of (OP) 3 amounts to 1, and that of (OP) 26 amounts to 1000. Under these assumptions, point A is thus by 0.8 volt more positive than point B. Accordingly, point C at the output of the (OP) 3 lies amountwise likewise at 0.8 volt, circuit-occasioned by with negative sign, thus minus 0.8 volt. Since (OP) 26 has a high amplification, this would travel into the saturation to about 11 volt with positive sign on account of the inverting behaviour of (OP) 26. The capacitor C3 is charged by way of the resistor R with the value standing at the point D, in which respect the RC-member brings about a slower rise of the voltage at the points E and B than at the point D. The same voltage is conducted by way of (OP) 27 without signa reversal to the point B. If the voltage at the points D, E and B has reached the value, to be compensated, of +1 volt at the point A, (OP) 26 ceases running into the saturation of +11 volt. Since then the voltage values at the points A and B are the same, point C lies at nil volt. Since (OP) 26 now does not have to amplify a voltage, point D likewise lies at nil. At the capacitor C3 there now lies a voltage of +1 volt, so that it could discharge itself again by way of the (OP) 26. However, this is compensated for by the closed control loop, as described. If now the contact K opens, there obtains furthermore at the capacitor C3 the voltage of +1 volt, which is needed in order to level control, stabilize or bring the point C to zero volt. If now there occurs at the point A as a result of a pressure drop at the measuring transducer 2 a voltage differing from +1 volt, this is considered as the measuring voltage and further processed. The open control or regulating circuit prevents a further compensation. The previously obtained compensation voltage at the capacitor C3 is maintained, depending on the dimensioning of R, C3 and (OP) 27, for 5 up to 60 min. at the point B. The described regulating procedure takes its course in the region of milliseconds. The circuit can also be used to generate a virtual nil point. For example, a specific pressure can be imparted to the measuring transducer 2 and the voltage value, resulting therefrom, at the point A can be compensated by brief closure of the contact K and be considered as zero point. Only pressures deviating from this specific pressure would then have to be evaluated. It should be appreciated that the invention is not limited to the embodiments herein described but includes all modifications and variations falling within its scope.

In an apparatus for the insufflation of gas into a body cavity the dynamic pressure of the gas flow conducted to the body cavity and the static intra-abdominal pressure in the body cavity are detected with at least one measuring transducer. The electrical output signal of the measuring transducer detecting the pressure is converted by difference formation with a compensation signal, which substantially takes into account the resistance to flow of the instrument conducting the gas into the body cavity, into a difference signal corresponding to the static intra-abdominal pressure. With this signal a control circuit for the setting of the desired pressure value in the body cavity is controlled, in which respect the compensation signal in each case at the start of the insufflation is generated from the output signal of the relevant measuring transducer and is stored in a store and upon gas flow the stored compensation signal is fed to the one input and the output signal of the measuring transducer is fed to the other input of an operational amplifier for the formation of the difference signal, whilst the store at the input store is separated electrically from the measuring transducer by way of a switch.

CROSS REFERENCE TO RELATED APPLICATION This application is a continuation-in-part of applicant's co-pending application Ser. No. 14/510,014 filed Oct. 8, 2014 the entire contents of which is hereby expressly incorporated by reference herein. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT Not Applicable INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC Not Applicable BACKGROUND OF THE INVENTION Field of the Invention This invention relates to improvements in a device to carrying elongated objects. More particularly, the present Sling Carrier for Skis, Snowboard and Boots creates a method to carry skis and/or snowboard with boots. The sling carrier provides full mobility for the person carrying the sporting equipment. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98 For many people that participate in outdoor winter sports, must carry their equipment from a car or ski rental location to the lift line. When a person carries the equipment to the ski lift, the person must carry the equipment to the ski lift and then the person must place the equipment onto themselves for skiing or snowboarding. Most outdoor winter athletes either ski or snowboard, but some of these athletes perform both sports and must carry a large amount of equipment to the ski lift or to a place where instruction will take place. There are a number of different ways to carry ski and snowboard equipment. Without any external carrying equipment the person generally walks with the boots on and carries the ski/snowboard and possibly poles. A second alternative was to have some sort of external device that allows a person to carry the ski or snowboard equipment. There are a large number of variation for carrying the equipment in one hand or on their body. A number of patents and or publications have been made to address these issues. Exemplary examples of patents and or publication that try to address this/these problem(s) are identified and discussed below. U.S. Pat. No. 5,383,587 issue to Gary L. Carpenter issued on Jan. 24, 1995 to Gary L. Carpenter discloses a Device for Carrying Elongated Ski Equipment. This patent has a pocket where the end of the skies are placed, and a strap that connects from the pocket to an upper end of the skies. The strap is placed over a shoulder so the skies are slung from behind the person and under a shoulder to a position in front of the person and must be carried with at least one hand. With this configuration the person can't bend down or forward without the skies touching the ground. The patent further does not allow the person to transport the ski boots with the skies because the ski boots will occupy an area of the person transporting the equipment. U.S. Pat. No. 6,672,495 issued on Jan. 6, 2004 discloses a Bifurcated Carrier Pack for Transporting Recreational Equipment. The patent allows the person to transport a snowboard across the back of the user. With this embodiment the person can bend over, but the orientation of the snowboard makes it difficult to move through a door, and the straps make transportation of the boots difficult. The equipment further does not allow for transportation of skies. U.S. Publication 2007/0210570 that was published on Sep. 13, 2007 for Jasper C. Erichsen discloses a Ski-Carrier. This publication is for an extendable belt mounted pocket. The pocket is secured onto a belt that holds the pants of a user. When a user wants to transport their skies they extend a pocket and slide the end of the skies into the pocket to support one end of the skies and holds the free end of the skies. Due to the orientation of the skies, the invention does not allow for transportation of the boots with the skies. U.S. Publication 2010/0206930 that was published on Aug. 19, 2010 for Andrew Jason Sims discloses a Ski and Snowboard Sling-belt. The belt slings the snowboard diagonally across the back of the user. While this patent allows for transportation of ski equipment it only allows for transportation of skies or a snowboard. After transportation the invention does not have a pocket or pouch to transport the carrier after use. What is needed is a transportation device for a skies and/or snowboard along with the poles and boots. The transportation mechanism should further provide a storage mechanism for the transportation equipment. This document provides a solution. BRIEF SUMMARY OF THE INVENTION It is an object of the sling carrier for skis, snowboard and boots to be able to carry the skies and or snowboard across the back of the wearer. The ability to sling the equipment over the back of a user allows the user to have full mobility walk. A user can tighten the sling to adjust the location of the equipment in their back. Having the equipment supported on their back allows the user to walk in a more balanced stance and the user just needs to bend forward or backward to accommodate the load or the terrain. It is an object of the sling carrier for skis, snowboard and boots to include a pocket for transportation of the skies and or snowboard. It is also a function of the carrier for the pocket to be used to store the transportation equipment and therefore allow the user to easily transport the equipment after the skies and or snowboard have been transported. It is an object of the sling carrier for skis, snowboard and boots to be used for transportation of all the unique ski equipment. Along with the skies, one embodiment includes transportation of the ski poles and the boots. All of these pieces of equipment are slung over the back of the user and essentially leaves the hands free for paying for lift tickets, food or other items. This configuration also makes it possible for a person without limbs to transport the ski equipment by themselves, without requiring an additional person to transport the ski equipment. It is an object of the sling carrier for skis, snowboard and boots to be used transportation of all the unique snowboard equipment. Along with the snowboard, one embodiment includes transportation of the snowboard and the boots. All of these pieces of equipment are slung over the back of the user and essentially leaves the hands free for paying for lift tickets, food or other items. This configuration also makes it possible for a person without limbs to transport the ski equipment by themselves, without requiring an additional person to transport the ski equipment. It is another object of the sling carrier for skis, snowboard and boots to be used for transportation of all the unique ski equipment for a person that both skies and snowboards. Along with the skies and snowboard this embodiment includes transportation of the ski, snowboard, poles and either sets of boots. All of these pieces of equipment are slung over the back of the user and essentially leaves the hands free for paying for lift tickets, food or other items. This configuration also makes it possible for a person without limbs to transport the ski equipment by themselves, without requiring an additional person to transport the ski equipment. It is still another object of the sling carrier for skis, snowboard and boots to use adjustable buckles to connect straps together. Buckles allow the user to just “squeeze” elements together to release the straps. For connecting elements together the user just pushes the parts together. This is especially important when it is cold and the user's fingers and hands are cold. This is also superior to hook-and-loop fasteners that become brittle and can become clogged with ice and snow thereby rendering them non-functional in cold weather. Various objects, features, aspects, and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments of the invention, along with the accompanying drawings in which like numerals represent like components. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) FIG. 1 shows a sling carrier for skies with attached boots. FIG. 2 shows a view of the components used in the sling carrier for skies. FIG. 3 shows a view of the attachment of the ski poles. FIG. 4 shows the top of the skies being secured. FIG. 5 shows the bottom of the skies entering the pouch. FIG. 6 shows the top of the poles being secured to the skies. FIG. 7 shows positioning the D-ring on the bound skies. FIG. 8 shows securing the adjustable binding strap on the skies. FIG. 9 shows one embodiment of binding the bottom of the skies. FIG. 10 shows the bottom of the poles being secured to the skies. FIG. 11 shows pouch being secured to the opposing side of the sling. FIG. 12 shows the pouch secured over a shoulder of a user. FIG. 13 shows a sling carrier with a snowboard and snowboard boots. FIG. 14 shows the components used in the sling carrier for a snowboard. FIG. 15 shows a snowboard being secured into the pouch and the sling. FIG. 16 shows the snowboard pouch being carried on the back of a user. FIG. 17 shows a sling carrier for skis, snowboard and boots. FIG. 18 shows the carrier without the ski equipment being carried as a backpack. FIG. 19 shows the components used to carry skies and a snowboard. FIG. 20 shows the snowboard in the pouch with the skies being inserted. FIG. 21 shows the top end of the poles being secured to the skies and snowboard. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows a sling carrier for skies with attached boots. In this figure the back of the user 39 is shown with the ski equipment slung over the back of the user in a diagonal orientation. In this orientation the user can bend forward and can walk with the weight of the equipment fairly evenly distributed on the user 39 . The ski boots 48 and 49 are secured in the ski bindings 47 , thereby no additional securing mechanism is required to retain the ski boots 48 and 49 . While the ski boots 48 and 49 are shown secured into the ski bindings, the user can wear the ski boots 48 and 49 on their feet or can transport them on the skis as they transport the skies and ski poles slung over the back of the user. The curved end of the skies 42 and 43 are secured together with an upper ski strap 60 that both secures the skies 42 and 43 together and provides an upper connection for a front sling (not shown in this figure). The upper end of the poles 46 and 47 (obscured in this figure) are connected together with an upper pole strap 30 that is secured to a “D” ring (obscured in this figure) that is secured around the skis, in this case, skis 42 and 43 . The upper pole strap 30 is retained on the poles because the top of the ski poles include an enlarged top 44 to the hand grip portion of the pole(s). The flat under sides of the skies rest together and the bottom end of the ski poles are secured to the lower end of the skies 42 and 43 with a lower ski and pole strap 90 / 100 . The flat end of the skies 42 and 43 and secured into a pouch 80 . FIG. 2 shows a view of the components used in the sling carrier for skies. These are the components that are used to transport the skies, boots and pole. The lower ski and pole straps 90 and 100 can be placed within the ski pouch 80 and all the components can be carried by the user as a complete unit. This will be shown and described in other figures herein. The sling strap 50 has a separable buckle 53 with a male and a female clasp that allows a user to separate the two parts, 51 and 52 , of the sling strap 50 . The separable buckle 53 further includes an adjustment mechanism to alter the overall length of the sling strap to fit the geometry of a user to adjust the location of the equipment on the back of a user. On the opposing sides of the buckle 53 there are separate lengths of straps 51 and 52 . Each of these lengths of straps terminate with operable clasps 54 and 55 . The clasps 54 and 55 , along with the buckle 53 are designed to allow an operator to connect and disconnect the components in freezing condition and with limited dexterity caused by gloves and or cold conditions. The upper ski strap 60 has a central male clasp 63 that mates or connects into a complimentary female clasp 65 . An “O” or “D” ring 64 is positioned between the male 63 and the female 65 clasps. The ring 64 allows for connection of one of the operable clasps 54 or 55 on the sling strap 50 . A free end 62 of the strap 61 allows for a user to grasp to tighten a grip on skies placed in the strap between the male 63 and the female 65 clasps. The strap 60 can also include an alarm, combination lock or other anti-theft device 66 . It is also contemplated that the male 63 and female clasps 65 can include a key lock or a combination lock. The ski pouch 80 is essentially a pouch with an opening where the flat portion of the skies are placed to secure the flat end of the skies. The ski pouch 80 has a top flap that wraps around the opening to secure any contents within the pouch. The ski pouch 80 is shown with the lower ski strap components 90 and 100 secured to the ski pouch 80 . The lower pole strap components 90 and 100 are snapped 93 and 103 onto the ski pouch 80 . Lower pole strap component 90 has a snap 93 at a first end with a male clasp 94 and a free length of strap material 91 with a buckle 92 . A “D” ring 95 is secured to the front flap of the ski pouch 80 . The lower pole strap component 100 also snaps to the ski pouch 80 and has a female buckle 101 . While snaps are one preferred closure embodiment, other closure types are contemplated, including but not limited to, hook and loop, magnetic closure, slots and rotating clasps. An alternate embodiment of the straps is shown with the strap having an elongated central section 30 with an S-biner having two clip areas 32 and 33 . The other end of the strap 30 has a turnbuckle with a clasp 31 . Another contemplated retaining device is the strap with a ratchet clamp 97 that ratchets against the one-way teeth 96 to tighten and retain the strap 90 on skies. This strap has a “D” ring 98 . FIG. 3 shows a view of the attachment of the ski poles 46 and 47 . The ski poles 46 and 47 are secured by using the pole strap 30 that has two lengths of strap material 72 and 74 with an operable clasp 73 located at an equal distance between two separate “D” ring 71 and 75 . To install the ski poles 46 and 47 onto the pole strap 30 a portion of the strap material, 72 or 74 is looped 76 and passed through the respective “D” ring 71 or 75 and the hand grip 44 or 45 of the ski pole is passed through the loop. The loop is then tightened to secure the hand grip 45 of the ski pole. FIG. 4 shows the top of the skies being secured. Because current skies 42 & 43 are parabolic in shape, the upper ski strap 60 can be secured at a narrow portion of the skies 42 & 43 . The free end 62 of the strap 60 can be pulled to tighten the strap 60 in the buckle 63 and then moved 86 up to the wider portion of the skies 42 & 43 to increase the binding of the strap 60 on the skies 42 & 43 . FIG. 5 shows the bottom of the skies 42 & 43 entering 87 into the open 88 end of the pouch 80 . A backing lip 85 extends around the back of the pocket to provide a flat surface that sits on the flat surface of the ski. The end of the skies 42 & 43 are then seated into the pocket 80 . The flap portion 85 of the pocket 80 is brought along the back side of the skies 42 & 43 . The ski pouch 80 has a number of snaps 82 , 83 and 84 for securing some of the straps, in particular the lower pole strap 90 / 100 that wraps around the pouch 80 and previously shown. FIG. 6 shows the top of the poles 46 and 47 being secured to the skies 42 . The ski poles 46 and 47 have hand grips 44 and 45 respectively where the upper pole strap 72 is secured. The clasp 73 in the center of the pole strap 72 is secured to the ring 64 on the upper ski strap 60 and then the upper pole strap 72 is brought between the curved tips of the skies for stability. The clasp 54 on the lower sling strap 52 is also connected to the ring 64 on the upper strap 60 . It is important for the ring 64 to be positioned at the side of the skies to allow the apparatus to be slung diagonally across the back of a user. FIG. 7 shows positioning the D-ring 64 on the bound skies 42 . The strap 60 holds the skies 42 tightly together. The strap is installed and tightened on the skies 42 such that the D-ring 64 is positioned on the side of the skies 42 . This allows the skies to be strapped over the back of the user and reduces the edges of the skies being in contact with the user. FIG. 8 shows securing the adjustable binding strap 90 on the skies 42 . This binding strap 90 has a plurality of saw tooth teeth 96 . The teeth 96 engage into a ratcheting mechanism 97 that pulls on the teeth 96 to tighten the strap 90 onto the skies 42 to hold the skies within the strap 90 . FIG. 9 shows one embodiment of binding the bottom of the skies 42 with ski poles 46 and 47 . The skies 42 are shown with securing strap 90 within the storage pouch 80 . The strap 90 secures the skies 42 and the poles 46 , 47 as a collective group. FIG. 10 shows the bottom of the poles being secured to the skies. At this location the end of the ski poles 46 and 47 are shown secured to the bottom straight end of the skies 42 . The lower straps 90 / 100 secure all the skies and poles together to prevent undesirable movement while they are being transported. FIG. 11 shows pouch being secured to the opposing side of the sling strap 51 . The lower end 51 of the sling strap has a clasp 55 that connects to the “D” ring 87 on the flap 85 of the pouch 80 . The flat end of the skies 42 and 43 are shown in the pouch 80 . The snap 86 can be secured to one of the snaps 86 on the front of the pouch 80 . While snaps are one preferred closure embodiment, other closure types are contemplated, including but not limited to, hook and loop, magnetic closure, slots and rotating clasps. The ski poles 46 and 47 are shown secured to the skies 42 and 43 with the lower ski and pole strap 90 / 100 is wrapped around both the skies and both of the poles. Once both ends of the sling strap 50 have been secured with the clasp 54 in the “D” ring 64 (at the other end of strap 51 ) and the “D” ring 87 with clasp 55 of the ski pouch 80 , the user can place the sling 50 over their head and shoulder. Once the user is wearing the sling, the user can adjust the length of the sling 50 to set the preferred location of the sling on the user. To quickly remove the sling, a user can unbuckle the clasp or buckle 53 in the sling 50 . FIG. 12 shows the pouch 80 secured over a shoulder of a user 39 . When the pouch 80 is not being used to transport ski equipment, the remaining straps are placed into the pouch 80 . This view shows the clasp 53 of the sling 51 and 52 . The clasps 54 and 55 are secured to “D” ring on the back of the pouch 80 . The front flap 85 of the pouch 80 is brought over the pouch 80 where the “D” ring 87 is held by the straps. FIG. 13 shows a sling carrier with a snowboard 110 and snowboard boots 111 and 112 . The snowboard 110 , boots or boot bindings 111 and 112 are all carried on the back of the user 39 in a sling arrangement that allows the person 39 to easily walk and bend over because the equipment is distributed and balanced on the back of the user 39 . This further frees the hands of the user to pay for lift tickets or carry other items. The bottom of the snowboard 110 is held in a pocket 133 within a pouch 130 . The pouch 130 has a surrounding lip 134 with a raised front surface where the snowboard 110 fits inside of the pouch 130 . The front of the pouch 130 has some pockets with mechanical or magnetic snaps 135 and 136 for securing the pockets. A sling strap (not visible in this figure) connects from the pouch 130 to an upper strap 120 . The upper strap 120 wraps around the upper portion of the snowboard 110 to secure the snowboard 110 . The upper strap has a male 121 and a female 122 buckle portion secured on the strap 120 . The “O” or “D” ring 122 is placed in the center of the width of the snowboard. An end 123 of the strap 120 allows for tightening or loosening of the strap 120 on the snowboard 110 . FIG. 14 shows the components used in the sling carrier for a snowboard. The sling strap 50 has a separable buckle 53 with a male and a female clasp that allows a user to separate the two parts, 51 and 52 , of the sling strap 50 . The separable buckle 53 further includes an adjustment mechanism to alter the overall length of the sling strap to fit the geometry of a user to adjust the location of the equipment on the back of a user. An adjustable pad 56 is present on the strap 52 to provide a cushion and to distribute loads on the strap 50 . On the opposing sides of the buckle 53 there are separate lengths of straps 51 and 52 . Each of these lengths of straps terminate with operable clasps 54 and 55 . The clasps 54 and 55 , along with the buckle 53 are designed to allow an operator to connect and disconnect the components in freezing condition and with limited dexterity caused by gloves and or cold conditions. The pouch 130 is configured with a square or rounded bottom to accept either end of a snowboard. The pouch 130 has a front flap 132 that closes over a pocket opening 133 where an end of a snowboard is secured therein. The flap has a “D” ring at the front of the flap for securing one end 55 of the sling strap 50 . Mechanical or magnetic snaps 137 and 138 secure the flap 132 to the front of the pouch 130 . A plurality of “D” rings and clasps 127 , 128 and 129 are located on the front and back of the pouch 130 for converting the pouch into a backpack for storage of the straps and or other personal items. An upper snowboard strap 120 is configured to wrap around the snowboard. The inside of the upper snowboard strap 120 is reinforced or backed with leather or other equivalent material to protect the strap material from being damaged from the hard sharp edges of the snowboard. This strap 120 has a male connector 121 and a female connector 125 at opposing ends. The tail 123 can be pulled to tighten the strap 120 on the snowboard. Between the male 121 and the female 125 connectors an “O” or “D” ring is located between the strap portions 122 and 124 . The “O” or “D” ring is used to connect to the other clasp 55 on the opposing end of the sling strap 50 . Two additional strap members 140 are used to transport the pouch 130 as a backpack. The strap members 140 are essentially the same. The straps 140 include clasps 141 and 147 on each end of the strap. The strap 140 has three section 142 , 144 and 146 . Between section 144 and 146 a “D” ring 145 is located for securing the end of the strap 144 . An adjustable buckle 143 is located to adjust the overall length of the strap 140 . FIG. 15 shows a snowboard being secured into the pouch and the sling. First the upper strap is secured around the snowboard 110 and then buckle at the end of strap portions 122 and 124 is connected. The strap is tightened onto the snowboard 110 at a position above the top boot binding. When the top strap is attached, the “O” or “D” ring 123 is centered in the middle of the base width wise. Snowboards also have a parabolic shape. The method for attaching the top strap 122 is to clip it around the board just above the leading (top) binding, pull the adjuster strap down nice and snug making sure the “O” or “D” 123 is centered on the base, the strap is moved up until the strap reaches the widest part of the parabolic shape making a nice and tight strap on the snowboard. The bottom of the snowboard is slid into the pouch opening 139 to a position below the lower binding 111 . The top flap 132 is lifted to allow the clip 55 of the sling strap to connect to the “D” loop 126 . The other end of the sling strap 52 is then hooked 54 into the “O” or “D” ring 123 of the upper strap. The user can then enter into the sling strap and tighten the sling strap for the desired fit. When the board is being transported, the top strap will come into contact with the edges as it is positioned on the base. Those edges can be extremely sharp and would probably cut right through a standard nylon strap. As with the ski sling, the central buckle on the sling strap is disconnected to quickly exit from the snowboard sling carrier. FIG. 16 shows the snowboard pouch being carried on the back of a user. When the snowboard carrier is not being used to transport the snowboard the pouch 130 can be used as a backpack. The strap members 142 are connected to the “D” ring 129 at the top of the carrier and also connected to “D” rings 158 (obscured in this view) on the back of the carrier 130 . The straps 140 can then be adjusted to the desired fit based upon the desires of the user or the physical features of the user 39 . FIG. 17 shows a sling carrier for skis, snowboard and boots. In this embodiment a user 39 is able to carry all of the ski and snowboard equipment with a single sling carrier. The hands of the user remain free. The majority of the components have been shown and described in previous embodiments shown and described herein with the exception of the pouch 150 . The pouch has two pockets, a first pocket 151 where the snowboard 110 is inserted and a second pouch 153 where the flat ends of the skies are inserted, and the ends of the ski poles 46 and 47 are retained. The pocket 153 for the skies 42 & 43 essentially folds out perpendicular to the pocket 151 that retains the snowboard 110 . A flap 152 covers the ski retaining pocket 153 when the pocket is not being used. FIG. 18 shows the carrier without the ski and snowboard equipment being carried as a backpack. This figure shows the other side of the flap 152 with storage pockets 154 and 155 for storage of the securing straps. The back of the flap 152 further includes a transparent window 156 for storage of a license, lift ticket etc. When the carrier 150 is not being used to transport the skies and or snowboard the pouch 150 can be used as a backpack. The strap members 142 are connected to the “D” ring 157 at the top of the carrier and also connected to “D” rings (obscured in this view) on the back of the carrier 150 . The straps can then be adjusted to the desired fit based upon the desires of the user or the physical features of the user 39 . FIG. 19 shows the components used to carry skies and a snowboard. The straps 50 , 30 , 120 , 140 and 190 are essentially the same as previously described. Strap 50 includes a protective sleeve 57 to reduce abrasion of the clasp 54 . Strap 190 is essentially the same as strap 120 with a slight difference in the length of the strap and strap 120 further has an additional clip that is adjacent to the female part of the buckle. The clip is secured to the upper ski strap 190 . To assemble the skis within this storage version the curved ends of the skies are bound as previously described and the grip ends of the ski poles are bound as previously identified. FIG. 20 shows the snowboard in the pouch with the skies being inserted. The strap 120 is secured to the snowboard 110 as previously described. The snowboard 110 is inserted into the pocket 151 of the pouch 150 . An inner pocket 153 is exposed from the pouch 150 and the flat end of the skies are inserted into the inner pocket 153 . The skies 42 and 43 are elevated, essentially parallel to the snowboard 110 . FIG. 21 shows the top end of the poles being secured to the skies 42 & 43 and snowboard 110 . In this figure the strap 30 that retains the ski poles 46 & 47 are secured to the “D” ring of strap 190 . The “D” ring of strap 190 is connected to clip that is adjacent to the female buckle. The free end of the ski poles are the tucked into the pocket 153 . The sling strap 50 is secured to strap 120 and to the pouch 150 to allow a user to lift all the equipment onto their back for transportation. While specific materials of leather, nylon and “O” or “D” rings and buckles have been identified in the application, it should be obvious to one skilled in the art that future progression of the carriers can include alternative materials and construction that provide the same or superior functionality. Thus, specific embodiments of a sling carrier for skis, snowboard and boots has been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims.

Improvements in a sling carrier for skis, snowboard and boots to be able to carry the skies and or snowboard across the back of the wearer is disclosed. The ability to sling the equipment over the back of a user allows the user to have full mobility walk. A user can tighten the sling to adjust the location of the equipment in their back. Having the equipment supported on their back allows the user to walk in a more balanced stance and the user just needs to bend forward or backward to accommodate the load or the terrain. The carrier uses pockets for the equipment and for transportation of the carrier equipment. This also leave the hand of the user free while transporting equipment. The carrier uses Buckles that allow the user to just "squeeze" elements together to release the straps.

BACKGROUND [0001] Technical Field [0002] This disclosure relates to therapeutic use of 3,5-dihydroxy-4-isopropyl-trans-stilbene. [0003] Description of the Related Art [0004] 3,5-Dihydroxy-4-isopropyl-trans-stilbene (DHIS) is a naturally occurring compound discovered many decades ago. It is a metabolic product of symbiotic microorganisms present in the soil. Its structure is shown below: [0000] [0005] DHIS is known to have antibacterial, anti-inflammatory, immune modulating, and anti-tumor activities. Although its exact and full biological activities are unknown, DHIS has been used as a topical agent in clinical trials for treating inflammatory skin diseases such as psoriasis and atopic dermatitis, with promising efficacy and minimal side effect. See e.g., Bissonnette et al. Arch Dermatol, 146(4): 446-449 (2010); Bissonnette et al. Br J Dermatol, 166(4): 853-860 (2012). [0006] Due to its non-steroidal nature and ready availability through chemical synthesis, the therapeutic uses of DHIS would be significant. There is thus a need for exploring biological activities and effective therapeutic uses of DHIS. BRIEF SUMMARY [0007] Provided herein are various embodiments directed to therapeutic use of 3,5-Dihydroxy-4-isopropyl-trans-stilbene (DHIS) as a miticidal agent. [0008] One embodiment provides a method for treating skin affected by an overpopulation of skin parasites in a host, the method comprising contacting the affected skin with a therapeutically effective amount of DHIS. [0009] A further embodiment provides a method for treating rosacea or acne in a subject in need thereof, the method comprising contacting the subject with a therapeutically effective amount of DHIS. [0010] Yet another embodiment provides a method for eliminating mites or reducing mite population in a host, the method comprising contacting mites with 3,5-dihydroxy-4-isopropyl-trans-stilbene (DHIS). BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0011] FIG. 1 shows the treatment results of individuals (N=10) having papulopustular rosacea. [0012] FIG. 2 shows the treatment results of individuals (N=10) having acne. [0013] FIGS. 3A-3B are photos of a rosacea patient prior to treatment and after 4 weeks of treatment using DHIS, respectively. [0014] FIGS. 4A-4B are photos of an acne patient (cheek areas) prior to treatment and after 4 weeks of treatment using DHIS, respectively. [0015] FIGS. 5A-5B are photos of an acne patient (forehead area) prior to treatment and after 4 weeks of treatment using DHIS, respectively. DETAILED DESCRIPTION [0016] Described herein are therapeutic use of DHIS as an anti-parasitic agent and methods for treating skin conditions (e.g., rosacea and acne vulgaris) associated with skin parasites. In particular, it is disclosed herein that DHIS is a powerful miticidal agent for reducing or eradicating demodex mites. I. Skin Parasites and Associated Skin Conditions [0017] Demodex mites are commensal ectoparasites of the human skin. There are two main types, including D. folliculorum and D. bravis . On the skin they typically are present in low numbers (0.7 mites/cm 2 ) and reside in the hair follicles. Jarmuda et al, J Med Microbiol, 61(Pt 11): 1504-1510 (2012). They usually prefer areas of the skin with rich sebaceous glands, such as the face, forehead, nose, and the external ears. In these locations, the mites can mate and reproduce. The life span of demodex mites ranges 14-18 days. The propagation rate depends on the successful mating of the adult mites, which normally occur at the follicular openings of the sebaceous glands located at the surface of the skin. After mating, the female mites retreat back into the sebaceous glands located just below the surface of the epidermis, where they lay their eggs and start the life cycle of the next generation. [0018] Studies have shown that low numbers of these organisms are present in the human skin, especially the face. The density of demodex mites is very low in young children. They start to increase in number around puberty, and continue to increase into adulthood. [0019] In several skin conditions, such as rosacea, acne vulgaris, and blepharitis, perioral dermatitis, and alopecia, the mite density can be drastically increased compared to those without the skin conditions. In a survey of 860 individuals, individuals with normal facial skin only had a 5% chance to have mite density greater than 5/cm 2 , as compared with 38.5% chance for rosacea and 9.3% chance for acne rosacea. Zhao et al. J Zhejiang Univ Sci B, 12(12): 1008-1015 (2011). It has also been disclosed that normal facial skin had a density of 0.7 mites/cm 2 , as compared with 10.8 mites/cm 2 for rosacea. Forton et al. Br J Dermatol, 128(6): 650-659 (1993). In other studies, in addition to rosacea, several other skin conditions have been shown to be causally associated with increased infestation of the demodex mites, including blepharitis, and hair loss. Garcia-Vargas et al. J Am Acad Dermatol 57(2 Suppl): S19-21 (2007). [0020] It is believed that while low density of mites in the skin is harmless to the skin, increased density of mites can be detrimental to the health of the skin. It has been concluded that when demodex mites breach the epithelial barrier, their antigens influence the immune system of the host and induce a type IV hypersensitivity reaction. Jarmuda (Supra). [0021] Rosacea and acne vulgaris are described in further detail below. [0022] 1. Rosacea [0023] Rosacea is a common facial disease that affects about 6% of the general population. The affected individuals develop redness of the skin, dilated superficial blood vessels, papules, pustules on the cheeks, nose, and forehead. In some people, the eyes may also be affected, especially blepharitis. In other patients, especially males, hypertrophy of the nose can develop, resulting in rhinophyma. [0024] The exact etiology and pathogenesis of rosacea has not been clearly understood. Prevailing theories speculate on the role of vascular hypersensitivity versus increased immune activation. [0025] High density of demodex mites is pathogenically linked to rosacea. Studies have shown vastly increased demodex mite in the rosacea skin, at a density of 10.7 mites/cm 2 , at least 13 times higher than that of normal facial skin at a density of 0.7/cm 2 . Jarmuda et al (Supra). Rosacea does not have an ideal therapy that is both effective and free of side effects. The current options include oral anti-inflammatory medications (e.g., doxycyclines) and systemic isotretinoins. However, the effects of these agents are temporary and are often associated with adverse events such as teratogenesities, allergic responses, GI intolerance, as well as photosensitivities, among others. Accordingly, these therapies are limited in their long-term clinical usefulness and safety. Topical treatments also exist, including metronidazoles (a miticide), ivermectin (a miticide), and precipitated sulphur (miticides and anti-inflammatory). However, these drugs are highly irritating to the skin, and their effects are mild to moderate. [0026] 2. Acne Vulgaris [0027] Acne vulgaris is another follicular based skin disease centered on the face, chest, and upper back. The manifestations are similar to rosacea in terms of development of papules, pustules. However, acne patients tend to be much younger, and they do not typically develop facial flushing or dilated blood vessels. The pathogenesis is also unclear, although increased sebum production and blocked hair follicular openings are reported. Most recently multiple studies have shown that there is significantly increased density of demodex mites. In particular, a higher percentage of acne patients have significant demodex density compared to those without acne. Zhao et al. (supra). [0028] Treatment of acne involves either systemic therapies or topical therapies. Systemic therapies for acne are similar to rosacea. However, the topical therapies are different, including retinoic acids, benzoyl peroxides, antibiotics. These treatments are either modestly effective, or are associated with significant side effects. Thus new therapies that are both effective and safe are needed. II. Miticidal Activity of DHIS [0029] Various embodiments are directed to the miticidal activity of DHIS, which is proven effective in treating skin conditions such as rosacea and acne vulgaris. [0030] DHIS has potent miticidal activities. As described herein, an in vitro miticidal assay was performed to determine the miticidal activities of DHIS by using human demodex mites prepared with pressure scraping method, following by microscopic examination of the survival time of demodex under microscopy, using the method described in Chinese Journal of Parasitology and Parasitic Diseases 2011; 29:258-263. As further demonstrated in Example 1, DHIS showed dose-dependent miticidal activity. [0031] As used herein, mites include all demodex mites, such as human demodex folliculorum, D. bravis , and zoophilic demodex, such as D. canis, D. bovis, D. equi, D. ovis, D. cati, D. phyloides , and D. caprae . The demodex species include, without limitation, D. folliculorum and D. brevis. [0032] Thus, one embodiment provides a method for eliminating mites or reducing mite population comprising contacting mites with DHIS. [0033] In various specific embodiments, the mites are present on the skin of a host (e.g., human), including face, chest or upper back. In more specific embodiments, the mites are present on the skin at a density of more than 0.7 mite/cm 2 , or more than 1.0 mite/cm 2 , or more than 2.0 mites/cm 2 , or more than 5.0 mites/cm 2 , or more than 8.0 mites/cm 2 , or more than 10 mites/cm 2 , or more than 15 mites/cm 2 . III. Treatment of Skin Diseases [0034] Demodex mites are involved in the pathogenesis of several skin conditions, including rosacea and acne vulgaris. Consistent with the miticidal activities of DHIS observed in vitro, topical application of DHIS is further demonstrated to be effective in treating skin conditions (e.g., rosacea and acne vulgaris) associated with increased demodex mite. See Examples 2-5. [0035] Therefore, various embodiments provide methods for treating skin affected by an overpopulation of skin parasites in a host, wherein the method comprises contacting the affected skin with a therapeutically effective amount of DHIS. [0036] As used herein, a host refers to a human or an animal. [0037] In preferred embodiments, the skin parasites are mites. In other embodiments, the skin parasites are pediculosis (lice). [0038] As used herein, population or density of skin parasites (e.g, mites) refers to a number of parasites per unit area of skin surface. Typically, at a density of 0.7 mite/cm 2 or less, mites are harmless or nonpathogenic to the host. An increase in density from such a normal level (i.e., more than 0.7 mite/cm 2 ) can lead to overpopulation or over-infestation of mites. [0039] In addition to rosacea, acne vulgaris, skins affected by overpopulation or over-infestation of mites are associated with conditions such as ocular demodex infestation, blepharitis, Meibomian glandular abnormalities, chronic conjunctivitis, allergic conjunctivitis, scabies, animal scabies, animal demecidosis. [0040] In various embodiments, the DHIS can be administered by various means, including IV, oral, perrectum, sublingual, topical, and intraocular. [0041] If used as an oral agent, the DHIS can be formulated into tablets or capsules, which can be manufactured using non-medicinal materials such as starch, galactose, lubricants, humectants and so on. Oral application may also take the form of liquid or suspension, which may further include additives known in the art. [0042] In a preferred embodiment, DHIS is directly applied to the skin, e.g., directly to the affected skin. DHIS may be formulated into creams, lotions, ointment, suspension, adhesives, foams, sprays, cleansers, gels. [0043] In more specific embodiments, percutaneous or topical formulations may include one or more dermatologically acceptable excipients or additives to facilitate the per-cutaneous delivery (i.e., absorption through the skin). DHIS is typically present in the topical formulation at a concentration from approximately 0.2% to 20%, and any percentage or range in between. The compounded product or topical formulation may be applied in the amount of 0.5 mg to 1 gram. It is understood that the exact amounts or concentrations of DHIS may vary in individual circumstances depending on the severity of the skin condition. [0044] When used for the treatment of rosacea, acne vulgaris as well as blepharitis, DHIS can be prepared as a 0.1% to 20% w/w compounded substance, applied to the affected area, once to twice per day, for as long as it takes to achieve clinical improvement or resolution of the symptoms. [0045] DHIS may also be formulated as an instant release, delayed release or sustained release formula. [0046] DHIS can be used in the same manner for the treatment of animal demodex infestations. EXAMPLES Example 1 In Vitro Miticidal Activity of DHIS [0047] In vitro miticidal assay was performed using human demodex mites prepared with pressure scraping method, following by microscopic examination of the survival time of demodex under microscopy, using the method described in Chinese Journal of Parasitology and Parasitic Diseases (Supra). [0048] After mite isolation, 30 mites were placed on glass slides containing 200 ul of normal saline or saline containing various concentrations of DHIS (10 μM, 100 μM, and 1 mM). The slides were incubated at room temperature (20° C.) and under 70% humidity. The slides were examined under microscopy every 60 minutes for 8 hours after treatment. At each time point, the percentage of dead mites (no movements for 1 minute) was recorded for each treatment concentration. Each concentration was tested in triplicates, with the average for the three experiments recorded and shown in Table 1. [0000] TABLE 1 Miticidal activities of DHIS in vitro Number (%) mites dead at various time points Demodex sp. DHIS D. folliculorum D. bravis concentration 0 hr 1 hr 2 hr 3 hr 4 hr 0 hr 1 hr 2 hr 3 hr 4 hr 0 0 0 0.3 1 3.3 0 0 0 1 2 (0) (1) (3.3) (11) (0) (0) (3.3) (6.7)  1 μM 0 3 5 8.6 13 0 2 4 7 10 (10) (17) (28) (43) (6.7) (13) (23) (33)  10 μM 0 7 12.3 14 22 0 6 11 14 19 (23) (41) (47) (73) (20) (37) (47) (63) 100 μM 0 10 21.7 26 27.7 0 12 19 24 26 (33) (72) (87) (92) (40) (63) (80) (87)  1.0 mM 0 13 24 28 29 0 14 18 26 26 (43) (80) (93) (97) (47) (60) (87) (87) Example 2 DHIS Decreased Demodex Mites and Skin Manifestations of Patients with Papulopustular Rosacea [0049] Given the demonstrated miticidal effect of DHIS in vitro, an observation was performed to examine (1) if topical application of DHIS on the skin of rosacea (which is well documented to have increased demodex mites) could result in decrease or eradication of demodex mites, and (2) if this is accompanied with improvement or remission of the clinical symptoms of rosacea. [0050] A total of 20 volunteers (10 with papulopustular rosacea, 10 with papulopustular acne vulgaris) were recruited for this observation. [0051] For each volunteer, the duration of the condition, the baseline sign and symptoms of their facial conditions and the severity of their condition were recorded. For the signs of the condition, papules and pustules were counted as total number for each individual. Erythema was rated as severe (3, deep red to purple), moderate (2, red), mild (1, pink), or none (0, normal color). For burning and pruritus, visual analogue scale (10 cm line) was used, with the score recorded from 0 (no symptoms) to 10 cm (most severe). In addition, the baseline demodex mite density of the perinasal skin was measured using the modified pressure-scraping technique. For the purpose of this study, both D. folliculorum and D. bravis were counted together. Then each volunteer used DHIS topical cream at 0.75% concentration, twice daily to the affected areas on the face. They were seen again at 4 weeks, when the clinical signs and symptoms were recorded. Further the demodex mite density was assessed again using the modified pressure/scraping technique. [0052] Individuals with papulopustular rosacea ( FIG. 1 , N=10) and acne ( FIG. 2 , N=10) received DHIS 0.75% cream twice daily for 4 weeks. The demodex mite density (mite/cm 2 ) and clinical signs/symptoms are assessed at the baseline and again at 4 weeks. Papules and pustules are counted or the entire facial area for each individual. Erythema was graded as mild (1, pink), moderate (2, red), or severe (3, purple-red), whereas itchiness and burning sensation were graded according to a 10 cm visual analogue scale. * denotes p<0.05 (t-test) [0053] As shown in FIG. 1 , there was a significant reduction of demodex mite density at 4 weeks compared with at the baseline. Likewise, FIG. 2 shows a significant reduction of demodex mite density at 4 weeks compared with at the baseline for acne patients. The reduction of mite density was associated with dramatic reduction of lesional counts for papules and pustules, both for rosacea and for acne patients. The reduced erythema was also statistically significant. Other symptoms such as itchiness and burning sensation were reduced. Example 3 Case Study—Rosacea Patient [0054] Case 1 involved a 76-year old man with rosacea for 11 years. He had facial erythema and papules and pustules, with mild telangiectasia. There was burning sensation. This was associated with mild rhinophyma. There was foreign body sensation in the eyes. He had received tetracycline and sulfonamide based creams with no obvious improvement. At base line, there was more than usual number of demodex mites. He received DHIS 0.75% cream treatment BID for 4 weeks. At the end of the therapy, his demodex mite density markedly decreased. More importantly, rosacea signs and symptoms dramatically improved. See photos of the rosacea patient prior to treatment ( FIG. 3A ) and after 4 weeks of treatment ( FIG. 3B ). Example 4 Case Study—Acne Patient [0055] Case 2 involved a 21 year old woman with more than 3 years of acnes symptoms. She had open comedons as well as closed comedons. There were papules and pustules but only mild erythema. She had received topical retinoic acid therapy with no improvement. In addition, she received benzoyl peroxide/antibiotic combination topical therapy, oral birth control pills, oral tetracycline, as well as oral Traditional Chinese Medicine concoction, all without satisfactory effects. She had increased demodex mite count at base line. After receiving 4 weeks of DHIS 0.75% cream BID, her facial demodex mite density significantly decreased. Her facial acne papules and pustules resolved at the end of 4 weeks. See photos of the acne patient (cheeks and forehead) prior to treatment ( FIGS. 4A and 5A ) and after 4 weeks of treatment ( FIGS. 4B and 5B ). [0056] The various embodiments described above can be combined to provide further embodiments. All of the U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications and non-patent publications referred to in this specification and/or listed in the Application Data Sheet are incorporated herein by reference, in their entirety. Aspects of the embodiments can be modified, if necessary to employ concepts of the various patents, applications and publications to provide yet further embodiments. [0057] These and other changes can be made to the embodiments in light of the above-detailed description. In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the disclosure.

Disclosed herein are methods for treating skin conditions associated with skin parasites, including mites, by administering a therapeutically effective amount of 3,5-dihydroxy-4-isopropyl-trans-stilbene (DHIS).

FIELD OF THE INVENTION [0001] This invention relates to a method for treating humans with high levels of cholesterol and/or triglycerides using a combination of over-the-counter dietary supplements. DESCRIPTION OF THE PRIOR ART [0002] As is well known, increased levels of cholesterol, and in particular low density lipoproteins (LDL) is associated with circulation problems which often lead to heart attack and stroke. The increased level of cholesterol often is also accompanied by an increased level of triglycerides in the circulatory system. Increased plasma lipid levels have been associated with the build up of plaque within blood vessels, and there are a variety of treatments known to reduce these levels. Some treatments are more effective than others, and most are associated with undesirable side effects in many patients. [0003] The total cholesterol level includes both the beneficial high density lipoproteins (HDL) and the troublesome low density lipoproteins, (LDL). Measurement of the total cholesterol level then can be misleading because if the LDL concentration is low and the HDL is also low this can be an undesirable situation. It is necessary to have the HDL concentration above a preset value, and the LDL concentration below a preset value, and both must be measured to provide an accurate picture. [0004] It has been proposed to control cholesterol level merely with a strict dietary regimen. In most instances, however, diet alone cannot achieve the desired result. It is necessary to use an additional drug in order to achieve the healthy cholesterol and triglyceride levels. See The Niacin Solution , William B. Parsons, Jr. (Lilac Press 1998). [0005] It has been proposed especially with patients who have suffered a heart attack to take aspirin on a daily basis. Most studies indicate that aspirin has been beneficial and its use encouraged. In many patients, however, aspirin alone is insufficient. [0006] In general there are three groups of drugs on the market used for controlling cholesterol. They are bile secreted resins, fibrates, and statins. [0007] The resins act against bile acids in the intestine preventing them from being reabsorbed and recycled into cholesterol. While these drugs are capable reducing LDL cholesterol, they do not raise HDL cholesterol or lower triglycerides. The drugs further have uncomfortable side effects and can interfere with the absorption of various other drugs such as anticoagulants, diuretics, and the like. While fibrates are capable of raising triglycerides and raising HDL cholesterol they do not reduce LDL cholesterol levels. Furthermore there have been studies and in particular a double blind study in which the results were less than clinically significant. [0008] Finally, the drugs most commonly used are statins which act to alter liver functions and thereby the production of cholesterol. These drugs must be administered under a doctors care and have been associated with myopathy especially is the patient is taking another drug such as an antidepressant. Statins are metabolized by liven enzymes, and if an additional drug is taken such as an antidepressant which inhibits the liver enzymes the result can be similar to an overdose of the statin drug. [0009] Concerning diet, it is known that a high diet of polyunsaturated fatty acids is undesirable because it reduces HDL cholesterol, and monounsaturated fatty acids have a favorable effect by reducing LDL cholesterol. In U.S. Pat. No. 5,518,753 it was proposed to provide an edible fatty acid triglyceride mixture which included fatty acids rich in linoleic acids and alpha-linolenic acids from various vegetable oils and fish oils. [0010] In U.S. Pat. No. 5,886,037 a food composition was described using fish oil as an ingredient providing the beneficial fatty acids docosahexaenoic acid (DHA) and eicosapeiitaenoic acid (EPA) present in about 5-8% of the total composition. This patent describes then a food product and also requires a number of medium chain fatty acids and polyunsaturated fatty acids as ingredients. [0011] Accordingly, there remains a need for a food supplement without undue side effects which can be purchased over-the-counter and is effective to reduce LDL cholesterol and triglycerides and increase HDL cholesterol. SUMMARY OF THE INVENTION [0012] It has been discovered that a combination of fish oil concentrate, niacin, and lecithin taken in combination in pill form once a day will achieve the desired beneficial results with cholesterol and triglyceride reduction. [0013] Accordingly it is an object of this invention to provide a dietary supplement which can be purchased over-the-counter without a prescription which will be effective in reducing undesirable levels of triglycerides without undue side effects. [0014] It is another object of this invention to provide a combination of individually administered lecithin, niacin, and fish oil concentrate wherein the niacin is administered in pill form and the fish oil concentrate and lecithin in soft gel form whereby the patient can purchase these supplements and achieve a beneficial result without using prescription medication. [0015] It is a further object of this invention to provide a combination of well known dietary supplements which together function to reduce LDL cholesterol, increase HDL cholesterol, and reduce triglycerides when administered on a daily basis within about 4-6 weeks. [0016] These and other objects will be readily apparent with reference to the following description. DETAILED DESCRIPTION OF THE INVENTION [0017] The purpose of this invention is to provide the following goals of treatment: [0018] The total cholesterol level should be below 200 with the LDL cholesterol target below 100 for anyone with a previous cardiovascular event and below 130 for everyone else. The HDL cholesterol should be above 45 or between 40 and 45. Triglycerides should be below about 175. These values are expressed in milligrams per deciliter (mg/dL). [0019] This invention involves the discovery that the daily oral dosage of a combination of fish oil concentrate, niacin and lecithin will result in reaching the above identified goals as well as reducing triglycerides within about 6 weeks. [0020] Fish oil concentrate is available from a number of sources commercially in the form of soft gel dosages. Fish oil concentrate is a good source of omega-3 polyunsaturated fatty acids EPA and DHA. These fatty acids have been identified with beneficial results relative to lowering lipid levels in blood plasma. [0021] One source of fish oil concentrate is Dale Alexander's MaxEPA or Super MaxEPA marketed by Twinlabs as a cholesterol free product containing EPA and DHA. In the MaxEPA product each pair of soft gels provides 600 mg of EPA and 240 mg of DHA in a 2500 mg dosage. In the preferred embodiment of this invention Super MaxEPA provides 450 mg EPA and 300 mg DHA in each soft gel. [0022] The niacin ingredient preferably is a flush free product and in a preferred embodiment it is marketed in 500 mg tablets by KAL Dietary Supplements. The product is marketed as Inositol Hexanicotinate. [0023] One of the problems with niacin when it is ingested in its pure nicotinic acid form is that the patient will experience a skin flushing due to marked dilation of the capillaries. Even doses as small as 50 mg can produced such a severe flush. The flush is confined to the head and neck but it may involve the upper half of the body or occasionally the whole body surface. The skin feels hot in the effected area and may also tingle or itch. The flash lasts perhaps 15 to 20 minutes or longer, and many patients will not tolerate this occurrence. In order to counter act this flash the niacin is chemically combined to provide a more slow dissolving product. In the preferred embodiment of this invention the niacin is present as Inositol Hexanicotinate. [0024] If plain niacin is used, the dosage should be about twice that of the chemically combined product. Plain niacin, however, has been associated with nausea in addition to the flush and may alter liver function. Therefore the preferred embodiment of this invention is the chemically combined form. [0025] Finally, the third ingredient is lecithin. Lecithin is a well known antioxidant and preservative, and is available as a dietary supplement in soft gels. The preferred embodiment is 1200 mg units also supplied by KAL Dietary Supplements. This lecithin product is produced from soybeans. This particular product has an average of 61% phosphatides and contains a number of polyunsaturated fatty acids. [0026] The preferred daily dosage is two MaxEPA soft gels, two 500 mg flash free niacin tablets, and two 1200 mg lecithin soft gels. [0027] The following examples are illustrative of this invention but are not intended to limit the scope thereof. In each instance the combination of medication was as stated above, fish oil concentrate, flush free niacin, and lecithin in the quantities described. [0028] In the case of the first individual, the triglyceride measurement was 385, LDL cholesterol was 160 and HDL cholesterol was 43. After 6-7 weeks of taking the medication according to this invention, the triglyceride count dropped to 265, HDL cholesterol increased to 55, and the LDL cholesterol dropped to 156. [0029] In the case of a second individual, the triglyceride measurement was 213, with total cholesterol at 164. After 6-7 weeks of the medication according to this invention the triglyceride count dropped to 134 and total cholesterol dropped to 130 with HDL cholesterol measured at 40. Subsequently, one year later, the triglyceride count was 137 with total cholesterol at 116 and HDL, cholesterol at 29. Subsequently, the measurements were maintained at triglycerides of 182, HDL cholesterol at 45, and LDL cholesterol at 77. [0030] In the case of a third individual the initial triglyceride measurement was 404 with an HDL cholesterol measurement of 35. The triglyceride measurement was too high to permit calculation of the LDL cholesterol level. After the medication according to this invention the triglyceride level dropped to 250 with an HDL cholesterol measurement of 45 and an LDL cholesterol measurement of 75. The total cholesterol level dropped from 255 to 170. In each instance, no side effects were noted. [0031] In summary, according to this invention, a combination of over-the-counter food supplements has been found to be effective in reducing of blood lipid levels and specifically, to reduce LDL cholesterol, increase HDL cholesterol and reduce triglycerides. The overall result then is a combination of food additives which protect against circulatory conditions leading to heart attack and stroke. [0032] The food additives of this invention are niacin, fish oil concentrate, and lecithin. The niacin in the preferred embodiment is flush free chemically combined compound taken in the form of 500 mg tablets with two tablets being preferred per day. In the case of lecithin, soft gels are preferred, and two 1200 mg soft gels are the preferred dosage. Each 1200 mg soft gel typically supplied 192 mg phosphatidyl choline, 168 mg phosphatidyl ethanolamines and 108 mg of phosphatidyl inositol. [0033] The third ingredient, fish oil concentrate, typically is also in soft gels of 1250 mg, and two per day are preferred. In each two soft gels there are omega 3 polyunsaturates in the form of 450 mg EPA and 200 mg DHA (eicosapentaenoic acid and docosahexaenoic acid, respectively). [0034] In the case of each of these three food supplements, the dosage level is dictated by the commercially available dosages and the above is intended to merely illustrate a preferred embodiment rather than limit the invention to the dosage level set forth above. [0035] It will be readily seen by one of ordinary skill in the art that the present invention fulfills all of the objects set forth above. After reading the foregoing specification, one of ordinary skill will be able to effect various changes, substitutions or equivalents and various other aspects of the invention as broadly disclosed herein. It is therefore intended that the protection granted hereon be limited only by the definition contained in the appended claims and equivalents thereof.

A method of treating excessive blood lipid levels in humans is described. The treatment includes a daily dosage of food supplements available over-the-counter without a prescription. The supplements are fish oil concentrate, niacin (flush free), and lecithin. In the preferred embodiment two 500 mg tablets of niacin, 2 1200 mg soft gels of lecithin, and two 1250 mg soft gels of fish oil concentrate are administered orally once to twice per day.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 13/662,975 filed on Oct. 29, 2012, which is a continuation of U.S. patent application Ser. No. 11/402,319 filed on Apr. 11, 2006, which claims the benefit of U.S. Provisional Application No. 60/680,851, filed on May 13, 2005. The entire disclosures of each of the above applications are incorporated herein by reference. FIELD [0002] The present teachings relate to an apparatus for the correction of chest wall deformities, and more specifically to a pectus bar stabilizer. BACKGROUND [0003] To correct chest wall deformities, a pectus bar may be fixedly mounted to supporting structure, typically cartilage, using a stabilizer plate, which generally includes a single plate having a recess through a central portion and apertures therein for receiving and fixedly attaching a pectus bar thereto. A pectus bar stabilizer may also include a series of apertures on distal portions for fixedly securing the stabilizer plate to the supporting structure. To remove or adjust the pectus bar, screws securing the pectus bar to the stabilizer plate must be removed. But the screws are often difficult to access and remove due to surrounding tissue or bone growth. SUMMARY [0004] A pectus bar stabilizer assembly generally includes a pectus bar, a retainer assembly, a first base part and a second base part. The first and second base parts are separable from one another to facilitate removal and combinable to define a channel therebetween. The pectus bar is received by the channel and the retainer assembly retains the pectus bar in the channel. A portion of the retainer assembly may be removed, allowing the pectus bar to be removed or adjusted. [0005] Further areas of applicability of the present teachings will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present teachings. BRIEF DESCRIPTION OF THE DRAWINGS [0006] The present teachings will become more fully understood from the detailed description and the accompanying drawings, wherein: [0007] FIG. 1 is a perspective view of a first pectus bar stabilizer assembly shown partially assembled and partially exploded; [0008] FIG. 2 is a front perspective view of one base part of a pectus bar stabilizer; [0009] FIG. 3 is a rear perspective view of the base part of FIG. 2 ; [0010] FIG. 4 is a sectional view of the base parts of the pectus bar stabilizer as cut along line IV-IV of FIG. 1 ; [0011] FIG. 5 is a plan view of the tool and stopping member; [0012] FIG. 6 is a partial plan view of the tool and stopping member; [0013] FIG. 7 is a perspective view of a pectus bar stabilizer assembly shown partially assembled and partially exploded; [0014] FIG. 8 is a front perspective view of one base part of the pectus bar stabilizer shown in FIG. 7 ; [0015] FIG. 9 is a rear perspective view of the base part of FIG. 8 ; [0016] FIG. 10 is a perspective view of a pectus bar stabilizer assembly shown partially assembled and partially exploded; [0017] FIG. 11 is a front perspective view of one base part of the pectus bar stabilizer shown in FIG. 10 ; [0018] FIG. 12 is a rear perspective view of the base part of FIG. 11 . [0019] FIG. 13 is a perspective view of a pectus bar stabilizer assembly shown partially assembled and partially exploded; [0020] FIG. 14A is a front perspective view of one base part of the pectus bar stabilizer shown in FIG. 13 ; [0021] FIG. 14B is an additional front perspective view of the base part of FIG. 14A ; [0022] FIG. 15A is a rear perspective view of the base part of FIG. 14 . [0023] FIG. 15B is an additional front perspective view of the base part of FIG. 15A ; [0024] FIG. 16 is a front perspective view of one base part of the pectus bar stabilizer shown in FIG. 13 having an additional feature; [0025] FIG. 17 is a rear perspective view of the base part of FIG. 16 ; [0026] FIG. 18 is a perspective view of a pectus bar stabilizer assembly shown partially assembled and partially exploded; [0027] FIG. 19 is a perspective view of the pectus bar stabilizer of FIG. 18 ; and [0028] FIG. 20 is a sectional view of the pectus bar stabilizer of FIG. 19 taken at line 20 - 20 . DETAILED DESCRIPTION [0029] FIGS. 1-4 show a pectus bar stabilizer assembly 10 generally includes a pectus bar 12 and a pectus bar stabilizer 14 . The pectus bar stabilizer 14 retains the pectus bar 12 and may be fixedly attached to an external structure, such as cartilage. [0030] The pectus bar 12 may have a longitudinally extending bar of generally uniform thickness, a generally rectangular cross-section, and an end portion 24 opposite a second end portion 26 . The first and second end portions 24 , 26 may include an arcuate periphery and an aperture 25 . A series of apertures 28 , 30 , which may include internal threads, may be disposed inwardly from the end portions 24 , 26 . [0031] The pectus bar stabilizer 14 may include first and second base parts 20 , 22 and a retainer assembly 78 . The first and second base parts 20 , 22 may be generally similar to one another, with minor differences that will be discussed below. For simplicity in the description, first base part 20 will be discussed in detail. [0032] The first base part 20 may include a body portion 32 and a leg 34 extending therefrom. The body portion 32 may include an inner body wall 36 , a top body surface 38 , a lower body surface 40 and an outer body surface 42 . The top body surface 38 may include three main sections 44 , 46 , 48 . The first section 44 is generally planar and includes a series of notches 50 . The second section 46 is contoured and slopes downward from the first section 44 to the third section 48 . The third section 48 is generally planar and extends from the second section 46 . The lower body surface 40 is generally planar and generally parallel to the first and third sections 44 , 48 of the top body surface 38 . The outer body surface 42 connects the top body surface 38 , the lower body surface 40 and the inner body wall 36 . [0033] The inner body wall 36 may include two sections 56 , 58 . The first section 56 is generally rectangular and has a width L 1 and a height L 2 . The second section 58 is generally rectangular and has a width L 1 and a height L 3 . The height L 3 of the second section 58 is less than the height L 2 of the first section 56 . A recess 60 , defined below the second section 58 and proximate the first section 56 , extends into the body portion 32 a depth of L 4 and has a width L 1 and a height L 5 . [0034] A leg 34 extends generally perpendicularly from the first section 56 of the inner body wall 36 . The leg 34 may have a width generally equal to the width L 1 of the first section 56 of the inner body wall 36 and may be divided into a first leg portion 62 and a second leg portion 64 . The first leg portion 62 , which is located proximate the body portion 32 , may have a generally rectangular cross-section and a height less than the height L 5 of the recess 60 in the body portion 32 . The first leg portion 62 of the first and second base parts 20 , 22 may also each include an arcuate recess 63 at an inner edge portion 65 as shown in FIGS. 7-9 . The second leg portion 64 may have a generally rectangular cross-section and may be sized to generally fit within the recess 60 , having a height, length and width generally corresponding to the dimensions L 5 , L 4 , L 1 of recess 60 . [0035] A series of apertures may be located in the first base part 20 . A first aperture 52 may be located at a distal end 54 of the body portion 32 , passing through the third section 48 of the top body surface 38 and the lower body surface 40 . The first aperture 52 allows the first base part 20 to be coupled to a supporting structure, such as cartilage. A series of pin apertures 66 , 68 , 70 , 72 may be provided in the first and second base parts 20 , 22 . The pin apertures 66 , 68 extend partially into the first base part 20 . The first pin aperture 66 extends into body portion 32 through the recess side wall 74 in the recess 60 of body portion 32 . The second pin aperture 68 extends into the second leg portion 64 through the second leg portion side wall 76 . The pin apertures 70 , 72 in the second base part 22 may be positioned similarly to those in the first base part 20 , and may extend completely through the second leg portion 64 and the body portion 32 of the second base part 22 , as shown in FIG. 4 . Alternatively, the base parts 20 , 22 may not include any pin apertures, eliminating the need for pins as shown in FIGS. 7-9 . [0036] The retainer assembly 78 may include a series of pins 80 , a series of retaining bars 82 and a stopping member assembly 84 . The pins 80 may be generally cylindrical members, sized to be located within the pin apertures 66 , 68 , 70 , 72 . The pin may include a first portion 81 and a main portion 83 generally extending therefrom. The first portion 81 of the pin 80 may have a diameter greater than the diameter of the main portion 83 of the pin 80 . The main portion 83 of the pin 80 may be smaller in diameter than the pin apertures 66 , 68 , 70 , 72 . The main portion 83 may be first inserted into the pin apertures 66 , 68 , 70 , 72 . The first portion 81 may have a diameter similar to the diameter of the pin apertures, resulting in retention of the pin within the pin apertures 66 , 68 , 70 , 72 , due to friction between the first portion 81 and pin apertures 70 , 72 . [0037] The retaining bars 82 may include a first end portion 86 opposite a second end portion 88 . The retaining bars 82 may generally have flattened, substantially rectangular cross-sections with rounded edges at the first and second end portions 86 , 88 . The retaining bars 82 may have a generally uniform thickness throughout their length. The first and second ends 86 , 88 of the retaining bars 82 may be located in the notches 50 in the body portions 32 of the base parts 20 , 22 . [0038] The stopping member assembly 84 , shown in FIGS. 5 and 6 , may include a tool 90 , a neck portion 92 and a stopping member 94 . The tool 90 is generally cylindrical and may include a knurled surface 96 to facilitate grasp by a user. A distal end 98 of the tool 90 may be generally conical, having a greater diameter at a first end 100 and a reduced diameter at a second end 102 . A neck portion 92 may generally extend from the distal end 98 of the tool 90 to the stopping member 94 . The neck portion 92 may be substantially smaller in diameter than both the tool 90 and the stopping member 94 and provides a mechanism to separate the tool 90 from the stopping member 94 . The separation feature may be a necked-down portion facilitating separation by bending or twisting the tool 90 relative to the stopping member 94 , or may include a torque-limiting feature to sever the tool 90 from the stopping member 94 upon meeting a predetermined torque limit during insertion. The neck portion 92 diameter may be one-tenth of the diameter of the tool 90 and less than one-half of the diameter of the smallest diameter of the stopping member 94 . A variation may include a separate tool and stopping member. [0039] The stopping member 94 may include a hexagonal head 104 and a body portion 106 generally extending therefrom. The hexagonal head 104 may be attached to the neck portion 92 . The body portion 106 may include an unthreaded portion 108 and a threaded portion 110 . The unthreaded portion 108 may be located proximate the hexagonal head 104 and the threaded portion 110 may be located at the end of the body portion 106 distal from the hexagonal head 104 . [0040] The pectus bar stabilizer assembly 10 may retain the pectus bar 12 through the first and second base parts 20 , 22 and the retainer assembly 78 . The two base parts 20 , 22 may be placed proximate one another, inserting the second leg portion 64 of the first base part 20 into the recess 60 of the second base part 22 and inserting the second leg portion 64 of the second base part 22 into the recess 60 of the first base part 20 . In this configuration, the first and second base parts 20 , 22 define a channel 112 bound by the inner body wall 36 of the first base part 20 , the inner body wall 36 of the second base part 22 and the first leg portions 62 of the first and second base parts 20 , 22 . In this configuration, the pin apertures 66 , 68 , 70 , 72 of the first and second base parts 20 , 22 are in respective alignment. [0041] Once the first and second base parts 20 , 22 have been arranged to define the channel 112 , pins 80 may be inserted into the pin apertures 66 , 68 , 70 , 72 . The pins 80 may extend completely through the first base part 20 and partially into the second base part 22 , securing the first and second base parts 20 , 22 to one another in a transverse direction relative to the axis of the pins 80 . Next, the retaining bars 82 may be placed over the channel 112 . The first and second ends 86 , 88 may be located within the notches 50 in the body portion 32 of the first and second base parts 20 , 22 and welded in place. The retaining bars 82 secure the first and second base parts 20 , 22 to one another in a transverse direction relative to the bars 82 . [0042] Once the first and second base parts 20 , 22 are fixedly attached to one another, a first end portion 24 of the pectus bar 12 may be inserted into the channel 112 below the retaining bars 82 . After the first end portion 24 is located within the channel 112 , one of the apertures 28 in the first end portion may be aligned between the retaining bars 82 . After the desired aperture 28 is located between the retaining bars 82 , the stopping member 94 may be secured in the aperture 28 . Once the stopping member 94 is securely in place, the tool 90 is separated from the stopping member 94 at the neck portion 92 . The hexagonal head 104 may provide retention of the pectus bar 12 . The body portion 106 of the stopping member 94 may be attached to the aperture 28 in the pectus bar 12 and the hexagonal head 104 may extend above the pectus bar 12 , preventing the pectus bar 12 from translating axially beyond the retaining bars 82 . [0043] In FIGS. 1-3 , the stopping member 94 is shown only passing through the pectus bar because the channel 112 has no aperture therethrough. As shown in FIGS. 7-9 the channel may have an aperture allowing for passage of the stopping member 94 therethrough, providing further retention. The stopping member 94 may include an additional portion extending beyond the threaded portion 110 . This additional portion may be unthreaded, as shown in FIG. 7 , or may be threaded. [0044] Other stopping members may be used for retention of the pectus bar 12 within the pectus bar stabilizer 14 . One such example is a rivet, which may be applied to an aperture 28 in the pectus bar 12 , leaving a head portion exposed above the pectus bar 12 and retaining the pectus bar 12 within the pectus bar stabilizer 14 as described above. [0045] The pectus bar 12 may be removed from the pectus bar stabilizer 14 without removing any of the stopping members 94 . One of the retaining bars 82 located distal from the retained end portion 24 , 26 may be removed allowing the pectus bar 12 to translate axially in a direction free of the bars 82 . Both bars 82 may also be removed to eliminate retention of the pectus bar 82 within the pectus bar stabilizer 14 . [0046] The pectus bar stabilizer 14 may generally be attached to an external structure, such as cartilage. The pectus bar stabilizer 14 may be attached using the apertures 52 located in the distal portions of the first and second base parts 20 , 22 . The attachment may be made using any suitable method including sutures, screws or some other form of attachment. [0047] A typical pectus bar stabilizer assembly 10 may include two pectus bar stabilizers 14 , as shown in FIG. 1 . The second pectus bar stabilizer 14 may be identical to the first pectus bar stabilizer 14 , as described above. A second end portion 26 of the pectus bar 12 may be attached to the second pectus bar stabilizer 14 through a second series of apertures 30 in a manner similar to that described above. [0048] An additional pectus bar stabilizer assembly 210 is shown in FIGS. 10-12 and generally includes a pectus bar 12 and a pectus bar stabilizer 214 . The pectus bar stabilizer 214 retains the pectus bar 12 and may be fixedly attached to an external structure, such as cartilage. [0049] The pectus bar stabilizer 214 may include first and second base parts 220 , 222 and a retainer assembly 278 . The first and second base parts 220 , 222 may be generally similar to one another. For simplicity in the description, only first base part 220 will be discussed in detail with the understanding that the second base part 222 is similar in structure. [0050] The first base part 220 may include a first end 232 , a second end 234 and a channel 212 disposed therebetween. The first and second ends 232 , 234 are generally similar and only the first end 232 will be discussed in detail. The first end 232 may include an channel wall 236 , a top body surface 238 , a lower body surface 240 and an outer body surface 242 . The top body surface 238 may include three main sections 244 , 246 , 248 . The first section 244 is generally planar and includes a series of notches 250 . The second section 246 is contoured and slopes downward from the first section 244 to the third section 248 . The third section 248 is generally planar and extends from the second section 246 . An arcuate recess 252 is formed through the third section 248 of the top body surface 238 . The arcuate recess 252 aligns with a similar arcuate recess 252 on the second base part 222 , generally forming an aperture through the first end 232 thereof. The lower body surface 240 is generally planar and generally parallel to the first and third sections 244 , 248 of the top body surface 238 . The outer body surface 242 connects the top body surface 238 , the lower body surface 240 and the channel wall 236 . [0051] The channel walls 236 define the width of the channel 212 and the middle portion 262 defines the lower structure of the channel 212 . A series of channel notches 268 are located in the channel walls 236 and the first section 244 of the top body surface 238 . A threaded arcuate recess 266 may be formed on the inner surface of the middle portion 262 . When the first and second base parts 220 , 222 are assembled the threaded arcuate recesses 266 of each align, forming a threaded aperture. [0052] The retainer assembly 278 may include a series of retaining bars 282 and a stopping member assembly 284 . The retaining bars 282 may include a first end portion 286 opposite a second end portion 288 . The retaining bars 282 may generally have flattened, substantially rectangular cross-sections with rounded edges at the first and second end portions 286 , 288 . The retaining bars 282 may have a generally uniform thickness throughout their length. The first and second ends 286 , 288 of the retaining bars 282 may be located in the notches 250 in the first and second ends 232 , 234 of the base parts 220 , 222 . [0053] The stopping member assembly 284 may include a tool 90 , a neck portion 92 and a stopping member 94 similar to that described above. The stopping member 94 may include an additional threaded portion extending beyond the threaded portion 110 , as shown in FIG. 10 . [0054] The pectus bar stabilizer assembly 210 may retain the pectus bar 12 through the first and second base parts 220 , 222 and the retainer assembly 278 . The two base parts 220 , 222 may be placed proximate one another defining a channel 212 bound by the channel walls 236 and middle portion 262 . In this configuration, the notches 250 of the first and second base parts 220 , 222 are in respective alignment. [0055] Once the first and second base parts 220 , 222 have been arranged to define the channel 212 , the retaining bars 282 may be placed along the sides if the channel 212 . The first and second ends 286 , 288 may be located within the notches 250 in the first and second ends 232 , 234 of the first and second base parts 220 , 222 and welded in place. The retaining bars 282 secure the first and second base parts 220 , 222 to one another in both a transverse direction and an axial direction relative to the bars 282 . [0056] Once the first and second base parts 220 , 222 are fixedly attached to one another, a first end portion 24 of the pectus bar 12 may be inserted into the channel 212 . After the first end portion 24 is located within the channel 212 , one of the apertures 28 in the first end portion may be aligned with the aperture formed by the threaded arcuate recesses 266 in the middle portion 262 . After the desired aperture 28 is located above the aperture formed by the threaded arcuate recesses 266 , the stopping member 94 may be threaded into the aperture 28 and through the aperture formed by the threaded arcuate recesses 266 as well. Once the stopping member 94 is securely in place, the tool 90 is separated from the stopping member 94 at the neck portion 92 . The hexagonal head 104 may provide retention of the pectus bar 12 . The body portion 106 of the stopping member 94 may be attached to both the aperture 28 in the pectus bar 12 and the aperture formed by the threaded arcuate recesses 266 . The hexagonal head 104 may extend above the pectus bar 12 , providing for removal of the stopping member 94 from the pectus bar 12 if desired. [0057] Other stopping members may be used for retention of the pectus bar 12 within the pectus bar stabilizer 14 . One such example is a rivet, which may be applied to an aperture 28 in the pectus bar 12 , leaving a head portion exposed above the pectus bar 12 to retain the pectus bar 12 within the pectus bar stabilizer 214 as described above. [0058] The pectus bar 12 may be removed from the pectus bar stabilizer 214 without removing any of the stopping members 94 . The retaining bars 282 located distal from the retained end portion 24 , 26 may be removed allowing one of the base parts 220 , 222 to be removed. The pectus bar 12 may then translate axially in a direction free of the aperture formed by the threaded arcuate recesses 266 . The stopping member 94 may also be removed, freeing the pectus bar 12 from the pectus bar stabilizer 214 . [0059] The pectus bar stabilizer 214 may generally be attached to an external structure, such as cartilage as previously discussed. [0060] A further example of a pectus bar stabilizer assembly 310 is shown in FIGS. 13-15 and may generally include a pectus bar 12 and a pectus bar stabilizer 314 . The pectus bar stabilizer 314 retains the pectus bar 12 and may be fixedly attached to an external structure, such as cartilage. [0061] The pectus bar stabilizer 314 may include first and second base parts 320 , 322 and a retainer assembly 378 . The first and second base parts 320 , 322 may be generally similar to one another. For simplicity in the description, only first base part 320 will be discussed in detail with the understanding that the second base part 322 is similar in structure. [0062] The first base part 320 may include a body portion 332 and a leg 334 extending therefrom. The body portion 332 may include an inner body wall 336 , a top body surface 338 , a lower body surface 340 and an outer body surface 342 . The top body surface 338 may include three main sections 344 , 346 , 348 . The first section 344 is generally planar and includes a retainer recess 350 . [0063] The retainer recess 350 may include a first recess 350 a forming a channel in the first section 344 that is generally parallel to the inner body wall 336 . The first recess 350 a may extend the entire width of the first section 344 . The first recess 350 a may be defined by an outer wall 351 and an inner wall 353 located opposite one another. The inner wall 353 may include two discrete sections 353 a, 353 b forming an opening 350 b therebetween. [0064] The second section 346 is contoured and slopes downward from the first section 344 to the third section 348 . The third section 348 is generally planar and extends from the second section 346 . The lower body surface 340 is generally planar and generally parallel to the first and third sections 344 , 348 of the top body surface 338 . The outer body surface 342 connects the top body surface 338 , the lower body surface 340 and the inner body wall 336 . [0065] The inner body wall 336 may include two sections 356 , 358 . The first section 356 is generally rectangular and has a width L 31 and a height L 32 . The second section 358 is generally rectangular and has a width L 31 and a height L 33 . The height L 33 of the second section 358 is less than the height L 32 of the first section 356 . A recess 360 , defined below the second section 358 and proximate the first section 356 , extends into the body portion 332 a depth of L 34 at the outer body surface 342 and has a height L 35 . The recess 360 may include an upper recess 360 a and a lower recess 360 b. The upper recess 360 a is defined by a first recess wall 361 , an upper recess surface 367 , a lower recess surface 369 , and the plane of the second section 358 . The first recess wall 361 may have a generally curved profile and extends from the outer body surface 342 to the first section 356 . The lower recess 360 b is located below the upper recess 360 a and extends into the body portion a distance L 37 at the outer body surface 342 . The lower recess 360 b is defined by a second recess wall 371 , the plane of the lower recess surface 369 , the plane of the lower body surface 340 , and the plane of the second section 358 . The second recess wall 371 may have a generally curved profile and extends from the outer body surface 342 to the first section 356 . [0066] A leg 334 extends generally perpendicularly from the first section 356 of the inner body wall 336 . The leg 334 may be divided into a first leg portion 362 and a second leg portion 364 . The first leg portion 362 , which is located proximate the body portion 332 , may have a generally rectangular cross-section and a height less than the height L 36 defined between the second section 358 and the lower body surface 340 . The first leg portion 362 of the first and second base parts 320 , 322 may also each include an arcuate recess 363 at an inner edge portion 365 as shown in FIGS. 16-17 . The arcuate recess 363 may be optionally threaded (not shown). The second leg portion 364 may include a generally stepped arrangement having an upper portion 364 a and a lower portion 364 b. The upper portion 364 a may have a shape similar to the shape of the upper recess 360 a and the lower portion 364 b may have a shape generally similar to the lower recess 360 b, thereby allowing the second leg portion 364 to generally fit within the recess 360 . [0067] A series of apertures may be located in the first base part 320 . A first aperture 352 may be located at a distal end 354 of the body portion 332 , passing through the third section 348 of the top body surface 338 and the lower body surface 340 . The first aperture 352 allows the first base part 320 to be coupled to a supporting structure, such as cartilage. [0068] The retainer assembly 378 may include a retainer bar arrangement 382 and a stopping member assembly 384 . The retainer bar arrangement 382 may include a series of legs 386 interconnected by a series of cross bars 387 extending between the legs 386 and generally perpendicular thereto, forming a channel 389 between the legs 386 and cross bars 387 . The legs 386 may have end portions 391 extending beyond the cross bars 387 . The legs 386 may generally have flattened, substantially rectangular cross-sections. The cross bars 387 may also generally have flattened, substantially rectangular cross-sections similar to those of the legs 386 . The retainer assembly 378 may have a generally uniform thickness throughout its length. The legs 386 are located within the first recess 350 a, extending generally parallel to the channel 312 . The cross bars 387 may extend across the channel 312 and pass through the openings 350 b in the inner wall 353 . [0069] The stopping member assembly 384 may include a tool 90 , a neck portion 92 and a stopping member 94 similar to that described above. The pectus bar apertures 28 , 30 may be threaded or the aperture 363 in the base parts 320 , 322 may be threaded. If threading exists in either of these parts a screw may be used as the fastener and engage the threaded aperture. The stopping member 94 may include an additional portion extending beyond the threaded portion 110 . This additional portion may be unthreaded to mate with recess 363 in FIGS. 16 and 17 . [0070] The pectus bar stabilizer assembly 310 may retain the pectus bar 12 through the first and second base parts 320 , 322 and the retainer assembly 378 . The two base parts 320 , 322 may be placed proximate one another defining a channel 312 bound by the channel walls 336 and middle portion 362 . In this configuration, the retainer recesses 350 of the first and second base parts 320 , 322 are in respective alignment. [0071] Once the first and second base parts 320 , 322 have been arranged to define the channel 312 , the retainer bar arrangement 382 may be placed in the retainer recess 350 , thereby extending across the channel 312 . The retainer bar arrangement 382 may then be welded in place. The retainer bar arrangement 382 secures the first and second base parts 320 , 322 to one another in both a transverse direction and an axial direction relative to the retainer bar arrangement 382 . [0072] Once the first and second base parts 320 , 322 are fixedly attached to one another, a first end portion 24 of the pectus bar 12 may be inserted into the channel 312 . After the first end portion 24 is located within the channel 312 , one of the apertures 28 in the first end portion may be aligned with the channel 389 . After the desired aperture 28 is located below the channel 389 , the stopping member 94 may be threaded, or otherwise fixedly secured, into the aperture 28 . Once the stopping member 94 is securely in place, the tool 90 is separated from the stopping member 94 at the neck portion 92 . The hexagonal head 104 may provide retention of the pectus bar 12 . The body portion 106 of the stopping member 94 may be attached to the aperture 28 in the pectus bar 12 . The hexagonal head 104 may extend above the pectus bar 12 , providing for removal of the stopping member 94 from the pectus bar 12 if desired. [0073] Other stopping members may be used for retention of the pectus bar 12 within the pectus bar stabilizer 314 . One such example is a rivet, which may be applied to an aperture 28 in the pectus bar 12 , leaving a head portion exposed above the pectus bar 12 to retain the pectus bar 12 within the pectus bar stabilizer 314 as described above. [0074] The pectus bar 12 may be removed from the pectus bar stabilizer 314 without removing any of the stopping members 94 . The retainer bar arrangement 382 may either partially or entirely removed. The pectus bar 12 may then translate axially free from the retainer bar arrangement 382 . The stopping member 94 may also be removed, freeing the pectus bar 12 from the pectus bar stabilizer 314 . [0075] The pectus bar stabilizer 314 may generally be attached to an external structure, such as cartilage as previously discussed. [0076] An additional example of a pectus bar stabilizer assembly 410 is shown in FIGS. 18-20 and may generally include a pectus bar 12 , a one-piece pectus bar stabilizer 414 , and a stopping member assembly 484 . The pectus bar stabilizer 414 retains the pectus bar 12 and may be fixedly attached to an external structure, such as cartilage. [0077] The pectus bar stabilizer 414 may be machined as a single piece and include outer portions 416 , 418 and a central recessed portion 420 . The pectus bar stabilizer 414 may include inner body walls 436 defining central recessed portion 420 . Pectus bar stabilizer 414 may further include top, lower, and outer body surfaces 438 , 440 , 442 . Top body surface 438 may include three main sections 444 , 446 , 448 . First section 444 may be generally planar. Second section 446 may be contoured and slope downward from first section 444 to third section 448 . Third section 448 may be generally planar and extend from second section 446 . Lower body surface 440 may be generally planar and parallel to first and third sections 444 , 448 of top body surface 438 . Outer body surface 442 may connect top body surface 438 , lower body surface 440 , and inner body wall 436 . Central recessed portion 420 may additionally include a threaded or unthreaded aperture extending therethrough generally similar to the aperture created by unthreaded recess 63 in FIG. 9 or threaded recess 266 in FIG. 10 . [0078] A series of retaining bars 482 may be integrally formed with and extend between end portions 416 , 418 and over central recessed portion 420 . The retaining bars 482 may have flattened, generally rectangular cross-sections. The retaining bars 482 may have a generally uniform thickness throughout their length. [0079] A series of apertures 452 , 454 may be located in outer portions 416 , 418 , passing through third section 448 of top body surface 438 and lower body surface 440 . Apertures 452 , 454 allow pectus bar stabilizer 414 to be coupled to a supporting structure, such as cartilage. [0080] A channel 422 may be located in pectus bar stabilizer 414 . Channel 422 may have a starting point 424 located below and generally between ends of retaining bars 482 . As shown in FIG. 19 , starting point 424 may extend through inner body wall 436 . An end point 426 of channel 422 may extend through lower body surface 440 . Channel 422 may take the form of a variety of paths allowing separation of outer portions 416 , 418 once retaining bars 482 are severed, as discussed below. Channel 422 may be formed in a variety of ways, such as wire electrical discharge machining (EDM). [0081] Stopping member assembly 484 may include a tool 90 , a neck portion 92 and a stopping member 94 similar to that described above. Stopping member 94 may include an additional portion extending beyond threaded portion 110 , similar to that shown in FIGS. 7 and 10 . This additional portion may be threaded for mating with a threaded aperture or unthreaded to pass through an unthreaded aperture in central recessed portion 420 . [0082] A first end portion 24 of pectus bar 12 may be inserted into recessed portion 420 below retaining bars 482 . After first end portion 24 is located within central recessed portion 420 , one of apertures 28 may be located between retaining bars 482 , stopping member 94 may then be threaded, or otherwise fixedly secured, into aperture 28 . Once stopping member 94 is securely in place, tool 90 may be separated from stopping member 94 at neck portion 92 . Hexagonal head 104 may provide retention of pectus bar 12 . Body portion 106 of stopping member 94 may be attached to aperture 28 in pectus bar 12 . Hexagonal head 104 may extend above pectus bar 12 , providing for removal of stopping member 94 from pectus bar 12 if desired. [0083] Other stopping members may be used for retention of pectus bar 12 within pectus bar stabilizer 414 . One such example is a rivet, which may be applied to an aperture 28 in pectus bar 12 , leaving a head portion exposed above pectus bar 12 to retain pectus bar 12 within the pectus bar stabilizer 414 as described above. [0084] Pectus bar 12 may be removed from pectus bar stabilizer 414 without the removal of stopping members 94 . Retaining bars 482 may be severed resulting in outer portions 416 , 418 being separated from one another due to channel 422 . Pectus bar 12 may then be removed from pectus bar stabilizer 414 while still having stopping member 94 therein. [0085] The description is merely exemplary in nature and, thus, variations are not to be regarded as a departure from the spirit and scope of the present teachings.

An assembly for surgically treating a chest-wall deformity may include an implantable stabilizer member, an implantable pectus bar and an implantable stopping member. The implantable stabilizer member may include first and second base parts and a channel defined by the first and second base parts. The stabilizer member may include first and second retaining bars extending between the first and second base parts and traversing the channel. The first and second base parts may be adapted to be secured to tissue of the chest wall. The implantable pectus bar may be receivable within the channel of the stabilizer member. The implantable stopping member may be adapted to be engaged with the pectus bar between the first and second retaining bars after the pectus bar is inserted into the channel to restrict movement of the pectus bar relative to the tissue.

BACKGROUND AND SUMMARY OF THE INVENTION The present invention relates to a baby walker, and particularly to such a baby walker which comprises a fixed seat holder supported on a wheeled base, and a rotary carrier rotatably supported on the seat holder to hold a seat. A regular baby walker, as shown in FIG. 1, is generally comprised of a fixed seat holder supported on a wheeled base to hold a seat. The seat holder has a plurality of plug holes for the positioning of the seat. The seat has a plurality of mounting pins respectively fastened to the plug holes at the seat holder. When installed, the seat can not be rotated on the seat holder. According to one aspect of the present invention, the baby walker comprises a wheeled base, a fixed seat holder supported on the wheeled base, a rotary carrier supported on the seat holder to hold a seat, and a ball bearing mounted on the seat holder to support the seat holder, for enabling the rotary carrier and the seat to be rotated on the seat holder. According to another aspect of the present invention, a latch is provided at the seat holder, and moved to lock/unlock the rotary carrier. According to still another aspect of the present invention, the seat holder has a plurality of pin holes for the positioning of the seat after removal of the rotary carrier and the ball bearing from the seat holder. According to still another aspect of the present invention, the wheeled base is equipped with a folding collapsible stand, that can be extended out to support the baby walker on the floor positively. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a baby walker according to the prior art. FIG. 2 is an exploded view of a baby walker according to the present invention. FIG. 3 is a perspective assembly view of the baby walker shown in FIG. 2. FIG. 4 is an exploded view in an enlarged scale of a part of the present invention. FIG. 5 is similar to FIG. 4 but showing the ball bearing assembled. FIG. 6 is an assembly view of FIG. 5. FIG. 7 is similar to FIG. 6 but showing the latch engaged into the retaining hole at the rotary carrier. FIG. 8 is an oblique bottom view of the rotary carrier according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to Figures from 2 through 8, a baby walker 1 comprises a seat holder 2 supported on a wheeled base 5, a ball bearing 4 mounted on the seat holder 2, a rotary carrier 3 supported on the ball bearing 4, and a seat 10 supported on the rotary carrier 3. The seat holder 2, as shown in FIGS. 4 and 5, comprises an inner flange 23 around the inner diameter thereof, two endless upright flanges 21 and 21' concentrically raised from the top side wall 22 thereof around the inner flange 23, a top annular groove 220 defined between the inner flange 23 and the inner endless upright flange 21', a plurality of pin holes 2201 equiangularly spaced in the top annular groove 220 through the top side wall 22, a latch holder 24 provided inside the-outer endless upright flange 21, and a latch 25 moved in and out of the latch holder 24. The ball bearing 4, as show in FIGS. 4 and 5, is mounted within the annular groove 220 at the seat holder 2, comprised of two annular races 41 connected in parallel, and a plurality of steel balls 40 retained between the annular races 41. The races 41 each comprise a plurality of equiangularly spaced ball holes 411 of diameter smaller than the steel balls 40 for receiving the steel balls 40, a plurality of equiangularly locating pins 412, and a plurality of equiangularly spaced pin holes 413. By plugging the locating pins 412 at one race 41 into the pin holes 413 at another, the races 41 are connected together to hold the steel balls 40 in the ball holes 411 between the races 41. When assembled, the steel balls 40 peripherally project out of the ball holes 411 at the races 41. The rotary carrier 3, as shown in FIGS. 4 and 8, comprises an annular base 32, an inner vertical endless flange 33 raised from the bottom side wall 322 of the annular base 32 around the inner diameter thereof, an outer vertical endless flange 31 raised from the bottom side wall 322 of the annular bass 32 and spaced around the inner vertical endless flange 33, a bottom annular groove 34 defined between the inner vertical endless flange 33 and the outer vertical endless flange 31 which receives the ball bearing 4, a plurality of springy hooks 331 spaced around the inner vertical endless flange 33 and respectively hooked on the bottom edge 231 of the inner flange 23 of the seat holder 2, a plurality of pin holes 321 equiangularly spaced at the annular base 32 for the positioning of the seat 10, and a retaining holes 312 at the outer vertical endless flange 31 for engagement with the latch 25 at the seat holder 2. After installation of the rotary carrier 3 and the ball bearing 4 in the seat holder 2, the bottom edge 311 of the outer vertical endless flange 31 of the rotary carrier 3 is disposed in contact with the top side wall 22 of the seat holder 2, the bottom side wall 322 of the annular base 32 of the rotary carrier 3 is supported on the inner endless upright flange 21' of the seat holder 2, and the ball bearing 4 is received in the top annular groove 220 at the seat holder 2 and the bottom annular groove 34 at the rotary carrier 3. The seat 10, as shown in FIGS. 2 and 3, comprises a plurality of positioning pins 101 respectively plugged into the pin holes 321 at the rotary carrier 3. Referring to FIGS. 6 and 7 again, the latch 25 can be moved between the locking position where the latch 25 is engaged into the retaining hole 312 at the rotary carrier 3 to stop the rotary carrier 3 and the seat 10 from rotary motion relative to the seat holder 2 (see FIG. 7), and the unlocking position where the latch 25 is disengaged from the retaining hole 312 at the rotary carrier 3, for enabling the rotary carrier 3 and the seat 10 to be rotated on the seat holder 2 (see FIG. 6). Referring to FIG. 2 again, the wheeled base 5 is equipped with a folding collapsible stand 6. The stand 6 can be extended out to support the baby walker 1 on the floor positively. Furthermore, the ball bearing 4 and the rotary carrier 3 can be removed from the seat holder 2, enabling the seat 10 to be directly fastened to the seat holder 2 by plugging the positioning pins 101 of the seat 10 into the pin holes 2201 at the seat holder 2.

A baby walker, which includes a wheeled base, a fixed seat holder supported on the wheeled base, a rotary carrier supported on the seat holder to hold a seat, and a ball bearing mounted on the seat holder to support the seat holder, for enabling the rotary carrier and the seat to be rotated on the seat holder, and a latch moved to lock/unlock the rotary carrier.

BACKGROUND OF THE INVENTION 1. Field of the Invention A portable device for both trimming vegetation and for concomitantly collecting the resultant clippings. 2. Description of the Prior Art Most commercial portable hedge and shrub trimmers are not furnished with an integral clippings collector. Such appurtenances are common however in the case of lawn mowers such as the well known rotary power mowers. In this case a simple catch bag is provided behind the mower, with the grass clippings simply being flung, thrown or pushed into the bag. The advantages of providing an integral clippings collector in conjunction with a portable hedge and shrub trimmer are numerous, and the prior art has suggested several configurations of feasible clippings collectors. Among the pertinent prior art in this field may be mentioned U.S. Pat. Nos. 3,916,521; 3,795,050; 3,552,013; 3,073,025; 2,747,276; 2,281,189; and 1,833,246; and British Pat. Nos. 632,539 and 618,339. These prior art patents generally provide bulky and heavy configurations, albeit portability is contemplated. Generally there is nothing to prevent clippings from falling back out of the devices if they are tipped forwards. In this case, the clippings will fly out of the device due to brush action and will be widely scattered and dispersed. Generally these prior art devices are not amenable to cutting the sides of hedges or shrubs, and they are heavy in weight which necessitates the provision of straps etc. for mounting the device on the person of the operator, rather than being truly lightweight enough to be completely portable. SUMMARY OF THE INVENTION Purposes of the Invention It is an object of the present invention to provide an improved combination hedge trimmer and clippings collector. Another object is to prevent severed vegetation from being dispersed onto the ground, or onto hedges or shrubs or the like, when being cut with a hedge trimmer. A further object is to provide a lightweight portable hedge trimmer and clippings collector. An additional object is to provide an improved hedge trimmer with integral clippings collector. Still another object is to provide a hedge trimmer and clippings collector in which the jamming or clogging of the device due to accumulation of clippings is effectively prevented. Still a further object is to provide a hedge trimmer and clippings collector which may be operated at an angle to the horizontal plane without having collected clippings fall out of the device or back onto the hedge trimmer blades. Still an additional object is to provide a hedge trimmer and clippings collector which may be tipped forwards, or inclined rearwards, or employed in a sideways vertical orientation to cut the sides of hedges, shrubs or the like, without having accumulated clippings fall out of the clippings collector section of the device. An object is to provide a hedge trimmer and clippings collector in which clippings are immediately and permanently removed and separated from the hedge trimmer portion of the device. An object of the invention is to provide an improved device for the trimming or cutting of leaves, twigs, vines, excessive growth, branches, blades or shoots from hedges, shrubs; grass and/or weeds growth such as in parks, lawns, farms or cemeteries; or from trees, bushes and the like vegetation. These and other objects and advantages of the present invention will become evident from the description which follows. Brief Description of the Invention Within the context of the present invention, the term hedge trimmer will be understood to encompass and include a mechanical device provided with a plurality of juxtaposed blades, for the trimming or cutting of leaves, twigs, vines, branches, shoots, or any form of excessive growth of vegetation, from hedges, shrubs, bushes, trees, or from grass and/or weeds growth, such as in parks, lawns, farms, cemeteries, or about and around private homes and other dwellings. In the present invention, a combination hedge trimmer and clippings collector is provided which includes a generally linear, i.e. straight, slightly curved, arcuate or C-shaped, hedge trimmer portion. The hedge trimmer portion in any case consists essentially of a plurality of juxtaposed blades together with means to reciprocate the blades. Although reciprocation per se of the blades is the usual practice in hedge trimmer specification and design, within the context of the present invention reciprocation will be understood to encompass and include not only conventional opposed shearing movement of adjacent blades relative to each other, but also a chain saw type of motion of the blades, i.e., in a continuous looped path. In any event, the blades are movable relative to stationary vegetation so that at least a portion of the vegetation may be severed from connection to ground. In most instances, gaps between the teeth or blades of the hedge trimmer grab and pull branches or other vegetation into cutting grooves. Typically the blade is a single or double edged toothed blade of alloy steel which provides thousands of cuts per minute. The blade or blades are driven in most instances by an electric motor which receives power from ordinary house current (cord-type) or from rechargeable batteries (cordless type). The present device further includes a generally cylindrical brush which is of any generally cylindrical configuration, e.g. a plurality of parallel liner, spiral or circular rows of tufts of bristles which extend outwards from an inner attachment to a rigid support such as a metal pipe or cylinder. In any case the brush is rotatable about its central axis so that the tufts describe circular paths and a cylindrical sweeping action is attained. The central axis of the brush means is oriented substantially parallel to the hedge trimmer. In accordance with the present invention, a baffle of specific orientation relative to the balance of the elements in the device is provided. One edge of the baffle is juxtaposed with the hedge trimmer, and the baffle is disposed about a portion of the circular path of motion of the terminal ends of the brush means, so that these terminal ends of the tufts of the brush means are contiguous with the baffle during a portion of the rotation of the brush means. An enclosure is provided about and extending from the terminus of the baffle, such terminus being spaced away from the hedge trimmer portion of the device. Thus the severed portion of the vegetation is directed by the brush means to a disposition first adjacent to, and then contiguous with, the aforementioned baffle. Thereafter, the severed portion of the vegetation is discharged by the brush means from juxtaposition with the baffle and into the enclosure, wherein the successive clippings, i.e. severed portions of the vegetation, are accumulated. The device is completed in its broadest embodiment by the provision of suitable means to periodically remove accumulated severed portions of the vegetation from the enclosure, as well as by the provision of suitable means to manipulate the hedge trimmer so that the plurality of juxtaposed blades are brought in contact with further portions of stationary vegetation to be severed from connection to ground. The brush means generally will consist of a plurality of juxtaposed tufts, each of such tufts consisting of a plurality of contiguous linear bristles, fibers or strands, with the tufts extending radially outwards from the central axis of the brush means as mentioned supra. However, the brush means may alternatively consist of any type of cylindrical brush configuration, e.g. one in which the individual tufts or bristles are mounted on a plurality of parallel linear slats or holders which are spaced apart and oriented so as to define a cylindrical configuration, with the slats being attached by rods or the like to a central shaft or axle which in turn is rotated by suitable driving means. The hedge trimmer in a preferred embodiment will consist of at least two rows of blades, with the blades in each row being spaced apart from each other, and with the two rows of blades being contiguous. Reciprocating motion of one row of blades relative to the next in this case provides the cutting action. In most instances the hedge trimmer will be of straight line form, however other configurations such as a slightly bowed, curved or arcuate linear hedge trimmer may be employed, in which case the vegetation being trimmed or cut would be urged inwards into the blades or teeth area, the center of the hedge trimmer in this case being rearwards of the path of cutting action. Any suitable means to rotate the brush means about its central axis may be provided, however typically such rotation means includes a motor and a shaft, with the motor rotating the shaft and the shaft extending from the motor to connection with the central axis of the brush means. The shaft will usually be a rigid member of straight line form, and in this case the shaft will be coaxial with the central axis of the brush means. However, alternatively the drive shaft may be a flexible linear shaft within an annular casing, with the flexible linear shaft being curved to accommodate for the relative dispositions of the motor and brush means. The enclosure may be of any suitable configuration to accommodate the terminal dimension of the baffle and the path of travel of the severed portions of vegetation, however preferably the enclosure is of generally rectangular parallelpiped form. Typically the enclosure is provided with a movable panel, which when shut allows for the accumulation of clippings, i.e. severed portions of vegetation, and which when open permits the dumping of accumulated clippings of severed portions of vegetation into a trash bin or can or for other suitable disposal of the clippings, which clippings in some instances of home gardening will be added to a compost heap or pile. The movable panel may be slidably adjustable in grooves to alternate open and shut position, however in a preferred embodiment the movable panel is adjustable to alternate open and shut positions by the provision of suitable means to manually pivot the movable panel about one edge thereof. A unique configuration of means to pivot the movable panel about one edge thereof contemplated in the present invention entails the provision of an angular handle, which handle is mounted on the enclosure with the inner portion of the handle being partially rotatable about its central axis. The handle extends from within the enclosure to external means for manipulation of the handle. A lever is also provided, which lever extends laterally from the end of the handle within the enclosure. Finally, a rod is provided. One end of the rod is pivotally attached to the outer end of the lever, and the other end of the rod is pivotally attached to the movable panel, so that partial rotation of the handle causes the lever to displace the rod, the rod thereby pivoting the movable panel about its edge. The aforementioned handle will preferably be right angled, with the inner portion of the handle being perpendicular to and extending through a planar wall of the enclosure and with the outer portion of the handle being parallel to the wall of the enclosure and provided with staggered serrations, bumps or ridges for easy manipulation by the user. In a preferred embodiment, and in order to stabilize the movable panel in the closed position while still permitting easy manipulation of the movable panel to the opened position as a temporary expedient for periodic disposal of accumulated clippings, suitable spring means are provided external to the enclosure and in conjunction with the handle, to bias the handle away from the enclosure. At least one roller and detent means within the enclosure are provided in conjunction with the spring means. The roller extends laterally from the handle and is in contact with the detent means. The detent means extends about at least a portion of the handle and is attached to the inner wall of the enclosure, so that the handle is maintained in a fixed position, with the movable panel in shut position, by the roller mating with the detent means, except during periodic dumping of accumulated clippings, at which time the handle is concomitantly manually depressed into the enclosure and then is partially rotated, so as to pivot the movable panel about its edge. The movable panel is preferably rectangular so as to conform to the preferred rectangular parallelepiped configuration of the enclosure, and in this regard the movable panel may be and extend over all or a portion of a wall or walls of the enclosure. As will appear infra, this wall may be either a top wall, a side wall or a rear wall of the enclosure. Any of these configurations and orientations of discharge movable panel will work satisfactorily. The top discharge offers the least chance of damaging the movable panel, which is comparable to a door, when emptying the clippings into a trash can or the like. The rear discharge is the most convenient, but is also the most susceptible to damage. The side discharge is also highly susceptible to damage. Thus the main and most feasible orientation of the movable panel is as a top discharge door. A portion of the enclosure is preferably foraminous, i.e., all or a portion of one or more walls of the enclosure may be provided with perforations or an integral wire mesh screen or the like, so that air may escape from within the enclosure as the quantity of severed vegetation portions or clipping increases within the enclosure. Thus air pressure within the enclosure which could inhibit the action and movement of the brush means is prevented. The baffle is preferably slightly arcuate so as to conform to the circular path of motion of the ends of the tufts or bristles of the brush means, however a flat planar baffle may alternatively be provided for reasons of simplicity, lower cost and ease of assembly. However in most instances arcuate, i.e. curved, bowed or otherwise configured baffle will be provided so as to conform to the cylindrical configuration of the brush means and thereby to rapidly and completely direct clippings to the enclosure without the accumulation of clippings at the interface between the brush means and the baffle or at the terminal end of the baffle. In most instances, the means to reciprocate the cutter blades of the hedge trimmer, and the means to rotate the brush means about its central axis, extend from a common power generation means such as the electric motor or the like mentioned supra. However, it is evident that it is also feasible, and may prove desirable in some instances, to provide a separate individual drive means for the reciprocation of the blades, and a separate individual drive means for rotation of the brush means. The present combination hedge trimmer and clippings collector provides several salient advantages. One salient advantage is that the clippings are caught and collected in situ, so that the clippings are not scattered about adjacent to the hedge or shrub. Thus the clippings, which if left ungathered would soon age and wither to an unsightly brown color, are collected before they fall into the hedge or shrub or onto the ground, and the necessity of tedious raking around the hedge or shrub, or the shaking of the hedge or shrub to dislodge clippings, is obviated. Another desirable attribute of the present integral clippings collector is that the branches and/or stems, and leaves, when cut, cannot fall back into the cutting blades or associated mechanism, and hence the likelihood of the apparatus clogging or jamming due to a bulky accumulation of severed vegetation is eliminated. The present device is lightweight and is truly portable, and may be operated at an angle to the horizontal plane without having collected clippings fall out of the device or back onto the hedge trimmer blades. Thus the present hedge trimmer and clippings collector, during operation, may be tippd forwards, or inclined rearwards, or employed in a sideways vertical orientation to cut the sides of hedges, shrubs or the like, without having accumulated clippings fall out of the clippings collector enclosure section of the device, since the clippings are immediately and permanently removed and separated from the hedge trimmer portion of the device. Finally, the present device is of low cost and is relatively simple and easy to fabricate, assemble and market, since the present device does not entail the provision of complex or costly parts, structure and appurtenances. The invention accordingly consists in the features of construction, combination of elements and arrangement of parts which will be exemplified in the device hereinafter described and of which the scope of application will be indicated in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS In the accompanying drawings in which are shown several of the various possible embodiments of the invention: FIG. 1 is an overall perspective view of one embodiment of the device; FIG. 2 is a sectional elevation view of a portion of the device, taken substantially along the line 2--2 of FIG. 1; FIG. 3 is a sectional elevation view of the device taken substantially along the line 3--3 of FIG. 1; FIG. 4 is a perspective view of the handle and appurtenances thereto; FIG. 5 is a sectional elevation view taken substantially along the line 5--5 of FIG. 4; FIG. 6 is a bottom plan view taken substantially along the line 6--6 of FIG. 5; FIG. 7 is a perspective view of the handle similar to FIG. 4 but showing movement, i.e. rotation, of the handle so as to open the movable panel by a pivoting of the movable panel about one edge thereof; FIG. 8 is a perspective view of an alternative embodiment of the present device; FIG. 9 is a sectional elevation view showing an alternative embodiment in which the movable panel opens from the rear wall of the device; and FIG. 10 is a plan view showing an alternative embodiment in which the movable panel opens from a side wall of the device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to FIGS. 1, 2 and 3, the device is generally characterized by the provision of a hedge trimmer section 20, a clippings collector enclosure section 22, and a motor 24 to provide motive power for the device. The hedge trimmer section 20, as best shown in FIGS. 2 and 3, is provided with two rows 26 and 28 of reciprocating blades or teeth, mounted respectively in juxtaposition, so as to exert a cutting or shearing action, on stationary straight linear frame 30 and movable straight linear frame 32, which frame 32 is reciprocated by connection 34 and gearing, not shown, to motor 24. The upper stationary frame 30 is attached via bolting such as 36 (FIG. 3) to stationary parts of the framework of the device, in this case to a stationary baffle 38 furnished in accordance with the present invention. It will be evident that both frames 30 and 32 may be reciprocated in successive cyclic opposite directions by motor 24, if so desired. The device is grasped by knobbed or knurled handles 40 and 42. Forwards manual manipulative movement of the device, as indicated by the arrow 44, across and through vegetation 46 while the hedge trimmer blades 26 and 28 are reciprocating causes the severing of portions 48 of vegetation to take place, so that the severed portions 48 are no longer connected to ground. The severed portions or clippings 48 ultimately join a body of accumulated clippings 50 in the enclosure section 22 of the device as will appear infra. The clippings 48 are initially swept upwards and away from the teeth or blades 26 by virtue of the provision of a generally cylindrical brush means 52, best seen in FIG. 3 as composed of a plurality of tufts or bristles 54 in clumps which radially extend outwards from a central annular longitudinal mounting 56 which in turn is driven by a central axle or shaft 58. The shaft 58 extends to motor 24, as best seen in FIG. 2, so that the motor 24 provides motive power for both rotation of the bristles 54 and reciprocating movement of teeth or blades 28. The direction of rotation of the bristles 54 is indicated by arrows 60 (FIG. 3). This counterclockwise rotation of the bristles 54 serves to sweep the clippings 48 upwards and rearwards above baffle 38, and thereafter the momentum of the clippings 48 causes them to lodge with the accumulated clippings 50. As best seen in FIG. 3, the baffle 38 is slightly arcuate in this embodiment of the invention, so as to accommodate for the circular path of travel of the terminal ends of the bristles 54. Thus the clippings 50 lodge and accumuate on the lower wall or floor 62 of the enclosure 22, which as shown is a rectangular parallelepiped container extending rearwards from a curved front panel section 64 which is provided as a guard means to prevent inadvertnet extension of limbs such as a hand or an arm of the user into the moving parts of the device, which could cause injury to the person. The floor 62 of the container 22 also extends rearwards from a stiffening panel 66 which depends from the terminal end of baffle 38 so as to provide structural rigidity to the baffle 38. The box-like configuration of section 22 is preferably obtained by the provision of upper and lower opposed halves, sections 68 and 70, which are joined at a flanged interface 72 by bolts such as bolt 74 (FIG. 3). As shown in FIG. 2, bolting 76 secures connector beam 34 to the framework of the hedge trimmer and clippings collector so that motor 24 is permanently attached to the device. Electric power to drive the motor 24, which in this embodiment of the invention is an electric motor, is furnished by cord 78 which extends to a terminal plug 80 which is inserted into a socket or other electrical outlet, not shown. A wire mesh screen 82 is mounted in and forms part of the rear wall of upper container portion 68 so as to permit the egress of air from the interior of the device. Air pressure buildup within the enclosure, both from accumulation of clippings 50 and from the rotary motion of the bristles 54 of the brush means 52, is thus effectively prevented. Such air pressure buildup could act as an impediment to free rotary motion of the bristles 54 and thus as a drag and extra burden on the motor 24, as well as impeding free flow and motion of the cuttings or clippings 48 towards the rear of the enclosure. Referring now to the handle 40, and as best seen in FIGS. 3-7, in this embodiment of the invention, structure is provided to restrain a movable top panel 84 in a closed position during operation of the device to cut vegetation as shown in FIG. 3, while allowing for periodic pivotal displacement of the panel 84, as shown in phantom outline in FIG. 3, and also as shown in FIG. 7, to permit opening of the enclosure or container 22 so that accumulated clippings 50 may be removed from the device by inverting or tipping the unit thereby dumping the clippings 50 for suitable disposal as described supra. The handle 40 is mounted in front section 86 of top portion 68 of the enclosure 22 in such a manner as to permit restrained partial rotation of the dependent front portion 88 of the handle 40, which portion 88 extends at a right angle to the horizontal portion of handle 40 which is grasped by the hand of the user, and as shown in FIG. 3, portion 88 extends vertically downwards through section 86 and into the interior of the enclosure. A spring 90 circumscribes the portion 88 immediately external to section 86, and the spring 90 is maintained under compression by the provision of an upper circular ring 92 about portion 88, which ring 92 is restrained from moving away from section 86 by pin 94. Upwards motion of the entire handle assemblage away from the interior of the enclosure 22 is prevented by the provision of a lower pin 96 (FIGS. 5 and 6) which extends laterally through portion 88 to terminal rollers or roller bearings 98. Since the spring 90 is under compression, rollers 98 are urged upwards against circular plate 100 which is fastened to the underside of section 86 by bolts 102 and which is provided with detents 104 and 106. Thus the handle section or portion 88 is urged upwards by the spring 90 so that the rollers 98 tend to remain seated in detents 104 and 106, and the handle is restrained from any motion, in particular from partial rotational movement, unless and until downwards force is exerted against the handle 40 and/or concomitantly twisting force is exerted by the hand of the user. This is only done when dumping of accumulated clippings 50 is to take place, by the pivoting of panel 84 about one edge defined by hinge 108, as shown in FIG. 7 and in phantom outline in FIG. 3. The pivotal motion of panel 84 at this time is indicated by arrow 109 (FIG. 3) and the concomitant partial rotational motion of handle 40 and especially section 88 is indicated by arrows 110 (FIG. 7). In order to accomplish these motions, a lever 111 depends laterally from the lower and inner terminus of the handle portion 88. The lever 110 is secured to handle portion 88 by an inner sleeve 112 which extends upward concentrically within and contiguous to the lower part of portion 88 and which is secured in place by virtue of the pins 94 and 96 extending through opposed holes in both elements 88 and 112, see especially FIG. 5. A rod 114 is swiveledly or pivotally attached at one end to the outer end of the lever 111, and the other end of the rod 114 is swiveledly or pivotally attached to a fitting 116 which is secued to the lower surface of the movable panel 84. Thus the coaction of the handle portion 88, lever 111 and rod 114 serves to pivot panel 84 about hinge 108 when handle 40 is grasped and manipulatively partially rotated from the position shown in FIG. 4 to that of FIG. 7, as indicated by arrows 110. When this happens, the rollers 98 leave the detents 104 and 106 and assume positions juxtaposed with bolts 102. It will be understood as mentioned supra that during normal operating periods of the device, i.e. unless accumulated clippings 50 are being dumped, the handle 40 is in the position shown in FIG. 4 and the detents 104 and 106 serve to restrain the handle 40 against inadvertent or accidental rotation and thus accidental opening of the enclosure via pivoting of panel 84 about hinge 108 is effectively prevented, which is important since the device as discussed supra is intended to be used in a variety of dispositions, e.g. inclined forwards, backwards or sideways, in which case accidental opening of the enclosure and premature spillage of the accumulated clippings 50 onto the ground or onto the vegetation being trimmed or cut is effectively prevented. FIG. 8 shows an alternative configuration of the hedge trimmer and clippings collector in which the means to rotate the brush means is a flexible linear shaft within an annular casing 118, which element 118, and also the flexible shaft disposed coaxially inside elements 118, are curved to accommodate mechanical power transfer from an upper outlet 120 of motor 24 to a side inlet 122 of the brush means portion of the device. FIG. 8 also shows an alternative configuration of the enclosure or container for clippings collection, namely an entirely foraminous cloth or wire screen or mesh rear section 124 provided with a back horizontal zipper means 126 which is periodically manipulated by sliding end slider 128 laterally so as to open the zippered section 124, so that accumulated clippings may be removed from the device. The rear section 124 in this embodiment is supported by an internal or external rigid framework, ribs, or webs composed of rigid linear stiffening or beam members, not shown. FIG. 9 shows an alternative configuration in which the movable panel is disposed at the rear of the device as a rear wall. The foraminous screen 82 in this case is disposed in the top horizontal wall 68 of the device. FIG. 10 shows another alternative embodiment in which the movable panel is disposed as part of a side wall of the device. The disposition of the various appurtenances to acommodate for these configurations of FIGS. 9 and 10 is clearly evident. It thus will be seen that there is provided a device which achieves the various objects of the invention and which is well adapted to meet the conditions of practical use. As various possible embodiments might be made of the above invention, and as various changes might be made in the embodiments above set forth, it is to be understood that all matter herein described or shown in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense. Thus, it will be understood by those skilled in the art that although preferred and alternative embodiments have been shown and described in accordance with the Patent Statutes, the invention is not limited thereto or thereby.

A portable device for trimming hedges, shrubs and trees, cutting grass etc. In which an integral clippings collector is provided. The device features a hedge trimmer consisting of reciprocating blades, a generally cylindrical rotatable brush juxtaposed with the hedge trimmer, and a baffle so disposed in relation to the hedge trimmer and brush that severed portions of the vegetation are directed to an enclosure in which the severed portions are collected. In a preferred embodiment the enclosure may be periodically emptied of accumulated vegetation by pivoting a panel portion of the enclosure about one edge thereof.

REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. patent application Ser. No. 07/265,565, filed Nov. 1, 1988, now U.S. Pat. No. 4,950,268, issued Aug. 21, 1990, which is a continuation-in-part of U.S. patent application Ser. No. 07/019,755, filed Feb. 27, 1987 by the present inventor and Dan Rink and Garrett Lee, for which priority is claimed. BACKGROUND OF THE INVENTION In the field of medicine the use of laser devices for treatment purposes is becoming commonplace. Such devices are used for cauterization of wounds, excision of tissue, selective thermal absorption in tissue, welding of tissue through the formation of scar tissue, and the like. Recent developments in intravascular treatment point to recanalization of atherosclerotically occluded vessels virtually anywhere in the human body, including the relatively small vessels which supply the heart muscle itself. Such developments are described in copending U.S. patent application Ser. No. 07/109,755, filed Feb. 27, 1987 by the present inventor and Dan Rink and Garrett Lee. Generally speaking, lasers designed for medical use should be highly controllable with respect to the power output level of the laser, and the duration of the laser illumination. Paradoxically, although the laser output power rarely exceeds approximately 20-25 watts for medical treatment purposes, the amount of power used to generate this laser power level is extraordinarily high. In lasing medium which operates continuously, kilowatts of power are consumed, even on a standby basis, so that a few watts of light energy can be delivered briefly or sporadically to the desired application site. The heat generated in the lasing cavity and in the power supply require that an external cooling system be provided. Thus an external source of cold water is generally required, and hundreds of gallons of water are expended in relatively short procedures. External cooling systems add to the complexity and expense of a medical laser, and create further connection and maintenance problems. In pulsed mode laser devices, there is the opportunity to save power consumption since the lasing medium is operated only sporadically. However, pulsed mediums do not react predictably when first activated, due to thermal and dimensional effects. For example, when a NdYAG laser rod is first pumped by an arc lamp, the rod experiences a rapid thermal buildup which alters the axial dimension of the rod. As the rod changes in shape, the quality of the laser output pulse is severely affected. Thus prior art devices may provide erratic power outputs in pulse or burst modes of operation. This problem is complicated by the fact that many prior art pulsed laser systems measure the power output of each pulse (by any of several techniques known in the art), compare that power level to a preselected level, and in response alter the intensity or period of succeeding pulses. The inherent time lag of this process, together with the averaging errors and the potential instability in such level-hunting systems, can create unacceptably erratic performance. Prior art lasers have employed high voltage DC power supplies to pump and fire a pulsed mode laser, and pseudo-continuous operation may be added by charging capacitors with the high-voltage power and sequentially connecting the capacitors to a flash lamp or the like to fire the laser to produce a plurality of time-separated pulses. However, such power supplies are expensive and inefficient, and there is a limit to how many capacitors can be provided in a practical laser apparatus. Another difficulty found in medical and other forms of work with lasers is that prudent safety considerations that all personnel wear laser safety goggles whenever they are in an area in which a laser is in use. Particularly in medical settings such as a surgical operating room, the surgeons and assisting staff, the anesthesiologists and the patient must be equipped with safety goggles. Often the goggles interfere with other equipment, such as sterile masks, the anesthesia mask, and the like, and are a distraction at best. There is no remedy for this problem known to the present inventors. SUMMARY OF THE PRESENT INVENTION The present invention generally comprises a laser driving method and system that provides a laser system with a high safety factor, low power consumption, and a compact, simplified power supply. The laser system includes a pumped rod-type laser and an arc lamp or the like disposed to illuminate the lasing medium, such as a NdYAG crystalline rod. The apparatus includes a full wave rectifier to power the arc lamp, and a MOSFET switching circuit to turn on and off the arc lamp power at controlled times during each half cycle of the power waveform so that the laser medium is pumped and optically discharged once during each half cycle of the power supply. In order to control the power of the laser pulse, the laser power output is measured by a photodetector during each half cycle, and the photodetector output is integrated and compared with a pre-set, variable laser output power level. When the actual laser power reaches the preset power level, the comparator initiates turning off the MOSFET switching circuit power for that respective half cycle of the power waveform. At the beginning of the next half cycle the integrator is reset and the MOSFET switching circuit is turned on again. Thus the power of each pulse of the laser is measured and chopped at the appropriate instant to deliver the precise power level desired. The full wave rectified power is used to drive the laser medium in a burst mode of several pulses, or in a repetitive pulsed mode that emulate the effects of continuous output lasers. The full wave rectified power supply also permits the use of 110 VAC utility power, and obviates the need for external cooling of the laser. The apparatus also includes safety circuits that permit laser operation only when the internal cooling system is operating, when the current to the arc lamp is below a maximum level, and when the temperature created by the laser illumination on a target or on a portion of the beam delivery system is above a variable preset level, and the like. A further safety circuit detects the presence of laser radiation in the area surrounding the laser to shut it off when laser light escapes from the system. For medical, industrial, and experimental laser uses, this feature obviates the need for laser safety goggles for operational personnel. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a schematic representation of the laser power control circuit of the present invention, and in particular the circuit that senses and controls the portion of each half cycle of the power waveform that is applied to the laser pumping light source. FIG. 2 is a schematic representation of a portion of the laser power control circuit of the present invention, and in particular the temperature safety circuit that senses an overtemperature condition in the laser system and shuts off power to the laser power supply. FIG. 3 is a schematic representation of a portion of the laser power control circuit of the present invention, and in particular the cooling safety circuit that shuts off the laser power supply whenever there occurs an interruption in flow of coolant to the laser cavity. FIG. 4 is a schematic representation of a portion of the laser power control circuit of the present invention, and in particular the photodetector circuit that senses the laser output during each half cycle of the power waveform, and shuts off the laser whenever a desired, preset output power level is reached. FIG. 5 is a schematic representation of a portion of the laser power control circuit of the present invention, and in particular the current level sensing safety circuit that detects excessive current flow in the conductor to the laser optical pumping source and shuts off the laser power system. FIG. 6 is a graphic depiction of the timing sequence of the laser power control circuit of the present invention. FIG. 7 is a schematic representation of a portion of the laser power control circuit of the present invention, and in particular the FET signal control circuit that delivers power to the laser optical pumping source. FIG. 8 is a schematic representation of a portion of the laser power control circuit of the present invention, and in particular the laser radiation area detector safety circuit. FIG. 9 is a schematic representation of the fiber break detector circuit of the present invention. FIG. 10 is a graphic depiction of the timing sequence of the fiber break detector circuit of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention generally comprises a laser driving and control system and method of operation thereof. The most salient features of the invention is that it provides a laser system which is power efficient, stable, accurately controlled and extremely safe. Although the preferred embodiment is described with respect to medical applications, it may be appreciated that the attributes of the laser system of the present invention could be directed to industrial, investigative, and other uses. The invention is adapted to be employed with a standard-in-the-art laser generating unit, or head, which comprises a closed reflective chamber housing a lasing rod and an optical pumping source such as a flashlamp in operational relationship. One possible configuration of the laser head includes a optical enclosure having a uniform, elliptical cross-sectional configuration along a longitudinal axis, with focal lines parallel to the longitudinal axis, and the laser rod and flashlamp extending parallel along respective focal lines. The lasing rod material may be NdYAG or the equivalent. A conventional cooling system which circulates coolant in the laser head is provided to remove excess heat generated by absorption of a good portion of the flashlamp energy by the laser head. A significant aspect of the invention is the design and operation of the power supply that controls the flashlamp and thus the laser output power level. Unlike prior art laser systems, which use high voltage DC power supply arrangements, the present invention is designed to use 117 VAC (or 110 VAC) power directly from the utility power source. With regard to FIG. 1, the power control circuit includes a transformer 11 to step down the input line voltage and deliver it to a full wave rectifier 12. The result is the rectified sinusoidal power wave P, shown in FIG. 6. The power wave P is fed to a Zener diode voltage regulator, which chops the peaks of the power wave P at a desirable voltage to form a low voltage analog of the power voltage signal. The analog power signal is fed to the trigger input of a timer 16, such as the common 7555 IC timer known in the prior art. The circuit includes a trio of such timer circuits 16, 17, and 18, connected output-to-input in serial fashion. The input 19 of timer 16 is connected between a capacitor 21 leading to ground, and a resistor 22 connected to the 5 VDC power supply which also drives the timer 16. As is known in the prior art, the resistor 22 and capacitor 21 comprise an RC network which slowly charges the input 19 to 5 volts in a time period determined by the values of the resistor and capacitor. Each of the timer circuit 17 and 18 operate in a similar fashion, although the values of the respective resistors and capacitors at the input differ to determine selected time delay factors. In addition, the power wave analog signal is connected to the input 19. Whenever this signal pulls the input low, to a range of one-third the power supply voltage, the timer output 23 goes high forming the signal C 1 depicted in FIG. 6. Note that signal C 1 switches high as the power waveform P approaches zero, and stays high until P exceeds the threshold voltage once again. The on-off thresholds may be set to be identical so that the signal C 1 is symmetrical about the zero point of the power voltage P, but this in not necessary for the system to operate. The output of timer 16 is connected to the input of timer 17, which is connected to be triggered immediately by the fall of signal C 1 and to remain on only a short time. The output of timer 17, signal C 2 is fed to timer 18, which is connected to produce the signal C 3 . It is important to note that signal C 3 commences when C 2 goes low, so that C 2 comprises a firing signal for the system. The output of timer 18 is connected to an actuating input of a MOSFET laser power supply control 33, described in the following specification, so that the laser pumping light source is turned on whenever signal C 3 goes high. The operating period (on time) of timer 18 also establishes a maximum elapsed time for operation of the pumping light source during each half cycle of the power voltage waveform. It should be pointed out that the timer 18 differs from the others in that the reset input 31 is not connected to the 5 VDC power supply for instant reset. Rather, input 31 is connected to the output of reset AND gate 32, which has a plurality of reset inputs 32R. Whenever any of the reset inputs receive a low-going input, the AND gate 32 causes the timer 18 to reset and the output C 3 goes low. Thus the inputs to gate 32 determine that period of each pulse of signal C 3 and the laser pulse itself may be terminated before the maximum elapsed time, as shown by reference numeral RC 3 in FIG. 6. Furthermore, a continued low input to the gate 32 will effectively block operation of the laser. Thus the inputs 32R comprise important control factors for the operation of the laser. With regard to FIG. 4, another important portion of the invention is an output power monitor circuit 36, which has an output connected to one of the reset inputs 32R. The circuit 36 includes a photosensor 37, preferably a linear response photodiode fabricated of silicon or the equivalent, and placed in the laser light path to receive a small fraction of the laser output beam. For example, the photosensor 37 may be placed behind a partially conducting mirror disposed in the laser beam path, to receive the small percentage of beam power that is passed by the mirror. The photosensor outputs are connected across the inputs of an operational amplifier 38. The output of the op amp 38 is connected to the negative input in a feedback loop by capacitor 39, so that the output current of photosensor 37 is integrated with respect to time and represented by the voltage across the capacitor 39. The integration product is an analog signal having a voltage level which varies generally linearly with the energy output of each laser pulse. Also connected in parallel with the capacitor 39 is a solid state switch 41. The switch 41 has a trigger input connected to receive the signal C 2 and is actuated thereby to short out the capacitor and remove the accumulated voltage thereon. Thus the firing signal C 2 resets to zero the voltage signal at the op amp 38 output just prior to firing the next laser pulse. The voltage signal output of op amp 38 is conducted to the negative input of op amp 42. The other input is connected to the wiper connection of a potentiometer 43, which may be controlled manually or by appropriate software. It may be appreciated that whenever the signal from op amp 38 exceeds the voltage set by potentiometer 43, op amp 42 will emit a low-going signal that is connected directly to one of the inputs 32R of the reset AND gate 32. Thus the energy output of each pulse of the laser is monitored in real time, and the power supply is squelched when the pulse energy equals the selected, desirable pulse energy level. This system is extremely accurate in delivering the desired laser energy to the device utilizing the laser radiation, since it eliminates pulse power averaging errors and correctional time delays which are known in prior art systems. Another control circuit 46 connected to the safety reset switch 82, shown in FIG. 3, is designed to monitor the cooling fluid flow to the laser head, and to deactivate the laser when there is insufficient coolant flow. The circuit 46 includes a bridge-type resistive fluid pressure sensor 47. The sensor 47 is connected by fluid conduits in a parallel relationship to the main coolant supply conduit 48, so that the pressure drop produced by fluid flow resistance in the conduit 48 is presented to the sensor 47. The opposed bridge outputs of the sensor 47 are connected across the inputs of op amp 49. Connected from the output to the negative input of op amp 49 is a parallel resistive network 51 which establishes a feedback loop. The output of op amp 49 is connected to the positive input of op amp 52, and the respective negative input is connected to the wiper contact of a potentiometer 53. When the voltage level of the output signal of the op amp 49 falls below a level set by potentiometer 53, indicative of a decrease in the fluid pressure on sensor 47 and a loss of coolant flow, the output of op amp 52 goes low, and the system reset switch 82 is disabled to stop all power to the laser pumping light source. Thus the laser output is stopped immediately. A further safety circuit, shown in FIG. 2, is designed to prevent excessive heat in the laser system or in a laser beam receiving target from destroying system components by shutting off the laser when an excessive temperature condition is detected. The thermal safety circuit 56 includes an infrared sensitive photosensor 57, such as an infrared diode sensor, with its terminals connected across the inputs of an op amp 58. In a preferred embodiment of the invention, the infrared sensor may be directed to the transfer system that conducts the laser beam from the laser to a delivery system, such as fiberoptic beam guide that extends to a beam utilization device. An example of one such transfer system is described in copending U.S. patent application Ser. No. 07/180,950, filed on Apr. 11, 1988 by the present inventor, Dan Rink, and Garrett Lee, now U.S. Pat. No. 4,925,265, issued May 15 1990. The disclosure of that patent is incorporated herein by reference. In that apparatus there is a bushing component that supports the ends of a plurality of optical fibers while the focused laser beam is shifted among the plurality of fiber ends. Any misalignment of the focused beam can direct a focused laser pulse of extremely high power density onto the busing component, quickly generating very high temperatures that cause the emission of infrared light. The sensor 57 picks up the infrared light, and emits a proportional voltage in response thereto. Alternatively, the sensor 57 can be directed to monitor the infrared output of a beam-receiving target member, such as a laser heated cautery cap for recanalization of atherosclerotically occluded vessels, as described in the copending U.S. patent application Ser. No. 07/019,755, filed Feb. 27, 1987 and noted above. The output of op amp 58 is connected to a solid state switch 59, which has a trigger input connected to the firing signal C 2 . Switch 59 is connected in turn to the positive input of op amp 61, which is provided with a direct feedback loop 62 from output to input. The configuration of op amps 58 and 61 is such that the current level of the output of op amp 61 is proportional to the infrared radiation received by sensor 57. This current output signal is fed through resistor 63 to one input of op amp 64, so that the current through resistor 63 is a function of the magnitude of the infrared radiation. Op amp 64 includes a feedback capacitor 66 which integrates the current input to produce an output having a voltage proportional to the total infrared power received by the sensor, which in turn is indicative of the temperature of the component being sensed. Solid state switch 67 is connected in parallel with capacitor 66, and includes a trigger input connected to C 2 . It should be noted that the firing signal C 2 causes the switch 67 to reset the integration product to zero prior to each laser pulse. Furthermore, the switch 59 connects the infrared signal to the integrator only during the brief firing signal, before the laser pulse is fired. This arrangement assures that the infrared source is monitored only when it is not being illuminated by the laser, which would overwhelm the infrared signal of interest. The output of op amp 64, a voltage analog of the infrared power level and hence an indication of temperature level, is connected to one input of a comparator 68, and the output of comparator 68 is conducted through diode 69 to one of the reset inputs 32R. Comparator 68 includes a level-setting potentiometer 70 connected to the other input. Thus as the temperature of the monitored component increases, the voltage output of op amp 68 decreases, and when it fails to exceed the threshold of potentiometer 70 the output of op amp goes low and pulls the AND input 32R to a low state. This circuit effectively monitors the temperature of a component after a laser pulse, and serves to limit or chop the duration of the next successive laser pulse in response to the previous temperature level. For example, an excessive temperature condition in the component being monitored would cause the system to emit only a brief pulse in the next laser pulse cycle. The present invention also includes a high voltage lamp driver circuit for operating the flashlamp or the like that optically pumps the laser rod to emit a coherent beam. With regard to FIG. 7, the lamp driver circuit includes a transformer 81 connected through a main shutoff relay switch 82 to 117 VAC utility power. The transformer 81 includes a high voltage secondary winding 83 having an output of approximately 600 volta that is connected across a full wave bridge rectifier 84. The rectified voltage is fed to a flashlamp current control circuit 86, which includes filter capacitors that produce a smooth DC current that in turn is connected to one electrode of a flashlamp 87. The other electrode of the flashlamp is connected to one output terminal of the rectifier 84. The circuit 86 applies approximately 160 VDC to the flashlamp to maintain the lamp plasma in a conductive state, emitting light at a level well below the threshold of lasing in the NdYAG rod. The current control circuit is also connected to a spark transformer 88, which has a high voltage output connected to a spark electrode 89 adjacent to the flashlamp 87. The spark transformer is activated by circuit 86 to provide a high voltage pulse to initiate flashlamp conduction, after which the circuit 86 provides a steady "simmer" current to maintain conduction in anticipation of a high current pulse to dramatically increase flashlamp output and initiate lasing. To provide the high current pulse, the river circuit includes another full wave bridge rectifier 91 connected across the utility power supply. One output terminal of the rectifier 91 is connected to one electrode of the flashlamp, and the other output is connected to the drain terminals of a plurality of power MOSFETs 92 in a parallel configuration. The source connections of the MOSFETs 92 are connected in parallel fashion to the other flashlamp electrode. Thus switching of the MOSFET devices causes the output of the rectifier 91 to be applied directly across the flashlamp, and this branch of the circuit provides the substantial current required to sustain the output of the flashlamp at levels necessary to cause lasing. Switching of the MOSFETs 92 is accomplished by signal C 3 , which is fed to an opto-isolator 93 to isolate the logic circuits for the power circuits. The output of the isolator 93 is conducted to a two stage inverter, comprising gate 94 connected in series with a parallel array of gates 96. This double inverter arrangement comprises a high current source required to overcome the intrinsic gate-to-channel capacitance and switch the MOSFETs 92 as rapidly as possible. The outputs of gates 96 are connected together and lead to the gate connections of the MOSFETs 92. Thus whenever signal C 3 goes high, the MOSFETs 92 are switched on to provide high current to the flashlamp to sustain the lamp output as long as C 3 remains high. As soon as C 3 drops to zero, the MOSFETs switch off, lamp output ceases, and the maintenance voltage increases once again. It may be appreciated that the control system of the present invention is closely tied to the utility power supply, not only in terms of voltage and current requirements, but also for timing control and repetition. Each half-cycle of the sinusoidal power wave provides a timing signal for the system, and the laser will fire repetitively, once each half cycle, as long as the system is turned on and none of the safety circuits are activated. Each pulse will have a maximum period set by the circuit of FIG. 1, and an actual period set by the laser power sensing circuit of FIG. 4. A further safety circuit, shown in FIG. 5, is designed to shut off the laser system when excessive current is detected in the power circuit feeding the flashlamp. It includes a Hall effect transducer 101 which is disposed about one of the conductors connected directly to the flashlamp and adapted to sense the magnitude of the magnetic field created by the current flow in the conductor. The output of transducer 101 is conducted to op amp 102, which in turn has an output connected through a resistor to the negative input of op amp 103. Op amp 103 is provided with a parallel combination of a capacitor 104 and solid state switch 106 connected between the output and negative input. The capacitor integrates the current generated by the transducer to produce a voltage signal output on signal line 100 proportional to the current flow to the flashlamp. The solid state switch 106, which is triggered by signal C 2 resets the integration product to zero prior to each laser pulse. The output of op amp 103 is compared to an adjustable voltage reference 107 by comparator 108, the output of which is connected to one of the reset AND inputs 32R. Thus whenever the current to the lamp exceeds a selected maximum level, the laser is extinguished in the midst of an output pulse. The voltage produced by the potentiometer 107 sets the maximum current level permitted in the flashlamp driving circuit. The voltage signal output on signal line 100, proportional to the current flow to the flashlamp, is also conducted to op amp 111, wherein it is compared with a further adjustable voltage reference 112. As before, the voltage level of reference 112 establishes a maximum current level sensing circuit. However, the output of op amp 111 is connected to the actuating input of relay switch 82, so that an excessive current condition in the flashlamp driver circuit will shut off power to the entire laser system. Thus not only is the laser pulse terminated by a high current condition (by op amp 108), but the entire laser control and driving system is disconnected from the utility power supply. This feature assures that any malfunction or short circuit will be neutralized immediately, no shock hazard will develop, and the system components will be protected. The signal line 100 is further extended through resistor 113 to one input of op amp 114. This input is also connected to an RC integrating network 116, which produces a long-term average of the power consumed in the flashlamp driving circuit. This circuit detects current flow over the average of many laser pulses, and is provided as a further safety precaution to prevent excessive current flow. Another salient feature of the present invention comprises a novel approach to safe use of a laser in medical or industrial settings. Generally speaking, it is necessary for all personnel to wear laser safety goggles which block light radiation in a narrow range of the laser output. These goggles comprise a large expense for a group of people, such as the operating team in a surgery. Furthermore, the goggles often are distracting and annoying, especially for individuals who wear eyeglasses. In the present invention, these problems are alleviated by the provision of a further safety circuit shown in FIG. 8. This circuit, the laser radiation area detector, includes a photosensor 121 disposed adjacent to the housing in which the laser is enclosed, and directed obliquely toward a wall or ceiling surface in the room in which the laser is being used. The photosensor 121 may comprise a silicon photodiode or the equivalent, and is provided with a primary filter 122 that has a narrow optical passband in the range of the laser radiation. For example, commonly available filters transmit approximately 40% of light energy in the NdYAG output band, and only 1% of the remainder of the optical spectrum. The output of the photosensor, a current signal having a magnitude which is a function of the amount of laser light received by the sensor 121, is connected across the inputs of op amp 123. The output of op amp 123 is fed to differentiating capacitor 124, which in turn is connected to an input of AND gate 126. Also connected to the same input is a parallel network comprised of a resistor and a diode extending to ground. The capacitor, in combination with this network, determines that a signal C 5 will appear on the input of gate 126 only when an abrupt negative change occurs in the amplitude of light in the narrow band of the laser output. (See also FIG. 6.) The component values are chosen so that the output signal C 5 will comprise a brief pulse, on the order of microseconds, in response to the photosensor 121 receiving a sudden negative change in the ambient light level in the laser output band. Since virtually any broadband light source will emit some light energy in the laser output band, and this output can vary, it is important to distinguish sudden negative changes in the output band level that are indicative of laser pulse energy escaping into the area surrounding the laser itself. The laser radiation area detector also includes a timer 131, such as the standard 7555 timer known in the prior art, which is connected through resistor-diode network 132 and capacitor 133 to signal C 3 . Timer 131 is configured to produce a short output pulse C 4 , on the order of a few microseconds, immediately after signal C 3 (actually, RC3, since the signal is modified in duration by the various inputs to reset AND gate 32) goes to zero and the laser pulse has ended for that respective cycle, as shown in FIG. 6. Signal C 4 , which effectively comprises a time window during which the ambient light signal is sampled and detected, is also input to the AND gate 126. When signals C 4 and C 5 are coincident in time, as shown in FIG. 6, AND gate 126 is actuated to produce an output signal during this signal convergence. Thus the gate 126 produces an output only when the photosensor 121 picks up an abruptly falling amplitude of area illumination in the laser output band, and only when this negative change occurs immediately after the cessation of a laser pumping, as the laser output is rapidly decreasing. Such convergence is a reliable indication of the escape of laser radiation into the area near the laser. The output of gate 126 is fed through diode 136 to an integrating network 137 comprised of a resistor and diode connected in parallel to ground. It is also connected to an inverting gate 138 which has its output connected to the system reset switch 82. The integrating network 137 determines that more than one output pulse from AND gate 126 is required to trigger a signal from gate 138 to actuate switch 82 and shut off the laser system. In the preferred embodiment the component values are chosen so that two output pulses from gate 126 are required to shut off the laser system. Due to the fact that the safety circuit of FIG. 8 reliably distinguishes laser radiation from background light and ambient light, including fluorescent lights, surgical lights, photographic flash lamps, sunlight, and the like, the use of laser safety goggles may be obviated. The method of the present invention for controlling a laser is embodied in the functional description of the invention and in the operation of the various circuits described herein. The underlying concept in the method is the use of the AC power signal from the utility source, both as a power source and as a timing signal to drive a pulsed laser medium repetitively in synchronism with the AC power signal. The method of the present invention further includes the functional aspects of the laser safety circuits, for sensing temperature, power, and coolant flow, and in particular the laser radiation area detector that senses a decrease in area illumination in the laser output portion of the light spectrum in coincidence with termination of each laser pulse. A further safety circuit of the present invention, depicted in FIG. 9, is designed to detect a break, fracture, or similar fault in an optical fiber delivery system connected to the output of the laser system. An optical fiber delivery system may be used to transmit the laser output to an intravascular cautery cap used for laser angioplasty, or a laser surgical too, or the like. As shown in FIG. 10, a plurality of laser pulses, occurring during control pulses RC 3 , are used to heat an operating tip or tool element at the distal end of an optical fiber. The temperature of the operating tip, depicted by line T, tends to increase in stepwise fashion, with each laser pulse increasing the temperature and each quiescent period providing a small amount of cooling. Over the course of a few pulses the operating tip will heat to a nominal functioning range. In contrast, a broken or fractured optical fiber exhibits a much different temperature characteristic. When an optical fiber breaks or fractures, some of the laser energy will radiate from that point, illuminating the adjacent jacket material of the fiber. The jacket material will rapidly heat to incandescence, as shown by line T b in FIG. 10, defining a temperature spike. Due to the low thermal mass of the jacket material, the incandescence will decay very rapidly after the laser beam is turned off. The black body radiation from the hot jacket material can be sampled just after a laser pulse finishes and before the jacket material cools significantly, and this radiation can be distinguished from the radiation from the heated tip of the surgical tool. Returning to FIG. 9, the fiber break detector includes a timer circuit comprising a timer 131', such as a standard dual timer module known in the prior art, which is connected through resistor-diode network 132' and capacitor 133' to signal C 3 . Timer 131' is configured to produce a short output pulse C 6 , on the order of a few microseconds, shortly after signal RC 3 goes to zero (FIG. 10) and the laser pulse has ended for the respective cycle. The timer component values are selected so that the pulses C 6 are delayed sufficiently after the end of signal RC 3 to permit the laser pulse to extinguish, and to capture the timer interval in which incandescence of the fiber jacket would occur in the event of a break of fracture in the fiber. The fiber break detector circuit includes an infrared sensitive photosensor 157, such as an infrared diode sensor, with its terminals connected across the inputs of an op amp 158. The infrared sensor is directed to receive infrared emissions from the optical fiber delivery system. The sensor 57 picks up the infrared light, and emits a proportional voltage in response thereto. The output of op amp 158, which is a temperature signal having a magnitude proportional to the temperature detected by the sensor 157, is connected to a solid state switch 160, which has a trigger input connected to the firing signal C 6 . Thus the signal is conducted only during the brief period after the laser pulse is extinguished. The temperature signal is conducted to one input of op amp 168, the other input being a voltage reference 170 that sets a threshold level. When the temperature signal exceeds the threshold level, the op amp 168 produces a signal that is conduced through blocking diode 169 to the reset gate 32R. Thus a temperature signal which exceeds an empirically determined threshold will cause the laser to stop immediately, so that damage due to a broken or fractured fiber will be minimized.

A control apparatus for a pumped rod-type laser includes an arc lamp disposed to illuminate the lasing medium, such as a NdYAG crystalline rod. The apparatus includes a full wave rectifier to power the arc lamp, and a MOSFET switching circuit to turn on and off the arc lamp power at controlled times during each half cycle of the power waveform so that the laser medium is pumped and optically discharged once during each half cycle of the power supply. The laser power output is measured by a photodetector during each half cycle, and the photodetector output is integrated and compared with a manually set, variable laser output power level. When the actual laser power reaches the preset power level, the comparator initiates turning off the MOSFET switching circuit power for that respective half cycle of the power waveform. The apparatus also includes safety circuits that permit laser operation only when the internal cooling system is operating, when the current to the arc lamp is below a maximum level, and when the temperature created by the laser illumination on a target is below a variable preset level, and the like. A further safety circuit detects the presence of laser radiation in the area surrounding the laser to shut it off when laser light escapes from the system. For medical uses, this feature obviates the need for laser safety goggles for operational personnel.

BACKGROUND OF INVENTION This invention is in the general field of grain processing, more particularly as it relates to removing the edible portion of the grain from the inedible portion after harvesting. Still more particularly it relates to devices and methods for removing husks from ears of corn and removing corn kernels from the cobs, especially such devices and methods which are power-driven. Prior art in this field includes generally two separate devices or methods; one for removing the corn husk and silk from the corn ears (“husking”) and another for removing the kernels from the cob. The latter process is generally referred to as “shelling” or “stripping”, and involves a greater or lesser degree of piercing of the kernel wall depending on how the kernel is separated from the cob. Husking of the corn ear is a mechanical process in which the husk is pulled or brushed from the ear. The husk can be pulled downward from the free end of the ear and torn off at the butt by grasping the leaves manually, or it can be brushed or rubbed off with toothed, bristled, or abrasive surfaces or simple frictional contact with certain surfaces. Special additional means may be included to brush or pick the silk from the ear after the husk is removed. Shelling of the corn is generally also a mechanical process in which the kernels are cut or scraped off the cob. If whole kernel corn is desired, it is necessary to detach each kernel from the cob at or near its point of attachment to the cob without puncturing the kernel wall. This may be accomplished with a knife blade applied at the base of the kernels and moved parallel to the longitudinal axis of the ear. If the kernel wall is ruptured extensively during the shelling process, a substantial amount of the paste, or cream, within is released along with the kernels. This mixture is creamed corn, produced to a greater or lesser extent depending on the degree of kernel rupturing. Some creaming occurs when the corn is shelled by scraping the tops of the kernels first and moving downward toward the cob. The degree of rupture of the kernel walls is affected by the speed and direction of scraping and the shape of the scraping implement. In this patent specification, the process of removing the kernel material from the ear, regardless of degree, is referred to as “shelling”. Finally, the kernel material, cobs and husks are typically handled separately for further processing whether it be by hand or by machine. SUMMARY OF INVENTION In one embodiment, this invention provides a new apparatus for shelling or creaming corn using a power driver such as an electric drill. In another, preferred, embodiment, it provides an apparatus and method in which corn ears can be efficiently both husked and shelled in sequence and in tandem, one-by-one, using a power driver. To use either embodiment, a special mandrel is first affixed to an electric drill. Then the mandrel is screwed into the bottom end of an ear of corn that has been debutted. The mandrel with an unhusked corn ear thus affixed and revolved by the drill can then be husked by inserting the ear into the husking portion of the invention. The husking portion is configured to efficiently remove and dispose of both the husk and the corn silk. A husked ear can be shelled or creamed by inserting a husked ear, again on the revolving mandrel, into the shelling portion of the invention. This portion is configured to efficiently remove the kernel material from the cob. It is an object of this invention to provide an apparatus and method that increases the speed, ease, and efficiency of husking, shelling or creaming corn compared with existing methods. It is an object of the invention specifically to improve the efficiency of corn silk removal and recovery of desirable food. It is a further object of this invention to provide these features in a single portable and inexpensive device. Still another object of the invention is to provide an apparatus for husking, shelling or creaming corn that is comprised of few parts and can be cleaned and maintained easily. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a perspective view of the preferred embodiment of the invented apparatus. FIG. 2 is a side view of the preferred embodiment. FIG. 3 is a side view of the preferred embodiment secured to a table top. FIG. 4 is a front view of the husking tube of the preferred embodiment. FIG. 5 is an exploded view of the husking tube. FIG. 6 is a perspective view of the special mandrel of the preferred embodiment in exploded relation to an ear of corn and an electric drill used as a driver. FIG. 7 is a perspective view of the preferred embodiment being used to husk an ear of corn. FIG. 8 is a front view of the shelling tube of the preferred embodiment. This tube, as configured here, if taken by itself is a distinct embodiment of the invention. FIG. 9 is a view of the shelling tube looking straight down the tube to reveal detail. FIG. 10 is an exploded view of the shelling tube. FIG. 11 is a view of the shelling tube showing fit of a husked ear of corn in it. FIG. 12 is a perspective view of the preferred embodiment being used to cream and remove kernels from the cob. DETAILED DESCRIPTION Referring now in greater detail to the drawings, in which like elements are referred to by like reference numerals in each figure, FIG. 1 is a perspective view of the preferred embodiment of the invented apparatus. It shows a lower husking tube 101 and an upper shelling tube 102 connected by a mounting bracket 103 . The two tubes are comprised of open-ended cylinders, and the mounting bracket is a shaped flat bar. In the preferred embodiment of the invention, the mounting bracket is rigid metal with a hole 104 near its midpoint to enable fastening to a stationary object (not shown). In the preferred embodiment, the cylindrical parts are formed from thermoplastic pipe. The invented method comprises setting up an ear of corn on a power driver (not shown), inserting a revolving ear of corn first in the husking tube 101 , and then inserting it in the shelling tube 102 . FIG. 2 is a side view of the preferred embodiment, showing that the bracket 103 in this embodiment can be fastened to the two tubes using two conventional fasteners 201 each. The bracket is bent so as to align the tubes nearly parallel and create a horizontal section 202 . FIG. 3 is a side view of the preferred embodiment secured to a table top 301 by a stud 302 and a wing nut 303 . Note that when the apparatus is so affixed, the axes of the tubes are oriented by the bracket 103 to converge at a point to the upper right of the Figure (arrow A). This is so that the user can conveniently access the upper end of either tube with a minimum of motion. FIG. 4 is a front view of the husking tube 101 of the preferred embodiment. It comprises a flat, stiff-bristled brush 401 fastened to the inner wall of the tube by a screw 402 so that the bristles of the brush 401 face the center of the tube. In this view the brush 401 is fastened at its midpoint to the top of the tube 101 , but other orientations of the brush relative to the tube may be used effectively within the scope of this invention. Also visible in this view is one of the two bracket mounting holes 403 . FIG. 5 is an exploded view of the husking tube 101 showing how this portion of the preferred embodiment is assembled. Screw 402 is passed through hole 501 and screwed into the upper surface 502 of the brush 401 . FIG. 6 is a perspective view of the special mandrel 601 of the preferred embodiment in exploded relation to an ear of corn 602 and an electric drill 603 used as a driver. To use this invention effectively, it is necessary to secure the ear to the drill so that the ear is coaxial with the axis of the drill chuck 604 and rotates in fixed relation to the chuck. In the preferred embodiment, the mandrel 601 consists of a headless lag screw 605 with a collar 606 permanently fixed perpendicularly to it at the bottom 607 of the lag portion 608 of the screw. The lag portion 608 of the screw provides a shank by which the drill chuck 604 can grip the mandrel 601 . To establish the correct alignment of the ear and the drill, the ear is first “debutted” by cutting the stem 609 off the ear at more-or-less right angles to the axis of the ear, producing a flat end 610 . The mandrel 601 is secured then to the drill chuck 604 , and the mandrel is screwed into the end 610 by operation of the drill 603 until the collar 606 comes into contact with the end 610 . The collar 606 helps to assure that the screw will not keep advancing into the corn as it is processed and that the corn will be forced to rotate along with the mandrel. FIG. 7 is a perspective view of the preferred embodiment being used to husk an ear of corn. User 701 turns on the drill 603 and inserts the ear 602 into the husking tube 101 . As the ear enters the tube, it comes into contact with the brush 401 . As the ear 602 revolves against the brush 401 , the husk leaves 702 are brushed from the ear 602 and fall out of the bottom end 703 of the tube 101 . This brushing action to remove the husk has proved by experience to be very efficient, yet not damaging to the kernels. It also effectively removes the corn silk (not shown). FIG. 8 is a front view of the shelling tube 102 of the invention, which together with the bracket and husking tube (not shown) comprises the preferred embodiment of the invention, but by itself comprises an alternate embodiment. The shelling tube 102 comprises a curved cutter head 801 resiliently suspended inside it. In the preferred embodiment of the invented apparatus, the cutter head 801 further comprises a partial cylinder 802 of thermoplastic into which a grater 803 is set. The grater is in this case a piece of sheet metal stamped to as to provide a plurality of triangular points 804 . The grater 803 may be fixed to the partial cylinder by rivets or other means. A portion of the partial cylinder 802 behind the grater 803 may optionally be cut out for ease of cleaning. The cutter head 801 is suspended inside the tube 102 by two spring-biased bolts 806 . The bolts each compress a spring 807 between the inner wall of the tube 102 and the partial cylinder 802 , the compression of which is set by wing nuts 808 (only one shown, the other hidden behind it). Mounting holes 809 for connecting the bracket (not shown) to the tube 102 are shown opposite the cutter head 801 . FIG. 9 is a view of the shelling tube 102 of either embodiment looking straight down the tube to better show the cutting points 804 of the grater 803 protruding towards the center of the tube 102 . Note that the cutting points 804 show as lines here because the creases along which they are bent out by stamping are parallel to axis of the tube 102 . This means that the plane surfaces of the points 804 are parallel to the axis of the tube 102 , so that the widest face of each point is against in the direction of rotation of the corn (not shown). This has significance, as explained further below. Note also that the distance between the grater 803 and the bottom of the shelling tube 102 is at a minimum, represented by distance “d”, due to the extension of spring 807 to the maximum extent allowed by wing nut 808 . FIG. 10 is an exploded view of the shelling tube 102 better showing how the cutter head 801 is assembled into the tube. Grater 803 is affixed to partial cylinder 802 by rivets 805 through rivet holes 1001 . Bolts 806 are passed through cylinder holes 1002 , and springs 807 are placed over the bolts. The assembled head 801 is then set inside tube 102 so that bolts 806 pass through tube holes 1003 . Wing nuts 808 are screwed onto bolts 806 . The assembled shelling tube can then be affixed to the mounting bracket (not shown) through holes 809 . FIG. 11 is a view of the shelling tube 102 of the invented apparatus showing the fit of a husked ear of corn 1101 in it. (Husked ear 1101 is ear 602 after removal of the husk. It is distinct from ear 602 because it presents a corn kernel surface 1102 to grater points 804 .) Typically, a power drill will turn husked ear 1101 clockwise as shown by the arrow, causing kernel surface 1102 to rotate into points 804 . Points 804 will cut and dislodge kernel material as creamed corn particles 1103 . Note that the distance between the grater 803 and the bottom of the shelling tube 102 has been increased to “D” by the presence of husked ear 1101 . Because of the compression of spring 807 , distance “D” will always be whatever the width of husked ear 1101 is, and points 804 will be maintained in contact with the kernel surface 1102 . Thus, shelling of the corn will always occur without the user having to press the husked ear 1101 against the grater 803 . Any pressure applied by the user other than in the axial direction (into the paper) runs the risk of twisting the ear in the mandrel, causing uneven or incomplete shelling of the ear, or inclusion of cob material in the product. With this invention, all the user has to do to shell the corn is insert the ear into the tube while the drill rotates the ear. Wing nut 808 can be adjusted to a) set the minimum diameter of husked ear that can be shelled, and b) adjust the pressure applied to a typical ear and the consistency of the shelled or creamed corn produced. FIG. 12 is a perspective view of the preferred embodiment of the invented apparatus being used to shell an husked ear of corn. Note that bracket 103 is shaped so that tube 102 is high enough above the table 301 to allow container 1201 to be positioned to catch corn particles 1103 . Alternatively, the invented apparatus could be clamped to the corner of a table so that product and waste could both be collected in containers resting below the table top (not shown). It can be seen by examining FIGS. 3 , 6 , 7 and 12 in sequence that the preferred embodiment can be set up readily and that by using it, complete processing of an ear of corn from having been snapped off the stalk through to creaming of the kernels can be accomplished quickly and ergonomically.

An ear of corn attached to a power driver such as a drill can be husked and or creamed in a two-step process without detaching the ear from the driver. The shelling device uses a spring-biased grater inside a tube to cut the kernels from the cob, and may be used alone or in combination with the husking device. If desired, the two devices can be connected using an ergonomically designed bracket and used sequentially.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This is a non-provisional application based upon U.S. patent application Ser. No. 14/534,927, entitled “AGRICULTURAL TILLAGE IMPLEMENT WHEEL CONTROL”, filed Nov. 6, 2014, which is based on U.S. provisional patent application Ser. No. 61/903,529, entitled “AGRICULTURAL TILLAGE IMPLEMENT WHEEL CONTROL”, filed Nov. 13, 2013, both of which are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to agricultural implements, and, more particularly, to agricultural tillage implements. [0004] 2. Description of the Related Art [0005] Farmers utilize a wide variety of tillage implements to prepare soil for planting. Some such implements include two or more sections coupled together to perform multiple functions as they are pulled through fields by a tractor. For example, a field cultivator is capable of simultaneously tilling soil and leveling the tilled soil in preparation for planting. A field cultivator has a frame that carries a number of cultivator shanks with shovels at their lower ends for tilling the soil. The field cultivator converts compacted soil into a level seedbed with a consistent depth for providing excellent conditions for planting of a crop. Grass or residual crop material disposed on top of the soil is also worked into the seedbed so that it does not interfere with a seeding implement subsequently passing through the seedbed. [0006] Tillage equipment prepares the soil by way of mechanical agitation of various types, such as digging, stirring, and overturning. Examples of which include ploughing (overturning with moldboards or chiseling with chisel shanks), rototilling, rolling with cultipackers or other rollers, harrowing, and cultivating with cultivator shanks. [0007] Tillage is often classified into two types, primary and secondary. There is no strict definition of these two types, perhaps a loose distinction between the two is that tillage that is deeper and more thorough is thought of as primary, and tillage that is shallower is thought of as secondary. Primary tillage such as plowing produces a larger subsurface difference and tends to produce a rough surface finish, whereas secondary tillage tends to produce a smoother surface finish, such as that required to make a good seedbed for many crops. Harrowing and rototilling often combine primary and secondary tillage into one operation. [0008] Wheels are often integral with tillage implements and are used for both transportation of the implement, and for depth control of the tillage elements. The prior art includes control systems that raise and lower the implement as an entire unit, which can result in uneven tillage across the implement width of today's wider equipment. [0009] What is needed in the art is an easy to use mechanism for depth control of an agricultural tillage implement. SUMMARY OF THE INVENTION [0010] The present invention provides a tillage implement that has several tilling sections with the ability to independently control the depth of the tilling elements of the various sections. [0011] The invention in one form is directed to an agricultural tillage implement that includes a main section having a hitch extending in a travel direction, a plurality of foldable wing sections coupled with the main section, a plurality of ground engaging tilling elements, a plurality of wheel assemblies and a control system. The tilling elements are coupled to the main section and wing sections. Each of the wheel assemblies include an actuator. The wheel assemblies include a first plurality of wheel assemblies associated with the main section and a second plurality of wheel assemblies associated with the plurality of wing sections. The actuators of the first plurality of wheel assemblies being independent of the actuators of the second plurality of wheel assemblies. The control system is configured to actuate the actuators to control a depth of tilling elements in each of the sections when the implement is in a field mode. [0012] The invention in another form is directed to a control system of an agricultural tillage implement. The implement has a main section including a pull hitch extending in a travel direction, a plurality of foldable wing sections coupled with the main section and a plurality of wheel assemblies, each of the sections having at least one tilling element that is engageable with the ground. The control system includes a controller and a plurality of actuators. At least one actuator is associated with each of the wheel assemblies. The plurality of wheel assemblies include a first plurality of wheel assemblies associated with the main section and a second plurality of wheel assemblies associated with the plurality of wing sections. The actuators of the first plurality of wheel assemblies are controlled independently of the actuators of the second plurality of wheel assemblies by the controller. The controller is configured to actuate the actuators to control a depth of the tilling elements in each of the sections while the implement is in a field mode. [0013] The invention in yet another form is directed to a method of controlling profile heights of a plurality of sections of tilling assemblies of an agricultural implement. The method includes the step of independently actuating a plurality of actuators to control a depth of tilling elements in each of a plurality of foldable sections of the implement when the implement is in a field mode. [0014] An advantage of the present invention is that the implement has a decreased profile in the transport mode. [0015] Another advantage of the present invention is that the control system can be used to level the implement from side-to-side. BRIEF DESCRIPTION OF THE DRAWINGS [0016] The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of an embodiment of the invention taken in conjunction with the accompanying drawings, wherein: [0017] FIG. 1 is a top perspective view of an embodiment of an agricultural tillage implement of the present invention, in the form of a field cultivator, in an unfolded position; [0018] FIG. 2 is a front view of the field cultivator shown in FIG. 1 ; [0019] FIG. 3 is a top perspective view of the field cultivator shown in FIGS. 1-2 , with the outer wing sections folded to a transport position; [0020] FIG. 4 is a front view of the field cultivator shown in FIG. 3 , with the outer wing sections folded to the transport position; [0021] FIG. 5 is a top perspective view of the field cultivator shown in FIGS. 1-4 , with the middle wing sections folded to a transport position; [0022] FIG. 6 is a front view of the field cultivator shown in FIG. 5 , with the middle wing sections folded to the transport position; [0023] FIG. 7 is a top perspective view of the field cultivator shown in FIGS. 1-6 , with the inner wing sections folded to a transport position; [0024] FIG. 8 is a front view of the field cultivator shown in FIG. 7 , with the inner wing sections folded to the transport position; [0025] FIG. 9 is a perspective view of part of the main frame section of the field cultivator of FIGS. 1-8 ; and [0026] FIG. 10 is a side view of the field cultivator of FIGS. 1-9 , with a primary focus on a wing section. [0027] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplification set out herein illustrates embodiment of the invention, in one form, and such exemplification is not to be construed as limiting the scope of the invention in any manner. DETAILED DESCRIPTION OF THE INVENTION [0028] Referring now to the drawings, and more particularly to FIG. 1 , there is shown an embodiment of a tillage implement of the present invention. In the illustrated embodiment, the tillage implement is in the form of a field cultivator 10 for tilling and finishing soil prior to seeding. [0029] Field cultivator 10 is configured as a multi-section field cultivator, and includes a center frame section 12 , also referred herein as a main section 12 , and a plurality of wing sections 14 , 16 and 18 . In the illustrated embodiment, field cultivator 10 has a triple-fold configuration with three left wings sections designated 14 A, 16 A and 18 A, and three right wing sections designated 14 B, 16 B and 18 B. Wing sections 14 A and 14 B are each inner wing sections, wing sections 16 A and 16 B are each middle wing sections, and wing sections 18 A and 18 B are each outer wing sections. [0030] Center frame section 12 is the center section that is directly towed by a traction unit, such as an agricultural tractor (not shown). Center frame section 12 generally functions to carry a shank frame 20 for tilling the soil, and a rear auxiliary implement 22 for finishing the soil. A pull hitch 24 extends forward from shank frame 20 , and is coupled with the traction unit in known manner. [0031] Rear auxiliary implement 22 includes a spring tooth drag 26 and a rolling (aka, crumbler) basket 28 which coact with each other to finish the soil. However, rear auxiliary implement 22 can be differently configured, such as a spike tooth drag, cultivator shanks, etc. [0032] Shank frame 20 generally functions to carry cultivator shanks 30 with shovels 32 at their lower ends for tilling the soil. Rear lift wheels 34 are used for raising and lowering the shank frame 20 with a hydraulic lift cylinder (not specifically visible in FIGS. 1 and 2 ), and a pair of front gauge wheels 36 are used to level the shank frame 20 during a field operation. [0033] Similarly, each inner wing section 14 A and 14 B, middle wing section 16 A and 16 B, and outer wing section 18 A and 18 B includes a shank frame 20 for tilling the soil, a rear auxiliary implement 22 for finishing the soil, rear lift wheels 34 and front gauge wheels 36 . These components are slightly different from but still similar to the like-named components described above with regard to center frame section 12 , and are not described in further detail herein. [0034] During use, it is periodically necessary to move the field cultivator 10 from an unfolded (operating) position to a folded (transport) position. First, each outer wing section 18 A and 18 B is folded laterally inward and over a respective middle wing section 16 A and 16 B ( FIGS. 3 and 4 ). With the outer wing sections 18 A and 18 B in the folded state, each middle wing section 16 A and 16 B is then folded laterally inward and over a respective inner wing section 14 A and 14 B ( FIGS. 5 and 6 ). With the middle wing sections 16 A and 16 B in the folded state, each middle wing section 16 A and 16 B is then folded laterally inward and over the center frame section 12 ( FIGS. 7 and 8 ). To unfold the field cultivator 10 and transform back to the field or operating position shown in FIGS. 1 and 2 , the folding sequence described above is simply reversed. [0035] The outer wing sections 18 , middle wing sections 16 and inner wing sections 14 are stacked together in a vertically arranged stack over the center frame section 12 when in the folded state. To allow this type of nested stacking configuration, each of the wing sections 14 , 16 and 18 have a pivot axis 38 , 40 and 42 , respectively, which is vertically offset to allow the wing sections to lie flat against the laterally inward shank frame 20 /frame section 12 when in the folded state. The middle wing sections 16 have a pivot axis 40 that is vertically higher than pivot axes 38 and 42 of adjacent wing sections 14 and 18 , when in the unfolded state. [0036] Different countries and states have different regulatory highway requirements concerning oversized vehicles on the road. In the US, some states exempt agricultural equipment from such regulations, while others require that any type of vehicle on a road must comply with the oversized vehicle regulations. In Europe, the regulations may be more strict concerning the height and width of vehicles which may travel on a road without being accompanied by an escort vehicle. With the triple-fold field cultivator 10 of the present invention, the overall frontal profile dimensions when in the folded state fit within regulatory requirements for both the US and Europe. More particularly, with all of the wing sections 14 , 16 and 18 in the folded state, the field cultivator 10 is then in a transport position with an overall frontal profile having dimensions with a maximum width “W” of no greater than approximately 20 feet, preferably approximately 18 feet wide, and a height “H” of no greater than approximately 14 feet, preferably approximately 13 feet, 6 inches high ( FIG. 8 ). [0037] These maximum frontal profile dimensions include all of the shank frames 20 , shanks 30 , rear lift wheels 34 and front gauge wheels 36 , when in the folded state. The rear auxiliary implements 22 are considered to be add-ons to the main field cultivator 10 , and may be outside these overall frontal profile dimensions, at least if not folded upwardly for the transport position. However, it is the intention that all of field cultivator 10 , including the rear auxiliary implements 22 , be within these maximum frontal profile dimensions when in the transport position. [0038] Now, additionally referring to FIGS. 9 and 10 there is shown further details of implement 10 . Main section 12 is shown in FIG. 9 with wheel assemblies 50 having actuators 54 , which provide depth level control for main section 12 when implement 10 is in field mode and support for the folded implement 10 while in transport mode. [0039] A typical wheel assembly 52 is shown for one of the wing sections 14 , 16 and 18 in FIG. 10 . Wheel assemblies 52 include actuators 56 , a linkage system 60 and an adjustable link 62 . A controller 58 (shown abstractly in the figures) orchestrates the movement of wheel assemblies 50 and 52 in field and transport modes and during the transition to/from the field and transport modes. [0040] Wheel assemblies 50 are shown having actuator 54 coupled more directly to the rear wheels and a linkage system is used to move the wheels that are to the fore of the rear wheels. Wheel assemblies 52 have actuator 56 positioned between the rear and fore wheels with linkage system 60 coupling both the rear and fore wheels for coordinated movement. Adjustable link 62 allows for an independent manual fore/aft leveling adjustment of each section. [0041] Actuators 54 and 56 , are under the independent and individual control of controller 58 so that sections 12 - 18 can each be individually adjusted for depth control of shovels 32 (which are tillage elements) of each section in a manner substantially independent of the other sections while in the field mode of operation. As implement 10 is transitioned from the field mode to the transport mode and the sections are being folded together, controller 58 causes wheel assemblies 52 to go from the fully extended position, as shown in FIG. 10 with actuator 56 fully extended, to being partially retracted as seen in the folded wing sections of FIG. 6 . This effectively lowers the profile of each wing section 14 - 18 as the particular wing section is folded. While controller 58 may be a set of valves manually controlled by an operator, it is contemplated that controller 58 would be an electronic control system that controls the sequence of lowering the profile of each wing section, as it is being folded by the actuators used for the purpose of folding wing sections 14 - 18 . [0042] The present invention advantageously independently controls the depth of the tilling elements while implement 10 is in the field mode. The prior art used a common rocker shaft between lift wheels on the main frame, which is not as flexible as the present invention. The present invention uses the depth control mechanism to also minimize the height profile of each section as wing sections 14 - 18 are folded for transport and the process is reversed when implement 10 transitions from the transport mode to the field mode. [0043] While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

An agricultural tillage implement includes a main section including a hitch extending in a travel direction, a plurality of foldable wing sections coupled with the main section, a plurality of ground engaging tilling elements, a plurality of wheel assemblies and a control system. The tilling elements are coupled to the main section and wing sections. Each of the wheel assemblies include an actuator. The wheel assemblies include a first plurality of wheel assemblies associated with the main section and a second plurality of wheel assemblies associated with the plurality of wing sections. The actuators of the first plurality of wheel assemblies being independent of the actuators of the second plurality of wheel assemblies. The control system is configured to actuate the actuators to control a depth of tilling elements in each of the sections when the implement is in a field mode.

FIELD OF THE INVENTION This invention relates to golf-putters. BACKGROUND OF THE INVENTION It is known that even if a golf ball is putted with a ‘perfect robot’ (or any other form of precision mechanism) on a ‘perfect putting surface’, there will still be significant variation in the resulting ball-direction. The variation may be caused by spherical asymmetry in the mass and/or shape of the ball and by surface irregularities, in particular, in the dimpled-surface pattern. The dimpled pattern is an inherent part of golf-ball design and is provided to enhance aerodynamic performance. In putting, the impact footprint (that is, the area of contact between ball and putter) has a span of the order of 5 millimeters, which is comparable with dimple-diameter. Since dimples cause voids in the contact between the impact face of the putter and the golf-ball surface, the impact footprint is rarely symmetrical. Moreover, the distribution of the striking force is not uniform across the footprint, but is a maximum at the initial point of contact, falling off rapidly towards the outer extremities of the footprint. Thus, the resultant striking force imparted by the putter on the ball is generally displaced from the ball-centre by a small, random amount. The degree and sense with which this gives rise to directional error in the resulting track of the ball from the line of strike, depends upon the extent to which the ball is struck more to one side than the other of the ideal centre-impact point; striking the ball more to the left of this point, propels it more to the right, and vice versa. In addition to left/right (azimuthal) directional errors, the dimples similarly cause slight variations in the initial elevation trajectory. These errors can normally be ignored since they amount to slight variations in impact loft but do not measurably affect launch velocity or distance of putt. Accordingly, references to dimple-effect errors in the present context are to be understood to relate to errors in azimuth. The errors due to the dimple effect are greater for hard-covered balls than for soft-covered balls, and less significant for long putts where the impact footprints are larger (because the striking force required is greater) so as to give a less asymmetric force distribution. Nonetheless, although dimple-effect errors are in any event small in relation to overall putting performance, they are significant because scoring in golf is heavily weighted by putt strokes. One method of reducing dimple-effect errors is to provide golf balls with specially designed dimple patterns that distribute the impact force more evenly across the contact area. These modified dimple patterns may either cover the entire ball-surface or be limited to certain, identifiable zones; however, improving the dimple pattern for putting purposes, generally degrades the aerodynamic performance of the ball. A more practical approach instead, is to modify the impact face of the putter head itself to improve striking-force distribution so that the putter can be used advantageously with any make or pattern of golf ball. SUMMARY OF THE INVENTION It is an object of the present invention to provide a golf-putter head of improved form for reducing dimple-effect error. According to one aspect of the present invention there is provided a golf-putter head having an impact face for striking the dimpled surface of a golf ball, the impact face being defined by a multiplicity of substantially parallel ridges which extend substantially lengthwise of the head and which are for impacting the ball-surface in areas of contact that are distributed around dimples of that surface to tend collectively to centralise the resultant striking force on the ball, wherein the ridges are of a profile, width, pitch and hardness which in combination result in said head realising a reduction of at least 15% in the standard deviation of the dimple-effect error distribution in putting with an initial velocity of 2.5 meters per second of a ball that when putted at that initial velocity by a head having a plain, flat impact face exhibits a standard deviation of dimple-effect error distribution within the range 0.69 degrees to 0.75 degrees. Measurements show that dimple-effect errors in hard-covered golf balls have a standard deviation of about 0.7 degrees at one-STIMPMETER® putt strength when putted using a conventional metal putter having a plain, flat impact face. (The STIMPMETER® is a device for measuring the ‘speed’ or rolling friction of a putting surface; it also gives a measure of absolute putt strength.) Similarly, the standard deviation for dimple-effect errors with soft-covered (for example, balata) golf balls is found to be between 0.3 degrees to 0.4 degrees at one-STIMPMETER® putt strength. The standard deviations are found to increase by about 20% to 30% at half-STIMPMETER® strength, and it has been found that a golf ball with initial putt velocity of 2.5 meters per second and no initial spin travels very nearly the same distance as a ball launched from the STIMPMETER®. Since initial velocity can be determined very accurately, it is preferable to use this as a standard for putt strength. Further measurements show that modifications to the impact face can markedly alter the degree of dimple error. It is possible to reduce dimple-effect errors significantly by altering the shape and/or the material of the impact face of the putter so as to improve impact-force distribution across the contact area. However, in some cases altering the shape of the impact surface increases rather than reduces the degree of error; this occurs when the impact face of the putter contains features that concentrate the striking force. It has been estimated that a typical world-class golfer has on average a line error (i.e. directional error) of 1.3% and a length error of 6.5%. (Tierney, D. E. and Coop, R. H. 1999. A Bivariate Probability Model for Putting Proficiency, Science and Golf III, ed. A. J. Cochran and M. R. Farrally, 385-394, United Kingdom: Human Kinetics.) An average line error of 1.3% equates to a standard deviation from the ideal putt direction of 0.93 degrees. Other research indicates that players with a medium handicap have comparable chances of sinking putts at typically only half the range of world-class players (Beauchamp, P. H. et al. 1994. Towards putting performance enhancement: a methodology using quantitative feedback, Science and Golf II, ed. A. J. Cochran and M. R. Farrally, 174-179, London: E. & F. N. Spon.) From this, and assuming that skill level in both line and length are reduced in equal proportions, medium handicap players have typically 41% greater line error and 41% greater length error compared with world-class players. Thus, as a rough estimate, medium handicap players typically have a standard deviation of about 1.3 degrees in directional accuracy for putting. Most golfers will deviate above or below these values, but they give a basis for estimating the dimple-effect contribution to overall directional errors. The separate contributions to overall directional error combine as the root mean square of magnitude. In the hypothetical case of the ‘average’ medium-handicap player, the standard deviation in degrees for non-dimple effect errors is given by: ( 1.3 2 - 0.7 2 ) 1 2 = 1.1 so dimple-effect increases average directional errors by 18%. By substituting the putter head with a type that reduces the dimple-effect standard deviation by 40% to 0.42 degrees, the degradation (i.e. increase in errors) in the above case is reduced to 7%. Conversely, a putter that increases the dimple-effect standard deviation by just 10% to 0.77 degrees increases the degradation to 22%. Other forms of ridge-faced (or groove-faced) putters are known where the ridges are provided to increase the friction between ball and putter. The ridges in such putters are normally biased horizontally so that friction is especially increased in the vertical direction; it is asserted by the proponents of such ridges that they impart topspin to the ball at impact and that this improves putting accuracy. In some instances, dimple-effect errors are reduced by such ridges, but the improvement is small. According to another aspect of the present invention, there is provided a golf-putter head having an impact face for striking the dimpled surface of a golf ball, the impact face being defined by a multiplicity of substantially parallel ridges which extend substantially lengthwise of the head with a pitch p, and which each have a width w that is measured at 67% of ridge-depth from the apex where the ridge-depth is 0.3 millimeters or less, but otherwise measured at a depth of 0.2 millimeters from the apex, a hardness h and a profile represented by a parameter TSF, related to p, h, and w as follows: 1.0 <p< 400/(h+100) w< 0.4 ×p[ 80/( h− 20)] 0.5 <TSF< (0.91−0.003 ×h ) for p not exceeding 3.5, w not exceeding (p−0.4) and TSF not exceeding 0.72, where h is measured in durometer Shore D scale, w and p in millimeters and TSF is the ratio of the cross-sectional area of the ridge-profile measured to a depth of 0.1 millimeters from the apex to its cross-sectional area measured to a depth of 0.15 millimeters from the apex. The ridges of the putter-head according to both aspects of the invention specified above may be curved or slanted, but are preferably straight and parallel to the heel-toe axis of the head. Discontinuities along the length of the ridges may be used for cosmetic effect, but such discontinuities should not encroach within the normal ball-contact zone of the impact face, as these would tend to increase lateral friction in a random manner. The ridges form impact surfaces having raised elements, which provide a plurality of separate contact areas with the golf ball such that increased depth of deformation of contacting surfaces occurs during impact with the ball and the width of each contact area is substantially smaller than the overall footprint span. For a given golf-ball cover-material and a given putter impact face material, the maximum deformation depth according to the present invention is more than the maximum depth obtained with a conventional plain, flat-faced putter and an equal putt strength. Thus, using a putter according to the present invention increases the overall footprint area. The reduction of dimple-effect errors depends on the distribution of impact force being more evenly distributed laterally about the ideal centre of impact (that is to say, the centre of impact that would be obtained with a perfectly smooth and spherical ball). This more even distribution is provided by the present invention, in which the concentration of force that occurs near the centre of impact with a conventional flat-faced putter is replaced by a plurality of separate forces arranged to act on narrow elongate horizontal areas that act on different parts of the golf-ball dimple patter. The random error components from each of the separate forces will tend to cancel one another, provided that these separate forces are of roughly similar magnitude. However, if one contact force from, for example, a ridge-faced putter is dominant, then such random cancellation is not effective. It is found with ridge-faced putters that dimple-effect errors are sensitive to the position of the ridges relative to the centre of impact. With horizontal ridges, worst case errors occur when one ridge is coincident with the centre of impact and the two adjacent ridges are displaced by one pitch distance, one above and the other below the centre of impact. This impact condition maximises the ‘dominant ridge effect’, which tends to increase dimple-effect errors. Conversely, if the centre of the gap between two ridges is coincident with the centre of impact, dimple-effect reduction is greatest. The difference between the worst and best case ridge alignments can be large. When measuring the effectiveness of a given ridge configuration, it is preferable to arrange for the test set-up to give worst case positioning of the ridges. This results in an underestimate of the overall dimple-effect improvement but gives a much more sensitive and reliable indication of the relative performance of different ridge-configurations. A further advantage of horizontal ridges is that greater vertical traction between the putter and the golf ball is provided. Such modification enhances the ability of a putter to transmit topspin to a ball at impact. The ability of a putter to impart topspin at impact is generally considered advantageous and it is said that increased topspin at impact improves putting accuracy. The deeper deformation in separate contact areas gives rise to higher localised stress levels and tends to increase the degree of plastic deformation during impact. Preferably, plastic deformation in a golf ball should be minimised so that most of the deformation is elastic. Thus, it is found that one form of ridged impact surface can make deeper deformation compared to a second form at the same putt strength yet exhibit less dimple-effect improvement. Dimple-effect performance cannot be predicted by theoretical means or known design rules, so improved impact surfaces are developed using experiment and measurement. The applicants have devised a preferred measurement technique involving ballistic measurement. This replicates the required putt conditions (for example, a ball launch velocity of 2.5 meters per second with zero imparted spin) but at a known height and position above ground level. The direction of the ball trajectory through the air is then accurately measured using mechanical or electronic means. This technique ensures that errors from putting surface defects and mass imbalance effects in the ball are excluded. The dimple-effect performance of a putter is preferably evaluated at one standard putt condition and with one golf ball category. Thus a standard putt condition with an initial launch velocity of 2.5 meters per second and zero imparted spin is adopted. Small deviations from this standard putt condition can be ignored, since dimple-effect errors vary slowly with change in impact energy. The preferred ball category includes any hard-covered golf ball that exhibits a standard deviation for dimple-effect errors of about 0.72 degrees at 2.5 meters per second putt strengths. This standard deviation of dimple errors is common to a wide range of golf balls of different brands. The standard putt condition and golf ball category provides a reliable indicator of overall dimple-effect performance. Tests carried out by the applicants show that ridge-faced putter-heads with improved dimple-effect performance using hard-covered golf balls also exhibit improved performance using soft-covered golf balls, although the degree of improvement is not generally as great as with hard-covered golf balls. Tests also show that such heads exhibit very little degradation in elevation angle errors (that is in vertical launch-angle variations resulting from the dimples). The putter face and the ridges may be fabricated from a hard rigid material, a soft resilient material or any material intermediate these. The ridges can be of the same material as the remainder or bulk of the putter-head, or formed of a different material. Thus, the ridges can be provided as individual raised inserts embedded into the base material of the putter face. Alternatively, the individual raised inserts can comprise several elements or pixels in a ridge-like structure, with uniform or varying element properties along the length of the ridge. It is found that dimple errors are significant for impact deformation depths of about 0.15 millimeters, whereas the errors with impact depths of 0.4 millimeters to 0.5 millimeters or greater are negligible. Thus, the invention is particularly concerned with the shape and dimensions of ridge extremities ranging from the outer contacting surface—the apex—of the ridge, down to a depth of 0.5 millimeters from the apex. The shape of the tip of the ridge, in the sense of the shape of that part of the outer extremity of the ridge extending down to a depth of 0.15 millimeters from the apex, is relevant. The width of the ridge is also relevant in terms of its cross-sectional thickness as measured at 67% of ridge-depth from the apex in those circumstances where the ridge-depth is 0.3 millimeters or less, but otherwise measured at a depth of 0.2 millimeters from the apex. In practice, the preferred width and pitch of the ridges are a function of the hardness or softness of the ridge material. Thus, the preferred width and pitch vary continuously throughout the range of material hardness, as do the preferred tip shapes. With hard ridges it is preferable to have significantly smaller widths when the ridges are closely spaced (for example, when the pitch is 1.2 millimeters or less). The much smaller widths slightly reduce the force contributions from individual ridges, which compensates for the close spacing. Typically, the width w for hard ridges is within a range specified by: w< 0.4×( p− 0.4) where width w and pitch p are in millimeters. Thus, with a ridge spacing of 1.2 millimeters the preferred ridge widths are 0.32 millimeters or less, whereas with a pitch of 1.6 millimeters the preferred ridge widths can increase to 0.48 millimeters. In general, the widths for hard ridges as a function of pitch can extend within the range: w< 0.4 ×p where width w and pitch p are in millimeters. A preferred range for ridge pitch in soft materials is 1.5 millimeters to 2.5 millimeters, but otherwise the range may extend from 1 millimeters to 3.5 millimeters. With softer material significant deformation depth can be achieved with relatively wide ridges and there is greater scope to enlarge impact footprint areas. It is also preferable to increase the width in proportion to the softness and flexibility of the ridge material to avoid a delicate structure that would tend to collapse on impact. Preferably, the maximum ridge-width w in millimeters in any material is: w< 0.4 ×p×[ 801( h− 20)] where p is ridge-pitch in millimeters and h is hardness measured in durometer Shore D scale. As with hard ridges, the problem of widely spaced contact points arises if the pitch is greater than 2 millimeters or so. In a preferred embodiment for soft compliant ridges the ridges are flat-topped with the outer contact surface comprising at least 50% of the overall contact area. By this means, bulges or projections that would otherwise create a dominant contact are avoided. For the full range of possible material hardness h, the preferred TSF ratio is specified as follows: where h>44 Shore D: TSF ratio>0.8−0.003×h where h<44 Shore D: TSF ratio is nominally ⅔. The TSF ratio for hard ridges should be greater than 0.5 and less than 0.61, but is preferably between 0.53 and 0.59. A re-entrant ridge-profile (profile narrowing with depth) can be used with soft materials; in this case the TSF can be as large as 0.72. Also, the gaps between ridges may be filled or partially filled with a material that is softer than the ridge material; this prevents extraneous matter from collecting inside the narrow gaps separating ridges. Furthermore, the impact surface may be provided as a replaceable member; this increases the scope for performance improvement designs using more delicate surface structures that can be renewed as required. BRIEF DESCRIPTION OF THE DRAWINGS Golf-putter heads in accordance with the present invention will now be described, byway of example, with reference to the accompanying drawings, in which: FIG. 1 shows the general configuration of a golf-putter head in accordance with the invention; FIG. 2 is an enlarged vertical section of part of the golf-putter head of FIG. 1 , illustrating one example of ridge-configuration according to the invention for the impact face of the putter-head and identifying certain variables associated therewith; FIGS. 3 to 6 illustrate, respectively, additional examples of ridge-configurations according to the invention; FIGS. 7 and 8 are enlarged views of footprint traces that result respectively from striking a golf ball having a dimpled soft-cover with a plain, flat-faced putter-head, and with a ridge-faced putter-head according to the present invention; FIGS. 9 and 10 are graphical representations of the peak impact force contributions from two series of ridges according to the present invention, for which the ridge-spacings are different; FIGS. 11 and 12 are, respectively, a schematic plan and side view of apparatus used for measuring dimple-effect errors; FIGS. 13 and 14 are illustrative of recordings made with the apparatus of FIGS. 11 and 12 ; FIG. 15 is a histogram showing the distribution of dimple errors typical of putts on a hard-covered golf ball using a standard flat-faced putter; FIG. 16 is a histogram corresponding to that of FIG. 15 , showing the distribution of dimple errors typical of putts on a hard-covered golf ball using a ridge-faced putter according to the present invention; FIGS. 17 and 18 together tabulate the characteristics of nine impact-faces tested; and FIGS. 19 to 21 illustrate, respectively, further examples of ride configurations according to the invention. DETAILED DESCRIPTION OF THE INVENTION Referring to FIG. 1 , the putter-head 1 is attached at its heel 2 to a putter-shaft 3 via a neck 4 . The head 1 has an impact face 5 , located between its heel 2 and toe 6 , which is grooved to define a multiplicity of parallel ridges 7 that extend substantially lengthwise of the head 1 , that is to say in the general direction from heel 2 to toe 6 . The ridges 7 are of a high-impact material, being in the present example integral with the stainless-steel or brass head 1 , and, as illustrated in FIG. 2 , are spaced from one another by gaps larger than the widths of the ridges. Referring to FIG. 2 , the distance between corresponding points of adjacent ridges 7 is identified as their pitch p, and the distance between the apex 8 and base 9 of each ridge 7 as its depth d (measured normal to the impact face 5 ). The width w of each ridge 7 is its thickness measured at 0.2 millimeters below its apex, and its radius r is the radius of the ridge 7 at its apex. In this specific example, the pitch p of the ridges 7 is 1.6 millimeters being in this regard within the preferred range of 1.4 millimeters to 1.8 millimeters. An overall range of 1.0 millimeters to 2.0 millimeters is applicable provided the cross-sectional area of the ridge 7 is substantially less than the cross-sectional area of the gap separating adjacent ridges 7 . A wide spacing ensures that when adjacent ridges 7 strike the dimpled golf ball, they come into contact with different edge orientations of the same dimple, or with edges of adjacent dimples, so as to spread the force distribution at impact over a number of separate contact points with the ball. However, very wide spacing is counterproductive because the force contributions of ridges other than the central ridge or ridge pair, diminish rapidly and do not provide a well-distributed impact force. The improvement is unpredictable by theory so experimental methods have been adopted to determine optimum designs. It is intended according to the invention that the ridges 7 penetrate deeply into the cover of the golf ball, preferably without cutting the cover. To this end, the radius r is ideally in the range 0.05 millimeters to 0.25 millimeters, but the radius can be increased up to 0.50 millimeters over a small section of the ridge tip provided the width is small enough to allow penetration. A cylindrical top surface for each ridge is preferred (as illustrated), but other ridge sections including polygons with various corner radil may be used. The thickness of a ridge 7 near its base may be significantly greater than the average thickness since impact deformation near the base contributes little to the overall impact force; the nominal ‘base’ is located where the thickness of the ridge cross-section equals three times the thickness at 0.15 millimeters depth from the apex 54 . Another consideration is that the ridges 7 are not prone to damage by accidental impact with hard objects. Thus it is advisable, but not a necessity, that the ratio d/w is less than three, and also that the depth d is just sufficient to allow impact penetration to the desired maximum depth. Because the contact-area pattern of the ridges 7 on a dimpled golf ball surface is random, excessive damage of the ridges 7 is required before significant performance degradation occurs. It has been found that, compared with a plain, flat-faced putter-head, the ridge-faced putter according to the invention gives a perceptibly ‘softer’ impact (that is, with lower transient acoustic intensity, especially for high frequency components). This ‘softer’ characteristic derives from the more gradual application of impact energy to the ball, and the hardness of the ridge material has negligible effect. It is thus advantageous to fabricate the ridges, and the putter-head as a whole, of an extremely hard and durable material; this is not traditionally desirable in flat-faced putter designs. For example, a steel ridge-faced putter-head can be deep case hardened using a nitride hardening process and further surface protection can be provided with a titanium nitride (TiN) vacuum deposited coating. In addition to high resistance to wear, titanium-nitride coatings have an attractive metallic gold appearance, very high chemical inertness and low coefficient of friction, all of which enhance putter-head design. The following formula gives a fairly accurate relationship between the maximum depth (millimeters) of a footprint and its span (millimeters) for golf balls: footprint depth=0.006×(footprint span) 2 Here, the footprint span is taken to be equal to the diameter of a circular footprint that would be obtained with a flat putter on a smooth-surfaced golf ball. Thus, a footprint having a span of 5 millimeters (typical of a short putt with a hard covered golf ball) has a maximum footprint depth of only 0.15 millimeters. It has been found that dimple errors reduce to negligible levels with footprints having spans above 9 millimeters. A span of 9 millimeters equates to a footprint depth of 0.486 millimeters, and from this it can be determined that there is advantage in limiting ridge-depth to between 0.4 millimeters to 0.5 millimeters. Thus, in a typical embodiment, the following set of dimensions would obtain: p 1.60 millimeters d 0.40 millimeters w 0.36 millimeters r 0.18 millimeters The outermost surfaces of the ridges are desirably substantially coplanar throughout the impact face. Where a convex design of overall putter face is involved, the outermost surfaces of the ridges desirably conform to substantially smooth surfaces of relevant curvature. The ridges are normally of uniform cross-sectional dimensions and pitch throughout the putter face, but pitch and/or profile may be graduated in order to impart shaped force distribution properties to the impact area. FIGS. 3 to 6 show ridge-configurations that may be used as alternatives to that of FIG. 2 , in the putter-head 1 of FIG. 1 . Referring to FIG. 3 , the ridges 10 in this case have a symmetrical profile with a flat-top apex 11 , flat main flanks 12 and flat intermediate flanks 13 . The main flanks 12 may be angled, as shown, to converge towards the apex 11 , or may be parallel to one another. In FIG. 4 , the ridges 14 have a profile that involves a curved, cylindrical tip 15 together with convergent flat-flanks 16 that are tangential to the tip 15 . Similarly, in FIG. 5 , ridges 17 have a profile that is curved at the apex 18 and has convergent flat-flanks 19 , but in this case the flanks 19 are not tangential to the curve. FIG. 6 illustrates a further ridge-profile in which the ridges 20 have a flat-top apex 21 and flat flanks 22 to give a substantially rectangular cross-section. Footprint traces that result from striking a golf ball having a dimpled soft-cover with a plain, flat-faced putter-head, and with a ridge-faced putter-head according to the invention, are illustrated in FIGS. 7 and 8 respectively, for comparison purposes. The ball is struck in each case to produce an initial ball velocity of about 3 meters per second, and the ridges of the ridged putter-head have a pitch of about 1.4 millimeters. As illustrated in FIG. 7 , the footprint 23 of the flat-faced putter-head was delimited in practice by a circle 24 having a diameter of 7.0 millimeters. On the other hand, the circle 25 , illustrated in FIG. 8 , delimiting the footprint 26 of the ridge-faced putter-head was found to be 8.3 millimeters. This larger diameter for the footprint 26 indicates that penetration of the golf-ball surface by the ridge-faced putter-head was 40% deeper than by the flat-faced putter-head. It is to be noted that the greater part of the contact area (black) of footprint 23 of FIG. 7 is contained left of centre of the circle 24 . This means that in this (random) instance, the effective impact force was biased to the left of centre with the result that the ball would veer slightly to the right. In comparison, the total contact area for the ridge-faced putter-head in footprint 22 of FIG. 8 , has a better lateral distribution throughout the circle 25 , and comprises separate, substantially-horizontal contact areas made with the ball by six individual ridges of the head. The dominant ridges (that is to say, those at or near the centre of the footprint) form relatively deep impact indentations, which, being generally horizontal, impede vertical slippage between the impact face and the ball during impact. Conversely, the ball is more able to slip laterally, along the length of the rounded and smooth topped ridges. These conditions are optimum for imparting topspin while at the same time minimising errors due to incorrect swing path. FIGS. 9 and 10 are bar graphs showing computed peak-force contributions as a percentage of total peak impact-force for adjacent ridges of putter-heads according to the present invention, in respect, respectively, of two different ridge configurations. For simplicity, use of a smooth-surfaced ball with diameter 42.7 millimeters (as for a golf ball) is considered, and it is assumed that the Hertz law of contact approximates the force-deformation relation. Thus, the force contribution from each ridge is taken as proportional to its depth of penetration raised to the power 3/2. In the circumstances represented by FIG. 9 the ridge spacing is 1.4 millimeters and the depth of penetration is 0.41 millimeters (maximum), with six ridges contributing to the impact. This replicates the general impact conditions that obtained with footprint 26 of FIG. 8 . The ridge spacing for the circumstances represented in FIG. 10 , is 1.0 millimeters and eight ridges contribute to the impact. From this it is revealed that a maximum depth of penetration of 0.34 millimeters is required to develop the same total peak force as obtained in the circumstances of FIG. 9 . The peak depth of penetration is only 19% greater than that obtained with the flat-faced putter in footprint 23 of FIG. 7 , whereas with the ridge spacing of 1.4 millimeters applicable to FIG. 9 a penetration 40% larger is achieved. Thus, with a ridge spacing of 1 millimeters or less, the increase in penetration relative to a flat-faced putter is significantly less than that obtained with a ridge spacing of 1.4 millimeters or more (all other factors being equal). Since increasing the depth of a footprint reduces dimple-effect errors, it is revealed that the ridge spacing of 1.4 millimeters is an improvement compared with the ridge spacing of 1.0 millimeters. Measurement of dimple-effect error and obtaining statistical results for ridge-faced putter-heads according to the invention, can be readily carried out using the apparatus of FIGS. 11 and 12 . Referring to FIGS. 11 and 12 , the apparatus includes a fixture 31 for positioning the ball in front of an impact block 32 that is coupled to a linear actuator 33 via parallel drive shafts 34 . An impact-face member 35 under test is releasably attachable to the block 32 and a drop-impact recording plate 36 is used as a platform for recording results of the test. The ball-position fixture 31 and the linear actuator 33 are mounted above floor-level with the plate 36 on the floor in front of them. A golf ball 37 is placed on the fixture 31 and the linear actuator 33 is then operated so that the ball 37 is hit by the member 35 under test. As struck by the member 35 , the ball 37 is propelled through the air to drop onto the drop-impact plate 36 where the position of its landing is recorded as a mark on impact-sensitive paper. The process can be repeated to accumulate a series of test results for the relevant member 35 , and then for other configurations of impact-face members substituted for the member 35 . The actuator 33 can be set to give precisely repeatable strokes and arranged to launch the golf ball 117 with initial linear velocity of 2.5 meters per second and negligible imparted spin. In the absence of dimple-effect error, the direction of ball-launch is initially along a horizontal Y-axis direction normal to the plane of the impact-face of the member 35 , and the drop from the initial position of the golf ball to the landing position on the plate 36 is a known distance H measured along a vertical Z-axis. For a ball travelling horizontally with a velocity of 2.5 meters per second, the length L along the Y axis between its initial resting position and its impact on the plate 36 can be readily calculated. In particular, assuming that the local value of gravity is 9.81 meters per second per second, the value of L is calculated from: L= 1.129×H 1/2 Thus when the height H is 0.785 meters the length L is 1.00 meter for an initial horizontal velocity of the ball of 2.5 meters per second. With dimple-effect errors, the landing spot changes. Directional (that is, azimuthal) errors give rise to displacements along a horizontal X-axis transverse to the Y-axis, with the degree of angular error approximately proportional to the X-axis displacement and inversely proportional to L. Angular errors in launch elevation give rise to variations along the Y-axis, but the magnitude of these errors is approximately a quadratic function of L. The apparatus of FIGS. 11 and 12 demonstrates the principle of ballistic techniques for measuring putter characteristics, and provides a very accurate means for determining dimple-effect errors. The use of a linear actuator in this is much preferred to other means using a mechanically-swung putter since it is difficult to maintain precisely repeatable impact conditions with a mechanically swung putter. The accuracy of the apparatus of FIGS. 11 and 12 can be validated using a billiard ball, which has high spherical symmetry. In practice it is found that impact energy and angular errors in such a measurement system are very small compared with dimple-effect errors. The apparatus allows rapid testing of a ball or sample of balls. The drop impact recording plate 36 can with advantage be replaced by electro-optical means for measuring the ball displacement along the X-axis. The design of the initial ball-position fixture 31 is critical. It is important that the ball 37 is placed in a fixed and stable initial rest position for each shot but the fixture 31 should not significantly interfere with the movement of the ball at impact. In this regard it has been found advantageous to form the member 31 of foam rubber and bond to it a nylon washer 38 ( FIG. 12 ) having a hole diameter of 6.5 millimeters for seating the ball; this is sufficient for accurate location but also provides a very shallow seating. During impact, very little force is required to depress the washer 38 into the foam-rubber member 31 and so allow the ball to move virtually unimpeded. The height of the fixture member 31 can be finely adjusted with shims (not shown) and this allows very accurate positioning of the initial position of the ball along the Z-axis. This is required to ensure that the height of the initial position of the ball relative to the impact-face member 35 is adjusted for worst case impact, that is to say, with the centre of a ridge coincident with the centre of impact. This condition can be verified using a smooth-surfaced golf ball substitute, having the same diameter as the test golf balls and recording the impact footprint of the impact-face member 35 on the smooth-surfaced ball. It is found that the arrangement of FIG. 12 gives very stable and precise control of the impact position along the Z-axis so that worst case impact can be reliably tested. The ambient temperature of the test area should be monitored and controlled during measurement and comparative measurements of different impact-face members should be carried out at the same nominal ambient temperature. Handling of the test sample of balls should be minimised to ensure that they remain at ambient temperature during the testing. In practice various refinements are required so that error results of several hundred or even thousands of shots can be efficiently recorded. It is believed that the dimple-effect characteristics of a given impact-face configuration and a given golf ball type are best evaluated by taking large measurement samples with random initial golf-ball orientations. The sample size depends on the degree of confidence and precision required in the statistical measurement. Random initial golf-ball positions are easily obtained since it is very difficult to orientate a golf ball to ensure either a minimum or maximum dimple-effect error. The present invention seeks to provide reduction in dimple-effect errors relative to a hard flat-faced putter-head with specified ball type and putt strength. This reduction is measured as the difference in the standard deviations of dimple-effect errors for a putter-head according to the invention relative to a hard flat-faced putter-head. Preferably 99% confidence limits should apply. The upper limit of standard deviation for error measurements obtained with the improved dimple-effect impact-face should be a given percentage (85% or less) of the lower limit of standard deviation for dimple-effect error measurements obtained with the hard, flat-faced putter-head. In practice this means that the sample size (that is to say, the number of measurements) can vary depending on the margins of improvement obtained. FIGS. 13 and 14 show records of dimple-effect errors for two different impact-face members. These records are in the form of scatter graphs showing deviations of landing spots on the recording plate 36 of FIGS. 11 and 12 . FIG. 13 shows the deviations (due to dimple-effect errors) for a standard hard, flat-faced impact-face member for fifty shots, whereas FIG. 14 shows the results under the same measurement conditions as FIG. 13 except that the impact-face member, although again hard, was of the form of FIG. 3 with ridge widths of 0.4 millimeters and pitch of 3.0 millimeters. In FIG. 13 , the overall range of X-axis deviations is marked as 41 and the overall range of Y-axis deviations as 42 . Similarly in FIG. 14 , the overall range of X-axis deviations is marked as 43 , and Y-axis deviations as 44 . It is to be noted that the marker 43 is about 10% longer than the marker 41 indicating that directional errors due to dimple-effect are slightly greater. Also, the marker 44 is about 140% longer than marker 42 , showing that the impact-face member of the form applied in FIG. 14 degrades dimple-effect performance for elevation errors. The scatter graphs of FIGS. 13 and 14 give an example where small samples of measurements are sufficient to differentiate between good and bad performance. The impact-face member that was used to obtain the results in FIG. 14 was of a ridge-faced form with pitch dimension of 3.0 millimeters. This pitch dimension is found to be too large as it introduces a strong dominant ridge effect that concentrates the initial contact force and produces gross inconsistencies in elevation performance as well as degrading rather than improving directional accuracy. The scatter graph form of measurement is useful for quick initial evaluation of impact faces. For more detailed measurements, the position along the X-axis of each landing spot on the drop-impact recording plate 36 is required. Using a long strip or roll of impact-recording paper and shifting the Y-axis position of the paper after each shot can accomplish this. Successive shots are then separate and stretched out along the length of the paper. Y-axis information is lost, but the X-axis position of each shot is recorded and can be measured relative to the edge or other Y-axis reference on the strip or roll of paper. This technique has been used to analyze dimple-effect errors for a large variety of impact-face configurations, and further test results will now be described with reference to FIGS. 15 and 16 . FIG. 15 is a histogram showing the distribution of dimple errors from a SURLYN® covered golf ball using a standard flat-faced putter. The measurements were taken with the precision putting apparatus of FIGS. 11 and 12 , recording the angular error of each putt. Measurements for a sample of five hundred putts were taken and the results sorted into bins of 0.4 degrees. Each bar in the histogram represents the number of putts per bin as a percentage of the total sample. The errors appear approximately normally distributed with measured standard deviation of 0.66 degrees. FIG. 16 correspondingly shows the distribution of dimple errors in a sample of two hundred and fifty putts (bin size 0.4 degrees) on the same SURLYN® covered golf ball using a ridge-faced putter-head of the form of FIG. 2 . The ridges had a pitch of 1.6 millimeters, width of 0.32 millimeters and a depth of 0.32 millimeters. The tip shape was semi-cylindrical with a TSF of 0.58. The errors appear approximately normally distributed with measured standard deviation of 0.40 degrees—a reduction of about 40% compared with the results represented in FIG. 15 . It is to be noted that the measurements of FIG. 16 were obtained with the height of the initial-ball position fixture 31 varied throughout the test to give an average of worst-case and best-case impact positions. The characteristics of a variety of hard and soft ridge-faced impact faces are recorded in FIGS. 17 and 18 , the results for six hard impact-faces being tabulated in FIG. 17 , and for three soft impact-faces (all of the same grade of softness) in FIG. 18 . The standard deviation s determined from each test using a sample size N, is indicated in the last line of each table. All measurements were carried out using one type of hard-covered golf ball with a launch velocity of 2.50 meters per second ±1% and with the impact-face member 35 of the apparatus of FIGS. 11 and 12 positioned so that a ridge centre was substantially coincident with the centre of impact. Ambient temperature was maintained in the range 16 to 18 degrees Celsius. Referring to FIG. 17 , test No. 1 relates to a hard flat-face putter. This test used a large sample (N=1055) in order to establish the basic dimple-effect performance of the ball-type used. The ball used was such as sold under the trade mark DUNLOP DDH 110 , and the standard deviation of the sample was found to be 0.72 degrees. The measurements give 90% confidence that the population standard deviation for dimple-effect errors lie within the limits 0.69 to 0.75 degrees at 17 degrees Celsius. Preferably, all estimates of the performance of an impact surface should be carried out with a sample of golf balls whose standard deviation for dimple-effect errors lie within the above limits or equals that of the ball used, to within ±4%. Test No. 2 relates to the ridge configuration of a currently-marketed putter. The ridge profile (which as with all profiles shown in FIG. 17 , is represented with a 15× magnification) has a flat apex giving a high value of TSF outside the preferred range for hard ridges. The improvement in worst-ase dimple-effect errors is only about 8%. Test No. 3 relates to an experimental ridge configuration comprising a semi-cylindrical tip (radius 0.34 millimeters) with width slightly larger than the ridge shape of test No. 2 but with reduced TSF. Although the width is greater (which would tend to reduce improvement) the reduced TSF results in a significant improvement compared with test No. 2. Test No. 4 relates to a second experimental ridge configuration with radius reduced to 0.18 millimeters giving a width of 0.36 millimeters. It can be seen that the reduction in width significantly improves performance. Worst-case performance in the sample was measured as 26% below that of test No. 1 and overall performance is expected to be about 40% below or better. Tests No. 5 and 6 used very small TSF ridges and were fabricated using precision wire erosion machining. The data indicates that the lower TSF resulting from the smaller tip radii (0.05 millimeters in both cases) does not reduce dimple-effect errors to the same degree as the ridge configuration of test No. 4, or in any case provides limited improvement. It is believed that this is due to higher plastic deformation at impact and it is therefore considered that TSF values below 0.5 do not meet the aims of the invention. Referring now to FIG. 18 , test No. 7 relates to a flat-faced putter with one type of soft material, which was also used to fabricate rectangular-section ridge configurations (with TSF of 0.667) used for test Nos. 8 and 9. This material gave a nominally 15% improvement in dimple-effect performance relative to the hard surface of test No. 1. Test No. 8 demonstrates the dominant ridge effect in soft materials. The second design (again based on FIG. 7 ) has a pitch of 3.3 millimeters and a ridge-width of 1.4 millimeters. These measurements show a very severe degradation of 26% increased standard deviation compared with the flat-faced face of the same material, and are also worse than a flat-faced hard impact face. Test No. 9 shows that reducing the pitch to 1.6 millimeters (in this particular material) and slightly reducing the width improves performance significantly, namely 10% better than the flat-faced impact-face of the same material and 24% better than the standard hard face. The measurements of FIG. 18 demonstrate that when using soft impact-faces with rectangular-profile ridges performance is strongly affected by the dimensions used. Three alternative ridge-profiles are illustrated in FIGS. 19 to 21 and will now be described. Referring to FIG. 19 , a ridge 50 in this case has an asymmetric profile for use with hard material. The ridge 50 has upper and lower flanks 51 and 52 and a tip 53 (distinguished by crosshatching). The tip 53 , which extends from the apex 174 to a depth of 0.15 millimeters, comprises a variety of shape features, namely a sharp cornered apex 54 , an outer, angled flat 55 and a rounded corner 56 . The nominal base 57 (Indicated by dashed-line) of the ridge 50 extends parallel to the putter face 58 being (in accordance with the definition of “base”) located where the thickness of the ridge cross-section equals three times the thickness at 0.15 millimeters depth from the apex 54 . In most practical forms of ridge construction, mechanical features at depths beyond the defined base have negligible effect on putting performance. FIG. 20 shows an arrangement Involving soft resilient-ridges according to the invention. Referring to FIG. 20 , the ridges 60 in this case are of a rectangular profile having a flat-top apex 61 . The gaps between the ridges 60 are filled with material 62 of several durometer points softer than the ridges 60 , which themselves may be softer than the golf ball. The purpose of the filling material 62 is to prevent ingress of dirt inside the narrow deep gaps or grooves between ridges. Different colour materials may be used for the ridges 60 and filler material 62 for cosmetic effect. The filling material 62 may protrude or be flush with the apex 61 , or may be under-flush (as shown). Most of the impact force on a golf ball by the impact-face of FIG. 20 , is transmitted via the ridges 60 . The filling material 62 does not prevent deflection of the ridges 60 when subject to vertical shear forces or to lateral expansion under normal deformation forces. Thus, the filling material 62 contributes only a minor part of the impact forces on the ball. In this context, the gap between ridges 60 is defined as the thickness of the filling material 62 at a depth of 0.2 millimeters from the apex 61 . FIG. 21 shows an arrangement in which hard ridges 63 are embedded in a soft resilient base 64 . In a preferred arrangement, each ridge 63 is separately formed from strip steel or other hard material and is embedded into the resilient base 64 with its outer surface or apex substantially coplanar with that of each other ridge 63 and such as to create an array of substantially parallel horizontal ridges of uniform pitch. The ridges 63 may be interconnected with one another to facilitate assembly. The projecting parts of the ridges 63 are preferably dimensioned in a corresponding manner to the ridges of FIGS. 2 to 5 . The ridges 63 preferably extend deeply into the base 64 so that they are firmly embedded, and may be bonded to the base 64 or a tight fit into mating slots in it (allowing individual ridges 63 to be replaced).

A golf-putter head ( 1) has a grooved impact face ( 5) defining lengthwise ridges ( 7) for impacting a dimpled golf-ball in areas of contact that are distributed around the dimples for improvement of putt accuracy by collectively centralizing the resultant striking force on the ball. The profile, width w and pitch p of the ridges ( 7) are selected according to hardness h and with p and w not exceeding 3.5 mm and (p-0.4) mm respectively, to reduce the standard deviation of dimple-effect error distribution by at least 15% in putting with initial ball-velocity of 2.5 m/s. Ridge-profile is symmetrically rounded (FIGS. 2,4,5,21), flat (FIG. 6,20) or segmented-flat (FIG. 3), or asymmetrical (FIG. 19), and test apparatus (FIGS. 11, 12) uses a linear actuator ( 33) for projecting the ball repeatedly to drop onto an impact-recording plate ( 36) to reveal scatter due to dimple-effect error.

This application is a continuation-in-part of Ser. No. 365,418, filed Apr. 5, 1982, now abandoned. BACKGROUND OF THE INVENTION The present invention relates to the stabilization of drugs including antibiotics and food supplements. Particularly, it concerns the granulation of Efrotomycin, milbemycins, tylosin derivatives, e.g., A.I.V. (3-acetyl-4"-isovaleryl tylosin), antibiotics B-5050 and tetrahydro-B-5050, Ivermectin, mocimycin, goldinomycin and the like in alginic acid and magnesium hydroxide. It has been found that the granules so obtained exhibit unexpectedly enhanced stability and can be incorporated into various formulations without substantial decomposition. When the drugs or food supplements are administered to animals, the formulations include animal feed, pellets or feed premix. Efrotomycin (FR-02A) is a new antibiotic which also exhibits growth-promoting activity. It is effective against both gram-positive and gram-negative bacteria and accordingly is useful in the treatment of a broad spectrum of infections in animals. Efrotomycin is disclosed in U.S. Pat. No. 4,024,251 issued May 17, 1977 to Maiese and Wax. The antibiotic is isolated from the fermentation broth of Streptomyces lactamfuran by solvent extraction and is believed to have the molecular structure as follows: ##STR1## The physical properties of Efrotomycin (FR-02A) are summarized as follows: Elemental analysis: C 60.98% H 7.60% N 2.60% The corresponding empirical formula C 59 H 90 N 2 O 21 is consistent with monohydrated FR-02A. This is in agreement with a molecular weight of about 1168 of the sodium complex of FR-02A determined by field desorption mass spectrometry. Further mass spectroscopic study of FR-02A determined the molecular weight 1144 for the uncomplexed compound corresponding to the empirical formula C 59 H 88 N 2 O 20 . FR-02A as the ammonium salt is soluble in alcohol and chloroform. It is moderately soluble in water at pH 7.0 or higher. A U.V. spectrum of the ammonium salt in water showed: max. 233 nm: E 1 cm 1% =320 max. 328 nm: E 1 cm 1% =180 After further purification FR-02A in the free acid has the following U.V. spectrum in methanol--0.05M phosphate buffer pH 6.85 (20:80): max. 325 nm: E 1 cm 1% =317 max. 230 nm: E 1 cm 1% =554 max. 219 nm: E 1 cm 1% =556 Specific optical rotation of FR-02A sodium salt is [α] D 20 -56.6±0.5 (C=1, MeOH). The nuclear magnetic resonance spectrum of antibiotic FR-02A was obtained at 100 MHz with CDCl 3 as the solvent and tetramethylsilane (TMS) as the internal standard. Representative features of the spectrum were Doublets at 1.21(3H), 1.31(3H), 1.74(3H), 4.63(1H), 4.87(1H), 5.94(1H) and 7.32(1H) ppm. Overlapping signals of 4 other C-methyl groups centered at about 0.94 ppm; Singlets at 1.65(3H), 2.02(3H), 3.15(3H), 3.42(3H), 3.45(3H), 3.54(3H), and 3.58(3H) ppm. The infrared absorption spectrum of antibiotic FR-02A in a Nujol mull exhibits characteristic absorption at the following wave lengths expressed in reciprocal centimeters: Broad Band at: 3400 Strong bands at: 1640, 1460, 1380, 1080, 1020 Prominent bands at: 1550, 1505, 1240, 1195, 940, 860, 720, 620. Further characteristics of FR-02A as well as the process for isolating the antibiotic are described in U.S. Pat. No. 4,024,251 and are herein incorporated by reference. Efrotomycin is found to be unstable at elevated temperatures especially in the presence of moisture and feed components. However, in administering Efrotomycin to animals, it is most convenient and economic to include the antibiotic-growth promotor agent in premixes for animal feeds. Usually a premix is blended into animal feeds followed by injection of steam resulting in a final temperature of 85°-100° C. The mixing process takes about 2-15 minutes. The agglomerates may be either cooled and dried to produce a mash feed or extruded to give pelleted feed. In other words, Efrotomycin must be stabilized first before it can be incorporated into animal feeds. Accordingly, it is desirable to develop a method of formulation for the stabilization of Efrotomycin to enable the inclusion thereof in animal feed. One of the commonly used methods of formulation for stabilization is granulation because of ease, efficiency and consequently lower cost. Methods described in the literature include granulation with specific inorganic materials (U.S. Pat. No. 3,627,885, Dec. 14, 1971) or with starch (U.S. Pat. No. 4,048,268, Sept. 13, 1977). Neither of these techniques were suitable for Efrotomycin. Granulation with inorganic salts, particularly those of magnesium did result in some stabilization but unexpected synergistic improvement occurred when polysaccharides were incorporated into the formulation as can be seen from table 1. TABLE 1______________________________________The effect of the addition of polysaccharidegelling agents to magnesium hydroxide on thestability of efrotomycin stored in animal feedat 50° C., (all contain 5% efrotomycin andmagnesium hydroxide:gum in the weight ratio1:1). Magnesium Storage % of initialPolysaccharides hydroxide time remaining______________________________________ -- -- 17 days 12 -- present 25 days 56Guar gum (anionic) present 28 days 71Guar gum (nonionic) present 28 days 79Guar gum (cationic) present 28 days 55Tragacanth present 28 days 68Acacia present 28 days 81Alginic acid present 35 days 100Calcium alginate present 56 days 82Sodium alginate present 30 days 69Maize starch present 14 days 90Locust Bean gum present 14 days 83Agar-agar present 14 days 80______________________________________ For efrotomycin incorporation of alginic acid gives the best stabilization although all the polysaccharides including those listed in Table 1 and xanthan gum, karaya gum, gum ghatti, and carrageenan offer significant protection. In case of efrotomycin, the ratio of alginic acid to magnesium hydroxide is important as can be seen in table 2. TABLE 2______________________________________The effect of alginic acid - magnesiumhydroxide ratio on the stability ofefrotomycin stored in animal feed at 50° C.(all contain 10% efrotomycin). % of initial% Magnesium % Alginic remaining afterhydroxide w/w acid w/w 4 months storage______________________________________90 -- 2675 15 7360 30 9145 45 9330 60 10015 75 75-- 90 37______________________________________ It should be noted that the method of the present invention is not limited to Efrotomycin. Any other unstable animal drugs or food supplements may be incorporated into animal feeds or other formulations including human drug formulations according to the formula and process described herein. Particularly, for example, the following drugs: (1) Ivermectin: a potent antiparasitic agent disclosed in U.S. Pat. No. 4,199,569. (2) Milbemycins (antibiotics B-41): antibiotics characterized in U.S. Pat. Nos. 4,144,352; 3,950,360; and British Patent Specification No. 2,056,986. (3) Tylosin and derivatives, e.g., A.I.V.: antibiotics disclosed in U.S. Pat. No. 4,092,473. A.I.V. is the 3-acetyl-4"-isovaleryl derivative (R 1 is acetyl and R is isovaleryl in formula I) of tylosin. (4) Antibiotics B-5050 and tetrahydro-B-5050: disclosed in U.S. Pat. No. 3,853,842. (5) Mocimycin dihydromocimycin, antibacterial agents disclosed in U.S. Pat. Nos. 3,927,211 and 4,062,948. (6) Goldinomycin disclosed in U.S. Pat. No. 3,657,421. The physical characterization, the biological activity as well as the isolation of the above-identified drugs are herein incorporated by reference. It has been found that these drugs may also be stabilized by granulation with a polysaccharide gelling agent especially alginic acid blended with an inorganic salt, particularly metal oxides or hydroxides such as magnesium hydroxide. The granules may be incorporated into feed, tablets, capsules, or other formulations. SUMMARY OF THE INVENTION The present invention concerns a method of granulation for the stabilization of unstable or heat-sensitive animal drugs or food supplements, such as Efrotomycin, tylosin and derivatives (A.I.V.), milbemycins, avermectins such as Ivermectin, mocimycin, goldinomycin and the like. The granulation enables the incorporation of these drugs or food supplements into animal feeds or other formulations without substantial decomposition. Accordingly, it is the object of this invention, to (1) develop a granulation method which will produce sufficiently stable granules for inclusion of unstable drugs or food supplements in animal feeds, or other human and animal formulations; (2) provide a novel stable formula or composition containing one or more of the granulated drugs or food supplements which is resistant to heat, humidity, and other adverse conditions; and (3) apply the formula and process equally to other unstable human or animal drugs or food supplements for inclusion in feed, tablets or capsules or other suitable formulations. DETAILED DESCRIPTION OF THE INVENTION The stabilizing granulation formula of the present invention comprises: (a) 0.1 to 70 parts by weight of an active compound especially Efrotomycin, A.I.V. or Ivermectin; (b) 10 to 80 parts by weight of a polysaccharide gelling agent especially guar gums (natural or synthetic), tragacanth, acacia, alginic acid and its salts and derivatives, starch, locust bean gum, agar-agar, xanthan gum, karaya gum, gum ghatti and carrageenan or a mixture thereof; and (c) 10 to 80 parts by weight of a metal salt especially an oxide, a hydroxide, a carbonate or a silicate of aluminum, calcium or magnesium, for example, magnesium hydroxide. In a preferred embodiment, the formula comprises: (a) 2-40 parts by weight of an active compound; (b) 20-50 parts by weight of alginic acid; or calcium alginate or a combination thereof in the ratio 2-3 parts of alginic acid to 2-3 parts of calcium alginate; and (c) 20-85 parts by weight of a metal oxide or hydroxide. In the most preferred embodiment of this invention the formula comprises: (a) 5-35 parts by weight of an active compound; (b) 15-50 parts by weight of alginic acid; and (c) 20-80 parts by weight of magnesium hydroxide. Efrotomycin, while it is unstable in the below described feeds and feed additives, does not appear to be unstable to water alone. Thus, the instant process is not a strict protection method against hydrolysis. The instant formulation protects antibiotics against deterioration in the presence of feeds. Applicants do not wish to be bound by theory, but this may be accomplished by isolating the compound from the components of feed which cause the deterioration. Thus any compound which is intended for use in feed or feed-like components, and which is unstable in such feeds or feed-like components, but otherwise stable under neutral conditions will benefit from the use of the process of this invention. For preparing the above defined formulae, the active compound is mixed and agglomerated with other ingredients in the indicated amounts. A sufficient amount of a solvent, for example water; lower alkanol especially C 1-6 alcohol such as ethanol and methanol; and lower alkanone especially C 1-6 alkanone such as acetone and diethylketone or a mixture thereof is added and thoroughly dispersed to obtain a wet mass of the desired consistency. Usually, the amount of the solvent needed is about 0.05-2 parts per part by volume of the mixed ingredients. Subsequently, the wet blend is sieved, dried, and screened to yield granules of desired sizes. Alternatively, the mixing can be carried out in a high speed mixer granulator followed by milling and drying in a fluidized bed. Alternatively, the granulated product defined above may also be obtained by dry compression of the ingredients in the indicated amounts followed by subsequent grinding in order to get the granulated product. Alternatively, the mixed ingredients may be slurried with a suitable solvent and spray dried into granules. The amount of biologically active compound in the granules may be adjusted up to the most convenient range-e.g., from 0.1 percent to 70 percent by weight--for facilitating the dispersion of the compounds in the feed, and the resulting composition (granules) is then dispersed in any suitable feed, premix substrate or simply used as premix by itself. When the granules are dispersed in animal feed, it is usually incorporated at the rate of about 0.1-10 kg per ton preferably 0.5-2 kg per ton to achieve the desired dose. Usually the wet-granulation technique is used, the active compound, for example, Efrotomycin, is thoroughly mixed in the indicated amount with alginic acid and magnesium hydroxide. An adequate amount of water or other solvent is added to obtain a wet mass of required consistency. The resulting agglomerate is then granulated by passing through a 16 mesh (1000 μm) screen and dried at about 30°-60° C., preferably at about 45° C. for about 5-48 hours, usually about 15-20 hours. Optionally, the granules may be rescreened through a 30 mesh (595 μm) or other suitable screen to obtain the required size. Alternatively the mixing can be carried out in a high speed mixer granulator followed by milling and drying in a fluidized bed at about 30° C. to 55° C. for about 1-5 hours. Although it is not required for performing the invention the formulation may be admixed with suitable inert diluents such as lactose, sucrose, calcium phosphate or micro-crystalline cellulose. Disintegrating agents (e.g. starch or its modifications) or lubricants such as magnesium stearate, stearic acid, polyethylene glycol or talc may be added. The blend may be filled into capsules or compressed into tablets to allow the administration of stabilized drugs, e.g., Ivermectin, as a convenient oral dose. The following examples are intended to illustrate the preparation of compositions of the invention but they are not to be construed as limiting the scope thereof. EXAMPLE 1 A wet blend was prepared from mixing the following components: Efrotomycin (60% pure): 33.33 parts by weight Alginic acid: 13.33 parts by weight Magnesium hydroxide: 53.34 parts by weight Water: sufficient to granulate The wet blend was sieved 16 mesh, dried at 45° C. for 2 hours and then rescreened 30 mesh. The dried granule was used as a "concentrate" which may then be blended with other inert ingredients, e.g., oiled rice hulls and then incorporated into animal feed at the rate of 0.5-2 kg per ton to achieve the appropriate dose. The stabilization of Efrotomycin was achieved in both the premix and feed as shown below in Table III. TABLE III______________________________________Stability of unprotected and protected Efrothomycin(100 ppm) in feed and pelleted feed. (Concentrate)contains 20% by weight Efrotomycin; mean ± 1 std.deviation) Stability in feed Stability in (w/w % initial) pelleted feedStorage Efrotomycin Concentrate (w/w % initial)Conditions (60% pure) Concentrate______________________________________2 wks 40° C. -- -- 90.4 ± 13.1 50° C. -- 87.3 ± 13.3 80.7 ± 11.817 days 40° C. 22.1 ± 4.5 -- -- 50° C. 11.9 ± 3.3 -- --4 wks 40° C. 16.5 ± 6.3 75.0 ± 8.1 88.5 ± 5.7 50° C. Trace 73.1 ± 13.3 66.5 ± 4.76 wks 40° C. 10.5 ± 3.2 74.6 ± 4.2 98.2 ± 10.2 50° C. Trace 78.8 ± 8.1 64.3 ± 3.6712 wks 40° C. -- 106 ± 12.7 75.0 ± 8.1______________________________________ Following substantially the same procedure as described above, but substituting for Efrotomycin used therein Ivermectin, there is prepared a stabilized concentrate of Ivermectin. EXAMPLE 2 A wet blend was prepared from mixing the following components. Efrotomycin (60% pure): 8.35 parts by weight Alginic Acid: 18.33 parts by weight Magnesium hydroxide: 73.32 parts by weight Water: sufficient to granulate. The wet blend was treated as described in Example 1 and the stabilization achieved in feed is shown below. ______________________________________ Stability in feedStorage conditions (w/w % initial)______________________________________4 wks 40° C. 91.3 ± 7.9 50° C. 81.9 ± 8.77 wks 40° C. 89.8 ± 8.6 50° C. 72.1 ± 0.512 wks 40° C. 96.0 ± 9.6______________________________________ Following substantially the same procedure as described above, but substituting for Efrotomycin used therein Ivermectin, there is prepared a stabilized concentrate of Ivermectin. EXAMPLE 3 A wet blend was prepared by mixing the following components. Efrotomycin: 8.4 parts by weight Alginic acid: 45.8 parts by weight Magnesium hydroxide: 45.8 parts by weight Water: sufficient to granulate The wet blend was treated as described in Example 1 and the stabilization in feed is shown below. ______________________________________ Stability in feedStorage Conditions (% initial)______________________________________9 weeks at 50° C. 99 ± 9______________________________________ EXAMPLE 4 A wet blend was prepared by mixing the following components. Efrotomycin: 8.4 parts by weight Calcium alginate: 45.8 parts by weight Magnesium hydroxide: 45.8 parts by weight Water: sufficient to granulate The wet blend was treated as described in Example 1 and the stabilization in feed is shown below. ______________________________________ Stability in feedStorage Conditions (w/w % initial)______________________________________4 weeks at 50° C. 83 ± 48 weeks at 50° C. 82 ± 5______________________________________ EXAMPLE 5 A wet blend is prepared by mixing the following components. Efrotomycin: 8.4 parts by weight Calcium alginate: 22.9 parts by weight Alginic acid: 22.9 parts by weight Magnesium hydroxide: 45.8 parts by weight Water: sufficient to granulate The wet blend is treated as described in Example 1. EXAMPLE 6 A wet blend was prepared by mixing the following components. Efrotomycin: 8.4 parts by weight Maize starch: 45.8 parts by weight Magnesium hydroxide: 45.8 parts by weight Water: sufficient to granulate The wet blend was treated as described in Example 1 and the stablization in feed is shown below. ______________________________________ Stability in feedStorage Conditions (w/w % initial)______________________________________14 days at 50° C. 90 ± 828 days at 50° C. 83 ± 956 days at 50° C. 67 ± 8______________________________________ EXAMPLE 7 A wet blend was prepared by mixing the following components. Efrotomycin: 8.4 parts by weight Alginic acid: 45.8 parts by weight Magnesium oxide: 45.8 parts by weight Water: sufficient to granulate The wet blend was treated as described in Example 1 and the stabilization in feed is shown below. ______________________________________ Stability in feedStorage Conditions (w/w % initial)______________________________________18 days at 50° C. 94 ± 256 days at 50° C. 83 ± 25 months at 50° C. 82 ± 4______________________________________ EXAMPLE 8 A wet blend was prepared by mixing the following components. Efrotomycin (60% pure): 33.33 parts by weight Alginic Acid: 33.33 parts by weight Magnesium Hydroxide: 33.33 parts by weight Water: sufficient to granulate The wet blend was treated as described in Example 1 and the stabilization in feed is shown below. ______________________________________Storage Conditions Stability (%)______________________________________In Mash12 weeks at 37° C. 93 ± 612 weeks at 37° C. (Sodium Salt) 113 ± 7Pellets12 weeks at 37° C. 84 ± 1112 weeks at 37° C. (Sodium Salt) 93 ± 8______________________________________ EXAMPLE 9 A wet blend was prepared by mixing the following components. Ivermectin: 1 part by weight Alginic acid: 49.5 parts by weight Magnesium hydroxide: 49.5 parts by weight Water: sufficient to granulate The wet blend was treated as described in Example 1 and the stabilization in feed is shown below. ______________________________________ Stability in feed (w/w % initial) ProtectedStorage Conditions Ivermectin Ivermectin______________________________________ 7 days at 40° C. 90 --14 weeks at 40° C. 82 --4 weeks at 50° C. -- 85______________________________________ EXAMPLE 10 A blend is prepared by mixing the following components. Ivermectin: 2 parts by weight Alginic acid: 32.5 parts by weight Starch (Directly compressible): 32.5 parts by weight Magnesium hydroxide: 32.5 parts by weight Magnesium stearate: 0.5 parts by weight The blend is then compressed on a suitable tablet machine to produce thin compacts which are then milled to produce granules of about 0.5 mm diameter. Alternatively the blend may be passed through a roller compacter followed by screening. The granule is then incorporated into feed as described in Example 1. EXAMPLE 11 A wet blend is prepared by mixing the following components. A.I.V.: 20 parts by weight Alginic acid: 40 parts by weight Magnesium hydroxide: 40 parts by weight Water: sufficient to granulate The wet blend is treated as described in Example 1. EXAMPLE 12 Preparation of Tablet Formulation ______________________________________ MilligramsIngredient Per Tablet______________________________________Ivermectin granule 1.5Bone meal flour 300Microcrystalline cellulose 500Flavor 250Dibasic calcium phosphate 739.5Magnesium stearate 9______________________________________ The active granule is blended with a portion of the dibasic calcium phosphate and then incorporated with the flavor, microcrystalline cellulose and bone meal flour. The mix is blended to ensure homogeneity of Ivermectin, the magnesium stearate added and mixing continued for 3 minutes before compression on a suitable machine. Each tablet contains 75 μg of Ivermectin. EXAMPLE 13 Preparation of Capsule Formulation ______________________________________ Milligrams perIngredient Capsule______________________________________Ivermectin granule as 10prepared in Example 9Starch 109Magnesium Stearate 1.0______________________________________ The active ingredient, starch and magnesium stearate are blended together. The mixture is used to fill hard shell gelatin capsules of a suitable size at a fill weight of 120 mg per capsule. EXAMPLE 14 Following the procedure of Example 1, a protected wet blend containing mocimycin was prepared. The protected wet blend was granulated and incorporated into mash or feed pellets containing 100 ppm of mocimycin. The stability was noted as follows (percentages of original after the indicated time period): ______________________________________In mash 6 weeks at 30° C. 100% 6 weeks at 37° C. 99%In pellets 6 weeks at 30° C. 96% 6 weeks at 37° C. 83%______________________________________ The unprotected drug has a stability of less than 25% after 2 months at 37° C. EXAMPLE 15 Following the procedure of Example 1 a protected wet blend containing goldinomycin was prepared. The protected wet blend was granulated and incorporated into feed. The stability is rated as follows: ______________________________________Storage Conditions Stability (%)______________________________________6 weeks at 37° C. 97%______________________________________

A granulation method involving polysaccharide gelling agents, e.g., alginic acid, and a metal salt, e.g., magnesium salt is developed for the stabilization of heat and/or moisture sensitive drugs or food supplements such as Efrotomycin, avermectins, milbemycins, mocimycin and other drugs. It has been found that the granules so obtained can be incorporated into various formulations without substantial decomposition.

This application is a continuation of application Ser. No. 07/853,149 filed on Mar. 17, 1992, now abandoned. FIELD OF THE INVENTION The present invention relates to trocar devices or assemblies used in surgery and, more particularly, to an electrosurgical trocar device or assembly. BACKGROUND OF THE INVENTION Surgical procedures such as laparoscopic procedures require the surgeon to create one or more punctures in the anatomy of the patient to enable a guide tube, referred to as a cannula, to be sited and thereby enable surgical instruments to be passed down through the cannula into the patient in order to carry out the intended procedures. One method of accomplishing this is the open or "Hussan" method wherein an incision is made in the desired area to accommodate the cannula and sutures are put around the cannula to close the gap left by the incision. Sutures are also made from the skin to cannula to assist in holding the cannula in place. This technique is used primarily (but not exclusively) in situations wherein other abdominal surgeries pose potential adhesion complications. Such complications can cause an unintended puncture in the bowel or in other organs. A second method involves the use of a mechanical trocar device which comprises the combination of a trocar and a cannula. The trocar basically comprises a rod or shaft having a very sharp cutting edge or point at one end thereof and is enclosed within the tubular cannula. In some devices, the cannula incorporates some kind of safety mechanism, such as a shield, over the cutting tip prior to use to reduce the chance of unintended punctures. Trocar devices characteristically require substantial force to drive the cutting end or tip through the abdomen wall and as a result, trocar devices can be hard to control. A separate trocar device, i.e., comprising a trocar and cannula, is used for each puncture site. SUMMARY OF THE INVENTION In accordance with the invention, a trocar device or assembly is provided which overcomes the problems with prior art trocar devices discussed above. The trocar device of the invention comprises an electrosurgical cutting element, which, in common with electrosurgical cutting instruments commonly referred to as electrosurgical "blades," provides cutting of tissue through the transmission of radio frequency electrical energy to the area to be cut. The trocar device of the invention uses electrosurgery to make the guide hole for the cannula and thus enables the remainder of the cannula assembly to enlarge the puncture. This greatly reduces the force required as compared with mechanical trocar devices. This reduction in force enables an even, constant insertion pressure to be exerted, thereby allowing substantially greater control and reducing the chances of an unintended puncture. Further, the use of electrosurgery eliminates the need for a sharp point as is required in mechanical trocar devices, thereby allowing multiple uses of the same trocar. The electrosurgical cutting element is, in use, connected to a conventional electrosurgical generator or other source of radio frequency (r.f.) power or energy (the term electrosurgical generator being used herein to refer to any suitable source for driving the electrosurgical cutting element), and a further important feature of the trocar assembly of the invention is in the provision of an electronic control circuit for sensing current flow and, when the trocar breaks the wall of the organ involved, for opening or cutting off the connection to the electrosurgical generator. This feature substantially eliminates any chance of an unintended puncture. In addition, further circuitry is preferably provided which requires that the operator (surgeon) release a control switch for a predetermined time period prior to resuming surgical operations so that power is again provided to the electrosurgical cutting element only as the result of a conscious decision on the part of the operator. As a result, inadvertent operation of the cutting element, and thus possible inadvertent puncturing of the organ wall, are combatted or avoided. Advantageously, an indicator such as a light emitting diode (LED) is used to indicate that the generator is supplying power to the cutting element (preferably by providing a continuous light output) and to also indicate the predetermined time period before electrosurgery can be resumed (preferably by providing a blinking or intermittent light output). A further important feature of the invention involves the provision of multiple trocars as part of a trocar assembly or kit, independently of whether or not an electrosurgical cutting element is used. The provision of multiple trocars enables the same basic device to provide punctures or openings of different diameters. The trocars can be very simple in construction and thus can be made to be low cost disposable items. Other features and advantages of the invention will be set forth in, or apparent from, the following detailed description of preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view, partially in cross section, of a trocar assembly in accordance with a preferred embodiment of the invention; FIG. 2 is a side elevational view of one of the trocars of FIG. 2, with the second trocar being shown in phantom lines; FIG. 3 is a side elevational view of the second, outer trocar of FIG. 1; FIG. 4 is a cross section view, to an enlarged scale, of the distal or free end of the trocar assembly of FIG. 1; FIG. 5 is a partial cross sectional view of the cannula of the trocar assembly of FIG. 1 showing the operation of the seal rollers; FIG. 6 is a cross sectional view taken generally along line VI--VI of FIG. 5; FIG. 7 is a schematic circuit diagram of circuitry incorporated into the cannula of FIG. 1; FIG. 8 is a schematic circuit diagram of the cutoff circuit of FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring first to FIG. 1, there is shown a schematic side elevational view, partially in section, of a trocar assembly which is generally denoted 10. The trocar assembly 10 basically comprises a multi-element trocar 12 and a cannula 14. The multi-element trocar 12 includes a central or inner trocar member 16 (perhaps best seen in FIGS. 2 and 4) comprising a head portion 16a and a shaft or rod portion 16b, and an outer trocar member 18 (perhaps best seen in FIGS. 3 and 4) which comprises a head portion 18a and a hollow shaft portion 18b and which slides onto and releasably engages trocar member 16. As shown, head portion 18a of trocar member 18 is affixed to head portion 16a while shaft portion 18b surrounds shaft or rod portion 16b. The cannula 14, which is also shown in FIGS. 5 and 6, comprises a head or upper housing portion 14a and a guide tube or cannula portion 14b. As shown, head portion 14a is affixed to the head portion 18a of the outer trocar member 18 and the cannula portion 14b surrounds hollow shaft portion 18a. Considering the inner or central trocar member 16 in more detail and referring to FIGS. 1, 2 and 4, head portion 16a is generally cylindrical in shape and includes an outwardly extending locking member or skirt 20 having a shaped rim or circumferential lip portion which is adapted to be received in a corresponding recess 22 in head portion 18a of outer trocar 18 (see also FIG. 3) so as to provide a releasable snap fit, as is indicated in phantom lines in FIG. 2. It will be understood that a similar releasable connection can be provided between the trocar members 16 and 18 using other suitable connecting arrangements. Head portion 16a is also provided with an indicator light or lamp 24 for indicating the operating state of the device as explained below and a reset pushbutton switch 26 which resets the electronic circuitry described below. The shaft portion 16b of central trocar member 16 comprises a central metal rod 28 and an outer insulating trocar shaft or tube 30. In a specific exemplary embodiment, rod 28 is made of stainless steel and is about 0.075 inches in diameter while trocar shaft 30 is made of a plastic, ceramic or any like material capable of providing the appropriate temperature resistance as well as has a relatively low coefficient of friction and has an outside diameter of about 3/16 of an inch or 5 mm. The distal end of trocar shaft 30 is tapered as illustrated so as to enable ready insertion thereof into a small hole "burned" through the organ wall by rod 28. Electrical power is provided to rod 28 through an electrical circuit located in head portion 16a and discussed in more detail below in connection with FIG. 7. This circuit, which is also shown in dashed lines in FIG. 1 includes indicator lamp 24 and switch 26. Referring to FIG. 3, the head portion 18a of the second or outer trocar member 18 is also cylindrical in shape and, as noted above, includes a circumferential recess 22 for receiving locking or latching member 20. A similar locking or latching member or skirt 32 having rim or circumferential lip is provided at the other end of head portion 18a, as shown. The shaft portion 18b comprises a tubular trocar shaft 34 having a central bore 36 therein through which the central trocar shaft 30 extends. The distal end of trocar shaft 34 is tapered and as shown in FIG. 4 (and in FIG. 1), the overall taper provided by trocar shafts 30 and 34 is continuous or substantially continuous. Trocar member 18 does not contain any active components and in an exemplary embodiment has an outside diameter of about 13/32 inches or 10 mm and an inside diameter about 7/32 inches, i.e., a diameter just slightly larger than the outer diameter of inner trocar shaft 30. However, it is to be understood that outer trocar members of different sizes can be used and that a set of such trocar members can be provided which would selectively be slipped onto and over inner trocar shaft 30 to provide openings of different sizes in the wall of the abdomen or other organ. It will be appreciated that such outer trocars, which, as noted above, contain no active parts, are quite simple in construction and inexpensive to manufacture. Referring now to FIGS. 1, 5 and 6, it will be seen that the head portion 14a of the cannula member 14 is hollow in construction and includes a shaped circumferential recess 38 in the upper or proximal end thereof in which reciprocally shaped circumferential locking member 32 of outer trocar member 18 is received so as to provide a snap fit between members 14 and 18. Disposed within the head portion 14a of cannula member 14 are a pair of sealing rollers or rolls 40 which are suspended from the upper or proximal end wall of head portion 14a by springs 42 that bias the rolls 40 toward each other so as to close off an opening 44 in that proximal end wall, as shown in solid lines in FIG. 5. Inserting the shaft portions 16b and 18b of trocar members 16 and 18 down into opening 44 causes rolls 40 to be forced apart and to assume the positions shown in FIG. 1 and in dashed lines in FIG. 5. Reference is made to our commonly assigned copending application Ser. No. 07/846,386, filed on Mar. 5, 1992, and entitled LAPAROSCOPIC CANNULA for a further description of arrangement for permitting insertion of a trocar while shutting off the opening for the trocar after the trocar is removed. A selectable seal device 46 is best seen in FIG. 6. The seal device 46 includes a flat sealing member 48 having pull tabs 50 and 52 at opposite ends thereof and openings 54 and 56 of different sizes so as to accommodate trocars of different diameters. In the exemplary embodiment illustrated, the openings 54 and 56 are designed to receive the 10 mm trocar 18 and the 5 mm trocar 16 and tabs 50 and 52 are marked accordingly. Thus, with 10 mm tab 52 pulled out so that sealing member 48 is moved to the right as shown in FIG. 6, the 10 mm opening 54 is brought into alignment or registration with opening 44 so that the 10 mm outer diameter trocar 16 can be inserted therethrough as indicated in FIG. 1. Sealing member 48 is disposed in a slot in housing portion 18a and is slidable therein as described above. It will be appreciated that the embodiment just described is exemplary only and that, for example, the openings in sealing member 46 can be different in number and sizes so as to accommodate surgical instruments of various sizes during surgery. As shown in FIG. 5, an opening 58 is provided in head or housing portion 14a which enables irrigation fluid to be supplied to the puncture site through cannula shaft 14b, when the trocars 16 and 18 are removed. Referring to FIG. 7, there is shown a schematic circuit diagram of the electrical circuitry contained within the head portion 16a of the main trocar 16 (this circuitry also being shown in dashed lines in FIG. 1). As illustrated, four input leads or connections, denoted 60, 62, 64, and 66 are provided, one of which, lead 60 is the "hot" lead directly connected to electrosurgical rod 28. Leads 64 and 66 provide a current input and return path for switch 26 while lead 62 connects optional indicator lamp 24 to lead 64. Referring to FIG. 8, a preferred embodiment of the cutoff circuit for the electrosurgical generator is shown. As indicated in FIG. 1, the cutoff circuit, which is generally denoted 68, can be a separate package or unit connected into the cable 70 or in another connection between the electrosurgical generator (not shown) and the trocar assembly 10. Alternatively, the circuit can be built into the electrosurgical generator. The cutoff circuit 68 of FIG. 8 includes a current transformer 72 connected to the generator output line (which can correspond to cable 70 of FIG. 1) so as to sense or monitor the current flow from the electrosurgical generator (not shown) to the trocar assembly 10. The secondary winding 72a of transformer 72 is connected to a rectifier 74 which produces an output voltage that is a function of the current level. Rectifier 74 is connected to an adjustable voltage comparator 76 which determines the cutoff current by comparing the output voltage produced by rectifier 74 with a predetermined reference level. The output of comparator 76 is connected to one input of an OR gate 78 the output of which is connected to an AND gate 80. The functions of the gates 78 and 80 are described in more detail below. A control switch 82 is provided for controlling energizing of the electrosurgical generator. This switch can correspond to switch 26 described above and is controlled by the surgeon. A pair of delay networks, a start delay circuit 84 and a reset delay counter circuit 86, are connected to switch 82 in parallel with each other. Start delay circuit 84 begins timing out its associated delay when switch 82 is closed while reset delay counter circuit 86 begins timing out its associated delay when switch 82 is opened. The significance of delay circuits 84 and 86 is explained below. The output of start delay circuit 84 is connected to the other input of OR gate 78 and the delay provided allows time for the surgeon to start a cut after activating the switch 82. Thus, when switch 82 is closed the output of start delay circuit 78 provides for closing of a control relay 88 for the electrosurgical generator so as to turn on the electrosurgical generator. Relay 88 is connected to the output of AND gate 80 through an IGFET switch 90 provided so as to ensure that the appropriate relay switching levels are maintained. After delay circuit 84 times out, the operation of relay 88 is controlled by the output of the current sensor 72 and, more particularly, by the output of comparator 76. Thus, if this output drops below the level set within comparator 76, relay 88 is opened and power to the electrosurgical generator is cut off. The cutoff circuit 68 also includes an inhibit latch 92 which includes a first, set input connected to the output of OR gate 78, a second, reset input connected to the output of reset delay counter circuit 86 and an output connected to the other input of AND gate 80. When the sensed current drops below the preset or predetermined reference value dictated by comparator 76, this is reflected at the set input of inhibit latch 90 and latch 90 is set (in addition to the control relay 88 opening as mentioned above). The inhibit latch 90 will remain set until the switch 82 is opened for the reset delay period, i.e., the period of reset delay counter circuit 86, which is approximately three seconds in a specific exemplary embodiment. The reason for this provision is that the normal current level will drop when an initial puncture is made and the intention here is to ensure that the electrosurgical cutting element rod 28 will not be used to cut again until the surgeon intentionally provides for the electrosurgical generator to be turned back on, i.e., after the three second delay provided by reset delay counter circuit 86. As noted above, opening of switch 82 starts the inhibit or reset delay period, and during this delay period it is not possible to turn the generator on. In this regard, reactivating switch 82 resets the delay period, so that in order to turn on the electrosurgical generator, switch 82 must be released or opened, and left open for the full delay period, in order to reset the inhibit latch circuit 92. Of course, with inhibit latch 92 reset, the circuit operates as set forth above and the surgeon can begin cutting again. In order to alert the surgeon to the fact that the reset delay period is being timed out, an intermediate stage of the counter of the reset delay counter circuit 86 is used to cause an indicator light or lamp (e.g., a LED) 94 to blink during the inhibit delay period. (Again, indicator lamp 94 can correspond to indicator lamp 24 of FIG. 1.) Considering this operation in more detail, a negative OR or NOR gate 94 is provided which has a first input connected to the output of IGFET switch 90, a second input connected to the aforementioned intermediate stage of reset delay counter 86 and the output connected to the LED 94. When the output of switch 90 is low, meaning that control relay 88 is actuated and the electrosurgical generator is turned on, LED 94 will also be continuously on to provide an indication to the surgeon that the generator is on. Further, as set forth above, when the generator is off but the reset delay period is being timed out, the intermediate stage of reset delay counter 86 will provide a pulsed signal to NOR gate 96 which will cause blinking of LED 94 during this period. As explained previously, when this period is up, as indicated by the fact that LED 94 is no longer blinking, the surgeon will know that he can close switch 82 and resume surgery. Although the present invention has been described relative to specific exemplary embodiments thereof, it will be understood by those skilled in the art that variations and modifications can be effected in these exemplary embodiments without departing from the scope and spirit of the invention.

A trocar assembly includes an elongate trocar device and a surrounding cannula. The trocar device incorporates an electrosurgical cutting element which is used to make a guide hole for the cannula and thus enables the remainder of the trocar assembly to enlarge the puncture. An electronic control circuit senses the current flow to the cutting element and, when the trocar device breaks through the wall of the organ being cut, this circuit cuts off the connection to the associated electrosurgical generator. Further control circuitry prevents a surgeon from resuming electrosurgery until a predetermined time period has elapsed. Multiple trocars of different diameters are provided for the same assembly.

[0001] The present invention generally refers to probiotic and therapeutic formulations and, more in particular, it relates to compositions comprising lactic acid bacteria or bifidobacteria with low molecular weight non-proteinaceous iron chelators, useful for the treatment of infections of the human body cavities. BACKGROUND OF THE INVENTION [0002] Infections of human body cavities such as, for example, the female genital tract and the intestine, are widely spread pathological conditions known to affect, even recurrently, the majority of population. [0003] Antibiotics are often used to combat these pathological conditions despite the fact that their prolonged use may contribute to the emergence of antibiotic-resistant pathogenic bacterial strains. [0004] As this emergence may pose a serious risk to human beings, it is highly desirable to develop products for the therapy of infections of the body cavities that are not based on antibiotics and, hence, do not lead to the development of antibiotic resistance. [0005] Body cavities including the vaginal tract, the male urethra, the intestine and the buccal cavity, are known to be naturally colonized by probiotic bacteria, for instance lactic acid bacteria and bifidobacteria. The normal flora of both the vagina and the gastrointestinal tract consists of a wide variety of genera and species, either anaerobic or aerobic, dominated by the facultative microaerophilic anaerobic genus Lactobacillus (Ref. 1, 2 and 8). These species are known to defend the mucosal surfaces from colonization by pathogenic microorganisms such as, e.g., toxigenic bacteria and yeasts. [0006] In this respect, the so-called probiotic approach to health maintenance and therapy consists, essentially, in delivering the probiotic bacteria to the body cavities, which in healthy individuals are inhabited by commensal microorganisms, in order to fostering or reconstituting the natural environment. [0007] To this extent, as commensal microorganisms are known to compete with pathogenic ones, they can have disease preventive properties or even curative properties. [0008] Many commensal microorganisms have been studied so far and special attention has been given to various lactobacillus or bifidobacterium species as well as to Enterococcus faecium SF68 and the yeast Saccharomyces boulardii. [0009] Among them, particularly promising appear to be lactobacillus and bifidobacterium species. [0010] Lactic acid bacteria and bifidobacteria are natural hosts of the intestines and the vagina, where they protect the tissue from pathogenic organisms that, by adhering to the mucosa and tissues, may invade body cavities. [0011] It has been shown that Lactobacillus paracasei strains CNCM I-1390 and CNCM I-1391 and Lactobacillus acidophilus strain CNCM I-1447, isolated from healthy babies, bind in large numbers to both buccal and intestinal epithelial cells (Ref. 29), thus demonstrating that they naturally adhere to the same mucosal cells as it may occur for pathogenic microorganisms. [0012] As such, a competition for binding sites between pathogenic microbes and healthy lactic acid bacteria, within body cavities, has been demonstrated (Ref. 30 and Ref. 37). [0013] Some lactic acid bacteria, in addition, proved to inhibit growth of pathogens. Among them are, for example, Lactobacillus paracasei strains CNCM I-1390 and CNCM I-1391 and Lactobacillus acidophilus strain CNCM I-1447 that are able to inhibit, in vitro, the growth of enterotoxigenic E. coli ATCC 35401 or Salmonella enteritidis IMM 2. [0014] Moreover, a mixture of these lactobacillus strains resulted particularly effective in the inhibition, although weak, even of the Vibrio cholerae E1 Tor (Ref. 31). [0015] Because of all the above, pharmaceutical products containing lactic acid bacteria or bifidobacteria, for the prevention or treatment of pathological infections, are known in the art and have been already described. [0016] Among them are, just as an example, vaginal capsules comprising a strain of Lactobacillus gasseri; lactobacillus vaginal suppositories to prevent recurrence of urinary tract infections after antibiotic therapy (Ref. 3); vaginal medicaments based preferably on Lactobacillus crispatus CTV-05 effective against a variety of pathogens (Ref. 4). [0017] Various other products also intended for oral administration and containing live lactic acid bacteria or bifidobacteria are also known in the art and recommended, for instance, in the treatment of diarrhea. These products may come either as pharmaceutical formulations or in the form of fermented milk products. [0018] However, although disease prevention and/or therapy with commensal lactic acid bacteria and bifidobacteria have shown some efficacy (Ref. 5 to 12), the evidence was never sufficiently convincing to lead to a widely spread standard form of treatment. Presumably, this is because they are not yet as effective as one would expect, at least on theoretical basis. [0019] It is known that iron is an essential growth factor, basically for every cell and microorganism. The unsatisfactory therapeutic results obtained with previous products comprising commensal microorganisms have been thus associated with too elevated concentrations of free iron (III) ions, which promote the growth of pathogens while disfavoring a number of lactic acid bacteria. [0020] Lactoferrin (see The Merck Index, XIII Ed., 2001, No. 9647), a glycoprotein endogenously produced by neutrophils and also known to be a major component of secreted fluids, including saliva, gastric juices and bile, is a very important factor of the human milk bacteriostatic system. [0021] Because of its iron chelating properties, the inclusion of lactoferrin, either per se or in combination with other organic components, is widely known in the art, particularly regarding the dietary supplements (Ref. 14). [0022] Lactoferrin capsules may thus contain, for example, said protein with a degree of purity up to 95% and in amounts up to 480 mg. [0023] However, in preliminary therapeutic trials with very small numbers of patients, only few indications of any antibacterial (Ref. 15) and antiviral efficacy (Ref. 16) of the lactoferrin based products were obtained, and the results were insufficient to fostering further studies on this approach. [0024] Some combinations of lactic acid bacteria with lactoferrin are also commercially available (e.g., Colostrum with Lactoferrin Chewable Tablets, Peak Nutrition Inc., Syracuse N.Y.). In this product, however, the quantity of live bacteria (≦3.4×10 6 CFU) is orders of magnitude below the limit required for effective intestinal colonization. [0025] Moreover, to the extent of our knowledge, there are no animal or clinical studies demonstrating the efficacy of the combination of lactic acid bacteria with lactoferrin over the bacteria alone. [0026] Lactoferrin has also been suggested to have multiple biological roles including facilitating iron absorption, modulating the immune response, regulating embryonic development and influencing cell proliferation. In addition, it has also been demonstrated the role of the mentioned protein in regulating the release of tumor necrosis factor alpha and interleukin 6 (Ref. 17). [0027] Oral lactoferrin may thus produce many different effects than simple sequestration of iron ions. [0028] Remarkably, it has been demonstrated that certain pathogens can even utilize lactoferrin as an iron source (Ref. 18), thereby counteracting the intended purpose of withholding iron ions from bacteria. For these reasons, the possible therapeutic use of lactoferrin remains a very questionable choice if solely chelation or sequestration of iron ions is intended to be associated with probiotic bacteria. [0029] A low molecular weight natural chelator for iron, namely deferoxamine (see The Merck Index, XIII Ed., 2001, No. 2879), has been used to study the mechanisms of bacterial iron transport and its participation in the competition of commensal lactic acid bacteria with the pathogen Neisseria gonorrhoeae, in the mouse genital tract (Ref. 19). It was observed that “the degree of lactobacillus grown on base agar with and without deferoxamine was similar” and it was therefore concluded that “commensal lactobacilli may increase the availability of iron to N. gonorrhoeae during infection of females, although the exact mechanism by which this occurs is not known”. [0030] Furthermore, it is also known the ability of certain Bifidobacteria to produce a siderophore, particularly where said bifidocateria are grown on agar in the presence of an iron chelator moiety (Ref. 38). [0031] Nevertheless, no suggestions regarding the possible use of a chelator in the formulation of therapeutic or probiotic products were ever made. In any case, it is known that certain bacteria actually possess a deferoxamine receptor (Ref. 20). Accordingly, being a natural siderophore, i.e., an iron uptake mediator, from Streptomyces pylosus, it can also act as siderophore for certain pathogenic bacteria, e.g., Yersinia enterocolitica and Yersinia pseudotuberculosis (Ref. 21), thus exerting the undesired feature of iron donor. [0032] Low molecular weight non-proteinaceous iron chelators have been shown to possess antimicrobial activity on species that require iron. [0033] In particular, ethylenediaminetetraacetic acid (EDTA), diethylenetriaminepentaacetic acid (DTPA), trans-1,2-diaminocyclohexane-N,N,N′,N′-tetraacetic acid (CDTA) and triethylene-tetraaminehexaacetic acid (TTHA) have been shown to inhibit the growth of Staphylococcus epidermidis (Ref. 22). A number of chelators including R,S-ethylenediaminedisuccinic acid (R,S-EDDS), have been shown to inhibit growth of Corynebacterium xerosis ATCC 7711 (Ref. 23). [0034] Low molecular weight non-proteinaceous iron chelators have also been proposed as additives in buccal disinfectants (Ref. 24), as additives in topical deodorant formulations (Ref. 22, 23 and 25), as components of bactericidal compositions for intestinal use (Ref. 26) and, apparently, for topical use (Ref. 27). A catamenial tampon carrying a chelator was also conceived (Ref. 25). [0035] Chelators with selectivity for first transition series elements, which include iron, intended for use in several biomedical applications, including bacterial and fungal replication, are known in the art (Ref. 28). [0036] However, as the aforementioned prior art documents disclose compositions including chelators being intended for their bactericidal or even sterilizing property, said compositions could not be used for the prevention and/or treatment of infections within human body cavities, as their effect would be detrimental also for the lactic acid bacteria and bifidobacteria actually present in the flora of healty individuals. [0037] To our knowledge, no products combining lactic acid bacteria or bifidobacteria with low molecular weight non-proteinaceous iron chelators are described, or even theoretically suggested, in the prior art. SUMMARY OF THE INVENTION [0038] We have now found that selected iron chelating agents incorporated into pharmaceutical or probiotic formulations comprising live lactic acid bacteria or bifidobacteria permit, unexpectedly, the growth of probiotic bacteria while inhibiting the growth of pathogenic microorganisms. [0039] Accordingly, the present invention relies on a product that combines: [0040] (a) live bacteria belonging to the natural flora of the body cavity considered, preferably strains of lactobacillus or bifidobacterium species, even more preferably those species selected for their high tendency to bind to mucosal surfaces, and/or to co-aggregate with pathogens, with [0041] (b) low molecular weight non-proteinaceous iron chelators able to decrease the iron concentration over the physiological pH-range of relevance, to levels that inhibit the growth of pathogens, whilst allowing the growth of the bacteria of the composition. DETAILED DESCRIPTION OF THE INVENTION [0042] It is therefore a first aspect of the present invention a pharmaceutical or probiotic composition comprising: [0043] (a) at least one lactobacillus species and strain or at least one bifidobacterium species and strain, or any mixtures thereof; and [0044] (b) at least one low molecular weight non-proteinaceous iron chelator. [0045] The compositions of the invention are particularly advantageous as they may be used in the prevention and/or treatment of pathologies or pathological states due to infections of the human body cavities. [0046] In the present description, and unless otherwise provided, with the term lactobacillus species and strain and bifidobacterium species and strain we intend those species and strains having a good tolerability in humans and a high affinity for human mucosa. [0047] Preferably, the lactobacillus strain belongs to the species selected from Lactobacillus johnsonii, Lactobacillus reuterii, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus animalis, Lactobacillus ruminis, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus fermentum, and Lactobacillus delbrueckii subsp. Lactis. [0048] Even more preferably, lactobacillus strains are those selected from the group consisting of Lactobacillus johnsonii La1 NCC 2461 (=CNCM I-2116), Lactobacillus reuterii strains 4000 and 4020 (from BioGaia Biologics Inc., Raleigh, N.C.), Lactobacillus paracasei strains CNCM I-1390, CNCM I-1391, CNCM I-1392, Lactobacillus casei strain Shirota, Lactobacillus acidophilus strain CNCM I-1447, Lactobacillus acidophilus Lat 11/83, Lactobacillus acidophilus NCC 2463 (=CNCM I-2623), Lactobacillus rhamnosus GG (ATCC 53103), Lactobacillus rhamnosus 271 (DSMZ 6594) and Lactobacillus rhamnosus VTT E-800. [0049] As far as the bifidobacterium strain is concerned, it preferably belongs to the species selected from: Bifidobacterium spp., Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium pseudolongum, Bifidobacterium infantis, Bifidobacterium adolescentis, and Bifidobacterium lactis. [0050] Even more preferably, bifidobacterium strains are selected from the group consisting of: Bifidobacterium bifidum NCC 189 (=CNCM I-2333), Bifidobacterium adolescentis NCC 251 (=CNCM I-2168), Bifidobacterium lactis (ATCC 27536), Bifidobacterium breve CNCM I-1226, Bifidobacterium infantis CNCM I-1227, and Bifidobacterium longum CNCM I-1228. [0051] All the mentioned lactobacilli and bifidobacteria are well known to the skilled person and they may be isolated according to known methods or, in case, they may be obtained directly from the referred bacterial collections. [0052] Unless otherwise provided, the pharmaceutical or probiotic compositions of the invention may comprise one or more lactobacillus species and strain, or one or more bifidobacterium species and strain, or even any mixture thereof, selected from the aforementioned lactobacilli and bifidobacteria. [0053] Preferably, however, the compositions comprise at least one lactobacillus species and strain or at least one bifidobacterium species and strain. [0054] Even more preferably, the pharmaceutical or probiotic compositions of the invention comprise at least one lactobacillus species and strain. [0055] In the present description, unless stated otherwise, with the term chelator we intend chemical moieties, agents, compounds or molecules, either as such or in the form of pharmaceutically acceptable salts, characterized by the presence of functional groups which are able to form a complex by more than one coordination bond with a transition metal or another metal entity. [0056] In the specific case, the chelator, otherwise known as chelating agent, according to the invention, is a physiologically acceptable derivative enabling for the formation of an iron coordination complex, acting by that as an iron sequestring agent. [0057] Most preferred iron chelators are those with a conditional formation constant for iron (III) ions over the pH range of 4.6 to 8.2, of at least 10 15 L/mol, and preferably above 10 17 L/mol. [0058] With the term physiologically acceptable we intend any chelator suitable for the administration to humans for the intended therapeutic use, in combination with the above lactobacilli and/or bifidobacteria, in any suitable administration routes. [0059] With the term non-proteinaceous chelator or chelating agent we intend any chelators not having the characterizing structures of proteins, being the definition of protein widely known to the skilled person. [0060] Typically, the non-proteinaceous chelator of the invention has an average molecular weight (MW) lower than 10 kDa, more preferably lower than 5 kDa and even more preferably lower than 1 kDa, that is well below the average MW of the protein structures (e.g. lactoferrin MW=80 kDa). [0061] Suitable chelating agents are, for instance, selected from the group consisting of: pyridinone derivatives such as Deferiprone (see The Merck Index, XIII Ed. 2001, No. 2878), hydroxamates such as Desferroxamine B or acetohydroxamic acid; cathecols such as 1,8-dihydroxynaphthalene-3,6-sulfonic acid, MECAMS, 4-LICAMS, 3,4-LICAMS, 8-hydroxyquinoline or disulfocathecol; polyaminopolycarboxylic acids and derivatives thereof comprising, inter alia, ethylenediamine-N,N′-bis(2-hydroxyphenylacetic acid) (EDDHA), N-(hydroxyethyl)-ethylenediaminetriacetic acid (HEDTA), N,N′-bis(2-hydroxybenzyl)-ethylenediamine-N,N′-diacetic acid (HBED), N,N′-ethylenebis-2-(O-hydroxyphenyl)glycine (EHPG), triethylene-tetraaminehexaacetic acid (TTHA), diethylenetriamine pentaacetic acid (DTPA), DTPA-bismethylamide, benzo-DTPA, dibenzo-DTPA, phenyl-DTPA, diphenyl-DTPA, benzyl-DTPA, dibenzyl-DTPA, N,N-bis[2-[(carboxymethyl)[(methylcarbamoyl)methyl]ethyl]-glycine (DTPA-BMA), N-[2-[bis(carboxymethyl)amino]-3-(4-ethoxyphenyl)propyl)]-N-[2-[bis(carboxymethyl)amino]ethyl]glycine (EOB-DTPA), 4-carboxy-5,8,11-tris(carboxymethyl)-1-phenyl-2-oxa-5,8,11-triazatridecan-13-oic acid (BOPTA), N,N-bis[2-[bis(carboxymethyl)amino]ethyl]L-glutamic acid (DTPA-GLU) and DTPA-Lys; ethylenediaminotetraacetic acid (EDTA), trans-1,2-diaminocyclohexane; N,N,N′,N′-tetraacetic acid (CDTA), NTA, PDTA, 1,4,7,10-teraazacyclododecane-1,4,7,-triacetic acid (DO3A) and derivatives thereof including, for example, [10-(2-hydroxypropyl)-1,4,7,10-teraazacyclododecane-1,4,7,-triacetic acid (HPDO3A) and corresponding [10-(2-hydroxypropyl)-1,4,7,10-tetraazado decane-1,4,7-triacetato(3-)-N 1 ,N 4 ,N 7 N 10 ,O 1 ,O 4 ,O 7 ,O 10 ]calcinate(1-), calcium (2:1), better known as calteridol or Ca 3 (HPDO3A) 2 , 1,4,7-triazacyclononane-N,N′,N″-triacetic acid (NOTA), 6-[bis(carboxymethyl)amino]tetrahydro-6-methyl-1H-1,4-diazepine-1,4(5H)-diacetic acid (AAZTA) and derivative thereof, 1,4,7,10-tetraazacyclotetradecane-1,4,7,10-tetraacetic acid (DOTA) and derivatives thereof including, among others, benzo-DOTA, dibenzo-DOTA, (α,α′,α″,α′″)-tetramethyl-1,4,7,10-tetraazacyclo-tetradecane-1,4,7,10-tetraacetic acid (DOTMA), and 1,4,8,11-tetraazacyclotetradecane-N,N′,N″,N′″-tetraacetic acid (TETA), or corresponding compounds wherein one or more carboxylic group is replaced by a phosphonic and/or phosphinic group including, for instance, N,N′-bis-(pyridoxal-5-phosphate)-ethylenediamine-N.N′-diacetic acid (DPDP), ethylenedinitrilotetrakis(methylphosphonic) acid (EDTP), 1,4,7,10-tetraazacyclotetradecane-1,4,7,10-tetra(methylenepho sphonic) acid (DOTP); as well as texaphyrins, porphyrins and phthalocyanines. [0062] Preferred chelating agents according to the present invention include Deferiprone, HPDO3A and derivatives thereof such as, inter alia, calteridol, DTPA and derivatives thereof comprising, for instance, DTPA-Glu and DTPA-Lys; DOTA and derivatives thereof; BOPTA; AAZTA and derivatives thereof; EDTA and derivatives thereof; TETA and derivatives thereof. [0063] The above listed chelating agents are widely known in the art and may be in case prepared according to known methods. For most of them, in addition, there already exists experience with human use. [0064] For a general reference to iron chelators see, for instance, Zu D. Liu, Robert C. Hider; Design of iron chelators with therapeutic application; Coordination Chemistry Reviews Volume 232, Issues 1-2, October 2002, Pages 151-171. [0065] As an example, the iron chelator DTPA in the form of calcium trisodium pentetate (Ditripentat®, Heyl & Co., Berlin, Germany) is used subcutaneously, at daily doses of 0.5 to 1 g for 5 days a week, for the treatment of thalassemia in patients with high-tone deafness caused by deferoxamine (Ref. 32). [0066] Additionally, although in the form of a salified gadolinium complex, gadopentetate dimeglumine (Magnevist®, Schering AG, Berlin, Germany) is used as a contrast agent for magnetic resonance imaging. Its enteral form contains trisodium pentetate as excipient at a level of 455 mg/L of administrable drink. [0067] As the maximal recommended dose is 1 L, an oral dose of 455 mg (0.99 mmol) of trisodium pentetate is already being used and proven to be safe, at least for a single administration. The acute oral semilethal dose (LD 50 ) of DTPA in mice is 3500 mg/kg. Thus, DTPA is a safe oral drug, representing a preferred iron chelator for the compositions of the present invention. [0068] Likewise, the compound 4-carboxy-5,8,11-tris(carboxymethyl)-1-phenyl-2-oxa-5,8,11-triazatridecan-13-oic acid (BOPTA) has been found to have an acute oral LD 50 in mice of 8.4 mmol/kg. It is therefore a further preferred iron chelator for the compositions of the invention. [0069] For the pharmaceutical use, these chelators may also be formulated as complexes in the form of a pharmaceutical acceptable salt, including neutral salts, such as in particular, calcium complexes. In this direction, in fact, the calcium binding affinity is weak enough to not substantially interfere with the iron binding of pharmacological interest. [0070] In this respect, another preferred iron chelator in the form of a calcium complex, is calteridol also known as Ca 3 (HPDO3A) 2 and corresponding to [10-(2-hydroxypropyl)-1,4,7,10-tetraazadodecane-1,4,7-triacetato(3-)-N 1 ,N 4 ,N 7 ,N 10 ,O 1 ,O 4 ,O 7 ,O 10 ]calcinate(1-), calcium (2:1), which is used in the intravenous contrast agent formulations of Gadoteridol (see The Merck Index, XIII Ed., 2001, No. 4353). [0071] The preferred therapeutic or probiotic compositions of the invention can be formulated in different ways, depending on the desired route of administration, according to methods adopted in the pharmaceutical field. [0072] Preferably, the compositions of the invention may be administered either orally or topically, as reported in more details herein below. [0073] As an example, said compositions can be formulated as a mixture of components or, alternatively, they can equally be offered as separate pharmaceutical formulations in a single kit, for example for the simultaneous or sequential oral or vaginal administration. Therefore, it is an additional embodiment of the invention a kit of parts wherein a first part comprises at least one lactobacillus species and strain or at least one bifidobacterium species and strain, or mixtures thereof, and a second part comprises at least one low molecular-weight non-proteinaceous iron chelator. [0074] Non limitative examples of particularly preferred compositions of the invention are disclosed below. [0075] Compositions for Intestinal Use [0076] A first embodiment of the invention is represented by the compositions generally intended for gastrointestinal use, to be preferably administered as a drink, a capsule, an infant formula or a dairy product. [0077] To this extent, the selected bacterial strains may be suitably employed so that the amount of bacteria available to the individual corresponds to about 10 3 to about 10 14 CFU per day, preferably from about 10 7 to about 10 12 CFU per day, and even more preferably from about 10 9 to about 10 12 CFU per day. [0078] The corresponding amount of iron chelator may range from about 10 −3 to about 10 −9 mol, and preferably from 10 −4 to about 10 −7 mol. [0079] In case the compositions of the invention should be intended in the form of an oral formulation, they might be offered in any proper form, such as, among others, a milk drink, a yoghurt-similar milk product, a cheese, an ice-cream, a fermented cereal-based product, a milk-based powder, an infant formula, a tablet, a capsule, a liquid suspension, a dried oral grit or powder, a wet oral paste or jelly, a grit or powder for dry tube feeding or a fluid for wet tube feeding. [0080] Alternatively, the drink may be prepared before use from a dissolvable capsule containing the active ingredients. [0081] Preferably, the drink may be prepared before use by reconstituting a dry powder containing the lyophilized bacteria and the iron chelator or, alternatively, by reconstituting a dry powder containing the lyophilized bacteria with a physiological solution already comprising the chelator. [0082] The dry powder is preferably packaged in such a way that the stability of the solid may be retained along the time, such as for instance, into airtight and light-tight sachets, under air or nitrogen, under a noble gas or under vacuum. [0083] As far as the capsules are concerned, they may be properly manufactured according to conventional methods. [0084] From all of the above, it is clear to the skilled person that the compositions of the invention may further comprise any additional excipients among those commonly employed in pharmaceutical formulations, in order, for instance, to stabilize the compositions themselves, or to render them easily dispersible or to give them an agreeable taste. [0085] Among said excipients inulin, fructose, starch, xylo-oligosaccharides, silicon oxide, buffering agents as well as flavors, are suitable examples. [0086] Furthermore, optional active ingredients may be also present in the compositions of the invention such as, for instance, vitamins, amino acids, polypeptides and the like. [0087] An example of an optional active ingredient may be represented by glutamine (Ref. 33) which may help intestinal cells to defend themselves under stress conditions due to pathogenic organisms (Ref. 34 and 35). [0088] Alanyl-glutamine (Ref. 36) as well as a variety of vitamins may also represent additional ingredients within the compositions. [0089] The presence of transition metals should be preferably avoided so to not impair the binding and/or sequestration of the naturally occurring iron ions by the chelator. However, by considering that the preferred chelators according to the invention bind iron ions much stronger than other physiological transition-metal ions, for instance zinc or copper, the presence of these latter substantially does not affect the efficacy of the present compositions. [0090] Compositions for Vaginal Use [0091] According to an additional embodiment, the present invention also provides for a composition intended for the vaginal use, for instance as a compressed vaginal suppository or insert, preferably as a rapidly dissolving type, such as a tampon or a douche. [0092] Vaginal suppositories and capsules are well-known pharmaceutical formulations. During their manufacturing process, however, special cares should be taken to operate at temperature conditions at which the bacteria may survive, according to methods known in the art (Ref. 4). [0093] Vaginal inserts are also known in the art and may be manufactured, for instance, by powder compression of maltodextrin beads including the components of the invention (Ref. 4). [0094] Standard catameneal tampons, and their production methods, can be well adapted for obtaining vaginal tampons bearing the ingredients of the invention on their surface; preferably, the final tampon is packaged in a way suitable for the protection from moisture. [0095] Vaginal douches are commercially known and generally consist of a product to be locally applied by a proper applicator, hence suitable for the vaginal delivery of the compositions of the invention. [0096] Clearly, unlike otherwise provided, also the compositions intended for vaginal use may comprise additional excipients among those known in the art (e.g., buffering agents) and/or active ingredients known for formulations of this type. [0097] The compositions of the invention resulted to be particularly effective in the colonization of the gastrointestinal tract or the vaginal tract and, hence, allow for the restoration of a well functioning microflora, particularly in the case of a previous use of antibiotics. [0098] It will be self evident to the skilled person, that said compositions may find a wide range of applications either in the maintenance of probiotic bacteria adhering to healthy mucosal surfaces or in the treatment of the infections of the human body cavities such as, e.g., the vaginal tract, the male urethra, the intestine and the buccal cavity. [0099] Vaginal infections wherein the compositions of the invention may be advantageously used may comprise, as non limiting examples, bacterial vaginosis, symptomatic yeast vaginitis, gonorrhea, chlamydia, trichomoniasis, human immunodeficiency virus infection, urinary tract infection or pelvic inflammatory disease. [0100] Further, among the pathological conditions of the gastrointestinal tract, the compositions of the invention may be used for the treatment of acute diarrhea in adults and infants, rotavirus-related, travel's or antibiotic-associated diarrhea, and recurrent clostridium difficile colitis. [0101] Experimental Section [0102] With the aim of illustrating the present invention, without posing any limitation to it, the following examples are now given. EXAMPLE 1 [0103] Drink Formulation [0104] A powder containing lactobacilli and at least one small molecular weight non-proteinaceous iron chelator, suitable for preparing a drink, was formulated to have the following composition: [0000] Inulin 145.00 kg Fructose 57.69 kg L-glutamine 50.00 kg Xylo-oligosacchrides 25.00 kg Lactobacillus paracasei CNCM I-1390 11.13 kg (3.85 × 10 11 CFU/g) Orange aroma 10.50 kg Silicon dioxide 0.40 kg Pentetate calcium trisodium (DTPA CaNa 3 ) 0.21 kg Vitamin B6 hydrochloride 0.07 kg Lot 300.00 kg [0105] Portions of 7 g of this powder were filled into sachets under low humidity conditions and sealed. A single dose of the drink consisted in the content of a sachet suspended in a glass of water. EXAMPLE 2 [0106] Drink Formulation [0107] Analogously to Example 1, a powder containing the selected strain of lactobacilli and the small molecular weight non-proteinaceous iron chelator was formulated, wherein the chelator was calteridol, which is [10-(2-hydroxypropyl)-1,4,7,10-tetraazadodecane-1,4,7-triacetato(3-)-N 1,N 4 ,N 7 ,N 10 ,O 1 ,O 4 ,O 7 ,O 10 ]calcinate(1-), calcium (2:1), abbreviated Ca 3 (HP-DO3A) 2 , in the same amount. EXAMPLE 3 [0108] Drink Formulation [0109] A powder containing the selected lactobacilli strain and at least one small molecular weight non-proteinaceous iron chelator suitable for preparing a drink was formulated to have the following composition: [0000] Corn starch 86.24 kg Fructose 120.00 kg L-glutamine 42.87 kg Xylo-oligosacchrides 30.00 kg Lactobacillus paracasei CNCM I-1390 11.13 kg (3.85 × 10 11 CFU/g) Orange aroma Drycell 01142 9.00 kg Silicon dioxide 0.33 kg Deferiprone (1,2-dimethyl-3-hydroxypyrid-4-one) 0.43 kg Lot 300.00 kg [0110] Portions of 7 g of this powder were filled into sachets under low humidity conditions and sealed. A single dose of the drink consisted in the content of a sachet suspended in a glass of water. EXAMPLE 4 [0111] Therapeutic Infant Formulation [0112] A therapeutic infant formulation was obtained by mixing from 0.5% to 5%, preferably 2%, of polypeptides; from 0.2% to 10%, preferably 4%, of fat; from 1% to 25%, preferably 8%, of non-levan carbohydrates (including lactose 65%, maltodextrin 20% and starch 15%); a proper amount of an iron chelator, and at least 10 6 CFU/mL of the following strain: Lactobacillus acidophilus CNCM I-1447, in combination with traces of vitamins to meet the daily requirements; from 0.01% to 2%, preferably 0.3%, of minerals, and from 50% to 75% of water. EXAMPLE 5 [0113] Therapeutic Dairy Product [0114] A yoghurt-like milk product was prepared by the following procedure. One liter of a milk product containing 2.8% of fats and supplemented with 2% of skimmed milk powder and 6% of sucrose was prepared. Then, the product was pasteurized at 96° C. for 30 min according to known methods. A proper amount of calteridol was then added. [0115] A preculture of Lactobacillus paracasei CNCM I-1390 was reactivated in a medium containing 10% of reconstituted milk powder and 0.1% of commercial yeast extract with 1% sucrose. The pasteurized milk product was then inoculated with 1% of the reactivated preculture and this milk product was then allowed to ferment until the pH reaches a value of 4.5. The resulting therapeutic yoghurt-like milk-product was stored at 4° C. EXAMPLE 6 [0116] Vaginal Suppository [0117] In a sterilized blender, 0.12 kg finely ground calteridol was blended with 1.33 kg of polyethylene glycol 1000 (PEG 1000) under nitrogen, during which the polyethylene glycol melts. Under continued mild mixing the calteridol-PEG 1000 mixture was cooled until returned to a semi-solid consistency. [0118] By intensive mechanical mixing and under vacuum in a cooled container, the following ingredients were admixed: [0000] Polyethylene glycol 1000 72.43 kg Polyethylene glycol 4000 24.48 kg Lactobacillus paracasei CNCM I-1390 2.00 kg (3.85 × 10 11 CFU/g) Calteridol-PEG 1000 mixture 1.09 kg Lot 100.00 kg [0119] The resulting mixture was formed into 5 g suppositories by a cooled compression molding technique. EXAMPLE 7 [0120] Vaginal Capsules [0121] The procedure substantially follows the one of Example 3 of Ref. 4, with the difference that the maltodextrin beads was first sprayed with an aqueous solution of calteridol sodium and dried in a fluid bed drier, and then sprayed with the bacterial cell matrix suspension. [0122] A preservation matrix was prepared as follow: [0123] 2 parts gelatin (e.g., 137.5 g per 500 mL reagent water) and 4 parts skim milk (e.g., 15 g per 250 mL reagent water) were autoclaved at about 121° C. for about 15 min. 4 Parts xylitol (e.g., 59 g per 250 mL reagent water) and 4 parts dextrose (25 g per 250 mL reagent water) were mixed together, the mixture was adjusted to pH 7.2-7.4 and filter sterilized with a 0.22 μm filter. The sterile components were therefore combined into a single solution (gelatin base) and stored at 2-8° C. Ascorbic acid was prepared as a 5% (w/w) solution, filter-sterilized with a 0.22 μm filter and stored at −20° C. At the time of the production of the vaginal medicant, the gelatin base was melted and tempered to about 35° C. Then, the 5% (w/w) ascorbic acid was added to the gelatin base at a ratio of 1:10 to form the preservation matrix solution. [0124] A solution of calteridol (462 mg/mL reagent water) was prepared and sterilized at 121° C. for 20 min. [0125] Lactobacillus paracasei CNCM I-1390 is grown as described in Ref. 30 at a cell density of about 5×10 9 cells/mL and a cell pellet was prepared by centrifugation for 5 min at 1400-1600 rpm. [0126] The cell pellet was resuspended in a phosphate-buffered saline and pelleted again by centrifugation. The cell pellet was resuspended in 1 part of phosphate-buffered saline and 10 parts of preservation matrix solution. The cell matrix suspension was gently mixed and maintained under continuous mixing at 35° C. [0127] To form the complete vaginal medicant, a fluid bed dryer having sterilized components was assembled for use. Maltodextrin beads (Maltrin® QD M510, Grain Processing Corporation, Muscatine, Iowa) were placed into the fluid bed dryer and dried at 33° C. until a sufficient dryness was achieved. The air pressure was then set to 14 psi, and the solution of calteridol sodium [Ca 3 (HP-DO3A) 2 ] (50 mL per kg of maltodextrin beads) was sprayed onto the beads using a peristaltic pump. The beads were allowed to dry for 30 min at about 38° C. The temperature was decreased to 33° C. and the cell matrix suspension (50 mL per kg of maltodextrin beads) was sprayed onto the beads with the aid of the peristaltic pump. After 50% of the cell matrix suspension was sprayed onto the beads, the temperature was increased to 38° C. After all the cell matrix suspension was sprayed onto the beads, the coated beads were allowed to dry at about 38° C. for about 30 min. In case, the coated maltodextrin beads may be frozen and stored as a powder. [0128] The powder was filled into gelatin capsules Type 00 to a level of about 500 mg per capsule. One capsule contains about 5×10 8 CFU of lactobacilli. [0129] The capsules may be packaged, optionally under nitrogen or vacuum, into air and vapor-tight primary packaging material. EXAMPLE 8 [0130] Vaginal Capsules [0131] The procedure substantially follows the one of the preceding Example 7, with the difference that the phosphate-buffered saline used in the preparation of the cell matrix suspension was modified to contain 10 mM of a small molecular weight non-proteinaceous iron chelator, preferably calteridol sodium [Ca 3 (HP-DO3A) 2 ], under reduction of the sodium chloride concentration to achieve isotonicity, i.e., about 290 mOsmol/kg. EXAMPLE 9 [0132] Vaginal Capsules [0133] Vaginal capsules were prepared essentially as described in present Example 8, except that Lactobacullus paracasei CNCM I-1390 was replaced by the Lactobacullus crispatus CTV-05 described in Ref. 4. EXAMPLE 10 [0134] Vaginal Insert [0135] The maltodextrin beads coated with Lactobacullus paracasei CNCM I-1390 were prepared as described in Example 14. Vaginal inserts were prepared by compression. EXAMPLE 11 [0136] Vaginal Tampon [0137] A lyophilized powder containing lactic acid bacteria, the chelator and the excipients was prepared. [0138] A vaginal tampon was prepared composed of an absorbent compressed, cylindrical core of tissue pulp and short rayon fibers. Maximal dryness of the core was assured by placing it in a high vacuum overnight and working in a low humidity environment. The tailing one-third was temporarily wrapped with plastic and the leading two-thirds were covered with the described powder by turning and rubbing it by hand on a flat glass surface. A non-woven cover was wrapped around the core and a withdrawal string was knotted around the core at its trailing end. The finished tampon was packaged under dry nitrogen into airtight and light-tight pharmaceutical sachet. BIBLIOGRAPHY [0000] 1. Gorbach S. L., Menda K. B., Thadepalli H. & Keith L.: Anaerobic microflora of the cervix in healthy women. Am. J. Obstet. 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W., Madonna M. B., Thisted R. & Chang E. B.: Glutamine protects intestinal epithelial cells: role of inducible HSP70. Am. J. Physiol. 272 Gastrointes. Liver Physiol. 35 G879-G884, 1997. 35. Wilmore D. W. & Shabert J. K.: Role of glutamine in immunologic responses. Nutrition 14, 618-626, 1998. 36. Scheppach W., Loges C., Bartram P., Christl S. U., Richter F., Dusel G., Stehle P., Fuerst P. & Kasper H.: Effect of free glutamine and Alanyl-Glutamine dipeptide on mucosal proliferation of the human ileum and colon. Gastroenterology 107, 429-434, 1994. 37. Craven S. E. Journal of Food Protection, Vol. 61, No. 3, 265-271, 1998 38. O'Sullivan Daniel J., Bifidobacteria and siderophores produced thereby and methods of use, WO 01/98516.

The present invention relates to probiotic compositions and kits thereof, comprising live bacteria belonging to the natural flora of the human body cavity such as intestine and vaginal tract, in particular, strains of lactobacillus or bifidobacterium species, and low molecular-weight non-proteinaceous iron chelators capable of lowering the iron concentration over the whole physiological pH-range of relevance to levels that inhibit growth of pathogens, but which allow for the growth of the bacteria of the composition.

The present invention refers to new cysteine derivatives of the general formula (I) ##STR2## in which R represents a radical of a fatty saturated or unsaturated acid, or a radical of an aromatic acid, such as benzoic, salicylic, cynnamic, 2-acetoxy-benzoic acid or of a heterocyclic acid, as well as their salts, particularly Ca and Mg salts. The new derivatives are excellent bronchial liquefiers and expectorants, INVENTION FIELD The invention refers to new cysteine derivatives having a bronchial liquefying and expectorant activity, to a process for their preparation and to pharmaceutical compositions containing them as active ingredients. DESCRIPTION Operating according to the above mentioned reaction series, the starting compound for the preparation of derivatives of formula (I) according to the invention is the chloride of 3-chloro-L-alanine(II) which may be obtained from 3-chloro-1-alanine by any of the conventional methods employed for transforming an acid into its chloride, for instance by reaction with phosphorus pentachloride in a suitable solvent, such as chloroform or diethyl ether. The chloride is obtained as a precipitate from the reaction mixture by addition of e.g. ligroin (in the ether solutions) or of diethyl ether (in the chloroform solutions). The filtered product is reacted with an excess of potassium hydrosulfide (III) to obtain the L-2-ammino thiopropionic acid (IV). Compound (IV) is acetylated to obtain (VI) by any of the conventional methods employed for acylating an amino group, e.g. by reaction with acetyl chloride in a suitable solvent, such as chloroform, in the presence of an acid acceptor. Derivative (VI) by reaction in an alkaline medium with a thio-acid (VII) provides compound (VIII), which by reaction in an alkaline medium with derivative (IX) provides derivative (I). The reaction between compound (VIII) and compound (IX) is carried out at a pH between 5 and 7 and at a temperature between 15° and 25° C. Derivative (I) is obtained in a state of high purity by purification on a silica gel column, using as eluent chloroform-methanol (7:3). Operating according to (b) above, an alkali salt of acetyl-3-chloroalanine (X) is reacted with ethyl chloroformate (XI) and the mixed anhydride obtained (XII) as reacted with L-acetyl-cysteine (XIII) to give derivative (XIV); finally (XIV) by reaction in alkaline medium with the thioacid (VII), gives (I) which is purified on a silica gel column, employing as a eluent a chloroform-methanol 7:3 mixture. The reaction between compound (XII) and compound (XIII) is carried out at a pH between 6 and 8 and at a temperature of between -23° and -17° C., while the reaction between compound (XIV) and (VII) is carried out at a pH between 5 and 7 and at a temperature of between 15° and 25° C. The present invention also comprises pharmaceutical compositions containing as active ingredients one or more of the compounds of the invention, together with parmaceutically acceptable vehicles and diluents. The pharmaceutical compositions may be in the following forms: solid, such as capsules, tablets or bonbons with instantaneous or retarded action, monodosis sachets; liquid, such as solutions or emulsions instantaneous or retarded; as suppositories; solutions for injection or for instantaneous or delayed inhalation. In the treatment of bronchial affections, the compounds according to the invention may be administered orally in posologic doses containing, e.g., between 100 and 5000 mg of active substance two, three or four times a day; by injection and inhalation in posologic units of between 50 and 500 mg of active substance, two, three or four times a day; rectally in posologic units of 100 to 1000 mg of active substance two, three or four times a day. The derivatives of the invention are good bronchial liquefiers and expectorants, superior to cysteine at equal doses, while showing low toxicity. The DL 50 value determined on mice and rats, both intraperitoneally and orally, is higher than 3000 mg/Kg for all the examined compounds. The expectorant activity (DE 50 ), determined on rabbits according to (Boyd and Sheppard, Arch. Int. Pharm, 1966, 163, 284, is 100 mg/Kg. The same DE 50 determined on mice according to a modified Mavatari method shown in (Graziani, Cazzulani, I1 Farmaco Ed. Prat. 1981 XXXVI, 3, 167, is respectively of 37 mg/Kg. The following examples will illustrate the process of the invention without limiting it. EXAMPLE 1 Preparation of N-acetyl-S-{N-acetyl[(benzoyl)thio]alanyl}cysteine 1. Preparation of L-3-chloro-2-acetamido-thiopropanoic acid: In a 200 ml flask a solution is prepared by stirring 20 g (0.3 mol) of potassium hydroxide in 80 ml 90% ethanol. Into the flask a 50 ml separatory funnel is inserted and provided with a tube through which hydrogen sulphide is introduced until the solution is saturated and no longer alkaline to phenotphthalein. The mixture is cooled on ice to 10°-15° C. and 0.3 mol (49.3 g) of 3 chloro-L-alanine chloride-hydrochloride are added in 90 minutes while stirring at a temperature of 15° C.; the reaction mixture is then stirred for an additional hour. The potassium chloride which is formed is filtered off, washed with 20 ml 95% ethanol, the solutions are put together and ethanol is evaporated under reduced pressure. The solid residue is dissolved in 70 ml of cold water and the solution is filtered. 0.3 mol acetyl chloride are then added slowly, under strong stirring and under control of the pH, which should be about 8. The solution is stirred for an additional hour and acidified to pH 2.0 with hydrochloric acid. The formed precipitate is filtered off, washed with water and dried in a oven. The dry product is crystallized from water. 15 g of product are obtained. The structure is confirmed by spectral analysis. ______________________________________Elemental Analysis: C H Cl N S______________________________________Calculated Amount: 33.06% 4.43% 19.50% 7.71% 17.65%Amount Found: 33.5% 4.5% 19.3% 7.7% 17.5%______________________________________ 2. Preparation of L-3-benzoyl mercapto-2-acetamido thiopropanoic acid: 54.3 g (0.3 mol) of L-3-chloro-2-acetamido-thiopropanoic acid are suspended in 150 ml of water brought to pH 5.0 by addition of sodium hydroxyde. The temperature is brought to 20° C. and 46 g thiobenzoic acid, 24 g anydrous potassium carbonate and 300 ml water are added rapidly. A yellow, almost clear solution is obtained at pH 6.06 which is left standing overnight (in the darkness) at about 18° C. Thereafter 21 mol 35% hydrochloric acid are added slowly under pH control until a stable pH of 4.0 is reached. The formed precipitate is filtered on a Buchner funnel and washed with 4×100 ml water. The product is then oven dried. Approximately 80 g of product are obtained. The structure is confirmed by spectral analyses. ______________________________________51.14% 5.07% 5.42% 24.85%51.2% 5.04% 5.44% 24.7%______________________________________ 3. Preparation of N-acetyl-S-{N-acetyl[(benzoyl)thio]alanyl}cysteine: 49.69 g (0.3 mol) 3-chloro-N-acetyl-alanine are suspended in 150 ml of water, which is then brought of pH 5.0 by adding sodium hydroxide. The temperature is brought to 20° C. and 78.5 g of L-3-benzoyl mercapto-2-acetamido-thiopropanoic acid, 24 g anhydrus potassium carbonate and 300 ml water are rapidly added. A yellow almost clear solution is obtained at a pH of 6.06 which is left standing for one night at 18° C., in the darkness. Thereafter 35% hydrochloric acid is added slowly, under pH control, to a stable pH to 4.0. The precipitate is filtered off, washed with 4×100 ml water and oven dried. 120 g of product are obtained which can be purified by dissolving it in ethyl acetate and reprecipitating it by addition of ligroin or ethyl ether. The structure is confirmed by spectral analysis. ______________________________________51.36% 5.277% 7.046% 16.13%51.4% 5.28% 7.1% 16.2%______________________________________ EXAMPLE 2 Preparation of N-acetyl-s-(N-acetyl alanyl)cysteine: 1. Preparation of N-acetyl-s-(N-acetyl-3-chloro-alanyl) cysteine Suspension A In a 4 neck, 2 liter flask provided with stirrer, thermometer, calcium chloride protection tube, 67.20 g (0.330 mol) of finely powdered potassium salt of N-acetyl-3-chloro-L-alanine and 600 ml acetone are introduced. After cooling to 20° C., 33.6 g ethyl chloroformate and 26 mol N-methyl morpholine are added. The suspension is left standing for two hours at a temperature of 10° C. or lower, and then brought to 30° C. Solution B 50 g (0,276 mol) of N-acetyl-cysteine, 70 ml acetone and 25 g triethylamine are placed into a 400 ml beaker while stirring and under pH control in such a way that the pH does not rise above 7.5. The solution is then cooled to 0° to -3° C. Reaction Solution B is added to suspension A under stirring within a few minutes keeping the temperature at -15° to -20° C. The turbid solution is kept at -15° to -20° C. for three hours under stirring, then the temperature is raised to 0° C. and the stirring is continued for an additional 4 hours. 170 ml of water are then added and the solution is placed into a 2 liter beaker. It has a pH of aproximately 6.25. Keeping the temperature at between 0° and 5° C., hydrochloric acid is added to a constant pH of 4.0. The solution is extracted with 1000 ml methylene chloride. The precipitate which is formed is filtered off and washed with 4×100 ml of water. It is then dried in an oven obtaining 70 g of product. The structure is confirmed by spectral analysis. ______________________________________38.09% 5.656% 9.871% 11.299% 12.495%38.2% 5.66% 9.88% 11.25% 12.4%______________________________________ 2. (Preparation of N-acetyl-s-(N-acetyl-alanyl)cysteine In a 200 ml flask a solution of 20 g (0.3 mol) of potassium hydroxide in 80 ml 90% ethanol is prepared. Into the flask a 50 ml separatory funnel is inserted and provided with a tube through which hydrogen sulphide is introduced until the solution is saturated and no longer alkaline to phenophthalein. The mixture is cooled on ice to 10°-15° C. and 0.3 mol (85.12 g) of N-acetyl-s-(N-acetyl-3-chloro alanyl) cysteine are added. The mixture is heated on reflux for two hours. After cooling and filtration, the filtrate is diluted with 100 ml water. The pH is brought to 4.0. The obtained precipitate is filtered off, washed with water and oven dried. Aproximately 75 g of product are obtained. The structure is confirmed by instrumental analysis ______________________________________38.95% 5.198% 9.083% 20.79%38.9% 5.2% 9.1% 20.2%______________________________________ EXAMPLE 3 Preparation of N-acetyl-s-{N-acetyl[(benzoyl)thio]alanyl}cysteine Thiobenzoic acid is reacted with N-acetyl-s-(N-acetyl-3-chloroalanyl)cysteine EXAMPLE 4 The derivatives obtained in the preceding examples are treated with Ca(OH) 2 to obtain the respective salts.

The present invention covers D or L or DL-cysteine derivatives of the general formula (I) ##STR1## wherein R represents H or a fatty saturated or unsaturated acid radical, or a radical of an aromatic acid such as benzoic, cynnamic, salycilic, 2-acetoxybenzoic acid or a heterocyclic acid, as well as their salts, in particular the Ca and Mg salts. The invention refers also to a process for preparing said derivatives and to the pharmaceutical preparations containing them as active principle, having a bronchial liquefying and expectorating activity.

BACKGROUND OF THE INVENTION With the recent advent of aerobic type exercises such as swimming, cycling, jogging and tennis there has been a corresponding upsurge in the rate of deaths relating to cardiovascular exertion. The frequency of heart failures occurring, for example, in winter months due to the exertion on the heart by the over zealous snow shoveler is now occurring throughout the remaining seasons due to heart exertion caused by physical fitness enthusiasts. A person following the current fashion of weight reduction by early morning jogging may lose as much as 20 pounds in a month and may also lose his life. The sudden and continued exertion above a critical limit upon the heart caused by the tremendous amount of blood transport and oxygen consumption required results in a breakdown of the heart structure and, if immediate medical attention is unavailable, death may result. The unfortunate factor common for most cases of coronary failure due to overexertion is that the victim never knows when to stop and death in most cases could have been avoided if the victim didn't continue his exercise. The heart muscle, like any other vital organ, can build up tolerances to long and continued exertion if given time to develop sufficient cellular structure to accommodate the added workload and to provide for the increased blood handling capacity. By gradually exposing the heart to periods of temporary exertion over increasing periods of time, the body as a whole adapts to a lower oxygen consumption requirement and the heart readily supplies the increased demands for blood flow. Several devices are currently available for monitoring the pulse rate activity of the human heart. For example, U.S. Pat. No. 3,792,700 describes a technique for indicating the pulse rate of an inactive user by electrodes placed under the armpits of a user. This technique provides an indication of the pulse rate of an inactive user and signals when a coronary problem exists. U.S. Pat. No. 3,802,698 incorporates a pulse rate measuring device with a stationary exercise control system and signals when a particular pulse rate value is reached. U.S. Pat. Nos. 3,742,937; 3,807,388 and 3,863,626 describe miniature pulse monitoring devices that can be worn by persons undergoing physical fitness activities to indicate when a predetermined pulse rate has been exceeded. The aforementioned examples of the prior pulse rate indicators provide some means for detecting and monitoring the pulse rate of a person undergoing physical exertion and for indicating when the exertion is excessive, but are not tailored to the individual physiological characteristics of the user. SUMMARY OF THE INVENTION A pulse rate indicator is mounted to detect the heart pulse rate of a user. The indicator determines the average pulse rate of a user at rest and utilizes this rate as a reference to indicate the pulse rate at a safe exercise level as well as the pulse rate at a dangerous level. In one embodiment of the invention, the three conditions of pulse rate are displayed in color that is analogous to a traffic control pattern. Consequently, green is selected to represent a rest pulse rate, amber is selected to represent a safe exercise pulse rate level and red represents a dangerous pulse rate level. In another embodiment of the invention, the pulse rates are digitally displayed in number form as well as in color. Thus, the optimum pulse exercise rate for each individual user is displayed. Since the optimum pulse exercise rate varies from user to user depending on the particular physiological characteristics of each user, the indicator is tailored to each individual user. Further embodiments utilize an audible alarm to alert the user in a manner analogous to the color display. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a graphic representation of an electrocardiogram display of the surface potential changes of a heart in a person at rest; FIG. 1A is a graphic representation of the normal pulse displayed in FIG. 1; FIG. 2 is a graphic representation of an electrocardiogram display of the surface potential changes in a heart in the abnormal condition of tachycardia, which is an excessive heartbeat rate; FIG. 2A is a graphic representation of the electrical pulses generated in the circuit of the intant invention representing the abnormal pulse rate as shown in FIG. 2; FIG. 3 is a graphic representation of the pulse rate for a normal distribution of male population; FIG. 4 is a schematic circuit diagram of the pulse rate indicator of the instant invention; FIG. 5 is a top perspective view of one embodiment of the invention wherein the pulse rate is displayed in digital form; FIG. 6 is a top perspective view of a second embodiment of the invention wherein the pulse rate is displayed in color; FIG. 7 is a side perspective view of the embodiment of FIG. 6; and FIG. 8 is a pictorial representation of other embodiments of the invention. GENERAL DESCRIPTION OF THE INVENTION FIG. 1 shows normal pulses as displayed upon an electrocardiogram and with the standard points P Q R S and T indicated. For the purpose of this invention, the pulse rate is defined to be the number of times the R pulse point repeats itself over a given period of time. As shown, R' is the second occurrence of the R pulse point within a short time increment. The medical diagnostician measures the period of time between the occurrences of R and R' as an indication of the condition of a heart. The R pulse rate is related to the pressure exerted by the blood upon one of its chambers, and this in turn is an indication of the pressure exerted by the blood upon the particular artery where the pulse rate is being sensed. It is therefore common in the medical diagnostic field to attach a sensor such as a strain gauge or the like, which is responsive to pressure to produce an electrical pulse having the same frequency and intensity as the pulse shown in FIG. 1. The waveform of FIG. 1A is the electrical counterpart of the pulse R of FIG. 1 and represents the electrical variation in intensity pressure exerted by the heart. The normal pulse rate of FIG. 1 indicates that there is sufficient time between pulse R and pulse R' for the heart to recover in its continuing sequence of expansions and contractions. These expansions and contractions force the blood from one chamber to the other and through the large multiplicity of arteries and veins throughout the body. FIG. 2 illustrates an electrocardiogram display of a pulse rate in a state of excessive exertion known in the medical field as tachycardia. Here the time between successive pulses is very short and therefore allows the heart muscles very little time to expand and contract to perform the necessary functions of blood transport. The distance between recurrent R pulses therefore is very small and the pulse rate is much higher than the normal condition depicted in FIG. 1. FIG. 2A illustrates how the more rapid pulse rate under the condition of tachycardia is translated by this invention into a series of electrical pulses having the same pulse rate frequency as the pulse rate corresponding to the pulse rate occurring within the human body. The normal pulse rate for an adult male is designated as ranging from between 70-72 beats/minute and for an adult female as from 78-82. Pulse rates in both men and women rarely exceed 150 beats/minute in normal everyday activity and pulse rates in excess of 175 beats/minute may be fatal. The condition of tachycardia as portrayed in FIG. 2 corresponds to a pulse rate of 170 beats/minute. The condition of tachycardia therefore presents an excessive burden upon the heart muscle since the heart muscle is required to perform an excessive amount of work in a very short period of time. The pulse rate for humans varies over a wide range as the human progresses throughout life. Table I, as shown below, illustrates the pulse rate as a function of age where the pulse rate varies from as high as 150 in the early stages of life as to as low as 50 in the seventieth year. TABLE I______________________________________AGE PULSE RATE______________________________________Embryo 150At Birth 140-130First Year 130-115Second 115-100Third 100-90Seventh 90-85Fourteenth 85-80Fiftieth 75-70Seventieth 65-50______________________________________ This wide spread in pulse rates is also seen in the adult male population as shown in FIG. 3. Here the pulse rate is illustrated as a bell-shaped distribution of the healthy adult male population. The average pulse rate, for example, is 70 and some men have normal pulse rates as high as 90 and some men have normal pulse rates as low as 50. This distribution of so-called normal pulse rates from 50 to 90 indicates that the pulse rate of every individual must be exactly determined before any type of physical exertion is imparted to the heart. Tachycardia, described earlier as excessive heart pulse rate, occurs at approximately 170 pulses/minute. The person with the lower pulse rate of 50 would have to strain his heart to a substantial degree before the tachycardia pulse rate of 170 would occur. The person with the so-called normal pulse rate of 90 would reach the tachycardia condition of a pulse rate of 170 in a substantially shorter period of time. If a normal distribution is plotted for the onset of tachycardia based on the 170 pulse value then the range in population would be that depicted in FIG. 3. It is evident that persons with higher rest pulse rates would be more prone to the onset of tachycardia than those with lower rest pulse rates. The problem that this invention directs itself to is to determine the accepted pulse rate for exercising that would permit a particular individual to condition his body without excessive strain on the heart and to determine for each particular individual the particular pulse rate at which such physical strain would be excessive. DETAILED DESCRIPTION OF THE INVENTION FIG. 5 illustrates one embodiment of the programmable indicator 1 which includes a wristband 2 supporting an indicator face 3 that displays digital pulse rate 4. The indicator 1 is supported on a wrist 5 of a user and the indicator 1 includes a housing 6 that contains the programmable electrical components. The user can at any time see what his pulse rate is during any part of his physical exercise program. Referring to FIG. 7, the indicator 1 includes a contact type pulse detector 7 which extends from the indicator 1. The detector 7 contacts the radial artery in the vicinity of the user's wrist and relays the detected pulses to the programmable integrated circuit within the housing 6. The pulse detector 7 shown as depending from the indicator 1 can also be part of the wristband 2 since the band would provide a larger surface for detection purposes. The detected pulse rate is digitally displayed upon the viewing indicator face 3. A traffic control analogy may be utilized to display cnditions of pulse rates. FIG. 6 shows such an embodiment which includes red, amber and green indicating lights on the viewing indicator face 3. The indicator 1 activates the red, amber and green lights in the following manner. When the start and reset knob 10 is depressed energy is supplied by means of a miniature disc-shaped battery contained in the indicator 1 (not shown) and successive heart pulse beats are detected by detector 7 and processed within the indicator 1. The green light indicates that an average rest pulse rate has been determined. This is similar, for example, to the common traffic signal indicator where the green light indicates "go" and the presence of the green light insures the operator that the pulse is being detected and that the battery is operational. When the user begins to exercise moderately the pulse rate is detected and counted and an optimum exercise pulse rate for the particular average rest pulse rate is determined. For the example given earlier of the medium normal pulse rate of 70, the optimum exercise pulse rate should be 50 greater than the average rest value. Thus, for the 70 rest rate a pulse rate of 120 is the optimum exercise pulse rate for the user and an amber light begins to glow at this rate. The green light would therefore become extinguished at this value and the exerciser is instructed that he has reached the optimum safe exercise pulse rate period. Thus, the optimum safe exercise pulse rate calculated on the basis of 50 beat/minute above the rest value pulse rate indicated by the amber glow continues until a pulse rate of 150 pulses/minute is achieved. At this point the amber light is extinguished and the red light begins to glow indicating to the exerciser that the danger pulse rate condition has been reached and that the exerciser must slow down in order to extinguish the red light and regenerate the amber light. Table 2, shown below, illustrates the color conditions of green, amber and red along with the corresponding rest, optimum exercise, and dangerous pulse rates for the normal pulse conditions. Although the optimum exercise pulse rate for each group is determined by the addition of 50 pulses or beats/minute above the rest rate, to avoid the onset of tachycardia a red signal is energized to glow at a reduced safety pulse rate of 150 pulses/minute. TABLE 2______________________________________ GREEN AMBER RED (Rest Rate) (Exercise Rate) (Danger Rate)Low Normal 50 100 150Normal 70 120 150High Normal 90 140 150______________________________________ The color pattern can be utilized in the digital display embodiment shown in FIG. 5. Here the numeric display characters themselves can be caused to glow green, amber or red depending upon the pulse rate condition during exercise. The numerals indicating the average high normal rest rate of 90, in the example of Table 2 can be made to glow green. When the safe optimum exercise rate is reached the numerals glow in an amber color indicating to the user that this particular numerical value is his optimum safe exercise pulse rate. Although higher numerical pulse rates remain amber as exercise continues the user knows that he has exceeded the optimum safe pulse rate and should begin to slow down. If he doesn't slow down, and the pulse rate reaches 150, then numerals indicating this dangerous pulse rate are displayed in red. If he does not slow down at this stage of exercise, the tachycardia may occur. The visual display indicators depicted in both FIGS. 5 and 6 can have different degrees of light intensity and may have other attention directing characteristics. The amber light, for example, might be caused to blink at the optimum safe exercise pulse rate so that the operator, for example, by looking at the face of the indicator 1 would know that he is exercising within the safe condition of pulse rate. By practice he could pace himself by observing that his particular pulse is beating at the rate of the blinking light. By breaking his stride he could lower his pulse rate to remain at the optimum. Other attention directing means may be incorporated within the indicators of FIGS. 5 and 6 which could include an audible beep device which could be made to vary in frequency in accordance with the pulse rate. The rest condition green, for example, would require no indicating tone and the amber condition would require an auditory beep merely to indicate to the exerciser how fast his pulse rate is going with no possible indication of alarm. The dangerous condition indicated by the pulse rate occurring when the indicator is glowing red would have a rapidly repeating beep and the red light simultaneously could be caused to blink at the same rate to alert the exerciser to slow down. FIG. 8 depicts alternate embodiments of the pulse sensor of this invention. Here a jogger depicted generally at 21 could carry an indicator unit 1 mounted within a sweatband 23. Here the sensor 7 would contact the vicinity of temporal artery for receiving and recording pulse rates as described earlier. This particular embodiment would require only an audible indicator and the aforementioned red, amber and green indicator lights could be absent. Here the only requirement is that when the pulse rate of 150 is reached then the indicator 1 would begin to beep and the user would summarily have to slacken his pace until the sound disappears. A simplified embodiment is also depicted by the wristband 22. Here again the indicator 1 would contain the same necessary circuit elements to provide an audio beep when the pulse rate detected from the radial artery reaches 150 pulses/minute. Alternate embodiments within the scope of this invention include audible and visual low pulse level indication when the pulse rate falls below the recorded rest rate average value. This feature would indicate an abnormal physiological condition to the user. Since the pulse rate is lower when sleeping or lying down the long distance driver, for example, would receive an indication that he is starting to doze at the wheel and the audible and visual alarm would alert him of a very dangerous situation. The digital readout display device of FIG. 5 may serve the health conscious executive who is under a condition of emotional and mental stress even when in a sedentary position at his office. The visual indication of a rising pulse and the occurrence of an amber light in the absence of physical exercise would indicate to the user that his emotions are interferring with his cardiovascular activity. Keeping within the scope and teachings of the instant invention several safety features may be further incorporated within the indicator 1 depicted within the embodiments of FIGS. 5 and 6. Should the exerciser fail to heed the occurrence of the blinking light and the loud and intermittent beep emanating when the pulse rate exceeds 150 then after a time delay the beep is caused to increase in intensity and begin to sound the Morse Code Mayday audio alarm. This would direct a rescuer to the danger, for example, if the user should succumb to heart disease similar to arrythmia and becomes disabled. If the dangerous condition persists for an additional time period then the Mayday distress call also becomes transmitted within the citizens and police broadcast bands in order that immediate help be directed to the stricken individual. The operation of the inventive pulse indicator of FIG. 4 may be explained as follows. A block diagram of the electric circuit of the indicator is illustrated in FIG. 4. This circuit includes a detector or sensor 7 which may, for example, comprise a thin silicon metal piezoelectric transducer or a piezoelectric strain gauge consisting of barium titanate or barium zirconate. The detector 7 may be attached to the wrist or head of a jogger 21 as designated in FIG. 8 and is included in the indicator 1. The sensor 7 produces an electric output signal as shown in FIGS. 1A and 2A at every pulse beat as shown in FIGS. 1 and 2. The electrical output signal is amplified in the amplifier 210 and then peak detected in the shaper circuit 222. The shaper circuit 222 may, for example, comprise a peak detector and a squarer circuit that detects the peak of the R pulse 211 in the Q R S waveform shown in FIG. 1. The shaper circuit 222 is made variable to tailor it to the individual physiological characteristics of a user because the peak amplitudes of Q R S pulses vary from individual to individual. The shaped output pulse is applied to a counter 230 where the pulses are counted. At the end of a predetermined period, which may, for example, comprise 15 seconds or alternatively one minute, the count in the counter 230 is transferred through transfer gates 240 to a storage device 260 by a pulse from a clock or timer 270. The clock or timer may, for example, comprise the timer on the wristwatch worn by the jogger. After a slight delay, the counter 230 is reset by the clock 270 via delay 250. The storage device 260 may, for example, comprise a plurality of storage circuits such as shift registers. The count in the first storage circuit is transferred to the second storage circuit when the second count in the counter 230 is transferred through the transfer gates 240 to the storage circuit. At the end of a predetermined number of counts, an averaging circuit 280 adds the pulse counts stored in the storage device 260 and divides by the number of counts to determine the average rest pulse rate over a predetermined period. This average pulse rate is applied to a comparator circuit 290 and displayed in a display device 200. Thus, the display device 200 displays the average or rest pulse rate of the jogger. The display device 200 may, for example, display in green, amber or red and may include light-emitting devices that digitally display the pulse rate. The average rest pulse rate is usually displayed in green. The averaging circuit 280 also includes a set element 218 to fix or set the average of the pulse rate so that this figure remains constant during jogging. Alternatively, if an individual knows accurately his rest pulse rate, this rate may be set into the averaging circuit 280 by the manual set 220. Both the switch and set element 218 and the manual set 220 are coupled to the knob 10 shown in FIGS. 5 and 6. During the jogging period, the pulse rate is applied through the transfer gates 240 to the comparator 290. The average rest pulse rate stored in the averaging circuit 280 is, as explained previously, incremented by the number 50 to set the optimum safe exercise pulse rates. During a period when exercise is being done, the display device 200 may, for example, digitally display the pulse rate at that particular moment. When the pulse rate reaches the established optimum safe pulse rate number, this number is digitally displayed in amber and an audible indicator 300 may beep as described earlier. When the pulse rate reaches the danger pulse rate of 150 the comparator 290, set to detect this critical number, causes the display device 200 to glow red. Additionally, audible indicator 300 may beep at an increased rate. The time delay 250 connected to the counter 230 also provides the alternate safety function that when the circuit is first energized by means of knob 10 connecting energy source 278 to the circuit components the time delay 250 will not allow the sensor 7 to energize the aforementioned green light until a sufficient time span has occurred so that a representative average rest pulse rate can be determined. This is important since it is possible that an impatient jogger may upon early waking, when the pulse rate is at its lowest, immediately commence jogging and receive a false amber indication as to the optimum exercise pulse rate since the aforementioned rest rate average was excessively low. The time delay, for example, would give the user adequate time to provide sufficient sample pulse counts to the counter so that a true rest rate pulse average can be determined before the go ahead signal is indicated by means of the aforementioned green light. The components of the circuit depicted in FIG. 4 may comprise an integrated circuit. However, it is not necessary that the detector 7 be directly connected within the circuit. An alternate embodiment, for example, could consist of a sensor which incorporates an ultrasonic transmitter and the other circuit components could be at a remote location from the sensor. A heavily bundled snow shoveler wearing gloves may be unable to hear the audible alarm indicated from the pulse sensor and audible alarm on the wrist but would clearly hear an audible alarm generated within the sweatband embodiment described earlier as in contact with the temporal artery due to the proximity of the temporal artery and the ear. In the event that the snow shoveler may be reluctant to wear the complete sensor contained within the sweatband similar results could be achieved by locating the detector and transmitter portion of the circuit within a wristband proximate the radial artery and locating a simple receiver in the vicinity of the ear by means of a sweatband or similar device. Here the excessive pulse rate would be detected in the ultrasonic region and regenerated in close proximity to the ear within audible range. It is to be further noted that energy source 278 may be a self-contained battery of the rechargeable type and may provide power to each and every circuit element as required including the green, amber and red display elements which for their purpose of size and efficiency may comprise light emitting diodes. Although several limited embodiments have been described as operative examples of the inventive pulse rate indicator this is by way of example only and is in no way intended to limit the scope of this invention to these specific examples.

A pulse rate indicator automatically indicates a person's pulse rate and changes in this rate. The indicator is individually programmed for each user to account for the overall physiological characteristics of the user. The indicator may be mounted on a wristband and the pulse count is averaged over a time increment, stored and displayed as a reference or rest value. As the user undergoes physical exercise, the subsequent pulse rate is visually indicated and compared with the reference or rest value. When the pulse rate increases, but not to a dangerous level, the color of the indicator changes to inform the user that continued exercise is permissible. When an excessive pulse rate is reached, the indicator changes color and an audible alarm is sounded. The programmable feature therefore allows each person to exercise up to his particular limits for physical fitness tailored to his own physiological makeup, with sufficient advance warning to avoid excessive strain on the heart.

RELATED APPLICATIONS The present invention is a division of co-pending U.S. application Ser. No. 14/220,830 entitled, “Spinal Alignment Correction System And Methods Of Use” filed on Mar. 20, 2014. TECHNICAL FIELD The present invention is directed to a device for use in correcting various lumbar and thoracic spinal maladies including reduction of Spondylolisthesis and various other corrective procedures and surgical treatment including scoliosis, trauma and other malalignments of the spine. BACKGROUND OF THE INVENTION A recently published paper in The Journal of Bone and Joint Surgery Incorporated 2014; 96: 53-8 entitled “Evidence—Based Surgical Management of Spondylolisthesis Reduction Or Arthrodesis In Situ” reported “The role of reduction in the operative management of spondylolisthesis is controversial because of its potential complications, including neurologic deficits, prolonged operative time, and loss of reduction.” This study reported “The decision to correct high-grade slippage defects by reduction is still a controversial one. In an attempt to determine which patients should be treated with reduction, some authors have investigated the relationship between sagittal spinal parameters and pelvic morphology and orientation. Patients with high-grade spondylolisthesis could be classified on the basis of the orientation of the pelvis as having a “balanced” or unbalanced” pelvis. The balanced pelvis type of spondylolisthesis includes patients with low pelvic tilt and high sacral slope, whereas the unbalanced type includes patients with a retroverted pelvis having a high pelvic tilt and low sacral slope. On the basis of this classification, some authors suggest reduction of the deformity, restoring the spinopelvic balance, only in patients with an unbalanced pelvis, whereas arthrodesis in situ without correction would be preferred in patients with a balanced pelvis. Although reduction can potentially result in complications, complication rates in the present analysis did not differ between the reduction and arthrodesis in situ groups. On the other hand, reduction of a high-grade spondylolisthesis would improve overall spine biomechanics by correcting the local kyphotic deformity and reducing the vertebral slippage. We manage patients with high-grade spondylolisthesis by performing reduction under intraoperative neurophysiologic monitoring such as SSEPs combined with spontaneous electromyography. We usually perform a posterolateral or circumferential instrumented arthrodesis. In conclusion, we found no definite benefit of reduction over arthrodesis in situ except for a significantly lower rate of pseudarthrosis. Further adequately powered randomized trials with appropriate subjective and objective outcome measures are required to establish evidence-based surgical management of high-grade spondylolisthesis.” The current surgical practice for low to medium grade spondylolisthesis reduction employs the use of pedicle screws with connective rods. Wherein the surgeon measures the amount of reduction required to realign the vertebrae and then uses the connecting rod to pull the upper vertebral body back causing a lever type action and placing the rod fastener into the tulip connection to fix the connections. As one can appreciate, this current best practice is at best an estimate of final reduction, due in part to a lack of control; the final results are typically a compromised approximation, but not a true alignment. Often this procedure of moving the adjacent vertebral bodies closer to alignment is a sufficient improvement to help the patient; however, this inability of the surgeon to precisely control the reduction is far from ideal. Furthermore, if the reduction achieved is less than satisfactory, the surgeon must start over loosening the rod and repositioning the pedicle screws, thus extending the surgical procedure. The ideal reduction procedure would allow the surgeon to accomplish the reduction by controlling the movement in a consistent reliable and adjustable fashion so the exact optimal alignment is always achieved in the absence of predicting the preferred location, but rather controlling the movement to that exact location. Most importantly, this ability must occur in a timely fashion without unduly extending the surgical procedure. The present invention as described herein accomplishes all these objectives and does so in typically less than 5 minutes added surgical time, most typically less than 4 minutes. Most advantageously, the system of the present invention is so accurate and reliable it virtually eliminates any need to redo the steps as there is no estimation made as to final placement, but rather a controlled movement to alignment which is fixed by the independent adjustment capability of the device in the hands of the surgeon aided by fluoroscopic vision. These and other features of the system and its components afford new techniques in lumbar and thoracic spine surgery for use in a variety of indications as explained hereafter and shown in the attached drawings. SUMMARY OF THE INVENTION A method of treating and correcting a spinal misalignment is summarized in the steps: after exposing the spine and preparing it for instrumentation; Step 1—place MAC Pins bilaterally into the affected vertebral body, then one places standard top loading tulip pedicle screws into the vertebral body below. The listhesed segment such that two vertebral bodies are instrumented. Next a contoured rod is chosen based on the distance between the macpin and the pedicle screw discovered interoperatively. This rod is secured in an opening in the caudal edge of the coupler with a nut in the contoured position. The coupler is then slipped over the MAC Pin down into the surgical wound with the caudal edge of the rod falling into the top loading tulip of the pedicle screw below. At this point, the end cap is placed on the standard pedicle screw in the tulip and is tightened into position locking rods in the bilateral pedicle screws into a monoaxial and fixed relationship with regard to the instrumented vertebral bodies, the pedicle screws and the rods. The next step is to place the cannulated reduction tower over the macpin and through clockwise rotation of the reduction tower the listhesis is reduced in a slow, controlled and accurate method until the interoperative fluoroscope indicates a satisfactory reduction thus appropriate sagittal alignment. At this point, the second nut on the coupler is tightened with a wrench and this locks the entire construct into a rigid position therefore securing the spondylolisthesis reduction in place. The outer cannulated tower is then removed and the MAC Pins are sheared off flush with the coupler. It is at this point a laminectomy or decompression of the neural elements can be performed if so desired. Following the laminotomy, an interbody preparation fusion and graft placement can then take place. An alternative method would be to close the surgical wound and perform an anterior lumbar interbody fusion or a lateral transpsoas interbody fusion according to the pathology, indications and surgeon's surgical strategy. A spinal alignment correction system has an elongated shaft and a rod coupler assembly. The elongated shaft has an inner pedicle screw portion with pedicle threads, an outer second thread portion with second threads and a transition or intermediate portion disposed between the pedicle screw portion and the second thread portion. The rod coupler has a pair of openings, a first opening for passing over the elongated shaft and being movable lengthwise within the transition or intermediate portion and a second opening for receiving a rod. The rod coupler is rotationally movable about said shaft. The spinal alignment correction system further has a cannulated tower. The cannulated tower has a longitudinally extending opening having internal threads complimentary to said second thread of said elongated shaft. The cannulated tower when mounted over said elongated shaft abuts said coupler along an outer cam surface and further tightening rotation of the cannulated tower causes outward movement of the elongated shaft. The spinal alignment correction system further has a handle removably attached to the cannulated tower to facilitate rotation of the cannulated tower. The spinal alignment correction system further has a rod fastener, said rod fastener when attached to said rod connector locks a rod securely fixed in the rod receiving opening. The spinal alignment correction system further has a washer and a locking nut for attachment onto the coupler and abuttingly locking said washer against said coupler. The spinal alignment correction system further has a rod, a rod fastener and a pedicle screw with rod receiving connection. The pedicle screw when affixed to a lower vertebral body has the rod extend to the second rod receiving opening of the rod coupler positioned over the elongated shaft affixed to an upper vertebral body, when the rod is at one end is placed in said rod receiving connection of the pedicle screw and fixed by said fastener, the opposite rod is placed in the second rod opening of said coupler and fixed to said coupler after a desired vertebral alignment is achieved. The elongated shaft preferably is made of titanium. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be described by way of example and with reference to the accompanying drawings in which: FIG. 1 is a perspective view of the system or device of the present invention. FIG. 1A is a view of the system of FIG. 1 installed in a spine segment. FIG. 2 is an exploded view of the present invention of the system shown in FIG. 1 . FIG. 3 is a perspective view of the posted pedicle screw or MAC Pin. FIG. 3A a view of the MAC Pin with rod coupler assembly. FIG. 4 is an exploded view of the rod coupler. FIG. 4A is an exploded side view of the rod coupler. FIG. 4B is an as assembled view of the coupler. FIG. 4C shows an additional view of an alternative multiaxial or polyaxial coupler providing an ability to slightly tilt angle the MAC Pin in any direction to facilitate installation of the system. FIG. 4D is the alternative coupler of FIG. 4C shown in a perspective view assembled. FIG. 4E is a side view of the coupler of 4 D assembled. FIG. 4F is an alternative embodiment of the present invention shown in an exploded perspective view illustration of the MAC Pin made as a multi-piece posted lumbar pedicle screw and illustrating a medial offset or lateral offset coupler design. FIG. 4G is a side view of the alternative embodiment. FIG. 4H is a perspective view. FIG. 4I is an assembled view. FIG. 5 is a side view of the cannulated tower. FIG. 5A is a cross sectional view of the cannulated tower. FIG. 6 is a view of the handle for use with the cannulated tower. FIG. 6A is a cross section of the handle. FIG. 7 is a view of the wrenches shown above MAC Pins and cannulated towers of the system for final nut tightening. FIG. 7A shows the wrenches in place over the system to provide final nut tightening to fix the MAC Pin to the coupler. FIGS. 8A-8J are various views of spines having the system of the present invention used showing the various steps employed. FIG. 9A is a side view illustrating a malaligned spine and a use of the system showing the reduction direction as the handle is rotated. FIG. 9B shows the corrected spine segment of FIG. 9A . FIG. 10A shows a scoliosis treatment and how the system can be used to also provide a rotational correction of a vertebral body. FIG. 10B is a view showing the correction result provided to the spine segment of FIG. 10A . FIG. 11 is a view of a cannulated MAC Pin for use with a K-wire in a percutaneous procedure. FIG. 12A is a perspective view of an insertion tool, inserting a stabilizer rod into a bone screw system with leg extensions for use in a percutaneous procedure. FIG. 12B is a perspective view of the insertion tool of FIG. 12A , showing the insertion tool using the connector as a fulcrum to maneuver the stabilizer rod into position. FIG. 12C is a perspective view of the insertion tool of FIG. 12A , showing the insertion too using the connector as a fulcrum to further maneuver the stabilizer rod into position. DETAILED DESCRIPTION OF THE INVENTION The following description is best understood by reference to the attached drawings depicting one embodiment of the present invention. With reference to FIGS. 1 , 1 A and 2 . The device or spinal alignment system 1 is shown as described has a double threaded post lumbar pedicle screw 10 hereinafter also referred to as a Maximum Alignment Correction Pin (MAC Pin) that is placed in the vertebral body 201 and coupled with a special screw rod coupler or coupler assemblies 20 and that adjoins the posted screw 10 to a rod 100 connected into a lower vertebral body 202 of a particular segment of the spine 200 . The posted screw 10 is attached to the rod 100 and the other end of the rod 100 attached to a typical pedicle screw 110 placed in the vertebral body 202 below. The device or system 1 will include a double threaded post lumbar/thoracic pedicle screw thread end portion 12 on the screw 10 as well as a coupler 20 and there is also a technique for using this implanted device or system 1 . As shown in FIGS. 3 and 3 a , this posted pedicle screw 10 has a one piece shaft 11 with a double threaded pedicle screw thread 12 of a typical pedicle screw. The thread 12 extends from a leading tip 11 A to a length at least 40 mm, preferably of about 50-55 mm in length up the shaft 11 , thereafter the posted screw 10 has a smooth shaft portion 16 between two threaded portions. The pedicle threads of the screw 10 are in the range of 5.0 to 8.0 mm in size, more typically between 5.5 and 7.5 mm and have a self-tapping feature as shown at end 11 A. A second thread 14 at the other end of the shaft 11 of the screw 10 of the screw is used for the actual reduction or translation technique. The outer end 11 B of the second screw portion 14 that will be sticking out of the spine 200 may have a squared off or flat feature that will be able to connect to a handle or wrench that will allow the posted pedicle screw 10 to be installed into the vertebral bone 202 , independent of the rod coupler 20 . This shafted post pedicle screw 10 is called the MAC Pin (Maximum Alignment Correction Pin). For the first time this pedicle screw 10 and coupler 20 enables the vertebral body 201 to be pulled back in the sagittal plane to be realigned with the other vertebral bodies 202 to establish perfect mechanical alignment, restore the mechanical alignment of the spine 200 , believed to be the best outcome for the patient. The coupler 20 enables the tip 11 B of the posted pedicle screw or the MAC Pin 10 , once the pedicle portion 12 of the MAC Pin 10 has been placed within the vertebral body 201 of the lumbar spine 200 , to be pulled back. That threaded portion 14 will be used to pull the vertebrae 201 back 35-50 or 65 mm. The coupler 20 is slipped over outer the tip 11 B of the MAC Pin 10 , the coupler 20 as an assembly, but untightened, falls into the spine interoperatively into the smooth shaft portion 16 of the MAC Pin 10 between the two threaded 12 and 14 areas of the MAC Pin 10 . The coupler 20 is attached to an end of a contoured rod 100 which when placed down over the MAC Pin 10 , the opposite end of that rod falls into the top of aa top loading tulip 120 of the tulip headed pedicle screw 110 in the vertebral body 202 below. When the coupler 20 fixed to the rod 100 is placed within the pedicle screw 110 this enables not only translation again also distraction or compression of the motion segment 202 between the two vertebral bodies 201 , 202 . Once this assembly is accomplished, the technique can begin. With referenced to FIGS. 3A , 4 , 4 A and 4 B the rod coupler assembly 20 is shown, the coupler 20 has two holes 21 , 22 , one hole 21 is able to slip over the posted pedicle screw or MAC Pin 10 and then the other hole 22 will allow the contoured rod 100 to fit within it and then prior to placing the coupler 20 and rod 100 over the posted pedicle screw or MAC Pin 10 the surgeon will lock the rod 100 by choosing various lengths of rods according to what is discovered as needed interoperatively with the 5.5 diameter rod 100 , the rod 100 will slip into the caudal edge of the coupler 20 . Once the rod 100 is slipped into the caudal edge, there is a separate nut or set screw 102 and tightener that tightens this rod 100 in place into the threaded opening 103 of the coupler 20 . As shown in FIGS. 4 , 4 A, 4 B and 4 C, the rod coupler assembly 20 has a coupler body 24 which has the openings 21 and 22 for receiving and holding the MAC Pin 10 and rod 100 respectively. At the bottom of FIG. 4 is a hollow shaft holding coupling 90 with a threaded end 98 with flats 95 and an opposite rounded or spherical end 99 with a plurality of slots 97 to allow the end 27 to grip the MAC Pin 10 when the coupler assembly nut 60 is tightened against the washer 62 and the teeth 25 serrated sidewalls 23 . The washer 62 having can have complimentary flats 63 with or without serrated teeth 65 that interlock as the nut 60 threads onto the threads 98 of the shaft holding coupling 90 as shown in FIGS. 4 , 4 A- 4 E. Initially, the entire coupling assembly 20 is connected, but loosely so the coupling can slide freely over the MAC Pin 10 and move angularly about the smooth shaft portion 16 . Only when the proper vertebral body alignment is achieved by the use of the cannulated tower 40 and the handle 50 is the nut 60 tightened locking the coupler 20 onto the MAC Pin 10 fixing its position. As noted, all the parts aligned with opening 21 have openings allowing the MAC Pin 10 to pass as shown. The shaft holding coupling mechanism 90 provides for limited angular motion of the MAC Pin 10 . Nevertheless, this ability to tilt the assembly is beneficial to the installation of the instrumentation. As further illustrated, the system 1 further has a cannulated reduction tower or shaft 40 mounted over the MAC Pin 10 and resting on a nut 60 of the coupler assembly 20 . Above and removably affixed to the tower 40 is a handle 50 which is used to rotate the cannulated reduction tower 40 as the system 1 is employed to align the vertebral body 202 in the spine 200 . Once the rod 100 and coupler 20 are joined through this nut 102 , a fixed relationship is established between the rod 100 and coupler 20 . At that point, the other end, the cranial end, of the coupler 20 would then slip over the MAC Pin 10 until the coupler falls into the dorsal aspect of the bone of the vertebral body 201 which is the base of the lumbar pedicle and also at that point it will be positioned within the smooth shaft portion 16 of the MAC Pin 10 , the threaded pedicle portion 12 of the MAC Pin 10 would have been driven transpedicularly into the vertebral body 201 where whatever length has been chosen of the threaded pedicle portion 12 of the threads 12 A will be countersunk into the vertebral body and pedicle shaft. This can be anywhere from 35 mm up to 50-65 mm within the vertebral body 201 . At this point, sticking out of the posterior aspect of the pedicle and vertebral body 201 would be the MAC Pin 10 , the smooth shaft portion 16 and also the second thread portion 14 as well as the squared off tip 11 B. So when the coupler 20 slips over the post MAC Pin 10 , the coupler 20 is positioned within the smooth shaft portion 16 enabling it to more or less cam back and forth on the MAC Pin 10 so that a smooth frictionless relationship exists with the MAC Pin 10 and the rod. At this point again, simultaneously when the coupler 20 and the rod 100 are slipped over the MAC Pin 10 , the caudal of the 5.5 rod 100 would fall down into the opening of the tulip 120 the top loading tulip pedicle screw 110 and the vertebral body 201 . At that point, the end fastener cap 130 on the tulip 120 of the top loading pedicle screw 110 would be placed and the end cap 130 would be tightened after whatever distraction or compression is desired. Once the coupler 20 and the rod 100 slide down over the MAC Pin 10 and fall within the tulip 120 , the end cap 130 of the tulip 120 would then be placed. At this point, a distractor or a compressor can be utilized to distract between the MAC Pin 10 from the pedicle screw 110 once it achieves distraction of the this or the posterior neuroforamen, independently of the translation of the vertebral body 201 that follows this distraction. Once distraction or compression is accomplished, the end cap 130 and the posted pedicle screw 10 below would be tightened and then the rod 100 and the posted pedicle screw 10 relationship would become fixed. At that point the only motion that is still available between the MAC Pin 10 and the pedicle screw 110 below or at the rod 100 is the translation or the reduction of the spondylolisthesis. To visually appreciate the procedure, after the MAC Pins 10 have been inserted bilaterally, the surgeon would place the coupling assembly 20 over the MAC Pin 10 as shown in FIGS. 8E-8G and lock the connector rod 100 to the pedicle screw as discussed. Thereafter, the cannulated towers 40 and handles 50 would be placed over the MAC Pins 10 as shown in FIGS. 8A-8D . At this point, the rod coupler assembly is assembled, but is loose sitting over the smooth shaft portion 16 free to allow the MAC Pin 10 to be retracted. As shown in FIG. 8D , once the towers engage the second threads 14 A by rotation of the handle 50 , the MAC Pins 10 are retracted. The tower 40 abuts on the nut 60 which acts as a cam. Importantly, as the tower 40 rotates, the MAC Pin 10 does not rotate, but rather moves longitudinally in the direction of the handle rotation. In this way, the pedicle portion 12 does not change neither tightening nor loosening. This allows the vertebral body 202 to retract toward alignment. Once the desired alignment is achieved, the handle 50 can be removed and a wrench 70 , shown in FIGS. 7 and 7A , can pass over the tower 40 to securely tighten the nut 60 fixing and locking the rod coupler 20 to the MAC Pin 10 . This occurs as the slots 97 at the end of the coupling mechanism 90 close about the shaft 11 at the smooth portion 16 of the MAC Pin 10 . Once locked in position, the wrench 70 is removed and the cannulated tower 40 is removed from its attachment to the exposed second threaded portion 14 of the MAC Pin 10 . Once removed, the surgeon cuts the MAC Pin 10 flush to the nut 60 of the rod coupler assembly 20 as shown in views 8 H- 8 J. In FIGS. 9A and 9B an exemplary procedure of a spinal segment 200 is shown with the system 1 installed and being turned to retract the spondylolisthesis of vertebral body 202 as the rod 100 is fixed to the lower vertebral body 201 at the pedicle screw 111 . Once alignment is achieved, the tower 40 is removed after the nut 60 is tightened, see FIG. 9B . This is accomplished preferably using two MAC Pins 10 bilaterally as previously discussed in reference to FIGS. 8A-8J . The next step would be slipping a cannulated tower 40 , shown in FIG. 5 and cross section in FIG. 5A , over the exposed outer tip 11 B of the MAC Pin 10 with a handle 50 on that cannulated tower 40 . The cannulated tower 40 has an inner threaded portion 42 that threads onto the second set of threads 14 A on the exposed MAC Pin 10 . At this point, the handle 50 on the cannulated tower 40 is rotated moving the tower 40 over that threaded portion 14 of the MAC Pin 10 and as you move the handle 50 , the cannulated tower 40 moves down the threads 14 until it abuts against the nut 2 of the coupler; the pedicle screw portion and rod relationship and begins to pull that vertebral body into a more aligned position such that the surgeon would be able to translate or reduce the spondylolisthesis anywhere between 1 mm up to 2-3 cm and this is a unique property of the system 10 in that no other system allows an independent translation and independent distraction and compression of the motion segment that is so accurate. Once you begin to translate the MAC Pin 10 on the coupler 20 , it allows complete independent and accuracy whether or not you need 1 mm of reduction or 3 cm of reduction. The surgeon is able to dial that in interoperatively and stop at whatever point he wants between that 0 to 3 cm. There is no guesswork, no estimation, the surgeon simply begins to dial in the amount of reduction he wants and by checking interoperative fluoroscope he can judge when the reduction is complete and therefore stop the process at that point. As shown in FIG. 5 , the cannulated tower 40 has an end 40 A with flats 45 to receive the handle 50 . The tower 40 , as shown, further has a window opening 46 which allows the surgeon to see the MAC Pin 10 movement. A graduated scale 48 marked 10-60 increments of 10 mm is provided adjacent the window opening 46 . The handle 50 , shown in FIGS. 6 and 6A , when placed onto the tower 40 has an opening 54 that allows the MAC Pin 10 to pass. The opening 52 receives the end 40 A and has flats 55 to compliment the flats 45 to rotationally fix the tower to the removable handle 50 . Another unique feature of this system is the fact that as the surgeon reduces the spondylolisthesis, let's say for example 2 cm, and for whatever reason perhaps the nerve begins to show signal of being pinched, he can then go back and translate the vertebral body 201 forward again back to say 1 or 1.5 cm. Essentially, this device 10 gives the surgeon complete control of an accurate reduction, distraction and rotation of the vertebral body 202 like no other product does. Once the translation or rotation has been performed through the MAC Pin 10 and the cannulated tower 40 and handle 50 , at that point a separate wrench 70 and nut 60 are placed over the cannulated tower 40 and the MAC Pin 10 being held in place. The surgeon, using the separate wrench 70 , tightens a nut 60 on the coupler 20 , this locks the relationship between the coupler 20 and MAC Pin 10 so that is now a fixed relationship and once that fixed relationship is achieved, then the reduction is complete and locked in. At that point, the wrench 70 comes off the cannulated tower 40 and then the cannulated tower 40 is removed from the MAC Pin 10 and then a MAC Pin cutter 80 fits over the exposed tip of the MAC Pin 10 and cuts the MAC Pin 10 flush with the coupler 20 . Now the procedure is completed with a fully distracted or compressed and reduced vertebral body 202 in the spondylolisthesis. At this point, every relationship between the MAC Pin 10 , the pedicle screw 110 and the rod 100 are locked down and fixed ensuring the spondylolisthesis has been exactly reduced. At this point, that would be the completion of the procedure. Now the technique described above typically would be performed open, in an open procedure and also bilaterally with both pedicles and the right and the left side of the vertebral body that is in listhesis would be addressed. And then the procedure would alternate right versus left a little bit of reduction the right and then a little bit of reduction left, and then alternate the right to left so that the vertebral body is translated or reduced in a symmetrical fashion so that no undue rotation is performed during the reduction technique. And then after the reduction is complete, then again the MAC Pin 10 cut off flush to the coupler 20 . This procedure can be performed on a one level spondylolisthesis, a two level spondylolisthesis or in a situation where a spondylolisthesis is a top 1-2 or 3 segments that need to be instrumented according to the indications of the particular surgeon. This procedure can also be done percutaneous by cannulating the MAC Pin 10 so that this procedure could be performed percutaneously. That way a percutaneous posterior instrumentation of the vertebral body could be performed in adjunct with an anterior lumber interbody fusion or in adjunct with a trans lateral interbody fusion. So that this procedure and this system 10 can be utilized with almost any spinal pathology, spondylolisthesis, isthmic spondylolisthesis, traumatic spondylolisthesis also scoliosis, whether it be idiopathic or a degenerative condition, and finally spinal trauma. This system 10 also provides a different coupler 20 MO that is called a medial offset of lateral offset coupler. In this particular coupler 20 MO, the MAC Pin 10 would still be placed in the vertebral body 202 , but the coupler 20 MO would be placed not cranial and caudal but rather medial or lateral to the MAC Pin 10 and in that situation the holes 21 where the rod 100 adjoins to the coupler 20 MO would now be parallel with the rod 100 so that it could be medial or lateral to the MAC Pin 10 . And that would enable the surgeon to perform multiple spondylolisthesis reductions. For example, if you had a (L4 L5) as well as a (L5 S1) grade 1 or grade 2 spondylolisthesis, one could use the medial offset coupler 20 MO with a MAC Pin 10 at every vertebral body with a MAC Pin 10 placed at L4, L5 and S1 and then one could place a medial coupler 20 MO on each MAC Pin 10 and therefore one could perform independent distraction or compression between both motion segments and then also independent and accurate reduction of both the L4 body on L5 as well as the L5 body on S1 once again achieving complete and consistent accuracy. And that is the uniqueness this particular device 10 . The system 10 is designed to reduce spondylolisthesis whether it be grade 1, grade 2 or grade 3 according to the surgeon's desire to reduce the spine. In practicing these procedures, it is preferable that the surgeons are triangulating the MAC Pins 10 into the vertebral body 201 so that when the vertebral body 201 is pulled back or reduced that the force that is pulling the vertebral body 201 back to alignment is not only axial pullout strength, but also an actual purchase of the vertebral body through triangulating the MAC Pins 10 or converging the MAC Pins 10 from the right and left side in a triangular fashion in the vertebral body 201 so a separate force is pulling back against the mass of vertebral body 201 , not only axial pullout strength of the MAC Pin 10 . In describing how the triangulation of the MAC Pins 10 within a vertebral body 201 would work, consider for example if the surgeon is fixing a L4,5 degenerative spondylolisthesis that means that the L4 body is translated or listhesed out of proper alignment forward or anteriorly may be 2 mm may be 2 cm. He has to pull that L4 body back where it belongs in a direct line within the sagittal plane. That direct line must be consistently and accurately reproduced from surgery to surgery or else it could create rotation within the motion segment that will put a mechanical malalignment and possibly other problems. Every time he pulls back on spondylolisthesis an upper bone on top of a lower bone it must be in a symmetrical fashion and also along a vector directly within the sagittal plane. In order to do that, what is going to be done is to put a standard pedicle screw in the vertebral body below. The rod 100 is fixed within that pedicle screw 110 so that the pedicle screw 100 , the rod 100 , the vertebral body 202 are all fixed with respect to each other. This will serve as an anchor to pull back the L4 vertebral body within that sagittal plane. In order to establish a strong foothold in the upper vertebral body L4, the surgeon must do one thing and that is to insure a very strong purchase or grasp of that L4 vertebral body 201 and pull it back using the rod 100 , pedicle screw 110 and vertebral body 202 below once again as an anchor. Once the coupler 20 is placed on the MAC Pin 10 and the surgeon begins to pull the vertebral body above 201 , back within that sagittal plane, he must have achieved a strong foot hold and grasp of that L4 vertebral body 201 . The preferred way he would do that is from the right side and left side. He would place the MAC Pins 10 in the upper vertebral body at angles. He would come in at as an obtuse or oblique angle with respect to the sagittal plane or the vector within the sagittal plane that the bone must pull back in. In the way he want the MAC Pins 10 not only with strong axial pullout strength, but also wants the two MAC Pins 10 coming in from both the right and left side at an angle, preferably anywhere between 15 and 25 degrees in a convergent way so that the tips of the MAC Pins 10 are coming together within the midline of the upper vertebral body 201 . For example L4, once the MAC Pins 10 are hooked into the anchor at the rod 100 again to translate both right and left MAC Pins 10 with respect to the anchor or rod 100 the vertebral body 201 , the vertebral body can be translated posteriorly into alignment symmetrically within the sagittal plane. The foothold that is achieved by doing this is twofold. One, the MAC Pin 10 itself has an axial pullout strength that is going to add to the foothold. Two, by angulating the two MAC Pins 10 in a convergent manner within the vertebral body 202 increases the foothold on the medial aspect of the each of the MAC Pins 10 purchasing the mass of the vertebral body 202 , the mass of the bone also serves as a foothold for a grasp of the vertebral body 202 as the surgeon pulls the vertebral body 202 along a straight vector within the sagittal plane. It is because the angles of the MAC Pins 10 that are oblique to the sagittal plane, the force begins to pull within the vector of the sagittal plane. The obliqueness of the MAC Pin 10 has added strength for pulling the vertebral body back within that sagittal plane. Once that alignment is achieved, then the MAC Pins 10 are locked down and the actual pullout strength as well as the convergence of the two MAC Pins within the vertebral body 202 continue to hold that vertebral body within an aligned or reduced position until the fusion takes place. This system 1 allows the surgeon to pull from left and right sides if desired. The MAC Pin in the right or the left side allows not only for independent distraction or compression right versus left according to the need, but they also allow complete independent rotational control so that a surgeon if he wanted to could pull the right MAC Pin 10 back 1.5 cm, pull the left MAC Pin only 1 cm to create rotation within the vertebral motion segment so that the spondylolisthesis or scoliosis can be tuned to the situation the surgeon is seeing. The benefit of this device 10 is that if he had a rotation that could place the vertebral out of alignment, the surgeon would be able to distinctly and independently rotate, distract or reduce the vertebral right versus the left independent of each other the right or the left sides. It all depends on the technique the surgeon uses whether he reduces by the handle on the right side or the left side or both simultaneously or he can, if he chooses, utilize the MAC Pin 10 and the handle the right side versus the left side differently at different times completely independent of one another. There is nothing on the market that allows this reproducible, consistent accuracy with regard to distraction, rotation, and in particular reduction. The market has been flooded by multiple spinal instrumentation companies with what's called “reduction screws”. Reduction screws are just standard pedicle screws that have a long extended tulip. They are based on the fact that you can try and lock the lower pedicle screw in the lower vertebral body and then estimate again estimate the amount of reduction, translation or rotation that one might need and then a reduction screw is placed in the vertebral body above. At this point the theory is the rod is again fixed to the vertebral body below and again in this system the vertebral body below and the pedicle screw and the rod are fixed together and are going to be used as an anchor while the tulip and the end cap is placed on the reduction screw above. So the theory is that as the screw end cap down into this elongated reduction tulip at the relationship between the upper vertebral body and the lower vertebral body are going to remain the same and that is just simply never true and never accurate and never reproducible. As one begins to reduce the spondylolisthesis with a reduction screw, what happens is, the surgeon must rely on the anchor in the lower vertebral body 202 , the standard pedicle screw 110 and the rod 100 . And the theory is that he would like the rod 100 to be sitting the exact same distance in the tulip that he desires the spondylolisthesis to be reduced. So he is looking at an interoperative forum, so when the surgeon says he wants the reduce this spondylolisthesis let's say 5 mm, he is going to set the rod 5 mm above the bottom of the tulip on the reduction screw, then he is going to put the end cap in the reduction screw and tighten the end cap until the rod sits on the base of the tulip which will be 5 mm. The only problem with this system is that it requires that the pedicle screw and rod relationship in the vertebral body below does not change a bit. And that is where the problem with this system comes in is that it always changes. So what happens is the surgeon puts 5 mm between the rod and the tulip head and begins to tighten the end cap and what happens is that as the end cap tightens down the rod takes the vertebral body below into a different angulation and into a different position such that once you get to 5 mm of tightened down with the end cap, he may only have achieved 1-2 may be 3 mm of reduction, and once that end cap is set within the tulip that is all he's got. So that means he wanted to reduce 5 mm, but the vertebral changed in its angle relationship, then he only had 3 mm, then he has to reset that and there is no way to change that unless he takes out the rod and starts over. That adds time to the patient's surgery and a surgeon may find himself readjusting this 2, 3 to 4 times trying to get the estimation correctly based on something he has no control over. This relationship is based on the strength of the bone, meaning that if the pedicle screw in the vertebral body below moves, if it toggles within the vertebral body then that is going to take away 2-3 mm or if the polyaxial head of the screw anchor in the lumber vertebral body below starts to move at all will take away 2-4 mm of reduction. And finally, if the relationship within the sagittal plane of the upper vertebral body and the lower vertebral body begin to change with the respect to one another as the end cap is tightened down assuming the rod, the pedicle screw and the lower vertebral body are indeed fixed, then what has happened is the two vertebral bodies move inappropriately with relationship to each other and then again a loss of 3, 4, 5 mm of reduction occurs and so what it's going to result in is making the surgeon accept mediocrity. While reducing a grade 2 spondylolisthesis, to 0 in perfect alignment is usually found with that type of prior art instrumentation is a grade is not completely reduced, not completely restored within that mechanical alignment in the sagittal plane. In the present invention system 1 , the surgeon does not have to worry about those things. He won't have to even consider any of those things that cause problems with the reduction screw system, because the MAC Pin 10 allows adjustable, and reproducible amount of reduction or translation regardless of the relationship of the lower vertebral body 202 , it has no bearing on the procedure other than being an anchor point. You can take it to 1-2 cm, if you want to you can take anterior again, so you have complete control forward and backwards moving this vertebral body anywhere in space you want to and that is within the interoperative amount of time which is so important that with the system 1 which takes less than 5 minutes to reproduce consistently, the device 10 allows free independent reduction and rotation of vertebral body 201 with an additional time of less than 5 minutes. And no one can argue that the reduction pedicle screws allow for that amount of control with that few minutes of interoperative time addition. With regard to application of the system 1 in scoliosis, the MAC Pin 10 would be used and probably in every level of the scoliosis. As shown in FIGS. 10A and 10B , in a scoliotic spine 200 where a curve had to be reduced in the sagittal plane but also rotationally reduced, the MAC Pin 10 would be placed bilaterally, most likely, sometimes unilaterally in multiple levels throughout the entire affected instrumented spine. Every level that is going to be addressed with instrumentation in scoliosis may have one or two MAC Pins 10 in them. With regard to the coupler 20 , in scoliosis, most likely the coupler 20 could be a medial offset coupler 20 MO or a lateral offset coupler 20 LO as opposed to the cranial coupler 20 that would be used in spondylolisthesis. In the coupler 20 MO or 20 LO, the rod connection opening is positioned on a side of the coupler body 24 as shown in FIGS. 4F-4I . In this alternative embodiment, the MAC Pin 10 is made as at least a two part assembly, the pedicle screw 12 and the smooth transition 16 and second threaded portion 14 are separate pieces. Otherwise the alternative embodiment is similar in construction as the system 1 previously discussed. As designed one can use a coupler 20 as previously described in FIGS. 4-4B having monoaxial adjustment or a polyaxial construct as shown in FIGS. 4C-4E , or use a fixed coupler 20 design as illustrated for the couplers 20 LO/ 20 MO which by design are the same in terms of the location of the rod opening 22 . This allows the use of multiple MAC Pins 10 within the spine 200 and then the rod 100 would be placed either medially or laterally through the MAC Pin 10 and then coupled to the MAC Pin 10 again from the medial side or the lateral side. The rod 100 would most likely be utilized bilaterally in both the right and the left side to add a foothold or strength to the purchase of the various vertebral bodies of the spine 200 for not only reduction in not only the sagittal and coronal plane again also rotational such that again the MAC Pin 10 on the right side of the vertebral body 201 versus the MAC Pin 10 on the left side of the vertebral body 201 . Either way has complete independence from each other so that a surgeon may be able to utilize the MAC Pin 10 for rotation on the right side by leaving the left side in place. So the medial coupler 20 MO purpose or lateral coupler 20 LO simply would allow the MAC Pin 10 to be utilized in the vertebral body at multiple different levels. The MAC Pin 10 with regard to scoliosis procedures likely would be exactly the same, however, the coupler 20 going from what is called the cranial coupler to a medial or a lateral offset coupler, required the coupler design to be slightly different in the fact that the coupler 20 is slipped over the MAC Pin 10 and if for example the medial offset is placed on the MAC Pin 10 , the rod 100 would be placed medial to the MAC Pin 10 so therefore the slot or the hole 21 within the coupler 20 would need to run parallel with the axis of the spine 200 , such that the only difference would be that the coupler 20 MO allows the rod to be medial to the MAC Pin 10 as opposed to being caudal to the MAC Pin 10 . So the wrenches 70 that would be used would be the same, the two nuts 60 would be very similar, the only difference would be the relationship to the right of the MAC Pin and this is all based on the fact that the surgeon would need to place multiple MAC Pins 10 throughout the spine 200 . With regard to the physical structure of the MAC Pin 10 , this will be a one piece titanium pin with two sets of threads, there will be a pedicle screw portion 12 that will measure anywhere from 35 to 55 mm and will replicate at this point a pedicle screw thread. That typically is a double lead pedicle screw self-tapping thread with the single pole. Alternatively, in future generations the thread can be with the double threaded dual core system for the pedicle portion of the MAC Pin 10 . Beyond the inner tip 11 A of the pedicle screw portion 12 of the MAC Pin 10 there will be a smooth shaft portion 16 that will be from 1 to 2 cm or 1 to 3 cm in length and will be the same dimensions or radius as the inner core or shaft of the MAC Pin 10 most likely of the pedicle screw portion and that will be the space that is allowed for coupling of the coupler 20 to come down over the MAC Pin 10 . Furthermore beyond the smooth shaft portion 16 of the MAC Pin 10 there will be an outer portion 14 with a second set of threads. That second set of threads will be the threads that are actually used for the reduction or rotation of the vertebral body 201 by virtue of the fact that cannulated smooth shaft hitting a smooth surface of the coupler 20 over the MAC Pin 10 and this smooth cannulated tower has an inner set of threads that will operate and engage with the outer second set of threads on the outer portion 14 of the MAC Pin 10 . When the cannulated handle goes over the tip 11 B of the MAC Pin 10 and one rotates the outer cannulated tower 40 with respect to the MAC Pin 10 and because the coupler 20 is fixed to the rod 100 and vertebral body below, as you rotate the shaft 40 over the MAC Pin 10 that begins to pull the MAC Pin 10 in posteriorly within the sagittal plane and obviously the pedicle screw itself threaded within in the vertebral body 202 is going to pull the vertebral body back. So the final and last portion of the post or end of the MAC Pin 10 is simply again some type of squared off structure that will allow potentially a grasp of the MAC Pin so it can be rotated, if desired. The tip of the MAC Pin 10 may be smooth or squared off, it doesn't matter to the function of the MAC Pin because all of the function of the MAC Pin 10 takes place in the second set of threads within the cannulated tower 40 . The MAC Pin 10 is a screw that can be used with an open procedure, but the same pin can be cannulated for the purpose of percutaneous reductions and percutaneous use. The coupler 20 is loose on the non-threaded smooth shaft portion 16 . The coupler 20 that is on the MAC Pin 10 is loose on the smooth shaft portion of the MAC Pin and that relationship is not fixed. So although the tower between the outer diameter of the shaft pin and the inner diameter of the coupler is quite small it does allow the MAC Pin 10 to shift or cam within the coupler 20 so that as you are tightening down the cannulated tower 40 , the MAC Pin 10 is actually shifting or moving with respect to the coupler 20 so that the vertebral body portion of the MAC Pin 10 is remaining fixed. So the MAC Pin 10 within the vertebral body does not move, it only pulls the vertebral body 201 back through the cam action between the cannulated tower 40 and the coupler 20 and the MAC Pin 10 . That is why the MAC Pin 10 is made smooth on that one portion of the pin 10 . As you are pulling the vertebral body 201 back you are rotating the cannulated tower 40 moving outwardly the MAC Pin so the inner threads within the shaft 40 are operating in conjunction with the outer threads of the MAC Pin 10 so that the both sets of threads are slowly driving the vertebral body back within the sagittal plane. The MAC Pin 10 moves fore or aft relation to the rotational direction of the shaft 40 . Importantly, the MAC Pin 10 is not rotating as the cannulated tower 40 rotates and pushes against the coupler 20 . The rod 100 has already been placed in the coupler 20 , the rod 100 and the pedicle screw 110 below are the anchor. The MAC Pin 10 could spin within the coupler 20 at this point, but keep in mind the coupler 20 is fixed to the rod 100 which is fixed to the pedicle screw 110 below. The only motion that is remaining is the camming effect with respect to the MAC Pin 10 inside of the coupler 20 . Once the cannulated tower 40 has reduced the spondylolisthesis to the desired amount the cannulated tower 40 stays in place, one takes the handle or cogwheel 50 off the top and a cannulated wrench 70 is placed over both the cannulated tower 40 and the MAC Pin 10 and goes all the way to the coupler 20 where there is a nut 60 to tighten. As the nut 60 tightens, the relationship between the coupler 20 and MAC Pin 10 becomes fixed. There are two nuts on the coupler 20 , one nut 102 is in order to fix the coupler 20 to the rod 100 , the other nut 60 is placed on the threaded end of the coupler 20 over the MAC Pin 10 . So the nut compresses the coupler at the same hole that accommodates the MAC Pin 10 , so when the coupler is all the way down on the bone one tighten the nut and it fixes the relationship between the MAC Pin 10 and the coupler 20 . When one sends the cannulated tower 40 down the MAC Pin 10 the threads between those two entities are locked together that is what gave the reduction and so you leave that cannulated tower 40 on until one puts the wrench 70 over and tightens the nut 60 . That fixes everything, it fixes the relationship between the coupler 20 and the MAC Pin 10 , therefore locks in the reduction achieved with the vertebral body in place. The nut 60 is sitting there on the coupler 20 and doesn't get tightened until one tightens it with the cannulated wrench 70 . The nut 60 as designed will slide over the cannulated tower 40 and onto the coupler 20 so the nut 60 is going to slide over the shaft 40 and tighten on that slotted thread end area on the coupler 20 and when that area on the coupler 20 gets tightened down it will tighten down on the smooth shaft portion 16 of the MAC Pin 10 . Interbody fusion is not necessary, but if desired after shearing off MAC Pin post. The only implant you would have would be an interbody implant. After the instrumentation has been placed after the MAC Pin has been sheared off flush with the coupler, the reduction and the distraction or compression of the spondylolisthesis has been achieved and has been fixed with regard to the instrumentation. If a surgeon chooses at this point to decompress the neural elements or wishes to provide an interbody discectomy fusion or placement of an interbody posterior implant, now is the time that would be performed. At this point again after the instrumentation is complete with respect to the MAC Pin and the rod, a laminectomy or a laminotomy can be performed decompressing the neural elements. At this point a standard posterior lumber interbody fusion or a transforaminal lumbar interbody fusion can be performed. In which case the nerve root that has distracted from the midline and anulotomy is performed and the discwork including a total discectomy endplate preparation, insertion of bone graft material of choice and lastly insertion of a posterior interbody bone graft or cage dependent on surgeon's choice can be placed within the interbody space of the affected motion segment. In that situation, the inventor has found that after distracting with the rod posteriorly that one can now place an interbody graft within the anterior column of the disc space and create a parallel distraction of the disc height and therefore restoring lordosis. At this point it is also available with this system once the interbody implant has been placed in the anterior column of the intervertebral disc space, it is now possible to leave the coupler and the MAC Pin fixed but if a surgeon wanted to compress on an interbody implant he would then simply go to the lower pedicle screw in the lower vertebral body, loosen the end cap and therefore enable them to compress on the rod thus, interbody implant and then retighten the end caps maintaining the listhesis but allowing once again independent distraction or compression. With regard to placing the interbody implant, once the instrumentation is performed and the spondylolisthesis is reduced and locked in placed and fixed at that time a laminectomy or a laminotomy can be performed according to the surgeon's indication. At this point also would be a laminotomy and perhaps a posterior lumbar interbody fusion or a transforaminal interbody fusion. Also at that time the vertebral body may be retracted toward the midline and an anulotomy is made, and then finally a discectomy is performed in preparation and insertion of bone graft material according to the surgeon's choice. Once the bone graft has been placed in the interbody space, the surgeon then inserts the posterior interbody graft or cage according to his desire. After the placement of the interbody structure the surgery would be complete. There is an option if the surgeon wants to create more lordosis, he has two different ways to do that. One would be to insert a large interbody graft anteriorly in the anterior column as one is opening up the anterior disc space creating parallel disc height distraction or even a lordotic alignment. The second method by which the surgeon could create lordosis with this system 1 is at this point once the interbody implant is placed in the anterior column. He can loosen the end caps in the lower vertebral body standard pedicle screw and then perform compression of the rod within the standard pedicle screws at which point he will therefore be compressing not only the interbody graft or cage but also creating a lordotic alignment within the motion segment that has been instrumented. Once that compression takes place, then the surgeon would simply tighten up the end caps in the pedicle screws below and then the entire concept would be rigid and fixed. All the while the spondylolisthesis by virtue of the MAC Pin 10 and the coupler 20 have been made fixed and therefore the spondylolisthesis does not change, this is a unique feature to the system 1 . If a reduction pedicle screw on the lower pedicle screw is locked in the monoaxial position, and forms the anchor by which the reduction screw is going to be utilized using the prior art technique, the surgeon can then not go back and loosen this tulip head or else the reduction would be lost if the reduction screw had changed. This unique system 1 allows that feature which is again another benefit to accuracy and reproducible consistency of the system. The system with regard to rotational control as well as reduction control within that part of the spine. At this point the surgery would be complete and the surgeon would then begin his standard closure. One of the other features that is unique within the coupler 20 is that the MAC Pin 10 relationship within the coupler 20 not only has a cam relationship that can shift within the coupler 20 up and down, but it also will be able to change angulation with respect to the coupler 20 . That is the MAC Pin 10 will be able to change the angulation with regard to the coupler within the sagittal plane. There is a shaft holding coupling mechanism 90 within the coupler 20 , a separate shaft holding coupling mechanism 90 , within the titanium coupler 20 that moves with relationship to the coupler 20 itself, so as the MAC Pin 10 comes down through the coupler 20 it is also coming through this separate device 90 so that this coupling 90 allows movement within the sagittal plane with respect to the coupler and the importance of that is to allow MAC Pin 10 to enter into the pedicle at the vertebral body at different angles cranial or caudal within the sagittal plane. So that when the coupler 20 and the rod 100 are introduced simultaneously over the MAC Pin 10 , if there is an odd or unexpected angle in order for the caudal aspect of the rod 100 to fall into the top loading tulip of the pedicle screw 110 , this motion within the coupler 20 will accommodate that need. Such that when the coupler 20 is placed over the MAC Pin 10 , and the rod 100 needs to fall down into the space of the tulip head of the pedicle screw 110 below that shaft holding coupling mechanism 90 within the coupler 20 and that motion would then apply to the frame to allow that accommodation to occur. A side to side motion with respect to the device 90 inside the coupler 20 also can be provided to match the couple relationship. That purpose will be to allow surgeons a larger margin of error with regard to the angle at which he places his MAC Pin 10 into the vertebral body. So the system 1 allows for a margin of error respecting the fact that not all surgeons are going to optimally position the device 10 every time. The device 10 automatically can compensate for this fact. The placement of pedicle screws has long been known to be a skill that is developed and learned by each individual spine surgeon. So it was desirable to want to remove as much requirement for the perfect placement of this MAC Pin within the vertebral body as possible, therefore allowing the largest margin of error for surgeons to place the MAC Pin and then connect it through a rod, pedicle screw below. This device within the coupler currently has the ability to move within the sagittal plane both cranial and caudally allows for that and allows the coupler 20 to be attached to the rod 100 in the pedicle screws. Preferably, the coupler 20 is designed with 360 degree motion so as to allow the surgeon margin of error not only in the sagittal plane but also within the coronal plane such that regardless of the surgeons ability to place the MAC Pin 10 appropriately within the vertebral body, the attachment into the rod 100 and the pedicle screw 110 below would be made even easier for that surgeon. In another embodiment, the device or system 1 provides a percutaneous MAC Pin 10 . The MAC Pin 10 design would be the same; however, it is cannulated inside the entire length pin such that this could be done with a minimally invasive procedure as opposed to an open procedure. That would decrease the patient's postoperative pain, decrease the blood loss, decrease the hospital stay length, as well as decrease the patient's long term postoperative pain. Another benefit of doing this procedure percutaneously is that one could then couple this procedure with an anterior lumbar interbody fusion or perhaps a translateral interbody fusion and use a separate approach while placing these pins and reduce the spondylolisthesis percutaneously or in a minimally invasive technique. With regard to the coupler 20 , the coupler 20 probably would not change although modification improvements of the coupler 20 are certainly possible. The most important part of the procedures would remain the same the MAC Pin and the fact that under fluoroscopic assistance interoperatively a stab wound in the skin would be made as opposed to a complete opening of the skin and muscle tissue. So a small k wire (kirschner wire) could be inserted into the pedicle and finally into the vertebral body maintaining the above described technique and that would be followed by the placement of MAC Pins that would be cannulated and then attached to the coupler and the pedicle screw below. Similarly described in the open procedure. A jamsheedy needle would be used to place the guide wire into the vertebral body again percutaneously or minimally invasive and this is certainly a standard well known part of the procedure. However, once the guide wire 80 had been placed and confirmed to be in the appropriate placement, per the interoperative fluoroscope and that would be followed by measuring of the pedicle screw portion of the MAC Pin and then placement of the MAC Pin 10 with a cannulated opening 13 over the guide wire 80 and into the vertebral body to appropriate position based on the interoperative fluoroscope. The next step would be placement of percutaneous pedicle screws, shown in FIGS. 12A-12C , in the previously described placement of percutaneous pedicle screws already established by the assignee of this system as described in co-pending US patent publication 2013/0172937 A1 entitled “Extended Tab bone Screw System” filed Dec. 19, 2012; which is incorporated by reference herein in its entirety; and finally the coupler 20 would be applied over the MAC Pins 10 as described in the open technique and placed within the tulip head below through a minimally invasive being separately described. In another aspect, the two leg extensions are connected via a connector 249 positioned at a point spaced therefrom the first end of the leg extension and spanning the first insertion tool pathway 270 . In one aspect, the connector is positioned substantially perpendicular to the longitudinal axis AL. Positioning the connector 249 a predetermined distance from the first end provides a fulcrum point from which a rod insertion tool can rotate. As seen in FIGS. 19 , 20 and 21 , the stabilizer rod is positioned between the leg extensions with the insertion tool. As the stabilizer rod is positioned lower and toward the second end of the leg extensions, the insertion tool is partially positioned between the leg extensions. At this point, the handle of the insertion tool can be lifted, using the connector as a fulcrum to push the stabilizer rod into position within the rod receiving channel. At that point once again, the end caps on the pedicle screws below would be tightened and fixed once again to serve as an anchor for the MAC Pin after which the surgeon would go back to the MAC Pin 10 and begin the translation and distraction procedure as described above such that after reduction was achieved through the action of the MAC Pin, the cannulated wrench would be slipped over and the nut would once again be tightened and a separate shearing device would be developed to shear the MAC Pin flush with the coupler. And once again the surgeon has achieved a fixed reduced spondylolisthesis that he can now go and perform either anterior lumbar interbody fusion, lateral and foraminal interbody fusion or a posterior lumbar interbody fusion and perhaps even “OLIF” at this point consistent with amendia's portfolio. Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described, which will be within the full intended scope of the invention as defined by the following appended claims.

A spinal alignment correction system ( 1) has a posted lumbar pedicle screw called a MAC Pin ( 10) which has an elongated shaft ( 11) and a rod coupler assembly ( 20) and a cannulated tower ( 40). The elongated shaft ( 11) has an inner pedicle screw portion ( 12) with pedicle threads ( 12 A), an outer second thread portion ( 14) with second threads ( 14 A) and a transition or intermediate portion ( 16) disposed between the pedicle screw portion ( 12) and the second thread portion ( 14). The cannulated tower ( 40) when mounted over said elongated shaft ( 11) abuts said coupler ( 20) along an outer cam surface and further tightening rotation of the cannulated tower ( 40) causes outward movement of the elongated shaft ( 11). The system ( 1) allows for a controlled alignment correction of malaligned vertebral bodies using a number of methods used to correct a variety of indications.

FIELD AND BACKGROUND OF THE INVENTION [0001] The present invention relates to a nasal cannula and to an oral/nasal cannula, and, more particularly, to a nasal cannula and an oral/nasal cannula which permits both delivery of oxygen and accurate sampling of carbon dioxide. [0002] For purposes of description, the discussion herein is focused on cannulas for use with human patients, it being understood that the present invention is not limited in scope only to use with patients and can beneficially be used in various other contexts. [0003] Different types of oral/nasal cannulas are used to deliver oxygen to hospital patients who require assistance to breathe properly, to collect carbon dioxide samples from patients to monitor respiration, or to perform both functions. Such cannulas are used when direct ventilation is not provided. The term “oral/nasal” refers to the adaptable configuration of such cannulas which can be in close proximity to the oral cavity or inserted into the nasal cavity of the patient. In either arrangement, a sidestream of the patient's exhaled breath flows through the cannula to a gas analyzer to be analyzed. The results of this non-invasive analysis provide an indication of the patient's condition, such as the state of the patient's pulmonary perfusion, respiratory system and metabolism. [0004] The accuracy of this non-invasive of exhaled gases depends on the ability of a sampling system to move a gas sample from the patient to the gas anaylzer while maintaining a smooth, laminar flow of gases, such that there are as few alterations to the waveform and response time of the concentration of the gases as possible. The Waveform of the concentration of the gas is critical for accurate analysis. As the gas mixture travels from the patient to the gas analyzer, the concentration of the gases can be affected by nixing of the component gases, which reduces the accuracy of the analysis of the sample by the gas analyzer, and reduces the amount of information obtained from that analysis. [0005] Prior art nasal or oral/nasal cannulas unfortunately have caused significant alteraitions to these important features of the internal structure of the stream of exhaled gases. Such alterations have especially arisen as the result of attempts to combine the delivery of oxygen with the sampling of the exhaled breath of the patient. For example, the simplest nasal cannula design, consisting of a tube with two double hollow prongs for insertion into the nostrils, allows significant mixing of the oxygen which is delivered from the end of one tube, and the exhaled breath which is collected from the end of the second tube. Such mixing occurs when oxygen is delivered in a stream with strong force, so that the oxygen stream penetrates deeply into the nasal cavity even during expiration, thereby artifactually altering the composition of the exhaled gases. [0006] However, attempts to prevent mixing between delivered oxygen and exhaled gases have resulted in other alterations to the exhaled gases. For example, one type of prior art nasal cannula (Salter Labs. Arvin, Calif. USA) consists of a tube with two openings at either end, and two hollow prongs projecting pendicularly from the center of the tube with a partition between them. Oxygen enters the tube from one end and exhaled breath leaves the tube from the other end. The two hollow prongs are inserted into the nasal cavity of a patient, one prong in each nostril, so that oxygen could be delivered to, and exhaled breath collected from, the patient. Unfortunately, the reliance of this cannula on a single nasal prong for collection of exhaled gases does not prevent the strong flow of delivered oxygen from the other nostril mixing with exhaled gases deep in the nasal cavity, above the nasal septum. Such mixing of delivered oxygen with exhaled gases reduces the accuracy of gas analysis. [0007] In addition, this type of cannula usually has significant “void volume”, or space in which mixing of gases, and concurrent alteration of the gas waveform, can occur. Such space is often referred to as “void volume” because it is not part of the pathway for the flow of gases and hence is unproductive. For example, void volume arises in this cannula between the septum dividing the main tube and the junction of each prong with that tube. The presence of such void volume is a significant hindrance to the accurate analysis of exhaled gases. Thus, this prior art nasal cannula has a reduced efficiency for the collection of exhaled gases for analysis. [0008] Another design for a nasal cannula (Hospitak Lindenhurst, N.Y., (USA) has two parallel overlapping tubes, one for delivering oxygen and one for receiving exhaled gases. The tube which receives exhaled gases has two nasal prongs, while the tube which delivers oxygen has two holes parallel to these prongs. Both tubes have two holes, such that the gases can flow freely from the prongs to the holes. This configuration allows delivered oxygen to easily mix with expired gases, even at the end of the expiration period, thereby reducing the accuracy of the gas analysis. [0009] U.S. Pat. No. 5,046,491 discloses another type of nasal cannula which also includes a first tube with two double nasal prongs and a septum placed between the prongs. One prong delivers oxygen and the second prong collects exhaled gases. A second tube is attached to the first tube and has two holes which are placed in or near the oral cavity of the patient for collecting exhaled breath. One problem with this cannula is that the exhaled gases are collected through two outputs, which are then connected to two separate tubes. These separate tubes then join together before delivering the gases to the capnograph. If gases are not flowing at exactly the same rate through both tubes, for example due to condensation, then the waveform of the gas concentration is altered and the results of the analysis are affected. In addition, this cannula has significant void volume because of the large dimension of the tubes and because there are two outputs for collecting the exhaled gases. The large void volume also causes mixing of the gases. Thus, the cannula of U.S. Pat. No. 5,046,491 does not solve the prior art problems for accurate gas analysis by nasal cannulas. [0010] Furthermore, none of these prior art cannulas is a true oral/nasal cannula which can be placed in either the oral or nasal cavities of the patient interchangeably. Such prior art oral/nasal cannulas, which are described below in the “Description of the Preferred Embodiments”, also have significant problems regarding the collection of gases for accurate analysis, but offer the desirable feature of flexibility concerning the respiratory cavity from which exhaled gases are collected. Patients often alternately exhale through the nasal cavity and the oral cavity. The advantage of the oral/nasal cannula is that exhaled gases can be automatically collected from either cavity. The disadvantage is that many prior art oral/nasal cannulas are susceptible to the intake of ambient air through that portion of the cannula which is not receiving exhaled air. For example, if the patient exhales through the oral cavity, ambient air can be sucked into the cannula through the opening provided for the nasal cavity. Such ambient air can dilute the concentration of gas in the exhaled breath of the patient, thus giving misleading results for the gas analysis. [0011] Hereinafter, the term “respiratory cavity” refers to the oral cavity, the nasal cavity, or both cavities, of a patient. [0012] In addition, the effectiveness of oxygen delivery by a cannula is determined by two principles, neither of which is completely fulfilled by prior art cannlulas. The first principle is that the distribution of the delivered oxygen stream should be equal between the two nostrils of the patient. In most prior art cannulas, one nostril receives 1.2-2.0 times as much oxygen as the other. However, an equal distribution of oxygen is preferable for the following reasons. First, if one of the nostrils is blocked, the second will continue to deliver oxygen. Second, even flow rates for both nostrils will not cause the patient to feel excess pressure in one nostril, even at high flow rates for the delivered oxygen. Third, producing even flow rates through the presence of oxygen “clouds” near the nostrils of the patient will cause such “clouds” to be the same size at both nostrils, and will permit the more effective use of ambient oxygen present near the nostrils before the inspiration phase. [0013] The second principle is that the oxygen stream should be delivered at a relatively slow rate, rather than being forced into the nostrils at a high rate, for the following reasons. First, an oxygen stream which is delivered at a slows rate will not penetrate deeply into the nostrils of the patient and so will not be collected during the exhalation phase, thereby preventing distortion of the carbon dioxide measurements because of dilution of the exhaled gases. Second, the patient will feel more comfortable since the oxygen stream will not be so forceful. [0014] If both principles are fulfilled, then oxygen delivery and analysis of exhaled gases will be optimized. Unfortunately, many prior art cannulas fail to implement these principles and are thus lacking in this respect. [0015] There is thus a widely recognized need for, and it would be highly advantageous to have, a cannula which does not alter the gas waveform, which does not easily become blocked or clogged, which has minimal added void volume, and which can deliver oxygen without disturbing the waveform of exhaled gases, yet which has the flexibility and adaptability of an oral/nasal cannula. SUMMARY OF THE INVENTION [0016] According to the present invention there is provided a nasal cannula for collection of exhaled gases from a patient having nostrils, comprising (a) two nasal prongs for insertion into the nostrils of the patient; and (b) a collection tube for the collection of the exhaled gases from the patient, the nasal prongs and the collection tube being connected at a single junction, such that the exhaled gases flow freely from the nasal prongs to the collection tube. Preferably, the collection tube is a single collection tube. Also preferably, the nasal prongs are joined in an are substantially before being connected to the junction. Preferably, the collection tube delivers the exhaled gases to a capnograph for gas analysis. [0017] According to another embodiment of the present invention, there is provided a cannula for collection of exhaled gases from a patient having nostrils and an oral cavity, including: (a) two nasal prongs for insertion into the nostrils of the patient; (b) an oral prong for being located proximately to the oral cavity of the patient; and (c) a collection tube for the collection of the exhaled gases from the patient, the nasal prongs, the oral prong and the collection tube being connected at a single junction located substantially near the nostrils of the patient, such that the exhaled gases flow freely from the nasal prongs and the oral prong to the collection tube. Preferably, the collection tube is a single collection tube. Also preferably, the oral prong features a distal portion, the distal portion being bent at an angle. More preferably, the angle is about 90 degrees, such that the distal portion is located proximately to the oral cavity of the patient. Most preferably, the distal portion features a cap, the cap being attached to the distal portion, and the cap being made of a substantially hydrophilic material, such that the cap absorbs condensation from the distal portion. Also preferably, the nasal prongs are joined in an arc substantially before being connected to the junction. Preferably, the collection tube delivers the exhaled gases to a capnograph for gas analysis. [0018] According to preferred embodiments of the present invention, the cannula further includes (d) an oxygen tube for delivery of oxygen, the oxygen tube being located near the nostrils of the patient; and (e) two oxygen inlets connected to the oxygen tube and being disposed such that the oxygen flows from the oxygen tube into the nostrils of the patient. [0019] Preferably, the oxygen tube is located either above or below the nostrils of the patient. Also preferably, the oxygen tube includes a centrally located input for receiving oxygen being placed substantially equidistant from both oxygen inlets. Preferably, the oxygen inlets are holes. More preferably, the holes have an first diameter at an inner surface of the oxygen tube and the holes have a second diameter at an outer surface of the oxygen tube, the first diameter being smaller than the second diameter. Most preferably, the oxygen tube features a screen, the screen being placed within the oxygen tube such that the oxygen flows from the oxygen tube through the screen. Preferably, the screen is constructed of a material selected from the group consisting of a hydrophobic porous material, a wide mesh and a netting. [0020] Alternatively and preferably, the inlets are oxygen prongs for being inserted into the nostrils 0 f the patient. More preferably, the oxygen prongs are substantially shorter in length than the nasal prongs, such that the nasal prongs extend farther into the nostrils than the oxygen prongs. Also more preferably, the oxygen prongs are formed of a substantially porous material, such that the oxygen prongs are permeable to gases. Most preferably, the oxygen prongs are formed from an inner cylinder and an outer cylinder, both cylinders being made from the substantially hydrophobic porous material, and the inner cylinder being substantially shorter in length than the outer cylinder. [0021] According to other preferred embodiments of the present invention, at least a portion of the oxygen tube is formed from a substantially porous material such that the at least a portion of the oxygen tube is permeable to gases. More preferably, the at least a portion of the oxygen tube is located substantially between the oxygen prongs. [0022] According to another embodiment of the present invention, there is provided a method of using the cannula of claim 1 for collecting the exhaled gases from patient, including: (a) inserting the nasal prongs into the nostrils of the patient: (b) attaching the collection tube to a conduit for conducting gas; (c) connecting the conduit to a gas analyzer; and (d) applying a force at the gas analyzer such that the exhaled gases flowing through the cannula moves from the collection tube to the gas analyzer. [0023] According to yet another embodiment of the present invention, there is provided a cannula for collection of exhaled gases from a patient and for delivery of oxygen to a patient, the patient having nostrils and an oral cavity, including: (a) two nasal prongs for insertion into the nostrils of the patient; (b) an oral prong for being located proximately to the oral cavity of the patient; (c) a collection tube for the collection of the exhaled gases from the patient, the nasal prongs, the oral prong and the collection tube being connected at a single junction, such that the exhaled gases flow freely from the nasal prongs and the oral prong to the collection tube; (d) an oxygen tube for delivery of oxygen, the oxygen tube being located near the nostrils of the patient; and (e) two oxygen inlets connected to the oxygen tube and being disposed such that the oxygen flows from said oxygen tube into the nostrils of the patient. [0024] Hereinafter, the term “attached” is defined as connected to, or integrally formed with. Hereinafter, the term “connected” is defined as communicating with. Hereinafter, the term “prong” refers to a hollow tube with two openings, one at each end of the tube. BRIEF DESCRIPTION OF THE DRAWINGS [0025] The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein: [0026] [0026]FIG. 1 is an illustrative prior art oral/nasal carbon dioxide cannula. [0027] [0027]FIG. 2 is an illustrative prior art double nasal oxygen/carbon dioxide cannula for oxygen delivery and collection of exhaled gases; [0028] [0028]FIG. 3 is a second illustrative prior art divided nasal oxygen/carbon dioxide cannula for oxygen delivery and collection of exhaled gases; [0029] [0029]FIG. 4 is an illustrative oral/nasal cannula for the collection of exhaled gases according to the present invention; [0030] FIGS. 5 A- 5 C are cross-sectional views of the cannula of FIG. 4 according to the present invention; [0031] [0031]FIGS. 6A and 6B show cross-sectional views of a second illustrative embodiment of an oral/nasal cannula according to the present invention; [0032] [0032]FIGS. 7A and 7B show portions of the oral/nasal cannula of FIGS. 6A and 6B in more detail, with the preferred addition of a porous screen to the oxygen tube according to the present invention; [0033] [0033]FIGS. 8A and 8B show detailed cross-sectional views of portions of a third embodiment of an oral/nasal cannula with porous oxygen delivery tubes according to the present invention; and [0034] [0034]FIG. 9A shows a prior art cannula for oxygen delivery, and FIGS. 9 B- 9 C show a cannula with equal oxygen delivery to each nostril according to the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0035] The present invention is of a cannula which can effectively be used to collect samples of gas without reducing the accuracy of the analysis of the collected gas, and which is less likely to become blocked by condensed moisture, or by liquid or solid material, or their mixtures thereof, such as mucous or saliva. Specifically, the present invention has two prongs for insertion into the nostrils of a patient. These two prongs are joined outside the nasal cavity to a single output tube for collection of the exhaled gases. According to preferred embodiments of the present invention, a second tube is attached to the two prongs, which is parallel to the nasal prongs, for placement of the distal end of the tube near the oral cavity of the patient, thereby providing an oral/nasal cannula. According to other preferred embodiments of the present invention, an additional tube is provided for the delivery of oxygen, the additional tube having two additional prongs for insertion into the nostrils of the patient, and the additional tube being perpendicular to the additional nasal prongs. [0036] The principles and operation of an airway adapter according to the present invention may be better understood with reference to the drawings and the accompanying description. [0037] Referring now to the drawings, FIG. 1 shows a prior art oral/nasal carbon dioxide cannula. A cannula 10 has two nasal prongs 12 for insertion into the nostrils of a patient (not shown). Nasal prongs 12 are connected to a first side 14 of a hollow tube 16 . Hollow tube 16 is substantially perpendicular to nasal prongs 12 . Two oral prongs 18 are also connected to a second side 20 of tube 16 in a substantially perpendicular orientation, such that gas flow from nasal prongs 12 to oral prongs 18 through tube 16 is substantially free and unimpeded. Tube 16 also has two holes 22 , one at each end of tube 16 , for connection to one of a plurality of connectors 24 . Each connector 24 is attached to a gas line (not shown) which is then connected to a Y-connector 26 . Y-connector 26 is attached to a line which leads to a capnograph (not shown). Thus, cannula 10 is suitable only for collection of exhaled gases for analysis. [0038] Prior art cannula 10 unfortunately has a significant void volume 28 (also designated as V o ) between nasal prongs 12 , within which gases do not properly circulate. Two smaller void volumes 30 (also designated as V 1 and V 2 ) are also present parallel to nasal prongs 12 and oral prongs 18 . Such void volumes 28 and 30 , and especially the larger void volume 28 , permit the mixing of exhaled gases from a currently exhaled breath with previously exhaled breaths, thereby increasing the response time, altering the waveform and introducing an artifact into the gas analysis. Furthermore, the separation of the exhaled gases into two streams from nasal prongs 12 by tube 16 , the later reintegration of the two streams at Y-connector 26 and the subsequent great distance of about 0.5 m between tube 16 and Y-connector 26 , also increases the response time if there is even a slight difference in the flow rated of the gases between tubes 16 . Such separation potentially also results in two streams having different flow properties. For example, if one tube 16 accumulated more condensed water than the other, the corresponding stream of exhaled gases would have a lower flow rate, thereby altering the waveform of the gas concentrations and increasing the response time for gases in that tube 16 . Thus, prior art cannula 10 cannot provide completely accurate collection of gases for analysis. [0039] [0039]FIG. 2 shows an exemplary prior art double oxygen/carbon dioxide nasal cannula for the collection of exhaled gases and the delivery of oxygen. A prior art nasal cannula 32 again has a first pair of nasal prongs 34 for insertion into nostrils 36 of a patient. First nasal prongs 34 are again connected to a first hollow tube 38 . First hollow tube 38 is again substantially perpendicular to first nasal prongs 34 . In additions, nasal cannula 32 has a second pair of nasal prongs 40 for insertion into nostrils 36 . Second nasal prongs 40 are attached to a second hollows tube 42 in a substantially perpendicular orientation. First nasal prongs 34 and first hollow tube 38 are intended for the collection of exhaled gases from the patient, in a substantially similar configuration as that shown in FIG. 1. Second nasal prongs 40 and second hollow tube 42 are intended to deliver oxygen to the patient, so that nasal cannula 32 is capable of simultaneous oxygen delivery and gas collection. [0040] Unfortunately, prior art nasal cannula 32 also permits the mixing of delivered oxygen and exhaled gases between first nasal prongs 34 and second nasal prongs 40 in nostrils 36 , thereby diluting the true concentration of expired analysis of expired gases. [0041] Also, the efficiency of oxygen delivery by prior art nasal cannula 32 is not sufficient because the oxygen flow rate varies between nasal prongs 40 . Specifically, nasal prong 40 which is closer to the input of hollow tube 42 will have a higher flow rate than the other nasal prong 40 . In addition, the strong oxygen stream into the nostrils creates discomfort for the patient, the alleviation of which is especially important for long term oxygen delivery. [0042] [0042]FIG. 3 shows a second exemplary prior art divided oxygen/carbon dioxide nasal cannula for the simultaneous delivery of oxygen and collection of exhaled gases. A prior art nasal cannula 44 has a single tube 46 for both delivery of oxygen and collection of gases. Tube 46 has two nasal prongs 48 and 50 for insertion into nostrils 52 of a patient. Oxygen is delivered through nasal prong 48 and exhaled gases are collected from nasal prong 50 . A septum 54 is present inside tube 46 between nasal prong 48 and nasal prong 50 to separate the delivered oxygen from the exhaled gases. However, particularly forceful streams of delivered oxygen can pass from nasal prong 48 , penetrate deeply into nostrils 52 , entering nasal prong 50 and dilute the true concentration of exhaled carbon dioxide. Furthermore, a significant void volume 56 is present between septum 54 and nasal prong 50 , both increasing the response time and mixing the exhaled gases, which also reduce the accuracy of the analysis of the exhaled gases. Thus, prior art nasal cannula 44 is still not able to collect gases for a completely accurate analysis. In addition, the strong oxygen stream into the nostrils creates discomfort for the patient, the alleviation of which is especially important for long term oxygen delivery. [0043] [0043]FIG. 4 shows a schematic illustration of an exemplary novel oral/nasal carbon dioxide cannula for collection of exhaled gases according to the present invention. An oral/nasal cannula 58 also has a pair of nasal prongs 60 for insertion into the nostrils 62 of a patient. Cannula 58 preferably features an oral prong 64 for placement near the oral cavity of the patient (not shown) to form an oral/nasal cannula. If oral prong 64 is absent, then cannula 58 is a nasal cannula according to the present invention. Cannula 58 also has a collection tube 66 for collection of the exhaled gases for analysis by a capnograph (not shown). Nasal prongs 60 , oral prong 64 and collection tube 66 meet at a single junction 68 , which is preferably minimized to reduce void volume. Hereinafter, the term “single junction” refers to the joining of nasal prongs 60 , oral prong 64 and collection tube 66 at least in close proximity, and preferably at exactly one junction. [0044] At the very least, having the single junction 68 between all portions of oral/nasal cannula 58 significantly reduces the void volume, thereby reducing mixing of the gases and maintaining the response time. In addition, having the single collection tube 66 , rather than two such tubes as in prior art cannulas. eliminates the division of the stream of exhaled gases as well as reducing the amount of void volume created. [0045] A cross-sectional view of the oral/nasal cannula of FIG. 4 is shown in FIG. 5A- 5 C, clearly illustrating the small void volume created within the cannula. FIG. 5A shows a front cross-sectional view of oral/nasal cannula 58 . As clearly shown in the illustration, nasal prongs 60 , oral prong 64 and collection tube 66 all meet at a single small junction 68 with a minimum void volume. In practice, the void volume can be almost completely eliminated through this configuration, because there are no poorly ventilated areas within oral/nasal cannula 58 . As shown in the illustration, a portion 70 of collection tube 66 does extend past nasal prongs 60 opposite to the collection point. However, portion 70 is blocked and is only intended to permit the attachment of a symmetrical loop which extends around the head of the patient (not shown). [0046] [0046]FIG. 5B shows a side cross-sectional view of the connection between one nasal prong 60 and oral prong 64 . Preferably, a distal end 72 of oral prong 64 is bent, more preferably at approximately a 90 degree angle from the remainder of oral prong 64 , so as to be substantially parallel to the direction of flow of orally exhaled gases from the patient. Such an orientation both provides optimal response time for gas analysis and promotes self-clearing of condensation from oral/nasal cannula 58 . Furthermore, preferably nasal prongs 60 are joined in an are, so that condensation tends to move into oral prong 64 under dynamic pressure of the nasal exhalation of gases by the patient. [0047] The structure of oral/nasal cannula 58 is designed to eliminate one significant problem with certain prior art oral/nasal cannulas, which is the susceptibility of these prior art cannulas to the intake of ambient air through that portion of the cannula which is not receiving exhaled air. For example, if the patient exhales through the nasal cavity, ambient air can be sucked into the prior art cannula through the opening provided for the nasal cavity. Such ambient air can dilute the concentration of gas in the exhaled breath of the patient, thus giving misleading results for the gas analysis. The structure of oral/nasal cannula 58 reduces or eliminates this problem with the presence of single small junction 68 , and the bending of distal end 72 of oral prong 64 . The resultant structure substantially prevents ambient air from entering the portion of cannula 58 which is not directly receiving exhaled air from the patient. [0048] Also preferably, nasal prongs 60 and oral prong 64 have an optimal diameter, sufficiently large to promote rapid and easy removal of condensation from the interior of nasal cannula 58 , yet not so large as to increase the response time. For this configuration, an optimal diameter for both nasal prongs 60 and oral prong 64 is in a range of from about 1.6 mm to about 2.0 mm. [0049] Most preferably, distal end 72 of oral prong 64 features a porous, hydrophilic cap 74 , as shown in cross-section in FIG. 5C. Porous hydrophilic cap 74 covers distal end 72 and absorbs water droplets formed from condensation which collects in nasal cannula 58 . The particular advantage of cap 74 is that the material of cap 74 preferable attracts water away from oral prong 64 , and then provides a relatively large surface area for evaporation of that water. Additionally, cap 74 relieves potential patient discomfort from water dripping from cannula 58 into the mouth of the patient. [0050] [0050]FIGS. 6A and 6B show cross-sectional views of a second preferred embodiment of the oral/nasal cannula for oxygen delivery and gas collection of the present invention. Detailed illustrations of portions of the cannula of FIGS. 6A and 6B are show in FIGS. 7A and 7B. FIGS. 7A and 7B also show the preferred addition of a porous screen to the oxygen tube. [0051] In this preferred embodiment, as shown in FIG. 6A, an oral/nasal cannula 76 again has a pair of nasal prongs 78 for insertion into the nostrils of a patient (not shown). Cannula 76 again preferably features an oral prong 80 for placement near the oral cavity of the patient (not shown) to form an oral/nasal cannula. Cannula 76 also has a collection tube 82 for collection of the exhaled gases for analysis by a capnograph (not shown). Nasal prongs 78 , oral prong 80 and collection tube 82 again meet at a single junction 84 , which is preferably minimized to reduce void volume. [0052] Although cannula 76 also features an oxygen tube 86 for lying near the nostrils of the patient (not shown) and more preferably above or below the nostrils of the patient, substantially parallel with the upper lip of the patient (not shown). oxygen is not delivered through a second set of nasal prongs. Instead, oxygen tube 86 has two holes 88 , through which oxygen is delivered to the patient. Holes 88 are placed near the nostrils of the patient yet do not enter the nostrils, thereby preventing the delivered oxygen from entering as a forceful stream of gases which dilutes the exhaled gases and reduces the accuracy of gas analysis. [0053] [0053]FIG. 6B shows a side cross-sectional view of junction 84 between one nasal prong 78 and oral prong 80 , as well as a portion of oxygen tube 86 . Oxygen is shown being dispersed from oxygen tube 86 through hole 88 . [0054] [0054]FIG. 7A shows holes 88 in more detail. Holes 88 preferably have a relatively large diameter. Most preferably the diameter of holes 88 increases from the inner surface of oxygen tube 86 to the outer surface of oxygen tube 86 , in order to reduce the force of the delivered oxygen stream. Holes 88 have a first smaller diameter 90 at the inner surface of oxygen tube 86 , and a second larger diameter 92 at the outer surface of oxygen tube 86 , with the diameter of holes 88 preferably gradually increasing from the inner to the outer surface of oxygen tube 86 . [0055] In addition, as shown in FIG. 7A, oxygen tube 86 preferably features a screen 94 made from a substantially porous material which is permeable to oxygen, such as a wide mesh, a hydrophobic porous screen, netting or cotton wool, for example. The advantages of screen 94 are that the force of the delivered oxygen stream is reduced and an oxygen “cloud” is created near the nostrils of the patient. The combination of the dispersion of oxygen through screen 94 and hole 88 is shown in a side cross-sectional view in FIG. 7B, which also shows junction 84 . [0056] [0056]FIGS. 8A and 8B provide a detailed illustration of a portion of a third embodiment of an oral/nasal cannula according to the present invention. FIG. 8A shows a portion of an oral/nasal cannula 96 , showing a section of a pair of nasal prongs 98 for receiving exhaled carbon dioxide, an oxygen tube 100 and a pair of second nasal prongs 102 . As clearly illustrated, oxygen is delivered through oxygen tube 100 and is then dispersed through second nasal prongs 102 . [0057] Preferably, second nasal prongs 102 are constructed from two cylinders, in order to ensure that oxygen is delivered to the nostrils of the patient efficiently, yet is quickly dispersed within the nasal cavity. The first cylinder is an inner cylinder 104 . Preferably made from a substantially porous hydrophobic material. The material is preferably hydrophobic to prevent absorption of moisture. Inner cylinder 104 is surrounded by an outer cylinder 106 , also preferably made from a substantially porous hydrophobic material, such that oxygen is dispersed throughout the nostrils of the patient, rather than entering the nasal cavity as a highly pressurized stream of gas. [0058] [0058]FIG. 8B shows a side, cross-sectional view of the portion of the cannula illustrated in FIG. 8A. A junction 108 between one nasal prong 98 and an oral prong 110 is shown, as is one second nasal prong 102 with inner cylinder 104 and outer cylinder 106 . The advantage of constructing second nasal prong 102 from a porous material is such material would be permeable to oxygen, thereby allowing oxygen to disperse evenly from second nasal prong 102 . Such dispersion reduces the force of the delivered oxygen stream. [0059] FIGS. 9 A- 9 C show a comparison between a prior art oral/nasal cannula in which oxygen is delivered unequally to the nostrils of the patient (FIG. 9A), and a oral/nasal cannula according to the present invention in which oxygen is delivered at equal flow rates (FIGS. 9B and 9C). FIG. 9A shows a cross-sectional view of the oxygen-delivery portion of a typical prior art oral/nasal cannula 112 . Prior art cannula 112 has an oxygen delivery tube 114 for delivery oxygen to two outputs 116 and 118 . Outputs 116 and 118 could be holes or nasal prongs as shown previously. The problem with this configuration is that oxygen is not distributed evenly between both outputs 116 and 118 . Output 116 , which is closest to the start of oxygen delivery tube 114 , has a greater flow of oxygen than output 118 , as indicated by the arrows. Such a situation arises because the resistance of outputs 116 and 118 to the flow of oxygen is much lower than the resistance of the connecting portion of oxygen delivery tube 114 . [0060] [0060]FIG. 9B shows a cross-sectional view of the oxygen-delivery portion of a first exemplary oral/nasal cannula 120 according to the present invention. First cannula 120 has an oxygen delivery tube 122 for delivery oxygen to two sets of outputs 124 and 126 . Each set of outputs 124 and 126 includes at least two outputs, although three are shown here for illustrative purposes, without any intention of being limiting. Again, the outputs could be holes, holes with a porous screen, or nasal prongs as shown previously. The advantage of this configuration is that oxygen is distributed more evenly between both sets outputs 124 and 126 . Such a situation arises because the resistance of both sets of outputs 124 and 126 to the flow of oxygen is much greater than the resistance of the connecting portion of oxygen deliver tube 122 . [0061] [0061]FIG. 9C shows a cross-sectional view of the oxygen-delivery portion of a second exemplary oral/nasal cannula 128 according to the present invention. Second cannula 128 has an oxygen delivery tube 130 for delivery oxygen to two sets of outputs 132 and 134 . Each set of outputs 132 and 134 includes at least one output, although only one is shown here for illustrative purposes, without any intention of being limiting. Again, the outputs could be holes, holes with a porous screen, or nasal prongs as shown previously. Additionally, oxygen delivery tube 130 features a centrally located input 136 for the delivery of oxygen. Preferably, centrally located input 136 is located substantially equidistantly to outputs 132 and 134 . The advantage of this configuration is that oxygen is distributed more evenly between both sets of outputs 132 and 134 even for their relatively lower resistance to air flow in comparison to the resistance of oxygen delivery tube 130 . Such a situation arises because the resistance of each output 132 and 134 to the flow of oxygen is equal. TESTING OF THE ORAL/NASAL CANNULA [0062] The features and embodiments illustrated herein may be better understood with reference to the experiments described below. These experiments were conducted on oral/nasal cannulas according to the present invention, as well as on examples of prior art cannulas. [0063] Experimental Methods [0064] The first test performed was the self-cleaning test. Self-cleaning is important for preventing the accumulation of condensed water, which can disturb the sampling of carbon dioxide. The term “V ex ” is defined as the minimal volume of expired breath required for self-cleaning of water from the cannula. [0065] The second test was the response time test, performed in accordance with Regulation prEN 864:1992 (European Union standard) for capnography. All measurements were conducted on a capnograph with low flow rate of 47 ml/min. Response times (in mSec) were tested for nasal cannula blanks only, nasal cannula systems which also included the set of sample lines, and the entire capnograph set which included the nasal cannula system with a typical capnograph flow system. [0066] The third test determined the accuracy of measurements of expired carbon dioxide (EtCO 2 ). Expired carbon dioxide was measured both with and without oxygen delivery. In the absence of oxygen delivery, the alteration to the true EtCO 2 caused by the influence of the response time was calculated as: Δ(EtCO 2 )=EtCO 2 (True value)−EtCO 2 (with Entire Capnograph Set) [0067] In the presence of oxygen delivery, the alteration to the true EtCO 2 was calculated as Δ(EtCO 2 )=EtCO 2 (Q=0)−EtCO 2 (Q≠0) [0068] The fourth test measured the effectiveness of the delivery of oxygen according to the flow distribution between the two nasal cannula oxygen delivery outputs. Oxygen was delivered at the rate of 8 L/min. The flow of oxygen from each output, given as Q 1 and Q 2 , was measured. The efficiency (K eff ) was determined according to the ratio of Q 1 to Q 2 . [0069] These four tests where performed on several different types of cannulas. Three types of cannulas were obtained and tested from Salter Labs (Arvin, Calif., USA): a nasal cannula (catalog number 4000); a dual oral/nasal cannula (catalog number 4001); and divided oxygen/carbon dioxide nasal cannula (catalog number 4707). Two types of cannulas were obtained and tested from Hudson (Temecula, Calif., USA): a nasal cannula (catalog number 1103): and an oxygen/carbon dioxide nasal cannula (catalog number 1843). An oral/nasal cannula according to the present invention was also tested, in the embodiment of an oxygen/carbon dioxide oral/nasal cannula with inserts of braid or cotton wool for oxygen dispersion as shown in FIG. 7B. Results for all tests are shown in Table 1. [0070] Essentially, the cannula of the present invention performed at least as well as, and in many respects better than, the prior art cannulas. In particular, the cannula of the present invention had a much lower response time than any of the other tested prior art cannulas. For example, without any additional connections, the cannula of the present invention had a response time of 14, while those of the cannulas of Hudson were 97 and 47, and those of the cannulas of Salter Labs were 167, 143 and 239. Thus, clearly the cannula of the present invention had a far better response time than these tested cannulas. [0071] While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations modifications and other applications of the invention may be made.

A nasal/oral cannula for the collection of exhaled gases from the nostrils of a patient, made up of two nasal prongs for insertion into the patient's nostrils and a collection tube for the collection of the exhaled gases, the nasal prongs and the collection tube being connected at a single junction, such that the exhaled gases flow freely from the nasal prongs to the collection tube. An oral prong can also be provided, whose end is placed near the oral cavity of the patient, the oral prong too being connected at the single junction of the nasal prongs and the collection tube.

BACKGROUND OF THE INVENTION The invention relates generally to the field of apparatus for loading condoms onto mandrels. More particularly, the invention relates to a condom loading apparatus utilizing a number of rods to expand the condom as it is drawn down onto the mandrel. The handling of condoms by mechanized means has long been a problem within the industry. Because condoms are elastic, non-rigid devices made of thin-walled latex or similar materials with no particular configuration unless supported or held by outside means, few if any devices have been developed which can successfully perform handling operations, such that most handling operations are be necessity carried out by hand. For example, each condom must be tested for the presence of minute holes after manufacture. This is done by stretching each condom by hand onto a metal mandrel of appropriate shape. The condom is then passed over an electrically charged net. If any current passes from the net to the mandrel, the condom is rejected. It is an object of this invention to provide an apparatus which can mechanically load a condom onto a mandrel. It is a further object of this invention to provide such an apparatus which utilizes expansion rods mounted on a movable carriage to stretch the condom onto the mandrel, whereby the condom is positioned on the expansion rods and the carriage is moved in a linear motion to load the mandrel and then clear into a retracted position, such that the loaded mandrel can then be moved for testing. SUMMARY OF THE INVENTION The invention comprises in general an apparatus having mandrel loading means mounted onto a track, the loading means comprising a number of expansion rods which occupy a relatively restricted area in the rest position in order to receive a condom, but which can be expanded around the mandrel to stretch the condom onto the mandrel. The configuration of the carriage and mount holding the expansion rods allows the carriage to be passed over the length of the mandrel into a recessed position to allow subsequent movement of the loaded mandrel for testing purposes. The carriage is mounted onto a track such that it receives the condom from a condom retaining means at the uppermost portion of the track and is brought downward on a line such that the central axis of the group of expansion rods is on the same line as the central axis of a mandrel in the loading position. The mandrel expands the expansion rods, thereby stretching the condom. The movement of the carriage down and past the mandrel strips the condom onto the mandrel, and the mandrel can now be moved for testing and the carriage returned to the upper position. This cycle is then repeated for successive condoms. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a combination of front and side views of the two types of expansion rod configurations. FIG. 2 is a view illustrating the initial receiving positioning of the expansion rods and the mandrel loading positioning. FIG. 3 is a view of the rod carriage in the receiving position. FIG. 4 is a view of the loading apparatus showing rod carriages in various positions of the loading cycle. DETAILED DESCRIPTION OF THE INVENTION With reference now to the drawings, the invention will be described in detail with regard to the best mode and preferred embodiment. The invention is an apparatus for loading condoms 90 onto a mandrel 91 which is shaped in matching configuration to the condom 90 and comprises a movable carriage assembly 60 upon which are mounted a number of expansion rods 50 for receiving and stretching a condom 90, whereby the condom 90 is deposited onto the mandrel 91 by movement of the carriage 60. The expansion rods 50 act as runners on the surface of the mandrel 91, such that there is no resistance or contact between the mandrel 91 and the condom 60 until the tip of the condom 90 is brought down onto the tip of the mandrel 91. The carriage assembly 60 and expansion rods 50 can be seen in FIG. 3. This illustration shows the rods 50 in the receiving position to receive the condom 90 prior to loading it onto the mandrel 91. The carriage assembly 60 is comprised of a rod mount 62 to which are attached the multiple expansion rods 50. The carriage assembly 60 is mounted onto a linear carriage track 65 which allows reciprocal movement of the carriage 60 past the mandrel 91 to be loaded. Condom retaining means 30 holds the condom 90 is a vertical position with the tip of the condom 90 on top so that the base, ring and open end of the condom 90 hang downward. Condom retaining means 30 can be any suitable mechanism for presenting the condom 90 in the described manner, and can comprise mechanical or suction means 95 to hold the tip for release and to keep the body expanded to allow for insertion of the expansion rods 50 into the condom 90. Alternatively and preferably, it has been found that simply maintaining the tip of the condom 90 at the uppermost position and then releasing it to fall onto the expansion rods 50 is the simplest and most efficient way to place the condom 90 onto the expansion rods 50. As the condom 90 falls, air fills the interior through the open end, thus expanding the condom 90 like a parachute to settle onto the rods 50. Expansion rods 50 are preferably thin, elongated members of small cross-sectional diameter composed of a rigid metal or like material. While rods 50 may be configured in many various shapes, the configuration shown in FIGS. 1 and 2 has been found to be very effective in loading the condom 90 onto the mandrel 91. It is best to use at least three, and preferably four or more rods 50 to expand the condom 90 as it is drawn over the mandrel 91. The object is to minimize and preferably completely eliminate any contact between the sides of the mandrel 91 and the sides of the condom 90. The use of four rods 50 positioned 90 degrees apart in the expanded configuration is preferred. The rods 50 are pivotally mounted onto a generally U-shaped mount 62 surrounding a mandrel receiving opening 61. The connecting segment 51 of each rod 50 is attached to a pivoting post 63, which is biased by a spring 64 such that the rods 50 occupy a rest position, shown by the dotted lines in FIG. 2, with the tips 55 of all the rods 50 being relatively contiguous or adjacent to one another and the main body segments 53 being generally parallel and also contiguous or adjacent each other. A positioning pin 67 is used to maintain the rods 50 in this position. It is necessary that the tips 55 occupy a relatively small area so that they will not interfere with the drop of the condom 90, as the tip of the condom 90 should end up resting on the tips 55 of the rods 50. In the preferred configuration, as seen in FIG. 1, each rod 50 is comprised of a connecting segment 51 for insertion into the pivoting posts 63, a main body segment 53, a transition segment 52 joining the main body 53 and the connecting segment 51 angled such that the central axis of the main body segment 53 does not intersect the central axis of the connecting segment 51, and a blunt or rounded tip 55. Preferably, one rod 50 is slightly longer than the others and is provided with a centering extension segment 54, whereby the tip 55 of this rod 50 is positioned on the central axis of the grouping of all the rods 50. This results in only a single uppermost tip 55, thus insuring that the condom 90 will not be snagged as it is dropped onto the rods 50. This configuration is preferred as it enables the main body segment 53 of each rod 50 to remain parallel to the sides of the mandrel 91 as they are passed down over it. FIG. 4 shows an apparatus with two carriage tracks 65. A reciprocating means 66, such as an air cylinder, mounted onto a frame 94 moves each carriage 60 up and down track 65. Three positions A, B and C are illustrated. Position A is the receiving position previously described at which the condom 90 is placed onto the expansion rods 50. Position B is the mandrel loading position, and position C is the retracted position. After the condom 90 is placed onto the rods 50, the carriage is moved down along track 65 to mandrel 91. The mandrel receiving opening 61 is positioned opposite from the connecting means attaching the carriage 60 to the track 65, in the upward orientation as shown. The mandrel 91 is mounted so as to depend from a mandrel shuttle 92, with the connecting means being on top of the mandrel 91. As the carriage assembly 60 is brought down to mandrel 91, it freely passes the mandrel 91 because of the mandrel receiving opening 61. As the tip of the mandrel 91 encounters the transition segments 52 of the rods 50, they are forced outward to the positions shown by the solid lines in FIG. 2. This stretches the condom 90 to a size greater than the outer circumference of the mandrel 91, the main body segments 53 of the rods 50 acting as runners and spacers along the length of the mandrel 91. As the carriage 60 is brought lower, the tip of the mandrel 91 encounters the tip of the condom 90 and acts as an anchor, as shown in position B of FIG. 4. The carriage 60 continues downward and the expansion rods 50 are pulled out of the condom 90, leaving the condom 90 fully loaded onto the mandrel 91. With the carriage 60 now in the fully retracted position C, the mandrel shuttle 92 can move the loaded mandrel 91 to the testing and then the condom removal position. When mandrel 91 is moved away from track 65, the carriage 60 is returned to the receiving position A for another cycle. As explained, it is preferable that the rods 50 be in a vertical position to receive the condom 90, especially when the gravity drop method is utilized. For removal of the condom 90 from the mandrel 91 after testing, however, it is preferred that the mandrel 91 be non-vertically oriented. As shown in FIG. 4, this requires that the expansion rods 50 be repositioned from the vertical alignment of position A to the alignment of position B which matches the mandrel 91 alignment. In this embodiment, this realignment is accomplished by pivotally attaching the rod mount 62 to carriage 60 and positioning a roller 68 which enters an orienting slot 93 on frame 94 at the upper end of track 65. As carriage assembly 60 is moved upward by reciprocating means 66, the roller 68 pivots the mount 62 such that the rods 50 are vertically aligned. As the carriage 60 is lowered, the mount 62 pivots back into its resting position and the rods 50 are aligned with mandrel 91. It is understood that equivalents and substitutions to elements or components set forth above may be obvious to those skilled in the art. The full scope and definition of the invention therefore is to be as set forth in the following claims.

An apparatus for loading condoms onto mandrels is disclosed, the apparatus comprising a number of expansion rods adapted to receive and stretch a condom, the rods being mounted on a reciprocating carriage assembly which moves the rods past the mandrel, the mandrel itself stripping the condom from the rods.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of earlier filed U.S. Provisional Patent Application No. 60/760,638, filed Jan. 21, 2006, and having the same title and inventor as above. FIELD OF THE INVENTION [0002] The present invention relates to a board or other structure having skate wheels or the like that is self propelled in a forward trajectory by side-to-side movement. BACKGROUND OF THE INVENTION [0003] The prior art contains many different types of wheeled recreational devices, including skate boards and a collection of three-wheeled scooters or “cambering vehicles,” the latter being propelled by side-to-side movement. [0004] Skate boards tend to have a longitudinal axis and travel in a line-of-direction substantially aligned with that longitudinal axis. Forward travel is typically achieved by a push and coast movement, with a user pushing off the ground, placing the push foot on the board, and coasting until slow, then repeating. These types of devices require a user to continually remove their foot from the board and push off of a resistant substrate to attain forward propulsion. These devices tend to be well suited for sidewalk and street travel, but may be less suited for smaller or more restricted spaces. [0005] The cambering vehicles or the like tend to have three wheels, with a turnable front wheel and a handle bar for steering (similar to a conventional tri-cycle). While these vehicles may be propelled by side to side movement, they include a steering infrastructure, relatively extensive vertical supports and controls, and a limited wheel-base. [0006] The self-propelled wheeled device of the present invention is compact, relatively lightweight, and physically small in profile. In contrast to a conventional skate board, the present invention achieves forward propulsion in a manner that does not require a user to continually step on and off a board. With the present invention, a user leaves both feet positioned on the board or “platform” and achieves forward propulsion by shifting his or her weight from side to side. The present invention thus provides an alternative transportation method and different recreational outlets. [0007] Among other features and benefits, the present invention increases recreational opportunities available to youth (and to adults). For example, as we live at higher population densities, there is less space available to children and adults for recreational and/or physical exercise opportunities. Our less active lifestyles are further influenced by automobile travel (not self-propelled) and time in front of a television or computer. This lack of physical movement is deleterious to overall health. The present invention, due to its compact size, low weight and small profile, is well suited for use in or on the hard surfaces and restricted spaces of the urban and suburban landscape, thus providing needed recreational and exercise opportunities to youth (and others) living there. [0008] The attainment of the foregoing and related advantages and features of the invention should be more readily apparent to those skilled in the art, after review of the following more detailed description of the invention taken together with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIGS. 1-4 are an upside down perspective view, a side elevation view, a detailed cut-away view, and a bottom plan view, respectively, of one embodiment of a side movement propelled wheeled device 10 in accordance with the present invention. [0010] FIGS. 5-8 are an upside down perspective view, a side elevation view, a detailed cut-away view, and a bottom plan view, respectively, of another embodiment of a side movement propelled wheeled device 10 in accordance with the present invention. [0011] FIGS. 9-11 are an upside down perspective view, a side elevation view, a detailed cut-away view, and a bottom plan view, respectively, of another embodiment of a side movement propelled wheeled device 10 in accordance with the present invention. [0012] FIG. 12 is a bottom perspective view of an alternative four wheel side movement propelled device in accordance with the present invention. [0013] FIG. 13 is a bottom perspective view of a six wheel side movement propelled device in accordance with the present invention. [0014] FIG. 14 is a bottom perspective view of a eight wheel side movement propelled device in accordance with the present invention. DETAILED DESCRIPTION [0015] Referring to FIGS. 1-4 , an upside down perspective view, a side elevation view, a detailed cut-away view, and a bottom plan view, respectively, of a side movement propelled wheeled device 10 in accordance with the present invention is shown. [0016] Device 10 may include a platform or board 12 that acts as a support structure, receiving a human in a standing position (feet shown in phantom in FIG. 4 ) and supporting the wheels 21 - 24 in a fixed relative position. The wheels (and bearings) may be a conventional skate wheel. Many are known in the art and are available commercially. Wheels 21 - 24 are preferably coupled via casters 31 - 34 , respectively, to platform 12 . [0017] Referring to FIG. 2 , it can be seen that in device 10 each caster is preferably tilted backwards. The pivot point of caster rotation is located on the backward tilted caster mounting plate 36 - 39 and the pivot or axle 26 - 29 of each wheel 21 - 24 (in a default position) is located rearward of the pivot point of caster rotation. Each caster may be tilted at an angle, α. This angle may be 1-45 degrees and is preferably between 5-35 degrees. In one embodiment, α for the front wheels is approximately 18 degrees while α for the back wheels is approximately 15 degrees. The difference in α is due to the offset of the rear wheels (see discussion below with reference to FIG. 4 ). Since the rear wheels are offset, the height of the platform over the rear wheels would be slightly less than the front wheels if α were the same. Decreasing α a small amount for the rear wheels overcomes the height difference otherwise resulting from the offset. [0018] The tilt of the caster mounting plate causes each respective wheel to be biased, under weight, towards alignment with a line traversing the lowest and highest points of its respective caster mounting plate. FIG. 2 illustrates that the wheels are generally biased in line with a general line of forward travel of the device, indicated by arrow A. Closer inspection of the rear wheels 23 - 24 shows that they are preferably slightly offset (by an angle, β, discussed below). [0019] FIG. 4 illustrates that the two front wheels 21 - 22 are substantially aligned in parallel with the “straight ahead” direction of travel of device 10 . The rear wheels are preferably offset from this line by an angle, β. This angle may range from a degree to nearly 90 degrees. In a preferred embodiment the range may be from a few degrees to several dozen or more. In the embodiment of FIG. 4 , the offset is between 5 and 25 degrees, more preferably between 10 and 15 and even more preferably about 12 degrees. [0020] The front wheels are offset at 0 degrees, yet may be otherwise offset. While the rear wheels preferably have an angle great than 0 degrees, the angle of the rear wheels may be 0 without departing from the present invention. [0021] In use, device 10 is turned over from the position shown in FIG. 4 and a user stands with a foot located on each side (as roughly indicated by the phantom lines). To achieve initial forward movement, a user may push off the ground with one foot before placing it on the platform, though an initial push off is not necessary. [0022] From the legs apart or “slightly-straddled” position, a user shifts his or her weight from side to side, effectively pushing off one foot and then the other, in a motion similar to ice skating. This force propels the device forward. Continued operator movement in this side to side, ice-skating manner produces a repeated forward movement thrust that in aggregate propels the device and user ahead at a smooth velocity. [0023] Turning may be achieved by holding the push-off position on one side (for an increased length of time) or more rapidly by placing a foot outside the front and back wheels on one side and leaning to that side, lifting the opposite wheels off the ground and rotating the platform about the two wheels still contacting the ground, in much the same manner as one rapidly turns a conventional skate board. [0024] FIGS. 5-8 are an upside down perspective view, a side elevation view, a detailed cut-away view, and a bottom plan view, respectively, of another embodiment of a side movement propelled wheeled device 110 in accordance with the present invention. [0025] Device 110 of FIGS. 5-8 is similar to device 10 of FIGS. 1-4 . A difference is that the casters 131 - 134 are not biased by tilting, but rather biased by springs 141 - 144 . Springs 141 - 144 may be any suitable coil spring or any other type of spring or other bias device. In essence, they represent mechanical biasing of the wheels by spring or elastic material or other suitable mechanism. [0026] FIGS. 9-11 are a top perspective view, a side elevation view, and a bottom plan view, respectively, of another embodiment of a side movement propelled wheeled device 310 in accordance with the present invention. [0027] In device 310 , the platform 312 is comprised of two foot plates 313 - 314 , an adjustable-distance connecting rod 315 and two hubs 316 - 317 . FIG. 11 illustrates that wheels 321 - 324 and casters 331 - 334 are arranged in a manner similar to that disclosed with reference to device 10 of in FIGS. 1-4 . [0028] Referring to FIG. 12 , a bottom perspective view of an alternative four wheel side movement propelled device 410 in accordance with the present invention is shown. In device 410 , the front wheels are slightly offset in a direction generally opposite that of the rear wheels, i.e., if the rear wheels are angled out, the front wheels are angled in. [0029] Referring to FIG. 13 , a bottom perspective view of a six wheel side movement propelled device 510 in accordance with the present invention is shown. In device 510 , the front and rear wheels are slightly offset in generally opposite directions (as discussed with reference to FIG. 12 ) and the center wheels are not substantially offset. [0030] Referring to FIG. 14 , a bottom perspective view of an eight wheel side movement propelled device 610 in accordance with the present invention is shown. In device 610 , the outer front and rear wheels are offset more than the inner front and rear wheels. [0031] While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modification, and this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice in the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth, and as fall within the scope of the invention and the limits of the appended claims.

A recreational board propelled by side-to-side movement of a user. The board may be wider than deep, to accommodate a human standing at a slight straddle, and have a plurality of caster wheels mounted to an underside thereof. The wheels are preferably mounted in a biased direction wheel arrangement, the bias being provided by tilting, spring or other mechanism. The orientation of the front wheels may be different from that of the rear wheels. Four, six and eight wheel embodiments are disclosed.

RELATED APPLICATIONS This application is a Continuation-in-Part of U.S. patent applications Ser. Nos. 08/237,114, filed May 3, 1994 for "Brassiere Blank, Brassiere and Methods of Making Same", now U.S. Pat. No. 5,479,791, and 08/420,247, filed Apr. 11, 1995, for "Shirt Blank, Shirt and Methods of Making Same." BACKGROUND OF THE INVENTION (1) Field of the Invention The present invention relates to a shirt, bodysuit and teddy, and the blank and methods for making the same. More particularly, this invention relates to the production of a shirt or bodysuit blank on a circular knitting machine, and the production of a shirt or bodysuit from the blank having seams only at the shoulders and crotch, where applicable. Even more specifically, the invention relates to the production of a shirt, bodysuit or teddy having integrally knit compression areas to shape a wearer's body, and the blank and methods for making the same. (2) Description of the Prior Art Brassieres having fabric areas to define breast cups have been produced by full fashioned and reciprocating knitting machines, but blank and brassiere production tends to be slow and inefficient unless circular knitting is used. One circular knitting process is disclosed in U.S. Pat. No. 4,531,525 to Richards, wherein a brassiere blank is made on a circular knitting machine. The process includes producing a cylindrical tubular blank having a torso portion with a pair of breast cups, straps knit integrally with the torso portion, and turned welt portions at each end of the cylindrical blank. The tubular blank is slit on one side and laid flat for cutting neck and arm openings and seaming at each side to form the brassiere. Attempts have been made on certain nether-type knitted undergarments to provide variations in the compression provided by the undergarment in areas corresponding to particular areas of a wearer's body. For example, U.S. Pat. No. 4,390,999 to Lawson et al. describes the provision of a fabric portion having a medium amount of compressive force between a highly compressive upper waist or leg portion and a low compression body portion, in order to ease the transition from the highly compressive portion to the low compression portion and reduce the resultant body bulge which can be caused by that transition. The areas providing the medium amount of compressive force are shaped and located so that they extend circumferentially about the waist or leg of the wearer in the manner of a band, and they are formed by changing the yarn used to knit various courses. Similarly, U.S. Pat. No. 3,413,824 to Kuney discloses knitted undergarments which include form-fitting pockets in order that they can accentuate specific portions of the body. The garments are knitted using a constant stitch structure, with the stitch length being varied in selected areas to form spaced concave areas which are designed to correspond to specific regions of the wearer's body. In the illustrated embodiments, the nether garments include loosely knit regions corresponding to the buttock cheeks and a tightly knit seam piece extending vertically between the loosely knit regions. Though mentioning broadly that the structure could be used with brassieres, the Kuney patent does not disclose how the structure can be incorporated into such a brassiere. U.S. Pat. No. 3,425,246 to Knohl discloses a knitted brassiere having extra courses of elastic yarn knitted into the breast cups to shape the cups by providing fullness therein. U.S. Pat. No. 5,081,854 to Lonati describes a one-piece body garment which is knit on a circular knitting machine. An elastic thread or threads can be inserted in the waistband portion to form an elastic band at the waistband. These garments can tend to lack sufficient breast support for women, and fail to provide means for enhancing the appearance of the wearer's body. Blanks for the production of knitted shirts are conventionally knit in flat or tubular form. The blanks are then cut to form arm openings and a neck opening, seamed along the side if necessary, and the bottom of the shirt is hemmed. To complete the shirt, a separately manufactured neckband is then sewn to a neck opening of the T-shirt, usually with a double row of stitching, and the arm openings are then finished, usually either by hemming or attaching banding, to thereby form a finished shirt. Because all of these seaming processes require the input of labor, each seaming step increases the manufacturing costs of the shirt. Thus, a need exists for a method of making shirts which requires a minimal amount of seaming to provide an efficiently and rapidly producible garment, and blanks and shirts requiring only a minimal number of seams. In addition, a need exists for a shirt, bodysuit, and teddy construction which can provide shaping support for a wearer's body and can accommodate the curves of various wearer's bodies, and which can be rapidly and easily produced using only a minimal number of manufacturing steps and labor input. SUMMARY OF THE INVENTION With the foregoing in mind, it is therefore an object of this invention to provide a method of making a circular knit, tubular blank from which a shirt may be made with only a minimal number of seams, and which can be made to provide shaping support for the wearer's body. It is a further object of this invention to provide a method of making a circular knit, tubular blank from which a teddy or bodysuit can be made, and which requires only a minimal number of manufacturing steps for the conversion of the blank into the completed garment. It is also an object of the invention to provide a circular knit blank for the manufacture of a shirt which provides shaping support for a wearer. It is an additional object of the invention to provide a circular knit blank for the manufacture of a bodysuit or teddy which provides shaping support for a wearer. It is a further object of the invention to provide methods of making a shirt, bodysuit and teddy having knit-in shaping support using only a minimal number of manufacturing steps. An even further object of the invention is the provision of a shirt, bodysuit and teddy having knit-in shaping support and only a minimal number of seams. In accordance with the present invention there is described a method of manufacturing a circular knit blank for making a shirt which includes knitting a series of courses defining a non-raveling edge. In a preferred form of the invention, this non-raveling edge is provided in the form of a cylindrical tubular torso encircling portion in the form of a turned welt, as this enables the production of a shirt without the conventionally required hemming of the lower portion. A middle torso portion for covering the areas about the waist of a wearer's body is then knit to the torso encircling portion as a tubular fabric portion. This middle torso portion is knit so as to be compressible in order that it can provide compressive support to the underlying portions of a wearer's body. An upper torso portion comprising a series of courses defining a tubular fabric portion is then knit to the middle torso portion. The upper torso portion is knit to have greater cross-stretch (i.e. coursewise stretch) than the middle torso portion, preferably by lengthening the stitches making up the upper torso portion. In this way, when the blank is converted into a finished shirt, the upper torso portion does not compress the wearer's breasts in the manner that the rib and stomach areas covered by the middle torso portion are compressed. The upper torso portion also desirably includes a pair of breast cups integrally knit into a front portion thereof, the cups being defined by two areas in which the fabric is in simple knit courses with these areas being separated one from another. In a preferred embodiment of this invention, the breast cups are separated one from the other by a central area of gathered panels in which succeeding courses vary between simple knit and welt knit courses. In the embodiment of the shirt blank including breast cups, the rear portion of the blank desirably maintains a constant knit structure throughout the middle and upper torso portions, though the stitch lengths can be lengthened at the upper torso portion in the manner discussed above. A shoulder portion is then knit in tubular form to the upper torso portion. The shoulder portion includes elongated areas in which the courses are simple knit, with the areas being divided by elongated panel areas in which successive courses are also simple knit. Lastly, the circularly knit tubular blank is completed by knitting several courses forming a non-raveling edge. The shirt of the present invention is made from the circular knit tubular blank by cutting and removing selected portions of the blank to form a neck opening and arm openings. Front and rear portions of the shoulder portions are sewn together, and banding and the like can be added to finish the arm and neck openings, or the openings can be hemmed or selvaged. There is thus provided a shirt made from a blank of knit construction which can be shaped to the contours of a wearer's body, and requires only a minimal number of steps for its production. A blank for a bodysuit or teddy is produced in a similar manner to that of the shirt. A series of courses defining a non-raveling edge is knit in tubular form. A lower torso portion is knit to the non-raveling edge, and desirably includes a region proximate the non-raveling edge which has a modified knit configuration for forming the crotch portion of the garment. For example, the crotch forming portion of the blank can be knit to form a terry pile surface in a region which will correspond to the wearer facing portion of the crotch of the garment. A middle torso portion is knit to the lower torso portion, and is knit so that a garment made therefrom will provide compressive support to underlying regions of a wearer's body when the garment is worn. An upper torso portion is then integrally knit to the middle torso portion. The upper torso portion is knit to have greater cross-stretch than the middle torso portion, preferably by lengthening the stitches used to form the upper torso portion. In this way, when the blank is converted into a finished bodysuit or teddy the upper torso portion does not compress the wearer's breasts in the manner that the rib and stomach areas covered by the middle torso portion are compressed. It is noted that the lower torso portion can be compressive in the same manner as the middle torso portion, or it can be less compressive in the manner of the upper torso portion. The upper torso portion also desirably includes a pair of breast cups integrally knit into a front portion thereof, the cups being defined by two areas in which the fabric is in simple knit courses with these areas being separated one from another. In a preferred embodiment of this invention, the breast cups are separated one from the other by a central area of gathered panels in which succeeding courses vary between simple knit and welt knit courses. In the embodiment of the bodysuit and teddy blank including breast cups, the rear portion of the blank desirably maintains a constant knit structure throughout the middle and upper torso portions, though the stitch lengths can be lengthened at the upper torso portion in the manner discussed above. A shoulder portion is then knit in tubular form to the upper torso portion. The shoulder portion includes elongated areas in which the courses are simple knit, with the areas being divided by elongated panel areas in which successive courses are also simple knit. Lastly, the circularly knit tubular blank is completed by knitting several courses forming a non-raveling edge. The bodysuit and teddy of the present invention are made from the circularly knit tubular blank by cutting and removing selected portions of the blank to form a neck opening, arm openings, and leg openings and a crotch portion therebetween. Front and rear portions of the shoulder portions are sewn together, and banding and the like can be added to finish the arm and neck openings, or the openings can be hemmed or selvaged. Front and rear blank portions are then joined by sewing or the like to form a bodysuit. Alternatively, snaps, hook and loop fasteners, or other types of releasable fasteners may be attached to front and rear blank portions at the crotch region, to form a teddy. For purposes of this invention, a bodysuit is defined as a garment having upper and lower torso covering portions with a crotch portion which extends between a wearer's legs, with front and rear portions of the crotch portion being sewn or otherwise permanently attached together. In contrast, a teddy is defined as a garment like that of the bodysuit, but in which the front and rear portions of the crotch portion are joined by way of releasable fasteners, whereby the garment can be opened at the crotch. For purposes of the claims, a garment adapted to cover substantially the entire torso of a wearer is meant to encompass both bodysuits and teddies. However, it is noted that the specific garments disclosed can be used as under or outer garments, and may be used by men, women and children alike. The crotch portion can be specially configured to accommodate either male or female anatomy, at the preference of the manufacturer. There is thus provided a bodysuit and teddy made from a blank of knit construction which can be shaped to the contours of a wearer's body, have selected regions of compressive body control, and require only a minimal number of steps for their production. Other objects, features and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view illustrating an embodiment of a shirt according to the present invention, the shirt being made from the blank shown in FIGS. 2a and 2b show enlarged views of the knit structures shown in FIG.1 FIG. 3 is a perspective view of a blank for making the shirt of FIG. 1; FIG. 4 is a perspective view of a bodysuit or teddy according to the present invention, the bodysuit or teddy being made from the blank shown in FIG. 5; FIG. 5 is a perspective view of a circular knit blank in accordance with the present invention and from which the bodysuit or teddy of FIG. 4 is manufactured. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, FIG. 1 shows a preferred embodiment of the finished shirt of the present invention referenced generally at 10. The shirt 10 includes a non-raveling edge portion which is preferably in the form of a cylindrical tubular torso encircling portion 22, e.g. a turned welt. A middle torso portion 24 in the form of a fabric tube is knitted to the torso encircling portion 22 and is designed to cover the area of a wearer about the lower ribs and the waist, and below the waist as desired. It is particularly preferred that the middle torso portion be of sufficient length to enable a wearer to tuck the lower end of the shirt into his or her pants, though other lengths are within the scope of the invention, such as a length which enables the shirt lower edge to fall just above a wearer's waist. The middle torso portion is knit so that is can provide compressive support to the underlying portions of a wearer's body. An upper torso portion 27 comprising a series of courses defining a tubular fabric portion is knit to the middle torso portion 24 and includes a front upper torso portion 27a and a rear upper torso portion 27b. The front upper torso portion 27a, in a preferred embodiment of the invention, includes a pair of integrally knit breast cups 26 defined by areas in which the courses are simple knit and have succeeding areas of courses varying between simple knit and welt knit courses. The courses defining the front torso portion 27a differentially shape the breast cups 26. The upper torso portion 27 includes a rear upper torso portion 27b above the middle torso portion 24 in which the fabric is preferably in simple knit courses. In a preferred embodiment of this invention, the breast cups 26 are defined by areas in which the courses are simple knit with the breast cup areas 26 being separated by a center gathered panel area 25, shown in FIGS. 1 and 3, in which the courses vary between simple and welt knit courses. The gathered portion 25 is made by pulling the cams of the knitting machine away from the butts, allowing the shorter butt needles to pass through underneath the cams to hold the stitch for a predetermined number of courses, say 3 to 20 and preferably 10 to 12. The needles are then raised to clear the stitch to form a pleat, and the process is repeated until the gather is formed. Needles for tuck or pleat can be made without using cams by the selection of the needles to hold the stitch by knitting at welt height. The cams are then returned to the cylinder so that the short butt needles will rise. The upper torso portion 27 also desirably is knit to have greater cross-stretch than the middle torso portion 24, in order that the breast region of the wearer is not undesirably compressed. This is preferably achieved by forming the upper torso portion 27 from longer stitches than those used to form the middle torso portion 24. In this way, the compression provided by the garment to the underlying body portions of a wearer is reduced in the area of the breasts of the wearer, thereby preventing the breasts from experiencing the discomfort that compression would inflict on these areas. Further, the stitches are preferably lengthened starting immediately below the breast region of the wearer, enabling the compressive middle torso portion to assist in supporting the breasts, in addition to providing a more slimming appearance to the underlying regions. The differences in stitch lengths are shown in FIGS. 2a and 2b, which show the knitted structure of the upper torso 27 and the middle torso portion 24, respectively. Though the knitted stitches depicted are in simple form, it is noted that different types of knit stitches could be used to perform the invention. A shoulder portion 29 is then knit to the upper torso portion in the form of a tubular fabric portion. The fabric forming the shoulder portion 29 is preferably knit in simple knit courses with patterns. Front portions of the shoulder portion are sewn to rear portions of the shoulder portion at seams 32 to form shoulder straps, thereby forming a completed shirt. Turning now to FIG. 3, there is shown a shirt blank 30, made on a high speed circular knitting machine, from which the shirt 10 is produced. The blank 30 is in tubular form, and is knit to include portions which correspond to the portions of the shirt described in FIG. 1. The reference characters corresponding to those used with reference to FIG. 1 will be applied in FIG. 3, with the addition of prime notation. The torso encircling portion 22' in the blank 30 is preferably formed as a cylindrical tubular fabric portion in the form of a turned welt. A middle torso portion 24' is knit to the torso encircling portion 22' as a tubular fabric portion, and is knit so as that it provides compressive support on underlying portions of a wearer's body when it is converted into a shirt. An upper torso portion 27' is then knit to the middle torso portion 24'. The upper torso portion 27' is knit in tubular form to include a front upper torso portion 27a' and a rear upper torso portion 27b'. The upper torso portion 27' is knit to have a greater degree of cross-stretch than the middle torso portion 24', preferably by using longer stitches to form the upper torso portion than those which are used to form the middle torso portion. In a preferred embodiment of the invention, the blank includes a pair of integrally knit breast cups 26' on the front upper torso portion 27a' thereof. The breast cups 26' are defined by areas in which courses are simple knit, with the areas being spaced apart from one another. In a particularly preferred embodiment of the invention, the breast cups 26' are separated one from the other by areas of gathered panels 25' in which succeeding courses vary between simple knit and welt knit courses, the knitting of courses defining the front upper torso portion differentially shaping the breast cups with respect to the gathered panels. As will be understood, the degree of shaping will vary, and may be taken into account in accomplishing sizing of the shirt. A shoulder portion 29' is knit to the upper torso portion 27', and preferably includes elongated areas in which the courses are simple knit, with the areas being divided by an elongate panel area. In this way, a cutting pattern 33 can be formed in the knit structure of the blank itself, thereby enabling a worker to cut portions of the blank to form arm openings and define a neck section, without the need for additional patterning or marking. In addition, the yarn feeds can be manipulated in order that less yarn is fed to the portions of the blank 30 which are to be cut and removed, thereby reducing the amount of material waste produced as a result of shirt formation. The blank is finished by knitting a series of courses in the form of a non-raveling edge 34. The non-raveling edge 34 serves to prevent raveling of the blank 30 during the time between when the blank is produced and when it is converted into a completed shirt 10. The various portions of the circular knit tubular shirt blank 30 are integrally knit together and have stitch constructions as described hereinabove. Thus, the method of manufacturing the blank will become more clearly understandable and may be characterized as knitting a series of courses defining a first cylindrical tubular portion in the form of a turned welt 22', and then knitting to the turned welt portion a series of courses defining a middle torso portion 24'. The middle torso portion 24' is knit so as to have limited cross-stretch, in order that it will provide compressive support to the portions of a wearer's body located underneath the middle torso portion when the blank is converted into a shirt. An upper torso portion 27' formed by a series of courses defining a tubular fabric portion is then knit to the middle torso portion 24'. The upper torso portion 27' is knit to have a greater degree of cross-stretch than that of the middle torso portion 24', preferably by knitting the upper torso portion from longer knitted stitches or loops than the middle torso portion. In preferred embodiments of the invention, the upper torso portion can be knit to include first and second breast cups 26' in which spaced apart portions of the upper torso portion are simple knit. In a particularly preferred embodiment, the breast cups 26' are spaced apart by gathered panels 25', as discussed above. A shoulder portion 29' is then knit to the upper torso portion 27', and preferably is knit to include a plurality of elongated areas in which the courses are simple knit, with these elongated areas being separated from each other by elongated panel areas. To complete the blank, a plurality of courses defining a non-raveling edge 34 are then knit to the shoulder portion 29'. The manufacture of the shirt 10 is performed as follows, with particular reference being made to FIG. 3. The tubular blank 30 is cut along the cutting pattern, which is indicated by dotted lines 33 shown in FIG. 3. The cut portions are removed from the blank to thereby define arm openings 38 and a neck opening 44. The thus cut blank 30, as shown in FIG. 3, is then joined at seams 32 to connect front and rear portions of the shoulder portion 29 at opposite sides of the neck opening 44, to thereby form a completed shirt. Banding and the like 39 may be added at the arm openings and neck opening to finish off the shirt, or raw arm opening and neck opening edges can be hemmed or selvaged to form a finished shirt. Simple knit stitches are used to distinguish those stitch constructions possible on a circular knitting machine and in which yarn is taken into a needle during each rotation of the cylinder, such as plain, purl, tuck and combinations thereof. References to welt knit are intended to encompass miss-stitch or float stitch constructions in which loops in certain courses are held without additional yarns being taken and then knit into subsequent courses, thereby gathering the courses together and providing the characteristic turned welt or panel effect referred to above. FIGS. 4 and 5 illustrate another embodiment of the invention, namely a bodysuit or teddy 40 and a blank for making the bodysuit or teddy. Again, like numbers are used to represent like elements on the garment and the blank, with the common elements being primed on the blank. The blank 130 is made similarly to the blank 30 in FIG. 3, but is extended beyond the turned welt portion 22' of that blank to form a lower torso portion 42'. The blank 70 includes a series of courses forming a non-raveling edge 72 about a lower portion of the blank. A lower torso portion 42' is knit in the form of a tubular fabric portion to the non-raveling edge 72. This lower torso portion 42' preferably includes a crotch region 43' which has a modified stitch construction of the type conventionally used to form a panty crotch portions. Particularly preferred is a knit construction which includes a terry surface which is adapted to extend along a wearer-contacting surface of the crotch portion of a garment made from the blank 70. A middle torso portion 24' is integrally knit to the lower torso portion 42' in the form of a tubular fabric portion. This middle torso portion a 24' is knit to have limited cross-stretch which enables the portion of a garment made from the blank 70 which corresponds to the middle torso portion to compressively support a portion of a wearer's body which it covers. An upper torso portion 46' is knit in tubular form integrally with the middle torso portion 24', and includes for purposes of describing location a front upper torso portion 46a' and a rear upper torso portion 46b'. It is noted, however, that these portions form a part of the integrally knit tubular upper torso portion 46 rather than comprising separate elements. The upper torso portion 46' comprises a series of courses defining a pair of breast cups 48' on the front upper torso portion 46a' defined by areas in which the courses are simple knit and having succeeding courses varying between simple knit and welt knit courses. In a particularly preferred embodiment of the invention, the breast cups 48' are separated one from the other by areas of gathered panels 50' in which succeeding courses vary between simple knit and welt knit courses, the knitting of courses defining the front upper torso portion differentially shaping the breast cups with respect to the gathered panels. A shoulder portion 52' is then knit to the upper torso portion 46' to define front and back fabric straps 53a and 53b, each having an elongated patterned area in which the courses are simple knit with the areas being divided on the blank by an elongated panel area in which succeeding courses vary between simple knit and welt knit courses. The blank 70 is completed by knitting several courses forming a non-raveling edge 64. The bodysuit or teddy 40 shown is FIG. 4 is made from blank 70, shown in FIG. 5, by cutting and removing portions of the blank to form a neck opening 56, a pair of arm holes 54', and to define leg openings 45' having a crotch portion 43' located therebetween, as indicated by the cutting lines 66 on FIG. 5. The waste fabric is removed so as to define the front shoulder straps 53a and the rear shoulder straps 53b which are sewn together along seams 60 to complete the upper portion of the bodysuit or teddy. Front and rear portions of the blank 70 can be attached together along the crotch portion 43, as indicated at 62 in FIG. 4. The attachment can be a permanent attachment, such as by sewing, or releasable fasteners such as snaps, buttons, hook and pile fasteners and the like can be used to form a teddy garment. Banding and the like 58 may be added to finish off the bodysuit or teddy 40 at the neck, arm an leg openings 56, 54 and 45, respectively, or the edges may be selvaged or hemmed in a conventional manner. In addition, a supplemental crotch lining (not shown) can be attached in a conventional manner, where desired. The shirt, bodysuit and teddy blanks disclosed herein can thus be manufactured rapidly on high speed circular knitting machines and such garments can be manufactured from these blanks utilizing only a minimal number of seams. The shirt, bodysuit and teddy disclosed hereinabove can be used as either an outer or undergarment, depending on the materials used to manufacture the shirt and the wearer's desires, and can be used by women, men and children alike. In the drawings and specification there has been set forth a preferred embodiment of the invention, and although specific terms are employed, they are used in a generic and descriptive sense only and not for purposes of limitation, the scope of the invention being defined in the claims.

This invention discloses a shirt, bodysuit and teddy having built-in breast cups and/or selected areas of varying cross-stretch in order to provide compressive support for a wearer's body, and methods and blanks for manufacturing such shirts, bodysuits and teddies. In particular, circular knitting operations are used to produce garments having areas of compressive support in the middle torso region, and a greater amount of cross-stretch in the region corresponding to a wearer's breast area. In addition, the garments can include integrally-knit breast cups and a gathered panel located between the breast cups. Shirts made according to the present invention can include a turned welt about their lower or shirttail ends, in order to eliminate the need for hemming the lower shirt portion. Blanks and methods for making the garments are also disclosed, which require only a minimal number of manufacturing operations to be converted into completed garments.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Appl. No. 60/747,905, filed May 22, 2006, the contents of which are hereby incorporated by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable. REFERENCE TO APPENDIX [0003] Not applicable. BACKGROUND [0004] 1. Field of the Invention [0005] The invention relates to food service equipment. More specifically, the invention relates to modular counters. [0006] 2. Description of Related Art [0007] The food service industry is almost synonymous with the use of counters. This industry intensely depends on counters to prepare, hold, and serve food for customers, and clean up after the serving of the food. The counters are used to support the initial food preparation and washing, cooking ranges and ventilation hoods, sinks, food service hot and cold wells for maintaining a desired food temperature, holding trays, and dozens of other variations. For example, a well designed counter system with the accompanying appliances can cost over one million dollars in many schools. The counters are so ubiquitous to the food service industry that food service consultants and architects are frequently used to optimize the design and construction of counters for restaurants, schools and universities, and other commercial establishments. [0008] Current counters use well established designs and arrangements that have been developed and optimized for decades. The counters generally have rectangular or square patterns to optimize usage and floor space, such as wall space in a rectangular room. This typical arrangement can be characterized as an “orthogonal” arrangement in that the counters are spaced relative to each other in a grid pattern of X-Y dimensions. Frequently, the size and arrangement of the counters are customized for specific facilities with precise dimensions tailored for the facility. In recent years, some efforts have been made to create modules that can be assembled in different arrangements, so that the placement of certain counters could be varied for the particular application with minimal customization. However, even the modules have the orthogonal arrangement following conventional wisdom. To fit the orthogonal arrangement, the counters are most frequently designed with right angles to be attached to adjacent counters and continue the straight line or right angle orientations of a set of counters in the orthogonal arrangement. [0009] Thus, it is of significant moment in the industry when an original idea for counter design occurs, because it departs from the well understood and accepted knowledge of current counter designs developed over decades. BRIEF SUMMARY [0010] The present disclosure radically departs from conventional teaching and creatively offers a flexible alternative to the orthogonal arrangement. The present disclosure provides a system of modular counters that can be mixed to create arrangements shaped as an “S”, “C”, or a multitude of other modular arrangements by mixing predefined toroidal shaped modular radial counters with other modular radial counters and/or modular orthogonal counters. For the present disclosure, such radial arrangements represent a significant change in the accepted understanding of orthogonal counter design. Examples of such flexible radial arrangements are disclosed herein. Despite decades of efforts in this field and the opportunities to design similar modules, the field has simply been absent of such modular radial solutions. [0011] The disclosure provides a modular radial counter system comprising: a first modular radial counter comprising: a structural support system; a countertop coupled to the support system having an inner first arcuate surface having a first radius with a first origin in space and an outer second arcuate surface having a second radius with a second origin in space, and a first end and a second end coupled to the countertop, each end being radially aligned to project toward a convergence substantially at the origin of at least one of the radii. A method of using the modular radial counter system is also disclosed comprising: positioning the first modular radial counter so that the origins of the first modular radial counter are disposed toward a first side of the system, and positioning a second modular radial counter adjacent an end of the first modular radial counter so that the origins of the second modular radial counter are disposed toward a second side of the system different from the first side. The method can also comprise positioning a second modular radial counter adjacent an end of the first modular radial counter so that the origins of the first modular radial counter and the origins of the second modular radial counter are disposed toward a common side of the system. [0012] The disclosure further provides a modular radial counter system comprising: a first modular radial counter comprising: a structural support system; a countertop coupled to the support system having an inner first arcuate surface having a first radius with a first origin in space and an outer second arcuate surface having a second radius with a second origin in space, and a first end and a second end coupled to the countertop, each end being radially aligned to project toward a convergence substantially at the origin of at least one of the radii; and a second modular radial counter coupled to the first modular radial counter, the second modular radial counter comprising: a structural support system; a countertop coupled to the support system having an inner first arcuate surface having a first radius with a first origin in space and an outer second arcuate surface having a second radius with a second origin in space, and a first end and a second end coupled to the countertop, each end being radially aligned to project toward a convergence substantially at the origin of at least one of the radii, the system being adapted to form an “S” shape by an arrangement of the counters defined by the origins of the first modular radial counter disposed toward a first side of the system and the origins of the second modular radial counter disposed toward a second side of the system different from the first side, and the same system being adapted to form a “C” shape by an alternative arrangement of the counters defined by the origins of the first modular radial counter and the origins of the second modular radial counter disposed toward a common side of the system. BRIEF DESCRIPTION OF THE DRAWINGS [0013] While the concepts provided herein are susceptible to various modifications and alternative forms, only a few specific embodiments have been shown by way of example in the drawings and are described in detail below. The figures and detailed descriptions of these specific embodiments are not intended to limit the breadth or scope of the concepts or the appended claims in any manner. Rather, the figures and detailed written descriptions are provided to illustrate the concepts to a person of ordinary skill in the art as required by 35 U.S.C. §112. [0014] FIG. 1 is a schematic top view of an exemplary arrangement of a modular radial counter system. [0015] FIG. 2 is a schematic front elevation view of an exemplary modular radial counter system. [0016] FIG. 3 is a schematic rear elevation view of an exemplary modular radial counter system. [0017] FIG. 4 is a schematic top view of an exemplary generic modular radial counter. [0018] FIG. 5 is a cross-sectional view of one embodiment of a modular radial counter. [0019] FIG. 6 is a schematic top view of an exemplary arrangement of at least two modular radial counters. [0020] FIG. 7 is a schematic top view of an exemplary modular orthogonal counter. [0021] FIG. 8 is a schematic top view of an exemplary arrangement of at least one modular radial counter coupled with at least one modular orthogonal counter. [0022] FIG. 9 is a schematic top view of another exemplary embodiment illustrating a different arrangement of the modular counter system shown in FIG. 8 . DETAILED DESCRIPTION [0023] One or more illustrative embodiments of the concepts disclosed herein are presented below. Not all features of an actual implementation are described or shown in this application for the sake of clarity. It is understood that the development of an actual embodiment, numerous implementation-specific decisions must be made to achieve the developer's goals, such as compliance with system-related, business-related and other constraints, which vary by implementation and from time to time. While a developer's efforts might be complex and time-consuming, such efforts would be, nevertheless, a routine undertaking for those of ordinary skill in the art having benefit of this disclosure. [0024] FIG. 1 is a schematic top view of an exemplary arrangement of modular radial counter system. The modular radial counter system 2 can include one or more modular radial counters 4 , 30 , 60 . The system can further include modular radial counters coupled to modular orthogonal counters described below. The counters can be arranged end to end to form various shapes and arrangements that heretofore has not been possible. [0025] The modular radial counter 4 includes a structural support system 6 and a countertop 8 coupled to the support system 6 . The structural support system 6 can include ribs, channels, panels, tubes, pipe, plates and other support members as may be appropriate to the particular needs and uses of the counter. In some embodiments, the support system 6 can include arcuate members to align with the arcuate surfaces of the countertop described below. Structural members can be bent or otherwise formed into such arcuate shapes as appropriate. Other members of the support system 6 can be straight such as vertical members, or end pieces. [0026] A countertop 8 can be coupled to the support system 6 . The countertop 8 generally is shaped in the modular radial counter 4 with a first arcuate surface 10 shape having a first radius 12 with a first origin 14 that projects into space distal from the first arcuate surface. Similarly, the radial counter 4 includes an outer second arcuate surface 16 that likewise has a second radius 18 with a second origin 20 . The term “arcuate surface” is used broadly and can include a curved surface having a radius, or a plurality of faceted surfaces that resemble a curved surface and about which an arc having a radius can be circumscribed. Further, the term “origin” is used to describe in geometric terms the location of a starting point of a radius of an arcuate surface. The term “origin” would include a center of an arc where multiple perpendicular lines drawn from tangents on the arc surface intersect each other. However, it is to be understood that the term “origin” used herein is not limited to an exact theoretical point of a given geometric arc, since manufacturing tolerances in creating an arcuate surface may vary the exact intersection of the various perpendicular lines drawn from the tangents along the arc surface, and thus would represent a region of points as would be typical in manufacturing processes used to create an arcuate surface. [0027] The countertop 8 further includes a first end 22 and a second end 24 . The ends are generally coupled to the countertop and can be solid or open and generally provide support to strengthen the countertop 8 . In other embodiments, the ends 22 , 24 can simply represent the start and finish planes of the radial counter 4 . For example, the countertop 8 could be cantilevered with no actual support structure at the end if desired. Whether a physical structure or a representation of the termination points of the counter, each end is generally radially aligned to project toward a conversion substantially at the origin of at least one of the radii of the first arcuate surface or the second arcuate surface. Thus, the modular radial counter can represent a portion of a toroid having a common origin. In such instance, the first arcuate surface and the second arcuate surface with their respective origins would converge to a common point as illustrated. The radial counter 4 can be arranged so that the origins, described above, converge on one side 26 of the radial counter system, where the sides are defined by a line 50 that follows the arcuate surfaces through the approximate center of the plurality of radial counters. Thus, a first side 26 is defined on one side of the line 50 and a second side 27 is defined on a side distal from the first side 26 relative to the line. [0028] The radial counter 4 can include other elements as may be appropriate or desired. For example, a tray rest 28 can be formed on one or both sides of the radial counter to support food trays, cookware, products, and other items. The radial counter 4 can further be used to support various members that are useful to the food service or other industries. For example, without limitation, the radial counter 4 can include a display shelf 52 . The display shelf 52 can be positioned on top of the countertop 8 or can be at least partially inserted therethrough so that radial counter 4 will include one or more openings formed through the 8 to accommodate the various members. [0029] A second modular radial counter 30 can likewise be described. For example, the modular radial counter 30 generally includes a countertop 32 having a first arcuate surface 34 with a first radius 36 and a first origin 38 for the radius 36 . Similarly, the modular radial counter 30 includes an outer second arcuate surface 40 having a second radius 42 with a second origin 44 . In at least this embodiment, the origins 38 , 44 converged to a common point. Further, the modular radial counter 30 includes a first end 46 and a second end 48 . For example, the second end 24 of the radial counter 4 can be coupled to the first end 46 of the second modular radial counter 32 . As described below, in such arrangement, the system forms an “S” shape so that the origins of the first modular radial counter 4 are directed toward the first side 26 of the system and the origins of the second modular radial counter 32 are directed toward the second side 27 of the system. As further illustrated below, the radial counter 32 can be rotated 180 ° so that the origins are directed to the first side 26 . In such instance, the system could be described as a “C” shape. The flexibility of this modular radial counter system allows various combinations of various modules to create a variety of shapes. Part of the uniqueness of the system is that the ends are radially aligned to project toward a convergence at an origin which allows the counters to be coupled to other counters in interchangeable radial arrangements. [0030] The modular radial counter 32 can further include a tray rest 58 similar to tray rest 28 except that the tray rest 58 is disposed along the outer second arcuate surface 40 of the counter 32 . The radial counter 32 can include a variety of additional elements depending on its purpose in the radial counter system. For example, without limitation, the counter 32 can include one or more openings into which one or more food service wells 54 can be inserted. For hygienic reasons, a breath protector 56 can be disposed over the food service wells 54 , as is known in the industry. [0031] A third modular radial counter is shown for illustration and can be similarly described as the first and second occurred modular radial counters described above. In an exemplary embodiment, the third modular radial counter 60 can include a refrigerated or heated display case 62 . Without limitation, the display case can include chilled items, such as drinks, salads, desserts, and other fruit products that may benefit from refrigeration, or heated items such as hot sandwiches, meat products and other cooked items. Depending on the orientation of the first, second, and third modular radial counters, the arrangement can create an “S” shape appearance as shown. Alternatively, the modular radial counter 60 can be turned around and inverted relative to the modular radial counter 32 to create a “C” shape between the two counters 34 , 60 , and an “S“shape created between the radial counters 4 , 34 . Further, all counters can be rotated so that the origins were on one side of the system to extend the “C” shape. If the counters have sufficient length, or additional counters are included, the counters can form an “O“shape with substantially complete circle or oval. [0032] FIG. 2 is a schematic front elevation view of an exemplary modular radial counter system. The radial counter system 2 can include one or more of the modules described in FIG. 1 , including the first modular radial counter 4 , the second modular radial counter 30 , and the third modular radial counter 60 . In at least one embodiment, one or more of the radial counters can include wheels 78 , such as casters or other rolling elements, to facilitate movement of the counters. The counters can include decorative coverings such as along one or more sides 102 . The coverings can include tile, stainless steel, plastic, and other coverings known to those in the field. Lighting (not shown) can also be provided to the counters to highlight different items on the counters or in the counters. The tray rests 28 , 58 can be disposed at heights appropriate to the counter and are generally co-planer relative to each other. The display shelf 52 can be provided with the counter 4 that can display open food items that are heated, cooled, or ambient temperature. A breath protector 56 can be provided with a counter, such as counter 30 , that can provide hygienic protection for food items offered for consumption. A display case 62 can be provided with counter 60 . [0033] FIG. 3 is a schematic rear elevation view of an exemplary modular radial counter system. The modular radial counter system 2 can have decorative panels or can be open for easy access as may be appropriate for particular embodiments. In general, the radial counters include a structural support system 6 . The counter 4 can include the countertop 8 , module 30 can include the countertop 32 , and countertop 61 can include the countertop 61 . The wheels 78 can facilitate movement of the counters to the various locations, as well as facilitate rotation with the modules for coupling to other modules. In some cases, the modulars can include a refrigeration system (not shown) in conjunction with a display unit, such as a display shelf 52 , a display case 52 , or other units. Likewise, a heating system can be used. A plumbing system 84 can be used to provide water, such as to steam trays, or drainage for iced food wells disposed in the radial counter, or for other uses. A breath protector 56 can include a support 80 with one or more glass panels 82 to protect the food during distribution to customers. [0034] FIG. 4 is a schematic top view of an exemplary generic modular radial counter. In at least one embodiment, the modular radial counter 64 represents a base model of the different variations of other embodiments of the modular redial counters 4 , 30 , 60 . In similar fashion as has been described above, the generic modular radial counter 64 includes a countertop 70 , and a support structure 6 for supporting the countertop 70 . The radial counter 64 includes a first arcuate surface 66 and a second arcuate surface 68 . Each arcuate surface has a radius with an origin. In at least one embodiment, the radii of the arcuate surfaces converged to a common point 76 . Further, the generic modular radial counter 64 includes a first end 72 and a second end 74 where the ends are disposed in radial alignment toward the common point 76 . Thus, the modular radial counter 64 forms a section of a toroid. A tray rest 71 can be coupled to the modular radial counter 64 with a support 90 . [0035] FIG. 5 is a cross-sectional view of one embodiment of a modular radial counter. The modular radial counter 64 generally includes a support system 6 with a countertop 70 coupled thereto. The countertop 70 can include a tray rest 71 that can be coupled to the counter 64 with a support 90 . The counter can include various panels and decorative walls on a front or other surface, as a decorative panel as may be appropriate for the situation. A back side of the radial counter 64 can also include panels or doors, or be open for easy access to shelf space and other items under the countertop 70 . The support system 6 can further include a support layer 104 under the countertop 70 to support the countertop. The support layer includes a structural member or members. The end 72 of the counter 64 can be enclosed or opened as may be desired and applicable to the particular configuration. [0036] FIG. 6 is a schematic top view of an exemplary arrangement of at least two modular radial counters. In this exemplary arrangement, the first modular radial counter 4 is arranged end to end with the second modular radial counter 30 , so that collectively the system forms a shape that can be described as “C”. Thus, the radii of the first and second arcuate surfaces 10 , 16 of the counter 4 correlate with the first and second arcuate surfaces 34 , 40 of the second modular radial counter 30 to form a collectively longer arcuate surface. In at least one embodiment, therefore, the origins 14 , 20 , 38 , 44 of the radii of each radial counter converge on the side 26 of the system 2 . [0037] As noted above regarding FIG. 1 , the radial counters 4 , 30 can be rotated 180° relative to each other to form an “S” shape. For the particular configuration, the tray rest that can be associated with each radial counter may need to be substituted for a longer or shorter tray rest as may be appropriate to the particular side to be used in the system. [0038] FIG. 7 is a schematic top view of an exemplary modular orthogonal counter. FIG. 7A is a schematic top view of another exemplary modular orthogonal counter. FIGS. 7 and 7A will be described in conjunction with each other. The system 2 further includes one or more modular orthogonal counters 92 . In general, the modular orthogonal counter 92 will include a first end 94 , a second end 96 , a front 98 , and a back 100 . Generally, at least one of the angles of a side and front or back are formed at a right angle. Similarly, the ends 94 , 96 can be parallel to each other and perpendicular to at least the front 98 , the back 100 , or a combination thereof However, the modular orthogonal counter 92 could include a curved surface such as a corner piece shown in the corollary FIG. 7A . In such case, the ends 94 and 96 would adjacent to each other and formed at right angles. Thus, a modular orthogonal counter 92 as described herein includes at least two adjacent surfaces formed at right angles generally along at least a portion of their length. [0039] FIG. 8 is a schematic top view of an exemplary arrangement of at least one modular radial counter coupled with at least one modular orthogonal counter. In the arrangement shown, the first modular radial counter 4 can be coupled with the orthogonal counter 92 by coupling the ends of each module together. Further, the second modular radial counter 30 can be coupled with the other end of the modular orthogonal counter 92 . Such arrangement could be described as an elongated “C” shape, where one portion is elongated from use of the modular orthogonal counter 92 and the radial counters 4 , 30 are coupled to each end of the modular orthogonal counter. Alternatively, the second modular radial counter could be coupled to the other end of the first modular radial counter. Such arrangement could be described as an elongated “J” shape, where one portion is elongated from use of the modular orthogonal counter 92 and the radial counters 4 , 30 are coupled together. [0040] FIG. 9 is a schematic top view of another exemplary embodiment illustrating a different arrangement of the modular counter system shown in FIG. 8 . The modular counters shown in FIG. 8 can be coupled in a different arrangement as desired or needed. For example, by rotating one of more of the modular radial counters, such as the radial counter 30 , a different shape and arrangement can be made. Such arrangement could be described as an elongated “S” shape. As would be known to those with ordinary skill in the art given the description contained herein, additional shapes can be formed from different combinations of modular radial counters, modular orthogonal counters, or combinations thereof Such combinations could resemble various other shapes, such as a “D” shape with a combination of modular radial counters and orthogonal counters, an “O” shape with multiple radial counters sufficiently completing a circle or oval, a “P” shape, a “U” shape, and other shapes as may be useful or desired. Such flexibility is heretofore not been known to the use of modular systems. [0041] The embodiments shown are generally described in terms of the food service industry and it is believed that the module system will widely be used in such industry. However, the disclosure can be applicable to multiple fields that use counters for various purposes. [0042] The invention has been described in the context of various embodiments and not every embodiment of the invention has been described. Apparent modifications and alterations to the described embodiments are available to those of ordinary skill in the art. The disclosed and undisclosed embodiments are not intended to limit or restrict the scope or applicability of the invention conceived of by the Applicants, but rather, in conformity with the patent laws, Applicants intends to protect all such modifications and improvements to the full extent that such falls within the scope or range of equivalent of the following claims. [0043] The various methods and embodiments of the invention can be included in combination with each other to produce variations of the disclosed methods and embodiments, as would be understood by those with ordinary skill in the art, given the understanding provided herein. Also, various aspects of the embodiments could be used in conjunction with each other to accomplish the understood goals of the invention. Also, the directions such as “top,” “bottom,” “left,” “right,” “upper,” “lower,” and other directions and orientations are described herein for clarity in reference to the figures and are not to be limiting of the actual device or system or use of the device or system. Unless the context requires otherwise, the word “comprise” or variations such as “comprises” or “comprising”, should be understood to imply the inclusion of at least the stated element or step or group of elements or steps or equivalents thereof, and not the exclusion of a greater numerical quantity or any other element or step or group of elements or steps or equivalents thereof The device or system may be used in a number of directions and orientations. The term “coupled,” “coupling,” “coupler,” and like terms are used broadly herein and can include any method or device for securing, binding, bonding, fastening, attaching, joining, inserting therein, forming thereon or therein, communicating, or otherwise associating, for example, mechanically, magnetically, electrically, chemically, directly or indirectly with intermediate elements, one or more pieces of members together and can further include without limitation integrally forming one functional member with another in a unity fashion. The coupling can occur in any direction, including rotationally. Further, the order of steps can occur in a variety of sequences unless otherwise specifically limited. The various steps described herein can be combined with other steps, interlineated with the stated steps, and/or split into multiple steps. Additionally, the headings herein are for the convenience of the reader and are not intended to limit the scope of the invention. [0044] Further, any references mentioned in the application for this patent as well as all references listed in the information disclosure originally filed with the application are hereby incorporated by reference in their entirety to the extent such may be deemed essential to support the enabling of the invention. However, to the extent statements might be considered inconsistent with the patenting of the invention, such statements are expressly not meant to be considered as made by the Applicant(s).

The present disclosure radically departs from conventional teaching and creatively offers a flexible alternative to the orthogonal arrangement. The present disclosure provides a system of modular counters that can be mixed to create arrangements shaped as an "S", "C", or a multitude of other modular arrangements by mixing predefined toroidal shaped modular radial counters with other modular radial counters and/or modular orthogonal counters. For the present disclosure, such radial arrangements represent a significant change in the accepted understanding of orthogonal counter design. Examples of such flexible radial arrangements are disclosed herein. Despite decades of efforts in this field and the opportunities to design similar modules, the field has simply been absent of such modular radial solutions.

FIELD OF THE INVENTION The invention relates to an absorbent structure for cleaning surfaces, which has regions or portions or mixtures of different material characterized as being primarily absorbent or primarily cleaning-active. The absorbent structure also having a carrier structure with cleaning-active material applied to it. BACKGROUND OF THE INVENTION Cleaning textiles, cleaning structures and wiping coverings consist predominantly of a mixture of the basic components, cotton and synthetic fibers. The mixture of both basic components is necessary since the components sometimes have conflicting properties. A wiping covering can achieve maximum performance when a large number of positive properties are combined in it. There are several properties to take into consideration to achieve maximum performance of the cleaning textile, cleaning structure and wiping covering, such as water absorbency, dirt carrying capacity, abrasiveness, washability, and sliding behavior. The water absorbency of cotton is approximately 250% and that of synthetic fibers is virtually 0%. The dirt carrying capacity of cotton is good, whereas the dirt carrying capacity of synthetic fibers is poor, with the exception of microfibers and polypropylene fibers. The abrasiveness of cotton is very low, whereas that of synthetic fibers is high. Additionally, although cotton, polyester and polypropylene are washable up to 95° C., the washing stability of cotton is nevertheless poor, while that of polyester and polypropylene is good. Cotton also has pronounced shrinkage, whereas synthetic fibers exhibit low shrinkage. In addition, cotton displays poor sliding behavior, whereas that of synthetic fibers is good. Even though cotton absorbs 250% of its own weight of water, a pure cotton fabric is highly unfavorable on account of its poor sliding behavior and its instability during washing. Although properties such as abrasiveness, shrinkage, sliding behavior and washing stability, can be adapted to many situations by appropriately selecting material fractions of cotton and synthetics, the water absorbency is nevertheless, less than 250% when various mixtures of cotton and synthetics are used. A flat wiping covering for the care of hard floor surfaces, includes a carrier fabric to which material portions are stitched on the underside and on which holder push-in pockets are stitched on the top side of the longitudinal ends is known from DE 38 09 279 C1. This describes a wiping covering for floor care, preferably having a carrier fabric with holder push-in pockets stitched on the top side of the longitudinal ends of the carrier fabric and material attached on the underside of the carrier fabric for the absorption of dirt and moisture. The wiping covering has a low dead weight, good absorbency and a high water storage capacity. In this case, the underside material is in the form of sponge or nonwoven-cloth material with high liquid absorbency. The sponge or non-woven cloth material form a plurality of strips extending over the length of the carrier fabric and are arranged in rows adjacent and parallel to one another. The strips of sponge or non-woven cloth material being attached to the carrier fabric by stitching. The water absorbency of the sponge or nonwoven cloth material is up to 3,600 g/m 3 , and the relative water absorption of the sponge or nonwoven cloth material is up to 1,400%. The water absorbency being determined according to DIN 53 923. However, there is room for improvement in the flat wiping covering according to DE 38 09 279 C1. Considerable problems can arise in the handleability of the flat wiping coverings since the strips of sponge or non-woven cloth material are stitched to the carrier fabric, for example, reversible shrinkage of 30% in relation to the wet state can occur upon drying. In the wet state, the coverings have a calculated length, in which the covering sheet of the carrier material is flat. In the dry state, shrinkage of the sponge cloth lamellae of approximately 30% in relation to the cotton/polyester carrier fabric of the covering sheet occurs, leading to extreme distortions of the covering upon drying. The large degree of shrinkage of the sponge or non-woven cloth materials upon drying creates difficulty when inserting the wiping covering device into the holder push-in pockets of the carrier fabric. Nevertheless, forcibly inserting the wiping device into the holder push-in pockets damages the wiping covering. Even though the covering can be dampened before the wiping covering device is inserted into the push-in pockets of the covering, this is nevertheless disadvantageous since it entails a considerable amount of time and effort in handling. A further disadvantage is that the sponge or non-woven material is stitched onto the carrier fabric resulting in the water absorbency of the material being markedly reduced in the vicinity of the seams. An improvement in water absorbency or water absorption-power was achieved, for example, in the patent specification DE 38 09 279 C1, already mentioned above, in that, in addition to cotton and synthetic material, a sponge or nonwoven cloth material with a high viscose fraction is also used. Water-absorbing materials, such as sponge or wood, work by replacing their air filled cavities in the dry state with liquid, when they are dipped into a liquid. This liquid absorption, however, is necessitated by the dipping of the material into the liquid, making it difficult for cleaning liquid to be absorbed from hard floor surfaces when the water-absorbing materials are in their dry state. The water-absorbing materials in the dry state even fail to appreciably absorb liquid in the case of a residual quantity of 15 g of cleaning liquid per square meter, which amounts to only fractions of a millimeter of thickness, since liquid absorption is necessitated by dipping the material in the liquid. Moreover 15 g of cleaning liquid per square meter represents an unacceptable level of moisture for coated PVC floors. It is therefore necessary to have a different form of water absorbency which may be described by water suction capacity, for a wiping covering absorbing cleaning liquid. In this case, the material picks up the liquid on the contact interfaces via the suction effect, so that the liquid is downright sucked up. While a residue of 15 g of cleaning liquor per square meter on hard floor surfaces represents an unacceptable level of moisture, the aim is to achieve a residual liquid quantity of 10 g/m 2 . It was observed that, in the case of a residual moisture of 11 g/m 2 , the cleaning performance falls abruptly. This negative jump is explained by the free movability of the pigment dirt in the relatively higher moisture film on the wiping surface. This possibility is eliminated below 11 g/m 2 . The dirt can no longer escape from the wiping materials, but, instead, during the wiping movements, it adheres to the material of the cleaning-active side and can be removed in this way. SUMMARY OF THE INVENTION The object of the invention is to provide a solution which, in the case of an absorbent structure for the cleaning of surfaces, affords, in terms of its design possibilities, variations and variabilities which are broadened in respect of its cleaning-active and absorbent properties and or actions. In an absorbent structure of the type initially mentioned, this object is achieved according to the invention in that the structure has a pocket-shaped or bag-shaped cavity with snippets or strips of highly absorbent material arranged in it. The invention affords the possibility of arranging the primarily absorbently active material with highly absorbent properties on the absorbent structure elsewhere and independently of the regions or portions with material having primarily a cleaning-active effect. Preferably and in particular, the highly absorbent material is formed and arranged on the opposite side of the cleaning-active surface of the primarily cleaning-active material. Since the cleaning-active materials are separate and placed independent of the highly absorbent material, the cleaning-active material can be designed specifically for its cleaning-promoting action, while the highly absorbent material can be specifically designed for its water absorption action or the absorbency action. The cleaning structure according to the invention has, overall, a very high liquid absorbency as a result of the snippets or strips which, in particular, are loosely arranged within the closed cavity. The properties of the cleaning structure, such as abrasiveness, dirt carrying capacity, sliding behavior, etc., are determined by the properties of the primarily cleaning-actively acting material. In this way, the positive properties both of the cavity content, to be precise of the highly absorbent snippets, and of the outer material, including the carrier structure, are combined and optimized, without their respective properties having an adverse influence on one another. In one embodiment, the invention provides for the snippets or strips to be arranged loosely in the cavity, with the cavity being closed on all sides. A particularly preferred use of the absorbent structure is its design as a flat wiping covering for the care of hard floor surfaces. In the known abovementioned flat wiping covering, the technical problem is also, in particular, that of incorporating highly absorbent materials with other materials having different materials properties. In particular, the disadvantages of the highly absorbent materials having increased shrinkage upon drying in comparison with the low shrinkage of the carrier sheet material. It is an object to of the invention to provide a wiping covering that avoids the disadvantages arising from the different shrinkage behavior and from the impairment of the water absorbency in the seam region. To solve this problem the invention provides the absorbent structure be designed as a flat wiping covering for the care of hard floor surfaces. The absorbent structure includes a carrier structure, to which material portions of cleaning-active and/or absorbent material or material combinations are stitched on the underside and to which holder push-in pockets are stitched on the top side of the longitudinal ends of the carrier structure. The carrier structure being absorbent or water-permeable. The absorbent structure also including a covering sheet, in which all sides of the covering sheet are stitched to the top or upper side of the carrier structure, forming a cavity between the carrier structure and the covering sheet. The cavity being filled with snippets or strips of highly absorbent material loosely arranged on the carrier structure. The advantage of a flat wiping covering of this type is that, overall, it has a very high liquid absorbency, to which contribute in each case the material portions attached to the carrier structure on the underside, the carrier fabric and, predominantly, the snippets arranged loosely on the carrier fabric. The flat wiping covering is consequently suitable both for wiping wet hard floor surfaces and for applying cleaning liquid to the hard floor surfaces. In this case, the transport of liquid between the individual covering parts takes place via the absorbent material parts. For example, when wet surfaces are being wiped, the liquid is first sucked up from the surface by the underside material portions and transferred from these to the carrier fabric and transferred from the carrier fabric to the snippets arranged on the carrier fabric. The wiping covering is dipped into a container having the cleaning liquid prior cleaning a floor, so that the absorbent parts of the covering are saturated with the washing liquid. When the flat wiping covering is set down with the aid of the wiping appliance, the underside material portions come into contact with the floor first. As soon as these and, as a result, the carrier fabric have discharged the liquid stored in them, brief pressure on the snippets is subsequently sufficient to express the liquid stored in them and discharge it via the carrier fabric and the underside of the carrier fabric to the material portions and onto the surface to be cleaned. Since the absorbency and the liquid transportability are accomplished by the cotton fraction present in the mixture of the material portions and the water storage capacity is accomplished primarily by the highly absorbent snippets or strips present in the covering it is possible to at least partially replace the material portions on the underside of the carrier sheet with nonabsorbent materials, for example synthetic fibers. The use of synthetic fibers enhances other properties important for the cleaning performance, such as abrasiveness and/or sliding behavior. The use of synthetic fibers also improves the shrinkage stability and washing stability of the material mixture of the absorbent structure. Moreover, since the snippets of highly absorbent material are arranged loosely in the cavity and on the carrier fabric, the difference in shrinkage behavior properties does not have an effect on the dimensional stability of the coverings. Preferably, the cleaning-active material or the material portions of this kind are in the form of fringes, loops, rat's tails or lamellae. It is also preferred that it or they be arranged, distributed, over the entire underside surface of the carrier fabric. It is proposed, furthermore, that the cleaning-active material or the material portions of this kind consist of a synthetic material, in particular polyester, or microfibers or cotton or a mixture of these substances. The choice of materials depends on the desired cleaning properties. It is particularly advantageous, furthermore, if the flat wiping covering has a peripheral bead which consists, in particular, of the same material as the material portions attached to the carrier fabric. Particular advantages arise when the bead is stitched in the form of a hem to the flat wiping covering in such a way that the edge of the longitudinal strip/longitudinal strips which projects into the middle of the underside of the covering lies loosely on this underside. This results in two different effects, depending on the wiping direction. The front longitudinal strip of the bead lies flat and is between the underside and the wiping surface. By contrast, the opposite, that is to say rear longitudinal strip of the bead rises up and thereby forms a stripper which increases the cleaning performance even further. In a further important advantageous embodiment, the cavity has a plurality of, in particular two to five, chambers for the snippets or strips. The subdivision of the wiping covering into a plurality of chambers allows a more uniform distribution of the snippets, even when the covering is subjected to differing stress. Without this subdivision, it could happen that, for example in a wiping covering, the snippets or strips slip toward one end of the usually elongate flat wiping covering, so that the other end will be free of snippets. It is advantageous, moreover, if these chambers are divided off in the longitudinal direction. Such a division does not lead to an impairment of the cleaning performance. If the pockets were divided in the transverse direction, the corresponding seams would give rise to depressions on the cleaning-active side of a wiping mop, so that the contact of the wiping covering with the surface to be wiped would be prevented there and the wiped surface would acquire a stripy appearance. Furthermore, it is also proposed, for a flat wiping covering, that the holder push-in pockets be stretchable. The wiping covering can thus be used both for fold-down holders and for rigid holders. In the latter case, it is necessary for the holder push-in pockets to be stretchable. The invention does not, however, relate only to flat wiping coverings. The absorbent structure for the cleaning of surfaces may also be provided, in another particularly advantageous refinement, for manual use, that is to say without wiping appliances being employed. For this purpose, it is proposed that the absorbent structure for the cleaning of surfaces be designed as a bag, and that the carrier structure have on its outside bristles, in particular synthetic bristles, as cleaning-active material. This bag is capable, on the one hand, of sucking up a large quantity of water and, on the other hand, of holding it and discharging it onto the surface to be wiped. At the same time, the outside provided with bristles ensures a good cleaning action. The bristle trimming brings about the necessary abrasiveness. Dirt particles are removed from the smallest depressions of the surface being wiped by means of the bristle ends. An absorbent structure of this kind, having a bag-shaped cavity, can easily be produced as a sponge substitute in a size suitable for grasping with one hand. Moreover, both as regards the sponge bag and as regards the flat wiping covering, it is advantageous if the snippets or strips of highly absorbent material suck up 250 to 1,500% of their own weight of liquid. It is advantageous, furthermore, if the highly absorbent material consists at least predominantly of viscose, as also provided by the invention. In a further embodiment, the invention provides a system which consists of the absorbent structure of the present invention and of a wiping device with a handle and a wiping plate, connected or connectable to the handle via a preferably cardanic joint, for holding the absorbent structure on an underside of the wiping plate, and of an expressing device for the wiping device, the expressing device having a bearing surface provided with perforations and a counterbearing means arranged at a distance from said bearing surface, so that the wiping plate can be introduced between the bearing surface and the counterbearing means with a downwardly directed introduction movement and can be pressed, with its underside holding the absorbent structure, against the bearing surface by tilting, being supported at the same time on the counterbearing means. A wiping device of this kind and an expressing device of this kind, which cooperate in the way described, are known from WO-A-98/06316 and GB-C-330 543 and also from the Applicant's German patent application 100 13 044. Express reference is made thus far to the disclosure content of these publications. BRIEF DESCRIPTION OF THE DRAWINGS Exemplary embodiments of the invention are described in more detail below with reference to drawings in which: FIG. 1 shows a perspective illustration of a flat wiping covering according to the invention in a first exemplary embodiment, in an oblique view from above, FIG. 2 shows a plan view of the top side of a flat wiping covering according to a second exemplary embodiment of the invention, FIG. 3 shows a plan view of the underside of the flat wiping covering according to FIG. 2 , FIG. 4 shows a plan view of a cleaning structure according to the invention (third exemplary embodiment) designed as a bag, FIG. 5 shows part of a bristle row on the top side of the bag according to FIG. 4 , and FIG. 6 a / 6 b show diagrammatic sectional views of an expressing device. DETAILED DESCRIPTION OF THE INVENTION In all the drawings, identical parts have the same reference symbols and, if appropriate, are not mentioned separately for each drawing. It was shown, in tests, that viscose sucks up 15 times its own weight of liquid without mechanical action from outside, such as compression and expansion. These measurements were conducted with reference to DIN 53 923 and, in addition to this relative liquid absorption, showed wetting times of less than four seconds and a suction rate of more than 5 cm/s. Depending on the fraction of viscose in material mixtures with cotton, the liquid absorption capacity of the mixture is around 2.5 to 15 times its own weight, corresponding 250 to 1,500%. Snippets or strips of such a highly absorbent material are used as material having a highly absorbent action in the exemplary embodiments of the invention which are described below. In FIG. 1 , an absorbent structure for the cleaning of surfaces in the form of a flat wiping covering is illustrated in an oblique view from above. In the case of the flat wiping covering, a covering sheet 5 is applied to a carrier structure 6 , and stitched all-around the edges of the covering sheet to the carrier structure 6 designed as a woven or knitted fabric, referred to as a carrier fabric in the case of the flat wiping covering. Fastened to the carrier structure on the underside are material portions which consist of a material acting in a primarily cleaning-active way, that is to say having an abrasive, scouring and/or dirt-absorbing action, and which, in the exemplary embodiment illustrated, are in the form of fringes. However, these material portions way also have some absorbency. Holder push-in pockets 2 are stitched to the covering sheet 5 at the longitudinal ends. FIG. 1 illustrates a cutout 4 of the covering sheet 5 , so that it is possible to look through the opening 7 at snippets 1 arrange loosely on the carrier structure. These snippets 1 lie on the carrier structure 6 in a pocket-shaped cavity formed by the stitched-on covering sheet 5 and the carrier structure 6 . The ends of a folding holder can be pushed into the stitched-on holder push-in pockets 2 for fastening. By means of the spread: folding holder, during wiping, a surface pressure can easily be exerted on the covering sheet 5 and consequently on the highly absorbent snippets 1 arranged below the covering sheet 5 and on the carrier structure 6 , in order, depending on the magnitude of the pressure exerted, to express completely or partially a liquid quantity which is stored in the material. In exactly the same way, before the flat wiping covering is used for dry wiping, the stored liquid can be expressed from the flat wiping covering by corresponding pressure with the folding holder, so that the flat wiping covering has full suction capacity for wiping up. FIGS. 6 a and 6 b show a diagrammatic sectional view of an expressing device 29 suitable for this purpose, in FIG. 6 a during the introduction of the wiping plate 24 and in FIG. 6 b during the expressing of the flat wiping covering 25 . FIG. 6 a illustrates the introduction movement 34 , by means of which the wiping device or its wiping plate 24 is introduced, with a longitudinal edge 22 in front, into the expressing device 29 and between the bearing surface 31 provided with perforations and the counterbearing means 33 or its counterbearing elements 33 . The holding portions 28 assigned to or adjacent to the introduced longitudinal edge 22 are thereby brought into engagement with the counterbearing means 33 or its counterbearing elements 33 or engagement in this respect becomes possible, so that securing portions 35 , protruding or projecting relative to the bearing surface 31 , of the counterbearing means or of the counterbearing elements 33 engage or can engage behind the introduced holding portions 28 or their undercuts. How far the introduction movement 34 must involve a pivoting or tilting of the wiping plate 24 about its longitudinal axis depends on the clear distance A of the securing portions 35 from the bearing surface 31 in relation to the overall height of the wiping plate 24 together with the flat wiping covering 25 and with the holding portions 28 projecting the highest on the top side. Preferably, as indicated in FIG. 6 a , inward pivoting is necessary, so that the wiping plate 24 is secured positively against moving out of the expressing device 29 when the wiping plate 24 together with the flat wiping covering 25 lies over its full area on the bearing surface 31 , as shown in FIG. 6 b. It may also be gathered from FIGS. 6 a and 6 b that the expressing device 29 , illustrated in its state of use, is designed in such a way that the bearing surface 31 is inclined at an angle β relative to the horizontal 37 . Preferably, the angle of inclination is between 30° and 60°, in particular about 45°. In combination with a counterbearing means arranged in the lower region, here in the region of the lower longitudinal edge 36 , this results in a simple introduction and expressing of the wiping device. FIG. 6 b illustrates the expressing device. With the wiping plate 24 introduced, the handle 32 is folded down or pivoted about the longitudinal axis away from the counterbearing means according to the arrow 38 . The handle 32 or part of the joint in this case comes to bear on the wiping plate 24 , here, for example, in the region of the V-shaped recess 18 , so that further pressure on the handle 32 in the direction of the arrow 38 results in the wiping plate 24 being pressed down with its underside toward the bearing surface 31 , as a consequence of which the flat wiping covering 25 is expressed. In this case, the counterbearing means or its securing portions 35 cooperate, in particular in a hinge-like manner, with the introduced holding portions 28 of the wiping plate 24 , the counterbearing means forming virtually the pivot point for a one-armed lever formed from the wiping plate 24 and the adjoining handle 32 . By means of this one-armed lever, it becomes possible for the flat wiping covering 25 to be expressed in a simple way on the articulated wiping device. The transport of liquid during liquid absorption and during liquid discharge takes place via the absorbent parts of the flat wiping covering. In particular liquid moves from the underside material portions of primarily cleaning-active material to the at least water-permeable carrier structure to the snippets 1 and/or strips arranged on the carrier structure, and vice versa. There is no need for the material of the holder push-in pockets 2 and the covering sheet 5 to be absorbent and to have liquid absorbency. Only the fringe-like material portions 3 arranged along the edge can be seen in FIG. 1 . The material portions may also be in the form of loops, rat's tails or lamellae and, as a rule, are arranged so as to be distributed essentially over the entire underside surface of the carrier structure 6 . The underside material portions may be arranged in a straight line next to one another or along circular or zigzag paths next to one another. Since the liquid absorbency of the underside material portions having a primarily cleaning-active action make up only a relatively small fraction of the liquid absorption capacity of the entire flat wiping covering, while the snippets or strips arranged loosely in the pocket make up a very large fraction or the essential fraction of the liquid absorption capacity, the fraction of absorbent materials in these underside material portions may be reduced in favor of the fiber fractions which positively influence other necessary properties, such as abrasiveness and slidability. FIG. 2 shows a plan view of the top side of a particularly preferred exemplary embodiment of a flat wiping covering according to the invention. The highly absorbent snippets 1 , which cannot be seen in this figure, are arranged in two chambers 7 a , 7 b which extend in the longitudinal direction and which are delimited at the top by the covering sheet 5 and on the underside by the carrier structure 6 ( FIG. 3 ). The two chambers 7 a and 7 b are divided off by a continuous longitudinal seam 8 . This longitudinal seam also runs below the holder push-in pockets 2 which, in the present case, are designed elastically. The carrier structure 6 on the underside of the flat wiping covering ( FIG. 3 ) consists, here, of a microfiber with a pile height of 2 to 10 mm. The term “pile height” relates to the length of the outwardly protruding loops or fringes. A peripheral bead, which is formed by two longitudinal strips 9 and two transverse strips 10 , consist of the same material. The transverse strips 10 are stitched at their outer edges to the covering sheet 5 or the carrier structure 6 . This is indicated by the seams 11 passing through the flat wiping covering. In contrast to this, the two longitudinal strips 9 are stitched to the covering sheet 5 , in the region of their edges, only on the top side of the flat wiping covering. The corresponding longitudinal seams bear the reference symbol 12 . By contrast, on the underside, the longitudinal strips 9 are significantly wider, and the longitudinal seams 12 , which, like the transverse seams 11 , pass through the entire flat wiping covering, lie nearer to the edge of the flat wiping covering than to the edges to the longitudinal strips 9 , so that a relative wider part region 13 projects, unstitched, into the middle of the covering on both longitudinal sides of the latter. When wiping transversely to the longitudinal direction of the covering, the two longitudinal strips 9 behave differently. The front longitudinal strip lies flat, between the carrier structure 6 and the wiping surface. By contrast, the unstitched edge of the wider region 13 of longitudinal strips 9 located further to the rear can move and form a stripper which absorbs liquid and dirt and thereby increases the cleaning performance. It may also be pointed out that, in the present exemplary embodiment, the covering sheet 5 and the carrier structure 6 consist of different material. The covering sheet 5 consists of a firm woven textile. It is also possible, however, to use only microfiber or another cleaning-active textile both for the covering sheet 5 and for the carrier structure 6 . FIGS. 4 and 5 illustrate diagrammatically a further exemplary embodiment of the invention. Here, the absorbent structure for cleaning surfaces consists of a bag filled with the highly absorbent snippets or strips. This exemplary embodiment is intended advantageously to replace a conventional sponge. To be precise, conventional known sponges do not suck up any water, for example, as a result of capillary action. The foamed body of conventional sponges admittedly has a large number of open pores and, when the sponge is immersed, water runs into these cavities. This operation can be accelerated if the sponge is dipped in the compressed state under water and is expanded there. Sponges which are covered on one side with a pad are also known. The actual sponge body serves as a grip for handling an abrasive scouring pad of this kind. However, wet surfaces cannot be dried off with sponges of this kind. In contrast to this, the bag according to the invention is suitable not only for cleaning of surfaces, but, in addition, for wiping dry, as a result of its high-suction snippets or strips as material having a primarily absorbent action. The outer casing of the bag 14 in FIG. 4 , said casing surrounding the snippet-containing cavity on all sides, is formed by the carrier structure 6 which is water-permeable and which carries a close-mesh bristle trimming 15 , 16 . The bristles 15 , which are arranged in rows 16 on the carrier structure 6 , bring about the desired abrasiveness, that is to say have a primarily cleaning-active action. A bristle row 15 , 16 of this kind is illustrated, enlarged, in FIG. 5 . Dirt can be removed from the smallest possible depressions by means of the bristle ends. The bristles may also have some absorbency. The bristles are preferably 1 to 10 mm long and consist of a synthetic material, so that, in the sanitary sector, fittings are protected and are not scratched. The bag 14 is filled with the highly absorbent snippets of sponge cloth material, already discussed above, as material having a primarily absorbent action, which are capable of sucking up preferably up to 1,500% of their own weight of water. The bag according to the invention is therefore particularly suitable for drying off wet surfaces, since the snippet-like or strip-shaped material readily sucks up the water to be eliminated. The individual materials or material portions of the absorbent structure may be produced as a textile, woven or knitted fabric. Within the scope of the foregoing disclosure, the terms “absorbent” and “absorbency” also mean “water absorbent” or “water absorbency” or “water suction power” or “water suction capacity”, so that these terms are to that extent used as synonyms. A particularly suitable material for the highly absorbent snippets/strips is pieces which are sold by the company Kalle/Nalo and are produced during the production of sponge cloths as waste pieces from their edge region and which consist ⅔ of viscose and ⅓ of cotton fibers, preferably for dimensional stablization.

The invention relates to an absorbent structure for cleaning surfaces. The absorbent structure has areas or sections or mixtures comprising different material, these areas, sections or mixtures having either a primarily absorbent effect or a primarily cleaning effect. The structure has a support structure to which the cleaning material has been applied. The aim of the invention is to provide an absorbent structure with greater potential for variation and variants in terms of its cleaning and absorbency properties and/or effects. To this end, the inventive absorbent structure has a pocket or bag-shaped cavity in which pieces or strips of highly absorbent materials are located.

FIELD OF THE INVENTION This invention relates to catheters and in particular a haptically controlled active catheter instrumented with shape memory alloy actuators and a three degrees of freedom force sensor. BACKGROUND OF THE INVENTION Angioplasty is a minimally invasive procedure that involves the insertion of a catheter into the blood vessel for removal of blockages in blood flow. In the conventional approach, the catheter is inserted into the body through the femoral artery and is guided through the lumen of the blood vessel till it reaches a blockage. A stent (superelastic Shape Memory Alloy) is then deployed to open the blood vessel at the blockage and let normal blood flow resume. The surgeon is provided with images that are obtained either by X-ray imaging or by Magnetic Resonance Imaging. These images enable the healthcare provider to track the end point of the catheter (position in absolute coordinates) in real time and determine the future course of insertion. There are a number of problems associated with the conventional way of performing angioplasty. Specifically, the catheter insertion completely depends on the expertise and dexterity of the surgeon. In the case of intravascular neurosurgery, the catheter is pushed through extremely delicate and complex cranial blood vessels to treat aneurisms in the brain. The repeated insertion of the catheter through several trials could tear the blood vessel at the junction and cause heavy bleeding. This could also result in prolonged operating times and fatigue to clinicians and patients. The surgeon has no method of estimating the amount of force that is being applied by the tip of the catheter on the walls of the blood vessel. Excessive pressure could rupture the blood vessel with dire consequences. Plaque could also be dislodged which may block blood vessels in the brain or heart and cause a stroke or a myocardial infarction. The healthcare provider could have prolonged exposure to radiation or be subjected to a high-level of noise caused by the machinery generating magnetic fields for MRI. These pose danger or discomfort to the healthcare providers who perform the procedure over a prolonged period of time. Another problem with the present procedure of Angioplasty is restenosis. The deployment of a stent at the site of a blockage only provides a temporary solution for resuming blood flow. In 40% of the procedures already done, the plaque begins to build up after a couple of years, a process called restenosis. In addition, the stent, made of superelastic Shape Memory Alloy, has a life of only 10 years. For these reasons, there may arise a need to perform repeated angioplasties for a single patient. Accordingly it would be advantageous to provide a catheter wherein the movement of the tip can be controlled. Further it would be advantageous to provide a three degree of freedom force sensor that can be attached to a catheter. SUMMARY OF THE INVENTION The present invention describes a system for controlling a thin flexible thermoplastic catheter. The system includes a plurality of shape memory alloy filaments attached to the distal end of the catheter, each filament having a phase and a temperature; a means for receiving a strain value for at least one of the filaments; a means for determining the phase change that will result in the strain value, whereby the phase change is dependent on the temperature and the temperature is dependent on a voltage; and a means for setting the voltage in each filament thereby resulting in the bending of the catheter. In another aspect of the invention there is provided a three dimensional force sensor adapted to be attached to the distal end of a catheter. The sensor includes a two-dimensional optical position sensing detector, a spring, an optical fibre embedded within the catheter and a means for determining the position of the beam spot on the detector. The two-dimensional optical position sensing detector is spaced from the distal end of the catheter. The spring attaches the detector to the catheter whereby a force acting on the detector moves the detector relative to the distal end of the catheter. A light beam is emitted from the end of an optical fibre that is embedded within the lumen of the catheter. Further features of the invention will be described or will become apparent in the course of the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described by way of example only, with reference to the accompanying drawings, in which: FIG. 1 is a schematic diagram of the autonomous control of the instrumented catheter constructed in accordance with the present invention; FIG. 2 is a schematic diagram of the instrumented catheter constructed in accordance with the present invention and controlled by a haptic device; FIG. 3A is a cross sectional view of the three-dimensional force sensor of the present invention; FIG. 3B is a perspective view of the three-dimensional force sensor of the present invention; FIG. 4 is a three dimensional rendering of the three-dimensional force sensor of the present invention; FIG. 5 is a cross sectional view of the active catheter showing multiple shape memory alloy sections; FIG. 6 is a cross sectional view of the active catheter showing patterned shape memory alloy sections; FIG. 7 is hysteresis characteristics of the shape memory alloy for varying sinusoidal input; FIG. 8 is a simulated result showing a closed loop shape memory alloy response to a step reference input using the Linear Quadratic Regulator (LQR) controller; FIG. 9 is a simulated result showing a closed loop shape memory alloy response to a sinusoidal reference input using the Linear Quadratic Regulator (LQR) controller; FIG. 10 is an experimental result showing a shape memory alloy response to a step reference input using the Linear Quadratic Regulator (LQR) controller; FIG. 11 is an experimental result showing a shape memory alloy response to a sinusoidal reference input using the Linear Quadratic Regulator (LQR) controller; FIG. 12 is an experimental result showing a closed loop shape memory alloy responses to two sinusoidal reference inputs with different DC offsets using the Linear Quadratic Regulator (LQR) controller; FIG. 13 is an experimental result showing a closed loop shape memory alloy responses to two sinusoidal reference inputs with different frequencies using the Linear Quadratic Regulator (LQR) controller; FIG. 14 is a simulation result showing a closed loop shape memory alloy responses to a step reference input using the H ∞ loop-shaping controller FIG. 15 is a simulation result showing a closed loop shape memory alloy response to a sinusoidal reference input using the H ∞ loop-shaping controller; FIG. 16 is an experimental result showing a shape memory alloy response to a step reference input using the H ∞ loop-shaping controller; FIG. 17 is an experimental result showing a shape memory alloy response to a sinusoidal reference input using the H ∞ loop-shaping controller; FIG. 18 is a block diagram of a force control for autonomous guidance for the catheter of the present invention; FIG. 19 is a block diagram of a master-slave configuration for the catheter of the present invention; FIG. 20 is a picture of the haptic device for controlling the catheter of the present invention; and FIG. 21 is a cross-sectional diagram of the three-dimensional force sensor of the present invention and showing a surgical tool attached thereto. DETAILED DESCRIPTION OF THE INVENTION Researchers in the past have tried to instrument the catheter with Shape Memory Alloy actuators to actively control the tip of the catheter. This way the catheter can be smoothly guided into a branch in the blood vessel. The problem, however, is that the active catheters developed so far consist of actuators without any position feedback. Since most actuators used for the active catheter have a non-linear behavior, the control of the catheter by means of a joy-stick is extremely difficult and inaccurate and could cause damage to the blood vessels. In one embodiment, this invention describes a completely autonomous control of a catheter instrumented with Shape Memory Alloy (SMA) actuators 12 and a novel three Degree Of Freedom (DOE) force sensor 14 on the tip of the catheter 16 , as shown in FIG. 1 . The force sensor 14 at the tip measures the magnitude and direction of the force acting on the tip of the catheter 16 due to contact with the blood vessel when used in angioplasty. The force measured by the sensor 14 is fed to a control system to provide an input to the SMA actuators to minimize the force acting at the tip of the catheter. This way the force at the tip of the catheter is minimized to significantly reduce the likelihood of damage to epithelial cells of the blood vessel. In addition, the catheter 16 instrumented with SMA actuators 12 and the 3-DOF force sensor 14 can be used as a tool to perform minimally invasive surgery and therapy at remote locations. The instrumented catheter 12 can be interfaced to a haptic device 20 in a master-slave configuration, as shown in FIG. 2 . The haptic device 20 should have a minimum of 3 DOF position output 24 and force input 26 . The surgeon 22 , using the haptic device, provides the required position command to actuate the active catheter 16 . The force felt at the tip of the catheter 16 is reflected in 3 DOFs to the haptic device 20 . In this way, the surgeon 22 has access to remote sites in the blood vessel using the instrumented catheter 16 . The active catheter can also be fitted with microtools at the tip to perform on-site diagnosis, biopsies or plaque removal. In addition to application in angioplasty, the catheter can also be used for fetal and gastrointestinal surgeries. The sections below describes the design for the 3-DOF force sensor, the modeling of the Shape Memory Alloy Actuators, the LQR and H ∞ loop shaping controller design, the autonomous control of the catheter, and the force reflection to a haptic device. Sensor Referring to FIGS. 3 and 4 , the sensor 14 designed in accordance with the present invention is a miniaturized 3-DOF force sensor which is attached to the tip of the catheter 16 . The sensor 14 is capable of measuring the magnitude and direction of the force acting on the tip. The sensor 14 consists of a spring 30 preferably a conical spring (or any suitable elastic flexible material)—one end of which is attached to an optical fibre 32 which remains constrained to the catheter 16 , the other end is attached to a 2-d Optical Position Sensing Detector (2d PSD) 34 . The optical fibre 32 is coupled to a source of LASER 36 or a high intensity LED. The 2d PSD, which could be a quadrant detector or a lateral effect detector, consists of four independent photodetectors, which measure the intensity of light falling on it. The position sensor 34 provides four outputs from which the position of the beam spot on the surface of the PSD can be accurately calculated ( FIG. 3 and FIG. 4 ). The position sensor 34 has a hemispherical tip 35 attached thereto. A force acting on the sensor 14 due to contact with the walls of the blood vessel causes the spring 30 to bend. Since the optical fibre 32 and one end of the spring 30 are fixed to the catheter 16 , the spring bends 30 relative to the catheter 16 and as a result the position of the beam spot from the optical fibre 32 shifts along the surface of the 2d PSD 34 . The deviation of the beam spot along the surface of the 2d PSD 34 can be used to calculate the amount of bending in the spring which is proportional to the force acting on the tip of the catheter, by Hooke's Law. Therefore, the magnitude and direction of the force acting on the sensor can be measured accurately. The total voltage from all four outputs is an indication of the total intensity of light falling laterally on the PSD. The force sensor 14 is mounted on the tip of the catheter 16 . The sensor 14 measures the force exerted by the artery walls on the tip of the catheter. This force reading can be used to autonomously guide the catheter to prevent damage to the epithelial cells of the artery or it can be reflected to a haptic device. Actuators Referring to FIGS. 5 and 6 , the actuators 12 guide the catheter 14 through the lumen of the blood vessel without causing damage to the inner linings of the blood vessel. The actuators 12 also facilitate easy movement of the catheter 14 into one of the blood vessels at a branch. The actuators 12 could be made of Shape Memory Alloy (SMA) or Electro active polymers. SMA filaments (wire 40 and tube 44 ) are used to build the actuators 12 on the catheter 14 . The property of SMAs of demonstrating a change in strain by a change in temperature is due to a solid-state phase change from the Martensite form to the Austenite form. Martensite is relatively softer and easily deformable and exists at a lower temperature. Heating by means of current or hot water results in a phase transition from the Martensite phase to the Austenite phase. In the Austenite phase, the SMA is more structured and is harder and stronger than in the Martensite phase. The SMA actuators 12 on the instrumented catheter 16 could be either in the form of a wire, tube or sheet. Since the machinability of SMA is low, the wires or filaments 40 should be microwelded to the stainless steel pads 42 which can be glued to the catheter, as illustrated in FIG. 5 . A minimum of three wires 40 placed at 120° is required to bend the catheter 16 in all directions. The bending can be created by a number of sections of SMA to create variable bending radius and angles. The example shown in FIG. 1 shows one section of the SMA with one set of three wires 40 and the example shown in FIG. 5 shows two sections each having three wires 40 . SMA tubes and sheets can also be used to create the bending portion of the catheter. Patterns 44 can be laser-machined on the SMA tubes or sheets and can be directly glued to the catheter, as shown in FIG. 6 . In order to control the bending angle of the catheter, the amount of strain generated in the SMA actuators 12 should be controlled. For this, the physical behavior of the SMA should be described in dynamic equations. The model of the SMA set out below is based on the laws of physics. The modeling equations are as follows: Modelling of Phase Transformations Since an SMA exists in two states, it can be modelled as a two-state system. There is a similarity between this system and an electron, which can exist only in two states—the positive spin or the negative spin. The Fermi-Dirac statistics are used to describe the number of electrons in the two states depending on the energy of the electron. The state of an SMA in the Martensite and Austenite forms using the same statistics has been modeled. Two modelling equations were used based on whether the alloy is being heated or cooled due to hysteresis with two different transition temperatures. Since the SMA is in the Martensite form at lower temperatures, the phase transformation equation during heating is described by analogy with the Fermi-Dirac statistics in the form: ξ = ξ m 1 + exp ⁡ ( T f a - T σ a + K a ⁢ σ ) ( 1 ) where ξ is the fraction of the Austenite phase, is the fraction of the Martensite phase prior to the present transformation from Martensite to Austenite, T is the temperature, T fa is the transition temperature from Martensite to Austenite, ν a is an indication of the range of temperature around the transition temperature T fa during which the phase change occurs, σ is the stress and K a is the stress curve-fitting parameter which is obtained from the loading plateau of the stress-strain characteristic with no change in temperature. On cooling, the Austenite phase gets converted to the Martensite phase and the modelling equation during cooling is described by analogy with the Fermi-Dirac statistics in the form: ξ = ξ a 1 + exp ⁡ ( T f m - T σ m + K m ⁢ σ ) ( 2 ) where ξ a is the fraction of the Austenite phase prior to the present transformation from Austenite to Martensite, T is the temperature, T fm is the transition temperature from Austenite to Martensite, σ m is an indication of the range of temperature around the transition temperature T fm during which the phase change occurs, σ is the stress and K m is the stress curve-fitting parameter which is obtained from the unloading part of the stress-strain characteristic. Since the SMA is modelled as a two-component system, at any given time, the sum of the mole fractions of the Austenite and Martensite phase is 1, i.e., ξ a +ξ m =1  (3) The time derivatives of Eqns. (1) and (2) are as follows: For heating: ξ . = ξ 2 ξ m ⁡ [ exp ⁡ ( T f a - T σ a + K a ⁢ σ ) ] [ T . σ a - K a ⁢ σ . ] ( 4 ) For cooling: ξ . = ξ 2 ξ a ⁡ [ exp ⁡ ( T f m - T σ m + K m ⁢ σ ) ] [ T . σ m - K m ⁢ σ . ] ( 5 ) Modelling of Temperature Dynamics An SMA actuator is heated by the process of Joules heating by applying a voltage across the SMA. The loss of heat from the SMA is through natural convection. Mathematically the dynamics of the temperature are given by equation (6). T . = 1 mc p [ V 2 R - hA ⁡ ( T - T a ) ] ( 6 ) where m is the mass per unit length, c p is the specific heat capacity, V is the voltage applied across the SMA, R is the resistance per unit length, h is the coefficient of convection, A=πd is the circumferential area of cooling, d is the diameter of the wire, T is the temperature and T a is the ambient temperature. The coefficient h is assumed to have the characteristics of a second-order polynomial to enhance the rate of convection at higher temperatures as observed in open-loop results: h=h 0 +h 2 T 2   (7) Constitutive Equation The constitutive equation relating changes in stress, strain, temperature and mole fraction is given by the following equation: {dot over (σ)}= D {dot over (ε)}+θ t {dot over (T)} +Ω{dot over (ξ)}  (8) where σ is the stress in the SMA, D is the average of the Young's Moduli for the Martensite and Austenite phases, e is the strain, θ t is the thermal expansion factor and Ω is the phase transformation contribution factor. The model explains the hysteresis as well as the minor loops in the hysteresis, as illustrated in FIG. 7 . The dynamic characteristics of the SMA are completely defined by equation (4) or (5) (heating or cooling), together with equations (6) and (8). The σ e is defined as the integral of the error, i.e., {dot over (σ)} e =ε−ε ref   (9) where ε is the strain of the SMA actuator and ε ref is the reference trajectory. The dynamic equations of the SMA along with equation (9) can be represented in the state-space form: z _ . = f ⁡ ( z _ , u , t ) ⁢ ⁢ where ⁢ ⁢ z _ = [ ε T ξ σ e ] ( 10 ) and u is the input voltage to the SMA wire. The nonlinear equations are linearized about a set of operating points (ε 0 , T 0 , ξ 0 , u 0 ) on the reference trajectory. To obtain the operating points, ε 0 is chosen as the value of the reference strain at that instant of time. T 0 and ξ 0 are obtained by integrating equations (4) or (5) and (8), depending on whether the SMA is being heated or cooled, for a given value of ε 0 . The value of u 0 is obtained from equation (6) for a given value of T 0 , assuming steady-state conditions. Equation (10) is linearized about the calculated operating points to obtain linear models in the form: z _ . ⁢ A ⁢ z _ + Bu ( 11 ) y = C ⁢ z _ ⁢ ⁢ where ⁢ ⁢ A = [ ∂ f ∂ z _ ] ε 0 , T 0 , ξ 0 , u 0 ⁢ B = [ ∂ f ∂ u ] ε 0 , T 0 , ξ 0 , u 0 ( 12 ) For the no-load case, which is the case considered here, σ and {dot over (σ)} are equal to zero. In this case, the model given by (11) is not controllable since the number of independently controllable states is only 2. On removing the uncontrollable modes, the following state space model is obtained: x _ . = A ′ ⁢ x _ + B ′ ⁢ u ⁢ ⁢ where ⁢ ⁢ x _ = [ ε σ e ] ( 13 ) Controller Design The force measured by the sensor at the tip of the catheter is provided as input to the control strategy developed to provide an output to the SMA actuators to minimize the force at the tip of the catheter. The actuators could also be activated by the surgeon to guide the catheter into the branches of the blood vessel. The control scheme should provide fast and accurate control of the strain in the SMA. Two control strategies have been developed—a Gain Scheduled PI controller and a robust H ∞ loop-shaping controller using normalized coprime stabilization. Gain Scheduled Controller For a PI controller, the feedback is of the form, u=−K P (ε−ε ref )− K I σ e +u 0   (14) where K P is the proportional gain and K, is the integral gain. Writing K=[K P K I ], the gains are computed such that the resulting controller minimizes the quadratic cost function, J ( u )=∫ 0 ∞ ( x T Qx+u T Ru ) dt   (15) The choice of gains for minimizing J(u) are obtained by first solving for S in the algebraic Riccati equation: A′ T S+SA′−SB′R −1 B′ T S+Q= 0  (16) The matrix K is given by: K=R −1 B′ T S   (17) The simulation result for a step reference input is shown in FIG. 8 and that for a sinusoidal input is shown in FIG. 9 . The experimental verification of the controller was done on a 700 MHz Windows based PC at a sampling rate of about 65 Hz. Since the form of matrices A′ and B′ are fairly simple, the solution for the Ricatti equation was obtained in closed form using MAPLE. This also greatly reduced the computation time by avoiding matrix decompositions like the Schur decomposition. The response of the SMA to a step reference input is shown in FIG. 10 . From the experimental results, it can be observed that the response time for heating is approximately 1.0 second and for cooling is 2.1 seconds for a 0.012″ diameter SMA wire. The rate of heating and cooling is much higher for a thinner wire since the ratio of surface area to volume increases as the wire diameter is reduced, thereby increasing the rate of convectional cooling. The experimental result for a sinusoidal reference input is shown in FIG. 11 which shows an excellent tracking of the reference trajectory by the SMA in a closed loop. The DC offset of the reference was also varied to check the performance of the controller in the entire operating range. The results are shown in FIG. 12 . The graphs show an excellent response over the entire operating region. The frequency for the reference input was also varied to check the performance of the controller and the SMA. The results are shown in FIG. 13 . The response of the controller is satisfactory for frequencies lower than 0.1 Hz. Robust Controller The LQR based PI controller shows excellent response to a step and a sinusoidal reference input. The controller also has a good stability margin, thereby making the control law fairly insensitive to uncertainties in the parameters of the model. However, the controller is sensitive to unmodelled dynamics at high frequencies and thereby could lead to instability. For this reason, an H ∞ loop-shaping controller using normalized coprime stabilization is designed such that the gains are high when the model describes the SMA accurately and low at higher frequencies when the model is inaccurate. The loop-shaping controller, however, obtains a performance/robust stability tradeoff. The gain matrix K=[K P K I ] of the PI controller, as given by equation (14), is computed by the loop-shaping procedure using normalized coprime stabilization. The nominal plant (SMA) is first shaped by using a precompensator W 1 so that the singular values of the nominal plant G are shaped to a desired open-loop shape. The compensator also ensures that the shaped plant G s =GW 1 is square and G s has no hidden modes. For ensuring robust stabilization, ε max is calculated as, ε max = ( inf Kstabilizing ⁢  [ I K ] ⁢ ( I + G s ⁢ K ) - 1 ⁢ M ~ s - 1  ∞ ) - 1 ( 18 ) = 1 -  [ N ~ s M ~ s ]  H 2 < 1 ( 19 ) where {tilde over (M)} s and Ñ s define the normalized coprime factors of G s . An ε=ε max is selected to form a stabilizing controller K ∞ , which satisfies:  [ I K ∞ ] ⁢ ( I + G s ⁢ K ∞ ) - 1 ⁢ M ^ s - 1  ∞ ≤ ε - 1 ⁢ = . ⁢ γ ( 20 ) The final feedback controller K is obtained as the product of the precompensator W 1 and the H ∞ controller K ∞ i.e. K=W 1 K ∞   (21) The simulation of the robust controller and the SMA was done on MATLAB™. The desired loop shape was chosen so that the gains are high at low frequencies where the model describes the SMA accurately and the gains roll off at −20 dB beyond the corner frequency, thereby ensuring a low gain at high frequencies. The value of the corner frequency was chosen to be 1000.424 rad·sec −1 . The simulation result for input consisting of step changes is shown in FIG. 14 and for a sinusoidal reference input is shown in FIG. 15 . The experimental verification of the controller was done on a 700 MHz Windows based PC at a sampling rate of about 100 Hz. The response of the SMA to step changes is shown in FIG. 16 and for sinusoidal reference input is shown in FIG. 17 . Autonomous Control of the Active Catheter In the previous section, modeling and robust control of SMA actuators have been described. The simulation and experimental results show excellent tracking response for the SMA, thereby validating both the model and the control scheme. In autonomous control of an active catheter 16 fitted with SMA actuators 12 and a 3-DOF force sensor 14 , the force acting on the tip of the catheter 16 is regulated so that there is no damage to the epithelial cells of the artery. A force control algorithm is implemented to ensure that the tip interaction forces are minimized. The miniature force sensor 14 at the tip of the catheter provides the magnitude and direction of the force acting on the tip. This force is provided as a negative feedback signal to the robust control system, as shown in FIG. 18 . The sampling rate of the control algorithm is 100 Hz, providing fast response to minimize the error between the force signal F e and the desired force F d . The autonomous control of an SMA actuator 12 based on the force felt at the tip prevents any damage to the epithelial cells of the arteries. In addition, the catheter autonomously guides itself in the proximity of the blockage to prevent accidental dislodging of the plaque due to application of excessive force. This ensures a higher success rate of performing angioplasty by reducing the risk of rupturing blood vessels or dislodging plaque, which can cause a stroke or myocardial infarction if the plaque lodges itself in minute arteries of the heart or the brain. Force Reflection to a Haptic Device One of the major problems with the conventional way of performing angioplasty is restenosis. In nearly 40% of procedures, the plaque begins to rebuild at the site after a couple of years, causing an obstruction to blood flow. In addition, the superelastic stent used for reopening the blood vessel has a lifetime of only 10 years. Therefore, the patient would have to undergo multiple angioplasties during his/her life time. A solution to this problem is to perform microsurgery at the site of the blockage. The active catheter 16 fitted with SMA actuators 12 and a 3-DOF force sensor 14 can be controlled by a master haptic device 20 , as shown in FIG. 2 and FIG. 20 . The haptic device 20 provides position commands to the SMA actuators 12 . A minimum of 3 DOFs in position and force are required for the haptic device 20 . An inverse dynamics control scheme under image guidance is used to control the bending of the active catheter. The force acting on the tip of the catheter 16 is reflected to the stylus of the haptic device 20 . The surgeon can, therefore, feel these forces caused by interactions between the catheter 16 and the artery walls. In none of the technologies developed thus far has the surgeon had the capability of feeling the forces exerted on the tip of the catheter at a remote location. Micro tools 48 can be attached to the tip of the catheter 16 with 3 DOF position control and the ability to feel forces, also in 3 DOF. Using these tools, the surgeon can gently remove the plaque from the site under image guidance and force feedback, thereby leading to a permanent treatment of plaque buildup. This tool can also be used to perform various procedures like biopsies and on-site diagnosis, as shown in FIG. 21 . In addition to the application in Angioplasty, the instrumented catheter 16 can also be used to perform minimally invasive fetal surgery. An abnormality can arise in some fetuses where the diaphragm separating the chest cavity from the abdomen does not completely develop. As a result the intestines begin to grow in the chest cavity, preventing the development of the lungs. This abnormality is called Congenital Diaphragmatic Hernia (CDH). In such cases, the surgeon can perform “fetal endoscopic surgery” for CDH. In this procedure, a catheter along with surgical instruments is inserted through tiny ports in the mother's womb. The surgeon operates on the fetus entirely within the womb. The trachea of the fetus is clipped to block the windpipe. This causes the trapped liquid in the lungs to aid in the growth and expansion of the lungs. This is a high risk operation and requires high dexterity and maneuverability on the part of the surgeon to position the fetus and the mother accurately. In addition, it is extremely difficult to operate on a fetus floating in the amniotic fluid without any force or visual feedback. However, the procedure is safer for the mother and the fetus in comparison to open fetal surgery, where a large incision must be made in the uterus and in the amniotic sac, since it reduces the chances of pre-term labor. A premature birth would reduce the amount of time for the fetus to develop in the womb after prenatal surgery, and reduce its chances of survival. An instrumented catheter 16 as described in the invention would be useful in guiding the catheter into the windpipe of the fetus under image and haptic guidance. This would reduce the time taken and the chances of injury to the fetus in inserting the instrumented catheter 16 into the fetus, thereby making the procedure more reliable and efficient and reducing the amount of stress to the surgeon. The primary application of this invention is to insert a catheter instrumented 16 with a 3-DOF force sensor 14 and Shape Memory Alloy actuators 12 smoothly into an artery and guide it through the lumen of the blood vessel till the catheter 16 reaches a blockage. The stent is then deployed to resume normal blood flow. The 3-Degrees of Freedom (DOF) force sensor 14 measures the magnitude and direction of the force being applied. It could be used for a number of other applications. Specifically it could be used at the tip of a catheter to measure the forces exerted by the walls of the blood vessel on the tip of the catheter. It could also be used as a minimally invasive tool to measure the force exerted by the tool during surgery. As well it could be used to study soft tissue properties by measuring accurately the forces exerted by the soft tissue during deformation of the tissue. The Shape Memory alloy actuators 12 have a number of advantages. Specifically, SMA actuators have large plastic deformations which can be recovered; can generate large load forces; have high power to weight ratio; have low driving voltages; have no moving parts; are noiseless; can be used in compact workspace; and are biocompatible and corrosion resistant. The modeling and accurate control of the SMA actuators 12 enables its use for a number of applications. Specifically it could be used as an active catheter, biomedical forceps, tissue stapler, stent, and minimally invasive, tools. As used herein, the terms “comprises” and “comprising” are to construed as being inclusive and opened rather than exclusive. Specifically, when used in this specification including the claims, the terms “comprises” and “comprising” and variations thereof mean that the specified features, steps or components are included. The terms are not to be interpreted to exclude the presence of other features, steps or components. It will be appreciated that the above description related to the invention by way of example only. Many variations on the invention will be obvious to those skilled in the art and such obvious variations are within the scope of the invention as described herein whether or not expressly described.

The present invention describes a system for controlling a thin flexible thermoplastic catheter. The system includes a plurality of shape memory alloy filaments attached to the distal end of the catheter, each filament having a phase and a temperature; a means for receiving a strain value for at least one of the filaments; a means for determining the phase change that will results in the strain value, whereby the phase change is dependent on the temperature and the temperature is dependent on a voltage; and a means for setting the voltage in each filament thereby resulting in movement of the catheter. In addition, a three-degrees of freedom force sensor measures the magnitude and direction of the force exerted on the tip of the catheter. The catheter can be autonomously guided or it can be interfaced to a haptic device. The catheter can also be fitted with microtools.

FIELD OF THE INVENTION [0001] This invention relates to the field of preventing cancer and treatments for skin lesions. BACKGROUND OF THE INVENTION [0002] Skin cancer occurs when errors (mutations) form the in the DNA of healthy skin cells. The mutations cause the cells to grow out of control and form a mass of cancer cells. Skin cancer begins in your skin's top layer—the epidermis. The epidermis is a thin layer that provides a protective cover of skin cells that your body continually sheds. The epidermis contains three main types of cells: Squamous cells lie just below the outer surface and function as the skin's inner lining. Basal cells, which produce new skin cells, sit beneath the squamous cells. Melanocytes—which produce melanin, the pigment that gives skin its normal color—are located in the lower part of your epidermis. Melanocytes produce more melanin when you're in the sun to help protect the deeper layers of your skin. Extra melanin produces the darker color of tanned skin. SUMMARY OF THE INVENTION [0006] The present invention provides systems and method for preventing skin cancer and treatment of skin lesions. In a preferred embodiment, the present invention uses combinations of amino acids in a topical application for repairing the skin damage that results in skin cancer or lesions. Amino acids are critical to the health of the skin. They are the building blocks of many proteins, enzymes, antioxidants as well as being the material from which DNA and Collagen are constructed and repaired. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0007] The present invention, in a descriptive embodiment, provides a topical application treating and preventing skin cancer and lesions. This topical application, in a preferred embodiment, includes the following formulations. It is to be expressly understood that this embodiment is intended for descriptive purposes only and other variations and alternative embodiments are within the scope of the invention. [0008] The topical application includes the use of individual amino acids, either on their own or in groups of two or more, at a range of percentages in formulation between 0.1%-50%. These amino acids, either individually or in combinations of groups of two or more include but are not limited to; alanine, asparagine, aspartic acid, arginine, cysteine, cystine, glutamine, glycine, glutamic acid, histidine, lysine, leucine, phenylalanine, methionine, serine, proline, tryptophan, threonine, tyrosine, valine, taurine, guanidine, carnitine, adenine, guanine, thymine, cytosine, uracil, citruline, GABA, ornithine, glutamic acid, in their original chemical state and/or with modifications (example; histidine monochloride monohydrate). [0009] These amino acids may be liposomally delivered or not. They may also be added separately to other products as a powder or combined into a serum and/or emulsion. Liposomes [0010] Liposomes are microscopic spheres made from fatty materials, predominantly phospholipids. Because of their similarity to phospholipid domains of cell membranes and an ability to carry substances, liposomes can be used to protect active ingredients and to provide time-release properties in medical treatment. [0011] Liposomes are made of molecules with hydrophilic and hydrophobic ends that form hollow spheres. They can encapsulate water-soluble ingredients in their inner water space, and oil-soluble ingredients in their phospholipid membranes. Liposomes are made up of one or more concentric lipid bilayers, and range in size from 50 nanometers to several micrometers in diameter. Liposomal formulations have been used for many years to enhance the penetration of topically applied ingredients. Liposomes are made from lecithin, egg or it can be synthesized. These phospholipids can be both hydrogenated and non-hydrogenated. Phosphatidylcholine is extracted from these sources and can be both saturated and unsaturated. Other phospholipids including essential fats like linoleic acid and alpha linolenic acid can be used. Additionally, polyethylene glycol and cholesterol are considered liposomal material because of their lipid structure. Preparation of Exemplary Therapeutic Compositions [0012] Accordingly, a preferred embodiment of the present invention provides cosmetic as well as therapeutic compositions containing amino acids coated in liposomal material which when topically administered will increase the proliferation, growth, division and differentiation of cells. These cells are then able to improve skin health as well as to treat skin wounds and infections. [0013] The amino acids of the instant invention may be formulated for topical application in aqueous or non-aqueous solution, gel, lotion, cream or ointment containing 0.1 to 20 percent and preferably from 0.5 to 15 percent by weight of the total composition. Other additives may be used to stabilize or otherwise provide functionality such as solvents, plasticizers, emulsify, stiffen, or other functions. Liposomal lecithin or a liposome substitute or other lipid preparations are added to the above solution with mixing until a uniform consistency is obtained. [0014] To prepare a typical aqueous solution, the amino acids are dissolved in a mixture of water, ethanol and propylene glycol in a volume ratio of 30:50:20, respectively. Sodium metabisulfite is then added to the above solution. Liposomes such as lecithin or phosphatidylcholine or other lipid preparations are added to the above solution with mixing until a uniform consistency is obtained. [0015] To prepare a typical non-aqueous solution, the amino acids are dissolved in a mixture of ethanol, isopropyl myristate and squalane in a volume ratio of 70:20:10, respectively. BHT is then added to the above solution. Liposomes or liposome substitutes are added to this solution with mixing until a uniform consistency is achieved. When a combination composition is desired retinyl palmitate and/or hydroquinone, for example is added to the above non-aqueous solution. The preferred concentration of retinyl palmitate ranges from 1 to 5%. The concentration of hydroquinone may range from 1 to 5%, but the preferred concentration is 2% by weight of the total composition. [0016] A typical cream or lotion containing amino acids is created by dissolving amino acids in ethanol, acetone, propylene glycol or other solvent. The solution thus prepared is then admixed with commonly available oil-in-water emulsions. BHT or sodium metabisulfite may be added to such emulsions to stabilize the amino acids. Liposomes or liposome substitutes are added to this solution with mixing until a uniform consistency is achieved. [0017] A typical gel composition is formulated by first dissolving amino acidsin a mixture of ethanol, water and propylene glycol in a volume ratio of 50:30:20, respectively. A gelling agent such as hydroxyethylcellulose, hydroxypropylcellulose or hydroxypropylmethylcellulose is then added to the mixture with mixing. The preferred concentration of the gelling agent may range from 0.2 to 2 percent by weight of the total composition. Liposomes or liposome substitutes are added to this solution with mixing until a uniform consistency is achieved. [0018] The above examples of formulations and compositions of descriptive embodiments are provided as a general explanation of the present invention. It is expressly noted that these examples are intended to be illustrative and not limiting. Therapeutic Uses [0019] The present invention may in various embodiments be used to increase the efficacy of the use of amino acids for therapeutically and cosmetically treating many skin disorders and in particular skin cancer and or lesions. [0020] A preferred embodiment of the present invention increases the efficacy of a topical skin care product by increasing the penetration of amino acids that have been derived from stem cells or fibroblasts into the skin. Compositions containing amino acids are coated or mixed with liposomal materials as described above. The liposomal amino acids compound has been shown to increase the penetration of the amino acids thereby increasing the efficacy of the amino acids product. [0021] The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims and all changes which come within the meaning and equivalency of the claims are therefore intended to be embraced therein. [0022] The above described formulations may be used with other known ingredients and combinations of ingredients to form a topical application that suitable for application onto the skin of humans and to provide additional benefits as is within the realm and knowledge of one skilled in the preparation of topical compositions. [0023] The above formulations are provided for topical application in a product that helps prevent skin cancer and treat skin lesions.

Systems and methods of using a composition containing at least one or more amino acids for topical application to skin to prevent cancer and treat skin lesions.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of: [0002] U.S. Application No. 61/589,730, filed Jan. 23, 2012, entitled GLENOID VAULT FIXATION SYSTEM, Attorney's docket no. MLI-109 PROV, which is pending. [0003] The above-referenced document is hereby incorporated by reference in its entirety. [0004] This application incorporates by reference the following application in its entirety: [0005] U.S. patent application Ser. No. 12/640,892, filed Dec. 17, 2009, entitled INTERVERTEBRAL IMPLANT WITH INTEGRATED FIXATION, Attorney's docket no. SPINE 3.0-546 III, which is pending. BACKGROUND [0006] The present disclosure includes an embodiment of a fixation device that may be used for glenoid joint reconstruction. Specifically, the embodiment described may be used for glenoid vault reconstruction, for example, due to cavitary or non-cavitary bone loss. It will be appreciated that the disclosed embodiment may have application outside of glenoid vault reconstruction applications, and may be used in reconstruction of other joints or tissue junctions in the body. [0007] An example of the present technology is concerned with fusion of the glenoid vault by bladed anchors that extend outward from a central disc-like body. The bladed anchors may be secured to the body by dovetail features shaped to fit grooves on the body SUMMARY [0008] In an aspect of the technology, a system includes a body having a first surface, an opposite second surface, and a first channel, wherein the first channel extends through the first and second surfaces, wherein the first channel includes a discrete first enlargement of a width of the first channel; and a first anchor coupled to the body, wherein the first anchor includes a first rail portion, a first blade portion, and a first intermediate portion connecting the first rail and first blade portions together, wherein the first rail portion and the first enlargement have complementary interlocking shapes, wherein the first rail portion is fixed within the first enlargement, the first intermediate portion occupies at least a portion of the first channel, and the first blade portion extends from the first surface of the body. [0009] In an embodiment, the first channel includes a second discrete enlargement of the width of the first channel, wherein the first and second enlargements are periodically spaced along a length of the first channel, wherein the first rail portion and the second enlargement have complementary interlocking shapes. [0010] In another embodiment, the second enlargement is shaped to receive the first blade portion. [0011] In yet another embodiment, wherein the body includes a second channel spaced apart from the first channel, wherein the second channel includes a third discrete enlargement of a width of the second channel. [0012] In yet another embodiment, the first rail portion and the third enlargement have complementary interlocking shapes. [0013] In yet another embodiment, a second anchor is coupled to the body, wherein the second anchor includes a second rail portion, a second blade portion, and a second intermediate portion connecting the second rail and second blade portions together, wherein the second rail portion and the third enlargement have complementary interlocking shapes, wherein the second rail portion is fixed within the third enlargement, the second intermediate portion occupies at least a portion of the second channel, and the second blade portion extends from the first surface of the body. [0014] In another aspect of the technology, a system includes a body, wherein the body includes a first surface, an opposite second surface, and a first connection feature; and a first anchor coupled to the body at the first connection feature so that a portion of the first anchor protrudes from the first surface. [0015] In an embodiment, the system includes a second anchor; wherein the body includes a second connection feature; wherein the second anchor is coupled to the body at the second connection feature so that a portion of the second anchor protrudes from the first surface. [0016] In another embodiment, the first and second anchors are interchangeably couplable to the body at the first and second connection features. [0017] In yet another embodiment, the first and second anchors each include a blade portion, a rail portion, and an intermediate portion connecting the rail and blade portions together, wherein the rail portions of the first and second anchors are coupled to the body at the first and second connection features, respectively, and the blade portions of the first and second anchors protrude from the first surface. [0018] In yet another embodiment, the blade portions of the first and second anchors converge. BRIEF DESCRIPTION OF THE DRAWINGS [0019] While exemplary embodiments of the present technology have been shown and described in detail below, it will be clear to the person skilled in the art that changes and modifications may be made without departing from its scope. As such, that which is set forth in the following description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined by the following claims, along with the full range of equivalents to which such claims are entitled. [0020] In addition, one of ordinary skill in the art will appreciate upon reading and understanding this disclosure that other variations for the technology described herein can be included within the scope of the present technology. [0021] In the following Detailed Description, various features are grouped together in several embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that exemplary embodiments of the technology require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. [0022] Identical reference numerals do not necessarily indicate an identical structure. Rather, the same reference numeral may be used to indicate a similar feature or a feature with similar functionality. Not every feature of each embodiment is labeled in every figure in which that embodiment appears, in order to keep the figures clear. Similar reference numbers (e.g., those that are identical except for the first numeral) are used to indicate similar features in different embodiments. [0023] FIG. 1 is an isometric view of a glenoid fixation device; and [0024] FIG. 2 is an isometric view of the glenoid fixation device of FIG. 1 with a scapula and a clavicle. DETAILED DESCRIPTION [0025] Standard medical planes of reference and descriptive terminology are employed in this specification. A sagittal plane divides a body into right and left portions. A mid-sagittal plane divides the body into equal right and left halves. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. Anterior means toward the front of the body. Posterior means toward the back of the body. Superior means toward the head. Inferior means toward the feet. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means toward a central axis of the body. Abaxial means away from a central axis of the body. [0026] The present technology may be employed in a glenoid fixation device which may be included in a system of implant components to address a continuum of glenoid conditions. The present technology may provide firm initial implant fixation and satisfactory pull-out strength while requiring minimal bone removal or resection compared to, for example, screw fixation. The present technology, which relies upon straight-line sliding engagement of fasteners, may be ergonomically and/or technically less demanding than screw fixation. In situ assembly of implant components may be advantageous in minimally invasive surgical procedures. [0027] Referring to FIG. 1 , a glenoid fixation device 100 includes a central body 102 and at least one anchor 112 . The glenoid fixation device 100 may optionally include one or more of the following: screws, pegs, porous metal, and sutures. [0028] Body 102 may be disc-shaped, oval, elliptical, polygonal, cruciate, asymmetrical, or irregular in profile. The body may include a top surface 104 and a bottom surface 106 opposite the top surface. The body may also include a first side surface 108 that extends between the top surface 104 and the bottom surface 106 . First side surface 108 may extend circumferentially around at least a portion of the body 102 . Side 108 may be referred to as a perimeter surface, and may extend around the entire body 102 . A body center axis may be defined normal to (perpendicular to) the top surface 104 or bottom surface 106 at a centroid of the body. [0029] The body 102 includes at least one channel 114 that extends through the top and bottom surfaces 104 , 106 . The channel 114 may extend between an interior region of the body and an outer region of the body. The channel 114 may intersect or break through the first side surface 108 , or the first side surface 108 may remain intact. The channel 114 includes at least one cross slot, groove, or discrete enlargement 110 of the width of the channel. The cross slot 110 may be shaped for complementary fit with at least a portion of an anchor 112 , fin, wing, blade, or other means for securing the body 102 to the bones of the glenoid vault. The cross slot 110 may be referred to as an anchor connection feature. The channel 114 may include plural discrete enlargements 110 periodically spaced along the length of the channel. The body may also include more than one channel 114 . [0030] FIG. 1 shows a body 102 with four evenly spaced channels 114 radiating from a central location. Each channel includes two cross slots 110 , and two of the channels include a third cross slot. This arrangement may be appropriate when the body 102 is elliptical, so that longer channels with three cross slots are oriented along a major axis of the body, and shorter channels with two cross slots are oriented along a minor axis of the body. This arrangement may also be appropriate in order to provide wider spacing between cross slots along the channels with two cross slots and narrower spacing between cross slots along the channels with three cross slots. In other arrangements, there may be a different number of channels radiating outwardly from a central location. The channels may have varying numbers of cross slots. In yet other arrangements, the channels may lie tangential to the central location instead of radiating from the central location. [0031] The body may also include a means for attaching another implant component, such as interchangeable glenoid articulating components, augment components, glenosphere components, metaglene components, or fusion components. The implant component attachment means 128 may be a female Morse taper 128 . Other recessed and/or protruding connection features may be substituted, such as protruding Morse taper, internal or external threads, dovetails, undercuts, snap features, rails, and the like. The body may also contain at least one aperture, fenestration, or void (not shown) that may allow for the insertion of bone growth stimulation agents, such as osteoinductive and osteoconductive materials. The fenestration may be located in the central and/or outer region of the body. In one example, a fenestration may be present between each adjacent pair of channels 114 . In another example, unoccupied void space within the channel(s) and/or cross slot(s) 110 may be packed with bone growth stimulating material. [0032] The anchor 112 includes a blade portion 116 and a rail portion 118 connected together by an intermediate portion 117 . In an end view, the width of the blade portion 116 and rail portion 118 is larger than the width of the intermediate portion 117 . For example, FIG. 1 shows an anchor 112 which resembles a capital letter “H,” with the blade portion 116 forming a first upright of the “H,” the rail portion 118 forming a second upright of the “H,” and the intermediate portion 117 forming a crossbar of the “H.” In this example, width is along the uprights, or perpendicular to the crossbar. [0033] The blade portion 116 includes a first surface 120 and a second surface 122 opposite the first surface 120 . When the anchor 112 is attached to the body 102 , the first surface 120 of the blade portion 116 may face away from the body 102 and the second surface 122 may face toward the body 102 . The blade portion 116 may include a sharpened point 124 or edge to facilitate entrance of the anchor 112 into a bone or other tissue. The blade portion 116 may also include texture such as teeth 126 , roughening, or ridges to enhance fixation of the anchor 112 in the bone. [0034] The intermediate portion 117 extends between the blade portion 116 and the rail portion 118 , and may protrude from the second surface 122 . The length of the intermediate portion may be greater than, equal to, or less than the length of the blade portion 116 . The intermediate portion 117 may include a sharpened leading edge to facilitate entrance of the anchor 112 into a bone or other tissue. [0035] The rail portion 118 extends from the intermediate portion 117 opposite the blade portion 116 . The length of the rail portion may be greater than, equal to, or less than the length of the blade portion 116 , the intermediate portion 117 , and/or the thickness of the body 102 . FIG. 1 shows an example in which the length of the rail portion 118 is less than the length of the blade portion 116 and the intermediate portion 117 , and is about equal to the thickness of the body 102 . The rail portion 118 is shaped to fit into the enlargement 110 on the body 102 . The rail portion 118 and the enlargement 110 may have geometrically complementary interlocking shapes, and may be sized for an interference fit, a line-to-line fit, or a clearance fit. The rail portion 118 establishes an anchor longitudinal axis which extends parallel to the direction the rail portion 118 slides into the enlargement 110 . [0036] The anchors in the present disclosure may share some or all of the features of the anchors disclosed in pending U.S. patent application Ser. No. 12/640,892 to Bae, et al., which is incorporated by reference herein in its entirety. [0037] The anchor 112 may be attached to the body 102 by sliding the rail 118 into the cross slot 110 parallel to the anchor longitudinal axis such that the intermediate portion 117 occupies at least a portion of the channel 114 and the blade 116 extends from the bottom surface 106 of the body 102 . The body 102 and/or anchor 112 may include mutual locking features to prevent migration or unintentional removal of the anchor 112 from the body 102 . As the rail 118 slides forward into full engagement with the cross slot 110 , mutual locking features may prevent the rail from sliding farther in the cross slot, and may also prevent the rail from sliding backwards out of the cross slot. [0038] The number and location of the channels 114 and cross slots 110 may provide several choices of attachment location for the anchor 112 on the body 102 . Where multiple anchors are used, the anchors may be interchangeably coupled to the body at any attachment location, such that the anchors 112 may be adjusted, for example, inwards and outwards on the body. [0039] FIG. 1 shows an example in which the anchor 112 placement may be variable in the superior-inferior as well as the anterior-posterior directions to accommodate variations in the glenoid anatomy. Each anchor 112 may be independently radially positioned relative to the body 102 . [0040] In one example, the size and spacing between cross slots 110 along a channel 114 may complement the width and height of the anchor blade portion 116 and rail portion 118 . An anchor rail 118 may thus be complementarily received in a first cross slot 110 and the anchor blade 116 may be received in an adjacent second cross slot of the same channel 114 . All of the cross slots may be standardized so that any cross slot can receive the rail or the blade. The anchor blade 116 may be outboard of the rail 118 , as shown in FIG. 1 , or inboard. [0041] In another example, the variable may be the height of the intermediate portion 117 of the anchor 112 or, in other words, the spacing between the rail portion and the blade portion. In this example, the anchor blade portion 116 may consistently lie outboard of the body 102 . This arrangement may be appropriate in situations where the intermediate portion 117 and/or the rail portion 118 are long enough to protrude from the bottom surface 106 of the body 102 to contribute to overall bone fixation by the anchor 112 , particularly when the protruding portions of the rail 118 and/or intermediate portion 117 include bone fixation features such as texturing, porous coating, osteoactive properties, and the like. This arrangement may also be appropriate in situations where the rail portion is located at a trailing end of an anchor (based on the anchor insertion direction), and a second blade portion is formed between the trailing rail portion and a leading end of the anchor, although this anchor embodiment may be used with the other arrangements disclosed herein. [0042] The angle at which the blade 116 extends from the body 102 may vary to accommodate various joint anatomies. The cross slot 110 may hold the fully engaged anchor 112 at a fixed angle relative to the body 102 . For example, the cross slot 110 may extend through the body 102 parallel to the body center axis, or at an acute angle to the body center axis. Where multiple channels and/or cross slots are present, the individual cross slots may be angled with respect to the body center axis so that the array of fully engaged anchors protrudes from the bottom surface 106 and converges, is parallel, or diverges. Other angular arrangements are contemplated for multi-anchor applications, such as a quasi-helical arrangement, bilateral convergence/divergence, or multi-point convergence/divergence. [0043] In use, the anchors 112 may be secured to the body and driven into the glenoid to achieve fixation. These steps may occur in the stated order, a reverse order, or simultaneously. [0044] FIG. 2 illustrates the glenoid fixation device 100 positioned to be inserted into a glenoid vault. At least one anchor 112 may be inserted into one or more of the following bones: the coracoid process 30 , the acromion process 32 , the glenoid 34 , and the clavicle 36 . FIG. 2 illustrates an arrangement in which the channels 114 are formed into the body 102 along anatomical reference directions, axes, or planes. The channels 114 are aligned with anterior-posterior and superior-inferior directions. The channels 114 may optionally be aligned with major and minor dimensions of the glenoid socket regardless of anatomical reference directions. [0045] The components disclosed herein may be made from metals, polymers, ceramics, glasses, composite materials, biological materials or tissues, or other biocompatible materials. Different materials may be used for individual components. Different materials may be combined in a single component. [0046] It should be understood that the present system, kits, apparatuses, and methods are not intended to be limited to the particular forms disclosed. Rather, they are to cover all combinations, modifications, equivalents, and alternatives falling within the scope of the claims. [0047] The claims are not to be interpreted as including means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively. [0048] The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. [0049] The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more” or “at least one.” The term “about” means, in general, the stated value plus or minus 5%. The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.” [0050] The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes” or “contains” one or more steps or elements, possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes” or “contains” one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed. [0051] In the foregoing Detailed Description, various features are grouped together in several embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the embodiments of the invention require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment.

A glenoid vault fixation device includes a body and at least one blade anchor. Interchangeable glenoid articular components connect to the body. The set of interchangeable components may address a continuum of glenoid and/or total shoulder indications. The body may provide multiple attachment points for the blade anchor, or may accept multiple anchors.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application is a divisional of U.S. patent application Ser. No. 12/730,932 (Attorney Docket No. 20920-712.301), filed Mar. 24, 2010, which is a continuation of U.S. patent application Ser. No. 11/280,530 (Attorney Docket No. 20920-712.201), filed on Nov. 15, 2005, which claims the benefit of priority of U.S. Provisional Patent Application No. 60/628,856 (Attorney Docket No. 20920-712.101), filed on Nov. 16, 2004, the contents of each are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates generally to medical devices, systems and methods. In preferred embodiments, the present invention relates to methods and apparatuses for effecting lung volume reduction by aspirating isolated segments of lung tissue. [0004] Chronic obstructive pulmonary disease is a significant medical problem affecting 16 million people or about 6% of the U.S. population. Specific diseases in this group include chronic bronchitis, asthmatic bronchitis, and emphysema. While a number of therapeutic interventions are used and have been proposed, none are completely effective, and chronic obstructive pulmonary disease remains the fourth most common cause of death in the United States. Thus, improved and alternative treatments and therapies would be of significant benefit. [0005] Lung function in patients suffering from some forms of chronic obstructive pulmonary disease can be improved by reducing the effective lung volume, typically by resecting diseased portions of the lung. Resection of diseased portions of the lungs both promotes expansion of the non-diseased regions of the lung and decreases the portion of inhaled air which goes into the lungs but is unable to transfer oxygen to the blood. Lung reduction is conventionally performed in open chest or thoracoscopic procedures where the lung is resected, typically using stapling devices having integral cutting blades. Although these procedures appear to show improved patient outcomes and increased quality of life, the procedure has several major complications, namely air leaks, respiratory failure, pneumonia and death. Patients typically spend approximately 5-7 days in post-op recovery with the majority of this length of stay attributed to managing air leaks created by the mechanical resection of the lung tissue. [0006] In an effort to reduce such risks and associated costs, minimally or non-invasive procedures have been developed. Endobronchial Volume Reduction (EVR) allows the physician to use a catheter-based system to reduce lung volumes. With the aid of fiberoptic visualization and specialty catheters, a physician can selectively collapse a segment or segments of the diseased lung. An occlusal device is then positioned within the lung segment to prevent the segment from reinflating. By creating areas of selective atelectasis or reducing the total lung volume, the physician can enhance the patient's breathing mechanics by creating more space inside the chest wall cavity for the more healthy segments to breath more efficiently. [0007] Additional improvements to EVR are desired. A delivery system is desired which can position an occlusal device within a desired segment of a lung passageway with high accuracy. Such a delivery system should be easy to use, should allow interchangeability of a variety of instruments, and should allow delivery of multiple occlusal devices. It is desired that such delivery of multiple occlusal devices be achieved while maintaining evacuation of a diseased region of the lung. It is also desired to provide a system which utilizes conventional bronchoscopes to deliver the occlusal devices to the lung passageways. Such utilization should be easy to operate and should not interfere with additional therapies which utilize the bronchoscope. At least some of these objectives are met by the current invention. [0008] 2. Description of the Background Art [0009] Patents and applications relating to lung access, diagnosis, and treatment include U.S. Pat. Nos. 6,709,401; 6,585,639; 6,527,761; 6,398,775; 6,287,290; 5,957,949; 5,840,064; 5,830,222; 5,752,921; 5,707,352; 5,682,880; 5,660,175; 5,653,231; 5,645,519; 5,642,730; 5,598,840; 5,499,625; 5,477,851; 5,361,753; 5,331,947; 5,309,903; 5,285,778; 5,146,916; 5,143,062; 5,056,529; 4,976,710; 4,955,375; 4,961,738; 4,958,932; 4,949,716; 4,896,941; 4,862,874; 4,850,371; 4,846,153; 4,819,664; 4,784,133; 4,742,819; 4,716,896; 4,567,882; 4,453,545; 4,468,216; 4,327,721; 4,327,720; 4,041,936; 3,913,568 3,866,599; 3,776,222; 3,677,262; 3,669,098; 3,542,026; 3,498,286; 3,322,126; WO 98/48706; WO 95/33506, and WO 92/10971. BRIEF SUMMARY OF THE INVENTION [0010] The present invention provides methods, systems, and devices for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions where isolation of a lung segment or reduction of lung volume is desired. These methods, systems, and devices are likewise suitable for the treatment of bronchopleural fistula. The methods are minimally invasive with instruments being introduced through the mouth (endotracheally) and rely on isolating the target lung tissue segment from other regions of the lung and occluding various lung passageways with the use of occlusal stents. [0011] In a first aspect of the present invention, an occlusal stent delivery system is provided for delivering an occlusal stent to a target lung passageway. In preferred embodiments, the delivery system includes a visualization instrument configured for endobronchial advancement into a lung passageway leading to the target lung passageway. The instrument having a proximal end, a distal end, a working lumen extending therethrough, means for visualization near the distal end, and an occlusive member disposed near its distal end which is configured to be expandable to occlude the lung passageway. In addition, the system includes a delivery catheter having a proximal end, a distal end and a receptacle formable within its distal end for loading the occlusal stent therein. The delivery catheter is configured to be advanced through the working lumen of the visualization instrument so that its distal end extends beyond the distal end of the visualization instrument and wherein its distal end is retractable so that retraction of its distal end releases the occlusal stent to the target lung passageway. Typically, the distal end of the delivery catheter has portions of variable flexibility to allow the catheter to be advanced through a potentially curved working lumen without applying forces sufficient to redirect the visualization instrument. [0012] In preferred embodiments, the system further includes a clamp connector. In some embodiments, the clamp connector comprises a connector body having a passageway therethrough, and means for connecting the connector body to a visualization instrument having a working lumen so that insertion of an instrument through the passageway of the connector body inserts the instrument into the working lumen of the visualization instrument. In preferred embodiments, the passageway and the working lumen are non-axially aligned during connection. In some embodiments, the clamp connector comprises a connector body having a first end, a second end and an arc-shaped arm connecting the first and second ends, wherein the passageway passes through the first and second arms. However, it may be appreciated that the connector body many have a variety of suitable shapes and forms. Typically, the visualization instrument has a handle to which the connector body is attachable. The means for connecting may have a variety of forms including a fitting, such as a quick connector. In some embodiments, the quick connector comprises a side-action quick connector which allows the connector to be attached and detached from a side approach. Typically, the delivery catheter includes a handle at its distal end and the clamp connector includes a locking mechanism which is capable of locking the handle of the delivery catheter to the clamp connector. Such locking holds the delivery catheter in place in relation to the visualization instrument. In some embodiments, the locking mechanism tightens the passageway through the connector body to hold the at least a portion of the catheter by frictional forces. The locking mechanism may comprises a screw, knob or tensioning lever, among other mechanisms. While the delivery catheter is locked in place, the occlusal stent may be deployed from the delivery catheter by manipulation of the handle of the delivery catheter. [0013] In preferred embodiments, the delivery catheter comprises positioning rod, a tubular shaft extending from its proximal end to its distal end, and a handle positioned at its proximal end. The positioning rod is disposed within the tubular shaft and is fixedly attached to the handle. A receptacle formable within the distal end of the delivery catheter is disposed within the tubular shaft distal of the distal end of the positioning rod. The distance between the distal end of the positioning rod and the distal end of the tubular shaft is the axial length of the receptacle. The tubular shaft is slidable in relation to the positioning rod so that sliding of the tubular shaft shortens the axial length of the receptacle exposing the occlusal stent. When the occlusal stent has a self-expanding design, exposure of the occlusal stent deploys the occlusal stent within the lung passageway. In some embodiments, the occlusal stent is self-expanding in free space to a configuration that has an approximately 11 mm outer diameter. Alternatively, the occlusal stent may be expanded by alternative mechanisms after it has been released into the lung passageway. In either case, the occlusal stent may be comprised of a wire structure or any other type of framework at least partially encapsulated in a polymer. The wire structure is used as an example in the following descriptions but it can be appreciated that the framework can be of a variety of types. [0014] Typically, the positioning rod comprises a main body coil extending along the positioning rod terminating at a plunger tip. In some embodiments, the main body coil has an axial length in the range of approximately 80 to 100 cm and the main body coil is comprised of stainless steel wire. [0015] In some embodiments, the visualization instrument comprises a bronchoscope. It may be appreciated that any suitable bronchoscope may be used, including conventional bronchoscopes. A principal advantage of the present invention is that it allows a user to modify a conventional bronchoscope for use in delivery of occlusal stents in a convenient and economical manner. However, it may also be appreciated that other instruments or catheters may be used which provide viewing or visualization capabilities. Thus, the visualization instrument may further comprise a sheath having a proximal end, a distal end, a lumen extending therethrough and the occlusive member disposed near its distal end, the lumen configured to receive the bronchoscope so that the occlusive member is disposed near the distal end of the bronchoscope. The sheath typically comprises a flexible tubular body having a length in the range from 40 cm to 70 cm, an inside lumen diameter in the range from 1.5 mm to 10 mm, and a wall thickness in the range from 0.2 mm to 0.7 mm. [0016] In a second aspect of the present invention, a loading system is provided. In preferred embodiments, the loading system includes an occlusal stent, a loading body, and a loading mandrel. Again, the occlusal stent is transitionable between an expanded configuration and a contracted configuration. The loading body has a wide-mouthed end and a narrow-mouthed end, wherein the wide-mouthed end is configured to receive the occlusal stent in the expanded configuration and the narrow-mouthed end is configured to hold the occlusal stent in the contracted configuration. The loading mandrel has a proximal end, a distal end, and an attachment device disposed near its distal end that is removably attachable to the occlusal stent. The attachment device may be comprised of a hook, clasp, fastener or magnet, to name a few. The mandrel is configured to load the removably attached occlusal stent into the wide-mouthed end and move the occlusal stent to the narrow-mouthed end. [0017] In preferred embodiments, the loading body comprises a loading receptacle within the wide-mouthed end, wherein the loading receptacle is sized to receive the occlusal stent in the expanded configuration. The loading receptacle may have any suitable size or shape. Typically, the loading receptacle is cylindrical in shape and has a diameter in the range of approximately 10 to 13 mm. In addition, loading body comprises a holding tube within the narrow-mouthed end, wherein the holding tube is sized to receive the occlusal stent in the contracted configuration. Similarly, the holding tube may have any suitable size or shape, typically having a cylindrical shape with a diameter in the range of approximately 2 to 2.5 mm. Further, in preferred embodiments, the loading body comprises a restrictor disposed between the loading receptacle and the holding tube, wherein the restrictor has a funnel shape to transition the occlusal stent from the expanded configuration to the contracted configuration. In some embodiments, loading mandrel includes a first marking near its distal end and the loading body includes a second marking near its narrow-mouthed end, wherein alignment of the first marking with the second marking positions the occlusal stent within the narrow-mouthed end. [0018] In some embodiments, the loading system further comprises a delivery catheter having a proximal end, a distal end and a receptacle formable within its distal end for loading the occlusal stent therein. The narrow-mouthed end of the loading body is typically configured to mate with the distal end of the delivery catheter. The occlusal stent may then be moved from the narrow-mouthed end to the receptacle within the distal end of the delivery catheter with the use of the loading mandrel. Further, in some embodiments the catheter is provided pre-positioned to the narrow-mouthed end of the loading body and the occlusal stent is provided pre-positioned and or pre-attached to the wide-mouthed end and or pre-connected to the positioning rod of the catheter. [0019] In a third aspect of the present invention, methods of delivering an occlusal stent to a lung passageway within a lung of a patient are provided. In preferred embodiments, such methods include providing a visualization instrument, wherein the instrument has a proximal end, distal end, a working lumen therethrough, means for visualization near the distal end, and an occlusive member disposed near its distal end which is configured to be expandable to occlude the lung passageway. The visualization device is advanced through a trachea of the patient to a first location with the lung passageway. The lung passageway is then occluded at the first location with the occlusive member and the lung passageway evacuated. The method further includes providing a delivery catheter having a proximal end, a distal end, and an occlusal stent loaded within a receptacle within its distal end. The delivery catheter is advanced through the working lumen of the visualization instrument so that the distal end of the delivery catheter extends beyond the distal end of the visualization instrument to a second location within the lung passageway. The distal end of the delivery catheter is then retracted which releases the occlusal stent from the receptacle at the second location within the evacuated lung passageway. [0020] Such methods may be performed within lung passageways of various dimensions, shapes and branching patterns. For example, lung passageway may be comprised of a main passageway and at least one branch passageway. The first location may be disposed within the main passageway and the second location disposed within one of the at least one branch passageways. Thus, the distal end of the delivery catheter may be steered or guided in various directions as it is advanced beyond the visualization instrument to reach a desired branch passageway. [0021] Typically, the methods further comprise withdrawing the delivery catheter from the visualization instrument after releasing the occlusal stent while the lung passageway remains evacuated. Another delivery catheter having a proximal end, a distal end, and another occlusal stent loaded within a receptacle within its distal end may then be provided. This may be the delivery catheter that was removed with a new occlusal stent loaded therein, or a different delivery catheter that has been preloaded with an occlusal stent. The another delivery catheter is then advanced through the working lumen of the visualization instrument so that the distal end of the another delivery catheter extends beyond the distal end of the visualization instrument to a third location within the evacuated lung passageway. The third location may be disposed within another of the at least one branch passageways. [0022] Again, the delivery catheter typically comprises a tubular shaft extending from its proximal end to its distal end wherein the occlusal stent is disposed within the tubular shaft within the distal end of the catheter. Thus, releasing comprises withdrawing the tubular shaft to expose the occlusal stent. In preferred embodiments, the delivery catheter comprises a handle disposed at its proximal end and the tubular shaft is slidably connected with the handle by a handle button or any other hand-operated feature such as a loop or trigger, henceforth referred to as button. In these embodiments, withdrawing comprises moving the handle button to withdraw the tubular shaft. [0023] In some embodiments, the visualization instrument has a handle section near its proximal end, and the method further comprises connecting a clamp connector to the handle section of the visualization instrument. Typically, the clamp connector has a passageway therethrough so that advancing the delivery catheter comprises passing the distal end of the delivery catheter through the passageway of the clamp connector and into the working lumen of the visualization instrument. The working lumen is typically accessible via an access port, which extends through the proximal end and typically the handle section of the visualization instrument. The clamp connector can attach directly to the working lumen access port or elsewhere on the visualization instrument handle section as described in the following detailed descriptions. Again, the delivery catheter typically comprises a tubular shaft extending from its proximal end to its distal end and a handle disposed at its proximal end. The clamp connector may further include a locking mechanism wherein the method would further comprise actuating the locking mechanism to lock the handle of the delivery catheter to the clamp connector. The handle of the delivery catheter can be provided in a variety of configurations, such as a configuration that does not enter the working channel of the bronchoscope as well as a configuration that can enter the working channel of the bronchoscope, and combinations thereof. The clamp connector can also be provided in many configurations, wherein the clamp connector physically attaches to a portion of the bronchoscope, typically in the handle section and sometimes directly to the access port, and allows access of the catheter to the bronchoscope working channel. The clamp connector can be an item provided separately, or can be provided as an integral piece of the delivery catheter, and can be reusable or disposable. [0024] When the tubular shaft is slidably connected with the handle of the catheter by a handle button, releasing may comprise moving the handle button to withdraw the tubular shaft and expose the occlusal stent. Releasing may also comprise expanding the occlusal stent to occlude the lung passageway. [0025] In a fourth aspect of the present invention, methods are provided for using the loading system. Such methods include providing a loading mandrel having a proximal end, a distal end and an occlusal stent removably attached to its distal end, wherein the occlusal stent is transitionable between an expanded configuration and a contracted configuration. These methods also include providing a loading body having a wide-mouthed end and a narrow-mouthed end, wherein the wide-mouthed end is configured to receive the occlusal stent in the expanded configuration and the narrow-mouthed end is configured to hold the occlusal stent in the contracted configuration. The loading mandrel is positioned within the loading body so that the occlusal stent is near the wide-mouthed end. The loading mandrel is then manipulated to load the occlusal stent into the wide-mouthed end and move the occlusal stent to the narrow-mouthed end within the loading body. [0026] When the loading body comprises a loading receptacle within the wide-mouthed end, manipulating the loading mandrel may comprise moving the loading mandrel relative to the loading body so that the occlusal stent is positioned within the loading receptacle. When the loading body includes a restrictor adjacent to the loading receptacle, manipulating the loading mandrel may comprise moving the loading mandrel relative to the loading body so that the occlusal stent enters the restrictor. And when the loading body includes a holding tube adjacent to the restrictor, manipulating the loading mandrel may comprise moving the loading mandrel relative to the loading body so that the occlusal stent is positioned within the holding tube. In some embodiments, the loading mandrel includes a first marking near its distal end and the loading body includes a second marking near its narrow-mouthed end. In these embodiments, the method may further comprise aligning the first marking with the second marking indicating that the occlusal stent is positioned within the narrow-mouthed end. The methods may further comprise detaching the occlusal stent from the loading mandrel. [0027] A delivery catheter having a proximal end, a distal end and a receptacle formable within its distal end for loading the occlusal stent therein may also be provided. Such methods may then further include transferring the occlusal stent from the narrow-mouthed end of the loading body to the receptacle of the delivery catheter. To accomplish this, the method may further comprise mating the distal end of the delivery catheter with the narrow-mouthed end of the loading body prior to the transferring step. Transferring may also comprise advancing a loading mandrel through the open-mouthed end of the loading body which pushes the occlusal stent into the distal end of the delivery catheter. The delivery catheter loading system and occlusal stent can be provided separately in which case the user may mate the elements for transferring, or the pieces can be provided pre-positioned together or in a mated configuration so that the user only has to transfer the stent into the catheter through the pre-positioned loading system. [0028] It may be appreciated that the delivery system and/or loading system may be used for a variety of applications. For example, components of the delivery system may be used to deliver non-occlusal tracheobronchial stents, bronchopulmonary fistula plugs or stents, or occlusal stents for the treatment of tuberculosis. Further, components of the delivery system may be modified for to deliver vascular stents, vascular grafts or vascular occlusal devices to the vascular system to treat a variety of vascular ailments. Likewise, the loading system may be used to load a variety of stent-like devices within instruments and catheters having a receptacle for receiving the devices. Further, the clamp connector of the present invention may be used for the passage of any suitable instrument therethrough, such as instruments for implant removal, endoluminal injection (such as of a therapeutic agent, a hemostatic agent, etc.), specimen collection (such as for a biopsy), inspection, or other treatment, such a radiation therapy, etc. [0029] Other objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0030] FIG. 1 illustrates an embodiment of a delivery system of the present invention. [0031] FIG. 2 provides a cross-sectional side view of an embodiment of an occlusal stent delivery catheter. [0032] FIG. 3 provides a cross-sectional side view of a tubular shaft of the delivery catheter of FIG. 2 . [0033] FIG. 4 provides a cross-sectional side view of the positioning rod of FIG. 2 . [0034] FIGS. 5 , 6 - 6 A, 7 illustrates various views of an embodiment of a clamp connector. [0035] FIGS. 8A-8B illustrate an embodiment of a clamp connector having the form of a bracket. [0036] FIGS. 8C-8E illustrate an embodiment of a clamp connector having the form of an elongate holder. [0037] FIGS. 9-9A illustrate an embodiment of an occlusal stent. [0038] FIG. 10A illustrates an exploded view of an embodiment of a loading system of the present invention. [0039] FIG. 10B provides a top view of a loading body having a mandrel positioned therein. [0040] FIGS. 11A-11D illustrate loading of an occlusal stent into the loading system. [0041] FIG. 11E-11G illustrate transferring of an occlusal stent to a delivery catheter. [0042] FIGS. 12A-12C illustrate an alternative method of loading a delivery catheter with an occlusal stent. [0043] FIGS. 13A-13C illustrate an similar method of loading a delivery catheter to that of FIGS. 12A-12C . [0044] FIGS. 14A-14C illustrates methods of using the occlusal stent delivery system of the present invention within lung passageways. DETAILED DESCRIPTION OF THE INVENTION [0045] Lung volume reduction is performed by collapsing a target lung tissue segment, usually within lobar or sub-lobular regions of the lung which receive air through a single lung passage, i.e., segment of the branching bronchus which deliver to and receive air from the alveolar regions of the lung. Such lung tissue segments are first isolated and then collapsed by aspiration of the air (or other gases or liquids which may be present) from the target lung tissue segment. Lung tissue has a very high percentage of void volume, so removal of internal gases can reduce the lung tissue to a small percentage of the volume which it has when fully inflated, i.e. inflated at normal inspiratory pressures. [0046] The methods of the present invention rely on accessing the target lung tissue segment using an occlusal stent delivery system 10 adapted to be introduced endotracheally into the bronchus of the lung. An exemplary delivery system 10 is illustrated in FIG. 1 . As shown, the system 10 comprises a bronchoscope 12 having a proximal end 14 , a distal end 16 and at least a working lumen 18 and a scope lumen 20 extending from the proximal end 14 to the distal end 16 . Additional lumens, such as an aspiration lumen 22 , may also extend therethrough. The bronchoscope 12 also includes a handle 24 disposed near the proximal end 14 . The handle 24 is formed to include a sidearm 24 a which provides access to the working lumen 18 . The handle 24 also includes a connector 28 which permits attachment to an external viewing scope. [0047] It may be appreciated that the bronchoscope 12 included in this embodiment of the system 10 of the present invention may be comprised of any suitable bronchoscope, including conventional bronchoscopes. Conventional bronchoscopes are available from a number of commercial suppliers. Particular bronchoscopes which may be used in the methods and assemblies of the present invention are commercially available from Olympus and Pentax. A principal advantage of the present invention is that it allows a user to modify a conventional bronchoscope for use in delivery of occlusal stents in a convenient and economical manner. However, it may also be appreciated that other instruments or catheters may be used which provide viewing or visualization capabilities. [0048] In this embodiment, the system 10 also includes a sheath 30 having an occlusive member 32 disposed near its distal end, a full description of which is provided in U.S. Pat. No. 6,585,639[Attorney Docket No. 017534-001300US], assigned to the assignee of the present invention and incorporated by reference for all purposes. The sheath 30 includes a flexible tubular body having a distal end and an occlusive member 32 disposed at or near the distal end of the tubular body. Typically, the occlusive member will be formed from an inflatable elastomeric material which, when uninflated, lies closely over an exterior surface of the distal end of the flexible tubular body. Upon inflation, the material of the occlusive member will simply stretch and permit radial expansion. The elastic nature of the member will permit the member to conform to irregular geometries of a target lung passageway to provide for effective sealing. [0049] The system 10 of FIG. 1 also includes an occlusal stent delivery catheter 40 which is positionable within the working lumen 18 of the bronchoscope 12 . The catheter 40 comprises a tubular shaft 41 having a distal end 42 , wherein the distal end 42 is extendable beyond the distal end 16 of the scope 12 . This may be achieved by slidably advancing the catheter 40 within the working lumen 18 . The catheter 40 also includes a positioning rod 44 that is disposed within the tubular shaft 41 . The positioning rod 44 is used to expel an occlusal stent 46 from the distal end 42 of the catheter 40 , as will be described and illustrated in later sections. The catheter 40 is positionable within the working lumen 18 of the scope 12 by advancement through the sidearm 24 a of the handle 24 . [0050] The catheter 40 also includes a handle 48 which typically remains outside of the sidearm 24 a , though inn some optional configurations an extension of the handle 48 can enter the 24 a sidearm or the working lumen 18 of the bronchoscope. Both the tubular shaft 41 and the positioning rod 44 are attached to the handle 48 so that gross movement of the handle 48 toward or away from the sidearm 24 a advances or retracts the catheter 40 within the working lumen 18 . To assist in positioning the catheter 40 within the working lumen 18 and to lock portions of the catheter 40 in relation to the scope 12 , a clamp connector 60 may be used. The clamp connector 60 may be joined with the sidearm 24 a by a quick connector 62 , however any connecting mechanism may be used. The catheter 40 is advanceable through the clamp connector 60 and the handle 48 is lockable to the clamp connector 60 by a locking mechanism 64 . As shown in later figures, the clamp connector can assume other shapes and configurations and can attach to other portions of the bronchoscope in the bronchoscope handle area with a variety of connection mechanisms. [0051] As will be described in later sections, the positioning rod 44 is fixedly attached to the handle 48 and the tubular shaft 41 is slidably attached to the handle 48 . Thus, locking of the handle 48 to the clamp connector 60 using locking mechanism 64 in turn locks the positioning rod 44 in relation to the scope 12 . The tubular shaft 41 may then be slidably advanced or retracted in relation to the scope 12 and the positioning rod 44 by movement of a handle button 50 on the handle 48 . The handle button 50 is fixedly attached to the tubular shaft 41 . In this manner, the tubular shaft 41 may be retracted to deploy the occlusal stent 46 . It may be appreciated that such a handle button 50 is an example mechanism for achieving such movement of the tubular shaft 41 and that other suitable mechanisms may be used. Occlusal Stent Delivery Catheter [0052] FIG. 2 provides a cross-sectional side view of an embodiment of an occlusal stent delivery catheter 40 . As shown, the catheter 40 includes a positioning rod 44 having a distal end 45 , a tubular shaft 41 and a handle 48 . The positioning rod 44 is disposed within the tubular shaft 41 and is fixedly attached to the handle 48 , in this embodiment by a set screw 72 however any mechanism can be used. The tubular shaft 41 is fixedly attached to a catheter adapter 70 which is sized to fit at least partially within the handle 48 . The adapter 70 is slidably attached to the handle 48 with the use of a handle button 50 . The handle button 50 is attached to the catheter adapter 70 and shaped to extend through a slot (not shown) in the handle 48 so that the button 50 is able to slide along the slot thereby moving the tubular shaft 41 in relation to the handle 48 . [0053] The handle button 50 is positionable so that a receptacle 80 is formed within the tubular shaft 41 between the distal end 45 of the positioning rod 44 and the distal end 42 of the tubular shaft 41 . The receptacle 80 is sized to hold an occlusal stent 46 in a contracted form. In preferred embodiments, the maximum axial length of the receptacle 80 is in the range of approximately 20 to 30 mm. Movement of the button 50 along the slot retracts the tubular shaft 41 , shortening the axial length of the receptacle 80 until the distal end 45 of the positioning rod 44 meets the distal end 42 of the tubular shaft 41 . At this point the receptacle 80 is completely diminished and the occlusal stent 46 is fully exposed and released. [0054] FIG. 3 provides a cross-sectional side view of the tubular shaft 41 of FIG. 2 . As shown, the tubular shaft 41 is connected with a catheter adapter 70 . In this embodiment, the connection is achieved with adhesive and heat shrink tubing 74 , however any connection methods and materials may be used. In addition, the tubular shaft 41 has a end portion 52 that terminates at the distal end 42 of the shaft 41 . In preferred embodiments, the end portion has an axial length in the range of approximately 20 to 120 mm. The end portion 52 is typically comprised of a more flexible material than the remainder of the tubular shaft 41 . Such differences in flexibility provide sufficient rigidity throughout the shaft 41 while maintaining maneuverability and kink resistance near the distal end 42 . In addition, the end portion 52 typically has a slightly larger diameter than the remainder of the shaft 41 to accommodate the cross-sectional diameter of the collapsed stent 46 while minimizing the diameter of the remainder of the shaft 41 which minimizes friction within the visualization instrument. In preferred embodiments, the overall length of the tubular shaft 41 and adapter 70 is in the range of approximately 30 to 34 inches. [0055] The tubular shaft 41 may include markings 82 , as shown. The markings 82 may be comprised of ink or any suitable marking material. Any number of markings 82 may be present, such as a stripe approximately 20 mm from the distal end 41 and another approximately stripe 22.5 mm from the distal end 41 . Such markings 82 may be used to assist in positioning the distal end 41 in a passageway. The markings 82 may be observed through the scope 12 as the distal end 41 is manipulated within a lung passageway. Particular markings may be aligned with particular anatomical features to assist in proper placement of the stent 46 . For example, when a stent 46 is to be positioned within a relatively large lung passageway, a particular marking such as a distal-most marking may be aligned with the ostium associated with the target lung passageway. Whereas, when a stent 46 is to be positioned within a smaller lung passageway, a different marking, such as a proximal-most marking may be aligned with the ostium associated with the target lung passageway. [0056] FIG. 4 provides a cross-sectional side view of the positioning rod 44 of FIG. 2 . In this embodiment, the positioning rod 44 is comprised of a main body coil 92 which extends along the length of the rod 44 terminating at a plunger tip 94 . Thus, the axial length of the main body coil 92 is in the range of 34 to 40 inches. Typically, the main body coil 92 has an inner diameter in the range of 0.030 to 0.040 inches. The main body coil 92 is comprised of 304 stainless steel wire, however any suitable material may be used. In this embodiment, the plunger tip 94 is comprised of 303 stainless steel and has a maximum outer diameter in the range of 0.075 to 0.085 inches. The positioning rod 44 also includes a push end hypotube 90 disposed within the main body coil 92 opposite to the plunger tip 94 . In this embodiment, the hypotube 90 is comprised of 304 stainless steel, however any suitable material may be used. The hypotube 90 has an inner diameter of approximately 0.023 inches and an outer diameter of approximately 0.0355 inches. In addition, the hypotube 90 has an axial length of in the range of 14 to 18 inches. Adjacent to the hyptotube 90 , within the main body coil 92 , is a strain relief coil 96 . In this embodiment, the strain relief coil 96 has an axial length in the range of 1 to 2 inches. The strain relief coil 96 is comprised of 304 stainless steel wire, however any suitable material may be used. Clamp Connector [0057] FIG. 5 provides a perspective view of an embodiment of a clamp connector 60 . The clamp connector 60 comprises a connector body 100 , a quick connector 62 , and a locking mechanism 64 . The connector body 100 may be comprised of any suitable material, such as a rigid thermoplastic, acetyl butyl styrene (ABS), Delrin.RTM. acetal resin, nylon, polycarbonate, metal, or various polymers, to name a few. The connector body 100 may also have any suitable form. In preferred embodiments, the body 100 has a C-shaped form, as shown, having a first end 102 , a second end 104 and an arc-shaped arm 106 therebetween. The body 100 has a passageway 108 that extends through the first and second ends 102 , 104 . Therefore, an instrument, such as the delivery catheter 40 may be passed through the passageway 108 so that the handle 48 of the catheter 40 is positioned at least partially within at least the second end 104 , typically so that the handle button 50 remains outside of the connector body 100 . By positioning the handle 48 at least partially within the second end 104 , the handle 48 can be locked in relation to the connector 60 with the use of the locking mechanism 64 . In some embodiments, the passageway 108 extending through the second end 104 has a split 110 . Such a split 110 may be seen in FIG. 5 and FIG. 7 . The split 110 allows the passageway 108 through the second end 104 to expand. At least a portion of the handle 48 may then be advanced into the expanded passageway 108 . A locking mechanism 64 , such as a screw, knob or quick release tensioning lever, may then be tightened, turned or actuated to close the split 110 . This in turn applies compressive forces to the handle 48 so that it is held by friction. It may be appreciated, however, that any suitable locking mechanism may be used. The button 50 may then be manipulated to move the tubular shaft 41 of the delivery catheter 40 while the handle 48 is locked to the connector 60 . [0058] FIG. 6 provides a top perspective view of an embodiment of a clamp connector 60 . Again the clamp connector 60 is shown to have a first end 102 , a second end 104 and an arc-shaped arm 106 therebetween. A quick connector 62 is shown joined with the first end 102 , and a locking mechanism 64 is shown joined with the second end 104 . FIG. 6A illustrates a cross-sectional view along line A-A of FIG. 6 . This view illustrates the passageway 108 extending through the quick connector 62 , the first end 102 , and the second end 104 . In addition, this view illustrates the locking mechanism 64 . FIG. 7 provides another perspective view of the clamp connector 60 of FIG. 5 . [0059] The clamp connector 60 provides a number of advantages. As mentioned, the clamp connector 60 provides a stable platform for introduction of the stent delivery catheter 40 and various other instruments into the working lumen 18 of the bronchoscope 12 . As described in this embodiment, the clamp connector fixes the position of the catheter or instrument to the bronchoscope, or optionally fixes a component of the catheter or instrument to the bronchoscope while another component of the catheter or instrument is free to advance or retract within the bronchoscope working lumen while the fixed catheter component remains stationary. In addition, the connector 60 provides for locking of these instruments in a fixed position relative to the bronchoscope. Further, various embodiments of the connector 60 include a quick connector 62 which allows the connector 60 to be quickly and easily attached and detached from the bronchoscope 12 . Some embodiments include a side-action quick connector 62 which allows the connector to be attached and detached from a side approach rather than an axial approach. In addition to being more ergonomic, this approach reduces any axial pushing or pulling on the bronchoscope 12 which could inadvertently move the bronchoscope from its desired position. Some embodiments of the connector 60 also include a seal or are attachable with a seal. Commercially available seals include Biopsy Valve (MAJ-210) provided by Olympus America, Inc. (Melville, N.Y.). Such seals may be mounted on the connector 60 for mating with the bronchoscope 12 rather than mounted directly on the bronchoscope 12 . [0060] Although the clamp connector 60 may have various forms, the C-shaped form provides particular advantages. The C-shape provides direct access to the passageway 108 through the first end 102 while it is connected to the bronchoscope 12 . When the stent delivery catheter or other instrument is passed through the passageway 108 , the physician or user can easily grasp the catheter near the first end 102 to assist in advancing the catheter through the bronchoscope 12 . This may reduce any risk of kinking the catheter and may assist is passing the catheter through seals within the bronchoscope and/or clamp connector. In addition, such direct access to the passageway 108 through the first end 102 allows the insertion of various instruments without passing the instruments through the second end 104 . For example, a syringe may be inserted through the first end 102 to directly inject drugs, etc., into the working lumen 18 of the bronchoscope 12 . Likewise suction can be drawn through the working lumen 18 and the first end 102 without drawing suction through the entire connector 60 . [0061] FIGS. 8A-8B illustrate another embodiment of a clamp connector 60 . In this embodiment, the clamp connector 60 has the form of a bracket which attaches to the handle 24 of a bronchoscope 12 , as shown in FIG. 8A . An occlusal stent delivery catheter 40 may be advanced through the side arm 24 a of the bronchoscope handle 24 so that its distal end 42 passes through the bronchoscope 12 . The positioning rod 44 , which passes through the catheter 40 and extends from the its proximal end, may then be coupled with the clamp connector 60 to lock the positioning rod 44 in a fixed position in relation to the bronchoscope 12 . FIG. 8B illustrates the occlusal stent delivery catheter 40 of this embodiment showing the positioning rod 44 extending through the tubular shaft 41 . The occlusal stent 46 is shown disposed within the tubular shaft 41 near the distal end 42 . Thus, when the positioning rod 44 is locked to the connector 60 , the rod 44 is fixed in place. The tubular shaft 41 may then be retracted to expose and deploy the stent 46 . By fixing the positioning rod 44 in relation to the bronchoscope 12 , there is reduced variability in positioning the stent 46 thereby improving placement accuracy. [0062] FIGS. 8C-8E illustrate another embodiment of a clamp connector 60 . In this embodiment, the clamp connector 60 includes an elongate holder 170 , a base 172 and a support 174 , as illustrated in FIG. 8C . The elongate holder 170 is comprised of a shaft 176 having a plate 178 (with an aperture 180 ) attached near one end, and its other end is configured to receive the support 174 . Referring to FIG. 8D , the elongate holder 170 is coupleable with a bronchoscope 12 . The plate 178 may be positioned against the bronchoscope 12 so that the side arm 24 a of the bronchoscope 12 passes through the aperture 180 . The base 172 is positioned against the bronchoscope 12 on a side opposite to the side arm 24 a so that the base 172 wraps around the bronchoscope 12 as shown. The plate 178 may then be attached to the base 172 with the use of screws 182 or any suitable device. This fixes the clamp connector 60 to the bronchoscope 12 . The embodiments described in FIGS. 8A-8D are exemplary and any bracket configuration which attaches to the bronchoscope can be used. [0063] An occlusal stent delivery catheter 40 may then be advanced through the side arm 24 a and coupled with the clamp connector 60 to lock the positioning rod 44 in a fixed position in relation to the bronchoscope 12 . FIG. 8E provides a side view of the occlusal stent delivery catheter 40 positioned on the clamp connector 60 . The plate 178 may be connected with the shaft 176 at any suitable angle so that the shaft 176 holds the catheter 40 in a desired position while allowing manipulation of the bronchoscope 12 . The positioning rod 44 passing within the catheter 40 is locked in place by coupling the rod 44 with the support 174 . Thus, the rod 44 , clamp connector 60 and bronchoscope 12 are in fixed relation to each other. The tubular shaft 41 of the delivery catheter 40 may then be retracted to expose and deploy the stent 46 . Again, by fixing the positioning rod 44 in relation to the bronchoscope 12 , there is reduced variability in positioning the stent 46 thereby improving placement accuracy. Occlusal Stent [0064] The occlusal stent delivery system 10 may be used to deliver a variety of occlusal stents 46 . Occlusal stents 46 may also be referred to, for example, as occlusal devices, occlusive stents, obstructive devices or plugs. Exemplary occlusal stents 46 are provided in U.S. Pat. No. 6,527,761 [Attorney Docket No. 017534-001200US], and U.S. Provisional Patent Application No. 60/628,649 [Attorney Docket No. 017534-002000US], both assigned to the assignee of the present invention and incorporated by reference for all purposes. A number of embodiments of occlusal stents 46 are comprised of structural supports which expand to anchor the occlusal stent 46 in a lung passageway. [0065] Referring now to FIG. 9 and FIG. 9A , an embodiment of an occlusal stent 46 is shown. Here, the occlusal stent 46 comprises a braid 400 . The braid 400 may be comprised of any type of wire, particularly superelastic and/or shape-memory wire, polymer or suitable material. In this embodiment, the braid 400 is comprised of 0.006″ Nitinol wire (30-45% CW, oxide/etched surface). The wire braid 400 can be woven from wires having the same diameter, e.g. 24 wires each having a 0.006″ diameter, or wires having varied diameters, e.g. 12 wires each having a 0.008″ diameter and 12 wires each having a 0.003″ diameter. Other numbers of wires and combinations of wire diameters can also be used. [0066] The braid 400 is fabricated on a mandrel having a diameter close in size to the desired diameter of the occlusal stent 46 when unrestrained or in free space. The unrestrained diameter of the stent 46 is typically desired to slightly exceed the internal diameter of the bronchial tube within which it will be placed. Thus, the diameter of the braid 400 may vary depending on the intended usage of the stent 46 . Once the braid has been fabricated, the braid is then cut to an appropriate length and shape-set to a desired configuration by heat treatment. The desired configuration generally comprises the ends of the cut length of braid collapsed to form ends or tails, which will be secured and covered by bushings 401 , and a portion therebetween having an overall shape conducive to occluding a lung passageway. When other materials, such as Elgiloy.RTM. and stainless steel, are used, the wire is formed into the desired configuration using methods different from shape setting methods used for shape memory alloys. After shape-setting, the braid may then be etched to remove oxidation and to form a new passivation layer. [0067] The desired configuration may include a variety of overall shapes, each allowing the occlusal device 46 to perform differently or occlude lung passageways of differing shapes, sizes and configurations. FIG. 9 is a side view of one embodiment of the stent 46 having shoulders 402 which are at an angle which is approximately 90 degrees to a longitudinal axis 404 of the stent 46 . Shoulders 402 at such an angle allow maximum contact surface area in relation to length of the stent 46 . This is useful when placing the stent 46 into short bronchial segments or take-offs. FIG. 9A is an end view of the embodiment shown in FIG. 9 . [0068] Typically, the braid 400 is connected to, encapsulated in, coated or impregnated with a material to prevent flow of gases or liquids through the occlusal device 46 , thereby providing an obstruction. In addition, the material may optionally include an antibiotic agent for release into the lung passageway. Examples of obstructive materials include a thin polymer film 120 at least partially encapsulating the occlusal device 46 , which may be used to seal against the surface of the lung passageway. Such a design is depicted in FIG. 9 . As shown, the film 120 does not completely encapsulate the device 46 , leaving a portion of the shoulders 402 exposed. This allows for air to escape from the device 46 when the device is collapsed or contracted. In some embodiments, a bushing 401 located near the exposed area is color coded to signify the area so that the device 46 is loaded in the desired orientation within the delivery catheter 40 . Occlusal Stent Loading [0069] One or more occlusal stents 46 may be loaded within the delivery system 10 for delivery within a lung passageway. In preferred embodiments, the occlusal stent(s) are loaded into the delivery system 10 with the use of an occlusal stent loading system 130 . An embodiment of a loading system 130 of the present invention is illustrated in FIG. 10A . As shown, the system 130 includes a loading body 134 , a loading mandrel 136 , and a lubricious liner 132 . The loading body 134 has a wide-mouthed end 138 and narrow-mouthed end 140 , wherein the occlusal stent 46 is loadable into the wide-mouthed end 138 in an expanded configuration and removed from the narrow-mouthed end 140 in a contracted configuration. Thus, the loading body 134 contracts the occlusal stent 46 for loading into the delivery catheter 40 . The loading body 134 is also used to load the contracted stent 46 into the delivery catheter 40 . [0070] The occlusal stent 46 can be loaded into the loading body 134 with the use of the loading mandrel 136 . The mandrel 136 includes a proximal end 141 , a distal end 142 and a shaft 143 therebetween. An attachment device 144 is disposed near the distal end 142 which is used to removably attach to the occlusal stent 46 . The attachment device 144 may be integral with the mandrel 136 or mounted on, attached to, coupled with the mandrel 136 , for example. The attachment device 144 may have any suitable form, including a hook, fork, clasp, fastener, or magnet, to name a few. The mandrel 136 may also include a mandrel grip 146 which has an inner lumen 148 sized for passage of the mandrel 136 therethrough so that the grip 146 may be positioned at any location along the length of the shaft 142 . In some embodiments, the grip 146 also serves as a depth stop when loading the stent 46 within the loading body 134 . In these embodiments, the grip 146 is preferably positioned in the range of approximately 34 to 38 mm from the proximal end 141 of the shaft 143 . The use of the grip 146 as a depth stop will be further described in later sections. In addition, the mandrel 136 may also include one or more mandrel end covers 149 . [0071] The shaft 143 is sized to be passed through loading body 134 . FIG. 10B provides a top view of the loading body 134 having the mandrel 136 positioned therein. As shown, the body 134 includes a loading receptacle 150 , a restrictor 152 and a holding tube 154 . The lubricious liner 132 is shown inserted into the wide-mouthed end 138 and positioned so that the liner 132 extends through the restrictor 152 and holding tube 154 . FIGS. 11A-11D illustrate how an occlusal stent 46 may be prepared for loading into the catheter 40 with the use of these elements of the loading body 134 . [0072] FIG. 11A illustrates a portion of the loading body 134 wherein the distal end 142 of the loading mandrel 136 is shown passed through the narrow-mouthed end 140 to and beyond the wide-mouthed end 138 . The attachment device 144 is shown attached to the occlusal stent 46 . In this embodiment, the attachment device 144 comprises a fork which releasably joins with the occlusal stent 46 . The mandrel 136 is then retracted, drawing the occlusal stent 46 into the loading receptacle 150 at the wide-mouthed end 138 , as shown in FIG. 11B . Further retraction of the mandrel 136 pulls the occlusal stent 46 into the restrictor 152 which gradually collapses the stent 46 , as shown in FIG. 11C . As the stent 46 collapses, air within the stent 46 is forced out toward the narrow-mouthed end 140 . Still further retraction of the mandrel 136 pulls the contracted stent 46 into the holding tube 154 , as shown in FIG. 11D . The liner 132 serves to reduce any friction between the stent 46 and the loading body 134 as the stent 46 is collapsed and passed through the loading body 134 . Thus, the liner 132 may be comprised of any suitable material which reduces friction, such as Teflon.RTM. It may be appreciated that the liner 132 may alternatively be integral with the loading body 134 or may have the form of a coating on surfaces of the loading body 134 . The occlusal stent 46 is now ready for loading into the delivery catheter 40 . [0073] It may be appreciated that the loading system 130 may be constructed from any suitable materials. Preferably, the loading body 134 is constructed from a material which allows visibility of the stent 46 throughout the loading process. This may ensure that the stent 46 is properly loaded within the loading body 134 . Alternatively or in addition, a variety of markings 82 , 82 ′ may be used to ensure proper loading. For example, as shown in FIG. 10A , the mandrel 136 may include a marking 82 , such as a line of ink, on the shaft 143 a desired distance from the distal end 142 . In preferred embodiments, the marking 82 is disposed approximately 0.3 inches from the distal end 142 . The loading body 134 then includes a corresponding marking 82 ′ near the narrow-mouthed end 140 , approximately 0.35 inches from the holding tube 154 . When the mandrel 136 is retracted so that the marking 82 on the shaft 143 is aligned with the marking 82 ′ on the loading body 134 , the occlusal stent 46 is properly positioned within the holding tube 154 . [0074] The occlusal stent 46 may then be transferred to the delivery catheter 40 , as illustrated in FIGS. 11E-11G . FIG. 11E illustrates the delivery catheter 40 positioned against the holding tube 154 of the loading body 134 . The loading mandrel 136 or any other suitable instrument is used to transfer the occlusal stent 46 to the distal end 42 of the delivery catheter 40 . As shown, the proximal end 141 of the loading mandrel 136 is advanced through the loading receptacle 150 and the restrictor 152 until it contacts the occlusal stent 46 . Continued advancement of the loading mandrel 136 pushes the occlusal stent 46 from the holding tube 154 and into the catheter 40 . FIG. 11F illustrates the loading mandrel 136 fully advanced so that the occlusal stent 46 is fully loaded within the catheter 40 . In some embodiments, the mandrel grip 146 assists in proper placement of the stent 46 within the holding tube 154 by serving as a depth stop for the loading mandrel 136 . The grip 146 is sized so that it may be advanced into the loading receptacle 150 but cannot be advanced into the restrictor 152 , thus serving as a depth stop. The grip is positioned along the length of the mandrel 136 so that when the grip 146 is positioned against the restrictor 152 , as shown in FIG. 11F , the stent 46 is properly positioned within the holding tube 154 . FIG. 11G illustrates the distal end 42 of the catheter 40 removed from the loading body 134 and having the occlusal stent 46 loaded inside. [0075] It may be appreciated that the loading system 130 may be adapted to load more than one occlusal stent 46 . For example, the holding tube 154 may be lengthened to hold two, three, four, five or more stents 46 at one time. The stents 46 may be individually loaded into separate delivery catheters, simultaneously loaded into a single delivery catheter or loaded in groups into a few catheters. [0076] FIGS. 12A-12C illustrate an alternative method of loading a delivery catheter 40 with an occlusal stent 46 . In this embodiment, one or more stents are loaded directly into the distal end 42 of the delivery catheter 40 . As shown in FIG. 12A , the delivery catheter 40 includes a positioning rod 44 having a grasping device 160 disposed at its tip. In this example, the grasping device 160 has the shape of a ring, loop, hoop or circle. The device 160 may be comprised of any suitable material, such as wire, polymer, thread, fiber, or suture, to name a few. A restricting insert 162 is positioned at least partially within the distal end 42 , such as shown. Optionally it can be appreciated that the restricting insert 162 can be of the type that engages with an outer surface or edge of the distal end 42 so that the insert 162 is not at least partially within the distal end 42 . The restricting insert 162 is used to assist in collapsing and loading the stent 46 within the distal end 42 of the catheter 40 . This is achieved by retracting the tubular shaft 41 so that the grasping device 160 can be removably attached to a bushing 401 on an occlusal stent 46 . As shown in FIG. 12A , at least one of the bushings 401 includes a notch 164 which is mateable with the grasping device 160 . As shown in FIG. 12B , the grasping device 160 attaches to the bushing 401 and draws the occlusal stent 46 through the restricting insert 162 and into the tubular shaft 41 of the catheter 40 . FIG. 12C shows the distal end 42 of the catheter 40 having the occlusal stent 46 loaded inside and the restricting insert 162 removed. [0077] FIGS. 13A-13C illustrate an similar method of loading a delivery catheter 40 with an occlusal stent 46 . As shown in FIG. 13A , the delivery catheter 40 includes a positioning rod 44 having a grasping device 160 disposed at its tip. In this example, the grasping device 160 has the shape of a pincher or claw. The tubular shaft 41 is retracted so that the grasping device 160 pinch onto a bushing 401 on an occlusal stent 46 . As shown in FIG. 13A , at least one of the bushings 401 includes one or more protrusions 166 which the grasping device 160 is able to utilize in grasping. As shown in FIG. 13B , the grasping device 160 grasps the bushing 401 and draws the occlusal stent 46 through the restricting insert 162 and into the tubular shaft 41 of the catheter 40 . A restricting insert 162 is positioned at least partially within the distal end 42 , as shown. The restricting insert 162 is used to assist in collapsing the stent 46 and loading the stent 46 within the distal end 42 of the catheter 40 . The grasping device 160 may also be used to retrieve or adjust an occlusal stent 46 which has been deployed in a lung passageway LP, as illustrated in FIG. 13C . As shown, the distal end 42 of the catheter 40 may be retracted to expose the grasping device 160 which can be used to grasp onto the bushing 401 of the occlusal stent 46 . The stent 46 may then be manipulated by the grasping device 160 . In some methods, the occlusal stent 46 may be deployed in a more distal position within the lung passageway LP than desired so that the stent 46 may then be pulled proximally to a desired position with the use of the grasping device 160 . [0078] It may further be appreciated that delivery catheters 40 of the present invention may alternatively be provided to a physician or user in a preloaded state wherein one or more occlusal stents 46 are provided within the catheters 40 , ready for delivery. Further, it may be appreciated that automatic loading systems may be provided, or systems in which the stent is pre-connected to the catheter rod but not yet loaded into the catheter receptacle. Methods of Use [0079] The occlusal stent delivery system 10 of the present invention may be used for a variety of therapeutic procedures, preferably for performing “endobronchial volume reduction” (EVR). EVR is a non-surgical technique for isolating and occluding diseased lobar and sub-lobar regions of a patient's lung. An isolated region will be a portion (usually not the whole) of the right or left lung, and volume reduction will be accomplished by evacuating the region and occluding a bronchial passage within or leading to the region with an occlusal stent 46 . One or more bronchial passageways within or leading to the region may be occluded while the region is evacuated, as will be described. [0080] Initially, the bronchoscope 12 is separate from the sheath 30 and the distal end 16 of the scope 12 is then introduced through a luer or other proximal connector 34 of the sheath 30 . Referring back to FIG. 1 , the distal end 16 is advanced until the occlusive member 32 is disposed at a desired position along the length of the scope 12 . At that point, the luer or other connector 34 is then tightened on to the scope 12 . A suitable monitor may then be connected to the bronchoscope 12 in a conventional manner. Inflation of member 32 may be effected through an inflation tube 36 , typically using a pressurized air or other gas source. [0081] Referring now to FIG. 14A , the assembly of the sheath 30 and bronchoscope 12 may be introduced through the trachea T to a target location in a patient's lung LNG. The sheath-bronchoscope assembly 30 / 12 is introduced so that the occlusive member 32 reaches a desired location, in this example a major takeoff in the left lung. At that point, the member 32 may be inflated. During the advancement and after inflation of the member 32 , viewing through the bronchoscope 12 may be accomplished through the monitor connected to the scope 12 . [0082] While the member 32 is inflated, lung segments beyond the member 32 may be evacuated by applying vacuum suction through an aspiration lumen 22 in the bronchoscope 12 . The occlusal stent delivery catheter 40 (having an occlusal stent 46 pre-loaded within its distal end 42 ) is then advanced through the working lumen 18 of the bronchoscope 12 . Forward imaging by the bronchoscope 12 is effected by illuminating through light fibers within the scope lumen 20 and detecting an image through a lens at the distal end 16 of the bronchoscope 12 . The resulting image can be displayed on conventional cathode-ray or other types of imaging screens. In particular, forward imaging permits a user to selectively place the catheter 40 through a desired route through the branching bronchus. It may be appreciated, however, that as an alternative positioning could be done solely by fluoroscopy. [0083] In any case, referring again to FIG. 14A , the delivery catheter 40 is then advanced until its distal end 42 reaches a region in the bronchus or lung passageway which leads directly into a diseased region DR. The delivery catheter 40 is advanced through the working lumen 18 of the bronchoscope 12 via the passageway 108 of the clamp connector 60 attached to the side arm 24 a , as previously described. Once the distal end 42 of the catheter 40 is positioned in a desired location within the lung passageway, the catheter 40 is locked in place with the use of the locking mechanism 64 on the clamp connector 60 . The occlusal stent 46 may then be deployed in the passageway. Recall, the occlusal stent 46 is pre-loaded in a compressed or collapsed state within an interior lumen of the delivery catheter 40 . The occlusal stent 46 is deployed by retracting the tubular shaft 41 of the delivery catheter 40 . This is achieved by sliding the handle button 50 on the handle 48 of the catheter 40 , as previously described. As the tubular shaft 41 retracts, the positioning rod 44 holds the occlusal stent 46 in place. Thus, the occlusal stent 46 is gradually exposed. If the stent 46 is self-expanding, for example by tension or shape-memory, the stent 46 will expand and anchor itself in the passageway as the occlusal stent 46 is exposed, as shown in FIG. 14A . If the occlusal stent 46 is not self-expanding, it may be expanded with the use of a balloon or other mechanism provided by the delivery catheter 40 , a catheter or device delivered through the catheter 40 , or another device. [0084] While the sheath 30 and occlusive member 32 are in place, additional occlusal stents may be positioned within the evacuated lung passageways beyond the member 32 . The delivery catheter 40 may be removed and loaded with a second occlusal stent 46 ′ for reintroduction, or the delivery catheter 40 may be removed and replaced with another delivery catheter 40 that has already been preloaded with a second occlusal stent 46 ′. Referring now to FIG. 14B , the delivery catheter 40 is then advanced until its distal end 42 reaches a region in the bronchus or lung passageway which leads directly into a second diseased region DR′. Again, the delivery catheter 40 is advanced through the working lumen 18 of the bronchoscope 12 with the use of the clamp connector 60 attached to the side arm 24 a , as previously described. Once the distal end 42 of the catheter 40 is positioned in a desired location within the lung passageway, the catheter 40 is locked in place with the use of the locking mechanism 64 on the clamp connector 60 . The second occlusal stent 46 ′ may then be deployed in the passageway. The second occlusal stent 46 ′ is deployed by retracting the tubular shaft 41 of the delivery catheter 40 . As the tubular shaft 41 retracts, the positioning rod 44 holds the second occlusal stent 46 ′ in place. If the stent 46 ′ is self-expanding, the stent 46 ′ will expand and anchor itself in the passageway as the second occlusal stent 46 ′ is exposed, as shown in FIG. 14B . [0085] Further, while the sheath 30 and occlusive member 32 are in place, any number of additional occlusal stents may also be positioned within the evacuated lung passageways beyond the member 32 . Again, the delivery catheter 40 may be removed and loaded with a third occlusal stent 46 ″ for reintroduction, or the delivery catheter 40 may be removed and replaced with another delivery catheter 40 that has already been preloaded with a third occlusal stent 46 ″ (thus, it may be efficient to utilize two delivery catheters 40 so that one catheter 40 may be preloaded with an occlusal stent while the other is in use). The delivery catheter 40 is then advanced until its distal end 42 reaches a region in the bronchus or lung passageway which leads directly into a third diseased region DR″. Again, the delivery catheter 40 is advanced through the working lumen 18 of the bronchoscope 12 with the use of the clamp connector 60 attached to the side arm 24 a , as previously described. Once the distal end 42 of the catheter 40 is positioned in a desired location within the lung passageway, the catheter 40 is locked in place with the use of the locking mechanism 64 on the clamp connector 60 . The third occlusal stent 46 ″ may then be deployed in the passageway, as shown in FIG. 14C . [0086] The occlusive member 32 may then be deflated and the delivery system 10 removed, leaving the occlusal devices 46 , 46 ′, 46 ″ behind wherein each occlusal device isolates and occludes a diseased region DR, DR′, DR″, respectively. [0087] Although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that various alternatives, modifications and equivalents may be used and the above description should not be taken as limiting in scope of the invention which is defined by the appended claims.

Methods, systems and devices are provided for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions where isolation of a lung segment or reduction of lung volume is desired. The methods are minimally invasive with instruments being introduced through the mouth (endotracheally) and rely on isolating the target lung tissue segment from other regions of the lung and occluding various lung passageways with the use of occlusal stents. The occlusal stents are delivered with the use of an occlusal stent delivery system which is loaded with the occlusal stent with the use of an occlusal stent loading system.

PRIORITY Benefit is claimed under 35 U.S.C. 119(e) of pending provisional application 61/009,052 filed Dec. 26, 2007. This invention is in the field of sports equipment and more particularly relating to the game of golf, providing capability of adding a selectable amount of weight inside the shaft of an existing golf club and affixing the weight at a selectable location anywhere within the length of the shaft. BACKGROUND OF THE INVENTION In ongoing evolution in the game of golf, along with a shift to lighter weight shafts there has been increased interest in custom-matching golf clubs to individual golfers in recognition of the differences that characterize individual golfers such as height, weight, strength, firmness of grip, path and velocity of swing, etc., and the differences in golf clubs such as total length, total weight, weight distribution considering head weight, shaft weight and grip weight, along with other variables such as shaft stiffness and related resonances. The overall result of these variables determines how a particular club “feels” to that particular golfer. For club-matching purposes, the golf industry developed a rating known as “swing-weight”, based on balance measurements made on the club about a fulcrum point usually twelve or fourteen inches from the club cap, characterizing the club on a scale of 77 increments with letters A-G followed by numerals 1-10. Industry standards are D0 or D1 for men and C5 to C7 for women. In another rating system, the MOI (moment of inertia: in physics the product of mass and distance from the axis of rotation) is expressed in terms of total club weight and distance from the center of gravity (balance point) to an arbitrary axis of rotation, usually taken at the club cap end, but suggested by the present inventor as more realistic if taken at an outside point, e.g. twelve inches beyond the cap. Many golfers including pros are not fully satisfied with the existing rating systems and regard them as approximate guidelines at best, so there is an unfulfilled need for after-market accessories that enable even initially “matched” golf clubs to be fine-tuned to more closely match the golfer's individual physique and needs for improved performance. DISCUSSION OF KNOWN ART U.S. Pat. No. 6,765,156 B2 to Latiri for a GOLF CLUB SWING WEIGHT BALANCE AND SCALE provides detailed description regarding “swing weight” and its measurement. U.S. Pat. No. 5,528,927 to Butler et al for a CENTER OF GRAVITY LOCATOR discloses apparatus and method for measuring “center of gravity” of an object such as a golf club head. U.S. Pat. No. 4,059,270 to Sayers for METHOD FOR CUSTOM FITTING GOLF CLUBS discloses a device utilizing a system of photobeam measurers to detect the speed imparted to a golf ball and the related variables. In describing the method of evaluating and custom-fitting golf clubs to players, this patent sets forth “swing weight” and club length as the two major variable factors relating to optimization of the golf club. As examples of patents that teach adding mass to the club head the Sayer patent cites U.S. Pat. Nos. 1,306,029, 1,538,312, 2,163,091, 2,750,194 and 3,692,306. A more recent example, U.S. Pat. No. 6,514,154 to Finn discloses a GOLF CLUB HAVING ADJUSTABLE WEIGHTS AND READILY REMOVABLE AND REPLACEABLE SHAFT. Approaches to after-market weight-balancing golf clubs have included weights, e.g. in the form of a sleeve or lead tape to be attached on the outside of the shaft. As an environmental hazard, lead tape has become unpopular. Since other external approaches are considered unsightly, alternative internal approaches have included inserting a cork or other weight in the bore of the shaft of the club, pushing it in to an estimated best location where it is retained adhesively or by a tight friction fit such that typically it cannot be removed or even shifted upwardly in the shaft. Known golf club weighting approaches have suffered other drawbacks, for example: (1) unless the weight is made removable, it cannot be replaced to adjust to a lighter value: it can only be increased by adding another weight; (2) readjustment of the weight location, which is often desired, is impossible with adhesive fastening; with frictional fastening, typically the weight can be pushed further downwardly but cannot be shifted upwardly in the shaft; (3) a friction plug of relatively rigid material fails to accommodate the variations in the diameter of the tapered shaft bore, typically decreasing from 0.5 inches at the cap end to about 0.3 inches at the head end, thus the available range of location of any single weight plug is inadequate; and (4) there is a high probability of failure of the weight fastening system, allowing the weight to shift from the desired location under the strong forces applied during the swing stroke and in general handling and transporting of the golf clubs. Numerous patents and approaches such as these have failed to fully satisfy the unfulfilled need for an after-market device for conveniently and reliably “balancing” the club to match the golfer, i.e. adding a judicious amount of weight at a strategic “sweet spot” selected as optimal along the shaft to match the golfer and enhance the level of performance. OBJECTS OF THE INVENTION It is a primary object of the present invention to provide capability of adjusting and setting the balance of any golf club through the addition of a selectable amount of weight inside the shaft in a manner that it can be positioned throughout the length of a tapered shaft bore and secured reliably in place. It is a further object that after being secured in place, the weight can be released, relocated upward or downward and again secured reliably in place. SUMMARY OF THE INVENTION The objects of the invention have been accomplished by a generally cylindrical weight device including at least one expansion element made of sufficiently rubber-like material and dimensioned such that lengthwise compression causes radial expansion to a predetermined diameter range corresponding to at least a major portion of the typical diameter range of golf club shaft bores. The device includes at least one weight element and one expansion element. Typically the device is configured with three cylindrical shaped elements, each with a central passageway, located co-linearly, i.e. a single weight element located between a lower expansion element and an upper expansion element. The lower expansion element is configured at its lower end with a threaded bushing that serves as a compression plate engaged by a captive steel machine screw that traverses the passageways. A washer under the screw head forms a compression plate at the upper end. The device is initially pushed in to place using a special tool with an elongated shaft ending in a hex driver end that engages a hex socket in the head of the machine screw. The tool includes a permanent magnet acting on the screw head so as to retain engagement and to enable the weight device to be pulled upwardly in the golf club shaft. Initially the device is loaded onto the tool with the screw tightened only enough to create light friction in the upper region of the club shaft above the desired location; then it is pushed down to the desired location and then secured in place there by rotating the screw clockwise to tighten it securely then the tool is removed. To relocate the device for “fine tuning” or removal, the tool is reinserted and the screw is rotated counter-clockwise to reduce the holding friction sufficiently to remove the device or shift it up or down as required to a new location where it is again secured as described. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an elevational view of a weight device in a primary embodiment of the present invention. FIG. 2 is a cross-section of the weight device of FIG. 1 , shown installed in a golf club shaft, shown in part. FIG. 3 is an elevational view of a manual driver tool for installing, adjusting and removing the weight device of FIG. 1 . FIG. 4 is a cross section of the tool of FIG. 3 inserted through the cap of a grip showing the driver member on the shaft of FIG. 2 about to engage the weight device of FIG. 1 , shown in part. FIG. 5 is an elevational view of a secondary embodiment of a weight device of the present invention. FIG. 6 is a cross-section of the weight device of FIG. 5 installed in golf club shaft, shown in part. FIG. 7 is a three-dimensional view depicting a first alternative non-magnetic tool and bayonet engagement method for weight device relocation/removal. FIG. 8 is a three-dimensional view depicting a second alternative non-magnetic tool and bayonet engagement method for weight device relocation/removal. DETAILED DESCRIPTION FIG. 1 is an elevational view of a weight device 10 in a primary embodiment of the present invention. A first expansion element 12 of rubber or other elastic material, a weight element 14 and a second expansion element 16 similar to element 12 , are held together in a collinear elongated cylindrical assembly, as shown, by a machine screw 18 traversing central openings in the three elements and a washer 20 under the head of machine screw 18 . FIG. 2 is a cross-section of the weight device 10 of FIG. 1 , shown installed in a golf club shaft 22 , shown in part. Screw 18 , engaging a threaded bushing 16 A at the lower end, has been tightened sufficiently to expand the diameter of both expansion elements 12 and 16 so as to bear firmly against the inside surface of shaft 22 , securing weight device 10 in place. The golf club shaft 22 is typically made with a bore that tapers from about 2″ in diameter at the top cap end to about ⅜″ at the lower end. To accommodate this variation, a standard version of weight device 10 , for the major upper portion of the shaft 22 , is made with the weight element 14 and the (unexpanded) expansion elements 12 and 16 typically ⅜″ in diameter, and a scaled-down version for a minor lower portion of the shaft 22 , is made with these elements typically ¼″ in diameter. The weight device 10 is made to have, a designated total weight by the length of the weight element 14 and the density of its material, e.g. brass for high density. It is supported in a firm but resilient manner that prevents any metal-to-metal contact with shaft 22 , as deemed optimal for performance characteristics. At the lower end of screw 18 the threads at the extreme lower end of the threaded portion are crimped so as to keep screw 18 captive and avoid unintended disassembly of weight device 10 during removal or repositioning. In the standard version of weight device 10 , the weight element 14 and the expansion elements 12 and 16 are 3/16″ in diameter. FIG. 3 is an elevational view of a driver tool 24 for installing, adjusting and removing the weight device 10 of FIGS. 1 and 2 . A metal rod shaft 26 , made approximately the length of a golf club bore, has a blade handle 28 attached at the top end for manual rotation. At the lower end, a hex driver member 30 extends downwardly from a cylindrical permanent magnet 32 attached immediately above. FIG. 4 is a cross-section of shaft 22 equipped with a golf hand grip 34 , and with a weight device 10 ( FIG. 2 ), shown in part, and a tool 24 ( FIG. 3 ) having been inserted through a circular opening 34 A that has been cut in cap portion 34 A of grip 34 . Opening 34 A has a diameter equal or near that of the inside of shaft 22 at its top end. At the bottom end of tool 24 , an Allen hex driver member 30 is in position immediately above the corresponding hex head of machine screw 18 ready for engagement. Magnet 32 is magnetized in a manner to magnetically attract the (steel) head of machine screw 18 when nearby, and to abruptly force closure of the air gap to fully engage the hex driver member 30 in the head of screw 18 . The weight device 10 can then be relocated or withdrawn by first rotating screw 18 counter-clockwise to reduce the axial pressure and partially relax the expansion elements 12 and 16 to release their grip on shaft 22 to an optimally low amount of residual friction to facilitate relocation or withdrawal. For upward relocation or withdrawal, magnet 32 provides the transmission of the necessary amount of tensile pulling force. FIG. 5 is an elevational view of a secondary embodiment of a weight device 10 A of the present invention that has fewer parts and that may serve as an added auxiliary mass that can be located near the primary weight device or elsewhere. A relatively short weight element 14 A is located directly under the head of bolt 18 A, and the single compression element 12 is fitted at the lower end with a threaded “T-nut” 36 , as an alternative to bushing 16 A ( FIG. 2 ). FIG. 6 is a cross-section of the second embodiment weight device of FIG. 5 installed in golf club shaft 22 , shown in part. T-nut 36 , forming a threaded bottom end plate, is a commercial hardware product that is available with a set of spurs that extend upwardly into the expansion element 12 as indicated, for anti-rotation purposes. Insertion, relocation and removal for this second embodiment weight device are as previously described for the primary embodiment weight device 10 . While the dual expansion element mounting of the primary embodiment is inherently extremely robust with a weight element of practically any desired length, with the secondary embodiment having only the single expansion element, the weight element should be kept relatively short in length and possibly tapered to a smaller diameter at the upper end to prevent possibility of contact with the shaft in the event of off-axis displacement if the expansion element is not adequately secured in place. Possibility of such contact can be avoided by shortening of the weight element 14 A to the extreme of making it simply a metal washer of designated thickness, or a stack of several washers; the expansion element 12 may be lengthened for weight increase. FIG. 7 is a three-dimensional view depicting a first alternative tool 26 A and a corresponding bayonet engagement method for weight device relocation/removal that eliminates the need for a magnet on the tool. In this example, washer 14 B forms a weight element and end plate for expansion member 12 , shown in part. Screw head 18 B is fitted with one of more extending bayonet pins 18 C: in this example a single pin 18 C traversing the head 18 B extends outwardly as two diametrically opposed pins. Tool 26 A may be a hollow tube or may be a solid shaft fitted at the bottom end with a hollow sleeve: near the bottom end tool 26 A is configured with one or more specially shaped T slots 26 B as shown, one for each bayonet pin 18 C on head 18 B. FIG. 8 is a three-dimensional view depicting a second alternative non-magnetic tool utilizing a bayonet engagement method for weight device relocation/removal. In this example the tool 26 C may be a solid rod with the lower end preferably in the bullet shape shown and fitted with a pair of bayonet pins 26 D. A sleeve 18 D fastened to the bolt head of the weight device is configured with a pair of T slots as shown. The configurations of FIGS. 7 and 8 are essentially inversions of each other, and function in a similar manner. When engaged with pins located at one or other end region of the T slots, the tool can rotate the screw head clockwise or counter-clockwise, and can pull the weight device upwardly for relocation or removal. For release of tool from the screw head, a slight rotation of the tool relocates the bayonet pins centrally in the T slots in line with the slot entrance. In either version, alternatively, a single short pin could be utilized, or a set of two, three or more short pins could be arranged in a polar array and secured in place in drilled holes. Alternatively the slots could be L-shaped, in the manner of well known auto lamp sockets. To provide a range of weight that can be added to a golf club, the weight devices may be made available in selected steps; e.g. three basic weights: 50, 25 and 12.5 grams enable the weight to be set to any desired value from 12½ grams in steps of 12½ grams. The 50 gram weight device can be made in the primary embodiment using a brass weight element ⅜″ by about 4″ long. Weighting can be performed with one, two or more weight devices; they can be located together or located independently anywhere along the shaft. The 12.5 gram weight device, and even a 6¼ gram “fine tuner”, may be made either in the primary embodiment, possibly utilizing a plastic weight element, and/or made in the secondary embodiment. A single weight device may be located anywhere along the shaft length, and with more than one weight device there is full flexibility of locating the devices close together or elsewhere throughout the shaft length. As an alternative to utilizing a magnet for pulling the weight element to move it upwardly, a mechanical system could utilize a bayonet pin/slot type engagement, generally similar to that found on bayonet base electric lamps, particularly automotive lamps. The L shaped slots could be oriented opposite their normal direction, so that the fastening would tend to stay engaged for pulling purposes while urging the tool counter-clockwise. The invention may be embodied and practiced in other specific forms without departing from the spirit and essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention encompassing all variations, substitutions, and changes that come within the meaning and range of equivalency of the claims therefore are intended to be embraced therein.

A weight device for golf clubs can be secured at a selected location within the shaft. A cylindrical weight element is typically disposed between two expansion elements, all three elements being traversed by a machine screw that engages a threaded lower end plate. The screw head is made to be engaged and driven by a special elongated tool to put the device in a sliding-friction mode for moving to any desired location within a golf club shaft, where the device can be secured in place by rotating the screw clockwise to expand the expansion elements against the shaft bore in a compression-secured mode. A permanent magnet affixed to the tool enables upward relocation or removal of the weight device.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a division of, and claims priority to U.S. patent application Ser. No. 9/783,236, filed Feb. 13, 2001, for Implantable Retinal Electrode Array Configuration for Minimal Retinal Damage and Method of Reducing Retinal Stress. GOVERNMENT RIGHTS [0002] This invention was made with government support under grant No. R24EY12893-01, awarded by the National Institutes of Health. The government has certain rights in the invention. BACKGROUND OF THE INVENTION [0003] 1. Field of the Invention [0004] This invention relates to a prosthetic medical ocular device and methods, and more particularly to an intraocular electrical retinal stimulation device that minimizes retinal damage during and after surgery, is easily manipulated by the surgeon performing the implant procedure, and to a method of reducing retinal stress. [0005] 2. Description of the related art including information disclosed under 37 CFR Secs. 1.97-1.99 [0006] In 1755 LeRoy passed the discharge of a Leyden jar through the orbit of a man who was blind from cataract and the patient saw “flames passing rapidly downwards.” Ever since, there has been a fascination with electrically elicited visual perception. The general concepts of electrical stimulation of retinal cells to produce these flashes of light or phosphenes has been known for quite some time. Based on these general principles, some early attempts at devising a prosthesis for aiding the visually impaired have included attaching electrodes to the head or eyelids of patients. While some of these early attempts met with some limited success, these early prosthesis devices were large, bulky and could not produce adequate simulated vision to truly aid the visually impaired. [0007] In the early 1930's, Foerster investigated the effect of electrically stimulating the exposed occipital pole of one cerebral hemisphere. He found that, when a point at the extreme occipital pole was stimulated, the patient perceived a small spot of light directly in front and motionless (a phosphene). Subsequently, Brindley and Lewin (1968) thoroughly studied electrical stimulation of the human occipital cortex. By varying the stimulation parameters, these investigators described in detail the location of the phosphenes produced relative to the specific region of the occipital cortex stimulated. These experiments demonstrated: (1) the consistent shape and position of phosphenes; (2) that increased stimulation pulse duration made phosphenes brighter; and (3) that there was no detectable interaction between neighboring electrodes which were as close as 2.4 mm apart. [0008] As intraocular surgical techniques have advanced, it has become possible to apply stimulation on small groups and even on individual retinal cells to generate focused phosphenes through devices implanted within the eye itself. This has sparked renewed interest in developing methods and apparati to aid the visually impaired. Specifically, great effort has been expended in the area of intraocular retinal prosthesis devices in an effort to restore vision in cases where blindness is caused by photoreceptor degenerative retinal diseases such as retinitis pigmentosa and age related macular degeneration which affect millions of people worldwide. [0009] Neural tissue can be artificially stimulated and activated by prosthetic devices that pass pulses of electrical current through electrodes on such a device. The passage of current causes changes in electrical potentials across neuronal membranes, which can initiate neuron action potentials, which are the means of information transfer in the nervous system. [0010] Based on this mechanism, it is possible to input information into the nervous system by coding the information as a sequence of electrical pulses which are relayed to the nervous system via the prosthetic device. In this way, it is possible to provide artificial sensations including vision. [0011] One typical application of neural tissue stimulation is in the rehabilitation of the blind. Some forms of blindness involve selective loss of the light sensitive transducers of the retina. Other retinal neurons remain viable, however, and may be activated in the manner described above by placement of a prosthetic electrode device on the inner (toward the vitreous) retinal surface. This placement must be mechanically stable, minimize the distance between the device electrodes and the neurons, and avoid undue compression of the neurons. [0012] In 1986, Bullara (U.S. Pat. No. 4,573,481) patented an electrode assembly for surgical implantation on a nerve. The matrix was silicone with embedded iridium electrodes. The assembly fit around a nerve to stimulate it. [0013] Dawson and Radtke stimulated cat's retina by direct electrical stimulation of the retinal ganglion cell layer. These experimenters placed nine and then fourteen electrodes upon the inner retinal layer (i.e., primarily the ganglion cell layer) of two cats. Their experiments suggested that electrical stimulation of the retina with 30 to 100 uA current resulted in visual cortical responses. These experiments were carried out with needle-shaped electrodes that penetrated the surface of the retina (see also U.S. Pat. No. 4,628,933 to Michelson). [0014] The Michelson '933 apparatus includes an array of photosensitive devices on its surface that are connected to a plurality of electrodes positioned on the opposite surface of the device to stimulate the retina. These electrodes are disposed to form an array similar to a “bed of nails” having conductors which impinge directly on the retina to stimulate the retinal cells. Such a device increases the possibility of retinal trauma by the use of its “bed of nails” type electrodes that impinge directly on the retinal tissue. [0015] The art of implanting an intraocular prosthetic device to electrically stimulate the retina was advanced with the introduction of retinal tacks in retinal surgery. De Juan, et al. at Duke University Eye Center inserted retinal tacks into retinas in an effort to reattach retinas that had detached from the underlying choroid, which is the source of blood supply for the outer retina and thus the photoreceptors. See, e.g., E. de Juan, et al., 99 Am. J. Opthalmol. 272 (1985). These retinal tacks have proved to be biocompatible and remain embedded in the retina, and choroid/sclera, effectively pinning the retina against the choroid and the posterior aspects of the globe. Retinal tacks are one way to attach a retinal array to the retina. [0016] The retina is extraordinarily fragile. In particular, retinal neurons are extremely sensitive to pressure; they will die if even a modest intraocular pressure is maintained for a prolonged period of time. Glaucoma, which is one of the leading causes of blindness in the world, can result from a chronic increase of intraocular pressure of only 10 mm Hg. Furthermore, the retina, if it is perforated or pulled, will tend to separate from the underlying epithelium, which will eventually render it functionless. Thus attachment of a conventional prosthetic retinal electrode device carries with it the risk of damage to the retina, because of the pressure that such a device could exert on the retina. [0017] Byers, et al. received U.S. Pat. No. 4,969,468 in 1990 which disclosed a “bed of nails” electrode array which in combination with processing circuitry amplifies and analyzes the signal received from the tissue and/or which generates signals which are sent to the target tissue. The penetrating electrodes are damaging to the delicate retinal tissue of a human eye and therefore are not applicable to enabling sight in the blind. [0018] In 1992 U.S. Pat. No. 5,109,844 issued to de Juan et al. on a method of stimulating the retina to enable sight in the blind wherein a voltage stimulates electrodes that are in close proximity to the retinal ganglion cells. A planar ganglion cell-stimulating electrode is positioned on or above the retinal basement membrane to enable transmission of sight-creating stimuli to the retina. The electrode is a flat array containing 64-electrodes. [0019] Norman, et al. received U.S. Pat. No. 5,215,088 in 1993 on a three-dimensional electrode device as a cortical implant for vision prosthesis. The device contains perhaps a hundred small pillars each of which penetrates the visual cortex in order to interface with neurons more effectively. The array is strong and rigid and may be made of glass and a semiconductor material. [0020] U.S. Pat. No. 5,476,494, issued to Edell, et al. in 1995, describes a retinal array held gently against the retina by a cantilever, where the cantilever is anchored some distance from the array. Thus the anchor point is removed from the area served by the array. This cantilever configuration introduces complexity and it is very difficult to control the restoring force of the cantilever due to varying eye sizes, which the instant invention avoids. [0021] Sugihara, et al. received U.S. Pat. No. 5,810,725 in 1998 on a planar electrode to enable stimulation and recording of nerve cells. The electrode is made of a rigid glass substrate. The lead wires which contact the electrodes are indium tin oxide covered with a conducting metal and coated with platinum containing metal. The electrodes are indium tin oxide or a highly electrically conductive metal. Several lead-wire insulating materials are disclosed including resins. [0022] U.S. Pat. No. 5,935,155, issued to Humayun, et al. in 1999, describes a visual prosthesis and method of using it. The Humayun patent includes a camera, signal processing electronics and a retinal electrode array. The retinal array is mounted inside the eye using tacks, magnets, or adhesives. Portions of the remaining parts may be mounted outside the eye. The Humayun patent describes attaching the array to the retina using retinal tacks and/or magnets. This patent does not address reduction of damage to the retina and surrounding tissue or problems caused by excessive pressure between the retinal electrode array and the retina. [0023] Mortimer's U.S. Pat No. 5,987,361 of 1999 disclosed a flexible metal foil structure containing a series of precisely positioned holes that in turn define electrodes for neural stimulation of nerves with cuff electrodes. Silicone rubber may be used as the polymeric base layer. This electrode is for going around nerve bundles and not for planar stimulation. SUMMARY OF THE INVENTION [0024] The apparatus of the instant invention is a retinal electrode array assembly in various embodiments with features that reduce irritation of the retina and the surrounding tissues during surgery and post-operatively and that facilitate installation by making the mounting aperture for placement of a surgical tack easy to locate and by providing a handle for use by the installing surgeon. [0025] The retinal electrode array is made up of the electrode array body, which contains an array of electrodes and which is attached directly to the retina, feeder cable for transmitting electrical signals to the retina, and electronics which process the electrical signal before it is sent to the electrodes. [0026] The electrode array body is made of soft silicone, having a hardness of about 50 on the Shore A scale as measured with a durometer, to assure intimate contact with the retina and to minimize stress concentrations in the retina. It has an over all oval shape avoiding stress concentrations in the retina by eliminating array corners. It is spherically curved so that it conforms readily to the curvature of the eye thereby minimizing contact stresses with the retina. It also has rounded edges to avoid contact stresses with the retina or tearing of the retina at the edge of the electrode array body. The edges may alternatively be progressively thinned (like a diver's flipper) to make a taper. The radius of curvature is reduced near the edge of the electrode array body, thus lifting the edge of the electrode array body away from the retina, thereby avoiding edge stress concentrations. [0027] The electrode array body has at least one mounting aperture for attaching the electrode array to the retina by means of a mounting tack. The array also has a colored reinforcing ring that surrounds the mounting aperture in the array. The reinforcing ring is used for visually locating the mounting aperture during surgery and for structural support of a surgical tack. [0028] In an alternate embodiment, the aperture and mounting tack are replaced with a ferromagnetic keeper that is placed in the electrode array body for mounting the electrode array body to the retina using magnetic attractive forces between the ferromagnetic keeper and a magnet. [0029] The electrode array body contains an array of conductive electrodes to transmit electrical signals to the retina. One electrode may serve as a reference or ground potential return. [0030] In order to eliminate stress in the retina from the mounting tack a strain relief internal tab is formed by placing a strain relief slot partially around the mounting aperture. The strain relief internal tab may be made of thinner silicone to minimize stress transfer from the mounting tack to the retina. [0031] A grasping handle that is attached to the electrode array body is provided for use by the surgeon during placement of the electrode array body to avoid trauma to the eye during implantation. The feeder cable carries electrical signals between the electrodes and the electronics and contains a coil of electrical conductors to eliminate pulling of the array by the cable post-operatively due to mechanical or thermal stresses. The feeder cable is filled with soft silicone to stabilize the wire and to allow the coil to move somewhat within the cable. OBJECTS OF THE INVENTION [0032] It is the object of the invention to attach an electrode array body to the retina of an eye and enable blind people to see images. [0033] It is the object of the invention to attach an electrode array body to the retina while avoiding or minimizing harmful stresses on the retina from the electrode array body. [0034] It is the object of the invention to enable a surgeon to easily locate the mounting aperture for attachment of an electrode array body to the retina of an eye by a surgical tack. [0035] It is the object of the invention to provide tabs for attachment of the electronics and feeder cable to the recipient of the retinal electrode array. [0036] Other objects, advantages and novel features of the present invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawing. BRIEF DESCRIPTION OF THE DRAWINGS [0037] FIG. 1 illustrates a perspective view of the retinal electrode array assembly showing the electrodes and signal conductors as well as mounting aperture for tacking the assembly inside the eye, wherein both the array and its associated electronics are located inside the eye. [0038] FIG. 2 illustrates a perspective view of the retinal electrode array assembly showing the electrodes and signal conductors as well as mounting aperture for tacking the assembly inside the eye, wherein the associated electronics are located outside the eye. [0039] FIG. 3 illustrates a perspective view of the retinal electrode array assembly wherein the array is installed inside the eye and the associated electronics are installed outside the eye at some distance from the sclera wherein the feeder cable contains both a coiled cable leading between the electronics and the sclera and a series of fixation tabs along the feeder cable for securing the feeder cable by suture. [0040] FIG. 4 depicts a cross-sectional view of the retinal electrode array, the sclera, the retina and the retinal electrode array showing the electrodes in contact with the retina. [0041] FIG. 5 depicts a cross-sectional view of the retinal electrode array showing a strain relief slot, strain relief internal tab and a mounting aperture through a reinforcing ring for a mounting tack to hold the array in position. [0042] FIG. 6 illustrates a cross-sectional view of the retinal electrode array showing a strain relief slot and a ferromagnetic keeper to hold the array in position. [0043] FIG. 7 illustrates a cross-sectional view of the retinal electrode array showing a strain relief slot and a mounting aperture through a reinforcing ring for a mounting tack to hold the array in position, wherein the strain relief internal tab containing the mounting aperture is thinner than the rest of the array. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0044] FIG. 1 provides a perspective view of a preferred embodiment of the retinal electrode array, generally designated 2 , comprising oval-shaped electrode array body 4 , a plurality of electrodes 6 made of a conductive material, such as platinum or one of its alloys, but that can be made of any conductive biocompatible material such as iridium, iridium oxide or titanium nitride, and single reference electrode 6 A made of the same material as electrode 6 , wherein the electrodes are individually attached to separate conductors 8 made of a conductive material, such as platinum or one of its alloys, but which could be made of any biocompatible conductive material, that is enveloped within an insulating sheath 10 , that is preferably silicone, that carries an electrical signal to each of the electrodes 6 . “Oval-shaped” electrode array body means that the body may approximate either a square or a rectangle shape, but where the corners are rounded. The reference electrode 6 A is not necessarily stimulated, but is attached to a conductor, as are electrodes 6 . The electrodes could be used in another application as sensors to transmit electrical signals from a nerve. The electrodes 6 transmit an electrical signal to the eye while reference electrode 6 A may be used as a ground, reference, or control voltage. [0045] Electrode array body 4 is made of a soft material that is compatible with the body. In a preferred embodiment array body 4 is made of silicone having a hardness of about 50 or less on the Shore A scale as measured with a durometer. In an alternate embodiment the hardness is about 25 or less on the Shore A scale as measured with a durometer. It is a substantial goal to have electrode array body 4 in intimate contact with the retina of the eye. [0046] Strain relief internal tab 12 , defined by a strain relief slot 13 that passes through the array body 4 , contains a mounting aperture 16 for fixation of the electrode array body 4 to the retina of the eye by use of a surgical tack, although alternate means of attachment such as glue or magnets may be used. Reinforcing ring 14 is colored and opaque to facilitate locating mounting aperture 16 during surgery and may be made of tougher material, such as high toughness silicone, than the body of the electrode array body to guard against tearing. [0047] Signal conductors 8 are located in an insulated flexible feeder cable 18 carrying electrical impulses from the electronics 20 to the electrodes 6 , although the electrodes can be sensors that carry a signal back to the electronics. Signal conductors 8 can be wires, as shown, or in an alternative embodiment, a thin electrically conductive film, such as platinum, deposited by sputtering or an alternative thin film deposition method. In a preferred embodiment, the entire retinal electrode array 2 including the feeder cable 18 and electronics 6 are all implanted inside the eye. Electronics 20 may be fixated inside the eye to the sclera by sutures or staples that pass through fixation tabs 24 . The conductors are covered with silicone insulation. [0048] Grasping handle 46 is located on the surface of electrode array body 4 to enable its placement by a surgeon using forceps or by placing a surgical tool into the hole formed by grasping handle 46 . Grasping handle 46 avoids damage to the electrode body that might be caused by the surgeon grasping the electrode body directly. Grasping handle 46 also minimizes trauma and stress-related damage to the eye during surgical implantation by providing the surgeon a convenient method of manipulating electrode array body 4 . Grasping handle 46 is made of silicone having a hardness of about 50 on the Shore A scale as measured with a durometer. A preferred embodiment of the electrode array body 4 is made of a very soft silicone having hardness of 50 or less on the Shore A scale as measured with a durometer. The reinforcing ring 14 is made of opaque silicone having a hardness of 50 on the Shore A scale as measured with a durometer. [0049] FIG. 2 provides a perspective view of the retinal electrode array assembly 2 wherein the electrode array body 4 is implanted inside the eye and the electronics 20 are placed outside the eye with the feeder cable 18 passing through sclera 30 . In this embodiment, electronics 38 are attached by fixation tabs 24 outside the eye to sclera 30 . [0050] FIG. 3 provides a perspective view of retinal electrode array 2 wherein electrode array body 4 is implanted on the retina inside the eye and electronics 38 are placed outside the eye some distance from sclera 30 wherein feeder cable 18 contains sheathed conductors 10 as silicone-filled coiled cable 22 for stress relief and flexibility between electronics 38 and electrode array body 4 . Feeder cable 18 passes through sclera 30 and contains a series of fixation tabs 24 outside the eye and along feeder cable 18 for fixating cable 18 to sclera 30 or elsewhere on the recipient subject. [0051] FIG. 4 provides a cross-sectional view of electrode array body 4 in intimate contact with retina 32 . The surface of electrode array body 4 in contact with retina 32 is a curved surface 28 substantially conforming to the spherical curvature of retina 32 to minimize stress concentrations therein. Further, the decreasing radius of spherical curvature of electrode array body 4 near its edge forms edge relief 36 that causes the edges of array body 4 to lift off the surface of retina 32 eliminating stress concentrations. The edge of electrode array body 4 has a rounded edge 34 eliminating stress and cutting of retina 32 . The axis of feeder cable 18 is at right angles to the plane of this cross-sectional view. Feeder cable 18 is covered with silicone. [0052] FIG. 5 provides a cross-sectional view of electrode array body 4 showing spherically curved surface 28 , strain relief slot 13 and mounting aperture 16 through which a tack passes to hold array body 4 in intimate contact with the eye. Mounting aperture 16 is located in the center of reinforcing ring 14 that is opaque and colored differently from the remainder of array body 4 , making mounting aperture 16 visible to the surgeon. Reinforcing ring 14 is made of a strong material such as tough silicone, which also resists tearing during and after surgery. Strain relief slot 13 forms strain relief internal tab 12 in which reinforcing ring 14 is located. Stresses that would otherwise arise in the eye from tacking array body 4 to the eye through mounting aperture 16 are relieved by virtue of the tack being located on strain relief internal tab 12 . [0053] FIG. 6 provides a cross-sectional view of a preferred embodiment of electrode array body 4 showing ferromagnetic keeper 40 that holds electrode array body 4 in position against the retina by virtue of an attractive force between keeper 40 and a magnet located on and attached to the eye. [0054] FIG. 7 is a cross-sectional view of the electrode array body 4 wherein internal tab 12 is thinner than the rest of electrode array body 4 , making this section more flexible and less likely to transmit attachment induced stresses to the retina. This embodiment allows greater pressure between array body 4 and the retina at the point of attachment, and a lesser pressure at other locations on array body 4 , thus reducing stress concentrations and irritation and damage to the retina. [0055] Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.

This invention is a retinal electrode array assembly and methods of using the same that facilitate surgical implant procedures by providing the operating surgeon with visual references and grasping means and with innovations that reduce actual and potential damage to the retina and the surrounding tissue.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS [0001] Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. [0002] This application claims priority to Ecuadorean Patent Application No. SP2013-12745 filed on Jun. 28, 2013, the entire contents of which are hereby incorporated by reference and should be considered a part of this specification. BACKGROUND [0003] 1. Field [0004] The present application is directed to a system for collecting an endometrial tissue sample, and more particularly to a non-invasive endometrial sample collector. [0005] 2. Description of the Related Art [0006] There are several existing procedures for obtaining samples of endometrial tissue. One such procedure involves the sampling of the endometrium with a small plastic device that is introduced in the uterine cavity and through the uterine cervix in order to obtain the tissue sample. This procedure is usually performed in a doctor's office, without anesthesia. [0007] Another existing procedure for obtaining an endometrial tissue sample involves cervical dilation and curettage (D&C). The D&C procedure requires insertion of instruments (e.g., curette or sharp curettage, suction curettage, electric vacuum aspiration) in the uterine cavity and through the uterine cervix to remove endometrial tissue samples, such as by scraping and scooping the endometrial tissue sample. This procedure is performed in a hospital, under anesthesia. The procedure is often performed blindly by the doctor (e.g., without the use of any imaging technique such as ultrasound or hysteroscopy) [0008] Still another existing procedure for obtaining an endometrial tissue sample involves a hysteroscopy. This procedure involves introducing an optical system (e.g., endoscope) within the uterine cavity and through the uterine cervix to directly observe the endometrium. The endoscope can have operative channels through which instruments (e.g., biopsy instruments, resectoscope) can be deployed to obtain a sample of the endometrial tissue under the visual guidance provided by the optical system. Such a procedure can be performed at a hospital or surgical centers, or a clinic, and can be performed under local anesthesia. Hysteroscopies are more expensive procedures (from the patient's and doctor's point of view) since they require expensive equipment and trained specialists. [0009] All of the above described existing procedures for obtaining endometrial tissue samples have numerous disadvantages and potential risks to the patient, including: the risk of infection (e.g., due to the introduction of instruments into the vaginal cavity); the risk of perforating the endometrium and uterine wall (e.g., and possibly damage other organs, such as the intestines); severe bleeding (even in the absence of perforation of the endometrium); endometrial lesions by scarring, leading to infertility (i.e., Asherman's Syndrome); the risk of interrupting an existing but undiagnosed pregnancy; the risk of side effects from antibiotics or pain medication; the risks associated with anesthesia; pain and/or discomfort to the patient; interruption of sexual activity following the procedure; interruption of work and/or social activity for the patient following the procedure; and the risk of allergic reactions to drugs (e.g., antibiotics, analgesic, anesthesia, etc.), iodine (used for cleaning the uterine cervix and vagina during the procedure), latex (e.g., surgical gloves). Other drawbacks of existing procedures include the amount of time the procedures take, the elevated cost of the procedures and the complications they cause in the patient's lives (e.g., anxiety, interruption of work, family interactions and sexual activity). SUMMARY [0010] Accordingly, there is a need for an improved system and method for obtaining an endometrial tissue sample that does not suffer from the drawbacks associated with existing procedures, such as those described above. [0011] In accordance with an aspect of the invention, an endometrial sample collector is provided. The collector comprises an outer body of absorbent material configured for insertion into a vaginal cavity of a patient such that a distal end of the body is positioned proximate a uterine cervix of the patient. The collector also comprises an internal collection assembly disposed within the outer body of absorbent material. The internal collection assembly comprises a funnel having an opening at the distal end of the outer body configured to face the uterine cervix when the outer body is positioned in the vaginal cavity, and a reservoir in fluid communication with the funnel. During a menstruation cycle of the patient when endometrial tissue cells are shed within menstrual fluid that passes through the uterine cervix, at least a portion of said menstrual fluid is directed to the reservoir via the funnel under the force of gravity. [0012] In accordance with an aspect of the invention, an endometrial sample collector is provided. The collector comprises an outer body of absorbent material configured for insertion into a vaginal cavity of a patient such that a distal end of the body is positioned proximate a uterine cervix of the patient. The collector also comprises an internal collection assembly disposed within the outer body of absorbent material. The internal collection assembly comprises a funnel having an opening at the distal end of the outer body configured to face the uterine cervix when the outer body is positioned in the vaginal cavity, a conduit in fluid communication with the funnel, and a reservoir in fluid communication with the conduit. During a menstruation cycle of the patient when endometrial tissue cells are shed within menstrual fluid that passes through the uterine cervix, at least a portion of said menstrual fluid is directed to the reservoir via the funnel and the conduit under the force of gravity. [0013] In accordance with an aspect of the invention, a method for passively collecting an endometrial tissue sample is provided. The method comprises inserting a sample collector into a vaginal cavity of a patient so that a distal end of the collector is positioned proximate a uterine cervix of the patient. The method also comprises collecting an endometrial sample in the sample collector during a menstrual cycle of the patient or during any type of normal or abnormal bleeding solely under the force of gravity. The method also comprises sending the sample collector with the collected sample to a laboratory for evaluation. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a schematic perspective top view of an endometrial sample collector. [0015] FIG. 2 is a schematic perspective top view of the endometrial sample collector of FIG. 1 , showing internal components of the collector in phantom. [0016] FIG. 3 is a schematic bottom view of the endometrial sample collector of FIG. 1 . [0017] FIG. 4 is a schematic front view of the endometrial sample collector. [0018] FIG. 5 is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. [0019] FIG. 6A is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. [0020] FIG. 6B is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. [0021] FIG. 6C is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. [0022] FIG. 6D is a schematic perspective top view of one embodiment of a collection assembly of the endometrial sample collector. [0023] FIG. 7A is a schematic top view of the collection assembly of FIG. 6A . [0024] FIG. 7B is a schematic top view of the collection assembly of FIGS. 6B , 6 C and 6 D. [0025] FIG. 8 is a block diagram illustrating a method of collecting an endometrial tissue sample. DETAILED DESCRIPTION [0026] FIGS. 1-4 show and endometrial sample collector 100 that extends between a proximal end 2 and a distal end 3 and includes and outer body 10 and an internal collection assembly 50 . The outer body 10 is of an absorbent material (e.g., cotton, rayon, sponge material, absorbent polymer), such as the material used in typical tampons, and has absorption channels 11 through which fluid passes toward the internal collection assembly 50 . The outer body 10 of absorbent material advantageously facilitates patient comfort during collection of an endometrial sample in the manner discussed further below. The sample collector 100 can have a thread or cord 20 attached to it to aid in the removal of the collector 100 . As shown in FIG. 1 , the thread or cord 20 is in the form of a loop. However, the thread or cord 20 can optionally be a single string that extends to a free end (e.g., not a loop). [0027] The endometrial sample collector 100 has a length L between the proximal end 2 to the distal end 3 of between about 4 cm and about 6 cm, and has a width W of between about 1 cm and about 3 cm. However, the endometrial sample collector can have other suitable dimensions. [0028] The inner collection assembly 50 can be wrapped by the outer body 10 . The collection assembly has a cup or funnel 52 with an open end at the distal end 3 of the collector 100 that receives the sample therein. The funnel 52 is in fluid communication with a conduit 54 , which is itself in communication with a reservoir 56 , such that the conduit 54 is interposed between the funnel 52 and the reservoir 56 . The reservoir 56 can be at least partially filled with a fluid 4 that preserves the endometrial sample once received. The funnel 52 , conduit 54 and reservoir 56 can be separate components that are coupled together to form the collection assembly 50 . Optionally, the funnel 52 , conduit 54 and reservoir 56 can be made as a single monolithic piece (e.g., via an injection molding process). In other variations, the funnel can be augmented to have, or can be replaced with, a mesh or screen or permeable layer (e.g., foam layer) through which the sample fluid can pass to the reservoir 56 . The funnel 52 , conduit 54 and reservoir 56 can be made of a bio-compatible material, such as a plastic material, or other suitable material. The conduit 54 can optionally be excluded and the funnel 52 be in fluid communication with the reservoir 56 . [0029] As discussed above, the fluid 4 in the reservoir 56 facilitates preservation of the collected endometrial sample. In one embodiment, the fluid 4 can be sterile saline. In another embodiment, the fluid 4 can be a solution made from a 1 L amount of distilled water in combination with the following composition: 0.9 gm/L Sodium Thioglycollate, 10.0 gm/L Sodium Glycerophosphate, 0.1 gm/L Calcium Chloride, and 3.0 gm/L Agar. The solution has a pH of 7.4±0.2. In some embodiments, the composition can optionally include 0.002 gm/L of methylene blue. [0030] As shown in FIG. 5 , the collection assembly 50 can have a length L 2 that is substantially equal to the length L of the collector 100 . In one embodiment, the length L 2 is about 6 cm. The funnel 52 has a width W 1 (e.g., a diameter), and the reservoir 56 has a width W 2 , with the conduit 54 having a width smaller than the widths W 1 , W 2 of the funnel 52 and reservoir 56 . Optionally, the width of the conduit 54 can be generally equal to the widths W 1 , W 2 of the funnel 52 and reservoir 56 . The width W 1 of the funnel 52 can optionally be substantially equal to the width W 2 of the reservoir 56 . Optionally, the widths W 1 , W 2 (e.g., diameters) of the funnel 52 and reservoir 56 can be about 2 cm. As shown in FIG. 5 , the reservoir 56 has a generally spherical shape. However, the reservoir 56 can have other suitable shapes (e.g., oval). [0031] FIGS. 6A-6D show various embodiments of the collection assembly 50 , in which the funnel 52 and reservoir 56 are the same, but where the conduit 54 is different for each embodiment. [0032] In FIG. 6A , the conduit 54 A has a cross-shaped cross-section (see FIG. 7A ) that defines channels 54 A 2 between adjacent fins 54 A 2 of the conduit 54 A. The channels 54 A 2 can extend along the length of the conduit 54 A and can receive fluid axially from the funnel 52 as well as radially through the outer body 10 of absorbent material. The channels 54 A 2 can direct the sample fluid to the reservoir 56 . [0033] In FIG. 6B , the conduit 54 B has a plurality of openings 54 B 1 distributed on a surface of the conduit 54 B (e.g., in spiral form) that are in fluid communication with an inner flow channel 54 B 2 of the conduit 54 B. Fluid can pass axially through the flow channel 54 B 2 from the funnel 52 to the reservoir 56 (see FIG. 7B ). Fluid can also pass transversely from the outer body 10 of absorbent material, through the openings 54 B 1 and into the flow channel 54 B 2 , which then directs the fluid to the reservoir 56 . [0034] In FIG. 6C , the conduit 54 C has a plurality of openings 54 C 1 distributed on a surface of the conduit 54 C (e.g., in linear form) that are in fluid communication with an inner flow channel 54 C 2 of the conduit 54 C. Fluid can pass axially through the flow channel 54 C 2 from the funnel 52 to the reservoir 56 (see FIG. 7B ). Fluid can also pass transversely from the outer body 10 of absorbent material, through the openings 54 C 1 and into the flow channel 54 C 2 , which then directs the fluid to the reservoir 56 . [0035] In FIG. 6D , the conduit 54 D is a tube that without any openings on its outer surface and has an internal flow channel 54 D 2 that directs fluid from the funnel 52 to the reservoir 56 , as shown in FIG. 7B . [0036] FIG. 8 is a block diagram illustrating a method 200 of collecting an endometrial tissue sample using the sample collector 100 . The sample collector 200 is first inserted 210 (e.g., by the patient) into the vaginal cavity, in a similar manner as a tampon, so that the distal end 3 of the collector is proximate the uterine cervix and so that the funnel 52 faces the uterine cervix. Optionally, the distal end 3 is placed in contact with the uterine cervix. During menstruation, menstrual fluid, which will include endometrial tissue that is shed during the menstrual cycle and passes through the uterine cervix, is collected 220 by the collector 100 in the manner discussed above. For example, menstrual fluid can be collected in the funnel 52 and directed via the conduit 54 A, 54 B, 54 C, 54 D to the reservoir 56 , where the endometrial cells in the sample can be preserved in the preservation liquid 4 . Additionally, menstrual fluid absorbed by the outer body 10 of absorbent material can be directed transversely through channels (e.g., 54 A 1 ) or openings (e.g., 54 B 1 , 54 C 1 ) in a surface of the conduit 54 A, 54 B, 54 C, which can then also be directed to the reservoir 56 . Advantageously, the endometrial sample collector 100 passively collects the endometrial tissue sample using gravity and without the use of an external actuation force (e.g., without an aspiration or vacuum force, without a mechanical force such as scraping, etc.). Once the sample has been collected, the collector 100 can be can packaged in a container (e.g., plastic receptacle) and be sent 230 to a laboratory for evaluation. For example, the sample collector 100 can include user instructions directing the user on how to collect the sample, and how to package the sample for shipping to the laboratory, and optionally instructions on where to ship the collected sample. [0037] Advantageously, the endometrial sample collector 100 and its use allows the patient to collect the sample without having to visit a doctor's office, clinic or hospital, and therefore without disruption to their normal daily activities. Additionally, the use of the collector 100 is non-invasive and does note expose the patient to the potential risks noted above with existing procedures (e.g., risk of infection, risk of perforation of the endometrium, pain and discomfort, bleeding, allergic reaction to medication, risks associated with anesthesia). Further, the sample collector 100 is as easy to use for patients as existing tampons. Additionally, the sample collector 100 can be used in patients with intact hymens (e.g., virgin women), patients that refuse gynecological exams or who live in remote areas far away from healthcare facilities, or patients who have problems adopting the correct gynecological position due to problems in their pelvic articulations, which is often the case following menopause. Further, the sample collector 100 allows the collection of endometrial tissue samples at much lower cost than existing procedures because, for example, doctor's fees (e.g., gynecologist, anesthesiologist), hospital fees, and disposable instruments and devices are avoided. [0038] While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the systems and methods described herein may be made without departing from the spirit of the disclosure. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the disclosure. Accordingly, the scope of the present inventions is defined only by reference to the appended claims. [0039] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed. [0040] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a sub combination. [0041] Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. [0042] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. [0043] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment. [0044] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z. [0045] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree. [0046] The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

A non-invasive endometrial sample collector has an outer body of absorbent material configured for insertion into a vaginal cavity of a patient such that a distal end of the body is positioned proximate a uterine cervix of the patient. The collector has an internal collection assembly disposed within the outer body of absorbent material. The internal collection assembly includes a funnel having an opening at the distal end of the outer body configured to face the uterine cervix when the outer body is positioned in the vaginal cavity, and a reservoir in fluid communication with the funnel. During a menstruation cycle of the patient when endometrial tissue cells are shed within menstrual fluid that passes through the uterine cervix, or during any type of normal or abnormal bleeding episode, at least a portion of said fluid is directed to the reservoir via the funnel under the force of gravity.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application claims priority from U.S. application Ser. No. 61/785,189, filed Mar. 14, 2014 incorporated by reference in its entirety. BACKGROUND [0002] The present invention relates to a container and case for the storage and transport of a bicycle. More particularly, the invention relates to a container for storage and transport of a bicycle in partial disassembly. [0003] In recent years, the popularization of lightweight bicycles has greatly increased sport and competitive usage of such machines, particularly bicycles especially designed with extremely lightweight frames and other components and intended for long distance riding. Such machines are constructed of lightweight metals or carbon fiber and are precision machined and balanced to provide maximum speed and range with minimum weight. Such machines are commonly provided with derailleur multi-speed mechanisms. [0004] Unfortunately, as the weight of modem bicycles is reduced, and the precision machining features are increased, the bicycle mechanism becomes more fragile and susceptible to damage from abusive handling. Lightweight wheels and rims are susceptible to bending, and derailleur mechanisms are susceptible to misalignment. [0005] Bicycle touring has also become popularized in recent years. One aspect of this sport involves the long distance touring of groups of bicyclists in places remote from their homes. Typically, the bicyclist transports himself and his machine to a remote starting point by auto, train, bus or airplane and engages in the sport of touring in regions remote from the bicyclist's home location. At the completion of such touring events the bicyclist and his machine are transported back to their home location. [0006] In the normal and other usage of a modem lightweight bicycle great care must be taken for the storage and transport of the machine to avoid damage or destruction to the machine. Since machines of such precision have become extremely expensive and difficult to repair, a need has arisen for a container device which can safely store and transport a bicycle, even under the abusive handling conditions typically found in commercial airline service. Such a container must be more than a mere box for enclosing the bicycle, for it must be as compact as possible to conserve space during shipping, and it must protect the components of the bicycle from wear and damage caused when the frame of the bicycle contacts other bicycle components, such as the wheels of the bicycle, during transport. [0007] Various configurations of bicycle cases have been developed. However, one problem that has not been satisfactorily addressed is the storage of the wheels for the bicycle. As can be imagined, the bicycle case should be designed to be as compact as possible while providing enough interior room to pack the bicycle safely and securely. Typically, the wheels of the bicycle are removed for shipment. Various configurations have been used to position the wheels alongside the bicycle to minimize the profile of the bicycle within the box or carrier. However, the rims and spokes of the bicycle often are left in contact with the frame or components of the bicycle, which may damage the bicycle or the wheels if the wheels shift during transport. [0008] What has been needed and heretofore unavailable is a compact, light yet robust, carrier box and wheel transportation system providing for safe and easy shipment of a bicycle, while incorporating features, particularly with respect to storing the wheels, that prevent damage to the frame, wheels and other components of the bicycle during transport of the bicycle. The present invention satisfies these and other needs. SUMMARY OF THE INVENTION [0009] In its most general aspect, the present invention includes a bicycle transport case having a plurality of sides that are interconnectable to form a cavity in which a bicycle and its components may be securely mounted for transport. [0010] In another aspect, the present invention includes a bicycle transport case, comprising: a base having at least two wheels mounted at a bottom surface at one end of the base for rolling the case across a surface, the base having a slot formed at one end of base; a fork mount mounted to the base, the fork mount configured to releasably engage the fork drop outs of a bicycle; a rear frame mount having a top end and a bottom end, the top end configured to engage the rear drop outs of a bicycle frame in a releasable manner, the bottom end configured to engage with the slot formed in the base to provide for movement of the rear frame mount to position the rear frame mount to accommodate different sizes of bicycle frames; at least one hook providing a tie down surface for securing accessories to the base; a first side releasably mountable to the base, the first side also having a pair of side panels and a top panel defining a cavity open on one side to partially enclose the bicycle mounted to the base by way of the fork mount and the rear frame mount; and a second side releasably mountable to the base, the second side also having a pair of side panels and a top panel defining a cavity open on one side to partially enclose the bicycle, the first and second sides cooperating to completely enclose the bicycle when the bicycle transport case is in a closed condition, the second side including wheel mounts for mounting the wheels of the bicycle to the second side, and also including a cushioning layer releasably mounted to the second side and disposed within the cavity to isolate the wheels from the bicycle mounted to the base. [0011] In another aspect, the present invention includes a bicycle transport case, comprising: a base having at least two wheels mounted at a bottom surface at one end of the base for rolling the case across a surface; a fork mount mounted to the base, the fork mount configured to releasably engage the fork drop outs of a bicycle; a rear frame mount having a top end and a bottom end, the top end configured to engage the rear drop outs of a bicycle frame in a releasable manner, the bottom end of the rear frame mount movably mounted to the base to provide for movement of the rear frame mount to position the rear frame mount to accommodate different sizes of bicycle frames; at least one hook providing a tie down surface for securing accessories to the base; a first side releasably mountable to the base, the first side also having a pair of side panels and a top panel defining a cavity open on one side to partially enclose the bicycle mounted to the base; and a second side releasably mountable to the base, the second side also having a pair of side panels and a top panel defining a cavity open on one side to partially enclose the bicycle, the first and second sides cooperating to completely enclose the bicycle when the bicycle transport case is in a closed condition, the second side including at least one wheel mount for releasably mounting a wheel removed from the bicycle to the second side, and also include a cushioning layer releasably mounted to the second side and disposed within the cavity to isolate the wheel from the bicycle mounted to the base. [0012] In one alternative aspect, the front fork mount is removably mounted to the base. In still another aspect, the base has a channel formed in a top surface of the base, the channel being configured to receive a head of a pin extending from a bottom end of the front fork mount, the head having a width dimension larger than a width dimension of the pin such that when the head of the pin in inserted into the channel, the channel engages the head to maintain the head in the channel while still allowing the pin to move in a longitudinal direction along the base to provide for adjustment of the front fork mount to accommodate different bicycle sizes. [0013] In another aspect, the base has a channel formed in a top surface of the base, the channel being configured to receive a head of a pin extending from the bottom end of the rear frame mount, the head having a width dimension larger than a width dimension of the pin such that when the head of the pin in inserted into the channel, the channel engages the head to maintain the head in the channel while still allowing the pin to move in a longitudinal direction along the base to provide for adjustment of the rear frame mount to accommodate different bicycle sizes. [0014] In a further aspect, the present invention may also include a wheel mount fixture configured to engage the wheel mount to hold the bicycle wheel in place within the transport case. In still another aspect, four wheels are mounted adjacent four comers of the base. [0015] In still another aspect, the present invention includes a bicycle transport case, comprising: a base having at least two wheels mounted at a bottom surface at one end of the base for rolling the case across a surface; a fork mount slidably mounted to a top surface of the base, the fork mount configured to releasably engage the fork drop outs of a bicycle; a rear frame mount mounted to a top surface of the base and configured to engage the rear drop outs of a bicycle frame in a releasable manner; at least one hook providing a tie down surface for securing accessories to the base; a first side releasably mountable to the base, the first side also having a pair of side panels and a top panel defining a cavity open on one side to partially enclose the bicycle mounted to the base; and a second side releasably mountable to the base, the second side also having a pair of side panels and a top panel defining a cavity open on one side to partially enclose the bicycle, the first and second sides cooperating to completely enclose the bicycle when the bicycle transport case is in a closed condition, the second side including at least one wheel mount for releasably mounting a wheel removed from the bicycle to the second side, and also include a cushioning layer releasably mounted to the second side and disposed within the cavity to isolate the wheel from the bicycle mounted to the base. [0016] Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the features of the invention. BRIEF DESCRIPTION OF DRAWINGS [0017] FIG. 1 is frontal view of an embodiment of a bicycle transport case in accordance with principles of the present invention. [0018] FIG. 2 is a side view of the bicycle transport case of FIG. 1 . [0019] FIG. 3 is a top view of the bicycle transport case of FIG, 1 . [0020] FIG. 4 is a top view looking down onto a base of the bicycle transport case of FIG, 1 illustrating one embodiment of the arrangement of various articles designed to hold a bicycle and its components within the case. [0021] FIG. 5A is a front view of an interior of one side of the bicycle transport case of FIG. 1 shown mounted to the base of the bicycle transport case of FIG. 1 . [0022] FIG. 5B is a front view of a panel which may also include layer of foam that faces wheels mounted to the side of FIG. 5A to isolate the wheels from the remaining interior of the bicycle transport case. [0023] FIG. 6A is side view of an embodiment of an assembly for providing an adjustable mount for holding the front fork of the bicycle to the base of the bicycle transport case of FIG. 1 . [0024] FIG. 6B is a front view of the fork mount embodiment of FIG. 6A . [0025] FIG. 7A is a perspective top view of an embodiment of an assembly in for providing an adjustable mount for holding the rear portion of the bicycle to the base of the bicycle transport case of FIG. 1 , including one embodiment of a spindle assembly for holding the rear portion of the bicycle in place and for engaging a chain of the bicycle. [0026] FIG. 7B is a side view of the embodiment of the rear mounting assembly of FIG. 7A . [0027] FIG. 7C is a rear view of the embodiment of the rear mounting assembly of FIG. 7A showing, in phantom, a bore for receiving a spindle. [0028] FIG. 7D is a front view of the embodiment of the rear mounting assembly of FIG. 7A . [0029] FIG. 8A is a side view of an embodiment of a quick release spindle including an embodiment of a chain holder configured for use with the rear mounting assembly of FIG. 7A . [0030] FIG. 8B is a side view of a quick release spindle for use with a track bicycle configured for use with the fork mount of FIG. 6A and the adjustable mount of FIG. 7 the rear mounting assembly of FIG. 7A . [0031] FIG. 8C-8D is a side view of a quick release spindle for use with a road bicycle configured for use with the fork mount of FIG. 6A and the adjustable mount of FIG. 7A . [0032] FIG. 9 is a view of an embodiment of a fixture that is attached to an axle or quick release of a wheel and configured to cooperate with a fixture mounted on one side of the bicycle transport case to hold the wheel when the bicycle is being shipped. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0033] Referring now to the drawings in detail, in which like reference numerals indicate like or corresponding elements among the several figures, there is shown in FIGS. 1-3 a series of views of a one embodiment of a bicycle transport case 10 in accordance with the principles of the present invention. The case includes a base 15 , a first side 30 and a second side 35 that removably attaches to the base using fasteners 40 , 45 , 50 of a type well known in the art. [0034] As shown in the FIGS. 1-3 , a pair of rear wheels 20 may be disposed at a bottom rear of the base 15 to facilitate movement of the base across a surface. In some embodiments, a pair of front wheels 25 may be disposed at a front end of base 15 , resulting in the placement of wheels at all four corners of the base, as shown in the figures, so that the base may be freely rolled from one location to another. Those skilled in the art, however, will recognize that rollers may be substituted for the wheels, and that the case can be moved even if it only includes a single pair of wheels or a roller or rollers disposed at one end of the case, allowing the non-wheeled end to be tilted up and the case rolled on the wheeled end. [0035] A handle or strap 60 may be mounted on one side of the case to assist in pulling the case over a surface. In an embodiment having only a pair or wheels mounted at one end of the base, the strap or handle would typically be mounted on the opposite end of the case relative to the wheels. One or more handles or straps 55 may also be mounted on a top surface of the case 10 to facilitate lifting of the case. In the embodiments shown, the handles or straps 55 , 60 are shown mounted on the second side 35 of the case. Alternatively, they may be mounted on the first 30 , or mounted on a combination of first and second sides. Of course, additional handles or straps may be mounted on the sides or side panels of the case without departing from the intended scope of the invention. [0036] FIG. 2 illustrates how the exemplary embodiment includes both a first side 30 and second side 35 which releasably couple using couplers 45 , 50 to each other to form a cavity that is configured to enclose a bicycle mounted to the base 15 . Typically, as will be discussed in more detail below, the wheels of the bicycle are removed from the frame of the bicycle prior to mounting the bicycle within the case 10 . Each of the first side 30 and second side 35 also include couplers to couple the respective sides to the base 15 . [0037] Each of the first and second sides 30 , 35 has a height dimension, a length dimension and a width dimension, with the length dimension being approximately the same as a length dimension of the base. The sum of the width dimensions of the first and second sides approximates the width of the base, and the height dimension of the first and second sides are generally the same, and sufficient to enclose the height of a bicycle that is mounted to the base. Note, however, that the width dimensions of the first and second side may not be equal, and in some embodiments, will not be equal, as is shown in FIGS. 1-3 . [0038] Referring now to FIG. 4 , details of the base 15 of the transport case are shown. The base 15 of the transport case includes various fixtures and assemblies configured to securely hold a bicycle frame, and in some embodiments, additional accessories, tools or other items securely within the case during shipment. As shown, the base includes a bottom 105 , and low sides (See FIG. 1 ) that surround the circumference of the base to define a shallow cavity having bottom 105 at one end, and open above to allow placement of a bicycle onto the fixtures attached to bottom 105 of base 15 . It will be understood, however, that the low sides are not necessary to the invention. All that is needed is that the base be configured to allow the first and second sides to mate with the base to form a cavity in which a bicycle may be mounted. The base also includes appropriate fixtures or fasteners 110 that cooperate with fixtures or fasteners 40 mounted to the first and second sides to secure the first and second sides to the base. [0039] Base 15 is configured to allow attachment of various fixtures and assemblies configured to secure the bicycle to the base. In one embodiment, one or more slots 95 may be machined into a top surface of the bottom 105 of base in such as manner as to form a groove or grooves shaped to receive a pin having a head configured to be retained within the groove. An opening may be formed at one end of the groove to allow the pin to be inserted into the groove. In another embodiment, a pair of L-shaped or U-shaped rails (not shown) may be mounted to the base, the pair of rails cooperating such that a pin having shaft sized smaller than the width of the groove, and also having a head sized larger than the groove, but smaller than the separation between the interior of the rails, can be placed within the assembly, yet retained by the assembly. [0040] In another embodiment, a second plate may be mounted over the bottom 105 of the base in such a manner that grooves may be formed in the second plate to accept the mounting pins of various fixtures, as will be described below. [0041] In still another embodiment, various hooks, loops or other fasteners 100 may be affixed to the base to facilitate tying down various accessories, tools or other items, such as handle bars, seat/post, helmet, shoes, aero bars, pump, track sack, pedals, shoes or tools. [0042] As shown, a rear dropout receiving assembly 90 , also called a rear mounting assembly or rear dropout mount, as will be described in more detail with reference to FIGS. 7A-7C , may also be mounted on bottom 105 of base 15 . The rear mounting assembly may be fixed in place, as shown, or may also be configured to engage one or more grooves or rails as discussed above to maintain the rear mounting assembly in place, yet allowing the rear mounting assembly to be moved forward and rearward to assist in accommodating different sized bicycles. [0043] FIG. 5A is a side view of case 10 looking into the interior portion of the second side 35 when second side 35 is mounted to the base 15 . As shown in FIGS. 1-3 , second side 35 has a pair of raised side lips 155 and a top lip 160 that are joined to back panel 150 of the second side to define a cavity for accommodating a pair of bicycle wheels. In one embodiment, a tap 165 is mounted to the top edge, the tab having an opening 170 formed therein. In other embodiments, tab 165 may be a fastener or catch. Also mounted to the side lips are one or more fasteners 175 , which may be one side of a hook and loop fastener, or may be one side of a magnet and plate fastener. [0044] A pair of wheel mounts 180 , 185 are mounted to back panel 150 and configured to receive at least a portion of an axel assembly of a bicycle wheel in such a manner so as to maintain the wheel in position relative to the wheel mount 180 , 185 when the wheel is so mounted. Wheel mounts 180 , 185 may be formed so as to hold and lock the axel in place, or they may be configured to be used with a quick release system, wherein the mount receives one end of bicycle quick release skewer, which when hand tightened by activating the cam of the skewer of the quick release, tightens the wheel against the wheel mount to releasably hold the wheel in place. [0045] FIG. 5B is a side view of a protective panel 200 that is sized to fit within the area bounded by the inner walls of raised side lips 155 and top lip 160 and the top of the base. Protective panel 200 is typically fairly stiff, and may be coated on one or more sides with a protective material. A layer of compressible foam may also be attached to one or both sides of panel 200 . In use, panel 200 is placed over the wheels once the wheels are mounted in wheel mounts 180 , 185 . In this manner, panel 200 isolates the wheels from the rest of the bicycle that is mounted to the base 15 of the transport case 10 . The wheel side of panel 200 may also include one or more fasteners, such as the opposite side of hook and loop fastener system, or magnet and plate system. For example, where fastener 175 is a hook portion of a hook and loop system, the loop portion of the fastener system would be mounted on the wheel side of panel 200 so that when panel 200 is positioned over the wheels mounted to second side 35 , the loop portion engages the hook portion to hold panel 200 in place. Of course, it does not matter whether the hook portion or the loop portion is mounted to the second side or the panel 200 , as long as each portion engages the other to hold panel 200 in place. Those skilled in the art will understand that a hook and loop fastener system, or magnet and plate system have been described for example only, and that releasable fastener systems may be used without departing from the intended scope of the invention. [0046] In one embodiment, panel 200 includes an opening 205 that allows for use of a finger or other instrument to be inserted to facilitate removal of panel 200 from its mounted position to expose the wheels of the bicycle. Opening 205 may also be used accommodate a releasable latching system, the hole being used to mount a locking mechanism such as a camlock that then cooperates with opening 170 (or an assembly disposed within hole 170 ) of tab 160 ( FIG. 5A ) to securely hold panel 200 in place. [0047] In another embodiment, the second side may also include slots, brackets or other features such as rotatable tabs or latches to allow attachment of a panel to be removably mounted to the second side overlaying the attached wheels. In this manner the panel encloses the wheels within the cavity formed by the second side and its two side panels and top panel, and provides for separation of the wheels from the frame of the bicycle during shipment. The panel may be any suitable material, such as plastic, wood or wood product, metal or foam. In an alternative embodiment, the sides of the panel may include various hooks, loops or other fasteners to facilitate tying down various accessories, tools or other items. [0048] FIGS. 6A and 6B illustrate embodiments of a front fork mount 200 that may be mounted to the base 15 to secure the front fork of a bicycle being shipped in the transport case 10 . A quick release axle spindle ( FIGS. 8C-D ) is received in an appropriately sized bore 205 of the front fork mount 200 . In the embodiment shown, the mount includes a bottom portion 201 and a removable top portion 215 that holds the quick release axle spindle in place in bore 205 . In this embodiment, the quick release axle spindle is held within bore 205 in a fixed position by pressure on the spindle when top portion 215 is fastened onto bottom portion 210 using fasteners 220 . [0049] In an alternative embodiment, top portion 215 and bottom portion 210 may be a single piece, with bore 205 sized slightly larger than the diameter of the quick release axel spindle so that the spindle may be inserted through the bore 205 . The spindle is held within bore 205 when a wheel is mounted on the spindle and a quick release skewer is threaded through the spindle and tightened. [0050] A tab 225 configured to cooperate with the one or more grooves 95 in the base 15 is disposed at a bottom end 230 of bottom portion 210 . Tab 225 is inserted into a groove in the base 15 to provide adjustment of the position of the fork mount along the lengthwise dimension of the base 15 to accommodate different sizes of bicycles. Tab 225 may be mushroom shaped, as shown in FIG. 6A , or it may take on other shapes, such as the T-shaped tab 235 shown in FIG, 6 B. For example, the mushroom shaped tab 225 of FIG. 6A or the T-shaped tab 235 of FIG. 6B may be used where a single groove is formed in the base 15 . Where a pair of rails are mounted on base 15 to provide for lengthwise adjustment of the position of front fork mount 200 , the T-shaped tab 235 may be used. Both the mushroom shape and the T-shape may be characterized generally in that the shapes have a pin 227 , 228 to which is mounted a head 228 , 238 respectively. [0051] In some embodiments, the bottom end 230 may include a portion 240 that is angled relative to the remainder of bottom end 230 . This angulation provides a locking capability to hold the front fork mount in place on base 15 when the mount is in position to receive the front fork of a bicycle. This angulation allows the mount to lean backwards slightly, tilting the pin and head and locking the head against the top surface of the groove or rail. The position of the front fork mount may be adjusted by simply leaning the front fork mount 200 in an appropriate direction to “unlock” the front fork mount, and then sliding the front fork mount along the groove or rails to reposition the front fork mount. [0052] FIGS. 7A-D illustrate embodiments of a rear drop out mount 300 that is similar to the front fork mount, but may be sized differently to ensure adequate clearance of various bicycle components above the base 15 of the transport case 10 when the bicycle is mounted to the base to prevent damage to those components. [0053] FIG. 7A is a perspective view of one embodiment of the rear drop out mount 300 showing a bottom portion 305 and a top portion 310 that is fastened to the bottom portion 305 using fasteners 320 , such as threaded screws or bolts, inserted through bores formed into top portion 310 and threaded into threaded holes formed in bottom portion 305 . This arrangement allows top portion 310 to place pressure on a spindle that that is inserted through bore 315 ( FIGS. 7B-D ) to hold the spindle in place. [0054] In an alternative embodiment, as described with reference to the front fork mount 200 above, rear drop out mount may be formed in a single piece, with bore 315 sized to be slight larger than the diameter of a spindle, allowing the spindle to be inserted into and extend through bore 315 in a loosely fitting manner. A quick release skewer 325 ( FIG. 7A ) may be inserted through the spindle to hold the spindle in place when lever 330 of the quick release spindle is actuated to tighten the quick release skewer. [0055] Also shown in FIG. 7A is a faux cog 335 which may be mounted on the spindle, either fixedly, or rotatably and removably. Faux cog 335 provides for mounting of the chain of the bicycle being transported in such a manner as to put tension on the chain so that the chain does not move during transport, which would otherwise possible cause damage to the bicycle frame or other components. [0056] In some embodiments, the quick release skewer 330 may include a round wheel- or gear- chain holder 335 for holding the chain of the bicycle to prevent movement of the chain during shipment of the transport case. This prevents the chain from marring the paint of the bicycle, or otherwise damaging the bicycle. A similar quick release mechanism is utilized to hold the front fork of the bicycle. However, as is well known in the art, a chain holder is not needed at the front fork mount. [0057] The rear drop out mount 300 may be fixed to the base 15 , or rear drop out mount 300 may include a tab 340 such as that previously described with reference to the front fork mount 200 . This tab can be received into the groove of the base to allow adjustment of the position of the rear drop out mount along the lengthwise dimension of the base to accommodate different sizes of bicycles. A bottom end 345 of the rear drop out mount 300 may have an angled portion 350 to provide a “locking” capability to hold the rear drop out mount 300 in position on the base 15 , in those embodiments where rear drop out mount 300 is not fixed to base 15 , but is instead moveable. This angulation allows the mount to lean backwards slightly, tilting the pin and head of the tab and locking the head of the tab against the top surface of the groove or rail. [0058] While the figures illustrate both front fork and rear drop out mounts as both having tabs, and thus both being adjustable, those skilled in the art will appreciate that only one of the mounts can be adjustable, with the other mount fixed, and still provide the amount of adjustment necessary to accommodate different sized bicycles. Similarly, in embodiments where only one of the mounts is moveable, the length of the groove or slot in the base that receives the tab of the moveable mount need only be as long as necessary to provide the amount of movement needed to accommodate a typical range of bicycle sizes. Also, while a mushroom-shaped tab is disclosed and shown in FIGS. 6 and 7 , other shapes are possible, so long as they provide for retention of the tab within the groove or slot when the mount is moved. [0059] FIG. 8 illustrates various embodiments of quick release mechanisms that are may be used in concert with the mounts of FIGS. 7A-D to hold the rear drop outs of the bicycle to the base 15 of the transport case 10 . FIG. 8A is a side view of a quick release spindle 400 showing a chain holder 405 mounted to one end of a faux axle 410 having a bore 415 through which a hand actuated skewer commonly known in the art extends. [0060] FIG. 8B shows an embodiment of a spindle 430 having a hollow faux axle 435 that is designed for use with a track bicycle. Its length is generally shorter than a spindle 450 that is used for mounting a road bicycle, as shown in FIG. 8C and 8D , due to the increased length needed to accommodate the wider separation between chain stays commonly found on a bicycle having a rear cassette and derailleur system for changing gears, unlike a track or fixed gear bicycle which typically has only one cog and lacks a derailleur. [0061] Referring again to FIG. 5A , there is shown an embodiment of wheel mounting brackets 180 , 185 mounted to the inside of the second side 35 of the transport case 10 . These brackets are configured to accept a fixture 500 attached to an axle or quick release of a wheel, as is shown in FIG, 9 . The fixture of FIG. 9 includes a central portion 505 that projects above a main body 510 of the fixture. Central portion 505 includes a bore 515 that extends through the fixture. The main body 510 is sized and configured to engage the wheel mounts 180 , 185 mounted to the second side 35 of the transport case 10 in such a manner as to hold a bicycle wheel in place in the transport case 10 . [0062] In some embodiments, the bore 515 of central portion 505 may be threaded and configured to thread onto a wheel axle. Alternatively, the bore may be threaded to accept the threaded end of a quick release skewer inserted through a hollow axle of a bicycle wheel, (hollow axles are common on most bicycles, as they allow a quick-release skewer to be used to removably attach the wheel to the drop outs of the fork and frame). Once the fixture 500 is threaded onto the wheel axle or quick release of the wheel, the main body 510 of the fixture is inserted into a slot 182 , 187 of the wheel mounting bracket 180 , 185 respectively ( FIG. 5A ), and is maintained within the wheel mounting bracket through the cooperation of the main body and wheel mounting bracket to retain the wheel in the bracket. The slot of the wheel mounting bracket ( FIG. 5A ) may also be configured so that as the projecting central portion 505 of the fixture 500 is slid into the slot 182 , 187 , the shape of the slot cooperates with the shape of the projecting central portion of the fixture to lock the fixture in place in the wheel mounting bracket. [0063] In one embodiment, two adjacent corners 520 , 535 along one side of main body 510 may be rounded, or otherwise configured, to improve the ease of insertion of fixture 500 into wheel mounting brackets 180 , 185 . Alternatively, main body 510 may have a rounded shape. [0064] The bicycle transport case may be formed from metal, wood, plastic, or any combination of these. For example, the outer sides and surfaces of the case may be formed of plastic, and the base may have a metal insert forming a foundation for the groove and mounts to be mounted thereon. Alternatively, the base may be formed entirely of metal. Where a suitable plastic is used for the base, the grooves may be formed in the plastic and used for mounting the fork and rear drop out mounts, while reducing the overall weight of the transport case. [0065] While the bicycle transport case has been described as having the wheel mounts for the bicycle's wheels mounted on one of the sides (specifically, the second side) of the case, other embodiments are possible where the width dimension of both the first and second sides is sufficient to allow a wheel, or more than one wheel, to be mounted on each side. In those embodiments, a protective panel could be included for each side to isolate the wheel or wheels mounted on each side to be isolated from a bicycle mounted on the base between the two sides. In other embodiments, the base is wide enough to accommodate at least two bicycle frames, and wheel mounts are provided on each of the first and second sides for mounting the wheels of both bicycles. [0066] While several particular forms of the invention have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention.

A transport carrier or case for storing and/or transporting a partially disassembled bicycle is disclosed. The carrier includes means for mounting the partially disassembled bicycle to a base while providing for adjustment of the mounting means dependent on the size of the bicycle. Also disclosed are wheel retention means for releasably mounting the wheels of the bicycle to one side of the transport case, and isolation means to separate the bicycle frame from the wheels.

RELATED APPLICATION DATA The present disclosure is a continuation-in-part application related to the U.S. patent application entitled "Augmentation of Electrical Conduction and Contractility by Biphasic Cardiac Pacing", Ser. No. 08/699,552, filed Aug. 8, 1996, now U.S. Pat. No. 5,871,506. FIELD OF THE INVENTION The present invention relates generally to an anti-reentry apparatus and method that can favorably influence the beating of ineffective hearts, especially hearts with pathological conditions that interfere with normal rhythmicity, electrical conduction, and/or contractility by causing ventricular fibrillation. The present invention particularly relates to an anti-reentry apparatus and method that provides simultaneous or progressive biphasic stimulation at multiple sites in one or both ventricles. BACKGROUND OF THE INVENTION Heart disease and malfunction is a major killer of men and women in America A variety of pathologies can affect the beating patterns of a heart, and thereby predispose it to developing ventricular fibrillation. Prior to the occurrence of such a severe and ineffective rhythm, conventional pacemakers can be used to treat, for example, such disorders as sino-atrial (SA) node block, A-V block, and multiple independent sites of contraction in the ventricles (also termed ectopic foci), which, in the extreme, can lead to life threatening ventricular fibrillation. Conventional pacemakers often will control and prevent the recurrence of ectopic foci by preprogrammed stimulation of (usually) the right ventricle via a single electrode. Some pacemakers also employ a second electrode that is dedicated to the left ventricle. In addition, conventional pacemakers utilize a range of circuit logic patterns to counter specific problems that are encountered in the more common pathologies. However, conventional single ventricular electrode technologies, including the use of a separate single electrode to each ventricle, fail in cases in which ventricular fibrillation has ensued (particularly when the fibrillation is due to multiple random reentry), and single site stimulation does not entrain sufficiently large areas of surrounding tissue to produce the concerted contraction that is necessary for optimal efficiency in pumping blood. In such cases of ventricular fibrillation from multiple random reentry, the patient is put in grave jeopardy for the basic reason that virtually all of the body functions depend on delivery of blood to the tissues in order to supply oxygen and nutrients, and also to carry away metabolic waste products. Failure to correct such a condition, where the rhythm is so far from optimal, results in the patient being in substantial danger of dying in a very short period of time. Though cardioversion/defibrillation may be employed, including that preprogrammed in the control logic for automatic activation in some pacemaker-defibrillators, such protocols typically require large doses of electrical energy to the patient. In addition to producing extreme discomfort and sharp pain, these large doses of electrical energy often also produce cardiac damage. The voltage for standard internal defibrillation/cardioversion is from 150 to 800 volts, corresponding to approximately 10-35 joules. Several approaches to these problems have been disclosed. One approach is to stimulate greater portions of ventricular myocardium by utilizing larger electrodes so that greater portions of myocardium are simultaneously stimulated. For example, U.S. Pat. No. 5,411,547 to Causey, III discloses the use of defibrillation electrode patches for more efficient bipolar cardiac stimulation. In addition, the use of large, plate-like electrodes for defibrillation and cardioversion is well known. However, the use of such larger electrodes suffers from the problem of delivery of large doses of electrical energy that produce great discomfort to the patient and the possibility of tissue damage. Yet another approach is to use multiple individual electrodes appropriately placed about the ventricles, as has been disclosed in the following U.S. Pat. Nos. 5,649,966 to Noren. et al., 5,391,185 to Kroll, 5,224,475 to Berg. et al., 5,181,511 to Nickolls, et al., and 5,111,811 to Smits. Though these patents disclose the use of multiple electrodes, they do not disclose or suggest their use for gradually (yet quickly) entraining the various reentrant foci that can exist in pathological ventricles by stimulating in a progressive pattern that mimics the normal wave of depolarization that occurs in the heart. Thus, a need exists for an anti-reentry apparatus and method that will require the use of less electrical current/voltage than is typically used for defibrillation and cardioversion in order to decrease the likelihood, or at least the severity, of tissue damage. A need also exists for an anti-reentry apparatus and method that will simultaneously stimulate greater portions of ventricular myocardium to increase the probability of ventricular conversion (particularly in the presence of multiple random reentry), but with delivery of lower doses of electrical energy per stimulation, which, consequently, will prolong the life of the apparatus's batteries and decrease myocardial soft tissue damage. A need also exists for such an anti-reentry apparatus and method that not only will produce the vitally needed improvement in cardiac pumping efficiency, but additionally will simultaneously lower the probability of tissue damage, and provide greater comfort for the patient. In addition, a need exists for an anti-reentry apparatus and method that progressively stimulates the ventricles in a manner that mimics the normal cardiac wave of depolarization, thereby providing rapid control and reversion of cardiac rhythm to a normal beating pattern. SUMMARY OF THE INVENTION In view of the foregoing limitations in the art, it therefore is an object of the present invention to provide an apparatus and method that more efficiently and quickly entrains larger areas of myocardium to promote ventricular conversion, particularly in patients suffering from episodes of multiple random ventricular reentrant foci that produce, or may produce, ventricular fibrillation. It is another object of the present invention to provide an apparatus and method that, while entraining larger areas of myocardium, does so with smaller doses of electrical energy than typically are used in defibrillation and cardioversion. It is yet another object of the present invention to provide an apparatus and method that, while entraining larger areas of myocardium, does so by stimulating in a progressive pattern that mimics the normal wave of depolarization of the heart. It is a further object of the present invention to provide an apparatus and method that, while entraining larger areas of myocardium, does so with less stress on the heart and greater comfort to the patient. It is yet another object of the present invention to provide an apparatus and method that, while entraining larger areas of myocardium, does so with less damage to cardiac tissue. It is yet a further object of the present invention to provide an apparatus and method that, while entraining larger areas of myocardium, also promotes greater myocardial blood pumping efficiency. It is yet a further object of the present invention to provide an apparatus and method that entrains larger areas of myocardium by using multiple electrodes that provide biphasic stimulation. Pacemakers, which utilize low energy stimulation pulses, constitute a separate and distinct art from cardioverters/defibrillators, which utilize stimulation pulses of much larger energy--even when the electrodes are positioned directly on the heart. Thus, according to conventional practice, more energy is required to entrain the entire heart (cardioversion/defibrillation) than to exogenously employ the traditional pacemaker that typically utilizes the natural cardiac conducting fibers and/or endogenous pacemaker(s) to control the beating of a heart that is only slightly "out of synch" relative to the more dangerous rhythmicity disorders that often result in extensive fibrillation. An intermediate ground is demonstrated by the present invention. By using multiple electrodes and applying biphasic stimulation, one or both ventricles may gradually (yet quickly) be entrained to beat more normally in the face of multiple random reentry, even though the stimulation energy level used is lower than that generally used for cardioversion/defibrillation. Thus, the present invention accomplishes the above objectives by utilizing multiple electrodes that contact multiple ventricular areas 1) for simultaneous biphasic stimulation, or 2) for progressive biphasic stimulation, that is, the mimicking of the physiological patterns of electrical current flows or waves of depolarization in the myocardium. The control circuit logic can activate the multiple site, biphasic ventricular stimulation upon the occurrence of A-V block in a patient known to be susceptible to multiple random ventricular reentrant foci, or upon the direct or indirect sensing of ventricular fibrillation. For example, direct sensing of ventricular fibrillation can be based on data from multiple ventricular sensing electrodes, and indirect sensing can be based on any of various functional parameters, such as arterial blood pressure, size and/or presence of an R wave, rate of the electrogram deflections, or the probability density function (PDF) of the electrogram. The present invention accomplishes the above objectives through the use of multiple site, biphasic ventricular stimulation in one or both ventricles to 1) gradually (yet quickly) entrain and interrupt substantially all of the multiple random reentrant circuits that are present; or, failing that, 2) reduce the number of such reentrant circuits to a level at which much smaller stimuli may be used than in conventional defibrillation/cardioversion to convert the rhythms to more normal ones, and thereby produce coordinated and efficient cardiac function. The first and second phases of stimulation consist of an anodal pulse (first phase) followed by a cathodal pulse (second phase). In a preferred embodiment, the first phase of stimulation is an anodal pulse at maximum subthreshold amplitude and for a long duration in order to precondition the myocardium for subsequent stimulation, and the second phase of stimulation is a cathodal pulse with a short duration and a high amplitude. Additional embodiments of the first phase include, but are not limited to, the use of ramped pulses, a series of short duration square wave pulses, anodal pulses that are less than the maximum subthreshold amplitude, and pulses whose magnitudes decay from an initial subthreshold amplitude to a lower amplitude, where the shape of the decay can be linear or curvilinear. It is to be understood that the use of the phrase "medium energy" stimulation or pulse refers to electrical stimulation or electrical pulses in which the magnitude of the voltage of the electrical stimulation/pulse is lower in magnitude than that used in typical defibrillation/cardioversion. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1-A depicts a heart with multiple ventricular electrodes that are introduced via the vena cava. FIG. 1-B depicts a heart with multiple ventricular electrodes that are connected to external surfaces of the ventricles, and include a separate electrode set each for the right and left ventricles. FIG. 2 is a schematic representation of leading anodal biphasic stimulation. FIG. 3 is a schematic representation of leading anodal stimulation of low level and long duration, followed by cathodal stimulation. FIG. 4 is a schematic representation of leading anodal stimulation of ramped low level and long duration, followed by cathodal stimulation. FIG. 5 is a schematic representation of leading anodal stimulation of low level and short duration administered in a series, followed by cathodal stimulation. DESCRIPTION OF THE PREFERRED EMBODIMENTS The apparatus and method of the present invention may be understood with reference to FIGS. 1-A, 1-B, and 2 to 5. Referring to FIG. 1-A, a diagram of the heart is shown connected to vena cava 103, and having four chambers: right atrium (RA), left atrium (LA), right ventricle (RV), and left ventricle (LV). Electrode lead 101 is shown feeding into the right ventricle via vena cava 103, the right atrium, and tricuspid valve 111. Individual electrodes 102, 104, 106, 108 and 110 are connected to electrode lead 101, and contact multiple internal sites of the right ventricle. No set number, or absolute range as to the number, of individual electrodes is required to practice this embodiment of the present invention. A typical range could encompass 2 to 30 electrodes, though numbers greater than 30 are also contemplated. In addition, there is no set placement of these electrodes. In a preferred embodiment, 6 or less electrodes are used, 4 in the left ventricle and 2 in the right ventricle. It is noted that stimulation of the atria through the practice of the present invention also is envisioned. Referring to FIG. 1-B, a similar diagram of the heart is shown in which two sets of multiple electrodes are depicted connected to external ventricular surfaces. Electrode lead 201, connected to individual electrodes 202, 204, 206, 208 and 210, is shown with the individual electrodes connected to multiple points on the external surfaces of the right ventricle. Electrode lead 301, connected to individual electrodes 302, 304, 306, 308 and 310, is shown with the individual electrodes connected to multiple points on the external surfaces of the left ventricle. In alternative embodiments, the locations of the individual electrodes in FIG. 1-A (102, 104, 106, 108 and 110), and in FIG. 1-B (202, 204, 206, 208 and 210; and 302, 304, 306, 308 and 310) may 1) follow a regular or relatively regular geometric pattern (e.g., an orthogonal or other patterned grid) so as to cover well the ventricular surfaces in appropriate locations; 2) be localized to a particular ventricular area that is known or suspected to be a source of random reentry circuits; 3) be randomly placed about the selected ventricular surfaces; and/or 4) be placed about the ventricular surfaces in a progressive pattern to facilitate mimicking the normal physiological flow of the depolarization wave that leads to the most efficient contraction of the particular ventricle(s). The latter progressive stimulation embodiment, which mimics the normal physiological flow of the normal ventricular depolarization wave, requires that areas closest to (or at) the A-V node be the areas first stimulated during a given beat, and that areas farthest from the A-V node--following the normal intrinsic conduction paths--be the last areas to be stimulated. Areas intermediate between these two extremes are appropriately stimulated on a scaled time basis that, again, mimics the normal intrinsic conduction paths that facilitate the most efficient cardiac contraction. This progressive stimulation embodiment requires specific knowledge of the placement of each electrode relative to each other electrode, as well as the placement relative to the electrical conduction pathways in the heart. Thus, it is appropriate to contemplate "classes" of electrodes, in which, for example, electrodes are identified or categorized according to when they are fired. In a simplistic five tier system, e.g., the first tier elect-odes are designated as the first to be fired (i.e., the electrodes closest to the A-V node), followed successively (and temporally progressively according to the normal conducting paths) by the second, third, fourth, and fifth tier electrodes, where the fifth tier electrodes would be the last to be fired, and whose locations on the ventricle(s) would correspond to the last areas to be depolarized in the course of a normal ventricular contraction/beat. An even simpler (i.e., two, three or four) tiered system may be used, or one more complex (i.e., one with greater than 5 tiers, or with any other basis of electrode placement, such as a honeycomb-like array in a particular area with a known or suspected pathology as to rhythmicity, reentry, conduction, contractility, etc.). Furthermore, multiple electrodes within a given tier may be numbered or otherwise distinctly identified so that the practitioner may test and use electrodes with respect to known locations in the heart, for example, to anticipate and/or bypass an area of electrical blockage. This type of embodiment would require the use of multiple, small electrodes pulsed in a physiologic sequential fashion. In application to atria, electrodes are progressively placed from close to the SA node (first to be fired) to close to the AV node (last to be fired), mimicking the normal intrinsic conduction paths. Bypassing an area of electrical blockage is also anticipated by the present invention, and can be effected by first identifying such areas, for example, by determining myocardial resistance values between electrodes. Electrical pulses then are routed to those myocardial areas with appropriately low resistances, following as closely as possible the lines of conduction of the normal intrinsic conduction paths. Communication of, and control of, measurements of resistance between electrodes, as well as developing a bypass protocol for a particular patient, can be effected by an external computer. The external computer can communicate with the pacemaker by any convenient method, for example, radiotelemetry, direct coupling (as by connecting to an external wire from the pacemaker to the surface of the skin of the patient), etc. FIGS. 2 through 5 depict a range of biphasic stimulation protocols. These protocols have been disclosed in U.S. patent application Ser. No. 08/699,552 to Mower, which is herein incorporated by reference in its entirety. FIG. 2 depicts biphasic electrical stimulation in which a first stimulation phase comprising anodal stimulus 202 is administered with amplitude 204 and duration 206. The first stimulation phase is followed immediately by a second stimulation phase comprising cathodal stimulus 208, which is of equal intensity and duration to those of anodal stimulus 202. FIG. 3 depicts biphasic electrical stimulation wherein a first stimulation phase comprising low level, long duration anodal stimulation 302 having amplitude 304 and duration 306 is administered. This first stimulation phase is immediately followed by a second stimulation phase comprising cathodal stimulation 308 of conventional intensity and duration. In an alternative embodiment of the invention, anodal stimulation 302 is at maximum subthreshold amplitude. In yet another alternative embodiment of the invention, anodal stimulation 302 is less than three volts. In another alternative embodiment of the invention, anodal stimulation 302 is a duration of approximately two to eight milliseconds. In yet another alternative embodiment of the invention, cathodal stimulation 308 is of a short duration. In another alternative embodiment of the invention, cathodal stimulation 308 is approximately 0.3 to 1.5 milliseconds. In yet another alternative embodiment of the invention, cathodal stimulation 308 is of a high amplitude. In another alternative embodiment of the invention, cathodal stimulation 308 is in the approximate range of three to twenty volts. In yet another alternative embodiment of the present invention, cathodal stimulation 308 is of a duration less than 0.3 milliseconds and at a voltage greater than twenty volts. In another alternative embodiment, anodal stimulation 302 is administered over 200 milliseconds post heart beat. In the manner disclosed by these embodiments, as well as those alterations and modifications which may become obvious upon the reading of this specification, a maximum membrane potential without activation is achieved in the first phase of stimulation. FIG. 4 depicts biphasic electrical stimulation wherein a first stimulation phase comprising anodal stimulation 402 is administered over period 404 with rising intensity level 406. The ramp of rising intensity level 406 may be linear or non-linear, and the slope may vary. This anodal stimulation is immediately followed by a second stimulation phase comprising cathodal stimulation 408 of conventional intensity and duration. In an alternative embodiment of the invention, anodal stimulation 402 rises to a maximum subthreshold amplitude. In yet another alternative embodiment of the invention, anodal stimulation 402 rises to a maximum amplitude that is less than three volts. In another alternative embodiment of the invention, anodal stimulation 402 is a duration of approximately two to eight milliseconds. In yet another alternative embodiment of the invention, cathodal stimulation 408 is of a short duration. In another alternative embodiment of the invention, cathodal stimulation 408 is approximately 0.3 to 1.5 milliseconds. In yet another alternative embodiment of the invention, cathodal stimulation 408 is of a high amplitude. In another alternative embodiment of the invention, cathodal stimulation 408 is in the approximate range of three to twenty volts. In yet another alternative embodiment of the present invention, cathodal stimulation 408 is of a duration less than 0.3 milliseconds and at a voltage greater than twenty volts. In another alternative embodiment, anodal stimulation 402 is administered over 200 milliseconds post heart beat. In the manner disclosed by these embodiments as well as those alterations and modifications which may become obvious upon the reading of this specification, a maximum membrane potential without activation is achieved in the first phase of stimulation. FIG. 5 depicts biphasic electrical stimulation wherein a first stimulation phase comprising series 502 of anodal pulses is administered at amplitude 504. In one embodiment rest period 506 is of equal duration to stimulation period 508 and is administered at baseline amplitude. In an alternative embodiment, rest period 506 is of a differing duration than stimulation period 508 and is administered at baseline amplitude. Rest period 506 occurs after each stimulation period 508 with the exception that a second stimulation phase comprising cathodal stimulation 510 of conventional intensity and duration immediately follows the completion of series 502. In an alternative embodiment of the invention, the total charge transferred through series 502 of anodal stimulation is at the maximum subthreshold level. In yet another alternative embodiment of the invention, the first stimulation pulse of series 502 is administered over 200 milliseconds post heart beat. In another alternative embodiment of the invention, cathodal stimulation 510 is of a short duration. In yet another alternative embodiment of the invention, cathodal stimulation 510 is approximately 0.3 to 1.5 milliseconds. In another alternative embodiment of the invention, cathodal stimulation 510 is of a high amplitude. In yet another alternative embodiment of the invention, cathodal stimulation 510 is in the approximate range of three to twenty volts. In another alternative embodiment of the invention, cathodal stimulation 510 is of a duration less than 0.3 milliseconds and at a voltage greater than twenty volts. The individual pulses of the series of pulses may be square waves, or they may be of any other shape, for example, pulses which decay linearly or curvilinearly from an initial subthreshold amplitude, to a lower amplitude. In the preferred biphasic stimulation protocol practiced by the present invention, the magnitude of the anodal phase does not exceed the maximum subthreshold amplitude. The anodal phase serves to precondition the stimulated myocardium, thereby lowering the excitation threshold such that a cathodal stimulation of lesser intensity than normal will produce depolarization leading to contraction. The values of duration and amplitude will depend on factors such as the placement/position of the particular electrode (including, e.g., whether the electrode is in purely muscle tissue versus in specialized conducting or pacemaking tissue), whether damaged/scarred tissue is in close vicinity to the electrode, depth of the electrode within the tissue, local tissue resistance, presence or absence of any of a large range of local pathologies, etc. Nonetheless, typical anodal phase durations often fall within the range from about two milliseconds to about eight milliseconds, whereas typical cathodal durations often fall within the range from about 0.3 millisecond to about 1.5 millisecond. Typical anodal phase amplitudes (most commonly at the maximum subthreshold amplitude) often fall within the range from about 0.5 volt to 3.5 volts, compared to typical cathodal phase amplitudes from about 3 volts to about 20 volts. The present invention also permits the physician to readily test ranges of stimulation and other parameters (voltage, duration, shape of voltage versus time pulses, etc.) once the anti-reentry system is in place in the patient. Thus, the ability to engage in trial and error testing of pulsing parameters permits the physician not only to determine such a parameter as maximum subthreshold amplitude, but also to optimize other stimulation parameters to fit a given patient's condition, location of electrodes, etc. Furthermore, the physician may so determine optimal parameters for each individual electrode in a set of multiple electrodes. Such a system of testing could be related to defibrillation threshold testing, wherein ventricular fibrillation is deliberately provoked and various levels of defibrillatory shocks are given to determine the amount of energy needed. In the present application, testing is done with the various patterns of pacing so as to find the one with the lowest requirement for countershock energy. Based on the examples provided herein, the skilled practitioner in the art will readily appreciate that generalization of the teachings expands the scope of the present invention to include stimulation time and voltage ranges to beyond those mentioned herein, as well as to beyond the numbers of individual electrodes employed, and other parameters subject to simple and quick experimentation in a specific situation not specifically addressed in the verbiage presented on the practice of the present invention. Having thus described the basic concept of the invention, it will be readily apparent to those skilled in the art that the foregoing detailed disclosure is intended to be presented by way of example only, and is not limiting. Various alterations, improvements and modifications will occur and are intended to those skilled in the art, but are not expressly stated herein. These modifications, alterations and improvements are intended to be suggested hereby, and within the scope of the invention. Accordingly, the invention is limited only by the following claims and equivalents thereto.

An anti-reentry apparatus and method for reverting ventricular arrhythmias. Biphasic stimulation is applied at multiple ventricular sites to revert arrhythmias caused by reentry, particularly multiple random reentry. In the preferred embodiment, the first phase of biphasic stimulation is anodal, and is at a maximum subthreshold amplitude. The anodal phase preconditions the myocardium to accept the second phase (cathodal) such that less electrical energy is required to reach the threshold amplitude to produce depolarization. The anodal phase stimulation may have a shape over time that is square wave, ramped, or a series of short square wave pulses. Multiple electrodes located at multiple ventricular sites may be stimulated simultaneously, or they may be sequentially stimulated over time in a manner mimicking the normal progress pattern of cardiac depolarization. The multiple ventricular electrodes may stimulate from internal or external surfaces. One or both ventricles may receive biphasic stimulation from multiple electrodes. The invention also may be practiced with respect to atria.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application relates to, and claims the benefit of the filing date of, co-pending U.S. Provisional Patent Application Ser. No. 60/785,195 entitled “FLEXIBLE CAGE SPINAL IMPLANT,” filed Mar. 23, 2006, the entire contents of which are incorporated herein by reference for all purposes. This application also relates to co-pending U.S. Provisional Application 60/825,089, entitled “OFFSET RADIUS LORDOSIS,” filed Sep. 8, 2006, and to U.S. patent application Ser. No. ______, entitled “INSTRUMENTS FOR DELIVERING SPINAL IMPLANTS” filed concurrently herewith, and to U.S. application Ser. No. 11/303,138, entitled “THREE COLUMN SUPPORT DYNAMIC STABILIZATION SYSTEM AND METHOD OF USE,” filed Dec. 16, 2005, the contents of which are incorporated herein by reference for all purposes. BACKGROUND OF THE INVENTION Field of the Invention [0002] This disclosure relates to systems and methods for treating diseases of human spines, and more particularly, to interbody implant devices. [0003] The human spine is a complex structure designed to achieve a myriad of tasks, many of them of a complex kinematic nature. The spinal vertebrae allow the spine to flex in three axes of movement relative to the portion of the spine in motion. These axes include the horizontal (e.g., bending either forward/anterior or aft/posterior), roll (e.g., lateral bending to either left or right side) and rotation (e.g., twisting of the shoulders relative to the pelvis). [0004] The inter-vertebral spacing (between neighboring vertebrae) in a healthy spine is maintained by a compressible and somewhat elastic disc. The disc serves to allow the spine to move about the various axes of rotation and through the various arcs and movements required for normal mobility. The elasticity of the disc maintains spacing between the vertebrae during flexion and lateral bending of the spine, allowing room or clearance during the compressive movement of neighboring vertebrae. In addition, the disc enables relative rotation about the vertical axis of the neighboring vertebrae, allowing for the twisting of the shoulders relative to the hips and pelvis. Clearance between neighboring vertebrae maintained by a healthy disc is also important to enable the nerves from the spinal cord to extend out of the spine, between neighboring vertebrae, without being squeezed or impinged by the vertebrae. [0005] In situations (e.g., based upon injury or otherwise) where a disc is not functioning properly, the inter-vertebral disc tends to over compress. With the over compression, pressure may be exerted on nerves extending from the spinal cord due to this reduced inter-vertebral spacing. Various other types of nerve problems may also be experienced in the spine, such as exiting nerve root compression in neural foramen, passing nerve root compression, and enervated annulus (i.e., where nerves grow into a cracked/compromised annulus, causing pain every time the disc/annulus is compressed), as examples. Many medical procedures have been devised to alleviate such nerve compression and the pain that results from the nerve pressure. Many of these procedures revolve around attempts to prevent the vertebrae from moving too close to each other by surgically removing an improperly functioning disc and replacing the disc with a lumbar interbody fusion (“LIF”) device. Although prior interbody devices, including LIF cage devices, may be effective at improving patient condition, these LIF cage devices may not provide the range of flexibility and support of a properly functioning disc. [0006] It would be desirable to improve the flexibility of the LIF cage devices, while maintaining the high strength, durability and reliability, of the LIF cage device. A flexible LIF cage device may better enable a patient move about the various axes of rotation and through the various arcs and movements required for a normal range of mobility. SUMMARY [0007] An embodiment of the present invention may comprise a flexibility enabling member on a section of an implant. BRIEF DESCRIPTION OF THE DRAWINGS [0008] For a more complete understanding of this disclosure reference is now made to the following Detailed Description taken in conjunction with the accompanying drawings, in which: [0009] FIG. 1 illustrates an oblique view of an embodiment of a flexible spinal implant designed to be inserted into an intervertebral space; [0010] FIG. 2 illustrates a top view of the flexible spinal implant; [0011] FIG. 3 illustrates an anterior view of the flexible spinal implant; [0012] FIG. 4 illustrates a midline cross-sectional view of the flexible spinal implant; [0013] FIG. 5 illustrates an anterior view of the flexible spinal implant, wherein a force is applied to the top portion of the implant; [0014] FIG. 6A illustrates a side view of the flexible spinal implant, wherein a force is applied to the anterior portion of the implant; [0015] FIG. 6B illustrates an alternative side view of the flexible spinal implant, wherein a force is applied to the posterior portion of the implant; [0016] FIG. 7 illustrates an oblique view of the flexible spinal implant, wherein openings of the implant may be pushed out; [0017] FIGS. 8A-D illustrate anterior views of some of the various embodiments of the flexible spinal implant; [0018] FIG. 9 illustrates a sagittal view of the flexible spinal implant, wherein the implant is located between two adjacent vertebrae; [0019] FIG. 10 illustrates an oblique view of a flexible spinal implant, wherein the implant is being injected with a material; [0020] FIG. 11A illustrates a sagittal view of the flexible spinal implant, wherein the implant comprises a port for injecting a material; and [0021] FIG. 11B illustrates a midline section view of the flexible spinal implant, wherein the implant comprises a port for injecting a material. DETAILED DESCRIPTION [0022] In the following discussion, numerous specific details are set forth to provide a thorough understanding of the present invention. However, those skilled in the art will appreciate that the embodiments described in this disclosure may be practiced without such specific details. In other instances, well-known elements may have been illustrated in schematic or block diagram form in order not to obscure the present invention in unnecessary detail. Additionally, for the most part, details concerning well known features and elements may have been omitted inasmuch as such details are not considered necessary to obtain a complete understanding of the present invention, and are considered to be within the understanding of persons of ordinary skill in the relevant art. An Illustrative Embodiment [0023] Turning now to the drawings, FIG. 1 shows an oblique view of an illustrative embodiment of a flexible spinal implant 100 configured according to at least a portion of the subject matter of the present invention and designed to be inserted into an intervertebral space. The flexible spinal implant 100 may have multiple flexural components 102 provided in an anterior surface of the implant 100 . The flexible spinal implant 100 may also have multiple flexural components 104 provided in a posterior surface of the implant 100 . These flexural components 102 and 104 may comprise empty space (e.g., voids, apertures, cavities, or no material) or they may be filled with a material having a lower modulus of elasticity than a surrounding portion of the implant 100 . The flexural components 104 may be of a similar configuration to the flexural components 102 , or they may be different. Additionally, all of the flexural components 102 , 104 of an anterior or a posterior surface may comprise the same or different configurations. Although, multiple flexural components 102 , 104 are shown in this illustrative embodiment of the present invention, a single flexural component 102 , 104 may exist on an anterior and/or a posterior surface. [0024] Multiple protrusions 106 may be located on the top surface and/or the bottom surface of the implant 100 . In certain embodiments, these protrusions 106 may help to prevent the implant 100 from substantially moving within the intervertebral space. Although the protrusions 106 may be shown in FIG. 1 as being rectangular shaped, the protrusions 106 may not be limited to this configuration. Any geometric configuration may be used. In addition, an undulating surface may also provide the benefit of fixing the implant 100 in place without necessarily being a distinct protrusion. A single protrusion 106 on the top surface and/or the bottom surface of the implant 100 may also be used. The protrusions 106 may restrain the implant in a relatively fixed location by engaging the opposing surfaces of the endplates of adjacent vertebrae. [0025] As shown in FIG. 1 , in some embodiments the endpoints 108 of the anterior flexural components 102 may extend to the side surfaces of the implant 100 . The endpoints 110 of the posterior flexural components 104 may be limited to the posterior surface of the implant 100 . Accordingly, in multiple embodiments the anterior flexural components 102 and the posterior flexural components 104 may have a wide range of lengths, widths, and positions. These flexural components 102 and 104 may be configured to alter, reposition, or increase the flexibility of the spinal implant 100 . [0026] With multiple flexural components 102 on the anterior surface of the implant 100 , the anterior surface of the implant 100 may exhibit an increased ability to resiliently deform when a force is applied to the anterior portion of the implant 100 . Similarly, with multiple flexural components on the posterior surface of the implant 100 , the posterior surface of the implant 100 may also exhibit an increased ability to resiliently deform when a force is applied to the posterior portion of the implant 100 . Accordingly, the implant 100 may be able to provide support within the intervertebral space and also provide a range of flexibility when adjacent vertebrae exert a force on the implant 100 . In certain embodiments, these flexural components 102 and 104 may provide flexibility through less material (e.g., through the use of a cavity, orifice, or a variable thickness of material), which may produce a lower modulus of elasticity, or through a lower modulus material (e.g., through the use of different heat treatments or material processing, or the substitution or addition of a separate material). [0027] The implant 100 may be manufactured from a variety of biocompatible materials. For example, the implant 100 may be made from biocompatible plastics or metals such as PEEK(poly-ether-ether-ketone), carbon filled PEEK, titanium, or stainless steel, among others. The implant 100 may preferably comprise a sufficient level of strength to at least partially replace a supporting function of an intervertebral disc such that adjacent vertebrae may maintain a desired minimum amount of spacing between opposing surfaces. In some embodiments, the implant 100 may be made of metal, such as cobalt chrome, or titanium. In other embodiments, the implant 100 may be made of ceramic materials or a combination of both metal and ceramic materials, such as oxidized zirconium. [0028] Turning now to FIG. 2 , this figure illustrates a top view of the flexible spinal implant 100 . Multiple protrusions 106 may be located on the top portion of the implant 100 . As more easily seen in FIG. 2 , in some embodiments the length of the anterior flexural components, which may be defined by the endpoints 108 , may be longer than the length of the posterior flexural components, which may be defined by the endpoints 110 . In this view, the endpoints 108 may be seen as extending to the sides of the implant 100 while the endpoints 110 may be confined to the posterior side surface of the implant 100 . However, the locations and separations of the various endpoints 108 , and 110 may not be limited to this illustrative embodiment. [0029] The implant 100 may be a substantially oval-shape with a relatively empty center. This oval-shape of the implant 100 may correspond to the shape of the intervertebral disc. This empty center of the implant 100 may be filled with cadaveric bone, autologous bone, bone slurry, bone morphogenic protein (“BMP”) or a similar material. These types of materials may help with tissue growth within the intervertebral space. In some embodiments, openings created by the openings 102 and 104 may further help with tissue growth by allowing the material to seep into the intervertebral space. The illustrative embodiment is shown with a relatively consistent wall thickness. However, depending upon the flexibility configuration, the wall thickness may vary around the perimeter of the implant 100 . [0030] Referring now to FIG. 3 , this figure illustrates an anterior view of the flexible spinal implant 100 . As stated previously, in certain embodiments the anterior openings 102 may extend further in length than the posterior openings 104 (the posterior openings 104 are seen through the anterior openings 102 in this figure). Accordingly, from an anterior view the endpoints 110 of the posterior openings 104 may be visible because the endpoints 108 of the anterior openings 102 may extend to the side portions of the implant 100 . The anterior openings 102 are shown as being approximately the same number and overall design as the posterior openings 104 as an example of one amongst many embodiments. The protrusions 106 are shown as existing on both the top surface and the bottom surface of the implant 100 in this representation of an exemplary embodiment. [0031] Turning now to FIG. 4 , this figure shows a midline cross-sectional sagittal view of the flexible spinal implant 100 . As seen in this drawing, in certain embodiments the anterior openings 102 may extend to the side portions of the implant 100 , while the posterior openings 104 may not extend to the side portions of the implant 100 . In addition, the top and bottom surfaces may be substantially parallel in the absence of an applied force to the implant 100 . [0032] However, some embodiments of the implant (not shown) may be configured such that the top or bottom surfaces may be at an angle to each other in an unloaded condition. These implants may help to restore or recreate a lordosis angle (or other angle) of a human spine. In addition, both of the top and bottom surfaces of the implant may be at an angle relative to a horizontal midline of the implant in an unloaded condition. Alternatively, in certain embodiments (not shown), the top and/or bottom surfaces may be formed from a curved or compound curved surface, instead of the relatively straight line configurations shown in the figure. These implants may also help to restore or recreate a lordosis angle (or other angle) of a human spine. In addition, the contoured top and bottom surfaces (i.e., superior and inferior surfaces) may conform more closely to the concave end plates of the adjacent vertebra. More particularly, the compound curved surfaces may be created by offsetting the radii used to machine the top and bottom (i.e., bearing) surfaces of the implant. [0033] Further, the cross-sections are shown in FIG. 4 with relatively straight line configurations to aid in simplifying the figures. Although an embodiment of the current invention may be formed as shown, the implant may not be limited to such a configuration. The cross-sections may comprise curved, angular, arcuate, and other configurations able to alter the flexibility of the implant 100 . Additionally, all of the anterior openings 102 and the posterior openings 104 are shown as establishing communication between the interior and the exterior of the implant 100 . As stated previously, in some embodiments, the anterior openings 102 and/or the posterior openings 104 may extend only partially through the walls of the implant 100 . [0034] Referring now to FIG. 5 , this figure illustrates an anterior view of the flexible spinal implant 100 (shown in broken lines), wherein a force 602 is applied to the top portion of the implant 100 . The force 602 applied to the top portion of the implant 100 may cause the implant 100 to deform or compress into a form of an implant 600 (actual deformation may be exaggerated in this figure for the purposes of illustration). As shown in FIG. 5 , the anterior openings 102 may also compress, enabling the top surface of the implant 600 to move closer to the bottom surface of the implant 600 . The deformation of the implant 600 may enable a larger range of motion for a spinal column in which the implant 600 has been inserted. The deformation is shown as being larger in the central section than at the sides of the implant 600 . This may be due in part to the increased stiffness of the sides of the implant 600 due to a relatively smaller quantity of openings. Although the posterior openings 104 ( FIG. 3 ) may not be visible in FIG. 5 , these openings 104 may exhibit a similar type of compression in response to a force applied to the implant 100 . [0035] Turning now to FIG. 6A , this figure shows a side view of a spinal implant 700 in which a force 706 has been applied to an anterior portion of the implant 700 . When a force 706 is applied to an implant (e.g., such as illustrated in FIG. 4 ), the anterior openings 102 may compress as described with reference to FIG. 5 . In addition, since the force 706 may be applied primarily to the anterior portion of the implant 700 , the posterior openings 104 may expand. This corresponding behavior between the openings 102 and the openings 104 may be attributed at least in part to the additional flexibility provided by the openings 102 and the openings 104 (the deformation may be exaggerated for the purposes of illustration). [0036] Accordingly, an area comprising the anterior openings 102 may be defined as a first flex-zone 708 of the implant 700 , while an area comprising the posterior openings 104 may be defined as a second flex-zone 712 of the implant 700 . The first flex-zone 708 may flexibly contract while the second flex-zone 712 may flexibly expand. However, in the event of a relatively uniform force applied to the top surface of the implant 700 , both the first flex-zone 708 and the second flex-zone 712 may be flexibly contracted or expanded, to either the same or differing degrees, depending upon the quantities and configurations of the anterior openings 102 and the posterior openings 104 . [0037] The middle portion of the implant 700 , which may comprise the side walls, may be defined as a low-flex-zone 710 of the implant 700 . The low-flex-zone 710 may provide a more consistent level of support for two adjacent vertebrae, while the flex-zones 708 and 712 may provide additional flexibility. This additional flexibility may provide an additional range of motion with respect to the two adjacent vertebrae. The low-flex-zone 710 may help to prevent excessive vertical compression and consequential damage to nerve endings passing between the two adjacent vertebrae. The relatively stronger low-flex-zone 710 may also provide a more stable platform for the flex-zones 708 and 712 . [0038] Referring now to FIG. 6B , this figure illustrates an alternative side view of a flexible spinal implant 750 in which a force 714 has been applied to a posterior portion of the implant 750 . When a force 714 is applied to an implant (e.g., such as illustrated in FIG. 4 ), the posterior openings 104 may contract and the anterior openings 102 may expand. As stated previously, the area comprising the anterior openings 102 and the area comprising the posterior openings 104 may be described as the flex-zones 708 and 712 , respectively. The middle portion of the implant 750 , which may comprise the side walls, may be described as the low-flex-zone 710 of the implant 750 . [0039] As shown in FIGS. 6A and 6B , there may be at least two degrees of motion for an implant 700 , 750 depending upon the direction and location of the applied force. The motion illustrated in an embodiment of the present invention may allow for more natural movement of a spinal column and may begin to replace at least a portion of the functionality of a collapsed intervertebral disc. Additionally, the openings 102 and 104 may function to control motion during both expansion and contraction of an implant 700 , 750 . [0040] Turning now to FIG. 7 , this figure shows an oblique view of an embodiment of a flexible spinal implant 800 in which the openings 102 of the implant 800 may be pushed out or removed. In certain embodiments, the implant 800 may have one or more removable members 105 retained within the implant 800 through the use of perforated dividers, interlocking features, friction forces, threaded fasteners, and adhesive forces, among others. The removable members 105 may be detached in response to a force 802 applied to the anterior or posterior portion of the implant 800 . Accordingly, a tool 804 may be utilized to apply a force 802 to the implant 800 and produce an opening 102 , by detaching the removable members. [0041] This feature may enable a physician to adjust the flexibility of the anterior or posterior portion of a standard or common implant 800 to be adapted to the specific needs of a patient or a specific requirements of a portion of a patient's spine. The removable portions 105 may be removed prior to insertion of the implant 800 within a patient's body. However, there may be situations in which a range of motion of a patient may be adjusted via the removable members 105 after insertion. Additionally, the implant 800 is shown as configured with removable members 105 . However, the flexibility of the implant 800 may be also be adjusted through the insertion of members with appropriate degrees of flexibility into openings 102 . In some embodiments, the distraction height that the implant 800 provides may be increased by placing appropriate inserts into the openings 102 . Consequently, the flexibility of a portion of a standard or common implant 800 may be increased or decreased (i.e., modified) through the removal of removable members 105 and/or insertion of other inserts into the openings 102 . [0042] Referring now to FIG. 8A , this figure illustrates an anterior view of an embodiment of the flexible spinal implant 902 . In one example amongst many of an embodiment, the implant 902 may comprise a single opening 904 . The opening 904 for example, may be irregularly shaped, symmetrical, or asymmetrical, in order to provide additional flexibility to the anterior portion (for example) of the implant 902 . The overall design configuration for the opening 904 may be determined based upon results from finite element analysis for example. [0043] Turning now to FIG. 8B , this figure shows an anterior view of another alternative embodiment of the flexible spinal implant 912 . In one example of an embodiment of the present invention, the implant 912 may comprise two corresponding openings 914 . These corresponding openings 914 may provide additional flexibility to the anterior portion (for example) of the implant 912 . As seen in FIG. 8B , the two corresponding openings 914 may be configured to create an interconnecting member 915 located there between. The interconnecting member 915 may provide an additional degree of resiliency for the anterior portion of the implant 912 . While the interconnecting member 915 may be shown as being integral to the anterior portion of the implant 912 , other resilient members such as springs, compressible material, and others may be used to provide the additional degree of resiliency. [0044] Referring now to FIG. 8C , this figure illustrates an anterior view of another alternative embodiment of the flexible spinal implant 922 . In one illustrative embodiment, the implant 922 may comprise multiple circular or other configurations of openings 924 . As shown in this example, these cylindrical openings 924 may provide additional flexibility to the anterior portion (for example) of the implant 922 . Cylindrical openings 924 may be easily created in the anterior portion of the implant 922 through the use of drills or cores during molding for example. As with the illustrative embodiment discussed along with FIG. 7 , the numbers, sizes, and placements, of the openings 924 may be made in a more common, generic implant according to the requirements of the patient. [0045] Turning now to FIG. 8D , this figure shows an anterior view of an alternative embodiment of the flexible spinal implant 932 . In one example of an embodiment, the implant 932 may comprise a single oval-shaped opening 934 . The oval-shaped opening 934 may provide additional flexibility to the anterior portion (for example) of the implant 932 . A large relatively smooth opening such as the opening 934 may reduce local areas of stress concentration within the implant 932 . [0046] Additional embodiments of the anterior portion of an implant 100 are within the scope of this disclosure. This disclosure should not be limited to the embodiments shown in FIGS. 8A-8D . In addition, the embodiments shown in FIGS. 8A-D and other additional alternative embodiments of openings may be applied to the posterior portion or side portions of an implant 100 . The other embodiments may be applied singly, in multiple numbers, or in combinations without limit as long as the flexibility and strength of an implant 100 are maintained at desired levels. [0047] Referring now to FIG. 9 , this figure illustrates a sagittal view of the flexible spinal implant 100 in which the implant 100 is located between two adjacent vertebrae 1002 and 1004 . As shown in FIG. 9 , the implant 100 may be placed in an intervertebral space. In this position, the flexible spinal implant 100 may function similarly to an intervertebral disc by providing both support and flexibility. Accordingly, anterior openings 102 and posterior openings 104 may provide an appropriate amount of flexibility to the implant 100 . [0048] Protrusions 106 may help to prevent the implant 100 from significantly moving within the intervertebral space relative to the two adjacent vertebrae 1002 and 1004 . The protrusions 106 may be located on the top and bottom surface of the implant 100 and engaged with the opposing surfaces of the two adjacent vertebrae 1002 and 1004 . [0049] In certain embodiments the implant 100 may be configured as a dynamic device, such as a partial disc replacement (PDR). The implant 100 may be used to stabilize adjacent vertebrae as the spine moves in various directions. A dynamic stabilization device may be used in conjunction with the implant 100 as part of a three column support dynamic stabilization system as is described in more detail in co-pending U.S. application Ser. No. 11/303,138, entitled “THREE COLUMN SUPPORT DYNAMIC STABILIZATION SYSTEM AND METHOD OF USE,” filed Dec. 16, 2005, and incorporated herein by reference for all purposes. [0050] Turning now to FIG. 10 , this figure shows an oblique view of a flexible spinal implant 1110 in which the implant 1110 is being injected with a material 1106 . This material 1106 may be injected in situ. In one embodiment, the implant 1110 may have a port 1102 . An insertion tube 1104 may couple to the port 1102 such that a material 1106 may be injected into the interior of the implant 1110 . This material 1106 may be utilized to provide additional support or flexibility, or to enhance tissue growth within the intervertebral space. Accordingly, materials such as cadaveric bone, autologous bone, bone slurry, BMP, or other similar material, may enhance tissue growth within the intervertebral space. In some embodiments, a separate container or walls may be provided to contain the material within the interior of the implant 1110 . [0051] Referring now to FIG. 11A , this figure illustrates a sagittal view of the flexible spinal implant 1110 in which the implant 1110 comprises the port 1102 for injecting the material 1106 . The port 1102 may be located in any of the anterior openings 102 and the posterior openings 104 , or the port 1102 may be located in an opening configured specifically for the port 1102 . The material 1106 may be injected into the implant 1110 via this port 1102 . The material 1106 may fill the center portion of the implant 1110 as shown in FIG. 11A . In addition, only two ports are shown in FIG. 10 and only one port 1102 is visible in FIG. 11A , however, a single port or a plurality of ports 1102 may be provided in the implant 1110 . Further, although a separate port 1102 may be described for inserting the material 1106 , the material 1106 may be inserted through an existing anterior and/or posterior opening 102 and 104 . [0052] Turning now to FIG. 11B , this figure shows a midline cross-sectional view of the flexible spinal implant 1110 , in which the implant 1110 comprises a port 1102 for injecting the material 1106 . The material 1106 may be injected into the implant 1110 via this port 1102 . The material 1106 may fill the center portion of the implant 1110 as shown in FIG. 11B . As previously stated with regard to FIG. 4 , in certain embodiments the anterior openings 102 may extend to the side portions of the implant 1110 , while the posterior openings 104 may not extend to the side portions of the implant 1110 . In addition, the top and bottom surfaces may be substantially parallel in the absence of an applied force to the implant 1110 . [0053] The cross-sections are shown with relatively straight line configurations for the purposes of illustration. The cross-sections may comprise curved, angular, arcuate, and other configurations able to alter the flexibility of the implant 1110 . Additionally, all of the anterior openings 102 and the posterior openings 104 are shown as establishing communication between the interior and the exterior of the implant 1110 . In some embodiments, the anterior openings 102 and/or the posterior openings 104 may extend only partially through the walls of the implant 1110 . The insertion port 1102 may establish communication between the interior and the exterior of the implant 1110 . The insertion port 1102 may further comprise corresponding engagement surfaces for locating an insertion tube 1104 ( FIG. 10 ) in addition to one way valves or devices necessary to facilitate the insertion of material 1106 into the interior of the implant 1110 . [0054] It is understood that multiple embodiments can take many forms and designs. Accordingly, several variations of these embodiments may be made without departing from the scope of this disclosure. Having thus described specific embodiments, it is noted that the embodiments disclosed are illustrative rather than limiting in nature. A wide range of variations, modifications, changes, and substitutions are contemplated in the foregoing disclosure. In some instances, some features may be employed without a corresponding use of the other features. Many such variations and modifications may be considered desirable by those skilled in the art based upon a review of the foregoing description of embodiments.

A implant is provided for placement in a space between boney structures. The implant may comprise a flexible section. The flexible section may be either the anterior side or the posterior side of the implant or both, among other sides. The flexible section or sections may comprise one or more orifices, cavities, or low modulus of elasticity materials among others. The flexible section or sections may facilitate a wider range of motion than otherwise possible for a spinal column comprising a Lumbar Interbody Fusion (LIF) device. Additionally, the anterior side comprising a flexible section may have a different modulus of elasticity than the posterior side comprising a flexible section. The difference may facilitate a wider range of responses from the implant to movement generated forces in at least two directions.

FIELD OF THE INVENTION [0001] The present invention relates to a filter cap for the hygienic preparation of a nutritional composition, especially an infant/toddler formula. More particularly, the invention relates to a filter cap for being connected to a container containing a predefined amount of nutritional formula base for the preparation of a ready-to-drink aqueous nutritional formula composition in combination with supplied liquid. BACKGROUND OF THE INVENTION [0002] Nutritional formulas or compositions can be, for instance, infant formulas or also nutritional liquids for toddlers, invalids, elderly people, humans having nutritional deficiencies and/or having a deficient immune system or athletes. [0003] In the field of nutritional compositions, single-serving solutions are known which enable to provide a predefined amount of comestible product to a consumer. [0004] WO2009/083495 for example relates to a packaging for a consumable articles such as a comestible product or medicine, that comprises a container including an amount of the consumable article necessary for a single use, wherein the container is provided at one end thereof with an opening being surrounded by a rigid skirt adapted for being connected to a liquid container such as a bottle. Opening means of the container enable to mix the consumable article of the container with liquid provided within the bottle. [0005] A more convenient preparation of a nutritional composition is enabled by a preparation device in which a single-serving of a preferably powdered composition being provided within a capsule or cartridge is dissolved by means of injection with filtered respectively sanitized liquid such as water. Thereby, any undesired contaminants should be removed from the liquid before the liquid is mixed with the ingredients. For this purpose, such a device preferably comprises filter means for filtering respectively sanitizing the water. [0006] In recent development, capsules with integrated antimicrobial filter have been introduced into the market in order to ensure the provision of filtered respectively sanitized liquid to the capsule for the preparation of the nutritional composition. [0007] US2011233119A1 relates to a sports bottle device with filter isolated from filtered fluid and may have particular application for baby formulas. The device comprises a lower filtering bottle section for connecting to an upper bottle delivery section. However, such lower filtering bottle section is not formed as a cap for connecting to a feeding container. It is furthermore not adapted to be connected to external liquid dispensing means for being supplied with liquid by these means. In particular, the lower filtering section must be disconnected from the upper bottle section before being fed with liquid such as from a water supplying tap. Furthermore, the filter assembly is not arranged in the lower filtering section to remove contaminants from liquid supplied into the feeding container through the inlet means by the external liquid dispensing means. The filter assembly is configured to filter liquid when the liquid is transferred from the lower bottle section to the upper bottle section. As a result, the device lacks hygiene as the upper bottle section may be contaminated by the lower bottle section when the lower bottle section is connected to the upper bottle section after refilling of the lower bottle section. Furthermore, the device is not adapted to provide a good powder dissolution in liquid since the liquid is transferred from the lower bottle section to the upper bottle section by effect of pumping with the bellows provided in the lower bottle section thereby conferring potentially low energy to the liquid flow. [0008] WO2009/092629A1 for example relates to a capsule for use in a beverage production device, the capsule containing ingredients for producing a nutritional liquid when a liquid is fed into the capsule at an inlet face thereof, the capsule being provided with an anti-microbial filter. [0009] WO2010/128051A1 relates to a capsule for preparing a nutritional product including a filter adapted for removing contaminants wherein the filter is formed of a filter unit that comprises a filter membrane and an outlet wall for supporting the filter membrane; the outlet wall comprising at least one liquid outlet communicating with the container. [0010] A drawback with the known capsule-based preparation devices comes from the fact that in addition to the capsules containing the infant formula base, a serving vessel for the instant formula such as a baby bottle is required. Accordingly, the required space for storage and transport of the components necessary for the preparation of the instant formula is relatively large. [0011] Another drawback comes from the fact that the release of a reconstituted liquid composition from a capsule requires a complete dissolution or dispersion of the ingredients/formula with the diluents (e.g. ambient or warm water) to ensure a complete release of the resulting composition from the capsule to the serving bottle. [0012] Another drawback remains the requirement for cleaning and sterilizing serving vessel that is to be carried out after each and/or before each preparation of the nutritional composition. [0013] Therefore, a solution is sought-after which overcomes these problems. [0014] In particular, it is desirable to enable a facilitated storage and transport of the components of the beverage preparation system. It is also desirable to reduce the number of these components and their volume in order to reduce the environmental impact of the packaging. [0015] It is also an object to remove the need for cleaning respectively sterilization of any major component. [0016] The present invention seeks to address the above-described problems. The invention also aims at other objects and particularly the solution of other problems as will appear in the rest of the present description. Object and Summary of the Invention [0017] In a first aspect, the present invention relates to a filter cap for filtering liquid, the filter cap comprising a liquid inlet means designed to be supplied with liquid from external liquid dispensing means, an adaptor for connecting the filter cap to the liquid dispensing means, connection means designed for selectively connecting an opening of the filter cap to a container designed to hold a powdered or concentrated liquid nutritional formula base for the preparation of the nutritional composition upon hydration with the supplied liquid, and a filter assembly in the flow path of the liquid from the inlet means to the opening, the filter assembly being configured to remove contaminants from liquid supplied into the container through the inlet means. [0018] In particular, the liquid inlet means is arranged to supply liquid from an inlet face of the cap to the opening such that, when connected to the feeding container, liquid is fed from the external liquid dispensing means into the container. Therefore, the dissolution of the powdered or concentrated liquid nutritional formula base can be more effectively obtained since the energy provided by the flow can be obtained from the external liquid dispensing means and the liquid can be supplied in the form of a jet through the inlet opening into the container. Furthermore, there is no need for removing the cap from the container during liquid supply and dissolution of the nutritional formula is obtained as liquid is fed. [0019] According to the present invention, a filter cap for filtering liquid provided to an interior of a container holding a concentrated liquid nutritional formula base is provided, whereby the filter cap may be independently provided and connected to any given container holding an amount of the formula base or may be assembled to a given container such as at a manufacturing site. [0020] In the following application, the simplified terms “formula base” means a powdered or concentrated liquid nutritional formula base specifically designed for infants, toddlers, humans having nutritional deficiencies and/or having a deficient immune system, invalids, elderly people, or athletes; such formula base requiring a liquid, such as water, for the preparation of a ready-to-drink nutritional composition. [0021] In a preferred mode, the filter cap comprises a body portion having a first side to which the filter assembly is connected and a second side in fluid communication with the first side, on which the opening is arranged. On said second side, the connection means of the filter cap are preferably integrally formed with the body portion. The connection means are preferably arranged annular to the opening. Thereby, the connection means may be a protruding connection skirt which is designed to match a standard screw threat of a bottle such as e.g. a baby bottle. [0022] In a preferred embodiment, the filter cap further comprises liquid outlet means that are designed to release gas and/or liquid from the container connected to the filter cap to the exterior of the filter cap. [0023] The liquid outlet means may for example be constituted by an aperture or opening in the body portion of the filter cap and connected at least to the opening provided on the second side of the filter cap. Thereby, the liquid outlet means are preferably extending from the second side to the first side of the body portion of the filter cap. [0024] In an alternative embodiment, the outlet means are designed to provide an additional flow path for liquid from the container connected to the filter cap respectively from the opening on the second side of the body portion in fluid connection with the container to the exterior of the filter cap. [0025] Thereby, said additional flow path is preferably different from the flow path from the inlet means to the opening. [0026] The additional flow path is preferably arranged in series or in parallel to the flow path from the inlet means to the opening. [0027] The filter cap preferably further comprises a gas-liquid equilibrium means to allow gas, e.g., air or a protective gas contained in the container connected to the filter cap, to leave the container as liquid is fed thereto through the filter means. In a mode, the gas-liquid equilibrium means may be a one-way valve which is permeable to gas but impermeable to liquid, thereby allowing the exit of gas from the interior of the container when water is fed thereto. Such gas-liquid equilibrium means may, for example, be constituted by a venting membrane connected or integrally formed with the body portion of the filter cap to equalize the pressure within the container when liquid is provided to the container by means of the filter cap. [0028] The gas-liquid equilibrium means may as well be arranged in the flow path from the inlet to the opening of the body portion or the additional flow path from the opening to the outlet means. [0029] In a preferred embodiment, the liquid inlet means are designed to be connected by an external liquid probe of the liquid dispensing means. Accordingly, provided liquid such as preheated water can be directly fed to the inlet means and thus to the interior of a container connected to the filter cap in order to prepare the nutritional composition. [0030] In a preferred mode, the filter assembly according to the present invention is designed to be selectively removed from the filter cap. [0031] Thereby, the filter assembly is preferably removably connected to the body portion of the filter cap. In particular, the filter cap may comprise a disposable portion fixedly connected to at least the filter assembly and removably connected to the body portion. [0032] The filter assembly comprises a filtering membrane and at least one rigid supporting wall downstream of the membrane. Preferably, the membrane is placed between a rigid upper (i.e. upstream) and lower (i.e. downstream) supporting wall. The micro-porous membrane is arranged to form a barrier to contaminants, in particular, microorganisms such as bacteria. For antimicrobial purpose, the filter membrane has preferably a pore size of less than 0.4 microns, most preferably of less than 0.2 microns. It may have a thickness of less than 500 microns, preferably between 10 and 300 microns. The material of the membrane can be chosen from the list consisting of PES (polyethersulfone), cellulose acetate, cellulose nitrate, polyamide and combinations thereof. Thereby, the outer wall of the filter assembly preferably comprises a liquid inlet and the inner wall comprises a liquid outlet to direct at least one liquid jet into the container. The liquid inlet of the filter assembly is preferably designed to be connected to an outlet probe of the liquid dispensing means in order to provide liquid to the filter assembly and thus, to the interior of the container. [0033] The filter assembly is preferably designed as a handleable rigid unit to withstand the pressure exerted thereon by liquid fed in the container and also to resist to manual mechanical constraints such as squeezing or piercing of the membrane by the outlet probe of the dispensing device. [0034] The filter assembly according to the present invention may be designed as the filter unit described e.g. in WO 2010/128051. [0035] The filter cap preferably further comprises a resealable portion arranged in the flow path of the liquid from the inlet means to the opening. Thereby, the resealable portion is preferably designed to close-off the flow path between the inlet means and the opening after provision of liquid by the external liquid dispensing means. [0036] Hence, during feeding of the prepared nutritional formula from the container to the outlet means of the filter cap, liquid is prevented from bypassing the outlet means of the filter cap and thus, the serving of the complete nutritional formula to the human is ensured. [0037] According to a preferred mode, the resealable portion is designed to interact with the disposable portion of the filter cap to close-off the flow path from the opening to the liquid inlet upon removal of the disposable portion. Thereby, the resealable portion may be designed to elastically and/or plastically deform in order to close-off said flow path. [0038] In another preferred embodiment of the present invention, the filter cap further comprises feeding means such as a teat or nipple assembly. [0039] Thereby, the teat assembly may be provided as an additional part to the filter cap which may be connected to the filter cap by means of additional connection means of the filter cap. Thereby, the teat assembly may be designed to match with a correspondingly shaped connection means. The connection means may also be designed to fit a standard teat available on the market. [0040] Accordingly, the user may provide an external teat assembly to the filter cap in order to facilitate feeding of the nutritional composition from the container to the consumer. [0041] Thereby, the connection means are preferably arranged in the vicinity of the outlet means of the filter cap and designed to enable a stable connection of the filter cap with the nipple assembly. [0042] Alternatively, the filter cap may comprise an integrally formed feeding means respectively a teat assembly which is arranged in fluid communication to the opening of the filter cap. The teat assembly may be connected to the outlet means or may constitute the outlet means of the filter cap. [0043] Thereby, the integrally formed teat assembly is preferably connected to the body portion of the filter cap. The integrally formed teat assembly may as well be designed to be selectively removable from the body portion of the filter cap. [0044] In a preferred embodiment of the invention, the filter cap further comprises sealing means such as a sealing membrane or sealing cap that is arranged to cover the first inlet side of the filter cap, and in particular the liquid inlet in order to prevent ingress of contaminants before use. Preferably, when the filled cap is a separate part of the container, a sealing membrane or cap is also arranged to cover the second outlet side. [0045] In a preferred embodiment, the outer wall of the filter assembly is preferably covered by a puncturable membrane made of polymer and/or aluminium to enable liquid to be supplied to the filter assembly by means of a liquid outlet probe of the liquid dispensing means. [0046] The sealing means may as well at least partially constitute the disposable portion of the filter cap which is removably connected to the body portion in order to remove the filter assembly from the body portion of the filter cap. Thereby, at least a portion of the sealing means may be fixedly connected to the filter assembly and designed to allow a selective removal of the filter assembly from the body portion of the filter cap. [0047] Therefore, the sealing means according to the present invention preferably comprise a first sealing membrane and a second sealing membrane with different respective sealing strength. Thereby, the second sealing membrane is at least partially fixedly connected to the filter assembly. Preferably, the sealing connection of said second membrane and the filter assembly is stronger than the sealing connection between the second membrane and a portion of the filter cap. [0048] The filter cap preferably comprises a reinforcing structure for supporting the filter membrane within the body portion of the filter cap. Thereby the reinforcing structure may be a recession or protrusion formed within the filter cap. Moreover, the reinforcing structure may be a T-shaped, an X-shaped or a Y-shaped support which is preferably provided in the flow path from the filter membrane to the opening of the filter cap. [0049] The reinforcing structure is preferably designed to support the filter membrane against pressure and/or force supplied from the exterior thereon. Moreover, the reinforcing structure is preferably positioned to abut the filter membrane and to prevent a displacement of the filter membrane towards the opening respectively towards a container connected to the filter cap. Such displacement could indeed damage the filter membrane, e.g., causing its breakage, and consequently would reduce the safety level of the device. [0050] The adaptor of the filter cap is preferably designed to match with an additionally provided cap connector e.g. for connecting the filter cap to a liquid dispensing means. The adaptor can be one or more portions of wall protruding transversally or being recessed from an outer surface of the filter cap. [0051] In another aspect, the present invention relates to a beverage production system, comprising a filter cap according to the present invention, a container or bottle designed to hold a powdered or concentrated liquid nutritional formula base for the preparation of the nutritional composition upon hydration with the supplied liquid, and a liquid dispensing means having: connection means for connecting to at least a portion of the filter cap and outlet means for supplying liquid to the filter cap. [0052] Moreover, system according to the present invention preferably also comprises an additionally provided cap connector for connecting the inlet means of the filter cap to the outlet means of the liquid dispensing means. BRIEF DESCRIPTION OF THE FIGURES [0053] FIG. 1 a is a sectional side view of an embodiment of the filter cap according to the invention. [0054] FIG. 1 b is a sectional side view of the filter cap according to FIG. 1 a , wherein a container or bottle has been connected to the filter cap. [0055] FIG. 2 is a sectional side view of another embodiment of the filter cap according to the invention, wherein a container or bottle has been connected to the filter cap. [0056] FIG. 3 is a sectional side view of an embodiment of the system according to the present invention, wherein the bottle is connected to the water dispensing means. [0057] FIG. 4 is a sectional side view of a preferred embodiment of the system according to the present invention, wherein the filter cap is connected to the water dispensing means by means of a cap connector. [0058] FIG. 5 a is a perspective top view of the embodiment according to FIG. 1 a in which an outer membrane is removed from the filter cap. [0059] FIG. 5 b is a sectional side view of the embodiment according to FIG. 5 a , wherein the filter assembly is removed. [0060] FIG. 5 c is sectional side view of the embodiment according to FIGS. 5 a and 5 b , wherein an additionally provided feeding assembly is attached onto the filter cap. [0061] FIG. 6 a is a sectional side view of another embodiment of the filter cap according to the invention, wherein the filter cap comprises an integrally formed feeding means. [0062] FIG. 6 b is a sectional side view of the embodiment according to FIG. 6 a , to wherein the filter cap is connected to a feeding container or bottle. [0063] FIG. 7 a is a perspective side view of an assembly of a filter and bottle of the embodiment according to FIG. 6 b. [0064] FIG. 7 b is a perspective side view of the embodiment according to FIG. 7 a , wherein the filter assembly has been removed from the base portion of the filter cap. [0065] FIG. 7 c is a perspective side view of the embodiment according to FIGS. 6 a and 6 b , wherein the feeding assembly is in an extended ready-to-feed position. [0066] FIG. 8 a is a sectional side view of the embodiment according to FIGS. 6 a and 6 b , wherein the filter cap is connected to a cap connector of the system. [0067] FIG. 8 b is a perspective side view of the embodiment according to FIG. 8 a. [0068] FIG. 9 a is a perspective side view of an injection head of water dispensing means and a cap connector. [0069] FIG. 9 b relates to the embodiment according to FIG. 9 a , wherein the cap connector is inserted into the injection head. [0070] FIG. 9 c shows the assembly according to FIG. 7 a being inserted into the injection head by means of the cap connector. DETAILED DESCRIPTION OF EMBODIMENTS [0071] FIG. 1 shows a sectional side view of a preferred embodiment of the filter cap 1 according to the present invention. [0072] The filter cap 1 comprises a tubular body portion 17 that is preferably integrally formed with connection means 13 designed to connect the filter cap 1 to a feeding container or bottle 3 (see FIG. 1 b ). [0073] The body portion 17 preferably comprises an opening 10 which is designed to contact to an inlet respectively outlet aperture 3 a of the feeding container 3 in order to establish a fluid connection between the container 3 and the body portion 17 . [0074] The opening 10 preferably extends from a first end 17 a of the body portion 17 to a second end 17 b thereof, which is preferably arranged opposite to the first end 17 a. [0075] The filter cap 1 further comprises a filter assembly 7 that is removably connected to the body portion 17 of the filter cap 1 . Thereby, the filter assembly 7 may be arranged within the opening 10 of the body portion 17 as shown in FIG. 1 a . The, the filter assembly 7 is arranged to at least partially close-off the opening 10 . [0076] The filter assembly 7 is preferably held within the opening 10 by means of provided reinforcement structure 12 . The reinforcement structure 12 may be any structure integrally formed or provided within the filter cap 1 . In particular, the reinforcement structure 12 may be a protrusion and/or a recession integrally formed within the body portion 17 . [0077] The filter cap 1 further comprises sealing means 9 a , 9 b , 9 c which prevent the ingress of the contaminants into the filter cap 1 before use thereof. [0078] Thereby, the sealing means comprise at least one sealing membrane and/or cap, preferably sealing membranes 9 b , 9 c and a sealing cap 9 a which are arranged on a first and second sides 17 a , 17 b of the filter cap 1 and which may be sealed to an outer surface of the filter cap 1 . The outer sealing membranes 9 b , 9 c and cap 9 a are preferably designed to be removable by a user before use of the filter cap 1 . Instead of the outer sealing membranes and/or sealing cap the filter cap 1 may be provided in a sealing enclosure such as a removable sealing package. [0079] The sealing means may also comprise an inner sealing membrane 9 b that is at least partially fixedly connected to the filter assembly 7 of the filter cap 1 . Thereby, the outer sealing means 9 a provided on the first side 17 b of the body portion 17 may as well be sealed to the inner sealing means 9 b in a manner to enable a facilitated removal of the outer sealing means 9 a by manual pulling force of a consumer. [0080] The filter assembly 7 is in connection or comprises a liquid inlet 6 suitable for being connected by a specifically designed liquid probe 11 of a dedicated liquid dispensing means 20 (see FIG. 3 ). [0081] The filter assembly 7 preferably comprises a filter membrane 7 a and a filter outlet 7 b which connects the liquid inlet 6 to the opening 10 of the bottle 1 . The filter membrane 7 a is situated in the liquid flow path between the inlet 6 and the filter outlet 7 b . The membrane is preferably a micro-porous membrane designed for removing any contaminants present in liquid provided to the filter assembly 7 . [0082] The liquid inlet 6 is preferably sealed by the inner sealing means respectively the inner sealing membrane 9 b sealed to the filter assembly 7 . The inlet 6 may however also be sealed by means of a piercable material respectively sealing means integrally formed with the filter assembly 7 , such as e.g. plastic material designed to be pierced by on outlet probe 11 of the liquid dispensing means 20 . [0083] The filter cap 1 further comprises outlet means 8 which enable the ejection of liquid and/or air from a container 3 (see FIG. 1 b ) connected to the filter cap 1 to the exterior of the filter cap 1 . [0084] The outlet means 8 may be constituted by at least a portion of the opening 10 formed in the body portion 17 of the filter cap 1 . [0085] According to the embodiment of FIGS. 1 a and 1 b , the opening 10 in the body portion 17 is not fully covered respectively closed-off by means of the filter assembly 7 and thus, during the injection of the liquid to the interior of a connected container 3 , air may be removed from the container 3 . For this purpose, the inner sealing means respectively sealing membrane 9 b preferably comprises a gas-liquid equilibrium means such as a venting opening 15 which allows the removal of internal gas from the container 3 as liquid is filled in the container through the liquid inlet and after the outer sealing means 9 a have been removed from the filter cap 1 . [0086] As an alternative, the filter assembly 7 may comprise integrally formed gas-liquid equilibrium means (such as described later in conjunction with the mode of FIG. 2 ) such as for example a venting opening. Said integrally formed venting opening may be sealed by the provided sealing means 9 a . Thereby, the venting opening may be opened by a user, e.g. by removing the sealing means 9 a or by dedicated opening means provided at a liquid dispensing means 20 . [0087] The filter cap 1 further comprises connection means such as an adaptor 2 which are designed to enable a connection of the filter cap 1 to a dedicated liquid dispensing means 20 or an additionally provided cap connector 25 , 25 a (as apparent in FIG. 4 ). The connection means 2 may be at least one protrusion and/or recession formed in the filter cap 1 . For example, the connection may be a bayonet-type connection or a thread. [0088] FIG. 1 b shows a sectional side view of the embodiment according to FIG. 1 a , wherein the filter cap 1 is connected to a feeding container 3 such as a feeding bottle. [0089] The container 3 has an opening 3 a in fluid connection with the opening 10 of the filter cap 1 and encloses a predefined portion of powdered or concentrated nutritional formula base 5 that has been provided by a user before assembling the filter cap 1 onto the feeding container or bottle 3 . Alternatively, the filter cap is assembled to a feeding container filled with a dose of powdered or concentrated nutritional formula base at a manufacturing site. [0090] The connection means 13 for connecting the filter cap 1 with the container 3 is preferably a protruding skirt comprising an inner standard screw threat suitable for connecting to common feeding bottles such as standard baby bottles. The connection means 13 could as well be of special design to be assembled only to matching connection means of non-standard feeding bottles. [0091] The connection means 13 may as well be adaptable such as e.g. an adaptable clamping means designed for being connected to different containers 3 respectively bottles of variable neck portions. [0092] FIG. 2 shows a sectional side view of another embodiment of the filter cap 1 according to the invention. Thereby, the filter assembly 7 fully covers the opening 10 provided in the body portion 17 of the filter cap 1 . [0093] The filter assembly 7 according to said embodiment comprises an integrally formed gas-liquid equilibrium means 8 a , such as for example a vent or air outlet channel or a valve, in order to allow gas to exit the container 3 during filling of the container with liquid provided from water dispensing means 20 when connected to the liquid inlet 6 . Therefore, the inner membrane 9 b comprises a venting aperture 15 which connects the gas-liquid equilibrium means 8 a of the filter assembly to the exterior of the filter cap 1 . It is to be noted that FIG. 2 refers to a state of the filter cap 1 , wherein the outer membrane or cap 9 a has already been removed by the user. Thereby, the inner membrane 9 b may comprise a protruding lip or tab 15 a in order to facilitate removal of the inner membrane 9 b from the filter cap 1 . The inner membrane 9 b is perforable by a probe of the water dispensing means through the liquid inlet 6 . [0094] FIG. 3 shows a schematic drawing of the dispensing system according to the present invention comprising liquid dispensing means 20 and a filter cap 1 with a feeding container 3 connected thereto. The liquid dispensing means 20 preferably comprise a water reservoir 30 , a pump 40 and a heater 50 suitable for heating the liquid provided by means of the liquid supply in a continuous flow. [0095] The liquid dispensing means 20 preferably further comprise connection means 20 a designed for connecting the adaptor 2 of the filter cap 1 . [0096] Moreover, the liquid dispensing means 20 comprise an outlet probe 11 which is designed to connect to the inlet 6 of the filter assembly 7 of the bottle 1 . [0097] In addition, the liquid dispensing means 20 may further comprise opening means 22 which are designed to tear or perforate the sealing membrane 9 a . Thereby, the opening means 22 may be arranged to open the membrane 9 a in order to allow venting of the container 3 during liquid injection thereof. Moreover, the opening means 22 may be integrally formed with the outlet probe 11 . The outlet probe 11 and/or the opening means 22 are preferably movable relative to the connection means 20 a of the dispensing means 20 . For example, the probe 11 and opening means 22 can be moved in a coordinated manner to provide each opening at the same time or sequentially. [0098] After opening of the membrane 9 a by means of the outlet probe 11 and/or the opening means 22 , liquid may be injected into the filter cap 1 and thus, into container 3 . Thereby, a user may control the amount of liquid provided into the container 3 e.g. by means of a dedicated control means (not shown) connected at least to the pump 40 of the water dispensing means 20 . A dedicated control means suitable to provide a proper amount of water in the bottle may use a flow meter and a control unit as known per se. [0099] FIG. 4 relates to another preferred embodiment according to the present invention, wherein the system further comprises a cap connector 25 which is designed to act as an interface between the water dispensing means 20 and the filter cap 1 . Thereby, the cap connector 25 preferably comprises connecting means 25 a for connecting to the adaptor 2 of the filter cap 1 , as well as connecting means 25 b being designed to connect the cap connection to the water dispensing means 20 . [0100] The cap connector 25 may comprise an integrally formed liquid path 25 c connecting an inlet adapter 25 d at an inlet portion of the cap connector to an outlet probe 25 e at an outlet portion thereof. Thereby, the inlet adapter 25 d is designed to be connected to the outlet probe 11 . The outlet probe 25 e is designed to be connected to the inlet means 6 of the filter cap 1 . [0101] FIG. 5 a relates to the filter cap 1 being at least partially opened by removing the first membrane or cap 9 a sealed to the outer portion of the second sealing membrane 9 b and/or the body portion 17 of the filter cap 1 . Thereby, an outlet aperture 15 or valve which is preferably provided within the membrane 9 b is laid open. [0102] The liquid inlet 6 is preferably still covered by the inner membrane 9 b and is opened upon contact with the outlet probe 11 of the dispensing means 20 . [0103] After the injection of liquid into the container 3 by means of the outlet probe 11 being connected to the filter assembly 7 , the filter assembly 7 may be removed from the filter cap 1 by tearing the second membrane 9 b as shown in FIG. 5 b (see arrow A). Thereby, the sealing between the second membrane 9 b and an outer circumferential portion 27 of the body portion 17 is weaker than the sealing connection between the second sealing membrane 9 b and the filter assembly 7 . [0104] By removing the filter assembly 7 , a liquid outlet 8 b of increased cross-sectional area is provided which enables to facilitate the removal of the complete liquid nutritional composition 5 a from the container 3 . [0105] Before the withdrawal of the nutritional composition 5 a , a feeding means such as a nipple or teat assembly 14 may be provided to the filter cap 1 . As can be seen in FIG. 5 c , the teat assembly 4 may be connected for example by means of a dedicated connection means such as a cap nut 32 which interacts with the provided screw thread 16 at the circumference of the body portion 17 or another connection means. [0106] The teat assembly 14 may as well be specifically designed to match the screw thread respectively connection means 16 and/or an outer portion of the body portion 17 . [0107] FIG. 6 a relates to another preferred embodiment of the filter cap 1 according to the invention, wherein the filter cap 1 comprises feeding means 14 a. [0108] The filter cap 1 further comprises a disposable cap portion 19 which is connected to the body portion 17 of the filter cap 1 . Thereby, the disposable cap portion 19 forms preferably a sealing collar connected to an annular portion 17 c of the body portion 17 . The disposable portion 19 is preferably secured to the body portion 17 , e.g. by means of a removable latch member 19 a. [0109] The filter assembly 7 is preferably fixedly connected to the disposable cap portion 19 which holds the filter assembly 7 in position above the feeding means 14 a by means of integrally formed reinforcement structure 12 a. [0110] The feeding means 14 a is preferably a nipple or teat assembly which is connected to an inner annular surface 17 d of the body portion 17 , thereby preferably fully closing-off the opening 10 extending from a first side 17 a to a second side 17 b of the body portion 17 . [0111] The integrally formed feeding means 14 a are preferably in a compressed respectively retracted state when the disposable cap portion 19 is connected to the body portion 17 . Thereby, the disposable cap portion 19 preferably at least partially covers the opening 10 on the first side 17 a of the body portion 17 in order to hold the feeding means 14 a in a retracted state as shown in FIG. 6 a. [0112] The feeding means 14 a preferably constitute the outlet means of the filter cap 1 when the filter cap 1 is connected to a container or bottle 3 . Thereby, the feeding means 14 a comprise an outlet 8 c providing an additional outlet flow path from the opening 10 to the exterior of the filter cap 1 when liquid, e.g., nutritional composition, is dispensed from a connected container 3 . [0113] The outlet 8 c preferably serves as a venting means in order to enable gas present in the container to exit the container 3 during provision of liquid thereto by means of the filter cap 1 . [0114] The flow path from the inlet means 6 to the opening 10 which is used to fill the container 3 with liquid, in particular water, connected to the opening 10 is preferably arranged in parallel to the additional outlet flow path between the opening 10 and the outlet 8 c which is used to deliver the liquid nutritional composition. [0115] Thereby, the disposable cap portion 19 preferably comprises an integrally formed liquid channel 6 b which is connected to the filter assembly 7 allowing flow communication between the inlet 6 and the opening 10 of the body portion 17 in order to constitute an inlet flow path for feeding liquid into the container 3 . [0116] The filter cap 1 further comprises a resealable means 23 of the liquid channel 6 b. [0117] The resealable means 23 is preferably formed by a tubular portion of the cap portion 19 holding open a resealable portion made of elastically deformable material comprising an aperture. In particular, the aperture of the resealable portion is held open by the tubular portion when the portion is inserted into the aperture and the aperture closes-off when the tubular portion is removed from the aperture such as when the cap portion 19 is removed from the body portion 17 of the cap. Thereby, the resealable portion 23 is preferably integrally formed with the feeding assembly respectively teat 14 a connected to the body portion 17 . The resealable portion may be formed on the border of the teat with the aperture traversing the border. The teat 14 a can, for instance, be formed of moulded silicone, elastomer or resilient and soft plastic. [0118] FIG. 6 b shows the embodiment of the filter cap 1 according to FIG. 6 a in a state connected to a container respectively bottle 3 by means of the connection means 13 , wherein the bottle 3 is filled with a desired amount of nutritional formula base 5 and which may be designed expandable and/or retractable. Accordingly, the volume of the container 3 enclosed by an outer wall 30 of the bottle 3 is designed to be variable. [0119] The bottle 3 may comprise an expandable and/or retractable portion 31 integrally formed with the outer wall 30 . The expandable and/or retractable portion 31 may be a concertina-like structure having a plurality of recesses and/or protrusions arranged about the circumference of the container 3 . [0120] The bottle 3 may be stored in its retracted state as shown in FIG. 7 a . Thereby, the concertina-like portion 31 of the outer wall 30 is folded together in order to occupy a minimum storing space, but at the same time provides a sufficient volume for enabling the user to provide an amount of powdered or concentrated nutritional formula base 5 within the bottle 3 , sufficient to prepare the nutritional formula 5 a by injection of liquid into the filter cap 1 . [0121] The concertina-like portion 31 of the bottle 3 may then be expanded as shown in FIG. 7 b either manually or by the liquid filling the bottle 3 during liquid provision to the filter cap 1 . [0122] After the provision of liquid into the bottle 3 , the disposable portion 19 is removed from the body portion 17 by pulling the securing latch member 19 a. [0123] The teat assembly 14 a that is preferably arranged within the filter cap 1 in a retracted state may then be brought into an extended state manually, e.g. by squeezing the bottle 3 (see FIG. 7 c ). [0124] Instead of a bottle 3 having an expandable and/or retractable portion 31 , the system according to the present invention may as well comprise a expendable preform or a flexible, folded pouch that has a rigid rim portion to which the connection means 13 of the filter cap 1 may be connected. Thereby, the preform or pouch may be designed to automatically expand, respectively inflate or unfold during provision of liquid thereto by means of the filter cap 1 . [0125] FIGS. 8 a and 8 b show the embodiment of the filter cap 1 according to FIGS. 6 a and 6 b , wherein the filter cap 1 is connected to a cap connector 26 that is designed for connecting the filter cap 1 to the dispensing means 20 and in particular to a dispensing head 30 a of the dispensing means 20 as also shown in FIGS. 9 a - 9 c. [0126] The cap connector 26 preferably comprises a connecting portion 31 that connects to the adaptor 2 provided at a circumferential portion of the filter cap 1 . Thereby, the connecting portion 31 may be at least one guiding rail which interacts with the recessed or protruding adaptor 2 of the filter cap 1 (see FIG. 9 c , arrow C). [0127] The connecting portion 31 may as well be designed as a snap-fit connection connecting to the adaptor 2 upon insertion of the filter cap 1 and/or turning of the filter cap 1 about a vertical axis thereof. [0128] The cap connector 26 is preferably designed to be selectively connected to a receiving recess 34 of the dispensing head 30 a (see FIGS. 9 a and 9 b , arrow B). Thereby, the cap connector 26 may as well comprise an aperture 31 a for holding a cartridge or capsule containing a predefined amount of infant formula base, which is designed to receive the capsule when inserted from above in said aperture 31 a (see FIGS. 9 a - 9 c ). [0129] The cap connector 26 preferably comprises integrally formed interface means 33 which are arranged to provide a signal transfer from the dispensing means 20 , to which the cap connector 26 is intended to be connected, to the filter cap 1 or vice versa. Thereby, the interface means 33 may be any means enabling the transfer of an optical, electrical and/or acoustical signal between the dispensing means [0130] Preferably, the interface means 33 is a mirror arranged at the cap connector 26 such as to transfer or redirect a signal 35 from the dispensing means 20 towards an outer portion of the filter cap 1 . Thereby, the signal may be e.g. an optical signal 35 from a barcode reader 36 that is transferred by the interface means 33 of the cap connector 26 to a peripheral outer surface 19 b of the disposable portion 19 of the filter cap 1 onto which a barcode 37 may be provided. [0131] It is to be understood that by means of the signal transferred from the filter cap 1 to the dispensing means 20 or vice versa, a dedicated control unit (not shown) of the dispensing means 20 may adjust the injection parameters such as the temperature, the flow rate and the amount of the liquid to be injected into the container or bottle 3 connected to the filter cap 1 . [0132] Although the present invention has been described with reference to preferred embodiments thereof, many modifications and alternations may be made by a person having ordinary skill in the art without departing from the scope of this invention which is defined by the appended claims.

The invention relates to a filter cap ( 1) for filtering liquid and dispensing an aqueous nutritional composition to a human, the filter cap ( 1) comprising a liquid inlet means ( 6) designed to be supplied with liquid from external liquid dispensing means ( 20), an adaptor ( 2) for connecting the filter cap ( 1) to the liquid dispensing means ( 20), connection means ( 2) designed for selectively connecting an opening ( 10) of the filter cap ( 1) to a container ( 3) designed to hold a powdered or concentrated liquid nutritional formula base ( 5) for the preparation of the nutritional composition ( 5 a) upon hydration with the supplied liquid, and a filter assembly ( 7) in the flow path of the liquid from the inlet means ( 6) to the opening ( 10), the filter assembly ( 7) being configured to remove contaminants from liquid fed into the container through the inlet means ( 6).

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the field of apparatus for ophthalmic surgery. More particularly, the present invention relates to the field of apparatus for cataract surgery. 2. Description of the Related Art With today's modem cataract surgery, it is routinely necessary to incise the anterior lens capsule of the crystalline lens of an eye to provide an opening on the anterior lens capsule so that the cataractous opaque lens can be removed. However, the anterior lens capsule of the eye is shielded by the corneal tissue. Therefore, before any cataract surgical apparatus can reach the anterior lens capsule of the eye, a passage wound has to be cut in the corneal tissue. The following prior art patents are found to be related to the field of surgical apparatus used in cataract surgeries: 1. U.S. Pat. No. 4,959,070 issued to McDonald on Sep. 25, 1990 for "Intraocular Lens Implantation" (hereafter referred to as the "McDonald Patent"). 2. U.S. Pat. No. 4,844,065 issued to Faulkner on Jul. 4, 1989 for "Intraocular Lens Inserting Tool and Methods" (hereafter referred to as the "/Faulkner Patent"). 3. U.S. Pat. No. 4,785,810 issued to Baccala et al. on Nov. 22, 1988 for "Intraocular Lens Folding And Insertion Apparatus" (hereafter referred to as the "Baccala Patent"). 4. U.S. Pat. No. 4,766,897 issued to Smirmaul on Aug. 30, 1988 for "Cataract Surgical Instrument" (hereafter referred to as the "Smirmaul Patent"). 5. U.S. Pat. No. 5,135,530 issued to Lehmer on Aug. 4, 1992 for "Anterior Capsular Punch with Deformable cutting Member" (hereafter referred to as the "Lehmer Patent"). In the above five prior art patents, three of them, the Baccala Patent, the Faulkner Patent and the McDonald Patent, are not anterior lens capsule incising apparatus, but rather intraocular lens implanting apparatus. An anterior lens capsule incising apparatus is used in cataract surgery for cutting an incision on the anterior lens capsule of an eye, so that the natural lens of the eye can be removed and an artificial intraocular lens can be implanted therein. Alternatively, an intraocular lens implanting apparatus is used in the cataract surgery for inserting the artificial intraocular lens into the lens capsule of the eye, after the incision is cut on the anterior lens capsule of the eye and the natural crystalline lens of the eye is removed. The apparatuses envisioned by the Baccala Patent, the Faulkner Patent and the McDonald Patent are each more like a forceps apparatus because none of them contain cutting blades for performing the function of cutting the incision on the anterior lens capsule of the eye. The Smirmaul Patent apparatus 10 is an anterior lens capsule incising apparatus. Its forward portion, including the circular lens holder 18, can be inserted through a passage wound cut on the corneoscleral tissue of an eye, and disposed above the anterior lens capsule of the eye, so that its rotatable cutting blade 20 can cut a circular incision on the anterior lens capsule. The Smirmaul Patent incising apparatus 10 requires a wide passage wound cut on the corneoscleral tissue. The diameter of the rotatable circular cutting blade 20 of the Smirmaul Patent incising apparatus 10 is about six millimeters (6 mm) (Column 3, line 23), which is the necessary size for cutting an adequate incision on the anterior lens capsule for further surgeries. Therefore the overall diameter of the circular blade holder is at least above seven millimeters (7 mm). This requires that the width of the passage wound cut on the corneoscleral tissue to be not less than seven millimeters (7 mm), which is wide by eye surgery standards. It is desirable to have the width of the passage wound cut on the corneoscleral tissue as narrow as possible, since a wider wound requires more surgical closing procedures and increases the period of convalescence. The Lehmer Patent discloses an annular capsular punch with a deformable cutting member. A cutting member 130 is elliptical when inserted through an incision 16 on the corneoscleral tissue of the eye. Once the cutting instrument 130 is in the anterior chamber of the eye, it is allowed to expand a circular shape and then pressed against the anterior lens capsule of the eye. According to the Lehmer patent, the circular shape would have a circular cutting blade having a diameter of not less than five millimeters (5 mm). Additionally, the preferable anterior lens capsule incising apparatus should be able to pass through a narrow corneoscleral tissue wound having a width of not more than four millimeters (4 mm). This deformable circular cutting ting is provided between the two forward portions of two elongated arms. The two elongated arms crisscross each other and are hinged together at the crisscross joint. The rearward portion of the two arms are spring biased to keep the forward portion of the two arms spaced apart, such that the deformable circular cutting ring is in its original circular shape. When the rearward portions of the two arms are squeezed toward each other, the forward portions of the two arms will move toward each other to compress the deformable circular cutting ring into a narrow elliptical shape. The overall width of the narrow elliptical shaped deformable circular cutting ring and the forward portions of the two elongated arms become less than four millimeters (4 mm), so that the narrow elliptical shaped deformed cutting ting and the forward portions of the two elongated arms can be inserted into the anterior chamber of the eye through a narrow corneoscleral tissue wound of about four millimeters (4 mm) in width. The crisscross joint of the two elongated arms is located at or adjacent to the corneoscleral tissue wound. Once inside the anterior chamber of the eye, the rearward portions of the two arms are released, so that the forward portions of the two arms can move away from each other to allow the deformable circular cutting ring return to its original circular shape. Then the full size circular cutting ring is pressed onto the anterior lens capsule to cut an adequate sized circular incision, so the natural crystalline lens of the eye can be removed, and an artificial intraocular lens can be implanted therein. The deformable circular cutting ring is taken out of the anterior chamber through the narrow wound on the corneoscleral tissue by again compressing it into a narrow elliptical shape. Also, a locking mechanism is to be provided to the anterior lens capsule incising apparatus for preventing the deformable cutting ring from rotating about its axis, so that the cataract surgeon can control the exact orientation of the deformable cutting ring and the cutting edge of the deformable cutting ring is evenly applied on the anterior lens capsule. It is desirable to provide a reliable tool for performing capsulorrhexis through a small incision cataract without the unpredictability, inconsistency and unreliability of capsulorrhexis performed with a cystatome and/or capsulorrhexis forceps and which operates in a manner different from conventional teachings of tools for carrying out a capsulorrhexis. SUMMARY OF THE INVENTION One aspect of the present invention resides in a capsulorrhexis instrument that is retractable within a tube and extendable into a position projecting out of the tube. The instrument comprises a flexible band having a razor sharp cutting edge which is fixed to a plunger and located within an inserter tube. While in its retracted position within the inserter tube, the flexible band assumes an elliptical or oblong shape. However, when the flexible band is in its extended position outside of the inserter tube such as inside the eye, it deforms into a circular shape whose cutting edge is sufficiently sharp to cut corneal tissue in response to pressure being applied to the corneal tissue by the cutting edge. The dimension to which the flexible band expands to reach the circular shape upon becoming clear of the inserter tube is larger than a cross-section of the gap defined by the inserter tube through which the flexible band travels in its elliptical or oblong shape. BRIEF DESCRIPTION OF THE DRAWINGS For a better understanding of the present invention, reference is made to the following description and accompanying drawings, while the scope of the invention is set forth in the appended claims. FIG. 1 is a schematic representation of a capsulorrhexis instrument in accordance with the invention with its band in a retracted position. FIG. 2 is a schematic representation of the instrument of FIG. 1 except with its band in an extended position. FIGS. 3-5 are progressive schematic representations of the capsulorrhexis instrument of FIGS. 1-2 in use showing the flexible band in, respectively, the retracted position, the extended position and the retracted position after cutting. FIG. 6 is a perspective view of the flexible band with dye. FIG. 7 is a schematic elevational view of a further embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENT FIGS. 1 and 2 show an introducer tube 10, a plunger housing 12, and plunger 14, and a spring 16 that biases the head disc 18 within the plunger housing 12. A stem 20 extends from the head disc 18 and a flexible band 22 is connected to the free end of the stem 20. The operation of the plunger within the plunger housing is in accord with conventional teachings in other arts. The flexible band, however, changes from an elliptical or oblong configuration when residing within the introducer tube in the fully retracted position of FIG. 1 to a circular configuration while emerging free of the introducer tube to reach the fully extended position of FIG. 2. The flexible band 22 is normally in the circular condition while in an uncompressed state, but resiliently flexes into the elliptical or oblong condition when squeezed into the introducer tube that has a smaller cross-section. The flexible band may be constructed of metal or any other material with at least one razor sharp edge 24 as identified in FIG. 6. Preferably, the other edge is smooth. The plunger may be plastic or metal construction. The plunger housing 12 serves as a handle for a surgeon to hold onto. The inserter tube may have an inner diameter of 11/2-3 mm and the flexible band in its circular configuration may have a 4-8 mm inner diameter. Before an incision 30 can be cut on the anterior lens capsule 32 of an eye for removing the natural crystalline lens of the eye and implanting an artificial intraocular lens therein, a small wound 34 must be cut on the corneoscleral tissue 36 of the eye to gain access to the anterior chamber of the eye, which anterior chamber is shown in FIGS. 3 through 5 by the space between the anterior lens capsule 32 and the corneoscleral tissue 36. It is preferable to have a small and narrow corneoscleral wound 34, preferably not more than three millimeters (3 mm) in width. However, the size of the anterior capsular incision 30 should be no less than five millimeters (5 mm). The present invention solves this problem by utilizing the deformable flexible band 22 with a sharp edge 24. In addition, a viscoelastic material, such as Healon™, Amvisc™, Viscoat™ or Vitrax™, must be injected to fully expand the anterior lens chamber prior to use of the capsulorrhexis instrument, as is done conventionally. Such chamber expansion is needed before the surgery can be performed to avoid tissue damage as the flexible band is inserted into position for cutting. To insert the flexible band 22 into the anterior chamber of the eye, the flexible band 22 is initially retracted within the introducer tube 10 as the distal end of the introducer tube is inserted through the narrow corneoscleral wound 34. Thereafter, the plunger 14 is forced against spring bias to force the flexible band 22 out of the introducer tube 10 and into the anterior chamber of the eye but clear of the narrow corneoscleral wound 34. Once so free, the flexible band 22 resiliently flexes from the elliptical shape to return to its original circular shape. As the deformable flexible band 22, now circular in shape, is accurately located above the anterior lens capsule 32 of the eye, a force is applied on the flexible band 22 directed perpendicular to the insertion direction via the stem 20 to cut the incision 30 to have an adequate size, typically about five millimeters (5 mm) in diameter. This cutting process is done while keeping the distal end of the introducer tube 10 at or adjacent the narrow corneoscleral wound 34, so that further swings of the introducer tube will not require a wider wound. To effect the cutting, the surgeon presses on the anterior lens capsule, thereby providing the force through anterior lens capsule that is necessary for the sharp edge to cut. If desired, a non-toxic dye 35 such as fluorescein may be applied to the sharp edge 24 to serve as a marker for the surgeon as to where the cut was made (see FIG. 6). Thus, as the sharp edge comes into contact with tissue to effect cutting, the dye comes off and onto the tissue, thereby leaving a visual imprint along the boundary of incision 30 (see FIG. 5). After the incision 30 is made, the plunger 14 is released (e.g., via spring bias) into the introducer tube 10 so as to form the flexible band 22 by compressing the flexible band 22 into the narrow elliptical shape. Once the plunger is fully retracted, the introducer tube 10 can be withdrawn from the anterior chamber through the narrow corneoscleral wound 34. The flexible band 22 and introducer tube 10 are intended to be disposable as a single use item. An advantage of the present invention lies in that the introducer tube may have a width of as small as 11/2 mm, easily fitting within incisions as small as 2.5 mm. In the past, incisions were typically in the order of 4 mm, which gave extra room to accommodate capsulorrhexis instruments of larger dimensions. However, with incisions as small as 2.5. mm, the need for smaller dimensioned capsulorrhexis instruments is apparent, particular when one considers that incisions in the future will be still smaller in size. The configuration of the capsulorrhexis instrument may be curved to accommodate performing cataract surgery from above the forehead of the patient where it may be difficult to circumvent the brow of the patient. If the cataract surgery is performed from the side of the eye of the patient, then no such curvature is needed. There are various embodiments to aid the surgeon in knowing when the flexible band has reached its fully extended state or has been withdrawn into its fully retracted state. In all cases, full retraction would be from visual observation. One embodiment employs a locking mechanism that locks the flexible band in the extended position as the plunger is pushed to an intermediate position (closer to the fully extended position) such as 95% of the way and that unlocks the flexible band from that extended position as the plunger is pushed the rest of the way to the fully extended position, such as the remaining 5%. This simulates the locking mechanism of a ballpoint pen by allowing the flexible band to alternate between the fully extended and fully retracted states. Starting from the fully retracted position, the plunger is pushed as far as possible until further movement is blocked at a blocking position by the mechanism and is then released. The release allows the spring bias to force the plunger into the 95% position where the flexible band is fully expanded, thereby positioning the band for cutting. When done cutting, the plunger is again pushed as far as possible until blocked, but this time release causes the spring bias to force the plunger all the way back to the fully retracted position. Such continues in an alternating manner as much as desired as in actuation of a ballpoint pen. Another embodiment dispenses with the locking mechanism, but the plunger is blocked upon reaching full extension and this blocking is felt as a noticeable increase in resistance to pushing of the plunger. In this manner, the surgeon comes to realize that the flexible band has reached its fully expanded state. Thus, the procedure followed by the surgeon is making an incision in the eye, placing the introducer tube at or into the incision, pushing the plunger until the flexible band has emerged from the introducer tube into its fully expanded state, feeling the resistance to further movement in the direction of pushing, engaging the anterior lens capsule and pressing the same to cut tissue with the sharp edge of the flexible band, releasing the plunger to retract the flexible band back into the introducer tube, and removing the introducer tube from the eye. Still another embodiment locks or dicks when the flexible band clears the edge of the introducer tube and a further embodiment that locks in after the plunger stem extends several millimeters into the eye to space the flexible band from the introducer tube to allow for more maneuvering of the expanded band if the surgeon wished to place the cut in a more posterior or lateral or medial position. However, for most surgeries where the incision is 2.5 mm, allowing the locking or clicking to arise as the flexible band expands at the edge of the introducer tube provides plenty of maneuverability without opening the incision further provided the introducer tube has a width of at most 2 mm. Where the eye is particularly deep-set, however, additional maneuverability may be needed so it would be more advantageous to keep the inserter tube outside the incision and pen the band further inside the eye by a few millimeters with a longer and curved plunger stem such a curved stem as shown in FIG. 7 allows better access to the eye where the surgery is to be conducted from above the forehead as opposed to the side. To prevent the possibility of the expanded flexible band springing back inadvertently into the introducer tube while the introducer tube is outside the incision, a spring release mechanism would need to be actuated by the surgeon to release the spring. While the preferred embodiment employs a spring bias to retract the flexible band into the inserter tube, the spring bias could instead be opposite to push the flexible band out of the inserter tube. Also, the spring could be dispensed with altogether, but such would require greater dexterity on the part of the surgeon to steady the inserter tube in its relative position to the eye as the flexible band is either pulled into the inserter tube or forced out. The inserter tube may be of uniform dimension along its full length, such as having an inner diameter of about 2 mm. The inserter tube need not be narrower at its distal end through which the flexible band emerges or retracts. If a spring is to be used, however, an inwardly directed projection about the inner periphery at an intermediate location of the inserter tube is needed to provide the spring with a surface against which it may compress. Of course, a wider proximal end is more advantageous for grasping purposes. While the foregoing description and drawings represent the preferred embodiments of the present invention, it will be understood that various changes and modifications may be made without departing from the spirit and scope of the present invention.

A capsulorrhexis instrument that is retractable within a tube and extendable into a position projecting out of the tube. The instrument comprises a flexible band having a razor sharp cutting edge which is fixed to a plunger and located within an inserter tube. While in its retracted position within the inserter tube, the flexible band assumes an elliptical or oblong shape. However, when the flexible band is in its extended position outside of the inserter tube such as inside the eye, it expands into a circular shape whose cutting edge is sufficiently sharp to cut lens capsular tissue in response to pressure being applied to the lens capsular tissue by the cutting edge. The dimension to which the flexible band expands to reach the circular shape upon becoming clear of the inserter tube is larger than a cross-section of the gap defined by the inserter tube through which the flexible band travels in its elliptical or oblong shape.

CROSS REFERENCE TO RELATED APPLICATIONS This application claims benefit under 35 U.S.C. §119(e) of U.S. provisional application No. 60/072,084, filed Jan. 21, 1998, now abandoned. BACKGROUND OF THE INVENTION (a) Field of the Invention The invention relates to a continuous process for the denaturation of proteins using dynamic high-pressure homogenization (HPH). (b) Description of Prior Art Whey proteins have been extensively studied for their structure and functional properties. Most of researchers have shown that whey proteins undergo denaturation when heat-treated at temperatures exceeding 60° C. (De Wit et al., 1988, IDF Symposium Quebec, Canada, 129-148). Recently, denaturation, aggregation and gelation processes of whey proteins have been described in three steps. The first step involves the unfolding of molecules followed by a second step which is related to the aggregation process of partially unfolded whey proteins. The last step involves the polymerization of the protein network which leads to gelation. The use of high hydrostatic pressures on whey protein solutions have been reported to initiate protein-unfolding and result in gelation of protein solutions without heat-treatments (Hayakawa et al., 1992, J. Food Sci., 57:288-292; Johnston et al., 1992, Milchwissenchaft, 47:760-763). In these cases, the pressure caused a volume reduction in the solution which led to a reorganization of hydrogen bonds and hydrophobic interactions (Hoover et al., 1989, Food Technol., 43:99-107). High-shear forces have also been shown to affect protein denaturation, as demonstrated by studies on denaturation of protein solutions by extrusion (shear forces) (Rha and Pradipasena, 1977, J. Texture Stud., 8:339; Ker and Toledo, 1992, J. Food Sci., 57:82-89; Taylor and Fryer, 1994, Food Hydrocolloids, 8:45-61). These results show that both high pressure (static) and shear forces can modify proteins by partial denaturation. However, these studies did not demonstrate that the use of both high pressures and shear forces together have a specific effect on the proteins. Also, static high pressure is limited because it is done in a batch system and not in a continuous process. To date, there has not been shown a continuous process for the denaturation of proteins using dynamic high-pressure homogenization (HPH). It would be highly desirable to be provided with partial or total denaturation of proteins using a continuous process consisting in a combination of shear forces cavitation and turbulences at high pressures with a very short heat treatment (milliseconds) in the reaction chambers of a high-pressure homogenization (HPH) equipment. SUMMARY OF THE INVENTION One aim of the present invention is to provide a continuous process for the denaturation of proteins using dynamic high-pressure homogenization (HPH). Another aim of the present invention is to provide partial or total denaturation of proteins using a continuous process consisting in a combination of shear forces cavitation and turbulences at high pressures with a very short heat treatment (milliseconds) in the reaction chambers of a high-pressure homogenization (HPH) equipment. The process of the present invention is used on food proteins to produce partial or total denaturation of proteins. The proteins are modified by the effect of dynamic high-pressure and possess different functional properties, such as solubility, emulsification, foaming or gelation, which in turn affect their use in food products (mayonnaise, salad dressing, meat emulsion, foam and mousse, among others). In accordance with the present invention there is provided a continuous process for denaturation of proteins, which comprises the steps of: a) subjecting a protein solution to a high pressure homogenizer at a pressure of about 500 to about 5000 bar, at a recirculation ranging from 0 to about 50 and at a temperature ranging from about 20° C. to about 80° C. for a period of time from about 1 milliseconds to about 10 minutes, wherein the protein solution consisting of a protein fraction dispersed in water, buffer or salt solution at a concentration ranging from about 2% to about 35% w/w and at a pH adjusted between about 2.0 to about 12.0; b) concentrating the protein solution by i) evaporation, ii) ultrafiltration and sprayed dried or iii) ultrafiltration and freeze dried. The denaturation may be partial or total. The protein fraction may be selected from the group consisting of egg, milk, and vegetable. The preferred milk protein is whey protein. The protein may be a protein concentrate at a concentration about 35% to about 99%. The whey protein is a whey concentrate or a whey isolate. The whey protein is at a concentration about 35% to about 99%. The preferred pH ranges between 6.0 to about 7.0 and the preferred protein fraction is at a concentration of about 5% to about 14%. The preferred pressure is more than 1500 bar, the temperature is 22° C. or 55° C. and the preferred recirculation is ranging from 1 to 5. In accordance with the present invention there is provided a food protein composition, which comprises partially or totally denatured protein with enhanced viscosity and gel firmness properties, with higher solubility, wherein the protein is obtained by the process of the present invention. For the purpose of the present invention the following terms are defined below. The term “high homogenization pressure” is intended to mean a pressure between about 500 to about 5000 bar, with a preferred pressure of about 3 kbar. The preferred protein used in accordance with the process of the present invention is whey protein. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates the evaluation of turbidity by transmittance at λ=700 nm; FIG. 2 illustrates emulsion made with WPI control at a magnification of 100×; FIG. 3 illustrates emulsion made with WPI Avestin ceramic 1 p/55° C. at a magnification of 100×; FIG. 4 illustrates emulsion made with WPC control at a magnification of 100×; FIG. 5 illustrates emulsion made with WPC Avestin ceramic 1 p/55° C. at a magnification of 100×; FIG. 6 illustrates effect of WPI treated by HPH on the hardness of gels; FIG. 7 illustrates effect of WPC treated by HPH on the hardness of gels; FIG. 8 illustrates Evolution of the viscosity of cheese sauces made with 1.62% of WPI at a shear rate of 1.0 s −1 ; FIG. 9 illustrates Evolution of the viscosity of cheese sauces made with 1.00% of WPI at a shear rate of 1.0 s −1 ; FIG. 10 illustrates the development of elastic modulus with increasing frequency oscillation of cheese sauces made with 1.62% of WPI; FIG. 11 illustrates the development of elastic modulus with increasing frequency oscillation of cheese sauces made with 1.00% of WPI; FIG. 12 illustrates the development of viscous modulus with increasing frequency oscillation of cheese sauces made with 1.62% of WPI; FIG. 13 illustrates the development of viscous modulus with increasing frequency oscillation of cheese sauces made with 1.00% of WPI; FIG. 14 illustrates values of phase angle as a function of frequency of oscillation for cheese sauces made with 1.62% of WPI; FIG. 15 illustrates values of phase angle as a function of frequency of oscillation for cheese sauces made with 1.00% of WPI; FIG. 16 illustrates dynamic viscosity with increasing frequency of oscillation for cheese sauces made with 1.62% of WPI; and FIG. 17 illustrates dynamic viscosity with increasing frequency of oscillation for cheese sauces made with 1.00% of WPI. DETAILED DESCRIPTION OF THE INVENTION In accordance with the present invention, there is provided the denaturation of proteins using dynamic high pressure. Food protein, such as whey protein, dispersed at a concentration of about 2 to about 35% is treated by a high pressure homogenizer with a pressure of about 500 to about 5000 bar and of 0 to about 50 recirculations. Equipments which may be used in accordance with the present invention include, without limitation, Emulsiflex™ or Microfluidization equipments (sold by Avestin Canada, Microfluidic Booter). The treatment is carried out at a temperature ranging from about 20° C. to about 80° C. and at a pH ranging between about 2.0 to 12.0 for a period of time necessary to obtain the partial or total denaturation of proteins, from about 1 milliseconds to about 10 minutes. Finally, the solution is concentrated by evaporation or ultrafiltration and sprayed dried or freeze dried, with such conditions that are not detrimental to the ingredient. The process of the present invention is a continuous process that denatures or modifies food protein and their functional properties. Various food proteins, such as milk, egg or vegetable, can be used. Generally, the invention gives good results with milk proteins, preferably whey proteins. Different whey protein fractions can be used, whey concentrate (35% to 90%) or preferably whey isolate, the latter has shown to give very good results. These protein ingredients are dispersed in water or in buffer or in salt solutions, at a concentration ranging from about 2% to about 35% w/w and adjusted at pH ranging from about 2.0 to about 12.0. Preferably at a pH ranging from about 6.0 to about 7.0 and at a concentration of about 5% to about 14%. The protein solutions are treated by dynamic high pressure homogenizers using pressures ranging from 500 bar to about 5000 bar. Specific equipment is used to reach these high pressures (Collision-impact technology equipment U.S. Pat. No. 4,533,254 and a high pressure homogenizer from Avestin™, Emulsiflex™ C-5 or C-50). In accordance with the process of the present invention, the modification of protein solutions requires the use of a combination of conditions, such as pressures ranging from 500 bar to about 5000 bar, number of recirculations from 0 to 50, temperature ranging between 20° C. to 80° C., and pH ranging from about 2.0 to about 12.0. The preferred pressure is a pressure exceeding 1500 bar, the preferred temperature is 22° C. or 55° C. and the preferred number of recirculation is ranging from 1 to 5. In accordance with the process of the present invention, the dynamic high-pressure treatment affects protein suspensions in two different ways: first, the high pressure (500 to 2000 bar) disperses aggregates or soluble aggregates that are present in the solution; then at higher pressures (2000 to 5000 bar) the molecular structure of protein is affected. Protein denaturation or modification occurs in the reaction chambers, in the order of milliseconds, by a combination of different parameters including shear forces, cavitation, turbulence and a flash-heat treatment. The specific design of the chambers of the high pressure equipment are critical in the process. Two types of equipment have been used to produce the modification. The first one is a Collision-impact technology equipment (U.S. Pat. No. 4,533,254) which has reaction chambers where the liquid is divided into two microchannels in which the solution is subjected to high-shear forces. Finally, the two jet streams of liquid end up in an impact area zone where the two liquids collide at a angle of about 1800, at this level both turbulence forces and cavitation are involved. The chambers of the Avestin™ (Emulsiflex™ C-5 or C-50) equipments differs in their design; it resembles a conventional homogenization flat-bead valve, but a micrometric adjustment of the gap is necessary to reach such high pressures. These valves can also be made of different materials, such as stainless steal or ceramic for a better resistance to such high pressures. There are also different valve designs, such as flat-head or needle shape, that will give different results for specific applications. After the pressure treatment, when the product exits the high pressure zone of the equipment, the solution is cooled down with refrigerated water in order to bring the temperature of the sample back to about 20° C. to 25° C. The solution can be used in the liquid form or then be concentrated by evaporation or by membrane separation (ultrafiltration/microfiltration) in order to increase the total solid content of the solution. Afterwards the sample is spray dried using normal conditions which are inlet temperature of about 200° C. and outlet temperature of about 85° C. Analyses of modified protein powders have shown that under specific conditions either protein aggregation is modified or molecular structure of the protein is affected. For a whey protein isolate solution (14% w/w) microfluidized at 1000 bar for 5 recirculations the transparency of the solution is modified, as shown by measuring transmittance at 700nm. These results show that treated samples are more translucent than the non-treated samples, this suggests that some colloids ore aggregates have been disrupted by the HPH treatment. Heat-treated gels have been produced by heating the solutions at 80° C. for 30 minutes by immersing tubes in a water bath. Measurements of gel properties (deformation) have shown that treated samples produced harder gels than the non-treated samples (FIG. 7 ). At pressures higher than 2000 bar under specific conditions, gelation can be directly produced by high pressure homogenization (no cooling on the chambers), without a subsequent heat treatment. For a whey protein isolate solution at 14% w/w, treated by high pressures of 2068 bar with 15 and/or 20 recirculations at pH 6.0 and 5 recirculations at pH 9.0 gelation can be obtained when the samples are held at 10° C. for 12 hours without a subsequent heat treatment (or 1500 bar/22° C./8 recirculations or 1500 bar/22° C./8 recirculations; Table 4). These gels possess textural characteristics comparable to the heat treated gels. In order to characterized the protein modifications that have occurred in the protein due to the HPH treatment, different analysis of the basic functional properties have been realized. 1.0 STUDY OF WHEY PROTEIN ISOLATE (WPI) AND WHEY PROTEIN CONCENTRATE (WPC) Protein substrates: Whey protein isolate (WPI, 97% Bipro) Whey protein concentrate (WPC 50%) Parameters Evaluated: The reaction chambers: Microfluidizer 110 Y and Avestin C-50 ceramic Number of recirculation: 1 and 5 passes Temperature of homogenization 22° C. and 55° C. Non Variable Parameters: Protein concentration: 14.00% pH of solution: 6.00 Pressure of homogenization: 1500 Bar Functional Properties Analysis: Solubility of protein Turbidity Emulsification Gelation EFFECT OF HEATING ON GEL FORMATION WITH AVESTIN CERAMIC HOMOGENIZER TABLE 1 Experimental Process Temperature Substrates Chambers Passes (° C.) WPI control WPI Microfluidizer 1 22 WPI Microfluidizer 5 22 WPI Microfluidizer 1 55 WPI Microfluidizer 5 55 WPI Ceramic 1 22 WPI Ceramic 5 22 WPI Ceramic 1 55 WPI Ceramic 5 55 WPC control WPC Microfluidizer 1 22 WPC Microfluidizer 5 22 WPC Microfluidizer 1 55 WPC Microfluidizer 5 55 WPC Ceramic 1 22 WPC Ceramic 5 22 WPC Ceramic 1 55 WPC Ceramic 5 55 METHODOLOGY FOR THE EVALUATION OF FUNCTIONAL PROPERTIES Solubility of Protein The protein solubility of WPI and WPC was determined at pH 6.0 and pH 4.6. The pH of a 1% true protein solution was adjusted to 6.0 or to 4.6 and centrifuged at 20,000 g for 15 minutes at 25° C. The protein content of the supernatant was measured by the Kjeldahl method (N×6.38). Soluble protein at pH 6.0 represents all proteins soluble and soluble protein at pH 4.6 represents the native or the non-denatured proteins. Total protein of WPI and WPC was also determined by the Kjeldahl method. The analyses were made in duplicate. Turbidity Solutions of WPI were prepared at a concentration of 14% w/w of protein and the pH was adjusted to 6.0. Degassed Protein solutions were put in a 3 ml polystyrene cuvette. The turbidity of the protein solutions was measured by transmittance at λ=700 nm with the 8451A diode array spectrophotometer. Emulsion Preparation and Determination of Particle Size The aqueous phase of the emulsion consisted of 0.5% protein of WPI or WPC. Corn oil (20%) and aqueous phase (80%) were homogenized together during 1 minute with the Ultra-Turax™ T25 high speed blender. This emulsion was then homogenized using the Emulsiflex™-C5 (Avestin™ Inc., Ottawa, Canada) at a pressure of 345 bar. Each sample was circulated 2 passes in the homogenizer. Emulsions were made in duplicate. The size of the oil droplet was measured using an optical microscope at 100× magnification with the image analyzer Matrox™ inspector. For each emulsion, six measures of the size of the oil droplets were realized. The analysis were made 24 hours after the production of the emulsions. Gelation The gels of WPI were made with a solution containing 14% w/w of protein and the pH was adjusted to 6.0. The protein solutions were degassed and put in glass tubes (7 mm diameter×14 cm longer). The tubes were closed with parafilm. The tubes were put in a heating bath at 80° C. during 30 minutes. The gels were refrigerated at 40° C. The gels were made in duplicate. The gels texture analysis was made after 18 hours with a Texturometer™ TA-XT2. The gels were put at room temperature (20° C.) one hour before the analysis. The gels were moved out of the tubes and they were cut in 11 cylinders (6 mm height×7 mm larger). A double compression at 20% of deformation was executed on the gels with a cylinder (2.5 cm diameter) at a moving speed of 0.5 mm/sec. Ten measures were executed for each preparation of gel. The texture profile analysis (TPA) was realized to determined the hardness of the gels. Effect of Heating Solution of WPI at a protein content of 14% w/w and at a pH of 6.0 was used. 200 ml of the solution was passed in the homogenizer EmulsiFlex™-C50 (Avestin™ Inc. Ottawa, Canada) with the ceramic chamber at a pressure of 1.5 kbar. Two temperatures of inlet were evaluated: 22° C. and 55° C. The time and the number of the passes were calculated until the solution was a gel. The tests were made in duplicate. RESULTS Solubility of Protein Table 2 presents the different protein fractions in WPI and WPC products. Total proteins content were relatively the same for all types of WPI products and all types of WPC products. WPC products showed a higher content of insoluble aggregated protein (IAP) compared to the WPI products. The high-pressure homogenization (HPH) treatment had no effect on the content of IAP because the value for the WPI and WPC control were similar to WPI treated and WPC treated. WPI products presented a higher quantity of soluble aggregated proteins (SAP) than the WPC products. Also, HPH treatments had an effect on the quantity of SAP for the WPI products but not for the WPC products. WPI microfluidizer (1 p/55° C., 5 p/55° C.) and Avestin™ ceramic (1 p/55° C., 5 p/55° C.) showed a higher content of SAP compared to the WPI control. Temperature of the treatment at 55° C. and number of recirculation (1 and 5 passes) affected the solubility of the aggregated proteins. We don't see any difference between WPC products because the WPC is composed of 52.16% of proteins but contains also more lactose, fat, and ash than the WPI products. The others constituents of WPC and the quantity of insoluble aggregated protein in WPC had an effect on the proteins treatments. WPI products are composed of 97.90% of proteins and the others constituents had no major effect on the protein treatments. High-pressure homogenization treatment at a temperature of 55° C. Avestin™ or Microfluid™, 1 or 5 passes) for the WPI modify the solubility of whey proteins at pH 4.6 and the content of soluble aggregates. TABLE 2 Different protein fraction (total proteins, soluble proteins at pH 6.0 and pH 4.6, IAP and SAP) in WPI and WPC Soluble Soluble Total proteins proteins Proteins pH 6.0 pH 4.6 IAP 1 SAP 2 Substrates (%) (%) (%) (%) (%) WPI Control 96.18 95.01 87.74 1.17 7.27 WPI Microfluidiz. 96.98 96.29 87.07 0.69 9.22 1 p/22° C. WPI Microfluidiz. 98.77 98.86 89.13 0.00 9.73 5 p/22° C. WPI Microfluidiz. 98.49 98.96 88.53 0.00 10.43 1 p/55° C. WPI Microfluidiz. 99.78 98.95 73.04 0.83 25.91 5 p/55° C. WPI Ceramic 96.13 95.76 89.27 0.37 6.49 1 p/22° C. WPI Ceramic 98.47 96.70 89.35 1.77 7.35 5 p/22° C. WPI Ceramic 97.19 94.94 84.92 2.25 10.02 1 p/55° C. WPI Ceramic 99.17 98.95 80.72 0.22 18.23 5 p/55° C. WPC Control 52.75 39.46 36.49 13.29 2.97 WPC Microfluidiz. 52.46 40.48 36.15 11.98 4.33 1 p/22° C. WPC Microfluidiz. 51.54 41.55 36.24 9.99 5.31 5 p/22° C. WPC Microfluidiz. 51.17 39.30 36.77 11.87 2.53 1 p/55° C. WPC Microfluidiz. 53.18 39.11 37.53 14.07 1.58 5 p/55° C. WPC Ceramic 51.24 38.96 36.42 12.28 2.54 1 p/22° C. WPC Ceramic 50.98 39.18 37.42 11.80 1.76 5 p/22° C. WPC Ceramic 53.81 39.37 36.29 14.44 3.08 1 p/55° C. WPC Ceramic 52.31 39.82 36.65 12.49 3.17 5 p/55° C. 1 IAP: Insoluble aggregated proteins = total proteins-soluble proteins pH 6.0 2 SAP: Soluble aggregated proteins = soluble proteins pH 6.0-soluble proteins pH 4.6 Turbidity Evaluation of the turbidity of solutions made with WPI with a protein content of 14% w/w by transmittance at λ=700 nm is showed at the FIG. 1 . Solutions were made with WPI and the protein content was 14% w/w. Microfluidizer solutions presented a higher transmittance value compared to WPI control. Avestin™ ceramic solutions showed the same tendency as Microfluid™ at 22° C. but a lower transmittance value for the treatment (1 and 5 passes) at 55° C. The solutions were more cloudy for these treatments. It seems from these results that at 55° C. Avestin™ does not reduced aggregation like the Microfluid™ do. The analysis of WPC products for the turbidity was impossible because the solutions of WPC were very cloudy even for the non-treated sample. Emulsion Mean diameter of oil droplets of corn oil-in-water emulsions (0.5% protein, 20% oil) made with WPI and WPC products were compared (Table 3). The oil droplets diameter of emulsions made with WPI was lower than the one made with WPC. The average droplets diameter for WPI control emulsions was 1.41±0.50 μm. The oil droplets size was slightly increasing for the emulsion made with the WPI treated at 55° C. WPI treated by Microfluidization 5 passes/55° C. gave a mean diameter of 1,64±0.63 μm and WPI treated by Avestin ceramic 5 passes/55° C. gave a mean diameter of 1,71±0.90 μm. The size of oil droplets diameter of emulsions made with WPI treated at 22° C. was similar to the one made with WPI control. The mean oil droplets diameter for WPC control was 2.14±1.15 μm. The size of oil droplets was slightly increasing for the emulsion made with WPC microfluidizer 5 passes/55° C. (mean diameter of 2.88±2.31 μm) and emulsion made with WPC Avestin ceramic 5 passes/55° C. (mean diameter of 2.78±2.21 μm). High-pressure homogenization treatment of WPI and WPC had no positive effect on oil droplets size for stabilized oil in water emulsion. High pressure treatment does not appear to improve emulsifying properties of whey proteins. It does however increase the aggregation properties of the proteins, which sows that protein has been affected by the HPH treatment. The increase in the average particle size associated to the HPH treatment WPI at 55° C. was associated to an increase in aggregation between fat globules showing aggregating properties of the treated proteins. FIGS. 2 and 3 present the particle size by optical microscopy at magnification 100× of emulsions made with WPI control and WPI Avestin ceramic 1 p/55° C. FIGS. 4 and 5 show the particle size by optical microscopy at magnification 100× of emulsions made with WPC control and WPC Avestin™ ceramic 1 p/55° C. TABLE 3 Mean diameters of oil droplets for emulsions (0.5% protein, 20% oil) made with WPI and WPC Diameters (Optical microscopy 100x) (μm) Substrates Mean SD Maximum Minimum WPI Control 1.41 0.50 4.92 0.63 WPI Microfluidizer 1.42 0.47 4.17 0.66 1 p/22° C. WPI Microfluidizer 1.38 0.42 4.05 0.71 5 p/22° C. WPI Microfluidizer 1.46 0.49 4.12 0.66 1 p/55° C. WPI Microfluidizer 1.64 0.63 4.96 0.63 5 p/55° C. WPI Ceramic 1.47 0.39 4.79 0.66 1 p/22° C. WPI Ceramic 1.54 0.44 3.76 0.63 5 p/22° C. WPI Ceramic 1.61 0.51 5.06 0.65 1 p/55° C. WPI Ceramic 1.71 0.90 10.95 0.66 5 p/55° C. WPC Control 2.14 1.15 8.82 0.69 WPC Microfluidizer 2.29 1.80 14.26 0.66 1 p/22° C. WPC Microfluidizer 2.24 1.46 11.36 0.68 5 p/22° C. WPC Microfluidizer 2.05 1.52 12.52 0.76 1 p/55° C. WPC Microfluidizer 2.88 2.31 19.92 0.69 5 p/55° C. WPC Ceramic 2.01 1.63 17.44 0.69 1 p/22° C. WPC Ceramic 2.57 2.34 21.47 0.72 5 p/22° C. WPC Ceramic 2.22 1.53 15.17 0.65 1 p/55° C. WPC Ceramic 2.78 2.21 18.32 0.63 5 p/55° C. Gelation Effect of WPI and WPC treated by HPH on the hardness of gels made with a solution. of protein content of 14% WIW are presented in FIGS. 6 and 7. The hardness of gels produced with WPI treated was increasing compared to the gels made with WPI control. WPI treated by microfluidizer 5 p/55° C. and Avestin™ ceramic 5 p/55° C. produced gels with the highest values of hardness. The hardness of gels made with WPI microfluidizer was very similar of the hardness of gels made with WPI Avestin™ ceramic. The hardness of gels made with WPC control was similar of the hardness of gels made with WPC treated 1 p/22° C. and 5 p/22° C. The hardness of gels produced with WPC treated 1 p/55° C. and 5 p/55° C. was slightly higher then the gels made with WPC control. The results showed that WPI treated at a temperature of 22° C. and 55° C. by high-pressure homogenization improve the gelation properties of whey proteins. HPH treatment at a temperature of 55° C. for the WPC improve slightly the gelation properties of whey proteins. Effect of Heating Table 4 shows the effect of the inlet temperature of a solution of WPI at a concentration of 14% of protein recirculated in an homogenizer Avestin™ C-50 ceramic at a pressure of 1.5 kbar for the production of a gel. Temperature of the solution after 1 pass in the homogenizer was 50.0° C. for the WPI 22° C. and 66.7° C. for the WPI 55° C. The time for made a gel was lower for the WPI 55° C. and the number of recirculation was only 4 passes. The solution of WPI 22° C. was recirculated 8 passes for made a gel and the temperature at the end was around 78.8° C. The temperature at the end of the recirculation for the WPI 55° C. was around 82.7° C. TABLE 4 Effect of the temperature of a solution of WPI for the production of gel with the homogenizer Avestin ceramic at a pressure of 1.5 kbar Gelation Inlet Temperature Outlet temperature after 1 passe Time Number of temperature (° C.) (° C.) (min.) recirculation (° C.) WPI 22° C. 50.0 4.42 8 78.8 WPI 55° C. 66.7 2.58 4 82.7 2.0 STUDY OF CHEESE SAUCE With the results obtained from the functional properties analysis in the study of WPI and WPC, we have decided to retain two WPI treated by HPH for a reincorporation in a formulation of cheese sauce. WPI Avestin ceramic 1 passe/22° C. and WPI Avestin™ ceramic 1 passe/55° C. were used for the study. These two ingredients have been selected due to the facility to use the Avestin technology and the 1 passe procedure is more acceptable in an industrial process. The main objective of this experiment was to substitute soy protein isolate (SPI) in a formulation of cheese sauce by whey protein isolate (WPI) treated by dynamic high-pressure homogenization. The rheological properties of the cheese sauces were characterized. METHODOLOGY Materials Soy protein isolate (SPI) was purchased from UFL. The quantity of SPI used in the formulation of cheese sauce control was 3.25%. WPI control, WPI Avestin™ ceramic 1 p/22° C. and WPI Avestin™ ceramic 1 p/55° C. were used for the formulation of the cheese sauce. The quantity of WPI used in the formulation was 1.62% and 1.00%. Cheese sauces were made in triplicate. Table 5 shows the original formulation of the cheese sauce. TABLE 5 Formulation of cheese sauce Ingredients % by weight Salt 0.77 Monosodium glutamate 0.08 White pepper 0.01 Milk, whole 65.50 Soy protein isolate 3.25 Cheddar cheese, six months 26.09 Sequestrant, i.e., tetrasodium 0.30 pyrophosphate Fat, i.e., margarine 4.00 Rheological Measurements Rheological measurements were performed with a shear strain-controlled rheometer (ARES-100 FRT, Rheometric Scientific). Parallel plate geometry was used with a plate diameter of 50 mm. The gap between the two plates was set at 1 mm. The rheological measurements were performed in a step rate test and a dynamic frequency sweep (strain-controlled) test. Analysis were made in duplicate at a room temperature of 20° C. 24 hours after the production of the cheese sauce. All the samples were stand still 5 minutes before running any measurements, to allow some stress relaxation. Step rate is a steady transient test that applies a constant commanded shear rate of 1.0 s −1 for a selected time period of 5 minutes. Cheese sauce viscosity was dependent of the time. When subjected to shear, structure was broken down and the materials reach a minimum thickness. This is the behavior of a thixotropic fluid. Dynamic rheology analyzed the viscoelastic behavior of cheese sauce and characterized the levels of both viscous and elastic behavior. Dynamic frequency sweep applies a sinusoidal deformation of constant amplitude of 0.56 over a range of frequency of 0.01 at 10 Hz. Small amplitude oscillatory experiments, carried out within the linear viscoelastic region, have the advantage of avoiding destruction in the sample. We get the values of G′ elastic modulus (called also the shear storage modulus), G″ viscous modulus (called also the shear loss modulus), phase angle (δ) and dynamic viscosity (η*) The value of G′ is an indication of the character solid or elastic of the products tested. The value of G″ is an indication of the character liquid or viscous of the product tested. Phase angle gave an idea of the elastic character compare to the viscous character of the products because tgδ=G″/G′. For a material perfectly elastic δ=0° and δ=90° when it is a material viscous. For a viscoelastic material like a cheese sauce, δ is situated between 0° and 90°. RESULTS Rheological Measurements Steady Rheology Evolution of the viscosity of the cheese sauce as a function of time is showed in the FIGS. 8 and 9. The viscosity of cheese sauces made with WPI decreased in function of time. This is the behavior of a thixotropic fluid. The viscosity of SPI cheese sauce remained stable in function of time. Viscosity of the cheese sauces made with WPI ingredients was higher than the one made with SPI. Cheese sauces made with WPI treated by HPH gave a higher value of viscosity than the WPI control for the two levels of incorporation (1.62% and 1.00%). Table 6 presents the viscosity of the cheese sauces after 5 minutes of analysis at a shear rate of 1.0 s −1 . TABLE 6 Steady viscosity of cheese sauces at a shear rate of 1.0 s −1 after 5 minutes Viscosity (Pa-s) Products Mean SD SPI (3.25%) 1.52 1.61 WPI control (1.00%) 6.43 2.03 WPI 1 p/22° C. (1.00%) 9.07 2.28 WPI 1 p/55° C. (1.00%) 10.32 2.12 WPI control (1.62%) 8.10 2.49 WPI 1 p/22° C. (1.62%) 11.52 3.25 WPI 1 p/55° C. (1.62%) 12.79 1.59 Dynamic Rheology In FIGS. 10 and 11, the G′ values at a deformation amplitude of 0.5% are plotted against frequency. The shapes of the curves are quite similar for all cheese sauces made with the WPI, which can be attributed to the fact that all the WPI ingredients must exhibit similar viscoelastic behavior. The shapes of the mechanical spectra showed that cheese sauces made with WPI ingredients have a Theological behavior of a gel type with G′ varied slightly with the frequency. The shape of the mechanical spectra for cheese sauce made with SPI is very different. The cheese sauce SPI curve represented a rheological behavior of a solution. Cheese sauces made with WPI treated by HPH gave higher values of G′ compared to the WPI control for the two levels of incorporation (1.62% and 1.00%). Cheese sauces made with WPI treated are more elastic than the one made with WPI control. In FIGS. 12 and 13, the G″ values at a deformation amplitude of 0.5% are plotted against frequency. Viscous modulus G″ of the cheese sauces made with WPI ingredients was higher than the one made with SPI. Cheese sauces made with WPI treated by HPH gave higher values of G″ compared to the WPI control for the two levels of incorporation (1.62% and 1.00%). Cheese sauces made with WPI treated are more viscous than the one made with WPI control. The phase angle (δ) is used to summarize the viscoelastic character of materials because tgδ=G″/G′. Cheese sauces made with WPI ingredients presented a character more solid than cheese sauce made with SPI because phase angle values were lower for the cheese sauces made with WPI (FIGS. 14 and 15 ). No differences of phase angle values were observed between the WPI ingredients. In FIGS. 16 and 17, dynamic viscosity of cheese sauces are presented. Dynamic viscosity of the cheese sauces made with WPI ingredients was higher than the one made with SPI. Cheese sauces made with WPI treated by HPH gave higher values of dynamic viscosity compared to the WPI control for the two levels of incorporation (1.62% and 1.00%). Table 7 presents the values of modulus G′ et G″ of cheese sauces at a frequency of 1 Hz and a deformation amplitude of 0.5%. Table 8 shows the values of phase angle and dynamic viscosity of cheese sauces at a frequency of 1 Hz and a deformation amplitude of 0.5%. TABLE 7 Values of modulus G′ et G″ of cheese sauces at a fre- quency of 1 Hz and a deformation amplitude of 0.5% Modulus G′ Modulus G″ (Pa) (Pa) Products Mean SD Mean SD SPI (3.25%) 171.77 126.19 90.69 57.08 WPI control 263.24 110.05 77.50 25.74 (1.00%) WPI 1 p/22° C. 729.91 239.07 203.46 62.81 (1.00%) WPI 1 p/55° C. 849.17 295.68 241.81 83.39 (1.00%) WPI control 391.33 151.58 115.24 34.81 (1.62%) WPI 1 p/22° C. 730.97 321.37 200.78 82.46 (1.62%) WPI 1 p/55° C. 896.41 331.67 245.77 94.84 (1.62%) TABLE 8 Values of phase angle and dynamic viscosity of cheese sauces at a frequency of 1 Hz and a deformation amplitude of 0.5% Phase angle Dynamic Viscosity (°) (Pa-s) Products mean S. D. mean S. D. SPI (3.25%) 31.78 7.01 30.97 21.94 WPI control 16.99 2.08 43.70 17.92 (1.00%) WPI 1 p/22° C. 15.64 0.53 120.60 39.32 (1.00%) WPI 1 p/55° C. 15.91 0.59 140.53 48.88 (1.00%) WPI control 16.96 1.77 64.95 24.69 (1.62%) WPI 1 p/22° C. 15.51 0.73 120.65 52.79 (1.62%) WPI 1 p/55° C. 15.27 0.33 147.93 54.89 (1.62%) S. D. = Standard deviation CONCLUSION First, the results. of the present invention confirm that it is possible to obtained comparable results using the Emulsiflex Avestin technology than the Microfluid technology, and this is of importance since the EmulsiFlex Avestin technology is a more transferable technology to the industry. WPI give increase emulsion aggregation, gels firmness and thickening properties both in model systems and in food product (cheese sauce) whereas the results for WPC are less evident. We have shown that the HPH modified the protein properties at temperature below the denaturation temperature at 22/150.0° C. and at 55/166.70° C. (FIG. 4 ). Cheese sauce product : the static viscosity SPI 3.25% 30.97 Pa.S-1 WPI 1.62% 64.95 Pa.S-1 WPI/22/1 1.62% 120.5 Pa.S-1 WPI/55/1 1.62% 147.93 Pa.S-1 These results represent an increase by 1.8 and 2.3 times vs. the control WPI and of 8 to 10 times vs. the SPI considering the concentration differences. Costs Considerations: Considering the fact that the treated sample increase by almost two times the viscosity of the cheese sauce, it is clear from the present results that HPH represent a potential technology for the modification of proteins functionalities which lead to economical benefits. The present invention will be more readily understood by referring to the following examples which are given to illustrate the invention rather than to limit its scope. EXAMPLE I Commercial Applications of the Invention The pressure-treated proteins obtained by the process of the present invention may be used in fillers or gel food products. At very high homogenization pressures (3 kbar), gelation can be induced without subsequent heat treatment; these gels can be used in gel-like products, such as pudding or gelatin gel products. Other processing conditions produce proteins with modified functionality. Increase in solubility (dispersion translucidity) results in protein solutions that may be used for soup, cream, or sports drinks. The HPH is used to modify the emulsification/foaming properties of the proteins to favor their applications in emulsions meat products. As an example, in liver paté, these modified-proteins resulted in a softer texture due to their higher hydration capacity and emulsification. While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modifications and this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth, and as follows in the scope of the appended claims.

The present invention relates to a continuous process for denaturation of proteins, which comprises the steps of: a) subjecting a protein solution to a high pressure homogenizer at a pressure of about 500 to about 5000 bar, at a recirculation ranging from 0 to about 50 and at a temperature ranging from about 20deg C. To about 80deg C. For a period of time on the order of milliseconds, wherein the protein solution consisting of a protein fraction dispersed in water, buffer or salt solution at a concentration ranging from about 2% to about 35% w/w and at a pH adjusted between about 2.0 to about 12.0; b) concentrating the protein solution by i) evaporation, ii) ultrafiltration and sprayed dried or iii) ultrafiltration and freeze dried.

FIELD OF THE INVENTION The present invention relates in general to a category of golf equipment and in particular to two types of golf swing training devices. BACKGROUND OF THE INVENTION A dictum of golf technique is that the club face should remain parallel to and on the swing plane except near the impact point if the desired delayed hit is to be achieved. This preceding dictum means that the golfer must rapidly rotate the club shaft 90 degrees about its longitudinal axis in approximately 58 milliseconds just prior to impact given a club head velocity of 75 MPH. The delayed hit which is essential to a good golf swing requires the golfer to : (a) maintain a cocked wrist position until approximately the last 90 degrees of swing arc just prior to impact, (b) while in this cocked wrist position, the club face must be parallel to and on the swing plane, (c) and then in approximately 58 milliseconds, just prior to impact, rotate the club shaft so that the club face is perpendicular to the swing plane. The center of gravity of the club head which is approximately at the mid-point of the club head between the heel and toe extremities must be moved off of the swing plane by rotating the club shaft 90 degrees about its longitudinal axis in 58 milliseconds. The rotation of the club shaft is accomplished by the use of the golfer's pronator and supinator wrist muscles. The club head center of gravity, is experiencing high centrifugal forces during this critical 90 degrees (last arc segment before impact) of the swing arc. Centrifugal force can be defined as, a n =v 2 /r. If we let r=4.04 feet and v=110 feet/second (75 MPH), we are looking at a centrifugal force of approximately 93 Gs. Due to the movement of the pivot point during the golf swing, it is expected that the G force would be considerably less than 93, but even with a G force of 50, the golfer is compelled to rotate the club shaft 90 degrees about its longitudinal axis in 58 milliseconds against this high G force which is resisting any reaction to move the club head center of gravity off of the swing plane. It is the wrist muscles, mainly the left wrist supinator muscle and the right wrist pronator muscle, that provides the reaction to rotate the club shaft about its longitudinal axis. An authority states that: "Every good golfer has his left wrist in this supinating position at impact." [Ben Hogan in Five Lessons The Modern Fundamentals Of Golf, pp 101, 102; A Fireside Book, Simon & Schuster, Inc. New York Copyright 1957 by Ben Hogan]. It is important to note that the authority Ben Hogan pages 101 and 103 strongly advises against pronation of a golfer's left wrist just before impact. It is the intent of this invention's golf swing trainer to enhance the development of the golfer's left wrist supinator muscle and right wrist pronator muscle and the other muscles required to perform a good golf swing. The pronator muscle is defined as the right wrist muscle required to rotate the club shaft counterclockwise (for a right handed golfer) about its longitudinal axis, just prior to impact. The supinator muscle is defined as the left wrist muscle required to rotate the club shaft counterclockwise about its longitudinal axis, just prior to impact. Hereinafter, the pronator and supinator muscles maybe referred to as the delayed hit muscles. The delayed hit has already been defined as a special case condition existing through the last 90 degrees of the swing arc just prior to impact. Hence, there is a need for the golfer to develop his delayed hit muscles if he is to consistently achieve the delayed hit which is so essential to a good golf swing. OBJECT OF THE INVENTION To provide a golf swing training device that enhanced and accelerates the development of the golfer's delayed hit and other muscles required in the performance of a delayed hit golf swing. To provide a golf swing training device that can be used by the golfer in between shots during the course of playing a round of golf wherein his practice swings will serve as a reminder of the importance of the delayed hit. Toward this end, the present invention's training device incorporates a standard grip and a straight shaft so that said training device conveniently fits into an ordinary golf bag tube. To provide a golf swing training device wherein its swing weight does not depart too greatly from the golfer's accustomed swing weight. A correlation of swing weights between this training device and the golf club normally used by the golfer ensures that the golfer is not faced with two entirely different swing weight situations during his practice swing and actual golf swing. Using a trainer, in between golf shots, that has a large departure from the golfer's accustomed swing weight may well be detrimental to the golfer. To provide a golf swing training device affording a very high axial moment of inertia. The golf swing training device of the present invention is configured to provide the maximum available axial moment of inertia consistent with its swing weight and form factor constraints. The training device head form factor is constrained to be approximately 4.0 inches along its longitudinal axis and 2 inches in height. The training device head bear some resemblance to an iron golf club head. To provide a very high axial moment of inertia training device by ensuring that the toe weighted mass section is devoid of any holes to maximizes the air resistance presented by said mass sections during practice swings taken by the golfer. When using the training device of the present invention, the golfer will be forced to use his pronator and supinator muscles to overcome the additional torque generated by the air resistance. To provide a training device that affords the maximum practical available axial moment of inertia about its longitudinal axis consistent with its weight and form factor by ensuring that the hosel and the interconnect between the hosel and toe mass section are configured to provide a low weight structure. To provide a training device that is suitable for either a right or left handed golfer. To provide a training device that is simple and economical to produce. Some of the general objectives of the present invention is summarized as: to provide a golf swing training device that is uniquely structured and weighted so that it affords, a high axial moment of inertia training device, a swing weight that is consistent with the swing weight of an ordinary golf club, a high air resistance toe mass section to further enhance the delayed hit muscle development of the golfer, adjustability of the swing weight to accommodate the special needs of a golfer, utility so that either a right or left handed golfer is allowed to use said training device, a form factor bearing some resemblance to an iron golf club, and a configuration which allows said training device to conveniently fit into an ordinary golf bag tube so that it may be conveniently carried by a golfer while playing a round of golf. To provide a golf swing training device comprised of a weighted implement configured to be attached to the toe extremity of a conventional golf club. Said weighted implement in combination with a conventional golf club becomes a trainer that enhances and accelerates the development of the golfer's delayed hit and other muscles required in the performance of the delayed hit golf swing. To provide a configuration of said weighted implemented so that at least 75 percent of its weight is concentrated at the toe extremity of the conventional golf club. The concentration of weight location affords, in combination with the conventional golf club, a high axial moment of inertia golf swing trainer. To provide said weighted implement with attachment means to readily attach or detach said weighted implement to or from a conventional golf club so that said weighted implement may be conveniently used by the golfer during a round of golf. Prior art does not provide a golf swing training device that provides: a high axial moment of inertia (consistent with its weight), a structure that increases the axial moment of inertia due to air resistance created during a swing, a swing weight that is consistent with swing weights used by most golfers, a weight that is consistent with the weight of a golf club that is used by most golfers, adjustability of the training device swing weight to accommodate the special needs of a particular golfer, broad utility (may be used as a two-handed training device by either left or right handed golfers, and will fit into a standard golf bag tube), and economical construction. In an embodiment of the present invention, the golf swing training device is comprised of a grip, a shaft, and a trainer head somewhat resembling a golf club head except that the trainer head lacks a ball striking face since the trainer head is not designed to strike a golf ball. This training device contains a concentration of weight at the opposite end of the hosel. The opposite end of hosel will be referred to as the toe end or toe extremity, wherein the hosel is the part that interfits with a shaft. The concentration of weight at the toe end of the training device head affords a high axial moment of inertia device. High axial moment of inertia is defined for the present invention as high rotational moment of inertia about the shaft longitudinal axis and is related to high torque about the shaft longitudinal axis. Because of its high axial moment of inertia, said training device will particularly enhance the development of the golfer's delayed hit muscles. In a preferred embodiment of the present invention, the training device will provide a fixed swing weight of approximately F-0 on a prorhythmic swing weight scale. A typical swing weight of an ordinary golf club is approximately D-0 on this prorhythmic swing weight scale. This preferred embodiment of the training device has a swing weight of approximately 20 points above said ordinary golf club. This increase in swing weight, D-0 to F-0, will not appreciably affect the swing velocity of the golf swing. One intention of this invention is to provide a golf swing training device that enhances the development of the delayed hit muscles of the golfer but not at a sacrifice to the development of the golfer's other, including speed, muscles. In another preferred embodiment of the present invention, the concentration of the weight at the toe end shall be adjustable to accommodate the particular needs of a golfer. The adjustability of the weight will accommodate the golfer's degree of muscle development and/or other special needs. If said training device is adjusted to equal the swing weight that the golfer normally uses, his golf swing velocity will not be affected, by a noticeable extra demand will be placed on the golfer's delayed hit muscles in the critical (delayed hit) zone because of the high axial moment of inertia uniquely afforded by the present invention's training device. Of course, additional weighting over and beyond the golfer's normal swing weight may be used to further enhance the development of the golfer's delayed hit and other muscles required for a delayed hit golf swing. The delayed hit is essential to any good golf swing. The fundamental and unique concept of the present invention is to provide a golf swing training device that enhances the development of the so essential delayed hit muscles without sacrificing the development of the golfer's speed or other muscles required in the performance of a good solid golf swing. It is well known that club head velocity (speed) is required to obtain distance. Said concept of the present invention is realized by providing a high axial moment of inertia training device, but wherein the swing weight and weight of said training device is consistent with the golfer's accustomed swing weight and golf club weight. SUMMARY OF THE INVENTION To provide a golf swing training device that is uniquely structured and weighted so that is affords, a high axial moment of inertia training device, a swing weight that is consistent with a swing weight of an ordinary golf club, a high air resistance toe mass section to further enhance the delayed hit muscle development of the golfer, adjustability of the swing weight to accommodate the special needs of a golfer, utility so that either a right or left handed golfer is allowed to use said training device, a form factor bearing some resemblance to an iron golf club, and a configuration which allows said training device to conveniently fit into an ordinary golf bag tube so that it may be conveniently carried by a golfer during a round of golf. This training device is approximately 38 inches long which is substantially the length of a number four iron golf club. This training device may be carried by the golfer during a round of golf to stimulate his delayed hit muscles in between golf shots. This method of use will serve as a mental reminder, to the golfer, as to the importance of the delayed hit. The delayed hit muscles are defined as the muscles required to very rapidly rotate the golf club shaft about its longitudinal axis just prior to impact. Said delayed hit muscles involve the right wrist pronator and left wrist supinator muscles. To achieve the so essential delayed hit, the golfer must rotate the golf shaft 90 degrees about its longitudinal axis in approximately 58 milliseconds given a club head velocity of 75 MPH. If a golfer is to achieve even a modicum of success, it is imperative that the golfer develops his delayed hit muscles. The GOLF magazine, June 1991, "The Iron Men", pages 97 through 103 illustrates golf swings by three well known golf professionals. And in particular, bottom of pages 99, 101 and 103 illustrates the positions of their wrists (hands) through the critical swing arc segment (delayed hit zone) just before impact. It is clear from these illustrations that all three golf professionals have rotated their wrists (hands) approximately 90 degrees about the club shaft longitudinal axis in the critical delayed hit zone to obtain their desired results. It is clear from these illustrations that it is imperative for the golfer to develop his delayed hit muscles. One golf swing training device of the present invention is a uniquely structured weighted (adjustable or fixed) device comprised of a grip, a shaft, and a training device head bearing some resemblance to an iron golf club except that it lacks a ball striking surface. This training device is not designed to strike a golf ball. To enhance the development of the delayed hit muscles, the present invention's training device simulates a golf club which exhibits high axial moment of inertia about its longitudinal axis. This feature is obtained by extensive toe weighting of the training device head. In one preferred embodiment, said extensive toe weighting is adjustable and may be tailored to the meet the needs of the golfer. Another type of golf swing training device is a weighted implement which is readily attachable to the toe extremity of a conventional golf club. Said weighted implement may be left attached to the toe extremity of a conventional golf club during muscle development training sessions. For practice swings during a round of golf, the golfer attaches this weighted implement to the toe of the club which he intends to use on his next shot, takes a couple of practice swings, detaches this weighted implement and proceeds with his play. Attaching this weighted implement to the toe extremity dramatically increases the axial moment of inertia of the golf club, but at only a small increase in golf club swing weight, since substantially all of the weight of this weighted implement is attached to the toe extremity. Said weighted implement is configured to be usable on most golf club ranging from the driver to the number nine iron. Using the high axial moment of inertia training devices of the present invention, the golfer will rapidly develop his delayed hit and other golf swing muscles. Additionally, use of these training devices between golf shots on the course will stimulate the delayed hit muscles and reminds the golfer of the importance of the delayed hit golf swing. The unique features of the golf equipment that are considered characteristic of the present invention are set forth in the appended claims. The invention will readily be understood from the following description when read in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1 and 2 are frontal views of two prior art golf training clubs. FIG. 3 is a frontal view of the fixed swing weight head of the present invention's golf swing training device. FIG. 4 is a top view of the fixed swing weight head of the present invention's golf swing training device. FIG. 5 is a frontal view of the adjustable swing weight head of the present invention's golf swing training device. FIG. 6 is a top view of the adjustable swing weight head of the present invention's golf swing training device. FIG. 7 is a frontal view of the weighted implement of the present invention's golf swing training device. Said weighted implement is uniquely positioned over the toe extremity of a conventional wood type golf club. FIG. 8 is a view of the weighted implement as seen from the toe end of the conventional wood type golf club. FIG. 9 is a view of the weighted implement as seen from above the conventional wood type golf club. DESCRIPTION OF PREFERRED EMBODIMENTS FIG. 1 is frontal view of a prior art (U.S. Pat. No. 4,511,147) golf swing training club. This prior art golf swing training club features a head made from bent bar stock and formed to provide an open head to minimize the air resistance. The present invention's training device describes and claims features diametrically opposed to this prior art. The present invention's training device specifics a mass section surface area of at least 2 square inches to provide air resistance so that the golfer will be compelled to use his pronator and supinator muscles (delayed hit muscles) to overcome the additional torque generated by the air resistance created by its mass section's surface area. This additional torque experienced by the golfer will enhance and accelerate the development of his delayed hit muscles. FIG. 2 is frontal view of a prior art (U.S. Pat. No. 4,529,204) training club for golfers. This prior art training club for golfers features a short pitching wedge shaft and a hand grip adapted to be grasped by one hand. The present invention's training device is preferably 38 inches long and features a standard two-handed grip. A standard pitching wedge is only 35.5 inches long. The purpose of the present invention's training device, is in part, to enhance the development of the golfer's right wrist pronator and left wrist supinator muscles (delayed hit muscles). Simultaneous development of the right wrist pronator and left wrist supinator muscles is not possible with only one hand grasping the training device. This prior art training club for golfers illustrates an adjustment means of its swing weight, but does not specify the location of this adjustment means relative to its shaft longitudinal axis. Therefore, it could be deduced that Yamakawa is not concerned with providing a trainer that exhibits high axial moment of inertia. The golf swing training device of the present invention is configured to provide the maximum available axial moment of inertia consistent with its swing weight and form factor constraints. The present invention specifies and claims that the weighted mass center of gravity is located at least 2.5 inches from its shaft longitudinal axis affording a high axial moment of inertia training device. FIG. 3 is a frontal view of the fixed swing weight head of the present invention's golf swing training device. Said fixed swing weight head is comprised of a low weight hosel 10, a low weight interconnect 11, and a substantial mass section 12. The location of the mass section 12 center of gravity 14 relative to the hosel centerline is shown by dimension 15. In one preferred embodiment, the weight of the hosel 10 and interconnect 11 is two ounces and the weight of the mass section 12 is seven ounces. This head weight of nine ounces combined with a light-weight steel shaft, cut for a training device length of 38 inches, and a standard grip will afford a swing weight of approximately D-3 on a prorhythmic swing weight scale. This preferred embodiment meets the present invention's intent to provide a high axial moment of inertia training device consistent with ordinary swing weight and training device head form factor constraints. Said training device head form factor is constrained to be approximately 4.0 inches in length, measured along its longitudinal axis, with a height dimension of approximately 2.0 inches. A D-3 swing weight is consistent with a swing weight used by many golfers. Because the dimension 15 is specified to be at least 2.5 inches, this preferred embodiment of the present invention will afford a high axial moment of inertia device with a torque about its shaft axis of more than 17.5 in-oz. The frontal surface area of the mass section 12 is specified to be at least 2.0 square inches. This surface area creates additional torque for the golfer to overcome during practice swings because of its air resistance. When using the training device of the present invention, the golfer will be forced to use his pronator and supinator muscles (delayed hit muscles) to overcome the additional torque generated by the air resistance of the mass section 12. This additional torque is over and beyond the torque generated by the unique structure of the present invention's high axial moment of inertia training device. The static torque of 17.5 in-oz becomes magnified in a dynamic situation involving high centrifugal forces. The golfer is compelled to rotate the club shaft against the effects of high centrifugal and air resistance forces and will quickly develop his delayed hit and other swing muscle by using the training device of the present invention. FIG. 4 is a top view of the fixed swing weight head of the present invention's golf swing training device. This view also shows the interconnect 11 to be rather thin so that the weight of this interconnect is minimized. A highly rigid massive interconnect is not necessary since the training device is not intended to be used for striking a golf ball. Moreover, it is the intent of the present invention to provide a high moment of inertia training device by concentrating the available weight far away as practical from its hosel. It is not critical as to the type of materials used for the the present invention's training device but should preferably be of one piece economical construction. FIG. 5 is a frontal view of the adjustable swing weight head of the present invention's golf swing training device. FIG. 6 is a top view of the adjustable swing weight head of the present invention's golf swing training device. Said adjustable swing weight head is comprised of a low weight hosel 20, a low weight interconnect 21, and a substantial mass section 22. This mass section 22 has an axial borethrough hole 23 to accommodate a bolt shaft 24. A bolt comprised of a head 27, a shaft 24, and nut 26 is used to mount additional weights, 28 and 29, to the mass section 22 to suit the needs of then golfer. These additional weights are made of tungsten steel, stainless steel, or any other suitable weighting materials. For the sake of brevity, locking or captive hardware is not discussed or shown. The location of the mass section 22 center of gravity 19 relative to the hosel centerline is shown by dimension 25. In one preferred embodiment, the combined weight of the hosel 20 and interconnect 21 is approximately two ounces and the weight of the mass section 22, not including any additional weights, is approximately 6.0 ounces. This mass section of 6 ounces should accommodate even the weakest of golfers. This preferred embodiment meets the present invention's intent to provide a high axial moment of inertia training device consistent with swing weights commonly used and form factor constraints. Since the dimension 25 is specified to be at least 2.5 inches, this preferred embodiment of the present invention, without any additional weights, will afford a high axial moment of inertia device affording a torque of more than 15.0 in-oz about its hosel centerline. If additional weights were used to bring the combined mass section weight up to 8 ounces, then the torque about its hosel centerline would be 20.0 in-oz. The frontal surface area of the mass section 22 is specified to be at least 2.0 square inches. This surface area creates additional torque for the golfer to overcome during practice swings because of the air resistance generated by said surface area. When using the training device of the present invention, the golfer will be forced to use his pronator and supinator muscles (delayed hit muscles) to overcome the additional torque generated by the air resistance of the mass section 12. This additional torque is over and beyond the torque generated by the unique structure of the present invention's high axial moment of inertia training device. The static torque of 20.0 in-oz becomes magnified in a dynamic situation involving high centrifugal forces. The golfer is compelled to rotate the club shaft against the effects of high centrifugal and air resistance forces and will; therefore, quickly develop his delayed hit and other swing muscle by using the training device of the present invention. FIG. 7 is a frontal view of the weighted implement of the present invention's golf swing training device. Said weighted implement is uniquely positioned over the toe extremity of a conventional wood type golf club 33. The toe extremity being the part a golf club head that is the farthest from the golfer as he takes his stance. In regards to weighted trainer attachments, prior art puts the attachment around the shaft of the golf club to increase the golf club swing weight. In this embodiment of the present invention, this weighted implement is comprised of two cords affording means to readily attach this weighted implement to a conventional golf club head. This weighted implement is designed to be readily carried by the golfer during the course of playing a round of golf. The golfer simply attaches this weighted implement to one of his golf clubs, preferably the club he intends to use on his next shot, and then takes a few practice swings to stimulate his delayed hit muscles. Additionally and importantly, practice swings with this weighted element will serve as a mental reminder to the golfer, of the importance of the delayed hit. Since this weighted implement is attached to the toe extremity, the golf club becomes a high axial moment of inertia training device. In this preferred embodiment, said weighted implement will increase the swing weight of a driver club by approximately twenty points on the prorhythmic swing weight scale. In other words, a driver club with a swing weight of D-0 will become a F-0 swing weight club after the weighted implement is attached to its club head. Said weighted implement may be left attached to a golf club during training periods to enhance the development of the golfer's delayed hit muscles and other muscles required to perform a delayed hit golf swing. This increase of twenty points on the prorhythmic swing weight scale will not appreciably affect the swing velocity of the golfer's swing. The prior art weighting device (U.S. Pat. No. 3,716,239) modifies a golf club swing weight to a point where the swing weight can not be measured on a standard prorhythmic swing weight scale. In regards to this embodiment of the present invention's weighted implement, the fundamental and unique concept is to provide a training device that affords high axial moment of inertia but without unduly increasing the swing weight of the golf club. This embodiment does not simply add weight around the shaft of the golf club to increase the golf club's swing weight but uniquely locates the weighted implement at the toe extremity of the club head to increase the axial moment of inertia of the golf club. The intent is to provide a training device wherein its swing weight does not depart too greatly from the golfer's accustomed swing weight yet places extra demands on the golfer's delayed hit muscles. A similarity of swing weights between this training device and the golf club normally used by the golfer ensures that the golfer is not faced with two entirely different swing weight situations during his practice swing and actual golf swing. Using a trainer, in between golf shots, that has a large difference in swing weights, between the trainer and the golf club, may well prove to be detrimental. Referring to FIG. 7, the weighted implement body is secured to the club head, in this preferred embodiment, by using the attachment cords 31 and 32. These cords 31 and 32 are terminated with spring biased hooks 35 and 36. These cords 31 and 32 are sufficiently long to be wrapped around the hosel 34 two times and then return to the weighted implement body 30. Hooks 35 and 36 are used to attach the free end of the cords to hook receptacle 37 through 44. Hook 35 will be attached to either hook receptacle 37, 38, 39, or 40. Hook 36 will be attached to hook receptacle 41, 42, 43, or 44. The center of gravity 45 of the weighted implement body 30 location relative to the hosel centerline is shown by dimension 46. The inside surface of the weighted implement body 30, the surface that makes contact with the golf club, is coated with a resilient material to form a large contact surface area. This large contact surface area minimizes the movement of the weighted implement relative to the golf club during practice swings. FIG. 8 is a view of the weighted implement as seen from the toe end of the conventional wood type golf club. FIG. 9 is a view of the weighted implement as seen from above the conventional wood type golf club. As discussed above, the considerations that contribute towards the attainment of the present invention's objective of providing a high axial moment of inertia training device are the location of the mass section center of gravity relative to the hosel centerline and the weight of the mass section. In FIG. 3, it is the distance 15 and the weight of the mass section 12 that is mainly controlling the torque about the hosel 10 centerline. In FIG. 5 and 6, it is the distance 25 and the combined weight of the mass section 22, bolt assembly 24, 26 and 27; and weights 28 and 29 that is mainly controlling the torque about the hosel 20 centerline. While a preferred embodiment of the present invention has been shown for a particular design in the drawing and discussed herein, many modifications thereof may be made by a person skilled in the art without departing from the spirit and scope of the present invention. For the purpose of the present invention: A conventional golf club is defined as a golf ball striking implement used by the great majority of golfers, wherein said golf ball striking implement is comprised of a grip, a shaft, and a club head, wherein said club head is comprised of a body, wherein said body is comprised of at least a hosel and a toe extremity, wherein the hosel is the part that interfits with the shaft and the toe extremity is the part that is the farthest from the hosel. A straight shaft is defined as a shaft that is substantially straight from one end to the other end. A standard grip is defined as a grip that is substantially circular in cross-section, except that a continuous, straight, slightly raised rib may be incorporated along the full length of the grip, may be tapered but must not have any bulge or waist, and the axis of the grip must coincide with the axis of the shaft. The shaft longitudinal axis is identical to the hosel centerline.

This invention relates in general to a category of golf equipment and in particular to two golf swing training devices. The two golf swing training devices are primarily used to accelerate the development of the golfer's, particularly the wrist, muscles required to properly perform the golf swing. The first swing training device is a uniquely weighted device bearing some resemblance to an iron golf club. The second golf training device is a weighted attachment which is readily and quickly attached to the club head toe of a golf club. Both of these swing training devices simulate a golf club exhibiting very high axial moment of inertia. Since these swing training devices afford very high axial moment of inertia, rapid development and stimulation of the right wrist pronator and left wrist supinator muscles will be realized by the golfer. The delayed hit which is essential to any good golf swing places stringent demands on the golfer's wrist muscles just prior to impact. The attachment of the second golf swing training device to the golf club head is facilitated through use of a single or a plurality of leads wherein said leads are an integral part of the second training device.

FIELD OF THE INVENTION [0001] The present invention relates generally to in vivo filters that filter debris from a fluid stream in which the filter is disposed. BACKGROUND OF THE INVENTION [0002] In 1977 Andreas Gruntzig performed the first successful balloon angioplasty on an obstructed human artery, thereby opening the vessel and allowing improved flow of blood. [0003] Balloon angioplasty is a catheter-based procedure in which a long, thin tube with a deflated balloon at the tip is inserted into an artery. The balloon is guided to a stenotic lesion using X-ray fluoroscopy, rapidly inflated to a pressure of several atmospheres and deflated. Several rounds of inflation and deflation cause the stenotic lesion to crack and squash radially outward, thereby opening the obstructed lumen. [0004] Balloon Angioplasty may be indicated for improving circulation to virtually any stenosed organ vasculature or peripheral vasculature, including opening occluded vessels during an acute heart attack; and in place of surgical endarterectomy, treatment of carotid artery stenosis, in high-risk surgical patients. [0005] A problem associated with balloon angioplasty is that the stenotic lesion may release debris that travels to vital organs, for example the brain and/or lungs, causing vascular blockage, tissue necrosis and/or patient death. [0006] To prevent such draconian sequela, a number of in vivo debris filter devices have been developed that are designed to capture debris released from stenotic lesions during an angioplasty procedure. [0007] Using a guide passage, such a debris filter is positioned downstream of the intended angioplasty site and expanded to press against the tissue surrounding the lumen, thereby effectively filtering all blood passing through the lumen. A balloon angioplasty catheter is then introduced into the artery and the balloon is positioned adjacent the stenotic lesion. The balloon is inflated, the lesion releases debris and the filter captures the debris. After deflation and removal of the balloon, the filter is contracted and removed with the captured debris. [0008] The use of in vivo debris filters during balloon angioplasty, however, may fail to prevent vascular blockage, tissue necrosis and/or patient death. To be effective, in vivo debris filters are positioned quite a distance downstream from the lesion undergoing angioplasty; considerably raising the chances that a vessel branching off the treated vessel will be located between the angioplasty balloon and the filter. Debris generated by the angioplasty will likely find its way into the branch vessel and travel to the lungs or brain, causing the above-noted sequela. [0009] Additionally the filter itself may pose a health hazard to the patient. The deployment zone for the filter often comprises healthy vascular tissue. Positional adjustments and expansion of the filter against the healthy vascular tissue can cause tissue scars and plaques that, of themselves, provide a breeding ground for additional, full-blown, stenotic lesions. [0010] In spite of the above-noted risk and health hazard, use of a debris filter is indicated for patients having “rupture-prone” lesions; stenotic lesions characterized by thin fibrous caps and large lipid cores. Even though it is impossible to introduce a filter once the balloon angioplasty has begun, in theory, pre-operative identification of a rupture-prone stenotic lesion would allow the patient and surgeon to weigh the risks and benefits of using an in vivo debris filter in addition to the angioplasty balloon catheter. [0011] Unfortunately, the above theoretical solution is almost totally unworkable in practice because the very lesions that are rupture-prone are often not visible by x-ray angiography. [0012] (Z. A. Fayad et al: “Clinical Imaging of the High-Risk or Vulnerable Atherosclerotic Plaque”; Circulation Research. 2001; 89: 305.) [0013] The surgeon and patient, therefore, are left to grope in the dark for answers as to whether to risk patient health and deploy a debris filter. [0014] In general, existing devices and technology present a number of additional disadvantages associated with the stand-alone in vivo debris filter, including: 1) the additional thousands of dollars to pay for each disposable filter for each surgery; 2) the difficulty in surgically deploying the filter in addition to a balloon angioplasty; and 3) the additional surgical fee charged by the surgeon for performing a second surgical procedure associated with the filter. SUMMARY OF THE INVENTION [0018] Some embodiments of the present invention successfully address at least some of the shortcomings of the prior art by providing an assembly for filtering debris flowing in an in vivo fluid stream, the assembly comprises a balloon configured to volumetrically expand and, during at least a portion of the expansion, operatively connect with a filter, thereby expanding the filter. [0019] There is thus provided an assembly for filtering debris flowing in an in vivo fluid stream, the assembly comprising at least one balloon configured to volumetrically expand and, during at least a portion of the expansion, operatively connect with a filter, and to contract following the expansion. The assembly further comprising a filter configured to operatively connect with the at least one balloon during at least a portion of the volumetric expansion of the at least one balloon, such that the filter expands during the operative connection in order to filter debris from a fluid flowing in a fluid stream within which the expanded filter is disposed. [0020] In embodiments, the at least one balloon comprises at least one proximal portion and at least one distal portion. In embodiments, and the operative connection between the at least one balloon and the filter occurs in the at least one proximal portion. In embodiments, the operative connection between the at least one balloon and the filter occurs in the at least one distal portion. [0021] In embodiments, a maximal expansion diameter of the at least one distal portion is greater than a maximal expansion diameter of the at least one proximal portion. In embodiments, a maximal expansion diameter of the at least one proximal portion is greater than a maximal expansion diameter of the at least one distal portion. [0022] In embodiments, the at least one balloon comprises at least one angioplasty balloon. In embodiments, the at least one balloon comprises at least two balloons, at least one first balloon and at least one second balloon. [0023] In embodiments, the at least one first balloon is positioned proximally to the at least one second balloon. In embodiments, the at least one first balloon has a first maximal inflation diameter and the at least one second balloon has a second maximal inflation diameter. [0024] In embodiments, at least a portion of the filter is configured to removably connect to a luminal aspect associated with the fluid stream, in response to pressure by the at least one balloon of between at least about one atmosphere and no more than about 20 atmospheres. [0025] In embodiments, at least a portion of the filter is configured to remain removably connected to the luminal aspect during the contraction of the at least one balloon. In embodiments, the at least one balloon is configured to sequentially pass through at least two sequences of the expansion and contraction of the at least one balloon. [0026] In embodiments, at least a portion of the filter is configured to remain removably connected to a luminal aspect associated with the fluid stream during at least a portion of the at least two sequences. [0027] In embodiments, the assembly includes at least one cord operatively associated with the filter and configured to disconnect at least a portion of the filter from the luminal aspect when tension is applied to the at least one cord. [0028] In embodiments, at least a portion of the filter is configured to disconnect from the luminal aspect in response to tension applied to the at least one cord of at least about one Newton. [0029] In embodiments, at least a portion of the filter is configured to disconnect from the luminal aspect in response to tension applied to the at least one cord of no more than about 20 Newtons. [0030] In embodiments, at least a portion of the filter includes a pressure-sensitive adhesive having an affinity for a tissue associated with an in vivo luminal aspect. [0031] In embodiments, the adhesive is an adhesive from the group of adhesives comprising fibrin, biological glue, collagen, hydrogel, hydrocolloid, collagen alginate, and methylcellulose. [0032] In embodiments, at least a portion of the filter is configured to removably connect to a luminal aspect associated with the fluid stream, in response to pressure by the at least one balloon of between at least about one atmosphere and no more than about 20 atmospheres. [0033] In embodiments, at least a portion of the filter is configured to remain removably connected to the luminal aspect during the contraction of the at least one balloon. [0034] In embodiments, the at least one balloon is configured to sequentially pass through at least two sequences of the expansion and contraction of the at least one balloon. [0035] In embodiments, at least a portion of the filter is configured to remain removably connected to the luminal aspect during at least a portion the at least two sequences. [0036] In embodiments, the assembly includes at least one cord operatively associated with the filter and configured to disconnect at least a portion of the filter from the luminal aspect when tension is applied to the at least one cord. [0037] In embodiments, at least a portion of the filter is configured to disconnect from the luminal aspect in response to tension applied to the at least one cord of at least about one Newton. [0038] In embodiments, at least a portion of the filter is configured to disconnect from the luminal aspect in response to tension applied to the at least one cord of no more than about 20 Newtons. [0039] In embodiments, the assembly includes a compression sleeve comprising a substantially curved wall having a proximal end, a distal end and a lumen extending from the proximal end to the distal end, the lumen having a cross sectional diameter that is substantially smaller than the maximal cross sectional diameter of the luminal aspect and at least one cord operatively associated with the filter, at least a portion of the at least one cord slidingly juxtaposed within the compression sleeve lumen, such that in response to at least one first distal sliding of the sleeve while the at least one cord is held stationary, the filter is caused to disconnect from the luminal aspect. [0040] In embodiments, in response to at least one second distal sliding of the sleeve while the at least one cord is held stationary, the filter is caused to radially contract such that a maximal cross sectional diameter of the filter is smaller that a cross sectional diameter of the sleeve lumen. [0041] In embodiments, in response to at least one third distal sliding of the sleeve while the at least one cord is held stationary; at least a portion of the filter is caused to enter the sleeve lumen. [0042] In embodiments, the at least one balloon comprises an outer wall having a distal end and a proximal end and an inner wall defining a lumen, the lumen extending from the distal end to the proximal end, and [0043] In embodiments, at least a portion of the at least one cord is configured to slidingly pass through the lumen. [0044] In embodiments, the at least one cord is configured to pull at least a portion of the filter into contact with the distal end of the at least one balloon. [0045] In embodiments, the assembly includes a catheter having a distal end and a proximal end and a lumen extending from the distal end to the proximal end, wherein the at least one balloon proximal end is operatively associated with the distal end of the catheter. [0046] In embodiments, the at least one balloon lumen is substantially continuous with the catheter lumen. [0047] In embodiments, at least a portion of the at least one cord additionally extends through the catheter lumen. [0048] In embodiments, the filter includes a distal portion, a proximal portion, an opening to the filter associated with the proximal portion and at least one strut operatively associated with the proximal portion. [0049] In embodiments, the assembly includes at least one cord operatively associated with the at least one strut, such that at least a portion of the opening is configured to contract radially inwardly in response to tension applied to the at least one cord. [0050] In embodiments, the at least one strut comprises at least two struts operatively associated with the at least one cord. [0051] In embodiments, each of the at least two struts is configured to resiliently flex outward to form at least one expanded cross sectional diameter. [0052] In embodiments, the at least one expanded cross sectional diameter defines at least two sections, a first section having a first radius and a second section having a second radius. [0053] In embodiments, the at least one strut comprises at least six struts operatively associated with the at least one cord. [0054] In embodiments, the at least one cord comprises at least two cords and the at least one strut comprises at least two struts. [0055] In embodiments, the at least one cord comprises at least six cords and the at least one strut comprises at least six struts. [0056] In embodiments, the at least one balloon includes an inflation channel in fluid communication with an interior portion of the at least one balloon, wherein the channel is configured to inflate the at least a portion of the at least one balloon by introduction of a fluid through the inflation channel. [0057] In embodiments, the assembly includes a catheter comprising a curved wall extending proximally from the at least one balloon and the inflation channel comprises a curved wall surrounding at least a portion of the catheter. [0058] In embodiments, the at least one balloon comprises a material from the group consisting of: rubber, silicon rubber, latex rubber, polyethylene, polyethylene terephthalate, and polyvinyl chloride. [0059] In embodiments, the filter includes a distal portion, a proximal portion, an opening to the filter associated with the proximal portion, and at least one cord guide channel circumferentially encircling at least a portion the proximal portion. [0060] In embodiments, the assembly includes at least one cord, at least a portion of the at least one cord passes through the guide channel, such that at least a portion of the opening is configured to contract radially inwardly in response to tension applied to the at least one cord. [0061] In embodiments, the filter comprises a flexible sheet material and the guide channel is formed from at least one of a bending of a portion of the sheet material, and a shaped component attached to the sheet material. [0062] In embodiments, the at least one cord channel comprises at least two cord channels located substantially on the same cross sectional plane of the filter and the at least one cord comprises at least two cords. [0063] An assembly for filtering debris flowing in an in vivo fluid stream, the assembly comprising at least one balloon configured to volumetrically expand and, during at least a portion of the expansion, operatively connect with a filter, and to contract following the expansion, and a filter comprising a material having tissue connective properties for a tissue associated with an in vivo fluid stream, the filter positioned to operatively connect with the at least one balloon and removably connect to least a portion of the tissue and remain so connected during the contractions of the at least one balloon. [0064] In embodiments, the at least one balloon comprises at least one proximal portion and at least one distal portion. In embodiments, and the operative connection between the at least one balloon and the filter occurs in the at least one proximal portion. [0065] In embodiments, the operative connection between the at least one balloon and the filter occurs in the distal portion. [0066] In embodiments, a maximal expansion diameter of the at least one distal portion is greater than a maximal expansion diameter of the at least one proximal portion. [0067] In embodiments, a maximal expansion diameter of the at least one proximal portion is greater than a maximal expansion diameter of the at least one distal portion. [0068] In embodiments, the at least one balloon comprises at least one angioplasty balloon. In embodiments, the at least one balloon comprises at least two balloons, at least one first balloon and at least one second balloon. [0069] In embodiments, the at least one first balloon is positioned distally to the at least one second balloon. In embodiments, the at least one first balloon has a first maximal inflation diameter that a maximal inflation diameter of the second balloon. [0070] In embodiments, at least a portion of the filter is configured to removably connect to a luminal aspect associated with the fluid stream, in response to pressure by the at least one balloon of between at least about one atmosphere and no more than about 20 atmospheres. [0071] In embodiments, the at least one balloon is configured to sequentially pass through at least two sequences of the expansion and contraction of the at least one balloon. In embodiments, at least a portion of the filter is configured to remain removably connected to a luminal aspect associated with the fluid stream during at least a portion of the at least two sequences. [0072] In embodiments, the assembly includes at least one cord operatively associated with the filter and configured to disconnect at least a portion of the filter from a luminal aspect associated with the fluid stream when tension is applied to the at least one cord. [0073] In embodiments, at least a portion of the filter is configured to disconnect from a luminal aspect associated with the fluid stream when the applied tension to the at least one cord is between at least about one Newton and no more than about 20 Newtons. [0074] In embodiments, at least a portion of the filter includes a pressure-sensitive adhesive having an affinity for a tissue associated with an in vivo luminal aspect. In embodiments, the adhesive is an adhesive from the group of adhesives comprising fibrin, biological glue, collagen, hydrogel, hydrocolloid, collagen alginate, and methylcellulose. [0075] In embodiments, at least a portion of the filter is configured to removably connect to a luminal aspect associated with the fluid stream, in response to pressure by the at least one balloon of between at least about one atmosphere and no more than about 20 atmospheres. [0076] In embodiments, the at least one balloon is configured to contract following the expansion and at least a portion of the filter is configured to remain removably connected to the luminal aspect during the at least one balloon contraction. [0077] In embodiments, the at least one balloon is configured to sequentially pass through at least two sequences of the expansion and contraction of the at least one balloon. [0078] In embodiments, at least a portion of the filter is configured to remain removably connected to the luminal aspect during at least a portion the at least two sequences. [0079] In embodiments, the assembly includes at least one cord operatively associated with the filter and configured to disconnect at least a portion of the filter from the luminal aspect when tension is applied to the at least one cord. In embodiments, at least a portion of the filter is configured to disconnect from the luminal aspect in response to tension applied to the at least one cord of between at least about one Newton and no more than about 20 Newtons. [0080] There is thus provided a method for collecting debris from a stenotic lesion associated with a primary stenotic vessel while preventing passage of the debris into a branch vessel branching from the primary vessel, the method comprising detecting the stenotic lesion in the primary stenotic vessel, locating a filter in the primary stenotic vessel such that an opening of the filter is distal to a center of the stenotic lesion, locating at least a proximal portion an angioplasty balloon proximal to the opening in the filter, expanding the angioplasty balloon, contacting the opening of the filter with at least a distal portion of the angioplasty balloon during the expanding, causing the filter to open during the contacting, generating debris from the stenotic lesion by the expanding of the angioplasty balloon, capturing the debris in the filter, preventing passage of the debris into the branch vessel by the contacting of the opening of the filter with the at least a distal portion of the angioplasty balloon, contracting disengaging the angioplasty balloon, and removing the angioplasty balloon from the primary stenotic vessel. [0081] In embodiments, the method further comprises contracting the filter. In embodiments, the method further comprises removing the filter from the primary stenotic vessel. [0082] There is thus provided a method for collecting debris within a blood vessel, the method comprising juxtaposing an opening of an in vivo debris filter with at least one balloon, expanding the at least one balloon in a blood vessel, opening the filter during the expansion of the at least one balloon, collecting debris within the filter, disengaging the at least one balloon from the filter, and removing the at least one balloon from the vessel. [0083] In embodiments, the method further comprises contracting the filter, and removing the filter from the blood vessel. In embodiments, the method further comprises contacting a stenotic vascular lesion during the expanding. [0084] In embodiments, the method further comprises compressing the lesion during the expanding. In embodiments the method further comprises releasing debris from the lesion during the compressing. BRIEF DESCRIPTION OF THE DRAWINGS [0085] The invention for safely collecting debris using a debris filter positioned in assembly with an angioplasty balloon is described by way of example with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred method of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the methods of the invention may be embodied in practice. [0086] FIG. 1 a - 1 d show deployment of an in vivo filter and balloon assembly in a vessel shown in cross section, according to an embodiment of the invention; and [0087] FIGS. 2 a - 2 d, 3 a - 3 c, 4 , and 5 a - 5 e show alternative embodiments of the filter and balloon assembly shown in FIGS. 1 a - 1 d, according to the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0088] The present invention relates to an in vivo filter that is biased to an open position in conjunction with inflation of an angioplasty balloon. In an exemplary embodiment, during balloon inflation against a stenotic lesion, the balloon presses the outer surface of the filter into a luminal aspect directly upstream from the lesion to capture stenotic debris. The filter maintains thus positioned throughout multiple angioplasty inflations and deflations, following which cords are used to remove the filter from the lumen. [0089] The principles and uses of the teachings of the present invention may be better understood with reference to the accompanying description, Figures and examples. In the Figures, like reference numerals refer to like parts throughout. [0090] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth herein. The invention can be implemented with other embodiments, and can be practiced or carried out in various ways. [0091] It is also understood that the phraseology and terminology employed herein is for descriptive purpose and should not be regarded as limiting. [0092] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. In addition, the descriptions, materials, methods, and examples are illustrative only and not intended to be limiting. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. [0093] As used herein, the terms “comprising” and “including” or grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. This term encompasses the terms “consisting of” and “consisting essentially of”. [0094] As used herein, “a” or “an” mean “at least one” or “one or more”. The use of the phrase “one or more” herein does not alter this intended meaning of “a” or “an”. Filter Assembly 100 [0095] FIG. 1 a shows an exemplary representation of an in vivo debris filter assembly 100 of the present invention, in a cross section of a blood vessel 141 . A filter 122 is shown in a contracted, pre-dilated, position with loose cords 110 attached to two struts 128 that are connected to filter 122 . Cords 110 exit filter 122 and pass through a lumen 138 and into and through a catheter 132 . Cords 110 typically exit lumen 138 ex vivo, thereby allowing ex vivo manipulation by an operator. [0096] A balloon 130 projects downstream of catheter 132 and is positioned adjacent a stenotic lesion 144 . Balloon 130 typically comprises a biologically compatible elastomeric material, or semi compliance material, for example: rubber, silicon rubber, latex rubber, polyethylene, polyethylene terephthalate, Mylar, and/or polyvinyl chloride. [0097] In FIG. 1 b, balloon 130 has been inflated by introducing fluid through a fluid channel 148 that is substantially coaxial to catheter 130 . During inflation of balloon 130 , after the diameter of balloon 130 reaches the distance between struts 128 , continued inflation of balloon 130 causes struts 128 to bias radially outwardly, thereby expanding filter 122 . [0098] Once inflated, filter 122 filters debris 160 that is released from stenotic lesion 144 and continues to filter debris 160 even as balloon 130 is deflated, as explained below. [0099] While filter 122 is shown in an expanded position as a generally curved structure, balloon 130 may alternatively have a variety of shapes, including a conus having an apex located downstream of balloon 130 . [0100] Filter 122 typically comprises a mesh sheet material that is configured to filter debris 160 from a lumen 142 . Filter 122 typically includes apertures having diameters of between at least about 20 microns and no more than about 200 microns in diameter. [0101] Additionally, filter 122 and/or struts 128 , are configured to flex outward until such flexion is limited by a luminal aspect 140 , for example a diameter of between 3.0 and 6.0 millimeters, depending on the size of lumen 142 in which filter 122 is deployed. [0102] In further embodiments, portions of filter 122 and/or struts 128 comprise super elastic material, for example nitinol; an elastic material; and/or a plastic material; the many materials and their properties being well-known to those familiar with the art. [0103] Similarly balloon 130 has an inflation diameter of between 3.0 and 6.0 millimeters, depending on the cross sectional diameter of lumen 142 . In larger vessels 141 , balloon 130 and filter 122 optionally are manufactured to have larger maximal diameters. In smaller vessels, for example to cut down on the bulk of deflated balloon 130 and filter 122 , smaller maximal diameters are optionally appropriate. [0104] Filter 122 comprises materials and/or apertures that aid in removably connecting filter 122 to an in vivo luminal aspect 140 . In this manner, filter 122 remains connected to luminal aspect 140 for a period of time after balloon 130 has deflated, herein contracted, by egress of fluid through channel 148 . By remaining in contact with luminal aspect 140 , filter 122 continues to filter debris 160 that may be released into lumen 142 from lesion 144 while balloon 130 is in a contracted state. [0105] In some embodiments, the material and configuration of filter 122 ensures that filter 122 remains removably connected to luminal aspect 140 following deflation of balloon 130 . In other embodiments, filter 122 includes a pressure sensitive adhesive having an affinity for luminal aspect 140 so that the adhesive, optionally in conjunction with the material of filter 130 , remain removably connect to vessel luminal aspect 140 following deflation of balloon 130 . [0106] There are many adhesives that may be contemplated for use in providing a removable connection of filter 122 to luminal aspect 140 including, inter alia: fibrin, biological glue, collagen, hydrogel, hydrocolloid, collagen alginate, and methylcellulose, to name a few. [0107] Whether filter 122 comprises a mesh material alone or in combination with an adhesive, filter 122 is optionally configured to removably connect to luminal aspect 140 from a pressure exerted by balloon 130 of, for example, between one and twenty atmospheres. [0108] In further exemplary embodiments, for example when there is continued danger of debris 160 being generated after lesion 144 has been compressed, balloon 130 is optionally deflated and removed from lumen 142 while filter 122 is left in place. Filter 122 optionally is left connected to luminal aspect 140 by the configuration of filter 122 and/or biological glues noted above until the danger of generation of debris 160 has passed. [0109] As noted above, during a typical balloon angioplasty, balloon 130 is sequentially inflated to a pressure of several atmospheres and deflated. In exemplary embodiments, filter 122 remains removably connected to luminal aspect 140 following the first inflation of balloon 130 and throughout several sequences of inflation and deflation. [0110] As filter 122 is deployed relatively proximate to lesion 144 where luminal aspect 140 generally comprises unhealthy tissue, the chance that filter 122 will cause damage to healthy tissue of luminal aspect 140 is very low. [0111] Additionally, the proximity of filter 122 to balloon 130 substantially lowers the odds that a branch artery will be located between filter 122 and balloon 130 , to act as a conduit for debris 160 . Further, as balloon 130 and filter 122 are deployed on single catheter 132 , the cost for each assembly 100 should be lower than existing technology employing a separate filter. Moreover, as assembly 100 includes balloon 130 and filter 122 mounted on a single catheter, the complexity of manufacture, deployment and the surgical fees to the surgeon should be reduced over existing technology. [0112] As seen in FIG. 1 c, after stenotic lesion 144 has been cracked and squashed radially outwards, balloon 130 is deflated and filter 122 remains in an expanded state and continues to capture debris 160 . As the fluid contained in lumen 142 is moving in a direction 162 , in a distal or downstream direction with respect to filter 122 , debris 160 remains in place, captured within filter 122 . [0113] As used herein, the terms distal and distally refer to a position and a movement, respectively, in downstream direction 162 . [0114] To disconnect filter 122 from luminal aspect 140 , cords 110 are pulled proximally, upstream, in a direction 164 . As used herein, the terms proximal and proximally refer to a position and a movement, respectively, in upstream direction 164 . [0115] While cords 110 , as shown, pass through catheter lumen 138 , in alternative embodiments, cords 110 pass to the side of balloon 130 without passing through a lumen 138 . Further, while balloon 130 is shown attached to catheter, 132 , there are many alternative options for delivering balloon 130 and filter 122 , for example using a guide wire. Those familiar with the art will readily recognize the many alternative modes and configurations available for delivery and operation of balloon 130 and filter 122 . [0116] In an exemplary embodiment, filter 122 is configured to disconnect from luminal aspect 140 in response to tension applied to cords 110 of at least about one Newton and no more than about 20 Newtons. [0117] As the diameter of lumen 142 is larger than the diameter of catheter lumen 138 , continued upstream pull in direction 164 on cords 110 , biases the proximal portions of struts 128 radially inward, causing the proximal edges of filter 122 to move radially inward so that filter 122 disconnects from luminal aspect 140 . Following disconnection of filter 122 from luminal aspect 140 , continued pulling of cords 110 in direction 164 causes struts 128 to inwardly bias, thereby reducing the upstream cross sectional diameter of filter 122 . [0118] As the fluid in lumen 142 travels distally in direction 162 , pulling catheter 132 and filter 122 in proximal direction 164 causes debris 160 to move downstream against filter 122 so that debris 160 remains captured by filter 122 . [0119] Thus, filter 122 maintains captured debris 160 even when there is a distance between struts 128 , as might occur when there is considerable volume of debris 160 , for example in large arteries. Optionally, cords 110 are pulled in direction 164 until a portion of filter 122 contacts balloon 130 and/or enters catheter lumen 138 . [0120] While two struts 128 are shown connected to two cords 110 , the present embodiments, contemplate four or even eight struts 128 , with each strut 128 , or each pair of struts 128 , being attached to individual cords 110 that remove filter 122 from luminal aspect 140 . [0121] Alternatively, assembly 100 contemplates using a single strut 128 with a single cord 110 connected to single strut 128 that encircles filter 122 and slidingly attaches to strut 128 in a lasso configuration. Pulling on single cord 110 causes contraction of struts 128 and of the associated cross-sectional circumference of filter 122 , thereby preventing egress of debris 160 filter 122 . The many options available for configuring cords 110 and struts 128 to effectively close filter 122 are well known to those familiar with the art. Filter Assembly 200 [0122] FIG. 2 a shows an exemplary embodiment of an assembly 200 in which a single cord 112 passes distally in direction 162 through catheter lumen 138 . Cord 112 then curves within filter 122 to pass in a proximal direction 164 into a cord inlet 184 and through a cord channel 120 . Cord channel 120 guides cord 112 circumferentially around filter 122 . After circling filter 122 , cord 112 exits channel 120 through cord outlet 186 and passes distally in direction 162 into filter 122 . Cord 112 then curves within filter 122 to pass in a proximal direction 164 into and through catheter lumen 138 . [0123] In this manner both ends of cord 112 exit catheter lumen 138 and, by pulling both ex vivo ends of cord 112 in direction 164 , filter 122 is contracted along channel 120 , as seen in FIG. 2 d. While a single cord 112 is shown, channel 120 optionally comprises multiple pairs of inlets 184 and outlets 186 , each associated with a separate cord 112 . The many configurations and modifications of channel 120 , inlet 184 , and outlet 186 are well known to those familiar with the art. [0124] FIG. 2 d shows an exemplary embodiment of a tubular compression sleeve 134 that is coaxial with catheter 132 . Sleeve 134 has been slidingly pushed through vessel lumen 142 in direction 162 until sleeve 134 approaches filter 122 . [0125] In an exemplary embodiment, pulling cord 112 and/or catheter 132 in direction 164 while holding sleeve 134 substantially stationary pulls filter 122 into compression sleeve 134 . Alternatively, compression sleeve 134 is advanced in direction 162 while catheter 132 and/or cord 110 are held substantially stationary. [0126] In an exemplary embodiment, compression sleeve 134 serves as a housing for filter 122 to prevent filter 122 from scraping along luminal aspect 140 during removal from lumen 142 . Additionally or alternatively, compression sleeve 134 serves to compress filter 122 into a smaller maximal circumferential diameter so that filter 122 more easily passes through lumen 142 during removal of filter 122 . Balloon Assembly 300 [0127] In embodiments, balloon 130 optionally includes alternative shapes, for example having varied cross sectional diameters. As seen in assembly 300 ( FIG. 3 a ), the diameter associated with a distal portion 133 of deflated balloon 130 is larger than the diameter associated with a proximal portion 139 . [0128] As seen in FIG. 3 b, filter 122 reaches a maximal diameter initially as distal balloon portion 133 inflates. In this manner, filter 122 is fully in position and expanded prior to inflation of proximal balloon portion 139 . [0129] As seen in FIG. 3 c, proximal balloon portion 139 has been fully inflated to compress lesion 144 , thereby releasing debris 160 that is captured by filter 122 . The many options for configuring alternative shapes of balloon 130 are well known to those familiar with the art. Balloon and Filter Assembly 400 [0130] There are additionally many methods of assembling filter 122 and balloon 130 , as seen in assembly 400 ( FIG. 4 ). In a non-limiting embodiment, balloon 130 is seen having an overall length 209 of approximately 38 millimeters and a maximal inflation diameter 211 of approximately 5 millimeters. [0131] Additionally, balloon 130 is shown with a proximal portion 207 having a length 235 of approximately 18 millimeters and a distal portion 208 having a length 233 of approximately 18 millimeters. [0132] In an exemplary embodiment, filter 122 extends to substantially cover distal portion 208 while proximal portion 207 is unprotected by filter 122 . [0133] In alternative configurations of assembly 400 , filter 122 optionally substantially fully covers distal balloon portion 208 and extends over at least a portion of proximal balloon portion 207 ; the many configurations of assembly 400 being well known to those familiar with the art. Dual Balloon Assembly 500 [0134] Assembly 500 ( FIGS. 5 a - 5 e ) demonstrates just one more of the many embodiments of the instant invention that are easily contemplated by those familiar with the art. Assembly 500 comprises a proximal balloon 230 and a distal balloon 101 . As seen in FIG. 5 b, distal balloon 101 is inflated to expand filter 122 and substantially take up the volume within filter 122 . As seen in FIG. 5 c, proximal balloon 230 is inflated separately and pressed against lesion 144 . [0135] After deflation of proximal balloon 230 as seen in FIG. 5 d, distal balloon 101 remains inflated so that debris 160 remains proximal to distal balloon 101 . Upon deflation of distal balloon 101 , debris 160 enters and is captured by filter 122 . Alternative Environments [0136] While assemblies 100 - 500 have been described with respect to vessel 141 , assemblies 100 - 500 can be easily configured for use in a wide variety of in vivo lumens 142 including inter alia: a lumen of a urethra, a biliary lumen and/or a renal calyx lumen. Additionally or alternatively, filter 122 can be easily modified to capture debris in virtually any in vivo lumen 142 including, inter alia: biliary stones and/or renal stones. The many applications, modifications and configurations of assemblies. 100 - 500 for use in virtually any in vivo lumen 142 will be readily apparent to those familiar with the art. Materials and Design [0137] In embodiments, filter 122 comprises a sheet material configured to extend distally with respect to balloon 130 while filter 122 is expanded. In embodiments, the sheet material of filter 122 is selected from the group consisting of: meshes and nets. [0138] In embodiments, bending of a portion of the sheet material of filter 122 forms filter cord channel 120 . In embodiments, attaching a shaped component to filter 122 forms filter cord channel 120 . [0139] In embodiments, the material of filter 122 has a thickness of at least about 20 microns. In embodiments, the material of filter 122 has a thickness of no more than about 200 microns. In embodiments, the material of filter 122 includes apertures having diameters of at least about 20 microns. In embodiments, the material of filter 122 includes apertures having diameters of no more than about 80 microns in diameter. In embodiments, the material of filter 122 is manufactured using a technique from the group of techniques consisting of: interlacing, knitting, weaving, braiding, knotting, wrapping, and electro spinning. [0140] In embodiments, filter 122 is configured to expand to a cross sectional diameter of at least about 1.0 millimeters. In embodiments, filter 122 is configured to expand to a cross sectional diameter of no more than about 6.0 millimeters. In embodiments, the extent of the expansion of filter 122 is configured to be limited by the walls of luminal aspect 140 in which filter 122 is deployed. [0141] In embodiments, balloon 130 has a maximum inflation diameter of at least about 1.0 millimeter. In embodiments, balloon 130 has a maximum inflation diameter of no more than about 6.0 millimeters. [0142] In embodiments, balloon 130 has a wall thickness of at least about 0.2 millimeters. In embodiments, balloon 130 has a wall thickness of no more than about 0.5 millimeters. [0143] In embodiments, strut 128 has a substantially circular cross section having a diameter of at least about 0.1 millimeters. In embodiments, strut 128 has a substantially circular cross section having a diameter of no more than about 0.6 millimeters. [0144] In embodiments, strut 128 has a cross section having greater and lesser measurements and the greater measurement is at least about 0.1 millimeters. In embodiments, strut 128 has a cross section having greater and lesser measurements and the greater measurement is no more than about 0.6 millimeters. In embodiments, strut 128 has a cross section having greater and lesser measurements and the lesser measurement is at least about 0.1 millimeters. In embodiments, strut 128 has a cross section having greater and lesser measurements and the lesser measurement is no more than about 0.6 millimeters. [0145] In embodiments, filter 122 has an internal and an external aspect and strut 128 is attached to the internal aspect or the external aspect of filter 122 . In embodiments, strut 128 is attached to filter 122 using a process selected from the group consisting of: sewing, adhesion, gluing, suturing, riveting and welding. [0146] In embodiments, cord channel 120 comprises at least two cord channels; and cord 112 comprises at least two cords. [0147] In embodiments, catheter 132 has an outside diameter of at least about 1.0 millimeter. In embodiments, catheter 132 has an outside diameter of no more than about 5.0 millimeters. In embodiments, catheter 132 has a length of at least about 0.8 meter. In embodiments, catheter 132 has a length of no more than about 1.5 meters. [0148] In embodiments, the walls of catheter 132 compression sleeve 134 have a thickness of at least about 2 millimeters. In embodiments, the walls of catheter 132 compression sleeve 134 have a thickness of more than about 5 millimeters. [0149] In embodiments, filter 122 , cord 110 ( FIG. 1 a ) and cord 112 ( FIG. 2 a ), strut 128 , compression sleeve 134 , and catheter 132 , comprise a material from the group consisting of: polyethylene, polyvinyl chloride, polyurethane and nylon. [0150] In embodiments, filter 122 , cord 110 ( FIG. 1 a ) and cord 112 ( FIG. 2 a ), strut 128 , compression sleeve 134 , and catheter 132 , comprise a material selected from the group consisting of: nitinol, stainless steel shape memory materials, metals, synthetic biostable polymer, a natural polymer, and an inorganic material. In embodiments, the biostable polymer comprises a material from the group consisting of: a polyolefin, a polyurethane, a fluorinated polyolefin, a chlorinated polyolefin, a polyamide, an acrylate polymer, an acrylamide polymer, a vinyl polymer, a polyacetal, a polycarbonate, a polyether, an aromatic polyester, a polyether (ether keto), a polysulfone, a silicone rubber, a thermoset, and a polyester (ester imide). [0151] In embodiments the natural polymer comprises a material from the group consisting of: a polyolefin, a polyurethane, a Mylar, a silicone, a polyester and a fluorinated polyolefin. [0152] In embodiments, filter 122 , cord 110 ( FIG. 1 a ) and cord 112 ( FIG. 2 a ), strut 128 , compression sleeve 134 , and catheter 132 , comprise a material having a property selected from the group consisting of: compliant, flexible, plastic, and rigid. [0153] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. [0154] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. [0155] Accordingly, the invention is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Disclosed is an assembly for filtering debris flowing in an in vivo fluid stream, the assembly comprising at least one balloon configured to volumetrically expand and, during at least a portion of the expansion, operatively connect with a filter, and to contract following the expansion. The assembly further comprising a filter configured to operatively connect with the at least one balloon during at least a portion of the volumetric expansion of the at least one balloon, such that the filter expands during the operative connection in order to filter debris from a fluid flowing in a fluid stream within which the expanded filter is disposed.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority and benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/013,423 filed Jun. 17, 2014, which is incorporated herein in its entirety by reference. FIELD OF THE INVENTION [0002] The present invention relates to an exoskeleton device for use in rehabilitation of a person's body part, and method of using the same. In some instances, the person may be recovering from a stroke or a spinal cord injury. BACKGROUND OF THE INVENTION [0003] Many accidents or ailments can result in a person losing function in a body part. For example, nearly 800,000 individuals in the United States experience a new or recurring stroke every year, and the resulting hemiparesis can impair the motor function of a stroke survivor. There are also approximately 12,000 incidences of Spinal Cord Injury (SCI) in the United States each year. In moderate to severe cases, a person may undergo physical therapy in order to restore function to the impaired body part. [0004] Physical therapy is the typical rehabilitation procedure for a person who loses function in a body part, including people who survive a stroke or a spinal cord injury. Some types of physical therapy require one-on-one physical interaction between a therapist and the injured person. While effective in many instances, these types of physical therapy can have several limitations. Due to human nature, different physical therapists may have different techniques, different systems or programs, and different levels of proficiency that result in a wide variety of outcomes for the injured person. In addition, a physical therapist may have difficulty in objectively evaluating the performance of an injured person with quantitative metrics such as the force generated by the injured person's body part or the precise movement trajectory or range of motion of the person's body part expressed in angles, distance, and other similar metrics. A physical therapist may also have difficulty in precise and repeatable application of forces, torques or trajectories to the person's body part. [0005] Some attempts have been made to incorporate machines or robots into the physical therapy process to address some of the deficiencies outlined above. Some examples may be found in U.S. Patent Publication Nos. 2010/0280628, 2008/0009771, 2012/0330198, 2007/0225620, and 2011/0313331, which are incorporated herein in their entireties by reference. In another example, a wrist and upper extremity motion system is described in U.S. Pat. No. 7,618,381 (“the '381 patent”), which is incorporated herein in its entirety by reference. The '381 patent describes a system that secures a person's forearm and permits movement of the person's arm and hand in multiple degrees of freedom. However, the design described in the '381 patent relies on multiple motors interconnected to differential motors and gear systems. This configuration physically limits the range of motion of the person's arm, wrist, and hand in some directions and allows backlash which can deteriorate fidelity of force feedback. The '381 patent presents an “open on top” design, which requires use of limited number of bearings/guides that cannot provide support across a complete rotation. This configuration requires use of bulkier or heavier materials and parts to ensure device rigidity or structural integrity. [0006] These deficiencies, among others, are addressed in the present invention described in detailed below. SUMMARY OF THE INVENTION [0007] It is therefore an aspect of the present invention to provide an exoskeleton device that supports a full range of motion for the distal end of a person's limb in multiple degrees of freedom. In some embodiments, the distal end of a person's limb can be a person's arm, wrist, and hand. However, it will be appreciated that while some embodiments of the present invention are described with respect to a person's arm, wrist, and hand, embodiments of the invention may apply to other joints such as the leg, neck, etc. [0008] A pronation/supination (P/S) motion refers to the inward and outward twisting of a person's forearm along the length of the person's forearm, and thus one degree of freedom may be an axis of rotation along the length of the person's forearm. A flexion/extension (F/E) movement refers to an articulation of the wrist joint such that the palm travels toward and away from the forearm, and an adduction/abduction (A/A) movement refers to an articulation of the wrist joint such that the thumb side of the hand bends toward and away from forearm. The axes of the A/A and F/E movements through the wrist joint may be second and third degrees of freedom of the exoskeleton device, with respect to the device base. Some embodiments of the invention are directed to a combination of two of the above degrees of freedom, and various embodiments of the invention are directed to three or more degrees of freedom. [0009] Another aspect of the present invention is to provide an exoskeleton device that has a ring bearing located between a limb rest and a handle. This configuration allows a person to rest the upper portion of the person's forearm and grasp a handle of the exoskeleton device without other components of the exoskeleton interfering with the person's arm between the limb rest and the handle. This feature enables a person to have a full range of motion when engaging the exoskeleton device, which is critical to physical therapy. [0010] Some embodiments of the invention provide an exoskeleton that enables three degrees of freedom where a F/E assembly is nested within an A/A assembly, which in turn is nested within a P/S assembly. Each assembly allows for one degree of freedom, and the various assemblies are operably interconnected to each other via bearings or other devices that allow free movement of the various assemblies. Therefore, a person's wrist may be articulated in any direction and engage each available degree of freedom simultaneously. [0011] Some embodiments of the invention provide an exoskeleton device that has multiple modes of operation. In a resistive mode, actuators resist a person's movement in a degree of freedom. If a person moves their arm in a pronation direction, the actuator can resist this movement to help the person, for example, build up muscle strength in that particular movement. In contrast, in an active mode, the actuator can assist or supplement the person's strength to achieve a greater range of motion. This may be beneficial, for example, at an early stage of physical therapy when a person is simply trying to regain a full range of motion. In another mode of operation, the actuators may passively allow a person to freely move the person's arm, wrist, and hand. This passive mode is useful to objectively evaluate the limb's current strength and range of motion. [0012] An aspect of the invention is an exoskeleton device for articulating a limb. The device includes a base with a first pronation/supination (P/S) bearing and a second P/S bearing. The first P/S bearing is a ring bearing that is configured to receive a portion of a limb through it. The device includes a P/S assembly operably interconnected to the base via the first and second P/S bearings. A P/S actuator is operably interconnected to the P/S assembly to rotate the P/S assembly about an axis. The P/S axis, and the P/S assembly has a first auxiliary bearing. The actuator can be connected to the P/S assembly via a cable drive mechanism which involves a capstan and a pulley, to avoid backlash, to reduce friction and to improve force feedback fidelity. The device includes an auxiliary assembly operably interconnected to the P/S assembly via the first auxiliary bearing. An auxiliary actuator is operably interconnected to the auxiliary assembly to rotate the auxiliary assembly about an auxiliary axis. The device also includes a securing feature operably interconnected to the auxiliary assembly. The securing feature is configured to selectively interconnect to a portion of the limb. [0013] An aspect of the invention is an apparatus for articulating a limb. The apparatus includes a base having a first P/S bearing and a second P/S bearing. The apparatus includes a P/S assembly operably interconnected to the base via the first and second P/S bearings. The P/S actuator is operably interconnected to the P/S assembly in order to rotate the P/S assembly about a P/S axis. The P/S assembly includes a first abductor/adductor (A/A) bearing. An A/A assembly is operably interconnected to the P/S assembly via the first A/A bearing. The A/A actuator is operably interconnected to the A/A assembly to rotate the A/A assembly about an A/A axis. The A/A assembly includes a first flexion/extension (F/E) bearing. The F/E assembly is operably interconnected to the A/A assembly via the first F/E bearing. The F/E actuator is operably interconnected to the F/E assembly to rotate the F/E assembly about a F/E axis. The F/E assembly also has a securing feature that is configured to selectively interconnect to a portion of a limb. [0014] An aspect of the invention is an exoskeleton device for articulating a limb. The device includes a base having a first P/S bearing and a second P/S bearing, wherein the first P/S bearing is a ring bearing configured to receive a portion of a limb through the first P/S bearing. The P/S assembly is operably interconnected to the base via the first and second P/S bearings. The P/S actuator is interconnected to the base, and is operably interconnected to the P/S assembly to rotate the P/S assembly about a P/S axis. The P/S assembly has a first F/E bearing and a second F/E bearing. The F/E assembly is operably interconnected to the P/S assembly via the first and second F/E bearings. The F/E actuator is interconnected to the P/S assembly, and the F/E actuator is operably interconnected to the F/E assembly to rotate the F/E assembly about a F/E axis. The F/E axis is substantially perpendicular to the P/S axis. A handle is operably interconnected to the F/E assembly and is configured to selectively interconnect to a portion of the limb. The handle has a handle axis that is substantially parallel to the F/E axis. The handle axis is offset from the F/E axis by an adjustable distance. A limb rest is operably interconnected to the base, and has a vertical adjustment feature that raises and lowers the limb rest relative to the P/S axis, and a lateral adjustment feature that extends and retracts the limb rest relative to said first P/S bearing. [0015] Another aspect of the invention is a method for operating the exoskeleton device. The method may be performed manually or using a program, such as a software program. The method allows for a user to engage a limb to the device and measure or train the different variables associated with the limb. [0016] The method may include an interface, such as a visual interface or virtual environment displayed on a screen or monitor. The interface can contain game-like elements and tasks assigned to the user of the invention for therapy or exercise purposes. The limb of the user coupled with the exoskeleton may act as a controller for the visual interface or tasks. [0017] These and other advantages will be apparent from the disclosure of the present invention(s) contained herein. The above-described embodiments, objectives, and configurations are neither complete nor exhaustive. The Summary of the Invention is neither intended nor should it be construed as being representative of the full extent and scope of the present invention. Moreover, references made herein to “the present invention” or aspects thereof should be understood to mean certain embodiments of the invention and should not necessarily be construed as limiting all embodiments to a particular description. The present invention is set forth in various levels of detail in the Summary of the Invention as well as in the attached drawings and Detailed Description and no limitation as to the scope of the present invention is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary of the Invention. Additional aspects of the present invention will become more readily apparent from the Detailed Description particularly when taken together with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the disclosure and together with the general description of the disclosure given above and the detailed description of the drawings given below, serve to explain the principles of the disclosures. [0019] FIG. 1 is a perspective view of an exoskeleton device with two degrees of freedom in accordance with various embodiments of the invention; [0020] FIG. 2 is a perspective view of the exoskeleton device of FIG. 1 wherein one assembly has been rotated in accordance with various embodiments of the invention; [0021] FIG. 3 is a side elevation view of the exoskeleton device of FIG. 1 in accordance with various embodiments of the invention; [0022] FIG. 4 is a top plan view of the exoskeleton device of FIG. 1 in accordance with various embodiments of the invention; [0023] FIG. 5 is a perspective view of an exoskeleton device with three degrees of freedom in accordance with various embodiments of the invention; and [0024] FIG. 6 is another perspective view of the exoskeleton device of FIG. 5 in accordance with various embodiments of the invention. [0025] To assist in the understanding of the embodiments of the present invention the following list of components and associated numbering found in the drawings is provided herein: COMPONENT NO. COMPONENT [0000] 2 Exoskeleton Device 4 Base 6 Limb Rest 8 Pronation/Supination (P/S) Assembly 10 P/S Longitudinal Frame 12 P/S Lateral Frame 14 First P/S Bearing 16 Second P/S Bearing 18 P/S Actuator 20 P/S Pulley 22 P/S Axis 24 Flexion/Extension (F/E) Assembly 26 First F/E Bearing 28 Second F/E Bearing 30 F/E Axis 32 Handle 34 Handle Axis 36 F/E Actuator 38 F/E Pulley 40 Vertical Adjustment Feature 42 Lateral Adjustment Feature 44 Abductor/Adductor (A/A) Assembly 46 A/A Lateral Frame 48 A/A First Bearing 50 A/A Second Bearing 52 A/A Actuator 54 A/A Pulley 56 A/A Axis [0054] It should be understood that the drawings are not necessarily to scale, and various dimensions may be altered. In certain instances, details that are not necessary for an understanding of the present invention or that render other details difficult to perceive may have been omitted. It should be understood, of course, that the present invention is not necessarily limited to the particular embodiments illustrated herein. DETAILED DESCRIPTION [0055] The present invention has significant benefits across a broad spectrum of endeavors. It is the Applicant's intent that this specification and the claims appended hereto be accorded a breadth in keeping with the scope and spirit of the present invention being disclosed despite what might appear to be limiting language imposed by the requirements of referring to the specific examples disclosed. To acquaint persons skilled in the pertinent arts most closely related to the present invention, a preferred embodiment that illustrates the best mode now contemplated for putting the present invention into practice is described herein by, and with reference to, the annexed drawings that form a part of the specification. The exemplary embodiment is described in detail without attempting to describe all of the various forms and modifications in which the present invention might be embodied. As such, the embodiments described herein are illustrative, and as will become apparent to those skilled in the arts, and may be modified in numerous ways within the scope and spirit of the present invention. [0056] Although the following text sets forth a detailed description of numerous different embodiments, it should be understood that the detailed description is to be construed as exemplary only and does not describe every possible embodiment since describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims. To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term by limited, by implication or otherwise, to that single meaning. [0057] An aspect of the invention is an exoskeleton device for articulating a limb. The device includes a base with a first pronation/supination (P/S) bearing and a second P/S bearing. The first P/S bearing is a ring bearing that is configured to receive a portion of a limb through it. The device includes a P/S assembly operably interconnected to the base via the first and second P/S bearings. A P/S actuator is operably interconnected to the P/S assembly to rotate the P/S assembly about an axis, the P/S axis, and the P/S assembly has a first auxiliary bearing. The device includes an auxiliary assembly operably interconnected to the P/S assembly via the first auxiliary bearing. An auxiliary actuator is operably interconnected to the auxiliary assembly to rotate the auxiliary assembly about an auxiliary axis. The device also includes a securing feature operably interconnected to the auxiliary assembly. The securing feature is configured to selectively interconnect to a portion of the limb. [0058] In embodiments of the device, the securing feature can be a handle. The handle can rotate about a handle axis, which can be substantially parallel to the auxiliary axis. The handle axis can be offset from the auxiliary axis by a predetermined distance. The predetermined distance can be between about 0.5 inches to about 4 inches. In some embodiments, the predetermined distance can be about 0.5 inches, about 1 inches, about 1.5 inches, about 2 inches, about 2.5 inches, about 3 inches, about 3.5 inches, or about 4 inches, or any distance between about 0.5 inches and about 4 inches. In some embodiments, the P/S axis and the auxiliary axis can be substantially perpendicular to each other. In some embodiments, the P/S axis can be offset from the auxiliary axis by a predetermined distance. In some embodiments, the P/S axis and the auxiliary axis may be offset by an angle between about 5 degrees and about 90 degrees. In some embodiments, the P/S axis and the auxiliary axis may be offset by an angle of about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees, or about 90 degrees, or any degree between about 5 degrees and about 90 degrees. [0059] A rotation range of the P/S assembly about the P/S axis from a P/S datum position can be between approximately −70 degrees and 85 degrees. In some embodiments, the rotational range may be between any suitable sub range, including about −60 degrees to about 80 degrees, about −50 degrees to about 60 degrees, about −30 degrees to about 85 degrees, about −30 degrees to about 0 degrees, about −70 degrees to about 0 degrees, about 0 degrees to about 85 degrees. In some embodiments, the auxiliary assembly can rotate the limb about a A/A axis or a F/E axis. The rotation range of the A/A assembly about the A/A axis from an A/A datum position can be between approximately −20 degrees and 35 degrees. The rotational range may be any suitable sub range, including between about −20 degrees about 0 degrees, about −20 degrees to about 30 degrees, about −10 degrees to about 0 degrees, about 0 degrees to about 35 degrees, about 0 degrees to about 25 degrees, or about −5 degrees to about 10 degrees. The rotation range of the F/E assembly about said F/E axis from a F/E datum position is between −70 degrees and 75 degrees. The rotational range may be any suitable sub range, including between about −70 degrees to about 0 degrees, 0 degrees to about 70 degrees, −60 to about 60 degrees, −30 to about 30 degrees, about −30 to about 75 degrees or about −70 degrees to about 30 degrees. [0060] The P/S actuator can be interconnected to the base. In some embodiments, the auxiliary actuator can be interconnected to the P/S assembly. [0061] The device can further include a second auxiliary bearing disposed on the P/S assembly. The auxiliary assembly can be operably interconnected to the P/S assembly via the second auxiliary bearing. Some embodiments of the invention to provide an exoskeleton with two or more actuators in a balanced position such that a latent or residual torque is not imparted on the degree of freedom related to the position. At least one actuator may be used for each degree of freedom. In the above example where the various assemblies are nested within each other, actuators drive the motion of the various assemblies, and the actuators are interconnected to some of the assemblies. For example, an auxiliary actuator is interconnected to the P/S assembly. If these actuators are placed on the same side of the axis about which the P/S assembly rotates, the P/S axis, then a torque is imparted on the P/S assembly. However, if these actuators are positioned on opposite sides of the P/S axis, then the torques imparted on the P/S axis are equal and in opposite directions such that the torques “cancel” out, and the various assemblies are in balance without a latent or residual torque imparted on any of the assemblies. In some embodiments, at least one weight or one spring may also be used to “cancel” out torques due to gravity. [0062] The P/S actuator and/or the auxiliary actuator can have a resistive mode, an active mode and/or a passive mode. The resistive mode can inhibit the motion of the limb. The active mode can assist the motion of the limb. The passive mode can allow for free motion of the limb. [0063] The exoskeleton device can include a limb rest, which can be operably interconnected to the base. The limb rest can have a vertical adjustment feature that raises and lowers the limb rest relative to the P/S axis. The limb rest can have a lateral adjustment feature that extends and retracts the limb rest relative to the first P/S bearing. The limb rest can be a single piece, or multiple pieces. [0064] Some or all of the apparatus may be made from metal, polymers or combinations thereof. In some embodiments, it may be beneficial to produce some or part of the apparatus from materials that make the apparatus light, but durable, such as titanium or carbon composites. In some embodiments, heavier metals, such as aluminum, may be used. [0065] The base can be integrated to a table. In some embodiments of the invention, the device is in electronic communication with a display unit. The motion of a person's limb in the multiple degrees of freedom may affect what is displayed on the display unit, such as range, resistance, force, torque, and the like, for a user or another to review. Thus, a person's movement may allow the person to interact with games or other scenarios that make the person's use of the exoskeleton device more enjoyable. [0066] An aspect of the invention is an apparatus for articulating a limb. The apparatus includes a base having a first P/S bearing and a second P/S bearing. The apparatus includes a P/S assembly operably interconnected to the base via the first and second P/S bearings. The P/S actuator is operably interconnected to the P/S assembly in order to rotate the P/S assembly about a P/S axis. The P/S assembly includes a first abductor/adductor (A/A) bearing. An A/A assembly is operably interconnected to the P/S assembly via the first A/A bearing. The A/A actuator is operably interconnected to the A/A assembly to rotate the A/A assembly about an A/A axis. The A/A assembly includes a first flexion/extension (F/E) bearing. The F/E assembly is operably interconnected to the A/A assembly via the first F/E bearing. The F/E actuator is operably interconnected to the F/E assembly to rotate the F/E assembly about a F/E axis. The F/E assembly also has a securing feature that is configured to selectively interconnect to a portion of a limb. [0067] In embodiments of the apparatus, the securing feature can be a handle. The handle can rotate about a handle axis, which can be substantially parallel to an auxiliary axis such as the A/A axis or the F/E axis. The handle axis can be offset from the F/E axis by a predetermined distance. The predetermined distance can be between about 0.5 inches to about 4 inches. In some embodiments, the predetermined distance can be about 0.5 inches, about 1 inches, about 1.5 inches, about 2 inches, about 2.5 inches, about 3 inches, about 3.5 inches, or about 4 inches, or any distance between about 0.5 inches and about 4 inches. This distance can also be made adjustable. In some embodiments, the P/S axis and the F/E axis can be substantially perpendicular to each other. In some embodiments, the P/S axis can be offset from the F/E axis by a predetermined distance, wherein the offset between two axes can be characterized as the minimum distance between the P/S axis and the F/E axis. In some embodiments, the P/S axis and the F/E axis may be offset by an angle between about 5 degrees and about 90 degrees. In some embodiments, the P/S axis and the F/E axis may be offset by an angle of about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees, or about 90 degrees, or any degree between about 5 degrees and about 90 degrees. In some embodiments, the A/A axis can be substantially perpendicular to either the P/S axis and/or the F/E axis, or may be offset by a predetermined distance or angle. In some embodiments, the A/A axis and the P/S axis can be offset by an angle between about 5 degrees and about 90 degrees. In some embodiments, the A/A axis and the P/S axis may be offset by an angle of about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees, or about 90 degrees, or any degree between about 5 degrees and about 90 degrees. In some embodiments, the A/A axis and the F/E axis can be offset by an angle between about 5 degrees and about 90 degrees. In some embodiments, the A/A axis and the F/E axis may be offset by an angle of about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees, or about 90 degrees, or any degree between about 5 degrees and about 90 degrees. [0068] A rotation range of the P/S assembly about the P/S axis from a P/S datum position can be between approximately −70 degrees and 85 degrees. In some embodiments, the rotational range may be between any suitable sub range, including about −60 degrees to about 80 degrees, about −50 degrees to about 60 degrees, about −30 degrees to about 85 degrees, about −30 degrees to about 0 degrees, about −70 degrees to about 0 degrees, about 0 degrees to about 85 degrees. The rotation range of the A/A assembly about the A/A axis from an A/A datum position can be between approximately −20 degrees and 35 degrees. The rotational range may be any suitable sub range, including between about −20 degrees about 0 degrees, about −20 degrees to about 30 degrees, about −10 degrees to about 0 degrees, about 0 degrees to about 35 degrees, about 0 degrees to about 25 degrees, or about −5 degrees to about 10 degrees. The rotation range of the F/E assembly about said F/E axis from a F/E datum position is between −70 degrees and 75 degrees. The rotational range may be any suitable sub range, including between about −70 degrees to about 0 degrees, 0 degrees to about 70 degrees, −60 to about 60 degrees, −30 to about 30 degrees, about −30 to about 75 degrees or about −70 degrees to about 30 degrees. [0069] The P/S actuator can be interconnected to the base. In some embodiments, the F/E actuator can be interconnected to the P/S assembly, the A/A assembly or the base. In some embodiments, the A/A actuator can be interconnected to the P/S assembly and/or to the base. [0070] The device can further include a second auxiliary bearing disposed on the P/S assembly. The F/E assembly can be operably interconnected to the P/S assembly via the second auxiliary bearing. Some embodiments of the invention to provide an exoskeleton with two or more actuators in a balanced position such that a latent or residual torque is not imparted on the degree of freedom related to the position. At least one actuator may be used for each degree of freedom. In the above example where the various assemblies are nested within each other, actuators drive the motion of the various assemblies, and the actuators are interconnected to some of the assemblies. For example, a F/E actuator is interconnected to the A/A assembly, and an A/A actuator is interconnected to the P/S assembly. If these actuators are placed on the same side of the axis about which the P/S assembly rotates, the P/S axis, then a torque is imparted on the P/S assembly. However, if these actuators are positioned on opposite sides of the P/S axis, then the torques imparted on the P/S axis are equal and in opposite directions such that the torques “cancel” out, and the various assemblies are in balance without a latent or residual torque imparted on any of the assemblies. In some embodiments, at least one weight or one spring may also be used to “cancel” a torque due to gravity. [0071] While the apparatus allows for three degrees of freedom, it is possible that only two degrees of freedom or one degree of freedom is used to rotate a limb, while the remaining degree of freedom remains locked or unused. [0072] The P/S actuator, the F/E actuator and/or the A/A actuator can each have a resistive mode, an active mode and/or a passive mode. The resistive mode can inhibit the motion of the limb. The active mode can assist the motion of the limb. The passive mode can allow for free motion of the limb. A user may select a mode for a patient. [0073] The exoskeleton device can include a limb rest, which can be operably interconnected to the base. The limb rest can have a vertical adjustment feature that raises and lowers the limb rest relative to the P/S axis. The limb rest can have a lateral adjustment feature that extends and retracts the limb rest relative to the first P/S bearing. The limb rest can be a single piece, or multiple pieces. [0074] Some or all of the apparatus may be made from metal, polymers or combinations thereof. In some embodiments, it may be beneficial to produce some or part of the apparatus from materials that make the apparatus light, but durable, such as titanium or carbon composites. In some embodiments, heavier metals, such as aluminum, may be used. [0075] The base can be integrated to a table. In some embodiments of the invention, the device is in electronic communication with a display unit. The motion of a person's limb in the multiple degrees of freedom may affect what is displayed on the display unit, such as range, resistance, force, torque, and the like, for a user or another to review. Thus, a person's movement may allow the person to interact with games or other scenarios that make the person's use of the exoskeleton device more enjoyable. [0076] An aspect of the invention is an exoskeleton device for articulating a limb. The device includes a base having a first P/S bearing and a second P/S bearing, wherein the first P/S bearing is a ring bearing configured to receive a portion of a limb through the first P/S bearing. The P/S assembly is operably interconnected to the base via the first and second P/S bearings. The P/S actuator is interconnected to the base, and is operably interconnected to the P/S assembly to rotate the P/S assembly about a P/S axis. The P/S assembly has a first F/E bearing and a second F/E bearing. The F/E assembly is operably interconnected to the P/S assembly via the first and second F/E bearings. The F/E actuator is interconnected to the P/S assembly, and the F/E actuator is operably interconnected to the F/E assembly to rotate the F/E assembly about a F/E axis. The F/E axis is substantially perpendicular to the P/S axis. A handle is operably interconnected to the F/E assembly and is configured to selectively interconnect to a portion of the limb. The handle has a handle axis that is substantially parallel to the F/E axis. The handle axis is offset from the F/E axis by an adjustable distance. A limb rest is operably interconnected to the base, and has a vertical adjustment feature that raises and lowers the limb rest relative to the P/S axis, and a lateral adjustment feature that extends and retracts the limb rest relative to said first P/S bearing. [0077] Another aspect of the invention is a method for operating the exoskeleton device. The method may be performed manually or using a program, such as a software program. The method allows for a user to engage a limb to the device and measure or train the different variables associated with the limb, such as displacement, range of motion, force, strength, spasticity and other such variables. The method may include games to entertain the user while engaging the limb in exercises to measure or train the different variables associated with the limb. [0078] Various embodiments of the present invention are described herein and as depicted in the drawings. It is expressly understood that although the figures show exoskeletons, assemblies with degrees of freedom, actuators, and other components, the present invention is not limited to these embodiments. [0079] Now referring to FIG. 1 , an exoskeleton device 2 with two degrees of freedom is provided. A base 4 is provided from which other components attach and operate from. The base 4 in this embodiment is a combination of modular elements. However it will be appreciated that the base 4 may be any structure that supports the components described herein. Two limb rests 6 are interconnected to the base 4 . One limb rest 6 is oriented laterally with respect to the base 4 , and this limb rest 6 is configured to receive an upper portion of a person's arm. Another limb rest 6 is oriented longitudinally with respect to the base 4 , and this limb rest 6 is configured to receive a lower portion of the person's arm. Therefore, in this configuration, the person's elbow joint is positioned between the two limb rests 6 . [0080] Next, a pronation/supination (P/S) assembly 8 is interconnected to the base via a first P/S bearing 14 and a second P/S bearing 16 . This rotatable interconnection allows the P/S assembly 8 to rotate about a P/S axis 22 , and this is one degree of freedom for the exoskeleton device 2 . The first P/S bearing 14 in this embodiment is a ring bearing, which is comprised of an outer ring positioned around an inner ring with ball bearings positioned therebetween. This type of first P/S bearing 14 provides an area through which a person may extend a distal portion of a limb, such as a hand, into the P/S assembly 8 . [0081] The second P/S bearing 16 also has an outer portion and an inner portion with ball bearings positioned therebetween, but the second P/S bearing 16 is smaller in size than the first P/S bearing 14 . Further, the second P/S bearing 16 is positioned on the opposite side of the P/S assembly 8 . [0082] The P/S assembly 8 in this embodiment has a P/S frame that is generally comprised of a P/S longitudinal frame 10 and a P/S lateral frame 12 . The P/S longitudinal frame 10 is oriented with the longitudinal direction of the base 4 , and P/S longitudinal frame 10 is the portion of the P/S assembly that is operably interconnected to the base 4 via the first and second P/S bearings 14 , 16 . The P/S lateral frame 12 is oriented with the lateral direction of the base 4 . In other words, the P/S lateral frame 12 is positioned perpendicularly to the P/S longitudinal frame 10 , but it will be appreciated that other relative orientations are possible in other embodiments. As shown, other components of the exoskeleton device 2 may be interconnected or operably interconnect with the P/S longitudinal frame 10 and/or the P/S lateral frame 12 . [0083] A P/S actuator 18 is positioned on the same side of the P/S assembly 8 as the second P/S bearing 16 , and the P/S actuator 18 powers the movement of the P/S assembly 8 about the P/S axis 22 . The P/S actuator 18 in this embodiment is interconnected to a portion of the base 4 . The P/S actuator 18 is operably interconnected to a P/S pulley 20 , which in turn is interconnected to the P/S assembly 8 . The operable interconnection between the P/S actuator 18 and the P/S pulley 20 in this embodiment is a pulley and capstan type of interconnection constituting a cable drive. A shaft or capstan extends from the P/S actuator 18 and aligns with an outer surface of the P/S pulley 20 , and the P/S pulley's 20 outer surface is in the shape of a half circle. Thus, the P/S actuator 18 and its shaft drive the outer surface of the P/S pulley to rotate the P/S assembly 8 about the P/S axis 22 . Given the typical range of the pronation and supination motions of the arm, the P/S pulley's 20 shape is only a half circle. However, it will be appreciated that the shape of the P/S pulley 20 and the type of operable interconnection between the P/S actuator 18 and the P/S pulley 20 may come in various forms. For example, the P/S pulley 20 may be a complete circle in shape such that the P/S assembly 8 may continuously rotate about the P/S axis 22 in one direction. Or in other embodiments, the P/S pulley 20 is optionally removed, and the P/S actuator 18 is directly interconnected to the P/S assembly 8 , and the P/S actuator's 18 shaft is coaxial with the P/S axis 22 . [0084] Next, a flexion/extension (F/E) assembly 24 is positioned within the P/S assembly 8 , and the F/E assembly 24 is operably interconnected to the P/S assembly 8 at a first F/E bearing 26 and a second F/E bearing 28 . This operable interconnection allows the F/E assembly 24 to rotate about a F/E axis 30 that extends through the first and second F/E bearings 26 , 28 , which allows the F/E assembly 24 to accommodate the motion of, for example, a person's hand/palm flexing toward or away from the forearm. This motion represents a second degree of freedom for the exoskeleton device 2 . The F/E assembly 8 also has an actuator and pulley combination that is discussed in further detail in FIG. 2 below. [0085] A handle 32 having a handle axis 34 is interconnected to the F/E assembly. The handle 32 provides a location for a person to place a portion of the person's body such as the person's hand. Thus, the person may interact with the exoskeleton device 2 to perform various actions. In this embodiment, the handle axis 34 is substantially parallel with the F/E axis 30 , and these axes 34 , 30 are substantially perpendicular to the P/S axis 22 . However, it will be appreciated that the exoskeleton device may have these various axes configured at other relative angles to accommodate various body parts and various desired motions. [0086] Now referring to FIG. 2 , another perspective view of the exoskeleton device 2 is provided. The P/S assembly 8 has been rotated 90 degrees about the P/S axis 22 . Now a F/E actuator 36 is visible, including the operable interconnection between the F/E actuator 36 and a F/E pulley 38 . Similar to the operable interconnection between the P/S actuator 18 and P/S pulley 20 , the F/E actuator 36 has a shaft that drives the outer surface of the F/E pulley 38 to rotate the F/E assembly 24 about the F/E axis 30 . The F/E pulley 38 is a complete circle, but in other embodiments the F/E pulley 38 may comprise other shapes to accommodate other bodily motions. [0087] Now referring to FIG. 3 , a side elevation view of an exoskeleton device 2 is provided. The limb rest 6 that is oriented with the longitudinal direction of the base 4 is clearly shown. The limb rest 6 comprises a vertical adjustment feature 40 that raises and lowers the limb rest 6 relative to the P/S axis 22 . In embodiments where the person extends the person's arm into the exoskeleton device 2 , the person's forearm may be positioned substantially parallel with the P/S axis, and more specifically, substantially coaxial with the P/S axis. This allows the person to grasp the handle 32 and move the P/S assembly 8 with pronation and supination motions. Similarly, the limb rest 6 also has a lateral adjustment feature 42 that allows the limb rest 6 to be moved closer or further away from the first P/S bearing 14 . The lateral adjustment feature 42 allows a person to place the person's forearm at a proper distance from the handle such that the person may comfortably grasp the handle. [0088] Now referring to FIG. 4 , a top plan view of the exoskeleton device 2 is provided. The positions of the first and second P/S bearings 14 , 16 are more clearly shown as well as the positions of the first and second F/E bearings 26 , 28 . In alternative embodiments, the P/S assembly 8 may be rotatably interconnected to the base 4 via only one P/S bearing. Similarly, the F/E assembly may be rotatably interconnected to the base 4 via only one F/E bearing. In these embodiments, increased moment forces will be applied to the bearings, but the exoskeleton may comprise more discrete frames that have fewer parts and less mass. [0089] Now referring to FIG. 5 , a perspective view of an exoskeleton device 2 is provided that has three degrees of freedom. This embodiment shares some similarities to the embodiment or embodiments described in FIGS. 1-4 . For example, the exoskeleton device 2 in FIG. 5 comprises a base 4 and a limb rest 6 to help align the person's body part with certain features of the exoskeleton device 2 . The exoskeleton device 2 in FIG. 5 also comprises first and second P/S bearings that provide an operable interconnection between a P/S assembly 8 and the base 4 . The P/S assembly 8 is also rotatable about a P/S axis, however, the P/S assembly 8 in FIG. 5 has a frame with more components. The P/S assembly 8 has two P/S longitudinal frames 10 a , 10 b that are offset from each other about the P/S axis by 90 degrees. A P/S lateral frame 12 is oriented with the lateral direction of the base 2 and is interconnected to the two P/S longitudinal frames 10 a , 10 b such that the P/S lateral frame 12 is perpendicular to the two P/S longitudinal frames 10 a , 10 b. [0090] Next, an abductor/adductor (A/A) assembly 44 is mounted within the P/S assembly 8 . A first A/A bearing 48 and a second A/A bearing 50 are disposed in the P/S lateral frame 12 , and these bearings are operably interconnected to an A/A lateral frame 46 such that the A/A assembly 44 rotates about an A/A axis 56 that passes through the A/A bearings 48 , 50 . The A/A axis 56 in addition to the P/S axis 22 and the F/E axis 30 described in further detail below form the three major degrees of freedom for the exoskeleton device 2 in FIG. 5 . [0091] An A/A actuator 52 is interconnected to the P/S lateral frame 12 , and the A/A actuator 52 is operably interconnected to an A/A pulley 54 on the A/A lateral frame 46 . A shaft/capstan extends from the A/A actuator 52 and drives an outer surface of the A/A pulley 54 , forming a cable drive mechanism, which in this embodiment is a partial arc shape. As described elsewhere herein, the shape of a pulley may vary to accommodate different design requirements. The A/A pulley 54 may also serve as a counterweight that is interconnected to the A/A assembly 44 , the counterweight generates a torque about the A/A axis 56 in one direction, and the handle and/or the F/E pulley generate another torque about the A/A axis in the opposite direction, wherein the magnitude of the torques are equal and thus cancel out such that there is no latent or residual torque on the A/A assembly 44 or the A/A axis 56 . [0092] A F/E actuator 36 is interconnected to the A/A assembly 44 , and the F/E actuator 36 is operably interconnected to a F/E assembly 24 to rotate the F/E assembly 24 a F/E axis as described in FIGS. 1-4 above. The positions of the A/A actuator 52 and the F/E actuator 36 place the various assemblies 8 , 24 , 44 of the exoskeleton device 2 in substantial balance. The P/S actuator is interconnected to the base 4 , and thus does not affect the overall balance of the assemblies 8 , 24 , 44 . However, the A/A actuator 52 and the F/E actuator 36 are generally placed on opposite sides of the P/S axis to maintain a balance of the various assemblies 8 , 24 , 44 . Stated another way, if the F/E actuator 36 was interconnected to the same side of the A/A assembly 44 as the A/A pulley 54 , then both the F/E actuator 36 and the A/A actuator 52 would be positioned on the same side of the P/S axis. This would result in a latent or residual torque about the P/S axis that would pull the P/S assembly 8 in a counterclockwise direction when viewed down the P/S axis from the limb rest 6 and the first P/S bearing 14 . Conversely and as presented in FIG. 5 , the F/E actuator 36 is positioned to the “lower right” of the P/S axis, and the A/A actuator 52 is positioned to the “upper left” of the P/S axis. Therefore, the F/E actuator 36 generates a torque in a first direction toward the second P/S bearing, and the A/A actuator 52 generates an equal torque in a second direction toward the first P/S bearing 14 , and the two torques substantially “cancel” each other out. This leaves the various assemblies 8 , 24 , 44 in balance, and puts less strain on the P/S actuator. [0093] Now referring to FIG. 6 , another perspective view of an exoskeleton device 2 with three degrees of freedom is provided. The P/S assembly 8 , the A/A assembly 44 , and the F/E assembly 24 are each rotatable about their respective axes to provide three degrees of freedom. However, embodiments of the invention are not limited to three rotational degrees of freedom. In other embodiments, the base 4 may translate positions in a plane. Specifically, the base 4 may comprise adjustable rails, linear bearings, or other similar devices that translate the base 4 , and thus the various assemblies 8 , 24 , 44 , in both the lateral and longitudinal directions of the base 4 . [0094] The various pulleys may relate to the general range of motion of a distal end of a limb such as a forearm, a wrist, and a hand. From a datum position or plane, the rotation range of the various assemblies about the various axes may be expressed in degrees. In some embodiments, a rotation range of the P/S assembly about the P/S axis from a P/S datum position is between approximately −70 degrees and 85 degrees. In various embodiments, a rotation range of the A/A assembly about the A/A axis from an A/A datum position is between approximately −20 degrees and 35 degrees. In some embodiments, a rotation range of the F/E assembly about the F/E axis from a F/E datum position is between −70 degrees and 75 degrees. [0095] The embodiments of the exoskeleton devices 2 described herein may be in electronic communication with a display unit that is visible to a user. The user may move his or her hand, for example, in an exoskeleton device 2 to play a game or other scenario on the display unit. In one specific example, movements within the exoskeleton control a first area of the display unit that is a cursor. The person may move the cursor toward one or more second areas of the screen to demonstrate a range of motion. Therefore, the person's engagement of the exoskeleton device can be enhanced with a game-like experience, which may improve the outcome of the person's use of the exoskeleton device 2 . [0096] The present invention has significant benefits across a broad spectrum of endeavors. It is the Applicant's intent that this specification and the claims appended hereto be accorded a breadth in keeping with the scope and spirit of the present invention being disclosed despite what might appear to be limiting language imposed by the requirements of referring to the specific examples disclosed. [0097] The phrases “at least one”, “one or more”, and “and/or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B, and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C,” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together. [0098] Unless otherwise indicated, all numbers expressing quantities, dimensions, conditions, and so forth used in the specification, drawings, and claims are to be understood as being modified in all instances by the term “about.” [0099] The term “a” or “an” entity, as used herein, refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. [0100] The use of “including,” “comprising,” or “having,” and variations thereof, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Accordingly, the terms “including,” “comprising,” or “having” and variations thereof can be used interchangeably herein. [0101] It shall be understood that the term “means” as used herein shall be given its broadest possible interpretation in accordance with 35 U.S.C., Section 112(f). Accordingly, a claim incorporating the term “means” shall cover all structures, materials, or acts set forth herein, and all of the equivalents thereof. Further, the structures, materials, or acts, and the equivalents thereof, shall include all those described in the summary of the present invention, brief description of the drawings, detailed description, abstract, and claims themselves. [0102] The foregoing description of the present invention has been presented for illustration and description purposes. However, the description is not intended to limit the present invention to only the forms disclosed herein. In the foregoing Detailed Description for example, various features of the present invention are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the present invention. [0103] Consequently, variations and modifications commensurate with the above teachings and skill and knowledge of the relevant art are within the scope of the present invention. The embodiments described herein above are further intended to explain best modes of practicing the present invention and to enable others skilled in the art to utilize the invention in such a manner, or include other embodiments with various modifications as required by the particular application(s) or use(s) of the present invention. Thus, it is intended that the claims be construed to include alternative embodiments to the extent permitted by the prior art.

An exoskeleton device and method of using the same is provided that helps rehabilitate limbs such has the lower arm. Embodiments of the exoskeleton device have multiple degrees of freedom so that a limb such as the lower arm may flex or rotate in multiple directions to establish or re-establish neural connections in the brain. With the lower arm example, a person may grasp a handle in the exoskeleton and then flex the lower arm about a pronation/supination axis, a flexion/extension axis, and/or an abductor/adductor axis. The exoskeleton device has several modes of operation where actuators can aid the person's motion, resist the person's motion, or passively allow free motion of the person's limb.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the field of snowboarding and more particularly to a device for retaining a boot on a gliding board adapted for snowboarding. 2. Description of Background and Material Information The practice of snowboarding is generally done with either rigid shell boots or flexible boots. For flexible boots, certain retaining devices have at least one shock-absorbing support pad, generally located between a baseplate of the device and the boot when the latter is retained on the device. The support pad is provided to improve the user's comfort and to absorb the impacts or short displacements of the boot with respect to the device. It has been observed that certain support pad deteriorate very quickly when the device is used and, as a result, they no longer fulfill their shock-absorbing role. It has also been observed that the support pad that resist a quick deterioration do not absorb the impacts or short displacements enough, and that these support pad do little to improve the user's comfort. SUMMARY OF THE INVENTION An object of the invention is to provide a support pad that improves the user's comfort and absorbs the impacts or short displacements of the boot with respect to the retaining device, i.e., the binding, while resisting the wear and abrasion caused by the boots. Another object of the invention is to provide a retaining device having at least such a support pad. A shock-absorbing support pad according to the invention is provided to be arranged between a boot and a board, or between the boot and a device for retaining a boot on the board, the board being adapted to snowboarding. The support pad, according to the invention, has at least two layers of materials with a different hardness, a first layer which has a support surface provided to make contact with the boot and which has a bonding surface opposite to the support surface, and a second layer which is joined to the bonding surface from the first layer, the hardness of the second layer being less than the hardness of the first layer. This structure improves the user's comfort and absorbs the impacts or short displacements of the boot due to the second layer. Additionally, this structure offers a good resistance to the wear and abrasion caused by the boots due to the first layer. According to a particular feature of the invention, the first layer and the second layer are glued together. According to another feature of the invention, the first layer is made from a relatively flexible plastic material with a substantially continuous structure, and the second layer is made from a relatively flexible plastic material with a cell-type structure. In addition to the foregoing, the invention also encompasses a device for retaining a boot on a gliding board adapted to snowboarding, the device comprising at least one shock-absorbing support pad provided to make contact with the boot, wherein the wedge comprises at least two layers of materials of a different hardness, a first layer which has a support surface provided to make contact with the boot and which has a bonding surface opposite to the support surface, and a second layer which is joined to the bonding surface of the first layer, the hardness of the second layer being less than the hardness of the first layer. Further according to the invention, the support pad is arranged to contact a baseplate of the device, so that the first layer touches the sole of the boot when the latter is retained on the device. Still further according to the invention, the first layer and the second layer are glued together, and the first layer is glued to the baseplate. Still further according to the invention, the first layer of the support pad is made from a relatively flexible plastic material with a substantially continuous structure, and the second layer of the support pad is made from a relatively flexible material with a cell-type structure. BRIEF DESCRIPTION OF DRAWINGS Other characteristics and advantages of the invention will be better understood with the following description with reference to the attached drawings which show, by way of non-limiting examples, how the invention can be obtained, and in which: FIG. 1 is a perspective view of a retaining device for a flexible boot, the device having two support pad; FIG. 2 is a cross-section taken along the line II—II of FIG. 1 corresponding to a first embodiment; and FIG. 3 is similar to FIG. 2 but corresponds to a second embodiment. DETAILED DESCRIPTION OF THE INVENTION A retaining device or binding 1 according to the invention and shown in FIG. 1 is provided to retain, in a known manner, a boot (not shown) on a board 2 . The device 1 has a baseplate 3 provided to receive the sole of the boot, as well as a rear support element 4 allowing a rear support by contact with the boot upper at the rear of the lower part of the user's leg. The device 1 is affixed to the board 2 by a disk 5 and by means for retaining the disk 5 onto the board 2 . A first embodiment of the invention is described with reference to FIG. 2 . As known, the baseplate 3 has an upper surface 6 facing the sole of the boot when the latter is retained on the device 1 , as well as a lower surface 7 opposite to the upper surface 6 . The board 2 has a support surface 8 opposite to a gliding surface 9 , the surface 8 of the board 2 touching the lower surface 7 of the baseplate 3 . A shock-absorbing support pad 10 is housed in a closed cavity 1 of the baseplate 3 , the cavity 11 having a bottom 12 and a peripheral edge 13 . The support pad 10 has a first layer 14 provided to make contact with the sole, as well as a second layer 15 located between the layer 14 and the bottom 12 . A support surface 16 of the first layer 14 is upwardly exposed for contacting the sole of the boot when the latter is retained on the baseplate 3 . A bonding surface 17 of the layer 14 , opposite to the support surface 16 with respect to the thickness of the layer 14 , is joined to the second layer 15 . Preferably, the bonding between the layers 14 and 15 is obtained by an adhesive, but any other technique could be used. The first layer 14 is made from a relatively flexible material which resists well attrition, pulling, cutting, or other mechanical biases. It is preferably obtained from a flexible plastic material having a homogenous and continuous structure, as a polyurethane sheet, a rubber sheet or any suitable material. For example, the layer 14 can measure between 1 and 2 mm thick and bends easily between the fingers when manipulated. Its thickness is reduced from 1% to 10% when it is subjected to a compression force which generates a stress between 50 and 100 N/cm 2 . The second layer 15 is made from a flexible material which has good elastic deforming and shock-absorbing abilities. The flexible material can be a foam made from a plastic material with a cell-type structure, a rubber foam, or any other suitable material such as a fiber mat. For example, the layer 15 can measure between 2 and 10 mm thick and bends easily between the fingers when manipulated. Its thickness is reduced from 30% to 50% when it is subjected to a compression force, which generates a stress between 50 and 100 N/cm 2 . In any case, the second layer 15 has greater flexibility than the first layer 14 . Preferably, the wedge 10 is retained in the cavity 11 by a retaining means constituted here by gluing. A second embodiment of the invention is seen in FIG. 3 . For convenience, the same reference numerals are used to designate the same elements or similar elements. The support pad 10 is housed in a through cavity 18 of the baseplate 3 whose opening facing the board 2 is larger than the opening leading to the upper surface 6 . The first layer 14 is pressed against a peripheral edge 19 of the cavity 18 . The second layer 15 is arranged between the first layer 14 and the board 2 . The materials used for implementing the second embodiment are similar to those of the first embodiment. The respective shapes of the support pad 10 and the cavity 18 allow maintaining the support pad 10 in the cavity 18 . However, it is possible to provide a complementary means for affixing such as gluing the support pad 10 to the peripheral inner surface edge 19 of the cavity 18 of the baseplate 3 . Preferably for all embodiments, the support surface 16 of the support pad 10 projects slightly with respect to the upper surface 6 of the baseplate 3 . Thus, the contact between the sole and the support pad 10 is preferred with respect to a contact between the sole and the surface 6 of the baseplate 3 . When the boot takes support on the device 1 , the thickness of the support pad 10 is reduced, essentially by compression of the second layer 15 . Inversely, when the boot is separated from the device 1 , the support pad 10 returns to its original shape due to the elasticity of the constitutive material of the second layer 15 . As seen in FIG. 1, the baseplate 3 of the device 1 has a crescent-shaped support pad 10 located substantially at the metatarsal bones of the foot, as well as a crescent-shaped support pad 20 located substantially towards the heel of the foot. The shapes of the support pad 10 , 20 improve foot stability and comfort during torsional biases of the user's leg. The invention is not limited to the embodiments described herein, and includes all technical equivalents within the scope of the following claims. In particular, the shapes of the wedges 10 , 20 and the thicknesses of their materials can vary to allow selecting specific shock-absorbing values, for example. The shapes of the cavities 11 , 18 can also vary, and possibly be different from the shapes of the support pad 10 , 20 . The bonding surface 17 of the first layer 14 can be planar as in the first embodiment, curved inward as in the second embodiment, or have any suitable shape. Furthermore, each support pad 10 , 20 can have additional layers which, in this case, would be located between the second layer 15 and the bottom 12 , or between the second layer 15 and the surface 8 of the board 2 . This application is based upon French Patent Application No. 97 12738, filed Oct. 3, 1997, the disclosure of which is hereby incorporated by reference thereto in its entirety, and the priority of which is hereby claimed under 35 USC 119.

Shock-absorbing support pad to be positioned between a boot and a snowboard, or between the boot and a snowboard binding, and a snowboard binding incorporating such support pad. The support pad has at least two layers of material having different hardnesses. A first layer has a support surface for contacting the boot and it has a bonding surface opposite to the support surface. A second layer is joined to the bonding surface of the first layer. The hardness of the second layer is less than the hardness of the first layer.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] This invention relates generally to programming of implantable devices, and more particularly to a programming system which addresses the dangers raised by the presence of multiple programming devices. [0003] 2. Description of the Related Art [0004] Implantable devices have become a standard method of treating various medical conditions, many of which relate to the heart. Examples of implantable devices include pacemakers, defibrillators, nerve stimulators, drug delivery devices, and implanted personal identification chips. Many types of implantable devices are available with high capacity memories for storing data and various programmable configuration parameters. In the case of medical devices, the data to be stored may include physiological data such as the electrogram (electrical waveform of the heart detected at the electrodes), instantaneous heart rate, blood pressure, volume pumped, body temperature, etc. Configuration parameters that are stored may include modes of operation, amplifier sensitivity, filter bandwidth, adaptation algorithms, output voltages, currents and pulse widths, blanking periods, various pacing rates, circadian response patterns, lead characteristics, delay intervals, detection thresholds, safety margins, logging criteria, and error messages. As implantable devices increase in sophistication, the number of configuration parameters is also expected to increase. [0005] Referring now to FIG. 1 , a human torso 102 is shown having an implantable device 106 coupled to a heart 104 . When a wand 108 from an external programming device 110 is placed in proximity to implantable device 106 , the programming device 110 can establish two-way communication with implantable device 106 to retrieve data and to provide new configuration parameters. Often the device 106 collects data over a period of hours or days. In the case of a pacemaker, the data may represent measured physiological signals such as cardiac voltages (EKG signals), blood temperatures, oxygen levels, sugar levels, and other physical parameters. [0006] Illustratively, the programming device 110 comprises an implantable device programmer and data analyzer that is used by a physician. The programmer/analyzer operates to download information stored in implantable device 106 by transmitting signals which place the pacer in a mode for downloading, and thereafter detecting signals sent by the device. Then, under control of the physician or other medical professional, the programmer/analyzer operates to analyze and display the information in a format which allows the physician to diagnose any problems. After performing an analysis, the physician may instruct the programmer/analyzer to adjust operating parameters for a different mode of operation, sensitivity setting, or other parameter value, to tailor the behavior of the device to the patient and thereby optimize the patient's quality of life. If this is the case, the programmer/analyzer 110 provides new operating parameters to the implantable device 106 . [0007] Implant manufacturers have long been aware of a danger known as the “multiple programmer” problem which can result in an implantable device having incorrect and perhaps even dangerous or harmful configuration parameters. The following scenario is presented to illustrate this problem. [0008] A patient with an implantable device enters an examination room, and as part of a routine initial examination has a medical technician use a first programming device “A” to download data and configuration parameters from the implantable device. Depending on the amount of data and the baud rate of the device, the download time may range from 20 seconds to 20 minutes. In the absence of any gross abnormalities in the downloaded data, the patient is sent to another room for an exercise session to determine “rate modulated” settings, i.e. configuration parameters for adjusting the pacemaker pace rate in response to detecting patient exertion. In this room, a physician uses a second programming device “B” to download and adjust the configuration parameters in response to the results of the exercise session. Programming device “B” is used to reprogram the implantable device with the adjusted parameters. The patient then returns to the examination room, where a physician uses programming device “A” to adjust some of the configuration parameters in response to analysis of the downloaded data. Programming device “A” is then used to reprogram the implantable device with the adjusted parameters. It is important to note'that programming device “A” is, at this point, operating with an obsolete version of the implant's configuration settings. This situation occurs whenever changes are made to the implantable device's configuration parameters by a second programming device “B” between the download and reprogramming operations of the first programming device “A”. [0009] The configuration parameters of an implantable device such as a pacemaker can individually be set to typical values within a normal operating range, but the programming device must still check for incompatible parameter settings to avoid dangerous combinations of parameter values. For example, programming an inappropriately long refractory period in conjunction with a short pacing cycle may lead to unpredictable pacing behavior. If a programming device with an obsolete version of the implant device's configuration settings reprograms only a few parameters, any safeguards that the programming device implements to avoid incompatible parameter settings could be unintentionally circumvented. [0010] One programmer safeguard that has been employed is to have programming device “A” reprogram the implantable device with a complete set of configuration parameters rather than just the parameters which have been adjusted. Although this successfully prevents incompatible configuration settings, the previous adjustments are completely undone without any indication to the physician. Further, the reprogramming time is unnecessarily increased beyond what may be strictly necessary. [0011] The solution commonly employed by implant manufacturers has been simply to issue warnings regarding the danger of using multiple programming devices. A more effective and inexpensive solution to the multiple programming device problem is desirable. SUMMARY OF THE INVENTION [0012] Accordingly, there is provided herein a multiprogrammer system for monitoring and optimizing implantable device performance. In one embodiment, the system includes at least two programming devices and an implantable device. Each of the programming devices may be used to perform inquiry and programming operations on the implantable device. In an inquiry operation, the programming device retrieves some or all of the configuration parameters from the implantable device. In a programming operation, the programming device provides one or more modified parameters to the implantable device. As part of the programming operation, the programming device is configured to verify that it is aware of the implantable device's current parameters before sending the modified parameters. In other words, the current programming device verifies that the implantable device's parameters have not been altered by another programming device since the current programming device's last interaction with the implantable device. If the parameters have been altered, the current programming device aborts the programming operation and notifies the operator. In alternate embodiments, the verification may be performed by the implantable device, i.e. the implantable device may verify that the programming device is aware of the current device parameters before the implantable device accepts the modified parameters. [0013] As part of the multiprogrammer system provided herein, there is disclosed a programming device embodiment, an implantable device embodiment, and various methods for verifying that the programming device has been provided with a current version of the implantable device's configuration parameters. The programming device preferably comprises a user interface, a memory, a communications circuit, and a microprocessor. The communications circuit generally includes a communication coil, receive sensor, modulator, and demodulator, and is configurable to send and receive configuration parameters to and from the implantable device. The microprocessor couples to the user interface, the memory, and the communications circuit, and it operates under control of the user interface to retrieve configuration parameters from the implantable device and to store the parameters in memory. The configuration parameters may be modified, and the modified parameters can be sent to the implantable device. In certain disclosed embodiments, the microprocessor uses one of the following methods to verify that the stored configuration parameters are “current” before sending the modified parameters, that is, the microprocessor verifies that the implantable device's parameters have not been altered .since this programmable device last retrieved the implantable device's parameters. [0014] The implantable device comprises a microprocessor coupled to a memory and a telemetry module. The memory stores configuration parameters, and the telemetry module transmits and receives external communications. The microprocessor performs some algorithm in a manner governed by the configuration parameters stored in the memory. In certain disclosed embodiments, the microprocessor uses one of the following methods to verify that an external programming device has received a current version of the configuration parameters before accepting modified configuration parameters from the programming device. [0015] The disclosed methods for verifying that a programming device is aware of the implantable device's current configuration parameters include: (1) providing a programming device serial number to the implantable device as part of every inquiry operation; (2) allowing a programming operation only within a predetermined time interval after an inquiry operation; (3) storing the date and time of the most recent inquiry operation; (4) storing the date and time of the most recent programming operation; and (5) retrieving the implantable device's current parameters as part of every programming operation. For method (1), the implantable device or the programming device can be configured to compare the programming device's serial number with the serial number of the last programming device to retrieve the implantable device's configuration parameters. A match indicates that the programming device is aware of the implantable device's current parameter values. [0016] For method (2), the implantable device or the programming device can determine if the downloaded version of the configuration parameters has “expired”, that is, whether a predetermined amount of time has passed since the configuration parameters were last retrieved. For method (3), the implantable device or programming device can be configured to compare the date and time of the most recent inquiry stored in the programming device to that stored in the implantable device. A match indicates that the programming device is aware of the implantable device's current parameter values. [0017] Similarly, for method (4), the implantable device or programming device can be configured to compare the date and time of the most recent programming operation stored in the programming device to that stored in the implantable device. Finally, for method (5), the programming device can be configured to retrieve the implantable device's configuration parameters immediately prior to a programing operation to verify that the programming device has a current version. These methods will be described in more detail further below. BRIEF DESCRIPTION OF THE DRAWINGS [0018] Other objects and advantages of the invention will become apparent upon reading the following detailed description and upon reference to the accompanying drawings in which: [0019] FIG. 1 shows an implantable medical device and a programming device; [0020] FIG. 2 is a block diagram of an implantable pacemaker; [0021] FIG. 3 is a block diagram of an exemplary embodiment of a programming device; [0022] FIG. 4 is a flowchart depicting a method for performing inquiry and programming operations; [0023] FIG. 5 is a flowchart illustrating the multiprogrammer problem; [0024] FIG. 6 is a flowchart depicting a first method for performing inquiry and programming operations in a multiprogrammer environment; [0025] FIG. 7 is a flowchart depicting a second method for performing inquiry and programming operations in a multiprogrammer environment; [0026] FIG. 8 is a flowchart depicting a third method for performing inquiry and programming operations in a multiprogrammer environment; [0027] FIG. 9 is a flowchart depicting a fourth method for performing inquiry and programming operations in a multiprogrammer environment; [0028] FIG. 10 is a flowchart depicting a fifth method for performing inquiry and programming operations in a multiprogrammer environment; [0029] FIG. 11 is a flowchart depicting a sixth method for performing inquiry and programming operations in a multiprogrammer environment; [0030] FIG. 12 is a flowchart depicting a seventh method for performing inquiry and programming operations in a multiprogrammer environment; [0031] FIG. 13 is a flowchart depicting an eighth method for performing inquiry and programming operations in a multiprogrammer environment; and [0032] FIG. 14 is a flowchart depicting a ninth method for performing inquiry and programming operations in a multiprogrammer environment. [0033] While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of examples in the drawings and will herein be described in detail. It should be understood, however, that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the present invention as defined by the appended claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0034] The following description illustrates the principles of the present invention with respect to an implantable pacemaker (“pacer”) and a programming device (“programmer”). The invention, however, is directed to a system for permitting multiple programming devices to interact with an implantable device. Thus, the invention applies to implantable cardioverter/defibrillators (ICD's), nerve stimulators, drug delivery devices, or any other implantable device which may have programmable configuration parameters set by a programming device. [0035] Referring now to FIG. 2 , an exemplary implantable device 106 (such as a pacemaker) preferably includes a power supply 202 coupled to a microprocessor 204 . The power supply 202 provides power to all the devices shown in FIG. 2 through connections which are not specifically shown. In the exemplary embodiment, the microprocessor 204 couples to a memory 206 , a first interval timer 208 , and a second interval timer 210 via an I/O (input/output) bus 211 . The microprocessor 204 also couples to control an atrium sensor/stimulator 212 and a ventricle sensor/stimulator 214 , each of which may be coupled to the heart by flexible leads. Finally, microprocessor 204 couples to a telemetry module 218 to communicate with programming device 110 . [0036] The microprocessor 204 preferably is programmable and operates according to a program stored preferably in a nonvolatile memory such as a read-only memory (not specifically shown). The program is parameterized—i.e. one or more of the operations the microprocessor performs is alterable by setting a configuration parameter. For example, the microprocessor may be programmed to periodically trigger the atrium sensor/stimulator 212 to deliver a pulse to the heart 104 . In this instance, one of the configuration parameters for this operation is the maximum trigger delay, that is, a value specifying the maximum time delay before the atrium stimulator is triggered. The maximum trigger delay, along with other configuration parameters, is provided to microprocessor 204 via telemetry module 218 and stored in memory 206 . During pacemaker operation, the microprocessor 204 retrieves the maximum trigger delay from the memory 206 and uses it to set interval timer 210 after each triggering of the atrium sensor/stimulator. If the interval timer 208 expires, the microprocessor then triggers atrium sensor/stimulator 212 . [0037] Referring still to FIG. 2 , the first interval timer 208 determines the delay between trigger signals applied to atrium stimulator 212 and ventricle stimulator 214 . The second interval timer 210 measures the time since the last heartbeat sensed by the atrium sensor/stimulator 212 or ventricle sensor/stimulator 214 . When either timer elapses, the elapsed timer asserts an interrupt signal to microprocessor 204 to notify the microprocessor 204 that the set amount of time has passed. Microprocessor 204 determines the source of the interrupt according to conventional techniques and takes the appropriate action. For example, if the maximum trigger delay (interval timer 210 ) has elapsed since the last heartbeat, the microprocessor 204 triggers atrium sensor/stimulator 212 . [0038] The microprocessor 204 also preferably monitors one or more physiological signals. In the pacemaker example, the microprocessor 204 detects cardiac voltage signals via atrium sensor 212 and/or ventricle sensor 214 . The heart leads which provide electrical pulses to the heart may also be used to sense electrical signals created by the heart as it beats, and these signals are used by the microprocessor 204 to adjust the timing of the electrical pulses. When other sensors are coupled to the implantable device 106 , the microprocessor can also monitor blood pressure, body temperature, oxygen levels, and other physiological parameters. The microprocessor 204 can also track its own performance, perhaps by logging the manner in which adaptation is performed on the parameters. The physiological signals and performance information can be logged in memory 206 for later retrieval by programming device 110 . The memory 206 preferably is large enough to store data regarding several physiological signals that being are monitored over a period of several days. Memory 206 preferably is implemented as dynamic random access memory (DRAM) or other suitable memory type. [0039] The atrium sensor/stimulator 212 is an interface circuit between microprocessor 204 and a heart lead coupled to an atrium of the heart. An interface circuit is necessary to allow the digital, low voltage microprocessor to control the high-energy pulses delivered to the heart, and additionally, to allow the microprocessor to monitor the analog electrical signals that are generated by the heart as it beats. Similarly, the ventricle sensor/stimulator 214 is an interface circuit between microprocessor 204 and a heart lead that couples to a ventricle of the heart. When atrium sensor/stimulator 212 receives a trigger signal from microprocessor 204 , it generates a shaped electrical energy pulse to the atrium. Likewise, when ventricle sensor/stimulator 212 receives a trigger signal from microprocessor 204 , it provides a shaped electrical energy pulse to the ventricle. If the microprocessor is using atrium sensor/stimulator 212 or ventricle sensor/stimulator 214 to measure cardiac voltage signals from the electrodes to monitor the performance of the heart, the microprocessor 204 stores the cardiac waveforms (or “electrograms”) in memory for subsequent retrieval by a medical technician. [0040] Telemetry module 218 may be designed to be activated by programming device 110 when wand 108 enters into proximity with pacer 106 . For example, the telemetry module 218 may continually be checking for an activation signal that the wand 108 transmits. Activation of the telemetry module 218 causes the telemetry module 218 to establish bidirectional communication with wand 108 and to notify microprocessor 204 of an incoming communication. As the wand 108 transmits a message signal, the telemetry module demodulates the message signal and delivers the incoming message to the microprocessor 204 . The microprocessor 204 decodes the incoming message and stores any received data or parameters. In addition, the microprocessor 204 responds to any received commands from the programming device 110 . For example, one command might be an “inquiry”, that is, a request for the microprocessor 204 to transfer configuration parameters from memory 206 to programming device 110 . In this case, microprocessor 204 provides the configuration parameters from memory 206 to telemetry module 218 for transferal to programming device 110 . [0041] Referring now to FIG. 3 , programming device 110 includes a microprocessor 302 , a modulator 304 coupled to a transmit coil 306 , a demodulator 310 coupled to a receive sensor 308 , a memory 312 , and a user interface 314 . The microprocessor 302 responds to user input via the user interface 314 (which may comprise a graphic display and user input device such as a keypad) and initiates communications with pacer 106 ( FIG. 2 ). For example, if a user requests a download of data from the pacer to programming device 110 , microprocessor 302 formulates a command signal, and sends the signal to modulator 304 . Modulator 304 converts the command signal into a modulated signal for driving transmit coil 306 . The signal driving the transmit coil 306 produces a changing magnetic field which induces a current in a receive coil in the pacer. The pacer processes the induced current to reconstruct the information sent from the programming device, and formulates and sends a reply. The pacer can transmit signals to programming device 110 by various means including modulating a light signal or driving a transmit coil. Receive sensor 308 detects and amplifies the signal transmitted by the pacer to produce a detection signal. Demodulator 310 demodulates the detection signal and converts it into the data transmitted by the pacer 106 . Demodulator 310 then provides the data to microprocessor 302 for eventual analysis and display via user interface 314 . Memory 312 may be used to store data and configuration parameters downloaded from the pacer. [0042] Referring now to FIG. 4 , a pair of flowcharts are provided to illustrate the operation of the processor 302 in the programming device 110 and the operation of the processor in 204 the implantable device 106 during the inquiry and programming operations. The programming device's processor 302 starts in step 401 and the implantable device's processor 204 starts in step 411 . In step 402 the processor 302 initiates an inquiry operation by sending a command to the implantable device requesting the implantable device to transmit its model and serial number. In step 403 the processor 302 receives the model and serial number information and stores it for future identification of the implantable device. In step 404 the processor 302 sends a request to the implantable device for the implantable device to transmit one or more of its configuration parameters. The parameter request may be a partial request, in which only certain specified parameters are requested, or a full request, in which a download of all the configuration parameters is requested. In a typical initial inquiry operation, the parameter request is a full request. In step 405 the processor 302 receives the transmitted configuration parameters and stores them in memory for analysis and possible alteration by the user of the programming device 110 . This may complete the inquiry operation, or as a further part of the inquiry operation the processor 302 may request and receive stored physiological data from the implantable device. [0043] After a user examines the configuration parameters and analyzes any downloaded data, the user may wish to modify one or more of the configuration parameters and to perform a programming operation to reprogram the implantable device with the modified parameters. In step 406 the processor 302 initiates a programming operation by sending a command to the implantable device requesting the implantable device to transmit its model and serial number. In step 407 the processor 302 receives the model and serial number information and verifies that it matches with the stored identification information from step 403 . The processor then in step 408 transmits the modified parameters. The programming device transmits a partial or complete parameter set to the implantable device. A partial parameter set is preferred for a faster programming operation, but a complete parameter set is preferred for added safety against incompatible configuration parameter settings. In step 409 the processor 302 receives confirmation from the implantable device that the transmitted parameters were successfully received. If confirmation is not received, in step 409 , then the user is notified of a failure to reprogram the implantable device. The processor 302 completes the programming operation by entering into end state 410 . [0044] In step 412 processor 204 of the implantable device receives the model and serial number request command sent by the programming device in step 402 . In step 413 the processor 204 responds by transmitting the model and serial number of the implantable device. In step 414 the processor 204 receives the configuration parameter request command from the programming device, and in step 415 the processor responds by transmitting the current configuration parameter values. Subsequently during a programming operation, the processor 204 receives another model and serial number request command in step 416 , and responds in step 417 by transmitting the model and serial number of the implantable device. Then in step 418 the processor 204 receives modified parameter values from the programming device. After verifying that the parameters have been correctly received, the processor updates the configuration parameters with the new values and, in step 419 , transmits a confirmation message to the programming device. [0045] FIG. 5 illustrates how the use of multiple programming devices can introduce safety concerns when a second programming device interacts with an implantable device between the inquiry and programming operations of the first programming device. An implantable device begins in step 502 . In step 504 , an inquiry operation is performed by a first programming device “A”. Subsequently, a second programming device “B” performs an inquiry operation on the implantable device in step 506 , and a programming operation on the implantable device in step 508 . The first programming device “A” is then used to program the implantable device in step 510 , and at the end of this sequence in step 512 , the implantable device may be left with an undesired set of configuration parameters. To avoid this, programming device “A” or the implantable device may be provided with a means for detecting if another programming device interacted with the implantable device between the inquiry and program operations of programming device “A”. [0046] A first embodiment of a multiple programming device-implantable device system is shown in FIG. 6 . The programming device's processor 302 proceeds through the inquiry operation steps 401 - 405 as outlined previously. After the processor 302 successfully receives all the requested parameters in step 405 , in step 601 the processor 302 sends a programming device identification number to the implantable device for the implantable device to store. The programming device identification number preferably includes the model number and serial number of the programming device. In this system embodiment, the implantable device always has a record of the last programming device to successfully perform an inquiry or programming operation on it. [0047] Subsequently, when the programming device is ready to transmit altered parameters to the implantable device, the processor 302 proceeds through steps 406 , 407 , and after verifying that the implant identification information matches, the processor transmits the programming device identification number in step 602 before transmitting the modified configuration parameters in step 408 and proceeding through steps 409 and 410 . [0048] The implantable device's processor 204 similarly proceeds through inquiry operation steps 411 - 415 as outlined previously. After the processor 204 transmits the requested parameters in step 415 , it receives and stores the programming device identification information in step 603 . Then when the programming device initiates a programming operation, the processor 204 performs steps 416 , 417 before receiving the programming device's identification information in step 604 . In step 606 the processor 204 compares the received identification information to the previously stored identification information from step 603 . If they do not match, then in step 608 the processor 204 transmits a denial to the programming device and ends the programming operation in step 420 . If the information matches, then the processor 204 performs steps 418 - 420 to accept and confirm the modified parameters. [0049] This system embodiment provides that only the programming device which has most recently interacted successfully with the implantable device is allowed to program the implantable device. Referring back to FIG. 5 , in step 510 this embodiment of programming device “A” would receive a denial from the implantable device when a programming operation is attempted. Programming device “A” would preferably inform the user of the denial and allow the user to initiate an inquiry operation to discover any alterations which may have been made to the configuration parameters. [0050] Another system embodiment is illustrated in FIG. 7 . The inquiry operation of this embodiment matches that of the previous embodiment for both the programming device and the implantable device. After step 417 of the programming operation, the implantable device's processor 204 sends the programmer identification information to the programmer device in step 705 . Then in step 418 , the processor 204 receives any transmitted parameters and proceeds through steps 419 , 420 as outlined previously. [0051] After step 407 of the programming operation the programming device's processor 302 receives in step 701 the identification information of the last programmer to interact with the implantable device. In step 703 the processor 302 verifies that the identification information matches the programming device's model and serial number. If they do not match, the processor 302 terminates the programming operation in step 410 and preferably notifies the user of the error. Otherwise, the processor proceeds through steps 408 - 410 of the programming operation to provide the modified parameters to the implantable device. This embodiment advantageously places fewer demands on the implantable device, thereby minimizing implementation cost. [0052] Another programming device embodiment is shown in FIG. 8 . In this embodiment, after successfully receiving the configuration parameters in step 405 , the programming device's processor 302 starts a timer in step 801 . Subsequently, before initiating a transmission of altered parameters, the processor 302 checks for expiration of the timer in step 803 . If too much time has elapsed, the processor 302 aborts the programming operation and preferably notifies the operator. Otherwise, the processor 302 continues with the programming operation in steps 406 - 410 . An implantable device embodiment which operates similarly is shown in FIG. 9 . After successfully completing transmission of requested parameters, the implantable device's processor 204 starts a timer in step 902 . After a programming operation is initiated, the processor 204 checks for expiration of the timer in step 904 . If too much time has elapsed, the processor 204 transmits a denial in step 906 , and the programming device preferably notifies the operator of the failure of the programming operation. Otherwise, the processor 204 continues the programming operation in steps 418 - 420 . In a variation on the embodiments of FIGS. 8 and 9 , the timers may be restarted after successful completion of the programming operation. The timers in FIGS. 8 and 9 preferably run for a time period greater than 5 minutes and less than 60 minutes. A time period of between 10 and 20 minutes is contemplated. [0053] Two more system embodiments are shown in FIGS. 10 and 11 . These embodiments are closely related to those of FIGS. 6 and 7 , respectively. However, rather than using the programming device's identification number to identify the programming devices, these embodiments use the time and date of last access to identify the programming devices. [0054] Referring now to FIG. 10 , after the programming device's processor 302 successfully receives all the requested parameters in step 405 , in step 1001 the processor 302 stores and sends a current time and date to the implantable device for the implantable device to keep on record. Subsequently, when the processor 302 is instructed to send altered parameters to the implantable device, the processor 302 performs steps 406 , 407 and then in step 1002 transmits the stored time and date to the implantable device before proceeding with the remaining steps 408 - 410 . [0055] The implantable device's processor 204 performs steps 411 - 415 of the inquiry operation and in step 1003 receives and stores the date and time transmitted by the programming device. In the subsequent programming operation the processor 204 performs steps 416 , 417 before receiving the transmitted time and date from the programming device in step 1004 . Then in step 1006 the processor 204 compares the transmitted time and date to the stored time and date at which the last programming device successfully inquired or programmed the implantable device. If the numbers do not match, the processor 204 transmits a denial to the programming device in step 1008 . Otherwise the processor 204 proceeds to receive the new parameters in step 418 . Upon successful reception of all the transmitted parameters, the processor 204 sends a confirm signal in step 419 and stores the new parameters. [0056] Referring now to FIG. 11 , the inquiry operations of both the programming device and implantable device are the same as those of FIG. 10 . In step 1105 , the implantable device's processor 204 sends the stored date and time after establishing the implantable device's identity in steps 416 - 417 , and before performing the remaining programming steps 418 - 420 . After steps 406 - 407 of the programming operation, the programming device's processor 302 receives the date and time of last successful inquiry operation from the implantable device in step 1101 . In step 1103 , the processor 302 compares the received date and time to its own stored date and time of last successful operation to determine if any other programming device has successfully interacted with the implantable device since the current programming device's last inquiry operation. If the access date and times are the same, the processor 302 proceeds with steps 408 - 410 of the programming operation. Otherwise, the processor 302 terminates the program operation in step 410 and preferably notifies the user of the error. [0057] A preferred system embodiment is shown in FIG. 12 . In this embodiment, a time and date is associated with the last successful programming of the implantable device 106 . After the programming device's processor 302 performs steps 401 - 405 of the inquiry operation, in step 1201 it receives and stores the time and date of the last programming operation on the implantable device. In any subsequent programming operation, the processor 302 establishes the identity of the implantable device in steps 406 - 407 and sends the stored time and date in step 1202 before sending any parameters in step 408 . After transmitting the parameters, the processor 302 sends the current date and time to the implantable device. The processor 302 then completes the programming operation steps 409 - 410 . [0058] After the implantable device's processor 204 performs inquiry operation steps 411 - 415 , it sends the time and date of the last programming operation in step 1204 . In the subsequent programming operation, the processor 204 establishes the implant's identity to the programming device in steps 416 - 417 . In step 1205 , the processor 204 receives the programming device's record of the last programming date and time, and compares it with the implantable device's record of the last programming date and time in step 1206 . If they do not match, then the implantable device has been reprogrammed since the last inquiry operation by the programming device, and the processor 204 transmits a denial in step 1208 and terminates the programming operation in step 420 . Otherwise, the is processor 204 accepts the new parameters in step 418 , and the current date and time in step 1210 . If the programming operation is successful, the implantable device stores the current date and time as the new programming date and time, and in step 419 sends a confirmation to the programming device. [0059] A more preferred embodiment is shown in FIG. 13 . The inquiry operation is the same as the inquiry operation of the embodiment shown in FIG. 12 . The programming operation differs for the implantable device in that after transmitting its identification information in step 417 , the processor 204 transmits the stored programming date and time to the programming device in step 1305 . The processor 204 then accepts any transmitted modified parameters in step 418 and if the transmission is successful, accepts and stores the current date and time in step 1210 before sending a confirmation in step 419 . [0060] The programming operation for the programming device begins with the processor 302 requesting and receiving the implantable device's identification information in steps 406 - 407 . In step 1301 the processor receives the transmitted date and time from the implantable device and in step 1303 compares the transmitted date and time to the stored programming date and time. If they match, then none of the configuration parameters has been re-programmed since the programming device's last inquiry operation. Consequently, the processor 302 proceeds to send the new parameters in step 408 and the current date and time in step 1203 . Otherwise, the programming device ends the program operation in step 410 and preferably notifies the operator of the error. [0061] The embodiments of FIGS. 12 and 13 are preferred relative to the previously described embodiments since in these embodiments, multiple programming devices can simultaneously be qualified to provide a new set of parameters to the implantable device. Any programming device with a current version of the configuration parameters (as indicated by the associated programming date and time) can successfully program the implantable device. Conversely, in the other previously described embodiments, only a single programming device at a time (the one which has most recently interacted with the implantable device) can successfully program the implantable device. [0062] Referring now to FIG. 14 , yet another embodiment is shown. In this embodiment, prior to each programming operation, programming device 110 inquires the configuration parameters in order to verify the accuracy of programming device 110 's copy of those parameters. The inquiry operations for the implantable device and the programming device is the same as that of FIG. 4 . For the programming operation, the implantable device's processor 204 performs steps 416 - 417 to establish its identity to the programming device. Then in step 1406 the processor 204 receives a parameter request similar to that of step 414 , and in step 1407 responds to the parameter request by sending the requested parameters. Then in step 418 the processor 204 may receive modified parameters from the programming device, and in step 419 the processor 204 acknowledges a successful receipt of the parameters and updates the current parameters with the new parameter values. [0063] The programming device's processor 302 performs steps 406 - 407 to establish the implantable device's identity, then in step 1401 , the processor 302 transmits a request for the configuration parameters similar to that of step 404 . The processor 302 receives the transmitted parameters in step 1403 and in step 1405 compares them with the parameters from the previous inquiry. If there is no change (or only a slight change which may be attributed to adaptation or progression of a programmed algorithm), then the implantable device has not been reprogrammed since the inquiry. The processor 302 consequently transmits the new configuration parameters in step 408 . Otherwise, the programming device terminates the programming operation in step 410 and preferably notifies the user of the failure. [0064] Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.

A multiprogrammer system, for monitoring and optimizing implant performance, includes at least two programmers and an implant. Each programmer may perform inquiry and programming operations on the implant. In an inquiry operation, the programmer retrieves some or all of the configuration parameters from the implant. In a programming operation, the programmer provides one or more modified parameters to the implant. As part of the programming operation, the programmer is configured to verify that it is aware of the implant's current parameters before sending modified parameters. The current programmer verifies that the implant's parameters have not been altered since the current programmer's last interaction with the implant. If the parameters have been altered, the current programmer aborts the programming operation and provides notification. The verification may be performed by the implant, i.e., it may verify that the programmer is aware of the current device parameters before the implant accepts modified parameters.

FIELD OF THE INVENTION The present invention relates to new peptides, a method for the preparation of said peptides and a pharmaceutical preparation containing said peptides. The peptides according to the present invention are excellent as immunomodulating agents. BACKGROUND OF THE INVENTION There has been a longfelt need for new safe immunomodulatory agents in the treatment of many different diseases including malignant diseases, autoimmune diseases and asthma/allergy. Present immunomodulatory agents such as Cyclosporin A and steroids, are very potent immunosuppressive agents but also present severe side effects in a dose dependent manner. New immunomodulatory agents with higher specificity for the immune system, showing less side effects will be of great benefit in the treatment of diseases with a pathological immune response as an important component in the disease process. PRIOR ART Signalling between cells are to a major extent mediated by oligo- or polypeptide principles, including cytokines, neuropeptides and hormones. One possible way such a signal can be transmitted may involve oxidoreductase activity mediated by thiol-disulfide interaction of cysteine residues. This type of action can induce conformational changes of proteins which ultimately may result in a signal to the cell nuclei. Thus redox systems, based on oxidised or reduced cysteines, play important roles in initiating, maintaining and/or downregulating inflammatory responses. Redox systems that are characterized today are the thioredoxin (TR)/thioredoxin reductase (TRR) system (Holmgren et al, 1989, J.Biol.Chem, 264, 13963) and similar systems like the glutaredoxin/glutathione reductase (Bushweller et al., 1992, Biochemistry, 31, 9288) and the protein disulfide isomerase (PDI) systems (Noiva and Lennarz, 1992, J.Biol.Chem., 267, 3553). The TR/TRR system and related redox systems are potent regulators of different known immunological and inflammatory parameters, like IL-2R α-chain expression (Espinoz-Adelgado et al, 1992, J.Immunol., 149, 2961), modulation of expression of IFN-γ activity (Deiss and Kimchi, 1991, Science, 252, 117), differentiation and effector function of lymphocytes (Yodoi and Uchiyama, 1992, Immunol. Today 13, 405-411), regulation of eosinophil effector functions (Balcewics et al, 1991, J. Immunol., 147, 2170), activation of glucocorticoid receptor (Grippo et al, 1985, J.Biol.Chem. 260, 93-97) and modulation of immune response during pregnancy (Clarke et al, 1991, J.Reprod.Fert., 93, 525). The active site of TR includes a sequence with a -Cys-Gly-Pro-Cys- motif. Selected virus proteins, e.g. gene products coded from X regions of human T-cell leukaemia viruses (Shimotohno et al, 1985, P.N.A.S. 82, 302-306) and human immunoregulatory proteins may have cysteine-containing sequences which are homologous to such a -Cys-Gly-Pro-Cys- motif. We have considered that these proteins may either express oxidoreductase activity or can be substrates for such an activity or possibly act as inhibitors of such an activity. Previously peptides based on the cysteine-rich TR active site sequence mentioned above have been produced and shown to exhibit biological activities similar to the native protein Another example of a cysteine-containing peptide with thioredoxin-like activity was obtained from hFSH-β-(81-95) (Grasso et al, 1991, Molecular and Cellular Endocrinology 78, 163). Analogs of thymic humoral factor γ2 (ThF-γ2) for use as immunomodulatory agents in pharmaceutical compositions are described in WO, A1, 9501182 (12.01.95). This document discloses two cyclic analogs; Leu-Glu-Cys-Gly-Pro-Cys-Phe-Leu (SEQ ID NO: 34) and Leu-Cys-Ala-Gly-Pro-Cys-Phe-Leu (SEQ ID NO: 35);, which are excluded from the present invention. However, this document does not reveal the active importance of cysteine-containing sequences. We have prepared peptides with cysteine-containing motifs, selected from virus structural proteins e.g. retroviral transmembraneous protein p15E, and human proteins involved in regulation of inflammnation, e.g. TGF-β. Peptides were then modified to get optimal immuno-regulatory properties. OUTLINE OF THE INVENTION We have now surprisingly found a novel group of peptides which are excellent as immunomodulators. The peptides according to the present invention comprise 4-15 amino acids and can be described by the general formula (I): A-X-Y-Cys-Z-B (I) wherein X is selected from Gly, Ala, Ile, Asp, Thr, Ser, Arg or Trp; Y is selected from Pro, pipecolic acid (hereinafter called Pec) or Ile: Z is selected from Ile, Phe, Pro, Ala, Tyr or Gly; A is H, a protecting group, an amino acid in either L- or D-form with or without protected sidechain-functionality and/or N-terminal protection or an amino acid sequence with or without protected sidechain-functionalities and/or N-terminal protection; B is OH, NH 2 , a protecting group, an amino acid in either L- or D-form with or without protected sidechain-functionality and ending with a C-terminal amide, a free carboxyl or a protecting group or an amino acid sequence with or without protected sidechain-functionalities and ending with a C-terminal amide, a free carboxyl or a protecting group; and provided that the following sequences are excluded from the formula (I): Leu-Glu-Cys-Gly-Pro-Cys-Phe-Leu (SEQ ID NO: 34), Leu-Cys-Ala-Gly-Pro-Cys-Phe-Leu (SEQ ID NO: 35), Tyr-Ile-Pro-Cys-Phe-Pro-Ser-Ser-Leu-Lys-Arg-Leu-Leu-Ile (SEQ ID NO: 36), Tyr-Ile-Pro-Cys-Phe-Pro-Ser-Ser-Leu-Lys-Arg-Leu-Ile (SEQ ID NO: 37), Ser-Gly-Pro-Cys-Pro-Lys-Asp-Gly-Gln-Pro-Ser (SEQ ID NO: 38) and Thr-Pro-Pro-Thr-Pro-Cys-Pro-Ser (SEQ ID NO: 39). The length of A and B can vary, as long as the criteria concerning length and possible amino acids or other substituents are fulfilled. The amino acids according to the present invention can be both naturally occurring amino acids and non-naturally, synthetic amino acids or amino acid analogues. Examples of protecting groups for A are a variety of carbamates and amides of which the following protecting groups are preferred: acetyl (Ac), 9-fluorenylmethyl carbamate (Fmoc), 1-methyl-1-(4-biphenylyl)ethyl carbamate (Bpoc), trityl (Trt), allyl carbamate (Alloc) and t-butyl carbamate (Boc). Especially preferred protecting groups for A are acetyl (Ac), 9-fluorenylmethyl carbamate (Fmoc) and t-butyl carbamate (Boc). Examples of protecting groups for B are a variety of esters such as C 1 -C 6 alkyl, allyl, adamantyl, benzyl, and t-butyl. Also within the scope of the present invention are homodimers according to the formulae (II), (III) and (IV) ##STR1## i.e. homodimers of the peptides of the formula (I) according to the invention. Also within the scope of the present invention are pharmaceutically acceptable salts of peptides of the formulae (I), (II), (III) and (IV). Peptides of the formula (I) containing several cysteine residues may exist both in an oxidized and in a reduced form. The oxidized form may contain intramolecular disulfide bonds resulting in oxidized monomers or intermolecular disulfides resulting in both head to head and head to tail dimers of the peptides of formula (I). Preferred peptides according to the present invention are peptides of the formulae (I), (II), (III) and (IV) wherein X is Gly, Y is Pro and Z is Ile; X is Gly, Y is Pro and Z is Gly; X is Ala, Y is Pro and Z is Ala; X is Ile, Y is Pro and Z is Tyr; X is Ala, Y is Pro and Z is Ile; X is Arg, Y is Pro and Z is Ile; X is Ile, Y is Pro and Z is Ile; X is Asp, Y is Pro and Z is Ile; X is Trp, Y is Pro and Z is Ile; X is Trp, Y is Pro and Z is Gly; X is Gly, Y is Ile and Z is Ile; X is Gly, Y is Pec and Z is Ile; X is Thr, Y is Pro and Z is Tyr; X is Thr, Y is Pec and Z is Phe; X is Ala, Y is Pro and Z is Phe; X is Ser, Y is Pro and Z is Phe; X is Gly, Y is Pro and Z is Pro; or X is Gly, Y is Pro and Z is Tyr; wherein A and B can be varied as defined above; and provided that the following sequence is excluded from the formulae (I), (II), (III) and (IV): Ser-Gly-Pro-Cys-Pro-Lys-Asp-Gly-Gln-Pro-Ser (SEQ ID NO: 38). Preferred peptides according to the invention are H-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 1); Fmoc-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 1); H-Gly-Pro-Cys-Gly-OH (SEQ ID NO: 2); H-Ala-Pro-Cys-Ala-OH (SEQ ID NO: 3); H-Ile-Pro-Cys-Tyr-OH (SEQ ID NO: 4); H-Trp-Pro-Cys-Gly-OH (SEQ ID NO: 32); H-Phe-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 5); H-Gly-Pro-Cys-Ile-Leu-Asn-NH 2 (SEQ ID NO: 6); H-Gly-Pro-Cys-Ile-Leu-Asn-Arg-OH (SEQ ID NO: 7); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 8); H-Leu-Leu-D-Phe-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 8); H-Leu-Leu-Phe-Ala-Pro-Cys-Ile-OH (SEQ ID NO: 9); H-Leu-Leu-Phe-Arg-Pro-Cys-Ile-OH (SEQ ID NO: 10); H-Leu-Leu-Phe-Ile-Pro-Cys-Ile-OH (SEQ ID NO: 11); H-Leu-Leu-Phe-Asp-Pro-Cys-Ile-OH (SEQ ID NO: 12); H-Leu-Leu-Phe-Trp-Pro-Cys-Ile-OH (SEQ ID NO: 13); H-Leu-Leu-Phe-Gly-Ile-Cys-Ile-OH (SEQ ID NO: 14); H-Leu-Leu-Phe-Gly-Pec-Cys-Ile-OH (SEQ ID NO: 15); H-Ala-Val-Trp-Thr-Pro-Cys-Tyr-OH (SEQ ID NO: 33); H-Tyr-Phe-Tyr-Thr-Pec-Cys-Phe-OH (SEQ ID NO: 16); H-Phe-Val-Met-Ala-Pro-Cys-Phe-OH (SEQ ID NO: 17); H-Leu-Leu-Tyr-Ser-Pro-Cys-Phe-OH (SEQ ID NO: 18); H-Ile-Ser-Gly-Pro-Cys-Pro-Lys-OH (SEQ ID NO: 19); H-Phe-Leu-Phe-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 20); H-Leu-Phe-Gly-Pro-Cys-Ile-Leu-NH 2 (SEQ ID NO: 21); H-Glu-Lys-Gly-Pro-Cys-Tyr-Arg-OH (SEQ ID NO: 22); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-OH (SEQ ID NO: 23); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-NH 2 (SEQ ID NO: 24); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-OAllyl (SEQ ID NO: 23); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-NH 2 (SEQ ID NO: 25); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-Arg-OH (SEQ ID NO: 26); H-Phe-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-NH 2 (SEQ ID NO: 27); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-Arg-Leu-Met-Glu-NH 2 (SEQ ID NO: 28); H-Phe-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-Arg-Leu-Met-Glu-NH 2 (SEQ ID NO: 29); Fmoc-Phe-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-Arg-Leu-Met-Glu-NH 2 (SEQ ID NO: 29); H-Phe-Cys-Leu-Gly-Pro-Cys-Pro-OH (SEQ ID NO: 30); ##STR2## Especially preferred peptides according to the invention are peptides of the formulae (I), (II), (III) and (IV) wherein X is Gly, Y is Pro and Z is Ile; X is Ala, Y is Pro and Z is Ala; X is Ala, Y is Pro and Z is Ile; X is Asp, Y is Pro and Z is Ile; X is Gly, Y is Ile and Z is Ile; X is Gly, Y is Pec and Z is Ile; X is Ser, Y is Pro and Z is Phe; or X is Gly, Y is Pro and Z is Pro; wherein A and B can be varied as defined above; and provided that the following sequence is excluded from the formulae (I), (II), (III) and (IV): Ser-Gly-Pro-Cys-Pro-Lys-Asp-Gly-Gln-Pro-Ser (SEQ ID NO: 38). Especially preferred peptides according to the invention are the peptides H-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 1); H-Ala-Pro-Cys-Ala-OH (SEQ ID NO: 3); H-Phe-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 5); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 8); H-Leu-Leu-Phe-Ala-Pro-Cys-Ile-OH (SEQ ID NO: 9); H-Leu-Leu-Phe-Asp-Pro-Cys-Ile-OH (SEQ ID NO: 12); H-Leu-Leu-Phe-Gly-Ile-Cys-Ile-OH (SEQ ID NO: 14); H-Leu-Leu-Phe-Gly-Pec-Cys-Ile-OH (SEQ ID NO: 15); H-Leu-Leu-Tyr-Ser-Pro-Cys-Phe-OH (SEQ ID NO: 18); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-OH (SEQ ID NO: 23); ##STR3## The most preferred peptides according to the invention are peptides of the formulae (I), (II), (III) and (IV) wherein X is Gly, Y is Pro and Z is Ile, X is Ala, Y is Pro and Z is Ile; X is Asp, Y is Pro and Z is Ile; X is Ser, Y is Pro and Z is Phe; or X is Gly, Y is Pro and Z is Pro; wherein A and B can be varied as defined above; and provided that the following sequence is excluded from the formulae (I), (II), (III) and (IV): Ser-Gly-Pro-Cys-Pro-Lys-Asp-Gly-Gln-Pro-Ser (SEQ ID NO: 38). The most preferred peptides according to the invention are the peptides H-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 1); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 8); H-Leu-Leu-Phe-Ala-Pro-Cys-Ile-OH (SEQ ID NO: 9); H-Leu-Leu-Phe-Asp-Pro-Cys-Ile-OH (SEQ ID NO: 12); H-Leu-Leu-Tyr-Ser-Pro-Cys-Phe-OH (SEQ ID NO: 18); H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-OH (SEQ ID NO: 23); ##STR4## We have now surprisingly found that peptides of the formulae (I), (II), (III) and (IV) are excellent as immunomodulators, thus having either immunostimulating or immunoinhibitory effect. The invention thus provides peptides with advantageous properties for the treatment of diseases where an anergy of the immune response or an aberrant immune response or an ineffective host defence can be suspected. Such diseases include chronic bronchitis, where a reduction of the rate of exacerbations has previously been reported with immune response modifiers such as Biostim (Radermecker, M. et al. Int. J. Immunopharmac. 10, 913-917, 1988, Scheffer, J. et al. Arzneim Forsch/Drug Res: 41, 815-820, 1991), Ribomunyl and BronchoVaxom (Paupe, J. Respiration 58, 150-154, 1991) as well as with N-acetylcysteine (See Bergstrand, H. et al J. Free Radic. Biol. Med. 2, 119-127, 1986). Such diseases also include certain forms of malignant diseases. Thus, numerous research institutes round the world aim at finding ways of stimulating the immune response in patients with various forms of malignant diseases and numerous reviews in the literature deal with this approach (Stevenson, F. K. FASEB J 5: 2250-2257, 1991; Melief, C. J. M. Advances in Cancer Research 58: 143-75, 1992, Chen, J. et al., Immunology Today 14:10, 483-86, 1993). To mention one example patients with intracranial tumours (gliomas) exhibit a profound decrease in immunity possibly due to a defect in the secretion of IL-2 as well as the expression of IL-2 receptors in T cells from these patients (Roszman, T. et al. Immunology Today 12, 370-374, 1991). Moreover, a significant adjuvant effect in immunotherapy of melanoma and colon carcinoma has been documented for the immunostimulator Levamisole (Van Wauwe, J. and Janssen, P. A. J: Int J. Immunopharmac 13, 3-9, 1991) and immunotherapy with IL-2 in vivo or treatment of patients lymphokine activated killer cells with IL-2 ex vivo has caused the regression of cancer in selected patients (Rosenberg, S. A. Immunology Today 9, 58-62, 1988). The malignant diseases where the peptides of the formulae (I), (II), (III) and (IV) can be expected to have advantageous effects include tumours of mesenchymal origin such as sarcomas like fibrosarcoma, myxosarcoma, liposarcoma, chondrosarcoma, osteogenic sarcoma or chordosarcoma, sarcomas like angiosarcoma, endotheliosarcoma, lymphangiosarcoma, synoviosarcoma or mesotheliosarcoma, leukemias and lymphomas like granulocytic leukemia, monocytic leukemia, lymphocytic leukemia, malignant lymphoma, plasmocytoma, reticulum cell sarcoma or Hodgkins disease, sarcomas like leiomysarcoma or rhabdomysarcoma, tumours of epithelial origin (Carcinomas) like squamous cell carcinoma, basal cell carcinoma, sweat gland carcinoma, sebaceous gland carcinoma, adenocarcinoma, papillary carcinoma, papillary adenocarcinoma, cystadenocarcinoma, medullary carcinoma, undifferentiated carcinoma, bronchogenic carcinoma, melanoma, renal cell carcinoma, hepatoma-liver cell carcinoma, bile duct carcinoma-cholangiocarcinoma, papillary carcinoma, transitional cell carcinoma, squamous cell carcinoma, choriocarcinoma, semonoma or embryonal carcinoma, tumours of the central nervous system like glioma, meningoma, medulloblastoma, schwannoma or ependymoma. Moreover, the peptides according to the present invention also have advantageous properties for the treatment of chronic infections such as herpes, aphtous stomatitis and minimal change syndrome where clinical improvement has previously been reported by treatment with an immunostimulator such as Levamisole as well as other chronic inflammatory diseases in the urinary tract or in ear, nose or throut, which benefit from treatment with immunostimulators such as Biostim, Broncho-Vaxom and Ribomunyl, or at HIV infection or AIDS. Moreover, an impairment, a defect or an imbalance of the immune response has also been postulated to exist at atopic diseases such as atopic dermatitis, rhinitis and asthma (Katz, D. H. Immunology Rewiews 41, 77-108, 1977). Since theoretical considerations suggest that stimulation of an immune response would possibly be the best way of restoring imbalances and autoimmunity (Varela, F. J. and Coutinho, A. Immunology Today 12, 159-166, 1991), the peptides can also be expected to have advantageous properties for the treatment of asthma, rhinitis, atopic dermatitis and autoimmune diseases like non-obese diabetes, systemic lupus erythematosus, sclerodermia, Sjogren's syndrome, dermatomyositis or multiple sclerosis, rheumatoid arthritis and possibly psoriasis. Moreover, the peptides according to the present invention, due to their immune modulating properties, may have advantageous properties as adjuvants in various forms of vaccine preparations. Due to their immune modulating properties, the peptides can also be expected to have favourable properties in inhibiting rejection of organs/transplants. Finally, the peptides according to the present invention can be expected to have advantageous properties in the treatment of artheriosclerosis, whether or not they will influence a putative inflammatory process in this condition (Hansson. G. K. et al. Proc. Nat. Acad. Sci. USA 88, 10530, 1991). The peptides according to the present invention are particulary suitable for treatment of malignancies such as melanoma, mammary carcinoma, gastrointestinal carcinoma, glioma, bladder carcinoma and squamous cell carcinoma of the neck and head region; infections such as chronic bronchitis, hepatitis, post-infectious anergy and aquired immune deficiencies such as AIDS; posttraumatic immunological anergy; and purported autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, artheriosclerosis and psoriasis. Preparation The peptides according to the present invention may be prepared using the standard solid phase sequential coupling technique utilizing an automatic peptide synthesizer (see for example: Jones, J. The Chemical Synthesis of Peptides, pp 132-156, first edition, Oxford University Press, 1991 and R. Epton (ed) Innovation and Perspectives in Solid Phase Synthesis, SPCC (UK) Ltd, 1990). The preparation starts form the C-terminal amino acid which can be obtained grafted to a methylbenzhydrylamine, benzhydrylamine or chloromethylated resin or other suitable solid support. The other amino acids are grafted step by step, after having protected the side chains thereof. In this coupling method the α-amino groups of the amino acids are protected either with Fmoc or t-Boc methodology. Protective groups for the side chains of amino acids are well known in the art. The whole protected peptide is released either from the chloromethylated resin by ammoniolysis to obtain the protected amide, or from the methylbenzhydrylamine or benzhydrylamine resins by acidolysis. Peptides according to the invention may also be prepared using solution methods, by either stepwise or fragment condensations (see for example: Jones, J. The Chemical Synthesis of Peptides, pp 115-131, first edition, Oxford University Press, 1991). An appropriately alpha aminoprotected amino acid is coupled to an appropriately alpha carboxyl protected amino acid (such protection may not be required depending on the coupling method chosen) using diimides, symmetrical or unsymmetrical anhydrides, or other coupling reagents or techniques known to those skilled in the art. These techniques may be either chemical or enzymatic. The alpha amino and/or alpha carboxyl protecting groups are removed and the next suitably protected amino acid or block of amino acids are coupled to extend the growing peptide. Various combinations of protecting groups and of chemical and/or enzymatic techniques and assembly strategies can be used in each synthesis. The dimers (peptides of the formulae (II), (III) and (IV)) and peptides containing intramolecular disulfide bonds between cysteine residues may be prepared via general oxidation techniques described by Andreu et al in Methods in Molecular Biology, Peptide Synthesis Protocols vol 35 (Humana Press Inc., Totowa, N.J., 1994) and Ruiz-Gayo et al, 1988, Tetrahedron Letters, 29, 3845-3848, as well as in other reference works known to those skilled in the art. Low-resolution mass spectra and accurate mass determinations were recorded on an Autospec-Q, Fisons Analytical, double focusing sector instrument equiped with a LSIMS interface. DETAILED DESCRIPTION OF THE INVENTION The invention will now be described in more detail with the following examples which are not to be construed as limiting the invention. EXAMPLE 1 Synthesis of H-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 1) A resin (0.37 g, 0.22 mequiv/g, 81 μmol) consisting of a crosslinked polystyrene backbone grafted with polyethyleneglycol chains, functionalized with the linker p-hydroxymethylphenoxyacetic acid (Sheppard and Williams, 1982, Int. J. Peptide Protein Res., 20, 451-454) and Fmoc-Ile, from Rapp Polymere (Germany) was used for the synthesis. N.sup.α -Fmoc amino acids were from Bachem (Switzerland), and Cys was protected with a triphenylmethyl (Trt) group. DMF was distilled before being used. The N.sup.α -Fmoc amino acids were coupled to the peptide-resin as 7-aza-1-benzotriazolyl (HOAt) esters (Carpino, 1993, J. Am. Chem. Soc. 115, 4397-4398). These were prepared, in situ, in the peptide synthesizer from the appropriate N.sup.α -Fmoc amino acid (0.32 mmol) and HOAt (65 mg, 0.48 mmol) by addition of DMF (0.5 ml) and a solution of 1,3-diisopropyl-carbodiimide in DMF (0.39 M, 0.8 ml, 0.312 mmol). After 45 min bromophenol blue (Flegel and Sheppard, 1990, J. Chem. Soc., Chem. Commun. 536-538) in DMF (0.15mM, 0.4 ml) was added to the HOAt ester by the synthesizer, and the resulting solution was recirculated through the column. The acylation was monitored (Flegel and Sheppard, 1990, J. Chem. Soc., Chem. Commun. 536-538) using the absorbance of bromophenol blue at 600 nm, and when the coupling was complete the peptide-resin was automatically washed with DMF. Coupling times for different N.sup.α -Fmoc amino acids were approximately 30 min. N.sup.α -Fmoc deprotection of the peptide resin was performed by a flow of 20% piperidine in DMF through the column for 12.5 min, and was monitored (Dryland and Sheppard, 1986, J. Chem. Soc. Perkin Trans. I, 125-137) using the absorbance of the dibenzofulvene-piperidine adduct at 350 nm. After completion of the N.sup.α -Fmoc deprotection the peptide-resin was again washed automatically with DMF. After completion of the synthesis and cleavage of the N-terminal N.sup.α -Fmoc group, the resin was washed with dichloromethane (5×5 ml) and dried under vacuum. The peptide (40 μmol) was then cleaved from the resin (200 mg), and the amino acid side chains were deprotected, by treatment with trifluoroacetic acid-water-thioanisole-ethanedithiol (87.5:5 5:5:2.5, 20 ml) for 2 h, followed by filtration. Acetic acid (20 ml) was added to the filtrate, the solution was concentrated, and acetic acid (20 ml) was added again before the solution was concentrated. The residue was dissolved in acetic acid-water (4:1, 25 ml) and the solution was freeze dried. The residue was triturated with ether (10 ml) which gave a solid, crude peptide (21 mg) after drying under vacuum. The peptide was analyzed on a Beckman System Gold HPLC using a Kromasil C-8 column (1000 Å, 4.6×250 mm) and a linear gradient of 0-80% of B in A over 60 min with a flow rate of 1.5 ml/min and detection at 214 nm (solvent systems A: 0.1% aqueous trifluoroacetic acid and B: 0.1% trifluoroacetic acid in acetonitrile). Purification of the crude peptide (21 mg) was performed with the same HPLC system on a 20×250 mm Kromasil C-8 column with a flow rate of 11 ml/min and gave pure a product (8.5 mg, 55%). FAB-MS: 389 (MH + ). The compound is also listed in table 1. EXAMPLES 2-33 The peptides according to examples 2-33 were prepared using the same protocol as in example 1. The compounds are listed in table 1. EXAMPLE 34 ##STR5## A solution of the monomer (1.5 mg/ml, in 50 nM phosphate buffer, pH=7.2) containing 5 ppm copper(II)-sulphate was stirred at room temperature for 20 hours. The solution was lyophilized and redissolved in water/acetonitrile (80/20) and purified by reverse phase HPLC using a VYDAC C-18 column (5 μm, 4×250 mm). An aqueous solution containing 0.1% trifluoroacetic acid and 5% acetonitrile was used as a mobile phase. The concentration of acetonitrile was increased linearly to 60% over a time scale of 25 min. The flow rate was 1.5 ml/min and the components were detected with UV at 220 nm. Fractions were collected manually and checked with FAB-MS. Repeated injections were pooled to give a solution of the product which was lyophilized. FAB-MS: 1521 (MH + ). The compound is listed in table 1. EXAMPLES 35-37 The peptides according to examples 35-37 were prepared using the same protocol as in example 34. The compounds are listed in table 1. EXAMPLE 38 The peptide according to example 38 was prepared using the same protocol as in example 1. The compound is listed in table 1. EXAMPLE 39 The peptide according to example 39 was prepared using the same protocol as in example 34-37. The compounds are listed in table 1. EXAMPLES 40-41 The peptides according to examples 40-41 were prepared using the same protocol as in example 1. The compounds are listed in table 1. EXAMPLE 42 ##STR6## To prepare the parallel (head to head) homodimer a single peptide chain with an Acm (acetamidomethyl) protecting group on one of the cysteines and with the other cysteine unprotected (H-Phe-Cys-Leu-Gly-Pro-Cys(Acm)-Pro-OH) was synthesized using the same protocol as in example 1. The monomer was dimerized through oxidation of the free cysteines using the same protocol as in example 2. The second disulfide bond was accomplished using the protocol of Ruiz-Gayo (Ruiz-Gayo et al, 1988, Tetrahedron Letters, 29, 3845-3848) in which a onepot deprotection and oxidation of the Acm protected cysteine with iodine in 80% aqueous acetic acid resulted in a crude product which was purified on HPLC. The compound is listed in table 1. EXAMPLE 43 ##STR7## To prepare the antiparallel (head to tail) homodimer the general procedure of Ruiz-Gayo was used (Ruiz-Gayo et al, 1988, Tetrahedron Letters, 29, 3845-3848). Two single peptide chains each with an Acm (acetamidomethyl) protecting group on one of the cysteines and with the other cysteine unprotected (H-Phe-Cys-Leu-Gly-Pro-Cys(Acm)-Pro-OH and H-Phe-Cys(Acm)-Leu-Gly-Pro-Cys-Pro-OH) was synthesized using the same protocol as in example 1. The unprotected cysteines on one of the monomers was activated with dithiopyridine resulting in the S-pyridyl derivative H-Phe-Cys(SPyr)-Leu-Gly-Pro-Cys(Acm)-Pro-OH. This derivative was reacted with the second peptide chain resulting in the first disulfide. The second disulfidebond was accomplished using the same protocol as in example 42 with iodine in 80% aqueous acetic acid which, after purification on HPLC, resulted in the final product. The compound is listed in table 1. The following Table 1 lists compounds according to the invention and their identification by FAB-MS spectra. TABLE 1______________________________________Ex. No. Peptide MH.sup.+ (m/z)______________________________________1 H-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 1) 3892 Fmoc-Gly-Pro-Cys-IIe-OH (SEQ ID NO: 1) 6113 H-Gly-Pro-Cys-Gly-OH (SEQ ID NO: 2) 3334 H-Ala-Pro-Cys-Ala-OH (SEQ ID NO: 3) 3615 H-Ile-Pro-Cys-Tyr-OH (SEQ ID NO: 4) 4956 H-Trp-Pro-Cys-Gly-OH (SEQ ID NO: 32) 4627 H-Phe-Gly-Pro-Cys-Ile-OH (SEQ ID NO: 5) 5378 H-Gly-Pro-Cys-Ile-Leu-Asn-NH.sub.2 calcd: 615.329 (SEQ ID NO: 6) (Exact miss) found: 615.3299 H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-OH calcd: 762.422 (SEQ ID NO: 8) (Exact mass) found: 762.41910 H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-OH 762 (SEQ ID NO:8)11 H-Leu-Leu-Phe-Ala-Pro-Cys-Ile-OH calcd: 776.438 (SEQ ID NO: 9) (Exact mass) found: 776.43812 H-Leu-Leu-Phe-Arg-Pro-Cys-Ile-OH 861 (SEQ ID NO: 10)13 H-Leu-Leu-Phe-Ile-Pro-Cys-Ile-OH 808 (SEQ ID NO: 11)14 H-Leu-Leu-Phe-Asp-Pro-Cys-Ile-OH 819 (SEQ ID NO: 12)15 H-Leu-Leu-Phe-Trp-Pro-Cys-Ile-OH 891 (SEQ ID NO: 13)16 H-Leu-Leu-Phe-Gly-IIe-Cys-Ile-OH 778 (SEQ ID NO: 14)17 H-Leu-Leu-Phe-Gly-Pec-Cys-Ile-OH calcd: 776.438 (SEQ ID NO: 15) (Exact mass) found: 776.43918 H-Ala-Val-Trp-Thr-Pro-Cys-Tyr-OH 839 (SEQ ID NO: 33)19 H-Tyr-Phe-Tyr-Thr-Pec-Cys-Phe-OH 954 (SEQ ID NO: 16)20 H-Phe-Val-Met-Ala-Pro-Cys-Phe-OH 814 (SEQ ID NO: 17)21 H-Leu-Leu-Tyr-Ser-Pro-Cys-Phe-OH 842 (SEQ ID NO: 18)22 H-Ile-Ser-Gly-Pro-Cys-Pro-Lys-OH calcd: 701.384 (SEQ ID NO: 19) (Exact mass) found: 701.38623 H-Phe-Leu-Phe-Gly-Pro-Cys-Ile-OH 796 (SEQ ID NO: 20)24 H-Leu-Phe-Gly-Pro-Cys-Ile-Leu-NH.sub.2 calcd: 761.438 (SEQ ID NO: 21) (Exact mass) found: 761.43725 H-Glu-Lys-Gly-Pro-Cys-Tyr-Arg-OH 852 (SEQ ID NO: 22)26 H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-OH 875 (SEQ ID NO: 23)27 H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-NH.sub.2 878 (SEQ ID NO: 24)28 H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-OAllyl 915.5 (SEQ ID NO: 23)29 H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-NH.sub.2 988 (SEQ ID NO: 25)30 H-Phe-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-NH.sub.2 calcd: (SEQ ID NO: 27) 1022.550 (Exact mass) found: 1022.55131 H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-Arg- 1517 Leu-Met-Glu-NH.sub.2 (SEQ ID NO: 28)32 H-Phe-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-Arg- 1552 Leu-Met-Glu-NH.sub.2 (SEQ ID NO: 29)33 Fmoc-Phe-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn- 1776 Arg-Leu-Met-Glu-NH.sub.2 (SEQ ID NO: 29)34 ##STR8## 1521 (homodimer of SEQ ID NO: 8)35 ##STR9## 1682 (homodimer of SEQ ID NO: 18)36 ##STR10## 775 (homodimer of SEQ ID NO: 1)37 ##STR11## 3101 Arg-Leu-Met-Glu-NH.sub.2 Arg-Leu-Met-Glu-NH.sub.2 (homodimer of SEQ ID NO: 29)38 H-Phe-Cys-Leu-Gly-Pro-Cys-Pro-OH 736 (SEQ ID NO: 30)39 ##STR12## 734 (SEQ ID NO: 31)40 H-Gly-Pro-Cys-Ile-Leu-Asn-Arg-OH 772 (SEQ ID NO: 7)41 H-Leu-Leu-Phe-Gly-Pro-Cys-Ile-Leu-Asn-Arg- 1146 OH (SEQ ID NO: 26)42 ##STR13## 1467.7 (head to head homodimer of SEQ ID NO: 30)43 ##STR14## 1468 (head to tail homodimer of SEQ ID NO: 30)______________________________________ Pharmaceutical Preparations The peptides according to the invention may be administered orally, nasally, rectally, intravenously or by inhalation. The dosage will depend on the route of administration, the severity of the disease, age and weight of the patient and other factors normally considered by the attending physician, when determining the individual regimen and dosage level as the most appropriate for a particular patient. The pharmaceutical preparations comprising the peptides according to the invention may conveniently be tablets, pills, capsules, syrups, powders or granules for oral administration sterile parenteral solutions or suspensions for parenteral administration or suppositories for rectal administration. For the preparation of pharmaceutical preparations containing a peptide according to the present invention in the form of dosage units for oral administration, the active peptide may be admixed with an adjuvant or a carrier, e.g. lactose, saccharose, sorbitol, mannitol, starches such as potato starch, corn starch or amylopectin, cellulose derivatives, a binder such as gelatine or polyvinylpyrrolidone, and a lubricant such as magnesium stearate, calcium stearate, polyethylene glycol, waxes, paraffin, and the like, and then compressed into tablets. If coated tablets are required, the cores, prepared as described above, may be coated with a concentrated sugar solution which may contain e.g. gum arabic, gelatine, talcum, titanium dioxide, and the like. Alternatively, the tablet may be coated with a polymer known to the man skilled in the art, dissolved in a readily volatile organic solvent or mixture of organic solvents. Dyestuffs may be added to these coatings in order to readily distinguish between tablets containing different active substances or different amounts of the active peptides. For the preparation of soft gelatine capsules, the active substance may be admixed with e.g. a vegetable oil or polyethylene glycol. Hard gelatine capsules may contain granules of the active substance using either the above mentioned excipients for tablets, e.g. lactose, saccharose, sorbitol , mannitol, starches (e.g. potato starch, corn starch or amylopectin), cellulose derivatives or gelatine. Also liquids or semisolids of the drug may be filled into hard gelatine capsules. Dosage units for rectal application may be solutions or suspensions, or may be prepared in the form of suppositories comprising the active substance in admixture with a neutral fatty base, or gelatin rectal capsules comprising the active substance in admixture with vegetable oil or paraffin oil. Liquid preparations for oral application may be in the form of syrups or suspensions, for example solutions containing a peptide as herein described as the active substance, the balance being sugar and a mixture of ethanol, water, glycerol and propylene glycol. Optionally such liquid preparations may contain colouring agents, flavouring agents, saccharine and carboxymethylcellulose as a thickening agent or other excipients known to the skilled man in art. Solutions for parenteral applications by injection may be prepared in an aqueous solution of a water-soluble pharmaceutically acceptable salt of the active substance. These solutions may also contain stabilizing agents and/or buffering agents and may involve the use of surface acting agents to improve solubility. They may conveniently be provided in various dosage unit ampoules. The compounds according to the invention may be formulated in pressurised metered dose inhalers or dry powder inhalers for oral or nasal inhalation or in liquid formulations for nebulisation. The active substance is micronised or otherwise processed to a particle size suitable for inhalation therapy (mass median diameter <4 μm). For pressurised metered dose inhalers the micronized substance is suspended in a liquefied propellant or a mixture of liquefied propellants which also can act as solvents and filled into a container which is equipped with a metering valve. The propellants used may be hydrofluoroalkanes (HFAs) of different compositions. The most frequent used HFAs are tetrafluoroethane (propellant 134a) and heptafluoropropane (propellant 227). Low concentrations of surfactants such as sorbitan trioleate, lecithin, oleic acid or other suitable substances may be used to improve the physical stability of the preparation. Ethanol or other solvents may be used to increase the solubility of the substances in the propellants. The active substance may also be delivered through a portable inhaler device suitable for dry powder inhalation. The active substance may be used alone or be combined with a suitable carrier substance such as lactose, mannitol or glucose. Other additives may also be included in the powder formulation by various reasons, such as to increase the stability. The inhaler may be a single dose inhaler with one predispensed dose or a multi dose inhaler in which the dose is created by a metering unit within the inhaler or is delivered from an assembly of predispensed doses. Biological Studies The ability of the peptides according to the invention to modulate immune responses can be illustrated by its efficacy in the animal delayed type hypersensitivity (DTH) test in mice. Both male and female Balb/c mice, obtained from Bomholtsgaard (Denmark), were used with a weight of 18-20 gram. 4-Ethoxymethylene-2-phenyloxazolin-5-one (OXA) (England) and served as the antigen in this test. The mice were sensitized, Day 0, by epicutaneous application of 150 μl of an absolute ethanol-acetone (3:1) solution containing 3% OXA on the shaved abdomen. Treatment with the peptide or vehicle (0.9% NaCl) was initiated by oral feeding immediately after sensitization an continued once daily until Day 6. Seven days (Day 6) after the sensitization, both ears of all mice were challenged on both sides by topical application of 20 μl 1% OXA dissolved in peanut oil. Ear thickness was measured prior to and 24 or 48 hours after challenge using an Oditest spring calliper. Challenges and measurements were performed under light pentobarbital anaesthesia. The intensity of the DTH reactions was expressed according to the formula: T t24/48 -T t0 μm units, where t0, t24 and t48 represent the ear thickness before and 24 or 48 hours after challenge respectively, in individual tests (T). The result were expressed as the mean ±S.E.M. The level of significance between means of the groups was obtained by Student's two-tailed t-test. The immunomodulating effect of the peptide is reflected in a significant difference in the increase or decrease in ear thickness as compared to the control. DISCUSSION The present invention describes peptides that can be expected to have favorable effects for the treatment of various diseases, affecting the immune system including diseases where an anergy of the immune response, an aberrant immune response or peripheral tolerance to pathogenes or an ineffective host defence by other reasons can be suspected. These type of drugs have an urgent need on the market, instead of or as a complement to present more toxic drugs, for the treatment of many diseases. ______________________________________Abbreviations______________________________________Pec pipecolic acidAc acetylFmoc 9-fluorenylmethyl carbamateBpoc 1-methyl-1-(4-biphenylyl)ethyl carbamateTrt tritylAlloc allyl carbamateBoc t-butyl carbamateFAB-MS fast atom bombardment mass spectrometryDTH delayed type hypersensitivityOXA 4-ethoxymethylene-2-phenyloxazolin-5-oneAcm acetamidomethyl______________________________________ __________________________________________________________________________# SEQUENCE LISTING- (1) GENERAL INFORMATION:- (iii) NUMBER OF SEQUENCES: 39- (2) INFORMATION FOR SEQ ID NO:1:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 4 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:1:- Gly Pro Cys Ile 1- (2) INFORMATION FOR SEQ ID NO:2:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 4 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:2:- Gly Pro Cys Gly 1- (2) INFORMATION FOR SEQ ID NO:3:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 4 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:3:- Ala Pro Cys Ala 1- (2) INFORMATION FOR SEQ ID NO:4:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 4 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:4:- Ile Pro Cys Tyr 1- (2) INFORMATION FOR SEQ ID NO:5:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 5 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:5:- Phe Gly Pro Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:6:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 6 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (ix) FEATURE: (A) NAME/KEY: Other (B) LOCATION: 6...6#where Xaa at position 6 is "Asn-NH2"- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:6:- Gly Pro Cys Ile Leu Xaa 1 5- (2) INFORMATION FOR SEQ ID NO:7:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:7:- Gly Pro Cys Ile Leu Asn Arg 1 5- (2) INFORMATION FOR SEQ ID NO:8:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:8:- Leu Leu Phe Gly Pro Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:9:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:9:- Leu Leu Phe Ala Pro Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:10:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:10:- Leu Leu Phe Arg Pro Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:11:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:11:- Leu Leu Phe Ile Pro Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:12:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:12:- Leu Leu Phe Asp Pro Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:13:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:13:- Leu Leu Phe Trp Pro Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:14:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:14:- Leu Leu Phe Gly Ile Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:15:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (ix) FEATURE: (A) NAME/KEY: Other (B) LOCATION: 5...5#where Xaa at position 5 is "pipecolic acid"- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:15:- Leu Leu Phe Gly Xaa Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:16:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (ix) FEATURE: (A) NAME/KEY: Other (B) LOCATION: 5...5#where Xaa at position 5 is "pipecolic acid"- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:16:- Tyr Phe Tyr Thr Xaa Cys Phe 1 5- (2) INFORMATION FOR SEQ ID NO:17:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:17:- Phe Val Met Ala Pro Cys Phe 1 5- (2) INFORMATION FOR SEQ ID NO:18:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:18:- Leu Leu Tyr Ser Pro Cys Phe 1 5- (2) INFORMATION FOR SEQ ID NO:19:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:19:- Ile Ser Gly Pro Cys Pro Lys 1 5- (2) INFORMATION FOR SEQ ID NO:20:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:20:- Phe Leu Phe Gly Pro Cys Ile 1 5- (2) INFORMATION FOR SEQ ID NO:21:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (ix) FEATURE: (A) NAME/KEY: Other (B) LOCATION: 7...7#where Xaa at position 7 is "Leu-NH2"- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:21:- Leu Phe Gly Pro Cys Ile Xaa 1 5- (2) INFORMATION FOR SEQ ID NO:22:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:22:- Glu Lys Gly Pro Cys Tyr Arg 1 5- (2) INFORMATION FOR SEQ ID NO:23:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 8 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:23:- Leu Leu Phe Gly Pro Cys Ile Leu 1 5- (2) INFORMATION FOR SEQ ID NO:24:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 8 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (ix) FEATURE: (A) NAME/KEY: Other (B) LOCATION: 8...8#where Xaa at position 8 is "Leu-NH2"- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:24:- Leu Leu Phe Gly Pro Cys Ile Xaa 1 5- (2) INFORMATION FOR SEQ ID NO:25:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 9 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (ix) FEATURE: (A) NAME/KEY: Other (B) LOCATION: 9...9#where Xaa at position 9 is "Asn-NH2"- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:25:- Leu Leu Phe Gly Pro Cys Ile Leu Xaa 1 5- (2) INFORMATION FOR SEQ ID NO:26:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 10 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:26:- Leu Leu Phe Gly Pro Cys Ile Leu Asn Arg# 10- (2) INFORMATION FOR SEQ ID NO:27:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 9 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (ix) FEATURE: (A) NAME/KEY: Other (B) LOCATION: 9...9#where Xaa at position 9 is "Asn-NH2"- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:27:- Phe Leu Phe Gly Pro Cys Ile Leu Xaa 1 5- (2) INFORMATION FOR SEQ ID NO:28:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 13 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (ix) FEATURE: (A) NAME/KEY: Other (B) LOCATION: 13...13#where Xaa at position 13 is "Glu-NH2"- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:28:- Leu Leu Phe Gly Pro Cys Ile Leu Asn Arg Le - #u Met Xaa# 10- (2) INFORMATION FOR SEQ ID NO:29:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 13 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (ix) FEATURE: (A) NAME/KEY: Other (B) LOCATION: 13...13#where Xaa at position 13 is "Glu-NH2"- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:29:- Phe Leu Phe Gly Pro Cys Ile Leu Asn Arg Le - #u Met Xaa# 10- (2) INFORMATION FOR SEQ ID NO:30:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:30:- Phe Cys Leu Gly Pro Cys Pro 1 5- (2) INFORMATION FOR SEQ ID NO:31:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:31:- Phe Cys Leu Gly Pro Cys Pro 1 5- (2) INFORMATION FOR SEQ ID NO:32:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 4 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:32:- Trp Pro Cys Gly 1- (2) INFORMATION FOR SEQ ID NO:33:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 7 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:33:- Ala Val Trp Thr Pro Cys Tyr 1 5- (2) INFORMATION FOR SEQ ID NO:34:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 8 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:34:- Leu Glu Cys Gly Pro Cys Phe Leu 1 5- (2) INFORMATION FOR SEQ ID NO:35:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 8 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:35:- Leu Cys Ala Gly Pro Cys Phe Leu 1 5- (2) INFORMATION FOR SEQ ID NO:36:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 14 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:36:- Tyr Ile Pro Cys Phe Pro Ser Ser Leu Lys Ar - #g Leu Leu Ile# 10- (2) INFORMATION FOR SEQ ID NO:37:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 13 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:37:- Tyr Ile Pro Cys Phe Pro Ser Ser Leu Lys Ar - #g Leu Ile# 10- (2) INFORMATION FOR SEQ ID NO:38:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 11 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:38:- Ser Gly Pro Cys Pro Lys Asp Gly Gln Pro Se - #r# 10- (2) INFORMATION FOR SEQ ID NO:39:- (i) SEQUENCE CHARACTERISTICS:#acids (A) LENGTH: 8 amino (B) TYPE: amino acid (D) TOPOLOGY: linear- (ii) MOLECULE TYPE: peptide- (xi) SEQUENCE DESCRIPTION: SEQ ID NO:39:- Thr Pro Pro Thr Pro Cys Pro Ser 1 5__________________________________________________________________________

Novel homodimers that include cysteine-containing peptides having 4-15 amino acid residues can be administered to modulate the immune response in an animal.

The present application is a continuation of application Ser. No. 09/813,944, filed Mar. 22, 2001, entitled “Method and Device for Full Thickness Resectioning of an Organ,” now U.S. Pat. No. 6,343,731, which is a continuation of application Ser. No. 09/694,894 filed on Oct. 25, 2000, entitled Method and Device for Full Thickness Resectioning of an Organ, now U.S. Pat. No. 6,241,140. FIELD OF THE INVENTION The present invention relates to full thickness resection devices for performing localized resections of lesions in tubular organs, particularly the colon. BACKGROUND INFORMATION A resection procedure involves excising a portion of an organ, approximating the surrounding tissue together to close up the hole created by the excision, and removing the excess tissue. Various conventional devices and procedures are available for resectioning lesions in tubular organs. For example, several known resection devices and procedures requires at least one incision in an area near the portion of the organ to be excised for access to the lesion or treatment site (because, for example, the resectioning device may lack steering and/or viewing capabilities). Thus, the incision is required to allow the physician to access the organ section to be excised and guide the device to that section. Alternatively, when the organ section to be excised is beyond the reach of the surgical device, or the surgical device is not flexible enough to wind through the organ to the site to be excised, an incision will be required to position the device for the procedure. Of course, these incisions are painful and may involve a partial or entire loss of mobility while recuperating from the incision, in addition to recovering from the tubular resectioning procedure itself. In addition, the time required to recover from such a procedure is often longer than for procedures which do not require incisions. One type of conventional resection procedure utilizes a circular stapling instrument in which a tubular section of a tubular organ is excised, resulting in the tubular organ being separated into a first segment and a second segment. The end sections of the first and second segments are then individually tied in a purse-string fashion, approximated, stapled, and the “purse-stringed” end sections are then cut off. In this full circle resectioning procedure, at least one separate invasive incision must be made near the section to be excised in order to cut and individually tie the separate end sections of the organ. Also, a separate incision is necessary to place one part of the resectioning device in the first segment and a corresponding second part of the device in the second segment so that the device can then bring the first and second segments together to re-attach the organ sections back together. A first of these separate parts may generally include a staple firing mechanism while the second part includes an anvil for forming the staples. Thus, this type of resectioning procedure involves the drawbacks mentioned above in regard to procedures requiring invasive incisions. In addition, the separation of the organ into two segments creates the risk of spillage of non-sterile bowel contents into the sterile body cavity, which can cause severe infection and possibly death. An alternative resectioning device includes a stapling and cutting assembly on a shaft which can be bent or formed into a desired shape and then inserted into a patient's body cavity. Once the shaft has been bent into the desired shape, the rigidity of the shaft ensures that that shape is maintained throughout the operation. This arrangement limits the effective operating range of the device as the bending of the shaft into the desired shape before insertion and the rigidity of the shaft once bent require the physician to ascertain the location of the organ section to be removed before insertion, and deform the shaft accordingly. Furthermore, the rigidity of the shaft makes it difficult to reach remote areas in the organ - particularly those areas which must be reached by a winding and/or circuitous route (e.g., sigmoid colon). Thus, an incision may be required near the organ section to be excised in order to position the device at the organ section to be excised. SUMMARY OF THE INVENTION The present invention is directed to a full-thickness resection system comprising a flexible endoscope and a stapling mechanism, wherein the endoscope is slidably received through at least a portion of the stapling mechanism. The stapling mechanism includes an anvil and a stapling head mounted to the anvil so that the anvil and the stapling head are moveable with respect to one another between a tissue receiving position and a stapling position and wherein a gap formed between the stapling head and the anvil is larger in the tissue receiving position than it is in the stapling position. A position adjusting mechanism is provided for moving the anvil and the stapling head between the tissue receiving and stapling positions and a staple firing mechanism sequentially fires a plurality of staples from the stapling head across the gap against the anvil and through any tissue received in the gap and a knife cuts a portion of tissue received within the gap. A control unit which remains outside the body is coupled to the stapling mechanism for controlling operation of the position adjusting mechanism and the staple firing mechanism. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a device according to a first embodiment of the present invention; FIG. 2 shows the device of FIG. 1 mounted on a conventional endoscope; FIG. 3 shows the device of FIG. 1 with a grasper mechanism extending therefrom; FIG. 4 shows a cutaway of the device of FIG. 1 showing a drive mechanism thereof; FIG. 5 shows a cutaway of the device of FIG. 1 showing an actuating mechanism; FIG. 6 shows a detailed view of the wedge used in the actuating mechanism of FIG. 1; FIG. 7 shows a cut-away view of a working head assembly of the device of FIG. 1; FIG. 8 shows a rear cover plate of the working head assembly of FIG. 7; FIG. 9 a shows a mechanism for restricting motion of a drive shaft of the device of FIG. 1; FIG. 9 b shows a first coupling arrangement for a drive cable and a drive shaft in the device of FIG. 1; FIG. 9 c shows a second coupling arrangement for the drive cable and the drive shaft in the device of FIG. 1; FIG. 9 d shows a perspective cut-away view of a sheath of the device of FIG. 1; FIG. 10 a shows a perspective view of an alternative construction of the wedge of FIG. 6; FIG. 10 b shows a cut-away view of the wedge of FIG. 10 a; FIG. 10 c shows a blade portion corresponding to the wedge of FIG. 10 a; FIG. 11 shows a device according to a second embodiment of the present invention; FIG. 12 shows a device according to a third embodiment of the present invention; FIG. 13 shows a device according to a fourth embodiment of the present invention; FIG. 14 a shows a device according to a fifth embodiment of the present invention; FIG. 14 b shows a detailed cut-away view of the device of FIG. 14 a and a conventional endoscope; FIG. 15 shows a control handle for use with the devices according to the present invention; FIG. 16 shows a blade housing arrangement for use with a device according to the present invention; FIG. 17 shows a first arrangement of a blade shield for use with a device according to the present invention; FIG. 18 shows a second arrangement of the blade shield for use with a device according to the present invention; FIG. 19 a shows a third arrangement of the blade shield for use with a device according to the present invention; FIG. 19 b shows a tissue blocker of the blade shield of FIG. 19 a; FIG. 19 c shows a distal end of a proximal housing of the device of FIG. 19 a ; and FIG. 20 shows a device according to a sixth embodiment of the present invention. FIG. 21 shows a device according to a seventh embodiment of the present invention. FIG. 22 shows a first perspective view of the device of FIG. 21 . FIG. 23 shows a second perspective view of the device of FIG. 21 . FIG. 23 a shows a third perspective view of the device of FIG. 21 . FIG. 24 shows a side cut-away view of the device of FIG. 21 . FIG. 25 shows a fourth perspective view of the device of FIG. 21 . FIG. 26 shows a cut-away view of an exemplary stapler member of the device of FIG. 1 . DETAILED DESCRIPTION As shown in FIGS. 1 and 2, an apparatus according to a first embodiment of the present invention comprises a working head assembly 2 which may preferably be connected to a distal end 4 a of a sheath 4 . The proximal end 4 b of the sheath 4 may preferably be connected to a control handle 6 . In operation, the entire apparatus is mounted onto an endoscope 8 by passing the endoscope 8 through the control handle 6 , the sheath 4 , and the working head assembly 2 , as shown in FIG. 2 . The endoscope 8 is then inserted into a body orifice to locate a lesion in the tubular organ under visual observation (usually while insufflating the organ). Once the lesion has been located, the working head assembly 2 and the sheath 4 are slidably advanced along the endoscope 8 into the tubular organ until the working head assembly 2 is in a desired position adjacent to the lesion. Those skilled in the art will understand that in an alternative embodiment, the working head assembly 2 may also be detachably coupled to a distal end of the endoscope 8 , and the entire arrangement may then be inserted into the body orifice under visual observation. As shown in FIG. 1, the working head assembly 2 comprises an anvil member 10 coupled to a distal end 12 a of a proximal housing 12 . The anvil member 10 has a substantially crescent-shaped cross-section (i.e., the outer edge 18 of the anvil member 10 substantially forms a portion of a first circle with a second smaller circular cut-out 13 formed within the first circle) with a proximal face 14 and a smaller distal face 16 . The cut-out 13 of the anvil member 10 is included to allow the endoscope 8 to be slid through the entire working head assembly 2 so that the endoscope 8 may be advanced into the body passage allowing the working head assembly 2 to later be advanced into the body to the lesion. In addition, the cut-out 13 also provides forward vision via the endoscope 8 . Thus, any shape of the cut-out 13 may be selected which is large enough to accommodate the endoscope 8 , with a larger cut-out providing a larger field of vision. An outer surface 18 of the anvil member 10 extends substantially parallel to a central axis of the working head assembly 2 while the proximal and distal faces 14 , 18 of the anvil member 10 extend in planes substantially perpendicular to the central axis. The outer surface 18 is joined to the distal face 16 by a tapered portion 5 . As shown in FIG. 3, the proximal face 14 of the anvil member 10 includes a first cavity 37 and a rim 41 encircling the first cavity 37 . A plurality of staple-forming grooves 19 are arranged in two offset rows on the rim 41 of the anvil member 10 and a circular guiding slit 21 extends radially within the rows of grooves 19 . The rim 41 protrudes from the remainder of the proximal face 14 so that a shallow cavity is formed on the proximal face 14 . The anvil member 10 is coupled to the proximal housing 12 by means of two mounting shafts 20 a and 20 b , which may preferably be substantially cylindrical. Each mounting shaft 20 a , 20 b is coupled to the proximal face 14 of the anvil member 10 on a respective one of two horns 22 a , 22 b formed by the crescent-shaped anvil member 10 . Although the anvil member 10 is shown fixedly coupled to the mounting shafts 20 a , 20 b , those skilled in the art will understand that the anvil member 10 may also be pivotally coupled to the mounting shafts 20 a , 20 b in order to provide a greater field of vision through the endoscope 8 as shown in FIG. 3 a . In this pivoted-type arrangement, the anvil member 10 is angled in a first configuration so that the horns 22 a , 22 b are closer to the distal end 12 a of the proximal housing than the rest of the anvil member 10 . Then, as the anvil member 10 is drawn towards the distal end 12 a of the proximal housing 12 , the anvil member 10 would be pressed against the distal end 12 a beginning with the horns 22 a , 22 b , which would cause the anvil member 10 to pivot until the proximal face 14 of the anvil member 10 is parallel to the distal end 12 a. As shown in FIG. 1, the mounting shafts 20 a , 20 b are slidably received in mounting holes 26 a , 26 b , which have a size and shape substantially corresponding to the size and shape of the mounting shafts 20 a , 20 b and which run axially through the proximal housing 12 . The mounting shafts 20 a , 20 b are preferably movable axially proximally and distally within the mounting holes 26 a , 26 b between a proximal most position in which a tissue gripping gap of a first predetermined width is formed between the rim 41 and the distal end 12 a of the proximal housing 12 , and a distal most position in which a tissue receiving gap of a larger second predetermined width is formed between the rim 41 and the distal end 12 a of the proximal housing 12 . The second predetermined width should preferably be more than twice the thickness of a wall of the organ being resectioned so that a section of the tubular organ may be pulled into a resectioning position between the anvil member 10 and the proximal housing 12 . As shown in FIG. 4, the proximal end of at least one of the mounting shafts 20 a and 20 b is coupled to a drive mechanism 102 provided within the proximal housing 12 . In a preferred embodiment, the drive mechanism 102 is composed of a yoke 103 and a drive shaft 105 . The yoke 103 is preferably slidably received within the proximal housing 12 for longitudinal movement along the axis of the proximal housing 12 so that, when the anvil member 10 is in the proximal most position, the yoke 103 is in a corresponding proximal most position and, when the anvil member is in the distal most position, the yoke 103 is in a corresponding distal most position. The yoke 103 may preferably be substantially semicircular with a substantially rectangular cross-section. Although the semicircle formed by the yoke 103 in FIG. 4 forms substantially a quarter arc of a circle, the yoke 103 may form a larger semicircle based upon the interior accommodations of the proximal housing 12 and the position of the mounting shafts 20 a , 20 b . The mounting shaft 20 a may preferably be coupled to the yoke 103 at a first end 103 a of the yoke 103 , and the mounting shaft 20 b may be coupled at a second end 103 b of the yoke 103 . A shaft hole 107 , having a diameter substantially corresponding to a diameter of a complementarily threaded distal end 105 a of the drive shaft 105 , extends through the yoke 103 at a point substantially midway between the first end 103 a and second end 103 b . Thus, when the drive shaft 105 is rotated, the threaded distal end 105 a engages the shaft hole 107 to move the yoke 103 proximally or distally (in dependence upon the direction of rotation of the drive shaft 105 ). The distal end 105 a of the drive shaft 105 should preferably be threaded over a first section 105 t substantially corresponding in length to at least the distance between the proximal and distal most yoke positions, while a remainder portion 105 r may have no threads thereon. The drive shaft 105 may have an increased cross-section in the areas immediately adjacent to the threaded first section lost (proximally and/or distally of section 105 t ), thereby limiting the movement of the yoke 103 to the first section 105 t . Those skilled in the art will understand that the drive shaft 105 is preferably rotatably mounted within the proximal housing 12 so that it may only rotated and may not move relative to the proximal housing 12 . The drive shaft 105 preferably extends to a proximal end 105 b which is coupled to a drive cable 100 which extends to the control handle 6 through the sheath 4 . The drive cable 100 may preferably run axially along the peripheral interior of the sheath 4 . Those skilled in the art will understand that the sheath 4 is preferably torsionally stiff to resist the torque forces from the drive cables rotating therein. However, the sheath 4 is longitudinally flexible to so that it may be slidably advanced along the endoscope 8 , while minimizing interference with the operation of the endoscope 8 and trauma to surrounding tissue. The sheath 4 is preferably constructed similar to known endoscope insertion tubes, which are flexible yet allow the transfer of forces to swivel the distal end of the endoscope 8 in multiple directions nd the torqueable rotation of the endoscope. FIGS. 7-10 show a cutaway view of the working head assembly 2 in FIG. 1, in which the respective movements of the drive shaft 105 and the yoke 103 are restricted in the manner described above. As shown in FIG. 8, a pear-shaped rear cover plate 460 may preferably be connected to the proximal end 12 b of the proximal housing 12 . A first shaft hole 462 having a cross-sectional size substantially corresponding to the cross-sectional size of the drive shaft 105 is provided in a lower portion of the rear cover plate 460 for receiving the drive shaft 105 therethrough. Thus, the yoke 103 is restricted to only longitudinal movement in this arrangement because, the distal side of the yoke 103 is coupled to the mounting shafts 20 a , 20 b which are disposed in the mounting holes 26 a , 26 b , and the proximal side of the yoke 103 is coupled to the drive shaft 105 which is disposed in the first shaft hole 462 . As shown in FIG. 9 a , the movement of the drive shaft 105 may be restricted to only rotation movement about its axis by two washer-type devices 470 fixedly attached to the drive shaft 105 on either side of the rear cover plate 460 . A similar result may be achieved by providing the drive shaft 105 with a larger cross-sectional size on either side of the rear cover plate 460 in relation to the portion of the drive shaft 105 within the rear cover plate 460 . Alternatively, the cross-section of a bulging portion 476 of the drive shaft 105 located substantially in the center of the rear cover plate 460 may be larger than the portions of the drive shaft 105 immediately adjacent to the bulging portion 476 . The first shaft hole 462 may then have a center portion 474 with a larger cross-section than the rest of the first shaft hole 462 to accommodate the bulging portion 476 of the drive shaft 105 . FIG. 9 b shows a coupling arrangement between the drive cable 100 and the drive shaft 105 in which a proximal end 105 a of the shaft may have a D-shaped hole 105 h extending therethrough. A distal end 102 b of the drive cable 100 has a D-shape corresponding to the shape of the hole 105 h so that the distal end 102 b of the drive cable may be received within the hole 105 h in the drive shaft 105 . FIG. 9 c shows an alternative coupling arrangement for coupling the drive cable 100 to the drive shaft 105 in which the hole 105 h in the proximal end 105 a of the drive shaft 105 a and the distal end 102 b of the drive cable 100 have corresponding squarish shapes. The single edge provided by the D-shapes in FIG. 9 b and the four edges provided by the squarish shapes in FIG. 9 c allow the drive cable 100 to transfer a rotational force to the drive shaft 105 with minimal slippage. In operation, the user advances the endoscope 8 , with the working head assembly 2 received therearound, to a portion of tissue to be resectioned until the working head assembly 2 is in a desired position adjacent to the tissue to be resectioned. The user may then apply a force to the control handle 6 to rotate the drive cable 100 which in turn rotates the drive shaft 105 to advance the yoke 103 and the anvil member 10 distally away from the distal end 12 a of the proximal housing 12 . As shown in FIG. 3 when the anvil member 10 has reached the distal most position, a known grasping device 108 is advanced through the sheath 4 and through the working head assembly 2 to enter the gap between the anvil member 10 and the distal end 12 a via one of the grasper holes 32 and 33 . Although the device in FIG. 3 is shown using a duodenoscope as the endoscope 8 , those skilled in the art will understand that other types of endoscopes may also be used, such as, for example, gastroscope, colonoscope, etc. A shown in FIG. 1, at least the distal end 12 a of the proximal housing 12 preferably has a cross-section corresponding in size and shape to the proximal face 14 is of the anvil member 10 , including a cut-out 29 substantially corresponding in size and shape to the cut-out 13 of anvil member 10 . The cut-out 29 is provided to receive the endoscope 8 therein and allow the proximal housing 12 to be slidably advanced along the endoscope 8 . Of course, those skilled in the art will understand that the shape of the outer surface of the working head assembly 2 may be selected in order to accommodate various desired resectioning shapes, and the shape of the anvil member 10 may preferably be selected to form a continuous surface when positioned adjacent to the proximal housing 12 to facilitate advancing the working head assembly to into and removing it from, body passages. It is preferable that the working head assembly have a maximum diameter at any point between 15 mm and 40 mm. A tissue receiving cavity 30 is formed substantially centrally in the distal end 12 a of the proximal housing 12 to facilitate the drawing of sections of tubular organs into the gap between the anvil member 10 and the distal end 12 a . Those skilled in the art will understand that the depth of the cavity 30 may vary depending on the amount of tissue to be pulled into the cavity 30 and the size of the proximal housing 12 . Two grasper holes 32 and 33 extend axially, preferably slightly off-center from the longitudinal axis of the proximal housing 12 . In a preferred embodiment, the grasper holes 32 and 33 may each preferably receive a grasping device 108 advanced from the control handle 6 , through the sheath 4 , and through a respective one of the grasper holes 32 and 33 . In operation, either one or two grasping devices 108 may then be used to pull a section of the tubular organ between the anvil member 10 and the distal end 12 a of the proximal housing 12 and into the cavity 30 . A third grasping device 108 may also be inserted through the working channel of the endoscope 8 to provide another means of positioning the organ section between the anvil member 10 and the proximal housing 12 . Of course, those skilled in the art will understand that any desired instrument may be advanced to the gap between the anvil member 10 and the distal end 12 a through any of the grasper holes 32 , 33 and the working channel of the endoscope 8 . A plurality of staple slits 34 are preferably disposed in two offset substantially circular rows extending along the periphery of the distal end 12 a of the proximal housing 12 . The staple slits 34 extend from an area adjacent to the mounting shaft 26 a to an area adjacent to the other mounting shaft 26 b . The plurality of staple slits 34 may preferably be arranged so that when the anvil member 10 is in the proximal most position, each of the staple slits 34 is aligned with a corresponding one of the staple-forming grooves 19 . When the device is configured for operation, a plurality of staples is received within the working head assembly 2 with each of the staples being aligned with a respective one of the staple slits 34 . The staples are then sequentially fired from the respective staple slits 34 by an actuating mechanism 104 (shown in FIG. 5) disposed in the proximal housing 12 . A substantially circular blade slit 36 extends substantially radially within the staple slits 34 so that, when the anvil is in the proximal most position, the blade slit 36 is aligned with the guiding slit 21 on the anvil member. As shown more clearly in FIG. 12, extensions 84 a and 84 b of the blade slit 36 extend into blade housings 74 a and 74 b , respectively, which project distally from the distal end 12 a of proximal housing 12 . The blade housings 74 a and 74 b are preferably situated so that when the anvil member 10 is in its proximal most position, the blade housings 74 a and 74 b contact portions 43 a and 43 b of the rim 41 of the anvil member 10 . The extension of the blade housings 74 a and 74 b from the proximal housing 12 is preferably selected so that when the blade housing devices 74 a and 74 b engage the remainder portions 43 a and 43 b of the rim 41 (thereby stopping a proximal movement of the anvil member 10 and defining the proximal most position thereof), a gap is formed between the anvil member 10 and the distal end 12 a of a length sufficient to allow the anvil member 10 to securely hold a portion of the organ against the proximal housing 12 without crushing and damaging the portion of the organ. When positioned at one end of the blade slit 36 (i.e., in one of the extensions 84 a and 84 b ), a cutting blade 202 is preferably completely enclosed within the respective one of the blade housing devices 74 a and 74 b and the guiding slit 21 , so that the cutting blade 202 does not cut any tissue until the physician intentionally operates the blade 202 . When the physician operates the blade 202 , the blade 202 is driven from its initial position received within one of the extensions 84 a and 84 b around the blade slit 36 with its cutting edge facing a direction of movement, until the blade 202 is received into the other one of the extensions 84 a and 84 b . Thus, after a cutting operation has been performed, the blade 202 is once again prevented from inadvertently injuring the patient. FIG. 6 shows a wedge 402 , a first portion 402 a of which is non-rotatably coupled to an actuating shaft 400 so that rotation of the shaft 400 the wedge 402 rotates, preferably about the longitudinal axis of the working head assembly 2 . The wedge 402 includes a blade handle 408 which extends from a first portion 408 a coupled to the wedge 402 to a second portion 408 b which is coupled to the blade 202 so that, when the wedge 402 is rotated, the blade 202 is rotated through the blade slit 36 . The wedge 402 has a substantially bell-like cross-section when viewed axially, with a second portion 402 b extending radially outward from the first portion 402 a and, consequently, from the longitudinal axis of the shaft 400 which preferably coincides with the longitudinal axis of the working head assembly 2 . A notch of varying depth is cut out of a radially outer portion of the second portion 402 b to form a cam surface 412 thereon. A first ramp section 412 a ramps up from a leading face 402 d of the wedge 402 to adjoin a second ramp section 412 b that ramps down to adjoin a rear face 402 e of the wedge 402 . The wedge 402 is preferably arranged in the proximal housing 12 so that the cam surface 412 is substantially aligned with the staple slits 34 . A staple driver 472 extends substantially longitudinally, proximally from each of the staple slits 34 having toward the plane in which the wedge 402 rotates and each staple driver 472 is slidably received within the working head assembly 2 for motion between a distal most, staple driving position and a proximal most inoperative position. In the inoperative position, an upper end of each of the staple drivers 472 is completely received within the proximal housing 12 , just proximal of a respective staple. The staple drivers 472 are preferably substantially rectangular in shape, although bottom edges 472 a thereof may more preferably be rounded. The length of the staple drivers 472 is preferably selected so that, in the inoperative position, the bottom surfaces 472 a extend into the plane of rotation of the wedge between the proximal and distal most extents of the first ramp portion 412 a . The bottom surfaces 472 a are, in the inoperative position, more preferably substantially aligned with the distal most projection of the of the cam surface 412 at the leading face 402 d. Thus in operation, the wedge 402 is rotated by the actuating shaft 400 so that the first ramp section 412 a of the cam surface 412 successively drives each of the staple drivers 472 into contact with a corresponding staple so that each staple driver 472 and its staple are driven distally through a respective one of the staple slits 34 . This drives the staples across the gap from the distal end 12 a into the anvil member 10 , through any tissue held between the anvil member 10 and the proximal housing 12 , and into the corresponding staple forming grooves 19 . Thus the section of the tissue gripped between the anvil member 10 and the proximal housing 12 is stapled in a pattern substantially the same as that formed by the staple slits 34 (i.e., substantially circular). At the same time, the blade 202 is rotated through the blade slit 36 to cut the tissue which has just been stapled through the rotation of the wedge 402 . After each of the plurality of staples has been fired, the wedge 402 may be driven in a reverse direction to reload a new plurality of staples. The wedge 402 may rotate in a direction opposite the staple firing direction without getting caught on any of the staple drivers 472 because the staple drivers are pushed out of the way by the second ramp section 412 b of the cam surface 412 . In operation, the user applies a force to the control handle 6 to rotate an actuating cable 450 about its longitudinal axis. This rotational force is transferred to the actuating shaft 400 , which then rotates the wedge 402 around the longitudinal axis of the actuating cable 450 . The first ramp section 412 a of the cam surface 412 of the wedge 402 then individually drives the staple drivers 472 distally as described above to staple the tissue received between the anvil member 10 and the proximal housing 12 with the cutting blade 202 lagging behind the firing of the stapling since the blade handle 408 is coupled to the rear face 402 e of the wedge. FIG. 10 a shows an alternative configuration of the wedge 402 of FIG. 6 including a separate blade portion 420 . The blade portion 420 is preferably rotatably coupled to the distal end 400 a of the actuating shaft 400 so that a rotation of the actuating shaft 400 about its longitudinal axis does not cause a corresponding rotation of the blade portion 420 . As in FIG. 6, the wedge 202 of this apparatus is non-rotatably coupled to the distal end 400 a of the shaft 400 . The blade handle 408 of this apparatus, which is coupled to a peripheral edge 420 e of the blade portion 420 , extends to the cutting portion of the blade 202 . As described above, the cutting portion of the blade 202 extends past the distal end 12 a except when the blade 202 is received within one of the extensions 84 a and 84 b. The wedge 402 substantially corresponds in shape and size to the wedge 402 of FIG. 6, except that the blade handle 408 is not coupled thereto. In addition, a locking shaft 402 h extends into a distal surface 402 t located as shown in FIG. 10 a so that when the blade portion 420 and the wedge portion 410 are aligned, the locking shaft 402 h and a locking dimple 414 (shown in FIG. 10 c ) on the bottom face 420 b of the blade portion 420 are substantially aligned. As shown in FIG. 10 b , a spring 416 is received within the locking shaft 402 h with a proximal end of the spring coupled to the proximal end of the locking shaft 402 h . A locking ball 418 coupled to the distal end 416 b of the spring 416 is sized so that when a proximally directed force is applied to the locking ball 418 , the locking ball 418 may be slidably received within the locking shaft 402 h . In addition, when no distally directed force is applied to the locking ball 418 , the spring 416 preferably extends so that approximately one half (or more) of the locking ball 418 extends distally out of the locking shaft 402 h . Thus, when the wedge 402 is rotated toward the blade portion 420 , the locking ball 418 is received in a cut-out 425 formed on the proximal surface 420 b of the blade portion 420 . As shown in FIG. 10 c , the cut-out 425 slopes downward to adjoin the locking dimple 424 so that when the locking ball 418 is received, the slope of the cut-out 425 gradually pushes the locking ball 418 into the locking shaft 420 h . Then, when the wedge 402 moves into alignment with the blade portion 420 , the locking ball 418 extends out of the locking shaft 402 h and enters the locking dimple 414 to couple the wedge 402 to the blade portion 420 so that a rotation of the wedge 402 causes a corresponding rotation of the blade portion 420 . A radial length B 1 between the peripheral edge 420 e of the blade portion 420 and the actuating shaft 400 may substantially correspond to a radial length W 1 between the wall 402 f of the wedge portion 410 and the actuating shaft. This places the blade handle 408 in substantially the same position, relative to the cam surface 402 c of the wedge portion 410 , as in the previous embodiments. Of course, those skilled in the art will understand that it is important that the blade 408 should extend substantially distally to the blade slit 36 so that rotation of the blade portion 420 will cause a corresponding rotation of the blade 202 through the blade slit 36 . In operation, the wedge 402 is initially situated distally of one of the blade housings, e.g., 74 a while the blade portion 420 is situated distally of the blade housing 74 b with the blade 202 received in the blade housing 74 b . When the lesion tissue has been drawn into position between the distal end 12 a and the anvil member 10 , the physician actuates the shaft 400 by applying a force at the control handle 6 . This causes the wedge portion 410 to rotate distally of the staple slits 34 , to sequentially drive each of the staple drivers 472 distally through the corresponding staple slit 34 . When the wedge 402 has rotated fully into alignment with the blade portion 420 and the locking ball 418 is received into the locking dimple 414 , the operator then operates the control handle 6 in the opposite direction to draw the blade 202 out of the blade housing 74 b to cut all of the tissue extending radially inward of the rows of staples. When the blade 202 is received in the other blade housing 74 a , the wall of the body passage is released and the lesion tissue remains within the gap between the distal end 12 a and the anvil member 10 held by the grasping devices 108 . The lesion tissue may then be withdrawn from the body for analysis. This embodiment of the wedge 402 provides a safeguard in case the stapling process must be prematurely aborted due to, for example, a jam in one of the staple slits 34 . Using this embodiment, the cutting process is not begun until all of the staples have been fired. Thus, it is possible to reduce the risk of cutting an opening in-an organ which is not completely closed by the staples. As shown in FIG. 5, the actuating mechanism 104 includes the actuating cable 450 which extends from a proximal end 450 a coupled to the control handle 6 to a is distal end 450 b coupled to the proximal end 400 a of the actuating shaft 400 . Those skilled in the art will understand that the wedge 402 should preferably be situated towards the distal end 12 a of the proximal housing 12 so that the yoke 103 does not interfere with rotation of the wedge 402 around the longitudinal axis of the actuating shaft 400 (discussed below) even when the yoke 103 is in its distal most position. As shown in FIGS. 7-9 a , the rear cover plate 460 may preferably be coupled to the proximal end 12 b of the proximal housing 12 . The proximal end 12 b of the proximal housing 12 is then connected to the sheath 4 . The actuating shaft 400 may preferably extend through a second shaft hole 464 formed in the rear cover plate 460 of the proximal housing 12 and preferably abuts an interior portion of the cavity 30 provided on the proximal housing 12 . An endoscope hole 466 may preferably be provided on a portion of the rear cover plate 460 radially separated from the longitudinal axis of the working head assembly 2 to guide the endoscope 8 into the cut-out 29 of the proximal housing 12 . The endoscope 8 may preferably be received into the endoscope hole 466 from an endoscope lumen 40 provided within the sheath 4 which is preferably disposed along a periphery of the sheath. FIG. 9 d shows a perspective cut-away view of the sheath 4 with the various devices (i.e., the two grasping devices 108 , the drive cable 100 , the actuating cable 450 , and the endoscope 8 ) extending therethrough. Each of the various devices are further enclosed by one of a plurality of tubes 510 which allow either a rotational movement (for the cables 100 , 450 ) or a longitudinal (for the two grasping devices 108 and the endoscope 8 ) movement therein. Similar to the sheath 4 , the plurality of tubes extend from a proximal end coupled to the control handle 6 , to a distal end coupled to the working head assembly 2 . The plurality of tubes 510 provide protection against damage due to, for example, abrasion, and provide an isolated path through the sheath 4 which prevents tangling between the various devices. FIG. 18 shows a cross-section of the control handle 6 which may be used in conjunction with a resectioning device of the invention. The control handle 6 may preferably be substantially “Y” shaped, with a first branch 500 for operating the actuating mechanism 104 and a second branch 502 for operating the drive mechanism 102 and a body 520 . A receiving hole 512 runs longitudinally through the center of the body 520 for receiving the endoscope 8 therethrough. A first force transferring mechanism 504 is coupled to an actuating control knob 508 , and extends axially through the first branch 500 , through the body 520 , where it is coupled to the actuating cable 450 which extends through the sheath 4 to connect to the actuating mechanism 104 . A second force transferring mechanism 506 is coupled to a drive control knob 510 , and extends axially through the second branch 502 , through the body 520 , where it is coupled to the drive cable 100 which extends through the sheath 4 to the drive mechanism 102 . Those skilled in the art will understand that the control handle may be designed in any variety of shapes to accommodate, for example, different hand sizes, comfort, etc. In addition, different force transferring methods may also be used instead of a knob such as, for example, actuating levers, etc. In operation, the user applies a rotational force to one of the control knobs 508 and 510 , the rotational force is transferred through a respective one of the force transferring mechanisms 504 and 506 which then transfers rotational force to a respective one of the drive cable 100 and actuating cable 450 , thereby operating the actuating mechanism 104 or the drive mechanism 102 as described above. FIG. 11 shows a device according to a second embodiment of the present invention in which like reference numerals identify the same elements. The anvil member 10 of this embodiment preferably has a substantially circular or elliptical cross-section and is gradually tapered from the proximal face 14 to its distal end 16 , forming a bullet-like structure. This tapered shape allows the device to be more easily inserted into the patient's body as the distal end 16 has a smaller cross-sectional size than in the first embodiment. Those skilled in the art will understand that the anvil member 10 may have other tapered shapes besides a bullet-like structure without departing from the scope of the present invention. Instead of providing the cut-out 13 shown in the first embodiment to receive the endoscope 8 therein, a substantially cylindrical first endoscope lumen 13 extends axially through the center of the anvil member 10 . The distal end 16 of the anvil member 10 may preferably have a beveled edge 54 adjoining the first endoscope lumen 13 to allow for an expanded field of forward vision via the endoscope B. The proximal housing 12 may preferably have a cross-section corresponding in size and shape to the cross-section of the proximal face 14 of the anvil member 10 (i.e., substantially circular or elliptical). In this embodiment, the cavity 30 in the first embodiment has been omitted and a substantially cylindrical second endoscope lumen 52 extends axially through the center of the proximal housing 12 . However, as in the previous embodiment, two grasper holes 32 , 33 extend axially through the proximal housing. The two grasper holes 32 and 33 may preferably be disposed between the mounting holes 26 a and 26 b since the first endoscope lumen 13 now extends through the axial center of the proximal housing 12 . In addition, the grasper holes 32 , 33 in this embodiment may preferably have a substantially circular cross-section. However, those skilled in the art will understand that the cross-sectional shape of the grasper holes 32 and 33 may be selected to, for example, accommodate another type of device. A receiving sleeve 55 is provided on the proximal end 12 b of the proximal housing 12 for receiving the endoscope 8 and for guiding the endoscope 8 into the proximal housing 12 . The receiving sleeve 55 may preferably have a first section 56 and a second section 58 . The first section 56 and second section 58 may preferably both have an annular cross-section forming a continuous center hole 59 therethrough. The center hole 59 has a diameter which preferably corresponds to the diameter of the receiving hole 52 so that the endoscope 8 may be continuously received through the center hole 59 into the second endoscope lumen 52 in the proximal housing 12 . The second section 58 preferably has a thicker wall than the first section 56 , such that an annular ring formed by the cross-section of the second sections 58 has a larger width than an annular ring formed by the cross-section of the first section 56 . In contrast to the endoscope lumen 40 disposed along the periphery of the sheath 4 as shown in FIG. 1, the endoscope lumen 40 in this embodiment preferably runs along an axial center of the sheath 4 , so that when the sheath 4 is coupled to the working head assembly 2 , a substantially continuously aligned path is formed through the center hole 59 , through the second endoscope lumen 52 , and through the first endoscope lumen 13 . The actuating shafts 400 and 105 and the drive cables 450 and 102 are then located concentric to the endoscope lumen 40 in the sheath 4 . FIG. 12 shows a device according to a third embodiment of the present invention. The proximal face 14 of the anvil member 10 of this embodiment has a cross-section similar to the crescent-shaped cross-section of the anvil member 10 of the device of FIG. 1 . Thus, the anvil member 10 has two horns 22 a and 22 b formed on either side of a cut-out 13 which extends axially through the anvil member 10 from the proximal face 14 to the distal end 15 to receive the endoscope 8 therein. As with the device of FIG. 11, the cross-sectional size of the anvil member 10 diminishes in overall size from a maximum at the proximal face 14 to a minimum size at the distal end 15 , and the horns 22 a and 22 b become less pronounced from the proximal face 14 to the distal end 15 . In a side view, the anvil member 10 becomes gradually tapered from the proximal end 14 to the distal end 16 . As in the device of FIG. 11, the tapered shape of the anvil member 10 of the device of FIG. 12 allows for easier insertion of the device into the patient's body. In contrast to the second embodiment, the cut-out 13 provides a larger field of vision via the endoscope 8 as the anvil member does not totally enclose the cut-out 13 . And, as in the first embodiment, two substantially cylindrical mounting shafts 20 a and 20 b are coupled to the proximal face 14 of the anvil member 10 on horns 22 a and 22 b and are received within the mounting holes 26 a and 26 b , respectively. In contrast to the previous embodiments, the proximal housing 12 in this embodiment may preferably have a substantially oval cross-sectional shape. This shape of the proximal housing 12 is formed by extending the proximal housing 12 shown in FIG. 1 around the cut-out 29 to create the substantially cylindrical second endoscope lumen 52 . The oval shape allows the second endoscope lumen 52 to be offset from the axial center of the proximal housing 12 and aligned with the first endoscope lumen 13 . This offset of the second lumen 52 allows the cavity 30 to be provided adjoining the blade slit 36 . In all other material respects, the proximal housing 12 in this embodiment is substantially identical to the proximal housing 12 illustrated in FIG. 1 . FIG. 13 shows a device according to a fourth embodiment of the present invention. This embodiment is substantially similar to the embodiment shown in FIG. 12 . However, the proximal face 14 of the anvil member 10 in this embodiment has a substantially oval-shaped cross-section corresponding to the proximal housing 12 . The anvil member 10 is tapered towards the distal end 16 to form a substantially bullet-like structure having an oval-shaped cross-section. The cut-out 13 shown in FIG. 12 may preferably be enclosed within the anvil member 10 and thereby forms an extension of the first endoscope lumen 13 . A substantially semicircular shield 31 extends from the proximal face 14 of the anvil member 10 and shields a hemispherical portion of the gap formed between the anvil member 10 and the proximal housing 12 . The shield 31 allows a tissue section to be drawn primarily in the gap between the staple-forming grooves 19 and the staple slits 34 with minimal spill-over into the rest of the gap. A recessed groove 35 may preferably be formed around a portion of the proximal housing 12 for slidably receiving the shield 31 therein. The recessed groove 35 may preferably have a size and shape substantially corresponding to the size and shape of the shield 31 so that when the anvil member 10 is in its proximal most position, the shield 31 is received within the recessed groove 35 to form a substantially completely continuous outer surface of the proximal housing 12 . In operation, the user may utilize suction through the endoscope 8 to draw a tissue section into the gap between the anvil member 10 and the proximal housing 12 . In such a situation, the shield 31 prevents a portion of the tissue section or loose debris from being pulled into the area around the mounting shafts 20 a and 20 b which may otherwise interfere with the axial movement of the mounting shafts 20 a , 20 b . In addition, the shield 31 also serves to direct the pulling force of the suction to pull tissue primarily in the gap between the staple-forming grooves 19 and the staple slits 34 . FIGS. 14 a and 14 b show a device according to a fifth embodiment of the present invention in which the working head assembly 2 is coupled to the endoscope 8 without the sheath 4 . As described above, distal ends 500 a of control cables 500 (i.e., drive cable 100 and actuating cable 450 ) may preferably be coupled to the working head assembly 2 while proximal ends 500 b of the control cables 500 are coupled to the control handle 6 as in the previous embodiments. However, instead of using a flexible sheath 4 to receive the control cables 500 and the endoscope 8 , the control cables 500 are inserted into respective tubes 510 . Each of the tubes 510 should have a sufficient cross-section to allow the control cables 500 to rotate within the tubes 510 . The tubes 510 are then fastened at various predetermined points along their lengths to the endoscope 8 by a plurality of fasteners 502 . Those skilled in the art will understand that many different types of fasteners may be used either alone or in combination for this purpose so long as the fasteners do not impede the steering of the endoscope 8 or the rotation of the cables 500 . Those skilled in the art will understand that tape (e.g., surgical, electrical, etc.), electrical cable, rubber bands, other belt-style fasteners, etc. may be used as fasteners. FIGS. 16-18 illustrate alternative configurations of the blade housing 74 b and it will be understood that similar alternative embodiments may be implemented for the blade housing 74 a. The blade slit 36 continues through the blade housing 74 b into housing porion 84 b which extends from a forward end at which the blade slit 36 enters the blade housing 74 b to a rearward end where the blade slit 36 and the housing portion 84 b terminate. A shield receiving slit 480 extends through the blade housing 74 b substantially perpendicular to the housing portion 84 b between the forward and rearward ends thereof. After an organ section has been stapled between the anvil member 10 and the proximal housing 12 , and the blade 202 is drawn through the stapled tissue, there may be a problem if tissue stretches along with the blade 202 into the housing portion 84 b without being completely severed. Withdrawal of the resectioned tissue might then lead to tearing of the tissue which is to remain in place. As seen in FIG. 17, a flexible breakaway shield 482 having a shape and size substantially corresponding to the shape and size of the shield receiving slit 480 is inserted into the shield receiving slit 480 . After entering the housing portion 84 b , the cutting blade 202 contacts the shield 482 and further progress of the blade 202 deforms the shield 482 until the shield 482 is cut in half. When the shield 482 is cut in half, each half snaps back pulling the tissue in a direction opposite the direction of travel of the blade allowing the cutting blade 202 to completely sever the tissue. FIG. 18 shows a second alternative arrangement in which a flexible gate 484 , having a first gate half 484 a and a second gate half 484 b , may be removably or fixedly mounted within the shield receiving slit 480 . Each of the halves 484 a and 484 b may preferably be mounted within a respective half of the shield receiving slit 480 , so that a small gap formed therebetween substantially corresponds in width to the width of the cutting blade 202 . The wiping action in a direction opposed to the direction of travel of the blade 202 is substantially the same as that of the shield 482 without requiring the severing and replacement of the shield 482 after each use. FIGS. 19 a and 19 b show a third alternative arrangement in which a pair of tissue blockers 600 and 602 facilitate the cutting of the resectioned tissue. Although, the following discussion will focus on the first tissue blocker 600 , those skilled in the art will understand that a similar arrangement may be provided on the second tissue blocker 602 . As shown in FIG. 19 a , the first tissue blocker 600 is composed of a first rectangular bar 610 and a second rectangular bar 612 situated at a first end 21 a of the guiding slit 21 . The first rectangular bar 610 has a first base 610 a and the second rectangular bar 612 has a second base 612 a , which are both fixedly coupled to the proximal face 14 of the anvil member 10 and arranged so that the bases 610 a , 612 b straddle both sides of the guiding slit 21 with a gap formed therebetween corresponding to the width of the guiding slit 21 . A first slot 614 a is provided in the first base 610 a of the first rectangular bar 610 , and a second slot 614 b is provided in the second base 612 a of the second rectangular bar 612 so that when the rectangular bars 610 , 612 are coupled to the anvil member 10 , the flexible breakaway shield 482 (shown in FIG. 17) may be disposed within the slots 614 a , 614 b . As shown in FIG. 19 c , a pair of L-shaped holes 620 , 622 are provided on both ends of the blade slit 30 on the distal end 12 a of the proximal housing 12 . The L-shaped holes 620 , 622 extend longitudinally within the proximal housing 12 to receive the rectangular bars 610 , 612 therein when the anvil member 10 is coupled to the proximal housing 12 . This arrangement operates similarly to the arrangement shown in FIG. 17, so that the wiping action of the shield 482 in a direction opposite to a movement of the blade 202 allows the blade 202 to completely cut through the resectioned tissue. Although the shield 482 is initially a single piece in a first operation of the device, the shield 482 may be re-used without replacement in further operations with minimal diminishment of its effectiveness. FIG. 20 shows a device according to a sixth embodiment of the present invention in which like reference numerals identify the same elements. The sheath 4 is substantially more rigid and shorter than in previous embodiments. Although this decreases the effective operative range of the device, the rigidity of the sheath 4 increases its overall structural strength, allowing greater forces to be transferred therethrough to the working head assembly 2 than in the previous embodiments. The cables 100 , 450 driving the various mechanisms 102 , 104 may then need to be stronger and stiffer in order to accommodate the increased forces. As a result of these changes, the overall size of the working head assembly 2 may then be increased to, for example, treat lesions that may be too large for the devices according to the previous embodiments to treat in a single procedure. FIGS. 21-25 show a device according to a seventh embodiment of the present invention in which the working head assembly 2 comprises the anvil member 10 , a stapler member 17 , and a connecting adapter 25 . As shown in FIG. 21, the anvil member 10 and the stapler member 17 preferably have substantially semi-circular shapes complementary to one another such that, when they are positioned adjacent to each other, they form a substantially annular clamp-like device (as shown in FIG. 23 ). The anvil member 10 and the stapler member 17 are pivotally connected via a substantially cylindrical hinge-pin 60 which is provided on a distal end 25 a of the connecting adapter 25 . A proximal end 25 b of the connecting adapter 25 may preferably be coupled to the sheath 4 in a manner similar to that in which the proximal housing 12 is connected to the sheath 4 in the previous embodiments. Those skilled in the art will understand that the shape of the anvil member 10 and the stapler member 17 may be modified to accommodate specific needs or applications without departing from the scope of the present invention. As shown in FIG. 22, a plurality of first ring-like extensions lob are formed on a first end 10 a of the anvil member 10 . The first extensions 10 b may preferably be separated a predetermined distance from one another to form a plurality of spaces in which a corresponding plurality of second ring-like extensions 17 b formed on a first end 17 a of the stapler member 17 are accommodated. The first extensions 10 b may substantially correspond in shape and size to the second ring-like extensions 17 b so that when the first anvil end 10 a and the first stapler end 17 a are engaged, an alternating arrangement of first and second extensions 10 b , 17 b is formed in which the holes of each of the first and second extensions 10 b , 17 b are substantially aligned to form a continuous hole in which a hinge-pin 60 is received. Thus, the hinge-pin 60 and the first and second extensions 10 b , 17 b form a hinge which allows the anvil member 10 and the stapler member 17 to pivot about the hinge-pin 60 . A locking ring 62 may preferably be attached to a distal end 61 of the hinge-pin 60 to secure the first and second extensions 10 b , 17 b to the hinge-pin 60 . A first anchoring joint 23 a is formed on an interior face 10 i of the anvil member 10 . The first anchoring joint 23 a may preferably have a substantially triangular cross-section viewed along the longitudinal axis of the working head assembly 2 . However, a side of the first anchoring joint 23 a that is attached to the anvil member 10 may preferably be convex in shape complementary to the concave shape of the interior face 10 i of the anvil member 10 . A substantially similar second anchoring joint 23 b is formed on an interior face 17 i of the stapler member 17 having a size and shape corresponding to the size and shape of the anchoring joint 23 a. As shown in FIG. 23, first and second coupling elements 64 a , 64 b are disposed on respective anchoring joints 23 a , 23 b to couple the anchoring joints 23 a , 23 b to two rod links 150 a , 150 b , respectively. The rod links 150 a , 150 b provide a rigid coupling between the anchoring joints 23 a , 23 b and a distal end 154 of a push rod 152 . Thus, a longitudinal force in a distal or proximal direction applied to the push rod 152 is transferred to the anchoring joints 23 a , 23 b , and thereby to the anvil member 10 and the stapler member 17 . In operation, when a distally directed pushing force is applied to the push rod 152 , the force is transferred through the link rods 150 a , 150 b to the anvil member 10 and the stapler member 17 via the respective anchoring joints 23 a , 23 b , gradually separating an anvil head 10 c on the anvil member 10 from a stapler head 17 c on the stapler member 17 until they reach a tissue receiving position. Similarly, when a proximally directed pulling force is applied to the push rod 152 , the anvil head 10 c and the stapler head 17 c are drawn toward one another until they reach a stapling position, in which the anvil head 10 c and the stapler head 17 c are adjacent to one another separated by a narrow gap. As the anvil head 10 c and the staler head 17 c are drawn together by the push rod 152 , a stabilizer tongue 308 extending from the stapler head 17 c of the stapler member 17 is gradually received within a stabilizing groove 304 on the anvil is head 10 c . This tongue/groove arrangement provides a guide and a securing/stabilization mechanism for the anvil member 10 and the stapling member 17 . The anvil head 10 c is disposed on a second end 10 e of the anvil member 10 that is opposite to the first end 10 a thereof. The anvil head 10 c may preferably have a substantially rectangular cross-section larger than a cross-sectional size of the rest of the anvil member 10 . The anvil head 10 c has an anvil face 10 d on which a plurality of staple-forming grooves 19 may preferably be arranged in two offset, substantially straight lines. In addition, a substantially straight guiding slit 21 may preferably extend substantially along the center of the anvil face 10 d , substantially parallel to the lines of staple-forming grooves 19 , while the stabilizing groove 304 is preferably formed along a distal side of the anvil face 10 d for receiving the stabilizer tongue 308 . The stabilizing groove 304 may preferably have a shape and size substantially corresponding to the stabilizing tongue 308 so that the stabilizing tongue 308 is snugly received within the stabilizing groove 304 when the anvil member 10 and the stapler member 17 are in the stapling position. As shown in FIG. 23 a , the stapler head 17 c is formed on a second end 17 e of the stapler member 17 opposite to the first end 17 a thereof, and preferably has a cross-section corresponding, at least in the area adjacent to a stapler face 17 d , to the size and shape of the anvil head 10 c . A plurality of staple slits 34 are arranged on the stapler face 17 d in positions corresponding to the position of the staple-forming grooves 19 on the anvil head 10 c so that when the stapler face 17 d and anvil face 10 d are positioned adjacent to each other, each of the plurality of staple slits 34 is substantially aligned with a corresponding one of the plurality of staple-forming groove 19 . Additionally, a substantially straight blade slit 36 extends across the stapler face 17 d corresponding to the guiding slit 21 on the anvil head 10 c so that when the stapler head 17 c and the anvil head 10 c are positioned adjacent to one another, the blade slit 36 is substantially aligned with the guiding slit 21 . As shown in FIG. 23, the distal end 25 a of the connecting adapter 25 preferably has a cross-section corresponding to the shape and size of the peripheral surface of the annular clamp-like shape formed by the anvil member 10 and the stapler member 17 so that a substantially smooth, continuous outer surface is formed by the anvil member 10 , the stapler member 17 , and the connecting adapter 25 when the anvil member 10 and the stapler member 17 are in the stapling position. The connecting adapter 25 is preferably gradually tapered from the distal end 25 a to the proximal end 25 b thereof, and the proximal end 25 b may then. be coupled to the sheath 4 as shown in FIG. 24 . As further shown in FIG. 24, a substantially cylindrical endoscope lumen 52 preferably extends axially through the center of the connecting adapter 25 for receiving a conventional endoscope 8 therethrough. The connecting adapter 25 may also have a substantially cylindrical rod hole 322 extending axially along the periphery of the connecting adapter 25 extending through an area adjacent to the hinge-pin 60 , for receiving the push rod 152 therein. As shown in the cut-away view of FIG. 25, a track 350 is provided within the stapler head 17 c extending within the stapler head 17 c from an area adjacent to a distal end 352 of the stapler head 17 c to an area adjacent to a proximal end 354 thereof. FIG. 26 shows a cutaway view of the stapler head 17 c showing the track 350 having a substantially L-shaped cross-section. The track 350 may preferably be situated so that a first leg 350 a of the track 350 extends substantially beneath the plurality of staple slits 34 on the staple face 17 d , and a second leg 350 b of the track 350 extends substantially beneath the blade slit 21 on the staple face 17 d. In a first configuration shown in FIG. 25, a wedge-sled 402 is provided (instead of the wedge 402 described in the previous embodiments) on a distal end 350 a of the track 350 . The wedge-sled 402 has a cut-out in a corner forming a cam surface 412 thereon and a blade handle 408 . This provides the wedge-sled 402 with a substantially L-shaped cross-section substantially corresponding to the cross-sectional shape of the track 350 . The wedge-sled 402 is arranged in the track 350 so that the cam surface 412 is substantially disposed in the first leg 350 a of the track facing toward the plurality of staple slits 34 . Furthermore, the wedge-sled 402 is arranged in the track 350 so that the blade handle 408 is subsantially disposed in the second leg 350 b beneath the blade slit 21 . Thus, when the cutting blade 202 is coupled to the blade handle 408 , the cutting blade 202 extends out of the blade slit 21 as in the previous embodiments. As shown in FIG. 26, the stabilizing tongue 308 has a receiving slit 309 for receiving the cutting blade 202 therein when the wedge-sled 402 is positioned at the distal end 350 a of the track 350 . This prevents unintentional cutting of tissue as the device is inserted and guided within the organ. As shown in FIG. 25, an actuating cable 450 for operating the stapler head 17 c is coupled to the leading edge 402 d of the wedge-sled 402 and extends through the track 350 , through a tube 332 (which is coupled to the proximal end 354 of the stapler head 17 c and extends through the sheath 4 to the control handle) of the plurality of tubes 510 (shown in FIG. 9 d ), and is then coupled to the control handle 6 (not shown). In operation, the wedge-sled 402 is initially positioned at the distal end 350 a of the track 350 with the blade 202 received within the receiving slit 309 of the stabilizing tongue 308 as the operator maneuvers the device to a desired location within the body. While the device is being maneuvered to the desired location, the anvil member 10 and the stapler member 17 are located adjacent to each other in the stapling position. When the desired position is reached, the operator pushes the push rod 152 distally to separate the anvil member 10 and the stapler member 17 into the tissue receiving position. Then the operator draws the portion of tissue to be is resectioned into the gap between the stapler member 17 and the anvil member 10 and draws the push rod 152 proximally to return the anvil member 10 and the stapler member 17 to the stapling position, gripping the tissue to be resected within the gap. The operator then pulls actuating cable 450 proximally, drawing the wedge-sled 402 towards the proximal end 350 b of the track 350 . As the cam surface 412 on the wedge-sled passes beneath each one of the plurality of staple slits 34 , the cam surface 412 drives each one of a plurality of staple drivers 472 (each being disposed within a corresponding one of the staple slits 34 ) sequentially driving a plurality of staples out of the staple slits 34 to staple the tissue gripped between the anvil head 10 c and the stapler head 17 c . In addition, the cutting blade 202 coupled to the blade handle 408 of the wedge-sled 402 is pulled through the blade slit 21 to resection the tissue which has now been stapled off from the organ. When the tissue has been resectioned, the operator pushes the operating cable 450 distally to return the cutting blade 202 to the receiving slit 309 of the stabilizing wedge 308 . The device may then be withdrawn from the body. As shown in FIGS. 23 and 25, the anvil member 10 and the stapler member 17 have a tissue receiving position shown in FIG. 25, and a stapling position shown in FIG. 23 . Therefore, it is necessary to allow the actuating cable 450 disposed within the tube 332 and received within the stapler head 17 c to correspondingly move with the stapler member 17 . Accordingly, a channel 330 is provided in the connecting adapter 25 to receive the tube 332 therein. The channel 330 may preferably be formed within the connecting adapter 25 to substantially correspond to the arc path along which the tube 332 is pulled by the stapler member 17 , as the stapler member 17 moves between the tissue receiving and the stapling positions. Thus, the channel minimizes bending and crimping of the tube 332 . Those skilled in the art will understand that although the proximal housing 12 in any of the embodiments may preferably be composed of a metallic-type material, the proximal housing 12 may also be composed of a clear plastic-type material which would allow the user to operate the working head assembly 2 under visual observation by partially withdrawing the endoscope 8 into the second endoscope lumen 52 in the proximal housing 12 . The user could then look through the walls of the endoscope lumen 52 into the proximal housing 12 to, for example, observe whether each of the plurality of staple drivers 472 have been actuated. In addition, the user may also observe whether the wedge 402 shown in FIGS. 10 a and 10 b is locked into the blade portion 420 as described above. Alternatively, selected portions of the proximal housing 12 may be composed of the clear plastic-type material providing a ‘window’ to view through the proximal housing 12 . Those skilled in the art will also understand that although the above-described embodiments show mechanical force transmission between the control handle and the working head assembly, this device could alternatively include an electronic control for receiving input from an operator coupled to a series of motors in the working head assembly. Those skilled in the art will further understand that the relative positioning of the stapling mechanisms and the position adjusting mechanisms to each other may be reversed, placing the stapling mechanisms in a distal-most position in relation to the position adjusting mechanism. The above described embodiments are for purposes of illustration only and the various modifications of these embodiments which will be apparent are considered to be within the scope of the teachings of this invention which is to be limited only by the claims appended hereto.

A full-thickness resection system comprises a flexible endoscope and a stapling mechanism, wherein the endoscope is slidably received through at least a portion of the stapling mechanism. The stapling mechanism comprises an anvil and a stapling head mounted to the anvil so that the anvil and the stapling head are moveable with respect to one another between a tissue receiving position and a stapling position and wherein a gap formed between the stapling head and the anvil is larger in the tissue receiving position than it is in the stapling position. A position adjusting mechanism is provided for moving the anvil and the stapling head between the tissue receiving and stapling positions and a staple firing mechanism sequentially fires a plurality of staples from the stapling head across the gap against the anvil and through any tissue received in the gap and a knife cuts a portion of tissue received within the gap. A control unit which remains outside the body is coupled to the stapling mechanism for controlling operation of the position adjusting mechanism and the staple firing mechanism.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the priority benefit of U.S. provisional patent application Ser. No. 60/941,707, filed on Jun. 4, 2007, the contents of which are incorporated by reference in their entirety herein. FIELD OF THE INVENTION [0002] The present invention relates, in general, to bite blocks for use in endoscopic surgical procedures, and in particular, to endoscopic bite blocks for use in procedures involving sedation and analgesia systems. BACKGROUND OF THE INVENTION [0003] During some medical procedures, specifically endoscopic procedures, it is necessary to insert medical instruments, such as an endoscope, into the mouth and down the trachea or esophagus of a patient. It is common to use in such procedures a bite block or mouthguard to protect both the patient's mouth from the endoscope and the endoscope from the patient's mouth. The bite block or mouthguard essentially maintains the patient's mouth in the open position, providing an opening through which the endoscope can be passed, and prevents the patient from biting down on the endoscopic instruments, which are often quite expensive. Bite blocks capable of such function are generally known in the art; bite blocks designed for use with sedation and analgesia delivery and patient monitoring systems, however, are not. [0004] In order to increase comfort and reduce patient resistance to the advancing of the scope, patients are often sedated during endoscopic procedures. In the case when the particular sedation drugs are respiratory depressants, there exist certain well-known risks related to patient respiration, including hypoventilation, oxygen desaturation, and apnea. In order to mitigate these risks, supplementary oxygen and respiratory monitoring are often utilized. Both the administration of supplementary oxygen and the sampling of respiratory gasses for monitoring require access to the patient's respiratory orifices, usually accomplished via oral-nasal cannula. Difficulties sometimes arise, however, when simultaneously managing the scope, delivering supplementary oxygen, and sampling respiratory gasses via the oral cavity. If the oral cavity could be reserved for exclusive use by the endoscope and the nasal passages used for oxygen delivery and respiratory sampling, the difficulty would be greatly reduced. Unfortunately, this method would require that the patient inhale and exhale only through the nasal passages for the duration of the procedure; in a real-world scenario, however, this is not the case. [0005] It is therefore desirable for endoscopic procedures that require sedation to allow maneuvering of an endoscope into the oral cavity simultaneous with oral and nasal oxygen delivery and expired gas sampling. It indeed requires little imagination to see that accommodating all three activities simultaneously through the oral cavity with instruments not designed to be used together would prove troublesome. It follows that, as the endoscopy is the main focus of the procedure, it would take priority in use of the oral cavity over the other two functions. While focusing on the endoscope, an oral-nasal cannula is rather easily bumped and relocated during the maneuvering of the scope, leaving its oral ports situated too far from the oral cavity and occasionally causing bruising internal to the nasal passages. The consequence is decreased effectiveness in the administration of supplementary oxygen and sampling of respiratory gasses, which in turn may compromise patient safety. [0006] In addition, in current practice, some doctors use a finger to help guide the endoscope into the mouth and down the trachea or esophagus of the patient. To do so, a doctor may stick a finger inside a patient's mouth, outside of the bite block, in order to control the endoscope near the opening to the trachea or esophagus. This requires that the finger be inserted at least to the depth of the end of the bite block, which may cause the bite block to move around. This adds to the risk that, during all of the jostling of the bite block associated with the maneuvering of the endoscope and insertion of a finger, the oral ports of the cannula may be unintentionally relocated away from the oral cavity. [0007] It is therefore the object of the present invention to provide a bite block with means for locating and protecting the oral ports of an oral-nasal cannula and to facilitate simultaneous use of the oral cavity for an endoscopic diagnostic or surgical procedure, supplemental oxygen delivery, and respiratory sampling. BRIEF DESCRIPTION OF THE DRAWINGS [0008] The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which: [0009] FIG. 1 is a front perspective view of a bite block in accordance with the present invention; [0010] FIG. 2 is back perspective view of a bite block in accordance with the present invention; [0011] FIG. 3 is a side view of a bite block in accordance with the present invention, shown in a section view of a patient's mouth; [0012] FIG. 4 is a perspective view of a bite block in accordance with the present invention and a typical oral-nasal cannula, shown together, interfaced as they would be used during a procedure; [0013] FIG. 5 is a front view of a bite block in accordance with the present invention; [0014] FIG. 6 is a side section view of a bite block in accordance with the present invention and a typical oral-nasal cannula, shown together, interfaced as they would be used during a procedure; and [0015] FIG. 7 is a rear perspective view of an alternate embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0016] Referring to FIG. 1 and FIG. 2 , the bite block 8 of the present invention consists of a generally elliptical cylindrical main body 20 , having a proximal end, which sits outside of a patient's mouth, and a distal end, which sits inside a patient's mouth. Main body 20 surrounds main oral passage 7 , which is sized to allow for passage of an endoscope and ventilation of the patient. Integral to the proximal end of main body 20 is flange 14 , which sits outside of a patient's lips and serves both to locate bite block 8 relative to the patient's mouth and protect the patient's lips and teeth from an endoscope. Flange 14 is integral to main body 20 at distal surface 22 . Attached at each side of flange 14 is strap attachment wing 6 for strap 19 that goes around the patient's head and helps secure bite block 8 . [0017] Referring to FIG. 3 , extending from the proximal to distal end of main body 20 , are a raised top surface 17 and bottom surface 18 for seating patient's upper teeth and lower teeth, respectively. Located at the distal end of top surface 17 is upper protruding retention feature 9 , protruding up generally perpendicular to top surface 17 . Upper protruding retention feature 9 serves as a stop to keep bite block 8 from being expelled from a patient's mouth by requiring the mouth (or more particularly, the teeth) to be opened wide enough to get around retention feature 9 . Similarly, on bottom surface 18 is lower protruding retention feature 11 serving the same purpose. [0018] Referring also now to FIGS. 4 and 6 , some features of the present invention are intended to interface with an oral-nasal cannula 1 , generally known in the art, with oxygen outlet port 2 and CO 2 sampling inlet port 3 . A representative oral-nasal cannula is described in pending application US-2006-0042636, the contents of which are incorporated by reference in its entirety herein. Oxygen outlet port 2 is the end of the oxygen delivery fluid line that delivers oxygen into the patient's oral cavity, and CO 2 sampling inlet port 3 is the end of the fluid line of a capnometry or capnography system through which expired CO 2 enters from a patient's oral cavity. Oxygen outlet port 2 and CO 2 sampling inlet port 3 consist of tubular extensions downward from the main body of cannula 1 , bent in a generally perpendicular fashion towards the patient's mouth. In the absence of a bite block, the openings of oxygen outlet port 2 and CO 2 sampling inlet port 3 would rest at the opening to the oral cavity. [0019] Referring also now to FIG. 5 , internal to main body 20 , and extending from the proximal end to the distal end of main body 20 , and adjacent to main oral passage 7 , is internal gas channel 10 . Internal gas channel 10 consists of two parallel adjacently-connected sub-channels, each of semi-circular cross section. Internal gas channel 10 occupies the area under raised top surface 17 . Internal gas channel 10 allows the exchange of gas from the proximal end (external to the patient's mouth) of bite block 8 to the distal end (internal to the patient's mouth), and vice versa, without using a significant amount of the cross-sectional area of main oral passage 7 , which is reserved for use by the endoscope. As seen in FIG. 4 , internal gas channel 10 provides a path via one sub-channel for oxygen to flow from oxygen outlet port 2 of an oral-nasal cannula 1 into the patient's mouth and, via the other sub-channel, for CO 2 to flow from the patient's mouth into CO 2 sampling inlet port 3 of cannula 1 . The sub-channels of internal gas channel 10 can be used interchangeably for either oxygen or CO 2 , depending on where the respective ports are located on cannula 1 . [0020] Oxygen port support 4 and CO 2 port support 5 protrude from proximal surface 21 of flange 14 , and proximal from internal gas channel 10 . Oxygen port support 4 and CO 2 port support 5 , each consist of a generally flat extension extending from proximal surface 21 , and generally symmetrical with respect to the vertical plane aligned longitudinally along main body 20 . From their points of attachment located on the side away from the center axis of main body 20 , oxygen port support 4 and CO 2 port support 5 slope slightly downward toward the center of main oral passage 7 . Oxygen port support 4 and CO 2 port support 5 also extend in the distal direction for approximately the thickness of flange 14 , as best seen in FIGS. 1 and 6 , partially separating main oral passage 7 and internal gas channel 10 . This arrangement is designed to allow the ends of oxygen outlet port 2 and CO 2 sampling inlet port 3 of cannula 1 to rest inside internal gas channel 10 , as shown in FIG. 6 . Oxygen port support 4 and CO 2 port support 5 each terminate on their proximal ends in an upward-curving quarter-circular shaped feature, which provides a means for more securely locating near the oral cavity oxygen outlet port 2 of the oxygen delivery system and CO 2 sampling inlet port 3 of a capnometry or capnography system. Oxygen port support 4 and CO 2 port support 5 are intended to provide a means for protecting the location of oxygen outlet port 2 and CO 2 sampling inlet port 3 against jostling from the movement of the scope. The terms “oxygen port support” and “CO 2 port support” are used only illustratively in this description; since the supports are generally symmetrical, they could be used interchangeably, depending on which side of cannula 1 each port was located. [0021] An alternate embodiment of the present invention, shown in FIG. 7 , adds additional functionality by allowing a doctor to insert a finger a short distance into the patient's mouth to help guide the endoscope down into the trachea or esophagus, while again preventing excessive jostling of bite block 8 and cannula 1 . In the alternate embodiment, main body 20 has curved cutouts 23 on its distal end, on both of its sides. In addition, integral to flange 14 , and extending out on both of its sides, are strap attachment wing extenders 24 , each consisting of a thin arced, ‘c’-shaped protrusion. Cutouts 23 and strap attachment wing extenders 24 are sized and located such that a finger may be inserted through the open side of the ‘c’ of strap attachment wing extender 24 and past cutout 23 into the patient's mouth. Strap attachment wing extenders 24 also locate the strap attachment wings 6 such that the strap is not in the way of a finger. In this manner, a doctor would be able to easily guide an endoscope with a finger without using any of the cross sectional area of main oral passage 7 , and without too much jostling of bite block 8 and cannula 1 . [0022] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. In addition, it should be understood that every structure described above has a function and such structure can be referred to as a means for performing that function. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.

A bite block that is inserted into a patient's mouth during an endoscopic diagnostic or surgical procedure that has a channel for receiving an endoscope or other surgical instrument through the patient's mouth and additional channels transmitting a gas to the patient and transmitting expired gas from the patient.

This is a continuation of application Ser. No. 893,921, filed Aug. 6, 1986, which was abandoned upon the filing hereof. FIELD OF THE INVENTION The invention relates to an applicator device for a liquid product contained in a bottle, a device of the kind comprising an applicator brush carried by a cap, or similar, intended to close the neck of the bottle and to be fixed on this neck with the brush situated inside the bottle. The invention concerns more particularly but not exclusively, applicator devices for nail varnish. PRIOR ART It is known that the use of such applicator devices comprising a brush necessitates frequent immersion of the brush in the liquid for replenishing it with the product. To remedy this drawback, it has already been proposed to use "marker" type applicators which, however, do not allow liquids to be used having formulas approximately to the traditional formulas, in particular in the field of nail varnish. These applicators, moreover, pose problems of sealing and generally comprise relatively complicated valve mechanisms. OBJECTS OF THE INVENTION The principal object of the invention is to provide an applicator device for a liquid product, of the kind defined above, such that it meets the various practical requirements better than heretofore. It is a further object of the invention to make it possible to reduce substantially the number of times necessary for immersing the brush in the bottle to spread the product. It is yet another object of the invention to provide such an applicator device comprising a brush which is always in contact with liquid, once the cap is replaced on the bottle, which prevents the brush from drying out. SUMMARY OF THE INVENTION These objects, as well as others which will emerge below, are attained by an applicator device for a liquid product contained in a bottle comprising an applicator brush which is formed by a stem carrying at one end a tuft of hairs and being joined at its opposite end to a cap or the like, intended to close the bottle neck and to be fixed on this neck with the brush situated inside the bottle, the said applicator device comprising reservoir means capable of storing some liquid product of the bottle in order to feed the hairs of the applicator brush when the brush is withdrawn from the bottle with a view to applying some of the product, these reservoir means being capable of replenishment between two uses of the brush. The said reservoir means are constituted by an interstice formed between the applicator brush and a tubular sleeve surrounding it and whose base is in contact with the hairs of the brush when the brush is withdrawn from the bottle. In accordance with a first embodiment of the present invention, the reservoir means are provided in the brush stem which stem comprises a hollow portion constituting the interstice delimited by the wall forming the downwardly open sleeve of the stem, the hairs of the brush being accommodated in the interstice. Advantageously, the hairs of the brush are embedded in the bottom of the hollow portion of the stem and extend over the whole length of this hollow portion, while spreading out to project outside the said hollow portion. Generally, an air hole is provided in the wall surrounding the hollow portion towards the centre of this portion to facilitate replenishment of the stem interior. The applicator device preferably comprises a wiper mounted inside the bottle neck and fitted in its lower portion with a lip capable of wiping the stem when it is withdrawn from the bottle, the air hole being provided in the wall of the stem so as to be located below the wiper when the brush is fitted on the bottle. In accordance with a second embodiment of the present invention, the sleeve fixed in relation to the brush comprises at least one notch in the free edge of the sleeve opposite the portion of the set of hairs of the brush which is next to the stem. In particular, the or each notch is V-shaped. In accordance with a particular embodiment of the present invention, the sleeve forms an element attached to the applicator brush and comprises fixing means complementary to the means carried by the applicator brush. The fixing means carried by the sleeve consist, for instance, of an internal catch-engagement bead engaging complementary fixing means carried by the applicator brush and consisting of an external groove intended to accommodate the said catch engagement bead. Preferably, the sleeve is cylindrical with a circular cross-section whose axis is identical with that of the applicator brush, the brush stem comprising: a portion with an oval cross-section in the region adjacent to the tuft of hairs of the brush; and, on the opposite side from the tuft near the transition zone with the cap, a portion whose cross-section is a cylindrical shell of a circular cross-section and which comprises, over at least one circular cross-section cylindrical sector, the means fixing the said applicator brush to the sleeve by catch-engagement. In particular, the portion of the stem whose cross-section is cylindrical is delimited by two opposite cylindrical sectors and by two opposite half-flats parallel to the axis of the applicator brush, these half-flats being situated in the extension of the greatest curvature walls of the oval cross-section portion of the stem. The tuft of hairs of the brush of the device in accordance with the present invention may, in particular, have a flattened shape; in that case, it is advantageous to provide a notch disposed opposite the median longitudinal plane of the tuft of hairs. In accordance with another characteristic of the device, the applicator brush enters the bottle via an opening edged by the pliable lip of a wiper cooperating with the external wall of the sleeve. In accordance with a third embodiment, the reservoir means may comprise a sleeve slidably mounted in the cap, provision being made for elastic means for straining the sleeve in such a way that, when the cap is fitted on the bottle, the sleeve is pushed back towards the end panel of the cap so as to release that portion of the stem next to the hairs of the brush and, when the cap is removed, the sleeve is displaced by the elastic means and surrounds the above-mentioned portion of the brush stem as far as the base of the brush hairs, some of the liquid product being trapped between the brush stem and the sleeve. Preferably, the elastic means comprise a helical spring mounted between the cap and a tubular member inside the cap and on which the brush stem is fixed, this tubular member serving for guiding the displacement of the sleeve. The bottle is fitted with a duct mounted inside its neck. The base of this duct constitutes a stop for the sleeve when the cap is mounted on the bottle to push the sleeve back into a high position. The stem supporting the brush may have an undulating shape in its portion situated near the hairs of the brush. In the first and third embodiments of the present invention it may be advantageous for the internal portion of the brush stem or of the sleeve to comprise capillary striations. BRIEF DESCRIPTION OF THE DRAWINGS Apart from the features set out above, the invention involves several other objects and advantages which will be discussed in greater detail below in connection with particular but non-restrictive embodiments, described with reference to the accompanying drawings. In these drawings: FIG. 1 is a transverse cross-section of a bottle provided with an applicator device in accordance with a first embodiment of the invention; FIG. 2 is a cross-section along line II--II of FIG. 1; FIG. 3 is an axial cross-sectional view of a bottle provided with an applicator device according to a second embodiment of the present invention, the stem of the applicator brush being partly shown in elevation; FIG. 4 is a cross-sectional view along line IV--IV of FIG. 3, FIG. 3 itself being an axial cross-section along line III--III of FIG. 4; FIG. 5 is a partly cross-sectional and partly elevational view of the applicator device of FIG. 3, viewed at an angle displaced by 90° in relation to the representation of FIG. 3; FIG. 6 is an axial cross-section of a bottle provided with an applicator device in accordance with a third embodiment of the invention; and FIG. 7 shows the bottle of FIG. 6 when the cap has been withdrawn therefrom. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1 of the drawing, there can be seen an applicator device 1 for a liquid product L contained in a bottle 2. In the example considered, the liquid product is nail varnish. The device 1 comprises an applicator brush 3 which is carried by a cap 4 or the like intended to close the neck 5 of the bottle and to be fixed on this neck with the brush 3 situated inside the bottle. Generally the neck 5 comprises an external thread 6 capable of cooperating with a conjugate internal thread 7 of the cap 4 to fix the cap in place. The bottle 2 is generally made of glass, whilst the cap 4 is made of a plastic material, in particular polypropylene. The brush 3 comprises a tuft of hairs 8 carried by a stem 9 whose upper portion forms a head 10 with a larger diameter, held in a recess 11 of the cap 4. At its base, the head 10 comprises a peripheral flange 12 axially abutting a shoulder 13 marking the separation between the larger diameter internal portion of the cap 4 and the inlet of the recess 11. The head 10 is fixed in the recess 11 by any appropriate means, in particular by force-fitting or bonding. The applicator device 1 comprises reservoir means R capable of storing some of the liquid product L of the bottle so as to feed the brush 3 when the brush has been withdrawn from the bottle 2 with a view to applying this liquid product. In accordance with the embodiment of FIGS. 1 and 2, reservoir means R are provided in the stem 9 whose diameter is relatively large. This stem 9 comprises a hollow portion 14 opening towards the bottom 15 of the bottle and accommodating the hairs 8 of the brush. The reservoir means R, that is to say, the chamber corresponding to the hollow portion 14, are capable of replenishment by capillarity when the hairs 8 of the brush are immersed in the liquid product L. This hollow portion 14 constitutes a chamber or an interstice, of cylindrical shape, delimited by the wall 17 forming the sleeve of the stem 9. It is coaxial with the stem 9 and is open at its lower portion. The hairs 8 of the brush are embedded in the bottom 9' of the hollow portion and extend over the whole length of this hollow portion 14, while spreading out to project outside the said hollow portion 14. The hairs 8 form a brush of the type used for water colours which has the advantage, in contrast to the conventional nail varnish brushes generally used, of ensuring an effective control of the flow and discharge of the varnish. There is an air hole 16, in the wall 17 surrounding the hollow portion, and situated substantially towards the centre of this hollow portion to facilitate replenishment of the interior of the stem 9 with the liquid product L. As may be seen in FIG. 2, the hollow portion of the stem 9 comprises capillary striations 18 orientated parallel to the axis of the stem and promoting the rising and retention of the liquid product in the hollow portion 14. A wiper 19 of a pliable material, in this case an elastomeric material, is mounted inside the neck 5 and is provided in its lower portion with a lip 20 surrounding the stem 9 on which it exerts a light pressure. The wiper 19 comprises, in its upper portion, a radially outwardly projecting flange 21 capable of bearing against the end of the neck and of being gripped between the end of the neck 5 and the flange 12 referred to above. The position of the air hole 16, and the axial dimension of the wiper 19, are chosen so that the air hole 16 is located as shown in FIG. 1 below the lip 20 of the wiper when the brush 3 is in the bottle. The pressure inside the hollow portion 14 is thus in balance with the pressure in the bottle 2. The lower end 22 of the stem 9 forming the base of the chamber 14 is in contact with the hairs of the brush. The upper end 23 of the stem 9 forms a frusto-conical transition zone to the head 10. The operation and use of the applicator device 1 are as follows. When the cap 4 is screwed on the neck 5 of the bottle 2, the brush 3 is located inside the bottle. When the hairs 8 of the brush penetrate into the liquid product L, in this case the varnish, the product rises by capillarity along the hairs as far as the hollow portion or chamber 14 of the stem 9, thus forming a reservoir. This rising of the liquid product is facilitated by the presence of the air hole and the capillary striations 18. When the stopper 4 is unscrewed and the brush 3 is withdrawn from the bottle 2, the stem 9 is wiped by the lip 20 of the wiper. The reservoir of the liquid product remains in the hollow portion 14. The application of the liquid product, namely nail varnish, then takes place. In the course of the application by the hairs 8, the liquid product contained in the hollow portion 14 feeds the hairs, thanks to the striations 18, until this hollow portion 14 has become empty. With such a suitably dimensioned applicator device 1, especially as regards the hollow portion 14, it is possible to apply the nail varnish over the whole hand without having to reimmerse the hairs 8 of the brush 3 in the liquid product of the bottle. FIGS. 3 to 5 relate to a second embodiment of the present invention wherein those elements which are similar or equivalent to the elements already described with reference to FIGS. 1 and 2 are designated by the same numerals followed by the letter a. Their description will not be repeated, or if so then only briefly. A wiper 19a of pliable material, in particular of an elastomeric material, is mounted inside the neck 5a and is provided, in its lower portion, with a lip 20a surrounding the sleeve attached to the applicator brush 3a (which sleeve will be described below) whereon it exerts light pressure. The wiper 19a comprises, at its upper portion, a radially outwardly projecting flange 21a capable of bearing on the end of the neck 5a and of being gripped between the end of the neck 5a and the flange 12a of the head 10a of the applicator brush 3a described below. The brush 3a comprises hairs 8a carried by a stem 9a whose upper portion forms a head 10a secured in a recess 11a of the cap 4a. The head 10a and the stem 9a proper are joined by transition zone 23a of a generally frusto-conical shape. The stem 9a comprises, successively between the hairs 8a and the head 10a: a portion 36 of an oval cross-section as may be seen in FIG. 4; and a portion which is of smaller height than the portion 36 and which is delimited on the one hand by two opposite sides 38 forming two sectors of one and the same cylinder whose axis is identical with the axis of the stem 9a and two opposite half-flats 39 parallel to the axis of the stem 9a. The two portions of the stem 9a are joined by a shoulder 40 flaring from the portion 36 towards the other portion. Moreover, in each of the walls 38, there is an annular groove 41 situated in a plane perpendicular to the axis of the stem 9a near the transition zone 23a of the stem to the head 10a, each groove extending from one edge to the other of the respective part cylindrical wall 38. The head 10a, having an overall cylindrical shape, is secured in a recess 11a of the cap 4a. It comprises at its base, that is to say near the zone 23a, the above-mentioned peripheral flange 12a, which axially abuts a shoulder 13a, marking the separation between the larger diameter internal portion of the cap 4a and the inlet of the recess 11a. Moreover, in the end wall of the head 10a is a cylindrical cut out 42 whose axis is identical with that of the applicator brush 3a. To facilitate the insertion of the said applicator brush 3a in the recess 11a, the free external edge of the head 10a is chamfered. The head 10a is fixed in the recess 11a by an appropriate means, in particular by force-fitting or bonding. The applicator device 1a comprises reservoir means R capable of storing some of the liquid product L of the bottle 2a so as to supply the applicator brush 3a when the brush is withdrawn from the bottle 2a for application of the product. These reservoir means R are formed by the interstice existing between the stem 9a and the adjacent portion of the set of hairs 8a, and a cylindrical external sleeve 44 fixed to the stem 9a. For this purpose the sleeve 44 has, near its edge on the opposite side to that facing the tuft of hairs 8a, an internal peripheral ring 45 intended to cooperate with the grooves 41 in the cylindrical sectors 38, these latter being situated in the extensions of the smaller curvature walls of the portion 36 of the oval section of the stem 9a. Moreover, along its lower edge 22a opposite the hairs 8a in the mounted position of the said sleeve 44, the sleeve 44 comprises a V-shaped notch 46. As may be seen in FIGS. 3 and 5, the tuft of hairs 8a has a flattened shape. It is arranged that in the final position, the notch 46 is situated opposite the median longitudinal plane of the said tuft of hairs 8a. The mounting of the sleeve 44 on the applicator brush 3a is extremely simple since it suffices to slide the sleeve 44 around the end of the stem 9a carrying the hairs 8a until the retaining ring 45 becomes catch engaged in the grooves 41, and then to adjust the sleeve 44 by rotation so that the notch 46 has precisely the desired position in relation to the set of hairs 8a. When the cap 4a is screwed on to the neck 5a of the bottle 2a, the applicator brush 3a is inside the bottle 2a. When the hairs 8a penetrate into the liquid, e.g. nail varnish, the liquid rises by capillarity along the hairs 8a up to the interstice forming the reservoir R. When the stopper 4a is unscrewed, and the brush 3a is withdrawn from bottle 2a, the sleeve 44 is wiped by the lip 20a of the wiper 19a. The reservoir R of the liquid product remains in the above mentioned interstice. The application of the liquid product can then be effected. In the course of this application, the liquid contained in the reservoir R feeds the hairs 8a, and this is facilitated by the presence of the notch 46, until this reservoir R has become exhausted. With such a suitably dimensioned applicator device 1a, particularly as regards the reservoir R, it is possible to apply the nail varnish over the whole of one hand without having to re-immerse the hairs 8a of the applicator brush 3a in the liquid of the bottle 2a. FIGS. 6 and 7 show another embodiment wherein those elements which are similar or equivalent to the elements already described with reference to FIGS. 1 and 2 are designated by the same numerals followed by the letter b. Their description will not be repeated or if so then only briefly. The reservoir means R comprise a sleeve 24 slidably mounted to the cap 4b. Elastic means E restrain the sleeve 24 so that when the cap 4b is fitted on the bottle 2b, the sleeve 24 is biased towards the bottom of the cap so as to release the portion 25 of the stem next to the hairs 8b of the brush whilst, during the removal of the cap 4b, the sleeve 24 comes to surround the above-mentioned portion 25 of the stem, under the action of the elastic means, as far as the base of the hairs 8b of the brush. The elastic means E are advantageously provided between the bottom of the cap 4b and the sleeve 24. Preferably, these elastic means E are formed by a helical spring 26 mounted inside the cap around a tubular member 27 integral with the cap and coaxial with it. The stem 9b of the brush is fixed at its head 10b in the lower open end of the tubular member 27. The sleeve 24 comprises a lower portion 28 of smaller diameter, within which the stem 9b slides with restricted play, and an upper portion 29 of larger diameter in which the tubular member 27 is fitted with restricted play. This tubular member 27 thus serves to guide the sliding displacement of the sleeve 24. The transition between these two portions 28 and 29 is at a frusto-conical zone 30. The portion 28 of sleeve 24 comprises, internally, longitudinal capillary striations similar to the striations 18 of FIG. 2. The bottle 2b is provided with a duct 31 mounted inside its neck 5b. The base 32 of this duct forms a stop for the lower end of the sleeve 24 when the cap 4b is fitted on the bottle 2b. This stop 32 biases the sleeve 24 into a high position against the spring 26 as shown in FIG. 6. The stem 9b, provided with hairs 8b, preferably has an undulating shape in its portion 25 situated near the hairs of the brush. This undulating shape may be obtained by a succession of spherical or substantially spherical bulges joined by smaller diameter zones 34. This undulating shape favours the retention of some of the liquid product on the portion 25. The hairs 8b are fixed at the base of this portion 25 which they extend. The passage opening 35 of the duct 31 has a larger diameter than the maximum diameter of both the stem 9b and the stem lower portion 25. The functioning and use of the applicator device 1b of FIGS. 6 and 7 are as follows. When the stopper 4b is screwed onto the bottle 2b, the lower end of the sleeve 24 abuts the base 32 of the duct 31 and this pushes the sleeve 24 against the spring 26, as shown in FIG. 6. The portion 25 of the stem 9b penetrates into the bottle 2b with the hairs 8b and they become impregnated with the liquid product L. When the cap 4b is unscrewed, the stem 9b takes out, essentially by means of its portion 25, a certain quantity of liquid adhering to its surface. Because of the larger diameter of the opening 35 the portion 25 of the stem is not wiped, and the liquid product is placed in reserve within the sleeve 24, and more particularly the portion 28 is not wiped, when the portion 25 of the stem enters the sleeve, as shown in FIG. 7. In the position of use, shown in FIG. 7, the sleeve 24 comes into contact at its lower end 22b with the base of the hairs 8b of the brush, so as to ensure that the brush is properly fed by the reserve stored in the sleeve 24, and in particular by the striations (similar to the striations 18) which serve as reservoir. The application of the product, e.g. to the fingernails, is then effected in the conditions explained above with reference to FIGS. 1 and 2. It is also possible to apply the nail varnish over the whole of one hand without having to recharge the brush with the product by re-immersion in the bottle 2b. The tuft of hairs 8b of FIGS. 6 and 7 preferably has a "tear drop" shape allowing the flow to be controlled. Whatever the embodiment, once the cap has been screwed back onto the bottle, the brush is always in contact with the liquid product L and does not dry out. The explanations given above make it clear that the reserve means R are capable of replenishment between two uses of the brush, each use following a removal of the cap from the bottle. As can be understood, in the three embodiments described above the reservoir means R are situated outside the hair tuft of the applicator brush (3,3a,3b): because of this, the liquid product L does not pass between the hairs (8,8a,8b) fixed in the stem (9,9a,9b) but instead passes axially along the outer surface of the tuft.

An applicator for a viscous liquid such as nail varnish has an applicator brush in the form of a tuft of hairs which is anchored at its upper end in an applicator stem and a part of the tuft downwardly of the point of anchorage is surrounded by a reservoir space R into which an optional air hole passes. While the applicator brush is being used, varnish or other liquid passes axially along the tuft from the reservoir R, thereby increasing the duration of an applicator phase before the need to reimmerse the tuft in the liquid product L in the bottle.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is based on, claims the benefit of, and incorporates by reference U.S. Provisional Application Ser. No. 61/125,691 filed Apr. 28, 2008, and entitled “Method and Apparatus for Assessing Atrial Electrical Stability” and U.S. Provisional Application Ser. No. 61/134,325 filed Jul. 9, 2008, and entitled “Method and Apparatus for Assessing Atrial Electrical Stability.” BACKGROUND [0002] Cardiovascular disease is the greatest cause of morbidity and mortality in the industrialized world. It not only strikes down a significant fraction of the population without warning but also causes prolonged suffering and disability in an even larger number. [0003] Atrial fibrillation (AF) is a common arrhythmia, affecting approximately 1% of the general population and 8% of those over the age of 80. As a result, AF places a substantial financial burden on the healthcare system, accounting for over $6 billion in direct treatment costs in the United States in 2006. More importantly, AF is associated with substantial morbidity and mortality. For example, several studies have documented a two-fold increase in mortality and a 2 to 7-fold increase in stroke rate for patients in AF compared to age-matched controls in normal sinus rhythm. Unfortunately, current pharmacologic therapy for the prevention of AF (anti-arrhythmic drugs) is hampered by major dose-limiting toxicities and high rates of arrhythmia recurrence. [0004] In some cases, radio-frequency catheter ablation of the pulmonary veins is used to isolate unorganized electrical activity generated therein to prevent AF. Current catheter based techniques generally use an anatomic approach to identify ablation targets—regions targeted for radio-frequency ablation are identified largely based on their anatomic proximity to the pulmonary veins resulting in the same basic set of ablation lesions being generated in all patients. Using this approach, however, long-term success has been limited with an AF recurrence rate of up to 50% within 12 months following a single ablation procedure. The limited efficacy of pulmonary vein ablation is at least partly due to the fact that atrial fibrillation is a heterogeneous disease and arises from different sites in different patients. [0005] In fact, many non-pulmonary vein sites have been identified as potential triggers for AF. Unfortunately, methods to identify these other sites during ablation procedures are lacking. In addition to the pulmonary veins, other cardiac veins are potentially arrhythmogenic, and may also be involved in the initiation and perpetuation of AF. [0006] More recent techniques for AF ablation have used complex electroanatomic mapping systems to identify non-pulmonary vein sites as targets for ablation. These newer methods are technically complex, difficult to apply broadly and still do not provide an easily applied measure for defining the adequacy of ablation. [0007] Pulmonary vein ablation is hampered by safety concerns with a major complication rate around 6%, including stroke, pulmonary vein stenosis, cardiac tamponade, atrio-esophageal fistula and death. In most cases, complications of catheter ablation occur as a result of thermal injury to the atrium and surrounding structures. Limiting the amount of tissue targeted for ablation may prevent complications from thermal injury but may also compromise efficacy by leaving behind un-ablated sites that later serve as the substrate for recurrent AF. One of the major limitations of the anatomic approach to pulmonary vein ablation has been the inability to determine, in real-time, when enough tissue has been ablated to achieve a successful outcome—that is no recurrence of AF. SUMMARY OF THE INVENTION [0008] The present invention involves a method for recording a multiplicity of electrocardiographic signals in and/or on the heart and/or tissues and blood vessels that are connected to the heart and/or on the body surface, to determine susceptibility to atrial-rhythm disturbances. [0009] In one embodiment, the present invention is a method for identifying a susceptibility of a subject to atrial-rhythm disturbances. The method includes a) placing a plurality of sensors on the subject to measure a physiologic signal of the subject, and b) recording the physiologic signal from the sensor. The physiologic signal includes an atrial electrical activity of the subject. The method includes c) determining a beat-to-beat variability in the atrial electrical activity of the subject. The beat-to-beat variability includes alternans of electrocardiographic waveforms of a predetermined number of a sequence of heart beats. The method includes d) determining a susceptibility to atrial-rhythm disturbances of the subject using the beat-to-beat variability in the atrial electrical activity determined in step c), and e) generating a report of the susceptibility to atrial-rhythm disturbances of the subject. [0010] In another embodiment, the present invention is a method for identifying a susceptibility of a subject to atrial-rhythm disturbances. The method includes a) placing a sensor on the subject to measure a physiologic signal of the subject, and b) recording the physiologic signal from the sensor. The physiologic signal includes an electrical activity of a heart of the subject. The method includes c) determining a beat-to-beat variability in the atrial electrical activity of the subject during a sequence of heart beats, d) determining a susceptibility to atrial-rhythm disturbances of the subject using the beat-to-beat variability in the atrial electrical activity, and e) generating a report of the susceptibility to atrial-rhythm disturbances of the subject. [0011] In another embodiment, the present invention is a system for identifying susceptibility to atrial-rhythm disturbances. The system includes a plurality of sensors configured to measure a physiologic signal of a subject, and a computer for recording the physiologic signal from the sensor. The physiologic signal includes an atrial electrical activity of the subject. The computer is configured to determine a beat-to-beat variability in the atrial electrical activity of the subject. The beat-to-beat variability includes alternans of electrocardiographic waveforms of a predetermined number of a sequence of heart beats. The computer is configured to use the beat-to-beat variability in the atrial electrical activity to determine a susceptibility to atrial-rhythm disturbances of the subject. The system includes a user interface for displaying the susceptibility to atrial-rhythm disturbances of the subject. BRIEF DESCRIPTION OF THE DRAWINGS [0012] For a more complete understanding of this disclosure, reference is now made to the following brief description, taken in connection with the accompanying drawings and detailed description, wherein like reference numerals represent like parts. [0013] FIG. 1 is a schematic diagram illustrating the formation of spatial alternans in cardiac tissue leading to a dispersion of recovery, wave front fractionation, and reentry; [0014] FIG. 2 is a flow chart setting forth the steps of a method for determining a subject's susceptibility to atrial-rhythm disturbances and for treating the subject to minimize the occurrences of atrial-rhythm disturbances; [0015] FIG. 3 is a three dimensional (3D) illustration of an anterior view of the left atrium and pulmonary veins of a heart indicating potential catheter lead locations; [0016] FIG. 4 is a 3D illustration of a posterior view of the left atrium and pulmonary veins of a heart indicating potential catheter lead locations; [0017] FIG. 5 is a 3D illustration of a top view of the left atrium and pulmonary veins of a heart indicating potential catheter lead locations. [0018] FIG. 6 is an exemplary electrocardiographic waveform including annotations identifying a plurality of portions of the electrocardiographic waveform; [0019] FIG. 7 is a flow chart illustrating the steps of an algorithm for estimating alternans of atrial electrocardiographic waveforms; [0020] FIG. 8 shows a plurality of exemplary electrocardiographic waveforms illustrating time-aligned samples within the P-wave used for the depolarization alternans of atrial electrocardiographic waveforms estimation; and [0021] FIG. 9 is a schematic diagram of a system for assessing atrial electrical stability. DETAILED DESCRIPTION [0022] The present invention is directed to a system and method for assessing atrial electrical stability. More specifically, a system and method are provided for guiding radio-frequency catheter ablation to minimize instances of atrial fibrillation (AF). In one implementation, catheter ablation procedures are guided using measurements and analysis of atrial alternans, a beat-to-beat variation in the morphology of the atrial electrocardiographic (ECG) waveform. In some cases, atrial alternans are associated with the same myocardial substrate that gives rise to AF. [0023] Electrical alternans are a pattern of variation in the shape of electrocardiographic waveform that appears on an every other beat basis. In humans, visible (macroscopic) alternations in ventricular repolarization have been associated with an increased vulnerability to ventricular arrhythmias under diverse pathophysiologic conditions. [0024] A Fast Fourier Transform (FFT) spectral method may be used to detect microvolt level T-Wave Alternans (TWA) and the establishment of a relationship between TWA and Ventricular Fibrillation (VF) threshold (VFT). An increased dispersion of repolarization (DR) is an important condition for the development of reentrant arrhythmias and may be associated with both VT/VF and concordant or discordant alternans (DR is greater at sites of discordant vs. concordant alternans). In some cases, action potential (AP) duration (APD) alternans can provide the substrate for reentry, indicating that TWA is also a short-term predictor of arrhythmia susceptibility. Accordingly, the mechanisms that generate VRA (functional spatial dispersion of refractoriness) are likely to also lead to VT/VF, requiring that the heart pass through a VRA stage on the way to VT/VF or VRA occurs in conjunction with developing VT/VF. [0025] Action potential alternans involve an alternating sequence in which the shape of the action potential (the wave-like pattern of variation of a cell's transmembrane potential) associated with an individual cardiac cell changes on an every other beat basis. If the duration of the action potential alternates on an every other beat basis, then the duration of the refractory period also alternates in duration because the refractory period is generally comparable to the duration of the action potential. Thus, action potential alternans create a situation in which a region of the myocardium has a long refractory period on an every other beat basis. Referring to FIG. 1 , on these alternate beats, regions 2 with long action potential duration alternans can create islands of refractory tissue with respect to areas 4 of short action potential duration alternans. These variations between the regions 2 , 4 cause fractionation of activation wavefronts 6 and promote the development of reentry. [0026] A major factor leading to the creation of ventricular arrhythmias during ischemia is dispersion of refractoriness. Dispersion of refractoriness is a measure of non-homogeneous recovery of excitability in a given mass of cardiac tissue (tissue is called refractory when it cannot be re-stimulated until it has recovered). In normal myocardium, the excitability is strictly proportional to the duration of repolarization. Reentry is the most likely mechanism of arrhythmia facilitated by enhanced dispersion of repolarization. The elements that are most often represented in the experimental or clinical models of arrhythmias attributed to reentry include non-uniform conduction, non-uniform excitability, and non-uniform refractoriness. An important mechanism for enhancing dispersion of the refractory period is alternation of the action potential from beat to beat. [0027] Thus, as illustrated in FIG. 1 , action potential alternans 2 , 4 , which generally occur in diseased tissue, can promote the formation of islands of refractory tissue which promote the development of reentry. Therefore, localized cardiac alternans may be reflected in the surface ECG as TWA. Concomitantly, localized regions of AP alternans that exhibit delayed recovery on an every other beat basis are intrinsically linked or even lead to increased repolarization gradients sufficient to produce unidirectional block and reentry. Therefore, localized AP alternans lead to TWA as well as to increased DR, wavefront fractionation, reentry and VT/VF. [0028] Similarly to ventricular alternans, localized regions of atrial APD heterogeneity can be identified on the ECG waveform as atrial (depolarization and/or repolarization) alternans, and the presence of alternans of atrial electrocardiographic waveforms is linked to the gradients of repolarization that give rise to multiple-wavelets and AF. Furthermore, by identifying local regions and/or periods of heightened alternans of atrial electrocardiographic waveforms in the heart and/or tissues that are connected to the heart and targeting them, catheter ablation can sufficiently modify the electrical substrate to prevent AF. Suppression of alternans of atrial electrocardiographic waveforms may also be used as a marker for identifying a suitable end-point for ablation and limiting further thermal injury. [0029] The use of alternans of atrial electrocardiographic waveforms to guide catheter ablation procedures of AF and verify and confirm its success, provides several advantages, such as: (i) a real-time, rapid and highly efficient method for identifying ablation targets based on electrophysiologic properties, not just anatomic markers; (ii) an approach that would limit thermal injury by preventing ablation of “non-culprit” atrial tissue; (iii) a marker to define the success of ablation and identify a procedural end point; (iv) a marker to predict long-term risk of arrhythmia recurrence; and (v) a broadly applicable approach to meet the substantial demand for AF therapy. [0030] Heart rate variability (HRV), a variability of ventricular depolarization times, also acts as an indicator of sudden cardiac death in post myocardial infarction patients. As such, a mathematical model has been developed for describing HRV. In an analogous manner to measuring variability of ventricular depolarization times, the altered variability of atrial depolarization times and/or variability in the duration of atrial depolarization and/or variability in the duration from the onset of atrial depolarization to the offset of atrial repolarization and/or parameters of the signal averaged P-wave, may be intrinsically linked to periods of increased susceptibility of atrial arrhythmias and AF. Furthermore, identifying local regions and/or periods of altered variability of atrial depolarization times and/or variability in the duration of atrial depolarization and/or variability in the duration from the onset of atrial depolarization to the offset of atrial repolarization and/or parameters of the signal averaged P-wave and/or the tissues that it is connected, and targeting them for catheter ablation can sufficiently modify the electrical substrate to prevent AF. [0031] As will be described, the present method involves recording electrocardiographic signals associated with the heart, tissues or blood vessels that are connected to the heart, and/or the body surface, to determine a susceptibility to atrial-rhythm disturbances. The atrial-rhythm disturbances may involve atrial tachycardia, atrial fibrillation, atrial flutter, or other disturbances to the operation of the atria. Using the present method, sites that originate atrial-rhythm disturbances are identified in the atria or tissues and blood vessels that are connected to the heart. After identifying the sites originating atrial-rhythm disturbances, appropriate medical treatments such as the delivery of a chemical or biochemical substance, or the application of electrical energy are guided to those sites. The present method may also involve determining the risk or likelihood of a subject to develop atrial-rhythm disturbances. [0032] FIG. 2 is a flow chart setting for the steps of an exemplary method 100 for determining a subject's susceptibility to atrial-rhythm disturbances and treating the subject to minimize the occurrences of atrial-rhythm disturbances. Using method 100 , electrical activity originating in and/or on the heart and/or tissues and blood vessels that are connected to the heart and/or on the body surface are collected and processed. After processing, the system assesses a susceptibility to atrial-rhythm disturbances by further processing of atrial electrical activity data. [0033] In step 102 , atrial activity of the heart is recorded using one or more electrodes connected to a subject to collect electrical data describing the activity of the heart tissue of the subject. The electrodes may include passive electrodes and may be placed in the atria, pulmonary veins, the coronary sinus, or any other tissue or blood vessels attached to the heart. FIGS. 3-5 illustrate a heart 10 of a subject having example placements of electrode or sensors 12 around a proximity of heart 10 . FIG. 3 illustrates an anterior view of the left atrium and pulmonary veins of heart 10 . FIG. 4 illustrates a posterior view of the left atrium and pulmonary veins of heart 10 . FIG. 5 illustrates a top view of the left atrium and pulmonary veins of heart 10 . In FIGS. 3-5 , dots 12 indicate exemplary placement positions for the sensors or catheter leads. [0034] The electrodes or sensors may be in a bipolar configuration for recording localized atrial electrical activity, or in a unipolar configuration for recording remote or global atrial electrical activity. Alternatively, atrial activity data may be collected using catheters similar to those used as part of the atrial fibrillation ablation procedure and the detected signals, following amplification, filtering and conditioning, are used for further analysis. [0035] Depending upon system requirements, placement of the electrodes may optionally be guided or facilitated by the use of various imaging modalities, such as magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound. The catheter lead location placement with respect to each other may be circular or straight. In one implementation, catheter leads in the heart (see, for example, FIGS. 3-5 ) may be positioned at or close to the pulmonary veins, in the high and/or low, anterior and/or posterior surfaces of the left atrium, or at any other tissue close to the atria, such as the coronary sinus. Catheter leads in the heart may be positioned at the corresponding sites in the right atrium and may occur sequentially at the aforementioned or different locations providing a detailed spatio-temporal (time-dependent anatomical) characterization of the beat-to-beat variability of atrial electrical activity. [0036] In an alternative implementation, the leads for acquiring the electrocardiographic waveforms within or on the body may include Frank orthogonal leads or may be mathematically combined to form Frank orthogonal leads. In that case, the selected atrial waveforms of the three orthogonal bipolar leads (X, Y, Z) may be combined into a vector magnitude by the formula (X 2 +Y 2 +Z 2 ) 1/2 . [0037] Referring again to FIG. 2 , step 102 may be implemented using leads of an implanted device such as an implantable cardioverter defibrillator or cardiac pacemaker. The devices may contain micro-processors or other electronic circuitry capable of performing the computations necessary for the measurement. Furthermore, the devices can also serve as a cardioverter defibrillator or pacemaker during the therapy portions of the present method. [0038] At step 103 , the signals representing the collected atrial activity data are stored in a computer or other electronic storage medium using an analog to digital card. In one implementation, the data is stored in a database, or other electronic storage medium on a computer's hard disk. After storage, the data is further processed to determine susceptibility to atrial-rhythm disturbances. [0039] In one implementation, the method continues by manipulating the data stored in step 103 to determine beat-to-beat variability in step 104 . For example, the beat-to-beat variability may include atrial depolarization and/or repolarization alternans, or alternans of the PQ interval, as illustrated in FIG. 6 . After determining beat-to-beat variability, the method includes estimating alternans of atrial electrocardiographic waveforms in step 106 . Further detail of step 106 will be described with respect to FIG. 7 . [0040] After determining the alternans of atrial electrocardiographic waveforms, in step 108 , output data is generated that may be used for treatment of the atrial-rhythm disturbances. For example, when the level of alternans of the selected atrial waveform estimated from one or more leads, exceeds a threshold value over some period of time (such as for example, one minute), susceptibility to atrial-rhythm disturbances may be indicated at step 108 . Furthermore, when the level of alternans of the selected atrial waveform estimated from one lead, but not all leads, exceeds a threshold value over a predetermined period of time (such as for example, one minute), it may be determined that the site of origin of the atrial abnormal heart rhythm is close and/or around that lead, and susceptibility to atrial-rhythm disturbances may be indicated at that particular location. Successful elimination, interruption and/or isolation of the atrial heart-rhythm disturbances may be manifested by suppression and/or elimination of the alternans level of the selected atrial waveform. After detecting an on-going susceptibility to atrial-rhythm disturbances, various treatments or therapy are provided in step 110 . [0041] Referring now to FIG. 7 , in one exemplary implementation, the process for estimating alternans of atrial electrocardiographic waveforms described with respect to step 106 of FIG. 2 , may use 128 electrocardiographic waveforms and may be updated or shifted forward with every new electrocardiographic waveform recorded. The algorithm for estimating alternans of atrial electrocardiographic waveforms may be triggered either from the ventricular R-wave (R v ) of the QRS complex or the P-wave (seen in FIG. 6 ) in a double triggering approach in step 602 . Double triggering first identifies the high amplitude ventricular R v -wave and then a backwards algorithm may be applied to trigger on the P-wave. Alternatively, the algorithm for estimating alternans of atrial electrocardiographic waveforms may be triggered from the atrial R a -wave. [0042] The R v -wave (indicating ventricular depolarization, as illustrated in FIG. 6 ) detection occurs in the electrocardiographic waveform obtained from any of the sensors placed in or on the patients' heart or tissues and blood vessels attached to the heart or on the patient's body surface. Following R v -wave detection, the “baseline” for each beat (considered to be the mean or median value of the electrocardiographic waveform during the PQ interval seen in FIG. 6 ), may be adjusted by subtracting the baseline value from the value of the electrocardiographic waveform segment used for further analysis in step 604 . [0043] In another implementation, however, the PQ interval baseline can be adjusted by high-pass filtering. For example, to filter the effect of respiration at a rate of 9 breaths per minute on the ECG signal, a 128 order digital finite impulse response filter with a low cut-off frequency of 0.16 Hz with a normalized gain at that frequency at a magnitude of approximately −6 dB and having magnitude 1 at the pass-band may be used. Alternatively, the low cut-off frequency of the filter to reduce the effect of respiration on the ECG signal may be dynamically adjusted based on a real-time estimate of the respiration rate. In one implementation, for example, a high-pass filter impulse response is windowed with a 129 point length window (for example, Hamming or Hanning). [0044] Following PQ interval baseline adjustment in step 604 , an average or median ventricular QRS complex (for example, 70 milliseconds long) is formed and each ventricular QRS complex in the 128-beat sequence is repeatedly cross-correlated (convoluted) and shifted against the average or median ventricular QRS complex of that sequence of beats in step 606 . The sample point at which the cross-correlation takes its maximum value is considered the true R v -wave (fiducial point). To make the fiducial point as accurate as possible, an additional interpolation may optionally be performed to determine the fiducial point to the nearest sample point. [0045] Following refinement in identifying the peak of the ventricular QRS complexes, erroneous ventricular QRS complexes are detected in step 608 based on at least one of two criteria: (i) the morphology criterion, in which the correlation coefficient between the present beat ventricular QRS complex and the average or median ventricular QRS complex of the, for example, 128-beat sequence, is less than a threshold value of, for example, 0.95; and (ii) the R v -to-R v (R v R v ) interval criterion, in which the present beat's R v R v interval minus the mean R v R v interval of the previous, for example, 5 beats is less/more than a threshold value of, for example, 50 milliseconds. [0046] A beat may be classified as good if both the morphology (indicated as “1” in Table 1) and the R v R v -interval (indicated as “1” in Table 1) criteria are satisfied, as indicated in a decision matrix that may help classify beats. After the erroneous beats are detected, for each erroneous beat, the appropriate number of atrial electrocardiographic waveforms are removed from that sequence of beats, as indicated in Table 1 and step 610 . [0000] TABLE 1 Decision matrix for beat classification based on analysis of the ventricular QRS complex. Morphology R V R V Removed Case Criterion Criterion Outcome Beats Classification 1 0 0 0 3 Premature (previous + Ventricular present + next) Contraction 2 0 1 0 2 Supraventricular (present + next) 3 1 0 0 2 Aberrantly (previous + conducted sinus present) beat (i.e. bundle branch block) 4 1 1 1 0 Normal [0047] In one implementation, the fiducial point is shifted to the far left of the acquisition window enabling maximal visibility of the P-wave and the PQ interval. This allows for the identification of the P-wave boundaries (P beg and P end ) using either the raw ECG signal or its filtered version in step 612 . [0048] Following identification of the P-wave boundaries, an average or median P-wave may be estimated (for example, being 100 milliseconds long) and each P-wave in the 128-beat sequence is repeatedly cross-correlated (convoluted) and shifted against the average or median P-wave of that sequence of beats in step 614 , and the sample point at which the cross-correlation takes its maximum value is considered the true P-wave peak (fiducial point). In some cases, to make the fiducial point increasingly accurate, an additional interpolation is performed to determine the fiducial point to the nearest sample point. [0049] Following refinement in identifying the peak of the P-wave, erroneous P-waves may be detected based on one or more of the following criteria: (i) the morphology criterion (as it applies to the P-wave), in which the correlation coefficient between the present beat P-wave and the average or median P-wave of the beat sequence is less than a threshold value of, for example, 0.90, see step 616 , and (ii) the P-to-P interval criterion in which the present beat's P-to-P interval minus the mean P-to-P interval of the previous, for example, 10 beats is less/more than a threshold value of, for example, 50 milliseconds. [0050] A beat may be classified as good if the morphology indicated “1” in Table 2 criterion alone and/or the P-to-P interval indicated “1” in Table 2 criteria are satisfied, as indicated in a decision matrix that may help classify beats (Table 2). Again, once all of the erroneous beats are detected, then for each erroneous beat the appropriate number of the selected for analysis atrial electrocardiographic waveforms are removed from that sequence of beats, as indicated in Table 2. [0000] TABLE 2 Decision matrix for beat classification based on analysis of the P-wave. Morphology R a R a Removed Case Criterion Criterion Outcome Beats Classification 1 0 0 0 3 (previous + present + next) 2 0 1 0 2 (present + next) 3 1 0 0 2 (previous + present) 4 1 1 1 0 Normal [0051] Therefore, in a sequence of beats selected for analysis, after all erroneous beats are detected and for each erroneous beat the appropriate number of the selected atrial electrocardiographic waveforms are removed, the selected atrial electrocardiographic waveform of each removed beat is substituted with a median odd or even selected atrial electrocardiographic waveform template depending on whether the removed beat was an odd or an even one in that sequence in step 618 . After the appropriate beat removal and substitution, a sequence of selected atrial electrocardiographic waveforms may be eligible for further analysis if the number of removed beats is, for example, less than 9%; if the latest condition is not satisfied, the sequence moves forward, is updated with, for example, a new beat, and steps 606 through 610 are repeated. [0052] If an eligible sequence of beats is identified for further analysis, then for example, if the selected atrial electrocardiographic waveform is a P-wave, an average or median P-wave is obtained and the P-wave boundaries (P beg and P end ) are obtained as previously described. In another implementation an average or median T a -wave (reflecting atrial repolarization) may also be obtained and its boundaries (beginning and end) are again obtained as previously described. The analysis that follows may be applied in either or all selected atrial waveforms reflecting or being part of atrial excitation (for example the P-wave reflecting atrial depolarization and the T a -wave reflecting atrial repolarization). [0053] In steps 620 and 622 , the power spectrum may be estimated for each time-aligned sequence of sample points within the selected atrial waveform, as previously described. In one case, the selected atrial waveform is split into bins, each bin consisting of at least one sample point. The power spectra for each sample point in a bin may be averaged and the statistical estimates of alternans of atrial electrocardiographic waveforms (for example, the alternans voltage, noise and K-score) are obtained as previously described in step 624 . [0054] Estimation of alternans of atrial electrocardiographic waveforms can be performed on unipolar signals alone or in combination with bipolar signals in order to more accurately determine susceptibility to atrial-rhythm disturbances. In one example, the use of unipolar and/or bipolar signals may also determine more accurately the site of origin of the atrial-rhythm disturbance. For example, if alternans of atrial electrocardiographic waveforms are present in bipolar signals (e.g. obtained from a pulmonary vein) or unipolar signals (e.g. obtained from the coronary sinus) before treatment, then, if, after treatment of the atrial-rhythm disturbances, alternans of atrial electrocardiographic waveforms persist only in the unipolar signal, treatment at and/or around the site that the bipolar signal was recorded from may be determined to be successful, although there is at least one more site of origin of atrial-rhythm disturbances that should be treated. [0055] In one example treatment system, the same catheters used to record the fluctuations in the beat-to-beat variability of the selected atrial waveform are used to deliver therapy to the heart via electrical stimulus, ablation, delivery of medication, or other treatment methods. One therapy method involves the delivery of electrical energy to the heart through electrodes in and/or on the heart. This electrical energy may suppress and/or terminate and/or isolate the initiation of atrial-rhythm disturbances at and/or around the site of origin of the abnormal atrial rhythm. The energy of this therapy would be appropriate to interrupt an atrial-rhythm disturbance, such as preventing AF from spreading to the atrial tissue. The therapy may include the delivery of a chemical or biochemical substance. The chemical substance may include a pharmacological agent or gene therapy that reduces the likelihood of an atrial-rhythm disturbance from occurring. The substance may be delivered into the blood stream or directly at and/or around the tissue site of origin of the atrial-rhythm disturbances. [0056] Therapy may be delivered by an implanted device through electrodes in and/or on the heart and/or tissues and blood vessels that are connected to the heart. The device may be configured to implement the measuring and analysis methods illustrated in FIGS. 2 and 7 and described above. Accordingly, such an implanted device, in addition to performing the measuring steps described above (steps 100 - 102 of FIG. 2 ) may identify time periods and locations within the subject having an increased probability that a heart rhythm disturbance may occur and during which therapy may be delivered. For example the implantable device can incorporate means for generating electrical stimulating pulses of specified energies and apply the pulses to body tissue at specified times, and deliver the impulses used for pacing the heart at the appropriate times and energy levels. The electrical impulses may be delivered at varying inter-impulse intervals so as to increase the level of heart rate variability. For example, the inter-impulse intervals may have a mean of 600 milliseconds and a standard deviation of 120 milliseconds. In general, the mean inter-impulse interval is small enough so that most of the heart beats result from the applied impulses and not from spontaneous cardiac electrical activity. The variable inter-beat intervals will also cause the diastolic intervals associated with cardiac electrical activity in the heart's ventricles to vary. Since the STa and Ta-wave morphology also depend on the duration of the preceding diastolic interval, the variability in the timing of the electrical impulses will also cause increased variability in STa and Ta-wave morphology and thus tend to suppress ατριαλ repolarization alternans. [0057] The delivered therapeutic electrical stimulus may have a minimum energy level similar to that delivered by pacemakers (pacing pulse), and a maximum energy level similar to that delivered by defibrillators (defibrillation shock). The therapeutic electrical stimulus should be delivered outside the vulnerable window wherein ventricular fibrillation may be induced. When there is alternation in the atrial beat duration (the duration of time from the beginning of depolarization to the end of repolarization), the electrical impulse is delivered at a time interval after the end of repolarization in the beats with the shorter beat duration. This time interval is longer than the diastolic interval that follows the beats with the longer beat duration but shorter than the diastolic interval that follows the beats with the shorter beat duration. Adaptive pacing can be employed in such a way that electrical stimuli will be applied on alternate beats during alternans. [0058] In another implementation, non-excitatory current will be applied during the absolute refractory period to modulate the local atrial APD and, consequently, the QTa interval. Current pulses may be applied on a beat-to-beat basis during alternans by attempting to prolong (by applying a positive amplitude pulse or anodic stimulus) or shorten (by applying a negative amplitude pulse or cathodic stimulus) the QTa interval, on either the short (in an attempt to prolong it) or the long (in an attempt to shorten it) beats on alternate beats. In one implementation, the following parameters of the current pulses are adjusted to confirm suppression/termination of RA, the: (i) amplitude, (ii) duration, and (iii) delay from the Ra-wave. Monophasic square-wave current pulses with (i) peak amplitudes ranging between 1 and 20 mA in incremental steps of 1 mA (corresponding to an approximate range of 0.5 to 10 V, for ˜500 Ohms impedance), (ii) duration ranging from 10 to 50 milliseconds, in incremental steps of 2 milliseconds, and (iii) delivery of 10 to 50 milliseconds in incremental steps of 2 milliseconds after the Ra-wave, are applied on alternate beats. [0059] Using the present method, the level of alternans of the selected atrial waveform may be quantified by obtaining the Fast Fourier Transform of the windowed auto-correlation function of a time-aligned sequence of sample points, and then obtaining a measurement of the alternans voltage, noise and the alternans ratio, in one or more electrocardiographic leads. Threshold values of these parameters can be established. For example, the threshold values may include 1.9 microvolts for the alternans voltage and a value of 3.0 for the alternans ratio. Other threshold values may require noise estimates during the alternans estimation to be below a value such as 1.8 microvolts. [0060] Other threshold values may require that the optimal heart rate for the alternans estimation of the selected atrial waveform be, for example, 105 beats per minute or 5-40% above the patient's intrinsic heart rate. This threshold may be applied by pacing (electrical stimulation of the heart), exercise and/or delivery of a chemical (pharmacologic) substance. If pacing is used, the pacing pulse (artifact) may be eliminated by: (i) high-pass filtering of the ECG signal with a cut-off frequency of, for example, 180 Hz; (ii) application of a threshold algorithm on the filtered signal; or (iii) identification of the pacing pulses as the local maxima. [0061] When determining estimates of the alternans voltage or the noise from the power spectrum, respiration may affect the amplitude of one or both of them. Accordingly, the respiration frequency may be monitored and the respiration affect on the amplitude of the power spectrum at the alternans frequency (for example, 0.5 cycles/beat) or the noise-band frequencies may be reduced or eliminated, by requiring the subject to breath at a different and specific breathing pattern, by appropriate filtering of the respiration signal, or by appropriately adjusting the estimation of the alternans voltage and noise, and the like. [0062] The beat-to-beat variability may be manifested as fluctuations of the selected atrial waveform at specific frequencies in the Fast Fourier Transform power spectrum; the amplitude of the Fast Fourier Transform power spectrum at such frequencies is higher (“dominant frequency”) than other frequencies in the spectrum. The Fast Fourier Transform may be obtained on a sequence of time aligned points with respect to fiducial points of the selected atrial waveform (see, for example, FIG. 8 ), such as the peak of the P-wave or the peak of T a -wave. Further analysis of these dominant frequencies may indicate the presence of a site of origin of atrial-rhythm disturbances, or the distance of the site of origin of the atrial-rhythm disturbances from the lead that recorded the specific electrocardiographic waveform. Identification of a dominant frequency may be also used to identify individuals susceptible to abnormal atrial rhythms over the long-term. [0063] Alternatively, the beat-to-beat variability of the selected atrial electrocardiographic waveform may include a measurement of P-to-P interval variability. Reduced heart rate (R v R v ) variability is a well known predictor of the development of ventricular arrhythmias. A threshold value of P-to-P interval variability may be established, such as the standard deviation of normal-to-normal (SDNN) P-to-P interval variability being, for example, equal to 60 milliseconds. When the P-to-P interval variability (estimated from atrial electrical activity recorded from a specific lead), is less than this threshold value for some period of time (for example one minute), then the site of origin of the atrial abnormal rhythm can be determined to be close and/or around that lead and therapy is delivered to eliminate and/or interrupt the atrial-rhythm disturbances. In that case, successful elimination and/or interruption of the atrial abnormal rhythm may be manifested by adjusting to normal the P-to-P interval variability. [0064] FIG. 9 illustrates a system 200 for assessing atrial electrical stability. System 200 includes one or more sensors 202 configured to detect atrial activity of the heart of a subject. Sensors 202 may include one or more electrodes and can be connected to a subject to collect electrical data describing the activity of the heart tissue of the subject. The electrodes may include passive electrodes and may be placed in the atria, pulmonary veins, the coronary sinus, or any other tissue or blood vessels attached to the heart. The electrodes may be in a bipolar configuration for recording localized atrial electrical activity, or in a unipolar configuration for recording remote or global atrial electrical activity. Alternatively, atrial activity data may be collected using catheters similar to those used as part of the atrial fibrillation ablation procedure and the detected signals, following amplification, filtering and conditioning, are used for further analysis. [0065] Sensors 202 may include leads or electrodes of an implanted device such as an implantable cardioverter defibrillator or cardiac pacemaker. The devices may contain micro-processors or other electronic circuitry capable of performing the computations necessary for the measurement. Furthermore, the devices can also serve as a cardioverter defibrillator or pacemaker during the therapy portions of the present method. [0066] In some implementations, sensors 202 are fabricated within a portable ambulatory electrocardiographic device that also continuously monitors the electrical activity of the heart for 24 hours or more (e.g., a Holter monitor). The extended recording period provided by the ambulatory electrocardiographic device may be used to capture and observe occasional cardiac arrhythmias that would be difficult to identify in a shorter period of time. For patients having more transient symptoms, a cardiac event monitor can be used. Unlike the Holter monitor, however, which records continuously throughout the testing period of 24 to 48 hours, the event monitor does not record until one feels symptoms and triggers the monitor to record ECG tracings at that time. [0067] The Holter and the event monitor record electrical signals from the heart via a series of electrodes attached to the chest. The number and position of electrodes may vary, but most monitors employ from three to eight. These electrodes are connected to a small piece of equipment that is attached to the patient's belt, and is responsible for keeping a log of the heart's electrical activity throughout the recording period. On the other hand, the event monitor may wirelessly transmit the recording of the event to a physician or to a central monitoring center. [0068] The electrical signals collected by sensors 202 represent atrial activity data are stored in a computer or other electronic storage medium 204 . In one implementation, the data is stored in a database, or other electronic storage medium on a computer's hard disk. After storage, the data is further processed to determine susceptibility to atrial-rhythm disturbances. [0069] The data stored in storage system 204 are retrieved by computer 206 for analysis. Computer 206 may include a personal computer, file server, workstation, minicomputer, mainframe, or any other computer capable of communicating and interconnecting with other computers. Input devices such as a mouse and/or a keyboard, a monitor, disk drives, memory, a modem, and a mass storage device such as a hard disk drive may be connected to computer 206 . Computer 206 retrieves data from storage system 204 and is configured to implement one or more steps of the present method. For example, computer 206 may include software for retrieving data from storage system 204 and implemented the method illustrated in FIG. 2 or 7 , for example. [0070] Computer 206 is connected to output device 208 for outputting data generated by system 200 . In one implementation, output device 208 includes a display system having a two-screen layout and/or a printer. One screen may display raw ECG signals as they are recorded from multiple sites (i.e. coronary sinus, pulmonary veins . . . ), while the second screen may display visual outputs for real-time estimates of atrial alternans magnitude. [0071] System 200 includes treatment device 210 connected to computer 206 for administrating therapy to a subject. Treatment device 210 may include a mechanism for therapy may include the delivery of a chemical or biochemical substance. The chemical substance may include a pharmacological agent or gene therapy that reduces the likelihood of an atrial-rhythm disturbance from occurring. The substance may be delivered into the blood stream by treatment device 210 or directly at and/or around the tissue site of origin of the atrial-rhythm disturbances. [0072] Alternatively, treatment device 210 includes an implanted device and is configured to generate electrical stimulating pulses of specified energies and apply the pulses to body tissue at specified times and deliver the impulses used for pacing the heart at the appropriate times and energy levels. The delivered therapeutic electrical stimulus may have a minimum energy level similar to that delivered by pacemakers (pacing pulse), and a maximum energy level similar to that delivered by defibrillators (defibrillation shock). The therapeutic electrical stimulus should be delivered outside the vulnerable window wherein ventricular fibrillation may be induced. When there is alternation in the atrial beat duration (the duration of time from the beginning of depolarization to the end of repolarization), the electrical impulse is delivered at a time interval after the end of repolarization in the beats with the shorter beat duration. This time interval is longer than the diastolic interval that follows the beats with the longer beat duration but shorter than the diastolic interval that follows the beats with the shorter beat duration. Adaptive pacing can be employed in such a way that electrical stimuli will be applied on alternate beats during alternans. [0073] While several embodiments have been provided in the present disclosure, it should be understood that the disclosed systems and methods may be embodied in many other specific forms without departing from the spirit or scope of the present disclosure. The present examples are to be considered as illustrative and not restrictive, and the intention is not to be limited to the details given herein. For example, the various elements or components may be combined or integrated in another system or certain features may be omitted, or not implemented. [0074] Also, techniques, systems, subsystems and methods described and illustrated in the various embodiments as discrete or separate may be combined or integrated with other systems, modules, techniques, or methods without departing from the scope of the present disclosure. Other items shown or discussed as coupled or directly coupled or communicating with each other may be indirectly coupled or communicating through some interface, device, or intermediate component, whether electrically, mechanically, or otherwise. Other examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the spirit and scope disclosed herein.

A method for identifying a susceptibility of a subject to atrial-rhythm disturbances includes a) placing a plurality of sensors on the subject to measure a physiologic signal of the subject, and b) recording the physiologic signal from the sensor. The physiologic signal includes an atrial electrical activity of the subject. The method includes c) determining a beat-to-beat variability in the atrial electrical activity of the subject. The beat-to-beat variability includes alternans of electrocardiographic waveforms of a predetermined number of a sequence of heart beats. The method includes d) determining a susceptibility to atrial-rhythm disturbances of the subject using the beat-to-beat variability in the atrial electrical activity determined in step c), and e) generating a report of the susceptibility to atrial-rhythm disturbances of the subject.

BACKGROUND OF THE INVENTION [0001] Many individuals desire a “bright” smile and white teeth, and consider dull and stained teeth cosmetically unattractive. Unfortunately, without preventive or remedial measures, stained teeth are almost inevitable due to the absorbent nature of dental material. Everyday activities such as smoking or other oral use of tobacco products, and eating, chewing or drinking certain foods and beverages (in particular coffee, tea and red wine), cause undesirable staining of surfaces of teeth. Staining can also result from microbial activity, including that associated with dental plaque. The chromogens or color causing substances in these materials become part of the pellicle layer and can permeate the enamel layer. Even with regular brushing and flossing, years of chromogen accumulation can impart noticeable tooth discoloration. [0002] There are a variety of compositions described in the art for preventing or treating the discoloration of teeth. In particular, to combat staining and brighten or restore the natural enamel color, a variety of products containing bleaching materials are commercially available for professional and consumer use. The materials most commonly used in teeth whitening today are peroxides. Peroxides are generally deemed safe from a physiological standpoint, and can be effective to whiten teeth. [0003] Professional dental treatments frequently include a tooth surface preparation such as acid etching followed by the application of highly concentrated bleaching solutions (e.g., up to 37% hydrogen peroxide) and/or the application of heat or light. These procedures provide rapid results, but are expensive, and often require several trips to the dentist. Alternatively, at-home bleaching systems can be used. These systems have gained significant popularity in the past decade because of reduced cost, and increased convenience. Instead of time consuming and frequent trips to the dentist, the tooth whitener is purchased at a consumer retail store and may be easily integrated into the daily hygiene program. At-home treatment methods include whitening strips, abrasive toothpastes, and toothpastes that contain peroxides. These peroxide toothpastes require the use of a dual chamber system that separates the peroxide from other ingredients. If the contents of the two chambers are mixed prematurely, the oxidation activity and whitening benefits are lost. [0004] It would be desirable to provide a whitening oral care composition which promotes consumer compliance and utilizes a single chamber or tube to deliver sufficient amounts of whitening ingredients and other oral care actives without adverse reaction between the ingredients. BRIEF SUMMARY OF THE INVENTION [0005] The invention provides a single phase whitening dentifrice that includes (i) a whitening agent selected from the group consisting of hydrogen peroxide, a bound peroxide and a solid peroxide (ii) an abrasive and (iii) a substantially anhydrous orally acceptable carrier, for example, polyethylene glycol. The bound peroxide may be hydrogen peroxide and a polymer and/or any peroxide compound and a porous cross-linked polymer, such as polymers of polyvinylpyrrolidone, polyacrylates, a polymethacrylates, and a polyitaconates. The solid peroxide may be sodium perborate or urea hydroxide. [0006] The invention also provides methods of whitening the tooth surfaces by contacting the surface with the composition. DETAILED DESCRIPTION OF THE INVENTION [0007] The present invention provides single phase whitening oral care compositions, comprising a peroxide whitening agent; a peroxide incompatible abrasive; and a substantially anhydrous orally acceptable carrier. In various embodiments, the substantially anhydrous orally acceptable carrier and the particular peroxides employed allow for a shelf-stable single tube oral care composition where the peroxide and the peroxide incompatible ingredients, such as abrasives, may be combined. The oral care composition provides highly efficacious whitening and cleaning. [0008] The single phase oral care composition has a “low water” content, meaning that a total concentration of water, including any free water and all water contained in any ingredients, is less than about 4%, about 7% or les than about 10% water. The selection of the whitening agent in conjunction with the low water carrier provides stabilized delivery of the whitening agent. The whitening activity is maintained for application to the tooth or oral surface and is maintained through storage. [0009] Any whitening agent known or developed in the art may be used. Preferably, the whitening agent includes solid whitening agents and bound whitening agents which are substantially anhydrous oxygen generating compounds. Solid whitening agents useful herein include peroxides, metal chlorites, persulfate. Exemplary peroxide phases include hydroperoxides, hydrogen peroxide, peroxides of alkali and alkaline earth metals, organic peroxy compounds, peroxy acids, pharmaceutically-acceptable salts thereof, and mixtures thereof. Peroxides of alkali and alkaline earth metals include lithium peroxide, potassium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, barium peroxide, and mixtures thereof. Organic peroxy compounds include urea peroxide, glyceryl hydrogen peroxide, alkyl hydrogen peroxides, dialkyl peroxides, alkyl peroxy acids, peroxy esters, diacyl peroxides, benzoyl peroxide, and monoperoxyphthalate, and mixtures thereof. Peroxy acids and their salts include organic peroxy acids such as alkyl peroxy acids, and monoperoxyphthalate and mixtures thereof, as well as inorganic peroxy acid salts such as and perborate salts of alkali and alkaline earth metals such as lithium, potassium, sodium, magnesium, calcium and barium, and mixtures thereof. Preferred solid peroxides are sodium perborate, urea peroxide, and mixtures thereof. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. The whitening agent may be preferably bound. For example, peroxide may be bound to a polymer such as PVP (poly(N-vinylpyrrolidone). Suitable PVP complexes are disclosed, for example, in U.S. Pat. No. 5,122,370, the contents of which are incorporated herein by reference. In some embodiments, it may be desirable to use any known whitening agent except sodium percarbonate and/or any of the percarbonate salts. [0010] The compositions of the present invention may include any dental abrasive or combination of dental abrasive agents known or to be developed in the art. “Abrasive” is as used herein is meant to include materials commonly referred to as “polishing agents” as well. Suitable abrasive may include those previously considered to be incompatible in a peroxide containing formulation (“a peroxide-incompatible abrasive”). Such abrasive is one which, in an aqueous solution with hydrogen peroxide, substantially reacts with the hydrogen peroxide so as to reduce whitening efficacy of the solution. [0011] Any orally acceptable abrasive can be used, but preferably, type, fineness (particle size) and amount of abrasive should be selected so that tooth enamel is not excessively abraded in normal use of the composition. Suitable abrasives include without limitation silica, for example in the form of silica gel, hydrated silica or precipitated silica, alumina, insoluble phosphates, calcium carbonate, resinous abrasives such as urea-formaldehyde condensation products and the like. Among insoluble phosphates useful as abrasives are orthophosphates, polymetaphosphates and pyrophosphates. Illustrative examples are dicalcium orthophosphate dihydrate, calcium pyrophosphate, β-calcium pyrophosphate, tricalcium phosphate, calcium polymetaphosphate and insoluble sodium polymetaphosphate. Average particle size of an abrasive, if present, is generally about 0.1 to about 30 μm, for example about 1 to about 20 μm or about 5 to about 15 μm. One or more abrasives are present in an abrasive effective total amount, typically about 0.1% to about 40%. [0012] In various embodiments of the present invention, the oral composition comprises an anticalculus agent. Generally, tartar control agents are categorized as being incompatible with some whitening agents, but embodiments of the present invention incorporate tartar control agents and whitening agents in a single phase whitening composition. Suitable anticalculus agents include without limitation phosphates and polyphosphates (for example pyrophosphates), polyaminopropanesulfonic acid (AMPS), hexametaphosphate salts, zinc citrate trihydrate, polypeptides, polyolefin sulfonates, polyolefin phosphates, diphosphonates. The anticalculus agent is present at about 0.1% to about 30%. The oral composition may include a mixture of different anticalculus agents. In one preferred embodiment, tetrasodium pyrophosphate (TSPP) and sodium tripolyphosphate (STPP) are used. The anticalculus agent comprises TSPP at about 1% and STPP at about 7% to about 10%. [0013] The oral care composition can optionally include at least one orally acceptable source of fluoride ions. Any known or to be developed in the art may be used. Suitable sources of fluoride ions include fluoride, monofluorophosphate and fluorosilicate salts. One or more fluoride ion-releasing compound is optionally present in an amount providing a total of about 100 to about 20,000 ppm, about 200 to about 5,000 ppm, or about 500 to about 2,500 ppm, fluoride ions. [0014] The carrier is preferably low water content orally acceptable carrier and may include any known ingredients or additives. [0015] In preferred embodiments of this invention, the oral composition is a dentifrice. Such dentifrices may include toothpowder, a dental tablet, toothpaste (dental cream), tooth powders, or gel, or any other known form known to one of skill in the art. [0016] The substantially anhydrous carrier may also comprise various dentifrice ingredients to adjust the rheology and feel of the composition such as humectants, surface active agents, thickening or gelling agents, etc. [0017] The compositions of the present invention preferably comprise a surface active agent. Suitable surfactants include without limitation water-soluble salts of C 8-20 alkyl sulfates, sulfonated monoglycerides of C 8-20 fatty acids, sarcosinates, taurates, sodium lauryl sulfate, sodium cocoyl monoglyceride sulfonate, sodium lauryl sarcosinate, sodium lauryl isoethionate, sodium laureth carboxylate and sodium dodecyl benzenesulfonate, and cocoamidopropyl betaine. [0018] The compositions of the present invention optionally comprise a thickener. Any orally acceptable thickening agent can be used, including without limitation carbomers, also known as carboxyvinyl polymers, carrageenans, also known as Irish moss and more particularly ι-carrageenan (iota-carrageenan), high molecular weight polyethylene glycols (such as CARBOWAX®, available from The Dow Chemical Company), cellulosic polymers such as hydroxyethylcellulose, carboxymethylcellulose (CMC) and salts thereof, e.g., CMC sodium, natural gums such as karaya, xanthan, gum arabic and tragacanth, colloidal magnesium aluminum silicate, and colloidal and/or fumed silica and mixtures of the same. One or more thickening agents are optionally present in a total amount of about 0.1% to about 90%, for example about 1% to about 50% or about 5% to about 35%. [0019] In various preferred embodiments, the carrier may comprise polymers and/or copolymers of polyethylene glycol, of ethylene oxide propylene oxide, and of silicone. IF such copolymers/polymers are used, they may be selected from the commercially available materials PLURAFLO® L4370 and PLURAFLO® L1220 (available from BASF, Wyandotte, Mich., United States of America). It is preferred that the carrier(s) provide a dentifrice with a viscosity of about 10,000 CPS to about 700,000 CPS, preferably about 30,000 CPS to about 300,000 CPS. [0020] As recognized by one of skill in the art, the oral compositions of the present invention optionally include other materials, such as for example, anti-caries agents, desensitizing agents, viscosity modifiers, diluents, surface active agents, such as surfactants, emulsifiers, and foam modulators, pH modifying agents, abrasives, in addition to those listed above, humectants, mouth feel agents, sweetening agents, flavor agents, colorants, preservatives, and combinations thereof. It is understood that while general attributes of each of the above categories of materials may differ, there may be some common attributes and any given material may serve multiple purposes within two or more of such categories of materials. Preferably, the carrier is selected for compatibility with other ingredients of the composition. [0021] Flavorants, sweeteners, colorants, foam modulators, mouth-feel agents and others additively may be included if desired, in the composition. [0022] The compositions of the present invention optionally comprise one or more further active material(s), which is operable for the prevention or treatment of a condition or disorder of hard or soft tissue of the oral cavity, the prevention or treatment of a physiological disorder or condition, or to provide a cosmetic benefit. [0023] The compositions may include a stannous ion or a stannous ion source. Suitable stannous ion sources include without limitation stannous fluoride, other stannous halides such as stannous chloride dihydrate, stannous pyrophosphate, organic stannous carboxylate salts such as stannous formate, acetate, gluconate, lactate, tartrate, oxalate, malonate and citrate, stannous ethylene glyoxide and the like. One or more stannous ion sources are optionally and illustratively present in a total amount of about 0.01% to about 10%, for example about 0.1% to about 7% or about 1% to about 5%. [0024] The compositions of the present invention optionally comprise an antimicrobial (e.g., antibacterial) agent. A further illustrative list of useful antibacterial agents is provided in such as those listed in U.S. Pat. No. 5,776,435 to Gaffar et al., the contents of which are incorporated herein by reference. One or more antimicrobial agents are optionally present in an antimicrobial effective total amount, typically about 0.05% to about 10%, for example about 0.1% to about 3%. [0025] The compositions of the present invention optionally comprise an antioxidant. Any orally acceptable antioxidant can be used, including butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, herbal antioxidants, chlorophyll, melatonin, and mixtures thereof. [0026] The compositions of the present invention optionally comprise a sialagogue or saliva-stimulating agent, an antiplaque agent, an anti-inflammatory agent, a desensitizing. [0027] Methods are provided to whiten an oral surface in a human or animal subject comprising storing in stable form a whitening oral care composition comprising a peroxide whitening agent, a peroxide incompatible abrasive, and a substantially anhydrous and a substantially anhydrous orally acceptable carrier; and contacting said composition with the oral surface. As used herein “animal subject” includes higher order non-human mammals such as canines, felines, and horses. The oral care composition is contacted with an oral surface of the mammalian subject to thereby whiten teeth in a highly efficacious manner, without any negative interaction between the whitening agent, the peroxide incompatible abrasive, and other ingredients. [0028] In various embodiments, it is preferred that the oral care composition is applied and contacted with the oral surface. The dentifrice, prepared in accordance with the present invention is preferably applied regularly to an oral surface, preferably on a daily basis, at least one time daily for multiple days, but alternately every second or third day. Preferably the oral composition is applied to the oral surfaces from 1 to 3 times daily, for at least 2 weeks up to 8 weeks, from four months to three years, or more up to lifetime. [0029] The invention is illustrated in the following non-limiting examples. EXAMPLES Comparative Example I [0030] A comparative, non-abrasive containing single phase dentifrice is prepared by mixing the ingredients of Table 1. After aging the dentifrice for two weeks at approximately 49° C., the peroxide recovery was 89% of the initially present amount. TABLE 1 Ingredients Weight Percentage Cross-linked polyvinyl pyrrolidone - 16.50 hydrogen peroxide complex Polyethylene Glycol/Ethylene Oxide Block 42.44 Copolymer (PLURAFLO ® L4370) Ethylene Oxide/Propylene Oxide Block 25.00 Copolymer (PLURAFLO ® L1220) Silicone fluid 5.00 Saccharin 0.42 Flavor 1.20 Tetrasodium pyrophosphate 1.00 Sodium tripolyphosphate 7.00 Sodium fluoride 0.24 Sodium lauryl sulfate 1.20 TOTAL 100.00 Example 1 [0031] A single phase dentifrice was prepared by mixing the ingredients of Table 2. A peroxide incompatible silica abrasive is included at 12.44% and increases the cleaning and whitening benefits of the dentifrice. After aging the dentifrice for two weeks at approximately 49° C., the peroxide recovery was 77% of the initially present amount. TABLE 2 Ingredients Weight Percentage Cross-linked polyvinyl pyrrolidone - 16.50 hydrogen peroxide complex Polyethylene Glycol/Ethylene Oxide Block 30.00 Copolymer (PLURAFLO ® L4370) Ethylene Oxide/Propylene Oxide Block 25.00 Copolymer (PLURAFLO ® L1220) Silicone fluid 5.00 Saccharin 0.42 Flavor 1.20 Tetrasodium pyrophosphate 1.00 Sodium tripolyphosphate 7.00 Sodium fluoride 0.24 Silica abrasive 12.44 Sodium lauryl sulfate 1.20 TOTAL 100.00 [0032] The examples and other embodiments described herein are exemplary and not intended to be limiting in describing the full scope of compositions and methods of this invention. Equivalent changes, modifications and variations of specific embodiments, materials, compositions and methods may be made within the scope of the present invention, with substantially similar results.

The invention provides a single phase whitening dentifrice that includes (i) a whitening agent selected from the group consisting of hydrogen peroxide, a bound peroxide and a solid peroxide (ii) an abrasive and (iii) a substantially anhydrous orally acceptable carrier, for example, polyethylene glycol. The bound peroxide may be hydrogen peroxide and a polymer and/or any peroxide compound and a porous cross-linked polymer, such as polymers of polyvinyl pyrrolidone, polyacrylates, a polymethacrylates, and a polyitaconates. The solid peroxide may be sodium perborate or urea peroxide. The invention also provides methods of whitening the tooth surfaces by contacting the surface with the composition.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] This invention relates to an exercise device utilizing a resistance element for development of muscular strength, size and endurance. [0003] 2. Description of Background and Relevant Information [0004] Exercise devices for muscular strength training typically employ resistance elements utilizing a gravitational mass or resilient materials. Exercise devices utilizing a gravitational mass resistance element exhibit the highly desirable characteristic of providing a constant resistance force throughout the range of exercise movement. However, the high weight of a gravitational resistance element causes considerable difficulties in shipping and on site mobility of the exercise device. Resilience based exercise machines such as the Bowflex™ (U.S. Pat. No. 4,620,704) and Soloflex™ (U.S. Pat. No. 4,587,320) therefore dominate the direct sales market. [0005] Exercise devices based on resilient materials, although light, suffer from the problem of a varying resistance force. Resistance increases progressively during the exercise stroke as the elongation or compression of the resilient medium increases. A resistance too low for maximal muscular development occurs over most of the exercise stroke. Designs to convert a resilient resistance to constant force are often complicated (U.S. Pat. No 5,382,212). Other designs fail to adequately deal with the large ratio of force possible with a resilient element with zero initial resistance. [0006] Adjustment of the exercise force is a crucial factor in the success of strength training devices. Resistance should be adjustable to accommodate different exercises and users. Users also need to increase resistance over time for an exercise movement as strength develops. Most resilient exercise machines, such as the Bowflex™ and Soloflex™, allow resistance to be changed by selectively engaging different resistance elements, or by adding resistance elements in parallel. Adjusting resistance in this way is time consuming and only permits resistance changes in fixed increments, usually 5 lbs at a time. Tension must be removed from the resistance elements to effect the change, so the exercise stroke begins at a minimal resistance level. [0007] Another method of adjusting resistance of a resilient resistance involves varying the force attachment point along a lever arm (U.S. Pat. No. 3,638,941). Lever arm arrangements suffer from a few problems. First, the lever arm modifies the input resistance force according to a cosine function. This results in greatest force transmission when the level position is perpendicular to the input force, and lower forces elsewhere along the arc of the lever arm. Second, lever arms are not space efficient. [0008] An exercise device that solves these problems efficiently could be produced at lower cost, allowing more consumers to experience the benefits of strength training and muscular development. An easy to use mechanism for adjusting resistance force can reduce workout times and increase opportunities for strength progression. Constant force allows a user to perform more exercise work during a stroke. BRIEF DESCRIPTION OF THE INVENTION [0009] The invention is an exercise machine containing a rotary force transmission device that compensates for the varying force of a resilient resistance and also allows adjustment of output resistance force of the resilient resistance. The force transmission device combines an eccentric cross section that compensates for the increasing resistance of a spring, with a conical shape that allows selection of the effective size of the eccentric. A moveable mounting point allows the position of force attachment to be selected without affecting the total working length of the flexible force transmission cables. Adjustment can be accomplished with minimum force and without introducing slack into the force transmission system. A pre-biased resistance element allows the system to deliver a constant output force. OBJECTS AND ADVANTAGES [0010] It is an object of the invention to compensate for the increasing force of a resilient resistance during compression or tensioning movements, so as to produce a more constant output force. [0011] It is an object of the invention to provide a simple mechanism for adjusting the output force delivered to the user from a single fixed resistance, without introducing unwanted modifications to the force such as a cosine multiplier. [0012] It is an object of the invention to provide an infinitely adjustable output force of the system. [0013] An advantage of the invention is that the working length of the flexible transmission mechanisms used in the machine is constant with no problems of slack management. It is an object of the invention to achieve these goals in a simple machine, with a minimal part count, that is inexpensive to manufacture. [0014] An advantage provided by the simple structure of the invention is that frictional losses are minimized, so negative exercise movements receive a high force relative to positive movement effort. [0015] It is an object of the invention to allow selection of force output from a single resilient resistance and without requiring the resilient resistance to be in a zero tension state. BRIEF DESCRIPITION OF THE DRAWINGS [0016] [0016]FIG. 1—An isometric view of the preferred embodiment of the device. [0017] [0017]FIG. 2—Side and front views of the eccentric cone of the force transmission system. [0018] [0018]FIG. 3—Side and front views of a circular cone and eccentric pulley. [0019] [0019]FIG. 4—Side and front views of a circular cone and pulley. [0020] [0020]FIG. 5—Side and front views of the force attachment device and channel. [0021] [0021]FIG. 6—Top view of force selection controlled remotely by cable. [0022] [0022]FIG. 7—Top view of force selection controlled remotely by selector fork. [0023] [0023]FIG. 8—Top view of force selection controlled remotely by interlocking cones. [0024] [0024]FIG. 9—Graph of work performed during stroke with typical spring machine. [0025] [0025]FIG. 10—Graph of work performed during stroke with the invention. REFERENCE NUMERALS IN DRAWINGS [0026] [0026] 10 Frame [0027] [0027] 12 Vertical track member [0028] [0028] 14 Grip attachment rack [0029] [0029] 16 Hand grip [0030] [0030] 17 Pull down bar [0031] [0031] 18 Stabilizing base plate [0032] [0032] 30 User force transmission cable [0033] [0033] 32 Resistance force transmission cable [0034] [0034] 34 Resistance force attachment mount [0035] [0035] 35 Crimp clamp [0036] [0036] 36 Pulley [0037] [0037] 40 Eccentric cone [0038] [0038] 42 Cone pulley [0039] [0039] 44 Cone axel [0040] [0040] 46 Fixed size eccentric pulley [0041] [0041] 48 Circular cone [0042] [0042] 50 Spring [0043] [0043] 52 Spring retention endplate [0044] [0044] 54 Spring tension retainers [0045] [0045] 60 Channel track [0046] [0046] 61 Cable sheath [0047] [0047] 62 Force adjustment cable [0048] [0048] 63 Torsion reel spring [0049] [0049] 64 Selector fork [0050] [0050] 65 Selector guide [0051] [0051] 66 Selector control rod [0052] [0052] 67 Interlocking ribbed code DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0053] The preferred embodiment of the present invention is shown in FIG. 1. A frame 10 provides a structure to support tension or compression of a resilient exercise resistance 50 . The frame is mounted on a stabilizing base plate 18 . The base plate is further stabilized by the user's weight during use. A vertical track member 12 is attached to the frame. A grip attachment rack 14 moves along the vertical track member. The grip attachment rack can only move vertically. Rollers or bushings in the grip attachment rack reduce friction with the vertical track member. The grip attachment rack contains numerous holes to allow insertion of a hand grip 16 at different points, for different sized people and exercises. A second plate internal to the grip attachment rack contains matching holes, and fixes the hand grip in a horizontal plane. Detents in the hand grip at the point of insertion prevent accidental removal under load. Different styles of grips and user interface elements, such as shoulder pads for squats, can replace the basic hand grip. [0054] A pulldown bar 17 is mounted to allow chinning and other downward stroke exercises. The pulldown bar is attached to a user force transmission cable 30 . This cable runs over pulleys 36 and attaches to the grip attachment rack. The user force transmission cable is further routed through additional pulleys to the large cone pulley 42 . The cone pulley is connected directly to the eccentric cone 40 , and both revolve around an axel 44 inserted laterally into the frame. [0055] The eccentric cone contains an embedded channel track 60 , which allows a resistance force attachment mount 34 to slide laterally along the edge of the cone. The resistance force attachment cable 32 is connected to the force attachment mount and the resistance spring. The eccentric cone tapers from an outer diameter matching the cone pulley to a small diameter. Lateral movement of the attachment mount in the track allows selection of the user's effective leverage from 1:1 to high values. The attachment mount moves laterally with ease under resting slack conditions. Tension in the system applies torsion to the mount, preventing changes to the selected leverage under working conditions. The slide track may have periodic detents and a measure scale to provide positive confirmation of a selection points along the track. [0056] User exercise force and motion is conducted to the cone pulley producing rotation of the cone pulley and eccentric cone. Resistance to the eccentric cone's rotation occurs as the force resistance cable winds around the eccentric cone. The cone pulley is sized at about 12 inches in diameter. Thus a typical exercise movement, requiring withdrawal of 2 to 3 feet of cable, produces less than one rotation of the cone pulley. The eccentric pulley is shaped so that as it rotates, the effective diameter also shrinks. This compensates for an increase in force due to increasing compression of the resistance spring. [0057] To produce a constant exercise resistance, the decrease in radius occurring for a cross section of the eccentric cone can be matched to the spring characteristics. The resistance spring in the preferred embodiment is initially pre-compressed between two spring retention endplates 52 . The endplates are connected together by spring tension retainer 54 rods. The retainer rods prevent expansion of the spring end plates but allow further compression and constrain the compression path. The resistance force transmission cable is connected to one end plate and passes through a guide hole in the other before attaching to the force attachment mount on the eccentric cone. Assuming the spring tension increases 100% from initial tension to maximum excursion caused by a full rotation of the eccentric cone, the eccentric cone's effective diameter should be sized to shrink 50% to compensate. Initial spring resistance will determine maximum output resistance at the 1:1 selection setting, so an initial resistance of 200-300 lbs will work well for most users. Additional pulleys could or a smaller cone diameter be used to reduce the spring compression stroke, in order to allow a reduction in spring size. [0058] [0058]FIG. 2 shows a close up of the eccentric cone with force transmission points illustrated. The length of the eccentric cone should be at least 150% of the diameter of the cone pulley. This length minimizes unintended changes in resistance output due to the resistance force transmission cable wrapping across, or slipping down, the cone. Use of plastic or resin materials allows economical manufacture of the eccentric cone and cone pulley by molding processes. FIG. 3 shows an alternate form of the force transmission cone, with a circular cross section cone 48 and an eccentric cone pulley element 46 . The eccentric pulley element increases in radius as rotation increases from the start position. FIG. 4 shows an alternate form of the force transmission cone, with a constant diameter cone and pulley. This embodiment would be useful for varying resistance of a fixed but constant force resistance, such as a vacuum cylinder or fixed weight. [0059] [0059]FIG. 5 shows a close up side and front view of the resistance force attachment mount. The mount is enclosed within a C shaped channel track, which allows lateral movement within the channel. The force transmission cable runs through a hole in the force attachment mount and is secured with a compression crimp clamp 35 . The attachment mount may be equipped with a handle to assist direct force selection by the user. [0060] Remote selection of the lateral position of the force transmission mount may be desirable for convenience or to minimize user exposure to the working elements. FIG. 6 depicts a top view of the eccentric cone, and a means of remotely controlling the position of the force attachment mount via a cable 62 running in a sheath 61 . The cable enters through the axel, allowing the cable to accept twisting without involvement of the sheath. The cable connects to the force attachment mount. A torsion reel spring 63 returns the force attachment mount to the far position if the user relieves tension on the cable. [0061] [0061]FIG. 7 shows a top view of a mechanism for controlling the force attachment mount with a selector fork 64 . The selector fork moves laterally along a selector guide 65 rail. The position of the force attachment mount is maintained between the tines of the fork. The fork can be cam shaped and mounted on a pivot, to allow continued engagement during rotation of the eccentric cross section. The selector fork is moved remotely via a selector control rod 66 attached to the fork. [0062] [0062]FIG. 8 shows a top view of a selection mechanism having two steeply tapering cones, where the force attachment point will be drawn to the intersection of the two cones by tension or a torsion reel spring. The cones can overlap because they aren't solid, but are constructed of offset, interlocking ribs. One of the cones can move laterally on the axel, with its position controlled by a selector rod. These cones can also be eccentrically shaped. [0063] [0063]FIG. 9 shows the work (integral of force over distance) performed during a exercise stroke with the resilient exercise devices that dominate the market currently. Work is constrained by the low initial starting resistance and the maximum force the user can deliver. FIG. 10 shows the increased work performed during a stroke with the invention. Resistance can be delivered at the user's maximum tolerated force throughout the repetition. Increased exercise workload translates into increased exercise effectiveness. SUMMARY: RAMIFICATIONS AND SCOPE [0064] Accordingly, significant improvements in exercise machine performance can result from use of the invention. The invention will allow use of a single fixed input resistance to produce a continuously selectable output force. Resistance selection can be quickly accomplished with minimum effort. Resistance level is easily changed, even for a resilient resistance biased to produce significant initial output force. The invention compensates for the progressive force characteristic of a resilient resistance over an exercise movement. A constant output force feels natural and maximizes the work performed by a user's muscles. The design of the invention minimizes problems of slack management within the machine. The simple design of the machine can allow low cost manufacture and distribution, increasing the penetration of strength training products in the market and increasing availability for lower income consumers. [0065] Although the descriptions above contain many specificities, these should not be construed as limiting the scope of the invention, but merely as providing illustrations of the some of the presently preferred embodiments of the invention. Thus the scope of the invention should be determined by the appended claims and their legal equivalents, rather than by the examples given.

An exercise machine that outputs constant force from resilient resistances and allows continuously selectable levels of strength training resistance. The machine consists primarily of a pre-biased resistance element ( 50), a conical pulley structure with eccentric cross section ( 40), an axially adjustable force attachment point ( 34) and a frame ( 10). Flexible force transmission elements ( 30) conduct force to the user interface elements ( 16, 17) via pulleys ( 36).

This is a continuation of application Ser. No. 08/225,797, filed Apr. 11, 1994, now abandoned, which is a continuation of application Ser. No. 08/072,122 filed Jun. 7, 1993, now abandoned. BACKGROUND OF THE INVENTION 1. Technical Field This invention relates to a treatment for stress in livestock, and more particularly to a product and method for successfully drenching rumen animals having symptoms of neurological stress, optimum stress or psychological stress caused by such factors as transportation, weather conditions, nutrient imbalance because of ration changes or geographic changes, and working the animals. 2. Description of the Prior Art The livestock industry of the present day is spread over a vast geographical area, extending literally from coast to coast. Because of this, it is becoming less common to find cattle raising operations and finishing and slaughter processing facilities close to one another. Therefore, transportation of livestock over large distances has become increasingly common. Such transport from one area of the United States to another can often take up to 36 hours, during which time livestock in the vehicle have no way to get water or feed for themselves. This induces great amounts of stress in the livestock. The net result is that livestock arriving at finishing facilities do so having all degrees of adequate and inadequate nutrition and consequently nutrient levels of the tissues. Furthermore, this shipping and handling stress comes at a most inopportune time, specifically, during “lot adaptation”, the period of least resistance to disease and parasites and the period in the feeding program when the animals are challenged to create an immune response to build immunity to protect them during the remaining feeding period. The end result is that this “lot adaptation” time has the highest incidence of disease and other livestock health problems. There is therefore a need for a livestock treatment product and method which will substantially reduce livestock losses due to problems encountered during this time period. Additionally, shipping and handling stress can and usually does result in diminished appetite among the transported livestock. As the livestock must eat and drink to replenish lost minerals and energy to successfully combat disease and other such health problems, getting the just-transported livestock to the feed bunk as soon as possible after transport is very important. There is therefore a need for a method and product which will induce livestock to feed as soon as possible following transport. Also, it is important that the livestock replenish the liquids lost during transport, and thus the livestock's thirst must also be stimulated. The quicker the animal recovers from its stress, the quicker the animal may resume feeding and drinking, and thus the animal's susceptibility to disease and parasitical infection may be returned to near-normal levels. However, merely stimulating the thirst and appetite of the livestock is not always sufficient to prevent the animal from being infected or to reenergize the animal's immune system. For this purpose, there is a need for a treatment product which will replace minerals and vitamins lost by the livestock during transport. However, while the use of both water and fat-soluble vitamins as replacements is fairly well known, it is also understood that replacement of lost minerals by introduction of trace minerals into the livestock is not the most efficient or effective method of replacement of minerals. This is because trace minerals are not easily absorbed by the digestive system of the livestock, in many instances having a bio-availability in the animal's systems of only 15%-20%. However, if instead of trace minerals, amino acid chelated minerals are used, such minerals are absorbed intact via active transportation through the intestine, thus allowing the essential minerals to be used intercellularly as needed in vital metabolic reactions. In many instances, use of an amino acid chelated mineral can increase bio-availability of the mineral to the system of the animal to greater than 90%. There is therefore a need for a treatment product which combines the advantages of vitamin replacement with the absorption advantages of chelated minerals and further includes a stress-reducing element. Therefore, an object of the present invention is to provide an improved method and product for reducing neurological stress, optimum stress and/or physiological stress in livestock. Another object of the present invention is to provide a livestock treatment product which will considerably reduce the length of, and amount of, lot adaptation stress. Another object of the present invention is to provide a livestock treatment product which includes chelated minerals to quickly and efficiently replace minerals lost by livestock during transport. Another object of the present invention is to provide a method of preparing a livestock treatment product including as major ingredients molasses, water, ethyl alcohol and chelated minerals and as minor ingredients, at least a vitamin mix, wherein the method includes the steps of mixing the ethyl alcohol and water separately, then adding each of the other ingredients to the initial mixture and then mixing until homogeneous. Another object of the present invention is to provide a method of treating livestock to reduce livestock adaptation stress wherein the method includes the step of administering to livestock a treatment product as described above. Another object of the present invention is to provide a product for treating livestock which includes ethyl alcohol to reduce stress in livestock. Finally, an object of the present invention is to provide a method and product for treating stress in livestock which is relatively inexpensive to manufacture and is safe, convenient and effective in use. SUMMARY OF THE INVENTION A method of preparing a product for treating livestock comprises mixing ingredients including molasses, water, ethyl alcohol and chelated minerals and at least a vitamin mix. In accordance with the method, the ethyl alcohol and the water are mixed together, after which each of the other ingredients is separately added to the mix. The combination is then mixed until homogenous to provide a liquid treatment, which, when introduced into livestock, will reduce considerably the length of, and amount of, adaptation stress. The product of the present invention is a generally homogenous mixture of at least the following ingredients: water, ethyl alcohol, molasses, chelated minerals and a vitamin mix. Water makes up about 10%-50% of the mixture by weight, ethyl alcohol makes up about 3%-25% of the mixture by weight, molasses makes up about 20%-65% of the mixture by weight, chelated minerals make up about 1%-10% of the mixture by weight and vitamin mix makes up about 0.01% to 2% of the mixture by weight. When this product, prepared as previously described, is administered to livestock following arrival of the livestock in a new lot, lot stress is significantly reduced, and the animals are more quickly returned to a state of normalcy, thus reducing the instances of illness and death. DESCRIPTION OF THE PREFERRED EMBODIMENT The major ingredients of the product of the present invention are water, ethyl alcohol, molasses, chelated minerals and a vitamin mix. The amount of water in the product may vary from about 10% to about 75% by weight of the composition. The amount of ethyl alcohol may vary from about 3% to about 25% by weight of the composition. The amount of molasses can vary from about 20% to about 65% by weight of the composition. The amount of chelated minerals can vary from about 1% to about 10% by weight of the composition, and the amount of vitamin mix can vary from about .01% to about 2% by weight of the composition. It is preferred that the molasses be black strap cane molasses, as this type of molasses is an excellent carrier for the other ingredients in the mixture and is also palatable to livestock. While the preferred embodiment of the present invention is described in connection with black strap cane molasses, it is to be understood that various other kinds of molasses may be substituted for the black strap cane molasses used in the present invention. Similarly while any grain alcohol, synthetic ethanol or other alcohol with or without suitable denaturants can be used, it is preferred that ethyl alcohol be used to provide an immediate energy source for the livestock being administered to. An example of a desirable ethyl alcohol is formula SDA (special denatured alcohol) 35-A (Alcohol Tabacco Tax Division, Internal Revenue Service U.S. Treasury Department). Such an ethyl alcohol is the preferred choice as it may be absorbed immediately from the alimentary canal without the necessity of undergoing digestion, thus providing an immediate rich energy source. The vitamin mix, as is preferred for processing, can be divided into a fat soluble mix portion including such vitamins as A, D and E and a water soluble vitamin portion including such vitamins as thiamin B1, choline, riboflavin B2, niacin, pantothenic acid, pyridoxine B6, folic acid, biotin, and vitamin B12. An important element of the present invention is that trace minerals are not used, except those occurring naturally in other ingredients of the present composition and possibly selenium. Instead, it is preferred that a selection of chelated minerals be added to the product of the present invention. These include amino acid chelates of zinc, copper, magnesium, potassium and manganese, in addition to other amino acid chelates such as iron, phosphorous and cobalt which may or may not be added to the product of the present invention. Livestock's supply of minerals may be depleted during transport of the livestock, minerals which are necessary for proper immune system function. Therefore, it is vitally important to replace these minerals as quickly and efficiently as possible. Inorganic trace minerals generally have a bio availability to the livestock of about 17 to 18%. This means that over 80% of the minerals administered to livestock following transport are wasted. A metal amino acid chelate such as contemplated for use in the present invention is the product resulting from the reaction of a metal ion from a soluble metal salt with amino acids. In such a stable metal amino chelate, the metal or mineral is attached to two amino acids forming low molecular double heterocyclic rings. In this unique chelated state, the metal is protected by the amino acids and is not precipitated as minerals from salts. Therefore, as a stable amino acid chelate, the chelate is not ionized in the gut as trace minerals are, but is absorbed intact via a different pathway. As long as these amino acid chelates are smaller than dipeptide molecules, the metal or mineral contained within the chelate may be “smuggled” into the intestinal cells as part of dipeptide molecules. As stabilized amino acid chelates enter the lumen they can be absorbed anywhere on the small intestine. Most of this absorption occurs below the pancreatic duct and is completed in the upper third of the small intestine. The use of such metal amino acid chelates as substitutes for trace minerals used in other livestock treatments has several advantages. Intestinal absorption is more rapid when using amino acid chelates than minerals from salts. Second, the uptake of amino acid chelates is greater because there is no longer the need for a critical environment. Their absorption is not dependent upon the gut. Third, due to the better and more predictive mineral absorption, amino acid chelates produce less intestinal track side effects, such as irritation, constipation, and diarrhea. In fact, absorption of minerals into the animal's blood stream can be increased from two to five times that possible in using ordinary trace minerals, which are most often metal salts. The combination of water, ethyl alcohol, molasses, chelated minerals and a vitamin mix is thus unique and heretofore unknown in the prior art. As the main object of the present invention is to quickly and efficiently return livestock after transport to a normal condition, each of the ingredients has been selected to operate as quickly and efficiently as possible. The ethyl alcohol has been chosen to provide an immediate energy source which will help livestock to get to the feed bunk and begin eating in a short period of time. The chelated minerals may be absorbed into the livestock's blood stream with greater efficiency than was previously possible in using trace minerals, thus reducing the amount of minerals which must be ingested to replace those minerals lost by the livestock. Additionally, the molasses provides an ideal carrying agent for suspending all of the ingredients of the present product such that ingredients will not separate out during the time the product is not being used. Shown below is one preferred embodiment of the product of the present invention. The water, ethyl alcohol, vitamin mixes and cane molasses have been previously discussed, and the chelated minerals are represented by the “Nutra Sol Base” and “Mg/K Base”. TABLE 1 INGREDIENT WEIGHT (LBS.) PERCENT BY WEIGHT H 2 O 635.49 31.77 Ethyl Alcohol (190 proof) 240.00 12.00 Clay 30.00 1.50 Salt 50.00 2.50 Nutra Sol Base 40.00 2.00 (Cu, Zn, Mn) Mg/K Base 35.00 1.75 B Complex .42 .02 Vitamins A, D, E 3.31 .17 Cane Molasses 839.98 42.00 Ammonium Polyphosphate 124.00 6.20 Selenium 1.77 .09 Vitamin E .02 .00 “Nutra Sol Base” and “Mg/K Base” are chelated mineral products produced by Albion Laboratories of Clearfield, Utah, providing, respectively, amino acid chelates of copper, zinc and manganese and amino acid chelates of magnesium and potassium. Any replacement source of amino acid chelates may be substituted, however. Clay is provided in the product to act as a further suspension agent to assist the molasses in keeping all of the ingredients of the product homogeneously mixed. Both salt and ammonium polyphosphate have been added in accordance with Alcohol, Tobacco and Firearms Department regulations, which do not allow simple combination of molasses and ethyl alcohol. Additionally, the salt and ammonium polyphosphate provide nitrogen and phosphorous to assist in replacing those minerals. It is to be understood that any similar provider of nitrogen and/or phosphorous may be substituted for the salt or ammonium polyphosphate, in accordance with Alcohol, Tobacco and Firearms regulations. Finally, selenium, which is not a chelated mineral, is added to provide additional minerals for livestock. The amount of selenium present in the product is limited through regulation and thus may be changed or even eliminated depending on the use for which the product is intended. It is preferred that the product of the present invention be prepared by mixing the ethyl alcohol, clay suspension agent, and water for a total of approximately 5 minutes. The remaining ingredients are then added one at a time and all 12 ingredients are then mixed for a total of approximately 15 minutes. During this process, it is contemplated that the mixer be rotated continually at approximately 1,000 rpm. Most of the ingredients are put into the mixer at a fairly fast pace, except the molasses which flows into the mixer more slowly than the other parts of the formula. It is estimated that total time from start to finish for the product to attain homogeneity is approximately 30 minutes. The synergistic result of this method is that the product may be used to significantly reduce livestock stress during weaning and adapting to new feedlot and feeding environments. This alleviation of the stress results in animals going on feed faster, improved performance, less repeat treatments and reduced death loss. An important goal of the present invention is to allow a user of the invention to administer a dosage of the product and have a favorable response from livestock within 96 hours following the administration. While it is contemplated that the product of the present invention may be used as a feed supplement or as a top dressing for feed, it is preferred that the present invention be administered directly to livestock as a drench. In the preferred embodiment, a dosage of the product would be placed into a throat injecting device, and administered in the following manner. The livestock's mouth is opened, and the throat injection apparatus is inserted into the animal's mouth with the injection opening pointing down the animal's throat. The product of the present invention is then dispensed into the animal's throat and thus directly into the animal's digestive tract. No actual injection of the product, meaning penetration of flesh, takes place. This is the preferred method of application, as the dosage of the product may be precisely controlled and the animal may be treated without having to wait for the animal to feed. One of the disadvantages found in the prior art is that many of the products of the prior art designed to alleviate stress rely on the animal to feed to receive a dosage of the prior art product. However, one of the main problems encountered in transporting animals is loss of the animal's appetite. Therefore, if administration of treatment is intended to restore the animal's appetite, but treatment of the animal is accomplished by waiting for the animal to feed, it would seem that the intended treatment to induce appetite is administered too late, after the animal has already regained its appetite. As it is important to get the animal to the feed bunk as soon as possible after transport, administration of a stress-relieving treatment by the method described above in connection with the present invention is preferable. An additional feature of the present invention is that it may be administered using presently available drenching equipment, as the present product is in liquid form. It is to be understood that the present invention is not only designed to alleviate stress resulting from shipping and handling of livestock, but also stress resulting from any other operation involving livestock, such as dehorning, castration, or any other similar traumatic experience. The present invention thus provides a substantial improvement over the prior art. The use of molasses and ethyl alcohol in combination results in a rich and efficient energy source being introduced into the livestock's system. Furthermore, the use of chelated minerals in connection with the above ingredients leads to a much higher degree of bioavailability of minerals to the animal's system, thus resulting in a much quicker and more efficient absorption of minerals. The vitamin mix meets and in some cases exceeds the animals needs, and as has been shown, increased levels vitamins can contribute to stimulation of the immune system. The increased bioavailability of minerals due to the use of chelated minerals also contributes to proper immune system function. In combination, then, the above ingredients can significantly reduce stress in 24 to 96 hours following administration thereof, thus resulting in animals going on feed faster, improved performance, less repeat treatments and reduced death loss. It is to be understood that numerous modifications and substitutions may be made to the present invention. For example, various kinds of molasses may be used, and additional chelated minerals may be added to the product of the present invention, such as ion, phosphorous, or cobalt. It is intended that the scope of the invention be broad enough to cover any such substitutions, the scope of the invention defined and set forth in the claims which shall follow. There has thus been described and presented an invention which accomplishes at least all of the stated objectives.

A method of preparing a product for treating livestock comprising providing as ingredients molasses, water, ethyl alcohol, chelated minerals, and at least a vitamin mix. The method includes the steps of mixing the ethyl alcohol and water first, then adding each of the remaining ingredients separately to the mixture of ethyl alcohol and water. The composition is then mixed until homogeneous to provide a liquid treatment which, when introduced into livestock, will reduce considerably the length of, and amount of, lot adaptation stress.

CROSS-REFERENCE TO RELATED APPLICATIONS Not Applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH Not Applicable BACKGROUND OF THE INVENTION Arterial blockages, which are also called stenosis, lesions, stenotic lesions, etc, are typically caused by the build-up of atherosclerotic plaque on the inside wall of an artery. In fact, several such stenoses may occur contiguously within a single artery. This can result in a partial, or even complete, blockage of the artery. As a result of the danger associated with such a blockage, several methods and procedures have been developed to treat stenoses. One such method is an angioplasty procedure which uses an inflatable balloon to dilate the blocked artery. A typical inflatable angioplasty device, for example, is disclosed in U.S. Pat. No. 4,896,669. Angioplasty balloons have enjoyed widespread acceptance in the treatment of stenoses. Recent studies, however, have indicated that the efficacy of the dilation of a stenosis is enhanced by first, or simultaneously, incising the material that is creating the stenosis. Consequently, recent developments have been made to equip angioplasty balloons with cutting edges, or atherotomes, which are intended to incise a stenosis during the dilation procedure. For example, U.S. Pat. Nos. 5,196,024; 5,616,149 and 5,797,935, the entire contents of each of which are incorporated herein by reference, respectively describe an inflatable angioplasty balloon having a number of atherotomes mounted longitudinally on the surface of the balloon. Upon inflation of the balloon, the atherotomes induce a series of longitudinal cuts into the surface of the stenotic material as the balloon expands to dilate the stenosis. As a result of such cuts, the stenosis is more easily dilated, and the likelihood of damaging the artery during dilation is reduced. Blades in many existing cutting balloon assemblies tend to be fairly rigid, particularly in the axial direction. The rigid axial structure of the blade naturally limits the blades ability to elongate with the underlying balloon material during balloon expansion at high pressure. As a result, stress between the comparatively axially rigid blade and the elongating balloon may lead to stress therebetween. This stress can lead to de-lamination of the blade and/or adhesive from the balloon. The effect of balloon elongation is more pronounced in larger diameter balloons than in smaller diameter balloons, and is further amplified in longer balloon lengths as well. As such, it has been necessary, particularly in larger vessel applications, to limit the materials of blade equipped balloons to those that are fairly stiff such as PET, PEN, etc. in order to minimize axial elongation. Existing blades also tend to be fairly rigid in the transverse direction as well. This has the affect of limiting the flexibility of the balloon as it is advanced through the tortuous confines of a vessel or other body lumen. In light of the above it would be desirable to provide a cutting blade for use with a cutting balloon that is more flexible, and which does not interfere with or is compatible with the expansion characteristics of the balloon to which it may be mounted. All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety. Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below. A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims. BRIEF SUMMARY OF THE INVENTION The present invention is directed to several embodiments. In at least one embodiment the invention is directed to a medical balloon for use with a catheter or similar device, wherein the medical balloon is equipped with at least one cutting blade. In some embodiments one or more portions of the cutting blade or blades define a serpentine path or shape relative to the surface of the balloon upon which the blade is mounted. A serpentine path extends radially outward from the balloon surface and then back toward the balloon surface in a repeating pattern. In at least one embodiment the serpentine path is provided by a plurality of adjacent undulations. In at least one embodiment adjacent undulations define a substantially S-shaped segment of the blade. In at least one embodiment the blade has multiple serpentine regions, each of which define a separate serpentine path. Each serpentine region is separated by a region of the blade which is not serpentine. The non-serpentine regions may be characterized as being linear, and while such regions may define a path having one or more bends or curves to accommodate the shape of the balloon (e.g. the transition form the balloon waist to the balloon cone, the transition from the balloon cone to the balloon body, etc.) such regions do not define a serpentine path. In some embodiments the blade employs separate serpentine regions each of which extend along the surface of a balloon cone, and a serpentine region which extends along the surface of at least a portion of the balloon body. Such cone serpentine regions of the blades and the body serpentine regions of the blade may have similar or different serpentine shapes or pathways. For example, in at least one embodiment, the cone serpentine regions define a path having a shallower height and/or a longer wavelength than the body serpentine region. The blade may be constructed of any material suitable for forming a cutting blade. The body region of the blade defines at least one cutting surface or edge. Regions of the blade adjacent to the body region need not include a cutting surface. As such, in at least one embodiment different regions of the blade define one or more different cross-sectional shapes. In at least one embodiment the body region of the blade defines a substantially triangular shaped cross-section. In at least one embodiment regions of the blade adjacent the body region have rectangular (ribbon), round, ovoid, square or other cross-sectional shape(s). In at least one embodiment one or more portions of the blade in close proximity to the balloon surface are engaged to the balloon surface by an adhesive or other mounting material. The adhesive may be any adhesive material suitable for securing a metal, polymer or carbon based blade to the material of the balloon. In at least one embodiment portions of the blade engaged to the balloon are defined by the “troughs” of the serpentine path of the body region of the blade. Adjacent “peaks” are then free to flex, bend, or otherwise alter their position as the balloon is expanded, bent or otherwise altered in shape or configuration. This substantial freedom of movement of the peak portions of the body region allow the blade to remain in contact with the balloon regardless of the balloon's longitudinal expansion or axially transverse bending. In some embodiments the proximal and distal end regions of the blade, which respectively extend over the proximal and distal waists of the balloon are likewise engaged to the balloon and/or adjacent catheter shaft with an adhesive or mounting material. In some embodiments the blade ends are encased in adhesive or mounting material to prevent contact of the blade ends with the lumen wall through which the catheter is advanced. As indicated above, a balloon may be equipped with any number of blades as desired. In at least one embodiment for example, the balloon is provided with a single blade, while in other embodiments 2-20 blades may be mounted onto the balloon. Multiple blades may be uniformly or irregularly spaced apart, and may have similar or different shapes, lengths, serpentine paths, etc. These and other embodiments which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof However, for further understanding of the invention, its advantages and objectives obtained by its use, reference should be made to the drawings which form a further part hereof and the accompanying descriptive matter, in which there is illustrated and described a embodiments of the invention. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) A detailed description of the invention is hereafter described with specific reference being made to the drawings. FIG. 1 is a side view of an embodiment of the invention wherein a balloon is shown with a single serpentine blade. FIG. 2 is a cross-sectional view of the embodiment depicted in FIG. 1 . FIG. 3 is a side view of the embodiment shown in FIG. 1 wherein the balloon includes 2 serpentine blades. FIG. 4 is a cross-sectional view of the balloon shown in FIG. 3 FIG. 5 is a side view of the embodiment shown in FIG. 1 wherein the balloon includes 4 serpentine blades. FIG. 6 is a cross-sectional view of the balloon shown in FIG. 5 FIG. 7 is a detailed side view of a serpentine blade such as is shown in FIGS. 1-6 . FIGS. 8-12 are each cross-sectional views of respective portions of the blade shown in FIG. 7 . FIG. 13 is a side view of the embodiment shown in FIG. 1 wherein the serpentine blades are positioned on the body or working portion of the balloon. FIG. 14 is a side view of the embodiment shown in FIG. I wherein the serpentine blades are positioned on the body or working portion of the balloon, the serpentine blades having different lengths. DETAILED DESCRIPTION OF THE INVENTION While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated. As indicated above, the present invention is embodied in a variety of forms. In at least one embodiment, an example of which is depicted in FIG. 1 , the invention is directed to a catheter balloon 10 which has at least one serpentine, undulating, or similarly configured blade 12 mounted to the external surface 14 of the balloon. As shown, the blade 12 comprises at least one serpentine region 20 . The majority or all of the blade may have a serpentine configuration, the blade may comprise a single serpentine region or any number of serpentine regions separated by non-serpentine regions. In the example shown in FIG. 1 , the blade 12 may be characterized as having a number of adjacent serpentine regions: body region 20 , proximal cone region 22 and distal cone region 24 ; as well as one or more linear or non-serpentine regions: proximal end region 30 , proximal cone transition region 32 , distal cone transition region 34 , and distal end region 36 . The blade 12 extends substantially parallel to longitudinal axis 37 of the balloon 10 . In an alternative embodiment depicted in FIG. 13 , each blade 12 is in effect a body region 20 having an uninterrupted serpentine configuration extending along at least a portion of only the balloon body 40 . As is shown in FIG. 1 and FIG. 13 the body serpentine region 20 extends along the exterior surface 14 of at least a portion of the balloon body 40 . The body region 20 may be engaged to the balloon body 40 in any of a variety of ways such as by mechanical engagement, direct welding, through the use of an adhesive, etc. In the embodiment shown an adhesive material 18 is positioned on the surface 14 of the balloon 10 and the body region 20 of the blade 12 is adhesively engaged thereto. Any suitable adhesive may be utilized as the adhesive material 18 . For example adhesives such as polyurethane, epoxy, cyanoacrylate and/or combinations of such materials may by utilized as the adhesive material 18 . In at least one embodiment, portions of the blade 12 are adhesively engaged to the balloon surface with a polyurethane substrate or pad such as is described in U.S. Pat. No. 5,320,634, the entire contents of which being incorporated herein by reference. The nature of the serpentine regions 20 , 22 , 24 of the blade 12 is such that each serpentine region comprises a series of adjacent substantially S-shaped segments 50 (highlighted) which extend from a low point or trough 52 , immediately adjacent to the surface 14 of the balloon 10 , to a high point or peak 54 , which is a greater distance radially outward from the balloon 10 than the trough 52 . Adjacent peaks 54 and troughs 52 are engaged by arm portions 56 of the blade 12 . Each trough 52 is engaged to the balloon surface 14 by the adhesive material 18 . The arm portions extend from the ends of the troughs 52 to engage the adjacent peaks 54 . The arms 56 provide the peaks 54 with a significant degree of axial and transverse flexibility relative to the troughs 52 engaged to the balloon 10 . As a result, when the balloon is twisted, bent, expanded or lengthened, stress between the blade 12 and the balloon 10 is minimized as the majority of the body serpentine region 20 remains free to move in conjunction/response with the movements of the balloon, while only the discrete and separated troughs 52 remain secured to the balloon 10 . Such a configuration provides the cutting balloon 10 with improved resistance to delamination of the blade 12 from the balloon surface 14 by reducing the axial and transverse stress that the balloon/blade interface is subjected to during expansion and/or movement of the balloon. In some embodiments where the blade(s) 12 extend beyond the length of the balloon body 40 , such as is shown in FIGS. 1-5 , one or more blades 12 may be provided with cone regions 22 and 24 which also have a serpentine configuration. The cone regions 22 and 24 can be configured such that they elongate during balloon inflation resulting in a tension within the cone regions. Such tension will facilitate a desirable balloon refold, because during balloon deflation the cone region tension will preferentially draw in the blades 12 to a lower profile than the adjacent balloon folds. The serpentine configuration of the cone regions 22 and 24 provide additional flexibility, particularly in the axial direction, which allows the blade to accommodate expansion and/or elongation of the cones 42 and 44 , respectively, as the balloon 10 is expanded without affecting the position or exerting axial stress on the body region 20 of the blade 12 . In order to minimize profile and to aid in balloon folding/refolding, in some embodiments the cone regions 22 and 24 are spaced apart or separated from the body region by a non-serpentine cone transition region 32 and 34 . In other embodiments regions 32 and 34 may be serpentine, linear, or provided with any other configuration desired. In at least one embodiment the transition regions 32 and 34 as well as the serpentine cone regions 22 and 24 are not adhesively or otherwise engaged to the balloon surface 14 . By not adhering the respective regions to the balloon, the blade 12 is more readily able to accommodate much greater degrees of change in the shape and configuration of the balloon without placing stress on the body region 20 . The end regions, proximal end region 30 and distal end region 36 are also typically non-serpentine in configuration, in order to minimize their profile and to provide greater surface area for engagement to the balloon waists (proximal waist 46 and distal waist 48 ) respectively thereunder. In some embodiments the end regions 30 and 36 may be configured to extend beyond the waists 46 and 48 and engage the catheter shaft 60 directly. In at least one embodiment, at least a portion of each end region 30 and 36 of the blade 12 , is completely encased or enclosed by adhesive or other mounting material upon or within the respective waist of the balloon 10 or catheter shaft 60 . As is illustrated in FIGS. 1-6 , the balloon 10 may be equipped with any number of blades 12 , typically between 1 and 20, though other numbers may be provided. In FIGS. 1-2 for example, the balloon 10 is shown with a single blade 12 . In the embodiment shown in FIGS. 3-4 , the balloon 10 is provided with a pair of radially opposite blades 12 . In FIGS. 5-6 , the balloon is provided with four substantially circumferentially equidistant blades 12 . While the embodiments shown in FIGS. 2-6 have blades 12 arranged in a symmetrical fashion about the balloon 10 , such symmetry need not be the case in all embodiments. In some embodiments the blades may be of different or equal lengths; varyingly spaced apart, whether randomly or in accordance with a pattern; or otherwise arranged or positioned about the balloon in accordance with need, desire and/or performance. As is the nature of a “cutting blade” one or more portions of the surface 62 of the blade 12 define one or more cutting edges. In the various embodiments shown herein at least the peak portions 54 of the body region 20 define a single radially outward projecting cutting edge 64 . As is illustrated in FIG. 7 and in the cross-sectional views provided in FIGS. 11 and 12 the cutting edge 64 can be formed within the body region 20 with a substantially triangular cross-sectional shape, wherein the edge 64 is formed by the peak or apex 64 of the triangular shaped blade. While it is desired to provide at least the peaks 54 with an edge, in at least one embodiment, as illustrated in FIG. 12 , the troughs 52 may also be provided with an edge 64 as a consequence of the triangular cross-sectional shape of the region 20 . In the embodiments depicted in FIGS. 1-12 , the portions of the blade 12 adjacent to the body region 20 of the blade need not be provided with an edge, (as such portions are typically not positioned in such a manner so as to contact a lesion site). In some embodiments, those regions of the blade other than the body region 20 (e.g. regions 22 , 24 , 30 , 32 , 34 and 36 ) of the blade 12 can be configured with a cross-sectional shape different than that of the body region 20 . For example, as illustrated in FIGS. 7-10 , the regions 22 / 24 , 30 / 36 , 32 / 34 adjacent to the body region 20 are provided with comparatively thin, or ribbon-like cross-sectional shape, as shown in FIGS. 8-10 , which provides those portions of the blade adjacent to the body region 20 with a high degree of axial and/or transverse flexibility. It should be understood that the ribbon-like shape shown in FIGS. 8-10 is an example of a desired shape, others include but are not limited to, round, ovoid, ellipsoid, square, triangular, or any other geometric shape that may be desired. The blade 12 , regardless of its cross-sectional shape or shapes may be constructed by any of a variety of manufacturing methods. For example, the blade 12 , or at least the body region 20 may be constructed of metallic or other material wire stock, as it will facilitate the formation of the cutting edge. Other manufacturing techniques include photo-etching, laser cutting, water jet cutting, or flat stock stamping of a desired blade material to form one or more regions of the blade 12 . In some embodiments the blade 12 or one or more portions thereof may include one or more areas, coatings, materials, etc. that is (are) detectable by imaging modalities such as X-Ray, MRI or ultrasound. In some embodiments at least a portion of the blade is at least partially radiopaque. In at least one embodiment, the blade 12 , and/or the balloon 10 may be configured to deliver one or more therapeutic agents to the lesion site. A therapeutic agent may be a drug or other pharmaceutical product such as non-genetic agents, genetic agents, cellular material, etc. Some examples of suitable non-genetic therapeutic agents include but are not limited to: anti-thrombogenic agents such as heparin, heparin derivatives, vascular cell growth promoters, growth factor inhibitors, Paclitaxel, etc. Where an agent includes a genetic therapeutic agent, such a genetic agent may include but is not limited to: DNA, RNA and their respective derivatives and/or components; hedgehog proteins, etc. Where a therapeutic agent includes cellular material, the cellular material may include but is not limited to: cells of human origin and/or non-human origin as well as their respective components and/or derivatives thereof. Where the therapeutic agent includes a polymer agent, the polymer agent may be a polystyrene-polyisobutylene-polystyrene triblock copolymer (SIBS), polyethylene oxide, silicone rubber and/or any other suitable substrate. Blade 12 , may be constructed from one or more metals, polymers, combinations of one or more metals and/or polymers, and/or other desired material(s). In at least one embodiment, blade 12 is at least partially constructed of a shape memory material, such as nitinol and/or a shape memory polymer. The blade 12 , may comprise a plurality of separate blade segments or may be a single continuous structure as desired. The balloon 10 may be made of any suitable balloon material including compliant and non-compliant materials and combinations thereof. Some examples of suitable materials for constructing the balloon 10 include but are not limited to: low pressure, relatively soft or flexible polymeric materials, such as thermoplastic polymers, thermoplastic elastomers, polyethylene (high density, low density, intermediate density, linear low density), various co-polymers and blends of polyethylene, ionomers, polyesters, polyurethanes, polycarbonates, polyamides, poly-vinyl chloride, acrylonitrile-butadiene-styrene copolymers, polyether-polyester copolymers, and polyetherpolyamide copolymers; copolymer polyolefin material available from E.I. DuPont de Nemours and Co. (Wilmington, Del.), under the trade name Surlyn™; ionomer and a polyether block amide available under the trade name PEBAX™; high pressure polymeric materials, such as thermoplastic polymers and thermoset polymeric materials, poly(ethylene terephthalate) (commonly referred to as PET), polyimide, thermoplastic polyamide, polyamides, polyesters, polycarbonates, polyphenylene sulfides, polypropylene and rigid polyurethane; one or more liquid crystal polymers; and combinations of one or more of any of the above. In some embodiments a balloon 10 may be provided with one or more blades having different lengths, sizes, shapes, or configurations. For example, FIG. 14 depicts a balloon 10 having two blades, 12 ( a ) and 12 ( b ), with lengths L 1 and L 2 , respectively, where length L 1 is greater than length L 2 . In at least one embodiment one or more blades on a balloon have a length which extend from at least the body of the balloon and through at least a portion of the balloon waist, while the distal end of the blade terminates before reaching the distal waist. This and other configurations and arrangements of blades should be recognized as falling within the scope of the present invention. The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims. Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim 1 such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim 1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below.

A system for treatment of a vessel lesion comprises an expandable balloon and at least one cutting blade engaged to an exterior surface of the balloon. At least a portion of the cutting blade has a substantially serpentine configuration defined by a plurality of interconnected peaks and troughs wherein each trough is in closer proximity to the balloon than each peak.

CROSS-REFERENCE TO RELATED APPLICATION The present application claims priority to U.S. Provisional Application No. 61/806,443, entitled Animal Deterrent, filed on filed on Mar. 29, 2013, the contents of which are herein incorporated by reference in its entirety. FIELD OF THE INVENTION The invention relates to a device and a method for deterring animals from performing and unwanted behavior such as entering or approaching a designated area, climbing on indoor or outdoor furniture or the like. More specifically, the subject deterrent device utilizes a sudden jet spray of a compressed gas to startle the animal, deterring it from performing the unwanted behavior. BACKGROUND OF THE INVENTION Pet, such as dogs and cats, etc. have been known to cause harm to indoor furnishings, plants and the like by scratching, lying upon and in general having access to such objects. Similarly, pets and wild animals have been known cause harm to out furnishing, plants, and garden areas. To combat such unwanted behavior, devices are know to deter the animal by producing a deterring stimulus which startles or scares the animal. These deterring stimulus can include the spraying the animal with water, emitting a loud sound, or flashing lights, or combinations thereof. SUMMARY OF THE INVENTION The animal deterrent device of the present disclosure utilizes and automatic system to detect the presence of an animal in a designated area. Upon detection, the animal deterrent device releases a deterring stimulus. The deterring stimulus is intended to remove the animal from the designated area, and through continuous use, eventually training the animal from entering the designate area. The designation area can include: furniture, such as a couch, chair, table, etc; a room or portions thereof; plants, indoor or outdoor gardens; and the like. The animal deterrent device includes a housing having a canister containing a compressed gas connected to a valve system. The valve system can include a solenoid valve. The valve system includes an output nozzle, such that when the valve is open compressed gas exits the nozzle to create a deterring sound. A motion sensor is provided on the housing to actuate the valve. In this manner, when an animal passes with range of the motion sensor, the motion sensor actives (opens) the valve to create the deterring sound. The nozzle can be movable with respect to the housing, such that the output direction of the nozzle can be adjusted. Additionally, an orientation (tilt) sensor can be provided to verify that the animal deterrent device is in the proper (vertical) orientation for operation. If the animal deterrent device is tilted at a specified angle from vertical, the tilt sensor will prevent operation of the valve system. To operate the animal deterrent device the following step are performed: 1. Turn on the unit by pressing the control button in the front. The Green LED will light up. The Green LED flashes every 5 seconds once it has been turned on. 2. If the battery level is low, the LED will be flashing in RED. The system will not work until the user has replaced the batteries. 3. There is an orientation switch inside the PC board. Shall the device be tilted for a certain angle (varies by components), the device will stop working even though the ON/OFF switch is at ON position. This will avoid spraying liquid if the canister is inverted. 4. Once the unit has been turned on around 10 seconds by pressing the ON/OFF button, the passive infrared sensor will start detecting motion if the unit is at the upright position. If a motion was detected, the solenoid valve will be energized and push the valve open for 0.6 second. The sound level can be around 90 to 95 dBA measured at 12 inches. The device will be suppressed for 4 seconds which means the unit will spray again after 4 seconds if motions are detected. BRIEF DESCRIPTION OF THE DRAWINGS A more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein: FIG. 1 depicts a front isometric view of an animal deterrent device of the present disclosure; FIG. 2 depicts a front view of the animal deterrent device of FIG. 1 ; FIG. 3 depicts a side sectional view of the animal deterrent device of FIG. 1 ; FIG. 4 depicts a rear sectional view of the animal deterrent device of FIG. 1 ; FIG. 5 depicts a diagram of a controller for use n the animal deterrent device of the present disclosure; FIG. 6 depicts a first isometric view of a fluid dispensing system 40 for use in an animal deterring device; FIG. 7 depicts a second isometric view of a fluid dispensing system 40 for use in an animal deterring device; FIG. 8 depicts a front isometric view of an alternative animal deterrent device of the present disclosure; FIG. 9 depicts a front sectional view of the animal deterrent device of 7 ; and FIG. 10 depicts a rear sectional view of the animal deterrent device of FIG. 7 . DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawing figures in which like reference designators refer to like elements, there is shown in FIGS. 1 and 2 an animal deterrent device 10 of the present disclosure. The animal deterrent device 10 includes a housing 12 having a front portion 14 and a back portion 16 . The front and back portions 14 and 16 combine to form the housing 12 , defining a bottom surface 18 for supporting the housing in an upright position, where the back portion 16 can be removeably attached to the front portion 14 . The front portion 14 of the housing 12 can include a plurality of orifices 20 , 22 , 24 into which an ON/Off switch 26 , a sensor 28 , and a nozzle 30 are positioned. A light element 25 can be included to indicate the status of the animal deterrent device 10 . Referring to FIG. 3 , a controller 32 is provided within the front portion 14 of the housing 12 , and connected to a power supply 34 . The power supply 34 can take the form of one of one or more batteries 34 ( a )-( d ). Alternatively, the power supply 34 can include a power cord connected to a household power source (not shown). The ON/OFF switch 26 can be connected between the controller 32 and the power supply 34 , where the ON/OFF switch 26 can be movable between a first position and a second position. In the first position the ON/OFF switch 26 is closed providing power to the controller 32 , and in the second position the ON/OFF switch 26 is open removing power from the controller 32 . The ON/OFF switch 26 can be depression switch, slide switch, toggle switch, or other switches which perform the same function of turning ON and OFF the power to the controller 32 . The sensor 28 is also connected to the controller 32 . The sensor 28 is utilized to detect the presence of an animal in a designated area. When an animal is detected in the designated area the sensor provides a signal to the controller 32 to emit a deterring stimulus. For example, and describe in more detail below, upon detection of a animal in the designated area the sensor 26 send a signal to the controller 32 to emit the deterring stimulus of jet of compressed gas through the nozzle 30 . The sensor 28 can be a motion sensor, infrared sensor, and other known sensors for detecting the presence of the animal. An orientation (tilt) sensor 36 is connected to the controller 32 . The orientation sensor 36 operates to verify that the housing 12 is position in an operational, vertical or substantially vertical, position. If the housing 12 has been knocked over, and is in a horizontal or substantially horizontal position, the orientation sensor 36 sends a signal to the controller 32 to prevent operation and an emission of the deterring stimulus. Additionally, upon receipt of such a signal from the orientation sensor 36 , the controller 32 can active an alarm to indicate to a user that the housing 12 has be knocked over. The alarm can take the form of a visible alarm, such as a flashing light or led 25 , or an audible alarm. Referring also to FIG. 4 , a fluid dispensing system 40 can connected to the controller 32 . The fluid dispensing system 40 can include the nozzle 30 in fluid connection to an actuateable valve 42 , solenoid valve. A fluid source connector 44 is connected to the actuateable valve 42 , opposite the nozzle 20 . A fluid source 46 , such as a canister of compressed gas or liquid, is removeably connectable to the fluid source connector 44 . For example, the fluid source connector 44 can include a threaded interface 48 , such that the fluid source 46 can be threadably connected to the fluid source connector 44 . Additionally, a plurality of battery supports 50 ( a )-( d ) can be provide in the housing 12 , where each of plurality of batteries 34 ( a )-( d ) is positionable therein. Referring to FIG. 5 , an exemplary diagram of a controller 32 for use in the animal deterrent device 10 is provided. Referring also to FIGS. 6-7 , the nozzle 30 can be a adjustable nozzle were the direction of the nozzle output can be adjusted in both the vertical and horizontal directions, and combinations thereof. The nozzle 30 can be connected to the actuateable valve 42 with a flexible tube 52 , where a tensioning spring 54 can be positioned about the flexible tube 52 between the nozzle 30 and the actuateable valve 42 . The flexible tube 52 and spring 54 combination allows for relative movement of the nozzle 30 with respect to the actuateable valve 42 , while maintaining a open fluid path therebetween. A torsional member 56 is position about, and engagement with, the nozzle 30 . A second portion of the torsional member 56 is connected to the housing 12 . The torsional member allows for relative movement of the nozzle 30 with respect to the front portion 14 of the housing, where the torsional member 56 acts to retain the relative position of the nozzle 30 . In the manner, a user can position the nozzle 30 with respect to the housing 12 , such that the output of the nozzle 30 can be directed in a desired direction. In an exemplary method of use, a user positions the animal deterrent device 10 is a desired location, for example near a couch. The front portion 14 of the housing is directed towards the couch, such that the sensor 28 can detect the presence of an animal on the couch. The nozzle 30 is positioned by the user in the desired direction. To activate the animal deterrent device 10 the user depresses the ON/OFF switch 26 . Once activated, if the sensor 28 detects an animal in the designated areas, a signal is sent to the controller 32 . In turn, the controller sends a signal to the actuated valve 42 , opening the valve 42 to send a jet of compressed gas out through the nozzle 30 . The release of the compressed gas generates a sound of sufficient loudness to startle the animal, removing it from the designated area. Once the system has been activated, the system will be suppressed for a period of time, for example 4 seconds, before it can be active again. In an alternative embodiment, the animal deterrent device further includes a sound emitting device, such as a speaker or ultra sonic emitter. Referring to FIGS. 8-9 , the alternative embodiment of the animal deterrent device 70 is shown. The animal deterrent device 70 includes a housing 72 having a front portion 74 and a back portion 76 . The front and back portions 74 and 76 join to form the housing 72 , defining a bottom surface 78 for supporting the housing in an upright position, where the back portion 76 can be removeably attached to the front portion 74 . The front portion 74 of the housing 72 includes a plurality of orifices 80 , 82 , 84 into which a sound emitter 86 , a sensor 28 , and a nozzle 30 are positioned. A controller 92 is provided within the housing 72 , and connected to a power supply 94 . The sound emitter 86 is connected to the controller 92 . When activated, the sound emitter 86 emits a sound to startle the animal. The emitted sound can be an audible sound or an ultra sonic signal. Similar to the embodiment described above, the alternative animal deterrent device 70 includes the power supply 34 , motion sensor 28 , nozzle 30 , fluid deposing system 40 , and orientation (tilt) sensor 36 , all of which a operated in accordance as previously described. Referring to FIG. 10 , an ON/OFF switch 96 can be connected between the controller 92 and the power supply 94 , where the ON/OFF switch 66 can be movable between a first position and a second position. In the first position the ON/OFF switch 96 is closed providing power to the controller 92 , and in the second position the ON/OFF switch 96 is open removing power from the controller 92 . Alternatively, the ON/OFF switch 96 can be a multi-position switch, allowing a user to selection the mode of operation of the deterring stimulus of the animal deterrent device 70 . For example, the multi-position switch 96 can be a four position switch, which in a first position the animal deterrent device 70 is OFF, in a second position only the fluid dispensing system 40 is activated, in a third position only the sound emitter 86 is activated, and is a fourth position both the fluid dispensing system 40 and sound emitter are activated. In an exemplary method of use, a user positions the animal deterrent device 70 is a desired location, example near a couch. The front portion 74 of the housing 72 is directed towards the couch, such that the sensor 28 can detect the presence of an animal on the couch. The nozzle 30 is positioned by the user in the desired direction. To activate the animal deterrent device 70 the user selects the mode of operation ON/OFF switch 96 , moving the switch 96 from the first position to either the second, third or fourth positions. Once activated, if the sensor 28 detects an animal in the designated areas, a signal is sent to the controller 92 to activate a deterring stimulus. If the switch 96 is positioned in the second position, the controller 92 sends a signal to the actuated valve 42 , opening the valve 42 to send a jet of compressed gas out through the nozzle 30 . The release of the compressed gas generates a sound of sufficient loudness to startle the animal, removing it from the designated area. Once the system has been activated, the system will be suppressed for a period of time, for example four (4) seconds, before it can be active again. If the switch 96 is positioned in the third position, the controller 92 sends a signal to the sound emitter 86 . The sound emitter 86 can generate a sound of sufficient loudness to startle the animal, removing it from the designated area. Alternatively, the sound emitter 86 is an ultra-sonic emitter, and generates an ultra-signal to startle the animal, removing it from the designated area. Once the system has been activated, the system will be suppressed for a period of time, for example four (4) seconds, before it can be active again. If the switch 96 is positioned in the forth position, both the fluid dispensing system 40 and sound emitter 86 are activated. In such case, the controller 92 simultaneously sends a signal to the actuated valve 42 and the sound emitter 86 . The actuated valve 42 is opened to send a jet of compressed gas out through the nozzle 30 . The release of the compressed gas generates a sound of sufficient loudness to startle the animal The sound emitter 86 can generate a sound of sufficient loudness to startle the animal. The activation of the both the fluid dispensing system 40 and sound emitter 86 provide a deterring stimulus for removing the animal form the designated area. Once the system has been activated, the system will be suppressed for a period of time, for example four (4) seconds, before it can be active again. All references cited herein are expressly incorporated by reference in their entirety. It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention, which is limited only by the following claims.

The animal deterrent device of the present disclosure utilizes and automatic system to detect the presence of an animal in a designated area. Upon detection, the animal deterrent device releases a deterring stimulus. The deterring stimulus is intended to remove the animal from the designated area, and through continuous use, eventually training the animal from entering the designate area. The designation area can include: furniture, such as a couch, chair, table, etc; a room or portions thereof; plants, indoor or outdoor gardens; and the like.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a laser apparatus for irradiating an object to be irradiated with a laser beam. 2. Description of Related Art As a laser apparatus for irradiating an object to be irradiated with a laser beam emitted from a laser source, there is a laser treatment apparatus that irradiates an affected part of a patient with a treatment laser beam to treat the affected part. Such the laser apparatus is so configured as to have two operating statuses; an irradiation-ready status (hereinafter referred to as a READY mode) in which laser irradiation is enabled when a laser irradiation start signal (a trigger signal) is entered and a standby status (hereinafter referred to as a STANDBY mode) in which laser irradiation is locked even when a laser irradiation start signal is entered. The two operating modes can normally selectively be switched at the push of predetermined keys on a control panel. Accordingly, in switching from the READY mode to the STANDBY mode, an operator must search and push an appropriate key for switching to the STANDBY mode from among many keys on the control panel. This would be troublesome to the operator. In an emergency where operators and assistants have to quickly react, particularly, it would be difficult for them to promptly search and press an emergency stop button and the key for switching to the STANDBY mode. SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances and has an object to overcome the above problems and to provide a laser apparatus capable of correctly easily switching from a READY mode to a STANDBY mode. Additional objects and advantages of the invention will be set forth in part in the description which follows and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims. To achieve the purpose of the invention, there is provided a laser apparatus for irradiating an object to be irradiated with a laser beam emitted from a laser source, the laser apparatus including: a display serving as display means provided with a screen for displaying laser irradiation conditions, the display being a touch panel type capable of detecting a touch position on the screen; input means for inputting a signal to start laser irradiation; mode selection means for selecting one of an irradiation ready mode of enabling the laser irradiation when the signal is input from the input means and a standby mode of locking the laser irradiation even when the signal is input from the input means; and control means for controlling the laser irradiation in accordance with the mode selected by the mode selection means, and locking the laser irradiation when detects a touch within a predetermined area on the screen of the display during the laser irradiation. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification illustrate an embodiment of the invention and, together with the description, serve to explain the objects, advantages and principles of the invention. In the drawings, FIG. 1 is a schematic perspective view of a laser apparatus in an embodiment according to the present invention; FIG. 2 is a schematic structural view of a main part of an optical system and a control system of the laser apparatus in the embodiment; and FIG. 3 is an example of a screen of a liquid crystal display of the laser apparatus for setting laser irradiation conditions in the embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A detailed description of a preferred embodiment of a laser apparatus embodying the present invention will now be given referring to the accompanying drawings. FIG. 1 is a schematic perspective view of the laser apparatus in the present embodiment. A main unit 1 of the laser apparatus is provided at its front with a large-sized liquid crystal display (hereinafter referred to as LCD) 2 of a touch panel-type for displaying various laser irradiation conditions and other. It is to be noted that the touch panel in the present embodiment has a resistance membrane system (which may be either a digital or analog type) capable of detecting a touch position of a finger of an operator in X- and Y-directions (coordinates) of the panel. The thus configured touch panel will show no react even if for example clothes of the operator slightly touch the panel. The main unit 1 is also provided with a fiber cable 4 and a communication cable 5 which are extended from the top of the main unit 1 to a hand piece 3 . An emergency stop button 6 is provided at the front face of the main unit 1 . At the push of this button 6 , supply of electric power to the main unit 1 is shut down. FIG. 2 is a schematic structural view of the main part of an optical system and a control system of the laser apparatus. A laser source 10 is constructed of a plurality of diode laser sources each of which emits a treatment laser beam (hereinafter simply referred to as a treatment beam) that is a near-infrared light having a wavelength in the range of 800-820 nm in the present embodiment. This treatment beam is useful for treatments such as laser depilation in which a laser beam is irradiated to hair roots to cauterize them for depilation. The treatment beams emitted from the laser source 10 are condensed by condensing lenses 12 a and introduced into the entrance ends of fibers 13 a . The emergence ends of the fibers 13 a are bound into a bundle as shown in FIG. 2, thereby allowing emission of a treatment beam of high power. A laser source 11 emits an aiming laser beam (hereinafter simply referred to as an aiming beam) that is a red visible laser beam having a wavelength in the range of 620-650 nm in the present embodiment. The aiming beam emitted from the laser source 11 is condensed by a condensing lens 12 b and introduced into the entrance end of a fiber 13 b . The emergence end of the fiber 13 b is bound with those of the fibers 13 a , whereby to make the aiming beam coaxial with the treatment beam. The treatment beam and the aiming beam emerged from the emergence ends (i.e., fiber bundle portions) of the bound fibers 13 a and 13 b are then condensed by a group of condensing lenses 14 and introduced into a fiber cable 4 . This fiber cable 4 is connected to the hand piece 3 . Thus, the treatment beam and the aiming beam are introduced into the hand piece 3 through the fiber cable 4 . Galvano-mirrors 16 a and 16 b are disposed in the hand piece 3 . These galvano-mirrors 16 a and 16 b are driven for causing the treatment beam and the aiming beam to scan a wide area. That is, the treatment beam and the aiming beam introduced into the hand piece 3 are made into parallel luminous flux by a collimator lens 15 , moved or swung in X- and Y-directions by the galvano-mirrors 16 a and 16 b , and thus concentrated on a part to be treated by a condensing lens 17 . Numeral 18 is a glass plate which will be placed on the treatment part in direct contact therewith during treatment. This glass plate 18 is arranged at the condensing point of the beams by the condensing lens 17 , thus bringing the condensing point into correspondence with the treatment part. The size of the glass plate 18 is so designed to cover all the area to be scanned by the treatment beam and the aiming beam. In treating, an operator holds the hand piece 3 with the glass plate 18 pressed against the treatment part so that the surface of this treatment part becomes equally flat, whereby to uniformly perform laser irradiation to the part. Numeral 20 is a controller for controlling the whole apparatus. This controller 20 is mainly connected with the LCD 2 , the galvano-mirrors 16 a and 16 b through the communication cable 5 , and a footswitch 21 for generating a laser irradiation start signal (a trigger signal). FIG. 3 is an example of a screen of the LCD 2 for setting of laser irradiation conditions. In the left section of the screen, there are arranged an energy density display section 30 a which indicates the energy density (J/cm 2 ) of the treatment beam, an irradiation power display section 30 b which indicates the irradiation power (W) of the treatment beam, an irradiation time display section 30 c which indicates the irradiation time (ms) of the treatment beam, an interval time display section 30 d which indicates the interval time (s) in repetitive irradiation, and others. In the right section of the screen, on the other hand, there are arranged a READY key 32 a for selecting a READY mode, a STANDBY key 32 b for selecting a STANDBY mode, a scanning area information display section 33 which displays the information on an area to be scanned by the treatment beam (shape, size, etc. of the scanning area), an aiming light quantity display section 34 which indicates the luminous intensity of the aiming beam, and others. If requiring changing of the laser irradiation conditions, the operator touches one of the display sections 30 a - 30 d , 33 , 34 on the screen to select an option or item to be changed, and presses UP/DOWN keys 31 to increase or decrease a set value of the selected option to a desired value. For the shape of the scanning area, the operator presses a SHAPE key 33 a in the display section 33 to select a desired one. Operation of the laser apparatus having the above configuration will be explained below. When a surgeon or assistant (which will hereinafter be referred to as an operator) turns on the power of the laser apparatus, the controller 20 runs diagnostic checks on itself before startup. Upon startup, the STANDBY mode is established. In this mode, the STANDBY key 32 b is displayed in a bright color, e.g., orange, while the READY key 32 a in a dark color, e.g., gray. Such the keys 32 a and 32 b allow the operator to easily recognize the current operating mode. In the STANDBY mode, even when the controller 20 receives a trigger signal from the footswitch 21 depressed, the controller 20 does not supply power to the laser source 10 . Thus the treatment beam is not emitted. Subsequently, the operator controls the keys on the LCD 2 to set the laser irradiation conditions as needed. After completion of preparation for laser irradiation, the operator pushes the READY key 32 a to place the apparatus in the READY mode. Upon turn-on of the READY key 32 a , the controller 20 performs laser a power check (calibration) to detect whether the irradiation power is a predetermined value. When it is determined that the irradiation power is proper, the apparatus is put into the READY mode. In the READY mode, the READY key 32 a is displayed in a bright color, e.g., blue, while the STANDBY key 32 b is displayed in a dark color, e.g., gray. In this mode, when the controller 20 receives a trigger signal from the footswitch 21 , it supplies power to the laser source 10 to emit the treatment beam. After confirming that the READY mode is established, the operator depresses the footswitch 21 . In response to the trigger signal from the footswitch 21 , the controller 20 causes the laser source 10 to emit the treatment beam under the set irradiation conditions such as the irradiation power. The controller 20 simultaneously drives the galvano-mirrors 16 a and 16 b to cause the treatment beam to scan the predetermined scanning area (shape, size, etc.), thereby irradiating the treatment part. After the treatment is completed or when changing the laser irradiation conditions is required, the operator has only to touch the screen of the LCD 2 . This establishes the STANDBY mode. It is to be noted that the operator may touch any portion or position on the screen of the LCD 2 besides the keys arranged on the LCD 2 . During the READY mode, the controller 20 recognizes the whole area of the screen of the LCD 2 as a STANDBY key to switch from the READY mode to the STANDBY mode. If any portion except the STANDBY key 32 b is touched, therefore, the controller 20 acts in the same manner that the STANDBY key 32 b is exactly touched. In the READY mode, as mentioned above, the simple control of touching any portion or position on the LCD 2 by the operator makes it possible to easily switch to the STANDBY mode. Accordingly, the need for searching the STANDBY key 32 b can be eliminated, which can reduce labors of the operator. If a larger LCD 2 is used, its operability can be more improved. In the case of needing emergency stop of the laser irradiation because of some troubles in the patient or operator, the laser irradiation can be stopped with the touch of the screen of the LCD 2 having a wide area by the operator without a search and push of the emergency button 6 . Thus, the operator can correctly easily react in case of emergency. As described above, according to the above embodiment, the laser apparatus can properly easily be switched from the READY mode to the STANDBY mode. The present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. It is to be noted that the area of the screen of the LCD 2 (the area to be recognized as a STANDBY key) for switching the apparatus from the READY mode to the STANDBY mode is sufficient if it is larger than at least the STANDBY key 32 b . Preferably, the area is determined to be larger including the display sections 30 a - 30 d used as condition setting keys, the key 31 , and others. More preferably, the area recognized as a STANDBY key is determined to be the whole screen of the LCD 2 as in the above embodiment. However, the area is not strictly limited to the whole screen. The area is sufficient if including most of the main area serving as a touch panel. In the above embodiment, the controller 20 does not supply power to the laser source 10 during the STANDBY mode to thereby lock laser irradiation. Alternatively, a shutter may be inserted on the beam path to lock laser irradiation. The foregoing description of the preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents.

A laser apparatus for irradiating an object to be irradiated with a laser beam emitted from a laser source is disclosed. The laser apparatus includes a display provided with a screen for displaying laser irradiation conditions, the display being a touch panel type capable of detecting a touch position on the screen; an input device for inputting a signal to start laser irradiation; a mode selector for selecting one of an irradiation ready mode of enabling the laser irradiation when the signal is input from the input device and a standby mode of locking the laser irradiation even when the signal is input from the input device; and a controller for controlling the laser irradiation in accordance with the mode selected by the mode selector, and locking the laser irradiation when detects a touch within a predetermined area on the screen of the display during the laser irradiation.

This application claims the benefit of U.S. Provisional Application Ser. No. 60/190,862 filed Mar. 20, 2000, the entire contents of which are incorporated herein by reference in their entirety. BACKGROUND OF THE INVENTION This invention relates to lawn mowers in general and, more particularly, to systems for controlling the cutting assemblies of lawn tractors. It is known to provide a lawn mower with an electrical or mechanical interlock system to prevent a mower from being shifted to reverse with the cutting assembly operating. Some conventional interlock systems shut the lawn mower completely down when it is shifted into reverse. Other systems simply prevent the mower from being shifted into reverse while the cutting assembly is engaged. These require the user to disengage the cutting assembly prior to shifting the mower into reverse. Accordingly, there is a need in the art for an improved interlock system for disengaging a cutting assembly when a lawn tractor is shifted into a reverse mode. SUMMARY OF THE INVENTION The present invention provides an apparatus for engaging and disengaging a cutter of a vehicle. The apparatus includes a shifter for selecting a direction of travel of the vehicle. A clutch controls transmission of power to the cutter. Means for operating the clutch disengages the power from the cutter when the shifter is operated to select a reverse direction for the vehicle. The clutch operating means does not engage power to the cutter when the shifter is operated to select a forward direction for the vehicle. According to one aspect, the present invention is an apparatus for engaging and disengaging a clutch assembly used with a cutter assembly housed within a cutting deck mounted on a chassis of a lawn tractor having an engine also mounted on the chassis and operable to provide power to a plurality of tractor wheels to which the chassis is mounted and to a cutting blade included in the cutter assembly and enclosed by the cutting deck. The apparatus for engaging and disengaging the clutch assembly comprises: a clutch bracket mounted to the chassis of the lawn tractor; a deck engage lever movably connected to the clutch bracket; a deck engage bracket movably connected to the deck engage lever and to a deck control cable having a deck control cable first end that is operatively connected to the clutch assembly; a release latch connected to the deck engage bracket and to a reverse control cable having a reverse control cable first end that is movably joined to a transmission shift lever that is operatively connected with a transmission of the lawn tractor; and a switch housing secured to the clutch bracket, the switch housing including a starter interlock switch operable within an electrical circuit utilized to supply power to a starter that is operatively connected to the engine, the starter interlock switch including an actuator having a retracted position and an extended position, the transmission shift lever having a reverse position and a non-reverse position, the release latch having a latched position and an unlatched position, the deck engage bracket having neutral position and an active position, the deck engage lever having an engaged position and a disengaged position, and the clutch assembly having a drive position and a release position. When the deck engage lever is in the disengaged position and the transmission shift lever is in the non-reverse state, the deck engage bracket is latched to the deck engage lever, and when the deck engage lever is subsequently moved to the engaged state, the deck engage lever carries the release latch to the latched position and the deck engage bracket to the active position, thereby connecting power from the engine to the clutch assembly and causing the clutch assembly to be in the driven position. Additionally, when the transmission shift lever is moved from the non-reverse state to the reverse state while the clutch assembly is in the driven state, the reverse control cable moves the release latch to the unlatched position and unlatches the deck engage bracket from the deck engage lever, permitting the deck engage bracket to move, under a spring force created by a first spring and a second spring included in the clutch assembly, to the neutral position, thereby causing the clutch assembly to change from the drive position to the release position and disconnecting power from the engine to the clutch assembly. BRIEF DESCRIPTION OF THE DRAWINGS The features, aspects, and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings where: FIG. 1 shows a perspective view of a lawn tractor having a deck disengagement apparatus embodied in accordance with the present invention; FIG. 2 shows a schematic view of a cutter assembly of the lawn tractor; FIG. 3 shows a front perspective view of the deck disengagement apparatus; FIG. 4 shows a front view of the deck disengagement apparatus; and FIG. 5 shows a right side view of the deck disengagement apparatus. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS It should be noted that in the detailed description which follows, identical components have the same reference numerals, regardless of whether they are shown in different embodiments of the present invention. It should also be noted that in order to clearly and concisely disclose the present invention, the drawings may not necessarily be to scale and certain features of the invention may be shown in somewhat schematic form. Referring now to FIG. 1, there is shown a lawn tractor 10 having a deck disengagement apparatus 12 (shown in FIGS. 3-5) embodied in accordance with the present invention. The lawn tractor 10 includes a chassis 14 mounted on front and rear wheels 16 , 18 . A body 20 is mounted on the chassis 14 and encloses an engine (not shown) for driving the rear wheels 18 and a cutter, such as a cutting blade 22 (shown in FIG. 2 ). The engine is connected to the rear wheels 18 through a transmission (not shown). A cutting deck 24 enclosing the cutting blade 22 is secured to the bottom of the chassis 14 , between the front and rear wheels 16 , 18 . A seat 26 for an operator is mounted to the chassis 14 , rearward of the engine. A dashboard (not shown) is mounted to the body 20 and faces the seat 26 . A deck engage lever 28 extends from the dashboard. While FIG. 1 shows the deck engage lever 28 extending from the dashboard, it will be understood that the deck engage lever 28 may be located at and extend from any and all other desirable locations on the lawn tractor 10 and that any and all such other desirable locations are intended to be within the scope of the present invention. A shifter, such as a shift lever 30 , for controlling the transmission extends from a rear fender 32 of the body 20 , adjacent to the seat 26 . The shifter is movable between reverse, neutral, and drive positions. A first end of a reverse control cable 34 (shown in FIGS. 3-5) is connected to the shift lever 30 . The reverse control cable is covered with an outer sheath 35 . Referring now to FIG. 2, there is shown a schematic drawing of a cutter assembly 36 connected to the engine of the lawn tractor 10 . The cutter assembly 36 includes an engine pulley 38 and a cutter pulley 40 . The engine pulley 38 is secured to a drive shaft 42 of the engine so as to be rotatable therewith. The cutter pulley 40 is secured to the cutting blade 22 housed in the cutting deck 24 of the lawn tractor 10 . An endless belt 44 is disposed around the engine pulley 38 and the cutter pulley 40 . The belt 44 loosely engages the engine pulley 38 and the cutter pulley 40 so that power will not be transmitted from the engine pulley 38 to the cutter pulley 40 when the engine pulley 38 is rotating. A clutch assembly 46 is disposed adjacent to the belt 44 , between the engine pulley 38 and the cutter pulley 40 . The clutch assembly 46 includes an idler pulley 48 carried by a pivotable arm 50 . The clutch assembly 46 is movable between a release position (not shown), wherein the idler pulley 48 is spaced from the belt 44 , and a drive position (shown in FIG. 2 ), wherein the idler pulley 48 engages and thereby tightens the belt 44 . A coil spring 52 biases the clutch assembly 46 toward the release position. A first end of a deck control cable 54 is attached to the arm 50 of the clutch assembly 46 and is provided with a coil spring 53 that encircles the first end of the deck control cable 54 and has a first of its ends affixed to the arm 50 and a second of its ends joined to the cable 54 . As will be discussed in more detail below, a second end of the deck control cable 54 is connected to the deck disengagement apparatus 12 of the present invention. The deck control cable is covered by an outer sheath 55 . Referring now to FIGS. 3-5, there is shown the deck disengagement apparatus 12 of the present invention. The deck disengagement apparatus 12 generally includes the deck engage lever 28 , a clutch bracket 56 , a deck engage bracket 58 , and a release latch 60 . The deck engage lever 28 is formed from an elongated metal rod and includes a central portion 28 a joined between an upper handle portion 28 b and a lower mounting portion 28 c (see FIG. 4 ). The upper handle portion 28 b is joined to the central portion at an upper bend 28 d forming an obtuse angle, while the mounting portion 28 c is joined to the central portion 28 a at a lower bend 28 e forming a generally right angle. An annular flange 29 is disposed around the mounting portion 28 c, toward the lower bend 28 e. The clutch bracket 56 includes a base portion 62 joined at a substantially right angle to a main portion 64 . A linear slot 66 is formed in the base portion 62 and includes a closed end and an open end. The main portion 64 has a narrowed outer end 68 with a hole 70 extending therethrough. A first arm portion 72 and a second arm portion 74 extend from a side edge of the main portion 64 . The first arm portion 72 has an enlarged central opening 76 formed therein. The second arm portion 74 is L-shaped and includes an outer end 74 a having a slotted-opening 78 formed therein. A grommet 80 is secured within the slotted-opening 78 . A switch housing 82 is securely disposed within the central opening 76 of the first arm portion 72 . The switch housing 82 encloses a starter interlock switch connected into a circuit for supplying power to an electric starter (not shown) for the engine. The starter interlock switch includes a plunger-type actuator 84 (see FIG. 5) that extends outwardly from the switch housing 82 . The actuator 84 is movable between a retracted position, wherein the starter interlock switch closes the circuit to permit power to be supplied to the starter, and an extended position, wherein the starter interlock switch opens the circuit to cut-off power to the starter. The actuator 84 is biased toward the extended position. The deck engage bracket 58 is generally L-shaped and includes a leg portion 86 joined at a generally right angle to a body portion 88 . The leg portion 86 includes an outer end 86 a with a hole extending therethrough. The body portion 88 has an outer end with first and second guides 90 , 92 respectively secured to inner and outer surfaces thereof. A passage extends through the length of the first guide 90 . A cowled cable mount 94 is joined to the body portion 88 and extends outwardly therefrom. The release latch 60 includes a generally C-shaped body 96 having a top interior edge 98 that partially defines an enlarged opening 100 . A top portion of the release latch 60 has a sloping or cammed front edge 102 . A top opening 104 (see FIG. 4) is formed in the top portion of the release latch 60 , and a bottom opening is formed in a bottom portion of the release latch 60 . The release latch 60 is positioned to have the enlarged opening 100 face the leg portion 86 of the deck engage bracket 58 , and is pivotally secured to the deck engage bracket 58 by a bolt 106 (see FIG. 5) extending through the bottom opening and an opening in the body portion 88 of the deck engage bracket 58 . The release latch 60 is movable between a first or latched position, wherein the front edge 102 is disposed proximate the leg portion 86 of the deck engage bracket 58 , and second or unlatched position, wherein the front edge 102 is disposed distal to the leg portion 86 . A coiled latch return spring 108 (see FIG. 5) is disposed over the bolt 106 , between the release latch 60 and the body portion 88 of the deck engage bracket 58 . Ends of the latch return spring 108 respectively engage the release latch 60 and the body portion 88 . The latch return spring 108 is operable to bias the release latch 60 toward the latched position. A bent second end of the reverse control cable 34 is attached to the release latch 60 through the top opening 104 . The reverse control cable 34 extends from the release latch 60 through the passage of the first guide 90 to the shift lever 30 for the transmission of the lawn tractor 10 . The outer sheath 35 of the reverse control cable 34 terminates within, and is secured to, the first guide 90 . The first end of the reverse control cable 34 is connected to the shift lever 30 such that the reverse control cable 34 moves the release latch 60 to the unlatched position when the shift lever 30 is moved into the reverse position and allows the release latch 60 to move back to the latched position when the shift lever 30 is moved into the neutral position or the drive position. The second end of the deck control cable 54 is secured to the cable mount 94 of the deck engage bracket 58 . The deck control cable 54 extends from the cable mount 94 through the grommet 80 to the arm 50 of the clutch assembly 46 as described above. The outer sheath 55 of the deck control cable 54 terminates within, and is secured to, the grommet 80 . The clutch bracket 56 is secured to a dashboard of the lawn tractor 10 . A J-shaped slot (not shown) is formed in the dashboard of the lawn tractor 10 . The slot 66 in the clutch bracket 56 is aligned with a straight portion of the J-shaped slot. The mounting portion 28 c of the deck engage lever 28 is journalled through the hole 70 in the main portion 64 of the clutch bracket 56 , thereby pivotally mounting the deck engage lever 28 to the clutch bracket 56 . The central portion 28 a of the deck engage lever 28 extends through the slot 66 and the J-shaped slot. With the deck engage lever 28 mounted in this manner, the deck engage lever 28 is movable from a first or disengaged position located at the closed end of the slot 66 (and a closed end of the straight portion of the J-shaped slot) to a second or engaged position located at a closed end of a hook portion of the J-shaped slot. When the deck engage lever 28 is moved to the disengaged position, the deck engage lever 28 engages the actuator 84 of the starter interlock switch and moves the actuator 84 to the retracted position. A washer locator 110 is secured to the mounting portion 28 c of the deck engage lever 28 on an outer side of the clutch bracket 56 . A coiled return spring 112 is disposed over the mounting portion 28 c, between the washer locator 110 and the clutch bracket 56 . Ends of the return spring 112 respectively engage the washer locator 110 and the clutch bracket 56 . The return spring 112 is operable to bias the deck engage lever 28 toward the disengaged position. The deck engage bracket 58 is pivotally mounted to the mounting portion 28 c of the deck engage lever 28 , which extends through the hole in the leg portion 86 of the deck engage bracket 58 . The leg portion 86 is disposed between the annular flange 29 on the deck engage lever 28 and the clutch bracket 56 . The deck engage bracket 58 is movable between a neutral position, wherein a bottom edge 114 (see FIG. 5) of the release latch 60 abuts the second arm 74 of the clutch bracket 56 , to an active position, wherein the deck engage bracket 58 is latched to the deck engage lever 28 and the deck engage lever 28 is in the engaged position. When the deck engage lever 28 is in the disengaged position and the shift lever 30 is in the neutral position (or the drive position), the central portion 28 a of the deck engage lever 28 extends through the enlarged opening 100 in the release latch 60 and is aligned below the top interior edge 98 of the release latch 60 . With the deck engage lever 28 and the release latch 60 so positioned, the release latch 60 and, thus, the deck engage bracket 58 , are latched to the deck engage lever 28 . The operation of the lawn tractor 10 and the deck disengagement apparatus 12 will now be described. The description will begin with the lawn tractor 10 being in an inactive or stored condition, wherein the engine is not running, the shift lever 30 is in the neutral position, and the deck engage lever 28 is in the disengaged position. When the lawn tractor 10 is in the stored condition, the deck engage bracket 58 is latched to the deck engage lever 28 , and the starter interlock switch is closed. Thus, the starter may be provided with power to start the engine. When the engine is running, the drive 42 shaft and the engine pulley 38 rotate. At this point, it should be noted that the engine cannot be started when the deck engage lever 28 is in the engaged position because the deck engage lever 28 will be spaced from the actuator 84 of the starter interlock switch. Thus, the actuator 84 will be in the extended position and, thus, the circuit will be open, thereby preventing power from being supplied to the starter. When the deck engage lever 28 is moved to the engaged position, the central portion 28 a contacts the top interior edge 98 of the release latch 60 and carries the release latch 60 to the active position against the face 68 of the bracket 56 . The movement of the deck engage bracket 58 to the active position, pulls the deck control cable 54 , which moves the clutch assembly 46 to the drive position. As a result, the belt 44 tightens and power from the engine is transmitted to the cutter pulley 40 , thereby rotating the cutting blade 22 , i.e., engaging the cutter assembly 36 . If the shift lever 30 is moved to the reverse position while the cutter assembly 36 is engaged, the reverse control cable 34 moves the release latch 60 to the unlatched position. As a result, the deck engage bracket 58 becomes disengaged from the deck engage lever 28 and moves under the force the spring 52 and the spring 53 back to the neutral position. The movement of the deck engage bracket 58 to the neutral position, releases the deck control cable 54 , which allows the spring 52 to move the clutch assembly 46 back to the release position. As a result, the belt 44 loosens and power from the engine is no longer transmitted to the cutter pulley 40 , thereby disengaging the cutter assembly 36 . A brake (not shown) may be provided to immediately stop the rotation of the cutting blade 22 when the cutter assembly 36 is disengaged. Simply moving the deck engage lever 28 back to the disengaged position without moving the shift lever 30 out of the reverse position will not latch the deck engage bracket 58 onto the deck engage lever 28 again because the release latch 60 is still in the unlatched position. Thus, in order to move the deck engage bracket 58 back to the active position and re-engage the cutter assembly 36 , the shift lever 30 must be moved to the neutral position or the drive position, and the deck engage lever 28 must be moved back to the disengaged position to permit the deck engage bracket 58 to latch onto the deck engage lever 28 again. The deck engage lever 28 may then be moved back to the engaged position to carry the deck engage bracket 58 to the active position and thereby re-engage the cutter assembly 36 . The order in which the deck engage lever 28 and the shift lever 30 are moved to their required positions for re-engaging the cutter assembly 36 is not important. If the shift lever 30 is moved out of the reverse position first, the release latch 60 will move back to the latched position below the deck engage lever 28 . This is not a problem, however. When the deck engage lever 28 is subsequently moved to the disengaged position, the deck engage lever 28 contacts the cammed front edge 102 of the release latch 60 , which translates some of the downward movement of the deck engage lever 28 to lateral movement of the release latch 60 , away from the latched position. This lateral movement of the release latch 60 permits the deck engage lever 28 to move below the top interior edge 98 of the release latch 60 . The release latch 60 then moves back to the latched position, thereby positioning the deck engage lever 28 within the enlarged opening 100 in the release latch 60 and below the top interior edge 98 . Although the preferred embodiments of this invention have been shown and described, it should be understood that various modifications and rearrangements of the parts may be resorted to without departing from the scope of the invention as disclosed and claimed herein.

An interlock system for use with a cutting assembly of a lawn tractor. The interlock system automatically disengages the cutting assembly when the lawn tractor is shifted into a reverse mode and prevents re-engagement of the cutter assembly when the law tractor is subsequently shifted into a non-reverse mode.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is related to, and claims the benefit of, the provisional patent application entitled “Apparatus And Method For Enhancing A Woman's Cleavage With A Floating and Sliding Cup Brassiere”, filed Jul. 17, 2007, bearing U.S. Ser. No. 60/950,211 and naming Seka Kaytes, the named inventor herein, as sole inventor, the contents of which is specifically incorporated by reference herein in its entirety, and the provisional patent application entitled “Apparatus And Method For Enhancing A Woman's Cleavage With A Floating and Sliding Cup Brassiere”, filed Apr. 14, 2007, bearing U.S. Ser. No. 61/044,895 and naming Seka Kaytes, the named inventor herein, as sole inventor, the contents of which is specifically incorporated by reference herein in its entirety. BACKGROUND 1. Technical Field The present invention relates to breast support devices. In particular, it relates to a brassiere having “floating” cups that are fully or partially detached from the brassiere structure for the purpose of independently positioning the cups without disturbing the position of the brassiere as a whole. Independently movable floating brassiere cups allow the wearer to dynamically adjust the manner in which the brassiere supports and controls the position of the breasts and to enhance the breasts' cleavage, and to enhance the perceived fullness and firmness of the breasts. In addition, the floating cup solves the problem of approximately eighty percent of females who are wearing the wrong size bra. 2. Background of the Invention The use of brassieres to support a woman's breasts is well-known in the art. Traditionally, these devices have provided support for the breasts, but they do not allow individual custom positioning of the cups or the breast. More recently, attempts have been made to enhance the cleavage and appearance of a woman's breasts by pushing-up and pushing-in the individual breast using push-up cups or adding push-up inserts into the brassiere, or by pulling brassiere cups together via straps, thereby enhancing the perceived size of the breasts as well as the cleavage. While prior art brassieres serve their purpose to an extent, they also have disadvantages. In particular, prior art brassieres are restricted in how much bra cups can be moved inward because the cups are attached to the brassiere and their movement is limited. As a result, the cleavage enhancement they provide is limited. This is particularly true for females having a small breast size, such as A and B size cups. With prior art brassieres, typically only larger breast size females have significant cleavage enhancement. Another disadvantage associated with the prior art is that cups are fully attached and fixed in one position (i.e. cups are not movable) to a brassiere as a whole, when cups are moved toward each other it pulls on the entire garment and disturbs the position of a brassiere, thus resulting in: (a) Improper garment fit, (b) Tightness of the chest because of fabric pulling, (c) Discomfort, (d) Fabric wrinkling on the side of the bra back, and (e) Insignificant cleavage enhancement for bra cup sizes A and B. Another disadvantage associated with prior art brassieres is that when breasts are pulled together laterally for the purpose of enhancing cleavage, the brassiere also occasionally produces some undesirable side effects. In particular, when the brassiere pulls the breasts together, it sometimes creates the appearance of creases or wrinkles in the breasts which make the breasts unattractive and increases the apparent age of the woman. It would be desirable to have a method of adjusting and controlling a brassiere such that the cleavage of a woman could be improved while still maintaining a smooth surface texture on the skin of the breasts. Another disadvantage associated with prior art brassieres is that studies have shown that a significant percentage of women, up to eighty percent in some cases, wear the wrong size brassiere, which results in discomfort. It would be desirable to have a brassiere in which the cups could be independently adjusted to accommodate a wider variety of breast and body shapes such that the brassieres provide a more comfortable fit. While addressing the basic desirability of using brassieres, the prior art has failed to provide a device which allows woman with any breast size, including smaller cup sizes such as A and B, to dynamically control the amount of cleavage provided by a brassiere, which allows an individual woman to dynamically control the perceived size of the breasts, and the position and cleavage of each breast independent of the other breast without the drawbacks of the prior art, and which allows each cup to be individually positioned to maximize comfort. SUMMARY OF THE INVENTION The present invention solves the foregoing problems by providing a brassiere which has independently adjustable floating cups that are partially or fully detached from the brassiere as a whole, that allow the wearer, in particular a small bra cup female such as A and B, to have maximum benefits of a natural cleavage by independently changing the position of each cup and thereby repositioning the breast. Depending on the point of attachment of the cup to cup attachment points on the brassiere body, each cup of the brassiere is independently rotated, raised, lowered, or pulled in a lateral direction. The ability to independently move individual cups in relation to the brassiere body provides a “Give-In” feature that accommodates in-between sizes, and also accommodates breasts which are asymmetrical or vary in size from one another. By attaching the brassiere cups at various locations, the brassiere cups which hold the breasts are independently positioned by the wearer to allow the cleavage and perceived size of each breast to be individually adjusted to compensate for slightly asymmetrical breasts. Further, the ability to individually position cups provides the wearer to adjust the cups for maximum comfort. The present invention also provides an alternative embodiment that has cups which are separate from the brassiere. Namely, brassiere cups that are inserted into a brassiere or other top garment. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front view of a prior art brassiere which illustrates a brassiere that does not modify cleavage. FIG. 2 illustrates a front view of a prior art brassiere which has tension straps placed in between the brassiere cups that pull the brassiere cups together to enhance cleavage. FIG. 3A illustrates a front view of a preferred embodiment of the brassiere in which the brassiere cups are shown fully detached from the brassiere and held in place by stretch fabric. The brassiere cups are shown in the lowered position in this figure. Bra cups are attached to bra straps; locking mechanism is placed on cup holder and on bra cups too. FIG. 3B illustrates a front view of a preferred embodiment of the brassiere in which the tips of the support wires form cup support posts which are positioned between the brassiere cups. The brassiere cups are shown in the raised position in this figure. FIG. 4A illustrates a front view of an alternative preferred embodiment of the brassiere in which a decorative cup retainer is positioned between the brassiere cups. The brassiere cups are shown in the lowered position in this figure. FIG. 4B illustrates a front view of an alternative preferred embodiment of the brassiere in which a decorative cup retainer is positioned between the brassiere cups and functions as a front closure to keep the brassiere cups in a raised position. The brassiere cups are attached to the decorative cup retainer and shown in the raised position in this figure. FIG. 5A is a rear view of an alternative preferred embodiment which uses securing pockets that are integrated with the floating cups that secure to the support wire of the brassiere to hold the floating cup in a preselected position. FIG. 5B is a rear view of the embodiment shown in FIG. 5A which illustrates the floating cup in a raised position. FIG. 6 is a front view of an alternative preferred embodiment of the invention which uses elastic panels with elastic fabric on the side of the brassiere, to give the brassiere cup extra movement without pulling on the bra back. FIG. 7A is a rear view of an alternative preferred embodiment which uses floating cups that may be secured to the opposing bottom support wire. In this case, the brassiere cups are not secured to the opposing cup's bottom support wires, and are shown in the lowered and apart position. FIG. 7B is a rear view of the alternative preferred embodiment of FIG. 7A . In this figure, the floating cups are secured to the opposing cup's bottom support wires and are shown in the raised and pulled together position. FIG. 7C is a front view of a floating cup brassiere and illustrates and alternative embodiment of the shoe-string technique which allows floating cups to be brought closer together by tying opposing cups directly together. FIG. 8A is a rear view of an alternative preferred embodiment which uses floating cups that are secured by opposing straps, at the top and to the middle of the brassiere cup. Floating cups are shown in the lowered position. Opposing straps are shown as adjustable. FIG. 8B is a rear view of the alternative preferred embodiment of FIG. 8A . The floating cups are in the raised and closed together position via adjusting the opposing straps. FIG. 9A is a front view of an alternative preferred embodiment which uses floating cups that are secured to a brassiere body via an adjustable cup securing assembly. The floating cups are shown in the lowered position. FIG. 9B is a front view of the alternative preferred embodiment of FIG. 9A which shows the floating cups secured together in the raised position. FIG. 10 is a front view of a floating cup brassiere and illustrates the floating cups connected to the brassiere with stretch-lace material. FIG. 11 is a front view of a floating cup brassiere which illustrates the floating cups sandwiched in-between fabric, held by the fabric and bra straps, and shown in the lower position and without attachments. FIGS. 12A-D are front views of floating cup brassieres that illustrate examples of the floating cups attached to the floating cup brassiere without any attachments. FIG. 13 is a front view of a floating cup brassiere and illustrates the floating cups sandwiched in-between fabric and also using the shoe-string technique which allows floating cups to be brought closer together by tying opposing cups directly together. FIG. 14A is a front view of a floating cup brassiere and illustrates the floating cups secured to the brassiere body with a clip. FIG. 14B is a front view of a floating cup brassiere and illustrates the floating cups secured to the brassiere body with a clip, and also shows the shoe-string technique which allows floating cups to be brought closer together by tying opposing cups directly together. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Prior to a detailed discussion of the figures, a general overview of the features and advantages of the invention will be presented. As noted above, attempts have been made to enhance the cleavage and appearance of a woman's breasts through the use of devices associated with brassieres. Most notably, the attempts have been confined to pulling the cups of the brassiere together or increasing the support provided by a brassiere to lift the breasts. While this has been successful to a point, it has the drawbacks discussed above in regard in that not all individuals would benefit with the amount of cleavage equally. For example, small breast sized women, such as those having size A and B do not have any significant results with prior art brassieres. Further, it induces an additional problem in that when the brassiere cups are pulled together laterally to increase cleavage, a side effect occurs in which the skin on the top surface of the breast becomes wrinkled creating the illusion that the individual is older than the individual actually is. The invention uses a floating cup structure in which a floating cups move independently from the brassiere body. The floating cups allow greater freedom to independently position each cup, not only laterally, but also up or down. As a result, a woman can adjust the brassiere not only to enhance cleavage and/or apparent fullness, but also to address comfort and other physical issues. In particular, an advantage provided by the invention is that by allowing individual breasts to be independently positioned in a variety of directions: up, down, from left to right and vice versa, from bottom left to top right and vice versa, from bottom right to top left and vice versa, rotation in clockwise direction and counter clockwise, an individual can manipulate each breast to suit particular physical needs, and the brassiere cups will support the new position of the breast. For example, if a wearer has non-symmetrical breasts, one or both cups can be adjusted to give the appearance of symmetry. Likewise, if one breast is smaller than the other, a wearer can adjust an individual cup to give the appearance of greater size. A further advantage provided by the floating cups is that by being detached from the brassiere body, they have a “give-in” feature that stretches to accommodate a breast if it becomes larger due to swelling, pregnancy or weight gain. Having discussed the invention in general, we turn now to a more detailed discussion of the figures. FIGS. 1-2 illustrate prior art conventional brassieres, the remaining figures illustrate the floating cup embodiment. Referring to FIG. 1 , this figure shows a prior art brassiere 1 . In this figure, the brassiere 1 has two cups 2 which support the wearer's breasts. The cups 2 are supported by shoulder straps 3 . Also shown in this figure is center front 4 . In this type of conventional brassiere 1 , the brassiere 1 supports the breasts and does not manipulate their position. FIG. 2 illustrates another type of prior art brassiere 1 that attempts to enhance cleavage. In this embodiment, brassiere cups 2 are connected by a tension strap 5 which pulls the cups 2 of the brassiere 1 together. As the cups 2 are pulled together, the breasts are pulled toward the center of the brassiere to enhance cleavage. Likewise, the straps 3 can be used to provide upward pressure to the brassiere cups 2 . Unfortunately, this type of prior art brassiere 1 merely pulls the cups 2 together laterally, and has no advantage for smaller size breasts such as A and B cup size females. A disadvantage of this method is that it often distorts the appearance of the breast, and in addition, it may cause wrinkling of the skin on top of the breasts while it is won. As a result, the benefits of improved cleavage may be offset by the appearance of wrinkles and the illusion of advanced age which is caused by an improperly fit bra that is tight around chest as it pulls on entire garment. FIG. 3A illustrates a front view of a preferred embodiment of the brassiere 6 in which the brassiere cups 10 are shown in the lowered position. Floating cup 10 is fully detached from the brassiere body 17 and it is independently movable. Decorative elastic fabric 16 is positioned between brassiere body 17 and the bottom of floating cups 10 . Alternatively, floating cups 10 can be covered with decorative fabric 16 on both sides in a sandwich structure where cups 10 are held in place by decorative fabric 16 and shoulder straps 3 . Maneuvering cups 10 in any direction will not disturb the position of the brassiere body 17 or shoulder straps 3 . For ease of illustration, the shoulder straps 3 are shown as part of the brassiere cups 10 . However, those skilled in the art will recognize that while optional shoulder straps 3 are shown throughout the figures as attached to the floating cups 10 , they can also be entirely disconnected from the floating cups 10 . Likewise, many brassieres 6 do not have shoulder straps 3 for fashion reasons. Also shown in this figure are cup attachment points 15 . Cup attachment points 15 are the end portions of the bottom support wires 9 which are secured to brassiere body 17 . When the cups 10 are raised, they are secured to cup attachment points 15 . In addition, bottom support wire 9 can be a simple wire structure. FIG. 3B illustrates a front view of the preferred embodiment of FIG. 3A . In this figure, the brassiere cups 10 are shown in the raised position. Cup attachment points 15 are secured to the cups 10 . The cups 10 are held in the raised position by cup attachment points 15 . In addition, the cup attachment points 15 can be sewn into the floating cups 10 at the point of manufacture without requiring any additional attachments. FIG. 4A illustrates a front view of an alternative preferred embodiment of the brassiere 6 in which a cup retainer 31 is secured to the attachment points 15 or the bottom support wires 9 . In use, cup retainer 31 can then be secured to one or more locations on the cup 10 and brassiere 6 . The cups 10 are then positioned based on where they are attached. The floating cups 10 are shown in the lowered position in this figure. FIG. 4B illustrates a front view of the alternative preferred embodiment of FIG. 4A in which the cup retainer 31 is positioned between the floating cups 10 . The floating cups 10 are attached to the cup retainer 31 and shown in the raised position in this figure. FIGS. 4A-B also illustrates the use of decorative stretchable fabric panels 16 which are positioned between the brassiere cups 10 and the brassiere body 17 . FIG. 5A illustrates a rear view of an alternative preferred embodiment which uses a securing pocket 19 that is integrated with the floating cup 10 to secure it to bottom support wire 9 of the brassiere 6 . In the preferred embodiment, the securing pocket 19 accepts the tip of support wire 9 . The securing pockets 19 slip over the tips of the bottom support wires 9 to secure the brassiere cups 10 in a particular position. When the wearer wants to lower the floating brassiere cups 10 , she merely pulls the securing pockets 19 off of the tips. Those skilled in the art will recognize that multiple securing pockets 19 can be used by floating cups 10 to allow the wearer to adjust the movement of each floating cup 10 to any one of a number of predetermined positions by simply moving the floating cup 10 to the left, right, up or down position where the tip will go in specific securing pocket 19 . Of course, each floating cup 10 can be individually adjusted in this manner. Likewise, the securing pockets 19 are shown as discrete components for ease of illustration. However, for wearer comfort, the securing pockets 19 are envisioned as pockets that may be sewn into the floating cups 10 . Likewise, for ease of illustration, optional shoulder straps 3 are shown attached to bottom support wire 9 . However, those skilled in the art will recognize that the shoulder straps 3 , if used, can be secured to the bottom support wire 9 , the top support wire 8 , the brassiere body 17 , or the floating cups 10 . The choice of where the shoulder strap 3 is attached to the brassiere 6 will be governed by design considerations related to aesthetics, etc. FIG. 5B is a rear view of the embodiment shown in FIG. 5A . It further illustrates the attachment of the securing pocket 19 to the tip 12 of the bottom support wire 9 of the brassiere 6 . To raise the floating cup 10 , the wearer merely needs to lift the floating cup 10 upwards to allow the tip 12 of the support wire 9 to slide into it. Cups 10 can also be positioned in raised position at the point of manufacturing, which will result in custom pre adjusted cup position for a particular brassiere size. Of course, the more securing pockets 19 which are provided, the more flexibility the wearer will have when positioning their breasts. To lower the floating cup 10 , the wearer simply reverses the process. Those skilled in the arts will recognize that the securing pocket 19 can be constructed such that it has multiple slots at varying positions to allow the user to adjust the position of the floating cup 10 . FIG. 5B also illustrates the brassiere strap 3 attached to a bottom support wire 9 . Alternatively, brassiere strap 3 can be attached to both cup 10 and one or both top support wire 8 (not shown in this figure) or bottom support wire 9 . In the case where no top support wire 8 or bottom support wire 9 are not used, the brassiere strap 3 can be attached directly to the brassiere body 17 . FIG. 6 is a front view of an alternative preferred embodiment of the brassiere 6 which uses elastic side panels 20 on the brassiere body 17 of the brassiere 6 . These optional elastic side panels 20 contain extra stretch material for the purpose of providing additional comfort and serve as a flexible barrier between the brassiere cups 10 and the brassiere body 17 , so that pulling the brassiere cups 10 toward each other will not disturb the position of the brassiere body 17 . Also shown are optional support ribs 32 , which maintain the brassiere 6 in its proper shape. FIG. 7A is a rear view of an alternative preferred embodiment of the brassiere 6 which uses the “shoe string technique” in which floating cups 35 , 36 are secured to the opposing support wires 9 . The floating cups 35 , 36 may be attached to the support wire 9 which is associated with that cup 35 or 36 , or the floating cup 35 may be attached to attachment points 34 on the opposing support wire 9 , and floating cup 36 may be attached to attachment points 33 on the opposing support wires 9 . By using attachment points 33 , 34 on the opposing support wires 9 , the wearer has the ability to increase the amount of movement of the floating cups 35 , 36 toward one another. A plurality of cup attachment points can be incorporated into floating cups 35 , 36 to allow attachment of the cups 35 , 36 to any of the attachment points 33 , 34 on bottom support wires 9 . Any suitable method of securing the cup attachment points can be used. Also, the attachment points 33 , 34 can be placed at any suitable location of a top wire 8 , a bottom wire support 9 , a cup 10 , or on any suitable part of the brassiere 6 . Any suitable means can be used to secure the floating cups 35 , 36 to the attachment points, including straps, conventional brassiere closures, custom-made closures, snaps, hooks, etc. This allows each floating cup 35 to 36 to move independent of the brassiere body 17 . This provides improved comfort, and also allows greater ability to independently manipulate the position of each breast. For ease of illustration and discussion only four attachment points 33 and four attachment points 34 are shown. However, those skilled in the art will recognize that any suitable number of attachment points can be used to provide the greatest control over how the breasts are positioned. FIG. 7B is a rear view of the alternative preferred embodiment of FIG. 7A which are secured to the bottom support wire 9 . In this figure, the floating cups 10 are shown in the raised and pulled together position and secured to the opposing bottom support wire 9 . As noted above, the additional distance provided by attaching left and right floating cups 35 , 36 to the opposing bottom support wires in 19 allows the wearer to increase the distance which the floating cups 35 , 36 may be moved. FIG. 7C is a front view of the shoe-string technique that can be used with the floating cups 10 . The shoe-string technique allows the floating cups 10 to be brought closer together by securing the ties 46 together such that the floating cups 10 are pulled closer together to improve cleavage. In this embodiment, apertures 45 are located near the edge of each floating cup 10 . String ties 46 are inserted through the apertures 45 on each floating cup 10 and secured together. This technique can be used with any of the embodiments disclosed herein. FIG. 8A is a rear view of another alternative preferred embodiment of the brassiere 6 which uses floating cups 35 , 36 which are secured by adjustable tension straps 37 , 38 , respectively. In this embodiment, the floating cups 35 , 36 move free of the bottom supporting wire 9 . Adjustable tension straps 37 , 38 are attached to each floating cup 35 , 36 such that they create a crisscross connection for brassiere cups 35 , 36 . As tension adjustments 39 , 40 are adjusted, the tension on tension straps 37 , 38 is altered. As a result, the floating cups 35 , 36 can be rotated to adjust the amount of cleavage. Tension straps 37 , 38 can be placed at any convenient location on the brassiere 6 at the point of manufacturing or selectively positioned by the wearer. The tension straps 37 , 38 can be attached at first strap attachment points 41 , 42 to their respective floating cup 35 , 36 , or attached to their respective shoulder straps 3 . Likewise, tension straps 37 , 38 can be attached at second attachment points 43 , 44 to cups 35 , 36 or to opposing bottom support wires 9 as shown in the figure. This figure illustrates the floating cups 35 , 36 in the lowered position. FIG. 8B is a rear view of the alternative preferred embodiment of FIG. 8A where floating cups 10 are secured by suspension straps 23 , 24 . In this figure, the suspension straps 23 , 24 have been tightened to allow the floating cups 10 to be raised and to bring floating cups 10 closer together so as to alter the perceived cleavage. The adjustable straps 23 , 24 can be attached to the brassiere floating cup 10 , or the support wire 9 . FIG. 9A is a front view of an alternative preferred embodiment of the brassiere 6 which uses floating cups 10 that are secured to the brassiere body 17 . In this figure, the first portion 25 of the cup securing assembly 25 , 26 is secured to the brassiere body 17 and remains stationary. The second portion 26 of the cup securing assembly 25 , 26 is attached to the floating cup 10 and movably attached to the first portion 25 such that it can move from one position to another and be secured at any selected position. The cup securing assembly 25 , 26 allows the user to adjust the location of the floating cups 10 to any desired position. The cup securing assembly 25 , 26 can be a simple pressure clamping mechanism or alternatively have a series of locking points which allow the second portion 26 to be selectively stepped from one position to another. In this figure, the floating cups 10 are shown in the lowered position. Optional fabric 16 may be used for cosmetic purposes to cover the area between the brassiere body 17 and the floating cups 10 . Likewise, the brassiere 6 may optionally employ top support wires 8 (not shown in this figure) and/or bottom support wires 9 (not shown in this figure). If used, the cup securing assembly 25 , 26 may be secured to top support wires 8 and/or bottom support wires 9 . For ease of illustration, this embodiment has been shown with a cup securing assembly 25 , 26 which is relatively short in length. However, the cup securing assembly 25 , 26 may have any suitable length for its purpose. FIG. 9B is a front view of the alternative preferred embodiment of the brassiere 6 of FIG. 9A which uses floating cups 10 that are secured by a cup securing assembly 25 , 26 . In this figure, second portion 26 has been moved upward and is held in place by first portion 25 . As a result, the breasts are moved to a raised position. FIG. 10 is a front view of a preferred embodiment of a floating cup brassiere 6 that illustrates the floating cups 10 connected to the floating cup brassiere 6 with an elastic material 16 which can be fabricated from a stretch-lace material or any other suitable material. In this embodiment, floating cup brassiere 6 is shown without attachments and illustrates the floating brassiere cups 10 connected to the floating cup brassiere 6 with stretch-lace material 30 . By attaching the floating cups 10 in this manner, they have great amount of movement as they are not fixed to the floating cup brassiere 6 . Adjusting the shoulder straps 6 allows the wearer to custom adjust the floating brassiere cups 10 to a desired comfortable position. This ‘give-in’ cup feature also benefits both the manufacturer and retailer as it will reduce returns because more differently shaped women can be comfortably fit by the floating cup brassiere 6 . Also, women do not have to purchase bigger size brassieres for the days that their breasts are swollen due to a menstrual cycle. Likewise, it will eliminate the need to purchase larger sized brassieres for occasions when women gains extra weight. In addition, the “give-in” cup feature accommodates in-between sizes, and different size proportion breasts. FIG. 11 is a front view of a floating cup brassiere 6 and illustrates the floating cups 10 , in dashed lines, sandwiched in-between fabric 29 , and held by the fabric 29 and shoulder straps 3 . The floating cups 10 are shown in the lower position and without attachments. This figure illustrates the “comfort-lift” adjustable bra cup design. The floating cups 10 can also be a part of a multilayered brassiere. A multilayered brassiere has at least two cups. One cup being fixed to the floating cup brassiere 6 and a floating cup 10 fully or partially detached from the floating cup brassiere 6 such that it is movable and adjustable. Movable and adjustable cups can be placed behind the fixed cup or they can be sandwiched between two fixed cups. FIGS. 12A-D are front views of floating cup brassieres 6 that illustrate examples of the floating cups 10 attached to the floating cup brassiere 6 without any attachments. The figures illustrate benefits to a wearer. In particular, it shows how the ‘give-in’ cup feature results in better fitting for in-between breast sizes by providing a range of different attachment locations for the floating cups 10 . The more brassiere cup attachment points, the more choices a woman has to find a comfortable brassiere that fits her shape and size. Of course, floating cups 10 can be sandwiched in between fabric, covered with a fabric on the front side, or can be a part of a multilayered cup brassiere. FIG. 13 is a front view of a floating cup brassiere 6 that illustrates the floating cups 10 sandwiched in-between fabric 29 and also using the shoe-string technique which allows floating cups 10 to be brought closer together by tying opposing floating cups 10 directly together. The apertures 45 are located near the edge of each floating cup 10 . String ties 46 are inserted through the apertures 45 on each floating cup 10 and secured together. FIG. 14A is a front view of a floating cup brassiere 6 and illustrates the floating cups 10 secured to the brassiere body 17 with a clip 47 . In the preferred embodiment, the clip 47 can be moved to allow the wearer to move the floating cup in relation to the brassiere body 17 . Clip 47 can be implemented as a single piece, or as two pieces that interlock. Further, the clip 47 they have several points of attachment to allow the position of the cup to be adjusted. Tie string apertures 45 are also shown. In addition, the floating cups 10 can be detached from the clip 47 , the shoulder straps 3 which would allow the brassiere to be worn without a floating cups 10 . As a result, the brought cups can be a separate piece from the brassiere 6 . FIG. 14B is a front view of a floating cup brassiere 6 and illustrates the floating cups 10 secured to the brassiere body 17 with a clip 47 , and also shows the shoe-string technique which allows floating cups 10 to be brought closer together by tying opposing cups directly together. The floating cups 10 can be fabricated from any material that will provide suitable comfort and wear characteristics. In addition, it can be a multilayered structure of the outer layers for aesthetic and/or comfort purposes. Those skilled in the art will realize that for aesthetic purposes, any of the embodiments disclosed herein can be fabricated such that they provide an appearance which is substantially the same. This is possible because the cups can be concealed in a similar fashion. For example, the cups 10 can be sandwiched in between a fabric, in the case of a floating cup 10 , they can be connected to the brassiere body 17 with a stretch lace material which gives a similar appearance occurred as a result, many of the embodiments can be designed such that the structural elements of the invention are substantially concealed from view. In addition to the embodiments described above in regard to brassiere 6 , those skilled in the art will recognize that this invention can be implemented in the identical manner in conjunction with the other garments, in particular, bathing suits. In addition, the floating brassiere cups 10 can be separate components that are used in conjunction with conventional brassieres, or can be worn under any top garment. While the invention has been described with respect to a preferred embodiment thereof, it will be understood by those skilled in the art that various changes in detail may be made therein without departing from the spirit, scope, and teaching of the invention.

A brassiere with floating cups which are independently positionable in relation to the brassiere body. Depending on the point of attachment to the brassiere, the floating brassiere cups control the support, position, cleavage, and separation of individual breasts. The floating cups are partially or fully detached from the brassiere at various selectable locations. It is not just rotational motion, but also lifting the breasts upward and toward the center of the chest. The brassiere has floating cups that apply rotational pressure to move the breasts closer together if rotated in one direction, and will move the breasts apart if rotated in the other direction. The cup positioning mechanism can be implemented by an adjustable clip, by integral hook and loop strips, buttons, ornamental clasps, straps, string ties, or other suitable devices.

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims the benefit under 35 USC 119(e) of U.S. Provisional Patent Application No. 60/719,616, filed Sep. 22, 2005. The present application is also a continuation-in-part of U.S. Ser. No. 11/042,607, filed in the U.S. on Jan. 25, 2005 now U.S. Pat. No. 7,393,323. FIELD OF THE INVENTION This invention relates to a non-bacterial method and device for detoxification of ammonia produced from fish-gills, fish-urine/faeces and ammonia mineralized from organic fish-food. BACKGROUND OF THE INVENTION According to the Department of Fisheries and Wildlife Sciences, Virginia Tech., detoxification of ammonia occurs in biofilters through the process of nitrification. Nitrification refers to the bacterial conversion of ammonia nitrogen (NH4/NH3) to the less toxic NO2 and finally to “non-toxic” NO3. The bacterial nitrification process requires a suitable surface on the biofilter upon which the bacteria grow (biofilter media) pumping a continuous flow of tank-water through the biofilter and maintaining normal water temperature and good water quality. Two groups of aerobic (oxygen requiring) nitrifying bacteria are needed. Nitrosomonas bacteria convert NH4/NH3 to NO2 (they oxidize toxic ammonia excreted by fish-gills/urine and excreta into less toxic nitrite). The nitrobacter bacteria convert NO2 to NO3 (they oxidize nitrite to largely non-toxic nitrate). Bacterial nitrification is an aerobic process which requires oxygen. For every 1 mg of ammonia converted 5 mg of dissolved oxygen is consumed and an additional 5 mg of dissolved oxygen is required to satisfy the oxygen demand of the bacteria involved with the conversion. Therefore, tanks with large numbers of fish and heavy ammonia loads will require plenty of oxygen before and after the biofilter process. Bacterial nitrification is an acidifying process, but is most efficient when the water pH is maintained between 7 and 8 and the water temperature is about 27-28 C. Acid water, (less than pH 6.5) inhibits bacterial nitrification and should be avoided. Soft, acidic waters may require addition of carbonates (calcium carbonate, sodium bicarbonate) to buffer the water. Biofilters consist of actively growing bacteria attached to surfaces. Biofilters can fail if the bacteria die or are inhibited by natural aging, toxicity from chemicals, (for example, fish disease treatment), lack of oxygen, low pH. Biofilters, are designed so that aging cells can be sloughed off to create space for active new bacterial growth. However, there are situations, (e.g., cleaning too vigorously) where all bacteria are removed, or if chemical addition to tank water to fight fish disease results in biofilter failure then the water in the system should be exchanged. The biofilter would then have to be reactivated (taking 3 to 4 weeks) and the water pH adjusted to optimum levels. Activating a new biofilter, (i.e., developing a healthy population of nitrifying bacteria capable of removing ammonia and nitrite produced at normal feeding rates) requires one to three months. Many fish die during this period of biofilter activation. OBJECTS AND SUMMARY An object of the present invention is to provide an improved method and apparatus for reducing ammonia concentrations caused in tank water by the presence of fish gill/urine discharge, fish faeces and uneaten organic fish food particulate matter. Another object of the invention is to substitute a sono-molecular-conversion process for bacterial oxidation to accomplish nitrification and mineralization processes thereby eliminate or reduce the need for: the aforementioned bacterial dissolved oxygen demand, periodic bacteria replacement and ensuing production delay, water buffering to maintain the bacterial pH range requirement eliminating the bacteria water temperature range control requirement, and initial nitrification start-up time-delay. It is another object for some embodiments of the present invention to reduce ammonia to nitrite conversion output by a factor of at least 80. Another object of the invention is compatibility with the sonochemical germicidal, pollutant conversion and humane fish slaughter invention attributes described and claimed in, U.S. patent applications Ser. Nos. 10/676,061, 10/912,608, 11/042,607, which are hereby incorporated herein by reference. One embodiment of the present invention relates to a method of reducing ammonia concentration in tank water caused by the presence of fish-gill/urine discharge, fish faeces and ammonia generated from organic to inorganic mineralization of uneaten fish food particulate. The method is based on the considerable research carried out by the inventor in the field of low frequency ultrasound with respect to transient cavitation bubble collapse, wherein, very high temperatures (5,500 C) and pressures (several hundred atmospheres) cause organic compounds in the vicinity of the bubble-collapse to be degraded and inorganic compounds reduced or undergo molecular rearrangement. Detoxification of ammonia, as for oxygenation of tank water, is essentially, a continuous (24/7), ongoing process. The sono-molecular-conversion intensity control means may be manual or automatic, as preferred. When automatic, detoxification takes place under microprocessor control. When manual, the operator adjusts the sono-molecular-conversion control as indicated by ammonia concentration monitors. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 illustrates a recirculating aquaculture tank and attached sono-molecular-conversion device configuration suited to a serial mass production objective, whereby a series of these device configurations are connected together to enable the automatic transfer of fish from one recirculating tank to another as the fish graduate in size from fingerling to market size. The essential functions of such an aquaculture tank configuration are described by FIG. 1 . FIG. 2 illustrates an aquaculture tank and remotely located sono-molecular-conversion device suited to after-market applications whereby existing recirculating aquaculture tanks can be serviced by remotely located sono-molecular-conversion devices. The essentials functions of such an aquaculture tank configuration are described by FIG. 2 . FIGS. 3 and 4 illustrate the results of ammonia nitrification experiments. FIGS. 5 and 6 illustrate the results of ammonia mineralization experiments. FIG. 7 illustrates the timing of nitrification. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Based on the experimentation data set forth below, an embodiment of the present invention includes a sono-molecular-conversion apparatus that has a stand-alone console housing, an ultrasound powered tank, input/output water ports, an outlet delivery pump and a particulate filtration system illustrated in FIGS. 1 and 2 . Water contaminated with ammonia and uneaten food particulate is extracted from the recirculating aquaculture system (RAS) and subjected to sono-molecular-conversion to reduce ammonia concentration to the region of 0.1 mg/L or less before being fed back through a particulate matter filtration system to the RAS. This is a continuous 24/7 ammonia conversion process. The RAS water tanks are equipped with ammonia sensors at their water input and outlet ports. In the automatic ammonia sensing version, signal outputs from both ammonia sensors are fed to a microprocessor which adjusts the sono-molecular-conversion intensity amplitude to keep the required rate of ammonia reduction fed back to the RAS within specified limits. In the manual version the operator is provided with a manual sono-molecular-conversion control which is adjusted in correspondence with the ammonia concentration indicated by the input and output ammonia concentration gauges. Based upon its minimal usage of dissolved oxygen and negligible increase in pH the Sono-Molecular-Conversion Process, (SMCP) is the preferred decontaminant removal system when compared to the, state-of-the-art, Recirculating Aquaculture System, (RAS), biofilter (bacteria), used to effect ammonia nitrification and inorganic fish-food mineralization and partial denitrification. With a biofilter, autotrophic nitrosomonas bacteria and nitrobacter bacteria respectively convert ammonia to nitrite then nitrite to nitrate. With a biofilter, heterotrophic bacteria effect mineralization to convert organic matter such as fish-food into inorganic ammonia through removal of its carbon content. With a biofilter, partial denitrification, (disassimalation) is effected by heterotrophic bacteria which change nitrate to nitrite and ammonia. A major technological difference between the Biofilter and the Sono-molecular-conversion processes is that the former relies upon bacterial digestive oxidation processes of living aerobic and anaerobic organisms while the latter relies upon the sono-molecular-conversion process initiated by transient cavitation collapse of microsized bubbles. Sono-Molecular-Conversion Nitrification The inventor's experimentation, has demonstrated the following interrelationships associated with sono-molecular-conversion, ammonia (NH4/NH3) nitrification. Ammonia/water mixtures were irradiated with ultrasound pressure waves having a frequency of 30 kHz and intensity settings of 2.0, 1.5, and 1.0 W/cm2. The corresponding pressure amplitudes were, respectively, 212 kPa, 150 kPa, and 100 kPa. The ammonia/water concentrations were 2.0, 4.0, 8.0, and 250 mg/L. The water sources, variably experimented with, were Municipal, Spring and Distilled. FIGS. 3 and 4 and the following tables illustrate the results of the experiments. EXPERIMENT # 1 - Nitrification Results Summary Table - (see FIG. 3) NH3/ Status pH DO NH4 NO2 NO3 INTENSITY TIME Start 7.6 9.5 mg/l 2 mg/l 0 <5 mg/l 2 W/cm2  0 Hrs mg/l Finish 7.6 9.5 mg/l 0 mg/l <0.5 10 mg/l 2 W/cm2 21 Hrs mg/l EXPERIMENT # 2 - Nitrification Result Summary Table - (see FIG. 3) NH3/ Status pH DO NH4 NO2 NO3 INTENSITY TIME Start 7.6 10 mg/l 4 mg/l 0  5 mg/l 2 W/cm2 0 mg/l Hrs Finish 7.6  8 mg/l 0 mg/l <0.25 10 mg/l 2 W/cm2 20.5 mg/l Hrs EXPERIMENT # 3 - Nitrification Results Summary Table - (see FIG. 3) NH3/ Status pH DO NH4 NO2 NO3 INTENSITY TIME Start 7.6 9.5 mg/l 8 mg/l 0  5 mg/l 2 W/cm2  0 Hrs mg/l Finish 7.6 9.5 mg/l 0 mg/l <0.25 10 mg/l 2 W/cm2 20.5 mg/l Hrs EXPERIMENT # 4 - Nitrification Results Summary Table - (see FIG. 3) NH3/ Status pH DO NH4 NO2 NO3 INTENSITY TIME Start 7.6 9.5 mg/l 250 0   5 mg/l 2 W/cm2  0 Hrs mg/l mg/l Finish 7.6 9.0 mg/l 0 <0.25 >5 mg/l 2 W/cm2 20 Hrs mg/l mgl EXPERIMENT # 5 - Nitrification Results Summary Table - (see FIG. 4) NH3/ Status pH DO NH4 NO2 NO3 INTENSITY TIME Start 7.6 9.5 mg/l 4 mg/l 0  5 mg/l 1 W/cm2  0 Hrs mg/l Finish 7.6  10 mg/l 0 mg/l 0.25 10 mg/l 1 W/cm2 40 Hrs mg/l The following observations were made as a result of the experiments: 1) For equal water volumes containing different concentrations of ammonia, the time required to reduce all such varying ammonia concentrations to zero was the same. 2) The time required to decrease a given total ammonia concentration in water to zero was inversely proportional to the applied sono-molecular-conversion intensity, (W/cm2). For example, the time necessary to bring total ammonia concentration in water to zero with an applied sono-molecular-conversion intensity of 2 W/cm2 was half that required at 1 W/cm2. 3 ) After, sono-molecular-conversion irradiation reduced total ammonia concentration in water to zero, the remaining residual concentrations of nitrite and nitrate remained unchanged with continuing sono-molecular-conversion irradiation. Further, at this point, even with several sequentially added ammonia concentrations being reduced to zero by sono-molecular-conversion, the residual concentrations of nitrite and nitrate showed only slight increase. 4) Following initial nitrification, the residual concentration of nitrite was 0.25 mg/L and the residual concentration of nitrate was 5 mg/L. 5) Following each sono-molecular-conversion, nitrification experiment, water pH remained virtually unchanged, i.e., the increase in pH was slight. After each sono-molecular-conversion experiment was completed, the concentration of dissolved oxygen, remained the same or showed a slight increase. 6) The above sono-molecular-conversion nitrification experiment results were independent of temperature of the water/ammonia mixture over the range applicable to fish survival, 48 to 87F. For the above experiments, an 8.5 liter experimental tank volume contained 8,421,000 mg of water. The ammonia concentrations employed were 2 mg/l, 4 mg/l, 8 mg/l and 250 mg/l. Therefore, the corresponding weight of ammonia was 17 mg, 34 mg, 68 mg and 2125 mg, and the % weight of ammonia in tank water was 0.0002%, 0.0004% 0.0008% and 0.025%. Water and ammonia molecules weigh the same on the chemical scale. A water molecule consists of 2 atoms of hydrogen and 1 atom of oxygen while an ammonia molecule consists of 1 atom of nitrogen and 3 atoms of hydrogen. When ammonia is added to pH 7 water, 99% of the ammonia molecules bond with the water molecules to form ammonium (NH4) ions. Ammonium ions repel one another. Ammonia (NH3) is polar and readily dissolves in water. The end result is establishment of a widely separated 3D lattice-work of ammonium ions submerged within the experimental tank water volume. Within the experimental tank water is a seemingly endless invisible fog of micron size contaminant nucleation sites interspersed relatively evenly throughout the water volume. When ultrasonic irradiation commences, a significant number of nucleation sites will form micron size bubbles which, with each succeeding pressure wave, will grow until they finally collapse. This cavitation process is repeated over and over again while ultrasonic irradiation continues. However, since the population of ammonium ions are evenly distributed throughout the water volume, there is an equal chance that the ammonium ion population particular to each ammonia/water concentration will experience the same percentage loss of ammonium ions to nitrification at the same time. Hence, all the above levels of ammonia/water concentrations will, as the experiment confirmed, complete the reduction of ammonia concentration to zero in the same time period as each curve is asymptotic to zero. It was reported by O. I. Babikov in 1960, that increasing ultrasonic intensity (W/cm2) shortened the time from cavitation bubble initiation to its catastrophic collapse. More precisely, it is an increase in both the rarefactional and compressional pressure wave amplitudes that shortens the time from cavitation bubble initiation to its catastrophic collapse. Therefore, increasing the ultrasonic pressure amplitude increases the frequency of all individual microsized bubble initiation to collapse events than will occur at a lower ultrasonic pressure amplitudes. Since each ammonium ion situated adjacent to a collapsing microsized bubble undergoes the nitrification process it follows that increasing ultrasonic pressure amplitude shortens the time to reduce a given ammonia/water concentration to zero. FIG. 7 , demonstrates the relationship between ultrasonic pressure amplitude and the sono-molecular-conversion-process duration, in hours, necessary to reduce all the above ammonia/water concentrations to zero. Sono-Molecular-Conversion Mineralization The inventor also experimented with sono-molecular-conversion of organic fish waste (uneaten fish-food) into inorganic ammonia. The fish-food/water mixtures were irradiated at an ultrasound frequency of 30 kHz at intensity settings of 2.0 and 1.0 W/cm2. The concentration of fish food was 1.1 gm/L. The water source experimented with was municipal. FIGS. 3 and 4 and the following tables illustrate the results of the experiments. EXPERIMENT # 6 - Mineralisation Results Summary Table (TETRAFIN flakes, 0.38 gm/l), (see FIG. 5) pH DO NH3/NH4 NO2 NO3 INTENSITY TIME Denitrification Start 7.4 9.5 mg/l 0 mg/l 0.25 mg/l   5 mg/l 2 W/cm2 0 Hrs Finish 0.5 mg/l   0 mg/l 0 mg/l 2 W/cm2 3 Hrs Mineralisation Start 0.5 mg/l   0 mg/l 0 mg/l 2 W/cm2 3 Hrs Finish 4 mg/l 0 mg/l 0 mg/l 2 W/cm2 7 Hrs Nitrification Start 4 mg/l 0 mg/l 0 mg/l 2 W/cm2 7 Hrs Finish 7.4 9.5 mg/l 0 mg/l 0.25 mg/l   5 mg/l 2 W/cm2 35 Hrs  EXPERIMENT #7 - Mineralisation Results Summary Table (CHICLID pellets, 0.38 gm/l), (see FIG. 6) pH DO NH3/NH4 NO2 NO3 INTENSITY TIME Denitrification Start 7.4 9.5 mg/l 0 mg/l 0.25 mg/l 5 mg/l 2 W/cm2 0 Hrs Finish 1 mg/l 0 mg/l 0 mg/l 2 W/cm2 2 Hrs Mineralisation Start 1 mg/l 0 mg/l 0 mg/l 2 W/cm2 2 Hrs Finish 8 mg/l 0 mg/l 0 mg/l 2 W/cm2 9 Hrs Nitrification Start 8 mg/l 0 mg/l 0 mg/l 2 W/cm2 9 Hrs Finish 7.4 9.5 mg/l 0 mg/l <0.25 mg/l 5 mg/l 2 W/cm2 42 Hrs  The inventor's experimentation demonstrated the following interrelationships applicable to sono-molecular-conversion of organic fish waste (uneaten fish-food) into inorganic ammonia. 1) For equal water volumes containing the same measure of organic matter, (fish-food), the time required to reduce organic matter to zero was the same. Zero Organic Matter Concentration was defined as the level of highest ammonia concentration converted by the mineralization process. 2) The time required to decrease a given organic matter concentration to zero (as defined in 1, above) was inversely proportional to the applied ultrasonic intensity (W/cm2). For example, the time necessary to bring organic matter concentration in water to zero with an applied ultrasonic intensity of 2.0 W/cm2 was half that required at 1.0 W/cm2. 3) Following each sono-molecular-conversion mineralization experiment, the water pH remained virtually unchanged, i.e., the increase in pH was slight. After each sono-molecular-conversion mineralization experiment was completed the concentration of dissolved oxygen remained the same or showed a slight increase. 4) Coincident with the point of peak ammonia concentration and the simultaneous reduction of carbon to zero, the nitrification process automatically resumed and continued until the ammonia was reduced to 0.0 mg/L. Sono-Molecular-Conversion Denitrification The inventor's experimentation, demonstrated the following interrelationships are applicable to sono-molecular-conversion denitrification and occurred concurrently with the mineralization conversion of organic matter (uneaten fish-food) to inorganic ammonia. 1) Before denitrification, the residual concentration of nitrite in water was <0.25 mg/L and the residual concentration of nitrate was 5 mg/L. 2) Very rapidly following the sono-molecular-conversion initiation of the mineralization process, the above nitrite and nitrate concentrations within the aqueous medium were converted to inert dinitrogen gas (N2) and released from the water to atmosphere. 3) Thereafter, nitrite and nitrate concentration remained at 0.0 mg/L throughout the mineralization process, i.e., until the concentration of carbon was exhausted and ammonia concentration had peaked. 4) For equal water volumes containing the same measure of organic matter (uneaten fish-food), the time required to decrease a given residual concentration of nitrite and nitrate to zero was the same. 5) The time required to decrease a given concentration of nitrite and nitrate to zero was inversely proportional to applied sono-molecular-conversion intensity (W/cm2). For example, the time necessary to bring nitrite and nitrate concentration in water to zero with a sono-molecular-conversion intensity of 2.0 W/cm2 was half the time required at 1.0 W/cm2. 6) Following each sono-molecular-conversion denitrification experiment, the water pH remained virtually unchanged, i.e., the increase in pH was slight. After each sono-molecular-conversion denitrification experiment was completed, the concentration of dissolved oxygen remained unchanged or showed a slight increase. Sono-Molecular-Conversion Nitrification/Mineralization/Denitrification Each of the above water/contaminate mixture experiments were conducted separately using discrete but varying measures of ammonia (NH3) and organic fish food. Nitrification—For example, several separate concentrations of NH3 were added to the same, but separate volumes of water. Such mixtures were irradiated at specific sono-molecular-conversion intensities (W/cm2) and with 30 kHz ultrasound to create continuous transient cavitation within the mixture until the NH4/NH3 concentration was reduced to 0.0 mg/L. Mineralization—Similarly, several concentrations of organic fish-food were added to the same, but separate volumes of water. Such mixtures were irradiated at specific sono-molecular-conversion intensities (W/cm2) and with 30 kHz ultrasound to create continuous transient cavitation within the mixtures until the organic (carbon) matter was fully converted into inorganic matter as indicated by the maximum concentration of ammonia converted. Denitrification—Concurrent with the reduction of organic matter into inorganic matter (mineralization) it was observed that residual concentrations of nitrite (NO2) and nitrate (NO3) existing in the water volumes before commencement of the mineralization experiment were rapidly reduced to 0.0 mg/L and remained so throughout the mineralisation conversion of organic matter to inorganic matter. In the invention's preferred embodiment, the above separate experiment objectives are combinable and function together as one continuous 24/7 synergistic sono-molecular-conversion process to secure the above nitrification, mineralization and denitrification objectives. In practice, the sono-molecular-conversion intensity (W/cm2), is variably adjusted to the rate of ammonia concentration generated in a given aquaculture tank volume by the quantity of fish contained therein and the quantity of fish-food employed. That is, the sono-molecular-conversion intensity is adjusted in amplitude to reduce ammonia concentration at a rate equal to, or greater than, the combined rate at which the fish gill/urine, fish-food and fish faeces are generating ammonia. The prime-mover for sono-molecular-conversion (SMCP), in the aqueous medium is the presence of negative and positive alternating pressure waves which create micro-sized vapor-bubbles which, commensurate with the applied sono-molecular-conversion frequency, collapse upon reaching resonant size by a phenomenon known as transient cavitation. In the fish aquaculture SMCP application, frequencies of interest extend over the ultrasonic range 20 to 60 kHz with 30 kHz being the frequency of choice. The range for the sono-molecular-conversion intensity setting is adjustable from zero to 10 W/cm2, (zero to 387 kPa) which corresponds to safe ammonia concentration reduction rate for fish cultured at a density of 5 lb/cu ft and estimated un-eaten feed of 1 gm/L. The preferred ammonia detoxification apparatus for the Recirculating Aquaculture System illustrated by U.S. patent application Ser. Nos. 10/676,061, 10/912,608 and 11/042,607 is incorporated herein by reference, and is the same apparatus used herein. However, the invention's SMCP technology is applicable as a “stand alone” ammonia detoxification device for existing RAS, as well as for integration with municipal and industrial organic waste reduction/conversion applications. Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in the light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and the descriptions herein proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

A method for reducing ammonia concentration in an aqueous medium caused by the presence of fish gill/urine discharge, fish faeces and uneaten organic fish-feed particulate matter in recirculating aquaculture tanks. Fish in fish tank water are remotely located or partially isolated from the fish tank water utilized by the sono-molecular-conversion apparatus. Transient cavitation-created, collapsing microsized bubbles generated in the fishless portion of the fish tank water completes ammonia nitrification, mineralization and denitrification therein.

This application is a division of application Ser. No. 09/639,938, filed Aug. 17, 2000, now U.S. Pat. No. 6,599,874, which is a Division of application Ser. No. 08/793,047, filed Jul. 24, 1997, now abandoned, which is a 371 of PCT/SE94/00742, filed Aug. 16, 1994. DESCRIPTION Technical Field The present invention relates to a novel antibacterial protein and compositions, in the form of pharmaceutical compositions, human food compositions, and animal feedstuffs comprising said protein to be used in the therapeutic and/or prophylactic treatment of infections caused by bacteria, in particular Streptococcus pneumoniae and/or Haemophilus influenzae as well as a method for diagnosing infections caused by said bacteria. The object of the present invention is to obtain a protein and compositions containing said protein for prophylactic and/or therapeutic treatment of infections caused by bacteria, in particular Streptococcus pneumoniae and Haemophilus influenzae in the upper airways, ear-nose-and-throat infections, but also in the lower airways, e.g., the lungs by preventing adhesion of and/or causing a bactericidal effect on these bacteria. A further object is to be able to diagnose infections caused by these bacteria. BACKGROUND OF THE INVENTION Natural antimicrobial compounds exist in secreted form as well as in cells of immune and non-immune origin. Human milk has been used as a source for the purification of such compounds. These previously known compounds include specific antibodies to the micro-organism surface structure, casein, lysozyme, and oligosaccharides. The mechanism of action differs between the groups of antimicrobial molecules. Antibodies and receptor analogues prevent micro-organism adherence to mucosal surfaces. Lysozyme attacks the cell wall etc. The term bacterial adherence denotes the binding of bacteria to mucosal surfaces. This mechanic association is a means for the organism to resist elimination by the body fluids, and to establish a population at the site where relevant receptors are expressed. In most cases where the mechanisms of attachment have been identified it is a specific process. The bacterial ligands, commonly called adhesins bind to host receptors. For Gram-negative bacteria, the adhesins are commonly associated with pili or fimbriae, rigid surface organelles that help bacteria to reach the appropriate receptor in the complex cell surface. The fimbriae function as lectins, i.e. they show specificity for receptor epitopes provided by the oligosaccharide sequences in host glyco-conjugates (13). For Gram-positive bacteria, on the other hand, the adhesins are not expressed as a surface organell, but rather linked to cell wall components and lipoteichoic acids (21, 22). The receptor epitopes for Gram positive bacteria may consist of oligosaccharide sequences but can also be provided by peptides e.g. in connective tissue proteins (10). The functional consequences of adherence depend on the virulence of the bacterial strain, and on the form of the receptor. When cell-associated, the ligand receptor interaction facilitates colonization and tissue attack (8). When secreted the receptor molecule will occupy the adhesins, and competitively inhibit attachment to the corresponding cell-bound receptor. Human milk is a rich source of such competing soluble receptor molecules. The ability of specific antibodies to inhibit attachment is well established. This was first demonstrated for Vibrio cholera and oral streptococci. The anti-adhesive antibodies may act in either of two ways: 1) Antibodies to the receptor binding sites of the adhesin competitively inhibit receptor interaction or 2) antibodies to bacterial surface molecules which are not directly involved in adherence may agglutinate the bacteria and thereby reduce the number of organisms available for binding. In either of the above cases the anti-adhesive activity of the antibody is attributed to the specificity of the antigen-combining site. Recently an alternative mechanism of interaction between secretory IgA and E. coli based on lectin-carbohydrate interactions was identified. Human milk drastically inhibits the attachment of Streptococcus pneumoniae and Haemophilus influenzae to human nasopharyngeal epithelial cells. It contains antibodies to numerous surface antigens on these organisms. e.g., the phosphoryl choline and capsular polysaccharides of S. pneumoniae , the lipopolysaccharide and outer membrane proteins of H. influenzae . Accordingly, some of the anti-adhesive activity in milk resides in the immunoglobulin fraction. The remaining anti-adhesive activity in the non-immunoglobulin is fraction of milk may be explained by two types of molecules: free oligosaccharides and glycoproteins in the casein fraction. Human milk is unique with regard to its content of complex carbohydrates. The free oligosaccharide fraction of milk is dominated by the lactoseries and with improving methods of isolation and characterization of carbohydrates more than 130 oligosaccharides containing up to 20 monosaccharides per molecule have been identified. An anti-adhesive activity against S. pneumoniae in a low molecular weight fraction (<5 kDa) of milk was explained by the free oligosaccharides. In contrast there was no such effect against H. influenzae (15). An anti-adhesive activity of high molecular weight components of milk was localized to the casein fraction. Human casein drastically reduced the adherence both of S. pneumoniae and H. influenzae (15). This effect was species specific. Alpha-lactalbumin is a mettaloprotein, which shows some degree of heterogeneity depending on Ca(II) saturation and/or glycosylation (1). Alpha-lactalbumin acts as a specifier protein in the lactose synthase system. During lactation, alpha-lactalbumin is formed in the mammary gland and it alters the substrate specificity of the galactosyltransferase enzyme from N-acetyl glucosamine (GlcNAc) to glucose (Glc), enabling lactose synthesis to take place: Multiple forms of bovine, pig, sheep and goat alpha-lactalbumin have been isolated and well characterized (2, 3). These multiple forms differ in a few amino residues or the number of disulphide bonds (4, 5) but are all active in the lactose synthase system. The physiological relevance or functions of these different forms of alpha-lactalbumin are not known. Alpha-lactalbumin has undergone a high rate of evolutionary change and it shows homology with lysozyme (1). These two proteins are thought to originate from the same ancestral protein. Whereas lysozyme is known as an anti-bacterial agent, alpha-lactalbumin has not yet been found to have antibacterial functions. SUMMARY OF THE INVENTION The present invention describes the identification of a new anti-bacterial protein or group of proteins from milk. The protein comprises a multimeric form of alpha-lactalbumin. In the following this protein, or group of proteins, is abbreviated ALLP, Anti-adhesive. Lactalbumin Like Protein. The term antimicrobial or anti-bacterial protein used in the context of the present invention means here and in the following a protein which inhibits adherence of micro-organisms to tissue and/or exerts a bactericidal effect an microorganisms. Further characteristics of the invention will be evident from the accompanying claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 . The ion-exchange fractionation profile of casein ( FIG. 1A ) and commercial human alpha-lactalbumin ( FIG. 1B ). The arrow represents the time point at which 1 M NaCl was applied. FIG. 2 . Gel chromatographic fractionation profiles of pool VI obtained from fractionation of case in ( FIG. 2A ) and human alpha-lactalbumin before ion-exchange chromatography ( FIG. 2B ). FIG. 3 . Ion-exchange fractionation profile of pool LA 2 obtained after ion-exchange chromatography of alpha-lactalbumin. FIG. 4 . Mass spectrometry of ALLP. DETAILED DESCRIPTION OF THE INVENTION. The present invention will be described more in detail with reference to the example given below. Experimental Purification of the Active Anti-Adhesive and Bactericidal Protein (ALLP) Milk samples from lactating women were screened for anti-adhesive activity against S. pneumoniae and H. influenzae . About 50 l of breast milk with high anti-adhesive activity was collected from one healthy donor and used for the purification of ALLP. About 5 l of milk was thawed at a time and centrifuged to remove fat. Casein was prepared from the defatted milk by acid precipitation at pH 4.6. ALLP was purified as outlined below: (i) Ion-Exchange Chromatography of Casein. Casein was fractionated using an ion-exchange column (14 cm×1.5 cm) packed with DEAE-Tris-acryl M (LKB, Sweden) attached to an FPLC (Pharmacia, Sweden) using a NaCl gradient: 100 mg of the lyophilized casein was dissolved in 10 ml of 0.01 M Tris-HCl, pH 8.5. After centrifugation, the sample was directly applied to the column and the run was under the following conditions: buffer A: 0.01 M Tris-HCl, pH 8.5; Buffer B: buffer A containing 1 M NaCl/l. Gradient program: from 0–3 ml 100% A, from 3–60 ml 15% B; from 60–85 ml 25% B; from 85–87 ml 100% B; from 87–89 ml 100% B for 2 min; from 89–120 ml 100% A. The gradient was not linear, but was interrupted at the elution of each peak for better separation. Flow rate: 1 ml/min, recorder 0.2 cm/min. The buffers were degassed and filtered through a 0.22 um filter before use. The peaks were monitored at 280 nm and the fraction size was 3 ml. Fractions were pooled as shown ( FIG. 1A ). The pools (I–VI) were then desalted by dialysis (membrane cut off 3.5 kD) against distilled water for at least 48 hrs, lyophilized and tested for anti-adhesive activity. (ii) Gel Chromatography of Pool VI 100 mg of the active pool VI obtained after repeated FPLC fractionations of casein, were dissolved in 7 ml 0.06 M sodium phosphate buffer, pH 7.0 and applied to a Sephadex R G-50 (Pharmacia, Sweden) column (93 cm×2.5 cm). Flow rate was 30 ml/hr, peaks were monitored at 280 nm, 3 ml fractions were collected and pooled as shown ( FIG. 2A ). The pools were desalted by dialysis, lyophilized, tested for composition and for anti-adhesive activity. Ion-exchange chromatography of commercial alpha-lactalbumin. 20 mg of commercial (Sigma) human or bovine alpha-lactalbumin were dissolved in 2 ml 0.01 M Tris-HCl, pH 8.5. The ion-exchange chromatography of alpha-lactalbumin was under similar conditions as described above for the fractionation of casein. The NaCl gradient was linear (not interrupted), flow rate was 1 ml/min, 3 ml fractions were collected and pooled as shown in FIG. 1B . The pools were dialysed. (membrane cut-off 3.5 kD), lyophilized, resuspended to the required concentration and tested for anti-adhesive activity. Gel Chromatography of Commercial Alpha-Lactalbumin Approximately 8–10 mg of commercial human or bovine alpha-lactalbumin (Sigma) were dissolved in 3 ml 0.06 M sodium phosphate buffer, pH 7.0 and fractionated on the Sephadex R G-50 column as described above. Flow rate was 30 ml/hr, peaks were monitored at 280 nm, 3 ml fractions were collected and pooled as shown ( FIG. 2B ). The pools were desalted by dialysis (membrane cut-off 3.5 kD) against distilled water for at least, 48 hrs, lyophilized, tested for composition and for anti-adhesive activity. 6–8 mg retained of the material retained and eluting after 1 M NaCl during ion-exchange chromatography of alpha-lactalbumin were dissolved in 5 ml 0.06 M sodium phosphate buffer pH 70 and subjected to gel chromatography on the G-50 column as described above. 3 ml fractions were collected and pooled ( FIG. 3 ). The pools were desalted, lyophilized, and tested for anti-adhesive activity. Polyacrylamide Gradient Gel Electrophoresis (PAGGE). Analytical PAGGE was performed using 4–20%-polyacrylamide pre-cast gels (Bio-Rad, Richmond, Calif.) on a Bio-Rad Mini Protean II cell. To 10/ul (5–10 mg/ml) each of the lyophilized fractions, an equal volume of sample buffer (13.1% 0.5 M Tris-HCl, pH 6.8, 10.5% glycerol, 1.2% SDS and 0.05% bromophenol blue) was added. 20/ul of each was then loaded on to the gel which was run in Tris-glycine buffer (pH 83) with 0.1% SDS at 200V constant voltage for about 40 min. Staining of the proteins was made by immersing the gel in Coomassie Blue solution (0.1% in 40% methanol; 10% acetic acid) for about 0.5 hr. Destaining was by several changes ire 40% methanol, 10% acetic acid until a clear background was obtained. Ion Desorption Mass Spectrometry ALLP and commercial alpha-lactalbumin were analyzed by ion-desorption mass spectrometry. Bacteria S. pneumoniae (CCUG3114 and 10175) and H. influenzae (Hi198) were used throughout the experiments. These strains were known to adhere well to human nasopharyngal epithelial cells in vitro. These strains were initially isolated from the nasopharynx of children with frequent episodes of acute otitis media. The strains were kept lyophilized and were transferred to blood agar (10175) or Levinthal medium agar plates (Hi 198) S. pneumoniae was cultured for 9 hrs at 37° C. in liquid medium (17), harvested by centrifugation and suspended in 1 ml of 0.9% NaCl with 1% choline H. influenzae Hi198 was cultured for 4 hrs in haemophilus medium (18), harvested by centrifugation and suspended in phosphate-buffer saline, (PBS). Adhesion Inhibition Adhesion and inhibition of adhesion was tested as previously described (15, 19). In brief, epithelial cells from the oropharynx of healthy donors ( 10 5 /ml) were mixed with the bacterial suspensions (10 9 /ml). After incubation of bacteria and epithelial cells, unbound bacteria were eliminated by repeated cycles of centrifugation and resuspension in NaCl with 1% choline (10175) or PES (Hi 198). The inhibitory activity of the different fractions was tested by preincubation with bacteria for, 30 min at 37° C. prior to addition of epithelial cells. The number of epithelial cells attached was counted with the aid of an interference contrast microscope (Ortolux II microscope with interference contrast equipment TE Leitz, Wetzlar). Adherence was given as the mean number of bacteria/cell for 40 epithelial cells. Inhibition was given in percent of the value of the buffer control. Results Properties of ALLP ALLP was purified from human milk by fractionation of casein by ion-exchange chromatography and fractionantion of the pool eluting after 1 M NaCl by gel chromatography. The ion-exchange fractionation profile of casein is shown in FIG. 1A . Eluted fractions were pooled as indicated and tested for anti-adhesive activity. Pool VI retained the anti-adhesive activity of casein; this pool inhibited the attachment of S. pneumoniae and H. influenzae by more than 80% of the control (Table 3). The remaining fractions were inactive and were not analyzed further. Pool VI was fractionated by gel chromatography on the Sephadex R G-50 column. The fractionation profile showed two distinct well separated peaks ( FIG. 2A ). Eluted fractions were pooled as shown, desalted, and tested for anti-adhesive activity. Pool K retained 98% of the anti-adhesive activity against S. pneumoniae and 91% of the activity against H. influenzae . Pool L was inactive (Table 3). Analytical PAGGE of pool K showed the presence of bands in the 14–15 kD region, one band in the 30 kD region, and two bands stained in the 100 kD region. Pool L showed the presence of only one band in the 14–15 kD region ( FIG. 2A , inset). The N-terminal amino acid sequence analysis showed that the bands of pool K were similar and were identical to the N-terminal sequence of human alpha-lactalbumin. The active anti-adhesive protein in pool K was designated as Anti-adhesive Lactalbumin Like Protein (ALLP). ALLP reduced attachment of both S. pneumoniae and H. influenzae by about 60% at a concentration of 1 mg/ml Mass Spectrometry of ALLP The results from analytical PAGGE suggested that ALLP might occur in a multimeric form. By ion laser desorption mass spectrometry. ALLP showed three distinct mass fragments (1, 2 and 3) at 14128.7 m/z, 28470.5 m/z and 42787.8 m/z, respectively ( FIG. 4 ). These fragments agreed with the monomeric (14 m/z), dimeric (28 m/z) and trimeric (42 m/z) mass ranges of the protein. Comparison of ALLP and Commercial Alpha-Lactalbumin When tested for anti-adhesive activity, commercial alpha-lactalbumin did not inhibit the adherence of S. pneumoniae or H. influenzae even at a concentration of 10 mg/ml (Table 4). ALLP showed stained bands in the 14–15 kD, 30 kD and the 100 kD regions, whereas the commercial alpha-lactalbumin stained only one band in the 14–15 kD region. The N-terminal amino acid sequence of ALLP showed complete homology with the sequence of human alpha-lactalbumin. The lack of anti-adhesive activity of commercial alpha-lactalbumin, as compared to ALLP, might be due to a difference in their molecular forms. Therefore commercial human aloha-lactalbumin was subjected to ion laser desorption mass spectrometry. The spectrum showed only one mass fragment at 14128.7 m/z corresponding to the monomeric form of alpha-lactalbumin (calculated molecular mass=14.079 kD). Thus commercial human alpha-lactalbumin was in the monomeric form and lacked anti-adhesive activity, whereas, ALLP was found to be multimeric and inhibited the attachment of S. pneumoniae and H. influenzae to human oropharyngeal cells in vitro. Ion-Exchange Chromatography of Human Alpha-Lactalbumin In order to test the effect of ion exchange chromatography on the anti-adhesive effect of commercial human alpha-lactalbumin, 20 mg of the commercial sample was applied onto the Tris-acryl column. The ion-exchange profile is shown in FIG. 1B . About 50% of the material applied was retained on the column and eluted after the application of 1 M NaCl (arrow, FIG. 1B ). The different fractions were pooled as shown. After desalting and lyophilization the fractions were reconstituted to a concentration of about 5–10 mg/ml and tested for anti-adhesive activity. Anti-Adhesive Effect of Human Alpha-Lactalbumin after Ion-Exchange Chromatography Before ion-exchange chromatography commercial human alpha-lactalbumin lacked anti-adhesive activity (Table 4). After it was subjected to ion-exchange chromatography, the pool which was retained and eluted with 1 M NaCl (pool LA 2 , FIG. 1B ) inhibited the attachment of both S. pneumoniae and H. influenzae by more than 95% of the value of the control (Table 4). The other pool (LA 1 ) obtained was inactive. Gel Chromatography of Human Alpha-Lactalbumin before and after Ion-Exchange Chromatography Since about 50% of the commercial human alpha-lactalbumin had become active after ion-exchange chromatography it was decided to check the mobility of the alpha-lactalbumin and pool LA 2 on gel chromatography. The G-50 gel chromatographic profile of human alpha-lactalbumin before ion-exchange chromatography is shown in FIG. 2B . The alpha-lactalbumin eluted as a single peak, which gave a single band (14–15 kD) on PAGGE analysis (inset, FIG. 2B ). This pool LA was found to be inactive when tested for anti-adhesive activity (Table 4). The gel chromatographic profile of the active pool LA 2 , obtained after ion-exchange chromatography of alpha-lactalbumin is shown in FIG. 3 . This pool eluted as two well separated peaks (1 and 2, FIG. 3 ) corresponding to the eluting volumes of peaks K and L of the casein ( FIG. 2A ). When tested for anti-adhesive activity pool 1 retained the activity against both S. pneumoniae and H. influenzae , whereas pool 2 was inactive (Table 4). When pool 1 was analysed by analytical PAGGE a pattern similar to that of ALLP was obtained, bands stained at 14–15 kD region, 30 kD region, and two bands at 100 kD region. Pool 2 gave a single band at the 14–15 kD region, corresponding to monomeric alpha-lactalbumin (inset, FIG. 3 ). Properties of Commercial Bovine Alpha-Lactalbumin. Since commercial human alpha-lactalbumin could be converted to the active multimeric form by ion-exchange chromatography it was decided to test the activity of bovine alpha-lactalbumin and to test its mobility on ion-exchange and gel chromatography. When tested for anti-adhesive activity, bovine alpha-lactalbumin was found to be inactive in inhibiting the attachment of S. pneumoniae and H. influenzae (Table 5). 20 mg of bovine alpha-lactalbumin were subjected to ion-exchange chromatography under similar conditions described above for human alpha-lactalbumin. 50% of the material applied to the column was retained and eluted after 1 M NaCl. The elution pattern was similar to that obtained for human alpha-lactalbumin ( FIG. 1B ). Pool BL 2 of bovine alpha-lactalbumin, corresponding to the elution volume of pool LA 2 of human alpha-lactalbumin ( FIG. 1B ) inhibited the attachment of S. pneumoniae by more than 95% and of H. influenzae by more than 80% of the value of the control (Table 5). When subjected to gel chromatography on the G-50 column as described above, bovine alpha-lactalbumin eluted as a single peak corresponding to the elution volume of human alpha-lactalbumin ( FIG. 2B ). In contrast, the material in pool BL 2 resolved into two distinct peaks corresponding to pools 1 and 2 obtained for human alpha-lactalbumin ( FIG. 3 ). The pool eluting just after the void volume of the column (corresponding to pool 1) retained the anti-adhesive activity, whereas, the other pool was inactive. The active pool had a PAGGE pattern similar to that of ALLP, whereas, the inactive pool stained only one band in the 14–15 kD region. Thus a portion of the commercial bovine alpha-lactalbumin was also converted to the active multimeric form by ion-exchange chromatography. Bactericidal Effect The present ALLP was tested with regard to bactericidal effect on different strains of S. pneumoniae being known to be resistant to antibiotics, and some other strains of Streptococcus, E. coli, H. influenzae and M. cath. Thereby the different bacterial strains were inoculated onto growth plates after incubation with ALLP in different concentrations. The viable counts (CFU) were determined at inoculation, 0.5 h, 2 h, and 4 h (hours), respectively after inoculation. Table 1 below shows the viable counts after incubation to a medium containing 10 mg/ml of ALLP compared with the control. TABLE 1 Viable counts (CFU) on S. pneumoniae strains after exposure to ALLP. Strain Viable counts (CFU) designation 0 h 0.5 h 2 h 4 h 10175 control 2 × 10 6 1 × 10 6 1 × 10 5 1 × 10 4 ALLP 2 × 10 5 — — — 15006-92 control 1 × 10 4 2 × 10 4 1 × 10 3 — ALLP 2 × 10 4 — — — 14060-92 control 2 × 10 6 1 × 10 5 1 × 10 4 — ALLP 2 × 10 5 — — — 15256-92 control 1 × 10 6 2 × 10 6 2 × 10 5 4 × 10 4 ALLP 2 × 10 6 — — — 14326-92 control 4 × 10 5 2 × 10 5 2 × 10 4 2 × 10 3 ALLP 7 × 10 4 — — — Prag 1828 control 5 × 10 6 2 × 10 6 5 × 10 5 — ALLP 5 × 10 6 — — — 14091-92 control 3 × 10 5 5 × 10 5 1 × 10 5 — ALLP 7 × 10 5 — — — 14117-92 control 2 × 10 6 2 × 10 6 2 × 10 6 — ALLP 2 × 10 6 — — — 14612-92 control 3 × 10 5 1 × 10 5 2 × 10 4 1 × 10 3 ALLP 3 × 10 4 — — — Dk 84/87 control 1 × 10 7 5 × 10 6 2 × 10 6 6 × 10 4 ALLP 3 × 10 5 — — — 14007-92 control 1 × 10 5 5 × 10 4 4 × 10 3 — ALLP 1 × 10 5 — — — 14030-92 control 5 × 10 6 2 × 10 6 2 × 10 5 — ALLP 5 × 10 6 2 × 10 1 — — 14423-92 control 6 × 10 5 6 × 10 6 1 × 10 6 6 × 10 5 ALLP 2 × 10 5 3 × 10 1 — — 4502-93 control 4 × 10 5 — — — ALLP 5 × 10 4 — — — SA44165 control 2 × 10 5 5 × 10 3 — — ALLP 3 × 10 5 — — — 1017-92 control 1 × 10 6 5 × 10 5 4 × 10 3 — ALLP 9 × 10 5 — —. — 317-93 control 4 × 10 4 1 × 10 4 5 × 10 3 — ALLP 2 × 10 3 — — — 760-92 control 2 × 10 7 2 × 10 6 1 × 10 4 1 × 10 4 ALLP 8 × 10 6 — — — Hun 859 control 6 × 10 5 3 × 10 5 2 × 10 5 2 × 10 5 ALLP 3 × 10 5 — — — Hun 963 control 1 × 10 7 4 × 10 6 1 × 10 5 — ALLP 5 × 10 6 — — — BN 241 control 4 × 10 6 5 × 10 4 2 × 10 4 — ALLP 2 × 10 5 — — — TABLE 2 Viable counts (CFU) on different bacterial species Strain Viable counts (CFU) designation 0 h 0.5 h 2 h 4 h S. mitis control 1 × 10 6 10 × 10 6   2 × 10 5 1 × 10 5 116 ALLP 1 × 10 6 — — — S. sanguis control 5 × 10 7 3 × 10 7 4 × 10 7 5 × 10 6 197 ALLP 3 × 10 7 2 × 10 5 2 × 10 2 — E. coli control 6 × 10 6 5 × 10 6 3 × 10 6 3 × 10 6 60 ALLP 7 × 10 6 5 × 10 6 1 × 10 7 2 × 10 7 4 control 5 × 10 6 5 × 10 6 5 × 10 6 7 × 10 6 ALLP 5 × 10 6 6 × 10 6 1 × 10 7 2 × 10 7 H. influenzae control 4 × 10 7 1 × 10 7 4 × 10 6 2 × 10 5 21594 ALLP 3 × 10 7 4 × 10 5 <1 × 10 3    <1 × 10 3    21300 control 4 × 10 7 2 × 10 7 5 × 10 6 3 × 10 5 ALLP 4 × 10 7 2 × 10 6 2 × 10 4 2 × 10 3 M. cath. control 4 × 10 5 3 × 10 5 5 × 10 4 2 × 10 4 71257 C+ ALLP 3 × 10 5 2 × 10 5 3 × 10 3 — 71295 C+ control 2 × 10 7 1 × 10 7 3 × 10 6 6 × 10 5 ALLP 2 × 10 7 5 × 10 6 2 × 10 6 3 × 10 5 C+ = beta-lactamase producing A dose response curve was made up based on the bactericidal effect on S. pneumoniae 10175 at different levels of administration of ALLP compared with control (no addition). thereby ALLP was administered at 0.1 mg/ml, 0.5 mg/ml, and 1.0 mg/ml, respectively. As little as 0.1 mg/ml of ALLP provides a bactericidal effect on S. pneumoniae. The viable counts were further determined using different control proteins, viz. bovine serum albumine (BSA), aiphalactal-bumine (bovine origin), lactoferrin (bovine origin) in a concentration of 10 mg/ml, and control (no protein). These proteins had no bactericidal effect on S. pneumoniae 10175. A new form of alpha-lactalbumin (ALLP) with anti-adhesive activity and bactericidal effect against the respiratory tract pathogens S. pneumoniae and H. influenzae was thus isolated and characterized from a human milk sample. Commercial human or bovine alpha-lactalbumin lacked anti-adhesive activity in the assay system. A portion of the commercial human and bovine alpha-lactalbumin was converted to active form by ion exchange chromatography. The active and non-active forms of alpha-lactalbumin showed different mobilities on gel chromatography and their staining patterns on gel electrophoresis were also different. By ion-desorption mass spectrometry analysis, ALLP was found to be in the trimeric form, whereas commercial alpha-lactalbumin was monomeric. The activated forms of commercial human and bovine alpha-lactalbumin showed gel pattern similar to the trimeric form. A portion of the monomeric form of alpha-lactalbumin was separated from the multimeric form and was found to be inactive in inhibiting the adherence of both S. pneumoniae and H. influenzae . The three forms of alpha-lactalbumin (mono, di and tri) existed in some sort of equilibrium after ion-exchange chromatography and could not successfully be separated from each other. This proposes that the active anti-adhesive alpha-lactalbumin (ALLP) is a multimeric form not previously identified in human milk. The identification of ALLP in a previous case in preparation was a result of its purification being monitored by the biological activity (16). It retained all of the anti-adhesive activity of casein and thus could be followed during the purification procedures. This form of alpha-lactalbumin has not previously been disclosed to be present in human milk. The early studies of the present inventors showed that the anti-adhesive effect of human milk against S. pneumoniae and H. influenzae was independent from the specific antibody activity and was concentrated in a casein fraction (15). Casein was, however, found to have both a bactericidal effect and an anti-adhesive effect. A bactericidal effect was present and was found to be more pronounced against S. pneumoniae than H. influenzae . The anti-adhesive activity remained intact after removal of the fatty acids from casein. The mechanism of adhesion inhibition of ALLP was found to be independent from its carbohydrate content. Carbohydrate analysis of ALLP showed the presence of only one monosaccharide unit associated with the molecule. Removal of this monosaccharide unit by glucosidase treatment did not alter the anti-adhesive effect of ALLP. Also since the commercial forms of human and bovine alpha-lactalbumin could be activated by ion-exchange chromatography, it is very unlikely that the carbohydrate play any role in the anti-adhesive or bactericidal effect of ALLP tested by the biological analysis system. Being predominantly a whey protein, alpha-lactalbumin is usually purified from the alpha-lactalbumin rich fractions of whey. Since the monomeric form and the multimeric forms have different mobilities on gel chromatography, the active multimeric forms are lost during the purification procedures. It is thus not surprising that the commercial preparations of alpha-lactalbumin lacked anti-adhesive properties in the present system. Genetic variants of alpha-lactalbumin have been isolated from milk of other mammals including bovine. Most of these forms consist of four disulphide bonds and a form of bovine alpha-lactalbumin with three disulphide bonds have also been isolated (5). The physiological role of these different forms of alpha-lactalbumin is not known. The present data demonstrate that the monomeric alpha-lactalbumin completely lacked biological activity in the present system. Aggregation and polymerization may therefore be an important event in the anti-adhesive activity of ALLP against S. pneumoniae and H. influenzae. The present data demonstrate that the multimeric alpha-lactalbumin is active in adhesion inhibition of the respiratory tract pathogens and can thus play a role in the protection against respiratory and gastro-intestinal infections. It is also active as a bactericide on at least S. pneumoniae , even those being resistant to antibiotics. Comments S. pneumoniae and H. influenzae are important causes of morbidity and mortality in all age groups. Respiratory tract infections, e.g., meningitis, otitis, and sinusitis are caused by bacteria which enter via the nasopharynx. Colonization at that site may thus be an important determinant of disease (18). The finding that a specific alpha-lactalbumin derived from human as well as bovine milk inhibits attachment of both species opens the possibility to prevent colonization by specific interference of attachment using these structures. The bactericidal effect is hereby of importance as well. The importance of the antimicrobial molecules is shown by the protection against infections which is seen in breast-fed babies. Breast-fed babies have a reduced frequency of diarrhoea, upper respiratory tract infections and acute otitis media (AOM). The bacterial species discussed in this application are the most frequent bacterial causes of AOM, viz. Haemophilus influenzae and Streptococcus pneumoniae. As evident from the data shown the alpha-lactalbumin obtained from the human or bovine milk inhibits the attachment of S. pneumoniae and H influenzae to human respiratory tract epithelial cells in vitro. TABLE 3 Bacterial adhesion to oropharyngeal cells after incubation with active human milk, casein, and casein fractions obtained after ion-exchange chromatography on DEAE-Trisacryl Adhesion S. pneumoniae H. influenzae Sample Mean (%) Mean (%) Saline control 150 (100) 200 (100) Human milk 25 (17) 70 (35) Casein 4 (3) 10 (5)  Pool VI 14 (9)  22 (11) Pool K 3 (2) 17 (9)  Pool L 159 (100) 178 (89)  TABLE 4 Bacterial adhesion to oropharyngeal cells after incubation with human alpha-lactalbumin and the fractions obtained after ion-exchange chromatography and gel chromatography. Adhesion S. pneumoniae H. influenzae Sample Mean (%) Mean (%) Saline control  138 (100)  130 (100) Human alpha-lactalbumin 124 (90) 110 (85) Pool LA 2  4 (3)  9 (7) Pool LA 123 (93)  76 (58) TABLE 5 Bacterial adhesion to oropharyngeal cells after incubation with bovine alpha-lactalbumin and the fractions obtained after ion-exchange chromatography and gel chromatography. Adhesion S. pneumoniae H. influenzae Sample Mean (%) Mean (%) Saline control 138 (100) 130 (100) Bovine alpha-lactalbumin 130 (94)  99 (76) Pool BL 2 3 (2) 18 (14) Applications The alpha-lactalbumin of the present invention can be administered in the form of an oral mucosal dosage unit, an injectable composition, or a topical composition. In any case the protein is normally administered together with commonly known carriers, fillers and/or expedients, which are pharmaceutically acceptable. In case the protein is administered in the form of a solution for topical use the solution contains an emulsifying agent for the protein together with an diluent which can be sprayed into the nasopharynx, or can be inhaled in the form of a mist into the upper respiratory airways. In oral use the protein is normally administered together with a carrier, which may be a solid, semi-solid or liquid diluent or a capsule. These pharmaceutical preparations are a further object of the present invention. Usually the amount of active compound is between 0.1 to 99% by weight of the preparation, preferably between 0.5 to 20% by weight in preparations for injection and between 2 and 50% by weight in preparations for oral administration. In pharmaceutical preparations containing a protein of the present invention in the form of dosage units for oral administration the compound may be mixed with a solid, pulverulent carrier, as e.g. with lactose, saccharose, sorbitol, mannitol, starch, such as potatoe starch, corn starch, amylopectin, cellulose derivatives or gelatine, as well as with an antifriction agent such as magnesium stearate, calcium stearate, polyethylene glycol waxes or the like, and be pressed into tablets. Multiple-unit-dosage granules can be prepared as well. Tablets and granules of the above cores can be coated with concentrated solutions of sugar, etc. The cores can also be coated with polymers which change the dissolution rate in the gastrointestinal tract, such as anionic polymers having a pk a of above 5.5. Such polymers are hydroxypropylmethyl cellulose phtalate, cellulose acetate phtalate, and polymers sold under the trade mark Eudragit S100 and L100. In the preparation of gelatine capsules these can be soft or hard. In the former case the active compound is mixed with an oil, and the latter case the multiple-unit-dosage granules are filled therein. Liquid preparations for oral administration can be present in the form of syrups or suspensions, e.g., solutions containing from about 0.2% by weight to about 20% by weight of the active compound disclosed, and glycerol and propylene glycol. If desired, such preparations can contain colouring agents, flavouring agents, saccharine, and carboxymethyl cellulose as a thickening agent. The daily dose of the active compound varies and is dependent on the type of administrative route, but as a general rule it is 1 to 100 mg/dose of active compound at peroral administration, and 2 to 200 mg/dose in topical administration. The number of applications per 24 hrs depend of the administration route, but may vary, e.g. in the case of a topical application in the nose from 3 to 8 times per 24 hrs, i.a., depending on the flow of phlegm produced by the body treated in therapeutic use. In prophylactic use the number may be on the lower side of the range given. The topical form can preferably be used in prophylactic treatment, preferably in connection with an infection caused by a rhinitis virus. The protein can also be used as an additive in infant food, particularly for prophylactic reasons, in order to supply the casein in an easy way to the child. Infants normally reject pharmaceuticals for different reasons. The food product can thus be in the form of a pulverulent porridge base, gruel base, milk substitute base, or more complex food product as of the Scotch collops type, comprising vegetables and meat pieces, often in disintegrated form. In the case of protein administration to animals they are normally added to the feedstuffs, which besides the protein contains commonly used nutrients. In accordance with a further aspect of the invention there is provided a process for determining the presence of S. pneumococci and H. influenzae in a sample taken from the respiratory tract of an animal or human. This process is based on the technique of determining the degree of interaction between the bacteria of the sample and a composition of the present invention. Such interaction may be determined by inhibition or induction or the adherence of the bacteria to cells or other surfaces. REFERENCES 1. McKenzie, H. A., White, F. H. Jr Adv. Protein Chem. 41:173, 1991 2. Hopper, K. E. and McKenzie, H. A. Biochim. Biophys. Acta 295:352, 1973 3. Schmidt, D. V. and Ebner, K. E. Biochim. Biophys. Acta 263:714, 1972 4. Maynard, F. J. Dairy Res. 59:425, 1992 5. Barman, T. E. Eur J. Biochim. 37:86, 1973 6. Readhead, K., Hill, T. and Mulloy, B. FEMS Microbiol Lett. 70:269, 1990 7. Gilin, F. D., Reiner, D. S. and Wang, C. S. Science 221:1290, 1983 8. Fiat, A.-M., and Jolles, P. Mol. Cell Biochem. 87:5, 1989 9. Matthews, T. H. J., Nair, C. D. G., Lawrence, M. K. and Tyrrell, D. A. J. Lancet, December, 25:1387, 1976 10. Andersson, B., Dahmén, J., Frejd, T., Leffler, H., Magnusson, G., Noori, G., and Svanborg, C., J. Exp. Med., 158:559, 1983 11. Svanborg, C., Aniansson, G., Mestecky, J., Sabharwal, H., and Wold, A. In Immunology of milk and the neonate, J. Mestecky ed. Plenum Press, New York, 1991 12. Svanborg-Edén, C. and Svennerholm, A.-M., Infect. Immun. 22:790, 1978 13. In Microbial lectins and agglutinins, properties and biological activity, Mirelman, D., Wiley, New York, 1986 14. Andersson, B., Porras, D., Hansson, L. {dot over (A)}., Lagerg{dot over (a)}rd, T. and Svanborg-Edén, C. J. Infect. Dis. 153:232, 1986 15. Aniansson, G., Andersson, B., Lindstedt, R., and Svanborg, C., Microbial Pathogenesis 8, 365, 1990 16. Sabharwal, H., Hansson, C., Nilsson, A. K., Saraf, A., Lönnerdahl, B., and Svanborg, C. 1993, submitted 17. Lacks, S., and Hotchiss, R. D. Biochim. Biophys. Acta, 38:508, 1960 18. Branefors-Helander, P. Acta Pathol. Microbiol. Immunol. Scand. (B), 80:211, 1972 19. Porras, O., Svanborg Edén, C., Lagerg{dot over (a)}rd, T., and Hansson, L. {dot over (A)}. Eur. J. Clin. Microbiol., 4, 310–15, 1985 20. Vanaman, T. C., Brew, K., and Hill, R. L. J. Biol. Chem. 245:4583, 1970 21. Beachey, E. H., J. Infect. Dis. 143, 325, 1981 22. Andersson, B., Beachey, E. H., Tomasz, A., Tuomanen, E., and Svanborg, C., Microbial Pathogenesis, 4, 267, 1988 23. Andersson, B., Eriksson, B., Falsén, E., et al Infect. Immun. 32, 311–17, 1981

The present invention relates to the use of alpha-lactalbumin in the preparation of preparations to be used in therapeutic or prophylactic treatment and/or for diagnostic use for infections, preferably of the respiratory tract, caused by bacteria, in particular S. Pneumoniae and/or H. Influenzae. The present invention further relates to essentially pure protein complexes comprising alpha-lactalbumin and the use of these protein complexes for therapeutically or prophylactically treating a bacterial infection, especially infections of the respiratory tract caused by S. Pneumoniae and/or H. Influenzae.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. provisional Ser. No. 60/483,699, filed Jun. 30, 2003. BACKGROUND OF THE INVENTION [0002] This invention concerns collapsible portable supports as used in camping for chairs, tables, etc. The collapsible design allows these items to be brought along on camping trips since the amount of space required in a vehicle is greatly reduced. [0003] Camping usually involves cooking and washing of utensils, dishes, etc. Heretofore, washing the dishes has been quite inconvenient when, with the water stored in an often collapsible heavy jug and rinsing and washing in separate dishpan being quite awkward. Dispensing water from a large jug is also itself inconvenient. [0004] It is an object of the present invention to provide a collapsible two tier support for convenient washing of dishes in a pan on a lower support and dispensing of water from a water jug on an adjacent upper support. SUMMARY OF THE INVENTION [0005] The above object and others which will be understood upon a reading of the following specification and claims are achieved by a two tier collapsible support. The support is formed by four elongated uprights arranged vertically spaced apart and parallel to each other in a rectangle with a fabric panel attached at their upper ends to provide a first generally planar support surface as for holding a water jug. The four uprights have pivoted cross brace sets interconnected to respective pairs of adjacent uprights to be braced in their spaced apart position. [0006] Four sets of pivoted cross braces, each connected to an adjacent pair of uprights have brace members having a pivotal connection together with the bottom ends of the uprights to connector pieces. The upper ends of the brace members are connected to connector pieces slidable on a respective upright at an intermediate region thereof. [0007] A second fabric rectangular panel support is connected on one side of one pan of the uprights by an additional three sets of pivoted cross braces, arranged in a rectangle together with one of the cross brace sets interconnecting the uprights. The second fabric panel provides a second panel horizontal support surface at a lower height than the first horizontal support surface and immediately adjacent thereto. [0008] The entire assemblage can be collapsed laterally to bring all four uprights and cross brace members together by pivoting of the cross brace members. DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a pictorial view of a two tier collapsible support according to the present invention, with supported items shown in phantom lines. [0010] FIG. 2 is a side elevational view of the two tier collapsible support shown in FIG. 1 . [0011] FIG. 3 is a front view of the two tier collapsible support shown in FIGS. 1 and 2 . [0012] FIG. 4 is a pictorial collapsed view of the collapsible support shown in FIGS. 1 - 3 . [0013] FIG. 5 is an enlarged pictorial view of one of the short upright cross bracing connector pieces incorporated in the two tier support shown in FIGS. 1-4 , with fragmentary portions of the connected upright and cross bracing member. [0014] FIG. 6 is an enlarged pictorial view of the rear upright connector-cross bracing connector pieces, with a fragmentary portion of a rear upright and a cross bracing member. [0015] FIG. 7 is an enlarged pictorial view of a connector piece connecting the forward pair of uprights to members of three adjacent cross bracing sets, with a fragmentary view of the adjacent portions of the upright and cross brace set members. [0016] FIG. 8 is an enlarged pictorial view of a sliding connector piece fixed to a cross bracing member and slidable on an upright, portions of both shown in fragmentary form. [0017] FIG. 9 is a fragmentary pictorial view of one corner of fabric panel forming an upper planar support and adjacent portion of an upright. [0018] FIG. 10 is a fragmentary pictorial view of an inside corner of a fabric panel forming a lower horizontal support and adjacent portions of an upright and cross bracing members. DETAILED DESCRIPTION [0019] In the following detailed description, certain specific terminology will be employed for the sake of clarity and a particular embodiment described in accordance with the requirements of 35 USC 112, but it is to be understood that the same is not intended to be limiting and should not be so construed inasmuch as the invention is capable of taking many forms and variations within the scope of the appended claims. [0020] Referring to the drawings, and particularly FIGS. 1-4 , a collapsible two tier support 10 according to the invention includes an upper generally planar support surface 12 provided by a rectangular durable (nylon, etc.) fabric panel 14 attached at each corner to an upper end of a respective elongated upright 16 . [0021] A second lower generally planar support surface 18 is provided adjacent and below the upper support surface 16 by a rectangular fabric panel 20 attached to two forward corners to the top ends of two cross brace members 22 , and at two rear corners to two of the uprights 16 A, 16 B at an intermediate height as well as the upper ends of the cross brace set members interconnecting the uprights 16 A, 16 B. [0022] A mesh material storage bag 24 can be attached to one side of the lower fabric panel 20 . [0023] This arrangement provides a planar support for a water jug 26 on the upper support surface 12 above a dishpan 28 on the lower support surface 20 for convenient dishwashing. [0024] Each pair of the uprights 16 are interconnected by one of four cross brace sets 30 A, B, C, D, respectively mounted between each adjacent pair of uprights 16 by bottom connector pieces 32 A, B and 34 A, B and intermediate connector pieces which comprise inverted connector pieces 32 C, D and 34 C, D. [0025] Such connector pieces are commercially available and used in other types of collapsible furniture. [0026] Connector pieces 32 A-D ( FIG. 6 ) comprised molded plastic bodies having a vertical hole 38 able to receive the lower end of an upright 16 (secured with a screw, not shown) and walls 40 , 42 to which the lower ends of two cross brace members 44 are pivotally attached. [0027] Connector pieces 32 C, D ( FIG. 8 ) are the same as connector pieces 32 A, B but are inverted to receive the upper ends of cross brace members 44 . The uprights 16 C, D pass completely through holes 38 and are slidable thereon. [0028] Connector pieces 34 A, B ( FIG. 7 ) are also molded plastic bodies which have three vertical walls 46 , 48 , 50 to which are pivotally attached to the lower ends of three cross brace members 44 , and a hole 52 receiving a lower end of an upright 16 A or 16 B. [0029] Connector pieces 34 C, D are the same but are inverted and slidable on the uprights 16 A, B along an intermediate section thereof. [0030] There are three forward cross brace sets 30 E, F, G arranged in a rectangle with the forward cross brace set 30 D between uprights 16 C, D. [0031] The lower ends of formed cross brace members 44 of the cross brace sets are pivotally mounted to connector pieces 32 E, F ( FIG. 5 ) configured the same as connector pieces 32 A-D. [0032] The lower ends of the rear cross brace members 44 of cross brace sets 30 E, G are secured in connector pieces 34 A, B. [0033] The upper ends of the forward cross brace members 44 of cross brace sets 30 E, F, G are pivoted to inverted connector pieces 32 G, H. [0034] The rear upper ends of cross braces 30 E, G are pivotally mounted to connector pieces 34 D, C. [0035] The fabric panels 14 , 20 each have grommets at their corners ( FIGS. 9, 10 ). The upper fabric panel 20 is secured with headed plastic pieces 58 secured with screws (not shown) passing up through associated connector pieces 32 I, J. [0036] The entire assemblage can be collapsed by lifting, the same and pushing the uprights 16 and cross braces 30 E, F, G together in both orthogonal horizontal directions, to the greatly compacted condition shown in FIG. 4 . [0037] This allows for convenient storage and transport to provide a practical use in camping expeditions.

A collapsible two tier support as for use in camping dishwashing is formed by four uprights connected by pivoted cross brace sets and having a fabric panel defining on upper support connected to the tops. Additional cross brace sets support a second fabric panel at a lower level adjacent the uprights. The entire assemblage is collapsible by pivoting action of the cross brace members.

BACKGROUND OF THE INVENTION This invention relates to a structure of a device for varying the inclination in ski boots. As is known, ski boots in their most traditional embodiments comprise a shell to which there is pivotally connected for oscillation about a horizontal axis transverse to the longitudinal direction of the shell, a quarter in the instance of a front entrance ski boot, or possibly a front quarter and a rear quarter in the instance of rear entrance ski boots. For all these types of ski boots, growing acceptance is being gained by devices which enable the mutual inclination of the quarter(s) on the shell to be adjusted both lengthwise, i.e. on a vertical plane which lies through the longitudinal centerplane of the boot, and the side inclination, i.e. on a vertical plane transverse to the former. The currently known devices generally require external accessory means for effecting the inclination adjustment, which are unpopular with the users because the accessory elements required to effect the adjustment are liable to get lost and the known devices are generally fairly complicated to adjust. Another drawback of the prior art approaches is that such inclination adjusting devices are constructionally highly complex and unwieldly, thereby they may alter the traditional configuration of the boot. SUMMARY OF THE INVENTION It is the aim of this invention to obviate such prior drawbacks by providing a structure of a device which enables effectuation of the desired adjustment without resorting to accessory elements externally of the boot, and which enables the adjustment to be performed through extremely simple and quick operations. Within the above general aim, it is a particular object of the invention to provide a device which has a much simplified construction and an extremely reduced bulk, thereby it can be easily accommodated in the boot without the need to modify its intrinsic structure. Another object of this invention is to provide a structure of a device which is formed with few component elements which can be readily and quickly assembled together. A not unimportant object of this invention is to provide a structure of a device for varying the inclination in ski boots which has a much reduced cost, thus favoring its widespread acceptance and use. The above aim, as well as these and other objects to be made apparent hereinafter, are achieved by a structure of a device for varying the inclination in ski boots, according to the invention, characterized in that it comprises, on either of the two mutually movable parts of a ski boot, a detent block lockable releasably in a presettable position of said part and engageable by contact with an abutment detent defined on the other of said parts. BRIEF DESCRIPTION OF THE DRAWINGS Further features and advantages will be apparent from the detailed description of a structure of a device for varying the inclination in ski boots, as shown by way of illustration and not of limitation in the accompanying drawings, where: FIG. 1 shows a ski boot, of the rear entrance type, incorporating the device of this invention; FIG. 2 shows a front entrance ski boot incorporatng the device of this invention; FIG. 3 shows the device of this invention as applied to a ski boot for varying lateral inclination; FIG. 4 shows, in section, the device of this invention as applied to a rear entrance ski boot; FIG. 5 shows, in section, the device of FIG. 4 in a different operative position thereof; and FIGS. 6 and 7 show, in section and in two different operative positions, the device as applied to vary the side inclination. DESCRIPTION OF THE PREFERRED EMBODIMENTS With reference to the cited drawing figures, a structure of a device for varying the inclination in ski boots, according to the invention, which is generally designated with the reference numeral 1, comprises an engagement or detent block 2 which is associated with either of the mutually movable parts of a ski boot, preferably a generally flat body portion 3a of the quarter 3. The block 2 has, at a middle portion thereof, an elongate slit 4 which is laid side-by-side, at its longitudinal edges, with a serration 5. The cited block 2 is shown to be coupled to the quarter 3 through a stem 10 passed slidably through the elongate slit 4 and terminating in engagement teeth 11 which are removably coupleable with the serration 5. The stem 10 has, externally of the quarter 3, a pushbutton element 12 which is accessible from the outside. Between the pushbutton element 12 and a recess 14 defined in the quarter, there is active an elastic means comprising a spring 15 which has the function of holding the engagement teeth 11 elastically engaged with the serration 5. By applying a compressive action to the pushbutton element 12, by translation of the stem 10 along its own axis, the engagement teeth 11 are disengaged from the serration 5 and it becomes possible to provide a mutual sliding movement between the stem and the slit in the block, thereby obtaining a different positioning of the teeth 11 in the serration 5, in order to obtain the desired positioning of the detent block 2 relatively to the quarter. The block 2 acts in abutting relationship with an abutment detent 40 defined on the other of the two mutually movable parts and in this particular case on a generally flat body portion 50a of the shell 50 of the ski boot overlapped by the generally flat body portion 3a of the quarter 3. It should be added to the foregoing that an elastic pusher means 24 is provided which acts between the block 2 and an abutment wing 25 defined by the quarter, which have the function of elastically pushing the block 2 to abut against the abutment detent 40 on effecting the disengagement between the teeth 11 and serration 5. In practical use, the user, in order to perform a desired adjustment, one simply has to exert a pressure action on the pushbutton 12 to obtain the disengagement of the teeth 11 from the serration 5, and the obtain the desired positioning between the quarter and shell, thereafter on releasing the pushbutton 12, the teeth 11 by engaging in the new position on the serration 5 will retain the set inclination. It should be also pointed out that the device, as illustrated above, may be applied to the front portion, front quarter or shell of the boot, where it is used to adjust the inclination in rear entrance ski boots, or possibly to the rear portion, where the device is used to adjust the inclination in front entrance ski boots. It could be possible to use the device for adjusting the side inclination, as shown diagrammatically in FIG. 3, in which case it is convenient that the block 2 be attached to the shell 50. It may be seen from the foregoing that the invention achieves the proposed objects, and in particular that the device can be operated by simply acting with a pressure action on the pushbutton 12, without requiring accessory elements or complicated actuations, since the coupling of the detent block is simply effected by engaging the engagement teeth, PG,7 11, as provided on the stem 10, with the serration 5 which is provided on the block 2, with the possibility of selecting over a wide range the mutual positioning of the teeth 11 and serration 5. Another important aspect is the fact that a set inclination would be retained without involving the use of any special locking devices, but by merely exploiting the elastic action which, by urging the pushbutton 12 outwards, holds the teeth 11 engaged with the serration 5. In practicing the invention, the materials used, so long as compatible with the specific use, and the dimensions and contingent shapes may be any ones meeting individual application requirements.

The device for varying the inclination in ski boots comprises, on either of the two mutually movable parts of a ski boot, a detent block releasably lockable at a presettable position of said part and engageable by contact with an abutment detent defined on the other of said parts.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This is a divisional of U.S. patent application Ser. No. 09/936,319, filed on Dec. 19, 2001. FIELD OF THE INVENTION [0002] The present invention relates to the use of xenon for treating neurointoxications. More particularly, the present invention relates to a use of xenon in which the neurointoxication is caused by a neurotransmitter excess. BACKGROUND OF THE INVENTION [0003] The uncontrolled release of neurotransmitters, particularly glutamate, noradrenalin and dopamine, is responsible for many acute and chronic intoxications of the brain. These are called neurointoxications or neuropoisonings. These neurotransmitters kill the affected neurons either by induction of apoptosis (controlled cell death) and/or secondarily by their metabolites, by forming oxygen radicals which in turn have toxic effects. An uncontrolled release of neurotransmitters which result in a strongly increased concentration of the neurotoxins in the affected tissue, can be due to various endogenous or exogenous causes. For example, an increased release of glutamate or dopamine may result in an acute craniocerebral trauma. An increase in the neurotransmitter release has also been observed as a response to oxygen deficiency in the brain, e.g. in the case of apoplexy (ischemia) or in the case of other hypoxias, particularly during childbirth. Drug abuse represents another cause of impaired neurotransmitter release. In certain forms of schizophrenia, stress-induced relapses back into schizophrenia (acute episodes) are also accompanied by increased neurotransmitter release. Finally, a chronic shift of neurotransmitter balance, particularly of dopamine balance, has also been observed in various regions of the brain in the case of Parkinson's disease. Increased dopamine release and subsequent formation of free radicals occur in that case as well. Various investigations made with cell cultures and experimental animals have proven the release of neurotransmitters, particularly as a result of oxygen deficiency. [0004] For example, it can be shown that in rats into which the dopamine neurotoxin 6-hydroxy-dopamine was infused unilaterally into the substantia nigra, which resulted in a unilateral depletion of dopamine in the ipsilateral striatum, an experimentally induced ischemia in the regions of dopamine depletion led to damage which was less than that in other regions of the brain. These results suggest that dopamine plays a part in ischemia-induced striatal cell death (Clemens and Phebus, Life Science, Vol. 42, p. 707 et seq., 1988). [0005] It can also be shown that dopamine is released in great amounts from the striatum during cerebral ischemia (Kahn et al., Anest.-Analg., Vol. 80, p. 1116 et seq., 1995). [0006] The release of neurotransmitters during cerebral ischemia was investigated in detail and seems to play a key role for excitotoxic neural death. For example, Kondoh et al., Neurosurgery, Vol. 35, p. 278 et seq., 1994, showed that changes in the neurotransmitter release and metabolization can reflect changes in the cellular metabolism during ischemia. The increase in the extracellular dopamine concentration in the striatum of experimental animals in which experimental apoplexies were induced, is well documented. [0007] The contribution of excess dopamine to neuronal damage can be derived from the ability of dopamine antagonists to obtain protection of the neurons in ischemia models (Werling et al., Brain Research, Vol. 606, p. 99 et seq., 1993). In a cell culture, dopamine primarily causes apoptosis of striatal neurons, without damaging the cells by a negative effect on the oxidative phosphorylation the (ATP/ADP ratio remains unchanged). However, if its effect is combined with a minimum inhibition of mitochondrial functions, the neurotoxic effect of dopamine will be increased significantly (McLaughlin et al., Journal of Neurochemistry, Vol. 70, p. 2406 et seq., 1998). [0008] In addition to the direct hypoxic toxicity on neurons, the stress induced by oxygen deficiency, particularly during a birth, effects an increased dopamine release, which results in a negative conditioning of the brain for dopaminergic regulations. This means that even children who seem to survive a hypoxic birth phase uninjured, have a tendency towards convulsions and epileptic conditions when they are older. [0009] Another cause of a disturbed neurotransmitter release is represented by drug abuse. In particular, if drugs such as designer drugs (e.g. ecstasy, etc.) or heroin are consumed, and amphetamines are overdosed, the persons will show signs of intoxication and often spasmophilia, which is based on an increased neurotransmitter release. [0010] The causes of schizophrenia are also due to a complex impairment of the neurotransmitter regulation. Schizophrenia patients are often asymptomatic over a prolonged period of time, but they have a tendency towards spontaneous schizophrenia attacks which are obviously triggered by a stress-induced dopamine release, even in minor stress situations. Here, one speaks of catatonic schizophrenia. Further neuropsychiatric diseases which are based on an increased neurotransmitter release are depressions and Gilles de la Tourette syndrome (“maladie de tics”, “Tics impulsif”). [0011] Finally, one cause of Parkinson's disease is presently believed to be in dopamine modulation and in dopamine metabolism. In Parkinson's disease, dopaminergic neurons in the striatum are especially damaged. References exist to the effect that Parkinson's disease is caused by a dopamine excess in the affected region of the posterolateral hypothalamus and the substantia nigra. Many neurons which have lost their functionality but not their vitality are found in this region. These neurons, referred to as “orphan neurons,” continuously release neurotransmitter amounts having pathologic effects. [0012] With the exception of Parkinson's disease, where dopa precursors are used as preparations, basically of schizophrenia, no therapeutic approaches presently exist which focus on a reduction of the dopamine concentration in the environment of endangered cells. [0013] Therefore, there is a demand for a preparation which reduces or prevents the damaging effects of uncontrolled neurotransmitter release, e.g. of dopamine, glutamate or noradrenalin, from neurons. It is therefore an object of the present invention to provide such a preparation which can be of use in the above-mentioned, as well as in other fields of application. SUMMARY OF THE INVENTION [0014] In accordance with the present invention, these and other objects have now been realized by the discovery of a method for treating a mammal for neurointoxication comprising treating the mammal with a xenon-containing gas. Preferably, the xenon-containing gas comprises a mixture of gases. [0015] In accordance with one embodiment of the method of the present invention, the neurointoxication is caused by an excess of neurotransmitter in the mammal. [0016] In accordance with another embodiment of the method of the present invention, treating of the mammal with the xenon-containing gas comprises reducing the release of neurotransmitters in the mammal. Preferably, the neurotransmitters are dopamine, glutamate and/or noradrenalin. [0017] In accordance with another embodiment of the method of the present invention, the neurointoxication is caused by apoplexy. In other embodiments, the neurointoxication is caused by drug abuse, oxygen deficiency during birth, a craniocerebral trauma, loss of hearing, or migraine. [0018] In accordance with another embodiment of the method of the present invention, the neurointoxication is correlated with a condition such as Parkinson's disease, schizophrenia, or Gilles de la Tourette syndrome. [0019] In accordance with another embodiment of the method of the present invention, the treating of the mammal with the xenon-containing gas comprises using a cardio-pulmonary bypass machine. [0020] In accordance with another embodiment of the method of the present invention, the xenon-containing gas comprises an administered preparation containing from 5 to 90% by volume of the xenon. [0021] In accordance with another embodiment of the method of the present invention, the xenon-containing gas comprises an administered preparation containing from 5 to 30% by volume of the xenon. [0022] In accordance with another embodiment of the method of the present invention, the xenon-containing gas comprises an administered preparation containing a gas such as oxygen, nitrogen or air. Preferably, the xenon-containing gas comprises oxygen, and the ratio of the xenon to the oxygen is from about 80 to 20% by volume. [0023] In accordance with another aspect of the present invention, a treatment method has been discovered comprising using xenon as a neuroprotectant. [0024] In accordance with yet another aspect of the present invention, a method of providing neuroprotection in a mammal has been discovered, the method comprising administering to the mammal a therapeutically effective amount of xenon. Preferably, the method includes administering the xenon in combination with a compound such as a pharmaceutically acceptable carrier, diluent and/or excipient. [0025] In accordance with another embodiment of this method of the present invention, the method includes treating the mammal for a condition associated with NMDA receptor activity. [0026] In accordance with another embodiment of this method of the present invention, the method includes treating the mammal for a condition associated with NMDA receptor activation. [0027] In accordance with another embodiment of this method of the present invention, the xenon reduces the level of activation of the NMDA receptor. [0028] In accordance with yet another aspect of the present invention, a process has been provided for the preparation of a pharmaceutical composition suitable for neuroprotection, the process comprising adding xenon to a component such as a pharmaceutically acceptable carrier, excipient and/or diluent, and using the xenon as a neuroprotectant. [0029] In accordance with the present invention, it has been found that the noble gas xenon surprisingly now reversibly suppresses the release of neurotransmitters, particularly dopamine and glutamate. This unexpected discovery has thus created the possibility of producing preparations for treating cell damage and diseases, respectively, which are caused by an increased neurotransmitter release, and particularly dopamine release or glutamate release. [0030] Correspondingly, the present invention generally relates to the use of xenon for treating neurointoxications, and on the production of a preparation containing xenon for treating neurointoxications, respectively. The present invention also relates to the preparations per se and to a method of producing same. Such neurointoxications particularly concern an excess of neurotransmitter. The present invention is particularly based on the insight that xenon reduces the release of dopamine and/or glutamate. BRIEF DESCRIPTION OF THE DRAWINGS [0031] The present invention may be more fully appreciated with reference to the following detailed description, which, in turn, refers to the Figures wherein: [0032] [0032]FIG. 1A is a graphical representation of the release of dopamine under various hypoxic situations; [0033] [0033]FIG. 1B is a graphical representation of relative dopamine concentration as a result of various hypoxic situations; and [0034] [0034]FIG. 2 is a graphical representation showing release of dopamine in various stress situations. DETAILED DESCRIPTION [0035] According to the present invention neurointoxications are understood to mean acute or chronic “states of poisoning” of the central nervous system (CNS), and particularly of the brain, which in most cases result in severe deficiency symptoms of the affected areas. These states of poisoning result from an excess of neurotransmitter, particularly of glutamate, noradrenalin and/or dopamine, which can be due to a variety of causes. The above-mentioned diseases, such as apoplexy, hypoxias, oxygen deficiency during a birth, Parkinson's disease, craniocerebral trauma, drug abuse, schizophrenia, depressions and Gilles de la Tourette syndrome are among those that can be mentioned here. The inventors have also found that patients who must be connected to a cardio-pulmonary bypass machine often suffer from cerebral deficiency symptoms which are due to an excess of neurotransmitter caused by hypoxia. For example, the use of a cardio-pulmonary bypass machine can cause an often unidentified neurointoxication, which delays the patient's reconvalecence to a considerable extent. It has also been found that any prolonged artificial respiration can result in undesired neurointoxication as a side-effect. In recent investigations conducted by the inventors, the surprising insight has been gained that the hearing loss (e.g. due to noise, presbycusis, tinnitus, or sudden deafness) can also be caused by neurointoxication. The excess neurotransmitter release, particularly excessive glutamate and dopamine release, which can have been caused e.g. by an impairment in the body, an acoustic trauma, or an ischemia, results in an acute destruction of the nerve endings and subsequently death of the corresponding nerves in the hearing organs. Migraine has to be considered another disease which is most likely due to an impaired dopamine balance, and thus to neurointoxication. [0036] The discovery that the neurotransmitter release can be influenced by xenon enables an entirely new field of application for this noble gas, which has up to now been used increasingly as an inhalation anesthetic agent in the field of anesthetics. The treatment of the differing neurotransmitter excess diseases of the brain, such as those discussed above, can be carried out on the basis of the present invention by a simple inhalation therapy. The uptake of xenon by means of the respiratory system, and transport into the brain, are already proved by its use as anesthetic agent. It can also be assumed that the use of xenon has no damaging effect on the human organism, since many corresponding experiences can be realized by its use as an anesthetic agent. Xenon can be applied by various techniques, which can be chosen as a function of the location of use. For example, inhaling apparatus can be used in the clinics, which are also used for anesthesia by inhalation. If a cardio-pulmonary bypass machine or other artificial breathing apparatus is used, xenon can be added directly in the machine, and thus requires no further apparatus. In this case, standard xenon addition can prevent the formation of neurointoxications in the model case (prophylaxis) or at least reduce the deficiency symptoms. On an ambulant basis, e.g. in the primary treatment of victims of an accident, it is possible to use simpler inhalators which mix the xenon with the ambient air during the process of inhalation. In this connection, it is also possible to adapt the xenon concentration and the timing of xenon use, a in simple manner, to the therapeutic requirements. For example, it is advantageous to use mixtures of xenon with other gases, it being possible to mix the xenon with oxygen, nitrogen, air or other gases which are harmless for humans. [0037] In patients suffering from a severe craniocerebral trauma, respiration with a xenon-oxygen mixture, as also used in anesthesia, can prevent, or at least reduce, the release of dopamine and thus the secondary neurotoxic effects accompanying this trauma. In such accidents, the additional anesthetic side-effect is desired, since the patient can be freed from pain thereby. [0038] An essential feature of acute ischemia in the brain is represented by the secondary neurotoxic effects which form by an increase in the neurotransmitter release, and are responsible for the death of the neurons in the ischemic marginal region. Although an immediate xenon treatment, e.g. by the emergency physician who carries out the initial treatment in the case of an apoplexy patient, cannot prevent ischemia per se, but it can at least reduce, or even prevent, the neurotoxicity by the secondarily released neurotransmitters. Thus, the permanent damage frequently occurring in the case of apoplexy can be reduced. The same applies analogously to measures which will have to be taken if disease symptoms occur after drug abuse and loss of hearing, or a migraine attack. [0039] In the case of oxygen deficiency during a birth, e.g. during the entrance into the obstetric canal or in the case of problems with the umbilical cord, xenon-(oxygen) respiration of the mother and respiration of the child as soon after the birth as possible, respectively, can prevent the negative effects of increased dopamine release during the oxygen deficiency. [0040] In the case of schizophrenia, patients suffer from periodic schizophrenia (catatonia), the progress is very sudden, the picture of the state being characterized by dramatic symptoms which show varying pictures and are full of delusions and hallucinations. Often a phase disappears as rapidly as it started. Such phases or attacks can be triggered spontaneously by stress situations. Rapid respiration with a xenon gas mixture during the state of stress can at least reduce the intensity of the attack. For this application, it is an obvious thing to equip patients with xenon inhalators which permit self-medication.In this case, it is conceivable to use containers which, similar to asthma sprays, are filled with xenon which will be released if a trigger is pressed. The same applies analogously to the treatment of depressive patients whose moods change almost daily and who as a result thereof require state-related medication. [0041] Chronic Parkinson's disease is accompanied by progressive symptoms. A consequent xenon treatment reduces the neurotransmitter release and slows down the progression, or even brings the progression of the disease to a stand-still. In this case, intermittent treatment offers itself in which the patient is respirated with xenon at certain intervals. The same applies to patients who suffer from the Gilles de la Tourette syndrome. Their tics also become more and more distinct as the disease proceeds. [0042] In the case of acute threatening states, such as a craniocerebral trauma or an ischemia, respiration can advantageously be carried out with a xenon-oxygen mixture of 90:10% by volume, preferably 80:20% by volume, and most preferably 75-70:25-30% by volume, over several hours to one day. As compared thereto, the intermittent respiration by a xenon-air mixture to which less xenon has been added, e.g. 5 to 30% xenon, preferably 10 to 20% xenon, can be considered in chronic progressions of a disease. [0043] Various methods for the inhalation of xenon and xenon mixtures, respectively, can be used which depend on the respective intended use. In clinics, it is possible to use anesthetic apparatus, in which prefabricated xenon-oxygen mixtures can be connected to the corresponding inlets of the anesthetic apparatus. Respiration is then carried out according to a procedure which is common for such apparatus. The same applies analogously to the cardio-pulmonary bypass machine. [0044] As an alternative, xenon can be mixed with ambient air instead of oxygen in the mobile use, which due to the smaller size of the required pressure bottles increases the mobility of the apparatus. For example, it is possible to use an inhalator which supplies xenon from a pressure bottle and is accommodated in a support, together with the latter, to a mixing chamber. On one side, this mixing chamber contains a mouthpiece for inhaling the xenon, and on the other side on which the xenon is supplied to the mixing chamber it has at least one additional check valve which enables the inlet of ambient air. The xenon pressure container can be equipped with a pressure reducing valve, for example, which reduces the amount of xenon gas supplied to a suitable value. When the patient breathes in, he sucks in air from the air valves. In the mixing chamber, this air is mixed with the supplied xenon to the desired ratio and then inhaled by the patient. An advantageous inhalator intended for mobile use and serving for inhaling xenon and its mixtures is shown in, for example, European Patent No. 560,928. [0045] In a further simplified embodiment, e.g. for self-medication, a mouthpiece is connected directly to the xenon pressure container. During inhalation, the patient opens the pressure valve and inhales xenon simultaneously with the air from the environment. When he breathes out, he releases the valve, so that no more xenon reaches the mouthpiece. In this manner, at least a coarse regulation of the amount of inhaled xenon is possible. [0046] The present invention is explained in more detail below, reference being made to attached FIGS. 1 and 2, which show the dopamine release in cell cultures exposed to hypoxic shock. [0047] The function of the present invention shall be explained in more detail below by means of the following examples. EXAMPLE 1 [0048] An in vitro experiment with PC12 cells is concerned. These PC12 cells are dependants of a pheochromocytoma of rats. Here a catecholamine-producing tumor of the suprarenal cortex is concerned, which shows permanent dopamine release in a malignant form. PC12 cells can be reproduced continuously in vitro. Following the addition of “nerve growth factor”, they start differentiating and become neurons which in many respects have the property of in vivo neurons, particularly the properties which relate to the neurotransmitter release. PC12 cells are acknowledged as neuronal model. [0049] PC12 cells differentiated in such a manner when exposed to a hypoxic situation, release dopamine. Such a hypoxic situation is an artificially induced stress state for the cells, in which e.g. the oxygen supply is dropped or impeded. If the cells are treated under these hypoxic conditions with xenon in defined concentrations over the same period of time, the neurotransmitter release will be dropped. The time course of such an experiment is shown in FIG. 1 by way of example. The curve of the non-stressed controls, illustrated by solid squares, shows a low dopamine concentration throughout the time course, which is subject to certain fluctuations. If a hypoxic situation is triggered by a dose of helium instead of oxygen, the curve of the dopamine concentration will result as shown in the curve produced from the solid triangles. A maximum dopamine concentration is shown in this case after about 40 minutes. However, if xenon is given in a hypoxic situation, the cells will virtually no longer differ from the control cell population, as shown by the plot illustrated by solid circles. In connection with the relative dopamine concentration shown in part B of FIG. 1 it can also be clearly seen that the dopamine release is reduced down to values of the control cells. In this connection, it was found that the xenon effect is fully reversible, so that the cells treated in this way cannot be distinguished from untreated cells after the xenon is washed out. In the above-described experiment, the gases used were given to the cells by mixing them with the growth buffer for the cells. In this case, saturated gas buffer solutions are involved. EXAMPLE 2 [0050] The differentiated PC12 cells described in Example 1 were distributed to various vessels and exposed to differing conditions. The results are shown in FIG. 2. These conditions are defined as follows: Control: incubation in normal atmosphere (ambient air) N2: incubation in nitrogen (N2) for 30 minutes [= hypoxia] Xenon: incubation in xenon for 30 minutes Glu: addition of 10 M glutamate for 30 minutes of incubation in a normal atmosphere Glu + N2: addition of 10 M glutamate for 30 minutes of incubation in N2 Glu + Xe: addition of 10 M glutamate for 30 minutes of incubation in xenon. [0051] A hypoxic condition and an increased release of dopamine resulted in the cells incubated with nitrogen (group: N2). The dopamine release may even be increased if, in addition to the nitrogen atmosphere, glutamate, which represents a neurotransmitter and has a neurotoxic effect in greater doses, was given as well (group: Glu+N2). However, if 10 M glutamate was given in the simultaneous presence of xenon (Group: Glu+Xe), a slightly increased dopamine release would still result, but which was nevertheless reduced by two-thirds as compared to the corresponding (glutamate+N 2 ) experiment. [0052] The results shown in FIG. 2 demonstrate that in stress situations such as hypoxia, the neurotransmitters glutamate and dopamine are released in large quantities. This results in a) direct damage to the neighboring neuronal tissues, mainly by inducing apoptosis and b) indirectly, an additional increased release of other neurotransmitters. Thus, the addition of glutamate to the cells effects an increased dopamine release, particularly when the cells are kept under hypoxic conditions. The unintentional neurotransmitter release could be reduced many times over by the simultaneous supply of xenon. [0053] It can therefore be shown, on an overall basis, that in the present invention xenon can stop rapidly and without other permanent side-effects the neurotransmitter release temporarily. Hence it follows that xenon can be used in defined concentrations in a therapeutically useful manner in all pathologic conditions characterized by unregulated neurotransmitter release. The simple application by inhalation and the harmlessness of xenon render this therapy especially attractive. Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

Methods for treating mammals for neurointoxication are provided comprising treating the mammal with a xenon-containing gas. Methods of providing neuroprotection in mammals are also disclosed comprising administering therapeutically effective amounts of xenon, preferably in combination with pharmaceutically acceptable carriers, diluents or excipients.

This a continuation of application Ser. No. 07/851,960 filed Mar. 16, 1992, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the field of medical infusion apparatus. More specifically, the present invention relates to tamper resistant medical filling and containment systems which provide for ease in filling and use. 2. Description of the Prior Art In medical and related applications, it is often desirable to introduce a selected amount of a fluid solution, e.g., a nutrition solution, into the body of a patient over a predetermined period of time. Systems which have been developed to address this need generally include an infusion bag having two openings, where at least one opening is connected to a tube which in turn is connected to a catheter. In practice, the plastic infusion bag is filled with a nutrition solution through a fill tube connected to one of the openings. When the bag has been filled, the fill tube is clamped shut with either a plastic clamp or a metal crimp and the free end of the fill tube is cut off and discarded. Disadvantages which have heretofore existed with these systems include their difficulty of use, lack of aesthetic appeal and susceptibility to tampering. The current methods suffer from clamps that are lost before they can be used, bulky and unsightly protrusions on the outside of the bag, crimps that require additional tools to use and a product that is not altogether tamper-proof. SUMMARY OF THE INVENTION The present invention addresses the above noted and other disadvantages of prior art filling and containment systems. The present invention comprises a filling system including an integral fill tube whereby the fill tube may be essentially removed from the system and bag when the filling operation is completed without the use of tools or separate crimps or clamps. Moreover, the infusion bag, once filled, is resistant to tampering. In a preferred embodiment, the system includes a collapsible infusion bag provided with two or more openings formed at one end or edge of the bag in a conventional fashion. These openings include at least one fill port through which the bag may be filled, and at least one outlet port which may be connected to a flow conduit which in turn may be connected to a catheter. The fill port used to introduce a given fluid solution into the bag is receivable to a valve comprising a cylindrical body which may be reciprocated between an "open" and a "closed" position. This cylindrical is preferably hollow along at least a portion of its length to allow for fluid flow therethrough. When positioned in an "open" position, the valve allows a given fluid to be introduced into the bag. When moved to a "closed" position within the fill port, external ridges on the outer diameter of the valve press against the inner wall of the port, effectively seating the valve stem. When maintained in a "closed" position over a period of time, the elastic memory of the plastic forming the opening preferably secures the valve stem in this "closed" position. In another preferred embodiment, a reciprocating valve comprises a cylindrical body with a smaller diameter portion situated along its length. This smaller diameter portion allows the exposed filling end of the valve to be removed once the valve is moved to a "closed" position. In such a fashion, the valve cannot easily be reciprocated to an "open" position so as to allow access to the fluid contents of the bag. The filling system of the present invention has a number of advantages over the prior art. One such advantage is the increased ease in the filling operation provided by the reciprocating valve comprising the cylindrical body and the fill port. Another advantage of the present invention is that it removes the need to use a separate tube clamp or other similar mechanism to prevent fluid flow through the neck of the filling port after the bag is filled. Still another advantage is the fact that the system can be closed without the need for additional tools. Moreover, the filled container is more aesthetically pleasing due to the elimination of the tube clamp and is tamper resistant. Other advantages of the invention will become apparent to those skilled in the art in view of the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a perspective view of one embodiment of the infusion system of the present invention wherein the valve is shown situated in an "open" position. FIG. 2 illustrates the embodiment disclosed in FIG. 1 where the valve is disposed in a "closed" position. FIG. 3 illustrates the view of the embodiment disclosed in FIG. 2 wherein the filling end of the reciprocating valve has been removed. FIG. 4 is a view in partial cross section of the valve as depicted in FIG. 1. FIG. 5 is a view in partial cross section of the valve as depicted in FIG. 2. DESCRIPTION OF THE PREFERRED EMBODIMENT In accordance with a preferred embodiment of the present invention by reference to FIGS. 1-3, there is provided an infusion bag 3 and a valve 9. Infusion bag 3 described herein is preferably made from two superimposed sheets of plastic material welded around their edges to form a gas-tight bladder. In a preferred embodiment, a malleable gas impermeable plastic, such as Non-Dop PVC as manufactured by Ella Plastics, is used, although other types of materials having similar properties are also contemplated within the spirit of the invention. As illustrated in FIGS. 1-3, an infusion bag 3 is preferably rectangular in shape although other configurations may also be used. It is desirable, however, that the bag 3 be provided with a handle 22 or other means to carry and suspend the bag 3 as will be further described herein. Fluid communication with the bladder formed within the bag 3 is provided by two or more necks or openings including an inlet port 5 and an outlet port 6. As noted, the inlet port 5 preferably describes a tubular bore 12 to accommodate valve stem 8. As illustrated in FIGS. 1-3, ports 5 and 6 are preferably provided with reinforcing ribs 7 or the like to enhance their axial rigidity. Outlet port 6 is sealed via a puncturable membrane (not shown) by methods well known in the art. When administration of the liquid within the bladder to a patient is desired, this membrane is punctured by a flow spike or the like which is coupled to a transport conduit such as a tube (not shown), which in turn is coupled to a catheter (also not shown) for delivery of the liquid within the bag to the patient. Port 5 is comprised of an exterior end 25, an interior end 24 and an inner wall 26 as shown best in FIGS. 4 and 5. Referring again to FIGS. 1-3 and especially to FIGS. 4 and 5, reciprocating valve 9 comprises the inlet or fill port 5, which in this embodiment acts as the valve body, and an elongate cylindrical body or valve stem 8. The elongate cylindrical body 8 includes a bladder end 15 and a filling end 10. Valve stem 8 is adapted to reciprocate within the tubular bore 12 defined in inlet port 5 in a fluid-tight relationship. The movement of valve stem 8 in this fashion is illustrated in FIGS. 1-2. The filling end 10 of valve stem 8 is adapted to be coupled to a standard conduit means such as nylon or PVC tubing (not shown) to allow the bag to be filled. Preferably, this coupling is accomplished by tapering filling end 10 to allow for a friction fit with standard medical grade tubing. This filling operation is ordinarily accomplished at the pharmaceutical supply house or, in some instances, at the hospital. Filling end 10 includes a shoulder 22 to assist the user in moving the valve stem 8 between a first, or "open", and a second, or "closed", position as will be described below. Valve stem 8 is comprised of a longitudinal bore 19 extending from the filling end 10 to a point situated between the filling end 10 and the dispensing end 15. An aperture 11 is formed at the filling end 10. Fluid flow through the valve 8 into the bag 3 is enabled by one or more passages 14 formed approximately mid way between the bladder end 15 and the filling end 10 of the cylindrical body 8. These passages 14 are in fluid communication with the bore 19. In a preferred embodiment, passages 14 are formed at the bottom of and transverse to the bore 19. Other relative orientations may also be used to accomplish the objectives of the invention. Passages 14 are located at a point along the valve stem 8 to provide fluid communication between the aperture 11 and the bladder in the bag 3 when the valve 8 is in the "open" position. Conversely, there is no fluid communication when the valve 8 is in the closed position. As shown in FIG. 1, the valve 8 is "open" when the cylindrical body 8 is pushed into the bag 3 such that the shoulder 22 abuts the end of the inlet port 5. In this position, fluid (depicted by arrows 30 in FIG. 4) enters the valve stem 8 at aperture 11, flows through the bore 19 to passages 14 on into the bladder defined within bag 3. The valve 8 is "closed" by grasping the shoulder 22 and pulling the cylindrical body 8 until the stop 23 abuts the interior end 24 of the inlet port 5. As can be seen from FIG. 5 and FIG. 2, in the "closed" position, passages 14 are effectively blocked by the interior wall 26 of the port 5, thus, preventing fluid from flowing into or out of the bag 3. In the preferred embodiment, valve stem 8 includes a smaller diameter portion 13, which effectively divides valve stem 8 into a filling portion 27 and bladder portion 28. The smaller diameter portion 13 is designed to allow the filling portion 27 to be cleanly and easily separated from the bladder portion 28 after the bag 3 has been filled, and yet strong enough to allow the valve 8 to be reciprocated in port 5. While it is well known in the art how to achieve this dual purpose, it has been found that a wedge shaped cross sectional thinning formed at the passages 14 as best shown in FIG. 4, is most effective. The objective of the smaller diameter portion 13, namely being able to prevent the valve 8 from being easily or accidentally opened after filling, may be achieved by other methods without departing from the spirit of the invention. The bladder portion 28 of the valve 8 is preferably provided with a series of circumferential ridges 20. When the valve 9 is in the "closed" position, these ridges 20 form a series of complementary grooves 21 in the otherwise smooth interior wall 26 of port 5 due to the malleable nature of the plastic material used to form port 5. As can be seen in FIG. 5, it has been found advantageous to position the ribs 7 such that when the valve 8 is "closed" the ribs 7 are in alignment with the ridges 20. When valve 8 is positioned in the "closed" position for an extended period of time, e.g., two days, the memory of the plastic material forming port 5 permanently deforms to form grooves 21, thus enhancing the difficulty by which the valve may be opened. As would be apparent to those skilled in the art, the valve of the present invention need not be integrally formed with the bag 3. If the application warranted, the port 5 could be replaced with a separate valve body having a through hole in which the valve stem 8 is inserted. An infusion bag may be filled in accordance with the invention by the following preferred method. With the valve 8 in the open position, connecting a filling tube to a filling end 10 of an elongated cylindrical body 8 of the valve 8; filling the bag 3 with a desired fluid; and, closing the valve 8 by pulling the elongated cylindrical body 8 to a position such that there is no fluid communication between the filling end 10 of the valve 8 and the interior of the bag 3. If the bag is of the type that is reusable, after the fluid has been emptied from the bag, it may be refilled by opening the valve 8 by pushing valve 8 to a position such that fluid communication between the filling end 10 and the interior of the bag is established and performing the foregoing steps. If the bag is used in an application where reuse is not desirable, after filling the bag, the step of breaking off the filling portion of the cylindrical body should be performed. While certain specific and preferred embodiments of the present invention have been illustrated herein, as will be understood by those skilled in the art, still further variations and modifications can be made therein without departing from the spirit and scope of the invention as claimed below.

A tamper resistant filling and containment system useful in medicinal and related applications. A bladder includes at least two ports with one of the ports having a graspable, reciprocable tube inserted therein. The tube has an axially bore formed partially therethrough which terminates at side passages which communicate with the bladder when the tube is in a filling position. Movement of the tube to a second position prevents communication of the side passages with the bladder and a weakened portion of the tube located at the side passages permits the graspable or outer portion of the tube to be broken, thereby preventing access to the tube and movement thereof to the filling position.

BACKGROUND OF THE INVENTION [0001] The present invention relates to a protective element particularly for shorts for sports use, such as for example for cycling, motorcycling, and gymnastic activity such as spinning and triathlon. [0002] Currently, in cycling it is known to use shorts, made of optionally partially elasticated material, which cling to the body considerably and are usually worn without underwear. [0003] The main problem for the athlete is that during races or practice the crotch is subjected to continuous stresses, since this part of the body is continuously in contact with the saddle and is therefore subjected to all the jolts produced by the unevenness of the terrain and by the vibrations transmitted by the bicycle frame. [0004] Accordingly, localized reddenings are produced which can degenerate into cuts or blisters that make it difficult, if not impossible, to perform sports practice. [0005] As a partial solution to these drawbacks, it is known to use shorts inside which padding, constituted by a cloth of suitable thickness made of textile material, is sewn internally at the crotch. [0006] However, this solution is not ideal, since although the thickness of the padding can provide relief initially, it has been found that it tends to overheat the crotch and especially that also due to sweating there is continuous sliding between the crotch and the padding, which very soon cancels out the initial benefits. [0007] Moreover, it has been found that the crotch rests on the padding, and the padding rests on the saddle, so as to form compression concentration regions that depend on the stresses applied during sports practice, and this entails even the onset of aches. [0008] As a partial solution to these drawbacks, it is also known to provide shorts with which a bottom is associated by sewing at the crotch region, such bottom having a plurality of chambers arranged laterally to an axis that is longitudinal with respect to the saddle, the chambers being mutually separate and forming diversified contact regions for the crotch. [0009] Although the chambers solve part of the drawbacks mentioned above, this solution and the preceding ones have the drawback that the padding or bottom are made of materials that are substantially rigid or scarcely elastic in a percentage that varies between approximately 0 and 2%, and this renders ineffective any small elastic deformation of the fabric that constitutes the shorts. [0010] This fact limits considerably the freedom of movement of the body; moreover, the larger the padding, the thicker it becomes, further increasing overall rigidity and weight and thus preventing movements even more. [0011] Moreover, a “diaper effect” is produced: when the cyclist dismounts from the bicycle and walks normally, he is thus further hindered in his movements by the presence of the padding or bottom. [0012] Reducing the padding can provide greater freedom of movement, but has a considerable negative effect on the ability to protect from impacts and vibrations on the saddle. [0013] Moreover, the use of padding or bottoms has been found to be subject, during cycling, to the formation of creases, owing to the arc-like shape of the crotch, and these creases produce further regions of discomfort both longitudinally and transversely to the crotch region. [0014] Finally, it is noted that the use of padding in known bottoms affects the entire extension of the product, and this entails a further increase of the mentioned “diaper effect”. [0015] In all of the known background art, the padding is in fact present over the entire extension of the product; even in the method that uses differentiated thicknesses, the flat padding part is obtained by compressing the padding, which thus affects also the apparently flat portions of the bottom. SUMMARY OF THE INVENTION [0016] The aim of the present invention is to eliminate the drawbacks of the cited prior art, by providing a protective element that allows to achieve optimum comfort at the crotch and at the same time great freedom of movement both on the saddle and off the saddle together with an overall light weight of the shorts, thus avoiding the mentioned “diaper effect”. [0017] Within this aim, an object of the invention is to provide a protective element that allows to achieve greater comfort for the user while maintaining light weight and/or low thickness characteristics. [0018] Another important object is to provide a protective element that allows optimum adaptation to the anatomical shape of the male or female user once the shorts have been put on. [0019] Another important object is to provide a protective element that can be used in a distinct manner even for users having different clothing sizes. [0020] Another object is to provide a protective element that associates with the preceding characteristics that of having low costs and of being structurally simple, said invention being reliable and safe in use. [0021] This aim and these and other objects that will become better apparent hereinafter are achieved by a protective element, particularly for shorts, characterized in that it is constituted by a support that has, in an upper region, regions that protrude differently and, in a lower region, a layer of material that can be coupled detachably by simple resting on said shorts. [0022] Advantageously, the support has grip means for the user which are suitable to simplify removal and/or positioning of said support on the shorts. BRIEF DESCRIPTION OF THE DRAWINGS [0023] Further characteristics and advantages of the invention will become better apparent from the following detailed description of a particular embodiment thereof, illustrated only by way of non-limitative example in the accompanying drawings, wherein: [0024] [0024]FIG. 1 is a plan view of the protective element; [0025] [0025]FIG. 2 is a schematic perspective view of a pair of shorts, illustrating the protective element associated therewith; [0026] [0026]FIG. 3 is a front view of the shorts, illustrating the presence of a tape; [0027] [0027]FIG. 4 is a sectional view, taken along the line IV-IV of FIG. 1; FIG. 5 is a sectional view, taken along the line V-V of FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0028] With reference to the figures, the reference numeral 1 designates a protective element, which is used particularly at the crotch region 2 of shorts 3 , for example cycling shorts. [0029] The protective element is constituted by a support 4 , which has a lower surface 5 made of a material having a non-smooth, highly porous neoprene base; this material interacts, by contact, with the shorts, which advantageously but not necessarily have very fine grooves that allow to facilitate strong grip between the two parts. [0030] It is therefore sufficient for the user to place the support against the shorts, simply adapting its position according to his or her anatomical shape. [0031] The support 4 further has an upper surface 6 on which differentiated relief regions 7 are provided by thermoforming so as to further increase user comfort. [0032] There are also grip means 8 for the user which are suitable to simplify the removal or positioning of the support with respect to said shorts; such means are constituted by a tab 9 , which protrudes frontally with respect to the support 2 in its front region. [0033] Other grip means are constituted by a tape 10 , which protrudes inside the shorts in the crotch region 2 . [0034] The tape has an opening 11 that allows passage and engagement of the support to the shorts. [0035] The tape is advantageously rectangular and also elastic and acts as a sort of coupling guide, which thus allows to insert the support inside it, ensuring greater stability thereof and simultaneously ensuring that it remains at the center of the fork while leaving it free to be positioned at will by the user. [0036] It has thus been observed that the invention has achieved the intended aim and objects, a protective element having been obtained that can be applied to shorts rapidly and easily for the user, the protective element adapting in an optimum manner to the crotch during sports practice or being easily removable during walking or during sports practice. [0037] Moreover, the protective element can be positioned perfectly, with respect to the shorts, by the male or female user by virtue of the temporary mechanical connection provided by simple mutual resting contact. [0038] Moreover, the use of optional shorts without lateral seams increases user comfort, also by way of the presence of the differentiated relief regions: the use of yarns with a higher elasticity modulus allows optimum adaptation to the body, in a manner that is far more effective than conventional products, regardless of adaptability to a clothing size. [0039] The supports of the protective element are produced by thermoforming and/or high frequency technology, which allow to form the differentiated relief regions in order to better protect the more delicate parts of the body in contact with the saddle. [0040] These supports adhere naturally to the shorts without requiring uncomfortable stitched seams, by way of fabrics that are mechanically compatible with the shorts, and it is sufficient to position them as required and, if necessary, move them freely forward or backward, to the right or to the left, without limitations. [0041] These supports can therefore be washed separately and be removed at any time and can therefore be used with any type of shorts. [0042] Advantageously, the supports are made of a temperature-regulating microfiber covering, which ensures antibacterial protection and facilitates rapid evaporation of perspiration. [0043] Moreover, removability allows to solve any drawbacks due to possible overheating of the crotch. [0044] Further, removability allows the user to change, during sports practice, the type of protective element according to the sport being practiced, such as for example on-road or off-road use. [0045] Moreover, the particular shape of the protective element, whose surface practically affects only the region of contact with the crotch, has dimensions and a volume that minimize user discomfort, for example during walking. [0046] The materials used may of course be the most pertinent according to specific requirements. [0047] The disclosures in Italian Patent Application No. TV2001A000116 from which this application claims priority are incorporated herein by reference.

A protective element, particularly for shorts, for example for cycling, comprising a support that has, in an upper region, regions that protrude differently and, in a lower region, a layer of material that can be coupled detachably by simple resting on the shorts.

This application is a continuation-in-part of U.S. non-provisional application Ser. No. 13/622,398 filed on Sep. 19, 2012 which is included herein in its entirety by reference. COPYRIGHT NOTICE A portion of the disclosure of this patent contains material that is subject to copyright protection. The copyright owner has no objection to the reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright rights whatsoever. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to devices for protecting shoes. In particular, the present invention relates to a method for protecting the raised heel of a woman's high heel shoe. 2. Description of Related Art Women's high heel shoes are typically designed for dress-up occasions. They are designed to add height to a woman's stature as well as accent the musculature of the leg. While high heels have become thicker and flatter, the typical stiletto type high heel is still very popular as are other types of high heels. One problem that occurs when wearing stiletto heels or other such heels is the ease with which the heel portion of the shoe can become damaged. While the very bottom of the heel is replaceable, the upper portion that is normally colored is affixed to the shoe and is for the most part not replaceable without great cost if at all. Damage to the upper portion of a high heel is very noticeable and can cause the shoe to be unwearable from a fashion standpoint. Very little has been available to address this problem which has been around as long as there have been high heels. One attempt is shown in German patent DE 10 2009 051 289 A1 to Vera Zwiauer. In this attempt, a rectangular piece of material is wrapped around the lower portion of the upper heel. However, since a heel is not perfectly cylindrical and is tapered, the material bunches up in spots and must be overlapped causing a visible bulge when mounted. To date, this device has not seen any commercial use most likely because of fit problems as well as poor decorative look. BRIEF SUMMARY OF THE INVENTION The present invention involves the discovery that a tapered clear plastic material that is adjustable in size, e.g. by tearable perforations, allows the user to adjust a covering for the lower portion of the upper high heel in a manner that is barely visible during use and avoids fit problems. Accordingly, in one embodiment of the invention, there is disclosed a device for protecting the lower portion of a woman's tapered stiletto or high heel of a given diameter and taper above the replaceable heel portion comprising a piece of clear film having a lower portion of an essentially trapezoidal shape of a fixed height and width wherein the device is adjustable in width and taper to fit the diameter and taper of the heel and an upper tapered portion wherein the height of the tapered portion is adjustable and wherein there is an adhesive film on one side of the device for adhering the device to the tapered heel. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a frontal view of the device of the present invention. FIGS. 2 a , 2 b and 2 c are a perspective view of the device wrapping around a stiletto heel. FIG. 3 is a perspective view of the device mounted on a stiletto heel. FIG. 4 is a frontal view of an alternate embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION While this invention is susceptible to embodiment in many different forms, there is shown in the drawings and will herein be described in detail specific embodiments, with the understanding that the present disclosure of such embodiments is to be considered as an example of the principles and not intended to limit the invention to the specific embodiments shown and described. In the description below, like reference numerals are used to describe the same, similar or corresponding parts in the several views of the drawings. This detailed description defines the meaning of the terms used herein and specifically describes embodiments in order for those skilled in the art to practice the invention. The terms “about” and “essentially” mean±10 percent. The term “comprising” is not intended to limit inventions to only claiming the present invention with such comprising language. Any invention using the term comprising could be separated into one or more claims using “consisting” or “consisting of” claim language and is so intended. The terms “a” or “an”, as used herein, are defined as one or as more than one. The term “plurality”, as used herein, is defined as two or as more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language). The term “coupled”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically. Reference throughout this document to “one embodiment”, “certain embodiments”, and “an embodiment” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation. The term “or” as used herein is to be interpreted as an inclusive or meaning any one or any combination. Therefore, “A, B or C” means any of the following: “A; B; C; A and B; A and C; B and C; A, B and C”. An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive. The drawings featured in the figures are for the purpose of illustrating certain convenient embodiments of the present invention, and are not to be considered as limitation thereto. Term “means” preceding a present participle of an operation indicates a desired function for which there is one or more embodiments, i.e., one or more methods, devices, or apparatuses for achieving the desired function and that one skilled in the art could select from these or their equivalent in view of the disclosure herein and use of the term “means” is not intended to be limiting. As used herein the term “woman's stiletto” or “high heel” is the standard tapered woman's shoe heel as depicted in the figures and well known in the art. It is the generally non-replaceable part of the shoe heel. While a variety of different diameters and tapering exist (which has created the problem solved herein) the general style of heel is shown and well known. As used herein, the “lower portion of the stiletto or high heel” is the very bottom portion of the heel just above the replaceable heel (heel cap or heel tip) which is usually some sort of leather, rubber, or plastic portion that is worn down during walking and can be easily replaced by a cobbler. The upper portion of the heel is where the heel is attached to the rest of the shoe. The heel is essentially permanently attached to the shoe and is generally not replaceable. For purposes of this invention, the non-replaceable heel will have a lower portion that extends from the replaceable heel portion upwards to a desired height, such as ¾, half or a quarter, up the entire heel as necessary. The heel will have a diameter that varies depending on the distance from the replaceable heel but generally tapered as well. The problem being solved by the present invention is in part dealing with this variable diameter and taper of the heel and still making the device unobtrusive and effective. As used herein the term “clear plastic film” refers to a polymer film that is see tough and flexible enough to wrap around the stiletto heel in use. Examples of polymers suitable for the present invention include polyurethane but based on this disclosure, others are taught. The polymer has an adhesive backing. The adhesive is one that is compatible with the polymeric film and sticks to the material the outer surface of the heel is made of so for example it may need to be compatible with leather, plastic coatings or the like. As an example silicone adhesive could be used. Other adhesives could be used or found with little experimentation based on the disclosure herein. The polymeric film will have a lower portion of an essentially trapezoid shape (including a rectangle shape) having a fixed height and width or tapered width in a manner to match the stiletto or high heel shape (tapered heel). Generally the width of the present invention will be greater than the height but may change depending on the exact heel to be adapted. In order to be useful on a wide variety of heels, the straight or tapering sides have one or more adjustable features, for example, perforations which allow the width and taper to be adjusted to fit the circumference of the heel and taper of the heel and make a fit with little or no bulge. Perforations can be done in any convenient manner such as between about 2 perforations to about 12 perforations per inch. For example, perforations could be 0.07″ cut to 0.08″ cut and 0.01″ tear to 0.02″ tear. It will have an upper portion that is tapered and is adjustable in height. Again, adjustability can be by perforations which adjust the height of the upper portion. The circumference of the heel is the distance around the heel as shown in the figures, however, a wide variety of heels could be produced for a variety of heels but all can be made adjustable within the scope of the present invention. In one embodiment, there is a non-adhesive backing to protect the adhesive backing until the film is applied to the heel of choice. In applying the device of the present invention to a heel, the device's middle line is aligned with the center back of the heel and is positioned around the stiletto heel and portions of the side and top portion removed excess device until wrapping it around the heel matches the circumference and/or taper of the heel. Then the removable backing is removed and the device's side is placed against the heel (as shown in the figures), wrapped around the heel, and smoothed to remove any air bubbles and make sure it matches. In one embodiment, the seam created by the device is placed where it is least likely to be seen, that is facing the toe of the stiletto or high heel shoe. Now referring to the figures, FIG. 1 is a frontal profile of the device of the present invention. Protective wrap 1 is shown having trapezoid bottom portion 10 having parallel top 3 and bottom 2 and parallel sides 4 and 5 . (This example depicts a rectangle but nonparallel sides are also contemplated.) The device has left side 7 and right side 6 which are tapering from the top side 3 to the bottom side 2 to form a trapezoidal shape when torn on 8 a . In order to adjust the width of the device 1 , diagonal perforations 8 a and 8 b are shown in the rectangular portion. In FIG. 1 the device 1 has diagonal perforation 8 a being which can be torn to remove that piece and narrow the width as well as perforating for adjusting the height of lower portion 10 . It is clear there can be one or more perforations as desired to narrow the width of the device and the perforations can be angled as needed. One skilled in the art in view of this disclosure, could easily determine placement of perforations. Also shown is backing 9 which in this drawing is in the process of being pulled off the back side of device 1 which is being shown from the front side 15 . An adhesive would be on the back side. FIG. 1 shows tapered upper portion 11 . The upper portion 11 is tapered from the lower portion 10 down to the rounded top 12 . Perforations 13 and 14 are also shown for adjusting height. FIGS. 2 a , 2 b , and 2 c are a perspective series of the device 1 being wrapped around the lower portion of stiletto heel 23 on shoe 24 . Also shown is the replaceable heel cap 25 . While the wrapping is such that the seam will be to a side of the shoe 24 , in one embodiment, the seam is positioned to face shoe toe 26 (as shown in FIG. 3 ). FIG. 3 shows a perspective of the device completely wrapped around heel 23 without seems or bulges. Notice that it is mounted on the lower portion of the heel 23 but any height of the heel can be chosen especially with the adjustable height feature. When in place, it protects the heel from scuffing or damage and can be removed and replaced with a new device easily and quickly. FIG. 4 depicts another embodiment of the present invention. In this view the device 1 has additional vertical width adjusts perforations 20 and 21 which extend from the tapered portion 11 to the trapezoidal portion 10 . Also shown is notch 22 for making it easier to peel backing (not shown in this view) off of device 1 . Those skilled in the art to which the present invention pertains may make modifications resulting in other embodiments employing principles of the present invention without departing from its spirit or characteristics, particularly upon considering the foregoing teachings. Accordingly, the described embodiments are to be considered in all respects only as illustrative, and not restrictive, and the scope of the present invention is, therefore, indicated by the appended claims rather than by the foregoing description or drawings. Consequently, while the present invention has been described with reference to particular embodiments, modifications of structure, sequence, materials and the like apparent to those skilled in the art still fall within the scope of the invention as claimed by the applicant.

A device for the protection of a high heel is disclosed which is adjustable to adapt to various shoe heel diameters and is barely visible during use.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] Related applications: Under the provisions of 35 U.S.C. § 119(e), priority is claimed from Provisional Patent Application Ser. No. 60/591,764 filed Jul. 27, 2004. TECHNICAL FIELD [0002] The present invention generally relates to clasps. More particularly, the invention relates to jewelry clasps, interchangeable decorative pieces for jewelry, such as bracelets, necklaces, earrings, pendants, etc. and methods of connecting the same. BACKGROUND [0003] Jewelry clasps must provide a secure connection to prevent accidental unfastening, which often results in loss of the jewelry. At the same time, clasps must be relatively easy to connect, since often they must be connected behind the neck of the person wearing the jewelry (in the case of a necklace) or with only one hand (in the case of a bracelet). [0004] An early design for jewelry clasps consists of a small bead fastened to one end of the piece of jewelry. A seamed tubular member having a lateral opening on the seam and two smaller openings on the ends is fastened to the other end. To secure the two ends together, the ball is inserted into the lateral opening and pulled towards an end of the tubular member. The string or wire of the jewelry piece is forced through the seam until it extends through one of the smaller openings in an end of the tubular member. [0005] The claw-type jewelry clasp is another commonly used coupling for jewelry pieces. In the claw-type clasp, a ring is placed on one end of the jewelry piece, and a J-shaped member is placed on the other end of the piece. Usually, a spring-loaded member acts against the J-shaped member to close the gap of the J-shaped member forming a closed second ring. A force is exerted on the spring-loaded member to open the second ring. The first ring is then slid onto the J-shaped member and the spring loaded member is released to close the gap at the end of the J-shaped member, thereby preventing removal of the ring from the J-shaped member or second ring. [0006] Leaf spring type connectors are also commonly used in jewelry clasps. Typically, a male member is attached to one end of a jewelry piece that is releasably connectable to a female member attached to the other end of the jewelry piece. A leaf spring component, usually comprising a deflectable metal member supported at only one end thereof, is provided on the male member. The leaf spring component is deflected or compressed upon initial insertion into the female member. After the male member is inserted a predetermined distance into the female member, the resilience of the leaf spring component causes the component to snap back into mating abutment with a corresponding feature formed in the female member, thereby preventing removal of the male member therefrom. To release the male member from the female member, a user must exert a force on the leaf spring to force the component out of mating abutment with the corresponding feature of the female member while simultaneously pulling the two members apart. [0007] These clasps are often cumbersome and may unintentionally unfasten. While clasps may include safety or locking features, they are often difficult to use. Further, it is often awkward to connect a clasp for a necklace behind one's own neck or to connect a bracelet using only one hand. Thus, additional improvements are desired. Further, it may be appreciated that there is a need in the art for a clasp that may be incorporated into individual decorative jewelry pieces that may be removably fastened to one another, thereby providing an interchangeable jewelry piece that may be changed at any time to match clothing or to create a unique, one-of-a-kind design. SUMMARY OF THE INVENTION [0008] In accordance with one embodiment, a clasp is disclosed that includes at least one male member and a cooperating female member. The at least one male member includes a first section and a larger second section. The female member includes a main body having hollow portion, an outer wall, and an exterior surface. The female member further includes at least one aperture formed through the outer wall and a displaceable aperture sealing member adjacent the exterior surface of the main body. The at least one aperture of the female member includes a first portion sized to preclude passage of the larger second section of the male member and to allow passage of the first section of the male member therethrough, and a second larger portion continuous with the first portion sized to allow passage of both the first section of the male member and the second larger section of the male member therethrough. The displaceable sealing member may be movable between a first position at least partially covering the second larger portion of the at least one aperture, and a second position exposing the second larger portion of the at least one aperture. [0009] A piece of jewelry that includes a plurality of clasps is also disclosed. Each clasp of the plurality of clasps includes a first female member and a male member. The female member includes a main body having at least one hollow portion, an outer wall, and an exterior surface. The female member further includes at least one aperture formed through the outer wall, and a displaceable aperture sealing member adjacent the exterior surface of the main body. The at least one aperture includes a first portion and a second larger portion continuous with the first portion. The displaceable aperture sealing member may be movable between a first position, in which the sealing member at least partially covers the second larger portion of the at least one aperture, and a second position, in which the second larger portion of the at least one aperture may be exposed. The male member may include a rod extending from the exterior surface of the main body of the female member. The rod may be disposed on a side of the main body generally opposite the first portion of the at least one aperture. An enlarged member may be formed on an end of the rod distant to the main body. Alternatively, the enlarged member may be connected directly to the main body. The male member may be connected to a second female member. [0010] A piece of jewelry that includes a first member and a second member is also disclosed. The first member may include a decorative jewelry piece, an elongated rod extending from the decorative jewelry piece, and a retaining member on the end of the rod opposite the decorative jewelry piece. Alternatively, the retaining member may be connected directly to the decorative jewelry piece. The second member may include a main body and a void inside at least a portion of the main body. The second member may further include a first aperture and a second aperture in the exterior surface of the second member that communicate with the void. The first aperture may be sized to allow passage of the rod therethrough and to preclude passage of the retaining member therethrough. The second aperture may be sized to allow passage of the retaining member therethrough. The second member may also include a slot in the exterior surface of the main body that communicates with the void, the first aperture, and the second aperture. The slot may be sized to allow passage of the rod therethrough and to preclude passage of the retaining member therethrough. The second member may also include a displaceable external aperture sealing member disposed on the exterior surface thereof. The sealing member may be displaceable between a first position and a second position. In the first position, the sealing member may be disposed adjacent the second aperture to preclude passage of the retaining member therethrough. [0011] Also disclosed is a method of removably securing two members of a piece of jewelry using a clasp according to the invention. The female member and body with attached male member of the clasp of the present invention may be substantial in size which improves the ease with which a person may secure the clasp. For example, the female member may comprise a decorative element of a jewelry piece and the body may be, as a non-limiting example, a pearl with a male member therethrough. Thus, a user may easily grasp and maneuver the female member and pearl to secure the male member in the female member. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0012] While the specification concludes with claims particularly pointing out and distinctly claiming that which is regarded as the present invention, the advantages of this invention may be more readily ascertained from the following description of the invention when read in conjunction with the accompanying drawings in which: [0013] FIG. 1A is a perspective view of an exemplary embodiment of the invention; [0014] FIG. 1B is a perspective view of the exemplary embodiment of FIG. 1A in the assembled state; [0015] FIGS. 2A and 2B are sectional views taken along LINES 2 - 2 of the embodiment of FIG. 1A ; [0016] FIG. 3A is a perspective view of an exemplary embodiment of the invention; [0017] FIG. 3B is a perspective view of the exemplary embodiment of FIG. 3A in the assembled state; [0018] FIG. 4 is a perspective view of an exemplary embodiment of the invention; [0019] FIGS. 5A and 5B and 5 C illustrate front and back elevational and exploded views respectively of earrings comprising an exemplary embodiment of the invention; [0020] FIGS. 6A, 6B and 6 C illustrate front and back elevational views and an exploded view respectively of earrings comprising an exemplary embodiment of the invention; [0021] FIG. 7A is a front elevational view of a pendant comprising an exemplary embodiment of the invention; [0022] FIG. 7B is a back elevational view of the pendant of FIG. 7A hanging from a necklace; [0023] FIG. 8A is a plan view illustrating multiple, linked jewelry pieces, each comprising an exemplary embodiment of the invention; [0024] FIG. 8B is a sectional view of the embodiment of FIG. 8A ; [0025] FIG. 9 is a front elevational view of a clasp for a bracelet comprising an exemplary embodiment of the invention; [0026] FIG. 10 is a perspective view of an exemplary embodiment of the invention; and [0027] FIG. 11 is a sectional view of the embodiment of FIG. 10 ; and [0028] FIG. 12 is a perspective view of an exemplary embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION [0029] The present invention generally relates to clasps that may be used to connect or secure a variety of objects including jewelry such as bracelets, necklaces, earrings, pendants, etc. More particularly, the invention relates to clasps, interchangeable jewelry pieces, and methods of connecting the same. The clasps disclosed herein may be incorporated into individual and personalized jewelry pieces, such as individual links in a bracelet or chain, earrings, pendants, etc., thereby allowing a user to interchange individual pieces quickly and easily. In addition, the features of the clasps of the present invention may be incorporated into individual, interchangeable decorative jewelry pieces of different colors or designs. This allows a user to select and purchase individual pieces, which then may be used to create unique, personalized and interchangeable jewelry pieces. The clasps of the present invention may also be used as a traditional jewelry clasp for securing the ends of a jewelry piece. Like reference numerals refer to like elements throughout the specification and figures. [0030] A perspective view of an exemplary embodiment of the invention is shown in FIG. 1A . A clasp 100 is shown including a first body 140 and a second body 120 . The first body 140 includes a male member 110 having an elongated rod 112 with an enlarged member 114 formed on an end of the elongated rod 112 . The elongated rod 112 may be any desired length. Alternatively, the enlarged member 114 may be attached directly to the first body 140 . The second body 120 (or female member) is provided having a main body 122 , which is at least partially hollow, a first aperture 126 , a second aperture 128 , and a slot 130 extending continuously between the first aperture 126 and the second aperture 128 . The slot 130 may be any desired length, though for aesthetics, it may be desirable for length of slot 130 to be minimal. A displaceable aperture sealing member 136 may be movably attached to the main body 122 and may be disposed adjacent the exterior surface thereof. The aperture sealing member 136 is shown located laterally adjacent the second aperture 128 , which is exposed in FIG. 1A . Aperture sealing member 136 may be textured or raised such that it is easily gripped and moved. Alternatively, the aperture sealing member may be flat, domed or be a decorative aspect of the clasp. [0031] The male member 110 may be attached to a first body 140 by, for example, soldering. Alternatively, the elongated rod 112 of the male member 110 may be of sufficient length to extend entirely through the first body 140 , and may be attached to a chain or other jewelry piece at the end thereof opposite the enlarged member 114 on the opposite side of the first body 140 . Alternatively, the male member 110 may be attached to the end of a chain such as a bracelet or necklace. The second body 120 may be attached directly to a piece of jewelry to be fastened or may include a male member (not shown) on the side of the main body 122 opposite the first aperture 26 . Similarly, either the male member 110 (or a first body 140 attached to the male member 110 ) may be attached to the end of a piece of jewelry to be fastened, such as for example, a bracelet or necklace (not shown in FIG. 1A ). The first body 140 may be a decorative element or may be purely functional. [0032] The clasp 100 shown in FIG. 1A is shown in the assembled state in FIG. 1B . In the assembled state, the first body 140 is proximate the main body 122 of the second body 120 . The aperture sealing member 136 may be disposed directly above and covering the second aperture (not visible in FIG. 1B ). [0033] As seen in FIG. 1A , the displaceable aperture sealing member 136 may be displaceable in a direction generally parallel to a reference line 147 that extends along the outer surface of the hollow main body 122 of the second body 120 between the first aperture 126 and the second aperture 128 . Alternatively, the displaceable aperture sealing member 136 may be displaceable in any direction relative to the reference line 147 . [0034] The function of the clasp 100 may be further understood with reference to FIGS. 2A and 2B , which are cross sectional views of the clasp 100 taken along line 2 - 2 in FIG. 1A and FIG. 1B . FIGS. 2A and 2B show the clasp 100 in the disassembled and assembled configurations, respectively. The elongated rod 112 of the male member 110 may be formed as an elongated cylindrical member having a diameter D 1 . The elongated rod 112 alternatively may be formed as an elongated polyhedron or any other desired shape. The enlarged member 114 of the male member 110 may be formed as a sphere having a diameter D 2 , although any other enlarged shape such as an ovoid or a polyhedron may be used. The first aperture 126 of second body 120 may be formed having a circular shape having a diameter D 3 greater than D 1 but less than D 2 to allow the elongated rod 112 to pass therethrough, while precluding passage of the enlarged member 114 therethrough. Alternatively, the first aperture 126 may be formed having any size and shape allowing the elongated rod 112 to pass therethrough, while precluding passage of the enlarged member 114 therethrough. The second aperture 128 also may be formed having a circular shape having a diameter D 4 larger than both D 1 and D 2 , thereby allowing passage of both the enlarged member 114 and the elongated rod 112 of the male member 110 therethrough. Alternatively, the second aperture 128 may be formed having any size and shape allowing both the elongated rod 112 and the enlarged member 114 to pass therethrough. The general relationship of the size of each of the four diameters may be described as follows: D 1 <D 3 <D 2 <D 4 . [0035] The slot 130 should have a width greater than the diameter D 1 of the elongated rod 112 but smaller than the diameter D 2 of the enlarged member 114 . The slot 130 may have a width that is smaller than D 3 (as shown in FIG. 1A ); although the width of the slot 130 could be equal to, or slightly greater than D 3 provided the width is less than D 2 . As seen in FIG. 2A , the slot 130 may include two sections, a first section 131 that extends between the first aperture 126 and the second aperture 128 , and a second section 132 that extends a short distance from the second aperture 128 on the side thereof opposite to the first section 131 . The first aperture 126 , the second aperture 128 , and the slot 130 are all connected and continuous, and therefore may be considered portions of a single opening. In addition, the first aperture 126 and the second aperture 128 may be formed through the main body 122 of the second body 120 at any location on the exterior surface thereof provided the slot 130 extends therebetween. [0036] As seen in FIG. 2B , the displaceable aperture sealing member 136 may be coupled to the second body (female member) 120 by a vertical support member 137 , a horizontal support member 138 having a tubular section, a tubular member 150 , and a biasing member, shown as a spring 139 . The tubular member 150 may be welded or otherwise attached to an interior surface of the main body 122 of the second body (female member) 120 . The outer diameter of at least a section of the horizontal support member 138 may be smaller than the inner diameter of the tubular member 150 such that the section of the horizontal support member 138 , including the tubular section, may slide within the tubular member 150 . The biasing member, or spring 139 may be disposed within the tubular member 150 and may extend into the tubular section of the horizontal support member 138 . The biasing member, or spring 139 may act against the horizontal support member 138 , exerting a force therein which tends to move the horizontal support member 138 in the leftward direction in FIGS. 2A and 2B . The aperture sealing member 136 is shown in a first position in FIG. 2B , in which the spring 139 is extended and the aperture sealing member 136 is disposed adjacent the exterior surface 124 of the main body 122 directly above the second aperture 128 . In this position, the enlarged member 114 is precluded from passing either into or out of the main body 122 through the second aperture 128 . The aperture sealing member 136 is shown in a second position in FIG. 2A , in which the spring 139 is compressed and the aperture sealing member 136 is disposed laterally relative to the second aperture 128 , thereby exposing the second aperture 128 . In this configuration, the enlarged member 114 of the male member 110 may be inserted into or removed from the hollow main body 122 of the second body 120 . [0037] To fasten the male member 110 and the second body (female member) 120 together, a force may be exerted on the aperture sealing member 136 , causing the spring 139 to compress and the aperture sealing member 136 to move out of the first position ( FIG. 2B ) and into the second position ( FIG. 2A ), thereby exposing the second aperture 128 . The enlarged member 114 of the male member 110 then may be inserted through the second aperture 128 until the enlarged member 114 is disposed in a void 134 ( FIG. 2B ) of the second body (female member) 120 and the elongated rod 112 extends through the second aperture 128 . [0038] The male member 110 may be displaced relative to the second body (female member) 120 such that the rod 112 passes along or slides through the slot 130 of the second body (female member) 120 until the rod 112 extends through the first aperture 126 , the enlarged member continuing to be disposed within the void 134 of the main body 122 of the second body 120 and retained by the interior surface 125 thereof. [0039] The displaceable aperture sealing member 136 then may be released, allowing the biasing member or spring 139 to extend and causing the horizontal support member 138 , the vertical support member 139 , and the aperture sealing member 136 to return to the first position shown in FIG. 2B . In this configuration, the enlarged member 114 is precluded from passing through the second aperture 128 and may be retained and secured within the void 134 of the second body 120 . [0040] The internal components of the main body are not limited to the tubular member shown in FIG. 2A and FIG. 2B . Instead, any biasing system or spring which permits the aperture sealing member to move between a first and second position as described herein is sufficient. A biasing member may interact with the aperture sealing member to bias the aperture sealing member in the first position. As a non-limiting example, the biasing member may be a coil spring, a leaf spring or an elastomer material. The biasing member may be disposed adjacent the exterior surface of the main body. [0041] In another exemplary embodiment of the invention shown in FIG. 3A , a clasp 200 may include a first body 140 including male member 110 having an elongated rod 112 with an enlarged member 114 formed on an end of the elongated rod 112 . A female member 220 may be provided having an at least partially hollow main body 222 , a first aperture 226 , a second aperture 228 , and a slot 230 extending continuously between the first aperture 226 and the second aperture 228 . A displaceable aperture sealing member 236 may be movably attached to the main body 222 and may be disposed adjacent an exterior surface thereof. The clasp 200 is substantially similar to the clasp 100 of FIGS. 1A, 1B , 2 A, and 2 B, and may operate in a substantially similar fashion thereto. However, the main body 222 of the female member 220 has a square shape, the first aperture 226 may be disposed on a corner of the female member 220 at the junction of two side surfaces thereof, and the displaceable aperture sealing member 236 may be disposed on a side surface of the female member 220 . The displaceable aperture sealing member 236 is shown located laterally adjacent the second aperture 228 , which is exposed in FIG. 3A . In addition, the displaceable aperture sealing member 236 may be or may include a decorative piece such as a gem or stone. [0042] The clasp 200 shown in FIG. 3A is shown in the assembled state in FIG. 3B wherein the first body 140 is connected to main body 222 of the female member 220 via male member (not visible in FIG. 3B ). In the assembled state, the displaceable aperture sealing member 236 may be disposed directly above and covering the second aperture 228 (not visible in FIG. 3B ). [0043] Alternatively, the main body 222 of the female member 220 may be formed having any shape. For example, the main body 222 may have a generally spherical shape, and aperture sealing member 236 may be displaceable circumferentially about the hollow main body 222 . [0044] One feature of the clasps previously described herein is that the main body of the female members may rotate relative to the interchangeable decorative jewelry pieces. For example, referring to FIGS. 1A and 1B , the first body 140 may rotate freely relative to the second body (female member) 120 which may often be a beneficial and desirable characteristic. It is further understood that rotation may be affected by altering the size of the first aperture relative to the elongated rod and enlarged member. Sometimes, however, it may be preferable to provide a clasp that precludes the rotation of one piece relative to the other. An embodiment of the invention that precludes such rotation is shown in FIG. 4 . [0045] An exemplary clasp 300 is shown in FIG. 4 . The clasp 300 is substantially similar to the clasp 100 of FIG. 1A , and includes a T-shaped male member 310 having an elongated rod 312 and an enlarged member 314 provided on an end of the elongated rod 312 . The enlarged member 314 may be formed as an elongated rod attached to, and oriented substantially perpendicular to, the elongated rod 312 . The enlarged member 314 may have rounded or tapered surfaces and ends, as shown in FIG. 4 . A female member 320 may be provided having an at least partially hollow main body 322 , a first aperture 326 , a second aperture 328 , and a slot 330 extending continuously between the first aperture 326 and the second aperture 328 . The T-shaped male member 310 helps prevent the first body 140 from rotating. The second aperture 328 may be formed as an elongated opening to allow both the enlarged member 314 and the elongated rod 312 of the male member 310 to pass therethrough. The first aperture 326 and the slot 330 are formed so as to allow passage of the elongated rod 312 therethrough, but to preclude passage of the enlarged member 314 therethrough. A displaceable aperture sealing member 336 may be movably attached to the main body 322 and disposed adjacent the exterior surface thereof. The male member 310 may be attached to a first body 140 . The clasp 300 may be identical to the clasp 100 of FIG. 1A in all other respects and may operate in a similar fashion thereto as described previously herein. [0046] Because the male member 310 precludes rotation of the first body 140 relative to the female member 320 , each side of the first body 140 may include different designs, patterns, jewels, colors, etc., and the user may select which side of the first body 140 will be the front or visible surface. [0047] Even though the clasp 300 is shown having a T-shaped male member 310 , the clasp 300 alternatively may have a male member substantially similar to the male member (shown in FIG. 1A ). In addition, any of the other exemplary embodiments disclosed herein could be provided having a T-shaped male member 310 . [0048] An earring clasp 400 according to the invention is shown in FIGS. 5A and 5B . The earring clasp 400 may be substantially similar to the clasp 100 of FIG. 1 A , and may include a female member 420 and a male member (not visible in FIGS. 5A or 5 B). The female member 420 may include an at least partially hollow main body 422 , similar to the hollow main body 122 of FIG. 1A . The main body 422 of female member 420 may include an earring stud 444 . The female member 420 may include a first aperture, a second aperture, a slot, and an aperture sealing member identical to those of the female member shown in FIG. 1A . An interchangeable decorative jewelry piece 440 may be attached to the male member and may have an optional jewel 442 disposed thereon. In this configuration, several different decorative jewelry pieces 440 may be interchanged with the earring stud of female member 420 as desired. [0049] An elevational view of the back side of the earring clasp 400 is shown in FIG. 5B . The interchangeable decorative jewelry piece 440 is shown fastened and secured to the hollow main body 422 of the female member 420 by the male member (not visible). The displaceable aperture sealing member 136 is shown in the first position, directly above the second aperture (not visible). [0050] The earring clasp 400 may be provided with various multiple interchangeable decorative jewelry pieces 440 , each having different jewels, gem stones, patterns, colors, or other features that are interchangeable with the female member 420 of the earring clasp 400 . This allows the user to change and customize the earring to match clothing, create new and unique pieces of jewelry, etc. Further, by designing the earring clasp 400 such that the male member is attached to the decorative jewelry pieces 440 , the user can grasp the larger decorative jewelry piece 440 , rather than the smaller male member, which increases the ease with which the decorative jewelry piece 440 may be connected to the earring stud. It will be understood that the shape of female member 420 and the decorative jewelry pieces 440 are not limited. FIG. 5C depicts an elevational view of the back side of the earring clasp 400 . The female member 420 having an earring post 444 is shown separated from the decorative jewelry piece 440 . The decorative jewelry piece 440 attaches to the female member 420 via an elongated rod 112 and enlarged member 114 of a male member 110 . [0051] An exemplary earring clasp 500 according to the invention is shown in FIGS. 6A, 6B and 6 C. The earring clasp 500 may be substantially similar to the earring clasp 400 of FIGS. 5A, 5B and 5 C. The earring in FIGS. 6A, 6B and 6 C further includes a linker piece 540 disposed between the female member 420 and the decorative jewelry piece 440 . The linker piece 540 may include a male member 110 that attaches the linker 540 to the female member 420 as well as a first aperture 136 that connects the linker 540 to the decorative jewelry piece 440 . ( FIG. 6C ) The male member 110 of the decorative jewelry piece 440 may be attached to the linker piece as described in other embodiments. The earring of FIGS. 6A, 6B and 6 C may include a plurality of linker pieces 540 disposed between the female member 420 and the decorative jewelry piece 440 . Further, the decorative jewelry piece 440 could also be a linker piece 540 with both male and female connecting parts. It will be understood that while the decorative member having both male and female parts is shown as part of an earring in FIGS. 6A, 6B , and 6 C, the decorative member having both male and female parts may be incorporated into any piece including a bracelet, pendant, necklace, brooch, etc. [0052] A pendant clasp 600 according to the invention is shown in FIGS. 7A and 7B . The pendant clasp 600 may be substantially similar to the clasp 100 of FIG. 1A , and may include a female member 620 and a male member (not visible in FIGS. 7A and 7B ). The female member 620 may include an at least partially hollow main body 622 , similar to the main body 122 of FIG. 1A . The main body 622 of the female member 620 may include a decorative jewelry piece of the pendant. The female member 620 may include a first aperture (not visible), a second aperture (not visible in FIGS. 7A or 7 B), a slot (not visible in FIGS. 7A or 7 B), and an aperture sealing member 136 substantially identical to those of the second body 120 of FIG. 1A . An optional pin 646 for attaching the pendant to an article of clothing may be provided on the back side of the hollow main body 622 . An interchangeable decorative jewelry piece 640 is shown that is attached to a male member (not visible in FIGS. 7A or 7 B), by which the jewelry piece 640 may be fastened and secured to the main body 622 of the female member 620 . The displaceable aperture sealing member 136 is shown in the first position, directly above and covering the second aperture (not visible in FIGS. 7A or 7 B). The decorative jewelry pieces 640 may include both male and female parts and function as the linker piece 540 described in relation to FIGS. 6A, 6B and 6 C. The main body 622 of the female member 620 also may include additional apertures on the sides of the female member 620 , to allow a chain, necklace or bracelet to pass therethrough as shown in FIG. 7B . In this configuration, the pendant clasp 600 may be attached to clothing or worn on a necklace or bracelet. [0053] The pendant clasp 600 may include a tubular member (as described with reference to FIGS. 2A and 2B ) disposed within the main body 622 of the female member 620 . As illustrated in FIG. 7A , the tubular member 150 (shown by the dotted lines) extends laterally within the female member 620 , and the displaceable aperture sealing member 136 is displaceable in the leftward direction in FIG. 7A . The tubular member would be located so as not to interfere with passage of a chain or other material through any additional apertures in the side of female member 620 . [0054] By use of the pendant clasp 600 with interchangeable decorative jewelry pieces 640 attached to a male member, multiple interchangeable decorative jewelry pieces 640 may be provided, each having different jewels, patterns, colors, or other features that are interchangeable with the female member 620 of the pendant clasp 600 . This allows the user to change and customize the pendant to match clothing, create new and unique pieces of jewelry, etc. [0055] The use of clasps according to the invention allows for interchangeable decorative pieces to be used on various pieces of jewelry such as earrings, bracelets, necklaces, pendants, etc. For example, the interchangeable decorative jewelry pieces 640 may be used with the earrings clasp 400 of FIGS. 5A and 5B , while the interchangeable decorative jewelry pieces 440 may be used with the pendant clasp 600 of FIGS. 7A and 7B . [0056] When interchangeable decorative jewelry pieces are used in jewelry that includes a clasp according to the invention, the interchangeable pieces may include the male member, the female member or both. For example, an earring stud may be attached to the male member, and the main body of female member may include an interchangeable decorative jewelry piece that attaches to the male member of the earring stud. The same principle applies to pendants and other pieces of jewelry as well. In addition, individual pieces of jewelry could be provided having either two female members, one at each end, or two male members, one at each end. [0057] FIGS. 8A and 8B illustrate an exemplary piece of jewelry 700 that includes several interconnected, interchangeable decorative jewelry pieces 702 A, 702 B, 702 C, and 702 D. The piece of jewelry 700 may be part of a bracelet or necklace. Each interchangeable decorative jewelry piece may include a female member, such as female members 720 A, 720 B, 720 C, and 720 D, and a male member. Each female member may include a main body 722 , similar to the main body 122 of FIG. 1A . Each of the female members 720 A, 720 B, 720 C, and 720 D may include a first aperture, a second aperture, a slot, and an aperture sealing member 136 substantially identical to those of the second body 120 (as described with reference to FIG. 1A ). [0058] In addition, a male member, including an elongated rod 112 and an enlarged member 114 , may be attached to and extend from a surface of each of the main bodies 722 of female members 720 A, 720 B, 720 C, and 720 D. In this configuration, each of the interchangeable decorative jewelry pieces 702 A, 702 B, 702 C, and 702 D may be attached together, and may include individual links of a chain, such as a bracelet or necklace. As illustrated, each piece may be shaped differently, colored differently, have different patterns formed on the exterior surface, etc., thereby providing variability and allowing the user to design unique jewelry pieces. Also, a user may remove any of the links without disassembling the entire piece of jewelry as is required with conventional bracelets or necklaces. Referring to FIG. 8B , the displaceable aperture sealing member 136 may be located adjacent the top surface of the hollow main bodies 722 , as in interchangeable decorative jewelry pieces 702 B and 702 D. Alternatively, the displaceable aperture sealing member 136 may be located adjacent the bottom surface of the hollow main bodies 722 , as in interchangeable decorative jewelry pieces 702 A and 702 C. In addition, while the displaceable aperture sealing member 136 is shown as a partial dome, it could be configured in other decorative shapes such as, for example, a flat colored disc having a pattern thereon, and may include jewels, stones, etc. [0059] As seen in FIGS. 8A and 8B , one end of each of the decorative jewelry pieces 702 A and 702 D (the end pieces), may be attached by known methods to the ends of a bracelet or a necklace. Alternatively, several more decorative jewelry pieces may be provided to provide a complete bracelet or necklace consisting only of individual decorative jewelry pieces and no chain. Further, while the of the decorative jewelry pieces 702 B and 702 D are shown with the displaceable aperture sealing member 136 on the top of the jewelry piece, it is understood that the decorative jewelry pieces 702 B and 702 D may be positioned such that the displaceable aperture sealing member 136 is not visible when the jewelry is worn. [0060] A jewelry piece is illustrated in FIG. 9 that includes three strands of pearls, the ends of which are connected with a jewelry clasp 800 according to the invention. The jewelry clasp 800 is similar to the clasp 100 of FIG. 1A , except that jewelry clasp 800 includes two male members 110 , each including an elongated rod 112 and an enlarged member 114 . The female member 820 of the jewelry clasp 800 includes two first apertures (not visible in FIG. 9 ), two second apertures 128 , and two slots 130 . In addition, jewelry clasp 800 includes a displaceable aperture sealing member 836 that is larger than the displaceable aperture sealing member 136 of the clasp 100 (as disclosed with reference to FIG. 1A ) to allow coverage of both of the second apertures 128 . [0061] To fasten the male members 110 with the female member 820 , a force is exerted on the aperture sealing member 836 , causing a spring (not shown in FIG. 9 ), to compress and the aperture sealing member 836 to move out of the first position (not shown in FIG. 9 ) and into the second position as shown in FIG. 9 , thereby exposing the second apertures 128 . The enlarged members 114 of the male members 110 then may be inserted through the second apertures 128 until the enlarged members 114 are disposed in a void (not shown in FIG. 9 ) of the female member 820 and the elongated rods 112 are extending through the second apertures 128 . [0062] The male members 110 may be displaced relative to the second body 120 such that the elongated rods 112 pass along or slide through the length of the slots 130 of the female member 820 until the elongated rods 112 are extending through the first apertures, the enlarged members continuing to be disposed within the void of the female member 820 and retained by the interior surface (not visible in FIG. 9 ) thereof. [0063] The displaceable aperture sealing member 836 then may be released, allowing the biasing member or spring (not visible in FIG. 9 ) to extend causing the aperture sealing member 836 to return to the first position covering the second apertures 128 . In this configuration, the enlarged members 114 may be precluded from passing through the second apertures 128 and thereby retained and secured within the void of the female member 820 . The use of two male members 110 and two corresponding sets of apertures preclude rotation of one end of the bracelet relative to the other end. [0064] An exemplary clasp 900 is shown in FIG. 10 . The clasp 900 is substantially similar to the clasp 100 of FIG. 1A , and includes a male member 110 having an elongated rod 112 and an enlarged member 114 provided on an end of the elongated rod 112 . A female member 920 may be provided having an at least partially hollow main body 122 , a first aperture 126 , a second aperture 128 , and a slot 130 extending continuously between the first aperture 126 and the second aperture 128 . The second body (female member) 120 also includes a displaceable aperture sealing member 936 having a shape substantially similar to the shape of the hollow main body 122 as shown in FIG. 10 . The male member 110 may be attached to a first body 140 . The clasp 900 may be identical to the clasp 100 of FIG. 1A in all other respects and may operate in a similar fashion thereto as described previously herein. In this configuration, the entire top surface of the female member 920 , which includes the displaceable aperture sealing member 936 , is displaceable between a first position directly above and covering the second aperture 128 as shown in FIG. 11 , and a second position laterally adjacent the second aperture 128 as shown in FIG. 10 , in which the second aperture 128 is exposed. This configuration provides a larger surface against which a user may exert a force to open the clasp which makes the clasp easier to open and close. [0065] The displaceable aperture sealing member 936 is shown in FIGS. 10 and 11 having a flat upper surface. Alternatively, the displaceable aperture sealing member 936 may have a dome shaped upper surface, a textured upper surface for enhanced grip, and may include patterns, jewels, or other decorations on the upper surface. In addition, the female member 920 may have a dome shaped bottom surface, a textured bottom surface to enhance grip, and may include patterns, jewels, or other decorations on the bottom surface. In this configuration, a user may choose whether to wear the jewelry displaying either the upper surface or the bottom surface. [0066] An exemplary clasp 100 is shown in FIG. 12 . The clasp 100 is substantially similar to the clasp 100 of FIG. 1A , and includes a first body 140 having a male member 110 having an elongated rod 112 and an enlarged member 114 provided on an end of the elongated rod 112 . The male member may also include female connecting parts such as a displaceable aperture 136 , a first aperture 126 , a second aperture (not visible in FIG. 12 ), and a slot (not visible in FIG. 12 ) extending continuously between the first aperture 126 and the second aperture. [0067] A female member 1020 may be provided having an at least partially hollow main body 122 , a first aperture 126 , a second aperture 128 , and a slot 130 extending continuously between the first aperture 126 and the second aperture 128 . The female member 1020 also includes a displaceable aperture sealing member 1036 having a shape substantially similar to the shape of the main body 122 . The displaceable aperture sealing member 1036 may include a textured surface 1022 to assist in moving the displaceable aperture sealing member 1036 . If desired, the female member 1020 shown in FIG. 12 may also include a male member located anywhere on the main body that would allow attachment to another jewelry piece. The main body may also include additional openings 1060 to accommodate a string or chain so that the female member 1020 functions as a pendant. In FIG. 12 , the first aperture 126 , second aperture 128 , and slot 130 are shown proximate a side of the main body 122 . The clasp 1000 may be identical to the clasp 100 of FIG. 1A in all other respects and may operate in a similar fashion thereto as described previously herein. [0068] The female member 1020 may include a tubular member (as described with reference to FIGS. 2A and 2B ) disposed within the main body 122 of the female member 1020 . The tubular member may include a spring 139 that extends laterally within the female member 1020 parallel to the direction the displaceable aperture sealing member 1036 moves. The tubular member would be located so as not to interfere with passage of a chain or other material through any additional apertures in the side of female member 1020 . The spring 139 may function in a number of ways such as the systems described herein. [0069] The clasps disclosed herein may be incorporated into individual jewelry pieces to allow the sale of individual, interchangeable decorative jewelry pieces of different color or design. The clasps disclosed herein provide a secure connection between members, which prevents unintentional unfastening of the clasp. The clasps of the present invention may also be used as a conventional jewelry clasp for securing the ends of a jewelry piece together. The clasps provide both a releasable and a secure attachment between members. [0070] Many varying and differing embodiments of the invention may be made exhibiting the important features and characteristics disclosed herein. It should be understood that the description of the invention provided herein must be interpreted as illustrative of the novel features and characteristics of the invention and not as defining the limitations or as providing examples of the only embodiments that are within the scope of the invention.

A clasp for releasably fastening two objects is disclosed. The clasp includes a male member and a female member. The female member includes a displaceable member that is movable between a first position and a second position. In the first position, the displaceable member precludes insertion of the male member into or removal of the male member from the female member. In the second position, the male member may be inserted into or removed from the female member. Alternatively, the clasp may include two objects that each contains both male and female parts. Interchangeable jewelry pieces comprising the clasp and a method for removably securing two jewelry pieces are also disclosed.

FIELD OF THE INVENTION This invention relates generally to artificial respiratory devices and methods, and more particularly to chemical methods for providing whole body oxygenation of a mammal whose respiratory system is partially or completely inoperative. More particularly, the present invention relates to methods and devices for treating mammals suffering from anoxia. CROSS-REFERENCE TO RELATED APPLICATIONS AND PATENTS This application is related to U.S. Ser. No. 428,900, filed Sept. 30, 1982, entitled "Stroke Treatment Utilizing Extravascular Circulation Of Oxygenated Synthetic Nutrients To Treat Tissue Hypoxic And Ischemic Disorders" (TJU-3-12), and is also related to U.S. Ser. No. 582,961, filed Feb. 23, 1984 of the same title (TJU-3-13). Ser. No. 582,961 (TJU-3-13) is, in turn, a division of Ser. No. 428,850 filed Sept. 30, 1982, now U.S. Pat. No. 4,445,500 (TJU-3-11), which along with Ser. No. 428,900 (TJU-3-12) are both, in turn, divisions of Ser. No. 354,346, now U.S. Pat. No. 4,445,886 (TJU-3-3) and which, in turn, is a continuation-in-part of Ser. No. 139,886 (now U.S. Pat. No. 4,378,797 (TJU-3), all of which are incorporated herein by reference as if set forth in full. The present application is also related to the following issued United States patents, all of which are incorporated herein by reference as if set forth in full, and all of which are divisions of one or more of the other of the aforementioned Ser. Nos. 139,886 (TJU-3) and 354,346 (TJU-3-3): U.S. Pat. No. 4,445,514 (TJU-3-1); U.S. Pat. No. 4,393,863 (TJU-3-2); U.S. Pat. No. 4,450,841 (TJU-3-4); U.S. Pat. No. 4,445,887 (TJU-3-5); U.S. Pat. No. 4,446,154 (TJU-3-7); U.S. Pat. No. 4,446,155 (TJU-3-8); U.S. Pat. No. 4,451,251 (TJU-3-9); U.S. Pat. No. 4,445,888 (TJU-3-10); U.S. Pat. No. 4,445,500 (TJU-3-11). BACKGROUND OF THE INVENTION There are many post-traumatic and post-operative patients who develop major pulmonary complications which interfere with or preclude adequate oxygenation. The "shock lung" best characterizes this syndrome complex. Severe pneumonias, smoke inhalation, acute respiratory obstructions, pre-mature birth, and birth-related pulmonary injury also can lead to the same general problems with oxygenation. Patients with massive pulmonary embolism and hemothorax also suffer from severe hypoxemia. Combining patients in these categories, there is a substantial population of patients at high risk, but whose conditions are potentially reversible, given adequate oxygenation. The present invention utilizes an oxygenated fluorocarbon liquid for general body oxygenation, which is applied as a circulation through the peritoneal cavity. The aforementioned incorporated patents and patent applications reference in detail various prior art publications relating to fluorocarbons and their medical uses. More recently, in the British Journal of Anaesthesia 56: 867 (1984) in an article entitled "Whole Body Oxygenation Using Intra Peritoneal Perfusion of Fluorocarbons" by Faithfull, Klein, van der Zee and Salt, results of a preliminary study undertaken to assess the feasibility of increasing the arterial oxygen tension, and decreasing the arterial carbon dioxide tension, in intact animals, by means of peritoneal perfusion with the perfluorocarbon-containing, oxygen-transporting blood substitute, 20% Fluosol-DA, were disclosed. This British Journal of Anaesthesia article is not believed to be prior art to the present application. See also U.S. Pat. No. 4,402,984 (Moore). SUMMARY OF THE INVENTION The present invention provides a novel method of whole body oxygenation of the tissue of a living mammal comprising the steps of: providing an oxygenated fluorocarbon-containing liquid; injecting said oxygenated fluorocarbon liquid into the peritoneal cavity of said mammal; and withdrawing said fluorocarbon liquid from said cavity, said injecting and withdrawing being conducted at a rate sufficient to oxygenate at least a portion of the tissue of said mammal. In accordance with the preferred embodiment of the present invention, an oxygenated fluorocarbon emulsion having an aqueous component, a fluorocarbon component, and an emulsification component is utilized which is oxygenated to a pO 2 in excess of 500 mmH g prior to injection. The preferred rate of injection is above 20 milliliters per minute per kilogram of body weight of said mammal, preferably about 25 milliliters per minute per kilogram of said body weight. In the preferred embodiment, the perfusion rate is selected to increase the arterial blood gas of said mammal. Accordingly, the method of the present invention provides a novel "artificial lung" which may be used to provide sufficient oxygen to the blood to maintain life even in the presence of complete or near complete respiratory failure. These and other objects of the invention will become apparent from the following more detailed description. DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention provides a novel method for oxygenating the tissue of a living mammal employing an oxygenated fluorocarbon containing liquid. The preferred fluorocarbon containing liquid is the oxygenated fluorocarbon nutrient emulsion which is disclosed in my aforementioned United States patents, such as U.S. Pat. No. 4,445,886, which has been incorporated by reference as if fully set forth herein. Although this fluorocarbon containing emulsion is presently preferred, it is anticipated that certain constituents presently contained in this emulsion may be eliminated from the fluorocarbon containing liquid used in accordance with the preferred embodiment of the present invention. For example, to minimize the likelihood of bacterial growth, glucose may be eliminated from the fluorocarbon emulsion formulation. Similarly, the subject amino acids and steroids in the subject composition may be eliminated, if desired. Although not presently preferred, it is within the scope of the present invention to inject a liquid consisting essentially of the oxygenated fluorocarbon itself. In this treatment modality, it will be preferred to follow this fluorocarbon treatment with a lavage intended to wash remaining fluorocarbon from the peritoneum at the conclusion of treatment. This lavage may comprise injecting isotonic saline with or without a detergent or emulsifier, such as the pluronic disclosed in the aforementioned patent, to thereby reduce the likelihood of long term toxicity. Under most circumstances, it will be preferred that either or both of the subject perfusate and the subsequent lavage contain an antibiotic, such as bacitracin, to minimize the incidence of peritoneal infection. In order to ensure that substantial oxygen transfer will occur, it is presently preferred to oxygenate the subject fluorocarbon containing liquid to a pO 2 in excess of 500 mmHg prior to injection. As reported in the aforementioned patents, these oxygen tensions are easily obtainable with the subject oxygenated fluorocarbon emulsion. The present invention was reduced to practice, and its utility demonstrated, through performance of the following examples: Experiments were begun using a male 11 pound orange tabby cat which was anesthetized using a 35 milligram per kilogram intra-muscular injection of ketamine. Thirty minutes later, 20 milligrams of flexedil, a respiratory paralytic was administered at 20 milligrams intravenously, and the animal then placed on a respirator. After 20 minutes, its arterial blood was determined to have a pH of 7.430, a pCO 2 of 25.5, and a pO 2 of 103. The aforementioned oxygenated nutrient emulsion (using the fluorocarbon FC-80) was placed in a Harvey pediatric oxygenator (volume 1230 cc) and maintained at about 40° C. Large (1/2 to 3/4 inch) cannulas were placed through two flank incisions into the peritoneum. A Randoff pump was initially used to inject the oxygenated fluorocarbon nutrient emulsion into the peritoneum through one of the cannulas, the second cannula being routed back to the oxygenator for recirculation and reoxygenation of the subject fluorocarbon emulsion. After 10 minutes of administration of a 90% N 2 O--10% O 2 respiratory gas mixture, the pH of the arterial blood was determined to be 7.374, the pCO 2 to be 28.2, and the pO 2 to be 48. Perfusion of the peritoneal space was established at a flow rate greater than 200 milliliters per minute. Problems were encountered, however, with the patency of the return line. Apparently, fatty tissue was being drawn into the return line, a condition which persisted until the catheters were manipulated into the space below omentum, which resolved the problem. Before the collection of meaningful data could be obtained, however, an inadvertent disconnection of the respirator resulted in the expiration of the test animal. Accordingly, a second series of tests were performed using a male, white and grey, 91/2 pound cat. At 2:05 p.m. 150 milligrams of ketamine and 0.18 milligrams of atropine were administered intra-muscularly. At 2:15 p.m. a 70/30 mixture of N 2 O/O 2 was begun through a respirator. At 2:30 p.m. 20 milligrams of flexedil was administered. The arterial blood gas at 2:35 p.m. registered a pCO 2 of 43.2, a pO 2 313; the pH was 7.283. The relatively higher small pO 2 of this arterial blood gas is considered within the normal range given the possibility of some hyperventilation and the administration of a respiratory gas containing 30% oxygen. At 2:35 p.m. the respirator was adjusted to increase the volume to 45 from 35. At 2:50 p.m. the arterial blood gas was 36 pCO 2 , 306 pO 2 , at a pH of 7.318. At 2:55 p.m. a 90/10 N 2 O/O 2 mixture was substituted as the respiration gas. At 3:05 p.m. the aforementioned fluorocarbon emulsion from the Harvey pediatric oxygenator was determined to have an oxygen tension of 565, a carbon dioxide tension of 25, and a pH of 7.951. at 3:10 p.m. the arterial blood gas of the subject animal had an oxygen tension of 48, a carbon dioxide tension of 33.4 and a pH of 7.335. At 3:15 p.m. the arterial blood gas of that animal exhibited a pO 2 tension of 28 mmHg, a carbon dioxide tension of 38.4 mmHg and a pH of 7.354. At 3.24 p.m. the carbon dioxide tension was 43.5, the oxygen tension 36 and the pH 7.311. At 3:36 p.m. the carbon dioxide tension was 37.8, the oxygen tension 36, and the pH 7.292. At 3:58 p.m. the pH was 7.260, the carbon dioxide tension was 42.4, and the oxygen tension was 34. At 4:05 p.m. the oxygen tension of the injected and withdrawn fluorocarbons was determined. The fluorocarbon injected was determined to have an oxygen tension of 594 and a pH of 6.815; the fluorocarbon withdrawn from the peritoneum was found to have a pO 2 of 511 and a pH of 6.865. The carbon dioxide tension in the withdrawn fluid was determined to be 26.7, but was not determined for the input fluorocarbon at this time. At 4:15 p.m. the arterial blood gas was determined to have a pH of 7.212, a carbon dioxide tension of 40.7 and a pO 2 of 42. At 4:20 p.m. the fluorocarbon was determined to have pH of 7.612. Unfortunately, the pO 2 electrode used to determine oxygen tensions in this test was apparently poisoned by the fluorocarbon, and therefore provided doubtful accuracy. It is believed that it was recalibrated, and at 4:20 p.m. the arterial blood gas pH was found to be 7.170, the pO 2 tension to be 46, and the carbon dioxide tension to be 36.3. Return flow, i.e., withdrawal of the fluorocarbon containing liquid from the peritoneum, was improved in this test by routing the exit cannula to a ballast receptacle at atmospheric pressure which was then used as an intermediate reservoir to supply the oxygenator input. As seen from the above, a systemic arterial pO 2 of approximately 30 mmHg (i.e., 28-36 mmHg) was achieved by drastic hypoventilation. When oxygenated fluorocarbon was perfused through the cat peritoneum at rates of about 200 to 250 milliliters per minute, this severe hypoxia was alleviated, as indicated by increased systemic pO 2 of about 46 mmHg. Accordingly, the method of the present invention has been demonstrated as being useful in treating systemic anoxia under conditions where the subject mammal's respiratory system is not capable of providing normal arterial pO 2 tensions.

A novel method of oxygenating the tissue of a living mammal is disclosed comprising the steps of providing an oxygenated fluorocarbon-containing liquid; injecting that oxygenated liquid into the peritoneal cavity of said mammal; and withdrawing said fluorocarbon liquid from said cavity, said injecting and withdrawing be conducted at a rate sufficient to oxygenate said tissue. Accordingly, a novel "artificial lung" is disclosed which is useful to selectively oxygenate the body of a mammal, as reflected by increased arterial blood gas (pO 2) in said mammal.

FIELD OF THE INVENTION The present invention relates to assisting users of walkers with a safe and convenient place to sit while using a conventional stand-alone walker and more specifically to providing trailing chair attachments for operation with various makes and models of pre-existing walkers. BACKGROUND OF THE INVENTION In the past, it has not been uncommon in a nursing home environment to have many patients/residents each having their own personally owned conventional stand alone walker. The term “conventional stand alone walker” is hereby defined to be a walker apparatus for aiding a person walking, which includes at least three upwardly extending support members, which provide support to structures for two hands of a person to grasp while walking; and further having at least three points (either rolling, non-rolling, or a combination of the two) of contacting the ground. The term conventional stand alone walker shall specifically exclude a walker device which has a structure thereon which is specifically adapted to be coupled with a structure for pulling a rolling chair. At times, such as after surgery or other incident, residents may need to exercise by walking with a conventional stand alone walker. At times, these patients may temporarily require additional assistance. In such cases, many staff members can be needed in assisting users of conventional stand alone walkers. In many instances, two staff members are used simultaneously to aid a single user of a conventional stand alone walker. In such situations where the patient is using such a walker, one staff person is walking next to the patient and another follows with a wheel chair. In the event the patient begins to tire or fall, the person walking with the patient provides immediate support, while the other guides the wheel chair into place so the patient can be seated. In the past, it has been known to combine a walker and seat. U.S. Pat. No. 4,974,620 is directed to a walker with a seat which permits the person using the walker to take a rest by being seated in an opposite facing seat. Another patent describes a walker with an attached seat which allows the user to take a forward facing seat when desired. See U.S. Pat. No. 5,058,912. U.S. Pat. No. 5,277,438 describes a collapsible rolling apparatus with a seat and a walking support structure. While these devices do provide significant utility, they do have drawbacks. The '620 patent requires the walker to turn around to sit down. In some situations turning around may be difficult, especially if the patient is very unstable or needs to sit urgently. With the '912 patent, the seat is facing the direction of travel but the system, with only wheels contacting the ground, may not provide the same level of exercise as is required of a person using a conventional stand alone walker, nor does it provide the same level of stability as a conventional stand alone walker. This system, with its ability to roll in any direction, could be difficult for some individuals to use as a walker and entering/exiting it may also be difficult for some. Lastly, the '438 patent is a large structure, also with only wheels touching the ground, and the structure includes two collapsing segments which are not designed to work independently of the other. The '438 patent does not take advantage of the installed base of walkers, and can not provide the same familiarity as the person's own walker. Consequently, there exists a need for improvements in using conventional stand alone walkers which overcomes some of the problems of these prior designs. SUMMARY OF THE INVENTION It is an object of the present invention to provide an efficient and safe method for assisting a large group of users of their own personal conventional stand alone walkers. It is a feature of the invention to utilize an installed base of pre-existing conventional stand alone walkers from various manufacturers. It is another feature of the invention to provide a quick connecting and disconnection method for coupling a trailing chair attachment to a patient's own pre-existing conventional stand alone walker. It is an advantage of the present invention to reduce the expense of providing assistance to a large number of users of conventional stand alone walkers with minimal investment in equipment, while at the same time allowing the patient to enjoy the comfort and peace of mind of using their own familiar personal conventional stand alone walker. Accordingly, the present invention comprises a trailing chair attachment which works with a conventional stand alone walker from various manufacturers, without a need to make changes to the patient's own walker. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an assembly of the present invention. FIG. 2 is a dedicated trailing chair attachment of the present invention. FIG. 3 is a roll restricting assembly of the present invention. DETAILED DESCRIPTION Now referring to FIG. 1 , there is shown a device, generally designated 100 , of the present invention, which could be as simple as a well known and very popular prior art wheeled walker except that it is equipped with connection arms 210 and spring loaded casters 120 , which restrict rolling when a downward force is applied thereon. These spring loaded castors may have adjustable tension for different weights of persons using the walkers. Such spring loaded casters are well known for use with rolling step ladders which roll freely when moved without a load and then lock down, with an internal to the castor brake, when a person steps on the ladder. In some instances, the casters 120 could, instead, be spring loaded wheels 304 . Now referring to FIG. 3 , there is shown an alternate embodiment of the present invention which has standard walker legs 302 with firm gripping relatively soft pliable end caps 306 , such as found on crutches and walkers. The wheels 304 can be spring loaded to allow them to move upward relative to the legs when increased forces are being applied to the length adjustable handles 110 ( FIG. 1 ) or the seat 130 . These wheels 304 and casters 120 allow the trailing chair attachment 100 to roll freely when there is minimal force applied to the handles 110 or the seat 130 . Any suitable selective means for rolling could be used so long as the ability to roll is greatly reduced when pressure is increased on the walker. Spring loaded castors are just one method of allowing for weight sensitive rolling control to exist. For example, the castors 120 and 220 could be augmented with electric brakes which allow for the braking to occur in response to sensors detecting various things such as the amount of force the person walking applies to the handles 110 . A combination of rolling control mechanisms could be employed as well. Now referring to FIG. 2 , there is shown a dedicated trailing chair attachment of the present invention, generally designated 200 which also could have variable length connection bars 210 for connecting with the device 100 or any conventional stand alone walker. Snaps tethers or quick release connections 212 could be used to easily loosely couple the connection bars 210 between the seat portion 230 and the walker 100 . The trailing chair attachment 200 can roll behind any walker on casters 220 , similar to castors 120 , as the person walking is located between the walker and the seat 230 . The person using the walker can sit down at any time without the need to turn around. The length of connection bars can be adjusted for the size of the person, the speed of walking and other factors as well. Trailing chair attachment 200 may have a storage basket 240 , similar to storage basket 140 beneath seat 130 of FIG. 1 . The main structural portions of the trailing chair attachment can be made of pipe, rods, straps, etc. and made of various materials such as steel, aluminum, plastic, wood or other suitable material. The walker can be constructed like many prior art walkers with suitable materials. It may be preferred, but is not essential, that the walker also have spring loaded casters. Some of the benefits of the present invention would still exist if the walker 100 had non-rolling tips, i.e. crutch tips, etc. The trailing chair attachment is readily detachable and can be removed to allow the use of the walker without a chair if a chair is not necessary. In the method and system of the present invention, the device 100 could be used as both a walker, which the patient moves forward while walking and/or it could be used as a trailing chair attachment. In one embodiment of the present invention, they could be identical structures reversed in direction (i.e. the seats facing each other) and coupled to each other by connecting rods 210 . The patient would be located between the two and could push one while the other trails along. When the patient is tired, the patient can merely sit down in the seat of the trailing chair attachment. The Applicant believes that the present invention can be understood by a person skilled in the art after reading this application.

A system of attaching a trailing seat attachment to a walker so a person can sit down while using the walker without the need to turn around. The system comprising a pair of facing identical wheeled walkers coupled by an extension rod there between, where the walker includes spring loaded casters to restrict rolling when downward forces are applied to the walker seat or grips.

FIELD OF THE INVENTION [0001] The invention is directed to the use of Fructus Schisandrae and extracts thereof in preventing and reducing toxicity and side effects of antineoplastic agents. BACKGROUND ARTS [0002] Tumor is one of the main causes that leads to human death. Chemotherapy is a main approach to treat tumor. However, antineoplastic agent may result in various toxic and side effects, including cardiovascular toxicity, hepatotoxicity, nephrotoxicity, suppression of bone marrow, immunosuppression, and alopecia, etc. [0003] Fructus Schisandrae is the mature dry fruit of Schisandra chinensis (Turcz.) Baill. or Schisandra sphenanthera Rehd. Et Wits. Fructus Schisandrae was regarded as a top grade Chinese traditional medicine in an ancient book named “Shennong Ben Cao Jing”. Dibenzocyclooctadiene lignans (Dibenzocyclooctane lignan) are the main ingredient of Fructus Schisandrae , which is the mature dry fruit of Schisandra chinensis (Turcz.) Baill. or Schisandra sphenanthera Rehd. Et Wils. It was described in the book that Fructus Schisandrae had the function of astringency, arresting discharge, nourishing qi to generate fluid, and tonifying kidney to relieve mental stress. It is an usual medicine for strengthening by tonification in traditional Chinese medicine. It has various pharmacological actions, but it was not reported that Fructus Schisandrae and dibenzocyclooctadiene lignans could also prevent and reduce the toxic and side effects produced by an antineoplastic agent. SUMMARY OF THE INVENTION [0004] An object of the invention is to provide a new use of Fructus Schisandrae and its extracts, i.e., the use in preventing and reducing toxicity and side effects of antineoplastic agent. [0005] To achieve the objective, the invention provides the following technical solutions: [0006] Use of Fructus schisandrae in the preparation of a medicament for preventing and reducing the toxicity and side effects of antineoplastic agent. [0007] The toxicity and side effects of antineoplastic agent include cardiovascular toxicity, or hepatotoxicity, or nephrotoxicity, or suppression of bone marrow, or immunosuppression, or alopecia, etc., caused by antineoplastic agent. [0008] Use of the extracts of Fructus schisandrae in the preparation of a medicament for preventing and reducing the toxicity and side effects of antineoplastic agent. [0009] The toxicity and side effects of antineoplastic agent include cardiovascular toxicity, or hepatotoxicity, or nephrotoxicity, or suppression of bone marrow, or immunosuppression, or alopecia, caused by antineoplastic agent. [0010] The extracts of Fructus schisandrae are those extracted by organic solvents from Fructus schisandrae or those obtained by the supercritical fluid extraction. The extracts extracted by ethanol are preferred. [0011] The extract of Fructus schisandrae is dibenzocyclooctadiene lignan. Dibenzocyclooctadiene lignan has a core structure represented by formula 1 (J Chang, J Reiner, J. Xie. Chem. Rev. 2005, 105, 4581-4609). [0000] [0012] Concretely, the structure of the dibenzocyclooctadiene lignan is represented by formula (I): [0000] [0013] Wherein, R 1 , R 2 , R 5 , R 6 is independently hydroxyl or methoxyl, or, R1 and R2, and R5 and R6 independently take together to form an alkoxyl ring, or they independently do not form a ring; [0014] R 3 is selected from the group consisting of: [0000] [0015] R 4 is selected from the group consisting of: [0000] [0016] R 7 is selected from the group consisting of: [0000] [0017] R 8 , R 9 is independently selected from the group consisting of: {circle around (1)} —H {circle around (2)} —OH ; [0020] R 10 is selected from the group consisting of: [0000] [0021] or, R 7 and R 10 take together to form an oxygen bridge, wherein R 1 -R 6 , R 9 , and R 9 are defined as above; [0022] or, R 3 and R 7 take together to form an acyloxy ring, wherein R 1 , R 2 , R 4 -R 6 , R 8 -R 10 are defined as above. [0023] Preferably, the dibenzocyclooctadiene lignan is selected from the group consisting of: [0000] [0000] Preferably, the dibenzocyclooctadiene lignan is schisandrin B. The antineoplastic agent, the toxicity and side effects of which can be prevented or reduced by Fructus Schisandrae and its extracts as described above, is selected from the group consisting of aclarubicin, amrubicin, carubicin, daunorubicin, detorubicin, doxorubicin, epirubicin, esorubicin, galarubicin, idarubicin, ladirubicin, leurubicin, medorubicin, nemorubicin, pirarubicin, rodorubicin, sabarubicin, valrubicin, zorubicin, Bleomycin A5, Bleomycin, Pirarubicin, Dactinomycin, Aclarubicin, Mitomycin, Etoposide, Teniposide, Homoharringtonine, Hydroxycamptothecin, Topotecan, Paclitaxel, Docetaxel, Vincristine, Catharanthus Alkaloid, Vindesine, Vinorelbine, Lentinan, Tamoxifen, Formestane, Exemestane, Anastrozole, Letrozole, Toremifene, Flutamide, Bicalutamide, 5-fluorouracil, Cytarabine, Tegafur, Furtulon, fluridine, Mercaptopurine, Methotrexate, Gemcitabine, Capecitabine, Cytoxan, Ifosfamide, Busulfan, Melphalan, Chlorambucil, Semustine, Alestramustine, Mesna, Cisplatin, Carboplatin, Oxaliplatin, Dacarbazine, Asparaginase, Clodronate Disodium, Pamidronate disodium, Etidronate disodium, Ibandronate, Herceptin, Iressa, Mitoxantrone, Hydroxycarbamide, Methylcantharidnimide, Norcantharidin, Cinobufacini, Ubenimex, Arsenic Trioxide, AiDi, Amifostine, Matrine, Imatinfb, Sodium glycididazole, Dianhydrogalactitol, Procarbazine. [0024] Preferably, the antineoplastic agent is an anthracycline antibiotic. [0025] The medicine, which can prevent and reduce toxicity and side effects of antineoplastic agent, can be one dibenzocyclooctadiene lignan alone, or can be a mixture of two or more dibenzocyclooctadiene lignans. [0026] Fructus schisandrae and dibenzocyclooctadiene lignan, the extract of Fructus schisandrae , can be used in the preparation of a medicament for improving cardiac function. [0027] Drug excipients and carriers can be added with the medicine that can prevent and reduce toxicity and side effects of antineoplastic agent to prepare one of the following dosage forms: injection solution, tablet, capsule, granule, and decoction. [0028] The Fructus Schisandrae and its extracts of the present invention can produce good clinical foreground in preventing and reducing toxicity and side effects of antineoplastic agent. Fructus Schisandrae and its extracts, especially the ethanol extracts and schisandrin B, can effectively reduce the toxicity and side effects caused by antineoplastic agent, especially the side effects such as cardiovascular toxicity, or hepatotoxicity, or nephrotoxicity, or suppression of bone marrow, or immunosuppression, or alopecia etc., caused by antineoplastic agent. The invention also illustrates that Fructus Schisandrae and its extracts have good effect on improving cardiac function. BRIEF DESCRIPTION OF THE DRAWINGS [0029] FIG. 1 shows that the ethanol extracts of Fructus schisandrae can inhibit the increase of mouse serum myocardium enzyme, creatine kinase (CK), induced by Doxorubicin. [0030] FIG. 2 shows that the ethanol extracts of Fructus schisandrae can inhibit the increase of mouse serum myocardium enzyme, creatine kinase isozyme (CK-MB), induced by Doxorubicin. [0031] FIG. 3 shows that the ethanol extracts of Fructus schisandrae can inhibit the increase of mouse serum myocardium enzyme, glutamic-oxalocetic transaminase (GOT), induced by Doxorubicin. [0032] FIG. 4 shows that the ethanol extracts of Fructus schisandrae can inhibit the increase of mouse serum myocardium enzyme, lactic dehydrogenase (LDH), induced by Doxorubicin. [0033] FIG. 5 shows that the ethanol extracts of Fructus schisandrae can inhibit the increase of mouse left ventricular myocardium matrix metalloproteinase MMP-2 activity induced by Doxorubicin. [0034] FIG. 6 shows that the ethanol extracts of Fructus schisandrae can inhibit the death of mouse induced by Doxorubicin. [0035] FIG. 7 shows that the ethanol extracts of Fructus schisandrae can prevent the cardio toxicity of mouse induced by Epirubicin. [0036] FIG. 8 shows that the ethanol extracts of Fructus schisandrae can prevent the cardio toxicity of mouse induced by Daunorubicin. [0037] FIG. 9 shows that the ethanol extracts of Fructus schisandrae can prevent the cardio toxicity of mouse induced by Idarubicin. [0038] FIG. 10 shows that schisandrin B can inhibit the increase of mouse serum myocardium enzyme, creatine kinase (CK), induced by Doxorubicin. [0039] FIG. 11 shows that schisandrin B can inhibit the increase of mouse serum myocardium enzyme, creatine kinase isozyme (CK-MB), induced by Doxorubicin. [0040] FIG. 12 shows that schisandrin B can inhibit the increase of mouse serum myocardium enzyme, glutamic-oxalocetic transaminase (GOT), induced by Doxorubicin. [0041] FIG. 13 shows that schisandrin B can inhibit the increase of mouse serum myocardium enzyme, lactic dehydrogenase (LDH), induced by Doxorubicin. [0042] FIG. 14 shows that schisandrin B can inhibit the increase of mouse left ventricular myocardium matrix metalloproteinase MMP-2 activity induced by Doxorubicin. [0043] FIG. 15 shows that schisandrin B can inhibit the death of mouse induced by Doxorubicin. [0044] FIG. 16 shows that the prevention of cardio toxicity of mice induced by Daunorubicin by six dibenzocyclooctane lignans. DETAILED DESCRIPTION OF THE INVENTION [0045] The invention is further illustrated by the following examples. These examples are only intended to illustrate the invention, but not to limit the scope of the invention. Example 1 Preparation of the Ethanol Extract of Fructus Schisandrae [0046] Percolation Method: 5000 g of Fructus schisandrae powder was percolated with 85-95% ethanol in an amount of 6 times of the mass of the powder. The percolation velocity is 15 ml/min. The ethanol leachate was recycled. The ethanol was recycled under reduced pressure until there was no ethanol odor. The leachate was concentrated to obtain an extractum with density of 1.15 g/ml, which was ready for use. The ethanol can be replaced by other alcohols, such as methanol, propanol, etc. Other organic solvents, such as ethyl acetate, ether, etc. can also be used to replace ethanol to prepare the extract of Fructus schisandrae. Example 2 The Ethanol Extract of Fructus schisandrae can Prevent Toxicity and Side Effects Induced by Doxorubicin [0047] 1. Materials and Methods [0048] 1.1 Drugs and Agents [0000] Doxorubicin Hydrochloride Injection was obtained from Italy pharmacia Co. (Product No.: 5E2002-D). Ethanol extract of Fructus schisandrae prepared from Example 1 was dissolved in 0.5% Poloxamer. CK (creatine kinase), CK-MB (creatine kinase isozyme), LDH (lactic dehydrogenase) and GOT (glutamic-oxalocetic transaminase) were detected by automatic biochemistry analyzer. Tissue Protein extraction solution was obtained from American Pierce Co. Male ICR mice with a body weight of 25-30 g were obtained from Shanghai Experimental Animal Center. [0049] 1.2 Grouping and Administration [0050] 150 animals were divided randomly into 5 groups. [0051] Control group: 24 mice were dosed intragastrically with normal saline in an amount of 20 ml/kg each time at the 1 st -3 rd day of the experiment, once a day. At the 3 rd day, the mice were injected with normal saline in an amount of 25 ml/kg into their abdominal cavities within 2 hours after drench. [0052] Group of the ethanol extract of Fructus schisandrae (the X group): 24 mice were dosed intragastrically with the ethanol extract of Fructus schisandrae in an amount of 400 mg/kg each time at the 1 st -3 rd day of the experiment, once a day. [0053] Group of Doxorubicin (the Dox group): 42 mice were dosed intragastrically with normal saline in an amount of 20 ml/kg each time at the 1 st -3 rd day of the experiment, once a day. At the 3 rd day, the mice were injected with Doxorubicin of 25 mg/kg into their abdominal cavities. [0054] Group 1 of Doxorubicin plus the extract of Fructus schisandrae (group 1 of Dox +X): 24 mice were dosed intragastrically with the extract of Fructus schisandrae in an amount of 400 mg/kg each time at the 1 st -3 rd day of the experiment, once a day. At the 3 rd day, the mice were injected with 25 mg/kg of Doxorubicin into their abdominal cavities 0.5 hours after drench. [0055] Group 2 of Doxorubicin plus the extract of Fructus schisandrae (group 2 of Dox +X): 24 mice were dosed intragastrically with the extract of Fructus schisandrae in an amount of 200 mg/kg each time at the 1 st -3 rd day of the experiment, once a day. At the 3 rd day, the mice were injected with 25 mg/kg of Doxorubicin into their abdominal cavities 0.5 hours after drench. [0056] 1.3 Detection of Serum Myocardium Enzymes [0057] At the 5 th day (48 hours after injection of Doxorubicin into abdominal cavity), blood were collected. The serum was separated by regular separation and frozen at −80° C. CK, CK-MB, LDH and GOT were determined by automatic bio-chemistry analyzer. [0058] 1.4 Detection of Myocardium Matrix Metalloproteinase (MMP-2) [0059] Sample Preparation [0060] The mice were put to death by cervical dislocation after obtaining their blood and were dissected quickly to obtain the hearts. The left ventricular was separated, washed clean with normal saline and weighed. The left ventricular myocardium tissues were taken out, triturating under liquid nitrogen. 500 μl pre-cooling extraction buffer (10 mmol/L Tris-HCL, pH7.5, 1 mmol/L MgCl 2 , 1 mmol/L EGTA, 0.1 mmol/L PMSF, 5 mmol/L β-mercaptoethanol, 5 g/L CHAPS, 0.01% Triton X-100) was added. The mixture was put on the ice for 10 min, then centrifuged at 15000 g for 30 min. The supernatant was removed for detecting protein concentration by Bradford detection. 20 μl sample was added with 5× sample buffer (not including mercaptoethanol) 5 μl and were hold for 15 min under 37° C. [0061] 10% SDS-PAGE gel was prepared as separating gel (including 0.1% glutin), which is covered with 4% concentrating gel. 20 μl sample after treatment was loaded onto the gel to carry out electrophoresis with 40 mA constant current under a temperature of below 4 C. After electrophoresis, the gel was hold in the eluent (2.5% Triton X-100, 50 mmol/L Tri HCL, 5 mmol/L CaCl 2 , 1 μmol/L ZnCl 2 , pH7.6), agitated and eluted for 2 times, 45 min/time. The gel was then put in the rinsing solution (the eluent without Triton X-100) for rinsing for 2 times, 20 min/time. The gel was then put in the incubation solution (50 mmol/L Tri HCl, 5 mmol/L CaCl 2 , 1 μmol/L ZnCl 2 , 0.02% Brij 35 , pH7.6) for incubation for 18 h under 37° C. The gel was stained with the staining solution (0.05% Coomassie brilliant blue, 30% methanol, 10% acetic acid) for 3 h. After the gel was decolorated for 0.5 h, 1 h, and 2 h by using decoloration solution A, B, and C (containing methanol in a concentration of 30%, 20%, 10% respectively and acetic acid in a concentration of 10%, 10%, 5% respectively), respectively, matrix metalloproteinase (MMP) was showed as a transparent brilliant strip against the blue background. The gel was scanned by UVP gel scanner and was kept in the archives. The electrophoretogram was analyzed by GelWorks ID Advanced v4.01 software to determine the density of bands digested by gelatinase. [0062] 1.5 Survival Rate Observation [0063] The remainder mice were observed for 7 days from the day of administering Doxorubicin and the change of survival rate was recorded. [0064] 2. Results [0065] 2.1 Effect of the Extract of Fructus schisandrae on Serum Myocardium Enzyme Spectrum of Mice with Myocardial Damage Induced by Doxorubicin [0066] There was no significant differences between the serum myocardium enzyme spectrum indexes, including CK, CK-MB, LDH, GOT, of the control group and those of the X group (P>0.05). The 4 serum myocardium enzyme spectrum indexes of the Dox group were significantly higher than those of the control group and the X group (P<0.05). The serum enzyme indexes of the two dosage groups which were administered in combination with the extract of Fructus schisandrae were decreased to a certain extent as compared with those of the Dox group. Specifically, the 4 serum enzymology indexes of the group using 400 mg/kg of the extract of Fructus schisandrae for 3 times together with Doxorubicin were significantly lower than those of the group using Doxorubicin alone (P<0.05) (see FIGS. 1-4 ). These indicated that the cardio toxicity induced by Doxorubicin could be effectively prevented by the ethanol extract of Fructus schisandrae. [0067] 2.2 Detection Results of the Activity of Left Ventricular Myocardium Metalloproteinase [0068] No activity of left ventricular myocardium matrix metalloproteinase (MMP-2) were detected both in the normal control group and in the X group. The activity of left ventricular myocardium MMP-2 of the Dox group was increased significantly. The gelatinase activity of left ventricular myocardium MMP-2 were inhibited obviously in both groups using the extract of Fructus schisandrae together with Doxorubicin, wherein the inhibition effect of the group using 400 mg/kg of the extract of Fructus schisandrae together with Doxorubicin was the best (see FIG. 5 ). The results indicated that the cardio toxicity induced by Doxorubicin could be effectively prevented by the ethanol extracts of Fructus schisandrae. [0069] 2.3 Effect of the Extract of Fructus schisandrae on Survival Rate of Mice with Acute Toxicity Induced by Doxorubicin [0070] The death of mice in the Dox group and in the two groups of Dox+X occurred on the 5 th day. On the 7 th day, the survival rate of the Dox group was 3.7%, the survival rate of the group using 400 mg/kg of the extract of Fructus schisandrae for 3 times together with Doxorubicin was 50% (P<0.01), and the survival rate of the group using 200 mg/kg of the extract of Fructus schisandrae for 3 times together with Doxorubicin was 16.7% (P<0.05). See FIG. 6 . These indicated that toxicity and side effects induced by Doxorubicin could be obviously reduced by the extract of Fructus schisandrae. [0071] 2.4 Effects of the Ethanol Extract of Fructus schisandrae and Doxorubicin on Apparent Condition of Mice [0072] Mice in the group using Doxorubicin alone were in bad conditions, manifested as asthenia, listlessness, hypotrichosis. However, mice in the group administered with the extract of Fructus schisandrae for 3 times together with Doxorubicin were relatively active and eutrichosis. These indicated that toxicity and side effects induced by Doxorubicin could be reduced by the ethanol extract of Fructus schisandrae. Example 3 The Ethanol Extract of Fructus schisandrae Reduces the Cardio Toxicity of Induced by Epirubicin [0073] Experimental methods: The ethanol extract of Fructus schisandrae obtained in Example 1 was prepared with 0.5% poloxamer as 8 g/ml mutterlauge. ICR mice were purchased from Shanghai Experimental Animal Center. The animals were divided into two groups, 15 mice per group. Each mouse in group 1 was dosed intragastrically with 100 μl solvent (0.5% poloxamer), and each mouse in group 2 was dosed intragastrically with 100 μl ethanol extract of Fructus schisandrae , and then mice in each group were injected with 4 mg/kg Epirubicin through tail vein 3 hours after drench of solvent or the ethanol extract. These administrations were carried out once every 7 days for 10 times totally. The mice were put to death one week after the last injection and their hearts were taken out. The heart was fixed with 4% paraform. 48 hours later, the heart was dehydrated with ethanol and fixed with paraffin. The paraffin piece was sliced into sections (with thickness of 2 μm) and the sections were stained with toluidine blue and were observed under microscope. The heart trauma was evaluated by the reported method (Imondi A R, et al. Cancer Research. 1996, 56:4200-4204). The cardio toxicity was evaluated by Severity and Extent. Severity was divided into two grades: Grade 1, which was represented by sarcoplasmic microvacuolation and/or cellular edema and mesenchyme edema; and Grade 2, which was represented by atrophy, necrotic, fibrotic, endocardium trauma and blood clot based on Grade 1. Extent was divided into four grades. Grade 0.5 was represented by less than 10 exceptional myocardium cells within each view of microscope. Grade 1 was represented by more than 10 exceptional myocardium cells within each view of microscope. Grade 2 was represented by dispersal but agminate exceptional myocardium cells. Grade 3 was represented by some agminate exceptional myocardium cells. [0074] The myocardium trauma was calculated by the following formula: [0000] mean total score( MTS )=Σ( S×E )/number of mice [0000] in which S is Severity, E is Extent. Higher the mean total score, the severer heart trauma. [0075] Results: As indicated in FIG. 7 , cardio toxicity induced by Epirubicin was significantly prevented by the ethanol extract of Fructus schisandrae , i.e., the cardio toxicity induced by Epirubicin could be significantly reduced by the ethanol extract of Fructus schisandrae. Example 4 The Ethanol Extract of Fructus schisandrae Reduces Cardio Toxicity Induced by Daunorubicin [0076] Experimental methods: The ethanol extract of Fructus schisandrae obtained in Example 1 was prepared with 0.5% poloxamer as 8 g/ml mutterlauge. ICR mice were purchased from Shanghai Experimental Animal Center. The animals were divided into two groups, 15 mice per group. Each mouse in group 1 was dosed intragastrically with 100 μl solvent (0.5% poloxamer), and each mouse in group 2 was dosed intragastrically with 100 μl ethanol extract of Fructus schisandrae . Then mice were injected with 4 mg/kg Daunorubicin through tail vein 3 hours after drench of solvent or the ethanol extract. These administration were done once every 7 days for 10 times totally. The mice were put to death one week after the last injection and their hearts were taken out. The heart was fixed with 4% paraform. 48 hours later, the heart was dehydrated with ethanol and fixed with paraffin. The paraffin piece was sliced into sections (with thickness of 2 μm) and the sections were stained with toluidine blue and were observed under microscope. The heart trauma was evaluated by the methods as those described in Example 3. [0077] Results: As indicated in FIG. 8 , the cardio toxicity induced by Daunorubicin could be significantly reduced by the ethanol extract of Fructus schisandrae. Example 5 The Ethanol Extract of Fructus schisandrae Reduces Cardio Toxicity Induced by Idarubicin [0078] Experimental methods: The ethanol extract of Fructus schisandrae obtained in Example 1 was prepared with 0.5% poloxamer as 8 g/ml mutterlauge. ICR mice were purchased from Shanghai Experimental Animal Center. The animals were divided into two groups, 15 mice per group. Each mouse in group 1 was dosed intragastrically with 100 μl solvent (0.5% poloxamer), and each mouse in group 2 was dosed intragastrically with 100 μl ethanol extract of Fructus schisandrae . Then mice were injected with 4 mg/kg Daunorubicin through tail vein 3 hours after drench of solvent or ethanol extract. These administrations were done once every 7 days for 10 times totally. The mice were put to death one week after the last injection and their hearts were taken out. The heart was fixed with 4% paraform. 48 hours later, the heart was dehydrated with ethanol and fixed with paraffin. The paraffin piece was sliced into sections (with thickness of 2 μm) and the sections were stained with toluidine blue and were observed under microscope. The heart trauma was evaluated by the methods as those described in Example 3. [0079] Results: As indicated in FIG. 9 , the cardio toxicity induced by Idarubicin could be significantly reduced by the ethanol extract of Fructus schisandrae. Example 6 Prevention of Other Toxicity and Side Effects of Antineoplastic Agent by the Ethanol Extract of Fructus schisandrae [0080] 1. Materials and Methods [0081] 1.1 Experimental Materials [0082] Vincristine, Methotrexate, Cisplatin, Cytoxan, 5-fluorouracil and Doxorubicin were obtained from Shanghai Pharmacy Co. ICR mice with body weight of 20-25 g were from Shanghai Experimental Animal Center. The mice were grouped randomly as below, 6 mice per group. [0083] 1.2 Grouping and Administration [0084] Control group: mice were injected into their abdominal cavities with normal saline once every two days, consecutively for 7 times. [0085] Methotrexate group: mice were injected into their abdominal cavities with 2 mg/kg once every two days, consecutively for 7 times. [0086] Group of Methotrexate plus the ethanol extract of Fructus schisandrae : mice were dosed intragastrically with 400 mg/kg of the ethanol extract of Fructus schisandrae , followed by injection into their abdominal cavities with 2 mg/kg of Methotrexate within 2 hours, once every two days and consecutively for 7 times. [0087] Cisplatin group: mice were injected their abdominal cavities with 2 mg/kg Cisplatin once every two days and consecutively for 7 times. [0088] Group of Cisplatin plus the ethanol extract of Fructus schisandrae : mice were dosed intragastrically with 400 mg/kg of the ethanol extract of Fructus schisandrae , followed by injection into their abdominal cavities with 2 mg/kg of Cisplatin within 2 hours, once every two days and consecutively for 7 times. [0089] 5-fluorouracil group: mice were injected into their abdominal cavities with 30 mg/kg once every two days and consecutively for 7 times. [0090] Group of 5-fluorouracil plus the ethanol extract of Fructus schisandrae : mice were dosed intragastrically with 400 mg/kg of the ethanol extract of Fructus schisandrae , followed by injection into their abdominal cavities with 30 mg/kg of 5-fluorouracil within 2 hours, once every two days and consecutively for 7 times. [0091] Cytoxan group: mice were injected into their abdominal cavities with 30 mg/kg Cytoxan once every two days and consecutively for 7 times. [0092] Group of Cytoxan plus the ethanol extract of Fructus schisandrae : mice were dosed intragastrically with 400 mg/kg of the ethanol extract of Fructus schisandrae , followed by injection into their abdominal cavities with 30 mg/kg of Cytoxan within 2 hours, once every two days and consecutively for 7 times. [0093] Vincristine group: mice were injected into their abdominal cavities with 0.3 mg/kg once every two days and consecutively for 7 times. [0094] Group of Vincristine plus the ethanol extract of Fructus schisandrae : mice were dosed intragastrically with 400 mg/kg of the ethanol extract of Fructus schisandrae , followed by injection into their abdominal cavities with 0.3 mg/kg of Vincristine within 2 hours, once every two days and consecutively for 7 times. [0095] Doxorubicin group: mice were injected into their abdominal cavities with 4 mg/kg once every two days and consecutively for 7 times. [0096] Group of Doxorubicin plus the ethanol extract of Fructus schisandrae : mice were dosed intragastrically with 400 mg/kg of the ethanol extract of Fructus schisandrae , followed by injection into their abdominal cavities with 0.3 mg/kg of Vincristine within 2 hours, once every two days and consecutively for 7 times. [0097] 2. Results [0098] 2.1 Effect of Fructus schisandrae Together with Doxorubicin on Various Organs of Mice (See Tablet 1) [0099] Mice were put to death and their heart, liver, spleen, kidney and thymus were weighed. It was discovered that the immune organs of antineoplastic agent groups were obviously lighter than those of control group, indicating that antineoplastic agents produce obvious toxicity and side effects on each organ. The immune organs of the groups using the ethanol extract of Fructus schisandrae together were heavier to a certain extent than those of control group, indicating that the ethanol extract of Fructus schisandrae has potential in reducing toxicity and side effects of antineoplastic agent and in improving immune function. [0000] TABLE 1 Inhibition of the weight decrease of each organ of mice induced by antineoplastic agent by the ethanol extract of Fructus schisandrae Liver(g) Heart(mg) Kidney(mg) Thymus(mg) Spleen(mg) Control group(n = 6) 1.93 ± 0.365 162.2 ± 27.2 389.3 ± 58.9 98.2 ± 19.1 158.7 ± 44.2 Methotrexate 1.57 ± 0.192 161.8 ± 19.5 365.6 ± 27.5 53.9 ± 16.2 101.6 ± 36.7 group(n = 6) Group of Methotrexate 1.96 ± 0.49 161.7 ± 22.3 375.8 ± 41.6 96.1 ± 15.4* 147.1 ± 22.8* plus the ethanol extract of Fructus schisandrae (400 mg/kg; n = 6) Cisplatin group(n = 6) 1.78 ± 0.270 157.4 ± 24.9 313.5 ± 74.88 56.3 ± 12.6  98.4 ± 22.8 Group of Cisplatin plus 1.87 ± 0.19 168.3 ± 25.6 386.3 ± 58.9 89.9 ± 11.7* 151.2 ± 33.5* the ethanol extract of Fructus schisandrae (400 mg/kg; n = 6) 5-fluorouracil group 1.88 ± 0.28 159.6 ± 22.6 378.6 ± 59.3 61.9 ± 10.4 102.4 ± 22.8 Group of 5-fluorouracil 1.88 ± 0.34 162.5 ± 31.7 371.4 ± 35.7 97.3 ± 15.2* 157.1 ± 25.7* plus the ethanol extract of Fructus schisandrae (400 mg/kg; n = 6) Cytoxan group(n = 6) 1.88 ± 0.36 162.6 ± 31.4 396.3 ± 54.7 49.8 ± 12.4 113.5 ± 24.7 Group of Cytoxan plus 1.82 ± 0.35 157.2 ± 34.5 381.4 ± 32.5 89.7 ± 20.3* 149.6 ± 31.7* the ethanol extract of Fructus schisandrae (400 mg/kg; n = 6) Vincristine group(n = 6) 1.87 ± 0.33 159.5 ± 21.7 385.3 ± 85.7 58.9 ± 13.3 109.5 ± 18.9 Group of Vincristine 1.83 ± 0.46 161.6 ± 33.7 381.2 ± 62.4 89.3 ± 21.1* 152.5 ± 18.9* plus the ethanol extract of Fructus schisandrae (400 mg/kg; n = 6) Doxorubicin 1.51 ± 0.215 134.8 ± 19.5 335.6 ± 27.5 55.8 ± 14.2  91.6 ± 35.9 group(n = 10) Group of Doxorubicin 1.89 ± 0.26* 156.4 ± 22.1 398.3 ± 66.9* 89.1 ± 19.6* 158.7 ± 23.8* plus the ethanol extract of Fructus schisandrae (400 mg/kg; n = 6) *indicating that using in combination with ethanol extract of Fructus schisandrae had notable significance as compared with using antineoplastic agent alone [0100] 2.2 Effects of the Ethanol Extract of Fructus schisandrae and Antineoplastic Agent on Apparent Condition of Mice [0101] Mice in the group using antineoplastic agent alone were in bad conditions after 7-8 days, manifested as asthenia, listlessness and hypotrichosis. However, mice in the group administering in combination with the extract of Fructus schisandrae were relatively active and eutrichosis. These indicated that toxicity and side effects induced by antineoplastic agent could be reduced by the ethanol extract of Fructus schisandrae. [0102] Examples 2-5 indicated that the ethanol extract of Fructus schisandrae can reduce and prevent the toxicity produced by antibiotics anti-tumor agents. Example 6 indicated that the ethanol extract of Fructus schisandrae can reduce and prevent the toxicities of anti-tumor drugs originated from plant, antimetabolism agents, alkylating agents and platinum drugs. Example 7 Study on Prevention of Cardio Toxicity of Doxorubicin by Schisandrin B (SchB) [0103] 1. Materials and Methods [0104] 1.1 Drugs and Agents [0000] Doxorubicin Hydrochloride Injection was obtained from Italy pharmacia Co. (Product No.: 5E2002-D). SchB was obtained from National Institute for the Verification of Pharmaceutical and Biological Products (Product No.: 110765-200407), which was dissolved in 0.5% Poloxamer. CK, CK-MB, LDH and GOT were determined by automatic biochemistry analyzer. Tissue Protein extraction solution was obtained from American Pierce Co. Male ICR mice with a body weight of 25-30 g were obtained from Shanghai Experimental Animal Center. [0105] 1.2 Grouping and Administration [0106] 162 animals were grouped randomly into 6 groups. [0107] Control group: 24 mice were dosed intragastrically with normal saline at the 1 st -3 rd day of the experiment, once a day and each time with 20 ml/kg. At the 3 rd day, the mice were injected into their abdominal cavities with normal saline within 2 hours after drench. [0108] Group of Schisandrin B (SchB group): 24 mice were dosed intragastrically with SchB at the 1 st -3 rd day of the experiment, once a day and each time with 100 mg/kg. [0109] Group of Doxorubicin: 42 mice were dosed intragastrically with normal saline at the 1 st -3 rd day of the experiment, once a day and each time with 20 ml/kg. At the 3 rd day, the mice were injected into their abdominal cavities with Doxorubicin of 25 mg/kg. [0110] Group 1 of Doxorubicin plus Schisandrin B (group 1 of Dox +SchB): 24 mice were dosed intragastrically with SchB at the 1 st -3 rd day of the experiment, once a day and each time with 100 mg/kg. At the 3 rd day, the mice were injected into their abdominal cavities with 25 mg/kg of Doxorubicin 0.5 hours after drench. [0111] Group 2 of Doxorubicin plus Schisandrin B (group 2 of Dox +SchB): 24 mice were dosed intragastrically with SchB at the 1 st -3 rd day of the experiment, once a day and each time with 50 mg/kg. At the 3 rd day, the mice were injected into their abdominal cavities with 25 mg/kg of Doxorubicin 0.5 hours after drench. [0112] Group 3 of Doxorubicin plus Schisandrin B (group 3 of Dox +SchB): 24 mice were dosed intragastrically with SchB at the 1 st -3 rd day of the experiment, once a day and each time with 25 mg/kg. At the 3 rd day, the mice were injected into their abdominal cavities with 25 mg/kg of Doxorubicin 0.5 hours after drench. [0113] 1.3 Detection of Serum Myocardium Enzymes [0114] At the 5 th day (48 hours after injection of Doxorubicin into abdominal cavity), blood were taken from 6 mice of each group. The serum was separated by regular separation. CK, CK-MB, LDH and GOT were determined by automatic biochemistry analyzer. [0115] 1.4 Detection of Myocardium MMP [0116] The experimental method was carried out as those described in Example 2 (1.4). [0117] 1.5 Survival Rate Observation [0118] The remainder mice were observed for 7 days from the day of Doxorubicin administration and the change of survival rate was recorded. [0119] 2. Results [0120] 2.1 Effect of Schisandrin B on Serum Myocardium Enzyme Spectrum of Mice with Myocardial Damage Induced by Doxorubicin [0121] There were no significant differences between the serum myocardium enzyme spectrum indexes, such as CK, CK-MB, LDH, GOT, etc., of control group and those of SchB group (P>0.05). The 4 serum enzyme indexes of Doxorubicin group were significantly higher than those of control group and Sch B group (P<0.05). The serum enzyme indexes of the three dosage groups using in combination with Sch B were decreased to a certain extent as compared with those of the group using Doxorubicin alone. In particular, the 4 serum enzyme indexes of the group using 100 mg/kg of Sch B for 3 times in combination with Doxorubicin had no significant difference as compared with those of control group (P>0.05). The 4 serum enzyme indexes of the group using 100 mg/kg of Sch B for 3 times in combination with Doxorubicin, however, had significant difference as compared with the significantly increased serum enzymes produced by the group using Doxorubicin alone (P<0.05). The CK and CK-MB indexes of the group using 50 mg/kg of Sch B for 3 times in combination with Doxorubicin and those of the group using 25 mg/kg of Sch B for 3 times in combination with Doxorubicin had significant difference as compared with the group using Doxorubicin alone (P<0.05). See FIG. 10-13 . These indicated that the cardio toxicity induced by Doxorubicin could be prevented by Sch B. [0122] 2.2 Detection Results of the Activity of Left Ventricular Myocardium Metalloproteinase [0123] No left ventricular myocardium matrix metalloproteinase (MMP-2) activity were detected both in the normal control group and in Sch B group. The MMP-2 activity of the Doxorubicin group was increased obviously. The MMP-2 activity in the three dosage groups using Sch B in combination with Doxorubicin were inhibited significantly, wherein the inhibition effect of the group using 100 mg/kg of Sch B together with Doxorubicin was the best. See FIG. 14 . These results indicated that the cardio toxicity induced by Doxorubicin could be prevented by Sch B. [0124] 2.3 Effect of Sch B on Survival Rate of Mice with Acute Toxicity Induced by Doxorubicin [0125] The death of mice in the Doxorubicin group occurred on the 4 th day, and the death of mice in the three groups using Sch B together with Doxorubicin occurred on the 5 th day. On the 7 th day, the survival rate of the Doxorubicin group was 0, the survival rate of the group using 100 mg/kg of Sch B for 3 times together with Doxorubicin was 33.3% (P<0.01), the survival rate of the group using 50 mg/kg of Sch B for 3 times together with Doxorubicin was 25% (P<0.01), and the survival rate of the group using 25 mg/kg of Sch B for 3 times together with Doxorubicin was 16.67% (P<0.05). See FIG. 15 . These results indicated that toxicity and side effects induced by Doxorubicin could be obviously reduced by Sch B. Example 8 Five Dibenzocyclooctadiene Lignans can Prevent Other Toxicity and Side Effects of Doxorubicin [0126] 1. Materials and Methods [0127] 1.1 Experimental Materials [0128] Doxorubicin Hydrochloride Injection was obtained from Italy pharmacia Co. Six Dibenzocyclooctadiene lignans were obtained from National Institute for the Verification of Pharmaceutical and Biological Products (Product No.: 110765-200407), which were dissolved in 0.5% Poloxamer. Female ICR mice with a body weight of 25-30 g were obtained from Shanghai Experimental Animal Center, which were grouped randomly into 4 groups, 10 mice per group. [0129] 1.2 Animal Grouping and the Ways and Routines of Administration [0130] Control group: 10 mice were injected into their abdominal cavities with normal saline once every two days and consecutively for 7 times. [0131] Group of Doxorubicin (Dox group): 10 mice were injected into their abdominal cavities with 2 mg/kg of Doxorubicin once every two days, consecutively for 7 times. Group 1 of Doxorubicin plus Schisandrin B (group 1 of Dox +SchB): 10 mice were dosed intragastrically with 50 mg/kg of Sch B, followed by injection into their abdominal cavities with 2 mg/kg of Doxorubicin within two hours, once every two days and consecutively for 7 times. [0132] Group 2 of Doxorubicin plus Schisandrin B (group 2 of Dox +SchB): 10 mice were dosed intragastrically with 100 mg/kg of Sch B, followed by injection into their abdominal cavities with 2 mg/kg of Doxorubicin within two hours, once every two days and consecutively for 7 times. [0133] Group of Doxorubicin plus Schisandrin A: 10 mice were dosed intragastrically with 100 mg/kg of Schisandrin A, followed by injection into their abdominal cavities with 2 mg/kg of Doxorubicin within two hours, once every two days and consecutively for 7 times. [0134] Group of Doxorubicin plus Schisandrin C: 10 mice were dosed intragastrically with 100 mg/kg of Schisandrin C, followed by injection into their abdominal cavities with 2 mg/kg of Doxorubicin within two hours, once every two days and consecutively for 7 times. [0135] Group of Doxorubicin plus Schizandrol A: 10 mice were dosed intragastrically with 100 mg/kg of Schizandrol A, followed by injection into their abdominal cavities with 2 mg/kg of Doxorubicin within two hours, once every two days and consecutively for 7 times. [0136] Group of Doxorubicin plus Schizandrol B: 10 mice were dosed intragastrically with 100 mg/kg of Schizandrol B, followed by injection into their abdominal cavities with 2 mg/kg of Doxorubicin within two hours, once every two days and consecutively for 7 times. [0137] 2. Results [0138] 2.1 Effect of 5 Dibenzocyclooctadiene Lignans in Combination with Doxorubicin on Various Organs of Mice (See Tablet 2) [0139] Mice were put to death and their heart, liver, spleen, kidney and thymus were weighed. It was discovered that each organ of the Dox group were obviously lighter than those of the other groups, indicating that Doxorubicin produced obvious toxicity and side effects on each organ. The organs of groups using dibenzocyclooctadiene lignan together with Doxorubicin were heavier to a certain extent than those of the Dox group, indicating that dibenzocyclooctadiene lignans had the potential in reducing toxicity and side effects of Doxorubicin and in improving immune function. [0000] TABLE 2 Inhibition of the weight decrease of each organ of mice induced by Doxorubicin by 5 dibenzocyclooctadiene lignans Liver(g) Heart(mg) Kidney(mg) Thymus(mg) Spleen(mg) Control group(n = 10) 1.89 ± 0.436 160.2 ± 29.5 394.8 ± 60.99 95.1 ± 17.3 154.7 ± 51.0 Group of 1.51 ± 0.215 134.8 ± 19.5 335.6 ± 27.5 55.8 ± 14.2  91.6 ± 35.9 Doxorubicin(n = 10) Group 1 of Doxorubicin 1.66 ± 0.249 130.7 ± 20.4 384.8 ± 40.4* 57.1 ± 10.7 108.1 ± 33.7 plus Schisandrin B (50 mg/kg; n = 10) Group 2 of Doxorubicin 1.78 ± 0.270* 147.4 ± 24.9 393.5 ± 74.88* 73.8 ± 20.5* 130.4 ± 42.8* plus Schisandrin B (100 mg/kg; n = 10) Group of Doxorubicin 1.71 ± 0.16* 151.4 ± 21.6 389.2 ± 69.8* 69.6 ± 21.7* 144.6 ± 43.5* plus Schisandrin A (100 mg/kg; n = 10) Group of Doxorubicin 1.82 ± 0.21* 158.4 ± 25.5 373.5 ± 68.2* 76.9 ± 19.5* 129.4 ± 32.8* plus Schisandrin C (100 mg/kg; n = 10) Group of Doxorubicin 1.83 ± 0.310* 164.4 ± 34.9 401.3 ± 84.9 83.9 ± 25.3* 137.4 ± 42.6* plus Schizandrol A (100 mg/kg; n = 10) Group of Doxorubicin 1.85 ± 0.38* 161.5 ± 31.6 395.2 ± 84.66* 85.8 ± 22.3* 133.5 ± 38.68* plus Schizandrol B (100 mg/kg; n = 10) *indicating that as compared with the group of Doxorubicin, the difference was significant(P < 0.05) [0140] 2.2 Effects of Dibenzocyclooctadiene Lignans and Doxorubicin on Apparent Conditions of Mice [0141] Mice in the group using Doxorubicin alone were in bad conditions after 7-8 days, manifested as asthenia, listlessness and hypotrichosis. However, mice in the group administered with Doxorubicin in combination with dibenzocyclooctadiene lignans were relatively active and eutrichosis. These indicated that toxicity and side effects induced by antineoplastic agent could be reduced by dibenzocyclooctadiene lignans. [0142] The antineioplastic used in the Example was Doxorubicin. Doxorubicin has not only the common toxicity and side effects of antineioplastics, e.g. immune inhibition, marrow inhibition, etc., but also cardiovascular toxicity of the medicine with an anthracycline core structure. As a result, Doxorubicin can well reflect the toxicity and side effects of antineoplastic agent. Example 9 Six Dibenzocyclooctane Lignans can Reduce Cardio Toxicity of Induced by Daunorubicin [0143] Experimental method: ICR mice were purchased from Shanghai Experimental Animal Center. Schisandrin A, Schisandrin B, Schisandrin C, Schisantherin A, Schizandrol A, and Schizandrol B were prepared with 0.5% poloxamer as 1 g/ml mutterlauge respectively. The animals were grouped into 7 groups, 15 mice each group. Each mouse in group 1 was dosed intragastrically with 100 μl solvent (0.5% poloxamer), each mouse in group 2 was dosed intragastrically with 100 μl Schisandrin A, each mouse in group 3 was dosed intragastrically with 100 μl Schisandrin B, each mouse in group 4 was dosed intragastrically with 100 μl Schisandrin C, each mouse in group 5 was dosed intragastrically with 100 μl Schisantherin A, each mouse in group 6 was dosed intragastrically with 100 μl Schizandrol A, and each mouse in group 7 was dosed intragastrically with 100 μl Schizandrol B, and 3 hours after administration of solvent or the above dibenzocyclooctane lignans, mice in each group were injected with 4 mg/kg Daunorubicin through tail vein. The above administrations were carried out once every 7 days for 10 times totally. The mice were put to death one week after the last time of injection and their hearts were taken out. The heart was fixed with 4% paraform. The operation steps were the same as those in Example 3. [0144] Results: As indicated in FIG. 16 , the cardio toxicity induced by Daunorubicin could be significantly reduced by the 6 dibenzocyclooctane lignans, indicating that the 6 dibenzocyclooctane lignans had significant prevention effects on cardio toxicity induced by Daunorubicin. Example 10 Dibenzocyclooctane Lignans can Prevent and Reduce Other Toxicity and Side Effects of Antineoplastic Agent [0145] The above Examples indicated that dibenzocyclooctane lignans can reduce and prevent the toxicity of antibiotics anti-tumor agents. This Example indicateds that dibenzocyclooctane lignans can also reduce and prevent the toxicities of anti-tumor drugs originated from plant, antimetabolism agents, alkylating agents and platinum drugs. [0146] 1. Materials and Methods [0147] 1.1 Experimental Materials [0148] Vincristine, Methotrexate, Cisplatin, Cytoxan, and 5-fluorouracil were from Shanghai Pharmacy Co. 6 dibenzocyclooctadiene lignans were bought from National Institute for the Verification of Pharmaceutical and Biological Products, which were dissolved in 0.5% Poloxamer. ICR mice, body weight 20-25 g, were obtained from Shanghai Experimental Animal Center. The mice were divided randomly as following, 6 mice per group. [0149] 1.2 Animal Grouping and the Way and Routine of Administration [0150] Control group: mice were injected into their abdominal cavities with normal saline once every two days, consecutively for 7 times. [0151] Methotrexate group: mice were injected into their abdominal cavities with 2 mg/kg once every two days, consecutively for 7 times. [0152] Group of Methotrexate plus Schisandrin B: mice were dosed intragastrically with 100 mg/kg of Schisandrin B, followed by injection into their abdominal cavities with 2 mg/kg of Methotrexate within two hours, once every two days and consecutively for 7 times. [0153] Cisplatin group: mice were injected into their abdominal cavities with 2 mg/kg once every two days, consecutively for 7 times. [0154] Group of Cisplatin plus Schisandrin A: mice were dosed intragastrically with 100 mg/kg of Schisandrin A, followed by injection into their abdominal cavities with 2 mg/kg of Cisplatin within two hours, once every two days, consecutively for 7 times. [0155] 5-fluorouracil group: mice were injected into their abdominal cavities with 30 mg/kg once every two days, consecutively for 7 times. [0156] Group of 5-fluorouracil plus Schisandrin C: mice were dosed intragastrically with 100 mg/kg of Schisandrin C, followed by injection into their abdominal cavities with 30 mg/kg of 5-fluorouracil within two hours, once every two days, consecutively for 7 times. [0157] Cytoxan group: mice were injected into their abdominal cavities with 30 mg/kg once every two days, consecutively for 7 times. [0158] Group of Cytoxan plus Schisantherin A: mice were dosed intragastrically with 100 mg/kg of Schisantherin A, followed by injection into their abdominal cavities with 30 mg/kg of Cytoxan within two hours, once every two days and consecutively for 7 times. [0159] Vincristine group: mice were injected into their abdominal cavities with 0.3 mg/kg once every two days, consecutively for 7 times. [0160] Group of Vincristine plus Schizandrol A: mice were dosed intragastrically with 100 mg/kg of Schizandrol A, followed by injection into their abdominal cavities with 0.3 mg/kg of Vincristine within two hours, once every two days, and consecutively for 7 times. [0161] 2. Results [0162] 2.1 Effect of 6 Dibenzocyclooctadiene Lignans in Combination with Doxorubicin on Various Organs of Mice (See Tablet 3) [0163] Mice were put to death and their heart, liver, spleen, kidney and thymus were weighed. It was discovered that the immune organs of antineoplastic agent groups were obviously lighter than those of control group, indicating that antineoplastic agents produce obvious toxicity and side effects on each organ. The immune organs of the groups using dibenzocyclooctadiene lignans together were heavier to a certain extent than those of control group, indicating that dibenzocyclooctadiene lignans have potential in reducing toxicity and side effects of antineoplastic agents and in improving immune function. [0000] TABLE 3 Inhibition of weight decrease of each organ of mice induced by antineoplastic agents by 6 dibenzocyclooctadiene lignans Liver(g) Heart(mg) Kidney(mg) Thymus(mg) Spleen(mg) Control group(n = 6) 1.93 ± 0.365 162.2 ± 27.2 389.3 ± 58.9 98.2 ± 19.1 158.7 ± 44.2 Methotrexate 1.57 ± 0.192 161.8 ± 19.5 365.6 ± 27.5 53.9 ± 16.2 101.6 ± 36.7 group (n = 6) Group of Methotrexate 1.86 ± 0.249 159.7 ± 21.4 384.4 ± 40.4 86.1 ± 12.6* 138.1 ± 31.7* plus Schisandrin B (100 mg/kg; n = 6) Cisplatin group(n = 6) 1.78 ± 0.270 157.4 ± 24.9 313.5 ± 74.88 56.3 ± 12.6  98.4 ± 22.8 Group of Cisplatin plus 1.89 ± 0.18 158.9 ± 23.4 383.2 ± 67.6 89.7 ± 13.8* 156.6 ± 42.6* Schisandrin A (100 mg/kg; n = 6) 5-fluorouracil group 1.88 ± 0.28 159.6 ± 22.6 378.6 ± 59.3 61.9 ± 10.4 102.4 ± 22.8 Group of 5-fluorouracil 1.89 ± 0.32 162.1 ± 33.8 391.4 ± 45.8 89.8 ± 14.2* 147.4 ± 22.6* plus Schisandrin C (100 mg/kg; n = 6) Cytoxan group(n = 6) 1.88 ± 0.36 162.6 ± 31.4 396.3 ± 54.7 49.8 ± 12.4 113.5 ± 24.7 Group of Cytoxan plus 1.89 ± 0.39 169.2 ± 32.8 391.2 ± 35.6 84.7 ± 21.4* 143.5 ± 35.8* Schisantherin A (100 mg/kg; n = 6) Vincristine group(n = 6) 1.87 ± 0.33 159.5 ± 21.7 385.3 ± 85.7 58.9 ± 13.3 109.5 ± 18.9 Group of Vincristine 1.79 ± 0.36 162.3 ± 42.6 386.2 ± 64.9 81.9 ± 12.1* 143.5 ± 19.8* plus Schizandrol A (100 mg/kg; n = 6) *indicating that as compared with using antineoplastic agent alone, using together with dibenzocyclooctane lignan had notable significance [0164] 2.2 Effects of 5 Dibenzocyclooctadiene Lignans and Antineoplastic Agents on Apparent Conditions of Mice [0165] Mice in the group using antineoplastic agent alone were in bad conditions after 7-8 days, manifested as asthenia, listlessness and hypotrichosis. However, mice in the group administered in combination with dibenzocyclooctadiene lignans were relatively active and eutrichosis. These indicated that toxicity and side effects induced by antineoplastic agent could be reduced by dibenzocyclooctane lignans.

Use of Fructus schisandrae in preparation of medicaments for preventing and reducing toxicity and side effects of antineoplastic agents. The toxicity and side effects of antineoplastic agents are cardiovascular toxicity, hepatotoxicity, nephrotoxicity, suppression of bone marrow, immunosuppression, or alopecia etc induced by antineoplastic agents. Fructus schisandrae and extracts thereof, especially ethanol extracts, schisandrin B, are effective in reducing antineoplastic agent's toxicity and side effects.

CROSS-REFERENCE TO RELATED APPLICATIONS This is a continuation of application Ser. No. 07/944,132 filed Sep. 11, 1992, by Tomima L. Edmark entitled "Hair Pin For A Hair Styling Tool" now U.S Pat. No. 5,251,650, issued Oct. 12, 1993. TECHNICAL FIELD OF THE INVENTION This invention relates generally to a hair pin for securely mounting an ornamental decoration to a hairstyle characterized by an inverted ponytail. More particularly, this invention relates to a multiple prong hair pin with a stop means for positively engaging a hair-binding element, such as a rubber band, to thereby securely mount the hair pin and decorative ornamentation in place on the user's head. BACKGROUND OF THE INVENTION The hair styling tool used in connection with the hair pin of the present invention is illustrated in U.S. Pat. No. 5,036,870. The hair styling tool of U.S. Pat. No. 5,036,870 has achieved commercial success because it allows a user to create an attractive hairstyle in a minimum amount of time and it eliminates the need for expensive professional hairstyling. Specifically, the user forms a ponytail and binds the ponytail with a hair-binding element, such as an elastic or rubber band. Then, with a few easy motions and the assistance of the hair styling tool the user can easily invert the ponytail to create an attractive and stable hairstyle. The hairstyle is self-holding and requires little or no hair spray or other hair-holding applications. The hair styling tool and hairstyle disclosed in U.S. Pat. No. 5,036,870 has become popular because the resulting hairstyle is attractive, fast and easy. People from all walks of life enjoy the hairstyle because it takes little or no time to prepare and the hairstyle maintains its position for an extended period of time. People with straight hair find that the hairstyle provided by the hair styling tool takes less time to prepare on a daily basis than many permed hairdos. Further, many people are finding that the inverted ponytail hairstyle and the hair styling tool obviate the need for permanents which can be very expense. The inverted ponytail hairstyle disclosed in U.S. Pat. No. 5,036,870 has become known as a TOPSYTAIL hairstyle. One problem not addressed in U.S. Pat. No. 5,036,870 is how to adorn a TOPSYTAIL hairstyle with an ornamental hair pin that will maintain its position for as long as the inverted ponytail hairstyle. Specifically, only hair pins shaped like combs, barrettes or hair pins with a spring biased pin mechanism are provided in the prior art. No hair pin taught by the prior art provides a means for securely affixing the hair pin to the hair binding element, or elastic band, used to create the original ponytail of the hairstyle discussed above. The present invention addresses this problem and provides a hair pin that securely affixes to the elastic band used to create the original ponytail of a TOPSYTAIL hairstyle and thereby provides the user with an opportunity to further adorn this attractive hairstyle with an ornamental hair pin that will stay in place as long as a TOPSYTAIL hairstyle or other hairstyle employing an elastic band or other hair binding element. SUMMARY OF THE INVENTION The present invention makes a significant contribution to the art of hair styling by providing a hair pin that securely fastens to the hair binding element used to make a ponytail. Specifically, the present invention provides a hair pin that securely attaches to a hair binding element used to make an inverted ponytail, or a TOPSYTAIL hairstyle. The hair pin includes at least one front prong and at least one rear prong, with the upper ends of each prong being attached to a platform. The preferred embodiment includes two rear prongs and a single front prong. The platform connects the upper ends of all the prongs and slants upward and backward, toward the user's head, at an angle from about 0° to about 30° from the vertical. The rear prongs are disposed adjacent to the head of the user and the front prongs are disposed outward from the head. The hair binding element, or elastic band, is accommodated between the front and rear prongs. At least one prong also includes a stop means for lockingly engaging the hair binding element. The preferred stop means for lockingly engaging the hair binding element includes at least two inwardly extending tabs on the front prong. The tabs are separated by a space or a section. The hair binding element is engaged within this section so that the hair hiding element is accommodated between the front and rear prongs and the hair biding element is also engaged between the two tabs on the front prong when the hair pin is in place. This positioning of the hair binding element securely attaches the hair pin to a TOPSYTAIL hairstyle and no adjustments are required to the hair pin for an extended period of time. Alternatively, the hair binding element may be accommodated between the front and rear prongs and as well as between one tab and the platform, depending upon the hair thickness and desired elevation of the hair pin. Further, a third tab may be added for additional height adjustment. Thus, the hair binding element may be engaged between two tabs or between a tab and the platform as well as the front and rear prongs. Thus, the hair pin of the present invention and the hair styling tool disclosed in U.S. Pat. No. 5,036,870 provide a system for creating an attractive hairstyle and adorning the hairstyle with a hair pin that maintains its position for an extended period of time. The hair styling tool of the system includes an elongated probe with a lower end for insertion into the ponytail between the hair binding element and the head. The upper end of the probe is attached to a loop. The end of the ponytail is inserted through the loop and then the user pulls on the lower end of the probe thereby pulling the loop and distal end of the ponytail through the ponytail to create an inverted ponytail, or a TOPSYTAIL hairstyle. Preferably, the loop is formed of flexibly resilient material so that it passes through the upper portion of the ponytail easily. After the ponytail is inverted, or a TOPSYTAIL hairstyle is created, a portion of the hair binding element, or elastic band, is disposed between the user's head and the inverted ponytail. The rear prongs of the hair pin are inserted between this portion of the hair binding element and the user's head. The front prong of the hair pin is inserted between the hair binding element and the inverted ponytail. The hair pin is inserted downward far enough so that the hair binding element is further engaged between two inwardly protruding tabs of the front prong. Thus the hair binding element is accommodated between the front and rear prongs and further engaged between the upper and lower tabs of the front prong. It will be noted that the stop means for engaging the hair binding element (or two tabs or one tab and the platform) may also be disposed on one or more rear prongs and the invention is not limited to placement of the stop means on one or more front prongs. The present invention also includes a method of inverting a ponytail and affixing a decorative hair pin to the ponytail. First, the ponytail is created by binding the user's hair with a hair binding element. The lower end of the probe of the hair styling tool is inserted in the ponytail between the user's head and the hair binding element. The distal end of the ponytail is inserted through the loop in a direction toward the user's head. The lower end of the probe is pulled in a downward direction and the loop and ponytail are passed through the portion of the ponytail where the lower end of the probe was inserted. The user pulls the lower end of the probe, or the entire hair styling tool, far enough downward so that the ponytail becomes disengaged from the loop. An inverted ponytail, or TOPSYTAIL hairstyle, has been created. Then, the hair pin of the present invention is attached to the portion of the hair binding element disposed between the inverted ponytail and the user's head. The rear prongs are inserted between the head and the hair binding element and the front prong is inserted between the hair binding element and the inverted ponytail. The hair pin is pushed downward far enough so that the hair binding element becomes engaged between the two inwardly protruding tabs of the front prong. The hair binding element is disposed between the front and rear prongs and between the upper and lower tabs of the front prong to create a stable configuration for the hair binding element. A decoration or ornamental object is attached to the platform of the hair pin and is clearly visible and facing outward from the back of the user's head. It is therefore an object of the present invention to provide a multiple prong hair pin for securely attaching to a hair binding element or an elastic band used in hair styling. It is another object of the present invention to provide an improved system for creating an inverted ponytail and securely attaching a decorative hair pin thereto. It is still another object to the present invention to provide an improved method for creating an inverted ponytail and adorning the inverted ponytail with a decorative hair pin. Yet another object of the present invention is to eliminate the need for expensive professional hairstyling services for people whose hair is amenable to inverted ponytail hairstyles. BRIEF DESCRIPTION OF THE DRAWINGS This invention is illustrated more or less diagrammatically in the accompanying drawings, wherein: FIG. 1 is a left front perspective view of the hair styling tool made in accordance with the present invention; FIG. 2 is a left front perspective view of the hair pin made in accordance with the present invention; FIG. 3 is a left rear perspective view of the hair pin shown in FIG. 2; FIG. 4 is a sectional view taken substantially along lines 4--4 of FIG. 2; FIG. 5 is a rear perspective view of an ornamental article or decorative item to be affixed to the hair pin shown in FIG. 2; FIGS. 6, 7 and 8 illustrate the use of the hair styling tool shown in FIG. 1 to invert a hair tail, or a ponytail, to create an inverted ponytail hairstyle; FIG. 9 is an illustration of the hair pin shown in FIG. 2, adorned with the ornamental article shown in FIG. 5, as attached to the hairstyle shown in FIG. 8; and FIG. 10 is a sectional view taken substantially along lines 10--10 of FIG. 9. DETAILED DESCRIPTION OF THE INVENTION Like reference numerals will be used to refer to like or similar parts from Figure to Figure in the following description of the drawings. The dramatic improvement contributed by the present invention is best understood after consideration of the hair styling tool 10 shown in FIG. 1 and described in U.S. Pat. No. 5,036,870. The hair styling tool 10 includes a probe 11 with a lower end 12 and an upper end 13. The lower end 12, as will be seen below, is inserted into the hair in the first step in creating the inverted ponytail (see FIG. 6). A loop 14 is attached to the upper end 13 of the probe 11. The loop 14 accommodates the distal end 15 of the ponytail 16 when creating the inverted ponytail hairstyle 17 as shown in FIG. 8. FIG. 2 is an illustration of the preferred embodiment of the hair pin 20 of the present invention. The hair pin 20 preferably includes three prongs, specifically a left rear prong 21, a right rear prong 22 and a front prong 23. All three prongs include upper ends 24, 25 and 26 which are attached to the platform 27. The lower ends 28, 29 and 30 of the prongs 21, 23 and 22 extend downwardly into the hair as will be seen below. The inwardly protruding tabs 33 and 34 of the front prong 23 provide locking engagement of the hair binding element 35 or the stop means for engaging the hair binding element 35 (se FIG. 10). The platform 27 provides support for the decorative article 40 shown in FIG. 5. FIG. 3 illustrates the upper tab 33 and lower tab 34 of the stop means of the front prong 23. When the hair pin 20 is secured in place, the hair binding element 35 is disposed in front of the rear prongs 21 and 22 and behind the front prong 23 and further between the upper tab 33 and the lower tab 34. The upper tab 33 and the lower tab 34 prevent undue vertical movement of the hair pin 20 after the user has properly affixed the hair pin 20 to the hairstyle shown in FIGS. 8 and 9. Alternatively, the hair binding element 35 may be engaged between the upper tab 33 and the platform 27 or between the lower tab 34 and a third bottom tab (not shown). It will be noted that the tabs 33, 34, or the stop means, may alternatively be disposed on one or more rear prongs 21, 22 although the preferred embodiment includes the tabs 33, 34 disposed on the single front prong 23 shown in FIG. 3. Further, the hair pin 20 may include more than one front prong 23 and each front prong 23 may include tabs, such as 33, 34. FIG. 4 shows the relative displacement between the front prong 23 and the rear prongs 21 and 22. As noted above, the hair binding element 35 extends between the rear prongs 21, 22 and the front prong 23 and further below the upper tab 33 and above the lower tab 34 (not shown in FIG. 4). FIG. 5 is an illustration of a flower-type decorative item 40 affixed to its own support platform 41 which is then attached to the platform 27 of the hair pin 20. The decorative item 40 may be attached to the platform 27 by sewing, gluing, snapping or other means of attachment. Further, the decorative item 40 may be detachably attached to the platform 27 so that the decorative items, such as 40, may be removed from platform 27 and replaced with alternative decorative items. FIGS. 6 through 8 illustrate the method of creating the hairstyle first disclosed in U.S. Pat. No. 5,036,870, commonly referred to as a TOPSYTAIL hairstyle. First, the lower end 12 of the probe 11 of the hair styling tool 10 is inserted through the ponytail 16 between the hair binding element 35 (which may be an elastic or rubber band) and the user's head, shown generally at 36. The loop 14 is above the elastic band 35 so that the distal end 15 of the ponytail 16 may be inserted through the loop as shown in FIG. 7. After the position shown in FIG. 7 is achieved, the user grasps the lower end 12 of the probe 11 and pulls downward thereby pulling the ponytail 16 and the loop 14 of the hair styling tool 10 through the ponytail 16 to create the inverted ponytail 17 shown in FIG. 8. The hairstyle 17 shown in FIG. 8 is durable and self-holding. Further, as shown in FIGS. 6 and 7, the hairstyle shown in FIG. 8 is fast and easy to prepare. No additional hair spray or styling gels are required to keep the hair in the same position as shown in FIG. 8. The improvement to a TOPSYTAIL hairstyle shown in FIG. 8 contributed by the hair pin 20 first shown in FIG. 2 is illustrated in FIG. 9. Specifically, the hair pin 20 shown in FIG. 2 is adorned with the decorative item 40 shown in FIG. 5. The hair pin 20 is inserted downward through the hair far enough so that the elastic band 35 is engaged between the upper tab 33 and lower tab 34 of the front prong 23 as shown in FIG. 10. Further, the elastic band 35, or hair binding element, is securably accommodated in front of the rear prongs 21 (22 is not shown in FIG. 10) and behind the front prong 23 as well as between the upper tab 33 and the lower tab 34. The position of the hair pin 20 shown in FIG. 10 is secure and the tabs 33 and 34 prevent undue vertical movement of the hair pin 20 from the position shown in FIG. 10. Thus, an improvement to the hair styling tool and hair styling method disclosed in U.S. Pat. No. 5,036,870 is provided by the present invention. A TOPSYTAIL hairstyle is still easily created and can now be easily adorned with a decorative hair pin that will not fall out. The decorative hair pin provided by the present invention stays in place and does not come out of the hairstyle during the day because of the unique means for locking the hair pin in place provided by the tabs of the front prong. Although only one preferred embodiment of the present invention has been illustrated and described, it will at once be apparent to those skilled in the art that variations may be made within the spirit and scope of the invention. Accordingly, it is intended that the scope of the invention be limited solely by the scope of the hereafter appended claims and not be any specific wording in the foregoing description.

A hair pin is provided that maintains its position in the hair for an extended period of time. The hair pin is preferably used in connection with an inverted ponytail hairstyle. The multiple-prong hair pin includes at least one front prong and preferably two rear prongs. At least one prong includes two locking tabs. The elastic band used to create the ponytail is securably engaged between the front and rear prongs and between the upper and lower tabs thereby precluding vertical movement of the hair pin during use.

[0001] Malaria is an infectious disease caused by protozoan parasites of the Plasmodium genera. The species that cause malaria in humans are: P. falciparum (most malignant), P. vivax, P. malariae , and P. ovale (Mims, C A, et al. Medical Microbiology 1993; London: Mosby: 30.8-30.9). Plasmodium parasites are spread by the female anopheles mosquito, which transmits the infection to various primates and to non-immune human hosts (Boyd R F. Clinical parasitology. In Basic Medical Microbiology , 1995; Boston: Little, Brown and Company :513-514). Donated blood is not tested for infection with malaria, although there are no means to completely prevent the transmission of malaria by blood transfusion (Shulman I. Transmission of parasitic infections by blood transfusion. In Principles of transfusion medicine , eds. E C. Rossi, T L. Simon, G L. Moss, S A. Gould, 1996; Baltimore: Williams and Wilkins :733-8). In the United States, the risk of transfusion-transmitted malaria is limited by excluding blood donors who have traveled to malaria-endemic areas. This results in the deferral of 70,000 donors a year (Nahlen B L, et al. Reassessment of blood donor selection criteria for United States travelers to malarious areas. Transfusion . 1991;31:798-804). In countries with a high prevalence of malaria infection, deferral of donors may not be an option. A method for the inactivation of malaria parasites in blood may mitigate the risk of transfusion transmission from donors that are not removed through ordinary screening methods, and may allow the military to use donors that had been stationed in malaria-endemic areas. Such a method may also reduce the risk of transfusion-transmitted malaria in countries where large portions of the donor population have been exposed to the parasite. [0002] West Nile Virus has recently entered the United States and causes a variety of illnesses, including West Nile encephalitis, West Nile meningitis and West Nile meningoencephalitis. West Nile virus is transmitted through mosquitoes and birds. West Nile virus is known to be transmitted through transfusion of blood products from infected individuals (<http://www.cdc.gov/ncidod/dvbid/westnile/qa/transfusion.htm>). Currently, blood is not tested for West Nile virus and exclusion of donors who are believed to be infected with the West Nile Virus is the only method used to prevent the spread of West Nile virus through blood transfusions. However, most people who are infected with the West Nile Virus do not show symptoms and may not be excluded from the donation process, therefore, transmitting the virus through transfused blood. [0003] There are several reported methods of decontaminating blood. Solvent detergent methods of blood component decontamination work by dissolving phospholipid membranes surrounding viruses such as HIV, and do not damage protein components of blood; however, if blood cells are present, such methods cannot be used because of damage to cell membranes. [0004] The use of photosensitizers, compounds which absorb light of a defined wavelength and transfer the absorbed energy to an energy acceptor, has been proposed for blood component sterilization. For example, European Patent application 196,515 published Oct. 8, 1986, suggests the use of non-endogenous photosensitizers such as porphyrins, psoralens, acridine, toluidines, flavine (acriflavine hydrochloride), phenothiazine derivatives, and dyes such as neutral red and methylene blue, as blood additives. Protoporphyrin, which occurs naturally within the body, can be metabolized to form a photosensitizer; however, its usefulness is limited in that it degrades desired biological activities of proteins. Chlorpromazine is also exemplified as one such photosensitizer; however its usefulness is limited by the fact that it should be removed from any fluid administered to a patient after the decontamination procedure because it has a sedative effect. [0005] Goodrich, R. P., et al. (1997), “The Design and Development of Selective, Photoactivated Drugs for Sterilization of Blood Products,” Drugs of the Future 22:159-171 provides a review of some photosensitizers including psoralens, and some of the issues of importance in choosing photosensitizers for decontamination of blood products. The use of texaphyrins for DNA photocleavage is described in U.S. Pat. No. 5,607,924 issued Mar. 4, 1997 and U.S. Pat. No. 5,714,328 issued Feb. 3, 1998 to Magda et al. The use of sapphyrins for viral deactivation is described in U.S. Pat. No. 5,041,078 issued Aug. 20, 1991 to Matthews, et al. Inactivation of extracellular enveloped viruses in blood and blood components by Phenthiazin-5-ium dyes plus light is described in U.S. Pat. No. 5,545,516 issued Aug. 13, 1996 to Wagner. The use of porphyrins, hematoporphyrins, and merocyanine dyes as photosensitizing agents for eradicating infectious contaminants such as viruses and protozoa from body tissues such as body fluids is disclosed in U.S. Pat. No. 4,915,683 issued Apr. 10, 1990 and related U.S. Pat. No. 5,304,113 issued Apr. 19, 1994 to Sieber et al. The mechanism of action of such photosensitizers is described as involving preferential binding to domains in lipid bilayers, e.g. on enveloped viruses and some virus-infected cells. Photoexcitation of membrane-bound agent molecules leads to the formation of reactive oxygen species such as singlet oxygen which causes lipid peroxidation. A problem with the use of such photosensitizers is that they attack cell membranes of desirable components of fluids to be decontaminated, such as red blood cells, and the singlet oxygen also attacks desired protein components of fluids being treated. U.S. Pat. No. 4,727,027 issued Feb. 23, 1988 to Wiesehahn, G. P., et al. discloses the use of furocoumarins including psoralen and derivatives for decontamination of blood and blood products, but teaches that steps must be taken to reduce the availability of dissolved oxygen and other reactive species in order to inhibit denaturation of biologically active proteins. [0006] Photoinactivation of viral and bacterial blood contaminants using halogenated coumarins is described in U.S. Pat. No. 5,516,629 issued May 14, 1996 to Park, et al. U.S. Pat. No. 5,587,490 issued Dec. 24, 1996 to Goodrich Jr., R. P., et al. and U.S. Pat. No. 5,418,130 to Platz, et al. disclose the use of substituted psoralens for inactivation of viral and bacterial blood contaminants. The latter patent also teaches the necessity of controlling free radical damage to other blood components. U.S. Pat. No. 5,654,443 issued Aug. 5, 1997 to Wollowitz et al. teaches new psoralen compositions used for photodecontamination of blood. U.S. Pat. No. 5,709,991 issued Jan. 20, 1998 to Lin et al. teaches the use of psoralen for photodecontamination of platelet preparations and removal of psoralen afterward. U.S. Pat. No. 5,120,649 issued Jun. 9, 1992 and related U.S. Pat. No. 5,232,844 issued Aug. 3, 1993 to Horowitz, et al., also disclose the need for the use of “quenchers” in combination with photosensitizers which attack lipid membranes, and U.S. Pat. No. 5,360,734 issued Nov. 1, 1994 to Chapman et al. also addresses the problem of prevention of damage to other blood components. [0007] Photosensitizers which attack nucleic acids are known to the art. U.S. Pat. No. 5,342,752 issued Aug. 30, 1994 to Platz et al. discloses the use of compounds based on acridine dyes to reduce parasitic contamination in blood matter comprising red blood cells, platelets, and blood plasma protein fractions. These materials, although of fairly low toxicity, do have some toxicity e.g. to red blood cells. This patent fails to disclose an apparatus for decontaminating blood on a flow-through basis. U.S. Pat. No. 5,798,238 to Goodrich, Jr., et al., discloses the use of quinolone and quinolone compounds for inactivation of viral and bacterial contaminants. [0008] Binding of DNA with photoactive agents has been exploited in processes to reduce lymphocytic populations in blood as taught in U.S. Pat. No. 4,612,007 issued Sep. 16, 1986 and related U.S. Pat. No. 4,683,889 issued Aug. 4, 1987 to Edelson. [0009] Riboflavin (7,8-dimethyl-10-ribityl isoalloxazine) has been reported to attack nucleic acids. Photoalteration of nucleic acid in the presence of riboflavin is discussed in Tsugita, A, et al. (1965), “Photosensitized inactivation of ribonucleic acids in the presence of riboflavin,” Biochimica et Biophysica Acta 103:360-363; and Speck, W. T. et al. (1976), “Further Observations on the Photooxidation of DNA in the Presence of Riboflavin,” Biochimica et Biophysica Acta 435:39-44. Binding of lumiflavin (7,8,10-trimethylisoalloxazine) to DNA is discussed in Kuratomi, K., et al. (1977), “Studies on the Interactions between DNA and Flavins,” Biochimica et Biophysica Acta 476:207-217. Hoffmann, M. E., et al. (1979), “DNA Strand Breaks in Mammalian Cells Exposed to Light in the Presence of Riboflavin and Tryptophan,” Photochemistry and Photobiology 29:299-303 describes the use of riboflavin and tryptophan to induce breaks in DNA of mammalian cells after exposure to visible fluorescent light or near-ultraviolet light. The article states that these effects did not occur if either riboflavin or tryptophan was omitted from the medium. DNA strand breaks upon exposure to proflavine and light are reported in Piette, J. et al. (1979), “Production of Breaks in Single- and Double-Stranded Forms of Bacteriophage ΦX174 DNA by Proflavine and Light Treatment,” Photochemistry and Photobiology 30:369-378, and alteration of guanine residues during proflavine-mediated photosensitization of DNA is discussed in Piette, J., et al. (1981), “Alteration of Guanine Residues during Proflavine Mediated Photosensitization of DNA,” Photochemistry and Photobiology 33:325-333. [0010] J. Cadet, et al. (1983), “Mechanisms and Products of Photosensitized Degradation of Nucleic Acids and Related Model Compounds,” Israel J. Chem. 23:420-429, discusses the mechanism of action by production of singlet oxygen of rose bengal, methylene blue, thionine and other dyes, compared with mechanisms not involving production of singlet oxygen by which nucleic acid attack by flavin or pteron derivatives proceeds. Riboflavin is exemplified in this disclosure as having the ability to degrade nucleic acids. Korycka-Dahl, M., et al. (1980), “Photodegradation of DNA with Fluorescent Light in the Presence of Riboflavin, and Photoprotection by Flavin Triplet-State Quenchers,” Biochimica et Biophysica Acta 610:229-234 also discloses that active oxygen species are not directly involved in DNA scission by riboflavin. Peak, J. G., et al. (1984), “DNA Breakage Caused by 334-nm Ultraviolet Light is Enhanced by Naturally Occurring Nucleic Acid Components and Nucleotide Coenzymes,” Photochemistry and Photobiology 39:713-716 further explores the mechanism of action of riboflavin and other photosensitizers. However, no suggestion is made that such photosensitizers be used for decontamination of medical fluids. [0011] Addition of riboflavin to in vitro cultures of P. falciparum has been reported to inhibit asexual parasite growth (Akompong, T., et al. In Vitro Activity of Riboflavin against the Human Malaria Parasite Plasmodium falciparum., Antimicrob Agents Chemother , January 2000;44: 88-96) and kill gametocytes (Akompong, T., et al. Gametocytocidal Activity and Synergistic Interactions of Riboflavin with Standard Antimalarial Drugs against Growth of Plasmodium falciparum In Vitro. Antimicrob Agents Chemother , November 2000; 44: 3107-3111). Riboflavin, when added to cultures in the asexual stage in combination with antimalarial drugs, was reported to enhance the drug activity (Akompong, T., et al. Gametocytocidal Activity and Synergistic Interactions of Riboflavin with Standard Antimalarial Drugs against Growth of Plasmodium falciparum In Vitro. Antimicrob Agents Chemother , November 2000; 44: 3107-3111). In earlier works (Das B S, et al. Riboflavin deficiency and severity of malaria, Eur J Clin Nutr , 1988 April;42:277-83; Dutta P. Enhanced uptake and metabolism of riboflavin in erythrocytes infected with Plasmodium falciparum. J Protozool 1991 September-October;38:479-83), riboflavin deficiency was observed to be detrimental to the parasite. The use of riboflavin as a photosensitizer to treat blood and blood components that may have malaria infection has not been reported. [0012] Apparatuses for decontamination of blood have been described in U.S. Pat. No. 5,290,221 issued Mar. 1, 1994 to Wolfe, Jr., et al. and U.S. Pat. No. 5,536,238 issued Jul. 16, 1996 to Bischof. U.S. Pat. No. 5,290,221 discloses the irradiation of fluid in a relatively narrow, arcuate gap. U.S. Pat. No. 5,536,238 discloses devices utilizing optical fibers extending into a filtration medium. Both patents recommend as photosensitizers benzoporphryin derivatives which have an affinity for cell walls. [0013] U.S. Pat. No. 5,527,704 issued Jun. 18, 1996 to Wolf, Jr., et al. discusses an apparatus to inactivate viruses contained in a body fluid in a container using methylene blue as a photosensitizer. The body fluid is maintained in a static state within the container during irradiation. U.S. Pat. No. 5,868,695 issued Feb. 9, 1999 to Wolf, Jr. et al. discloses a system where blood containing a photoactive material is directed in a predetermined flow path such as a serpentine in a narrow gap in a treatment chamber. PCT published application No. WO 96/06647 discloses irradiating a product in an array of light emitting diodes surrounded by a fluid used to prevent overheating of the diodes. Riboflavin and UV light inactivate viruses and bacteria in plasma and platelet products (Samar, R, et al. Poster, Viral Inactivation in Plasma Using Riboflavin-Based Technology. AABB 54 th Annual Meeting. November 2001; Goodrich R P. The use of riboflavin for the inactivation of pathogens in blood products. Vox Sang . 2000;78 (suppl 2):211-15). Riboflavin and visible light provide demonstrated virus inactivation in platelets (Goodrich, L, et al. Poster. Riboflavin Pathogen Inactivation Process Yields Good Platelet Cell Quality and Expedient Viral Kill. ASH 43 rd Annual Meeting. December 2001) and in red cell suspensions (McAteer M J, et al. Poster: Photo-inactivation of virus in packed red blood cell units using riboflavin and visible light. AABB 53rd Annual Meeting. November 2000). [0014] Sterilization procedures which do not damage cellular blood components but effectively inactivate infectious viruses and other microorganisms and contaminants are disclosed in U.S. Pat. Nos. 6,258,577, 6,277,337, 6,268,120 and PCT publications WO 01/28599, WO 00/04930. Storage solutions containing photosensitizers are disclosed in U.S. patent application Ser. Nos. 09/725,426 and 09/596,429. [0015] There is a need for an inactivation procedure for West Nile virus and malaria, as well as other microorganisms that are not detected in blood products. [0016] All references, publications, patents and patent applications referred to herein are hereby incorporated by reference to the extent not inconsistent with the disclosure herewith. SUMMARY OF THE INVENTION [0017] Methods and apparatuses are provided for treating a fluid to inactivate at least some of the microorganisms that may be present therein or thereon, said fluid containing one or more components selected from the group consisting of protein, (e.g. biologically active protein such as a therapeutic protein), blood and blood constituents. One such method comprises mixing an inactivation-effective, substantially non-toxic amount of an endogenous photosensitizer or endogenously-based derivative photosensitizer with said fluid; and exposing said fluid to photoradiation of sufficient wavelength and energy to activate the photosensitizer, whereby said microorganisms are inactivated. In one particular embodiment, at least one type of parasite or virus is inactivated. In another particular embodiment, at least one type of non-screened microorganism is inactivated. In another particular embodiment, viruses and parasites are inactivated in the same process (i.e., when both are present in the same fluid). [0018] Also provided is an apparatus for inactivating microorganisms which may be present in a fluid with an endogenous or endogenously-based derivative photosensitizer, comprising: [0019] (a) a source of light that emits light of a suitable wavelength and intensity to activate the endogenous or endogenously-based derivative photosensitizer; [0020] (b) means for maintaining the fluid and an effective amount of an endogenous or endogenously-based derivative photosensitizer in the light path for a sufficient time to achieve the desired level of inactivation. [0021] The means for maintaining the fluid and an effective amount of an endogenous or endogenously-based derivative photosensitizer in the light path may comprise a support surface substantially parallel to said source of light; a cuvette or bag; or other means known in the art. [0022] Also provided is a system for treating a fluid to inactivate microorganisms which may be present therein with an endogenous or endogenously-based derivative photosensitizer comprising: a container comprising said fluid, at least an effective amount of an endogenous photosensitizer or endogenously-based derivative photosensitizer, and optionally one or more additives, said container having a photopermeable surface sufficient to allow exposure of the fluid therein to an amount of photoradiation sufficient to activate the photosensitizer; at least one photoradiation source in light communication with said container, said source capable of generating a suitable wavelength and intensity to activate the endogenous photosensitizer or endogenously-based derivative photosensitizer whereby microorganisms present are inactivated. [0023] Other systems, methods and apparatuses are provided, including a flow-through system for inactivation of microorganisms in a fluid containing such microorganisms comprising: [0024] (a) means for mixing an effective amount of an endogenous photosensitizer or endogenously-based derivative photosensitizer with said fluid; [0025] (b) a photopermeable container for said fluid in fluid communication with said means for adding photosensitizer; [0026] (c) means for producing said selected flow rate of said fluid through said container; and [0027] (d) at least one photoradiation source for providing sufficient photoradiation to the fluid in said container of a type and amount selected to activate the photosensitizer. [0028] Also provided is a stand-alone or batch-wise system for treating a fluid to inactivate microorganisms which may be present therein comprising: [0029] (a) a photosensitizer in powdered form; [0030] (b) a photopermeable container for containing said fluid and photosensitizer; [0031] (c) means for agitating said container; [0032] (d) at least one photoradiation source in light communication with said container, said source capable of providing sufficient photoradiation to the fluid in said container of a type and amount selected to activate the photosensitizer whereby microorganisms are inactivated. [0033] The photopermeable container may be a transparent plastic bag, a transparent plastic container with rigid walls, or other containers as known to the art. The agitation may be provided by a shaker table, or other means for agitating known to the art. [0034] Also provided is a method for collecting a fluid with reduced levels of microorganisms that may be present therein, said fluid containing one or more members of the group consisting of: blood and blood components, comprising: [0035] (a) placing said fluid in a photopermeable container; [0036] (b) adding an endogenous or endogenously-based derivative photoactive material; [0037] (c) exposing said fluid to radiation of a sufficient wavelength and intensity to inactivate microorganisms which may be present in said blood or blood component. [0038] Also provided is an apparatus for collecting a fluid with reduced levels of microorganisms that may be present therein, said fluid containing one or more members of the group consisting of: blood and blood components, comprising: [0039] (a) a photopermeable container containing an endogenous or endogenously-based derivative photoactive material; [0040] (b) a light source that emits light of a suitable wavelength and intensity to inactivate microorganisms which may be present in said fluid. [0041] The photosensitizer may be a photo-activatable compound whose photolytic products (if any) are of low or no toxicity to humans or animals. The most preferred photosensitizer is 7,8-dimethyl-10-ribityl isoalloxazine. Other preferred photosensitizers are endogenous alloxazine or isoalloxazine photosensitizers. The photosensitizer is preferably a nucleic-acid-targeted non toxic photoactivatable compound which does not produce toxic photolytic breakdown products. Preferred photosensitizers are not porphyrin. [0042] Photoradiation may comprise light in the visible spectrum, the ultraviolet spectrum, or light in both the visible and ultraviolet spectra. Any suitable wavelength or wavelengths of light may be used in any proportion and energy that produces the desired level of inactivation of microorganisms. As used herein, “wavelength” does not necessarily mean one discrete wavelength. Wavelength may comprise a range of about ±100 nm centered around one wavelength. Preferably, if ultraviolet light is used, the amount of ultraviolet light is kept to a level that minimizes damage to desired fluid components. Generally, this is provided by using 50% or less ultraviolet light relative to the total light energy delivered. Also, the wavelengths of light may be centered around one peak wavelength (i.e., a range of ±10 nm centered around one wavelength). [0043] The fluid containing the photosensitizer is exposed to photoradiation of the appropriate wavelength to activate the photosensitizer, using an amount of photoradiation sufficient to activate the photosensitizer as described herein, but less than that which would cause non-specific damage to the biological components or substantially interfere with biological activity of other proteins present in the fluid. The wavelength used will depend on the photosensitizer selected and composition of the fluid, as is known to the art or readily determinable without undue experimentation following the teachings disclosed herein. Non-specific damage is damage that damages all components. [0044] The photoradiation in both the ultraviolet and visible spectra may be supplied concurrently or sequentially, with the visible portion preferably being supplied first. The photoradiation source may be a simple lamp or may consist of multiple lamps radiating at differing wavelengths. The photoradiation source should be capable of delivering a sufficient amount of light to activate the photosensitizer, preferably from about 1 to at least about 200 J/cm 2 , most preferably around 7 J/cm 2 . All values and ranges of power are included herein. [0045] As used herein, the term “inactivation of a microorganism” means totally or partially preventing the microorganism from replicating, either by killing the microorganism or otherwise interfering with its ability to reproduce. [0046] Microorganisms include viruses (both extracellular and intracellular), bacteria, bacteriophages, fungi, blood-transmitted parasites such as malaria, and protozoa. Exemplary viruses include acquired immunodeficiency (HIV) virus, hepatitis A, B and C viruses, sinbis virus, cytomegaloviris, vesicular stomatitis virus, herpes simplex viruses, e.g. types I and II, human T-lymphotropic retroviruses, HTLV-III, lymphadenopathy virus LAV/IDAV, parvovirus, transfusion-transmitted (TT) virus, Epstein-Barr virus, West Nile virus and others known to the art. Bacteriophages include ΦX174, Φ6, λ, R17, T 4 , and T 2 . Exemplary bacteria include P. aeruginosa, S. aureus, S. epidermis, L. monocytogenes, E. coli, K. pneumonia and S. marcescens . One particular class of microorganisms is non-screened microorganisms—those microorganisms that are not screened by current blood banking processes. Some non-screened microorganisms include malaria and West Nile virus. One class of microorganisms include those transmitted by mosquitoes, including malaria and West Nile virus. [0047] Materials which may be treated by the methods of this invention include any materials which are adequately permeable to photoradiation to provide sufficient light to achieve microorganism inactivation, or which can be suspended or dissolved in fluids which have such permeability to photoradiation. Examples of such materials are whole blood and aqueous compositions containing biologically active proteins derived from blood or blood constituents. Packed red cells, platelets and plasma (fresh or fresh frozen plasma) are exemplary of such blood constituents. In addition, therapeutic protein compositions containing proteins derived from blood, such as fluids containing biologically active protein useful in the treatment of medical disorders, e.g. factor VIII, Von Willebrand factor, factor IX, factor X, factor XI, Hageman factor, prothrombin, anti-thrombin III, fibronectin, plasminogen, plasma protein fraction, immune serum globulin, modified immune globulin, albumin, plasma growth hormone, somatomedin, plasminogen streptokinase complex, ceruloplasmin, transferrin, haptoglobin, antitrypsin and prekallikrein may be treated by the decontamination methods of this invention. The activity of a biologically-active protein in said fluid is at a biologically-active level after said exposing step. A therapeutic protein present in said fluid remains able to perform a therapeutic function after the exposing step. [0048] The term “biologically active” means capable of effecting a change in a living organism or component thereof. “Biologically active” with respect to “biologically active protein” as referred to herein does not refer to proteins which are part of the microorganisms being inactivated. Similarly, “non-toxic” with respect to the photosensitizers means low or no toxicity to humans and other mammals, and does not mean non-toxic to the microorganisms being inactivated. “Substantial destruction” of biological activity means at least as much destruction as is caused by porphyrin and porphyrin derivatives, metabolites and precursors which are known to have a damaging effect on biologically active proteins and cells of humans and mammals. Similarly, “substantially non-toxic” means less toxic than porphyrin, porphyrin derivatives, metabolites and precursors that are known for blood sterilization. [0049] The term “blood product” as used herein includes blood constituents and therapeutic protein compositions containing proteins derived from blood as defined above. Fluids containing biologically active proteins other than those derived from blood may also be treated by the methods of this invention. [0050] Decontamination methods of this invention using endogenous photosensitizers and endogenously-based derivative photosensitizers do not substantially destroy the biological activity of fluid components other than microorganisms. As much biological activity of these components as possible is retained, although in certain instances, when the methods are optimized, some loss of biological activity, e.g., denaturization of protein components, must be balanced against effective decontamination of the fluid. So long as fluid components retain sufficient biological activity to be useful for their intended or natural purposes, their biological activities are not considered to be “substantially destroyed.” [0051] Photosensitizers are known to be useful for inactivating microorganisms. A “photosensitizer” is defined as any compound which absorbs radiation of one or more defined wavelengths and subsequently utilizes the absorbed energy to carry out a chemical process. Examples of such photosensitizers include porphyrins, psoralens, dyes such as neutral red, methylene blue, acridine, toluidines, flavine (acriflavine hydrochloride) and phenothiazine derivatives, coumarins, quinolones, quinones, and anthroquinones. Photosensitizers of this invention may include compounds which preferentially adsorb to nucleic acids, thus focusing their photodynamic effect upon microorganisms and viruses with little or no effect upon accompanying cells or proteins. Other photosensitizers are also useful in this invention, such as those using singlet oxygen-dependent mechanisms. Most preferred are endogenous photosensitizers. The term “endogenous” means naturally found in a human or mammalian body, either as a result of synthesis by the body or because of ingestion as an essential foodstuff (e.g. vitamins) or formation of metabolites and/or byproducts in vivo. Examples of such endogenous photosensitizers are alloxazines such as 7,8-dimethyl-10-ribityl isoalloxazine (riboflavin), 7,8,10-trimethylisoalloxazine (lumiflavin), 7,8-dimethylalloxazine (lumichrome), isoalloxazine-adenine dinucleotide (flavine adenine dinucleotide [FAD]), alloxazine mononucleotide (also known as flavine mononucleotide [FMN] and riboflavine-5-phosphate), vitamin Ks, vitamin L, their metabolites and precursors, and napththoquinones, naphthalenes, naphthols and their derivatives having planar molecular conformations. The term “alloxazine” includes isoalloxazines. Endogenously-based derivative photosensitizers include synthetically derived analogs and homologs of endogenous photosensitizers which may have or lack lower (1-5) alkyl or halogen substituents of the photosensitizers from which they are derived, and which preserve the function and substantial non-toxicity thereof. When endogenous or endogenously-based derivative photosensitizers are used, particularly when such photosensitizers are not inherently toxic or do not yield toxic photoproducts after photoradiation, no removal or purification step is required after decontamination, and treated product can be directly returned to a patient's body or administered to a patient in need of its therapeutic effect. [0052] Non-endogenous photosensitizers based on endogenous structures, such as those described in U.S. Pat. No. 6,268,120 are also useful and included. These non-endogenous photosensitizers and endogenously-based derivative photosensitizers are referred to herein as endogenously-based derivative photosensitizers. [0053] Preferred photosensitizers (also referred to herein as “photoactivators”) are endogenous alloxazines, K vitamins and vitamin L, specifically 7,8-dimethyl-10-ribityl isoalloxazine, (riboflavin) 7,8-dimethylalloxazine, 7,8,10-trimethylisoalloxazine, alloxazine mononucleotide, isoalloxazine-adenosine dinucleotide, and isoalloxazine derivatives and analogs as set forth in U.S. Pat. No. 6,268,120 and U.S. patent application Ser. No. 09/777,727, both of which are incorporated herein by reference to the extent not inconsistent herewith. Specifically, the terms “endogenously-based derivative photosensitizers” and “isoalloxazine derivative photosensitizers” are synonymous and mean compounds having the structure: [0054] wherein R 1 , R 2 , R 3 , R4, R 5 and R 6 are, independently from one another, selected from the group consisting of hydrogen, optionally substituted hydrocarbyl, alcohol, amine, polyamine, sulfate, phosphate, halogen selected from the group consisting of chlorine, bromine and iodine, salts of the foregoing, and —NR a —(CR b R c ) n —X wherein X is a halogen selected from the group consisting of chlorine, bromine and iodine, R a , R b and R c are, independently of each other, selected from the group consisting of hydrogen, optionally substituted hydrocarbyl, and halogen selected from the group consisting of chlorine, bromine and iodine, and n is an integer from 0 to 20. [0055] Preferred endogenously-based derivative photosensitizers are compounds having the structure: [0056] provided that R 1 is not —OH or a straight chain alkyl group where the second carbon of the chain is substituted with —OH or ═O; and R 1 , R 4 , and R 5 are not all methyl groups when R 2 , R 3 , and R 6 ; are all hydrogen. In specifically exemplified classes of endogenously-based derivative photosensitizers, R 1 is not a 2-, 3-, 4- or 5-carbon straight chain alkyl that terminates in —OH, —COH, or —H when R 2 , R 3 and R 6 are H, and R 4 and R 5 are CH 3 ; R 1 is not —CH 2 CH 2 —(CHOH) 2 —CH 3 or —CH 2 CH 2 —(CHOH) 2 —CH 2 SO 4 or 1′-D-sorbityl or 1′-D-dulcityl or 1′-D-rhamnityl or 1′-D,L-glyceryl or —CH 2 —O—C(O)—CH 3 or —CH 2 —O—C(O)—CH 2 CH 3 or 2′, 3′, 4′, 5′-di-O-isopropyridene-riboflavin or 8-aminooctyl when R 2 , R 3 and R 6 are H and R 4 and R 5 are CH 3 ; R 1 is not 1′-D-sorbityl or 1′-D-dulcityl when R 4 and R 5 are both chlorines and when R 2 , R 3 and R 6 are all hydrogens; R 5 is not ethyl or chloro when R 1 and R 4 are methyl and R 2 , R 3 and R 6 are all hydrogens; R 4 and R 5 are not both methoxy or both tetramethylene when R 1 is methyl and R 2 , R 3 and R 6 are all hydrogens; R 2 is not —CH 2 CH 2 NH when R 1 , R 4 and R 5 are CH 3 and R 3 and R 6 are H; R 2 is not [0057] when R 1 , R 4 and R 5 are CH 3 and R 3 and R 6 are H; R 5 is not chloro when R 4 is methoxy and R 1 is ethyl-2′N-pyrrolidino and R 2 , R 3 , and R 6 are hydrogen; R 1 is not N,N-dimethylaminopropyl or N,N-diethylaminoethyl when R 5 is chloro or methyl and R 2 , R 3 , R 4 and R 6 are hydrogen; R 3 is not —NH(CH 2 CH 2 )Cl when R 6 is —NH 2 and R 1 , R 2 , R 4 and R 5 are H; R 1 , R 4 , R 5 are not all methyl groups when all of R 2 , R 3 and R 6 are hydrogens; R1 and R2 are not both methyl groups when R3, R4, R5 and R6 are H; R 1 , R 4 , R 5 and R 2 are not all methyl groups when R 3 and R 6 are hydrogens; R 2 is not carboxymethyl when R 1 , R 4 and R 5 are methyl and R 3 and R 6 are hydrogen; R 4 is not —NH 2 when R 1 and R 5 are methyl and R 2 , R 3 and R 6 are all hydrogen; R 1 is not a phenyl group when R 4 and R 5 are methyl and R 2 , R 3 and R 6 are all H; R 1 is not methyl or N,N-dimethylaminoethyl when all of R 2 , R 3 , R 4 , R 5 and R 6 are hydrogen; R 2 , R 4 , R 5 are not all methyl when R 1 is acetoxyethyl and R 3 and R 6 are hydrogen; R 5 is not methyl when R 1 is N,N-diethylaminoethyl and R 2 , R 3 , R 4 and R 6 are all hydrogen; R 4 and R 5 are not both chlorine when R 1 is methyl and R 2 , R 3 and R 6 are all hydrogen; R 1 is not ethyl, β-chloroethyl, n-butyl, anilino, benzyl, phenyl, p-tolyl or p-anisyl when R 5 is NH 2 and R 2 , R 3 , R 4 and R 6 are all hydrogen; and R 4 is not chlorine when R 1 is N,N-dimethylaminopropyl and R 2 , R 3 , R 5 and R 6 are all hydrogen. [0058] In one group of compounds, n is an integer between 0 and 5. In another group of compounds, n is an integer from 0 to 10. In another group of compounds, n is an integer from 0 to 20. [0059] Compounds containing any combination of substituents or members of the Markush groups specified above are within the scope of the invention. All compounds of the invention have the ability to neutralize microorganisms. All substituents of the compounds of the invention may be the same, all substituents may be different, or any combination of substituents may be the same or different. Substituents with a specified function, for example those that impart water solubility to the compound, may be included at any of R 1-6 . Compounds of the invention include all those compounds with the isoalloxazine backbone (shown below): [0060] where R 1 -R 6 are substituted with various substituents, as described elsewhere, except those previously known to the art. The substituents included in the compounds and used in the methods of the invention may be any substituent not having structures or reactivity which would substantially interfere with the desired microorganism neutralization of the microorganism neutralizer, as may readily be determined without undue experimentation by those skilled in the art. [0061] The invention provides a class of compounds wherein one or a plurality of R 1 , R 2 , R 3 , R 4 , R 5 and R 6 are neither CH 3 nor H; and a class of compounds wherein one of R 1 , R 2 , R 3 , R 4 , R 5 and R 6 is neither CH 3 nor H. The invention also provides a class of compounds wherein one or a plurality of R1-R6 are CH 3 or H. Particular embodiments of compounds of those classes include those wherein a R 1 , R 2 , R 3 , R 4 , R 5 or R 6 which is neither CH 3 nor H imparts substantial water solubility to the microorganism neutralizer. Preferred examples of these compounds are: [0062] wherein R is a substituent imparting water solubility to the molecule, including, but not limited to, ascorbate, alcohol, polyalcohol; amine or polyamines, straight chain or cyclic saccharides, sulfates, phosphates, alkyl chains optionally substituted with —OH at any position, glycols, including polyethylene glycol and polyethers. [0063] Another class of compounds of the invention include those wherein a R 1 , R 2 , R 3 , R 4 , R 5 or R 6 that is neither H nor CH 3 contains a halogen or is a halogen, wherein the halogen is selected from the group consisting of fluorine, chlorine, bromine and iodine. Particular embodiments of compounds of this class include compounds where a R 1 , R 2 , R 3 , R 4 , R 5 or R 6 that is neither H nor CH 3 is: —NR a —(CR b R c ) n —X wherein X is a halogen selected from the group consisting of chlorine, bromine and iodine, or is a water soluble group R a , R b and R C are, independently of each other, selected from the group consisting of hydrogen and optionally substituted hydrocarbyl, and n is an integer from 0 to 20. [0064] Preferred examples of compounds of this class are: [0065] where W is a substituent imparting water solubility to the molecule, including, but not limited to, ascorbate, alcohol, polyalcohol; amine or polyamines, straight chain or cyclic saccharides, sulfates, phosphates, alkyl chains optionally substituted with —OH at any position, glycols, including polyethylene glycol and polyethers. [0066] Another particular embodiment of compounds wherein a R 1 , R 2 , R 3 , R 4 , R 5 or R 6 that is neither H nor CH 3 contains a halogen or is a halogen includes compounds wherein a R 1 , R 2 , R 3 , R 4 , R 5 or R 6 that is neither H nor CH 3 is: X—(CH 2 ) n —, wherein X is a halogen selected from the group consisting of chlorine, bromine and iodine, and n is an integer from 0 to 6. A preferred example of compounds of this class include: [0067] Other classes of compounds of this invention include those wherein R 1 is CH 2 —(CH 2 OH) 3 —CH 2 OH and those wherein R 1 is not CH 2 —(CH 2 OH) 3 —CH 2 OH. Also, those compounds wherein R 3 and R 6 are H are included in the invention. [0068] A “carbonyl compound” is any compound containing a carbonyl group (—C═O). The term “amine” refers to a primary, secondary, or tertiary amine group. A “polyamine” is a group that contains more than one amine group. A “sulfate” group is a salt of sulfuric acid. Sulfate groups include the group (SO 4 ) 2− . “Phosphates” contain the group PO 4 3− . “Glycols” are groups that have two alcohol groups per molecule of the compound. “Glycols” are also known as diols. A glycol is described by the formula: C n H 2n (OH) 2 , where n is an integer. An “aldehyde” is a group containing the formula —(C═O)—H. A “ketone” is a group with formula R—(C═O)—R, where R is not hydrogen. The R groups on ketone do not need to be the same. A “carboxylic acid” is a group which includes the formula: —COOH. An “ether” is a group containing —O—. A “salt” is a group where a hydrogen atom of an acid has been replaced with a metal atom or a positive radical, such as NH 4 + . “Ascorbate” includes groups with formula: [0069] The term “hydrocarbyl” is used herein to refer generally to organic groups comprised of carbon chains to which hydrogen and optionally other elements are attached. CH 2 or CH groups and C atoms of the carbon chains of the hydrocarbyl may be replaced with one or more heteroatoms (i.e., non-carbon atoms). Suitable heteroatoms include but are not limited to O, S, P and N atoms. The term hydrocarbyl includes, but is not limited to alkyl, alkenyl, alkynyl, ether, polyether, thioether, straight chain or cyclic saccharides, ascorbate, aminoalkyl, hydroxylalkyl, thioalkyl, aryl and heterocyclic aryl groups, optionally substituted isoalloxazine molecules, amino acid, polyalcohol, glycol, groups which have a mixture of saturated and unsaturated bonds, carbocyclic rings and combinations of such groups. The term also includes straight-chain, branched-chain and cyclic structures or combinations thereof. Hydrocarbyl groups are optionally substituted. Hydrocarbyl substitution includes substitution at one or more carbons in the group by moieties containing heteroatoms. Suitable substituents for hydrocarbyl groups include but are not limited to halogens, including chlorine, fluorine, bromine and iodine, OH, SH, NH 2 , COH, CO 2 H, OR a , SR a , NR a R b , CONR a R b , where R a and R b independently are alkyl, unsaturated alkyl or aryl groups. [0070] The term “alkyl” takes its usual meaning in the art and is intended to include straight-chain, branched and cycloalkyl groups. The term includes, but is not limited to, methyl, ethyl, n-propyl, isopropyl, n-butyl, sec-butyl, isobutyl, tert-butyl, n-pentyl, neopentyl, 2-methylbutyl, 1-methylbutyl, 1-ethylpropyl, 1,1-dimethylpropyl, n-hexyl, 1-methylpentyl, 2-methylpentyl, 3-methylpentyl, 4-methylpentyl, 3,3-dimethylbutyl, 2,2-dimethylbutyl, 1,1-dimethylbutyl, 2-ethylbutyl, 1-ethylbutyl, 1,3-dimethylbutyl, n-heptyl, 5-methylhexyl, 4-methylhexyl, 3-methylhexyl, 2-methylhexyl, 1-methylhexyl, 3-ethylpentyl, 2-ethylpentyl, 1-ethylpentyl, 4,4-dimethylpentyl, 3,3-dimethylpentyl, 2,2-dimethylpentyl, 1,1-dimethylpentyl, n-octyl, 6-methylheptyl, 5-methylheptyl, 4-methylheptyl, 3-methylheptyl, 2-methylheptyl, 1-methylheptyl, 1-ethylhexyl, 1-propylpentyl, 3-ethylhexyl, 5,5-dimethylhexyl, 4,4-dimethylhexyl, 2,2-diethylbutyl, 3,3-diethylbutyl, and 1-methyl-1-propylbutyl. Alkyl groups are optionally substituted. Lower alkyl groups are C 1 -C 6 alkyl and include among others methyl, ethyl, n-propyl, and isopropyl groups. [0071] The term “cycloalkyl” refers to alkyl groups having a hydrocarbon ring, particularly to those having rings of 3 to 7 carbon atoms. Cycloalkyl groups include those with alkyl group substitution on the ring. Cycloalkyl groups can include straight-chain and branched-chain portions. Cycloalkyl groups include but are not limited to cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cycloheptyl, cyclooctyl, and cyclononyl. Cycloalkyl groups can optionally be substituted. [0072] Aryl groups may be substituted with one, two or more simple substituents including, but not limited to, lower alkyl, e.g., methyl, ethyl, butyl; halo, e.g., chloro, bromo; nitro; sulfato; sulfonyloxy; carboxy; carbo-lower-alkoxy, e.g., carbomethoxy, carbethoxy; amino; mono- and di-lower-alkylamino, e.g., methylamino, ethylamino, dimethylamino, methylethylamino; amido; hydroxy; lower-alkoxy, e.g., methoxy, ethoxy; and lower-alkanoyloxy, e.g., acetoxy. [0073] The term “unsaturated alkyl” group is used herein generally to include alkyl groups in which one or more carbon-carbon single bonds have been converted to carbon-carbon double or triple bonds. The term includes alkenyl and alkynyl groups in their most general sense. The term is intended to include groups having more than one double or triple bond, or combinations of double and triple bonds. Unsaturated alkyl groups include, without limitation, unsaturated straight-chain, branched or cycloalkyl groups. Unsaturated alkyl groups include without limitation: vinyl, allyl, propenyl, isopropenyl, butenyl, pentenyl, hexenyl, hexadienyl, heptenyl, cyclopropenyl, cyclobutenyl, cyclopentenyl, cyclopentadienyl, cyclohexenyl, cyclohexadienyl, 1-propenyl, 2-butenyl, 2-methyl-2-butenyl, ethynyl, propargyl, 3-methyl-1-pentynyl, and 2-heptynyl. Unsaturated alkyl groups can optionally be substituted. [0074] Substitution of alkyl, cycloalkyl and unsaturated alkyl groups includes substitution at one or more carbons in the group by moieties containing heteroatoms. Suitable substituents for these groups include but are not limited to OH, SH, NH 2 , CH, CO 2 H, OR c , SR c , P, PO, NR c R d , CONR c R d , and halogens, particularly chlorines and bromines where R c and R d , independently, are alkyl, unsaturated alkyl or aryl groups. Preferred alkyl and unsaturated alkyl groups are the lower alkyl, alkenyl or alkynyl groups having from 1 to about 3 carbon atoms. [0075] The term “aryl” is used herein generally to refer to aromatic groups which have at least one ring having a conjugated pi electron system and includes without limitation carbocyclic aryl, aralkyl, heterocyclic aryl, biaryl groups and heterocyclic biaryl, all of which can be optionally substituted. Preferred aryl groups have one or two aromatic rings. [0076] “Carbocyclic aryl” refers to aryl groups in which the aromatic ring atoms are all carbons and includes without limitation phenyl, biphenyl and napthalene groups. [0077] “Aralkyl” refers to an alkyl group substituted with an aryl group. Suitable aralkyl groups include among others benzyl, phenethyl and picolyl, and may be optionally substituted. Aralkyl groups include those with heterocyclic and carbocyclic aromatic moieties. [0078] “Heterocyclic aryl groups” refers to groups having at least one heterocyclic aromatic ring with from 1 to 3 heteroatoms in the ring, the remainder being carbon atoms. Suitable heteroatoms include without limitation oxygen, sulfur, and nitrogen. Heterocyclic aryl groups include among others furanyl, thienyl, pyridyl, pyrrolyl, N-alkyl pyrrolo, pyrimidyl, pyrazinyl, imidazolyl, benzofuranyl, quinolinyl, and indolyl, all optionally substituted. [0079] “Heterocyclic biaryl” refers to heterocyclic aryls in which a phenyl group is substituted by a heterocyclic aryl group ortho, meta or para to the point of attachment of the phenyl ring to the decalin or cyclohexane. Heterocyclic biaryl includes among others groups which have a phenyl group substituted with a heterocyclic aromatic ring. The aromatic rings in the heterocyclic biaryl group can be optionally substituted. [0080] “Biaryl” refers to carbocyclic aryl groups in which a phenyl group is substituted by a carbocyclic aryl group ortho, meta or para to the point of attachment of the phenyl ring to the decalin or cyclohexane. Biaryl groups include among others a first phenyl group substituted with a second phenyl ring ortho, meta or para to the point of attachment of the first phenyl ring to the decalin or cyclohexane structure. Para substitution is preferred. The aromatic rings in the biaryl group can be optionally substituted. [0081] Aryl group substitution includes substitutions by non-aryl groups (excluding H) at one or more carbons or where possible at one or more heteroatoms in aromatic rings in the aryl group. Unsubstituted aryl, in contrast, refers to aryl groups in which the aromatic ring carbons are all substituted with H, e.g. unsubstituted phenyl (—C 6 H 5 ), or naphthyl (—C 10 H 7 ). Suitable substituents for aryl groups include among others, alkyl groups, unsaturated alkyl groups, halogens, OH, SH, NH 2 , C.H., CO 2 H, OR e , SR e , NR e R f , CONR e R f , where R e and R f independently are alkyl, unsaturated alkyl or aryl groups. Preferred substituents are OH, SH, OR e , and SR e where R e is a lower alkyl, i.e., an alkyl group having from 1 to about 3 carbon atoms. Other preferred substituents are halogens, more preferably chlorine or bromine, and lower alkyl and unsaturated lower alkyl groups having from 1 to about 3 carbon atoms. Substituents include bridging groups between aromatic rings in the aryl group, such as —CO 2 —, —CO—, —O—, —S—, —P—, —NH—, —CH═CH— and —(CH 2 ) l where l is an integer from 1 to about 5, and particularly —CH 2 —. Examples of aryl groups having bridging substituents include phenylbenzoate. Substituents also include moieties, such as —(CH 2 ) l —, —O—(CH 2 ) l — or —OCO—(CH 2 ) l —, where l is an integer from about 2 to 7, as appropriate for the moiety, which bridge two ring atoms in a single aromatic ring as, for example, in a 1, 2, 3, 4-tetrahydronaphthalene group. Alkyl and unsaturated alkyl substituents of aryl groups can in turn optionally be substituted as described supra for substituted alkyl and unsaturated alkyl groups. [0082] The terms “alkoxy group” and “thioalkoxy group” (also known as mercaptide groups, the sulfur analog of alkoxy groups) take their generally accepted meaning. Alkoxy groups include but are not limited to methoxy, ethoxy, n-propoxy, isopropoxy, n-butoxy, sec-butoxy, isobutoxy, tert-butoxy, n-pentyloxy, neopentyloxy, 2-methylbutoxy, 1-methylbutoxy, 1-ethyl propoxy, 1,1-dimethylpropoxy, n-hexyloxy, 1-methylpentyloxy, 2-methylpentyloxy, 3-methylpentyloxy, 4-methylpentyloxy, 3,3-dimethylbutoxy, 2,2-dimethoxybutoxy, 1-1-dimethylbutoxy, 2-ethylbutoxy, 1-ethylbutoxy, 1,3-dimethylbutoxy, n-pentyloxy, 5-methylhexyloxy, 4-methylhexyloxy, 3-methylhexyloxy, 2-methylhexyloxy, 1-methylhexyloxy, 3-ethylpentyloxy, 2-ethylpentyloxy, 1-ethylpentyloxy, 4,4-dimethylpentyloxy, 3,3-dimethylpentyloxy, 2,2-dimethylpentyloxy, 1,1-dimethylpentyloxy, n-octyloxy, 6-methylheptyloxy, 5-methylheptyloxy, 4-methylheptyloxy, 3-methylheptyloxy, 2-methylheptyloxy, 1-methylheptyloxy, 1-ethylhexyloxy, 1-propylpentyloxy, 3-ethylhexyloxy, 5,5-dimethylhexyloxy, 4,4-dimethylhexyloxy, 2,2-diethylbutoxy, 3,3-diethylbutoxy, 1-methyl-1-propylbutoxy, ethoxymethyl, n-propoxymethyl, isopropoxymethyl, sec-butoxymethyl, isobutoxymethyl, (1-ethyl propoxy)methyl, (2-ethylbutoxy)methyl, (1-ethylbutoxy)methyl, (2-ethylpentyloxy)methyl, (3-ethylpentyloxy)methyl, 2-methoxyethyl, 1-methoxyethyl, 2-ethoxyethyl, 3-methoxypropyl, 2-methoxypropyl, 1-methoxypropyl, 2-ethoxypropyl, 3-(n-propoxy)propyl, 4-methoxybutyl, 2-methoxybutyl, 4-ethoxybutyl, 2-ethoxybutyl, 5-ethoxypentyl, and 6-ethoxyhexyl. Thioalkoxy groups include but are not limited to the sulfur analogs of the alkoxy groups specifically listed supra. [0083] “Optional” or “optionally” means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances in which it does not. For example, “optionally substituted phenyl” means that the phenyl radical may or may not be substituted and that the description includes both unsubstituted phenyl radicals and phenyl radicals wherein there is substitution. [0084] “Amino acids” as used herein include naturally occurring and commercially available amino acids and optical isomers thereof. Typical natural and commercially available amino acids are glycine, alanine, serine, homoserine, threonine, valine, norvaline, leucine, isoleucine, norleucine, aspartic acid, glutamic acid, lysine, omithine, histidine, arginine, cysteine, homocysteine, methionine, phenylalanine, homophenylalanine, phenylglycine, o-, m-, and p-tyrosine, tryptophan, glutamine, asparagine, proline and hydroxyproline. “Amino acid” as used herein includes amino acid residues and amino acid side chains. An “amino acid residue” is an amino acid radical —NHCH(R)C(O)—, wherein R is an amino acid side chain, except for the amino acid residues of proline and hydroxyproline which are —N(CH 2 —CH 2 —CH 2 )CHC(O)— and —N(CH—CHOHCH 2 )CHC(O)—, respectively. An amino acid side chain is a radical found on the α-carbon of an α-amino acid as defined herein, where the radical is either hydrogen (side chain of glycine), methyl (side chain of alanine), or is a radical bonded to the α-carbon by a methylene (—CH 2 —), or phenyl group. [0085] A protected glucose derivative takes its usual meaning in the art and includes a glucose molecule wherein some of the hydroxyl groups are substituted with acetate groups. [0086] “Straight chain or cyclic saccharides” include mono-, di- and poly-, straight chain and cyclic saccharides that are optionally substituted with an amino group which is optionally acetylated. Straight chain saccharides that are useful in this invention include but are not limited to those molecules with a chain of 5 or 6 carbon atoms with one or more —OH groups attached, and either an aldehyde or ketone group. Cyclic saccharides are saccharides that are in a ring form. Disaccharides are compounds wherein two monosaccharide groups are linked. Polysaccharides are compounds wherein more than two monosaccharide groups are linked. Specific examples of saccharides useful in this invention include glucose, ribose and glucosamine, among others. [0087] “Isoalloxazine”, “isoalloxazine derivative” or “core structure of isoalloxazine” include compounds that comprise the structure: [0088] where R 1 -R 6 are substituted with various substituents, as described elsewhere. [0089] As used herein, the term “neutralization of a microorganism” or “neutralizing” means totally or partially preventing the microorganism from replicating, either by killing the microorganism or otherwise interfering with its ability to reproduce. A “neutralizer” is a compound that is capable of neutralizing a microorganism. The neutralizers useful in this invention include molecules with the core structure of isoalloxazine, as defined above. To “activate the microorganism neutralizer” is to expose the microorganism neutralizer to a triggering event that causes it to become active toward neutralizing microorganisms. [0090] “Triggering event” refers to the stimulus that activates the microorganism neutralizer. Preferred triggering events include exposure of the neutralizer to a neutralization effective wavelength of light, or a pH sufficient to activate the neutralizer to neutralize microorganisms. [0091] “Water soluble group” includes a group that, when included as a substituent on the neutralizer, imparts substantial solubility in water to the compound. Typically, the compound is soluble in water at a concentration of about 10-150 μM. Water soluble groups as referred to in this invention include, but are not limited to alcohols; polyalcohols; straight chain or cyclic saccharides; amines and polyamines; sulfate groups; phosphate groups; ascorbate groups; alkyl chains optionally substituted with —OH at any position; glycols, including polyethylene glycols, and polyethers. [0092] “Decomposition” of the neutralizer upon exposure to light refers to the chemical transformation of the neutralizer into new compounds. An example of decomposition of the neutralizer is the production of lumichrome upon exposure of riboflavin to visible light. [0093] An “alkylating agent” is a compound that reacts with amino acid residues and nucleic bases and inhibits replication of microorganisms. [0094] The terms “photoactivator” and “photosensitizer” are used synonymously herein. [0095] As used herein, “powder” means dried medium, including powder or pill. When a dried medium of a substance is described herein, it is also intended that a solution or suspension of the powder in a suitable solvent may be used, and vice versa. [0096] The method of this invention requires mixing the photosensitizer with the material to be decontaminated. “Adding” is intended to include mixing the fluid with the photosensitizer. Mixing may be done by simply adding the photosensitizer or a solution containing the photosensitizer to a fluid to be decontaminated. In one embodiment, the material to be decontaminated to which photosensitizer has been added is flowed past a photoradiation source, and the flow of the material generally provides sufficient turbulence to distribute the photosensitizer throughout the fluid to be decontaminated. In another embodiment, the fluid and photosensitizer are placed in a photopermeable container and irradiated in batch mode, preferably while agitating the container to fully distribute the photosensitizer and expose all the fluid to the radiation. [0097] The amount of photosensitizer to be mixed with the fluid will be an amount sufficient to adequately inactivate microorganisms therein, but less than a toxic (to humans or other mammals) or insoluble amount. Excess photosensitizer may be used as long as the concentration is not so high that the photosensitizer prevents light from passing to the desired depth at a useful intensity. As taught herein, optimal concentrations for desired photosensitizers may be readily determined by those skilled in the art without undue experimentation. Preferably the photosensitizer is used in a concentration of at least about 1 micromolar. The optimum concentration of photosensitizer will vary depending on the blood component being treated and if plasma is removed, as discussed herein and in the references incorporated by reference. If red blood cells are being treated, a higher concentration of photosensitizer is desired than if plasma or platelets are being treated. If red blood cells are being treated with riboflavin, a useful concentration of riboflavin is about 1-500 micromolar, including all values and ranges therein, including 1 to 200 micromolar. A preferred concentration of riboflavin is about 300 to 500 micromolar when the plasma content is about 0 to 5% of the total volume of the solution. If plasma or platelets are being treated, a useful concentration of riboflavin is about 1-100 micromolar, and a preferred concentration of riboflavin is about 10 to 50 micromolar, including all values and ranges therein, including 10 to 30 micromolar when the plasma content is about 10-90% of the total volume of the solution. [0098] The activated photosensitizer is capable of inactivating the microorganisms present, such as by interfering to prevent their replication. Specificity of action of the photosensitizer is conferred by the close proximity of the photosensitizer to the nucleic acid of the microorganism and this may result from binding of the photosensitizer to the nucleic acid. “Nucleic acid” includes ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). Other photosensitizers may act by binding to cell membranes or by other mechanisms. The photosensitizer may also be targeted to the microorganism to be inactivated by covalently coupling to an antibody, preferably a specific monoclonal antibody to the microorganism. [0099] The fluid containing the photosensitizer may be flowed into a photopermeable container for irradiation. The term “container” refers to a closed or open space, which may be made of rigid or flexible material, e.g., may be a bag or box or trough. It may be closed or open at the top and may have openings at both ends, e.g., may be a tube or tubing, to allow for flow-through of fluid therein. A cuvette has been used to exemplify one embodiment of the invention involving a flow-through system. Collection bags, such as those used with the Trima™ Spectra™ and apheresis systems of GAMBRO, Inc., have been used to exemplify another embodiment involving batch-wise treatment of the fluid. [0100] The term “photopermeable” means the material of the container is adequately transparent to photoradiation of the proper wavelength for activating the photosensitizer. In the flow-through system, the container has a depth (dimension measured in the direction of the radiation from the photoradiation source) sufficient to allow photoradiation to adequately penetrate the container to contact photosensitizer molecules at all distances from the light source and ensure inactivation of microorganisms in the fluid to be decontaminated, and a length (dimension in the direction of fluid flow) sufficient to ensure a sufficient exposure time of the fluid to the photoradiation. The materials for making such containers, depths and lengths of containers may be easily determined by those skilled in the art without undue experimentation following the teachings herein, and together with the flow rate of fluid through the container, the intensity of the photoradiation and the absorptivities of the fluid components, e.g., plasma, platelets, red blood cells, will determine the amount of time the fluid needs to be exposed to photoradiation. [0101] In another embodiment involving batch-wise treatment, the fluid to be treated is placed in a photopermeable container which is agitated and exposed to photoradiation for a time sufficient to substantially inactivate the microorganisms. The photopermeable container is preferably a blood bag made of transparent or semitransparent plastic, and the agitating means is preferably a shaker table. The photopermeable container may be any other container, such as a rigid plastic container. The photosensitizer may be added to the container in powdered or liquid form and the container agitated to mix the photosensitizer with the fluid and to adequately expose all the fluid to the photoradiation to ensure inactivation of microorganisms. [0102] Photosensitizer may be added to or flowed into the photopermeable container separately from the fluid being treated or may be added to the fluid prior to placing the fluid in the container. In one embodiment, photosensitizer is added to anticoagulant and the mixture of photosensitizer and anticoagulant are added to the fluid. [0103] After treatment, the blood or blood product may be delivered to a patient, concentrated, or infused directly. [0104] Enhancers may also be added to the fluid to make the process more efficient and selective. Such enhancers include antioxidants or other agents to prevent damage to desired fluid components or to improve the rate of inactivation of microorganisms and are exemplified by adenine, histidine, cysteine, tyrosine, tryptophan, ascorbate, N-acetyl-L-cysteine, propyl gallate, glutathione, mercaptopropionylglycine, dithiothreotol, nicotinamide, BHT, BHA, lysine, serine, methionine, glucose, mannitol, trolox, glycerol, and mixtures thereof. These enhancers may be added in dried medium, including powder or pill form or in the form of liquids. [0105] This invention also comprises fluids comprising biologically active protein, blood or blood constituents and also containing endogenous photosensitizer, endogenously-based derivative photosensitizer, or photoproduct thereof made by the inactivation methods described herein. The fluid may also contain inactivated microorganisms. [0106] In decontamination systems of this invention, the photoradiation source may be connected to the photopermeable container for the fluid by means of a light guide such as a light channel or fiber optic tube which prevents scattering of the light between the source and the container for the fluid, and more importantly, prevents substantial heating of the fluid within the container. Direct exposure to the light source may raise temperatures as much as 10 to 15° C., especially when the amount of fluid exposed to the light is small, which can cause denaturization of blood components. Use of the light guide keeps any heating to less than about 2° C. The method may also include the use of temperature sensors and cooling mechanisms where necessary to keep the temperature below temperatures at which desired proteins in the fluid are damaged. Cooling mechanisms include flow of air or fluid, as well as other mechanisms known to the art. Preferably, the temperature is kept between about 0° C. and about 45° C., more preferably between about 22° C. and about 45° C., and preferably about 30° C., depending on the composition of the fluid. The heating of fluids from light exposure is known in the art and conditions to prevent damage to desired components of the fluids are known in the art without undue experimentation and described in the references cited herein. Usual operating temperature ranges for red blood cells are 32 to 36° C. and for platelets and plasma, below 30° C. [0107] Any means for adding the photosensitizer to the fluid to be decontaminated and for placing the fluid in the photopermeable container known to the art may be used, such means typically including flow conduits, ports, reservoirs, sterile docking, valves, and the like. The system may include means such as pumps or adjustable valves for controlling the flow of the photosensitizer into the fluid to be decontaminated so that its concentration may be controlled at effective levels as described herein. In one embodiment, photosensitizer is mixed with the anticoagulant feed to a blood apheresis system. For endogenous photosensitizers and derivatives having sugar moieties, the pH of the solution is preferably kept low enough, as is known to the art, to prevent detachment of the sugar moiety. Preferably the photosensitizer is added to the fluid to be decontaminated in a pre-mixed aqueous solution, e.g., in water or storage buffer solution. [0108] The photosensitizer and any optional desired additives may be placed in a container as dried medium, including powder or pill form, or as a solution. Optional additives may be chosen that help the components retain biological activity or improve the storage lifetime. These optional additives are known in the art. Desired additives and the photosensitizer may be sterilized as powders. In one embodiment, the powders desired are placed in the container prior to introduction of the fluid. [0109] The level of plasma in the solutions may be adjusted, if desired. If the photosensitizer and any desired additives are placed in the container as one or more solutions, the volume and composition of the solution(s) may produce the desired percentage of plasma in the sample, without further additions of solution, or the percentage of plasma may be adjusted before, during or after placing said fluid in said container. Adjustment of the percentage of plasma after placing the fluid in the container may occur by the introduction of a suitable solution after the fluid is in the container. Adjustment of the percentage of plasma may occur during introduction of the fluid in a container by the introduction of a suitable solution as the fluid is being placed in the container. [0110] The photopermeable container for the flow-through system may be a transparent cuvette made of polycarbonate, glass, quartz, polystyrene, polyvinyl chloride, polyolefin, or other transparent material. The cuvette may be enclosed in a radiation chamber having mirrored walls. A photoradiation enhancer such as a second photoradiation source or reflective surface may be placed adjacent to the cuvette to increase the amount of photoradiation contacting the fluid within the cuvette. The system preferably includes a pump for adjusting the flow rate of the fluid to desired levels to ensure substantial decontamination as described above. The cuvette has a length, coordinated with the flow rate therethrough, sufficient to expose fluid therein to sufficient photoradiation to effect substantial decontamination thereof. [0111] Also preferably the cuvette is spaced apart from the light source a sufficient distance that heating of the fluid in the cuvette does not occur, and light is transmitted from the light source to the cuvette by means of a light guide. [0112] In another embodiment the fluid is placed in a photopermeable container such as a blood bag, e.g. used with the apheresis system described in U.S. Pat. No. 5,653,887, and agitated while exposing to photoradiation. A photoradiation enhancer such as a second photoradiation source or reflective surface may be placed adjacent to the cuvette to increase the amount of photoradiation contacting the fluid within the cuvette. Suitable bags include collection bags as described herein. Collection bags used in the Cobe Spectra™ system or Trima™ apheresis system of GAMBRO Inc. are especially suitable. Shaker tables are known to the art, e.g. as described in U.S. Pat. No. 4,880,788. The bag is equipped with at least one port or opening for adding fluid thereto. In one embodiment the photosensitizer, preferably 7,8-dimethyl-10-ribityl-isoalloxazine, is added to the fluid-filled bag as dried medium, including powder or pill form. The bag is then placed on a shaker table and agitated under photoradiation until substantially all the fluid has been exposed to the photoradiation. Alternatively, the bag may be prepackaged with the powdered photosensitizer contained therein. The fluid to be decontaminated may then be added through the appropriate port. [0113] Decontamination systems as described above may be designed as stand-alone units or may be easily incorporated into existing apparatuses known to the art for separating or treating blood being withdrawn from or administered to a patient. For example, such blood-handling apparatuses include the Cobe Spectra™ or GAMBRO TRIMA® apheresis systems, available from GAMBRO Inc., Lakewood, Colo., or the apparatuses described in U.S. Pat. No. 5,653,887 and U.S. Ser. No. 08/924,519 filed Sep. 5, 1997 (PCT Publication No. WO 99/11305) of GAMBRO, Inc. as well as the apheresis systems of other manufacturers. The decontamination system may be inserted just downstream of the point where blood is withdrawn from a patient or donor, just prior to insertion of blood product into a patient, or at any point before or after separation of blood constituents. The level of plasma may be adjusted, if desired, at any point before fluid is exposed to irradiation. The photosensitizer is added to blood components along with anticoagulant in a preferred embodiment, and separate irradiation sources and cuvettes are placed downstream from collection points for platelets, for plasma and for red blood cells. The use of three separate blood decontamination systems is preferred to placement of a single blood decontamination system upstream of the blood separation vessel of an apheresis system because the lower flow rates in the separate component lines allows greater ease of irradiation. In other embodiments, decontamination systems of this invention may be used to process previously collected and stored blood products. [0114] When red blood cells are present in the fluid being treated, as will be appreciated by those skilled in the art, to compensate for absorption of light by the cells, the fluid may be thinned, exposed to higher energies of radiation for longer periods, agitated for longer periods or presented to photoradiation in shallower containers or conduits than necessary for use with other blood components. [0115] The endogenous photosensitizers and endogenously-based derivative photosensitizers disclosed herein can be used in pre-existing blood component decontamination systems as well as in the decontamination system disclosed herein. For example, the endogenous photosensitizers and endogenously-based derivative photosensitizers of this invention can be used in the decontamination systems described in U.S. Pat. Nos. 5,290,221, 5,536,238, 5,290,221 and 5,536,238. [0116] A photoradiation enhancer, such as a reflective surface may also be provided in any method or apparatus of the invention. The light may be guided to impinge on the fluid in any desired manner, including positioning the fluid in the light path of the light source, using a light guide, or other methods. The apparatuses of the invention may also comprise components such as a temperature monitor, temperature controller, means for flowing said fluid into and out of said container, means for agitating said fluid in said container, and other desired components to control various aspects of the system. The temperature controller may be a fan directed toward the light source, directed on the fluid, or both. One or more temperature controllers may be used to cool different components to different levels. [0117] The methods of the invention may be used in a kit, for example, a kit to determine if a virus or parasite (or other microorganism) is present in blood or a blood component. For example, one kit includes a sample of blood or a blood component that has been inactivated by the methods of the invention. This inactivated sample is compared to a non-inactivated sample to determine if a virus or parasite (or other microorganism) is present in the blood or a blood component or other sample. BRIEF DESCRIPTION OF THE DRAWINGS [0118] [0118]FIG. 1 shows P. falciparum inactivation results from 38% Hct red blood cell samples with no incubation prior to illumination. [0119] [0119]FIG. 2 shows P. falciparum inactivation results from illuminating the innoculum (no red blood cells). [0120] [0120]FIG. 3 shows P. falciparum inactivation results from illuminating 38% Hct red blood cell suspension that was incubated for 1 hour prior to illumination. [0121] [0121]FIG. 4 shows the log reduction in West Nile virus in platelets using various amounts of energy applied. [0122] [0122]FIG. 5 shows the log reduction in West Nile virus in plasma using various amounts of energy applied. [0123] [0123]FIG. 6 shows log reduction in West Nile virus in red blood cells using various amounts of energy applied. DETAILED DESCRIPTION OF THE INVENTION [0124] The following applications are hereby incorporated by reference to the extent not inconsistent with the disclosure herewith: U.S. patent application Ser. No. 10/104,766, filed Mar. 21, 2002; U.S. patent application Ser. No. 10/247,262 filed Sep. 18, 2002; United States provisional application serial No. 60/368,778, filed Mar. 28, 2002; U.S. patent application Ser. No. 10/159,781, filed May 30, 2002; U.S. patent application Ser. No. 09/982,298, filed Oct. 16, 2001; U.S. patent application Ser. No. 10/328,717, filed Dec. 23, 2002; U.S. patent application Ser. No. 10/065,073, filed Sep. 13, 2002; U.S. patent application Ser. No. 09/962,029, filed Sep. 25, 2001; United States provisional application serial No. 60/353,223, filed Feb. 1, 2002; United States provisional application serial No. 60/355,393, filed Feb. 8, 2002; United States provisional application serial No. 60/377,697, filed May 3, 2002; U.S. patent application Ser. No. 10/325,402, filed Dec. 20, 2002; United States provisional application serial No. 60/353,319, filed Feb. 1, 2002; United States provisional application serial No. 60/379,328, filed May 8, 2002; United States provisional application serial No. 60/375,734, filed Apr. 26, 2002; United States provisional application serial No. 60/373,198, filed Apr. 16, 2002; United States provisional application serial No. 60/373,936, filed Apr. 19, 2002; United States provisional application serial No. 60/378,374, filed May 6, 2002; United States provisional application serial No. 60/375,849, filed Apr. 24, 2002; U.S. patent application Ser. No. 09/586,147, filed Jun. 2, 2000; U.S. patent application Ser. No. 09/596,429, filed Jun. 15, 2000; United States provisional application serial No. 60/375,670, filed Apr. 26, 2002; PCT patent application Ser. No. PCT/US02/21925, filed Jul. 12, 2002; United States provisional application serial No. 60/319,488, filed Aug. 23, 2002; United States provisional application serial No. 60/319,641, filed Oct. 22, 2002; U.S. patent application Ser. No. 09/119,666, filed Jul. 21, 1998 (U.S. Pat. No. 6,258,577); U.S. patent application Ser. No. 09/357,188, filed Jul. 20, 1999 (U.S. Pat. No. 6,277,337); U.S. patent application Ser. No. 09/420,652, filed Oct. 19, 1999 (U.S. Pat. No. 6,268,120); U.S. patent application Ser. No. 09/777,727, filed Feb. 5, 2001; U.S. patent application Ser. No. 10/256,852, filed Sep. 26, 2002; U.S. patent application Ser. No. 09/725,426, filed Nov. 28, 2000. The present invention includes all aspects of the cited applications and patents that are not inconsistent with the disclosure herewith. For example, apparatuses and systems other than those specifically exemplified in the disclosure herewith are included in the cited applications and patents and are included herein. [0125] The decontamination method of this invention using endogenous photosensitizers and endogenously-based derivative photosensitizers is exemplified herein using 7,8-dimethyl-10-ribityl isoalloxazine as the photosensitizer, however, any photosensitizer may be used which is capable of being activated by photoradiation to cause inactivation of microorganisms. The photosensitizer must be one which does not substantially destroy desired components of the fluid being decontaminated, and also preferably which does not break down as a result of the photoradiation into products which significantly destroy desired components or have significant toxicity. The wavelength at which the photosensitizer is activated is determined as described herein, using literature sources or direct measurement. Its solubility in the fluid to be decontaminated or in a combination of carrier fluid and fluid to be contaminated is also so determined. The ability of photoradiation at the activating wavelength to penetrate the fluid to be decontaminated is also determined as taught herein and known in the art. Appropriate temperatures for the reaction of the photosensitizer with its substrate are determined, as well as the ranges of temperature, photoradiation intensity and duration and photosensitizer concentration which will optimize microbial inactivation and minimize damage to desired proteins and/or cellular components in the fluid. [0126] Once such system requirements have been determined for flow-through systems, apparatuses may be designed which provide the correct flow rates, photopermeabilities, plasma contents, light wavelengths and light intensities to cause inactivation of microorganisms present in the fluid, as is taught herein. In one embodiment, the fluid is mixed with photosensitizer and then irradiated with a sufficient amount of photoradiation to activate the photosensitizer to react with microorganisms in the fluid such that microorganisms in the fluid are inactivated. The amount of photoradiation reaching microorganisms in the fluid is controlled by selecting an appropriate photoradiation source, an appropriate distance of the photoradiation source from the fluid to be decontaminated, which may be increased through the use of light guides to carry the photoradiation directly to the container for the fluid, an appropriate photopermeable material for the container for the fluid, an appropriate depth to allow full penetration of the photoradiation into the container, photoradiation enhancers such as one or more additional photoradiation sources, preferably on the opposite side of the container from the first, or reflectors to reflect light from the radiation source back into the container, appropriate flow rates for the fluid in the container and an appropriate container length to allow sufficient time for inactivation of microorganisms present. Temperature monitors and controllers may also be required to keep the fluid at optimal temperature. [0127] For batch systems, it is preferred to place the fluid to be decontaminated along with photosensitizer in bags which are photopermeable or at least sufficiently photopermeable to allow sufficient radiation to reach their contents to activate the photosensitizer. Sufficient photosensitizer is added to each bag to provide inactivation, and the bag is preferably agitated while irradiating, for a period of time to ensure exposure of substantially all the fluid to radiation. The photosensitizer may be added in powdered form. [0128] The method preferably uses endogenous photosensitizers, including endogenous photosensitizers which function by interfering with nucleic acid replication. 7,8-dimethyl-10-ribityl isoalloxazine is the preferred photosensitizer for use in this invention. The chemistry believed to occur between 7,8-dimethyl-10-ribityl isoalloxazine and nucleic acids does not proceed via singlet oxygen-dependent processes (i.e. Type II mechanism), but rather by direct sensitizer-substrate interactions (Type I mechanisms). Cadet et al. (1983) J. Chem., 23:420-429, clearly demonstrate the effects of 7,8-dimethyl-10-ribityl isoalloxazine are due to non-singlet oxygen oxidation of guanosine residues. In addition, adenosine bases appear to be sensitive to the effects of 7,8-dimethyl-10-ribityl isoalloxazine plus UV light. This is important since adenosine residues are relatively insensitive to singlet oxygen-dependent processes. 7,8-dimethyl-10-ribityl isoalloxazine appears not to produce large quantities of singlet oxygen upon exposure to UV light, but rather exerts its effects through direct interactions with substrate (e.g., nucleic acids) through electron transfer reactions with excited state sensitizer species. Since indiscriminate damage to cells and proteins arises primarily from singlet oxygen sources, this mechanistic pathway for the action of 7,8-dimethyl-10-ribityl isoalloxazine allows greater selectivity in its action than is the case with compounds such as psoralens which possess significant Type II chemistry. [0129] 7,8-dimethyl-10-ribityl isoalloxazine (Riboflavine or vitamin B2) absorbs light from about 200 to 500 nm. The ring system core of 7,8-dimethyl-10-ribityl isoalloxazine is resistant to photodegradation but the ribityl side chain of riboflavin undergoes photodegradation. Photolysis of 7,8-dimethyl-10-ribityl isoalloxazine may form lumichrome (7,8-dimethylalloxazine) depending on conditions. 7,8-dimethylalloxazine strongly absorbs ultraviolet (UV) light and only weakly absorbs visible light. [0130] As a result of the degradation of 7,8-dimethyl-10-ribityl isoalloxazine upon exposure to light, a combination of visible and ultraviolet light is preferred in decontamination procedures using 7,8-dimethyl-10-ribityl isoalloxazine. Since UV light has a higher energy per photon than visible light, and because UV light is absorbed more strongly than visible light by useful compounds in the biological fluid, more damage to the useful components in the biological fluid containing the contaminants will occur when ultraviolet light is used in combination with visible light than when visible light can be used alone. [0131] The methods of this invention do not require the use of enhancers such as “quenchers” or oxygen scavengers, however these may be used to enhance the process by reducing the extent of non-specific cell or protein-damaging chemistry or enhancing the rate of pathogen inactivation. Further preferred methods using non-toxic endogenous photosensitizers and endogenously-based derivative photosensitizers do not require removal of photosensitizers from the fluid after photoradiation. [0132] Apparatus Design [0133] The methods of the invention may be used in a variety of devices. The devices generally comprise: a light source producing light having sufficient wavelength and power to induce inactivation of microorganisms which may be present in a sample; and means for positioning the sample so that it receives energy of sufficient wavelength and power to induce inactivation of microorganisms. [0134] The system preferably includes means for producing movement in the sample. Movement provides many benefits including improving the efficiency of the inactivation reactions by helping mix the photosensitizer with the fluid to be deactivated and providing turnover of sample at the container-light interface, for example. An agitator, such as a Helmer flatbed agitation system (Helmer) may be used. This agitator provides oscillatory motion. Other types of agitators may be used to provide motion normal to the bag. If a bag is used as a container, in combination with a source of movement, a pin or other structure may be placed across or within the bag to provide turbulent eddies in the fluid. The agitator may be connected to a computer or other controller in an inactivation system. Some parameters that may be controlled or monitored include temperature of the fluid, energy output of the lights, agitation motion, light control, timing control or monitoring, and other parameters. The light source and fluid being treated may both move to provide agitation of the fluid, or only the fluid being treated may move while the light source remains stationary. [0135] One particular embodiment of the apparatus is an enclosed photoradiation system where the sample would be placed in an apparatus similar to the Bio-Genic irradiator (Vilber-Lourmat, Cedex, France) that uses the appropriate wavelength or wavelengths. Another embodiment is a conveying apparatus used in a large-scale operation to carry samples through a light field or series of light fields. [0136] Means for positioning the sample so that it receives energy of sufficient wavelength and power to induce inactivation of microorganisms include a shelf or tray for the sample to be disposed upon; a gap between two supports which may be a light or light arrays, where the sample is positioned between the supports; or other means as known in the art. The shelf or tray may move, as in a conveyer line. Fluid-holding shelves may be transparent to one or more of the wavelength(s) of light applied. [0137] The sample may be placed in a suitable container on a support surface between two or more sources of photoradiation, like a sandwich. Alternatively, one of the photoradiation-sources may be a reflective material, to allow the light to contact both sides of the sample. Alternatively, or in combination, the sample may be placed on a support and light may impinge on one surface, with agitation, to allow different portions of the sample to be in contact with the light. [0138] Different sources of photoradiation may be used, depending on the wavelength desired and the power desired at the desired wavelength. One light source that may be used has an emission centered around 447 nm. [0139] Lights that emit in the blue spectral range come from various sources. Lamps with peak emissions around 420 to 450 nm may be purchased from LCD Lighting, Orange, Conn.; Bulbtronic, Farmingdale, N.Y.; National Biological Corp., Twinsburg, Ohio; The Fluorescent Co., Saugus, Calif.; Tek-West, Los Angeles, Calif.; or Southern NE UV, Bransford, Conn., for example. LED (light emitting diodes) may also be used. These LEDs may use a variety of materials to produce the desired spectral output, including silicon carbide (bandwidth around 100 nm; peak spectral output near 466 nm) or gallium nitride (bandwidth around 30- 35 nm; peak spectral output near 470 nm). Also, lights made from a combination of different materials can generate different wavelengths of light. For example, gallium nitride on a silicon carbide substrate can generate 430 nm. These LEDs are manufactured or distributed by Panasonic, Chicago Miniature, Nichia, Toyoda Gosei, Hewlett Packard, LEDTronics, for example. LED lights typically do not require any outside cooling. [0140] The lights may be used in different ways, depending the particular apparatus. For example, diodes may be duty cycled to emit light when the sample arrives in a flow cell light path. Arrays of diodes may surround the fluid in any desired configuration. In a flat bed apparatus, light arrays may surround the fluid from top or bottom, or both. [0141] Filters, such as color glass filters, may be used to isolate a desired band of the spectrum. Single wavelength or narrow band sources may also be used. [0142] One embodiment of an apparatus useful in the methods of the invention includes banks of interchangeable lights that produce the desired wavelength of light for the particular fluid being treated. A coral or aquarium light may be used to produce wavelengths between 440 and 470 nm that is useful in inactivating microorganisms in red blood cells. The lamps may be provided with separate power supplies to control the level of light output. These lamps may be sequentially placed in position to impinge light on the sample, or the sample may travel through lights of different wavelengths. Different LEDs emitting each desired wavelength may be combined in one array. [0143] Active (cooling through some applied means) or passive (air cooling) cooling may be used if necessary to cool either the lamps or the blood. Fans may provide cooling. One set of fans may be used to cool both the lamps and blood, or different fans may be used to provide different levels of cooling to both the lamps and the blood. A photopermeable fluid may surround the sample and/or lights to provide active cooling. This fluid may be optionally temperature controlled. [0144] Malaria Inactivation [0145] Inactivation of the malaria parasite Plasmodium falciparum in red blood cells was tested using Riboflavin (RF) and visible light. Inactivation of the malaria parasite Plasmodium falciparum in other blood components and with other regions of light proceeds analogously, and is well within the skill of one of ordinary skill in the art using the teachings herein and in the references incorporated by reference. Effectiveness of the method was evaluated with measurements of parasite viability in treated units compared to that in controls. Infected red cells were treated at two different hematocrits: 6%, with 4% of the red cells infected, and 38%, with 0.4% of the red cells infected. In each test, the parasite viability decreased to background levels during post-treatment incubation, indicating that riboflavin and light inactivate P. falciparum. [0146] Parasite Inoculum: [0147] [0147] Plasmodium falciparum parasite (strain NF54 [Ponnudurai T, et al. The production of mature gametocytes of Plasmodium falciparum in continuous culture of different isolates infective to mosquitoes. Trans Roy Soc Trop Med Hyg . 1982;76:242]) was cultivated from a continuous stock culture (modified Trager and Jensen technique [Trager W, Jensen J B. Human malaria parasites in continuous culture. Science . 1976;193:673]) maintained at the Walter Reed Army Institute of Research Malaria Culture Laboratory. The inoculum was prepared with 5 mL of stock culture, 95 mL of RPMI media, and 6% human red blood cells (RBCs) and incubated at 37° C. and 100 rpm after brief exposure to 5% CO 2 , 5% O 2 , and 90% N 2 gas. The inoculum media was changed daily when the parasitemia was below 5%, and twice daily for parasitemia greater than 5%. [0148] Donor Red Blood Cells [0149] Blood from volunteer donors was collected into citrate-phosphate-dextrose (CPD). The donor whole blood units were centrifuged at 5,000 g for 10 minutes; after centrifugation, plasma and some of the buffy-coat was removed and discarded, leaving packed RBCs (pRBCs). [0150] Preparation for Illumination [0151] The parasite inoculum was centrifuged and the supernatant was removed. For Illumination of Inoculum only: [0152] 16 mL of parasite inoculum and 24 mL of 500 μM riboflavin solution added to 150-mL PVC bag with 10 mL of air for a Hct=6% and parasitemia=4% [0153] Incubation for 1 hour at room temperature with mixing prior to illumination [0154] For Illumination of Red Cells at 38% Hct: [0155] 10 mL of pRBCs combined with 6 mL parasitized inoculum and 500 μM riboflavin solution to volume of 40 mL with Hct=38% and parasitemia=0.4% [0156] One set of tests at 38% Hct involved illumination directly after preparation of the suspension (No Incubation); the other set of tests at 38% Hct involved incubation for 1-hr at room temperature with mixing prior to illumination (With Incubation). [0157] Samples of 0.3 mL were removed from all suspensions before illumination. [0158] Illumination [0159] After preparation, and incubation with the riboflavin solution, red cell suspensions were illuminated with 450 nm light for 30, 45, or 60 minutes in 150 mL DEHP bags, CharterMed. [0160] Energy delivered was 60, 90, and 120 J/cm 2 , respectively. [0161] After illumination, 1-mL samples were removed from each suspension. [0162] Sample Preparation and Analysis [0163] Parasite viability was examined by measuring parasitic lactate dehydrogenase (pLDH) levels with a double monoclonal antibody ELISA technique (Druilhe, P., et al. A calorimetric in vitro drug-sensitivity assay for P. falciparum based on a highly sensitive two-site LDH antigen capture ELISA assay. Am J Trop Med Hyg 2001 May-June;64:233-41). Measurements of pLDH correlate linearly with % parasitemia. Viability of the parasite is reflected in pLDH. Samples removed prior to illumination were prepared for the assay and stored immediately. Samples removed after illumination were incubated for 2 weeks in multi-well plates with RPMI and aliquots were periodically removed, prepared for the assay, and stored. At the end of the 2-week incubation, all samples were assayed for pLDH content. % Parasitemia of the parasitic inoculum was determined from counts of infected RBCs per total number of RBCs; this value and the pLDH values for untreated inoculum and uninoculated RBCs were used to determine a proportionality constant relating pLDH to % parasitemia: κ=% Parasitemia of Inoculum/(pLDH inoculum -pLDH uninoculatedRBCs ) [0164] The proportionality constant, κ, is used to calculate % Parasitemia for all samples: % Parasitemia of Sample=κ*(pLDH sample -pLDH uninoculatedRBCs ) [0165] Results [0166] [0166]FIG. 1 shows inactivation results from 38% Hct RBC samples with no incubation prior to illumination. FIG. 2 shows inactivation results from illuminating the innoculum (no RBCs). FIG. 3 shows inactivation results from illuminating 38% Hct RBC suspension that was incubated for 1 hour prior to illumination. [0167] The results indicate that riboflavin and visible light significantly reduce parasite viability. Treatment of low Hct inoculum yielded most rapid reduction in parasite viability. Illumination of red cell suspension after 1 hour of incubation with riboflavin solution yielded more rapid reduction in parasite viability than illumination without incubation. Unilluminated controls with riboflavin solution exhibited decreased parasite viability over short incubation times; over longer times, parasite viability recovered. [0168] West Nile Virus (WNV) Inactivation [0169] Inactivation of the West Nile virus (New York 1999, flamingo, 35262-11, from CDC Laboratories, Fort Collins, Colo.) was tested using riboflavin (RF) and visible light for RBCs and riboflavin (RF) and ultraviolet light for plasma and platelets. Titers were determined using the Tissue Culture Infectious Dose (TCID50) method (the dose where 50% of the wells are infected) with Vero cells (African green monkey kidney cells). This is a standard technique known to those skilled in the art and is described in the following references: Karber, G. 1931 Beitrag zur kollektiven Behandlung pharmakologisher Reihenversuche. Arch. Exp. Pathol. Pharmakol. 162: 480-483; Reed, L. J., and H. Meunch. 1938. A sample method for estimating fifty percent endpoints. Am. J. Hyg. 27:493-497; Leland, D. S., and M. L. V. French. 1988. Virus Isolation and Identification, p. 39-59, In A. Balows, W. J. Hausler, and E. H. Lennette (eds.), Laboratory Diagnosis of Infectious Diseases, Principles and Practice. Volume II: Viral, Rickettsial, and Chlamydial Diseases. Springer-Verlag, New York. The Vero cells were fed with DMEM supplemented with 10% fetal bovine serum (Hyclone). The amount of virus that was added to each component was a certain number of plaque-forming units (pfu) based on a titration of the virus in a plaque assay test (infected cells covered by a nutrient agar overlay). The endpoint for testing was based on cytopathic effect (CPE) where the tissue cultured in wells is looked at with a microscope to determine if the virus has infected the cells to determine the 50% tissue culture infectious dose. The samples were incubated at 37° C., 5% CO 2 for 5 days and monitored daily. A 50 μL inoculum size was used. The results for sample size n=3 for each blood component are reported. Each run used RBCs, plasma or platelets from a different donor. [0170] Platelet Study [0171] A volume of 250 mL of platelets was used with 50 μM riboflavin. The platelets were illuminated with light having a peak at 320 nm to deliver 2, 4, 6, 8, 10 or 12 j/cm 2 . FIG. 4 shows the log reduction in WNV using various amounts of energy applied. [0172] Plasma Study [0173] 250 mL plasma was used with 50 μM riboflavin. The plasma was illuminated with lights having a peak wavelength at 320 nm to deliver 2, 4, 6, 8, 10 or 12 J/cm 2 . FIG. 5 shows the log reduction in WNV using various amounts of energy applied. [0174] Red Blood Cell Study [0175] The product volume was 266 mL at 30 Hct. The riboflavin concentration was about 500 μM. Visible light (400 to 520 nm) was used. The RBCs were illuminated to deliver was 30, 60, 90, 120 or 180 J/cm 2 . FIG. 6 shows log reduction in WNV using various amount of energy applied. [0176] Results [0177] The result show a reduction in the viral titers of platelets, plasma and red blood calls infected with West Nile Virus. TABLE 1 Energy Delivered, J/cm 2 Reduction of WNV in RBCs, log/mL 0 0.00 0.00 0.00 30 1.90 0.95 1.09 60 3.47 1.98 2.14 90 4.65 3.07 2.44 120 5.85 ≧4.50 3.30 180 ≧6.65 ≧4.50 ≧5.13 [0178] [0178] TABLE 2 Energy Delivered, J/cm 2 Reduction of WNV in Platelets, log/mL 0 0.00 0.00 0.00 2 2.67 1.66 2.64 4 3.86 2.96 3.76 6 4.26 3.85 4.89 8 ≧4.86 ≧4.50 5.10 10 ≧4.86 ≧4.15 ≧6.00 12 ≧4.86 ≧4.75 ≧6.00 [0179] [0179] TABLE 3 Energy Delivered, J/cm 2 Reduction of WNV in Plasma, log/mL 0 0.00 0.00 0.00 2 2.78 2.92 3.01 4 4.44 4.11 4.52 6 ≧5.44 4.98 ≧5.12 8 ≧5.44 ≧5.68 ≧5.12 10 ≧5.44 ≧5.68 ≧5.12 12 ≧5.44 ≧5.68 ≧5.12

Methods and apparatuses are provided for inactivation of microorganisms in fluids or on surfaces. Preferably the fluids contain blood or blood products and comprise biologically active proteins. Preferred methods include the steps of adding an effective, non-toxic amount of a photosensitizer to a fluid and exposing the fluid to photoradiation sufficient to activate the photosensitizer whereby microorganisms are inactivated.

FIELD OF INVENTION [0001] The present invention relates to a control lever having one end adapted for attachment to a resting device such as a chair and another end having a tactile contour for identifying the control lever. The invention also relates to a chair having a plurality of levers where each of said levers have a different tactile contour for distinguishing the levers. A guide is associated with said plurality of levers having different tactile shapes. The invention also relates to a method of correlating a plurality of lever control arms with respective corresponding plurality of movements of a chair, using a guide. BACKGROUND TO THE INVENTION [0002] Resting devices such as a chair or bed may be adjusted to fit the comfort of an individual user. [0003] Contemporary chairs particularly utilised in an office are becoming more sophisticated with respect to the different adjustments that can be made to these types of chairs. Typically such chairs provide that both the back and the seat of the office chair can be separately adjusted to a number of different settings by utilising a plurality of chair lever control arms. Generally speaking, all chair lever control arms or controls are generally located below the chair seat. This is generally the case for adjustable beds of the type having control arms located below the bed. [0004] A particular draw back of such prior art chairs resides in the likelihood that understanding of the use of the controls is often difficult. Much of the difficulty results from the positioning of the lever control arms below the chair seat where they are not readily visibly assessable. [0005] Accordingly, it is not unusual that the operation of most chair controls is understood after a trial and error test done by a person using the chair. Such person will generally try each control to determine its function and may reach a full understanding of the chair controls only after extended chair usage. This can be frustrating as the chair control arms can move a chair part, which has already been set to an appropriate optimal position, and require resetting. In some case, such person may not be able to properly reset the chair for optimal usage. [0006] In other cases movement of the lever control arms or devices without an understanding of its function can lead to adjustment of the chair parts which is inappropriate. For example, some chairs are equipped with a tension device that is rotatable and adjusts the tension on the “free float” tilting motion of the chair. This “free float’ motion may be locked (i.e. prohibits the swing) or unlocked by a chair lever arm. If the tension is adjusted for a heavy person and a light person sits on the chair it is possible that the light person may be catapulted forward by the spring activated movement when the lever arm is unlocked. [0007] Accordingly, various prior art devices have heretofore been constructed in order to address the difficulties referred to above. [0008] For example, reissue U.S. Pat. Re 36,928 relates to an operational guide mounted to an adjustable chair where the guide includes a card having a pictorial guide for operating the adjustable chair located on the top side of the card. [0009] Moreover, some prior art chairs included lever control arms having an end with a serrated edge along one side thereof. [0010] In other cases, Braille has been disposed on a top surface of a lever control arm in order to permit a blind person to locate the particular lever control arm and convey information regarding same. [0011] However, it is difficult for the general public to decipher the meaning of a serrated edge or Braille disposed on a lever control arm. Furthermore it is generally difficult to visually represent a serrated edge or Braille on a screen or guide which is easy to see or understand. [0012] Moreover the prior art devices have not addressed the issue of assisting a user to understand the operation of a lever control arm, apart from providing an instructional manual in a booklet of written form. In some prior art devices summaries of instructions are provided on a card as shown in Re 36,928 or card pivoting outwardly from an arm of a chair. [0013] According, it is an object of this invention to provide an improved lever control arm for a chair, which is more easily and readily understood by the general public. [0014] It is a further object of this invention to provide an improved chair having control levers for adjusting a chair having an improved method of conveying information concerning its functionality. [0015] It is an aspect of this invention to provide a control lever having one end adapted for attachment to a resting device for controlled adjustment thereof and another end having a tactile contour for identifying the control lever. [0016] It is another aspect of this invention to provide a plurality of levers each having one end adapted for attachment below a chair seat or controlling separate movements of a chair, each said lever having another end having tactile shapes different from one another so as to distinguish said levers. [0017] It is another aspect of this invention to provide a chair having a selectively moveable back and seat and a plurality of control arms attached below said seat for activating selected movements of said back and seat wherein said one of said control arms includes an end having a tactile shape different from an end of another one of said control arms. [0018] It is another aspect of this invention to provide a chair having a selectively moveable back and seat including a first lever control arm having one end attached below the seat and another end presenting a tactile shape, said first lever arm activating a selected movement of said back or seat; a second lever control arm having one end attached below said seat and another end presenting a tactile shape, said second lever control arm activating another selected movement of said back or seat different from said first lever control arm; said tactile shape of said second lever arm different from said tactile shape of said first lever arm; and a guide presented by the arm of the chair for displaying the different tactile shapes and the associated movements of said first and second lever control arms. [0019] It is another aspect of this invention to provide a guide for a chair having a plurality of lever control arms with ends having different tactile shapes, for activating a selective orientation of a back or seat of a chair comprising: a screen having visual representations corresponding to each said different tactile shapes; information associated with said visual representations and corresponding to selective orientations activated by said plurality of lever control arms respectively. [0020] It is another aspect of this invention to provide a method of correlating a plurality of separate movements of a chair with a plurality of lever control arms activating said movements respectively comprising the steps of: providing a plurality of lever control arms with ends having different tactile contour shapes; displaying a guide having said shapes with information associated with said movements of said plurality of lever control arms respectively. [0021] These and other objects and features of the invention shall now be described in relation to the following drawings. BRIEF DESCRIPTION OF DRAWINGS [0022] FIG. 1 is the rear perspective view of an office type chair having moveable chair parts and controls for those moveable chair parts. The chair shown in FIG. 1 is of a conventional design and is labelled as prior art. [0023] FIG. 2 is a perspective view of a chair and a display or control guide according to one preferred embodiment of the present invention. [0024] FIG. 3 is an enlarged perspective view of the armrest from the chair of FIG. 2 according to a further preferred embodiment of the present invention. [0025] FIG. 4 is an enlarged perspective view of the control lever arms removed from the chair FIG. 2 . DETAILED DESCRIPTION OF THE INVENTION [0026] In the description that follows, like parts are marked throughout the specification and drawings with the same respective reference numerals. The drawings are not necessarily to scale and in some instances proportions may have been exaggerated in order to more clearly depict certain features of the invention. DESCRIPTION OF THE PRIOR ART [0027] FIG. 1 shows a typical example of a prior art office type chair 1 . The chair includes a chair back 3 , a chair seat 5 , and a support frame 8 which includes a vertical column 7 and a frame 9 which supports the chair 1 . [0028] The back 3 and seat 5 of the chair 1 are adjustable to different positions. For example, the chair back 3 may be vertically adjusted at an angle relative to the seat 5 . Moreover the seat 5 may be adjusted relative the horizontal. Furthermore, the height of the seat 5 may also be adjusted from ground level, in a manner well known to persons skilled in the art. Furthermore, other parts of the chair may also be adjustable. [0029] The different adjustments or movements of each of the above chair parts is activated by a number of control levers or chair lever control arms 11 . Generally speaking prior art lever control arms 13 , 15 , and 17 are identically shaped. Generally speaking the prior art devices comprise lever arms 13 , 15 , and 17 having a substantially flat circular paddle at one end of the lever arm as shown. Furthermore they generally lie in substantially planar side-by-side relationship in close proximity to one another. [0030] Accordingly, a user will generally have difficulty distinguishing one control arm 13 from the others 15 and 17 . Generally speaking the user will need to operate the control to determine which chair part is controlled by the respective control lever 13 , 15 , and 17 . If the correct chair control lever 11 is not chosen, difficulties may arise as described above. [0031] FIG. 2 shows a chair 41 according to one preferred embodiment of the present invention. The chair 41 includes a back 43 and a seat 45 with a lower frame 46 . The lower frame 46 includes height adjustment means 47 and a frame 48 to which the seat 45 is attached and supported. [0032] The height adjustment means 47 can comprise of a number of devices including telescoping cylinders which comprise a gas cylinder for adjusting the height of the seat 45 relative to the floor in a manner well known to those persons skilled in the art. [0033] A plurality of control levers or lever control arms 49 are disposed below the seat 45 . In particular, the plurality of lever control arms 49 extend from the frame part 48 . Three lever control arms 52 , 54 and 56 are shown although any number of lever control arms may be utilised. Each of the lever control arms 52 , 54 and 56 present one end 59 , 61 and 63 respectively which are adapted for attachment to the chair. In particular, the one end 59 , 61 and 63 of the lever control arms 52 , 54 and 56 respectively extend from the frame part 48 and are fastened to the appropriate adjustment mechanisms not shown but well known to those persons skilled in the art. For example, the one end 59 , 61 and 63 of the lever control arms 49 may be snapped on or virtually engaged by the appropriate adjustment mechanisms. [0034] The other end 53 , 55 , 57 of the lever control arm 52 , 54 and 56 respectively have a shape or tactile contour for identifying the control levers 49 . In particular, each of the other ends 53 , 55 , 57 of the control levers 49 have a tactile contour which is different from one another so as to easily and readily distinguish the lever. The geometric shapes shown in the drawings, namely the circle, square and triangle are easily and readily distinguishable from one another by tactile contact with a users fingers (since the levers are located below the seat and out of view) in a way which has not been done before, either by serrated edge, Braille, or otherwise. [0035] Each of the tactile contours 53 , 55 and 57 are substantially flat or planar and define a substantially two-dimensional tactile shape for identifying the control levers 49 . In particular, the tactile shapes 53 , 55 and 57 are planer having a peripheral edge 65 , 67 and 69 defining the shapes. The peripheral edges 65 , 67 and 69 may be flat, smooth or curved. [0036] The tactile contours or shapes 53 , 55 and 57 as shown in the figures are disposed substantially horizontally relative to the chair 41 and seat 45 although they can also be disposed substantially vertically or other orientation relative to the chair 41 . [0037] The shapes of the other end 53 , 55 and 57 of the control levers 49 are in one embodiment selected from the group of circular, rectangular, triangular, square, oval or half-circular shapes. However other geometrical shapes, letters or symbols can be selected such as an arrow which may be oriented upwardly or downwardly to convey a selected message. Generally, this group defines planer shapes. The invention should not be limited to the shapes belonging to this group, as the group has been included as an example only. Any tactile contour shape can be selected so long as it is easily and readily distinguished by a person's tactile feel by the fingers or the like. It is possible that 3-dimensional shapes such as spheres, pyramids or cubes could be utilised, although it has been found that planer 2-dimensional shapes as described are easily distinguishable by touch or feel. [0038] Furthermore these shapes are in one embodiment disposed in two dimensional space, with a depth (i.e. third dimension) defining a peripheral edge 39 , 41 , and 43 of tactile contour 53 , 55 , and 57 of lever arms 52 , 54 , and 56 respectively. [0039] In one embodiment the tactile contours are defined and perceived by a user operably contacting the peripheral edge 39 , 41 , and 43 which define the shapes 53 , 55 , and 57 . [0040] Alternatively the planar surfaces S, T, C of tactile contours 53 , 55 , and 57 may be contoured. For example S may have a smooth surface, while T may be stippled and C being concave, provided such surface is capable of tactile perception and can be visually perceived and in one embodiment represented by indicia such as a visual symbol or in writing. [0041] Accordingly, the user of a chair is able to reach down and grasp any of the lever control arms 49 and recognise the distinctive shapes or contours that has been grasped as either circular, triangular, square, half-circular, rectangular, oval or the like. As such, the person may then activate the appropriate control lever to adjust or move the respective response in adjusting or moving the seat 45 or back 43 of the chair. [0042] Such user may then easily remember the particular function of the lever control arms 49 after a few uses as the tactile contours have different shapes. The geometric shapes shown in the figures i.e. circle, triangle, and square are easily remembered. [0043] Furthermore the side to side spacing can be selected to permit unobstructed manipulation without interference from the other control arms by a users fingers. [0044] A person can in accordance with another embodiment of this invention, utilise a display or control guide With the invention described above to determine what the particular control lever will do from the shape of the tactile contour. [0045] More specifically, FIG. 2 shows a control guide or display 65 may comprise a computer monitor, which is associated with the plurality of levers 49 . The computer monitor 65 may be disposed in the vicinity of the chair 41 so that a person sitting in the chair 41 can easily view the monitor screen, which will show or visually display representations of all of the shapes embraced by the tactile shapes 53 , 55 and 57 . [0046] In the embodiment shown the computer screen 66 will visually illustrate a circular, triangular and square representation. In one embodiment, the circular shape will appear at the top of the screen, while the triangular shape will appear at the middle of the screen, and the square shape appear at the bottom of the screen. Each of the shapes will have associated therewith on the screen information pertinent to the control having the particular shape. [0047] For example, the circular shape 57 is shown on the computer monitor 65 with indicia or information 85 beside it that the circular shape lever control arm 49 will tilt the chair back 43 vertically relative to the seat 45 . The triangular tactile shape 55 will also appear on the computer monitor 65 with indicia or information 83 beside it that the triangular lever will move the seat 45 at an angle to the horizon. The square tactile shape 53 will appear on the computer monitor 65 with indicia or information 77 beside it that activating the lever 49 will move the seat 45 vertically, upwardly or downwardly relative to a surface. [0048] Accordingly, a person using the chair 41 could then refer to the visual shapes described above on the monitor screen and reach down and feel for the particular control arm 49 that they need to make a particular chair adjustment. [0049] In another embodiment, the control guide information 77 , 83 , and 85 may be on a website, which could be accessed by the user. Alternatively, the control guide 65 may comprise of written information obtained in a booklet 67 , which can be stored in association with the chair as shown. Such booklet 67 may have pictures of the various different shapes and information concerning the operation and adjustment of each of the controls according to the shape of the handles. [0050] In another embodiment, the control guide 65 may be an audible rather than a visual guide. The user of the chair 41 can access this information by pressing a switch 33 , which may be disposed on the arm 71 and an audible recording which has been stored on, in or in association with the chair 41 , will then be activated and heard through an audio output such as a speaker 70 provided in the back of the chair or other location. Appropriate wires (not shown) and power supplies (not shown) can be provided to activate the audio information. Alternatively, the switch 33 may activate the speaker 70 by wireless means. [0051] FIG. 3 shows still another embodiment of the invention in which the control guide or display 65 is carried or provided in the armrest 71 of the chair. The display is electronic in one embodiment. The display or control guide 65 is presented on the upper surface of the armrest 71 and in one embodiment will be visible at all times. The control guide 65 can comprise of a liquid crystal display screen or other electronic screen, which can display the shapes of the tactile contours and include information concerning the various functions of the levers 49 . The display 65 can also comprise of buttons 57 , 55 and 53 which correspond to the shape of the tactile contours which in one embodiment can be pressed so as to provide information 79 , 83 , and 87 respectively. Information 79 , 83 and 87 corresponding to the levers 49 having the contour shapes 57 , 55 and 53 are displayed in association therewith as shown in FIG. 3 . [0052] Alternatively, the visual representation 57 , 55 and 53 can comprise of a visual electronic image, which is active by the touch of a finger that changes the electronic characteristics such as inductance or the like to turn on the written information 79 , 83 and 87 respectively. [0053] Alternatively the shapes of the buttons 57 , 55 , 53 may be embossed printed or recessed into the material of the arm rest during the fabricating or moulding step which buttons could include the words “RAISE”, “LOWER” and “TILT” for example embossed, printed or recessed inside or close to the buttons to act as a guide to the user of the chair. This would act as a guide to the user feeling the lever arms and looking at the shapes on the armrest to prompt the user as to the function of the appropriate lever arm. [0054] Furthermore by utilising the easily recognisable tactile shapes as described in association with shapes that are easily visually represented on a guide such as a computer screen or electronic display on a chair arm (where resolution may be limited) the user can select the appropriate lever arm for the desired movement of the chair. These advantages are not readily available on those prior art chairs utilising a serrated edge on a lever arm (i.e. pixel size of the screen may not permit visual representation of a serrated edge, particularly to someone with poor eyesight) or Braille on the surface of a lever arm. [0055] In one embodiment shown in FIGS. 2 and 3 the order or sequence is the same on the display 65 as on the levers 57 55 and 53 to assist in remembering and operation. In other words the visual appearance or order of the buttons 57 , 55 and 53 on the display 65 is the same as the order of the tactile contours 57 , 55 and 53 . However the invention is not to be limited to this particular order as benefits can be experienced with the sequence of the lever arms being different from the buttons. [0056] Although not shown it is possible that a hinged cover can be attached to the upper surface of the armrest 71 so as to cover the display or the control guide 65 . The information 77 , 83 and 85 is more visually accessible to the user of the chair 41 than the controls, which are located below the chair seat. The user of the chair 41 is able to simply reach down to feel the tactile shape of the ends of the lever control arms 49 which are readily recognisable to the touch of the user and then the user can refer to the control guide 65 to determine which lever control activates which part of the chair. [0057] Although the invention has been described herein with lever control arms 49 , which are substantially of the same length, such lever control arms 49 may have different lengths. [0058] The information to be displayed can be selected to include basic instructions concerning the operation of the lever control arms 49 or the literal information can scroll across the screen to provide full operational information concerning the chair as well as the lever control arms 49 . [0059] Although only three lever control arms 49 have been described a plurality of lever control arms can be utilised. Alternatively, at least two lever control arms can be utilised in accordance with the invention described herein. As described above, each of the levers 52 , 54 and 56 are associated with a control guide or display 65 , which display includes a visual representation corresponding to the shape and information corresponding to the separate movements of the chair. Furthermore it is also possible that one or more control arms 49 be disposed on both side of the seat 45 . [0060] The display 65 has indicia 77 , 83 and 85 for correlating the different tactile shapes of the control means and their associated movements. [0061] The invention described herein shows a chair 41 having a selectively moveable back 43 and seat 45 including: (a) a first lever control arm 52 having one end 59 attach below the seat 45 and another end 53 presenting a tactile shape, said first lever arm 52 activating a selective movement of the back 43 or seat 45 ; (b) a second lever control arm 54 having one end 61 attach below the seat 45 and another end 55 presenting a tactile shape, said second lever arm 54 activating another selective movement of the back 43 or seat 45 different from the first lever control arm 52 ; (c) the tactile shape 55 of the second lever arm 54 is different from the tactile shape 53 of the first lever arm 52 ; (d) a display 65 presented by the arm of the chair 41 for displaying the different tactile shapes and indicia from the associated movements of the first and second lever control arms. [0066] The invention described above also illustrates a display 65 for a chair 41 having a plurality of lever control arms 52 , 54 and 56 for activating a selected orientation of the back 43 or a seat 45 of the chair 41 comprising: (a) a screen 66 having visual representations corresponding to each of the different tactile shapes; and (b) information 79 , 83 and 87 associated with the visual representations and corresponding to the selected orientations activated by the plurality of lever control arms respectively. [0069] Finally the invention described herein illustrates a method of correlating the plurality of movements of a chair with a plurality of lever chair control arms 49 respectively comprising the steps of: (a) providing a plurality of lever control arms having ends with different tactile contour shapes; (b) displaying a guide having the shapes with information associated with said movements of said plurality of level control arms respectively. [0072] Although the preferred embodiment as well as the operation in use have been specifically described in relation to the drawings, it should be understood variations of the preferred embodiment can be achieved by a person skilled in the trade without departing from the spirit of the invention as claimed herein.

A control lever having one end adapted for attachment to a resting device for controlling movement thereof, and another end having a tactile contour for identifying said control lever.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to the field of barbecue grills, cookers, and smokers and, more specifically, to a new design for a smoker which allows for more evenly distributed heating and smoking of food and which can also be adjusted to act as a barbecue grill or cooker. 2. Description of Related Prior Art The prior art is crowded with barbecue grills and smokers, in combination and separately. Typically, these devices use charcoal briquettes or wood as a heat source to cook food placed on a grill near the heat source. The devices are often adjustable in some manner to allow for smoking the food as opposed to grilling it over an open flame. Traditional smokers are constructed with the fireboxes located to the right or left of the grill and the smoker housing. In this type of construction, smoke and heat from the firebox is allowed to drift into the smoker housing through vents and thereby cooking and smoking the meat. The problem with this traditional type of smoker is that food items placed closer to the firebox smoke and cook faster than food items placed further away. This requires food items to be continually monitored and rotated on the grill to ensure even cooking/smoking of the food items. There are many other smoker and barbecue grill designs where the cooking surface is positioned above the heat source. An example of these designs include the following: U.S. Pat. No. 4,094,295 to Boswell, et al; U.S. Pat. No. 4,467,709 to Anstedt; U.S. Pat. No. 4,495,860 to Hitch, et al; U.S. Pat. No. 4,962,697 to Farrar; and U.S. Pat. No. 5,359,923 to Boswell. Typically, the fireboxes and/or the grills in the aforementioned patents are adjustable to various heights depending on whether smoking or barbecue style heating is desired. Many of these inventions also contain water pans to create steam to mix with the smoke during the cooking process. A patent to Hastings, U.S. Pat. No. 2,666,425, describes a hooded barbecue grill with two sets of rails placed at different heights below in the grill to support a removable firebox. The upper rails are also used to support a heat deflector when the firebox is located and supported by the lower set of rails. A patent to Leech, U.S. Pat. No. 3,379,190, also discloses a barbecue pit which allows for a varying heights of the firebox. The Leech design has two fireboxes each of which is supported in a cantilever fashion from opposite sidewalls of the device. The fireboxes can be raised and lowered to vary the cooking heat at the grill level. While the Hastings and Leech design allow for adjustable firebox heights to vary temperatures at the grill, it does not allow for even distribution of smoke when smoking the food items placed on the grill. A patent to Bussey, U.S. Pat. No. 5,460,159, discloses a smoker/barbecue pit which allows smoking and barbecuing at the same time. This invention directs heat and smoke around and towards the grilling surface from the sides of the grilling surface. This patent also describes directing smoke and heat through opening on the sides of the units where detachable pot warmers can be attached. Finally, a patent issued to Ruben, U.S. Pat. No. 5,473,979, discloses a three-chambered “smoker”. The lower chamber where the firebox is located, has a rotatable partition plate which controls and directs heat and smoke from below and catches and funnels off drippings from above. Some or all of the aforementioned patents and prior art attempt to direct and channel heat and smoke in order to vary the temperature and more evenly distribute the heat and smoke. This is done with shielding devices which rest between the heat source and the grilling surface and/or the shape of the hood above the grilling surface. However, none of the aforementioned patents allow heat and smoke to collect and drift upwards toward the grilling surface in an even distribution. It can be seen that there remains a need for a smoker/barbecue grill which more effectively allows for an even distribution of smoke and heat from the fire pit. SUMMARY OF THE INVENTION It is an object of the present invention to provide a combination smoker and barbecue grill which evenly distributes smoke across food items being cooked on the grill. It is another objection of the present invention to provide a combination smoker and barbecue grill which encloses a fuel burning firebox underneath the grill. It is another object of the present invention to provide a combination smoker and barbecue grill which has a smoke shield positioned between the grill and firebox which deflects and directs smoke into smoke collection members. It is another object of this invention to provide a combination smoker and barbecue grill which directs smoke from the firebox into smoke collection members which in turn fill and allow smoke to drift in an even distribution towards food items cooked on the grill. It is another object of the present invention to provide a combination smoker and barbecue grill which has doors and vent hatches for the easy removal of a drip pan and the firebox. It is another object of the present invention to provide for vent hatches which function as air supply vents for the combustion process. It is another object of the present invention to make maximum use of the features of the combination smoker and barbecue grill by providing smoke collection members which also act as a support for placement of the firebox at an upper level closer to the grill for barbecuing. It is another object of the present invention to make maximum use of the features of the combination smoker and barbecue grill by providing the smoke shield which also acts as a support for the placement of the drip pan during the smoking process. In satisfaction of these and related objectives, Applicant's present invention provides for a combination smoker and barbecue grill which has a grill that rests on a housing and which is covered by a hood. The housing encloses a removable firebox for holding wood, charcoal, or other fuel while burning, a smoke shield positioned between the grill and firebox and smoke collection members are positioned between the grill and smoke shield. The smoke shield is centered above the firebox and deflects and directs smoke from the firebox around the front and back edges of the smoke shield into a pair of smoke chambers positioned within the housing and below the grill. Smoke is allowed to fill the smoke chambers from top to bottom. As the smoke reaches the bottom of the smoke chambers, it spills into a plurality of elongated, evenly spaced, smoke collection members attached to interior panels forming the interior barriers for the smoke chambers. Once the smoke fills the smoke collection members from top to bottom, it will spill out the open-ended bottoms of the smoke collection members. This causes a substantially even distribution of smoke to rise from the smoke collection members toward food items on the grill, allowing the food items to smoke and cook evenly. A drip pan, which is placed on the top surface of the smoke shield, catches and collects drippings from the food items. These drippings will evaporate in the drip pan creating vapors which will rise back towards the food items on the grill further flavoring the food items. Water can be placed in the drip pan during the smoking process which will create steam which rises with the smoke and helps prevent the food items from drying out during the smoking process. Side doors on both housing sidewalls can be rotated open to allow access to and removal of the drip pan and firebox for refueling and cleaning. A smaller vent hatch below the side doors also allow for access to and removal of the firebox and act as air supply vents for the combustion process. If desired, the invention can be converted to a traditional barbecue grill by placing the firebox on top of the smoke collection members. In this manner, the firebox is positioned above the smoke shield, closer to the grill and directly heats and cooks the food items on the grill in traditional barbecue style. The above and other objects and advantages of the present invention will become more readily apparent when references made to the following description taking in conjunction with the accompanied drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the preferred embodiment of the present invention. FIG. 2 is the same perspective view of the preferred embodiment of the present invention showing the hood and one side door in their open positions and partly cut away to show the relative positions of the internal structure. FIG. 3 is another perspective view of the present invention which is partly cut away to show the relative positions of the internal structure. FIG. 4 is a partial cross sectional side elevational view of the preferred embodiment of the present invention. FIG. 5 is a vertical cross sectional view along line 5 — 5 of FIG. 4 . FIG. 6 is a horizontal cross sectional view along line 6 — 6 of FIG. 5 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGS. 1–6 , a combination smoker and barbecue grill 10 is equipped with a hood 12 and a housing 14 . The hood 12 covers a grill 15 which rests on the outer surface of opposed upper shoulder panels 16 a and 16 b of the housing 14 . The housing 14 has a casing 11 and housing sidewalls 13 a and 13 b and forms and enclosure for a firebox 18 , a smoke shield 20 , a drip pan 22 , and a plurality smoke collection members 23 a , 23 b , 23 c , and 23 d. Referring FIGS. 1–3 , the hood 12 has a rotatable portion 30 pivotally connected to a stationary portion 32 by pins 34 a and 34 b . The rotatable portion 30 of the hood 12 has a vertical front panel 38 , an angled front panel 40 and two rotatable sidewalls 42 a and 42 b . The vertical front panel 38 and angled front panel 40 are constructed from one continuous sheet of material bent at its approximate centerline to form the vertical front panel 38 and the angled front panel 40 which angles upwardly and inwardly towards the crest of the hood 12 . The vertical front panel 38 is equipped with a handle 44 adjacent its lower end. A temperature indicator 46 is mounted to the upper angled front panel 40 . In the preferred embodiment of this invention, the temperature indicator is manufactured by Taylor, Model No. 1470 and the vertical front panel 38 and angled front panel 40 are constructed of 16 gauge sheet metal. Still referring FIGS. 1–3 , the rotator sidewalls 42 a and 42 b are hexagonal and have front vertical edges 50 a and 50 b and front angled edges 52 a and 52 b which are shaped to conform to the outer edges of the vertical panel 38 and upper angled panel 40 . A pair of horizontal bottom edges 54 a and 54 b of the rotatable sidewalls 42 a and 42 b rest against respective upper edges of the housing sidewalls 13 a and 13 b when the hood 12 is in its closed position. In order to allow the rotatable section 30 of the hood 12 to pivot at the pins 34 a and 34 b , lower back edges 56 a and 56 b of the rotating sidewalls 42 a and 42 b extend from the back ends of the bottom edges 54 a and 54 b and angle upwardly and backwardly in a direction generally towards, below and slightly beyond the pins 34 a and 34 b . Upper back edges 58 a and 58 b of the rotating sidewalls 42 a and 42 b extend vertically from the upper ends of the lower back edges 56 a and 56 b to points adjacent an angled back panel 49 of the stationary portion 32 of the hood 12 when the rotating portion 30 of the hood 12 is in its closed position (See FIG. 1 ). A pair of top edges 59 a and 59 b of the rotatable sidewalls 42 a and 42 b extend respectively from the upper ends of the upper back edges 58 a and 58 b of the rotating sidewalls 42 a and 42 b to the crest of the hood 12 . In the preferred embodiment, the rotating sidewalls 42 a and 42 b are constructed of 16 gauge sheet metal. Still referring to FIGS. 1–3 , the stationary portion 32 of the hood has a vertical back panel 48 , an angled back panel 49 and two stationary sidewalls 60 a and 60 b . The vertical back panel 48 and angled back panel 49 are preferably constructed from one continuous rectangular sheet of material bent at its approximate centerline to form the vertical back panel 48 and angled back panel 49 which angles forwardly and inwardly toward the crest of the hood 12 . As shown in FIGS. 3 and 4 , the angled back panel 49 does not extend to the crest of the hood 12 creating a rectangular vent opening 47 across the width of the stationary portion 32 of the hood 12 between the upper edge 45 of the upper angled back panel 49 and the crest of the hood 12 . In an exemplary embodiment, the size of the vent opening is 3 inches×24 inches. However, it is anticipated that the size of the opening could vary as long as it is sufficient to adequately vent smoke when desired. Referring to FIGS. 1–4 , a vent cover 70 is pivotally connected to the rotatable sidewalls 42 a and 42 b . The vent cover 70 has a top portion 72 which is of sufficient width and depth to allow the vent cover 70 to cover the vent opening 47 with minimal clearance with the vent cover 70 is in its closed position (See FIG. 1 ). Rectangular side flaps 74 a and 74 b extent perpendicularly from opposite side edges of the top portion 72 of the vent cover 70 . The side flaps are adjacent, parallel with, and pivotally connected to the respective rotatable sidewalls 42 a and 42 b with pins 41 a and 41 b . A front flap 76 extends perpendicularly from the front edge of the top portion 72 of the vent cover 70 along the entire width of the vent cover 70 . The height of the front flap 76 is sufficient to allow the lower edge of the front flap 76 to rest against the angled front panel 40 when the vent cover 70 is in its closed position (See FIG. 1 ). A handle 78 is centered on and extends from the top portion 72 of the vent cover 70 to allow an operator to rotate the vent cover 70 from a closed position to an open position (See FIG. 3 ). A spring loaded pressure pin 75 is mounted to the outer surface of the angled front panel 40 adjacent the crest of the hood 12 and positioned such that a pinhead 77 of the pressure pin 75 presses against the inner surface of at least one side flap 74 a and 74 b of the vent cover 70 at all times. The frictional force created between the pinhead 77 and the side flap 74 b is sufficient to allow the vent cover 70 to remain in place in any rotated position. In the exemplary embodiment, the vent cover 70 is constructed of 16 gauge sheet metal. However, it is anticipated that other gauges and material may be used. Referring again to FIGS. 1–3 , the stationary sidewalls 60 a and 60 b of the hood 12 have vertical back edges 62 a and 62 b and angled back edges 64 a and 64 b which conform to the shape of the vertical back panel 48 and angled back panel 49 at their side edges. The angled back edges 64 a and 64 b extend respectively from the upper ends of the vertical back edges 62 a and 62 b to a point adjacent the opposing side ends of the upper edge 45 of the angled back panel 49 . The stationary sidewalls 60 a and 60 b of the hood 12 each have angled front edge 66 a and 66 b with upper ends terminating at the crest of the hood 12 and lower ends adjacent the vertical edges of the vertical front panel 38 . The hood is rotated to a closed position (See FIG. 1 ). The stationary sidewalls 60 a and 60 b have vertical front edges 68 a and 68 b (See FIG. 2 ) which extend from the lower ends of the angled front edges 66 a and 66 b and rest against the upper shoulder 16 a of the casing 11 . Bottom edges 69 a and 69 b of the stationary sidewalls 60 a and 60 b extend from respective lower ends of the front edges 68 a and 68 b to the lower ends of the vertical edges 62 a and 62 b of the stationary sidewalls 60 a and 60 b . In the exemplary embodiment, the height of the front edges 68 a and 68 b is approximately 4 inches. However, it is anticipated that a range of heights are suitable as long as the rotating portion 30 of the hood 12 can open and close freely. Referring to FIGS. 1 , 2 , 3 , and 5 , the width of the stationary portion 32 of the hood 12 is equal to the width between the interior surfaces of the housing sidewalls 13 a and 13 b . As shown in FIGS. 2 and 4 , rectangular mounting flanges 67 a and 67 b extend from respective bottom edges 69 a and 69 b of each of the stationary sidewalls 60 a and 60 b and are positioned flush against the interior surfaces of the housing sidewalls 13 a and 13 b . The mounting flanges 67 a and 67 b are connected to the housing sidewalls 13 a and 13 b with nut and bolt combinations 65 . The stationary portion 32 of the hood 12 is mounted and fixed to the housing 14 in this manner. In the exemplary embodiment, each combination of the mounting flanges 67 a and 67 b and stationary sidewalls 60 a and 60 b are constructed of a continuous sheet of 16 gauge sheet metal. The shape of the hood 12 has been described in detail in this preferred embodiment. It is anticipated that various modifications to the shape and design of the hood 12 are acceptable and would become apparent to persons skilled in the art. As shown in FIGS. 2 , 4 , and 5 , the grill 15 rests on the upper shoulder panels 16 a and 16 b of the casing 11 and across the opening created between the upper shoulder panels 16 a and 16 b . The grill 15 also rests on mounting brackets 17 a and 17 b secured to the interior surfaces of the mounting flanges 67 a and 67 b with nut and bolt combinations 65 . Referring to FIGS. 1–4 , the housing 14 is formed by the housing sidewalls 13 a and 13 b mounted to the casing 11 ; the casing 11 is preferably formed by one continuous, rectangular sheet of material which is bent to form a floor panel 80 , a front panel 82 , a back panel 84 , the upper shoulder panels 16 a and 16 b , and two smoke deflection panels 86 a and 86 b , all of which are of equal width. Still referring to FIGS. 1–4 , the front panel 82 and back panel 84 of the casing 11 extend and angle inwardly respectively from the front edge and back edge of the upper shoulders 16 a and 16 b . The floor panel 80 is horizontal and extends between the lower ends of the front panel 82 and back panel 84 . The upper shoulder panels 16 a and 16 b are horizontal and extend inwardly from the upper ends of the front panel 82 and back panel 84 respectively. In the exemplary embodiment, the length of the front panel 82 and back panel 84 is approximately 28 inches and each forms an inward angle in a range of approximately 10°–15° with a vertical plane. However, it is anticipated that the length of the front panel 82 and back panel 84 and the inward angles formed by the front panel and the back panel 84 , with a vertical plane, can vary as long as the enclosure formed by the casing 11 is of sufficient size to contain the firebox 18 , a desired quantity of fuel 19 , the smoke shield 20 , the drip pan 22 , the upper smoke deflection panels 86 a and 86 , and the smoke collection members 23 a , 23 b , 23 c , and 23 d in a manner consistent with this invention. Referring to FIGS. 3–5 , the upper smoke deflection panels 86 a and 86 b extend downwardly and at an inward angle from the inner ends of the upper shoulder panels 16 a and 16 b respectively and form upper smoke chambers 88 a and 88 b within the housing between the upper smoke deflection panels 86 a and 86 b and the front panel 82 and back panel 84 respectively. In the exemplary embodiment, the inward angle formed with a vertical plane by the smoke deflection panels 86 a and 85 b are equal to or slightly greater than the inward angles formed by the front panel 82 and back panel 84 with a vertical plane. However, it is anticipated that the inward angle formed by the smoke deflection panels 86 a and 86 b with a vertical plane can vary as long as the smoke deflection panels 86 a and 86 b cause smoke from the fuel to be collected in the upper smoke chambers 88 a and 88 b , and direct it into the smoke collection members 23 a , 23 b , 23 c and 23 d in a manner consistent with this invention. Referring to FIGS. 1–4 , each of the housing sidewalls 13 a and 13 b are preferably constructed of one continuous solid sheet of material, which, in the exemplary embodiment, is 16 gauge sheet metal. The width of the housing sidewalls 13 a and 13 b is equal to the distance between opposing outer edges of the upper shoulder panels 16 a and 16 b . Preferably, the housing sidewalls 13 a and 13 b are mounted to the casing 11 along its outer edges with welds. However, other means of attachment are acceptable and anticipated. The length of the sheets of material forming the housing sidewalls 13 a and 13 b are sufficient to allow the housing sidewalls 13 a and 13 b to extend downwardly beyond the floor panel 80 of the casing 11 and to be bent 90° inwardly and then 90° upwardly along two horizontal creases to form feet 100 a , 100 b , 100 c , and 100 d with exterior segments 101 a , 101 b , 10 c , and 101 d , interior segments 103 a , 103 b , 103 c , and 103 d , base segments 105 a , 105 b , 105 c , and 105 d , and interior support panels 102 a and 102 b. Upper rectangular openings 104 a and 104 b are punched out of the housing sidewalls 13 a and 13 b and are covered with side doors 106 a and 106 b and vent hatches 136 a and 136 b both of which are pivotally connected to the housing sidewalls 13 a and 13 b. Still referring to FIGS. 1–4 , lower rectangular openings 108 a and 108 b are punched out of the housing sidewalls 13 a and 13 b to form the separation between the feet 100 a , 100 b , 100 c , and 100 d . In the exemplary embodiment, the depth of each of the exterior segments 101 a , 101 b , 10 c , and 101 d , interior segments 103 a , 103 b , 103 c , and 103 d and base segments 105 a , 105 b , 105 c , and 105 d are approximately 6 inches respectfully. In addition, the width of each of the base segments 105 a , 105 b , 105 c , and 105 d are equal and are approximately 3 inches. However, it is anticipated that these equal widths and equal depths are of the exterior segments 101 a , 101 b , 10 c , and 101 d , interior segments 103 a , 103 b , 103 c , and 103 d , and base segments 105 a , 105 b , 105 c , and 105 d may vary as long as the size of the feet 100 a , 100 b , 100 c , and 100 d is sufficient to support the weight of the combination smoker and barbecue grill 10 . The interior support panels 102 a and 102 b extend vertically from the upper ends of the interior segments 103 a , 103 b , 103 c , and 103 d of the feet 100 a , 100 b , 100 c , and 100 d and connect to the bottom, outer surface of the floor panel 80 of the casing 11 . In the preferred embodiment, the interior support panels 102 a and 102 b connect to the outer surface to the casing with welds. However, it is anticipated that other methods of connection may be used. Still referring to FIGS. 1–4 , the interior support panels 102 a and 102 b have tapered edges 107 a , 107 b , 107 c , and 107 d . Although not shown in the drawings, it can be appreciated that the interior support panels 102 a and 102 b are symmetrical from front to back and the back ends of the interior support panels have identical but opposite tapered edges as those shown in the drawings. The tapered edges 107 a , 107 b , 107 c , and 107 d angle inwardly from the top end of the outer edges of the interior segments 103 a , 103 b , 103 c , and 103 d of the feet 100 a , 100 b , 100 c , and 100 d to the floor panel 80 at its nearest outer edge. Referring to FIGS. 3–6 , the plurality of smoke collection members 23 a , 23 b , 23 c , and 23 d attach to and bridge the lower ends of the smoke deflection panels 86 a and 86 b . As shown in FIGS. 4 , 5 , and 6 , each of the smoke collection members 23 a , 23 b , 23 c , and 23 d are identical in size and shape and have a sufficient length such that the opposite ends of each smoke collection members 23 a , 23 b , 23 c , and 23 d extend an equal length beyond the lower ends of the smoke deflection panels 86 a and 86 b into the upper smoke chambers 88 a and 88 b at opposite ends. As shown in FIGS. 4 and 5 , each the smoke collection members 23 a , 23 b , 23 c , and 23 d have an open-ended bottom with a solid upper surface designed to trap and collect smoke which drifts into it from the upper smoke chambers 88 a and 88 b . In the exemplary embodiment, the upper surface of the smoke collection members 23 a , 23 b , 23 c , and 23 d is triangular and formed with two-inch angle iron. However, it is anticipated that other shapes, such as square or semicircular, are acceptable. Referring again to FIGS. 4 , 5 , and 6 , the smoke collection members 23 a , 23 b , 23 c , and 23 d are attached to the smoke deflection panels 86 a and 86 b by positioning them into cuts made in the lower ends of each of the smoke deflection panels 86 a and 86 b . The cuts are evenly spaced across the width of the lower ends of each of the smoke deflection panels 86 a and 86 b and positioned such that the smoke collection members 23 a , 23 b , 23 c , and 23 d are parallel to each other when attached. The cuts are shaped to conform to the shape of the upper surface of the smoke collection members 23 a , 23 b , 23 c , and 23 d so that the bottom edges of the smoke collection members 23 a , 23 b , 23 c , and 23 d are even with the lower edges of the smoke deflection panels 86 a and 86 b . The preferred embodiment of this invention has four smoke collection members 23 a , 23 b , 23 c , and 23 d . However, it is anticipated that a fewer or greater number of smoke collection members may be used. Referring now to FIGS. 2–4 , the smoke shield 20 is positioned between the firebox 18 and the lower edges of the smoke deflection panels 86 a and 86 b . The 11 smoke shield 20 is desirably constructed of one continuous rectangular sheet of material which is bent along two horizontal creases to form a bottom panel 90 and two angled side panels 92 a and 92 b . The smoke shield 20 is centered between the front panel 82 and back panel 84 of the casing 11 and positioned so that the bottom panel 90 is horizontal, and the angled panels 92 a and 92 b extend upwardly and outwardly towards the front panel 82 and back panel 84 respectively. The width of the smoke shield 20 is equal to the width of the casing 11 and is attached to the interior surfaces of the housing sidewalls 13 a and 13 b preferably with welds. However, it is anticipated that other means of attachment may be used. Preferably, the depth of the smoke shield 20 after bending is approximately equal to the depth of the floor panel 80 of the casing 11 . In the exemplary embodiment, the height of the smoke shield 20 after bending is approximately 4 inches and the angled panels 92 a and 92 b form approximately a 30° angle with a vertical plane (See FIG. 4 ). However, it is anticipated that the depth and height of the smoke shield 20 , as well as the angle of the angled panels 92 a and 92 b may vary as long as the size and shape of the smoke shield 20 is sufficient to direct smoke 21 from the firebox 18 into the upper smoke chambers 88 a and 88 b in a manner consistent with this invention. Referring again to FIGS. 2–4 , the rectangular firebox 18 has rectangular sidewalls and is placed on the floor panel 80 of the casing 11 during normal operation of the combination smoker and barbecue grill. The firebox 18 is small enough to fit within the perimeter of the floor panel 80 and through the upper rectangular openings 104 a and 104 b when a rotatable vent hatch 136 a and 136 b is rotated to an open position (See FIGS. 1 and 3 ) but large enough to hold fuel 19 , such as charcoal or firewood, sufficient to create adequate cooking temperatures. Still referring to FIGS. 2–4 , the drip pan 22 is also rectangular with rectangular sidewalls and is placed on the upper surface of the bottom panel 90 of the smoke shield 20 during normal operation of the combination smoker and barbecue grill. The drip pan 22 is large enough to catch the drippings from cooked items on the grill 15 and small enough to fit within the perimeter of the bottom panel 90 of the smoke shield 20 and through the upper rectangular openings 104 a and 104 b when the side doors 106 a and 106 b are rotated to an open position. FIG. 1 shows how one side door 106 a and vent hatch 136 a are mounted to the housing sidewall 13 a . It can be appreciated that a second door 106 b and a second vent hatch 136 b are mounted to the opposite housing sidewall 13 b in an identical manner as depicted in FIG. 3 . Now referring to FIGS. 1 and 2 , the side door 106 a is pivotally mounted to the housing sidewall 13 a by small cylindrical extensions 120 a and 120 b which extend horizontally from the lower ends of the vertical edges of the side door 106 a and which rotate and slide within lower notches 122 a and 122 b between the housing sidewall 13 a and lower door brackets 123 a and 123 b . As shown in FIG. 1 , the side door 106 a is held in its closed position by four rectangular tongue pieces 124 a , 124 b , 124 c , and 124 d which are mounted to the outer face of the side door 106 a . Two tongue pieces 124 a and 124 b are mounted near the upper end of the side door 106 a and extend outwardly and horizontally from opposite vertical edges of the side door 106 a . Two tongue pieces 124 c and 124 d are mounted near the lower end of the side door 106 a and also extend outwardly and horizontally from opposite vertical edges of the side door 106 a . As shown in FIGS. 1 and 2 , two tongue pieces 124 a and 124 b are positioned to slide into upper notches 126 a and 126 b in upper door brackets 128 a and 128 b when the 106 a is in a closed position. Similarly, two tongue pieces 124 c and 124 d are positioned to slide into upper notches 126 c and 126 d in the lower door brackets 123 a and 123 b when the side door 106 a is in a closed position. Still referring to FIGS. 1 and 2 , the side door 106 a is equipped with a handle 130 towards its upper end. In order to open the door 106 a , the handle 130 is lifted vertically causing the door 106 a to slide vertically and allow the tongue pieces 124 a , 124 b , 124 c , and 124 d to clear the lips of the upper notches 126 a , 126 b , 126 c , and 126 d . Simultaneously, the cylindrical extensions 120 a and 120 b slide upward within the lower notches 122 a and 122 b . The side door 106 a can then rotate outwardly with the lower tongue pieces 124 c and 124 d engaging and sliding on upper curved edges 132 a and 132 b of the lower door brackets 123 a and 123 b . The vertical height of the lower notches 122 a and 122 b is sufficient to allow the cylindrical extensions 120 a and 120 b to slide vertically a sufficient height which, in turn, allows the tongue pieces 124 a , 124 b , 124 c , and 124 d to clear the lips of the upper notches with minimal clearance when the side door 106 a is lifted vertically from its closed position. Still referring to FIGS. 1 and 2 , the lower brackets have shoulders 134 a and 134 b at the lower end of the curved edges 132 a and 132 b . The shoulders 134 a and 134 b engage the lower tongue pieces 124 c and 124 d as the side door 106 a rotates outwardly. The shoulders 134 a and 134 b are positioned to prevent the side door 106 a from rotating greater than 90°. When the lower tongue pieces 124 c and 124 d engage the shoulders 134 a and 134 b , the door 106 a rests in a horizontal plane and can act as a shelf for placement of the firebox 18 and drip pan 22 during cleaning. Still referring to FIGS. 1 and 2 , the vent hatch 136 a is positioned below the side door 106 a such that the upper edges of the vent hatch 136 a is adjacent the lower edge of the side door 106 a . The vent hatch 136 a is rectangular and has a width equal to the width of the side door 106 a and height sufficient to cover the remainder of the upper rectangular opening 104 a which is not covered by the side door 106 a and to allow the removal of the firebox 18 when the vent hatch 136 a is rotated to its opened positioned. An elongated rectangular plate 138 is attached to the outer surface of the vent hatch 136 a near its upper end. The width of the plate 138 is equal to the width of the vent hatch and the vertical height of the plate 138 is sufficient to allow the upper edge of the plate 138 to extend vertically from the upper edge of the vent hatch 136 a and overlay the bottom edge of the side door 106 a when the side door 106 a and the vent hatch 136 a are in their closed position. In the preferred embodiment, the plate 138 is attached to the vent hatch with welds. However, other methods of attachment are anticipated. The vent hatch 136 a is pivotally mounted to the lower door brackets 123 a and 123 b by an elongated cylindrical rod 140 mounted to the vent hatch 136 a along its bottom edge preferably with welds. Opposing ends of the rod 140 extend beyond the vertical edges of the vent hatch 136 a into holes in the lower brackets 123 a and 123 b . The opposing ends of the rod 140 fit and rotate in the holes with minimal clearance. A handle 144 is attached to and centered on the plate 138 and is used for opening and closing the vent hatch 136 a . A spring loaded pressure pin 146 is mounted to the vent hatch 136 a adjacent one vertical edge of the vent hatch 136 a near its upper end. The spring loaded pressure pin 146 is positioned so that a pinhead (not shown), presses against the inner surface of the lower bracket 123 a creating a frictional force which allows the vent hatch 136 a to remain in place in any rotated position. In this manner, the vent hatch can act as a vent by rotating the vent hatch into varying positions. The lower bracket 123 a has first and second holes 148 a and 148 b . The first hole 148 a is positioned to accept the pinhead (not shown) when the vent hatch 136 a is in its vertical, closed position. The second hole 148 b is positioned to accept the pinhead (not shown) when the vent hatch 136 a is rotated 90° to a horizontal open position. In this manner, the vent hatch 136 a will remain locked in a closed position or horizontally open position unless the pinhead (not shown) is manually released. In the exemplary embodiment, the side doors 106 a and 106 b , vent hatches 136 a and 136 b , and plates 138 are constructed of ¼ inch sheet metal. However, it is anticipated that other materials and suitable gauges of material can be used. FIG. 4 depicts how the combination smoker and barbecue grill works in normal operation. When it is desired to smoke food items placed on the grill 15 , the fuel 19 is first placed in the firebox 18 which is positioned on the floor panel 80 of the casing 11 . The fuel 19 is lit and when the temperature in the combination smoker and barbecue grill 10 reaches a desired level, food items are placed on the grill 15 and the hood 12 is closed. As shown in FIG. 4 , the smoke 21 and heat which rises from the burning fuel 19 is blocked by the smoke shield 20 and is caused to deflect and pass to the left and right of the smoke shield 20 and past the angled panels 92 a and 92 b of the smoke shield 20 . This directs the smoke 21 into the upper smoke chambers 88 a and 88 b where it collects and fills the upper smoke chambers 88 a and 88 b from top to bottom. As the collected smoke 21 reaches the bottom of the smoke chambers 88 a and 88 b , it drifts into the smoke collection members 23 a , 23 b , 23 c , and 23 d from their open-ended opposite ends and bottoms. The smoke 21 will then collect and fill each of the smoke collection members 23 a , 23 b , 23 c , and 23 d evenly from top to bottom along the length of the smoke collection members. Once the smoke 21 has filled each of the smoke collection members 23 a , 23 b , 23 c , and 23 d , it spills out the open-ended bottoms of the smoke collection members in a substantially even volume along the length of each of the smoke collection members. The smoke will also spill from the upper smoke chambers around the bottom edge of the smoke deflection panels 86 a and 86 b between the smoke collection members 23 a , 23 b , 23 c , and 23 d and between the housing sidewalls 13 a and 13 b and the outer most smoke collection members 23 a and 23 d . This creates a substantially even distribution of the smoke 21 drifting upwards from the smoke collection members 23 a , 23 b , 23 c , and 23 d to the food items on the grill 15 . In this manner, the food items are cooked and smoked evenly. As the smoke 21 drifts upward past the grill and food items, it will collect in the hood 12 . The vent cover 70 can be selectively rotated to either a partially or fully open to allow the collected smoke 21 to escape. The volume of smoke 21 which can escape from hood 12 can be regulated by the degree of rotation of the vent cover 70 . Still referring to FIG. 4 , the drip pan 22 is placed on the top surface of the bottom panel 90 of the smoke shield 20 . Drippings from the food items will fall into the drip pan 22 where they will evaporate creating vapors which will rise back towards the food items on the grill 15 , further flavoring the food items. If desired, water can be placed in the drip pan 22 during the smoking process which will create steam which mixes with the smoke 21 and helps prevent the food items from drying out during the smoking process. If it is desired to barbecue the food items, the firebox 18 is placed on top of, and rests on, the outer surfaces of the smoke collection members 23 a , 23 b , 23 c , and 23 d . In this manner, the heat and smoke 21 created by the burning fuel 19 is much closer to and directly heats and cooks the food items on the grill 15 in a traditional barbecue style. Although the invention has been described with reference to specific embodiments, this description is not meant to be construed in a limited sense. Various modifications of the disclosed embodiments, as well as alternative embodiments of the inventions will become apparent to persons skilled in the art upon the reference to the description of the invention. It is, therefore, contemplated that the appended claims will cover such modifications that fall within the scope of the invention.

A new and improved combination smoker and barbecue pit having a housing with an open top, a grill resting on said housing, and a hood. A firebox is placed within said housing and is used for holding fuel which, when burned, creates heat and smoke. During the smoking process, the firebox is positioned below a shield which deflects and directs smoke into a pair of chambers within the housing which in turn channel smoke into elongated collection members evenly spaced below the grill. When smoke fills the collection members, is spills out the open-ended bottom of the collection members and drifts toward the grill in an even distribution. The firebox can also rest on the collection members where it is directly beneath the grill for barbecuing.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] To the full extent permitted by law, the present United States Non-provisional patent application, is a Continuation, and hereby claims priority to and the full benefit of United States Non-provisional application entitled “Harness for Animals and Methods of Use,” having assigned Ser. No. 14/455,046, filed on Aug. 8, 2014, incorporated herein by reference in its entirety. TECHNICAL FIELD [0002] The disclosure relates generally to a harness for attaching a leash to an animal and more specifically it relates to a body worn harness that encircles the animal's body and is non-choking. BACKGROUND [0003] Various animal harnesses or breast collars are known in the prior art, such restraints include attaching a leash to a neck collar, choke chain, or slip type collar that encircles the animal's neck. Another approach is to attach a leash to a harness that encircles the animal's neck and body behind the front legs. Such restraint devices are assembled by joining together portions of leather or nylon straps fastened together by sewing, rivets, hook and loop, clasps, rings or clips. Moreover, these animal harnesses are built with different dimensions to accommodate animals of different size, and generally comprise systems for enclosing the animal within the harness and adjusting the length of the straps for properly fitting the harness to a given animal. Harnesses that encircle the animal's neck and body are cumbersome due to an array of complicated straps and buckles that have to be attached in various places including underneath the animal. Such assemblies take too much time to install on a domestic animal each time you want to take the animal outside. Due to the time allotments for harnesses that encircle the animal's neck and body most domestic animals have a neck collar. However, neck collars have their own short comings, such as when tugged to restrain the animal this may cause injury to the animal' wind pipe by putting pressure on the animal's neck and airway making it difficult to breathe. Additionally, the leash ring on neck collars is often positioned downward under the animal's neck making it difficult to locate and attach the leash. [0004] Therefore, it is readily apparent that there is a recognized unmet need for a harness for animals and methods of use, wherein such apparatus may be quickly placed on the animal with one hand and safely enables restraint of the animal without causing the animal to choke or wheeze. BRIEF SUMMARY [0005] Briefly described, in an example embodiment, the present apparatus and method overcomes the above-mentioned disadvantage, and meets the recognized need for a harness for animals and methods of use comprising, in general, a two part pivotable frame having a set of fingers or arms extended therefrom to encircle or saddle an animal body, a spring hinge to force the fingers together, tabs or opening handles to separate the fingers, one or more harness straps, and a leash clip positioned thereon the frame and, thus such apparatus enables a single person to quickly and/or efficiently place the harness assembly on the animal using one hand and such apparatus enables safe restraint of the animal without causing the animal to choke or wheeze. [0006] According to its major aspects and broadly stated, the harness for animals and methods of use comprising, in general, a two part frame having a set of fingers or arms to encircle or saddle an animal body, a spring hinge to force the fingers together, tabs or opening handles to separate the fingers, a breast collar strap having a first side connected to a first finger and the other side connected to a second finger, and ridge strap connected to the frame, the straps further converge to a leash clip positioned behind the frame. [0007] In a preferred embodiment, a harness for animals and methods of use, the apparatus a harness to releasably restrain an animal, including a pivotable frame, the pivotable frame having a first frame member and a second frame member hingedly attached to one another, the first frame member configured having at least one first finger and a first opening handle and the second frame member frame configured having at least one second finger and a second opening handle, a spring connected to each of the first frame member and the second frame member, the spring biases the at least one first finger and the at least one second finger together, and at least one harness strap affixed to the pivotable frame. [0008] In still a further exemplary embodiment of the method of restraining an animal, the method comprising the steps of providing a harness having a pivotable frame, the pivotable frame having a first frame member and a second frame member hingedly attached to one another, the first frame member configured having at least one first finger and a first opening handle and the second frame member frame configured having at least one second finger and a second opening handle, a spring connected to each of the first frame member and the second frame member, the spring biases the at least one first finger and the at least one second finger together, at least one harness strap affixed to the pivotable frame; and a leash ring attached to the at least one harness strap, attaching a leash thereto the leash ring, gripping the first opening handle and the second opening handle, opening the at least one first finger and the at least one second finger, positioning the animal between the at least one first finger and the at least one second finger, releasing grip on the first opening handle and the second opening handle, closing the at least one first finger and the at least one second finger, and restraining the animal therein the harness. [0009] Accordingly, a feature of the harness for animals and methods of use is its ability to enable a single person to quickly and/or efficiently place the harness assembly on the animal using one hand. [0010] Another feature of the harness for animals and methods of use is its ability to safely tug on the leash and restrain the animal without causing injury to the animal's wind pipe by putting pressure on the animal's neck and airway making it difficult to breathe or cause the animal to choke or wheeze. [0011] Still another feature of the harness for animals and methods of use is its ability to alleviate the hunt and search for leash ring to connect the leash especially since the ring on neck collars is often positioned downward under the animal's neck making it difficult to locate and attach the leash. [0012] Yet another feature of the harness for animals and methods of use is its ability to provide a compact, one hand operable, and portable harness and leash assembly ready for quick and/or efficient placement over the animals head and/or body. [0013] Yet another feature of the harness for animals and methods of use is its ability to be quickly and/or efficiently placed on a moving animal. [0014] Yet another feature of the harness for animals and methods of use is its ability to be adjustable in size to accommodate different sized animals and expand to accommodate animal growth. [0015] Yet another feature of the harness for animals and methods of use is its ability to have adjustable finger lengths to accommodate different sized animals and expand to accommodate animal growth. [0016] Yet another feature of the harness for animals and methods of use is its ability to have an adjustable breast collar strap to accommodate different sized animals and expand to accommodate animal growth. [0017] Yet another feature of the harness for animals and methods of use is its ability to have a breast collar strap that slides within the set of fingers to quickly and/or efficiently place the harness assembly on the animal using one hand. [0018] Yet another feature of the harness for animals and methods of use is its ability to have the fingers biased in a normally closed position. [0019] Yet another feature of the harness for animals and methods of use is its ability to have the fingers biased in a normally open position. [0020] Yet another feature of the harness for animals and methods of use is its ability to be utilized with existing leashes. [0021] Yet another feature of the harness for animals and methods of use is its ability to be easier, and simpler to use than existing technology. [0022] Yet another feature of the harness for animals and methods of use is its ability to provide a design that does not place any pressure on the animal's neck. [0023] Yet another feature of the harness for animals and methods of use is its ability to provide a design that encompasses the animal's back, rib cage, and chest as one unit. [0024] Yet another feature of the harness for animals and methods of use is its ability to provide a compact, collapsible, and portable harness assembly that is easily stored and transported. [0025] Yet another feature of the harness for animals and methods of use is its ability to automatically expand to accommodate animal growth. [0026] Yet another feature of the harness for animals and methods of use is its ability to provide a light weight apparatus that is operable with one hand installation. [0027] These and other features of the harness for animals and methods of use will become more apparent to one skilled in the art from the following Detailed Description of the Embodiments and Claims when read in light of the accompanying drawing Figures. BRIEF DESCRIPTION OF THE DRAWINGS [0028] The present harness for animals and methods of use will be better understood by reading the Detailed Description of the embodiments with reference to the accompanying drawing figures, in which like reference numerals denote similar structure and refer to like elements throughout, and in which: [0029] FIG. 1 is a top perspective view of an example embodiment of an animal harness assembly; [0030] FIG. 2 is an exploded top perspective view of the animal harness assembly of FIG. 1 ; [0031] FIG. 3 is a front perspective view of the animal harness assembly of FIG. 1 ; [0032] FIG. 4 is a side perspective view of the animal harness assembly of FIG. 1 ; [0033] FIG. 5 is a side perspective of the animal harness assembly of FIG. 1 positioned above the animal showing placement before installation; [0034] FIG. 6 is a side perspective view of the animal harness assembly of FIG. 1 , shown positioned on the animal; [0035] FIG. 7 is a top front facing perspective view of an alternate embodiment of the animal harness assembly of FIG. 1 , shown with a free sliding self-adjusting harness strap(s); [0036] FIG. 8A is a top front facing close-up perspective view of an alternate embodiment of the animal harness assembly of FIG. 1 , shown with a locking mechanism in a closed position; [0037] FIG. 8B is a top front facing close-up perspective view of an alternate embodiment of the animal harness assembly of FIG. 1 , shown with a locking mechanism in an open position; [0038] FIG. 9 is a top front facing perspective view of an alternate embodiment of the animal harness assembly of FIG. 1 , shown with overlapping size adjustable fingers; [0039] FIG. 9A is an exploded side front facing perspective view of an alternate embodiment of the animal harness assembly of FIG. 1 , shown with overlapping size adjustable fingers; [0040] FIG. 9B is a exploded top front facing perspective view of an alternate embodiment of the animal harness assembly of FIG. 1 , shown with side-by-side size adjustable fingers; [0041] FIG. 10 is a side perspective view of an exemplary embodiment of the harness assembly of FIG. 1 , shown with opening handles being pinched by a hand; [0042] FIG. 11 is a side perspective of the animal harness assembly of FIG. 10 positioned above the animal showing placement before installation; [0043] FIG. 12 is a side perspective view of the animal harness assembly of FIG. 10 , shown positioned on the animal; and [0044] FIG. 13 is a flow diagram of a method of restraining an animal utilizing animal harness assembly of FIGS. 1-12 . [0045] It is to be noted that the drawings presented are intended solely for the purpose of illustration and that they are, therefore, neither desired nor intended to limit the disclosure to any or all of the exact details of construction shown, except insofar as they may be deemed essential to the claimed invention. DETAILED DESCRIPTION [0046] In describing the exemplary embodiments of the present disclosure, as illustrated in FIGS. 1-13 specific terminology is employed for the sake of clarity. The present disclosure, however, is not intended to be limited to the specific terminology so selected, and it is to be understood that each specific element includes all technical equivalents that operate in a similar manner to accomplish similar functions. Embodiments of the claims may, however, be embodied in many different forms and should not be construed to be limited to the embodiments set forth herein. The examples set forth herein are non-limiting examples, and are merely examples among other possible examples. [0047] Referring now to FIGS. 1-4 , by way of example, and not limitation, there is illustrated exemplary embodiment of animal harness assembly, such as harness assembly 10 . Preferably, harness assembly 10 includes pivotable frame 20 , harness strap(s) 30 , and leash ring 40 . Preferably pivotable frame 20 includes a set or two part frame, jaw, or clam shell configuration, such as first frame member 21 and second frame member 22 , each frame member having at least one elongated arms or half saddle members extended therefrom to encircle an animal's body or torso therein, such as one or more sets of fingers, including first finger 21 and second finger 22 , and a hinge, rotatable coupler or spring hinge, such as hinge coupler 25 . Hinge coupler 25 preferably may be utilized to removeably affix hingedly affix first frame member 21 thereto second frame member 22 . First finger 21 and second finger 22 may be configured in an arcing or curved configuration whereby when rotated thereabout hinge coupler 25 this facilitates rotational opening of first finger 21 and second finger 22 of pivotable frame 20 to then encompass an animal's body or torso and rotational closure of first finger 21 and second finger 22 of pivotable frame 20 to grip or enclose an animal's body or torso. [0048] It is recognized herein that one or more sets of fingers 21 - 24 may further incorporate a padded section or padded sets of fingers. It is further recognized herein that one or more sets of fingers 21 - 24 may be removable or detachable or interchangeable to enable replacement of one or more sets of fingers 21 - 24 to accommodate animal growth. [0049] Pivotable frame 20 is preferably formed of a suitable material or fabric, such as plastic, rubber, vinyl, polyurethane, fiber, reinforced or coated canvas, wire, coated wire, coated fiber or mesh, nylon, metal, shape memory metal, steel, sprung steel, padded or unpadded or the like, capable of providing structure and comfort to pivotable frame 20 . Preferably, the material includes other suitable characteristics, such as rigidity, semi-flexibility, durability, strength, water resistant, puncture resistant, tear resistant, light weight, chemical inertness, oxidation resistance, ease of workability, or other beneficial characteristic understood by one skilled in the art. [0050] It is contemplated herein that pivotable frame 20 may include sprung steel or other like material and be configured as normally closed first finger 21 and second finger 22 or biasing first finger 21 and second finger 22 together. [0051] Referring again to FIG. 2 , by way of example, and not limitation, there is illustrated an exploded view of harness assembly 10 . Preferably hinge coupler 25 may include first hinge coupler 25 A disposed on a first end 21 . 1 of first frame member or first finger 21 and second hinge coupler 25 B disposed on a first end 22 . 1 of second frame member or second finger 22 . It is recognized herein that first frame member 21 and second frame member 22 may be are hingedly attached to one another. Furthermore, first hinge coupler 25 A is preferably offset from second hinge coupler 25 B to form gap 28 and first hinge coupler 25 A may be further positioned proximate second hinge coupler 25 B preferably in an end to end or an in-line configuration to enable an attachment device, such as pin 26 to be slidably inserted therein first hinge coupler 25 A and second hinge coupler 25 B to form rotationally couple of first end 21 . 1 of first finger 21 and first end 22 . 1 of second hinge coupler 25 B there together. It is recognized herein that first hinge coupler 25 A, second hinge coupler 25 B, and pin 26 are preferably configured to facilitate rotational opening of first finger 21 and second finger 22 of pivotable frame 20 to encompass an animal's body or torso and rotational closure of first finger 21 and second finger 22 of pivotable frame 20 to grip or enclose an animal's body or torso. It is further recognized herein that hinge coupler 25 may otherwise be configured by one of ordinary skill in the art and may be configured, for example, to snap first hinge coupler 25 A and second hinge coupler 25 B together. Moreover, first end 21 . 1 of first finger 21 may include one or more hand or finger grips or tabs, such as one or more opening handles 29 , including first finger tab or first opening handle 29 A disposed on first end 21 . 1 of first frame member 21 or first finger 21 and second finger tab or second opening handle 29 B disposed on first end 22 . 1 of second frame member 21 or second finger 22 . It is recognized herein that opening handles 29 may be hand gripped or finger pinched to facilitate rotational opening of first finger 21 and second finger 22 of pivotable frame 20 to encompass an animal's body or torso and rotational closure of first finger 21 and second finger 22 of pivotable frame 20 to grip or enclose an animal's body or torso. Still furthermore, a biasing element or torsion spring, such as spring 27 may be positioned in gap 28 when pin 26 is preferably slidably inserted therein first hinge coupler 25 A, spring 27 wrapped therearound pin 26 , and second hinge coupler 25 B to provide rotational biasing thereto pivotable frame 20 either maintaining pivotable frame 20 in a normally closed or normally open position. It is preferably recognized herein that spring 27 preferably maintains pivotable frame 20 in a normally closed position, wherein spring 27 biases first frame member or first finger 21 and second frame member or second finger 22 toward each other. It is further recognized herein that spring 27 may otherwise be configured by one of ordinary skill in the art and may be configured, for example, as a bent piece of sprung metal and positioned therein gap 28 between first hinge coupler 25 A and second hinge coupler 25 B to provide rotational biasing thereto pivotable frame 20 . [0052] It is contemplated herein that biasing element, such spring 27 may include curved or arcing configuration of sprung steel or other like material positioned on outer surface of first finger 21 and second finger 22 of pivotable frame 20 and configured as normally closed. [0053] It is further contemplated herein that biasing element, such spring 27 may include a variable tension spring capable of adjustment of spring force or rotational force Rf to enable varying grip force or grip strength of one or more fingers, such as first finger 21 and second finger 22 during close C. [0054] It is further contemplated herein that one or more opening handles 29 may include hand grips 29 or finger tabs 29 . [0055] Preferably, harness assembly 10 includes one or more flexible supports, such as harness strap(s) 30 . Harness strap(s) 30 may include at least one or one or more breast straps 31 / 32 , such as first breast strap 31 and second breast strap 32 . Furthermore, first breast strap 31 may include first breast strap end 31 . 1 and second breast strap end 31 . 2 wherein second breast strap end 31 . 2 may be affixed or removably affixed thereto first finger 21 of pivotable frame 20 . Still furthermore, second breast strap 32 may include first end 32 . 1 and second end 32 . 2 wherein second end 32 . 2 may be affixed or removably affixed thereto second finger 22 of pivotable frame 20 . It is contemplated herein that first breast strap end 31 . 1 of first breast strap 31 may be removably affixed or removably affixed to first end 32 . 1 of second breast strap 32 , via hook 36 . 1 and loop 36 . 2 as shown in FIGS. 1, 3 & 4 , or any other expansion device 36 , such as sewn, snap, button, clasp, buckle, magnetic device or the like. [0056] It is recognized herein that one or more breast straps 31 / 32 , such as first breast strap 31 and second breast strap 32 may be a single breast strap 31 / 32 having first end 31 / 32 . 1 and second end 31 / 32 . 2 wherein first end 31 / 32 . 1 may be affixed or removably affixed thereto first finger 21 of pivotable frame 20 and second end 31 / 32 . 2 may be affixed or removably affixed thereto second finger 22 of pivotable frame 20 . [0057] Furthermore, harness strap(s) 30 may include at least one or one or more torso straps 33 / 34 , such as first torso strap 33 and second torso strap 34 . Furthermore, first torso strap 33 may include first torso strap end 33 . 1 and second torso strap end 33 . 2 wherein second torso strap end 33 . 2 may be affixed or removably affixed thereto first finger 21 of pivotable frame 20 . Still furthermore, second torso strap 32 may include first torso strap end 34 . 1 and second torso strap end 34 . 2 wherein second torso strap end 34 . 2 may be affixed or removably affixed thereto second finger 22 of pivotable frame 20 . It is recognized herein that second torso strap end 33 . 2 of first torso strap 33 and second torso strap end 34 . 2 of second torso strap 34 may be affixed one to the other, or affixed to leash ring 41 . [0058] It is recognized herein that one or more harness strap(s) may be configured to enable linear length adjustment device, such as a buckle 36 or the like to accommodate size differences and/or volume of to accommodate different sized head H, back Bk, torso T of dog D utilizing. [0059] Harness strap(s) 30 are preferably formed of a suitable material or fabric, such as canvas, plastic, rubber, vinyl, polyurethane, fiber, wire, coated wire, coated fiber or mesh, nylon, Tyvek, elastic, spandex, stretch material or the like, capable of providing structure to harness strap(s) 30 . Preferably, the material includes other suitable characteristics, such as flexibility, durability, strength, water resistant, puncture resistant, tear resistant, light weight, heat-resistance, chemical inertness, oxidation resistance, ease of workability, or other beneficial characteristic understood by one skilled in the art. [0060] It is further contemplated herein that sling 11 may be configured and/or sized to accommodate various sized patients P to be secured therein. [0061] It is contemplated herein that one or more leash ring(s) 40 , such as leash ring 41 may be affixed or removably affixed thereto harness strap(s) 30 and/or leash ring 42 may be affixed or removably affixed thereto pivotable frame 20 . [0062] Furthermore, harness strap(s) 30 may include at least one or one or more ridge strap(s) 35 . Furthermore, ridge straps 35 may include first ridge strap end 35 . 1 and second ridge strap end 35 . 2 wherein second ridge strap end 35 . 2 may be affixed or removably affixed thereto leash ring 41 of pivotable frame 20 . Still furthermore, first ridge strap end 35 . 1 may be affixed or removably affixed thereto leash ring 41 . [0063] It is contemplated herein that first torso strap end 33 . 1 of first torso strap 33 and first torso strap end 34 . 1 of second torso strap 34 may be affixed or removably affixed to first ridge strap end 35 . 1 of ridge straps 35 , as shown in FIGS. 1, 3 & 4 , or any other attachment device, such as leash ring 40 , snap, button, clasp, buckle, magnetic device, or the like. [0064] It is recognized herein that one or more torso straps 33 / 34 , such as first torso strap 33 and second torso strap 34 may be a single torso strap 33 / 34 having first end 33 / 34 . 1 and second end 33 / 34 . 2 wherein first end 33 / 34 . 1 may be affixed or removably affixed thereto first finger 21 of pivotable frame 20 and second end 33 / 34 . 2 may be affixed or removably affixed thereto second finger 22 of pivotable frame 20 . [0065] It is still further recognized herein that one or more breast straps 31 / 32 and one or more torso straps 33 / 34 may be a single harness strap(s) 30 affixed or removeably affixed thereto first finger 21 and second finger 22 , respectively, of pivotable frame 20 . [0066] Referring again to FIG. 3 , by way of example, and not limitation, there is illustrated a front perspective view of harness assembly 10 . Preferably first opening handle 29 A and second opening handle 29 B may be configured at approximately ninety-degrees or other angle proximate ninety-degrees to first end 21 . 1 of first finger 21 and first end 22 . 1 of second finger 22 , respectively. It is recognized that spring ends of spring 27 , such as first spring end 27 . 1 and second spring end 27 . 2 may be positioned against back side 29 A. 1 of first opening handle 29 A and back side 29 B. 1 of second opening handle 29 B, respectively. Preferably spring 27 applies rotational force Rf to separate first opening handle 29 A and second opening handle 29 B and, thus rotational force Rf applied against hinge coupler 25 additionally forces or brings second end 21 . 2 of first finger 21 and second end 22 . 2 of second finger 22 together and/or in contact with one another. It is recognized herein that counter force against rotational force Rf applied against hinge coupler 25 additionally forces or separates second end 21 . 2 of first finger 21 from second end 22 . 2 of second finger 22 of pivotable frame 20 in the direction of open O to enable an animal to be positioned in gap or opening, such as torso opening 50 A and rotational force Rf of spring 27 applied against hinge coupler 25 additionally forces or brings second end 21 . 2 of first finger 21 from second end 22 . 2 of second finger 22 of pivotable frame 20 in the direction of closed to grip an animal positioned in torso opening 50 A. Moreover, first breast strap 31 and second breast strap 32 may be removeably affixed via hook 36 . 1 and loop 36 . 2 , to itself. [0067] It is recognized herein that expansion device 36 may accommodate size differences and/or volume of to accommodate different sized head H, back Bk, torso T of dog D. [0068] Referring again to FIG. 4 , by way of example, and not limitation, there is illustrated a side perspective view of harness assembly 10 . Preferably, first finger 21 and second finger 22 of pivotable frame 20 , and first breast strap 31 and second breast strap 32 are configured to create a gap or opening, such as head opening 50 B where a user of harness assembly 10 may pass through an animal's head, such as dog D. [0069] Referring again to FIG. 5 , by way of example, and not limitation, there is illustrated a side perspective view of harness assembly 10 affixed to leash Le. Preferably, in use, harness assembly 10 may be positioned above the animal, such as dog D. Next, opening handles 29 may be pinched or forced together to provide counter force against rotational force Rf applied against hinge coupler 25 , which additionally forces or separates normally closed first finger 21 from second finger 22 of pivotable frame 20 in the direction of open O, shown in FIG. 4 , to enable an animal torso to be positioned therein torso opening 50 A. In addition, first finger 21 and second finger 22 of pivotable frame 20 , and first breast strap 31 and second breast strap 32 are configured to create a gap or opening, such as head opening 50 B where a user of harness assembly 10 may pass through an animal's head, such as dog D. Next, harness assembly 10 may be lowered Lo over animal's head H and torso T, such as dog D. [0070] It is preferably recognized herein that spring 27 may maintain pivotable frame 20 in a normally open position—via reversed action of spring 27 wherein to close C harness assembly 10 a user may squeeze opening handles 29 together to close first finger 21 and second finger 22 , as shown in FIG. 3 . [0071] Referring to FIG. 6 , by way of example, and not limitation, there is illustrated a side perspective view of harness assembly 10 affixed to leash Le, shown positioned on dog D. In use, the head H of dog D is slipped through or positioned therethrough head opening 50 B between first finger and second finger 22 of pivotable frame 20 , and first breast strap 31 and second breast strap 32 . Next, harness assembly 10 is preferably positioned over or lowered Lo over the back Bk or torso T of dog D. Next, opening handles 29 may be released and rotational force Rf from spring 27 may be applied against hinge coupler 25 , which rotational force Rf brings together first finger 21 to second finger 22 of pivotable frame 20 in the direction of closed C to enable an animal to be securely held in torso opening 50 A and first finger 21 to second finger 22 of pivotable frame 20 is preferably closed, gripped or encircled around torso T of dog D securing dog D therein harness assembly 10 . [0072] Referring again to FIG. 6 , by way of example, and not limitation, there is illustrated a side perspective view of harness assembly 10 , shown with dog D secured therein harness assembly 10 with torso T of dog D enclosed, gripped or encircled by first finger 21 and second finger 22 of pivotable frame 20 and one or more breast straps 31 / 32 , such as first breast strap 31 and second breast strap 32 secured against the chest or breast B of dog D to enable dog D to be securely held therein harness assembly 10 . [0073] It is contemplated herein that harness assembly 10 may be stored with leash Le attached ready for quick one hand installation. [0074] It is further contemplated herein that harness assembly 10 may vary in configuration, size and adjustment to accommodate different sized head H, back Bk, torso T of dog D. [0075] Referring again to FIG. 7 , by way of example, and not limitation, there is illustrated a top front facing perspective view of another example embodiment harness assembly 10 A, shown with a free sliding self-adjusting harness strap(s) 30 . Preferably first finger 21 and second finger 22 of pivotable frame 20 may each include one or more passageways, such as conduit(s) 60 , which may include first conduit 61 formed therein or therethrough or positioned therein or disposed thereon first finger 21 of pivotable frame 20 and second conduit 62 formed therein or therethrough or positioned therein or disposed thereon second finger 22 of pivotable frame 20 . Preferably one or more breast straps 31 / 32 and one or more torso straps 33 / 34 or single harness strap(s) 30 , being a combination strap of harness straps 30 (one or more breast straps 31 / 32 and one or more torso straps 33 / 34 ), may be positioned therethrough conduit(s) 60 , such as first conduit 61 and second conduit 62 to form a loop around pivotable frame 20 and further configured to enable length longitudinal adjustment L directional movement or adjustment of harness strap(s) 30 relative to or proximately transverse to first finger 21 and second finger 22 of pivotable frame 20 . In use, harness assembly 10 A may be adjusted by sliding or pushing one or more breast straps 31 / 32 in a forward direction (longitudinal adjustment L) of pivotable frame 20 via conduit 60 , thus increasing or to make larger the size of head opening 50 B (the space between first finger 21 and second finger 22 of pivotable frame 20 , and breast straps 31 / 32 ) to enable a larger or enlarged head opening 50 B to simplify lasso or capture of the head H of dog D, as shown in FIGS. 5 and 6 . Moreover, after installation of harness assembly 10 A, first finger 21 and second finger 22 of pivotable frame 20 , thereon dog D a tug of leash ring 40 pulls harness strap(s) 30 in a rearward direction (longitudinal adjustment L) of pivotable frame 20 via conduit 60 , thus decreasing, to make smaller, or shrinking the size of head opening 50 B (the space between first finger 21 and second finger 22 of pivotable frame 20 , and breast straps 31 / 32 ) to secure breast straps 31 / 32 against breast B of dog D to restrain dog D therein harness assembly 10 A. [0076] It is recognized herein that conduit(s) 60 may be formed cross-wise, longitudinal L, within the width W of first finger 21 and/or second finger 22 or conduit(s) 60 may be formed within nodule or housing formed as part of finger 21 and/or second finger 22 . [0077] It is contemplated herein that pivotable frame 20 may include one or more passageways, such as conduit(s) 60 , which may include first conduit 61 positioned therein or disposed thereon pivotable frame 20 or may include first conduit 61 and second conduit 62 positioned therein or disposed thereon first finger 21 of pivotable frame 20 and one or more breast straps 31 / 32 may be moved in a direction (longitudinal adjustment L). [0078] It is further contemplated herein that pivotable frame 20 may include one or more passageways, such as conduit(s) 60 , which may include first conduit 61 positioned therein or disposed thereon pivotable frame 20 and one or more breast straps 31 / 32 may be moved in a direction (longitudinal adjustment L). [0079] It is still further contemplated herein that breast strap 31 / 32 may be configured as single breast strap disposed between first finger 21 and second finger 22 of pivotable frame 20 , may be configured as a loop or lasso disposed therefrom first finger 21 or second finger 22 of pivotable frame 20 . [0080] Referring again to FIGS. 8A and 8B , by way of example, and not limitation, there is illustrated a top front facing perspective view of another example embodiment harness assembly 10 B, with a lock, lock device, such as locking mechanism 70 . Preferably locking mechanism 70 may be positioned between back side 29 A. 1 of first opening handle 29 A and back side 29 B. 1 of second opening handle 29 B, respectively. In this example embodiment locking mechanism 70 may include pivot arm or bar device, such as D-ring 72 having first end 72 . 1 and second end 72 . 2 . Preferably first end 72 . 1 may be pivotally or hinge 73 mounted thereto back side 29 A. 1 of first opening handle 29 A and pivot or hinge between an unlocked and locked position of pivotable frame 20 . Moreover, back side 29 B. 1 of second opening handle 29 B or second end 72 . 2 may include a bump, or receptacle, such as latch 74 to releasably receive and latch second end 72 . 2 of D-ring 72 . In use, as shown in FIG. 6 , once dog D is preferably secured therein harness assembly 10 with torso T of dog D enclosed, gripped or encircled by first finger 21 and second finger 22 of pivotable frame 20 , locking mechanism 70 may be engaged by pivoting second end 72 . 2 of D-ring 72 about hinge 73 until second end 72 . 2 of D-ring 72 engages latch 74 , and latches locking mechanism 70 in a locked and closed position so first finger 21 and second finger 22 of pivotable frame 20 remain securely closed around torso T of dog D. [0081] Referring again to FIG. 9, 9A, 9B by way of example, and not limitation, there is illustrated a top or side front facing perspective view of another example embodiment harness assembly 10 C, with first finger 21 and second finger 22 overlapped or overlap one another to accommodate different sized animals and to automatically expand to accommodate animal growth. It is contemplated herein that first finger 21 and second finger 22 of pivotable frame 20 may be overlapping, interlocking, latchable via hook and loop, snap, button, clasp, buckle, magnetic device, or the like. It is recognized herein that expansion device 36 may accommodate size differences and/or volume of to accommodate different sized head H, back Bk, torso T of dog D, as shown in FIG. 9 . [0082] Referring again to FIG. 10 , by way of example, and not limitation, there is illustrated a side perspective view of another example embodiment harness assembly 10 D, shown with opening handles 29 being pinched by hand Ha. Preferably pivotable frame 20 includes two sets of elongated arms or saddle members to encircle an animal's body or torso therein, such as first set of fingers, including first finger 21 and second finger 22 , and second set of first finger 21 and second finger 22 , labeled as third finger 23 and fourth finger 24 hinged thereabout hinge coupler 25 . First finger 21 and second finger 22 , and third finger 23 and fourth finger 24 may be configured in an arcing or curved configuration whereby when rotated thereabout hinge coupler 25 this facilitates rotational opening of both first finger 21 and second finger 22 , and third finger 23 and fourth finger 24 of pivotable frame 20 to then encompass an animal's body or torso and rotational closure of first finger 21 and second finger 22 , and third finger 23 and fourth finger 24 of pivotable frame 20 to grip or enclose an animal's body or torso. [0083] It is contemplated that spring 27 rotational force Rf applied against hinge coupler 25 may additionally force or bring second end 21 . 2 of first finger 21 and second end 22 . 2 of second finger 22 together, and second end 23 . 2 of third finger 23 and second end 24 . 2 of fourth finger 24 together and/or in contact with one another, respectively. [0084] It is contemplated that spring 27 rotational force Rf applied against hinge coupler 25 may additionally force or bring second end 21 . 2 of first finger 21 and second end 22 . 2 of second finger 22 together, and second end 23 . 2 of third finger 23 and second end 24 . 2 of fourth finger 24 together and/or in contact with one another, respectively. [0085] It is still further contemplated that harness assembly 10 D may include overlapping first finger 21 and second finger 22 , as shown in FIG. 9 , and overlapping third finger 23 and fourth finger 24 to accommodate different sized animals and expand to accommodate animal growth. It is contemplated herein that first finger 21 and second finger 22 , and third finger 23 and fourth finger 24 of pivotable frame 20 may be overlapping, interlocking, latchable via hook and loop, snap, button, clasp, buckle, magnetic device, or other attachment device 36 or the like. [0086] Referring again to FIG. 11 , by way of example, and not limitation, there is illustrated a side perspective view of another example embodiment harness assembly 10 D affixed to leash Le. Preferably, in use, harness assembly 10 D may be positioned above the animal, such as dog D. Next, opening handles 29 may be pinched or forced together to provide counter force against rotational force Rf applied against hinge coupler 25 , which additionally forces or separates first finger 21 from second finger 22 , and third finger 23 from fourth finger 24 of pivotable frame 20 in the direction of open O, similar to that shown in FIG. 4 , to enable an animal to be positioned in torso opening 50 A and neck or head opening 50 B. [0087] Referring to FIG. 12 , by way of example, and not limitation, there is illustrated a side perspective view of another example embodiment harness assembly 10 D affixed to leash Le, shown positioned on dog D. Next, harness assembly 10 D is preferably lowered Lo over the neck H, back Bk, torso T of dog D. Next, opening handles 29 may be released and rotational force Rf from spring 27 may be applied against hinge coupler 25 , which rotational force Rf brings together first finger 21 to second finger 22 , and third finger 23 from fourth finger 24 of pivotable frame 20 in the direction of closed C to enable an animal, such as dog D to be securely held or restrained therein in torso opening 50 A and head opening 50 B. [0088] Referring again to FIG. 12 , by way of example, and not limitation, there is illustrated a side perspective view of harness assembly 10 D, shown with dog D secured therein harness assembly 10 D with neck or head H, back Bk, torso T of dog D enclosed, gripped or encircled by first finger 21 and second finger 22 , and third finger 23 from fourth finger 24 of pivotable frame 20 and preferably closed, gripped or encircled by first finger 21 to second finger 22 , and third finger 23 from fourth finger 24 of pivotable frame 20 to enable dog D to be securely held or restrained therein harness assembly 10 D. [0089] It is contemplated herein that harness assembly 10 may be stored with leash Le attached ready for quick one hand installation. [0090] It is further contemplated herein that harness assembly 10 may vary in configuration, size and adjustment to accommodate different sized head H, back Bk, torso T of dog D. [0091] It is still further contemplated that spring 27 rotational force Rf applied against hinge coupler 25 may additionally force or bring second end 21 . 2 of first finger 21 and second end 22 . 2 of second finger 22 in close proximity, and second end 23 . 2 of third finger 23 and second end 24 . 2 of fourth finger 24 in close proximity, respectively. [0092] Referring now to FIG. 13 , there is illustrated a flow diagram 1300 of a method of one handed animal harness installation utilizing harness assembly 10 as described herein in FIGS. 1-12 . In block or step 1305 , providing harness assembly 10 / 10 A/ 10 B/ 10 C/ 10 D, collectively 10 , as described herein in FIGS. 1-12 . In block or step 1310 , adjusting harness strap(s) 30 of harness assembly 10 to accommodate an animal, such as dog D. In block or step 1315 , attaching leash Le thereto leash ring 40 . In block or step 1320 , gripping or pinching or applying a force against one or more opening handles 29 . In block or step 1325 , opening one or more sets of fingers 21 , 22 , 23 , 24 , or spreading or applying counter force against rotational force Rf applied against hinge coupler 25 , with sufficient pressure to overcome spring 27 spring force to separate, one or more sets of fingers 21 , 22 , 23 , 24 open, as an open harness assembly 10 ready to receive an animal, such as dog D. In block or step 1330 , placing or positioning animal, such as dog D therein one or more sets of fingers 21 , 22 , 23 , 24 and/or harness strap(s) 30 of harness assembly 10 . In block or step 1335 , releasing grip thereof of one or more opening handles 29 . In block or step 1340 , closing one or more sets of fingers 21 , 22 , 23 , 24 or releasing rotational force Rf applied against hinge coupler 25 to bring one or more sets of fingers 21 , 22 , 23 , 24 closed, as a closed harness assembly 10 . In block or step 1345 , restraining an animal, such as dog D therein harness assembly 10 . In block or step 1350 , releasing an animal, such as dog D therefrom harness assembly 10 . [0093] The foregoing description and drawings comprise illustrative embodiments of the present invention. Having thus described exemplary embodiments, it should be noted by those ordinarily skilled in the art that the within disclosures are exemplary only, and that various other alternatives, adaptations, and modifications may be made within the scope of the present invention. Merely listing or numbering the steps of a method in a certain order does not constitute any limitation on the order of the steps of that method. Many modifications and other embodiments of the invention will come to mind to one ordinarily skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Although specific terms may be employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. Moreover, the present invention has been described in detail; it should be understood that various changes, substitutions and alterations can be made thereto without departing from the spirit and scope of the invention as defined by the appended claims. Accordingly, the present invention is not limited to the specific embodiments illustrated herein, but is limited only by the following claims.

A animal restraint harness having a two part pivotable frame having a set of fingers or arms extended therefrom to encircle or saddle an animal body, a spring hinge to force the fingers together, tabs or opening handles to separate the fingers, one or more harness straps, and a leash clip positioned thereon the frame and, thus such harness enables a single person to quickly and/or efficiently place the harness assembly on the animal using one hand and such harness enables safe restraint of the animal without causing the animal to choke or wheeze.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the general field of exercise apparatus used by individuals to maintain health and physical fitness. 2. Description of the Prior Art There are many types of exercise apparatus which are well known in the prior art. However, to the best of the inventor's knowledge, no individual piece of prior art exercise apparatus or combination of features from different prior art exercise apparatuses incorporate the novel features of the present invention. SUMMARY OF THE INVENTION The present invention is an exercise apparatus to exercise and strengthen the user's arms, shoulders and chest by performing pushups which combine raising and lowering the user's body through raising and lowering the user's arms while the user is in a face down horizontal position with the present invention exercise device used to simulate an up and down pumping action to cause the user to have his/her arms spread apart to make the pushups more difficult while providing a central chest support to facilitate the exercise. It has been discovered, according to the present invention, that if an exercise device incorporates a pair of parallel spaced apart rotatable arms with gripping members at their respective distal ends which are held by a respective hand of a user, and which exercise apparatus arms further support at their respective proximal ends a pair of support members which support a central seat or cushion, then the user can simulate a difficult pushup by resting his/her chest against the central seat and raising and lowering his/her body while grasping each grip with a respective hand. As the user pushes down on the grip of each arm, each arm rotates about a pivot point so that the distal end of each arm is rotated downwardly. Concurrently, the proximal end of each arm is caused to rotate upwardly, thereby causing the seat to push against the user's chest to further elevate the user's body. As a user pulls up on the grips, the distal end of each exercise apparatus arm rotates upwardly while the proximal end of each exercise apparatus arm rotates downwardly, causing the seat to be lowered to facilitate the user lowering his/her body but preventing the user's chest from hitting the floor. The device simulates a pump by which the user raises and lowers his/her body by raising and lowering the user's arms while the arms are spread apart to increase the difficulty of the exercise. It has been further discovered that if the exercise apparatus arms are each pivoted on a U-shaped bracket which is supported on a base, then the entire exercise device is structurally stable to facilitate a safe and easy to use exercise device. It is therefore an object of the present invention to provide an exercise device to facilitate performing pushups with the arms extending to each respective side of the user to increase the difficulty of the exercise. It is also an object of the present invention to provide an exercise device which fully supports a user's chest during the pushup exercise. It is additionally an object of the present invention to provide an exercise device which provides a stable base to enable the user to safely perform a difficult pushup exercise while supporting the user's hands through grip members on the exercise apparatus arms and supporting the user's chest through a support seat on the exercise apparatus. Further novel features and other objects of the present invention will become apparent from the following detailed description, discussion and the appended claims, taken in conjunction with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS Referring particularly to the drawings for the purpose of illustration only and not limitation, there is illustrated: FIG. 1 is a perspective view of the present invention exercise apparatus in the assembled condition; FIG. 2 is an exploded view of the present invention exercise apparatus showing all of the component parts of the present invention exercise apparatus; FIG. 3 is a perspective view of a user performing a downward motion on the exercise device wherein each of the user's hands pushes downwardly on a respective grip of an exercise apparatus arm and the arms rotatably cause the seat portion to push upwardly against the user's chest; and FIG. 4 is a perspective view of the exercise apparatus wherein the user now pulls upwardly on each respective grip member of each exercise apparatus arm and the user's chest is lowered but is supported by the central seat member of the exercise apparatus to prevent the user's chest from hitting the floor. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Although specific embodiments of the present invention will now be described with reference to the drawings, it should be understood that such embodiments are by way of example only and merely illustrative of but a small number of the many possible specific embodiments which can represent applications of the principles of the present invention. Various changes and modifications obvious to one skilled in the art to which the present invention pertains are deemed to be within the spirit, scope and contemplation of the present invention as further defined in the appended claims. The present invention is an exercise device for exercising the arms, chest and shoulder muscles. FIG. 1 is a perspective view of the present invention in the assembled condition and FIG. 2 is an exploded view showing all of the components of the present invention. The components of the exercise device 300 will be described in detail referring to the exploded view of FIG. 2 and described from the bottom of the device going upward. The exercise device 300 is mounted on a base 10 comprised of a flat elongated bar 12 with a pair of oppositely disposed parallel crossbars 14 and 16 at each respective lengthwise end of the flat elongated bar 12 . Extending transversely to the flat elongated bar 12 is a center crossbar 18 . The center crossbar 18 has a U-shaped bracket 20 mounted on the end of the crossbar remote from the flat elongated bar 12 , with a pair of oppositely disposed parallel openings 22 and 24 in the U-shaped bracket 20 . Crossbar 14 has openings which are filled by first plug 244 and second plug 252 . Crossbar 16 has two openings which are filled by first plug 248 and second plug 256 . Center crossbar 18 has an opening which is filled by plug 246 . Extending transversely to and extending upwardly from the left parallel crossbar 14 is a left elongated U-shaped bracket 26 having a pair of parallel oppositely disposed openings 28 and 30 . Extending transversely to and extending upwardly from the right parallel crossbar 16 is a right elongated U-shaped bracket 32 having a pair of parallel oppositely disposed openings 34 and 36 . Positioned transverse to the center of the flat elongated bar 12 is a base connector 38 . The base connector has an elongated bar 40 with a proximal hollow cylinder 42 at one end and a distal hollow cylinder 44 at its opposite end. The proximal hollow cylinder 42 has a pair of bushings 46 and 48 at either end. The proximal hollow cylinder 42 and its bushings 46 and 48 are inserted into the U-shaped bracket 20 such that the bushings and cylinder are aligned with openings 22 and 24 . A hex bolt 50 with a first washer 52 , a second washer 54 and nut 56 serve to rotatably secure the proximal cylinder 42 to the U-shaped bracket 20 . A connector plate is rotatably secured to the distal cylinder 44 in the following manner. The connector plate 58 is comprised of a left elongated plate 60 and a parallel right elongated plate 62 . Left elongated plate 60 has a proximal opening 64 adjacent one end and a distal opening 66 adjacent its opposite end. Right elongated plate 62 has a proximal opening 68 adjacent one end and a distal opening 70 adjacent its opposite end. Left elongated plate 60 is aligned parallel to right elongated plate 62 such that openings 66 and 70 are parallel and openings 64 and 68 are parallel. Distal hollow cylinder 44 has a pair of bushings 72 and 74 which combination is inserted between the distal end of elongated plates 60 and 62 so that the distal hollow cylinder 44 and its bushings 72 and 74 are aligned with openings 66 and 70 and rotatably secured to the connecting plate 58 by hex bolt 76 and its washers 78 and 80 and nut 82 . On the left side of the exercise apparatus 300 is a left arm 90 which comprises an elongated bar 92 having a transverse opening 94 adjacent its proximal end and a transverse plate 96 at its distal end to which is attached a left grip 98 which extends above and parallel to the elongated bar 92 and extends toward the proximal end of the elongated bar 92 . A pair of spaced apart and parallel stop members 100 and 102 extend transversely to the elongated bar 92 adjacent its distal end. Plug 101 is aligned with stop member 100 and plug 103 is aligned with stop member 102 . A hollow cylinder 104 is affixed to the lower surface of the elongated bar 92 such that the cylinder 104 and its pair of oppositely disposed bushings of which only one 106 is shown is inserted between the parallel member of left elongated U-shaped bracket 26 and aligned with openings 28 and 30 so that the hollow cylinder 104 and its bushings are rotatably fastened to left elongated U-shaped bracket 26 by hex bolt 108 and its washers 110 and 112 and a nut 114 . On the right side of the exercise apparatus 300 is a right arm 116 which comprises an elongated bar 118 having a transverse opening 120 adjacent its proximal end and a transverse plate 122 at its distal end and to which is attached a right grip 124 which extends above and parallel to the elongated bar 118 and extends toward the proximal end of the elongated bar 118 . A pair of spaced apart and parallel stop members 126 and 128 extend transversely to the elongated bar 118 adjacent its distal end. Plug 127 is aligned with stop member 126 and plug 129 is aligned with stop member 128 . A hollow cylinder 130 is affixed to the lower surface of the elongated bar 118 such that the cylinder 130 and its pair of oppositely disposed bushings of which only one 132 is shown is inserted between the parallel members of the right elongated U-shaped bracket 32 and aligned with openings 34 and 36 so that the hollow cylinder 130 and its bushings are rotatably fastened to the right elongated U-shaped bracket 32 by hex bolt 134 and its washers 136 and 138 and a nut 140 . A seat cushion 150 is supported above a seat liner 152 and which seat cushion 150 and its liner 152 are supported on a seat frame 154 , all centrally positioned on the exercise device 300 . The seat frame 154 has a lower surface 156 to which is affixed a bracket 158 having a pair of spaced apart parallel walls 160 and 162 . Parallel wall 160 has a first opening 164 adjacent one end and a second opening (not shown) adjacent its opposite end. Similarly, parallel wall 162 has a first opening 166 adjacent one end and a second opening (not shown) adjacent its opposite end. Openings 164 and 166 are aligned and the oppositely disposed openings adjacent the other end of the walls are also aligned. The seat frame 154 is supported by a pair of oppositely disposed right and left V-frame members. The left V-frame member 168 is composed of an upper section and a lower section. The upper section 170 terminates at its distal end in a hollow cylinder 172 having a pair of oppositely disposed bushings 174 and 176 at either end. The hollow cylinder 172 and its bushings 174 and 176 are inserted between parallel walls 160 and 162 so that they are aligned with openings 164 and 166 and attached thereto by hex bolt 178 and its washers 180 and 182 and nut 184 . The left-frame member 168 is also composed of a lower section 186 connected to the upper section 170 at their respective proximal ends. The lower section 186 also terminates at its distal end in a hollow cylinder 188 having a pair of oppositely disposed bushings 190 and 192 at either end. The lower section 186 is connected to the left arm 90 by having the hollow cylinder 188 and its bushings 190 and 192 aligned with transverse opening 94 in left arm 90 so that a hex bolt 194 and its washers 196 and 198 and a nut 200 connect the hollow cylinder 188 and its bushings 190 and 192 to the left arm 90 . Similarly, right V-frame member 202 is composed of an upper section and a lower section. The upper section 204 terminates at its distal end in a hollow cylinder 206 having a pair of oppositely disposed bushings 208 and 210 at either end. The hollow cylinder 206 and its bushings 208 and 210 are inserted between parallel walls 160 and 162 and aligned with openings in the parallel walls adjacent the end opposite openings 164 and 166 and affixed thereto by a hex bolt, washers and a nut. The right V-frame member is also composed of a lower section 212 connected to the upper section 204 and their respective proximal ends. The lower section 212 also terminates at its distal end in a hollow cylinder 214 having a pair of oppositely disposed bushings 216 and 218 at either end. The lower section 212 is connected to the right arm 116 by having the hollow cylinder 214 and its bushings 216 and 218 aligned with transverse opening 120 in right arm 116 so that a hex bolt 220 and its washers 222 and 224 and a nut 226 connect the hollow cylinder 214 and its bushings 216 and 218 to the right arm 116 . A vertical post 228 is affixed at its distal end to the lower surface 156 of seat frame 154 . At its proximal end the post 228 is affixed to a hollow cylinder 230 with bushings 232 and 234 aligned at either end of the hollow cylinder 230 . The hollow cylinder 230 and its bushings 232 and 230 are inserted between the proximal end of elongated plates 60 and 62 of connector plate so that the proximal hollow cylinder 230 and its bushings 232 and 234 are aligned with openings 64 and 68 and rotatably secured to the proximal end of the connector plate 58 by hex. bolt 236 and its washers 238 and 240 and nut 242 . The parts list as set forth in the very detailed description of the present invention is as follows: 300 exercise device 10 base 12 flat elongated bar 14 left parallel crossbar 16 right parallel crossbar 18 center cross bar 20 U-shaped bracket on center crossbar 22 left opening—U shaped neck 24 sight opening U-shaped neck 26 left elongated U-shaped bracket 28 opening in left elongated U-shaped bracket 30 opening in left elongated U-shaped bracket 32 right elongated U-shaped bracket 34 opening in right elongated U-shaped bracket 36 opening in right elongated U-shaped bracket 38 base connector 40 bar on base connector 42 proximal hollow cylinder on connector 44 distal hollow cylinder on base connector 46 bushing distal cylinder 48 bushing distal cylinder 50 hex bolt 52 first washer 54 second washer 56 nut 58 connector plate 60 left elongated plate 62 right elongated plate 64 proximal opening 66 distal opening 68 proximal opening 70 distal opening 72 bushing distal hollow cylinder 74 bushing distal hollow cylinder 76 hex bolt 78 washer 80 washer 82 nut 90 left arm 92 elongated bar 94 transverse opening 96 transverse plate 98 left grip 100 left stop member plate 101 102 left stop member plate 103 104 hollow cylinder 106 bushing 108 hex bolt 110 washer 112 washer 114 nut 116 right arm 118 elongated bar 120 transverse opening 122 transverse plate 124 right grip 126 right stop member—plate 127 128 right stop member—plate 129 130 hollow cylinder 132 bushing 134 hex bolt 136 washer 138 washer 140 nut 150 seat cushion 152 seat liner 154 seat framer 156 lower surface—seat frame 158 bracket 160 parallel wall 162 parallel walls 164 first opening 166 first opening 168 left V-frame member 170 upper section 172 hollow cylinder 174 bushing 176 bushing 178 hex bolt 180 washer 182 washer 184 nut 186 lower section left connection to the upper section of their respective proximal ends 188 hollow cylinder 190 bushing 192 bushing 194 hex bolt 194 hex bolt 196 washer 198 washer 200 nut 202 right V-frame member 204 upper section 206 hollow cylinder 208 bushing 210 bushing 212 lower section 214 lower hollow cylinder 216 bushing 220 hex bolt 222 washer 224 washer 226 nut 228 vertical post 230 hollow cylinder 232 bushing 234 bushing 236 hex bolt 238 washer 240 washer 242 nut 244 first plug on crossbar 14 252 second plug on crossbar 14 248 first plug on crossbar 16 256 second plug on crossbar 16 246 plug on center crossbar 18 Although described in great detail, the parts can also be described in broader language. Specifically, the various U-shaped brackets as described above can also be described as connector members. In addition, the elongated bars can also be described as members. This is set forth in the detailed recitation of the claims as set forth in the text reciting the parts in more broad form. Referring to FIG. 1 , described in its broadest terms, the present invention is an exercise apparatus with a base having a center retaining means, a left retaining means and a right retaining means, with a left arm having a grip member and retaining means by which the left arm is rotatably retained by the left retaining means of the base, and a right arm having a grip member and retaining means by which the right arm is rotatably retained by the right retaining means of the base. Further, the complicated apparatus as discussed in Part No. 38 for the base connector and its various components and the connector plate 58 and its various components and the left V-frame member 168 and its various components and the right V-frame member 202 and its various components and the seat assembly 150 and its various components can in general be described as follows. These elements are in fact a seat member rotatably connected to said left arm and said right arm and also rotatably connected to a center connecting means which is also rotatably connected to said center retaining means of said base, and the left arm and the right arm are rotatably connected to said seat member which permits the left arm and the right arm to rotate up and down to simulate a pumping action; whereby the seat member rotates inversely to the arm so that as the arms rotate downwardly, the seat member is caused to rotate upwardly and as the arms are caused to rotate upwardly the seat member is caused to rotate downwardly. This operation is further illustrated in FIGS. 3 and 4 . In FIG. 3 , the user is performing a downward motion on the exercise apparatus wherein each of the user's hands pushes downwardly on the respective grip of an exercise apparatus so that the arms rotate downwardly and this causes the seat portion to move upwardly and push against the user's chest. Conversely in FIG. 4 , the user now pulls upwardly on the grip member so that the arms are caused to rotate upwardly and concurrently, the seat member is lowered and moves downwardly. Also further defined in more detail, the present invention is as follows: Defined in detail, the present invention is an exercise apparatus comprising: (a) a base including a flat elongated bar, a left crossbar transversely attached to one end of the flat elongated bar and a right crossbar transversely attached to the opposite end of the flat elongated bar, the left and right crossbars being parallel, a center crossbar attached transversely to one vertical side of the flat elongated bar and at its lengthwise center location, and a U-shaped bracket having parallel openings attached to the center crossbar, a left elongated U-shaped bracket affixed to the left crossbar and extending upwardly therefrom and having a pair of oppositely disposed openings and a right elongated U-shaped bracket affixed to the right crossbar and extending upwardly therefrom and having a pair of oppositely disposed openings; (b) a base connector including a flat elongated bar having a first hollow cylinder with a bushing at each end affixed to a proximal end of the flat elongated bar and a second hollow cylinder with a bushing at each end affixed to a distal end of the flat elongated bar, the first hollow cylinder and its bushings rotatably affixed to the U-shaped bracket attached to the center crossbar of the base; (c) a connector plate having a left elongated plate and a right elongated plate, the plates being spaced apart and parallel to each other and having oppositely disposed parallel openings adjacent a proximal end of each plate and oppositely disposed parallel openings adjacent a distal end of each plate, the distal end of the left elongated plate and right elongated plate rotatably connected to the second hollow cylinder and its bushings of the base connector; (d) a left arm including an elongated bar having a transverse opening adjacent a proximal end and a transverse plate affixed at its opposite distal end with a left grip attached to the transverse plate and extending above and parallel to the elongated bar and extending toward the proximal end of the elongated bar, a pair of spaced apart parallel stop members extending transversely to the elongated bar adjacent its distal end, a hollow cylinder with bushings at either end affixed to a lower surface of the elongated bar, the hollow cylinder and bushings rotatably affixed to the left elongated U-shaped bracket on the base; (e) a right arm including an elongated bar having a transverse opening adjacent a proximal end and a transverse plate affixed at its opposite distal end with a right grip attached to the transverse plate and extending above and parallel to the elongated bar and extending toward the proximal end of the elongated bar, a pair of spaced apart parallel stop members extending transversely to the elongated bar adjacent its distal end, a hollow cylinder with bushings at either end affixed to a lower surface of the elongated bar, the hollow cylinder and bushings rotatably affixed to the right elongated U-shaped bracket on the base; (f) a seat cushion supported above a seat liner, which cushion and liner are supported on a seat frame having a lower surface to which is affixed a bracket having a pair of spaced apart parallel walls with each wall having an opening adjacent each end, the openings adjacent each respective end being aligned; (g) a left V-frame member having an upper section and a lower section attached to each other at their respective proximal ends, the upper section terminating at a distal end in a hollow cylinder having a pair of oppositely disposed bushings at either end, the hollow cylinder and its bushings inserted between a left end of the parallel walls of the bracket on the seat frame and rotatably attached thereto, the lower section also terminating at a distal end in a hollow cylinder having a pair of oppositely disposed bushings at either end, the hollow cylinder and its bushings rotatably connected to the left elongated bar of the left arm at the opening adjacent its proximal end; (h) a right V-frame member having an upper section and a lower section attached to each other at their respective proximal ends, the upper section terminating at a distal end in a hollow cylinder having a pair of oppositely disposed bushings at either end, the hollow cylinder and its bushings inserted between a right end of the parallel walls of the bracket on the seat frame and rotatably attached thereto, the lower section also terminating at a distal end in a hollow cylinder having a pair of oppositely disposed bushings at either end, the hollow cylinder and its bushings rotatably connected to the right elongated bar of the right arm at the opening adjacent its proximal end; and (i) a vertical post affixed at its distal end to the lower surface of the seat frame, the vertical post terminating in a hollow cylinder at its proximal end, the hollow cylinder having bushings at either end, the hollow cylinder and its bushings inserted between the elongated plates of the connector plate at their proximal ends and rotatably attached thereto. Defined more broadly, the present invention is an exercise apparatus comprising: (a) a base including a flat elongated bar, a left crossbar transversely attached to one end of the flat elongated bar and a right crossbar transversely attached to the opposite end of the flat elongated bar, the left and right crossbars being parallel, a center crossbar attached transversely to one vertical side of the flat elongated bar and at its lengthwise center location, a first base retaining means attached to the center crossbar, a left base retaining means affixed to the left crossbar and extending upwardly therefrom and a right base retaining means affixed to the right crossbar and extending upwardly therefrom; (b) a base connector including a flat elongated bar having a first connecting means affixed to a proximal end of the flat elongated bar and a second connecting means affixed to a distal end of the flat elongated bar, the first connecting means rotatably affixed to the first base retaining means; (c) a connector plate having a left elongated plate and a right elongated plate, the plates being spaced apart and parallel to each other and having retaining means adjacent a proximal end of each plate and retaining means adjacent a distal end of each plate, the distal end of the left elongated plate and right elongated plate rotatably connected through the retaining means to the second connecting means of the base connector; (d) a left arm including an elongated bar having a left connecting means adjacent a proximal end and a transverse plate affixed at its opposite distal end with a left grip attached to the transverse plate and extending above and parallel to the elongated bar and extending toward the proximal end of the elongated bar, at least one stop member extending transversely to the elongated bar adjacent its distal end, a left connecting means affixed to a lower surface of the elongated bar, the left connecting means rotatably affixed to the left base retaining means; (d) a right arm including an elongated bar having a right connecting means adjacent a proximal end and a transverse plate affixed at its opposite distal end with a right grip attached to the transverse plate and extending above and parallel to the elongated bar and extending toward the proximal end of the elongated bar, at least one stop member extending transversely to the elongated bar adjacent its distal end, a right connecting means affixed to a lower surface of the elongated bar, the right connecting means rotatably affixed to the right base retaining means; (f) a seat cushion supported above a seat liner, which cushion and liner are supported on a seat frame having a lower surface to which is affixed a bracket having a pair of spaced apart parallel walls with each wall having a connecting means adjacent each end; (g)a left support member having an upper section and a lower section attached to each other at their respective proximal ends, the upper section terminating at a distal end in an upper connecting means, the upper connecting means inserted between a left end of the parallel walls of the bracket on the seat frame and rotatably attached thereto through the bracket connecting means, the lower section also terminating at a distal end in a lower connecting means, the lower connecting means rotatably connected to the left elongated bar of the left arm through its left connecting means; (h) a right support member having an upper section and a lower section attached to each other at their respective proximal ends, the upper section terminating at a distal end in an upper connecting means, the upper connecting means inserted between a right end of the parallel walls of the bracket on the seat frame and rotatably attached thereto through the bracket connecting means, the lower section also terminating at a distal end in a lower connecting means, the lower connecting means rotatably connected to the right elongated bar of the right arm through its right connecting means; and (i) a vertical post affixed at its distal end to the lower surface of the seat frame, the vertical post terminating in a post connecting means, the post connecting means rotatably connected to the elongated plates of the connector plate at their proximal ends. Defined more broadly, the present invention is a An exercise apparatus comprising: (a) a base including a center member, a left crossbar transversely attached to one end of the center member and a right crossbar transversely attached to the opposite end of the center member, a center crossbar attached transversely to one vertical side of the center member at its lengthwise center location, a first base retaining means attached to the center crossbar, a left base retaining means affixed to the left crossbar and extending upwardly therefrom and a right base retaining means affixed to the right crossbar and extending upwardly therefrom; (b) a base connector including an elongated member having a first connecting means affixed to a proximal end of the elongated member and a second connecting means affixed to a distal end of the elongated member, the first connecting means rotatably affixed to the first base retaining means; (c) a connector plate having a first retaining means adjacent its proximal end and second retaining means adjacent its distal end, the distal end of the connector plate rotatably connected through the retaining means to the second connecting means of the base connector; (d) a left arm including an elongated member having a left connecting means adjacent a proximal end and a grip attachment means affixed at its opposite distal end with a left grip attached to the grip attachment means and extending above and parallel to the elongated member and extending toward the proximal end of the elongated member, a left connecting means affixed to a lower surface of the elongated member, the left connecting means rotatably affixed to the left base retaining means; (e) a right arm including an elongated member having a right connecting means adjacent a proximal end and a grip attachment means affixed at its opposite distal end with a right grip attached to the grip attachment means and extending above and parallel to the elongated member and extending toward the proximal end of the elongated member, a right connecting means affixed to a lower surface of the elongated member, the right connecting means rotatably affixed to the right base retaining means; (f) a seat cushion supported on a seat frame having a lower surface to which is affixed an elongated connecting means having a left end and a right end; (g) a left support member having a top end and a bottom end, the top end terminating in an upper connecting means which is rotatably connected adjacent to the left end of the seat frame connecting means, the bottom end terminating in lower connecting means which is rotatably connected to left elongated member at its left connecting means; (h) a right support member having a top end and a bottom end, the top end terminating in an upper connecting means which is rotatably connected adjacent to the right end of the seat frame connecting means, the bottom terminating in a lower connecting means which is rotatably connected to the right elongated member at its right connecting means; and (i) a vertical member affixed at its distal end to the lower surface of the seat frame, the vertical member terminating in a connecting means, the connecting means rotatably connected to the connector plate at its proximal ends. Defined even more broadly, the present invention is a An exercise apparatus comprising: (a) a base having support means including a centrally disposed first base retaining means, an upwardly extending left base retaining means and an upwardly extending right base retaining means; (b) a base connector having first connecting means at one end and second connecting means at its opposite end, the first connecting means rotatably affixed to the first base retaining means; (c) a connector plate having first retaining means adjacent one end and second retaining means adjacent its opposite end, the second retaining means rotatably connected to the second connecting means of the base connector; (d)a left arm having a grip means affixed adjacent its distal end and a left connector means by which the left arm is rotatably attached to the upwardly extending left base retaining means; (d) a right arm having a grip means affixed adjacent its distal end and a right connector means by which the right arm is rotatably attached to the upwardly extending right base retaining means; (f) a seat cushion supported on a seat frame having a lower surface to which is affixed an elongated connecting means having a left end and a right end; (g) a left support member having a top end and a bottom end, the top end terminating in an upper connecting means which is rotatably connected adjacent to the left end of the seat frame connecting means, the bottom end terminating in a lower connecting means which is rotatably connected to the left elongated arm at a left connecting means adjacent its proximal end; (h) a right support member having a top end and a bottom end, the top end terminating in an upper connecting means which is rotatably connected adjacent to the right end of the seat frame connecting means, the bottom end terminating in a lower connecting means which is rotatably connected to the right elongated arm at a right connecting means adjacent its proximal end; and (i)a vertical member affixed at its distal end to the lower surface of the seat frame, the vertical member terminating in a connecting means at its proximal end, the connecting means rotatably connected to the connector plate at its first retaining means. Defined even more broadly, the present invention is an exercise apparatus comprising: (a) a base having a center retaining means, a left retaining means and a right retaining means; (b) a left arm having a grip member and retaining means by which the left arm is rotatably retained by the left retaining means of the base; (c) a right arm having a grip member and retaining means by which the right arm is rotatably retained by the right retaining means of the base; (d) a seat member rotatably connected to the left arm and the right arm and also rotatably connected to a center connecting means which is also rotatably connected to the center retaining means of the base; and (e) the left arm and the right arm are rotatably connected to the seat member which permits the left arm and the right arm to rotate up and down to simulate a pumping action; (f) whereby the seat member rotates inversely to the arms so that as the arms rotate downwardly, the seat member is caused to rotate upwardly and as the arms are caused to rotate upwardly, the seat member is caused to rotate downwardly. Of course the present invention is not intended to be restricted to any particular form or arrangement, or any specific embodiment, or any specific use, disclosed herein, since the same may be modified in various particulars or relations without departing from the spirit or scope of the claimed invention hereinabove shown and described of which the apparatus or method shown is intended only for illustration and disclosure of an operative embodiment and not to show all of the various forms or modifications in which this invention might be embodied or operated. The present invention has been described in considerable detail in order to comply with the patent laws by providing full public disclosure of at least one of its forms. However, such detailed description is not intended in any way to limit the broad features or principles of the present invention, or the scope of the patent to be granted. Therefore, the invention is to be limited only by the scope of the appended claims.

An exercise apparatus to exercise and strengthen the user's arms, shoulders and chest by performing pushups which combine raising and lowering the user's body through raising and lowering the user's arms while the user is in a face down horizontal position with the present invention exercise device used to simulate an up and down pumping action to cause the user to have his/her arms spread apart to make the pushups more difficult while providing a central chest support to facilitate the exercise.

TECHNICAL FIELD [0001] The present disclosure generally relates to a protective device for a feeding bowl, and more particularly to a protective device which comprises a cover held in the depression of a feeding bowl by a hold-down device. BACKGROUND [0002] The problem with traditional feeding bowls is that dried residue, which is difficult to remove, often remains in the bowl after feeding. For reasons of hygiene, animal feeding bowls should be cleaned regularly. Cleaning, however, is time-consuming and costly, and is often neglected. Protective devices for feeding bowls do exist. They usually come in the form of inserts which are preformed to fit the shape of the feeding bowl. Inserts that are not preformed are also available, but in most cases they do not fit securely in the feeding bowl. They have a tendency to move around and can be pulled out by the animal [0003] An object of the present disclosure is therefore to provide a protective device for a feeding bowl that avoids the disadvantages of known devices. SUMMARY [0004] An improved protective device for a feeding bowl, incorporating a protective cover for the bowl, is provided as in the independent claims. Advantageous embodiments of the protective device are provided in the dependent claims. The device incorporates a secure, disposable cover sheet to protect the feeding bowl and thus make it easy and quick to keep clean. [0005] The protective device includes a hold-down device with one or more adjustable hold-down elements that reach into the depressed section of the feeding bowl. The one or more hold-down elements can be pivoted into a loading position. Subsequently, the depression in the feeding bowl is covered with a protective film, or other cover in the form of a flexible sheet material. The bottom side of the cover comprises one or more pocket-like or tube-like receiving portions into which one or more of the hold-down elements can be inserted. After the hold-down elements have been pivoted back down into working position, they press the cover flat against the inside of the depression and secure it in this position. [0006] The peripheral region of the cover is folded over the edge bead which surrounds the depression in the feeding bowl. A continuous annular groove runs around the circumference of the edge bead. The cover is pressed into the annular groove by a retaining ring. The cross sections of the retaining ring and the annular groove are constructed in such a way as to allow the retaining ring to be held securely in place in an interlocking and/or force-fitting manner. The annular groove allows the retaining ring to be connected and released easily. The peripheral region of the cover is clamped securely into position on the feeding bowl and protects it from contamination. [0007] After the food has been eaten, the cover, which can be used once or several times, can be separated from the feeding bowl and disposed of by following the covering procedure in reverse. The dispenser will hold an abundant supply of covers. In a first embodiment of the invention the dispenser may be an independent component that is connected to and released from the feeding bowl. A continuous supply roll of several cover sheets separated by perforations, and thus detachable, may be used. Alternatively, the dispenser may contain a stack of individual covers. [0008] The following detailed description is intended merely to exemplify the invention and to limit the invention or the application and uses of the invention. Furthermore, there is no intention to be bound by any theory presented in the preceding background of the invention or the following detailed description of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a plan view of a first arrangement of a feeding bowl with a protective device. The dispenser, from which portions of a rolled-up band of covers are extracted, is connected to the bowl. [0010] FIG. 2 is a side view of the arrangement illustrated in FIG. 1 . [0011] FIG. 3 is a cross section of the arrangement illustrated in FIG. 1 . [0012] FIG. 4 is a cross section of a detail of the arrangement with the retaining ring inserted in the edge bead. [0013] FIG. 5 is a cross section of a detail of an arrangement with a different retaining ring inserted in the edge bead. [0014] FIG. 6 is a section of a first band with detachable cover in plan view and in cross-section. [0015] FIG. 7 is a section of a different band with detachable cover in bottom-view and in cross-section. [0016] FIG. 8 is a section of a third type of band with detachable cover in plan view and in cross section. [0017] FIG. 9 is a wide hold-down element connected non-rotatably to a shaft. [0018] FIG. 10 is a section of a different band with a detachable cover in bottom-view and in cross-section. [0019] FIG. 11 is a cross-section of an arrangement with a retaining ring pivotally mounted on the edge bead. DETAILED DESCRIPTION [0020] FIG. 1 shows a plan view of a feeding bowl 1 with components of the protective device in a first embodiment. The feeding bowl 1 has a depression 5 surrounded by an edge bead 3 . The depression 5 is embedded within pairs of parallel-aligned straight edge bead segments 3 a, 3 b, 3 c, 3 d, which are connected by rounded corner sections. The edge bead 3 has a trapezoidal cross section and is bounded laterally by an inner wall 7 a and an outer wall 7 b and bounded on top by an annular edge 7 c. The lower edge of the outer wall 7 b is also the base edge of the feeding bowl 1 . The lower edge of the inner wall 7 a may be slightly higher than the lower edge of the outer wall 7 b and abuts the bottom 5 a of the depression 5 . The area of the edge bead 3 between the inner wall 7 a, the outer wall 7 b, and the edge 7 c is preferably formed as a hollow space; alternatively, it can be formed partially or completely as a solid body. [0021] In the lower part of the edge bead 3 a shaft 9 is mounted parallel to the front edge bead section 3 d and pivots about axis A on the edge bead 3 . On at least one side the end of the shaft 9 projects laterally from the edge bead 3 and is mounted for co-rotation with an operating lever 11 respectively with a pivoted lever. Inside the edge bead 3 or in a recess 4 ( FIG. 11 ) of the edge bead 3 , two rod-like flat tongues which form the hold-down elements 13 are connected to the shaft 9 for co-rotation and protrude parallel to the adjacent edge bead segments 3 a, 3 c into the depression 5 with the same orientation. [0022] By pivoting the operating lever 11 the hold-down elements 13 can be lowered or raised between a working position and a loading position. In the side view ( FIG. 2 ), the reference numerals 11 ′ and 13 ′ indicate the loading positions of the operating lever and hold-down elements respectively; reference numerals 11 and 13 indicate their working positions. The double arrows P 1 and P 2 illustrate the pivoting of the operating lever 11 and the hold-down elements 13 . In the working position the pivot angle is limited because the hold-down elements 13 touch the bottom 5 a of the depression or receiving grooves (not shown) at the bottom 5 a of the depression; and limited in the loading position because the hold-down elements 13 touch the upper edge of the recess 4 on the inside of the edge bead 3 . [0023] It is particularly advantageous if the hold-down device can be locked in the working position and/or the loading position by means of a releasable locking mechanism such as spring-loaded latching elements (not shown). In the working position the hold-down elements 13 push against the bottom 5 a of the depression respectively against receiving grooves set therein. They can be held in place against the bottom 5 a of the depression by the torque of a spring (not shown) or by their own weight and/or be secured by means of a releasable locking mechanism. This allows a portion of a cover 15 in the form of a flexible sheet material to be held in place by the hold-down elements 13 , which clamp it to the bottom 5 a of the depression. [0024] The bottom 5 a of the depression, or the receiving grooves, may be flat or curved. The shape and size of the hold-down elements is adapted to the shape and size of the bottom 5 a of the depression or the receiving grooves within it. [0025] The cover 15 is a plastic film with a receiving portion 17 on its bottom side into which the hold-down elements can be introduced, or which can be looped around the hold-down elements 13 when they are in the loading position. The cover 15 may, for example, be in the form of a rolled-up band of detachable sections which are stored in a dispenser 19 . As shown in FIGS. 1 through 3 , the dispenser 19 may be a separate component that can be connected to and disconnected from the edge bead 3 , or, alternatively, a permanent fixture built on to the edge bead itself. It may include a flip (double arrow P 3 ) cover 21 for inserting and removing rolls of film. The protective device does not necessarily need to have a dispenser 19 . Therefore, the feeding bowl 1 may be formed with or without a device for attaching a dispenser 19 . [0026] To secure or hold the cover 15 on to the periphery of the feeding bowl 1 an annular groove 23 running around on the top of the edge bead 3 may be provided. The cover 15 , which is held inside the depression 5 by one or more hold-down elements 13 , overlaps the edge bead 3 and may be clamped there, in the annular groove 23 , by a retaining ring 25 . The double arrow P 4 illustrates the insertion and removal of the retaining ring 25 in the annular groove 23 . Preferably, the annular groove 23 and the retaining ring 25 comprise at least in segments complementary retaining structures or profiles which enable a releasable latching connection of the retaining ring 25 and the annular groove 23 with the cover 15 clamped in between (not shown). [0027] FIG. 4 shows a detail of an arrangement with a simple retaining ring 25 inserted in the annular groove 23 . FIG. 5 shows a detail of a different arrangement in which the retaining ring 25 has a domed outwardly projecting deck leg 27 which overlaps the outer perimeter of the bead edge 3 . [0028] FIG. 11 shows yet another possible arrangement, in which the retaining ring 25 pivots on the upper part of the edge bead 3 . The retaining ring 25 is shown in two different pivot positions. As with the hold-down element 13 in FIG. 2 , reference numeral 25 ′ indicates the loading position and reference numeral 25 indicates the working position of the retaining ring 25 . [0029] FIGS. 6 through 8 illustrate embodiments of a band of film with a top sheet that is welded, glued, or otherwise connected to a bottom sheet or a partial bottom sheet by welds 29 in a way that creates pocket-shaped or tube-shaped receiving portions 17 which can be slipped over the hold-down elements 13 . In the embodiment illustrated in FIG. 6 , two narrow receiving portions 17 are formed for two hold-down elements 13 which are arranged near the edge of the bottom 5 a of the depression. At the front receiving opening 18 of the receiving portions 17 a flap 20 is formed by a length L 1 of the cover 15 without receiving portions 17 . This flap 20 can be placed over the front edge bead section 3 d after the cover material has been slipped over the hold-down elements 13 . A line of perforations 31 runs across the band of cover material, parallel to a weld seam and close to the rear of the receiving portions 17 , allowing easy separation from the next portion of cover material 15 ′. [0030] In the embodiment in FIG. 7 , instead of having another film that extends across the entire width of the cover 15 , two strip-shaped film sections, welded along their longitudinal edges to the upper film, extend along the entire length L of the cover 15 . In this embodiment the receiving openings 18 are in the form of holes in the film strips, into which the rod-shaped hold-down elements 13 are inserted. FIG. 8 shows another embodiment of the cover 15 comprising only one receiving portion 17 which is adapted to receive one wide hold-down element only 13 with the width B, as shown in FIG. 9 . The width B is preferably slightly smaller than the width of the bottom 5 a of the bowl. A one-piece hold down device may also be used in alternative embodiments of the protective device. [0031] The protective device includes embodiments with or without the shaft 9 , with or without an operating lever 11 attached to it. [0032] FIG. 10 shows a section of another band with cover 15 , from below. Here, two strip-shaped film sections are welded as receiving portions 17 along their longitudinal edges on the bottom side of the cover film. The length L 2 of these film sections provides a flap 20 of the length L 1 on both sides, between the receiving openings 18 and the adjacent perforation edges 31 . This flap 20 is folded over the edge bead segments 3 b and 3 d of the feeding bowl 1 . In the same way, there is also sufficient film on the longitudinal sides of the strips for them to be folded over the lateral edge bead segments 3 a, 3 c. [0033] Of course, the protective device may also be adapted for use in feeding bowls 1 with differently shaped depressions. Likewise, the cover 15 may have a different form and be adapted to differently shaped bowls. [0034] While the present invention has been described with reference to exemplary embodiments, it will be readily apparent to those skilled in the art that the invention is not limited to the embodiments disclosed or illustrated here. On the contrary, the invention is intended to accommodate numerous modifications, substitutions, variations and broad equivalent arrangements included within the spirit and scope of the following claims.

The protective device for a food bowl ( 1) with a depression ( 5) which is surrounded by an edge bead ( 3) comprises a hold-down device with at least one adjustable hold-down element ( 13) for holding a cover means ( 15) in the form of a flexible sheet material within the depression ( 5), said hold-down element extending into the depression region. The cover means can additionally be held on the food bowl ( 1) with a peripheral retaining device in the region of the edge bead ( 3). The cover means ( 15) can be stored as a detachable section of a rolled-up band in a dispenser ( 19). The cover means comprises at least one receiving portion ( 17) on the bottom side thereof for the at least one hold-down element ( 13).

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS This Application claims the benefit under 35 U.S.C. 119(a) of Canadian Patent Application No. 2,527,841, having a filing date of Nov. 25, 2005, titled “BATHROOM VANITY,” and under 35 U.S.C. 119(e) of U.S. Provisional Application No. 60/691,937, having a filing date of Jun. 17, 2005, titled “BATHROOM VANITY,” the disclosures of which are hereby incorporated by reference. FIELD OF THE INVENTION The present invention relates to furniture for a bathroom or the like. More specifically, the present invention relates to bathroom vanities and the like. BACKGROUND OF THE INVENTION In the last decade or two, increasing health consciousness among individuals has resulted in most bathrooms including a weigh scale. Such weigh scales occupy floor space, which is often quite limited in a bathroom, and typically are unattractive and/or difficult to match to the décor of the bathroom. In the last decade or two, increasing health consciousness among individuals has resulted in most bathrooms including a weigh scale. Such weigh scales occupy floor space, which is often quite limited in a bathroom, and typically are unattractive and/or difficult to match to the décor of the bathroom. Further, with technological developments in health equipment and other information systems, individuals can now have a great deal of information available to them which would usefully be accessed in the bathroom. However, to date there has not been any safe and/or convenient way to access such information in the bathroom. It is desired to have a bathroom vanity which provides effective storage space for a weigh scale such that the weigh scale no longer occupies floor space when not in use and such that the weigh scale is not visible when stored. It is further desired to have a bathroom vanity which provides a mechanism for the safe and convenient way to access information of interest to the bathroom user. SUMMARY OF THE INVENTION It is an object of the present invention to provide a novel bathroom vanity which obviates or mitigates at least one disadvantage of the prior art. According to a first aspect of the present invention, there is provided a bathroom vanity comprising: a structure for supporting a sink and including at least one storage volume, the structure further including a bathroom scale storage device. Preferably, the vanity includes a kick panel and the bathroom scale storage device is located in the kick panel. Also preferably, the bathroom scale storage device comprises a drawer in the kick panel, the drawer receiving a bathroom scale and being moveable between a closed position wherein the drawer is flush with the kick panel and an open position wherein the drawer extends from the kick panel to provide access to the scale. The present invention provides a bathroom vanity which provides storage space for a bathroom scale and which makes efficient use of the volume occupied in the bathroom by the vanity. In several embodiments, the bathroom scale is stored in a drawer in a kick panel, the drawer being moved between a closed position, wherein the scale is stored, and an open position wherein the scale can be used. Preferably, the scale is capable of providing an output of its readings to a digital display on the vanity. Also preferably, the digital display is multifunction allowing the display of a variety of information to a user. BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the present invention will now be described, by way of example only, with reference to the attached Figures, wherein: FIG. 1 shows a front and side perspective view of a bathroom vanity in accordance with the present invention; FIG. 2 shows a top view of a bathroom scale drawer of the vanity of FIG. 1 ; FIG. 3 shows a front and side perspective view of another bathroom vanity in accordance with the present invention; FIG. 4 shows a top view of a bathroom scale drawer of the vanity of FIG. 3 ; FIG. 5 shows a side view of the bathroom scale drawer FIG. 3 ; FIG. 6 shows a front and side perspective view of another bathroom vanity in accordance with the present invention; FIG. 7 shows a section taken along line 7 - 7 of FIG. 6 ; FIG. 8 shows a front and side perspective view of another bathroom vanity in accordance with the present invention; FIG. 9 shows a side view of a bathroom scale storage device of FIG. 8 ; FIGS. 10 and 11 show front and side perspective views of another bathroom vanity in accordance with the present invention; FIG. 12 shows a side view of another bathroom scale drawer for use with a vanity in accordance with the present invention; FIG. 13 shows a cross section taken along line 13 - 13 of FIG. 12 ; and FIG. 14 shows a side view of the drawer of FIG. 12 with the platform in a retracted position. DETAILED DESCRIPTION OF THE INVENTION A bathroom vanity in accordance with the present invention is indicated generally at 20 in FIG. 1 . Vanity 20 includes a vanity base 24 and a medicine chest 28 . As shown, vanity base 24 supports a counter top 32 and a sink 36 which can be integrally formed in countertop 32 , or sink 36 can be a separate component mounted in counter top 32 . Vanity base 24 preferably further includes a set of storage compartments, such as cupboards 40 and pull-out drawers 44 . In the illustrated embodiment, medicine chest 28 is separate from vanity base 24 and is attached, at a point above vanity base 24 , to a wall in the bathroom. However, as will be apparent to those of skill in the art, medicine chest 28 can also be integral with vanity base 24 . Medicine chest 28 typically includes at least one mirror 48 and one or more storage volumes, such as cupboards 52 and/or nooks 56 . Vanity bases usually include a kick panel between the bottom of the doors to the cupboards, and/or any lower drawers, and the floor to permit clearance for the doors and/or drawers to open and to raise the bottom of the cupboards, and/or drawers to a height which is more convenient for users to access. Typically, the space behind kick panel is unused “dead space”, although it is also known to provide a small cupboard or drawer in this dead space, instead of a kick panel. Unlike the prior art, vanity 20 includes a bathroom scale storage device, in this embodiment bathroom scale drawer 60 , shown in FIGS. 1 and 2 . Drawer 60 is located where a kick panel would conventionally be placed and is slidably mounted in vanity base 24 via a pair of drawer tracks 64 . Drawer 60 further preferably includes a biasing means which biases drawer 60 to the open position, shown in FIG. 1 . In the illustrated embodiment, best seen in FIG. 2 , the biasing means comprises a pair of spring loaded members 68 , mounted to drawer 60 , which abut a rear panel of vanity base 24 when drawer 60 is moved from the open position and which bias drawer 60 towards the open position. As will be apparent to those of skill in the art, the biasing means can be provided in many other configurations and arrangements, such as mounting spring loaded members 68 on the rear panel of vanity base 24 to abut the back of drawer 60 , providing an elastic member (not shown) extending across the space into which drawer 60 fits when in the closed position—the elastic member being tensioned when drawer 60 is moved to the closed position, providing a pressurized gas or hydraulic piston between drawer 60 and vanity base 24 , or any other suitable means for biasing drawer 60 towards the open position. Drawer 60 further includes a toggle latch (not shown) which operates such that a first press on the front of drawer 60 releases the latch to allow the biasing means to move drawer 60 to the open position and a second press on the front of drawer 60 , as the drawer is moved against the biasing means to a closed position wherein drawer 60 is substantially under vanity base 24 , caused the latch to engage and maintain drawer 60 in the closed position. Such toggle latches are well known and are available from a variety of manufacturers and in a variety of designs. In use, a user can press on the front of drawer 60 with a toe or other part of their foot to unlatch drawer 60 which is then biased to the open position by the biasing means. When finished with drawer 60 , the user again presses the front of drawer 60 with a toe, or other part of their foot, to return drawer 60 to the closed position, overcoming the biasing force of the biasing means, and latching the toggle latch so that drawer 60 is maintained in the closed position. In a presently preferred embodiment, a toggle latch, available from Richelieu Hardware, 6420 Viscount Road, Mississauga, Ontario, Canada and referred to as a Drawer Kicker, part number 102111, is employed with drawer 60 . The Drawer Kicker toggle latch is attached to the rear panel of vanity base 24 , adjacent where the back cross piece of drawer 60 is located when drawer 60 is in the closed position or to the back of the cross piece of drawer 60 , and the Drawer Kicker toggle latch performs both the above-described toggle latch functionality and also acts as a biasing means to bias drawer 60 to the open position when the latch is pushed and released. As illustrated, drawer 60 does not include a conventional bottom panel but instead includes a webbing of elastic straps 72 which serves instead of a bottom panel. In the illustrated embodiment, drawer 60 includes a pair of elastic straps 72 a extending between the sides of drawer 60 and another pair of elastic straps 72 b extending from the front to the back of drawer 60 . The number, arrangement, size and elastic force of straps 72 is selected such that straps 72 will support the weight of a bathroom scale in drawer 60 when the scale is not in use and will stretch to allow the bathroom scale to rest upon the bathroom floor when a user is standing on the scale. Thus, when the user is standing on the bathroom scale, straps 72 stretch such that the scale is supported by the bathroom floor and the scale can operate in a conventional manner. When the user steps off the scale, straps 72 contract, due to their elastic force, lifting the scale up and back into drawer 60 . In this manner, drawer 60 need not be constructed to carry the weight of the user and the scale and instead need only be constructed with sufficient strength to carry the forces generated by the weight of the scale and the forces transmitted by straps 72 . Further, by allowing the scale to be supported by the bathroom floor, no brake or other mechanism is required to prevent drawer 60 from moving when a user is standing on the scale as drawer 60 is effectively immobilized by the scale being in contact with the bathroom floor. To accommodate any irregularities in the floor on which vanity base 24 is installed, drawer 60 preferably includes a front panel 74 whose height is slightly less than the space in the front of vanity base 24 into which it is received. Front panel 74 is mounted to drawer tracks 64 , and their associate drawer side members, such that the vertical positioning of front panel 74 with respect to drawer tracks 64 , and thus vanity base 24 , can be adjusted to vertically clear minor irregularities in the floor on which vanity base 24 is installed or carpets, etc. It is contemplated that a vertical adjustment of as much as one quarter of an inch will suffice in most circumstances, although larger or smaller adjustment ranges can be provided if desired. The method of attaching front panel 74 to drawer tracks 64 is not particularly limited and a variety of mechanisms can be employed. For example, an angle bracket attached directly or indirectly to drawer tracks 64 can be employed, the angle bracket including vertical slots through which mounting screws extend into front panel 74 , the slots allowing the screws and front panel 74 to be vertically positioned as desired. As will be apparent to those of skill in the art, as front panel 74 is moveable with respect to drawer tracks 64 and drawer tracks 64 are mounted in a fixed relationship to vanity base 24 , vertical adjustment of front panel 74 does not result in vertical adjustment of the rest of drawer 60 with respect to vanity base 24 . If desired, vanity base 24 can be equipped with conventional storage drawers or cupboards, instead of kick panels, on either side of the volume which receives drawer 60 . In the case that storage drawers are provided, these storage drawers can also feature vertically adjustable front panels, similar to front panel 74 . The actual bathroom scale employed is not limited, except in regard of fitting within drawer 60 , and can be a mechanical scale, a digital electronic scale, etc. A digital electronic scale, which can provide other health related information such as percentage body fat, etc., is presently preferred for use with vanity 20 . For example, the digital weigh scale in drawer 60 can offer a range of other services such as measuring percentage body fat, percentage of water content, pulse, etc. Scales which can provide these measurements, or various subsets of these measurements are known. In particular, a digital electronic scale which supports a remote readout is presently preferred. For example, such a digital electronic scale can communicate its readings, via radio frequency transmission, infrared transmission or wired connection to a readout which is located substantially at eye height of a user standing on the scale. Many suitable radio frequency or infrared communications techniques for communicating with such remote readouts will be apparent to those of skill in the art, including Bluetooth, 802.11x, IrDA, wired Ethernet, etc. In the embodiment of FIG. 1 , a remote digital display 76 is provided on mirror 48 of medicine chest 28 . In a presently preferred embodiment, remote digital display 76 is located behind mirror 48 overlying a region of mirror 48 which is not coated with reflective material, or which has a thinner coating of such material, such that the information displayed by display 76 is visible through mirror 48 . However, it is also contemplated that display 76 , in a suitable moisture resistant enclosure, can be mounted to the front side of mirror 48 of elsewhere on medicine chest 28 , vanity base 24 or even on a wall or other structure in the bathroom in which vanity 20 is installed. If the digital electronic scale includes one or more controls to alter its operation, such as a switch to change the displayed weight from metric units to English units, or to change the display from displaying weight to displaying the percentage body fat, etc., such controls can be included with display 76 and can communicate with the scale via the above-mentioned radio, infrared or wired communications techniques to allow the user to operate the scale without the need to stoop to reach controls on the scale. Another embodiment of bathroom vanity 20 is illustrated in FIGS. 3 through 5 , wherein like components to those of FIGS. 1 and 2 are indicated with like reference numerals. In this embodiment, bathroom scale drawer 100 is equipped with support rollers 104 which engage the bathroom floor on which vanity 20 is installed and allow drawer 100 to be slid between open and closed positions. Unlike with drawer 60 described above, drawer 100 includes a rigid bottom panel 108 to support a bathroom scale. However, as before, drawer 100 is preferably equipped with a toggle latch to provide a “push to latch, push to unlatch” functionality. Also as before, vanity 20 is equipped with a biasing means to urge drawer 100 to the open position, illustrated in FIG. 3 , when the toggle latch is unlatched. In the illustrated embodiment, the biasing means is an elastic strap (not shown) extending across the volume into which drawer 100 is moved when being placed in the closed position. The rear of drawer 100 contact the elastic strap and tensions it as drawer 100 is moved to the closed position and this strap urges drawer 100 to the open position. The roller portion of support rollers 104 which engages the bathroom floor are spring mounted within the housings of support rollers 104 and operate such that, as a user stands on a scale in drawer 100 , the springs of support rollers 104 are compressed, bringing the underside of panel 108 into contact with the bathroom floor. At the same time, the upper surface of the roller portions of support rollers 104 engage a surface within the housing of support rollers 104 , this engagement of the rollers with the surface acting as a brake to prevent movement of drawer 100 when a user is standing on a scale therein. FIGS. 6 and 7 show another embodiment of the present invention, similar to that shown in FIG. 3 through 5 , wherein like components are indicated with like reference numerals. In this embodiment, bathroom scale drawer 200 is pivotally mounted to vanity base 24 by a hinge 204 located adjacent one side of drawer 200 which allows drawer 200 to be pivoted from the closed position to the open position illustrated in FIG. 7 . As before, drawer 200 is preferably equipped with a toggle latch and hinge 204 also permits vertical movement of drawer 200 to allow the springs in support rollers 104 to be compressed, so that panel 108 is supported by the bathroom floor. Further, as before, a biasing means is provided to bias drawer 200 to the open position. In the illustrated configuration, the biasing means is an elastic strap 208 extending across the space 212 occupied by drawer 200 when in the closed position. Yet another embodiment of the present invention is illustrated in FIGS. 8 and 9 wherein like components to those of embodiments discussed above are indicated with like reference numerals. In this embodiment, the bathroom scale storage device comprises a support platform 300 to which a bathroom scale 304 can be attached. Platform 300 is attached to vanity base 24 via a hinge 308 , which allows platform 300 to be pivoted up and over kick panel 312 and into the volume behind cupboard doors 316 . A stop support 320 is provided to support the end of platform 300 distal hinge 308 when platform 300 is in the closed position and platform 300 is also preferably equipped with one or more resilient pads 324 to engage the bathroom floor to prevent damage to the bathroom floor and/or to reduce noise when platform 300 is brought into engagement with the bathroom floor. As will be apparent to those of skill in the art, the bathroom scale should be fastened to platform 300 such that the scale remains attached thereto when platform 300 is in the closed position and the scale is inverted thereon. Further, it is contemplated that platform 300 can be further equipped with a biasing means, such as a coil spring on hinge 308 , to assist in moving platform 300 from the closed position to the open position. FIGS. 10 and 11 shows another embodiment of the present invention wherein like components to those of embodiments discussed above are indicated with like reference numerals. In this embodiment, vanity base 24 includes a bathroom scale storage device which comprises a pull out scale compartment 400 . Compartment 400 includes a roller 404 to engage the bathroom floor to support compartment 400 and compartment 400 slides, as indicated by arrow 408 , in roller tracks, not shown, between a closed position wherein the front 412 of compartment 400 is flush with the front of vanity base 24 and the open position illustrated in FIG. 11 . Compartment 400 is slid out of vanity base 24 until a scale support platform 416 , which is mounted to compartment 400 by a hinge, in a manner very similar to that discussed above with respect to the embodiment shown in FIGS. 8 and 9 , is free of vanity base 24 to pivot, as indicated by arrow 420 , to the open position shown in FIG. 11 . As before, the bathroom scale is suitably fastened to platform 416 and platform 416 can include one or more resilient pads to engage the bathroom floor. Alternatively, a bathroom scale can be directly hinged to compartment 400 , eliminating the need for platform 416 . FIGS. 12 , 13 and 14 show another drawer 500 for holding a weigh scale in accordance with the present invention. Drawer 500 , which can be installed in vanity 24 of FIG. 1 or the like, comprises a rectangular shaped drawer frame comprising a front panel 504 , a pair of drawer sides 508 and a rear cross member 512 . Front panel 504 can be attached to drawer sides 508 to allow for vertical adjustment of front panel 504 , as discussed above, and drawer tracks can be attached to drawer sides 508 , or any other suitable means employed, to allow drawer 500 to move into and out of the vanity it is installed in. The drawer frame of drawer 500 supports a platform 516 upon which a weigh scale or other device can be placed. Platform 516 is mounted to the drawer frame by spring guides 520 which extend between drawer sides 508 and platform 516 . Each spring guide 520 includes a coil spring which is at least partially inserted into a bore in drawer side 508 and one end of the coil spring abuts the bottom of the bore while the opposite end abuts the underside of platform 516 . Platform 516 further includes a set of depending legs 524 which preferably are closely adjacent the inner surfaces of the drawer frame to inhibit lateral movement of platform 516 with respect to the drawer frame. Further, each spring guide 520 can include a pin depending from platform 516 into the respective bore in drawer sides 508 , with the coil spring encircling the pin to further inhibit lateral movement of platform 516 . In use, platform 516 and the device (weigh scale, etc.) installed on it is supported by spring guides 520 such that legs 524 are not in contact with the floor as drawer 500 is moved between open and closed positions in the vanity, as shown in FIG. 14 . When a user steps onto the weigh scale of other device on platform 516 , the springs in spring guides 520 are compressed and platform 516 moves down until legs 524 contact the floor to stop further downward movement of platform 516 and to support the user on the device, as illustrated in FIGS. 12 and 13 . The length of legs 524 is selected such that platform does not directly contact the drawer frame and legs 524 can be equipped with rubber or other non-skid members on their lower ends to prevent movement of drawer 500 while legs 524 are in contact with the floor. As will be apparent to those of skill in the art platform 516 need not have four depending legs 524 . If spring guides 520 or any other suitable method is employed to inhibit lateral movement of platform 516 , then platform 516 can have any number of legs 524 as desired, including having only a single, albeit somewhat larger, centrally located leg 524 . It is contemplated that, if any of the above-described embodiments of vanity 20 is equipped with a digital readout 76 , relevant information and/or other information of interest to the bathroom occupant. When combined with other devices which can communicate with readout 76 via radio, infrared, wired Ethernet or other communications techniques, a variety of other functionalities can be offered by vanity 20 . Examples of such other information of interest include weather information from an external sensor station, time and date information, television programming and/or web browsing capabilities, etc. It is further contemplated that other bathroom objects can communicate with readout 76 to provide information of interest to the bathroom occupant. For example, the water tap for sink 36 can include a temperature sensor and a Bluetooth transceiver to provide on readout 76 a measure of the temperature of the water supplied from the tap. Further, a strain gauge, combined with a Bluetooth or other transceiver, can be placed under a tile in the bathroom floor, or under the seat of a toilet or the mounting of the toilet, to provide the weight and other information about a user in place of a conventional bathroom scale. The above-described embodiments of the invention are intended to be examples of the present invention and alterations and modifications may be effected thereto, by those of skill in the art, without departing from the scope of the invention which is defined solely by the claims appended hereto.

A novel bathroom vanity provides storage space for a bathroom scale and makes efficient use of the volume occupied in the bathroom by the vanity. In several embodiments, the bathroom scale is stored in a drawer in a kick panel, the drawer being moved between a closed position, wherein the scale is stored, and an open position wherein the scale can be used. Preferably, the scale is capable of providing a digital output of its readings to a digital display on the vanity.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application is a continuation in part application of U.S. patent application Ser. No. 10/037,207, filed Jan. 7, 2002, the entire contents of which are herein incorporated by reference. FIELD OF THE INVENTION [0002] This invention relates generally to the field of oxygen bottle carrying apparatus, particularly for individuals who have difficulty breathing and, in particular, to an oxygen bottle carrier that can be attached for use to an orthopedic appliance, such as a walker or a wheelchair. BACKGROUND OF THE INVENTION [0003] Many patients and, in particular, elderly patients, have breathing disorders that necessitate the use of oxygen. In certain extreme cases, the patient must have oxygen for breathing available at all times and, in particular, when the patient is exerting him or herself, as for example, when walking. Oxygen bottle caddies on wheels are presently available for transporting oxygen bottles. However, these devices require the use of one of the patient's hands to propel the bottle, thus rending them impractical for use when the patient must also use a walker to get about. Attempts to mount an oxygen bottle upon a walker have been proven to be less than satisfactory because the bottle typically renders the walker unstable and extremely difficult to manage. This, in turn, can pose a dangerous situation for an elderly or weak patient which can lead to a potentially damaging fall. [0004] Alternately, patients who cannot walk utilize wheelchairs to get from place to place. There are known oxygen bottle carriers that are designed specifically for use with such appliances, such as described in U.S. Pat. No. 5,288,001. However, there are associated problems with such carriers. For example, typically the extremely flexible fabric carrier sack must first be placed on the floor or other surface in a non-use position in order to push the oxygen bottle into the confines thereof. That is to say, it is extremely difficult, if not impossible for one person to load the bottle into the carrier in the use position on the wheelchair or walker. This is disadvantageous, particularly when attempting, for example, in trying to replace an empty bottle. In addition, there are also associated problems in attempting to attach the caddy to the wheelchair or other appliance in an effectively balanced manner. Still further, there are issues concerning whether the top of the bottle is effectively secured, for example, if the carrier were to fall, given the dangerous circumstances surrounding a pressurized oxygen bottle. SUMMARY OF THE INVENTION [0005] It is, therefore, a primary object of the present invention to improve oxygen bottle carriers in an effort to overcome the above-noted deficiences of the prior art. [0006] It is a further primary object of the present invention to provide for the safety of patients who require the use of both oxygen and a walker or other appliance, such as a wheelchair, when moving from place to place. [0007] It is a still further object of the present invention to mount an oxygen bottle upon a walker or other appliance in a stable condition that will not impede the user's ability to safely control the walker. [0008] It is still a further object of the present invention to provide a carrier for an oxygen bottle that permits same to more effectively support an oxygen bottle in the instance the carrier should fall. In addition, the carrier, can preferably include convenient means for supporting additional items and storage. [0009] These and other objects of the present invention are attained by a carrier for supporting an oxygen bottle, said carrier including an open-top flexible container having at least a pair of stabilizing straps are attached to the container, said straps being securable to lateral portions of said applicance to prevent the container and thus the oxygen bottle from moving out of the commonly shared frame with the wheels. BRIEF DESCRIPTION OF THE DRAWING [0010] For a better understanding of these and other objects of the present invention, reference will be made to the following detailed description of the invention which is to be read in association with the accompanying drawings wherein: [0011] [0011]FIG. 1 is a front perspective view of a walker having an oxygen bottle carrier made in accordance with a first embodiment of the present invention; [0012] [0012]FIG. 2 is a partial sectional view taken along lines 2 - 2 in FIG. 1; [0013] [0013]FIG. 3 is a further partial sectional view taken along lines 3 - 3 in FIG. 2; [0014] [0014]FIG. 4 is an enlarged rear perspective view of the walker and carrier of FIGS. 1 - 3 ; [0015] [0015]FIG. 5 is a rear perspective view of an oxygen bottle carrier made in accordance with a second preferred embodiment of the present invention, the carrier being used in conjunction with a wheelchair; [0016] [0016]FIG. 6 is a partial top view of the oxygen bottle carrier of FIG. 5; and [0017] [0017]FIG. 7 is a partial enlarged top view of the carrier of FIGS. 5 and 6 with the upper retaining portion of the bag removed for purposes of clarity. DETAILED DESCRIPTION OF THE INVENTION [0018] The following discussion relates to certain preferred embodiments of an oxygen bottle carrier that is made in accordance with the present invention and used in conjunction with certain orthopedic applicances. It should be readily apparent that certain modifications and variations will be available to one of sufficient skill in the field, after consulting the teachings provided herein. [0019] With regard to the first embodiment, and turning now to FIG. 1, there is illustrated a walker, generally referenced 10 , that includes an oxygen bottle carrier made in accordance with the present invention. The walker 10 is of typical construction and includes a pair of side frames 12 and 13 . Each side frame 12 , 13 is of similar construction and includes a vertically disposed front leg 15 and a vertically disposed rear bar 16 . A horizontally disposed handrail 18 is integrally joined to the front and rear legs 15 , 16 and provides a means by which a patient can securely grip and control the walker 10 when situated between the two side frames 12 , 13 . A lower rail 20 also extends between the front and rear legs 15 , 16 of each side frame 12 , 13 in order to provide additional strength to the walker 10 . [0020] The two side frames 12 , 13 are supported in a spaced apart relationship by an upper cross member 22 and a lower cross member 23 that are secured between the two front legs 15 of the frame. The rear section of the walker 10 remains open so that a patient using the walker can pass in an unobstructed manner between the two side frames 12 , 13 . Each of the side frames 12 , 13 is equipped with a wheel 21 that is rotatably supported upon a shaft 24 that is mounted in the lower part of the front leg 15 . In assembly, the two shafts 24 and the two cross members 22 , 23 lie close to or actually within a common vertical plane. The above construction defines the majority of walkers in general, whose construction in and of itself is acknowledged as well known in the field and not forming an essential part of the present invention. [0021] A container, preferably in the form of an flexible open top bag 29 , is suspended from the upper cross member 22 of the walker 10 , as best illustrated in FIGS. 1 and 4. The flexible bag 29 is preferably made from a flexible fabric, such as polyester or other lightweight material, and is of a size and shape such that the bag can hold a standard size oxygen bottle 25 that is slidably inserted into the bag through a top opening thereof. A close sliding fit is provided between the bottle 25 and the bag 29 so that the bottle is snugly supported within the bag. Preferably, the upper mouth portion of the bag 29 includes an imbedded plastic-reinforced periphery, see also FIG. 7, that maintains a predetermined shape and has adequate stiffness to easily permit a bottle 25 to be fitted directly into the bag 29 . The length of the bag 29 , according to this embodiment, is such that the upper part of the oxygen bottle 25 protrudes through the top opening whereby the regulator 26 and gauges 27 that are associated with the bottle are exposed and thus are easily accessible to one using the walker 10 . [0022] The flexible bag 29 is suspended from the top cross member 22 of the walker 10 by two-piece hanger straps which include a center strap 30 , and two smaller side straps 32 and 33 that are spaced to either side of the center strap. The two extreme ends of each strap are sewn into the bag 29 and the free ends of the straps are joined by releasable fasteners. In assembly, the flexible bag 29 is centered upon the upper cross member 22 between the two side frames 12 , 13 and each of the side straps 32 , 33 are looped over the cross member 22 and their free ends are tightly fastened together using a hoop and loop (e.g., Velcro) type fastener 40 as illustrated in FIG. 3. To pull the bag 29 securely against the cross member 22 , the hook and loop fastener includes a hook pad that is sewn into one of the strap's free ends and an elongated loop pad that is sewn into the free end of the other strap. [0023] The two side straps 32 , 33 are primarily used to hold the flexible bag 29 centered between the side frames 12 , 13 and to stabilize the top section of the bag. The center strap 30 , on the other hand, is designed to support the main weight of the bag 29 and a contained bottle 25 . The center strap 30 contains a first top piece 45 that has one end sewn into the bag 29 so that the top piece can loop over the upper cross member 22 , as illustrated in FIG. 2. The bottom piece of the center strap 30 has one end sewn into the bag 29 so that this end of the strap extends well below and behind the lower cross member 23 of the walker 10 when the top piece 45 is looped over the upper cross member 22 . As illustrated in FIG. 2, the two free ends of the center strap 30 are cojoined by a heavy duty buckle 47 . The strap parts 30 and the buckle 47 are fabricated of high strength materials, so that the strap is well able to support the container and the bottle 25 in an upright position upon the upper cross members 22 . [0024] The bottom section of the bag 29 is further stabilized by a pair of lower stabilizing straps 50 and 51 . Each stabilizing strap 50 , 51 has one end sewn into the lower part of the bag 29 and is of sufficient length so that the opposite ends of the strap can be looped around the lower part of one of the front legs of the walker as illustrated in FIGS. 1 and 4. Here again, hook and loop type fasteners 53 are employed to fasten the free end of each strap upon itself. Each fastener 53 , for example, may have a hook pad sewn into the free end of the strap and an elongated loop pad sewn into a length of its body section so that the strap can be pulled taut and closed to hold the bag centered between the side frames. [0025] As should now be evident, the bottle's center of gravity is located equidistance between the two side frames 12 , 13 of the walker 10 and lies about or within the vertical plane of the wheel shafts 24 . A patient (not shown) using the walker 10 needs simply to tip up the rear legs 16 of the walker about the axis of the wheels 21 and propel the walker in a forward direction. Because the center of gravity of the contained oxygen bottle 25 lies in a vertical plane that passes through or very close to the axis of the wheel 21 , the walker 10 can be easily tipped and propelled forwardly without much more exertion than that produced by a walker that is not equipped with an oxygen bottle. It should be further noted that because the bottle 25 is stabilized in this centered position, there is no tendency of the walker 10 to tip from side to side and it can be safely turned around corners without tipping over. [0026] As illustrated in FIG. 4, an open top pouch 60 is also sewn into the bag 29 about opposite the location of the strap fastener 30 . One or more tools 61 associated with the oxygen bottle 25 can be conveniently stored in the pouch 60 so that they are readily available in the event some adjustment must be made to the regulator 26 and other parts of the oxygen system while the walker 10 is in use. [0027] Referring now to FIGS. 5 - 7 , there is described an oxygen bottle carrier 70 made in accordance with a second embodiment of the present invention. The carrier in this instance is uses in conjunction with a wheelchair 74 shown most particularly in FIG. 5, the wheel chair including a frame 78 that is defined by a seat 82 and a backrest 86 . The frame 78 further includes a pair of spaced vertical handles 90 disposed on either side of the backrest 86 used for pushing the wheelchair 74 , whereas the seat 82 includes armrests 94 and respective vertically extending front and rear legs 98 , 102 . The wheelchair 74 further includes a pair of swivelable front wheels 106 connected to a lower portion of the front legs 98 of the frame 78 as well as a pair of rear wheels 110 attached to the lower portion of each of the rear legs 102 . The above construction defines the majority of wheelchairs in general, whose construction in and of itself is acknowledged as well known in the field and not forming an essential part of the present invention. [0028] Referring to FIGS. 5 and 6, the carrier 70 is defined by a flexible bag 114 made preferably from a fabric such as polyester or other lightweight material and having a configuration that permits same to establish a close fitting relationship with a standard sized oxygen bottle, shown partially as 25 . The bag 114 includes an upper mouth section 118 that includes a peripheral plastic reinforcement section, as more particularly shown at least partially in FIG. 7. The purpose of this section 118 is to provide certain stiffness and rigidity in initially accommodating an oxygen bottle 25 (not shown in FIG. 7), wherein the bottle can easily be loaded by one person while the carrier is attached to the appliance, whether a walker or wheelchair, for example. [0029] Still referring to FIGS. 5 and 6, the flexible bag 114 defining the carrier 70 further includes a flexible bottle retaining section 122 directly above the upper mouth section 118 made from a fabric, such as nylon, polyester or other lightweight material and including a drawstring 126 in order to tighten the section once a bottle 25 has been successfully accommodated into the bag 114 . The above section 122 is sewn, according to this embodiment, to the upper periphery of the upper mouth section 118 of the bag 114 . It should be readily apparent, however, that other forms of flexible sections can be attached through various means such as zippers, clips, and the like. The flexible covering section can also be alternately made from a transparent material and can cover the regulator and gauges, but provide needed access to the oxygen line directly. [0030] The carrier 70 further includes separate upper and lower retaining means for retaining the bag to each of the vertical handles 90 of the wheelchair behind the backrest 86 . The upper retaining means includes a strap 130 sewn or otherwise attached, either permanently or removably, to the bag 114 and including respective ends 134 and 138 . Each of the ends 134 , 138 of the strap 130 include a buckle 137 and a respective strap section 139 , wherein the entire length of the strap can be adjusted at either end, each of the strap sections being wrappable about a portion of the handle 90 . [0031] The bottom section of the bag 114 is further stabilized by a pair of lower stabilizing straps 140 , 142 . Each stabilizing strap 140 , 142 has one end sewn into the lower part of the bag 114 and is of sufficient length so that the opposite ends of the strap can be looped around the lower part of one of the rear legs 102 of the wheelchair 74 . Preferably, hook and loop type fasteners 145 are employed to fasten the free end of each strap 140 , 142 upon itself. Each fastener 145 , for example, may have a hook pad sewn into the free end of the strap 140 , 142 and an elongated loop pad sewn into a length of its body section so that the strap can be pulled taut and closed to hold the bag 114 centered between the rear legs 102 of the wheelchair 74 . [0032] Finally, the upper mouth section 118 of the bag 114 includes a pair of slots 149 , FIG. 7, used to accommodate a pair of straps that retain an outer basket 152 that can be used for storage of items. The basket 152 can further include at least one exterior pocket 156 . [0033] Parts List For FIGS. 1 - 7 [0034] [0034] 10 walker [0035] [0035] 12 side frame [0036] [0036] 13 side frame [0037] [0037] 15 front leg [0038] [0038] 16 rear leg [0039] [0039] 18 handrail [0040] [0040] 20 lower rail [0041] [0041] 21 wheels [0042] [0042] 22 upper cross member [0043] [0043] 23 lower cross member [0044] [0044] 24 wheel shafts [0045] [0045] 25 oxygen bottle [0046] [0046] 26 regulator [0047] [0047] 27 gauges [0048] [0048] 29 flexible bag [0049] [0049] 30 center strap [0050] [0050] 32 side strap [0051] [0051] 33 side strap [0052] [0052] 45 top piece [0053] [0053] 47 buckle [0054] [0054] 50 stabilizing strap [0055] [0055] 51 stabilizing strap [0056] [0056] 53 fasteners, hoop and loop [0057] [0057] 60 pouch [0058] [0058] 61 tool [0059] [0059] 70 carrier [0060] [0060] 74 wheelchair [0061] [0061] 78 wheelchair frame [0062] [0062] 82 seat [0063] [0063] 86 backrest [0064] [0064] 90 handles [0065] [0065] 94 armrests [0066] [0066] 98 front legs [0067] [0067] 102 rear leags [0068] [0068] 106 front wheels [0069] [0069] 110 rear wheels [0070] [0070] 114 bag [0071] [0071] 118 upper mouth section [0072] [0072] 122 flexible retaining section [0073] [0073] 126 drawstring [0074] [0074] 130 strap [0075] [0075] 134 strap end [0076] [0076] 137 buckle [0077] [0077] 138 strap end [0078] [0078] 139 strap section [0079] [0079] 140 stabilizing strap [0080] [0080] 142 stabilizing strap [0081] [0081] 145 hook and loop-type fasteners [0082] [0082] 149 slots [0083] [0083] 150 basket straps [0084] [0084] 152 outer basket [0085] [0085] 156 exterior pocket [0086] While the present invention has been particularly shown and described with reference to the preferred mode as illustrated in the drawing, it will be understood by one skilled in the art that various changes in detail may be effected therein without departing from the spirit and scope of the invention as defined by the claims. For example, the basket attachment described in the wheelchair embodiment can easily be utilized in a walker-type carrier as well. In addition, it should be apparent that the herein described carrier can be used with other appliances and that, for example, other pockets can be formed on the flexible bag other than a tool pouch. [0087] In addition, the preceding embodiments each supported a specifically sized oxygen bottle though it should be apparent that type “D” and “E” bottles, among others, can be supported. Moreover, the present carrier can be configured to accommodate different or varying lengths of bottles using the identical supporting details to attach to the various orthopedic appliances but include means within the bottle to define various sized compartments or enclosures to properly accommodate a given bottle. Such means can include belts, strips, hook and loop fasteners, as well as flaps, among others.

A carrier for retaining an oxygen bottle said carrier comprising a flexible open-top container adapted for maintaining a close fitting relationship with an oxygen bottle, said container including an upper mouth portion made at least partially from a stiff material to enable an oxygen bottle to be loaded therein vertically; and a flexible upper bottle retaining portion, for preventing said bottle from falling out of said carrier.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Not Applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH [0002] Not Applicable BACKGROUND OF THE INVENTION [0003] The use of stents, and other implantable medical devices such as grafts, stent-grafts, vena cava filters, etc, hereinafter referred to cumulatively as stents, to maintain the patency of bodily lumens is well known. [0004] Stents are typically delivered via a catheter in an unexpanded configuration to a desired bodily location. Once at the desired bodily location, the stent is expanded and implanted in the bodily lumen. [0005] Typically, a stent will have an unexpanded (closed) diameter for placement and an expanded (opened) diameter after placement in the vessel or the duct. Some stents are self-expanding; some stents are expanded mechanically with radial outward force from within the stent, as by inflation of a balloon; and some stents, known as hybrid stents, have one or more characteristics common to both self-expanding and mechanically expandable stents. [0006] An example of a mechanically expandable stent and associated delivery system is shown in U.S. Pat. No. 4,733,665 to Palmaz, which issued Mar. 29, 1988, and discloses a number of stent configurations for implantation with the aid of a catheter. The catheter includes an arrangement wherein a balloon inside the stent is inflated to expand the stent by plastically deforming it, after positioning it within a blood vessel. [0007] A type of self-expanding stent is described in U.S. Pat. No. 4,503,569 to Dotter which issued Mar. 12, 1985, and discloses a shape memory stent which expands to an implanted configuration with a change in temperature. Self-expanding stents are constructed from a wide variety of materials including nitinol, spring steel, shape-memory polymers, etc. [0008] In many stent delivery systems, particularly those used to deliver a self-expanding stent, the stent is typically retained on the catheter via a retention device such as a sheath. The stent may be deployed by retracting the sheath from over the stent. To prevent the stent from being drawn longitudinally with the retracting sheath, many delivery systems provide the catheter shaft with one or more bumpers or hubs. [0009] However it is known that in many cases when a sheath is withdrawn from a stent, particularly a self-expanding stent constructed of shape memory material, the stent may be displaced longitudinally relative to the catheter shaft as a result of so-called “stent jumping,” wherein when a sleeve or sheath is withdrawn from the stent during delivery the stent frictional forces and stent constrainment forces exerted by the retracting sleeve on the stent are less than those of the stent expansion force at an angle exiting the stent delivery system. As a result, in some instances, as the sheath is withdrawn from about the stent, the stent will tend to migrate or “jump” longitudinally relative to the stent mounting region of the catheter resulting in the imprecise delivery of the stent and/or distortion of the stent body. Because a portion of the stent is already expanding beyond the diameter of the catheter when stent jumping typically occurs, the presence of one or more hubs on the catheter shaft will typically not prevent stent jumping. [0010] It would thus be desirable to provide a stent delivery system and/or one or more components thereof which may reduce or eliminate occurrences of stent jumping in order to improve the accuracy of stent placement within a vessel or other body space. [0011] All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety. [0012] Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below. [0013] A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims. BRIEF SUMMARY OF THE INVENTION [0014] The present invention is directed to several embodiments which seek to improve the accuracy of stent placement and reduce the occurrence and severity of stent jumping. [0015] For example, in at least one embodiment, the invention is directed to a stent delivery system that reduces the potential for stent jumping by providing one or more protrusions to which the stent, or one or more portions thereof, may be temporarily engaged during retraction of a stent retaining sleeve or sheath. The protrusions do not interfere with the radial expansion of the stent but will prevent the stent from moving longitudinally relative to the catheter. [0016] In some embodiments, the invention is directed to one or more bands or collars, that may be disposed about the catheter under the stent. Bands may be provided with a variety of surface features such as bumps, flaps, tabs, fins or other protrusions or surface features, against or about which a portion of the stent may be temporarily engaged. In at least one embodiment the bands are radiopaque. In some embodiments the a band is positioned adjacent to or at least partially under an end of the stent to allow the surface features of the band to engage the end affects of the stent while the remaining portion of the stent is freed to expand. In at least one embodiment, a stent is provided with one or more end regions which define a relatively large opening or gap in the stent structure to engage the surface features of an engagement band catheter shaft. [0017] These and other embodiments which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for a better understanding of the invention, its advantages and objectives obtained by its use, reference should be made to the drawings which form a further part hereof and the accompanying descriptive matter, in which there is illustrated and described embodiments of the invention. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) [0018] A detailed description of the invention is hereafter described with specific reference being made to the drawings. [0019] [0019]FIG. 1 is a perspective view of an embodiment of the invention. [0020] [0020]FIG. 2 is a perspective view of the embodiment shown in FIG. 1 wherein the band defines an alternative pattern of surface features. [0021] [0021]FIG. 3 is a partial side view of a stent retaining region of a stent delivery catheter with the band of FIG. 1 positioned thereon and engaged to a portion of a stent. [0022] [0022]FIG. 4 is a perspective view of the band of FIG. 1 wherein the surface features are provided by cutting and folding selected portions of the band. [0023] [0023]FIG. 5 is a perspective view of the embodiment of FIG. 1 wherein the surface features are tabs. [0024] [0024]FIG. 6 is a cross-sectional view of the embodiment of FIG. 1 wherein the surface features are substantially fin shaped. [0025] [0025]FIG. 7 is a partial side view of the embodiment shown in FIG. 2 wherein at least a portion of the stent defines an enlarged opening for engaging the band. [0026] [0026]FIG. 8 is a cross-sectional side view of an embodiment of the invention. [0027] [0027]FIG. 9 is a cross sectional side view of the embodiment of FIG. 8 shown during stent delivery. [0028] [0028]FIG. 10 is a cross sectional side view of the embodiment of FIGS. 8 and 9 shown after the stent is fully deployed. DETAILED DESCRIPTION OF THE INVENTION [0029] While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. [0030] For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated. [0031] As mentioned above the present invention is embodied in a variety of forms. For example, in the embodiment shown in FIG. 1 the invention is embodied in a stent retaining band or collar, indicated generally at 10 , which has an outer surface 12 comprising one or more protrusions 14 . As illustrated by FIGS. 1 and 2 the protrusions 14 may have similar or differing dimensions and orientations relative to one another. In addition, the protrusions 14 may be arranged or positioned on the outer surface 12 by columns, rows, or any other pattern desired. [0032] As is shown in FIG. 3, the pattern of protrusions 14 is determined, at least in part, based on the geometry of the stent 26 to which the protrusions 14 are designed to engage. As is shown, band 10 is constructed and arranged to be mounted on the shaft 16 of a catheter 18 . The band is positioned on a stent retaining portion 20 of the shaft 16 . Typically the band 10 is positioned such that one or more of the protrusions 14 pass at least partially through one or more of the openings 22 defined by the tubular wall 24 of a stent, stent-graft, graft, filter or other implantable medical device, hereinafter referred to collectively as a stent 26 or stents. [0033] A band 10 may be positioned underneath one or both ends 30 of the stent 26 , or any other portion of the stent desired. In some embodiments the band 10 may have a length equal to or greater than the length of the stent 26 . [0034] The protrusions 14 extend at least partially through the openings 22 to engage the portions or struts 28 of the stent 26 immediately adjacent thereto. In addition to, or as an alternative to positioning the protrusions 14 through one or more of the stent openings 22 , in some embodiments the protrusions 14 may be positioned adjacent to one or both of the ends 30 of the stent 26 . [0035] In some embodiments of the invention, a stent 26 is provided with ends 30 whose struts 28 have been constructed to provide openings 22 which are enlarged or otherwise modified in order to more readily accommodate the positioning of the protrusions 14 therein. [0036] In the various embodiments shown and described herein, the band 10 may be at least partially radiopaque so that the band 10 may be utilized as a marker band on a stent delivery catheter 18 such as is shown in FIGS. 3 and 8- 10 . [0037] Band 10 may be constructed of a wide variety of materials including but not limited to metals, plastic, rubber, silicone, polymers, etc. Where the band 10 is at least partially constructed of metal, in at least one embodiment the metal is a radiopaque metal such as platinum, gold, iridium, etc. In at least on embodiment the metal is a biocompatible metal such as including but not limited to stainless steel, nitinol, cobalt and alloys thereof. Some polymer materials suitable for use in construction of the band 10 include one or more polyetheramide block copolymers, such as the ester linked polyetheramides sold under the trade mark PEBAX®; polyetherester block copolymer such as sold under the ARNITEL® and HYTREL®; nylon, polyethylene, etc. [0038] The protrusions 14 may be constructed of the same or different material as the rest of the band or band body 15 . [0039] As indicated above the protrusions 14 may be of any shape or configuration. For example in the embodiments shown in FIGS. 1-2 the protrusions are raised portions or bumps on the surface 12 of the band and may be formed by a variety of forming mechanisms including for example molding the band and protrusions into the shape shown. In some embodiments the protrusions 14 may be made from altering the inner shaft 16 to homogeneous with the material of the band 10 . Protrusions 14 may also be separate elements which are welded, stamped, punched, adhesively engaged, injection molded, melted or otherwise positioned and/or engaged onto the surface 12 of the band 10 . However, as is shown in FIG, 4 , protrusions 14 may also be formed by cutting out one or more openings 40 into the band 10 . The material or flap 42 cut from the tube 10 remains integral and engaged to the tube 10 along at least one line or point of engagement 44 . The resulting flap 42 of tube material is oriented to extend at least partially outward from the tube surface 12 to act as a protrusion 14 . Where multiple flaps 42 are provided for, flaps 42 may be of any shape desired and may be of a uniform or different configuration relative to one another. [0040] Alternatively, the band 10 may be provided with one or more flaps 42 to act as protrusions 14 without cutting or otherwise providing the band 10 with openings flaps or slots 40 from the band 10 by molding or otherwise shaping the band 10 to include flap style protrusions 14 such as are shown in FIG. 5. [0041] As a result of the plastic or deformable nature of the material of the band 10 , in some cases one or more protrusions 14 may be provided by pinching and or pulling selected portions of the band 10 together and radially outward in order to form one or more substantially fin shaped protrusions 14 such as is shown in FIG. 6. A band 10 may be provided with substantially fin shaped protrusions by manipulating a band 10 in the manner described or by molding or other wise forming the tube 10 with the protrusions already in place. [0042] As indicated above, the shape, size and arrangement of the protrusions of the band are selected in order to temporarily engage at least a portion of a stent when the stent is engaged to the stent retaining area 20 of a delivery catheter. As is shown in FIG. 7, where the band 10 employs flap, fin or other somewhat elongated protrusions 14 , the protrusions are designed to be positioned within the spaces or openings 22 between adjacent struts 28 of the stent 26 . [0043] When a stent delivery catheter 18 , such as is shown in FIG. 8 being advanced through a vessel 50 , is equipped with one or more bands 10 , the one or more protrusions 14 of the bands 10 will engage the stent 26 in the manner described above. [0044] As is shown in FIG. 9, when the catheter 18 has been positioned within the vessel 50 at a desired location, the stent retaining sheath 52 is retracted from the stent retaining area 20 to expose the stent 26 for delivery. In the embodiment shown, the protrusions 14 on the band 10 positioned adjacent to the distal end 56 of the stent 26 , will continue to engage the stent 26 until the sleeve 52 is fully retracted off of the stent 26 , such as is shown in FIG. 10. As a result of the engagement between the protrusions 14 and the stent 26 , the band 10 acts to anchor the stent 26 to the shaft 16 thereby preventing longitudinal jump of the stent 26 relative to the catheter 18 . Thus the stent 26 is deployed from the catheter 18 and into the intended area of the vessel 50 with improved precision and reliability. [0045] The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims. [0046] Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim 1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below. [0047] This completes the description of the preferred and alternate embodiments of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto.

A method and apparatus for reducing the longitudinal aspect of the catheter to stent force comprises at least one grip member for use with a stent delivery system. The grip engages a stent in the unexpanded state prior to delivery of the stent by retracting a stent retaining sheath. The grip comprises a body region having an outer diameter, a first end and a second end. The outer diameter of the first end is greater than the outer diameter of the second end. The grip is at least partially constructed from a polymeric material.

CROSS-REFERENCE TO RELATED APPLICATIONS Not applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable. BRIEF SUMMARY OF THE INVENTION When displayed, greeting cards are typically organized on a display fixture that has multiple rows or levels upon which to sit the cards. Each row may have a front piece that holds in the card, yet is transparent or short enough to still view at least a portion of the greeting card. Because display fixtures are manufactured to have a specified amount of rows or levels at a specified depth, in order to adjust the specifications of a display fixture, other pieces must be used, for example, attaching a separate divider to the display fixture to add another level or tier between a set row of the display fixture. By providing another row using a dividing piece, another set of greeting cards may be displayed between cards already displayed on adjacent rows of the original display fixture, thereby increasing the density of the overall display. However, when an extra row is not desired, the dividing piece must be removed from the display fixture and stored elsewhere. This presents problems with storage and may result in a loss of the divider. In one embodiment of the present invention, a card assembly apparatus for displaying multiple rows of greeting cards is provided. The apparatus comprises, in part, a display section with a back piece, one or more rows, and one or more front pieces, where a greeting card is placed on a row and portions thereof can be viewed through and/or above the front piece. The apparatus further comprises a collapsible row having a front divider and bottom divider attached at a joint. The joint permits movement of the collapsible row between a use or display position and a storage or non-use position. In the display position, the front divider is pulled out away from the display fixture, such that the bottom divider is perpendicular to the back piece. This allows for a greeting card to be supported for display on the bottom divider. In the storage or non-use position, the joint allows the front divider to be pushed against the back piece, such that the bottom divider is setting against the back piece. The apparatus also includes a divider clip that hooks on the front piece of the display section to separate cards and assist with maintaining the collapsible row in the display position. In yet another embodiment, a collapsible row for use with a display section for displaying greeting cards is provided. The collapsible row comprises, in part, a front divider, a bottom divider, and a joint connecting the front and bottom dividers. The joint allows the collapsible row to be moved between a display position, where the front divider is pulled out away from a display section such that the bottom divider is perpendicular to the back of the display fixture to allow for a greeting card to be displayed on the bottom divider, and in a non-use position, where the front divider can be pushed against the back of the display section such that the bottom divider is setting against the display section. In still another embodiment, a divider or support clip for separating greeting cards within a row of a display fixture and supporting a collapsible row is provided, in accordance with an embodiment of the present invention. The divider clip includes, in part, a clipping mechanism to attach the divider clip to the display fixture and an adjustable portion capable of adjusting itself to support a collapsible row used in the display fixture. BRIEF DESCRIPTION OF THE DRAWINGS The features of the invention noted above are explained in more detail with reference to the embodiments illustrated in the attached drawing figures, in which like reference numerals denote like elements, in which FIGS. 1-7C illustrate several possible embodiments of the present invention, and in which: FIG. 1 is a front perspective view of an exemplary card display fixture with a plurality of divider pieces, in accordance with an embodiment of the present invention; FIG. 2 is a cross-sectional side elevation view of the card display fixture with a plurality of divider pieces of FIG. 1 taken along the line 2 - 2 ; FIGS. 3A and 3B are enlarged, fragmentary views taken generally in the areas 3 A and 3 B of FIG. 2 and illustrate the cooperation between the divider piece and a clip; FIG. 4A is a perspective view of a dividing clip constructed in accordance with a first embodiment and illustrated in an open or support position; FIG. 4B is a side elevation view of the dividing clip of FIG. 4A in a hooked position; FIG. 5 illustrates a second possible embodiment of a dividing clip of the present invention; FIGS. 6A-6C illustrate a third possible embodiment of a dividing clip of the present invention; and FIGS. 7A-7C illustrate a fourth possible embodiment of a dividing clip of the present invention. DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings in more detail and initially to FIG. 1 , numeral 10 generally designates a card assembly apparatus constructed in accordance with an embodiment of the present invention. In this illustrated example, the apparatus 10 includes a display section or panel or tray 12 for coupling to and support on a display fixture (not shown). The display fixture may be any standard display fixture as is known in the art. As illustrated, the display section 12 includes two permanent levels 14 for displaying greeting cards 16 . As illustrated in FIG. 2 , each level 14 is defined by a ledge 18 , upon which an L-shaped row section 20 is supported. Each row section 20 includes a front wall 22 and a bottom wall 24 . Each front wall 22 is of a sufficient height to contain a greeting card 16 , while still allowing a portion thereof to be visible above the front wall 22 . Though not necessary, the row sections 20 , and in particular the front wall 22 , are preferably transparent, such that the full face of the cards 16 can be viewable. Each level 14 of the display section 12 also includes a rear wall 26 against which the greeting cards 16 would normally rest. The greeting cards 16 are supported on the bottom wall 24 of the row sections 20 . To provide for the ability to change the display arrangement, the illustrated display section 12 also includes a plurality of convertible rows 28 that are capable of being moved between a use or display position and a storage or non-use position. As illustrated in FIG. 1 , the display section 12 includes four convertible rows 28 , two to form an upper row and two to form a lower row. Alternatively, single convertible rows 28 could run the width of the display section 12 , such that only two convertible rows 28 would be provided. As illustrated, the upper left convertible row 28 is provided in the display position, while the upper and lower right convertible rows 28 are in the storage position. The lower left convertible row 28 has been illustrated in FIG. 1 in a position close to the storage position. Each convertible row 28 includes a front divider 30 and a bottom divider 32 . The front and bottom dividers 30 , 32 are connected by a joint 34 that permits the two dividers 30 , 32 to move relative to one another to create the two positions. In the display position, the front divider 30 is pulled out away from the rear wall 26 of the display section 12 . Such a position allows the bottom divider 32 of the convertible row 28 to be generally perpendicular to the rear wall 26 of the display section 12 , thereby providing another level or row to the overall display section 12 . Thus, in the configuration illustrated in FIG. 1 , the top row of the display section 12 is able to display greeting cards 16 at its set or permanent level 14 and additional greeting cards 16 on a level provided by the convertible row 28 . The front divider 30 of the convertible row 28 acts similarly to the front wall 22 of the row section 20 , and serves to support the greeting card 16 . The convertible row 28 will be further described herein below. The display section 12 preferably also includes a plurality of divider or support clips 36 . In the prior art, divider clips are clipped on the front piece (e.g., front wall 22 ) of a card row to horizontally separate different types of greeting cards 16 . In the present invention, the divider clips 36 may also be used to support the convertible row 28 and maintain it in either the display or storage positions. Multiple embodiments of divider clips 36 of the present invention are illustrated and will be further described below. When a convertible row 28 is no longer desired for use in displaying a row of greeting cards 16 , it may be collapsed and the pushed back against the rear wall 26 , as illustrated by the convertible rows 28 on the right side of the display section 12 of FIG. 1 . The convertible rows 28 may be moved from the display position to the storage position by folding the convertible row 28 at the joint 34 and moving the front divider 30 back against the rear wall 26 . This position and alternate embodiments are described in more detail below. Turning now to FIG. 2 , a cross-sectional, side elevation view of the card assembly apparatus 12 in FIG. 1 is shown. In this view, two convertible rows 28 are shown. The upper convertible row 28 is illustrated in the display position, with the bottom divider 32 generally perpendicular to the rear wall 26 . As will be further discussed below, a proximal edge 38 of the bottom divider 32 of the convertible row 28 is rotatably received in a horizontal channel 40 in the rear wall 26 of the display section 12 . The bottom divider 32 of the convertible row 28 supports the greeting card 16 , thereby providing another row to the set permanent row or level 14 immediately below that is also displaying a greeting card 16 . A portion of that greeting card 16 is displayed over the front wall 22 and a top edge 42 thereof rests against the front of the front divider 30 of the upper convertible row 28 . The upper divider clip 36 , which is adjacent to the upper convertible row 28 in the display position, is in its open or support position. A movable portion 44 of the divider clip 36 extends downward and provides support for the bottom divider 32 of the convertible row 28 . This serves to stabilize and support the convertible row 28 when displaying greeting cards 16 . The lower convertible row 28 of FIG. 2 is illustrated in the storage position. The bottom divider 32 of the convertible row 28 has been rotated downwardly and moved to an orientation where it is closer to parallel to the rear wall 26 of the display section 12 , thereby allowing the convertible row 28 to collapse and rest against the back of the permanent row or level 14 . By being collapsible, the convertible row 28 , when not desired for displaying an additional row of cards 16 , does not need to be removed from the display section 12 . Such a configuration thus avoids the need to remove a divider and store it until an additional row is needed. Here, in the bottom portion of FIG. 2 , only the set row of the display section 12 , formed by the row section 20 , is being used for displaying a greeting card 16 . When the convertible row 28 is in the storage position, the divider clip 36 adjacent to it is adjusted so that it presses against the convertible row 28 , holding it in place against the rear wall 26 of the display section 12 . Note that a divider clip 36 may be used adjacent a convertible row 28 whether it is in the display or storage position, and is adjusted accordingly As will be discussed in greater detail below, an adjustable divider clip, such as divider clip 36 , allows for more flexibility when determining which position a convertible row 28 is to be used. One skilled in the art will appreciate that various embodiments of divider clips may be used, and will be discussed in more detail below. Referring now to FIGS. 3A and 3B , enlarged views of the divider clips 36 from FIG. 2 are provided, in accordance with embodiments of the present invention. In FIG. 3A , where the convertible row 28 is in the display position, the divider clip 36 is in its open or support position. The divider clip 36 has a body portion 46 with a notch 48 therein. The notch 48 is sized to receive an upper edge 50 of the front wall 22 of a row section 20 , as illustrated. The notch 48 may also receive the upper edge 50 of the front divider 30 if the divider clip 36 is placed on the convertible row 28 when it is in its display position to separate cards 16 placed thereon. The notch 48 may also include a raised rib 52 therein to assist with retaining the divider clip 36 on the front wall 22 or front divider 30 , as the case may be. While a notch 48 has been shown, one skilled in the art will appreciate that any method of attaching the divider clip 36 to the front of the display section 12 may be used in accordance with this invention. The body portion 46 is connected with the movable portion 44 via an arm 54 . The arm 54 is preferably flexible such that it may be bent between the illustrated support and hooked positions. In that regard, the divider clip 36 may be made of a plastic and formed by a molding process. In such an arrangement, the arm may be naturally biased to a position intermediate the illustrated support and hooked positions. In this way, the arm 54 provides lift and secure engagement to the convertible row 28 when it is in the support position. To assist with secure engagement with the convertible row 28 , the movable portion 44 is provided with a nock 56 in its outer periphery 58 . The nock 56 is intended to receive a lower edge 60 of the front divider 30 of the convertible row 28 , as illustrated in FIG. 3A . In this arrangement, the clip 36 holds the convertible row 28 in the display position by preventing downward and rearward movement of the front divider 30 . Downward pressure on the bottom divider 32 , caused by the weight of the front divider 30 and any greeting cards 16 placed in the convertible row 28 , is transferred through the clip to the front wall 22 . Further, the body portion 46 spaces the front divider 30 from the front wall 22 and prevents forward rotation of the front divider 30 . To further prevent unintended movement of the convertible row 28 from the display position to the storage position, friction arrangement is provided. In that regard, the proximal edge 38 of the bottom divider 32 is provided with a generally cylindrical tube portion 62 . The tube portion 62 has a longitudinal slot 64 therein adjacent a stop flange 66 . When the tube portion 62 is received in the channel 40 of the rear wall 26 of the display section 12 , a longitudinal ridge 68 is received in the slot 64 when the bottom divider 32 is in a generally horizontal position, as illustrated in FIG. 3A and which corresponds with the convertible row 28 being in its display position. The ridge 68 in the slot 64 discourages rotational movement of the tube portion 62 in a direction where the ridge 68 is moved out of the slot 64 , as such requires the tube portion 62 to be compressed, as illustrated in FIG. 3B . This is helpful when the convertible row 28 is first placed in the display position before the divider clips 36 can be hooked on to the bottom of the convertible row 28 . The stop flange 66 discourages rotational movement of the tube portion 62 in a direction past that needed for the display position. In FIG. 3B , where the convertible row 28 is in the storage position, the divider clip 36 is in its hooked position. In this position, the arm 54 is generally perpendicular to the rear wall 26 of the display section 12 and preferably presses against the convertible row 28 to keep it collapsed and in the storage position. To maintain the divider clip 36 in the hooked position, the divider clip 36 , in this embodiment, includes a projection 70 that extends outwardly from a side of the arm 54 and is received in an aperture 72 of a tab 74 that extends from the body portion 46 of the divider clip 36 , as best illustrated in FIGS. 4A and 4B . Alternate embodiments of divider clips are illustrated and will be described below. FIGS. 4A and 4B illustrate alternate views of the first embodiment of the divider clip 36 . In this illustrated embodiment, the divider clip 36 comprises a singular piece of material. FIG. 4A shows the divider clip 36 is in its open or support position that corresponds with the convertible row 28 being in the display position, as discussed above. FIG. 4B shows the divider clip 36 is in its hooked position that corresponds with the convertible row 28 being in the in a storage position. As can be seen, the projection 70 is received in the aperture 72 to secure the movable portion 44 in a location to abut the front divider 30 of a convertible row 28 to maintain it in a storage position. The divider clip 36 may also be provided with a recess portion 75 in the body portion 46 adjacent to and of a corresponding shape as the notch 48 . As illustrated in FIG. 4A , the notch may be part of a clipping member 77 that extends laterally outward from the body portion 46 . The recess portion is adjacent a proximal end 79 of the clipping member and is designed to receive a distal end 81 of a clipping member 77 of another divider clip 36 placed adjacent thereto. This arrangement allows for a plurality of divider clips 36 to be coupled together for easy storage and to support the ease/speed of installation of the divider clips 36 during a reset/conversion of a display or a reduction/increase in the number of rows. Referring now to FIG. 5 , an alternative embodiment of a divider clip 36 is illustrated, in accordance with the present invention. The divider clip 36 has a body portion 76 with a clipping member 78 for attaching the divider clip 36 to a front wall 22 or front divider 30 . The divider clip further includes an adjustable portion 80 , which connects to the body portion 76 of the divider clip 502 via a bend 82 . The bend 82 functions similar to the arm 54 and biases the adjustable portion 80 to the position illustrated. The divider clip 36 further includes a hook 84 extending from a lower portion of the body potion 76 and having a notch 86 . In this embodiment, the divider clip 36 is illustrated in a position for use when the convertible row 28 is in the storage position. The adjustable portion 80 extends away from the body portion 76 of the divider clip 36 to press against the front divider 30 , which itself rests against the rear wall 26 of the display section 12 , as described above. When a convertible row 28 is used in the display position, the bend 82 will flex, and the adjustable portion 80 will be moved back into a correspondingly shaped cutout 88 . The lower edge 60 of a front divider 30 will then rest or otherwise be secured in the notch 86 of the hook 84 . Turning now to FIGS. 6A-6C , a third possible embodiment of a divider clip 36 is shown, in accordance with the present invention. Here, the divider clip 36 includes a fixed portion 90 and a rotatable portion 92 . These portions 90 , 92 are connected at joint 94 , about which the rotatable portion 92 pivots. The fixed portion 90 includes a clipping mechanism 96 for attaching the clip 36 to a front wall 22 or front divider 30 . When a convertible row 28 is in a display position, the divider clip 36 oriented to the position illustrated in FIGS. 6A and 6C , where the rotatable portion 92 is generally parallel to the fixed portion 90 . In this arrangement, a ledge 98 extends outwardly from a lower edge 100 of the rotatable portion 92 and is used to support the lower edge 60 of the front divider 30 of the convertible row 28 , as discussed above with respect to FIG. 3A . FIG. 6B illustrates the rotatable portion 92 rotated to be generally perpendicular to the fixed portion 90 , which is the position of the divider clip 36 when the convertible row 28 is in a storage position. FIGS. 7A-7C illustrate a fourth possible embodiment of a divider clip 36 , where the divider clip includes two separate pieces: a clipping portion 102 , which includes a clipping mechanism 104 , and an adjustable portion 106 , which slides on the clipping portion 102 . Flaps 108 secure the fixed portion 102 against a back 110 of the adjustable portion 106 . When a convertible row 28 is in a display position, the divider clip 36 is oriented to the configuration illustrated in FIG. 7A . Here, both the clipping portion 102 and the adjustable portion 106 are generally parallel to each other. A ledge 112 extends outwardly from a lower edge 114 of the adjustable portion 106 and is used to support the lower edge 60 of the front divider 30 of the convertible row 28 , in a manner similar to that discussed above with respect to FIG. 6A . The ledge 112 thereby supports the convertible row 28 and works to maintain it in the display position. FIG. 7B illustrates how these pieces 102 , 106 fit together when used in connection with a convertible row 28 in the display position. When the convertible row 28 is in a storage position, the divider clip 700 may be reconfigured to the arrangement illustrated in FIG. 7C . In this illustrated example, the adjustable portion 106 is secured to the clipping portion 102 by rotating it approximately 90° and receiving the clipping portion 102 in a transverse opening 116 in the adjustable portion 106 that is defined by the flaps 108 and sides 118 and 120 ( FIG. 7A ). Many variations can be made to the illustrated embodiments of the present invention without departing from the scope of the present invention. Such modifications are within the scope of the present invention. For example, the convertible rows 28 can span the entire width of the display section 12 . Similarly, while the joint 34 is illustrated as constructed in the illustrated manner, other versions of the joint that permit movement between the front divider 30 and the bottom divider 32 (such as a hinge type mechanism) are possible and within the scope of the present invention. Additionally, the display sections 12 can be molded with features or apertures in the rear of the section to facilitate coupling of the display section 12 to a display fixture. It should be noted that the increase of the row depth when a convertible row 28 is collapsed allows for the display of product having an increased product depth. Further, while the present invention has been described in connection with the display of greeting cards, the present invention is not limited to such a narrow use. Non-card products can be displayed as well. Other modifications would be within the scope of the present invention. From the foregoing it will be seen that this invention is one well adapted to attain all ends and objects hereinabove set forth together with the other advantages which are clear following the complete disclosure above and which are inherent to the methods and apparatuses described herein. It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations. This is contemplated by and is within the scope of the invention. Since many possible embodiments may be made of the invention without departing from the scope thereof, it is to be understood that all matter herein set forth or shown in the accompanying drawings is to be interpreted as illustrative of applications of the principles of this invention, and not in a limiting sense.

When displayed, greeting cards are typically organized on a display fixture having multiple rows or levels upon which to sit the cards. Each row then has a front wall to hold in the card, yet is short enough to still view a portion of the greeting card above the wall. Because display fixtures are manufactured to have a specified amount of rows or levels at a specified depth, in order to adjust the specifications of a display fixture, other pieces may be used, for example, by attaching to the display fixture a convertible row to add another level or tier between set rows of the display fixture. By providing another row using a convertible row, another set of greeting cards may be displayed between cards displayed on other rows of the original display fixture, increasing the density of the overall display. Further, when an extra row is not desired, such a convertible row may be pushed flush against the back of the display fixture, while still attached, allowing the full depth of the row of the display fixture to be used.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Not Applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable REFERENCE TO A MICROFICHE APPENDIX [0003] Not Applicable BACKGROUND OF THE INVENTION [0004] Maintaining a healthy level of muscle mass can play an important role in sustaining overall good health, with benefits such as increased basal metabolic rate, better disposal of dietary fats and maintenance of lower body fat levels, increased immune system health, and an increase in one's overall vitality and sense of well-being compared to maintaining lower than ideal levels of lean body mass. A number of pathological conditions exist that make it difficult to maintain a normal healthy level of muscle mass, including HIV (human immunodeficiency virus), andropause or hypogonadism (subnormal androgen levels), infection, trauma, burns, and spinal cord injury. Some individuals also fail to gain or to maintain normal lean body mass without definite pathophysiologic reasons. Many treatments are offered that would help an individual in need of such treatment promote the buildup of muscle tissue. [0005] Skeletal muscle mass is increased or maintained in the body through a number of separate and distinct mechanisms. Such mechanisms play a role in the regulation of either skeletal muscle protein synthesis or breakdown, and collectively control the total amount of accrued protein present in the muscle cell. The actions of androgens are among the most visibly tied to the regulation of skeletal muscle mass, as these hormones are collectively responsible for the development and maintenance of male sexual characteristics including external virilization, sexual maturity at puberty, spermatogenesis, sexual behavior/libido and erectile functioning and the support of bone and muscle tissue growth. It is well documented in the prior art that raising the level of androgenic hormones in the body can increase skeletal muscle mass. A number of methods have similarly been developed to increase the level of androgenic hormones in the body, which ultimately can be used to offer the benefits of increased skeletal muscle mass in humans. [0006] In searching for ways to increase androgen levels in the body, the use of androgen precursor hormones have been suggested. U.S. Pat. No. 5,578,588 to Mattern et al. relates a method of using a precursor hormone, namely androstenedione, as a means of increasing testosterone levels. Although the in-vivo conversion of endogenous androstenedione to testosterone had been documented and cited in this patent, the use of this compound as an external supplement for producing a stable and effective increase in serum testosterone had never been investigated before, and therefore represents a novel invention. The pharmacokinetics of administering such a precursor is such that hormone concentrations of active hormone (testosterone) peak within 90 minutes, and subsequently decline over a period of three to four hours. This more closely resembles the natural pulsating pattern in which the body releases testosterone, and avoids the prolonged peaks and troughs noted with use of esterified injectable hormone preparations. [0007] Several other methods of using different androgen precursor hormones have also been disclosed, including U.S. Pat. No. 5,880,117 to Patrick Arnold, which relates a method of using 4-androstenediol as a means of increasing testosterone levels in humans. This in-vivo conversion of 4-androstenediol to testosterone, again, was well documented in the prior art and this patent, however the use of this compound as an effective oral medicament for raising testosterone levels was never investigated prior, and therefore represents another novel invention. U.S. Pat No. 6,391,868 to Arnold similarly relates a method of using 5-alpha-androst-1-en-3-one for increasing levels of the anabolic/androgenic steroid 17-beta-hydroxy-5-alpha-androst-1-en-3-one in humans. Again the in-vivo bioconversion was known, however a formal investigation of its oral use to increase serum androgen levels had never been disclosed. U.S. Pat. No. 6,262,436 to Llewellyn further discloses the method of using 5-alpha-androstanedione or 5-alpha-androstanediol to increase levels of dihydrotestosterone in humans, a hormone which also offers the benefit of regulating protein synthesis and increasing skeletal muscle mass. [0008] The use of androgenic hormones in general, however, is often thought to entail some risk, as increasing the level of such hormones may also be relevant to the development of undesirable side effects such as gynecomastia, water retention (edema), unfavorable alterations in cholesterol levels (increased heart disease risk) and increased blood pressure to name just a few. If an individual is seeking solely to increase skeletal muscle mass, and is not in need of androgen replacement, then the methods regarding the use of androgen precursors may be less than ideal. It therefore became to focus of this inventor to find another distinct mechanism in the body that plays an important role in the regulation of protein synthesis, and can be affected externally by the similar use of a precursor compound to an active constituent in said mechanism to enhance the buildup of skeletal muscle tissue. [0009] This invention relates a method of administering arachidonic acid for the purpose of increasing the level of the prostaglandin PGF2alpha and subsequently skeletal muscle mass. PGF2alpha is not an androgenic steroid, but an endogenous prostaglandin. It is referred to commonly as an inflammatory hormone, and is related to several biological functions including immunity, response to allergens, intestinal mobility and blood flow in various regions of the body. PGF2alpha is also closely tied to skeletal muscle protein synthesis in the body (Biochem J 1983 Sep. 15;214(3):1011-4), and represents an important new target for the external modulation of skeletal muscle mass distinct from the mechanisms involving male sex steroids. This method of using arachidonic acid for increasing PGF2alpha and skeletal muscle mass is an ideal solution for an individual in need of such treatment, because PGF2alpha is non-steroidal, and can increase protein synthesis and muscle mass without the potential undesirable side effects associated with altering sex steroid levels with androgen precursor hormones. BRIEF SUMMARY OF THE INVENTION [0010] Prior art relates several novel methods of using precursors to hormones that regulate protein synthesis for the purpose of increasing the levels of said hormones, which ultimately can increase skeletal muscle mass. Although the suggested practice of using precursors to physiologically active hormones seems quite sound, the target hormones in the cited art, namely androgenic steroids, may be less than ideal in many cases, particularly in those where increases in skeletal muscle mass are desired but the potential side effects of androgens contraindicates their use. The problem of the present invention is therefore to provide a precursor to a target hormone that can also be used to increase skeletal muscle mass when administered, but is completely non-steroidal. According to the invention this problem is solved by the oral use of arachidonic acid, a direct precursor to the prostaglandin PGF2alpha. This method is ideal because it is natural, non-toxic, quickly metabolized to active form after oral administration, and can increase skeletal muscle mass without the potential side effects of androgenic precursors. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING [0011] Not Applicable DETAILED DESCRIPTION OF THE INVENTION [0012] Arachidonic acid is a naturally occurring polyunsaturated fat, belonging to the Omega-6 family of fatty acids. It is considered an essential fatty acid (EFA), because it is an essential nutrient that your body can't produce itself. The only way you can get arachidonic acid is through the food you eat. It is obtained in small amounts in the average human diet, coming from various plant and animal sources including milk. Arachidonic acid has furthermore been identified as a vital precursor to numerous hormones in the body including prostaglandins, prostacyclin (PGI2), leukotrienes, and thromboxanes. [0013] Studies by have fundamentally proven the in-vitro conversion of arachidonic acid to the prostaglandin PGF2alpha. Experiments by Berlin et al. (Acta Physiol Scand 1979 August;106(4):441-5) used 14C-labeled arachidonic acid to chart the metabolism of this essential fatty acid into various prostaglandins in human skeletal muscle and kidney homogenates. Those prostaglandins produced during this incubation include PGD2, PGE2, PGF2 alpha and 6-keto-PGF1 alpha. Further studies with labeled arachidonic acid have fundamentally proven the in-vivo conversion of this fatty acid into PGF2alpha (Acta Physiol Scand 1979 July;106(3):307-12). In this investigation the labeled metabolites of arachidonic acid were measured in serum extracted from the forearm and kidney of human volunteers after direct infusion into the brachial or renal artery. PGD2, PGE2, PGF2 alpha, 6-keto-PGF1 alpha and 13,14-dihydro-15-keto-PGE2 (Me) were all found in this experiment. [0014] The prostaglandin PGF2alpha has also been proven to play a vital role in skeletal muscle protein synthesis. In fact, it is one of the prostaglandins most closely tied to protein synthesis, and therefore the primary focus of this invention. Studies conducted by Smith et al. (Biochem J 1983 Jul. 15;214(1):153-61) have fundamentally proven the importance of PGF2alpha in stimulating protein synthesis in-vitro, by testing the effects of various arachidonic acid metabolites when incubated with intact rabbit muscle that was intermittently placed under stretch stimulus. In this study two prostaglandins, F2 alpha and A1, increased rates of protein synthesis in unstimulated muscles, but prostaglandins E2 and D2 and the leukotrienes C4 and D4 failed to do so. Further studies with the cox-1 enzyme inhibitors ibuprofen and acetaminophen, which exhibit their anti-inflammatory actions by inhibiting the synthesis of prostaglandins, suggest that these drugs can profoundly diminish the anabolic response of muscle to resistance exercise by inhibiting the normal post-exercise increase in levels of PGF2alpha (Clin Endocrinol Metab 2001 October;86(10):5067-7). A search of the prior art does not reveal any investigations into what effect additional arachidonic acid in the diet would have on total protein synthesis or skeletal muscle mass. [0015] Prior art also does not disclose any investigations regarding the effect oral arachidonic acid would have on the serum level of PGF2alpha. Human tests carried out by Kelley et al. (Lipids 1998 February;33(2):125-30), however, did look at the effect of oral arachidonic acid on in-vitro immune response as measured by the secretion of different prostaglandins and immune system factors. In this study, the in-vitro secretion of LTB4 and PGE2, as demonstrated by Influenza antibody titers determined on drawn blood, did seem to measurably increase after oral administration of 200 mg and 1.5 g of supplemented arachidonic acid per day. This suggested to this inventor that a similar increase might be noted in-vivo with other prostaglandins not measured in this experiment including PGF2alpha. [0016] After learning of the in-vitro and in-vivo conversion of arachidonic acid to PGF2alpha, plus the role PGF2alpha plays in the regulation of skeletal muscle protein synthesis, it became the focus of this invention that skeletal muscle mass can be increased by the oral administration of arachidonic acid. In an effort to prove this theory a clinical study was therefore undertaken by the inventor. Specifically, it was the intention of this inventor to prove that arachidonic acid would act as an effective in-vivo peroral PGF2alpha precursor in man capable of raising and sustaining elevated PGF2alpha levels, and that the resultant increases in levels of PGF2alpha would result in increases in the level of skeletal muscle mass. [0017] An effective oral daily dosage of arachidonic acid is between 100 mg to 5,500 mg. It is ideally provided as a soft gelatin capsule or oral liquid, due to the fact that arachidonic acid is in the form of free flowing oil at room temperature. Due to the rapidity in which the discussed compound is metabolized in the body, the total daily dosage can be further subdivided for a more sustained blood hormone concentration, with 2-3 applications per day being most preferred.

This invention discloses a method of orally administering arachidonic acid for the purpose of increasing the serum level of the prostaglandin PGF2alpha and subsequently the level of retained skeletal muscle mass.

FIELD OF THE INVENTION This application deals with exercise, fitness and therapeutic massage devices that may be held in one hand or both hands and used for a wide range of wrist, forearm and shoulder manipulation, massage and total body fitness exercises. BACKGROUND OF THE INVENTION Club-like exercise devices have been used for exercise, training and rehabilitation dating back for hundreds of years, if not longer. One country of origin for these club-like exercise devices was India. British colonialists brought these training tools back from India to England and they came to be called “Indian Clubs.” Indian Clubs became very popular in the late 1800's and into the early 1900's in England and then the United States. Indian Clubs were often made of wood and came in a wide variety of shapes and sizes. They were used by military soldiers for exercise and training, as well as by the general population for exercise. Modern club-like devices are generally made of wood, hard plastic composites or metal. Today Indian Clubs are making a resurgence but their popularity is limited in part because of the unforgiving hard materials used to construct them, and the associated risks of injury. Because Indian Clubs are constructed of a hard material they are dangerous, their application to total body exercise routines is limited for most people. Juggling clubs resemble Indian Clubs but are usually lighter. The lighter construction of juggling clubs enables users to throw and catch them more easily whereas Indian Clubs are generally heavier and are not thrown, but rather swung about the body. Some juggling clubs are designed more specifically for training and incorporate a soft padded surface to prevent injury when a juggler misses a catch and the club hits his/her (hereafter referred to as his for convenience) body. While these training juggling clubs are similar to the present invention in that they incorporate soft padding on the clubs, their design is distinctly different from the present invention so that they can facilitate juggling as opposed to swinging them for exercise. Juggling clubs are designed with a balanced weight distribution that enables them to turn or rotate about a central axis for even and fluid rotations through the air to facilitate juggling. The present apparatus and method taught in the present invention have an uneven weight distribution between the club handles which are light and the club heads which are heavier making them unsuitable for throwing and catching but rather optimizes them for swinging exercises. The weight distribution between the handle and head of the present invention helps encourage and teaches a user to articulate the wrists and shoulders through a greater range of motion than when manipulating a more evenly weighted club. Similar devices having extended handles such as sledgehammers are being used for exercise, primarily in the form of hitting truck tires in a gym. This exercise develops the coordination between the hands where one hand starts at the upper distal end adjacent to the head and slides down to the lower end of the handle during the swinging process, then connecting to a rigid object. Hammers and mallets with rubberized hammer heads are used as tools to hammer objects without denting or defacing them such as wooden furniture. Because many of these devices are constructed of hard materials with a rigid handle and metal hammer head, they are dangerous if not used with extreme caution. These hammers and mallets with rubberized heads are not suitable for many total body exercise routines because the rubberized hammer heads are still hard enough to cause injury if one happens to inadvertently strike his body. The act of hitting a rigged object with a limited cushioning effect provided by the present invention has additional benefits in some exercise routines. The present Hand Held Exercise and Fitness Devices disclosed within this application and method taught enable a wider population of people with many fitness levels enjoy the benefits of exercise routines with less risk of injury and far wider application to total body exercise. Numerous innovations for various hand held exercise and devices have been provided in the prior art that are described as follows. Even though these innovations may be suitable for the specific individual purposes to which they address, they differ from the present design as hereinafter contrasted. The following is a summary of those prior art patents most relevant to this application at hand, as well as a brief description outlining the difference between the features of the Hand Held Exercise Device and the prior art. U.S. Pat. No. 7,179,210 of John E. Soukeras describes an exercise club, which may be held comfortably in one hand. Two of these clubs may be used, one in each hand, to execute a series of planned movements, which result in a full body workout. The weight of the clubs may be easily adjusted, to alter the intensity of the workout as desired. Virtually any person can use the clubs to improve their strength, health and fitness. This club can be made preferably of enforced polypropylene for rapid and quick volume production through injection molding. This patent describes an exercise club with a head that is adjustable in position along the length of the handle but does not have the head with the unique capabilities of a club with a variety of soft polymer flexible heads that can be filled with varying quantities of a variety of granular substances including but not limited to ball bearings (commonly referred to as bb's), sand, gravel and variable density urethane foams or the additional inflatable head that will be capable of accommodating different air pressures. U.S. Pat. No. 4,279,416 of Oliver D. Finnigan describes a juggling club which is composed of a sturdy hollow one-piece molded plastic body formed with a bulged end for receiving a tapered resilient knob, and also formed with a notched end for receiving a resilient tip. The body is formed of, for example, polyethylene, and it is inexpensive in its construction since it does not include a dowel pin, or the like, extending through the club for supporting the knob and tip at the opposite ends of the body. This patent describes a juggling club which is composed of a sturdy hollow one-piece molded plastic body with a centralized weight distribution and does not incorporate the light weight handle along with not having the ability of a soft polymer flexible head. U.S. Pat. No. 4,466,610 of Terry P. Israel describes a light weight exerciser or club adapted to assist the user to perform stretching, isometric, isotonic, and isokinetic exercises and to combine them with various aerobic exercises of walking or jogging. The exercise club has the shape of an elongate cylindrical shaft terminated in coaxially mounted end knobs serving as hand grips and has a length corresponding to the width of the chest of the user. The end knobs are dimensioned to be gripped by the hand with the palm resting against their outer ends with the fingers curving around the edges of the knob. The knobs are rounded in peripheral dimension and continuous to an inner wall which continues smoothly to and joins with the shaft so that the finger tips can lie along and grip the inwardly facing walls of the knob. Means are provided for forming various hand, finger, and thumb gripping surfaces. When the exerciser is constructed of wood such means can comprise grooves formed in the parts by scoring together with scallops formed in the rounded peripheral portions of the end knobs. This patent describes a light weight exerciser or club adapted to assist the user to perform stretching, isometric, isotonic, and isokinetic exercises with hand knobs at both ends of a tubular member. It does not resemble the conventional Indian Club and does not indicate a club with a variety of soft polymer flexible heads that can be partially filled with a varying quantities of a variety of granular substances such as bb's, sand, gravel and low density urethane foam or the additional inflatable head that will be capable to different air pressures. U.S. Pat. No. 4,696,468 of Brian J. Dube describes a juggling club that is formed of a hollow, unitary molded plastic body having a bulged portion, a relatively heavy knob and handle portion, and a center of gravity located at between 55 and 59 percent of the length of the longitudinal axis toward the bulged end of the club. The thickness of the body wall of the club is substantially greater at the handle and knob portions than at the bulged portion. This patent describes another juggling club which is composed of a unitary molded plastic body having a bulged portion, a relatively heavy knob and handle portion with a centralized weight distribution and does not incorporate the light weight handle along with not having the ability of a number of soft polymer flexible heads. There are no devices in the prior art that exists that would address the needs and create the specific advantages and benefits attendant with the Apparatus and Method for total body exercise routines using a sledgehammer-like device. The present design is a new, useful and non-obvious combination of method steps and component elements, with the use of a minimum number of functioning parts, at a reasonable cost to manufacture, and by employing readily available materials. None of these previous efforts, however, provides the benefits attendant with the Hand Held Exercise and Fitness Devices disclosed within this application. The present designs achieve their intended purposes, objects and advantages over the prior art devices through a new, useful and non-obvious combination of method steps and component elements at a reasonable cost to manufacture, and by employing readily available materials. In this respect, before explaining at least one embodiment of the Hand Held Exercise and Fitness Devices as a method for more effective exercise in detail, it is to be understood that the design is not limited in its application to the details of construction and to the arrangement, of the components set forth in the following description or illustrated in the drawings. The Hand Held Exercise and Fitness Devices used as a method for total body exercise are capable of other embodiments and of being practiced and carried out in various ways. In addition, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for designing of other structures, methods and systems for carrying out the several purposes of the present design. It is important, therefore, that the claims be regarded as including such equivalent construction insofar as they do not depart from the spirit and scope of the present application. SUMMARY OF THE INVENTION The principal advantage of the preferred embodiment of the Hand Held Exercise Device is having an exercise club with a light weight handle and spherical head. An advantage is the Hand Held Exercise Device in the configuration of a club will have a head made from a soft polymer flexible very durable material. Another advantage of the Hand Held Exercise Device in the configuration of a club would be being able to use two of the devices, one in each hand. Another advantage of the Hand Held Exercise Device in the configuration of a club is having a soft polymer flexible head that can be partially filled with a variety of granular substances such as bb's, sand or gravel that will shift position to the front of the head on impact. Another advantage of the Hand Held Exercise Device is that it is safer when swinging around the body. Another advantage of the Hand Held Exercise Device is that it is suitable for percussive exercises where a user intentionally taps his body with the Hand Held Exercise Device. Another advantage of the Hand Held Exercise Device in the configuration of a club is having soft polymer flexible head that can be filled with a liquid. Another advantage of the Hand Held Exercise Device in the configuration of a club is having soft polymer flexible head that can be filled with compressed air to produce different degrees of firmness. Another advantage of the Hand Held Exercise Device in the configuration of a club is having a soft polymer flexible head that can be filled with a urethane foam material. Another advantage of the Hand Held Exercise Device in the configuration of a club is that it can be used to exercise the wrist by holding and rotating the wrist, the forearm by raising and lowering at the elbow, and shoulder by rotating the full arm. Another advantage of the Hand Held Exercise Device in the configuration of a club is that it can be used to massage body parts where the granular material inside the head produces a soft but firm impact conforming to the part of the body impacted. An alternate embodiment of the Hand Held Exercise Device will have an extended handle and a head resembling a sledgehammer made from a soft polymer flexible very durable material. Another advantage of the Hand Held Exercise Device resembling a sledgehammer is that the head may be filled with a soft urethane foam material. Another advantage of the Hand Held Exercise Device resembling a sledgehammer is that it may be swung like a conventional sledgehammer without the possibility of damaging things. Another advantage of the Hand Held Exercise Device resembling a sledgehammer is that it can be used to train individuals how to properly and safely swing a sledgehammer. Another advantage of the Hand Held Exercise Device resembling a sledgehammer is that the head may be partially filled with a variety of granular substances including but not limited to granular metal, steel shot, bb's, sand or gravel. Another advantage of the Hand Held Exercise Device resembling a sledgehammer is that the head may be partially filled with compressed air. Another advantage of the Hand Held Exercise Device resembling a sledgehammer is that it is safer when swinging around the body. Another advantage of the Hand Held Exercise Device resembling a sledgehammer is that it provides ideal rebound reaction when hitting hard surfaces to stimulate the muscles involved in decelerating the rebounding hammer. Another advantage of the Hand Held Exercise Device resembling a sledgehammer is that the rebound “bounce” it creates is easier on joints and more effectively exercises the muscles, ligaments and tendons. The preferred embodiment of the Hand Held Exercise Device would be in the configuration of a club with a lightweight ridged injection molded two part handle having restraining elements holding the spherical head made from a soft polymer flexible very durable material. The handle will be held together by the means of conventional screw type fasteners. A lanyard may be attached through an orifice in the lower distal end of the handle. The spherical head will have a groove around the mounting section with indentions on two opposing sides that engage with two restraining elements within the handle. The rib around the circumference of the inner surface lip of the two part handle engage within a groove in the spherical head, additionally restricting the movement within the device. Another style of head will have a thread on the insert section to engage within a threaded orifice in a one piece handle to be locked in place by the means of a single dowel pin. At this time it must be made clear that the spherical shape to the head of the device may have a wide variety of geometric shapes and sizes and still remain within the scope of this application. The spherical head made from a soft flexible very durable polymer material may incorporate a tubular orifice in the mounting end to insert a variety of different materials such as granular elements or liquid to be sealed with a compressive plug or a urethane foam material that can be inserted within the internal cavity. Additionally self-skinning foam can be molded to form the club head. The amount and weight of the material within the head section can greatly affect the unique operations of the device. The spherical head may also be sealed with a needle valve orifice in the flat portion for a pressurized inflation. An alternate embodiment of the Hand Held Exercise Device will have an extended fiber glass handle and a head made from a soft polymer flexible and very durable polymer material in a variety of shapes, with the preferred being of a sledgehammer. One design will have a weighted object, preferably steel, in the center of the head attached to the handle. The head would be filled with urethane foam or either using self-skinning foam molded for the outside covering. A second design would additionally be made from a soft polymer flexible very durable polymer material with a mounting cavity on the upper and lower surfaces. A lower steel retainer will be permanently affixed to a light weight fiberglass handle. An upper steel retainer attached to the handle will have screw type fasteners extending through the head engaging in the lower steel retainer. The size of the steel retainers can vary depending on the desired weight of the device head. The head may incorporate an orifice in the upper mounting cavity to insert a variety of elements effecting the weight and balance. The head may also be sealed with a needle valve orifice for a pressurized inflation. Additionally the head may have a sealed inner cavity that has been filled with low density urethane foam. In this respect, before explaining at least one embodiment of the preferred embodiment and alternate embodiment of the Hand Held Exercise Device application in detail, it is to be understood that the design is not limited in its application to the details of construction and to the arrangement of the components set forth in the following description or illustrated in the drawings. The Hand Held Exercise Device is capable of other embodiments and of being practiced and carried out in various ways. In addition, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments of the Hand Held Exercise and Fitness Device and together with the description, serve to explain the principles of this application. FIG. 1 depicts a perspective view of a person holding two of the preferred embodiments of the Hand Held Exercise Device. FIG. 2 depicts a perspective view of an exploded view of the preferred embodiments of the Hand Held Exercise Device. FIG. 3 depicts a cross section through the preferred embodiments of the Hand Held Exercise Device. FIG. 4 depicts a front view of the spherical head of the preferred embodiments of the Hand Held Exercise Device. FIG. 5 depicts a side view of the spherical head of the preferred embodiments of the Hand Held Exercise Device. FIG. 6 depicts a cross section of the spherical head with a partial granular filling. FIG. 7 depicts a cross section of the spherical head constructed of self-skinning urethane foam. FIG. 8 depicts a cross section of the spherical head filled with urethane foam. FIG. 9 depicts a cross section of the spherical head partially filled with a liquid. FIG. 10 depicts a cross section of the spherical head incorporating a needle valve opening. FIG. 11 depicts a perspective view of the style of spherical head having a thread on the insert section to engage within a threaded orifice in a one piece handle to be locked in place by the means of a single dowel pin. FIG. 12A depicts a perspective view of an alternate embodiment of the Hand Held Exercise Device illustrating a three piece handle in the preferred configuration of a spherical head. FIG. 12B depicts a perspective exploded view of the alternate embodiment of the Hand Held Exercise Device, shown in FIG. 12A , in the preferred configuration of a three piece handle and spherical head. FIG. 13A depicts a perspective view of another alternate embodiment of the Hand Held Exercise Device in the preferred configuration of a sledge hammer. FIG. 13B depicts a perspective exploded view of the alternate embodiment of the Hand Held Exercise Device, shown in FIG. 13A , in the preferred configuration of a sledge hammer. FIG. 14 depicts a top view of the head of the sledge hammer configuration of the Hand Held Exercise Device with the steel retainers. FIG. 15 depicts a cross section of the head of the sledge hammer configuration of the Hand Held Exercise Device with the steel retainers. FIG. 16 depicts a cross section of the head of the sledge hammer configuration of the Hand Held Exercise Device having a weighted insert attached to the handle with the molded self-skinning urethane outer covering. FIG. 17 depicts a cross section of the head of the sledge hammer configuration of the Hand Held Exercise Device with a partial granular filling. FIG. 18 depicts a cross section of the head of the sledge hammer configuration of the Hand Held Exercise Device with a partial liquid filling. FIG. 19 depicts a cross section of the head of the sledge hammer configuration of the Hand Held Exercise Device with a needle valve orifice for a pressurized inflation. FIG. 20 depicts a cross section of the head of the sledge hammer configuration of the Hand Held Exercise Device that is made with the steel retainers on the handle using a self-skinning urethane foam for the outer covering. For a fuller understanding of the nature and advantages of the Hand Held Exercise and Fitness Device, reference should be had to the following detailed description taken in conjunction with the accompanying drawings which are incorporated in and form a part of this specification, illustrate embodiments of the design and together with the description, serve to explain the principles of this application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, wherein similar parts of the preferred embodiment of the Hand Held Exercise Device 10 A and 10 B (wherein the detailed description of JOB in is shown beginning with FIG. 12 ) are identified by like reference numerals, there is seen in FIG. 1 a perspective view of a person holding two of the preferred embodiments of the Hand Held Exercise Device 10 A with one in his left hand 12 holding the handle 14 massaging his left shoulder with the spherical head 16 and the other in his right hand 18 holding the handle 14 in an upright position. Lanyards 20 are illustrated going around the wrists and attached through an orifice 22 in the grip end 24 of the handle 14 . FIG. 2 depicts a perspective view of an exploded view of the preferred embodiments of the Hand Held Exercise Device 10 A illustrating the reinforcing ribs 26 in the handle 14 with the mounting screw orifices 28 where the mounting screws 30 secure the two halves of the handle 14 together. Two additional mounting screw orifices 28 are located in the spherical head retainers 32 that locate within the two depressions 34 on either side of the head insertion section 36 of the spherical head 16 . The handle 14 may be constructed with an over-molded rubberized grip surface, and that rubberized grip surface may be comprised of thermoplastic rubber (also known as TPR). Other rubberized sleeves and grips can alternatively be used in place of over-molded material. FIG. 3 depicts a cross section through the preferred embodiments of the Hand Held Exercise Device 10 A illustrating the orifice 22 for the lanyard 20 in the grip end 24 of the handle 14 . A polarity of reinforcing ribs 26 extend through the central portion 38 of the handle 14 . Four mounting screw orifices 28 are the locations where the mounting screws 30 hold the two halves of the handle 14 together. The spherical head 16 consists of an outer shell 40 that can be manufactured by, but not limited to a rotational molding process with a flat surface 42 on the spherical end so that the device can stand upright and the head insertion section 36 at the other end. The insertion section 36 is held within the two halves of the handle 14 by the means of the two depressions 34 on the opposing sides being locked in place by the means of the two spherical head retainers 32 on both inside surfaces of the handle 14 . Additionally a circumferential rib 44 at the distal end of the handle 14 locks into the circumferential groove 46 at the edge of the insertion section 36 of the spherical head 16 . The central cavity 48 of the spherical head 16 is partially filled with a granular material 50 . At the upper end of the head insertion section 36 is a tubular orifice 52 for the purpose of installing a variety of materials into the central cavity 48 and will be sealed with a plug 54 . With regard to contemplated dimensions, the proportion of the club head diameter in relation to the widest portion of the handle at the attachment location may be in the ratio of 2:1, as shown here in FIG. 3 . For example, if the club head diameter is approximately 6 inches, then the fluted upper portion of the handle at the attachment location would be approximately 3 inches. FIG. 4 depicts a front view of the of the spherical head 16 of the preferred embodiments of the Hand Held Exercise Device 10 A further illustrating the locations of the two depressions 34 on the opposing sides of the head insertion section 36 . FIG. 5 depicts a side view of the spherical head 16 of the preferred embodiments of the Hand Held Exercise Device 10 A additionally illustrating the locations of the two depressions 34 on the opposing sides of the head insertion section 36 . FIG. 6 depicts a cross section of the spherical head 16 with a partial granular material filling 50 within the central cavity 48 . FIG. 7 depicts a cross section of the spherical head 16 constructed in one piece of self-skinning urethane foam 56 . FIG. 8 depicts a cross section of the spherical head 16 manufactured by a rotational molding process with a flat surface 42 on the spherical end and the surface 58 sealed to be filled with urethane foam 57 . FIG. 9 depicts a cross section of the spherical head 16 with the central cavity 48 partially filled with a liquid 60 . FIG. 10 depicts a cross section of the spherical head 16 incorporating a needle valve opening 62 into the central cavity 48 for a pressurized inflation. FIG. 11 depicts a perspective view of the style of spherical head 16 having a thread on the insert section 64 to engage within a threaded orifice 66 in a one piece handle 68 to be locked in place by the means of a single dowel pin 70 going through orifice 72 in the handle 14 . FIG. 12A depicts a perspective view of an alternate embodiment of the Hand Held Exercise Device illustrating a three-piece handle in the preferred configuration of a spherical head. The three piece handle is comprised of a handle upper portion 73 , a locking annulus side 1 74 and a locking annulus side 2 75 . The locking annulus sides function to secure the spherical head to the handle portion as described in FIG. 12 B below. FIG. 12B depicts a perspective exploded view of the alternate embodiment of the Hand Held Exercise Device, shown in FIG. 12A , in the preferred configuration of a three piece handle and spherical head. The three piece handle is comprised of a handle upper portion 73 , a locking annulus side 1 74 and a locking annulus side 2 75 . Each of the locking annulus sides 1 and 2, 74 and 75 , respectively, include a threaded locking channel 76 . The interface 77 of the club handle with the locking annulus is constructed with openings 78 which accept both of the locking annulus side 1 74 and locking annulus side 2 75 . These are then secured using fasteners, in this embodiment, screws 79 which are accepted by the threaded locking channels 76 of the locking annulus sides. In this way, the three-piece handle with locking annulus sides functions well to secure the handle to the spherical head. FIG. 13A depicts a perspective view of the alternate embodiment of the Hand Held Exercise Device 10 B in the preferred configuration of the head 80 made from a soft polymer flexible very durable polymer material in the same manner as the spherical club head 16 and in a variety of shapes with the preferred being of a sledgehammer appearance with a long extended fiber glass handle 82 having a grip stopper section 84 . The upper surface of the head 80 is cavity 86 with an upper metal handle retainer 88 with mounting screws 90 . FIG. 13B depicts a perspective exploded view of the alternate embodiment of the Hand Held Exercise Device 10 B in the preferred configuration of a sledge hammer illustrating the upper metal handle retainer 88 and the mounting screws 90 pulled away from the cavity 86 . The upper metal handle mount 88 has four counter bored orifices 92 for the mounting screws 90 and a central elongated orifice 94 for the fiber glass handle 82 . Below the head 80 is illustrated the lower metal handle mount 96 with four threaded orifices 98 for mounting along with a central elongated orifice 100 handle locking screw 102 on the side. The upper metal handle retainer 88 and the lower metal handle retainer 96 can vary in size and shape depending upon the desired weight of the device. FIG. 14 depicts a top view of the head 80 of the sledge hammer configuration of the Hand Held Exercise Device 10 B illustrating the location of the upper metal handle retainer 88 along with the mounting screws 90 and the direction that the lower sections were taken. FIG. 15 depicts a cross section of the head 80 of the sledge hammer configuration of the Hand Held Exercise Device 10 B with the upper metal handle retainer 88 and the lower metal handle retainer 96 in place within the outer shell 104 . The inner cavity 106 is filled with urethane foam 57 . FIG. 16 depicts a cross section of the head 80 of the sledge hammer configuration of the Hand Held Exercise Device 10 B having a weighted insert 110 attached to the fiber glass handle 82 with the molded self-skinning urethane foam 56 outer covering. The weighted insert 110 can be a variety of shapes but in this case has been shown as a sphere with a plurality of orifices 112 to help stabilize it within the foam structure. FIG. 17 depicts a cross section of the head 80 of the sledge hammer configuration of the Hand Held Exercise Device 10 B with a partial granular filling 50 in the inner cavity 106 . Within the cavity 86 and located below the upper metal handle mount 88 there is shown an orifice 87 for adding fill to the head 80 . FIG. 18 depicts a cross section of the head 80 of the sledge hammer configuration of the Hand Held Exercise Device 10 B with a partial liquid filling 60 in the inner cavity 106 . Within cavity 86 and located below the upper metal handle mount 88 there is shown an orifice 89 for adding fill to the head 80 . FIG. 19 depicts a cross section of the head 80 of the sledge hammer configuration of the Hand Held Exercise Device 10 B with a needle valve orifice 62 for a pressurized inflation in the inner cavity 106 . FIG. 20 depicts a cross section of the head 80 of the sledge hammer configuration of the Hand Held Exercise Device 10 B that is made with the metal handle retainers 88 and 96 on the fiber glass handle 82 using the molded self-skinning urethane foam 56 for the outer covering. The Hand Held Exercise and Fitness Devices 10 A and 10 B shown in the drawings and described in detail herein disclose arrangements of elements of particular construction and configuration for illustrating preferred embodiments of structure and method of operation of the present application. It is to be understood, however, that elements of different construction and configuration and other arrangements thereof, other than those illustrated and described may be employed for providing Hand Held Exercise and Fitness Devices 10 A and 10 B in accordance with the spirit of this disclosure, and such changes, alternations and modifications as would occur to those skilled in the art are considered to be within the scope of this design as broadly defined in the appended claims. Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly and readily the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way.

The present invention is directed to Hand Held Exercise and Fitness Devices that deals with exercise, fitness and therapeutic massage that may be held in the hand and used for a wide range of wrist, forearm and shoulder manipulation, massage and fitness exercises. The preferred embodiment will be in the shape of an Indian club with a light weight handle and a soft flexible polymer head that can have a variety of materials in the inner cavity. The second embodiment will have the head in the shape of a sledge hammer with a long handle and constructed in a similar fashion as the preferred embodiment.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 60/470,369, filed May 14, 2003, and U.S. Provisional Application No. 60/505,225, filed on Sep. 23, 2003. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The invention relates to bags and stands for notebook personal computers (also known as, PC's or laptops). [0004] 2. Description of the Related Art [0005] Notebook PC's have changed how business is conducted by providing the ability to access your computer on your lap: hence the name laptop. However, as the notebook computer evolved and uses and needs therefore grew, the notebook computer became a more important part of everyday life. Unfortunately, most people are still using laptop computers on their laps, which is not a very comfortable way to work. [0006] Business travelers need a desk at which they can work when out of the office. However, any portable desk must comply with airport security guidelines. In particular, parts of any portable desk should not be able to be disassembled into any potential weapon. SUMMARY OF THE INVENTION [0007] It is accordingly an object of the invention to provide a convertible laptop PC bag to workstation with legs that overcomes the hereinafore-mentioned disadvantages of the heretofore-known devices of this general type and that provides a carrying case that can convert to a desk-like workstation wherever the user takes their laptop. [0008] With the foregoing and other objects in view, there is provided, in accordance with the invention, a convertible laptop pc bag & workstation, including a standard laptop pc bag, and three adjustable legs. The invention enables the bag to transform into a desk. [0009] The invention, an improved laptop carrying case, has the ability to turn into a desk regardless of where the user is. The legs are lightweight, yet very strong, and fit neatly in the bottom of the laptop bag when not being used. Once the legs have been extended, one has a desk to work on rather than your lap: thus, a more ergonomic comfortable working position. In addition, since there is no direct contact between the laptop and one's legs, the bag can virtually eliminate the chances of leg burns, which can occur from the extraordinary heat laptops can reach, as high as 140° F. Finally, since the laptop computer is in the confines of the bag, the computer is protected at all times, rather than being completely exposed, possible leading to the computer being more easily dropped or broken. [0010] More importantly, according to an Intel article published in March of 2002, “92% of all corporate travelers use a laptop pc while on the road.” Additionally, and even more recently and compelling, for the first time ever, in quarter two of 2003, laptop computer sales outpaced desktop computer sales, proving the growing trend of laptop popularity. Therefore, this invention is one that will likely be in great demand. [0011] In accordance with a further object of the invention, the adjustable legs will provide an improved laptop carrying case. A more comfortable working environment for the user while using their laptop will serve multiple uses and overall will provide a more user-friendly, enhanced laptop bag. Further, this enhanced laptop carrying case will remain economically comparable to the existing standard laptop bag on the market. The actual bag will be a standard laptop bag, similar to one found in a computer store or one that comes with the computer. A preferred size is approximately fifteen by seventeen by eight inches. However, the bag will be manufactured in different sizes to accommodate various size laptop computers and other versions such as, but not limited to, a briefcase version made of leather, aluminum, or plastic, a portable DVD Player bag/stand version for viewing, a wheeling version more appropriate for airline travel, a hair and make-up case and stand, a disc jockey/music carrying case and stand, etc. All the previously mentioned embodiments can be made of various materials. [0012] In accordance with a further object of the invention, the bag can be made in various sizes, various colors, various materials, and various formats and purposes, for example a portable DVD viewing bag/stand made of leather. The DVD version would be considerably smaller bag than the average laptop PC bag. [0013] Above are listed various formats for the bag, such as the briefcase version, and the DVD player versions, as well as different possible materials and sizes for the bag and legs. However, the favored format or best mode is the standard black nylon bag, with the lightweight, heavy-duty black anodized aluminum legs, with rubber stoppers at the ends to provide a stable non-skid base. [0014] In accordance with a further object of the invention, a single leg can be attached to the center of the bottom of the bag. A tripod at the bottom of the leg stabilizes the workstation. [0015] With the objects of the invention in view, there is also provided a second embodiment of an improved laptop carrying case that has the ability to turn into a desk regardless of where the user is. The legs are lightweight, yet very strong, and fit neatly in the laptop bag when not being used. The four legs individually screw into the four designated sockets on the bottom portion of the bag. Once installed the user has a desk on which to work, rather than their lap. [0016] Other features that are considered as characteristic for the invention are set forth in the appended claims. [0017] Although the invention is illustrated and described herein as embodied in a convertible laptop PC bag to workstation with legs, it is, nevertheless, not intended to be limited to the details shown since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims. [0018] The construction and method of operation of the invention, however, together with additional objects and advantages thereof, will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0019] [0019]FIG. 1 is a diagrammatic front perspective of a bag according to a first embodiment of the invention in a closed position; [0020] [0020]FIG. 2 is a top perspective view of the first embodiment; [0021] [0021]FIG. 3 is a front perspective view of the first embodiment in an opened position; [0022] [0022]FIG. 4 is a partial front side view of a leg of the first embodiment; [0023] [0023]FIG. 5 is a front perspective view of the first embodiment; [0024] [0024]FIG. 6 is a front side view of the leg first embodiment; [0025] [0025]FIG. 7 is a front perspective view of the first embodiment with the legs deployed; [0026] [0026]FIG. 8 is a diagrammatic bottom side view of a second embodiment of the bag according to the invention; [0027] [0027]FIG. 9 is front perspective view of the second embodiment in an opened position; [0028] [0028]FIG. 10 is a front perspective view of the second embodiment in the opened position and with the legs deployed; [0029] [0029]FIG. 11 is a front side view of an unextended leg of the second embodiment; and [0030] [0030]FIG. 12 is a front side view of an extended leg of the second embodiment. DETAILED DESCRIPTION OF THE INVENTION [0031] Referring now to the figures of the drawings in detail and first, particularly to FIG. 1 thereof, there is shown a bottom side of bag 14 constructed in accordance with a first embodiment of the invention. The top part of bag 14 has handle 8 made of strong plastic and may be covered in the same material as bag 14 . Bag 14 has two compartments, the top being computer storage compartment 18 , and the bottom being leg storage compartment 16 . Unzipping their appropriate zippers (zipper for computer storage compartment 10 and zipper for leg storage compartment 12 ) opens the respective compartment. [0032] [0032]FIG. 2 is a perspective view of bag 14 in a closed state. Zipper for computer compartment 10 is in the top left corner of bag 14 when closed; when unzipped, computer storage compartment 18 is exposed, and the user is able to begin their task. Zipper for leg compartment 12 is in the bottom left corner of bag 14 when closed as well, and when unzipped legs 20 are exposed. [0033] [0033]FIG. 3 is a perspective view of the inside of the leg storage compartment 16 , the bottom part of bag 14 . The user pulls each leg 20 out and down individually from leg storage compartment 16 . At which point, each leg 20 swivels from a horizontal position to a vertical position. The back two legs 20 are connected to the corners of bag 14 by hinge 32 that is bolted into the two back corners of leg storage compartment 16 . The front leg 20 is in the center of the front part of leg storage compartment 16 , and is also attached by hinge 32 , which is bolted in as well. It is hinge 32 that enables the leg to swivel and move from a horizontal packed bag position to a vertical desk position, enabling the conversion from bag to desk. [0034] [0034]FIG. 4 is a perspective view of leg 20 with rubber stopper 22 at the bottom of leg 20 and quick-release lock 38 . This is leg 20 in its shortest form, before it is extended out, to a possible maximum of six times its shortest form. Leg 20 will measure approximately six inches, when not extended, and can extend out as far as approximately thirty-six inches. Legs 20 in the most favored form will be made of lightweight, heavy-duty black anodized aluminum and will have rubber stoppers 22 at the ends to provide a stable non-skid base. Legs 20 may also be made in materials such as, but not limited to, steel, aluminum, and plastic. [0035] [0035]FIG. 5 is a perspective view of bag 14 and computer storage compartment 18 in an open state. The inside of flap from computer compartment 30 has pockets for files 34 to hold files, papers folders, etc., and a pocket for disks 36 to hold standard computer accessories, such as computer disks, compact discs, DVD's, pens, etc. FIG. 5 shows bag 14 separated into two separate compartments: one compartment housing the computer equipment, computer storage compartment 18 , which will be padded with shock absorbing EVA foam for the laptop's protection and accommodating various size laptops, and the leg storage compartment 16 housing the legs. Legs 20 are exposed by unzipping flap from leg compartment 24 . Legs 20 are in a desk position and are at their shortest form, providing elevation from the ground, ones lap, or surface that one is working on. Additional compartments, which may or may not be added, may include small pockets for extra cords, computer accessories or personal items. [0036] [0036]FIG. 6 is a perspective view of leg 20 once it has been extended out to its greatest length, preferably, thirty-six inches. The adjusted height is determined by placing the spring-loaded button 26 into respective holes on legs 28 . This feature will be similar to an aluminum adjustable walking cane. [0037] [0037]FIG. 7 is a perspective view of bag 14 in its final form as a desk. Legs 20 are at their longest length, completing the transformation from bag to desk. Legs 20 are fully extended, and spring-loaded buttons 26 are locked into the respective holes on legs 28 . Flap 24 hangs down in the back so legs 20 can be exposed and extended out. [0038] In operation, one uses bag 14 in a normal manner, for carrying and protecting. Once the user has reached the destination where he or she plans to use the laptop, bag 14 turns from a carrying case into a desk/workstation. One can adjust the height of the workstation appropriately for the user's most comfortable ergonomic working position. [0039] [0039]FIG. 1 shows the bottom side of bag 14 . It is in this part of bag 14 where the user will find leg storage compartment 16 , which is where legs 20 are housed when not being used. The user will carry bag 14 while it is in its bag format, by carrying it by handle 8 . [0040] [0040]FIG. 2 shows bag 14 in a closed state, lying on its bottom side, showing the top side of bag 14 . The user will open and expose computer storage compartment 18 by unzipping flap for computer compartment 30 by using zipper 10 . [0041] [0041]FIG. 3 shows the inside of leg storage compartment 16 . Legs 20 are housed in this section of bag 14 . There are two legs in the back corners, and one leg in the center of the front of leg storage compartment 16 . The user will swivel each leg 20 individually down towards the ground into a vertical positioning, turning the bag into a desk. However, at this point in FIG. 3, legs 20 are still in a packed position. [0042] [0042]FIG. 4 shows leg 20 in its smallest form, as it will be when stored in leg storage compartment 16 and before being extended. The user will swivel each leg 20 individually, and move legs 20 from a horizontal position to a vertical position, enabling the base of the desk to be made. Also shown is quick-release lock 38 , which the user must twist to loosen the grasp of the other pieces of the telescoping legs, enabling leg 20 to extend, then one can tighten leg 20 once it is in an extended locked position. Rubber stopper 22 when in operation will provide a stable non-skid base. [0043] [0043]FIG. 5 shows a perspective view of bag 14 and computer storage compartment 18 in an open state, with legs 20 at the shortest possible length. The user would be using the bag 14 in its desk format, however this would likely be used while the user is sitting on the floor, and they simply need their laptop to be elevated. The user of course has many options as to the exact height they wish to work on, by simply extending legs 20 . [0044] [0044]FIG. 6 shows leg 20 in its fully extended form. The user can extend leg 20 to the appropriate length by first twisting the quick-release locks 38 , which allows each leg 20 section to telescope down to the floor, once the appropriate height is reached. The user simply places the spring-loaded button 26 into the appropriate hole on leg 28 , and this can be done any where along each section of leg 20 , maximizing the number of different heights the desk can be set at, just like an adjustable aluminum walking cane. The user has the option to sit in a chair and extend leg 20 to fit the user's height or the chair's height, or the user could sit on the floor, grass, sand, or virtually any surface, and just have the legs extended out slightly to provide elevation and a more comfortable ergonomic working position, instead of being hunched over. Typically, a table surface is about thirty inches high. A minimum length of the legs is a size that can fit within the smallest dimension (length or width) of the bag; this is usually about ten inches. [0045] [0045]FIG. 7 shows bag 14 in its desk format. Legs 20 have been fully extended and locked into place. The user can adjust the height of legs 20 , to match their appropriate height, or the appropriate height for the seat they are using, by simply telescoping out leg 20 . To assure the appropriate height and a stable workstation to work on, the user will use quick-release locks 38 and spring-loaded buttons 26 , locking the legs 20 into a locked stable position. [0046] [0046]FIG. 8 is a bottom side view showing the bottom side of bag 114 constructed in accordance with a second embodiment of the invention. The top part of bag 114 has handle 108 made of strong plastic and may be covered in the same material as bag 114 . On the bottom of bag 114 , are four designated areas 110 , encasing four sockets 112 , where legs 120 will screw and lock in. The four designated areas 110 where legs 120 screw in, will be made of the same material as legs 120 , the most favored format being lightweight, heavy-duty black anodized aluminum. [0047] [0047]FIG. 9 is a perspective view of bag 114 in an open state. Leg storage compartment 130 has flap 118 made of nylon secured by steel zipper 116 . Once flap 118 is unzipped using zipper 116 , four legs 120 are revealed and visible. Hook and loop fastener straps 132 , such as those sold under the trade name VELCRO®, secure legs 120 in leg storage compartment 130 . Flap 118 has pockets on the front side when zipped and closed, to hold standard computer accessories, such as disks, DVD's, compact disks, pens, etc. Flap 118 separates bag 114 into two separate compartments: one compartment housing the computer equipment (hereinafter the “main compartment”), which will be padded with shock absorbing EVA foam for the laptop's protection, and one compartment housing the legs (hereinafter the “leg storage compartment”). Additional compartments, which may or may not be added, may include small pockets for extra cords or personal items. [0048] [0048]FIG. 10 is a perspective view of the bag 114 when it is opened and legs 120 have been fully extended and attached, completing the transformation from bag to desk. In leg storage compartment 130 when zippered closed, the user will have two pockets, one pocket for files 134 and one pocket for disks 136 , other cords, cables, and peripherals can be stored in these pockets as well. Legs 120 are fully extended out and buttons 126 are in the appropriate holes 128 . [0049] [0049]FIG. 11 is a perspective view of a leg 120 , a rubber stopper 122 at the bottom of leg 120 , and a screw 124 at the top of leg 120 . This is leg 120 in its shortest form, before it is extended to a possible maximum of three times its shortest form. Preferably, leg 120 will measure approximately ten inches, when not extended, and can extend out as far as approximately thirty inches. Legs 120 in the most favored form will be made of lightweight, heavy-duty black anodized aluminum and will have rubber stoppers 122 at the ends to provide a stable non-skid base. Legs 120 may also be made in materials such as, but not limited to, steel, aluminum, and plastics. [0050] [0050]FIG. 12 is a perspective view of leg 120 once it has been extended out to its greatest length, thirty inches. The adjusted height is determined by the location of button 126 in appropriate hole 128 . This feature of leg 120 will be similar to an adjustable metal walking cane. [0051] In operation, one uses the second embodiment of the bag 114 in a normal manner, for carrying and protecting. Once the user has reached the destination where he or she plans to use the laptop, bag 114 turns from a carrying case into a desk/workstation. One can adjust the height of the workstation appropriately for the user's most comfortable ergonomic working position. [0052] [0052]FIG. 8 shows the bottom side of bag 114 . It is in this part of bag 114 where the user will find four designated areas 110 and four designated sockets 112 , which is where legs 120 screw and lock in. The user will carry bag 114 while it is in its bag format, by carrying it by handle 108 . [0053] [0053]FIG. 9 shows bag 114 in an open state. The user will expose legs 120 by unzipping flap 118 with zipper 116 . Legs 120 will be removed from the leg storage compartment 130 by opening the hook and loop fastener straps 132 , which will free legs 120 so they can be installed into the four designated areas 110 . [0054] [0054]FIG. 10 shows bag 114 in its desk format. Legs 120 have been fully extended and installed. The user can adjust the height of legs 120 , to match their appropriate height, or the appropriate height for the seat they are using, by simply telescoping out leg 120 . To assure the appropriate height and a stable workstation to work on, the user will lock in button 126 into appropriate hole 128 that suits the user. [0055] [0055]FIG. 11 shows leg 120 in its smallest form, as it will be when stored in bag 114 and before being extended. The user will take leg 120 and screw it into bag 114 using screw 124 , which is part of and at the top of leg 120 . Also shown is rubber stopper 122 , which is where the leg is extended from and when in operation will provide a stable non-skid base. [0056] [0056]FIG. 12 shows leg 120 in its fully extended form. The user can extend leg 120 to the appropriate length by pulling out from rubber stopper 122 and locking in button 126 into the appropriate hole 128 . The user will also have the option to sit in a chair and extend leg 120 to fit their height or their chair's height. Or, the user could sit on the floor, grass, or sand and just have the legs extended slightly to just provide a more comfortable ergonomic working position, instead of being hunched over. This is all accomplished while still protecting your computer.

A laptop pc bag provides not only a standard laptop carrying case for carrying and protecting a laptop PC but also a desk. The height of the bag can be adjusted by extending the legs as far as desired, from approximately six inches to thirty-six inches, thereby providing the right height of the desk for the user. This allows users of all ages and sizes to take advantage of bag in its desk format, regardless of where they are. The legs ultimately provide the user more freedom with their laptop PC and will allow the user to perform the tasks at hand in an easier and more comfortable manner than previously possible. A considerably more versatile laptop bag is provided, one that can be transformed from a normal standard laptop carrying case into a portable workstation, for today's more versatile user and workplace.

BACKGROUND OF THE INVENTION 1. Field of the Invention A fiber optic based dynamic light scattering apparatus is disclosed for in-vivo characterization of the concentration and size of various protein macromolecules in the anterior segment of the eye, which includes the crystalline lens, the aqueous humor and the cornea. A lens-less fiber optic probe comprising two optical fibers may be fixed onto an aplanation tanometer mount, which is a universal accessory to any commercial slit lamp microscope. A monomode optical fiber guides light from a semiconductor laser source to a point inside the eye lens, and a second optical fiber, positioned in close proximity, is used for coherent detection of the scattered light in the backward direction. The free end of the receiving optical fiber is connected to a photodetector, typically a photomultiplier. In this manner, light is detected and converted into a pulse position modulated electrical waveform, which is processed by a digital correlator to yield the first order electric field autocorrelation of the scattered laser light. Subsequent inversion of the data yields a distribution of diffusion coefficients, which can be scaled to give a distribution of particle size or molecular weight. The ability to track small changes in concentration and size are vital for the early detection and prevention of ocular disorders, such as cataractogenesis. 2. Brief Description of the Prior Art Cataract surgery is inevitable in many humans because of the changes caused to the transparency of the eye due to aging. Other known factors such as high blood sugar levels and long exposure to ultra violet light can accelerate this process. Current state-of-art systems, which include visual inspection through a slit lamp microscope or analysis of a photographic plate, lack the sensitivity to detect small molecular changes in the ocular tissue. Early detection of changes in relative concentration and size of the different protein species will permit development of preventive therapy, and possible reversal of cataractogenesis. A reliable apparatus for non-invasive, rapid, quantitative and causing the least trauma to the patient, has been long sought goal for the study of cataractogenesis and other ocular disorders. In the last three decades, following the invention of the laser, light scattering (LLS) has become an indispensable, non-invasive, and extremely sensitive technique for routine characterization of molecular changes in physiological, chemical, polymer and colloidal systems. A conventional light scattering apparatus requires illumination of the sample by a coherent source, detection of the weak scattered light at some specified scattering angle, processing of the data and inversion to yield the required information of size and shape. Until recently, conventional LLS systems, because of their large size and sensitivity to vibrations, were confined to a research laboratory. However, in the last five years, significant advances have been made in the miniaturization of these systems by utilizing fiber optics, semiconductor laser sources and detectors. Data acquisition and analysis have also been dramatically improved due to rapid technological advances in the microelectronics industry. LLS, in particular dynamic light scattering (DLS) or quasielastic light scattering, or intensity fluctuation spectroscopy, or photon correlation spectroscopy, has been successfully used for the characterization of protein macromolecules in excised eye lenses, however, a clinical apparatus in still not available. Benedek [U.S. Pat. No. 4,957,113] and Benedek and Magnante [U.S. Pat. No. 4,993,827] have disclosed an apparatus and a method for detection of ophthalmic diseases, respectively. Their apparatus comprises a conventional light scattering system, with all its inherent alignment and stability problems. A person skilled in the art usually requires several hours to align a conventional DLS apparatus. Analysis techniques described in the latter patent have been employed by researchers for the last two decades and have been commercially available for many years. Other apparatus pertaining to the detection of ophthalmic diseases are not based on dynamic light scattering, and therefore do not provide information on the molecular changes of the protein macromolecules. U.S Pat. Nos. 4,776,687 and 4,854,693 disclose such apparatus. SUMMARY OF THE INVENTION The present invention provides a method and an apparatus for in-vivo diagnostics of the eye using a compact light scattering system requiring no alignment, no moving parts, and no lenses. The optical system is very rugged, flexible, and compact. Micrometer stages, which can be mounted onto a universal aplanation mount, provide precise location of the scattering volume for repeatable measurements from any region in the anterior segment of the eye. The present invention further provides an in-vivo assembly for measuring the distribution in diffusion coefficients and relative concentrations of various protein macromolecules in the anterior segment of the eye. The assembly comprises: a fiber optic probe for delivering monochromatic laser light, the probe including a probe body, a lens-less, transmitting fiber for transmitting an expanding beam of laser light, and a lens-less, receiving optical fiber for coherently detecting scattered light, the transmitting and receiving fibers being mounted to the probe body such that an end of said receiving fiber is positioned in close proximity to an end of the transmitting fiber for coherently detecting the scattered laser light at an angle in the range 90° to 175°; a photon detector connected to the receiving fiber for converting a train of photon pulses into photoelectron pulses; a digital correlator for obtaining the first order electric field autocorrelation of the scattered light detected by the receiving fiber, and means for analyzing the first order electric field autocorrelation to determine the distribution in diffusion coefficients, and hence size. A plurality of probes are preferably provided with the assembly, each with the optical fiber ends oriented at different angles. Different probes are employed depending upon the depth at which the ocular tissue is to be examined. A method according to the invention includes the steps of causing a lens-less fiber to deliver an expanding beam of monochromatic laser light to ocular tissue, detecting back scattered laser light through a lens-less, multimode optical fiber positioned in close proximity to the lens-less, light-transmitting fiber, converting the detected light to electrical signals, and analyzing the electrical signals to determine whether changes in the molecular structure of the ocular tissue have occurred. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a graph illustrating the spatial coherence requirements for efficient self-beating detection of scattered laser light; FIG. 2 is an enlarged, schematical illustration of a fiber optic transmitting/receiving probe employed in accordance with the invention; FIG. 3 is a graph illustrating the scattering angle inside the eye lens, as a function of the inclination angle of the optical fiber above the optical axis; FIG. 4 illustrates the position of the edge of scattering region inside the eye lens as a function of the inclination angle of the optical fiber above the optical axis; FIG. 5 illustrates the length of the scattering region inside the eye lens as a function of the inclination angle; FIG. 6 is a schematical illustration which shows a clinical apparatus for characterization of the size of protein constituents in the transparent regions of anterior portion of the eye according to the invention; FIG. 6A is a schematic illustration showing the modification of a slit lamp microscope according to the invention. FIG. 7 is a schematic illustration of a dynamic light scattering apparatus employed in the clinical apparatus shown in FIG. 6 and FIG. 6A. FIG. 8 is a schematic illustration of an apparatus according to the invention used for characterization of protein size in excised bovine and human eye lenses; FIG. 9 is a graph illustrating a comparison of the normalized intensity-intensity autocorrelation, β|g.sup.(1) (t)| 2 , as the temperature is reduced in an excised bovine eye lens; FIG. 10 is a graph illustrating a comparison of the normalized intensity-intensity autocorrelation, β|g.sup.(1) (t)| 2 , as the temperature is increased in an excised bovine eye lens; FIG. 11 is a graph illustrating a comparison of the normalized intensity-intensity autocorrelation, β|g.sup.(1) (t)| 2 , for various ages, in excised human eye lenses, and FIG. 12 is a histogram showing the average crystalline size as a function of age. DETAILED DESCRIPTION OF THE INVENTION Brownian motion is a term used to describe many physical phenomena in which some quantity is continuously undergoing random fluctuations. It is used to described the countless diffusion processes occurring in many diverse disciplines from the motion of electrons and holes in semiconductor devices, to the motion of macromolecules and colloids in chemical systems, to the motion of macromolecules, such as proteins, in physiological systems, to the motion of pollutants in the atmosphere. The motion was first observed in 1828 by Robert Brown, and theoretically predicted by Albert Einstein in 1905, however, it was not until the discovery of the laser that Brownian motion became synonymous with quasielastic light scattering, or dynamic light scattering or intensity fluctuation spectroscopy or photon correlation spectroscopy. All of these refer to the same laser based probing technique which provides a measurement of the size (hydrodynamic radius or molecular weight) of particles undergoing Brownian motion. The variance of particle displacement for a collection of particles undergoing Brownian motion derived from Langevin's equation is ##EQU1## where m is the particle mass, ξ is the coefficient of friction, T is the absolute temperature, and k is Boltzman's constant. ##EQU2## Particles move with constant velocity and thus behave as free particles. For time ##EQU3## Particles experience viscous drag through collisions with the macromolecules of the surrounding medium. The first order electric field autocorrelation of laser light scattered from particles executing Brownian motion is ##EQU4## is the scattering wavenumber, θ is the scattering angle, λ o is the free space wavelength of light and η 3 is the refractive index of the medium in which the particles are suspended. The normalized first order electric temporal autocorrelation of the fluctuation in the scattered light amplitude due to particles undergoing Brownian motion, in the viscous regime, is g.sup.(1) (t)=exp(-Q.sup.2 Dt) For spherical particles, the Stokes-Einstein relation expresses D, the translational diffusion coefficient, as a function of hydrodynamic radius r of the particle, ##EQU5## where η is the viscosity of the medium. A self-beating experiment involves a measurement of an intensity-intensity temporal autocorrelation, G.sup.(2) (t), which for Gaussian statistics is related to g.sup.(1) (t) through the Siegert relation G.sup.(2) (t)=A[1+B|g.sup.(1) (t)|.sup.2 ](b 5) where β describes the spatial coherence of the scattering volume, and A is the baseline. For a monodisperse sample the measured intensity-intensity autocorrelation decays exponentially with a time constant 2Q.sup. D, and a simple transformation yields the particle size. However, for a polydisperse system the first order autocorrelation is ##EQU6## where p(D) is the distribution in diffusion coefficient due to species present in the solution, and a and b are the lower and upper bounds on D, respectively. The above equation represents an ill-posed inversion problem in the presence of additive noise which is unavoidable in experimental accumulation of data. The Stokes-Einstein relation together with a knowledge of the scattering strengths from each size species leads to a particle size distribution from p(D). Commercial software, using various established techniques, is available for inverting Eqn(6) to yield a distribution in size. Dynamic light scattering is concerned with measuring the intensity-intensity temporal correlation of the light scattered from particles illuminated by a monochromatic light source. In order to observe the modulation imparted by tee particles undergoing Brownian motion, the scattered light must be collected over a well defined coherence solid angle, which is a function of the size of the scattering volume. The spatial coherence requirements for efficient self-beating translate into an uncertainty in the scattering angle as defined by the detection geometry. For cylindrical incident and detection beams of diameter D I and D A , respectively, the planar coherence solid angle, assuming D A >D I , is given by ##EQU7## FIG. 1 shows a plot of (Δθ) coh as a function of D I for various values of the scattering angle, assuming a wavelength of 0.475 μm in water and ##EQU8## greater than unity result in more stringent requirements for (Δθ) coh . In a typical DLS experiment, a detection geometry using spherical lenses and apertures, an angle (Δθ) coh of 1.6 mrad(0.1°) may be obtained with some difficulty. The corresponding value D I , at a scattering angle of 90°, is 150 μm (point A in FIG. 1). However, at 170°, for the same incident beam diameter, (Δθ) coh =0.39 mrad (0.02°), point B in FIG. 1, is beyond practical considerations for conventional laser light scattering systems (LLS). Based on these observations, compact cylindrical fiber probes comprising an optical fiber and a graded index microlens have been constructed, as described in U.S. Pat. No. 4,983,040. Optimization of the fiber optic probes, for both DLS and static light scattering, can be achieved at each scattering angle. However, these probes alone are not suitable for a self contained back scatter system which is necessary for a real time clinical apparatus for the study of ocular disorders. From the above analysis it can be ascertained that spatial coherence requirements are most stringent in the back scatter regime. In fact, in the limit θ→π, (Δθ) coh →0, however, in practice the effective penetration depth into the sample places a lower bound on the value of (Δθ) coh . Typically, for a weakly absorbing medium, the effective penetration depth is fifteen times the core diameter. Even under these conditions a monomode optical fiber, without additional optics, is not suitable as a coherent back scatter receiver. An optical fiber with a numerical aperture of 0.1 in air gives an uncertainty angle of about 75 mrad(4.3°) in water. In order to use this optical fiber as a coherent receiver having a high self-beating efficiency, without additional optics, the incident beam diameter in the center of the scattering volume, computed using Eqn. (7), must be less than 0.05 μm and 3 μm for θ=170° and for θ=90°, respectively. A conventional LLS system can be designed to achieve the latter condition with considerable difficulty. However, a monomode optical fiber with a core diameter equal to about four microns may be useful for delivering a narrow, but rapidly diverging optical field to the scattering volume. An unnecessarily large numerical aperture leads to reduced resolution in particle size. In the limit of a point scattering volume, requirements on the coherence solid angle imply that an infinite aperture detection system could be employed. Setting aside the extremely weak signal strength from a point scatterer, the resultant uncertainty in scattering angle will lead to an unacceptable error in particle size. An uncertainty Δr in particle size can be expressed as a function of the scattering angle and the uncertainty Δθ in the scattering angle, ##EQU9## In the limit ##EQU10## Thus at θ=90° an optical fiber with a numerical aperture of 0.1 in air leads to a 7.5% error in particle size (in water). However, θ=π the same uncertainty produces an error of only 0.14% in particle radius. State of the art DLS systems can reproducibly measure particle size to within 1%. Clearly, use of a monomode optical fiber, without additional control of the numerical aperture, will lead to an unacceptably large error in particle size, except near back scatter. Theoretical modeling of DLS is based on the assumption of quasimonochromatic and plane wave incidence. Departure from this condition may lead to ambiguities in data interpretation. Conventional light scattering systems meet this requirement by confining the scattering to the focussed region of an incident laser beam. An unfocussed laser beam, though highly collimated, is not used because of the larger diameter (typically>1 mm). The ideal incident beam should have a diameter less than 100 μm and divergence less than 1 mrad. Delivery of a laser beam by means of a lens-less optical fiber requires careful consideration, and in particular, the use of an unlensed optical fiber, which has a divergence angle of 80 mrad, goes against the accepted body of knowledge in DLS. The near field distribution of the optical field emanating from the tip of a monomode optical fiber, excited by a spatially coherent quasimonochromatic source, is adequately described by a Gaussian distribution, thereby permitting the use of Gaussian optics to characterize and predict the expansion of the optical field away from the tip. The beam radius, w(z), and the radius of curvature, R(z), at a distance z from the beam waist is given by ##EQU11## where w o is the beam waist, (=core radius of the monomode optical fiber); ##EQU12## is the divergence angle. The above equation indicates that a narrow optical beam can be delivered into the scattering volume by means of a monomode fiber having a core radius equal to about two μm, however, at the expense of a rapidly changing radius of curvature of the incident laser beam, analogous to the situation of a highly focussed laser beam. It has been shown that the effects due to phase and amplitude variations of a collimated or focussed laser beam are minimal in the back scatter regime. Distortions in the autocorrelation are pronounced, particularly in the forward scattering direction, when focusing by a 50× (or higher power) microscope objective. This means that for a monomode optical fiber having a numerical aperture of 0.1, corresponding to a 5× microscope objective, the affects of phase and amplitude variations are not a serious concern. A lens-less probe comprised of two or more optical fibers exploits the relaxed spatial coherence requirements when the incident laser beam has a small cross-section, typically less than twenty microns. The benefits of the subsequent geometry are considerable, ranging from a reduction in size by one order of magnitude, to design flexibility which allows the center and size of the scattering volume as well as the scattering angle to be controlled by the designer. FIG. 2 provides a detailed schematic illustration of a fiber probe 9 utilizing a monomode optical fiber 1 and a multimode optical fiber 2, which are mounted into a specially designed stainless steel ferrule comprised of two parts, a face plate 5 and a cylindrical housing 7. The optical fibers 1,2 are attached to the face plate using epoxy 6. In constructing a particular probe, one can define the edge of the scattering volume 8 at Z; the length of the scattering volume, ΔZ; the scattering angle θ (in the range 90° to 175°). The relevant equations ##EQU13## In the above equations, n 1 , n 3 , and n 2 are refractive indices of the optical fiber core 4, cladding 3, and the suspension medium, respectively. D f and NA are the cladding diameter and numerical apertures, respectively of the two optical fibers assumed to be identical. In practice, the transmitting optical fiber is monomode at the operating wavelength, but the receiving optical fiber is slightly multimode. All other variables are as indicated in FIG. 2. Based on the above set of equations a lens-less probe can be designed to meet constraints imposed by the position and volume of the scattering region, as well as any scattering angle in the range 90° to 175°. FIGS. 3, 4, and 5 show the possible range of scattering angle, edge of the scattering region from the probe tip, and the length of the scattering region, respectively, as a function of the inclination angle, α and the height h, of the optical fiber above the optical axis. In accordance with this invention, a novel clinical apparatus as shown in FIG. 6, for in-vivo characterization of ocular tissues, is provided. Existing state-of-art systems employ distributed bulk optics and are subsequently rather complex in structure. The fiber probe 9, together with a micro-positioner 11, e.g. a micrometer stage, can be fixed onto a universal applanation tonometer mounting assembly 12. This arrangement provides precise location of the scattering volume 8 in any substantially transparent region of the anterior segment of the eye 10. Position information is issued from a microcomputer 20, via control lines 13. The transmitting monomode optical fiber 1 is pig-tailed to a semiconductor laser 14, and threaded through a ruggedized cable assembly 16, which also contains the receiving optical fiber 2. The semiconductor laser 14 is preferably coupled to the microcomputer by a connector 15. The free end of the receiving fiber is terminated with another connector 18, which allows easy coupling to a photodetector 19. The connector 18 allow the probe 9 and laser 14 to be easily disconnected from the apparatus and replaced by another probe and associated laser. As the angle between the fibers within the probe determines the location of the scattering volume, different probes can be used to study different portions of the anterior segment of the eye. For example, one probe can be designed primarily for use in studying the cornea where a high scattering angle (e.g. about 175°) would be employed. Another probe or set of probes may be employed for studying the lens, which requires a much lower scattering angle. A monitor 17, is used for displaying all the relevant information pertaining to the experiment. FIG. 6A shows the incorporation of the fiber optic probe 9 into a slit lamp microscope assembly 21. A patient's head 24 is positioned into the slit lamp 21 by means of forehead and chin restraints 22 and 23, respectively. The computer controlled micrometer stages 11, mounted on the aplanation tanometer mount 12, allows precise positioning of the fiber probe 9 in front of the patient's eye 25. The DLS portion of the apparatus is shown in FIG. 7. It is no more than 5 mm in diameter, and can be held in the palm of one hand (FIG. 7 accordingly provides a greatly enlarged view thereof). The monomode optical fiber 1 is pig-tailed to a semiconductor laser 14 operating at a wavelength of, for example, 670 nm. The monomode optical fiber is threaded through a protective Teflon tubing 29, and an outer pvc coated monocoil tubing 28, for ruggedization. A bare portion of the monomode optical fiber is epoxied into a precision machined hole 26. The monomode optical fiber delivers an expanding Gaussian laser beam to the scattering region. Laser light scattered in the backward direction, (scattering angle in the range of 90° to 175°), is detected by the second optical fiber 2, which is positioned in a second hole 27, in close proximity to the transmitting optical fiber 1. The receiving multimode optical fiber decreases the overall time required to accumulate the intensity-intensity temporal correlation but with a sufficiently good signal-to-noise ratio, permitting the recovery of the size distribution. The reduction in time adds to patient comfort. The end faces of both fibers 1, 2 are substantially coplanar with the outer surface of the face plate 5. The receiving fiber 2 is threaded through the same Teflon sleeving 29, and monocoil tubing 28, up until the point where the transmitting and receiving fibers are separated. The latter is terminated in a connector 18, which can be mated directly to a photoconductor (e.g. photodetector 19) for converting a train of photon pulses into a pulse position modulated electrical waveform. The invention accordingly provides a unique implementation of a DLS optical system which requires no lenses, no moving parts, no alignment, and is insensitive to any vibrations or other forms of interference. The transmitting and receiving fibers 1, 2 require no lenses, are permanently locked in position in the probe, and can simply be moved into position adjacent to the eye by operating the micropositioner 11. By providing a beam which begins expanding from the end of an extremely small optical fiber, the light which reaches the retina is even more diffused than that of a beam which is focussed within the ocular tissue. The apparatus 10 is accordingly very safe to use. The divergence angle of the laser beam leaving the posterior surface of the eye lens is at least a factor of fifteen larger than that used in existing systems. An experimental prototype of the invention has been used to investigate the formation a reversible "cold" cataract induced in excised bovine eye lenses and age dependent cataractogenesis in excised human eye lenses. The results have been summarized below and confirm that changes in the size of protein macromolecules is an early indication of opacity in the crystalline lens. The technique is very sensitive and will detect any changes in size induced by the normal aging process, or by drug therapy, and therefore can play a vital role in the prevention and detection of cataractogenesis. FIG. 8 shows a prototype implementation of the invention disclosed herein. Light from a helium neon laser 40 is launched into a transmitting optical fiber 1, by means of a ×20 microscope objective 34. The fiber probe 9, is positioned above the surface of the excised eye lens 30, which is held in an ice bath 31, for the "cold" cataract experiment. The scattered light is collected by a receiving optical fiber 2, the free end of which is coupled to a photomultiplier 19. Photoelectron pulses from the photomultiplier 19 are processed and correlated using a computer based digital correlator 20. Results are displayed on a monitor 17. A stabilized high voltage supply 32 provides the biasing for the photomultiplier. FIG. 9 shows a comparison of the normalized autocorrelation functions obtained at various temperatures as the lens 30 was cooled by packed ice. A change in average size is clearly indicated by an increase in the correlation time, 1/e point of the curve. FIG. 10 shows the set of curves as the temperature was increased, showing that the lens recovers from the cataract to its initial transparency. For these measurements a probe with a scattering angle of 143° was used. Five human eye lenses were excised from cadavers ranging in age from 18 to 73. Visual inspection indicated differences in transparency, or onset of cataractogenesis, in the older eyes. Another set of experiments, using a probe with a scattering angle of 155°, were performed using the apparatus shown in FIG. 8, and the results of autocorrelation measurements are plotted in FIG. 11 A standard cumulant analysis was used to determine the average diameter of the protein macromolecules in the eye lens. FIG. 12 shows a plot of the average diameter for various patients. These results correlate with visual observation. Repeated measurements on several days gave the same dependence. Other analysis techniques, such as non-negative least squares, or regularized inversion, usually give a distribution in size, and routinely can recover the presence of two distinct species. In this way, relative changes in the concentration and size of the various types of proteins can be tracked as a function of normal aging or drug therapy or diet therapy. Although illustrative embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the invention.

A method and apparatus for determining the physical characteristics of ocular tissue is provided. A lens-less monomode fiber is caused to generate an expanding beam of monochromatic laser light into ocular tissue such that the light is scattered by the tissue in the backward direction. A second optical fiber, which is multimode at the wavelength of the light passing through the monomode transmission fiber, coherently detects light scattered by the ocular tissue. The scattered light received by the second optical fiber is converted into an electrical signal, which is subsequently analyzed to determine whether changes in the molecular structure of the ocular tissue have occurred.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. patent application Ser. No. 09/776,523, filed Feb. 2, 2001. STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT Not Applicable BACKGROUND OF THE INVENTION This invention relates in general to braces for joint support, and in particular to an exteriorly positionable anatomical brace having a pivoting joint assembly with multi planar hinging for accurate alignment of joined limb structures in relation to each other, and additionally having an infinitely-adjustable, cable-controlled limb extension regulator. Both injury and disease can affect the health, well-being, and operability of various joints of the human body. Chief among such joints are the knee and elbow where disease such as osteo-arthritis can curtail normal activity or where an injury such as a sports-related abuse or impact can prevent or severely limit continued activity. One manner of treating such joint conditions and/or preventing or reducing the severity of sports related injuries is to fit the wearer with an appropriate brace whereby a pivotal support member is positioned adjacent the affected joint and held in place usually by cuffs situated around limb structure sites above and below the supported joint. As is apparent, the cuffs are responsible for stabilizing the support member and therefore must be well secured to their associated limbs. In addition to requiring proper limb structure embrace by cuffs, a joint brace also requires a joint pivoting assembly that supports, stabilizes, and protects the actual joint itself while pivotally joining the cuffs. Thus, in the knee joint for example, the joint pivoting assembly of the brace most beneficially should pivot in one bending or extension plane while also permitting multi planar motion such that the lower leg beneath the knee can be moved in a normal manner and the upper and lower leg structures can align with each other in a natural manner. Further, it many times is desirable to be able to precisely and infinitely limit or regulate the distance of the pivotal extension plane at the knee while allowing natural bendability and normal multi planar motion up to the controlled extension distance. Unfortunately, however, present braces generally are not able to offer multi-planar alignment capabilities or infinite extension control, thereby requiring a user to endure single-plane pivotability along with either a self-limit or pre-set limit of limb extendability. In view of such restrictions, it is apparent that a need is present for a joint brace that permits substantially natural limb movement in conjunction with limb extension control as indicated for particular limb care. Consequently, a primary object of the present invention is to provide a joint brace having a joint assembly with multi planar hinging for accurate alignment of joined limb structures in relation to each other. Another object of the present invention is to provide a joint brace having an infinitely-adjustable limb extension regulator for limiting limb extension as indicated for a particular user. These and other objects of the present invention will become apparent throughout the description thereof which now follows. BRIEF SUMMARY OF THE INVENTION The present invention is an exteriorly positionable anatomical brace for stabilizing a uniting pivoting joint such as a knee joint disposed between a first and second limb structure of a living being. The brace comprises an upper frame member and a lower frame member joined together by a pivoting joint member, with each such frame member having secured thereon a respective cuff for encompassing a portion of each limb structure above and below the joint. Retention of the brace in place at the joint site is preferably accomplished with respective upper and lower securement members each wrapping around a respective limb structure in alignment with and not encompassed by the cuff. The pivoting joint member comprises two opposing pivoting assemblies each positionable on one side of the anatomical joint of a wearer to thus join the upper and lower frame members together. Each of these assemblies includes a forward arm member and a rearward arm member each having an upper end and a lower end, with these ends connected respectively to the upper frame member and the lower frame member. Specifically, the upper ends of each arm are individually mounted within a spherically-pivotal socket in connection with the upper frame member, while the lower ends of each arm likewise are individually mounted within a spherically-pivotal socket in connection with the lower frame member. As is apparent, these individual spherical mounts permit the selection of differing pivot ratios at a total of eight sites (four sites per lateral and per medial side) to thereby enable the upper and lower frame members to assume many different angular relationships with each other. Because of the availability of such a vast number of relationship combinations, the frame members of the brace becomes substantially self-aligning with each individual joint encounter among many wearers, thus accomplishing simulation of actual limb movement and angular interrelations thereof as natural individual limb-structure correlations are maintained. As earlier noted, proper joint care many times requires limited or regulated limb extension, with such control emanating at the pivoting joint member. While prior art controls typically include inserts of a predetermined size for placement in the base path of upper and lower frame travel, the limb extension regulator of the present invention is a cable, preferably fabricated of braided metal strands, extending between each rearward arm member and the upper frame member. A cable-length adjuster, preferably externally accessible, is provided for infinitely adjusting the length of cable available between the arm member and frame member to thereby regulate extendability of the brace-bearing limb. Most preferably, a visible measurement scale is provided for each cable such that available cable length on each side of the joint is adjusted to be substantially identical. In addition to being infinitely length-adjustable, the cable additionally provides a modicum of elasticity such that cessation of limb travel produces a less dramatic limb impact, but, instead, a gentler limb-extension termination for the wearer. The brace here defined therefore substantially simulates natural joint behavior along with extension control as individually indicated. BRIEF DESCRIPTION OF THE DRAWINGS An illustrative and presently preferred embodiment of the invention is shown in the accompanying drawings in which: FIG. 1 is a perspective lateral view of a knee brace with upper and lower cuffs of respective upper and lower frame members in place on a patient leg shown in phantom; FIG. 2 is a perspective medial view of the knee brace of FIG. 1 ; FIG. 3 is a lateral perspective view of the upper cuff and upper frame member only of FIG. 1 in disassociated relationship; FIG. 4 is a medial perspective view of the upper cuff and upper frame member only of FIG. 3 ; FIG. 5 is a rear perspective view of the upper cuff and upper frame member of FIG. 1 in place on a leg; FIG. 6 is an interior perspective view of a portion of the upper cuff of FIG. 1 ; FIG. 7 a is an interior side elevation view of the upper cuff of FIG. 4 ; FIG. 7 b is a schematic interior side elevation view of the cuff of FIG. 7 a showing tensioning thereof; FIG. 7 c is a top plan view along line 7 c — 7 c of FIG. 7 a; FIG. 8 is an inner perspective view of the joint assembly and respective portions of joined upper and lower frame members of FIG. 1 ; FIG. 9 is an exploded perspective view of the joint assembly and frame members of FIG. 8 ; FIGS. 10 a and 10 b are perspective views of the inner and outer sides of the joint assembly of FIG. 8 ; and FIG. 11 is an exploded perspective view of the joint assembly of FIG. 10 a. DETAILED DESCRIPTION OF THE INVENTION Referring first to FIGS. 1-5 , a knee brace 10 is shown ( FIG. 1 ) in place on a leg 12 of a human being. The brace 10 has an upper frame member 14 and a lower frame member 16 , with each such frame member 14 , 16 having secured thereon a respective cuff 18 , 20 for disposition about the limb structures above and below the knee joint 22 . Each cuff 18 , 20 is an arcuate wall structure, which non-limitedly can be fabricated of a polymer plastic, for juxtapositioning with the respective limb structures as shown. A snap-in protective patella cup 24 can be included as shown for specific impact absorption that may occur at the patella of the knee joint 22 . The knee brace 10 is retained in place on the leg 12 with respective upper and lower securement members 26 , 28 each respectively wrapping around an adjacent rear portion of the leg 12 . While FIGS. 2-5 show only the upper securement member 26 , it is to be understood that the following description thereof applies equally to the lower securement member 28 . Thus, the securement member 26 includes a medial piece 30 and a lateral piece 32 each attached at outside edges thereof to an elastomeric central piece 34 disposed behind the medial and lateral pieces 30 , 32 . Respective inside edges 40 , 42 of the medial and lateral pieces 30 , 32 are provided with eyelets 44 through which is intertwined a length of non-elastomeric lace 46 in substantially the same manner as a shoe is laced to thereby permit the drawing of each inside edge 40 , 42 toward each other. As would be recognized by the skilled artisan, hook-and-loop connectors (e.g. VELCRO) or other appropriate engagers can be employed in place of the length of lace 46 . Finally, the elastomeric central piece 34 is secured along a generally central vertical length 48 thereof to a liner section (not shown) situated behind the central piece 34 to thereby permit elasticized movement of the medial and lateral pieces 30 , 32 . The lateral piece 32 is releasably secured respectively to the upper cuff 18 and the upper frame member 14 , and the medial piece 30 is releasably secured to the upper frame member 14 and the medial condyle 52 , all by way of respective quick-release tab members 54 situated within respective slots 56 . As shown, each tab member 54 is provided with a finger-receiving pressure button 58 which, when depressed, permits removal of the tab member 54 from the slot 56 . In operation, the brace 10 is placed at the limb site of a user and positioned about the involved limb structures. Upon first placement of the brace 10 , the lace 46 is tightened to appropriate tightness while the central piece 34 increases surface area on the leg 12 to disperse pressure and prevent pull from the leg 12 such that the cuff 18 is properly maintained in place. Once such lacing is accomplished the first time, re-lacing is not required during brace use. Specifically, when a user wishes to remove the brace, the user simply presses inwardly on the pressure buttons 58 of only laterally, or, preferably, only medially, situated tab members 54 to release these tab members 54 from their respective slots 56 and remove the brace 10 from the leg 12 . It is important to note that the above-described tab-member release does not require increased tension on the leg and therefore is both safe and comfortable. Subsequent re-positioning of the brace 10 merely requires placement thereof as previously situated and re-connection of the earlier disengaged tab members 54 into respective slots 56 . This re-connection requires no contact with, or re-adjustment of, the lace 46 or the central piece 34 , and thereby assures proper brace placement without awkward, and very possibly incorrect, orientation of the brace 10 . Because the medial connection involves connection to the medial condyle 52 which is, of course, at the hinge point of the upper and lower frame members 14 , 16 , a closer positioning of the securement member 26 to the body joint is permitted, thereby improving joint support. While a lateral condyle 60 does not bear a connector member, it is to be understood that such construction could be provided if desired. Construction of the cuffs 18 , 20 is illustrated in FIGS. 6-7 c . Both the upper cuff 18 and lower cuff 20 are substantially identical in construction except for overall size since, of course, the lower cuff 20 encompasses a smaller-diameter limb portion below the knee joint 22 . As shown particularly in FIGS. 6 and 7 a with respect to the upper cuff 18 , whose following description also applies to the lower cuff 20 , the cuff 18 has two tensioning strip members 62 , integral therewith and disposed within respective non-continuous sleeves 64 , 66 that are structurally a part of the cuff 18 and that converge toward each other medially. Each strip member 62 , which preferably is fabricated of titanium, stainless steel, or similar material possessing similar tensioning properties, continues medially into a cuff mount 68 that functions to secure the cuff 18 to the upper frame member 14 . Finally, a respective exteriorly-accessible threaded screw 70 extends into each strip member 62 for adjusting tension in each strip member 62 and simultaneously adjusting the arc defined by the upper cuff 18 . Thus, clockwise turning of the screw 70 incrementally draws the lateral end of the strip member 62 medially for arcuately tightening the cuff 18 , while counter clockwise turning of the screw 70 incrementally releases the lateral end of the strip member 62 for arcuately loosening the cuff 18 . Operationally, the brace 10 is fitted to a patient by encompassing the cuffs about the respective limb structures above and below the knee joint 22 as seen in FIG. 1 . Once the upper cuff 18 is situated about the limb structure, the screws 70 are threadingly advanced to thereby cause movement of the lateral end of the cuff 18 , as illustrated in FIGS. 7 b and 7 c , against the limb structure as the strip members 62 are forced to bend toward the encompassed limb structure. Continued screw advancement increases tightening of the cuff 18 against the encompassed limb structure to thereby accomplish superior anchoring of the brace 10 and consequent stabilization of the knee joint 22 . As earlier noted, the lower cuff 20 is constructed in the same manner as the upper cuff 18 and therefore encompasses and embraces the limb structure below the knee joint 22 in like fashion. Referring to FIGS. 8-11 , the pivoting assembly 72 uniting the upper and lower frame members 14 , 16 is illustrated. The assembly 72 includes an upper housing 74 and a lower housing 76 that fit, respectively, into a complementarity shaped opening 78 of the upper frame member 14 and a complementarity shaped opening 80 of the lower frame member 16 . Once so positioned, respective caps 82 , 84 are held in place with conventional set screws 86 passing respectively through apertures 88 a , 88 b and 90 a , 90 b . Those skilled in the art however will recognize that the housings 74 and 76 can be formed unitary with the frame members 14 and 16 . The lateral condyle 60 resides between the assembly 72 and the knee joint 22 . Both the upper and lower housings 74 , 76 have two respective openings 92 a , 92 b and 94 a , 94 b each having respective sidewalls 96 shaped to nest a spherical shape. Disposed between two openings 92 b , 94 a of the housings 74 , 76 is a forward arm member 98 having generally perpendicularly angled first and second ends 100 a , 100 b directable toward the openings 92 b , 94 a . In like manner, a rearward arm member 102 having generally perpendicularly angled first and second ends 104 a , 104 b is disposed between two openings 92 a , 94 b of the housings 74 , 76 such that the ends 104 a , 104 b are directable toward the openings 92 a , 94 b . A cable assembly 106 includes a cable 108 extending from the upper housing 74 to an upper edge portion 110 through an aperture 112 of the rearward arm member 102 , and is provided with a conventional set screw 114 at one end thereof for extending or shortening the length of the cable 108 disposed between the rearward arm member 102 and upper housing 74 . Such length adjustment is accomplished with an Allen wrench inserted into the enterable channel 116 leading to the set screw 114 . Because the upper housing 74 resides within the upper frame member 14 , the cable 108 functions as a joint extension limiter to determine the travel distance of the upper frame member 14 from the joint and thus the pivotal distance of the upper and lower frame members 14 , 16 in relation to each other. An opening 126 can be provided in the cap 82 such that the progressive placement of the cable 108 can be observed exteriorly and such placement can be made identical for both the lateral and medial sides. Two additional benefits are provided by the cable 108 in that, first, infinite pivot-distance adjustability, as opposed to prior-art pre-sized stop members, allows great flexibility in leg extension, and, second, the cable itself has a dampening, or minimal stretch, effect that results in a softer extension stop and a consequent reduced risk of joint trauma. As earlier described, the sidewalls 96 of the openings 92 a , 92 b and 94 a , 94 b are shaped to nest spherical forms. As clearly illustrated in FIG. 11 , spherical sockets 118 a , 118 b, 118 c , 118 d are disposed in these openings 92 a , 92 b and 94 a , 94 b in the constructed assembly 72 , and each such socket accepts one respective perpendicularly angled end of forward and rearward arm members 98 , 102 . Each angled end 100 a , 100 b , 104 a , 104 b has an aperture 120 there through which mates with a transverse aperture 122 of each socket 118 a , 118 b , 118 c , 118 d such that respective pins 124 can pass through such mated apertures and retain the angled ends 100 a , 100 b , 104 a , 104 b within the sockets 118 a , 118 b , 118 c , 118 d . Because of the spherical interface between each socket 118 a , 118 b , 118 c , 118 d and each sidewall 96 , multi planar movement of the upper and lower frame members 14 , 16 in relation to each other can be accomplished. In particular, the different pivot points thus provided allow different pivot ratios as needed for both lateral and medial sides to thereby simulate actual knee joint movement. This is, of course, in contrast to parallel planar hinges as found in the prior art where the knee joint and limb structures of a user are forced to adapt to knee brace construction instead of the knee brace adapting to the needs of the user. The present knee brace 10 , because of the multi planar and potentially differing pivot ratios and consequent multi planar movement capabilities of the lower frame member 16 in relation to the upper frame member 14 , provides automatic tibia alignment and automatic anatomical changes over time by accommodating anatomical differences among users. These properties accomplish all-important positive three-point positioning at the quadriceps muscle, the gastrocnemius (calf) muscle, and the knee joint itself. In this manner, stabilization and support of a uniting pivoting joint occurs economically, through an “off-the-shelf” brace, and, simultaneously, most effectively through continual self-alignment capabilities combined with sound limb-structure stability. While an illustrative and presently preferred embodiment of the invention has been described in detail herein, it is to be understood that the inventive concepts may be otherwise variously embodied and employed and that the appended claims are intended to be construed to include such variations except insofar as limited by the prior art.

A brace for stabilizing a joint such as a knee disposed between a first and second limb structure. The brace includes upper and lower frame members, cuffs for encompassing a portion of each limb structure, and a uniting pivoting joint member. The joint member includes two opposing pivoting assemblies, with each including a forward and a rearward arm member each having upper and lower ends spherically-pivotally connected to the upper and lower frame members for enabling multiple angular relationships. The pivoting assembly can include a limb extension regulator, preferably a cable, extending between the rearward arm member and the upper frame member to permit infinitely adjustable extendability of the brace-bearing limb. Most preferably, a visible measurement scale is provided for precise extension distances.

BACKGROUND OF THE INVENTION The present invention relates to wheelchairs and, in particular, to a wheelchair having a drive and steering linkage whereby a wheelchair bound user with a single hand and small hand movement can drive a small diameter idler wheel, independent of large diameter hand drive wheels, to rotate the idler wheel and steer the chair. A wide variety of wheelchairs exist for conveying geriatric and non-ambulatory individuals. Most chairs provide for a pair of relatively large diameter wheels that contain concentric hand rails. The rails can be grasped, rotated and/or manipulated by the user to drive and direct the chair. Most chairs also provide a pair of smaller diameter idler or non-driven wheels that typically support the front end of the chair. The idler wheels stabilize the chair and distribute the weight of the user. The idler wheels are mounted to rotate in associated support columns and follow motions directed by the larger diameter drive wheels A variety of after-market and integrated assemblies have also been developed to provide drive power to the drive wheels of a wheel chair. Many assemblies actively drive the chair with the aid of a battery power source and associated drive linkage. Many ratchet and lever arm accessories also exist in the art that apply drive power to the large diameter drive wheels without having to grip the hand rings. For example, U.S. Pat. No. 5,232,236 and published applications 2002/0043781; 2005/0269797; 2005/0275190; and 2006/0261571 disclose some of these assemblies. Some assemblies provide for foot and hand crank operation. U.S. Pat. Nos. 5,297,810; 5,873,589; 6,196,565; A variety of hand manipulated lever arm assemblies have also been developed for wheel chairs that include drive linkages that cooperate with the large diameter wheel drive axles. To and fro movement of one or more included lever arms mounted to pivot at the chair direct associated linkages (e.g. chain, belt and rod) coupled to supporting axles to drive the large diameter wheels. Some of these assemblies can be found at U.S. Pat. Nos. 4,641,847; 4,762,332; 5,007,655; 5,020,815; 5,236,398; 5,322,312; 5,499,833; 6,325,398; 6,715,7890; 6,746,034; and 6,820,885. An arm rest that pivots side to side and cooperates with an eccentric coupled link rod is disclosed at U.S. Pat. No. 5,509,673. A hand crank assembly that rotates about one axis to supply drive power to a depending chain and independently rotates about a second axis to provide steering to a large diameter drive wheel is shown at US published application 2006/0131832. A pivoting lever arm assembly and chain linkage that cooperates with a large diameter drive wheel and separately provides a rotating steering hand hold that cooperates with a small diameter idler wheel is shown at U.S. Pat. No. 6,916,032. In contrast to the foregoing, the present invention provides a multi-axial hand-operated lever arm that pivots with limited hand movement in one axis (i.e. Y axis) to couple drive power via a rigid drive arm to a one-way clutch and small diameter drive wheel. Reciprocating vertical movement of the hand arm particularly supplies drive power to an eccentric arm fitted to the one-way clutch and a drive axle of a small diameter, secondary drive wheel. The hand arm independently rotates 360° about a horizontal or Z axis within a support column to steer the associated secondary drive wheel. Large diameter, primary drive wheels with hand rings are separately available to the user for normal conveyance. SUMMARY OF THE INVENTION It is a primary object of the invention to provide a hand-operated assembly to supply drive power and steer a drive wheel of a wheelchair. It is further object of the invention to provide a hand-operated, multi-axis linkage operated by a single hand with limited movement to supply drive power and steer a secondary drive wheel of a wheelchair. It is further object of the invention to provide a hand-operated lever arm that pivots in the Y axis at a support column fitted to a wheel chair and manipulates a drive rod coupled to an eccentric arm fitted to a one-way clutch at a drive axle and supported drive wheel. It is further object of the invention to provide a pivoting hand arm that independently rotates 360° at a support column in the Z axis to steer a drive wheel driven by a drive rod and eccentric arm fitted to a one-way clutch at a drive axle. It is further object of the invention to provide a modular support column having drive and steering linkages that couple to an idler support wheel of a wheel chair. It is further object of the invention to provide a modular accessory drive and steering assembly for a secondary drive wheel of a wheelchair. It is further object of the invention to provide a drive and steering assembly that cooperates with an associated brake for a secondary drive wheel of a wheelchair. The foregoing objects, advantages and distinctions of the invention are obtained in a presently preferred assembly shown at attached figures. The assembly permits a wheelchair bound individual to selectively apply drive power with a single hand via a column mounted, pivoting lever arm or handle to a secondary drive wheel secured to the column. A linkage rod is directed from the lever arm to an eccentric arm fitted to a one-way clutch assembly secured to a wheel support axle at the secondary drive wheel. Limited, pivoting motions at the handle rotate and drive the axle and secondary drive wheel. Steering is obtained upon rotating the lever arm and linkage rod within the column and thereby the drive wheel. That is, the lever arm is independently mounted to rotate 360° within the column about the Z axis to turn and steer the secondary drive wheel. Relatively short strokes of the handle lever arm in the Y axis over a range of motion Y′ are translated into controlled movements of the secondary drive wheel. A longer stroke motion of the lever arm over a range of motion Y″ induces a flange at the linkage rod to engage a brake pad mounted to pivot at the column and engage the secondary drive wheel. Still other objects, advantages, distinctions, constructions and combinations of individual features of the invention will become more apparent from the following description with respect to the appended drawings. Similar components and assemblies are referred to in the various drawings with similar alphanumeric reference characters. The description to each combination should therefore not be literally construed in limitation of the invention. Rather, the invention should be interpreted within the broad scope of the further appended claims. BRIEF DESCRIPTION OF THE DRAWINGS Several figures and photographs are provided which disclose presently preferred constructions of the invention and comprise the following: FIG. 1 is a perspective drawing of a wheel chair fitted with the hand operated lever arm and associated secondary drive wheel assembly of the invention. FIG. 2 is a partial cutaway view to the lever arm, support column and drive linkage. FIG. 3 is a perspective drawing showing a keyed, ratchet and pawl one-way clutch assembly that mounts to a driven axle. FIG. 4 is a perspective drawing showing a roller, one-way clutch bearing assembly that mounts to a driven axle. FIG. 5 is a perspective drawing showing a wheel chair with a detachable idler wheel and a drive/steering assembly and associated secondary drive wheel. FIG. 6 is a perspective drawing showing a wheel chair with a pair of detachable drive/steering assemblies and associated secondary drive wheels. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGS. 1 , a perspective view is shown to a wheelchair assembly 2 of the invention. The wheelchair 2 is generally constructed in conventional fashion but is fitted with a novel, hand-operated drive/steering assembly 4 that cooperates with a secondary drive wheel 6 . The assembly 4 is operable with limited movements from a single hand and is described in greater detail below with additional attention to FIGS. 2 through 6 . Depending upon the manufacturer and chair application, the chair 2 can be constructed to a variety of forms and with a variety of wheel configurations. The depicted chair 2 however is representative of the most typical chair design used by hospitals, nursing homes etc. It is to be appreciated therefore that the assembly 4 can be adapted to a variety of chair constructions with differing seat, back rest and primary drive wheel configurations. The chair 2 provides right and left primary drive wheels 8 or relatively large diameter (e.g. 24 to 36 inches). Hand rings 10 are fitted to the drive wheels 8 to provide a mechanism for a physically able occupant to control movements of the wheels 8 to direct the chair 2 . Handles 12 are provided for an attendant to push and manipulate the chair 2 . A hammock or sling-type seat 14 and backrest 16 are stretched between frame members of a support framework 18 . Pairs of armrests 20 and footrests 22 are fitted to the framework 18 . The footrests 22 and/or support arms 24 can be constructed to pivot to facilitate ingress and egress from the chair or may be deleted such as with sport type chairs. Fitted to the forward end of the framework 18 is a typical idler wheel assembly 30 . The assembly 30 provides a secondary, chair support wheel 32 (e.g. 5-8 inches in diameter) that depends from a yoke 34 . The yoke 34 is supported to rotate on bearing surfaces fitted to a column piece 36 . Most wheelchairs include two idler wheel assemblies 30 that are permanently constructed with the chair to distribute the load of the occupant and stabilize the front of the chair 2 during a user's ingress and egress. The idler wheels passively follow motion directed by the primary drive wheels 8 . The wheel chair 2 has been improved to include at least one hand-operated drive/steering assembly 4 and secondary drive wheel 6 in combination with an idler wheel assembly 30 . The secondary drive wheel 6 of the assembly 4 is of a comparable size to the idler wheel 32 . The assembly 4 enables a user having some hand strength in at least one hand to manipulate and steer the chair 2 , even if unable to direct the primary drive wheels 8 . The idler wheel 32 and drive wheels 8 follow motions directed by the secondary drive wheel 6 and hand operations performed at a hand controlled, handle or lever arm 40 . The assembly 4 finds particular application for geriatric and infirmed individuals, who can now manipulate the chair 2 within activity spaces that don't require long distance movement (e.g. eating areas, social areas, reading areas or outdoor rest areas) without requiring an attendant. The assembly 4 can be fitted to a chair 2 with appropriate fasteners as an after-market improvement. Turning attention to FIGS. 2 through 4 , FIG. 2 depicts a perspective view of the drive/steering assembly 4 in partial cutaway. FIGS. 3 and 4 depict alternative constructions of one way, over-running clutch assemblies 42 and 44 that can be secured to a driven axle 46 supporting the secondary drive wheel 6 and coupled to the lever arm 40 . The assembly 4 can be permanently mounted to the chair 2 such as by welding. Alternatively, FIGS. 5 and 6 depict modular after-market assemblies 4 that can be fastened to a chair to obtain the benefits of the invention and enhance the utility of a chair 2 . Depending upon the chair 2 , minor modifications may have to be performed to adapt the drive/steering assembly 4 . The assembly 4 generally comprises the handle or lever arm 40 which is mounted to rotate about a support column 48 that is coupled to a yoke 50 that supports the driven axle 46 and the secondary drive wheel 6 . A rigid linkage rod 54 extends between the lever arm 40 and a one-way, over-running clutch 44 that is keyed or coupled to the driven axle 46 , reference FIG. 4 . Either of the clutch assemblies 42 or 44 of FIGS. 3 and 4 can be adapted to the assembly 4 . The clutch assembly 42 is secured to the axle 46 with a key (not shown) at mating keyways 60 let into the clutch 42 . The inner roller bearing portion 56 of clutch assembly 44 is press fit onto the axle 46 . A variety of alternative clutch assemblies and fastenings can be used to facilitate the coupling of the handle 40 and linkage rod 54 to the axle 46 and/or wheel 6 . The linkage rod 54 is fastened to an offset end of a lobe or eccentric 62 or 64 that project from the clutch assemblies 44 and 42 . The radial offset of the fastening point of the linkage rod 54 to the lobes 62 and 64 from the axle 46 serves as an eccentric or lever arm which defines the effective stroke length of the lever arm 40 . Presently, the lobes 62 and 64 projects approximately 1 to 2 inches and which translates to a range of travel distance at the secondary drive wheel 6 of approximately 2 to 4 inches over the equivalent range of motion Y′ at the lever arm 40 . The actual range of chair movement can be varied as desired by varying the fulcrum or pivot point 82 of the lever arm 40 and/or the length of the lobes 62 and 64 and displacement of the linkage rod 54 from the axle 46 or with other associated gearing etc. Returning attention to the lever arm 40 , the arm 40 is secured to a head piece 70 mounted to the column 48 . The head piece 70 is supported on a bearing 72 and the lever arm 40 thus can be rotated 360° about the Z axis. The lever arm 40 mounts to the head piece 70 at a pivot yoke 74 at a pivot pin 76 . The lever arm 40 extends approximately 5 to 6 inches and includes a rotating hand knob 78 to facilitate reciprocating vertical and rotational horizontal movements of the lever arm 40 . The linkage rod 54 is secured to a pivot bracket 80 formed with and that depends from an inner surface of the arm 40 and a pivot pin 82 that defines the fulcrum point of the lever arm 40 . Over the range of arm motion Y′, the rod 54 rises and falls within the column 48 to rotate an associated lobe 62 or 64 and associated outer clutch assembly 44 or 42 to advance the axle 46 in a preferred clockwise or counterclockwise direction. Counter rotation of the axle 46 is prevented such as by the cogs 84 and pawl 86 at the clutch assembly 42 . Roller bearings 85 that move along arcuate, ramped or tapered surfaces at depressions 87 of the clutch assembly 44 grip and release the axle 46 and similarly limit movement of the axle 46 to be unidirectional. With the operation of the hand lever 40 within the range of motion Y′, the secondary drive wheel 6 incrementally moves the chair 2 as desired by the occupant. Upon elevating the arm 40 into the Y″ range of motion, a flange 91 that projects from the linkage rod 54 engages and rotates a brake member 92 into engagement with the secondary drive wheel 6 . Upon engaging the wheel 6 , a frictional surface of the brake member 92 slows rotation of the wheel 6 . The brake member 92 is normally biased to prevent physical contact with the wheel 6 . A retainer mechanism may be included that cooperates with the latch arm 4 to secure the arm 40 in an elevated condition within the Y″ range of motion to lock movement of the chair 2 , once situated by the occupant. The mounting location of the lever arm 40 may also be re-located as desired with or without modification of the linkage rod 54 . Although the drive/steering assembly 4 is shown as being permanently mounted to the chair 2 , FIGS. 5 and 6 depict alternative arrangements wherein representative wheel chairs 100 are shown without any idler support wheels 32 . Combinations of one or two modular drive/steering assemblies 102 and/or a modular idler wheel assembly 104 are shown that can be coupled to improve the support of the chairs 102 . The depicted chairs exemplify the modularity of the drive/steering assemblies 4 and 102 to improve the functionality of a wheelchair during initial construction or as an after-market modification and improvement. The drive/steering assembly 102 and idler assemblies 104 are substantially identical to the assemblies 4 and 30 with the exception of including representative, detachable fasteners 106 and 108 . The fasteners 106 provide mating clamp collars 110 and 112 that cooperate with threaded fasteners 114 . The collars 110 and 112 detachably secure the assembly 102 to an upper end of a frame piece 120 at the chair 100 . The fasteners 108 provide an extension plate 116 and an upright pin 118 . The pin 118 mounts to a lower end of the frame piece 120 . Collectively the fasteners 106 and 108 effectively secure the assemblies 102 and 104 to the wheel chairs 100 yet permit adjustments to facilitate proper alignment. Other types of interconnected, detachable fasteners 106 and 108 can be adapted to obtain a desired retention of the drive/steering assemblies 102 and idler assembly 104 to a chair. The chair 100 at FIG. 5 when fitted with the assemblies 102 and 104 as an after-market modification is essentially identical to the chair 2 . The chair 100 of FIG. 6 in contrast includes a pair of independently mounted drive/steering assemblies 102 . The operator necessarily must coordinate and synchronize steering and drive hand movements to assure a desired travel. By operating the arms 40 in an alternating treadle fashion, the range of chair movement however is expanded. While the invention is shown and described with respect to a presently preferred wheelchair drive/steering assembly and several considered improvements, modifications and/or alternatives thereto, still other assemblies and arrangements may be suggested to those skilled in the art. It is also to be appreciated that the singular features of the drive/steering assembly of the invention can be arranged in different combinations and adapted to different chairs. For example, the drive steering assembly can be modified to provide for movement of the handle 40 along only one axis and combined with a chair to selectively steer or drive the wheel 6 . The foregoing description should therefore be construed to include all those embodiments within the spirit and scope of the following claims.

A hand-operated assembly that supplies secondary drive power and steering control to a secondary drive wheel of a wheel chair. The assembly comprises a handle that is controlled with one hand and a linkage rod that extends from the handle to an eccentric arm fitted to a one-way clutch assembly at a secondary drive wheel support axle. Reciprocating up-down, pivoting movements of the handle over a range Y' in the Y axis directs a linkage rod to rotate an eccentric arm fitted to a one-way clutch and a drive axle of a small diameter, secondary drive wheel. Independent 360deg rotation of the handle about a second, horizontal or Z axis steers the secondary drive wheel. A portion Y' of the range of handle motion directs a flange at the linkage arm to engage a brake piece that contacts the secondary drive wheel. Large diameter, hand driven, primary drive wheels are separately available to the user for effecting normal chair conveyance.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to an improved manual implement, and more particularly to a hand tool comprised of a novel handle and a combination blade, blade support and handle socket with an integral implement fulcrum, which efficiently translates a minimum of physical effort on the part of the user into superior torque and lever forces for effectively loosening, excavating, lifting and relocating a load of material. 2. Discussion of the Prior Art From farms to factories, from mines to the city, applications for shovels, spades and similar hand tools abound, and one of the most frequent and basic uses of such an implement is in a garden. Gardening is a greatly favored, widely practiced and highly profitable pastime. In urban areas, however, space is at a premium, and garden plots tend to be small. Since it is not feasible to employ machinery, and noise and pollution factors must be considered, various hand tools have always been used to accomplish the necessary gardening chores. The greatest time and effort consuming task of gardening, and possibly the most dreaded, is tilling. The hard physical exertion required just to cultivate the smallest plot is fatiguing, debilitating and can even be injurious, since such exertion places serious and sometimes unacceptable strain on the heart, the spine, the muscles, and other parts of the body. A yound and healthy person finds it to be a backbreaking job, and an elderly or infirm person may have no chance of performing this task at all. Many implements and accessories have been developed in an attempt to overcome or at least ease the hard physical labor required to wield a shovel, but these fall far short of their goal. The greatest inherent disadvantage in known tools is their inability to translate the efforts of the user into effective action by the implement so that minimal action and force by the user accomplishes the loosening, excavation and relocating operations of blade load in the most efficient manner possible with the least degree of strain and fatigue. Tools which have specifically addressed this problem include those disclosed in U.S. Pat. No. 738,057 to O'Connor, U.S. Pat. No. 2,716,538 to Arrowood and U.S. Pat. No. 3,436,111 to England. O'Connor teaches a fulcrum attachment for shovels which allows the shovel handle to act as a lever on the blade to loosen ground, but the device of O'Connor does nothing to alleviate the bending, lifting or physical stress on the user, and only makes loosening the soil easier. Arrowood discloses a soil loosening tool which is also used to remove weeds. Although it employs a lever and fulcrum configuration, it still necessitates bending by the user to upheave the loosened ground, as is shown in the drawings of the patent, and Arrowood makes no provision for excavating and relocating the loose soil. The hand tools of England also incorporate the fulcrum and lever principle for loosening ground, and yet do not provide for excavating and redepositing of the soil except by bending and lifting actions and the concomitant physical strain on the user. SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide a manual implement, comprised of an arcuate handle and a combination blade, blade support and handle socket with an integral implement fulcrum, which effectively accomplishes the operations of load loosening, excavating and relocating by efficient translation of a minimum physical effort by the user into the requisite mechanical forces and actions by the implement. Another object of the present invention is to provide a hand tool which precludes the stooping, bending or lifting normally necessary to perform the various load handling steps, thereby vastly diminishing the physical exertion of the user. It is also an object of the present invention to provide a manual implement which can be used by anyone, regardless of age or strength, with substantially the same results. A further object of the present invention is to provide a highly efficient, compact and lightweight hand tool which is inexpensive and easy to manufacture and use. Other objects within the scope of the invention will become apparent from the following specification, claims and the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side plan view of the improved manual implement of the present invention; FIG. 2 is a front elevational view of the combination blade, blade support and handle socket of the present invention; FIG. 3 is an exploded elevational view of the handle with the combination blade, blade support and handle socket of the present invention; FIG. 4 is a top perspective view of the combination blade, blade support and handle socket of the present invention, with the handle base in cross section; and FIG. 5 is a rear elevational view of the combination blade, blade support and handle socket of the present invention. FIG. 6 is a schematic illustration of a precut single blank of sheet material which forms the combination blade, blade support and handle socket means. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings, the improved manual implement of the present invention is shown at FIG. 1 in utile assembly. The implement includes a handle (10) and an integral blade, blade support and handle socket, generally denoted at (12). Member (12) can be metal or plastic, depending upon the application for which it is intended. A single precut blank of suitable sheet material, such as soft steel or a thermoplastic, can be stamped or folded by any suitable means to form the combined member (12) and may then be otherwise treated or tempered to prepare it for end use. Member (12) includes a main blade portion (14) with a blade tip (16). The blade shown in the figures is that of a shovel, but particularly configured blades can be formed for special applications or to handle materials of different weight, consistency and blade adherence. Centrally formed in blade (14) is an inverse wedge or V channel (18), the vertex of the V rearward of blade (14) with the edges of the channel sides integral with the blade face. V channel (18) commences upward in blade (14) substantially from blade midpoint. At the uppermost points of the side edges of V channel (18), which are approximately level with the top of the blade face, transition folds (20) commence. Transition folds (20) invert the sides of V channel (18), i.e., fold the sides back upon themselves. This reversal of the sides of V channel (18) at transition folds (20) terminates V channel (18) at blade top, and the angularly folded sides of V channel (18) form an inverted V channel (22) directly above and extending laterally rearwardly of V channel (18) and blade (14). Transition folds (20) terminate at the initial vertex point of inverted V channel (22), which is also the termination vertex point of V channel (18). Examples of angle dimensions may include an approximate 15 degrees off blade face to the vertex of V channel (18) proximate its commencement, and an approximate 26 degrees off V channel (18) vertex for transition folds (20). The top of blade (14) at its outermost edges is folded rearwardly of blade face to form substantially downturned lips (24). Lips (24) continue along the top of blade (14) toward transition folds (20) in smooth angular transition to blade (14) from substantially downturned at the edges to approximate 90 degree angles off blade (14) at their juncture with commencement of transition folds (20). At the commencement points of folds (20), lips (24) curve at an approximately planar right angles to continue along the bottom edges of inverted V channel (22) as flanges (26), which are attached and substantially perpendicular to inverted V channel (22) along its length. The portions of blade top between lips (24) and transition folds (20) are foot-rests (28), which are intended for step-pushing blade (14) into material in the conventional manner. Inverted V channel (22) extends rearwardly of blade (14) for a distance equal to approximately 70% of total blade length, and terminates at handle socket front faces (30), which are intersecting angularly offset planes between the terminal edges of the sides of inverted V channel (22) and the front edges of socket side faces (32). Socket side faces (32) are positioned substantially parallel to each other by the angular offset of socket front faces (30) from inverted V channel (22), and are of a length slightly greater than the length of the handle base from front to rear. The rear bottom edges of socket side faces (32) are curved in a substantially 90 degree quadrant to form socket fulcrum arcs. When the socket fulcrum arcs are tangential with the rear edges of socket side faces (32), the faces extend rearwardly to form socket tabs (34). Tabs (34) are of a width equal to the distance between the rear points of tangent of the socket fulcrum arcs and the tops of socket side faces (32), and are of a length slightly greater than the handle base width. Tabs (34) are folded one over the other, the outermost tab forming the rear face of the handle socket. At their initial contact point with socket side faces (32), flanges (26) curve through an arcuate quadrant portion to form flange fulcrum arcs complementary to the socket fulcrum arcs, and widen interiorly of socket side faces (32). At the socket fulcrum arc tangent points, the width portions of flanges (26) exterior of socket side faces (32) end in substantially planar edges, and the widened portions of flanges (26) interiorly of the socket side faces (32) extend to form flange tabs (36), which are of a width equal to the distance between socket side faces (32) and of a length equal to extend to the top of the socket rear face formed by overlapped socket tabs (34). Flange tabs (36) smoothly overlap interiorly of overlapped socket tabs (34), and the handle base is fastened in the rear of the socket through all four tabs (34, 36). Handle (10) includes grip (38) at its top end, which is substantially oval in cross section, and the handle smoothly transits from substantially oval in diminished section at grip (34) along its length to substantially rectangular in increased section at handle base (40), the longer sides of the rectangle being the side faces of the handle base. The transition of handle (10) over its length is shown more fully at FIG. 3. Handle (10) may be of other shapes, or combinations of shapes. Two requirements in configuration of the handle cross section are that the handle be of sufficient dimensions to efficiently withstand the physical stresses at the socket when the handle is moved and the blade meets the resistance of the load to be lifted, which is translated through the blade and blade support to the socket and thus to the handle base, and the grip be easily grasped and held by the hand of the user. The upper portion of the handle is in diminished cross section because this corresponds with diminished stresses at that portion of the handle, while the base is of sufficiently larger section to effectively wield member (12). An arc (42) is formed in handle (10) approximately one quarter of the total handle length from grip (38). Appropriate handle measurements are, by way of example, approximately 32" in length from base (40) to arc (42), and about 1' in length from the handle arc to grip (38), with an arc of approximately 128 degrees. While the overall length of the handle and degree of arc can vary, the detail proportions of the handle remain the same. The section of handle between grip (38) and handle arc (42) forms a torque shaft and lever portion, and the degree of arc extends that handle portion forward a distance substantially equal to the combined lengths of the blade support and socket. To accomplish this, the vertical axis of handle (10) off inverted V channel (22) would be 100 degrees in the case of the example proportions given above for handle length and handle arc degree. From the bottom to the rear face of handle base (40) is a one quarter curve which forms the handle fulcrum arc, also seen in FIGS. 3 and 5, and which allows base (40) to precisely seat in the socket. Handle (10) is secured in the socket by fastening means (44) through each socket side face (32) substantially at the lowermost front corners of base (40), and through the tabs (34, 36) substantially at its uppermost central portion within the socket. The position of the socket side face fastenings prevents the tendency of base (40) to drive forward and rupture socket front faces (30) and inverted V channel (22), in addition to otherwise securing the handle within the socket. The rear fastening stabilizes the socket and secures it to itself by securing overlapped socket tabs (34) and flange tabs (36) overlapped therebeneath. This fastening also precludes the tendency of base (40) to drive downward or otherwise deform the socket, as well as further fastening the handle within the socket. Upon fastening base (40) in the socket, the implement is complete, and a smoothly integral implement fulcrum is provided. In FIG. 2, the combination blade, blade support and handle socket is shown in elevation. A cover plate (46) is attached along the side edges of inverted V channel (22) and socket side faces (32) to thus close the bottom of the channel and socket from materials having high adherence, preventing them from compacting within the channel and the open bottom of the socket. Plate (46) extends perpendicularly beyond the side edges of inverted V channel (22) to form the flanges (26), with the flange ends proximate blade (14) attached to footrests (28). Plate (46) is attached to socket side faces (32) and includes a 90 degree curve to form the implement fulcrum arc, the flange portions exterior the socket ending as substantially planar surfaces. The distal portion of plate (46) extends to form socket rear face (48), which is attached to socket side faces (32) along their rear edges. Blade plate (50) is attached to V channel (18) at the channel edges on the blade and along transition fold lines (20) to close the blade face. The view at FIG. 3 illustrates the implement of the present invention with an exploded view of the handle to show its cross section along various points of its length. Tabs (34, 36) are illustrated in overlapped relationship, and the handle base fulcrum arc is shown. The positions of insertion for fastening means (44) are also illustrated. Fastening means (44) may be any pin type fastener, such as screw-threaded devices, dowel pins, rivets, etc., with suitable characteristics for attachment of the handle without shearing or damage to the handle base or socket under normal use. FIG. 4 illustrates a top perspective view of member (12) showing handle base (40) in cross section at the point where it enters the socket. Socket front faces (30) are angularly offset from the front face of handle base (40). Tabs (34, 36) are shown overlapped and fastened. The size of the socket and length/width of tabs (34, 36) are dependent upon blade size, since flanges (26) and inverted V channel (22) form the blade support and their size and length are also determined by blade size. Handle base (40) would be complementary in size to wield member (12); thus, a larger blade would entail a larger support and larger socket, and a larger handle base. The top view shows blade (14) substantially bowled and a point to tip (16). Blade (14) and tip (16) would alter from that shown if the blade were formed in a particular configuration for a specific application and, in that instance, V channel (18) might be partially visible in blade (14). FIG. 5 shows a rear view of member (12) of the present invention in slight perspective elevation, illustrating the widening of flanges (26) interiorly of socket side faces (30), the fulcrum arc curve of handle base (40), and the transit of lips (24) from downturned at blade edge to right angle off blade (14) at transition folds (20). Footrests (28) are at a slight slope but nearly perpendicular to blade tip (16), so the slope is not great enough to allow the foot of the user to readily slide off. Lips (24) are downturned at the outermost edges of blade (14) and continue along the top of the blade face while simultaneously and smoothly turning upward, so they are at a substantially 90 degree angle to blade (14) as they reach blade top terminii, approximately parallel to the ends of the edges of inverted V channel (22) and commencement points of transition fold lines (20). Formation of downturned lips (24), smooth transition of footrests (28) to right angle off blade (14) at blade top terminii, and planar right curves into flanges (26) provide the necessary rigidity for inverted V channel (22), and a highly effective stabilization of compression forces between the implement fulcrum and blade under load. FIG. 6 is an example of the precut single sheet material from which the integrally folded member is made. For the example of dimensions given above for the blade and handle, the angle of footrests (28) off inverted V channel (22) would be 80 degrees, thereby giving additional height to the outside top corners of blade (14) for downturned lips (24) to enhance the substantially perpendicular footrest angle off blade support. The angle of transition lines (20) between V channel (18) and inverted V channel (22) would be 41 degrees, causing the implement fulcrum to be lifted higher off grade in the fully formed member (12) when the blade is located and moved to depth, as well as allowing the handle to be thrust forward, away from the user, when secured into the socket formed in member (12). In use, the blade tip is positioned rearwardly adjacent the material to be excavated. The user initially grips the handle arc with either hand and steps on either footrest. The relationship of the straight sides of the blade and the blade tip provide enhanced facility for entry of the blade into the material, in this case compacted soil. The blade cuts slightly forward of a straight downward direction, and the implement fulcrum arc is raised approximately 15 degrees above the plane of the footrest as the blade sinks into the ground to the desired depth, thus raising the implement fulcrum from grade approximately two to three inches when the blade is at depth. With the first hand grasping the handle arc, the user draws the handle backward and downward, thereby breaking loose the soil as backward/downward movement of the handle brings the initial point of the implement fulcrum down to engage grade. The downward thrust on the handle causes the implement fulcrum to indent at grade level and thus become a radially moving point of fulcrum, or a fixed heel, and tensions the implement fulcrum in grade to prevent fulcrum slippage. The designed angle of blade penetration into material is to be rearward of vertical by only such degree as affords sufficient adherence of material to blade. With the second hand, the user then grips the torque shaft and lever portion of the handle between the grasped handle arc and the grip and continues backward/downward motion of the handle, which excavates the blade and its load without the user bending or lifting, and moves the point of fulcrum rearwardly along the arc curve. Releasing the handle arc, the user places the first hand on the grip and continues backward/downward handle movement. This latter step engages the rear point of arc of the implement fulcrum and raises the blade with its contents to a height equal to the length of the inverted V channel and handle socket with fulcrum radius above the excavation site, the blade substantially level with grade. At this point, for ease of the user, the handle end may be gripped with both hands or one hand may grip the other. The user then turns wrist and hand to either side to cause linear sideward movement of the blade, or can walk-pivot the blade between the points of the handle grip and fulcrum to a complete 180 degree turn if desired. However, a turn of the wrist and the stationary points of the implement fulcrum and the handle grip move that portion of the blade and blade support beyond the implement fulcrum in an exaggerated arc, and a flick or twist in either direction of wrist and hand strikes either side of the blade on grade at a desirable optimum distance from the site of excavation without necessitating lifting or throwing of blade load. This optimum set-aside distance of blade load, like the height of the blade off grade when fully excavated, is determined by the length of the inverted V channel and the socket with the radius of the implement fulcrum arc. The substantially straight edges of the formed blade combined with their angle off blade center insures that the sides of the blade strike grade along their entire length at the same instant, providing a maximum overturning and vacating of the load from the blade. The torque and leverage provided by the implement of the present invention is mainly an efficient relationship between the length of the blade, the length of the inverted V channel support, the shape and radial length of the fulcrum, and the angle of the handle and the length of the handle to its arc. Many variations and modifications as to materials of construction and the dimensions stated above in describing the invention are possible, for which reason the embodiment herein is detailed mainly by relative proportions. The implement describes a compact line of mechanical forces, twice offset but nonetheless linear, which provides a straight lever action with one part of a handle which becomes a lever and torque shaft with another, and a highly efficient blade, blade support and handle socket member which integrates an implement fulcrum and provides effective translation of physical action into optimum mechanical reaction. The line of mechanical forces presented by the implement configuration also overcomes the stresses of linear compression and tension without the need for any additional attachments, braces, or other implements. The particular construction of the handle and of the combined blade, blade support, handle socket and integral fulcrum provide lateral strength and stability along all of its individual components, thereby imparting inherent superior strength to a lightweight and compact implement. It can be seen from the description of the implement of the present application that the combination blade, blade support and socket member may be produced in a wide variation of sizes, shapes and attitudes for application to tasks involving many types of materials which may have differing weight, consistency and blade adherence. Although solving the problem of the physical exertion necessitated by the task of tilling is a major consideration to the spirit of the invention, the invention is by no means limited to that function. Any application requiring manual handling of load material such as by a conventional spade, shovel or similar implement is well within the scope of the present invention.

A manual implement comprises of a handle which incorporates a lever shaft in one portion and a torque and lever shaft in another, and a novel integral blade, blade support and handle socket. The implement presents a twice offset but linear line of mechanical forces which allows the user to loosen, excavate and relocate a load of material without the concomitant hard physical exertion normally necessary to accomplish these steps by efficiently translating a minimum amount of force and action by the user into effective mechanical force and action by the implement.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims priority to and incorporates by reference in its entirety U.S. Provisional Application No. 60,696,527 filed Jul. 6, 2005, titled “HEATED SHOE INSOLE”. TECHNICAL FIELD [0002] The following relates to an apparatus and method for providing heating in shoe insoles. BACKGROUND [0003] In cold environmental conditions, the extremities, such as toes, are particularly susceptible to losing body temperature and becoming uncomfortably cold. To provide insulation from cold temperatures, shoe uppers typically are made of leather or cloth, shoe soles are made of leather or rubber materials, and shoe insoles and liners include padding and other materials. The insulating properties of these materials helps to retain heat from blood circulation through the foot. For example, hunting boots or snow boots are designed with thick rubber soles and a significant amount of padding to help retain body heat while shoveling, hiking, or performing other activities during freezing weather conditions. [0004] In some circumstances, it is beneficial or necessary to supplement the human body's natural capabilities of temperature regulation by providing a heat source within a shoe or boot. For example, while snow boots or hiking boots may be effective for keeping a person comfortable outside in sub-freezing conditions for several minutes, a person's body temperature may begin to fall after several hours outdoors and the insulation in the boot may no longer be adequate. Once a person's feet become cold, there is a risk of numbness, frostbite, or even hypothermia. For persons with poor blood circulation, it may be beneficial to include heating mechanisms within shoes or boots even if the person does not intend to remain in a cold environment for a long period of time. [0005] Known mechanisms exist for applying heat within a shoe or boot. As one example, chemical hot packs can be inserted into socks or shoes to help retain heat and adequate body temperature within the shoe or boot. These packs create heat through a chemical reaction that can last up to several hours in some applications. The chemical heat pack must be replaced with a new one for each usage. Other known heating mechanisms use electrical wiring within a sock or shoe or boot to apply resistive heat through the wiring. These conventional electrical heating mechanisms are somewhat vulnerable to failure, however, because a puncture or disconnect at a single point within the wiring can completely disable the electrical circuit that generates the heat. Further, such electrical heaters commonly are powered by nickel cadmium batteries, which are toxic. SUMMARY [0006] A shoe insole apparatus is disclosed that includes a flexible semiconductive heater element adapted for insertion within a shoe to be in proximate contact with at least a portion of a foot when the shoe is worn. The apparatus also includes a battery in electrical communication with the heater element. The heater element provides warm to a portion of a wearer's food upon receiving current from the battery. [0007] The shoe insole may also include a sole. The shoe's space for receiving a foot is above the sole. [0008] The apparatus may be a warming slipper that includes a footpad with a heater element. The slipper also includes a toe cup that curls over the footpad to cover less than half of the footpad. A battery provides electricity to the heater element for the slipper. BRIEF DESCRIPTION OF THE DRAWINGS [0009] Additional embodiments will be more apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which: [0010] FIG. 1A is an illustration of a heated insole within a shoe according to an exemplary embodiment of the present invention; [0011] FIG. 1B is an illustration of the shoe in FIG. 1A in a side-view. [0012] FIG. 2A is an illustration of a heated insole within a shoe according to an alternative embodiment of the present invention; [0013] FIG. 2B is an illustration of the shoe in FIG. 2A in a side-view. [0014] FIG. 3 is a simplified illustration of a heater assembly that may be utilized within the shoe as illustrated in FIG. 1 ; [0015] FIG. 4 is a simplified illustration of a heater-enclosed insole and battery assembly that may be utilized within the shoe as illustrated in FIG. 1 and may include the heater assembly as illustrated in FIG. 3 ; [0016] FIG. 5 is a simplified circuit schematic for an insole circuit according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION [0017] The invention provides for a battery powered heated shoe insole. The insole may be an integral part of a shoe, slipper, or boot or may be a removable insert. The insole can be sized to fit various styles and sizes of shoes or boots. In some embodiments, the heater portion of the insole includes a cup over the wearer's toes, providing more heat to the toe area by enclosing it more. [0018] In accordance with the following, a heater assembly is provided in the insole or footpad of a shoe, boot, or slipper that provides electrical heating. Preferably, the heating is done by using one or more flexible, semiconductive, electrically resistive heating elements powered by a rechargeable battery pack. This heater assembly is preferred because it withstands the stresses that can break and disconnect an electrical wire-based heater and efficiently provides long-lasting heating capability with reduced power requirements. Further, the rechargeable battery enables frequent use and re-use without having to replace the heating assembly. [0019] FIGS. 1A and 1B illustrate a heated insole within a shoe according to an exemplary embodiment of the present invention. Insole 10 (shown with crossed-lines) is located within the boot 14 , above the sole 12 , such that it will directly contact the bottom portion of a sock when a foot is placed within the shoe. As can be seen, the insole 10 is substantially flat inside the shoe, extending from substantially along the toe area to substantially along the heel. In some embodiments, the insole 10 may be placed atop an existing insole as an insert that can be removed when the application of heat within the shoe is unnecessary or undesirable. In the exemplary embodiment illustrated in FIG. 1B , the insole includes wiring 18 that traces beneath the stitching and within a seam along the rear of the boot, toward where the heel and the back of the ankle fit within the rearmost section of the boot. The electrical wiring connects the heater 16 (illustrated as the darkened area at the front of the insole in the toe area of the shoe) in the insole 10 to a power source 19 . As shown in FIG. 1B , the power source 19 is a battery pack that attaches to the upper rear section of the boot above the ankle. In other embodiments, the battery pack attaches directly to the ankle or leg of the wearer by use of a strap. [0020] Although the embodiment depicted in FIGS. 1A and 1B is of a work boot, the insole 10 may be utilized in a boot for duty (for military or police use) or for leisure (such as a ski boot, an ice skating boot, a hiking boot, or cowboy boot), a shoe, or a slipper. Of course, the shoe upper may be leather, canvas, or any other material and the sole may be rubber, leather, or any other material, but for safety purposes, the shoe preferably should be constructed of materials, or those materials should be treated such that they are not flammable. If the power source 19 is to be affixed to the boot 30 , it may instead be affixed within the boot. The power source may be removable for re-charging, or there may be terminals that can be exposed to connect the power source to an AC outlet or another charging source to re-charge the power source. [0021] FIGS. 2A and 2B depict an alternative embodiment for the heated insole. As can be seen, the insole 20 includes the substantially flat portion shown in FIGS. 1A and 1B , but additionally includes a front covering section 22 that substantially encloses the toes of the foot when inserted into a shoe. Although the front covering section is identified separately from the flat portion of the insole, the two may be of the same material and may be part of the same continuous fabric or sheet. As in FIGS. 1A and 1B , the insole is connected via an electrical wire 24 to a power source 26 . In FIG. 2B , the wiring 24 can be stitched within the seam at the rear of the shoe. [0022] As a further alternative, the insole 20 and integrated covering 22 , depicted in FIG. 2A , may be further integrated with a slipper-type shoe to be worn indoors. In this embodiment, the fabric covering of the insole 20 and toe covering 22 , to be described in further detail below, can be sewn or otherwise affixed to a sole for contact with flooring as a user walks in the slipper. The wiring 24 and power source 26 may be attached to the user's ankle via a strap, or in a further embodiment, the power source may be located within the sole of the slipper itself. An advantage to placing the power source in the sole is to avoid any exposure of the wiring 24 . [0023] The insole of FIGS. 1 and 2 includes a heater that is intended to fit beneath (in FIG. 1 ) or around (in FIG. 2 ) the toes of the foot when worn in a shoe. In this manner, the insole provides localized heat to the toes, where the foot is the most susceptible to losing desired body temperature. Preferably, the heater portion of the insole includes a broad area semiconductor material on its upper surface. This material may be a semiconductive fabric, such as a graphite fabric or a carbonized fabric, or a felt-type material comprised of graphite, carbon, or one or more other semiconductive materials. The fabric or felt is particularly suitable for use in an insole because it is flexible, stretchable, and compressible. The fabric tends to heat quickly when provided with electrical energy from a power source and heats uniformly. If one point within the felt or fabric is damaged, broken, torn or punctured, the electrical circuit is still made such that heat continues to be created to warm the toes of the foot. This stands in marked contrast with a resistance wire heater, which is more vulnerable to failure in this regard. [0024] The heater may be configured as a circuitous serpentine configuration of a flexible graphite heating element with two electrical contacts. It is noted that, according to various embodiments, the use of a configuration in which the ends of the heating element are in close proximity to each other may be desired, e.g., to facilitate connection to the positive and negative terminals of the power source being used. According to the invention, the particular dimensions and configuration of the heating element being used may be chosen such that specific desired heater resistance requirements are met. [0025] FIG. 3 illustrates a heater within an insole in accordance with an exemplary embodiment of the present invention. The heater 30 includes metallic contacts 32 a and 32 b and dielectric insulation 34 . Two metallic electrodes are included to establish an electrical circuit. Electrical wires 36 a and 36 b connect to a power source. The electrical wiring is insulated so as not to expose a user to stray voltage. [0026] FIG. 4 illustrates an enclosed insole, heater, and power source assembly in accordance with an exemplary embodiment of the present invention. The insole 40 is enclosed in a flame retardant material, along with the heater fabric or felt and other electrical connections as described with reference to FIG. 3 . At the rear side portion of the insole 40 is attached an enclosed cord 42 that contains electrical wiring to an enclosed battery pack 44 as a power source. An enclosed strap 46 is optionally provided for wrapping the battery pack around an ankle. [0027] FIG. 5 is a circuit schematic for a heated insole in accordance with an exemplary embodiment of the present invention. Heater 50 is the felt, fabric, or other resistive material that applies heat under or around the toe area in the insole or in-seam of a shoe, as described above. Battery 54 is a power source in accordance with one embodiment of the invention. The battery 54 may be one or more batteries, which are preferably rechargeable to allow for efficient reuse. The battery or batteries may be charged either through a stand-alone charger or by connecting the battery pack to an AC or DC power supply. The overall system voltage may be less than 5 volts. Although nickel cadmium batteries may be used, these are toxic. A preferred implementation uses nickel metal hydride batteries or non-toxic lithium batteries. [0028] In series with the heater 50 and the battery 54 , an power switch 52 may optionally be provided for disabling the heating and associated power drain without requiring removal of the battery. The power switch may be provided on or near the battery pack, or may be anywhere on the insole or shoe. As opposed to a chemical heat pack, for which the chemical reaction that creates the heat cannot be easily discontinued and restarted, a battery-operated heated insole can be easily turned on and off depending upon the user's comfort level or change in temperature. This allows a user to temporarily go indoors while continuing to wear the shoe or boot with the heater, without experiencing overheating. Optionally, sensors can also be included (not shown in FIG. 5 ) to automatically shut-off the heater if the shoe is removed. For example, a pressure activated push switch may be used. [0029] An optional controller 56 may be placed in parallel with the heater for providing features such as high and low adjustability or other temperature regulation capabilities. Controller 56 can receive input from temperature sensors or motion sensors. The output of controller 56 feeds to a power setting switch 58 to adjust the current supplied to the heater 50 . A user may manipulate a control setting (e.g., a switch, knob, dial, or the like) that controls a field effect transistor (FET) or another suitable type of circuit device, which in turn controls the amount of time that the heating element is being heated versus the amount of time that it is not. The battery 54 , controller 56 , and heater 50 are connected to a common ground 59 . [0030] To prevent possible burning, a fuse circuit also may be included. A fuse circuit may be any suitable type of fuse circuit that is capable of providing over current protection. For example, the fuse circuit may be designed to melt and open the circuit under abnormally high electric loads. [0031] From the foregoing, it will be appreciated that specific embodiments of the invention have been described herein for purposes of illustration, but that various modifications may be made without deviating from the spirit and scope of the invention. Accordingly, the invention is not limited except as by the appended claims.

The invention relates to an apparatus for warming feet. The invention includes a flexible and compressible insole that can be removable or integral to boots, shoes, or other footwear. The entire apparatus is battery powered allowing it to be portable and lightweight enough to be comfortable. The battery can be mounted in many possible locations including but not limited to on the footwear, in the footwear, or on the user's lower leg.

[0001] This application claims priority to U.S. Provisional Application Ser. No. 61/043,946, filed on Apr. 10, 2008, the entire contents of which are hereby incorporated by reference. [0002] The present invention application relates to protective garments, and more particularly, to protective garments configured to increase protection from harmful materials, such as noxious vapors. BACKGROUND [0003] Protective or hazardous duty garments are used in a variety of industries and settings to protect the wearer from hazardous conditions such as heat, fire, smoke, cold, sharp objects, chemicals, liquids, fumes and the like. Such protective or hazardous duty garments are often used in adverse conditions, such as in the presence of high temperatures, smoke, chemicals, vapors and the like. However, existing garments may not provide sufficient protection from harmful vapors. SUMMARY [0004] In one embodiment, the present invention is a garment having a skirt to protect the wearer from harmful vapors and/or other undesired materials. In particular, in one embodiment the invention is a coat including a torso portion defining a torso cavity and including pair of portions that are releasably connectable together. The coat further includes a skirt positioned in the torso cavity. The coat is configured such that when the coat is worn by a wearer and the portions are releasably connected together the skirt generally sealingly engages the wearer. The coat is further configured such that the skirt automatically generally sealingly engages the wearer when the coat is worn by the wearer and the portions are releasably connected without requiring any further action by the wearer. BRIEF DESCRIPTION OF THE DRAWINGS [0005] FIG. 1 is a front perspective view of one embodiment of the coat of the present invention, with certain layers cut away for illustrative purposes; [0006] FIG. 2 is a front view of the coat of FIG. 1 being worn and opened to expose the vapor skirt; [0007] FIG. 3 is a sectional view taken through the torso of the coat and wearer of FIG. 2 ; [0008] FIG. 4 is a side cross sectional view of part of the coat of FIG. 2 , illustrating one manner in which the vapor skirt may be attached to the coat; and [0009] FIG. 5 is a side cross sectional view of part of the coat of FIG. 2 , illustrating a differing thermal liner system than that used in FIG. 4 . DETAILED DESCRIPTION [0010] FIG. 1 illustrates a protective or hazardous duty garment in the form of a firefighter's coat, generally designated 10 . The coat 10 may include a body portion 12 having a left front panel or portion 14 , right front panel or portion 16 , and a back panel or portion 18 . The panels/portions 14 , 16 , 18 may be made of separate pieces of material that are joined together, or can be made of a single piece of material, or various pieces of material joined in varying manners, etc. The left front panel 14 and right front panel 16 may each have an inner edge 20 that are releasably attachable together by a fastener 22 , such as a zipper, snaps, clasps, clips, hook-and-loop fastening material (i.e., VELCRO® fastening material), combinations of these components or the like. The body portion 12 defines a torso portion/torso cavity 24 that is shaped to receive a wearer's torso 26 therein (see FIGS. 2 and 3 ). The coat 10 may include a pair of sleeves 28 coupled to and extending generally outwardly from the body portion 12 that are shaped to receive a wearer's arms therein. [0011] The coat 10 may include various layers through its thickness to provide various heat, moisture and abrasion resistant qualities to the coat 10 so that the coat 10 can be used as a protective, hazardous duty, and/or firefighter garment. For example, the coat 10 may include an outer shell 30 , a thermal liner or barrier 32 located inside of and adjacent to the outer shell 30 , and a moisture barrier/vapor barrier 34 located inside of and adjacent to the thermal barrier 32 . A second thermal liner 36 may be located inside of and adjacent to the moisture barrier 34 , and an inner liner or inner face cloth 38 may be located inside of and adjacent to the second thermal liner 36 . [0012] The outer shell 30 may be made of or include a variety of materials, including a flame, heat and abrasion resistant material such as a compact weave of aramid fibers and/or polybenzamidazole fibers. Commercially available aramid materials include NOMEX and KEVLAR fibers (both trademarks of E.I. DuPont de Nemours & Co., Inc. of Wilmington, Del.), and commercially available polybenzamidazole fibers include PBI fibers (a trademark of PBI Performance Fabrics of Charlotte, N.C.). Thus, the outer shell 30 may be an aramid material, a blend of aramid materials, a polybenzamidazole material, a blend of aramid and polybenzamidazole materials, or other appropriate materials. If desired, the outer shell 30 may be coated with a polymer, such as a durable, water repellent finish (i.e. a perfluorohydrocarbon finish, such as TEFLON® finish sold by E. I. Du Pont de Nemours and Company of Wilmington, Del.). The materials of the outer shell 30 may have a weight of, for example, between about five and about ten oz/yd 2 . [0013] The moisture barrier 34 and thermal liners 32 , 36 may be generally coextensive with the outer shell 30 , or spaced slightly inwardly from the outer edges of the outer shell 30 (i.e., spaced slightly inwardly from the outer ends of the sleeves 28 , the collar 40 (or the upper edge of the collar 40 ) and from the lower edge 41 of the coat 10 ) to provide moisture and thermal protection throughout the coat 10 . The thermal liner 32 may be made of nearly any suitable material that provides sufficient thermal insulation. In one embodiment, the thermal liner 32 may include a relatively thick (i.e. between about 1/16″- 3/16″) batting, felt or needled non-woven bulk or batting material 32 a. The bulk material 32 a can also take the form of one or two (or more) layers of E-89® spunlace fabric made of a combination of NOMEX® and KEVLAR® fabric. The bulk material 32 a can also, or instead, include aramid fiber batting (such as NOMEX® batting), aramid needlepunch material, an aramid non-woven material, an aramid blend needlepunch material, an aramid blend batting material, an aramid blend non-woven material, foam (either open cell or closed cell), or other suitably thermally insulating materials. The bulk material 32 a may trap air and possess sufficient loft to provide thermal resistance to the coat 10 . [0014] The bulk material 32 a may be quilted to a thermal liner face cloth 32 b which can be a weave of a lightweight aramid material. Thus, either the bulk material 32 a alone, or the bulk material 32 a in combination with the thermal liner face cloth 32 b, may be considered to constitute the thermal liner 32 . In the illustrated embodiment, the bulk material 32 a is located between the outer shell 30 and the thermal liner face cloth 32 b. However, the orientation of the thermal liner 32 may be reversed such that the thermal liner face cloth 32 b is located between the outer shell 30 and the bulk material 32 a. If desired, the thermal liner 32 , or parts thereof, may be treated with a water-resistant or water-repellent finish. [0015] The second thermal liner 36 may have the same qualities and properties as the thermal liner 32 described above. For example, the second thermal liner 36 may have a bulk material 36 a and a liner 36 b. However, the liner 36 b may be omitted, and, for example, inner liner 38 may form the liner for the bulk material 36 a of the second thermal liner 36 . Moreover, the second thermal liner 36 may be completely omitted if desired, or omitted in only certain parts of the coat 10 , as will be described in greater detail below. In locations where the second thermal liner 36 is omitted, the thermal protective qualities of the thermal liner 32 may be increased to account for the omission of the second thermal liner 36 , as described in greater detail below. [0016] In one embodiment, the thermal liner 32 (or the combined qualities of the liners 32 , 36 ) may have a thermal protection performance (“TPP”) of at least about twenty, and in another embodiment, at least about thirty five. Moreover, in one embodiment the coat 10 as a whole has a TPP of at least about twenty, and in another embodiment has a TPP of at least about thirty-five. [0017] The moisture barrier 34 may include a semi-permeable membrane layer 34 a and substrates 34 b, 34 c positioned on either side thereof. The membrane layer 34 a may be generally water vapor permeable but generally impermeable to liquid moisture. The membrane layer 34 a may be made of or include expanded polytetrafluoroethylene (“PTFE”) such as GORE-TEX or CROSSTECH materials (both of which are trademarks of W.L. Gore & Associates, Inc. of Newark, Del.), polyurethane-based materials, neoprene-based materials, cross-linked polymers, polyamid, GORE® CHEMPAK® materials, sold by W.L. Gore & Associates, Inc. including GORE® CHEMPAK® Ultra Barrier Fabric, GORE® CHEMPAK® Selectively Permeable Fabric, or GORE® CHEMPAK® Sorptive Fabric, or other materials. [0018] The membrane layer 34 a may have microscopic openings that permit moisture vapor (such as water vapor) to pass therethrough, but block liquids (such as liquid water) from passing therethrough. The membrane layer 34 a may be made of a microporous material that is either hydrophilic, hydrophobic, or somewhere in between. The membrane layer 34 a may also be monolithic and may allow moisture vapor transmission therethrough by molecular diffusion. The membrane layer 34 a may also be a combination of microporous and monolithic materials (known as a bicomponent moisture barrier), in which the microporous or monolithic materials are layered or intertwined. [0019] The membrane layer 34 a may be bonded or adhered to substrates 34 b, 34 c of a flame and heat resistant material on either side thereof to provide structure and protection to the membrane layer 34 a. Each substrate 34 b, 34 c may be or include aramid fibers similar to the aramid fibers of the outer shell 30 , but may be thinner and lighter in weight. Each substrate 34 b, 34 c may be woven, non-woven, spunlace or other materials. If desired, and in certain embodiments, the moisture barrier 34 may include only a single substrate on one side thereof. [0020] In FIG. 1 the thermal liner 32 is shown as being positioned between the outer shell 30 and the moisture barrier 34 . However, if desired, and for use in certain applications, the positions of the moisture barrier 34 and thermal liner 32 may be reversed such that the moisture barrier 34 is located between the outer shell 30 and the thermal liner 32 . In addition, the second thermal liner 36 can be positioned at various locations throughout the thickness of the coat 10 . [0021] The inner face cloth 38 may be the innermost layer of the coat 10 , located inside the thermal liners 32 , 36 /moisture barrier 34 . The inner face cloth 38 can provide a comfortable surface for the wearer and protect the thermal liners 32 , 36 and/or moisture barrier 34 from abrasion and wear. The inner face cloth 38 may be quilted to the adjacent layer (i.e. the second thermal liner 36 in the embodiment of FIG. 1 ). The coat 10 may include various arrangements of liners/materials, as desired, in which the various layers described herein are included, omitted, and/or rearranged. For example, the coat 10 may lack any thermal liner 32 , 36 , and include only an outer shell 30 , moisture/vapor barrier 34 and inner face cloth 38 , or may include only an outer shell 30 and a moisture/vapor barrier 34 , or may include only a moisture/vapor barrier 34 , or may take on various other configurations as desired. [0022] Each layer of the coat 10 , and the coat 10 as a whole, may meet the National Fire Protection Association (“N.F.P.A.”) 1971 standards for protective firefighting garments (“Protective Clothing for Structural Firefighting”), which are entirely incorporated by reference herein. The NFPA standards specify various minimum requirements for heat and flame resistance and for tear strength. For example, in order to meet the NFPA standards, the outer shell 30 , moisture barrier 34 , thermal liners 32 , 36 and inner face cloth 38 must be able to resist igniting, burning, melting, dripping, separation and/or shrinking by more than 10% in any direction at a temperature of 500° F. for at least five minutes. Furthermore, in order to meet the NFPA standards, the combined layers of the coat 10 must provide a thermal protective performance rating of at least thirty-five. [0023] With reference to FIG. 2 , the coat 10 may include a vapor skirt 42 . The vapor skirt 42 can take the form of a generally flat, rectangular piece of material (when laid flat) coupled to an inner surface of the coat 10 . The vapor skirt 42 may be coupled to the inner surface of the coat 10 along the entire or substantially the entire inner perimeter of the coat 10 /torso portion 24 at a vertical height position 44 (also see FIG. 1 ). The skirt 42 /coat 10 are configured such that when the coat 10 is closed, the vapor skirt 42 may extend about 360 degrees about the wearer 26 , as shown in FIG. 3 . [0024] The vapor skirt 42 may have an elastic material 48 coupled to or forming an inner edge 46 thereof to ensure that the vapor skirt 42 contacts and generally forms a seal with the wearer 26 (i.e. the wearer's clothes) and generally blocks ambient and superheated vapors from extending upwardly past the vapor skirt 42 . [0025] In particular, in the illustrated embodiment the vapor skirt 42 includes a strip of elastic material 48 positioned on or adjacent to its inner edge 46 . As shown in FIG. 3 , when the coat 10 is closed, the elastic material 48 is stretched such that the inner edge 46 of the vapor skirt 42 fits around, and conforms to, the torso/body of the wearer 26 . Thus in this configuration when the coat 10 is closed the vapor skirt 42 is generally “disc” shaped with a central opening that corresponds to the torso of the wearer 26 . [0026] As shown in FIG. 2 , when the coat 10 is opened (i.e. the left front panel 14 is not attached to the right front panel 16 and the panels 14 , 16 are moved apart, and/or when the coat 10 is not being worn), the elastic material 48 retracts to its unstressed or undeformed shape, thereby gathering the material of the skirt 42 . The elastic material 48 may stretch between about 15%-75% (about 50%, in one case) when the coat 10 moves from its open position to its closed position, and return to its original state when the stretching forces are removed. It may be desired to configure the elastic material 48 so that when the coat 10 is closed and the vapor skirt 42 is deployed, the vapor skirt 42 is stretched smooth and flat, with little or no bunching at or adjacent to the elastic material 48 so that the vapor skirt 42 forms a good and relatively tight seal with the wearer. If there is too much elastic material 48 (or the elastic material 48 is too strongly elastic) then the vapor skirt 42 will not be pulled tight and will remained bunched up at or adjacent to the elastic material 48 when the vapor skirt 42 is employed. Conversely if there is not enough elastic material 48 (or the elastic material 48 is too weakly elastic) the vapor skirt 42 may not be about to be stretched about a wearer. Accordingly, the amount and strength of the elastic material 48 may be selected to ensure a proper seal is formed with wearers of a variety of sizes and shapes. [0027] In the embodiment of FIG. 4 , the material of the vapor skirt 42 forms or is formed into a closed loop 50 at its inner edge 46 , and the elastic material 48 is positioned in, or captured in, the loop 50 . This configuration protects the elastic material 48 , and allows the material of the skirt 42 (and the loop 50 ) to slide freely relative to the elastic material 48 as the elastic material 48 is stretched and retracts. In this embodiment, a gripping material 52 (such as rubber, synthetic rubber, or the like) may coupled to the radially inner edge 46 of loop 50 . The gripping material 52 helps to ensure that the inner edge 46 of the loop 50 frictionally engages the wearer's torso 26 (or clothing) to ensure a relative tight seal therewith, as shown in FIG. 3 . [0028] FIG. 5 illustrates an alternate embodiment wherein the vapor skirt 42 lacks the closed loop 50 . In this embodiment the elastic material 48 is directly attached to the inner edge 46 of the skirt 42 , such as by stitching, adhesives or the like. In this embodiment the elastic material 48 may act as a gripping surface which frictionally grips the wearer's torso, and a separate gripping surface may not be needed. [0029] The seal formed by the vapor skirt 42 can help to prevent the introduction of harmful materials into the torso cavity 24 of the coat 10 . Such harmful materials may include liquids (including chemical warfare agents, biological warfare agents and toxic industrial chemicals), vapors and aerosols (including chemical warfare agents and toxic industrial chemicals), and contaminated particulates (such as biological warfare agents). Examples of chemical warfare agents include soman (GD) nerve agent and distilled mustard (HD) blister agent. Examples of toxic industrial chemicals include acrolein (liquid), acrylonitrile (liquid), ammonia (gas), choline (gas), and dimethyl sulfate (liquid). However, it should be understood that the vapor skirt 42 can be utilized to prevent or minimize the introduction of nearly any desired material, gas, fluid, liquid, particulate solids, etc. into the torso cavity 26 , including smoke, water vapor, liquid water, etc. [0030] The vapor skirt 42 helps to form a seal and prevent, or significantly limit, the introduction of undesired materials into the torso cavity 24 above the vapor skirt 42 . NFPA 1971 standards include a Chem/Bio Option (the entire contents of which are hereby incorporated by reference) which provides specifications that protective ensembles must meet in order to be certified under that Option. For example, the Chem/Bio Option specifies that the garment must pass a MIST test (Man-In-Simulant-Test). In one case the MIST test essentially consists of introducing the garment 10 and a wearer (or mannequin) into a chamber filled with a vaporized test material (such as oil of wintergreen). Absorbent padding is placed on the wearer of the garment 10 , and/or inside the garment. After the garment 10 has been exposed to the vaporized material for a sufficient period of time, the garment 10 is removed from the chamber. The absorbent pads are removed and analyzed to determine how much of the vaporized test material they have absorbed. The vapor skirt 42 , in combination with various other protective features, may provide a garment/ensemble which passes the MIST test, and more broadly, which meets the Chem/Bio Option of NFPA 1971 standards. [0031] The vapor skirt 42 can be made of a variety of materials. For example, the vapor skirt 42 can be made of the same materials of the moisture barrier/vapor barrier 34 , which are described above. The advantage of this arrangement is that a separate material for the vapor skirt 42 does not have to be handled by the manufacturer. For example, the skirt 42 and/or moisture barrier 34 may be made of made of or include PTFE (such as GORE-TEX or CROSSTECH materials), polyurethane-based materials, neoprene-based materials, cross-linked polymers, polyamid, or GORE® CHEMPAK® materials, sold by W.L. Gore & Associates, Inc. including GORE® CHEMPAK® Ultra Barrier Fabric, GORE® CHEMPAK® Selectively Permeable Fabric, or GORE® CHEMPAK® Sorptive Fabric. The moisture barrier 34 and/or vapor skirt 42 may also include one or both of the substrates 34 b, 34 c described above. [0032] As noted above, the membrane layer 34 a of the moisture barrier 34 and/or the skirt 42 may be generally water vapor permeable but generally impermeable to liquid moisture. In this case the skirt 42 may allow water vapor to pass through (to allow venting), but block harmful materials due to the differing molecule size of water vapor and the harmful materials. Besides the materials outlined above, the skirt 42 can be made of nearly any material that is generally impermeable to the unwanted materials. [0033] Rather than being made of the same material as the moisture barrier 34 , the vapor skirt 42 can instead be made of a different material than that of the moisture barrier 34 . In this case the vapor skirt 42 may be made of a generally liquid and/or vapor and/or gas impermeable material, such as neoprene. The advantage of this arrangement is that a cheaper material, or a material that is more effective at blocking the undesired material, can be utilized in the vapor skirt 42 . Moreover, if desired, the moisture barrier/vapor barrier 34 can be made of a generally liquid and/or vapor and/or gas impermeable material, such as neoprene. [0034] The vapor skirt 42 may be attached to the moisture barrier 34 so as to form a seal therewith. In particular, as shown in FIG. 4 , the moisture barrier 34 of the garment may include an upper moisture barrier portion 34 ′ positioned above the vapor skirt 42 and a lower moisture barrier portion 34 ″ positioned below the vapor skirt 42 . Similarly, the inner-most inner face cloth 38 may include an upper face cloth portion 38 ′ and a lower face cloth portion 38 ″. The inner edge of the vapor skirt 42 may extend through the face cloth portions 38 ′, 38 ″ and moisture barrier portions 34 , 34 ′. [0035] In the illustrated embodiment the second thermal liner portion 36 is positioned only in the upper portion of the garment; that is, between the upper face cloth portion 38 ′ and the upper moisture barrier portion 34 ′. In this case the second thermal liner portion 36 is not provided below the skirt 42 . However, in order to accommodate for the lack of the additional thermal liner portion 36 below the vapor skirt 42 , a supplemental thermal liner portion 32 ′ is provided below the vapor skirt 42 , and coupled to the thermal liner 32 . FIG. 4 illustrates the supplemental thermal liner portion 32 ′ as a separate thermal liner attached to the thermal liner 32 . However, if desired the supplemental thermal liner 32 ′ may take the form of increased thickness and/or weight which is unitary/integral, and formed as one piece with, the remainder of the thermal liner 32 , as shown in FIG. 5 . Moreover, if desired, the coat 10 may have the same arrangement of the thermal liner 32 and/or 36 below the vapor skirt 42 as is provided above the vapor skirt 42 , or the lower arrangement shown herein may be provided above the vapor skirt 42 . In addition, as noted above the coat 10 may include various arrangements of liners/materials, as desired. For example, the coat 10 may lack any thermal liner 32 , 32 ′, 36 , and include only an outer shell 30 and moisture/vapor barrier 34 , etc. The garment 10 need not necessarily be NFPA compliant, and could be a non-NFPA compliant garment. [0036] The vapor skirt 42 may include an extension portion or a vertically flared portion 42 ′ sandwiched between the moisture barrier portions 34 ′, 34 ″ with stitching 56 extending through all three layers 34 ′, 42 ′, 34 ″. The lower moisture barrier portion 34 ″ may have a looped upper end that is attached by the stitching 56 . The upper moisture barrier portion 34 ′, second thermal liner 36 and upper face cloth portion 38 ′ may be attached by stitching 58 (positioned just above the vapor skirt 42 ), and the lower moisture barrier portion 34 ″ and lower face cloth portion 38 ″ may be attached by stitching 60 (positioned just below the vapor skirt 42 ). [0037] A sealing material 62 may be provided and extend between the upper face cloth portion 38 ′ and the vapor skirt 42 , and another piece of sealing material 62 extends between the lower face cloth portion 38 ″ and the vapor skirt 42 . In one embodiment, the sealing material 62 is a tape made of the same materials as the membrane 34 a of the moisture barrier 34 (such as PTFE), or the materials of the vapor skirt 42 , with an adhesive applied thereto, although the sealing material 62 can take a variety of other forms, including sealants applied in a liquid form and cured into a solid. This arrangement ensures that a generally continuous moisture barrier/harmful material barrier is maintained within the garment 10 which prevents undesired penetration of moisture/harmful material. In addition, to the extent the stitching 56 , 58 , 60 compromises the sealed integrity of the garment 10 , the tape/sealant 62 helps to minimize the effects of such a compromise. [0038] As shown in FIG. 2 , the vapor skirt 42 may be attached to the garment 10 along a pair short, vertical side seams 64 adjacent to the front of the coat 10 (adjacent to the edges 20 ), and along a longer horizontal seam 66 extending substantially the entire perimeter/width of the coat 10 (at the height location 44 ). In this manner, the skirt 42 may be permanently and fixedly coupled to the coat 10 , such as by stitching, adhesives, etc. This arrangement ensures that, whenever the coat 10 is closed (i.e. when the left front panel 14 and right front panel 16 are joined) the vapor skirt 42 forms a seal around the wearer 26 and helps to limit the introduction of harmful materials. Thus, this configuration provides a “always-on” feature such that the wearer 26 does not need to remember to secure the vapor skirt 42 , or carry out any other operations, to obtain the benefit of the protection of the vapor skirt 42 . In addition, the “always on” feature ensures that, should the wearer unexpectedly enter a hazard zone which includes harmful materials, the wearer does not need to open the coat 10 to ensure that the vapor skirt 42 is in a protective position. If the wearer were required to open the coat 10 in a hazard zone, the wearer's exposure to harmful materials is significantly increased while the coat 10 is opened, thereby defeating the very purpose of the protective nature of the garment 10 . [0039] Alternately, if desired, the vapor skirt 42 may be releasably/removably coupled to the coat 10 . For example, if desired, one or both of the side seams 64 of the vapor skirt 42 may be releasably coupled to the inner surface of the coat 10 by zippers, snaps, clasps, clips, hook-and-loop fastening material, combinations of these components, etc. This arrangements eliminates “pulling,” or resistance of the coat 10 to being closed due to the stretching of the elastic material 48 of the vapor skirt 42 . Alternately, or in addition, the outer edge 66 of the vapor skirt 42 may be releasably coupled by the same or similar means as the side edges 64 . In one embodiment, both the sides 64 and outer edge 66 of the vapor skirt 42 are releasably/removably attached such that the entire vapor skirt 42 is removable from the coat 10 to allow repair, replacement or cleaning thereof. [0040] The outer edge 66 /height location 44 of the vapor skirt 42 may be spaced from the bottom edge 41 the coat 10 by between about zero to about eighteen inches. It may be desired to space the vapor skirt 42 from the bottom edge 41 of the coat 10 to allow easy opening/closing of the coat 10 and to protect the vapor skirt 42 from abrasions, punctures, etc. However, if the vapor skirt 42 is positioned too high, its protective benefits are reduced. In particular, it may be desired to ensure that the vapor skirt 42 is not positioned above the upper edge (i.e. the waist edge) of a pair of trousers worn win the coat 10 , to ensure that harmful materials are also prevented from entering the trousers. [0041] If desired, the coat 10 may include a “chest gatherer” system to help reduce the volume of air trapped inside the coat 10 . For example, U.S. Pat. No. 5,157,790 to Aldridge, the entire contents of which are incorporated herein, discloses a lumbar support in the form elastic bands or strips extending around the waist portion of the garment. The straps can be pulled tight around the wearer's body and attached to each other. A similar arrangement can be utilized in the chest of the coat 10 (i.e. the straps can be positioned under the arms 28 of the coat 10 .) In this case, when the chest gatherer is utilized, the volume of air retained within the coat 10 is reduced, and therefore the volume of harmful materials able to enter the torso cavity 24 of the coat 10 is correspondingly reduced. The reduced volume inside the coat 10 works in concert with the vapor skirt 42 to protect the wearer. [0042] The coat 10 may include various other features to protect from harmful materials. For example, a hood, in the form of a one-piece or split hood (not shown), may be utilized to fit around a wearer's head, which can engage with a mask to form a fluid-tight ensemble. [0043] Although the invention is shown and described with respect to certain embodiments, it should be clear that modifications will occur to those skilled in the art upon reading and understanding the specification, and the present invention includes all such modifications.

A coat including a torso portion defining a torso cavity and including pair of portions that are releasably connectable together. The coat further includes a skirt positioned in the torso cavity. The coat is configured such that when the coat is worn by a wearer and the portions are releasably connected together the skirt generally sealingly engages the wearer. The coat is further configured such that the skirt automatically generally sealingly engages the wearer when the coat is worn by the wearer and the portions are releasably connected without requiring any further action by the wearer.

This application is a continuation-in-part of application Ser. No. 785,679 filed Apr. 7, 1977, now abandoned. The latter is a continuation of application Ser. No. 705,102 filed June 14, 1975 (now abandoned). The present invention relates to methods for protecting proteic foodstuffs against spoilage and, more specifically, to novel, improved processes of that character which do not require refrigeration of the foodstuff. The process has two stages, one denominated the stabilizing stage and the other called the recovery stage. In the first stage the foodstuff--an animal ("animal" is used generically herein to identify mammals, birds, fishes, selachii, crustaceans, etc.) or part thereof--is immersed in a stabilizing liquid composed of an acid or alkaline buffer solution, a proteolytic enzyme which is active in an acid or alkaline medium, depending upon the pH of the stabilizing liquid, and an antioxidant. Thereafter, the product may be stored at room temperature in either closed or open containers. The second stage is composed of three steps. In the first step, the pH of the foodstuff is adjusted to a preferred level by immersing the product in an acid or alkaline solution. This results in a rapid change of pH from acid to alkaline or vice versa which has been given the name "ionic blow". In the second step, carried out after the product has been drained, the product is placed in another receptacle which contains a hypertonic solution at a selected pH to dehydrate the cells of the foodstuff, eliminating the hypotonic solution therefrom. In the third step the product is placed in yet another receptacle which contains a rehydrating solution. Here, the foodstuff recovers ions it may have lost during preceding steps. This results in the foodstuff being restored, as nearly as possible, to its original, fresh or unpreserved form. BACKGROUND OF THE INVENTION My novel process may be used to preserve a great variety of proteic foodstuffs. One, commercially important application is the manufacture of fish meal for animal consumption. Based, for example, on tests involving lamb breeding, the results obtained by feeding fish meal as heretofore prepared were definitely inferior to those expected based on the amount of nitrogen reported by previous tests of fish meal. This was due to the very low digestibility of such meal, to its high content of toxic amines, and to its high bacterial counts. In reviewing the processes of manufacturing of fish meal heretofore employed, I found that the low digestibility is due to: 1. the fact that the making of the product involves dehydration by application of a direct flame in rotary furnace; or 2. that this is done at a very high temperature in a steam dehydrator (with the further disadvantage that the meal obtained by this process has a highly increased bacterial count); and 3. that meal obtained by the so-called "instant drying process" also suffers a very high thermal treatment which lowers digestibility. Furthermore, in some heretofore employed processes, the foodstuff is polluted with exhaust gases from internal combustion engines, this being added to the pollutants already in the fish because of the state of decomposition or decay it normally has when it is manufactured into meal. In an effort to overcome the disadvantages of the foodstuff preservation methods just described, a test was made in Teacapan, State of Sinaloa, Mexico of a modification of the Uruguayan system of fish siloing called "BIOPEZ" which, in turn, is a modification of the Swedish system designed by Virtanen. The tested process involves a bacterial promoted, hydrolysis or fermentation of fish, producing a paste which, while difficult to transport, can be delivered in tank trucks to distribution stations or to the consumer. More specifically, the fish are ground and then transferred to cement vats. To each 100 kilograms of ground fish is added 20 kilograms of concentrated yeast (Cndomycetaceae subfamilia, Saecharomycetoideae genus, Saccaromyces isolated from the body of sea-bass (Micropogon opercularis)). The ingredients are intimately mixed, and the mixture is agitated three times a day for 6-7 days, after which fermentation is completed. The paste retains its original volume and has a dark brown color with a pleasant odor similar to that of dry figs and a firm consistency. To preserve the preparation for extended periods, 20 kilograms of 50% sulphuric acid are added to each 100 kilograms of paste giving a pH of 4.0-4.5. The paste may be directly fed to the animal without neutralizing it. While an improvement over the other processes described above, the Mexican (modified Uruguayan) process just discussed is still not satisfactory as far as the quality of the product is concerned. Another heretofore available technique for preserving protein foodstuffs is the process of "formol sprinkling" used in Peru. However, this only protects the product for a few hours, and it is generally inapplicable. Furthermore, the 37.2% by weight formaldehyde used in the process lowers the digestibility of proteins, increasing costs. Furthermore, formaldehyde acts superficially, not penetrating to the viscera of even small fish such as anchovies; and the amounts which are used are critical. In short, to obtain adequate protein heretofore required the use of a fresh product; the only practical manner to achieve this to now has been to protect the material against decomposition by refrigeration. This may be done with ice as is done with shrimps and in the U.S. Gulf zone to manufacture fish meal or by using refrigerated brine as is done in Peru. Economically, neither of these two techniques is feasible for foodstuffs intended for consumption by animals. OBJECTS OF THE INVENTION It will be apparent to the reader from the foregoing that the primary object of the present invention resides in a novel, improved method of preserving proteic foodstuffs against decomposition. Another object of the present invention is to provide a process for preserving fishes, crustaceans, mollusks, selachii, birds and mammals which allows them to be maintained at room temperature for long periods without decay. Another object of the present invention is to provide a process for preserving proteic foodstuffs which minimizes changes in their proteins that would interfere with the digestibility of those constituents. Still another of the objects of the present invention resides in providing a process for preserving foodstuffs which avoids the oxidation of fats, preventing deterioration and avoiding self-combustion during storage. Other important objects, features, and advantages of the invention will be apparent to the reader from the preceding, from the appended claims, and from the ensuing detailed description of exemplary, preferred modes of carrying out its precepts. DETAILED DESCRIPTION OF THE INVENTION The process of preserving proteic foodstuffs described briefly above has been tested on many species of land and sea animals with good results. In the application of the process to the manufacture of fish meal, the protein was preserved in its initial condition; and bacterial counts were kept at less than 100 bacteria per gram during the whole process. Furthermore, the fats in the product were prevented from becoming rancid. The meal, as preserved, had a digestibility of 98 percent and favorably passed biological toxicity tests; the amino acid composition was very similar to that of the meal obtained by the reduction and heat-transfer methods described in FOODSTUFFS, Jan. 18, 1969, pp. 44 and 45. The processing costs were very low, and a study based thereon showed that a good recovery and profit could be obtained by selling the meal at prevailing market prices. The tests which produced the foregoing results involved a great variety of marine species of all shapes and sizes. They could be preserved without evisceration, and a thick magma that could be readily processed into a meal was obtained. In the tests carried out to "preserve" fish, the specimens generally maintained their shape. As discussed above, my novel process for preserving proteic foodstuffs has a stabilization stage followed by a recovery stage. In the first, stabilization stage, the animal or other proteic material is immersed in a liquid called a "stabilizer". This may be effected at room temperature with complete animals (even with viscera) or with portions of any size. It is possible to protect the whole animal or just a part thereof; e.g., the meat, blood, viscera, etc. The time for which the foodstuff is immersed will vary according to the size of the animal, the nature of its skin, the temperature at which the process is carried out, the concentration in which the "stabilizing" liquid or "stabilizer" is used, etc. After this first stage, the product can be handled and stored at room temperature. It is convenient to do so in bags (of polyethylene, for example) or in boxes or other packages which can be closed or sealed to avoid the dehydration of their contents. However, it is also possible to handle the product in bulk or in unsealed bags. In this case the product undergoes dessication but does not decay. The second, revovery stage is also effected by immersion in liquid, in this case in three steps. In the first step, the "protecting" or preservative effect of the stabilizing liquid is eliminated, and microorganisms present in the foodstuff are killed. In the second step, the product is washed; and, in the third step, the product is returned as nearly as possible to its initial condition; i.e., to the condition it enjoyed prior to immersion in the stabilizing liquid. The first stage of this system is very simple. It only requires a vessel for the stabilizing liquid. The shape and size of the vessel may vary, but it is necessary that the product be totally immersed in the liquid for the entire time necessary to insure its protection. The stabilizing stage is preferably effected at a site where the foodstuff can be protected against the sun, dust, insects, and animals. At the end of this first stage of the process, the product may stored at room temperature as indicated above. It is only necessary to allow for the outflow of excess liquid which will slowly come off of the product during storage. If the product is to be handled in bulk or packaging which is not waterproof; it is preferably to accelerate this exudation of liquid so that the product can be transported in a dry dehydrated condition. In the first, stabilizing stage of my process, use is made of the hydrogen ion to protect the proteins in the foodstuff being treated, advantage being taken of the inhibiting effect of such ions on enzymatic mechanisms which cause autolysis of cells. The hydrogen ions furnished by the donor also create a bacteriostatic and fungistatic environment, thus preventing microorganisms present in the foodstuff from attacking the proteic constituents thereof. The component furnishing the hydrogen ions may be a potable organic acid such as acetic, citric, or lactic or an inorganic acid, preferably potable, such as hydrochloric or phosphoric. In any case the acid should be free of pollutants. An enzyme is employed to break down the proteic intercellular cement between the cells of the material being treated especially those of the epithelal tissues. This permits the hydrogen ion furnishing component to penetrate rapidly into the material being treated. The enzymes employed for my purposes are proteolytic; they may be of animal or vegetal origin, or they can be produced by different strains of bacterias or molds (fungi). Enzymes that I have successfully used are pepsin, papain, and bromelain. The amount employed varies according to the activity of the enzyme. To guard against autolysis of the foodstuff cells, however, I employ the selected enzyme in a concentration which is approximately one tenth of that which would result in proteolytic activity. While the enzyme concentrations I employ thus do not result in breakdown of the cells, they are nevertheless capable of effecting the wanted dissolution of the intercellular cement. Enzymatic action is insured by using a buffer to adjust the pH of the stabilizing liquid to a level ≦5 which is optinum for the particular enzyme being used. As a buffer I employ the same acid employed as the hydrogen ion donor or a salt of that acid. Besides protecting the protein of the foodstuff being preserved, it is also necessary to inhibit decomposition of its fatty contituents. This is achieved in situ by adding a potable antioxidant to the stabilizing liquid. The amount of antioxidant is correlated to the amount of fat in the product so that the amount of antioxidant will not exceed the limits allowed for the use to which the product will be put. Other processes for preserving foodstuffs which employ acidic materials are of course known. One example of such a process is pickling. A proteic product pickled with an organic acid at a pH lower than 4.5 may be preserved for long periods. Another food preservation process employing an acid was developed by A. I. Virtamen for preserving green feed. This process, which involves the acidification of the product by one or more strong organic acids was used in Sweden in 1936 to preserve fish in an "ensiloed" condition at a pH of 2. Another prior art process of the type in question was developed by Edin in Denmark in 1940 for making fish paste. In this process molasses, a yeast culture, and sulphuric acid are added to the raw material. This process works at a pH from 4 to 4.5. Finally, Olsson (1940), Hanson and Lavern (1951), Petersen (1951), and Carl (1952) described a food preservation process in which use is made of mixtures of sulphuric acid plus hydrochloric acid, free sulphuric acid (i.e., free of arsenic), formic acid, sulphuric acid plus formic acid, and lactic acid plus molasses and a bacterial culture. In all of the foregoing processes, the material being preserved must be milled, minced, shredded, or otherwise comminuted. This step with its cost, perhaps unwanted changes in the physical characteristics of the foodstuff, and other disadvantages are eliminated by my process. The concept of treating proteic foodstuffs with a proteolytic enzyme is of course also not per se claimed to be novel. However, no one has herefore employed an enzyme in a food preservation process or, more particularly, to break down intercellular cement so that an acidic or alkaline material can penetrate through the foodstuff and create an environment which inhibits reactions that would cause decay of the foodstuff. For example, Ramsbottom et al U.S. Pat. No. 2,321,623 and Schack et al U.S. Pat. No. 3,533,803, both cited in parent application Ser. No. 785,679, are not concerned with preserving proteic foodstuffs but with tenderizing "the flesh of edible animal carcasses" by using enzymes. The Rutman (U.S. Pat. No. 3,561,973) and Brocklesby (U.S. Pat. No. 2,934,433) patents cited in that application are equally remote. The first is concerned with a method for digesting a mixture of pulped fish and fat, the second with a high temperature process for peptizing insoluble proteins. As mentioned above, the product being preserved is immersed seriatim in three different liquids in the second, recovery stage of the process. The objective of the first step is to rapidly change the pH of the product. This, which is done by immersing the product in an alkaline solution and which I term the "ionic blow", produces a beneficial bactericidal and fungicidal effect. The pH adjustment is facilitated by two characteristics of the stabilized product. First, the opening of the intercellular spaces allows the recovery liquid to penetrate to the interior of the product, insuring a rapid and adequate concentration of the hydroxyl ion in all cells of the product. Second, the cells are dehydrated when they are submitted to the stabilizing solution as the latter is hypertonic. This dehydrated condition speeds penetration of the hydroxyl ions into the cells as the first recovery solution is hypotonic. The bactericidal effect is obtained because most bacterial strains commonly found on the skin and mucous membrane of animals and in the contents of the intestinal tract are active only at a pH which is neutral, slightly acid, or slightly alkaline. When they are subjected to a sudden and large change in pH, first toward acidity and then toward alkalinity, or vice versa; i.e., to an ionic blow, they do not survive. The same is true of fungi found in the environments just described. The hypotonic alkaline solution employed to deliver the ionic blow is prepared by dissolving a potable base in water in an amount sufficient to produce a pH ≧9. Suitable bases include sodium, potassium, and calcium hydroxides and mixtures of the foregoing. This and the subsequent steps of the recovery stage should be performed under sterile conditions. Once the protective effect of the stabilizing liquid has been taken away by immersing the product in the alkaline solution, the product becomes highly susceptible to pollution by bacteria or fungi. If one carries out the second stage steps under strict aseptic conditions, the final product may be kept at room temperature in hermetically sealed, sterilized packages. If the conditions are not sufficiently aseptic, it is necessary to refrigerate the reconstituted product to avoid decay. The previously mentioned second step of the recovery stage involves the immersion of the foodstuff in a hypertonic solution having a pH of 5 to 7 in order to adjust the pH of the foodstuff to the desired level. Because of the previous breakdown of the intercellular cement this step also proceeds rapidly and efficiently. In addition, because of the lower osmotic pressure of the solution used to produce the ionic blow in the preceding step, that solution is efficiently expelled from the foodstuff cells by the hypertonic solution used in the second step. The hypertonic solution can be prepared by dissolving any of a wide variety of potatable salts evident to the average chemist in water. Sodium chloride will typically be employed because of its low cost and widespread availability. In the first and second steps of the recovery stage the ionic concentration in the foodstuff is altered by the osmotic pressure-induced passage of ions through the semi-permeable walls of the foodstuff cells. The electrolytic balance is restored and the fluid content of the foodstuff adjusted to the wanted level in the third step of the recovery stage, again by immersing the foodstuff in an appropriate solution. The composition of the rehydrating solution employed in the third step will depend upon, and can readily be determined for, the particular foodstuff involved. One exemplary composition is defined hereinafter. Preferred modes of carrying out my novel process are described in the examples wich follow. EXAMPLE 1 To stabilize 100 kg. of sardine with an approximate content of 14 percent of fat, the following constituents were employed. hydrochloric acid (30 percent), free of contaminants: 10 liters potassium chloride: 7.9 grams purified pepsin 1/10,000 (Difco): 1 gram Ionol 2,6-di-tert-butyl 4-methyl phenol antioxidant (Shell): 1 gram drinking water: 88 liters A buffer solution (Solution A) was prepared by adding the potassium chloride dissolved in one liter of water to 88 liters of water. Thereafter the hydrochloric acid was added with continual stirring (a long stem funnel or a hose is used to add the acid under the surface and avoid the generation of toxic vapors). The pepsin was dissolved in 400 ml of water, and the Ionol was added. This solution, called "Solution B", was mixed with Solution A; and the mixture was briefly homogenized before immersing the sardines in it to stabilize them. The stabilized sardines were placed in perforated plastic boxes or nets to facilitate handling and immersed (in a tank) in a hypotonic solution made by diluting 14 liters of a 10 N sodium hydroxide solution (NaOh 10/N) in 86 liters of drinking water. The liquid was agitated to accelerate the alkalinization process. The sardines were removed from the hypotonic solution, and excess fluid was allowed to drain off. Then the sardines were placed in another washing tank containing a hypertonic solution of sodium chloride to dehydrate the cells, thus accelerating the outflow of the hydroxyl ions. This solution was prepared by dissolving 12 grams of sodium chloride per liter in a large quantity of water. The product was introduced into a third tank containing a rehydrating solution from which the product recovered ions lost in the previous steps. This solution contained: ______________________________________ Grams/literIon of water______________________________________Na.sup.+ 3220K.sup.+ 390Ca.sup.++ 100.2Mg.sup.++ 36.5Cl.sup.- 3660Perfect Osmolarity 306 m mol/liter______________________________________ EXAMPLE 2 100 kilograms of anchovies were stabilized using the procedure of Example 1 except that sea water was used instead of drinking water. The anchovies were then converted to a meal. EXAMPLE 3 100 kilograms of shrimp were treated as described in Example 1. Both the stabilizing and recovery stages were employed. The products identified in Examples 2 and 3 were tested for proteic efficiency and subchronic toxicity and subjected to microbiological and proximate analyses. Proteic efficiency was evaluated using the protocol for measuring protein efficiency ratio (PER) promulgated by the assessor's group for proteins of the FAO (Food and Agricultural Organization, an agency of the United Nations). The growth of animals used for testing the shrimp was superior to the growth of animals fed with the protein of reference (casein) by a ratio of 1.91:1. The PER value obtained for casein was 2.51, and for the protein of the shrimps it was 2.78. This demonstrated the efficiency of the protein studied. Sub-chronic toxicity tests were made on groups of 10 male rats and 10 females rats at two ingestion levels of the test product (shrimp of Example 3). The test period lasted 90 days. Besides recording and analyzing food ingestion and growth, hemoglobin behavior was investigated; and biochemical data were obtained for blood and urine during the last week of the test. The study was completed by macroscopically examining all the animals via post mortem examination. From eight to ten organs were weighed. Tissue samples (20 to 30) were incorporated in paraffin and examined microscopically. The microscopical examination was restricted to the samples obtained from the animals that were fed with the larger quantities of the test products. Pathological examinations of organs such as the spleen, suprarenal gland and others showed them to be normal. The studies of haematic citology and blood chemistry gave values which are within normal limits. In short, the shrimps processed as described in Example 3 were found to be non-toxic and usable for human consumption. The results of the microbiological analyses of products described in Examples 2 and 3 were as follows: TABLE I______________________________________Microbiological Analysis of Fresh Anchovy (Control)and Anchovy Meals Treated by Different Methods ofPreservationL O T Commercial Product of Control Process Example 2______________________________________Total countof colonies/g 12,900 230 not presentColiformNMP/g 4 not present not presentFungi count,colonies/g 30 not present not present______________________________________ NMP: Most probable number of colonies per gram Commercial Process: Peruvian method (formaldehyde and sodium nitrite, see prior discussion "Background etc."- TABLE 2______________________________________Maximum Values in The Microbiological Control ofShrimps Preserved With The Preservation System ofEnzymatic Inhibition Shrimp of Control Example 3______________________________________Standard count of mesophillicorganisms - colonies/ml 2,200 0Standard count of coliformorganisms - NMP/ml 15 0Enterococcoes - colonies/ml 0 0Molds (Fungi) and yeastscolonies/ml 0 0______________________________________ Control: Shrimps frozen in natural state with heads conserved The following table contains data gathered from proximate analyses of anchovy meal prepared as described in Example 2, anchovies treated with a commercial additive and converted into meal, and a control. TABLE 3______________________________________Proximate Analyses of Fresh Anchovy (Control) andAnchovy Meal Treated by Different ProcessL O T Commercial Process of Control Process Example 2______________________________________Moisture 72.8 22.6 29.1Proteins BH 18.3 51.0 46.1(N × 6.25) BS 67.3 65.9 65.0Etherous BH 5.4 15.7 16.9Extract BS 19.9 20.3 23.8Ash BH 3.4 10.2 4.5 BS 12.5 13.2 6.4Non nitro- BH 0.1 0.5 3.4genized BS 0.3 0.6 4.8extract______________________________________ BH: Wet base BS: Dry base Commercial Process: same as identified in Table 1 To this point, my process for preserving proteic foods has been described primarily with reference to the use of an acidic buffering solution and hydrogen ions to protect the cells of the animal and inhibit activity of the accompanying microorganisms. However, as indicated above, the hydroxyl ion may also be employed for the same purpose. In that case I use a proteolytic enzyme which is active in an alkaline environment (pH≧9) and an alkaline buffer solution which is adjusted to the optimal pH for the selected enzyme. The remainder of the stabilizing stage remains the same. Various materials may be employed to prepared alkaline buffers of the desired pH and to furnish the hydroxyl ions. These include sodium, potassium, and calcium hydroxides and combinations of those compounds. In the second, recovery stage only the first step is changed and that only to the extent that an acid, rather than alkaline, hypotonic solution is used to produce the ionic blow. Those compounds which are used in the acidic buffer solutions can equally well be employed in the acidic hypotonic solutions. With the exceptions identified above, the process using an alkaline buffer solution can be carried out essentially as described in Example 1. The stabilization stage of my process can also be applied to whole animals to produce natural teaching models. These, among other advantages, do not have to be refrigerated. Also, the consistencies of the tissues remain similar to those of the unpreserved animal, and the preserved animals are not dangerous to handle. The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description; and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

A method for protecting animal derived foodstuffs against spoilage which does not require refrigeration. The foodstuff is immersed in a stabilizer composed of a buffer solution, a proteolytic enzyme, and an antioxidant following which it may be stored at room temperature. The foodstuff can be reconstituted by rapidly reversing its pH by immersion in a hypotonic solution to kill bacteria present in the foodstuffs and then first immersing it in a hypertonic solution to eliminate the hypotonic solution and then rehydrating it. Alternatively, the foodstuff may be utilized, typically as an animal food and in meal form, without reconstituting it.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the priority benefit of U.S. Provisional Application No. 61/837,153, filed Jun. 19, 2013, which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention relates to a system and a method for eliciting information to sensitive questions that require use of an input device (e.g., keyboard and/or pointing device, etc.) and reliably detects whether one is being deceptive, concealing information, or experiencing a heightened emotional or cognitive response to the question by analyzing the input device usage characteristic. In particular, the system and the method of the invention are based on analyzing the user behavioral biometric of using one or more input device(s). BACKGROUND OF THE INVENTION [0003] The threat of malicious insiders is a top concern for government and corporate agencies. Insider threats—a trusted adversary who operates within an organization's boundaries—are a significant danger to both private and public sectors, and are often cited as the greatest threat to an organization. Insider threats include disgruntled employees or ex-employees, potential employees, contractors, business partners, and auditors. The damage caused by an insider threat can take many forms, including workplace violence; the introduction of malware into corporate networks; the theft of information, corporate secrets, or money; the corruption or deletion of data; and so on. According to a recent survey, it takes on average 416 days to contain an insider attack (HP Cyber Risk Report, 2012), and insider threats have been estimated to result in “tens, if not hundreds of billions of dollars” in damages. The identification process of insider threats is heightened in very large organizations. For instance, identifying a small number of potential insider threats within an organization with thousands of employees is a literal “needle in the haystack” problem. [0004] Therefore, there is a need for a system and a method for determining whether a particular personnel poses an insider threat. SUMMARY OF THE INVENTION [0005] Some aspects of the invention address the insider threat challenge by providing a system and a method called ADMIT (i.e., Automated Detection Method for Insider Threat). In some embodiments, ADMIT is a web-based survey tool that elicits information to sensitive questions that requires an input device usage (e.g., keyboard, and/or a pointing device, etc.) and reliably detects whether one is being deceptive, concealing information, or experiencing a heightened emotional or cognitive response to the question by analyzing the input device usage characteristic. [0006] Prior research on deception has established that humans guilty of acts known to be immoral, criminal, or unethical have uncontrolled physiological changes that can be detected as observable behavioral changes when responding to questions regarding such events. Similar to the way a polygraph (i.e., lie detector) detects physiological changes in the body based on uncontrolled responses when answering sensitive questions. The present inventors have discovered that such responses can be detected through monitoring a person's input device usage, (e.g., mouse and keystroke behavior) when a person is guilty of actions known to be wrong. Abnormal behavior that is indicative of insider threat can then be highlighted or alerted to specified individuals in the organization for review and further investigation. ADMIT operates like well-known web-based survey tools like SURVEYMONKEY® or QUALTRICS®, and thus can be mass deployed to an entire organization simultaneously. [0007] In one embodiment, the system and the method are based on a subject's behavioral biometrics. The approach consists of establishing distinctive behavioral biometrics for a subject based on characteristic(s) of the subject's input device usage. The usage characteristic comprises how and the way the user uses the input device. [0008] Some of the variables for how the user uses the input device include, but are not limited to, input device dynamics. For example, when the input device is a keyboard, the keyboard (i.e., input device) dynamics include, but are not limited to, the dwell time (the length of time a key is held down), transition time (the time to move from one key to another) and rollover time for keyboard actions. After these measurements are collected, the collected actions are translated and analyzed in order to determine the truthfulness of the subject's answer to a particular questionnaire. An algorithm can be used to generate a Keystroke Dynamics Signature (KDS), which is used as a reference profile for the subject using non-threatening or seemingly innocuous or harmless questions. In some embodiments, the KDS is constructed using a key oriented neural network based approach, where a neural network is trained for each keyboard key to best simulate its usage dynamics with reference to other keys. [0009] When the input device is a pointing device such as a mouse, the pointing device dynamics include, but are not limited to, comparing selected pointing device actions generated by the subject as a result of subject's answer to an on-screen question or interaction with a graphical user interface (GUI) or any other display shown on the display screen. The data obtained from these actions are then processed in order to analyze the behavior of the user. Pointing device actions include general pointing device movement, drag and drop, point and click, and silence (i.e., no movement). The behavioral analysis utilizes neural networks and statistical approaches to generate a number of factors from the captured set of actions; these factors are used to construct what is called a Pointing Device Dynamics Signature (PDDS), a unique set of values characterizing the subject's behavior during both seeming innocuous or harmless questions and during a more direct question-and-answer sessions. Some of the factors consist of calculating the speed, total distance travelled, initial direction of movement, total response time, change in direction on the x-axis, change in direction on the y-axis, idle time, area under the curve, amount of deviation, reaction time, applied pressure, changes in angle, the pattern of a users' acceleration or deceleration during a movement, the precision of movements, the click latency, click pressure, or a combination of two or more thereof [0010] The detection algorithm for an input device calculates the significance of each factor with respect to the other factors, i.e. KDS, PDDS or other input device usage characteristics are weighted since certain actions are more prone to revealing truthfulness of the subject. [0011] One particular aspect of the invention provides systems and methods for detecting deception in a subject. In one embodiment, this deception detection system (sometimes referred herein as ADMIT or “Automated Detection Method for Insider Threat”) is a web-based survey tool that elicits information to sensitive questions and reliably detects whether one is being deceptive, concealing information, or experiencing a heightened emotional response to the question. [0012] As discussed above, systems and methods of the invention can also include eliciting information from the subject on non-sensitive, benign, innocuous or seemingly harmless questions (i.e., control questions) to establish reference input device usage characteristics of the subject. Control questions can be presented at the beginning of the session or it can be interdispersed with sensitive questions to establish the reference input device usage characteristics of the subject. For example, the system and method can include randomly inserting or presenting to the subject control questions to determine the reference (or baseline) input device usage characteristic. [0013] Alternatively, the reference input device usage characteristics can be based on the average input device usage characteristics of a plurality of subjects for a particular question. In this manner, the subject's input device usage characteristics (i.e., behavioral biometrics) can be compared to the “baseline” or the “reference input device usage characteristics” that consists of average or range of input device usage characteristic of a plurality of individual to the same question. Accordingly, the baseline or the reference input device usage characteristics can be based on the subject's own behavior biometrics during non-sensitive or non-threatening questionnaire session or it can be based on the input device usage characteristics of a plurality of subjects' input device usage characteristics for the same or similar question, or a combination of both. [0014] In general, ADMIT is based on the discovery that humans guilty of acts known to be immoral, criminal, or unethical have uncontrolled physiological changes that can be detected as observable behavioral changes when responding to questions regarding such events. Similar to the way a polygraph (lie detector) detects physiological changes in the body based on uncontrolled responses when answering sensitive questions when a person is guilty of actions known to be wrong, the present inventors have discovered that such responses can be detected through use of an input device such as by monitoring mouse or other pointing device usage characteristics and/or keystroke usage characteristics. Abnormal behavior that is indicative of insider threat can then be highlighted or alerted to specific individuals in the organization for review and further investigation. [0015] One particular aspect of the invention provides a behavioral biometric-based deception analysis system and/or method for determining whether a subject is truthful or deceptive to a question of interest (i.e., a sensitive question or key question). Such systems typically include displaying the question (e.g., on a computer screen or projecting the question on a display). The subject is then allowed to select or input subject's answer to the question presented using one or more input device. The system includes a data interception unit that is configured to intercept input from the subject who is directed to a question presented on a display screen. The data interception unit is configured to passively collect an input device (e.g., a pointing device, such as a mouse, a touch screen, a touch pad, a stylus, a track ball, etc.) usage characteristic. The system also includes a behavior analysis unit operatively connected to said data interception unit to receive the passively collected input device usage characteristic; and a behavior comparison unit operatively connected to said behavior analysis unit. In some embodiments, the system dynamically monitors and passively collects behavioral biometric information (i.e., input device usage characteristics), and translates the behavioral biometric information into representative data, stores and compares results, and outputs a result associated with truthfulness or deception to the question of interest presented on the display screen. [0016] In some embodiments, said behavior comparison unit is operatively connected to an application or program that presents a question on the display screen such that said behavior comparison unit influences the next question presented on the display screen by the application using a decision tree structure based on the result. Thus, for example, if the subject's behavior biometrics is ambiguous or inconclusive, a follow-up type of question can be displayed to further analyze the subject's behavior biometrics to a particular sensitive question. [0017] Yet in other embodiments, the input device usage characteristics comprise pointing (e.g., mouse, joystick, stylus, trackball, etc.) device usage characteristics. In some instances, the pointing device usage characteristics comprise movement of said pointing device between the starting position of said pointing device and the answer selected by the subject on the display screen, the elapsed time between presentation of the question on the display screen and the a selection of the answer by the subject, the speed, total distance travelled, initial direction of movement, total response time, change in direction on the x-axis, change in direction on the y-axis, idle time, area under the curve, amount of deviation, reaction time, applied pressure, changes in angle, acceleration, the precision of movements, the click latency, click pressure, or a combination of two or more thereof. [0018] When the pointing device is a touch screen or a touch pad, the usage characteristic can include finger movement, precise timing, and applied pressure between the initial position of a pointer and the answer on the display screen selected by the subject. In addition or alternatively, the input device usage characteristic can include characteristic can include speed, total distance travelled, initial direction of movement, total response time, change in direction on the x-axis, change in direction on the y-axis, idle time, area under the curve, amount of deviation, reaction time, applied pressure, changes in angle, the pattern of a users' acceleration or deceleration during a movement, the precision of movements, the click latency, click pressure, or a combination of two or more thereof. The term “area under the curve” refers to the area formed by the total distance or actual direction travelled by the user starting from the starting position of the pointer (x 1 , y 1 ) to the answer selected by the subject (x 2 , y 2 ), and the distance between y 1 and y 2 (i.e., absolute value of y 1 −y 2 ) and the distance between x 1 and x 2 . (i.e., absolute value of x 1 −x 2 ). [0019] Still in other embodiments, said input device (e.g., pointing device such as mouse) usage characteristic is based on the speed, total distance travelled, initial direction of movement, total response time, change in direction on the x-axis, change in direction on the y-axis, idle time, area under the curve, amount of deviation, reaction time, applied pressure, changes in angle, the pattern of a users' acceleration or deceleration during a movement, the precision of movements, the click latency, click pressure, or a combination of two or more thereof [0020] Yet in other embodiments, the behavior comparison unit compares the result of the subject's behavioral biometric to a reference behavioral biometric. In some instances, the reference behavioral biometric comprises the subject's behavioral biometric to a non-interested or non-sensitive question. In other embodiments, the reference behavioral biometric comprises behavioral biometric of a plurality of subjects based on the same non-interested or non-sensitive question. Still alternatively, the reference behavioral biometric can comprise behavioral biometric of a plurality of subjects who answered truthfully on the same sensitive question or who answered non-truthfully on the same sensitive question. It should be noted in this case, the reference behavioral biometric can comprise an average of behavioral biometric obtained from the plurality of subjects. Alternative, the reference behavioral biometric can be based on a desired confidence limit (e.g., 95%) under the standard curve. In this latter reference behavioral biometric, the subject's behavioral biometric is analyzed to determine whether it is within the desired confidence limit range. [0021] In one particular embodiment, said reference behavioral biometric comprises an average behavioral biometric to the same question presented on the display screen of a plurality of subjects. [0022] Yet in other embodiments, said behavioral biometric-based deception analysis system is suitably configured for real-time deception analysis. [0023] Still in other embodiments, said data interception unit is further configured to passively collect keyboard usage characteristic of the subject. In some instances, said keyboard usage characteristic comprises what key was pressed, what time (e.g., elapsed time between presenting the question on the display screen and the time) a key was pressed, what time it was released, or a combination thereof. Moreover, said keyboard usage characteristic can be based on or includes at least one of speed, transition time, dwell time, pressure of key pressed, or a combination thereof. [0024] Yet another aspect of the invention provides a method for determining whether a subject is truthful or deceptive to a question of interest, said method comprising: (a) presenting a question of interest and a plurality of answers on a display screen that requires use of an input device; (b) allowing a subject to select an answer using the input device (e.g., a pointing device, a keypad, a touch pad, or a touch screen); (c) passively collecting subject's input device usage characteristic; (d) comparing subject's input device characteristic with a reference input device usage characteristic to determine whether the subject is truthful or deceptive to the question of interest; and (e) optionally repeating steps (a)-(d) with a different question. [0030] The different question can be a non-sensitive question to further establish the subject's reference behavior biometrics. It can also be another sensitive question or a follow-up question to further establish the truthfulness of the subject. [0031] In some embodiments, such a method can further comprise the steps of: (a) presenting a benign or control question and a plurality of answers on a display screen that requires use of the input device; (b) allowing the subject to select an answer using the input device; (c) passively collecting input device usage characteristic of the subject; (d) storing passively collected input device usage characteristic of the subject as the reference input device usage characteristic (i.e., reference behavior biometrics); and (e) optionally repeating steps (a)-(d) with a different question. [0037] Still in other embodiments, said reference input device usage characteristic is an average input device usage characteristic of a plurality of subjects for the same question of interest. It should be noted that such reference input device usage characteristics can be either of those subjects who have truthfully answered the question or input device usage characteristics of those subjects who did not truthfully answer the question. Alternatively, the method can compare to both of these subjects to determine which reference input device usage characteristics more closely resembles the subject's input device usage characteristics. [0038] Yet in other embodiments, said input device usage characteristic comprises input device movement between the starting position of input device and the answer selected by the subject on the display screen. [0039] In other embodiments, said input device usage characteristic is based on at least one of speed, total distance travelled, initial direction of movement, total response time, change in direction on the x-axis, change in direction on the y-axis, acceleration, idle time, area under the curve, amount of deviation, reaction time, applied pressure, and changes in angle. BRIEF DESCRIPTION OF THE DRAWINGS [0040] FIG. 1 is a schematic representation showing combined mouse movement resulting when multiple answers catch a respondent's attention. [0041] FIG. 2 is an example of insider threat question. [0042] FIG. 3 is an example of one particular embodiment of ADMIT response analysis framework. [0043] FIG. 4 is a graph of X-location by real time for guilty participants in a simulated ADMIT test. [0044] FIG. 5 is a graph of X-locations by normalized time for guilty participants in a simulated ADMIT test. [0045] FIG. 6 is a graph of Y-locations by real time for guilty participants in a simulated ADMIT test. [0046] FIG. 7 is a graph of Y-locations by normalized time for guilty participants in a simulated ADMIT test. [0047] FIG. 8 is a graph of velocity by real time for guilty participants. [0048] FIG. 9 is a bar graph showing mean velocity for guilty participants on control vs. key questions. [0049] FIG. 10 is a graph showing angles by real time for guilty participants. [0050] FIG. 11 is a graph of X-locations by normalized time for key items. [0051] FIG. 12 is a graph of Y-locations by normalized time for key items. [0052] FIG. 13 is a graph of X-location by normalized time for control items. [0053] FIG. 14 is a graph of Y-location by normalized time for control items. DETAILED DESCRIPTION OF THE INVENTION [0054] The present inventors have discovered that input device (e.g., mouse and/or keyboard, other input devices known to one skilled in the art, an other input devices that are developed) usage features or characteristics are diagnostic of insider threats in sensitive questions (i.e., questions about insider threat activities or other key or security questions) administered on a computer. Some aspects of the invention are based on the discovery by the present inventors that when people see two or more answers to a question that catch or draw their attention (e.g., a truthful answer and a deceptive answer that the person will ultimately choose), the mind automatically starts to program motor movements toward both answers simultaneously. To eliminate one of the motor movements (e.g., eliminate the movement towards confessing to an insider threat activity), the mind begins an inhibition process so that the target movement can emerge. Inhibition is not immediate, however, but rather occurs over a short period of time depending on the degree both answers catch the respondents attention (up to ˜750 milliseconds or more). If movement begins before inhibition is complete, the movement trajectory is a product of motor programming to both answers. See FIG. 1 . Thus, in an ADMIT survey, when people are asked a question about an insider threat activity and the incriminating answer catches their attention, their mouse trajectory is biased toward this incriminating answer (measured on an x, y axis) on its way toward the non-incriminating (e.g., deceptive) answer. For innocent people, the incriminating answer generally does not catch their attention to the same degree, and thus inhibition occurs more quickly and their mouse movements is less biased toward the opposite response. [0055] In addition, being deceptive normally causes an increase in arousal and stress. Such arousal and stress causes neuromotor noise that interferes with people's fine motor skills (e.g., using the hand and fingers to move a mouse or use a touch screen to answer a question). As a result, the precision of mouse movements decreases when people are being deceptive, ceteris paribus. To reach the intended target (e.g., a deceptive answer in the ADMIT survey), people automatically and subconsciously compensate for this decrease in precision through reducing speed and creating more adjustments to their movement trajectories based on continuous perceptual input. Thus, in ADMIT surveys, the present inventors have found that people exhibit slower velocity, more adjustments (x and y flips), greater distance, and more hesitancy when being deceptive compared to when telling the truth. [0056] As another example, the present inventors have found that people guilty of insider threat activities display different mouse movements on non-incriminating questions compare to innocent people. In anticipation of a question that might incriminate them, guilty people show a task-induced search bias: before answering a question, they take a fraction of a second longer to evaluate the question. After seeing that the question is not relevant, they then move more quickly to the truthful answer than innocent respondents. Table 1 summarizes examples of mousing features that can be used to differentiate between how guilty insiders and innocent respondents respond to ADMIT questions. In some embodiments at least four or more, typically at least eight or more, often at least ten or more, still more often at least fifteen or more, and most often at least twenty or more of these characteristics are determined and analyzed. Still in other embodiments, all of the input device usage characteristics in Table 1 are determined and analyzed. [0000] TABLE 1 Examples of features that distinguish an insider threat (exemplary features monitored) Statistic Description X The X coordinates for each movement Y The Y coordinates for each movement Z The Z coordinate for each movement Pressure The pressure for each movement Rescaled X The X coordinates for the interaction normalized for screen resolution Rescaled Y The Y coordinates for the interaction normalized for screen resolution X Average The X coordinates averaged in buckets of 75 ms Y Average The Y coordinates averaged in buckets of 75 ms X Norm The X coordinates time normalized Y Norm The Y coordinates time normalized Pressure The pressure applied to the mouse for every raw recording Timestamps The timestamp for every raw recording Click Direction Whether the mouse button was pushed down (d) or released (u) for every time an action occurred with the mouse button Click X The X coordinates for each mouse click event Click Y The Y coordinates for each mouse click event Click Rescaled X The X coordinates for each mouse click event normalized for screen resolution Click Rescaled Y The Y coordinates for each mouse click event normalized for screen resolution Click Pressure The pressure applied to the mouse for every raw recording Click timestamps The timestamp for every mouse click event Acceleration The average acceleration for each 75 ms Angle The average angle for each 75 ms Area Under the Curve The geometric area between the actual mouse trajectory and the (AUC) idealized response trajectory (i.e., straight lines between users' mouse clicks); it is a measure of total deviation from the idealized trajectory. Additional AUC The AUC minimum the minimum AUC Overall Distance The total distance traveled by the mouse trajectory Additional Distance The distance a users' mouse cursor traveled on the screen minus the distance that it would have required to traveling along the idealized response trajectory (i.e. straight lines between users' mouse clicks), Distance Buckets Distance traveled for each 75 ms X Flips The number of reversals on the x axis Y Flips The number of reversals on the y axis Maximum Deviation The largest perpendicular deviation between the actual trajectory and its idealized response trajectory (i.e., straight lines between users' mouse clicks), Speed Buckets Average speed for each 75 ms Overall Speed Average overall speed Idle Time if there is a change in time greater than 200 ms but no movement, this is counted as idle time Idle Time on Same If there is a change in time but not a change in location, this mean an Location event other than movement triggered a recording (e.g., such as leaving the page, and other things). The time in this event is summed. Idle Time On 100 If there is a change in distance greater than 100 between two points, Distance this may indicate that someone left the screen and came back in another area Total Time Total response time Click Mean Speed The mean speed of users click Click Median Speed The median speed of users click Click Mean Latency The mean time between when a user clicks down and releases the click Click Median Latency The median time between when a user clicks down and releases the click Answer Changes The number of times an answer was selected; if over 1, the person changed answers Hover Changes The number of times an answer was hovered; if over 1, the person hovered over answers they didn't chose Hover Region The amount of time a person overs over a region Return Sum The number of times a person returns to a region after leaving it Dwell The measurement of how long a key is held down Transition Time between key presses Rollover The time between when one key is released and the subsequent key is pushed [0057] System Implementation: [0058] ADMIT asks specially designed questions on a computer about illicit behavior and requires respondents to answer by admitting to or denying the behavior by dragging a button on the bottom of the screen to ‘yes’ or ‘no’. Following polygraph techniques (the concealed information test, control question test, comparative questions test, etc.) survey items are normally crafted to conform to at least two categories: benign questions that can be used to establish baseline behavioral data, and sensitive questions that the organization is interested in the answer to. Responses are analyzed with both with-in subject comparisons as well as by comparing responses with the aggregate responses of other employees. For instance, FIG. 2 is an example of an insider threat question—“have you stolen any classified information?” In this example, the respondent must move the mouse from the lower middle of the screen to the “No” answer to deny stealing classified information or to “Yes” to confess. Mouse movements are captured while the respondent is answering the question and compared to an individual baseline (how the individual moves the mouse on truthful responses) and/or to a population baseline (how other people normally move the mouse on this question) to detect deception. [0059] Survey items (e.g., questions) have acceptable and non-acceptable ranges of responses. See FIG. 3 . These acceptable response ranges will be determined by the individual organization involved in the survey. For example, if the question were asked “A crime was committed in our organization. If you committed the crime, you will know what act was performed. Did you perform any of the following crimes?” The system would then list 6 options (e.g., unauthorized disclosure of classified information, theft of credit card numbers, theft of hardware, etc.). For the key item (the item of interest), a threshold is set on abnormal mouse movements; any abnormal mouse movements above this threshold is deemed as unacceptable (and anything below, acceptable). By observing both the answer provided by the user and using the mouse and keyboard behavior to detect changes in emotional response, one can make four potential observations about a response to a survey item using ADMIT ( FIG. 3 ): (i) Lower Left Quadrant: Answer was within acceptable range with normal emotional response (i.e., no action is necessary); (ii) Upper Left Quadrant: Answer is outside acceptable range with normal emotional response (i.e., an HR problem and alert needs to be generated); (iii) Upper Right Quadrant: Answer is outside acceptable range with elevated emotional response (i.e., an HR problem and alert needs to be generated); and (iv) Lower Right Quadrant: Answer was within acceptable range, however, with an elevated emotional response (i.e., a deceptive answer; an investigation needs to be launched). [0060] Several functionalities can be implemented in the ADMIT system to facilitate accurate and reliable analysis of mouse movements. For example, (i) Data is time-normalized (e.g., all trajectories are evenly split into 101 equal buckets) to compare trajectories between respondents for detecting deception; (ii) Data is averaged into 75 ms duration intervals to account for differences in computers speeds and mouse characteristics within subjects; (iii) Data is rescaled to a standard scale to account for the trajectories of respondents who used different screen resolutions; (iv) Respondents are required to start moving their mouse or finger before an answer is shown, so that a respondent's initial movements can be captured as soon as they see the answer; (v) If respondents stop moving their mouse or finger or stop dragging an answer, an error is shown; (vi) To help respondents get use to the testing format and improve the performance of the evaluation, a tutorial and practice test can be provided; (vii) All items (sensitive and control items) can be pilot tested to make sure innocent people respond as intended; (viii) A tree-like questioning framework can be implemented to ask follow-up questions when deception is detected or suspected; (ix) All input device usage characteristics (such as mousing data) can be sent to a server data server via a web service to be analyzed for deception. This reduces the likelihood that data can be tampered with during the analysis; (x) A secure management dashboard can be implemented to visualize (e.g., in real-time) the results and execute policy-driven responses to threats; (xi) Probabilities of deception can be calculated based on multi-tiered testing; and/or (xii) Different features of deception are extracted for different devices (desktop, iPad, etc.). [0061] ADMIT system introduces a lightweight and easily deployable system for quickly identifying potential threats. Many agencies go to significant lengths, and at great expense, to identify potential threats. Unfortunately, current techniques used to identify potential threats are labor intensive, laden with bias, and frequently miss potential threats. For instance, polygraphs are often used for employee initial and ongoing screening, but are extremely problematic for widespread deployment. A single polygraph test requires hours of pre-planning, pre-test interviewing, testing, and post-testing reviews, costing hours of productive time and thousands of dollars per administration. Other methods such as conducting face-to-face interviews (that must be done individually and at great expense) or traditional surveys (which are cheap to deploy but easy to subvert) are equally constrained. ADMIT can be deployed simultaneously to thousands of employees at minimal expense. Additionally, by eliminating humans and creating an objective methodology for identifying possible insider threats, ADMIT is not subject to the same biases that more conventional methods may fall victim to. Thus, ADMIT improves upon previous methods in at minimum the following ways: (i) Easy and inexpensive to deploy to a large number of employees simultaneously; (ii) A data capture process runs in the background during survey administration, while analysis can take place on a separate and secure remote system; (iii) Behavioral sensing data (e.g., keyboard and mouse usage) is gathered in an unobtrusive manner with no adverse effect to the user; (iv) Users need not be aware of the data collection that is taking place; (v) Unlike systems that rely on linguistic features, the system's behavioral analysis approach is language agnostic (i.e., the detection methodology will work with English, Spanish, Arabic, etc.) because it relies on system usage patterns rather than message content; (vi) Survey items or questions are specifically constructed to identify behaviors of interest; i.e., ADMIT can be deployed in a broad range of contexts, e.g., employment applications, healthcare (doctor or insurance), life insurance, loan application, ongoing employment screening, financial disclosure, etc.; (vii) The system is not easily fooled, as heightened emotions that would trigger anomalous event typically manifests itself as subtle differences in typing or mouse movement behavior that occurs between 20 and 100 milliseconds. Attempts to modify one's keystroke or mouse use can be flagged as abnormal, thus identifying individuals attempting to fool the system; and (viii) The system is not subject to biases that are common in face-to-face investigations. [0062] ADMIT can be used to confirm the individuals that are operating within a given acceptable range of behavior and system usage. It also provides a powerful tool for management to proactively identify and investigate those individuals who respond abnormally to targeted questions. ADMIT provides unprecedented and innovative capabilities to identify those individuals that are potentially a threat to the effective operation of an organization. [0063] Additional objects, advantages, and novel features of this invention will become apparent to those skilled in the art upon examination of the following examples thereof, which are not intended to be limiting. In the Examples, procedures that are constructively reduced to practice are described in the present tense, and procedures that have been carried out in the laboratory are set forth in the past tense. Examples [0064] Below is an example study conducted to validate ADMIT. This is only an example. In other types of assessments, the same or different factors may or may not be significant. [0065] A mock theft study was conducted using a multi-level experiment design ( 2 ). Half of the participants were randomly assigned to commit an insider threat activity (steal sensitive information). All participants—both innocent and guilty—then completed a computer-based screening test (an ADMIT test) that asked questions about the insider threat activity (i.e., key questions) and benign questions not related to the activity (i.e., control questions). [0000] TABLE 2 Multi-level experiment design Level 1 Committed the Did not commit the insider threat activity insider threat activity Level 2 Key Control Key Control questions questions questions questions [0066] Participants: [0067] A total of 75 people were recruited for the experiment from an undergraduate business course for extra credit. Of these, 5 of the participants in the guilty treatment refused to perform the mock insider threat theft. Four others confessed to committing the theft during the screening. This resulted in useable data from 66 participants (30 in the insider threat treatment and 36 in the innocent treatment). 59% of participants were female and the average age was 21.8. The average number of years of college education was 3.1. The most represented nationalities were American (69%), Chinese (11%), and Mexican (9%). Twenty-nine percent of students were business management majors, 27% accounting, 20% marketing, 15% finance, and 9% management information systems. [0068] Procedures: [0069] A task was designed to mimic a realistic insider threat scenario. Although the task was sanctioned (i.e., participants were told to perform the elicit act and appear innocent), it was conducted to solicit suspicion and anxiety. Participants registered for an appointment online and were randomly assigned to an innocent or guilty condition. Upon arriving at the experiment, the participant was given a consent form to review and sign. [0070] Guilty Condition: [0071] Participants in the guilty condition were given a folded piece of paper and a jump drive. They were instructed to go in the elevator (on the first floor), press the button to the fourth floor, and only then read the paper. The instructions on the paper are shown in Table 3. In summary, the instructions asked participants to go to the Management Information Systems department, login to a computer in the front office using a set of credentials, and steal a file containing department credit card numbers. Participants were instructed to lie if confronted about the theft. [0000] TABLE 3 Guilty participant instructions Your task is to commit a theft. You will go into the MIS department front office and steal a computer file that contains department credit card numbers. You will then go to room 109 for further instructions. During the entire experiment, please try your best to appear innocent, do not raise any suspicion, and do not confess to committing the theft. If you are asked any questions about the theft, LIE. Below are the steps of your task:  1. Go to the MIS Department front office-room 430 (see the first picture).  2. Go to the back-right corner of the reception area (circled in the lower picture; under the TV). Be confident. Don't talk with anyone unless talked to. If anyone asks what you are doing, say you are a TA, and you need to get a file.  3. Log in to the computer on the desk. Use the following credentials:  4. Username: CHROME13\eller  5. Password: manager  6. You should see a picture of a red sports car as the desktop background and a file called “department credit card numbers”  7. Open the file to make sure it contains the department credit card numbers  8. Copy the entire file to the given flash drive. You can plug the flash drive into the monitor or on the computer to the left side of the desk. DO NOT REMOVE THE FILE, JUST COPY IT.  9. Log out of the computer. 10. Go to room 109 with the flash drive when you are finished. To make sure you remember the details of this theft, please answer the following questions: What picture was on the desktop of the computer?                What information was in the file you stole?                Where did you copy the file to?                 What password did you use to login to the computer?                 [0072] Guilty participants then were instructed to go back to the room on the first floor. Upon arriving at the room, an experiment facilitator explained that a theft occurred and the participant was a suspect for that theft. The participant was then asked to take an investigation screening (an ADMIT test). [0073] Innocent Participants: [0074] Participants in the innocent condition were also given a folded piece of paper. They were instructed to go in the elevator (on the first floor), press the button to the fourth floor, and then read the paper. Similar to the guilty participants, the paper asked participants to go to the Management Information Systems department. However, rather than stealing information, innocent participants were asked to pick up a piece of paper (a news article) at the front desk and then go back to the room on the first floor. Upon arriving at the room, an experiment facilitator explained that a theft occurred and the participant was a suspect for that theft. The participant was then asked to take an investigation screening (ADMIT test described below). [0075] ADMIT Test: [0076] The ADMIT test consisted of a concealed information test (CIT) adapted to the ADMIT format and then several follow-up questions. All questioning was presented on a computer. The CIT is the most scientifically validated polygraph questioning technique (Ben-Shakhar and Elaad 2003; Council 2003; Fiedler et al. 2002). The objective of the CIT is to detect if a person has ‘inside’ or ‘concealed’ knowledge of an activity (e.g., stealing the credit card numbers) (Ben-Shakhar and Elaad 2003). In a standard CIT, the person being interviewed is presented a question or a stimulus about a specific target (e.g., a crime). In a face-to-face CIT, the interviewer verbally asks the interviewee a question such as, “Very important information was stolen today from a computer. If you committed the theft, you will know what was stolen. Did you steal any of the following information today?” The interview then recites five to six plausible answers. For example, the interviewer might recite: ‘passwords’, ‘credit card numbers’, ‘exam key, ‘social security numbers’, ‘health records’, or ‘encryption codes’. Usually, the interviewee is asked to verbally repeat the possible answer and then respond ‘yes’ or ‘no’. One of the plausible answers should relate directly to the target under investigation. This is referred to as the key item. For example, if the CIT is investigating theft of ‘credit card numbers’, this answer must be included in the set of answers accompanied by several other plausible yet unrelated answers (Krapohl et al. 2009). An innocent person with no insider knowledge′ should exhibit the same amount of arousal for each answer. However, a guilty person should experience a detectable psychophysiological change—an orienting response—when presented the key item. [0077] In designing the CIT for ADMIT in this experiment, all of the items (key and control items) were pilot tested to make sure that an innocent person will respond similarly to each item without unintended psychophysiological responses. Next, prior to administering the CIT, each participant was familiarized with the format of the CIT through a practice test. In the practice test, the program required the respondent to move the mouse within the first second, or displayed an error. This helps ensure the inhibition is not complete before movement occurs. This also reduces the likelihood that an orienting response would occur due to the novel format of the test and therefore confound the results (Krapohl et al. 2009). CIT was then administered to investigate the theft of the credit card numbers. The CIT was administered by a computer, rather than by a human facilitator. Screenshots and explanations of the CIT are shown in Table 4. [0000] TABLE 4 Experiment ADMIT test Screen display Explanation Very important information was The question for the first stolen today from a computer. If question is presented to the user you committed the theft, you will know what was stolen. Did you steal any of the following information today? (Press enter to see the possible answers) YES After pushing Enter, the user NO must move the mouse to the bottom-middle of the screen to push next before seeing the first item. This anchors the mouse in Next the same location for each item. The first item (passwords) is shown. The user must move the mouse from the bottom middle of YES the screen to the upper right or NO left hand corners to answer the question. The first item is always Did you steal any of the following thrown out because its novelty Information today? may solicit an orienting response (Krapohl et al. 2009). Thus, the Passwords first item is not randomized. The program requires the respondent to move the mouse within the Next first second, or display an error (the respondent becomes accustom to this in the practice test preceding the question). YES Second item - last item: The NO mouse is anchored at the bottom of the screen prior to displaying Next the next item. Second item - last item: Display the remaining items in random order, including the key item. YES The items in random order NO included: Credit Card Numbers Did you steal any of the following Exam Key Information today? Social Security Numbers Health Records Credit card numbers Encryption Codes The program requires the respondent to move the mouse Next within the first second, or display an error (the user becomes accustom to this in the practice test preceding the question). [0078] Measures: [0079] Mouse and electrodermal data were collected from each subject. The electrodermal response data is typically used in CIT polygraph testing. It was used here to compare to and validate the procedure for detecting insider threats based on mouse movements. [0080] Mousing: [0081] ADMIT performs several transformations and computations to facilitate analysis as follows: (i) Space rescaling—All mouse trajectory data were rescaled to a standard coordinate space (a 2×1.5 rectangle that is compatible with the aspect ratio of the computer screen). The top left corner of the screen corresponds to −1, 1.5, and the bottom right corner of the screen corresponds to 1,0. Thus the starting position is at position 0, 0; (ii) Remapping—All data were remapped so the mouse started at position 0,0. Although the user must click a button at the middle-bottom of the screen to see the next item, the button's size allows variations to exist (e.g., someone might actually click on the right side of the button). Thus, the trajectories are remapped for comparison; (iii) Time normalization—Time normalization was required for analysis of spatial attraction/curvature and complexity such as maximum deviation (maximum perpendicular deviation between the straight line trajectory), area under the curve (geometric area difference between the actual trajectory and the straight line), and x-flips and y-flips. The rational for time normalization is that recorded trajectories tend to have different lengths. For example, a trial that lasts 800 ms will contain 56 x, y coordinate pairs. However, a trial that last 1600 ms will contain 112 x,y coordinate pairs. Using linear interpolation, trials with different numbers of x, y coordinate pairs is divided up into 101 time-steps for average and comparison across multiple trials and computation of the aforementioned features; and (iv) Raw time analysis—For other analyses (velocity, acceleration, angle), the x, y location were analyzed for raw time (not normalized time) for the first 1500 ms. The x, y locations were averaged in intervals of 75 ms to account for the computers limitations of capturing movements at about 70 hz. Only the first 1500 ms were analyzed because most people take at least 1500 ms to respond. [0082] Electrodermal Responses: [0083] Using a polygraph machine, electrodermal responses were also captured using two sensors on the pointer and ring fingers of the participant's non-dominant hand (the hand not used to move the mouse). 12 seconds were allowed between each question/item for an individual's electrodermal activity to react and then to level out before asking the next question (Gamer et al. 2006). [0084] Pilot Tests: [0085] This test builds on 7 exploratory pilot studies with approximately 1293 participants to understand the dynamics of capturing mouse movements to detect deception, to validate that the items do not inherently cause an unanticipated response for an innocent person, and to discover what features to extract and analyze to detect deception and facilitate hypothesis creation. The specific scenario used in this experiment, was pilot tested with an additional 6 people to make final adjustments to the experiment protocol and tests. [0086] Analysis: [0087] Analysis were divided into three relevant areas to detect insider threats: (i) Area 1 examined what features differentiated how a guilty person answers a key question versus a control question (a within-subject analysis). This is a typical analysis done in polygraph administration; (ii) Area 2 examined what features differentiated between how a guilty person answers a key question versus how an innocent person answers a key question (a between-subject analysis); and (iii) Area 3 examined what features differentiated between how a guilty person answers a control question versus how an innocent person answers a control question (a between subject-analysis). [0088] Other possible areas of analysis were excluded at least in part for the following reasons: (i) Confessing to an act, whether truthfully or deceptively, will always flag the response for follow-up questioning. Hence, this eliminates the need to create a model to predict: a) when guilty people are being deceptive on a control question (falsely confessing), b) when deceptive people are being truthful on a key question (confessing), and c) when innocent people are being deceptive on either a key question or control question (falsely confessing); and (ii) Important for the validity of the CIT, innocent people should experience no systematic difference in how they response to key and control questions. This was confirmed through pilot testing. Hence, a model differentiating between the two types of questions for innocent people was not needed. [0089] Table 5 summarizes the areas of analysis. The analysis proceeded as follows. For each area, determination was made to see if there was a difference in electrodermal response as done in traditional polygraph testing. Determination was also made to see if differences in mousing behavior also existed. [0000] TABLE 5 Summary of areas of analysis Area 1: Guilty key vs. Area 2: control questions Key questions Control Questions Guilty Guilty key Innocent Guilty Innocent Guilty control questions key key control control questions (deceptive questions questions questions questions (truthful response) (truthful (deceptive (truthful (truthful response) response) response) response) response) [0090] Guilty Key Vs. Control Items: [0091] First, whether differences can be detected was investigated in how guilty individuals (n=30) answer control vs. key questions in the ADMIT test. The assumption of the CIT for ADMIT was that a difference can be detected via electrodermal responses. This assumption was cross-validated, and then the test was also analyzed to see whether mouse movements can also be predictive of deception. [0092] Electrodermal Response: [0093] The polygraph is based on the assumption that a guilty person will experience a heightened electrodermal response (caused by arousal and stress) when answering key questions deceptively compared to answering control questions truthfully (Krapohl et al. 2009). Results of ADMIT experiment confirmed that this effect was present in this experiment. A linear mixed model predicting deception (control vs. key item) was specified based on electrodermal responses nested within each participant. In other words, this experiment examined deviations from individual electrodermal baselines by examining z-scores. Thus, participants were only compared to their own electrodermal baseline to detect anomalies. [0094] It was found that the peak electrodermal response was a significant predictor of key items (p<0.05, z=1.911, n=30, one-tailed). In other words, after controlling for individual differences, people were significantly more likely to experience a higher electrodermal response on the key items than on the control item. Similarly, it was found that the minimum electrodermal responses were significant predictors of control items (p<0.05, z=−1.743, n=30, one-tailed). In other words, after controlling for individual differences, people were more likely to experience a lower electrodermal response on the control questions compared to the key questions. [0095] Mousing Behavior: [0096] Complementing the electrodermal responses, it was also found that several significant mousing differences existed in how guilty participants answered key vs. control questions. Linear mixed models was used to predict deception (key vs. control item) based on mousing behavior nested within each participant. In other words, models were constructed at each time interval to find deviations from individual mousing baselines through examining z-scores. Thus, participants were only compared to their own mousing baseline to detect anomalies. The results are described below. [0097] First, participants' mouse trajectories on key items (deceptive responses) showed more attraction toward the opposite answer than did their trajectories on control items (truthful responses). This was apparent in both the x-location by raw-time graph ( FIG. 4 ) and the x-location by normalized time graph ( FIG. 5 ). The raw-time graph for x-locations ( FIG. 4 ) shows that participants experienced an initial delay in moving horizontally on key questions (˜600 ms). After this delay, the rate at which participants moved along the x-axis when lying was slower than when telling the truth. For example, at time interval 526-600 ms, the average difference between truthful and deceptive responses in x-location was 0.0778 (on a transformed scale between 0 and 1); At time interval 1426-1500 ms, however, the difference in x-location was 0.2217; honest responses had traveled nearly twice as far on the x-axis as the deceptive responses at this time interval. [0098] To validate these observations, a linear mixed model was specified at each time interval (˜75 ms) to identify anomalies—a total of 20 independent tests were conducted. The results showed that the individuals' trajectories for key and control questions were significantly different on the x-axis at a p<0.1 level (z>1.282, n=30) for all time slots between 301 ms-1500 ms (16 sequential time slots). Furthermore, the trajectories were significantly different at a p<0.05 level (z>1.645, n=30) for a subset of these times slots between 901 ms-1500 ms (8 sequential time slots). [0099] Running multiple independent tests as done in this study may cause alpha slippage—i.e., something being significant due to random chance. To determine the extent alpha-slippage might account for the results, the probability were computed of having multiple significant tests in a row. The probability of having 16 time slots significant in a row at a p<0.1 level due to random chance is 0.1×10 16 (p<0.0000000000000001). The probability of having 8 time slots significant in a row at a p<0.05 level due to random chance is 0.05×10 8 (p<0.0000000000390625). Hence, it can be concluded that for the 20 independent tests run, the significant difference in the trajectories was likely not due to alpha-slippage. [0100] Next, by examining x-location by normalized time, the present inventors were able to measure spatial attraction toward an opposite choice. Similarly to the present inventors previous analysis, a linear mixed model predicting deception (control vs. key item) based on x-location was specified for each standardized time slot (101 independent tests conducted). Complementing the present inventors' previous findings, it was found that the normalized trajectories were significantly different at a p<0.1 level (z>1.282, n=30) from time slots 45-48 (4 sequential time slots), 55-69 (15 sequential time slots), and again in time slots 92-94 (3 sequential time slots). [0101] On the y-axis, the mouse trajectories during key questions (deceptive responses) showed increased hesitancy in moving upward. This was apparent in both the y-location by raw-time graph ( FIG. 6 ) and the y-location by normalized time graph ( FIG. 7 ). The raw-time graph for y-locations ( FIG. 6 ) revealed that participants started moving upward at approximately the same time when deceiving as they did when telling the truth. However, the rate of upward movement was slower. For example, the difference at the 451-525 ms time slot was 0.0675; whereas the difference at the 1426-1500 ms time slot was 0.3472. [0102] Specifying a linear mixed model for each time period (20 independent tests were conducted), whether individuals' trajectories while being deceptive was significantly different from their trajectories while being truthful was tested. It was found that the key item (deceptive) trajectories were significantly different at a p<0.1 level (z>1.282, n=30) from 451 ms to 1500 ms (15 sequential time slots); and within this time period, the trajectories were different at a p<0.5 level (z>1.645, n=30) from 826 ms to 1500 ms (9 sequential time slots). [0103] Using the y-location by normalized time, vertical hesitancy toward answering a key question deceptively was measured. Specifying a linear mixed model for each time slot (101 independent test runs), whether the deceptive and truthful trajectories were significantly different was tested. It was found that the key item trajectories were significantly different at a p<0.1 level (z>1.282, n=30) from time slot 56-74 (19 sequential time slots) and significantly different at a p<0.05 level (z>1.645, n=30) from timeslot 64-70 (7 sequential time slots). The trajectories were again different at a p<0.1 level (z>1.282, n=30) on the y-axis near the end of the movement from time slot 88-92 (5 sequential time slots) and, within this, at a p<0.5 level (z>1.645, n=30) from 89-90 (2 sequential time slots). [0104] As the rates of movement along the x-axis and y-axis were slower for deceptive responses than for truthful responses, not surprisingly deceptive responses also had a slower overall velocity. See FIG. 8 . Specifying a linear mixed model for each time slot (20 independent tests), it was found that deceptive responses showed a significantly lower velocity at the peaks in FIG. 8 from 376 ms-675 ms (4 sequential time slots) and from 901 ms to 1200 ms (4 sequential time slots) at a p<0.1 level (z>1.282, n=30). When examining the mean velocity across the entire movement, guilty participants showed significantly lower velocity on key question (p>0.01, z=−2.494, n=30). See FIG. 9 . Velocity on key questions was nearly half. [0105] Also in support that trajectories show attraction toward the truthful answer while moving toward the deceptive answer, data analysis showed that when guilty participants were deceptive, they actually had movement toward the truthful answer for a short period of time before moving toward the deceptive answer as shown in FIG. 10 . In this figure, any value over 90 degrees indicates movement along the x-axis in the opposite direction (going left toward the truthful response). As seen in the chart, deceptive responses on average move toward the truthful answer for a few hundred milliseconds before totally committing to the deceptive answer. Specifying a linear mixed model for each time period (20 independent tests), it was found that this difference is significant from 601 ms to 1050 ms at a p<0.1 level (z>1.282, n=30) (6 sequential time slots) and, within this time frame, significant from 601 ms to 900 ms at a p<0.05 level (z>1.645, n=30) (4 sequential time slots). [0106] Guilty and Innocent Key Item Trajectories: [0107] In this experiment, whether differences in mouse movement can be detected between how guilty and innocent people answer key items were tested. The first test was whether an electrodermal response was present, next test was whether differences in mousing behavior existed. [0108] Electrodermal Response: [0109] Typically, comparisons only within subject are made in a polygraph examination because of individual differences. Hence, a comparison of electrodermal activity in how guilty and innocent people answer key questions is not normally conducted. This was cross validated in the experiment by the present inventors and found no differences in electrodermal responses between how innocent and guilty people answered key questions. [0110] Mousing Behavior: [0111] Although electrodermal responses did not reveal differences, it was found that mousing behavior did show a significant diffference. Guilty individuals showed a more tentative commitment toward the opposite answer (for the guilty individual, the truthful answer) than did the innocent individuals on key items. FIG. 11 is a graph of the x-location by normalized time slots for guilty and innocent participants while answering the key questions. As can be seen, guilty individuals' mouse trajectories were more biased toward the opposite (i.e., the truthful) choice than those of innocent individuals. Using a series of t-tests (e.g., Duran et al. 2010) for each normalized time slot (total of 101 independent t-tests), it was found that the innocent and guilty participant trajectories are significantly different at a p<0.1 level (t>1.295, df=65) from time slots 1-9 (9 sequential time slots), 25-39 (15 sequential time slots), 72-101 (30 sequential time slots). Within these intervals, the trajectories were significantly different at a p<0.05 level (t>1.669, df=65) from time spots 1-2 (2 sequential time slots), 5-6 (2 sequential time slots), 28-36 (9 sequential time slots), and 73-101 (29 sequential time slots). [0112] FIG. 12 is a graph of the y-location by normalized time slots for guilty and innocent participants while answering the key questions. As can be seen, guilty individuals' mouse trajectories also were more hesitant toward moving upward toward the deceptive answer than were innocent participants moving upward toward the truthful answer. Using a series of t-tests (e.g., Duran et al. 2010) for each normalized time slot (total of 101 independent t-tests), we found that the innocent and guilty participant trajectories are significantly different at a p<0.1 level (t>1.295, df=65) from time slots 74-92 (19 sequential time slots). Within these intervals, the trajectories were significantly different at a p<0.05 level (t>1.669, df=65) from time spots 80-85 (6 sequential time slots). [0113] In the normal administration of the polygraph, an analysis between how guilty and innocent people answer key items is not normally done; as expected electrodermal was not able to differentiate responses between the guilty and innocent. However, mouse movements was able to significantly differentiate between the guilty and innocent. [0114] Guilty and Innocent Control Item: [0115] Whether differences exist in how guilty and innocent people answer control items was also tested. In this case, the difference is believed to be due solely to the arousal associated with committing the mock theft, and not due to being deceptive on a question. [0116] Electrodermal Response: [0117] The polygraph assumes that no-significant electrodermal difference will be found between innocent and guilty participants when answering control questions. Supporting this assumption, our analysis of electrodermal responses revealed no significant differences between innocent and guilty participants when responding to control items. [0118] Mousing Behavior: [0119] Although no differences were found in electrodermal data, differences in mouse behavior were found that may be suggestive of a task-induced search bias by guilty participants (a fundamentally different cognitive response compared to being deceptive). FIG. 13 and FIG. 14 show the x,y-locations, respectively, by normalized time slots for guilty and innocent responses to control questions. As a reminder, each participant answered 4 control questions regardless whether they were guilty or innocent. To test for significant differences in trajectories, a linear mixed model was conducted nesting participants' responses within each control item (e.g., finding anomalies from the baseline within each of the 4 control items through examining z-scores). [0120] The significant difference in x-locations took place at the beginning of the mouse trajectory. FIG. 13 . Trajectories between guilty and innocent individuals were different at a p<0.1 level (z>1.282, n=66) between time slots 12-31 (20 sequential time slots) and, with in this, different at a p<0.05 level (z>1.645, n=66) between slots 15-28 (14 sequential time slots) at a p<0.05 level (z>1.645, n=66). Whereas the innocent person started moving horizontally almost immediately to answer the question, the guilty person had a small hesitancy before committing to the answer. However, this difference only lasted a short while, after which the guilty person had moved as far or further horizontally along the x-axis than the innocent person. [0121] Interestingly, when examining the y-location on a time normalized scale, both guilty and innocent participants moved upward at about the same rate prior to the ‘decision period’ shown on the x-location chart (a little before time slot 40). However, immediately following this ‘decision period’, guilty participants' progressed along the y-axis at a faster rate than innocent participants. Thus, during the middle interval, guilty participants are significantly further along the y-axis than innocent participants. This difference is significant at a p<0.1 level (z>1.282, n=66) from time slots 52-66 (15 sequential time slots) and at a p<0.05 level (z>1.645, n=66) from time slots 53-64 (12 sequential time slots). [0122] This mousing behavior is suggestive of a task-induced search bias: Anticipating a question that will incriminate them, guilty insiders take a fraction of a second longer to determine how to respond (shown on the x-axis) rather than habitually responding as innocent respondents do. Realizing that the question is irrelevant to the crime, they make a quick and efficient move toward the correct answer catching up to innocent participants on the x-axis and passing them on the y-axis. [0123] The foregoing discussion of the invention has been presented for purposes of illustration and description. The foregoing is not intended to limit the invention to the form or forms disclosed herein. Although the description of the invention has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the invention, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter. All references cited herein are incorporated by reference in their entirety.

The present invention provides a system and a method for eliciting information to sensitive questions and reliably detecting whether one is being deceptive, concealing information, or experiencing a heightened emotional response to the question. In particular, the system and the method of the invention are based on analyzing the user behavioral biometric of using one or more input device(s).

FIELD OF THE INVENTION [0001] The present invention relates to a production of fine dried noodles, specifically to a processing of prepared fine dried noodles and particularly to dry-steamed fine dried noodles and a production device thereof. BACKGROUND OF THE INVENTION [0002] In China, the largest country where fine dried noodles are produced and consumed, an industrial production of the fine dried noodles has been realized. At present, a main production process of fine dried noodles is that the raw material is prepared, kneaded, cured, subjected to tabletting, slit, dried, cut off and packaged into finished products by paper packages or plastic packages. Drying fine dried noodles, as a procedure with the highest investment and the highest technology content in a whole production line, refers to dehydrating wet noodles to finally reach a moisture content specified by the production standard. This procedure not only concerns the quality of products, but also has important influence on energy consumption, yield and cost. The occurrence of phenomena during the production, such as noodle rupture, noodle damp and noodle acidification, is basically caused by unreasonable drying equipment and technologies. The difference between drying technologies of fine dried noodles lies in drying temperature and drying time. [0003] Document Production Formula and Process of Fine Dried Noodles (edited by Shen Qun, Chemical Industry Press, 2008) has described drying of fine dried noodles in Section III of Chapter II (P 107). At present, drying of fine dried noodles includes low-temperature low-speed drying which generally means that, the highest temperature of a primary drying area is below 40° C., and the drying time is 5 h-8 h, wherein there are imported and domestic ropeway-pattern drying chambers; intermediate-temperature intermediate-speed drying which generally means that, the highest temperature of a primary drying area is less than 45° C., and the drying time is 3 h-5 h, wherein based on ropeway-pattern high-temperature drying, the drying tunnel is extended and the drying time is prolonged properly, and the drying temperature is reduced, so that the drying temperature and drying time both are between those of the high-temperature drying and the low-temperature drying; and high-temperature high-speed drying which generally means that, the highest temperature of a primary drying area is greater than 45° C. but less than 50° C., and the drying time is less than 3 h (about 2 h, 40 min fastest). [0004] After the processes of rolling, curing, drying and the like are performed on fine dried noodles, due to the restriction of the amount of water added for kneading, the structural arrangement of gluten network tissues is not very uniform, the spacing between tissues is large and incompact, and the distribution of starch grains on a gluten film is not uniform. In addition, the fine dried noodles have ordinary taste, are boilproof and are difficult to store, and generation of worms is prone to happening. SUMMARY OF THE INVENTION [0005] An object of the present invention is to provide dry-steamed fine dried noodles having good taste, long shelf life and worm resistance, and a production device thereof. The structural arrangement of gluten network tissues of the dry-steamed fine dried noodles is uniform, the spacing between tissues is small and compact, and the distribution of starch grains on a gluten film is uniform. Compared with the noodles as raw material, the maximum load of the dry-steamed fine dried noodles is improved by 10%-200%, and the cooking loss rate is reduced by 0.5%-1.5%. [0006] To achieve the above object, the present invention employs the following technical solutions. [0007] Dry-steamed fine dried noodles are provided, which are prepared via the following steps by using fine dried noodles with a moisture content of 10%-16% as raw material: [0000] (1) heating and dry-steaming: heating and dry-steaming the fine dried noodles, wherein the heating and dry-steaming employs one of the following two solutions: solution 1: heating the fine dried noodles to 50° C.-80° C., and keeping for 1 h-35 h under a relative humidity of 60%-80%; solution 2: feeding the fine dried noodles into a dry-steaming device, heating air in the dry-steaming device to 50° C.-90° C., and keeping for 3 h-100 h under a relative humidity of 60%-80%; and (2) cooling and tempering: cooling the fine dried noodles dry-steamed in step (1) to room temperature by means of controlling a cooling rate to be 2° C./h-30° C./h and keeping the relative humidity at 60%-80%, thus obtaining dry-steamed fine dried noodles with a moisture content of less than or equal to 14.5%. [0008] Preferably, the maximum load of the dry-steamed fine dried noodles is greater than 0.95 N, and the cooking loss rate is less than 7.5%. [0009] The dry-steamed fine dried noodles are cut off or packaged by paper packages or plastic packages, and then sold. [0010] In solution 1 of step (1), the fine dried noodles are heated via microwaves. [0011] In solution 1 of step (1), the fine dried noodles are heated to 50° C.-80° C., and then are kept for 3 h-24 h under a relative humidity of 60%-80%. [0012] The room temperature is preferably 20° C.-25° C. [0013] The fine dried noodles, used as raw material in the present invention, are conventional fine dried noodles in the prior art, and are preferably prepared from wheat flour or composite powder of wheat flour and fruit and vegetable grains, wherein the content of the wheat flour in the composite powder by mass is greater than or equal to 90%. [0014] The preparation method is as follows: preparing, kneading, curing, tabletting, slitting and drying wheat flour to obtain fine dried noodles with a moisture content of 10%-16%. [0015] The wheat flour should meet the requirements of the national industry standard (LS/T 3202). The fine dried noodles are suspended fine dried noodles, cut-off fine dried noodles in bulk, paper-packaged fine dried noodles, or plastic-packaged fine dried noodles, preferably, suspended fine dried noodles, i.e., fine dried noodles which are suspended and dried in a drying room. [0016] In the prior art, preferably, during the main drying process, the moisture content (28%-34%) in the fine dried noodles is reduced to the moisture content requirement (10%-16%) of the product standard at an appropriate temperature (generally below 50° C.), humidity (70%-90%) and wind speed, thereby being suitable for the storage of the fine dried noodles for a long time. [0017] A device for producing dry-steamed fine dried noodles is provided, including a box body 1 provided with a noodle inlet and a noodle outlet, a heating mechanism disposed in the box body, a humidifier disposed on the box body, a detection mechanism for detecting the temperature and relative humidity of air in the box body, and a control mechanism including a PLC device, the control mechanism being electrically connected to the detection mechanism, the heating mechanism and the humidifier. [0018] The control mechanism controls the temperature, humidity and working time of air in the box body via the heating mechanism and the humidifier by means of the detection of the detection mechanism. [0019] The control range of temperature of the control mechanism is 50° C.-90° C., the control range of relative humidity is 60%-80%, and the control range of working time is 3 h-100 h. [0020] The present invention will be further explained and described as below. [0021] The dry-steamed fine dried noodles provided by the present invention are prepared via the steps of heating, dry-steaming, cooling and tempering by using the prepared fine dried noodles. The fine dried noodles have a moisture content of less than or equal to 14.5%, do not have obvious changes in color and appearance, and are not warped, nonacid, not crispy, and not sticky. The hardness of the fine dried noodles is enhanced. Compared with the control noodles, the maximum load in texture index is improved by 10%-200%, the gluten network structure is compact, the toughness of the fine dried noodles is enhanced, and the cooking loss rate is reduced by 0.5%-1.5%. The fine dried noodles have good taste, boiling fastness, long shelf life, and good edible quality, cooking performance and commodity effect. [0022] In a control experiment, wheat flour is directly processed by the method of the present invention, and then placed in an oven for dry-steaming for 16-20 h at 75° C. Then, the dry-steamed wheat flour is processed into noodles. By evaluating and analyzing the noodles, the result shows that it is difficult to process the wheat flour into noodles, and the prepared noodles cannot reach the effects of the dry-steamed fine dried noodles obtained from the finished fine dried noodles product under the same conditions. Meanwhile, potato starch and cassava starch are processed by the method of the present invention, and then 5% and 10% of starch in added into flour and then the mixture processed into fine dried noodles. The result shows that the noodles does not have obvious difference from the control group (starch is not subjected to high-temperature treatment) and cannot reach the effects of the dry-steamed fine dried noodles obtained from the finished fine dried noodles product under the same conditions. [0023] Compared with the prior art, the present invention has the following advantages: [0000] (1) by performing high temperature dry-steaming treatment on the prepared fine dried noodles, the present invention, breaking through the conventional modes of thinking, improves the quality of the fine dried noodles and particularly improves the hardness and toughness of the fine dried noodles while achieving sterilization and anti-insect effects, thus improving the quality guarantee period of the product, and avoiding the occurrence of quality problems such as noodle rupture and poor taste during direct high temperature drying; (2) the structural arrangement of gluten network tissues of the dry-steamed fine dried noodles prepared by the present invention is uniform, the spacing between tissues is small and compact, and the distribution of starch grains on the gluten film is uniform; and (3) compared with the noodles as raw material, the maximum load of the dry-steamed fine dried noodles prepared by the present invention is improved by 10%-200%, and the cooking loss rate is reduced by 0.5%-1.5%. BRIEF DESCRIPTION OF THE DRAWINGS [0024] FIG. 1 is a structure diagram of a production device according to the present invention; [0025] FIG. 2 is a scanning electron microscopic image of common fine dried noodles in embodiment 1; and [0026] FIG. 3 is a scanning electron microscopic image of suspended fine dried noodles after dry-steaming for 9 h at 85° C. in embodiment 1. DETAILED DESCRIPTION OF THE EMBODIMENTS [0027] The present invention will be further described as below in combination with accompanying drawings and embodiments. The percentage content in the embodiments refers to percentage content by mass. Embodiment 1 [0028] Fine dried noodles are prepared by the following steps: [0029] (1) Production of fine dried noodles: producing fine dried noodles is an industrial process for producing common fine dried noodles, including: processing raw material into fine dried noodles after steps of preparing, kneading, curing, tabletting, slitting and drying, wherein the moisture content of the fine dried noodles is 10%-16%. The fine dried noodles in this embodiment are suspended fine dried noodles, that is, the fine dried noodles are suspended and dried in a drying room, wherein the moisture content is 14%. The raw material in this embodiment is wheat flour. [0030] It can be seen from FIG. 2 that, although the processes of rolling, curing, drying and the like are performed on common fine dried noodles, the structural arrangement of gluten network tissues of the common fine dried noodles is not uniform, the spacing between tissues is large and incompact and the distribution of starch grains on the gluten film is not uniform due to the restriction of the amount of water added for kneading or the like. [0031] (2) Dry-steaming: in order to heat the fine dried noodles, the heating and dry-steaming method in this embodiment is as follows: fine dried noodles which have been normally dried in the drying room are suspended and fed into a dry-steaming device, air in the dry-steaming device is heated to 85° C. and kept for 24 h, and the relative humidity is kept at 80%. [0032] It can be seen from FIG. 1 that, a device for producing dry-steamed fine dried noodles (i.e., a dry-steaming device) includes a box body 1 provided with a noodle inlet 4 and a noodle outlet 6 , a heating mechanism 5 disposed in the box body 1 , a humidifier 7 disposed on the box body 1 , a detection mechanism 2 for detecting the temperature and relative humidity of air in the box body 1 , and a control mechanism 3 including a PLC device, the control mechanism 3 being electrically connected to the detection mechanism 2 , the heating mechanism 5 and the humidifier 7 . [0033] The control mechanism 3 controls the temperature, humidity and working time of air in the box body 1 via the heating mechanism 5 and the humidifier 7 by means of detection of the detection mechanism 2 . [0034] The control range of temperature of the control mechanism 3 is 50° C.-90° C., the control range of relative humidity is 60%-80%, and the control range of working time is 3 h-100 h. [0035] (3) cooling and tempering: the fine dried noodles dry-steamed in step (2) are cooled to room temperature, wherein a cooling rate is 2° C./h-30° C./h, the relative humidity is kept at 60%-80%, and the moisture content of the fine dried noodles is controlled to be less than or equal to 14.5%. [0036] In this embodiment, the cooling rate is 30° C./h, the relative humidity is kept at 80%, and the moisture content of the fine dried noodles is controlled to be 11.0%. [0037] The dry-steamed fine dried noodles are prepared via the steps of heating, dry-steaming, cooling and tempering by using the prepared fine dried noodles. The fine dried noodles have a moisture content of less than or equal to 14.5% (11% in this embodiment), do not have obvious changes in color and appearance, and are not warped, nonacid, not crispy, and not sticky. With the increase of dry-steaming time, the maximum load (reflecting hardness of the dry-steamed fine dried noodles) produced by the above process will rise. Compared with the control noodles, the hardness of the fine dried noodles is enhanced, and the maximum load in texture index is improved by 10%-200%. Furthermore, during dry-steaming, the fine dried noodles are further cured, the gluten network structure is compact, the toughness of the fine dried noodles is enhanced prominently, and the cooking loss rate is reduced by 0.5%-1.5% in comparison with the control noodles (refer to the attached table). The fine dried noodles have good taste, boiling fastness, long shelf life, and good edible quality, cooking performance and commodity effect. [0038] Attached Table shows test data of maximum load in texture index and cooking loss rate of suspended fine dried noodles after dry-steaming at 85° C. [0000] Hold time (h) Maximum load/N Cooking loss rate (%) 0 0.8552 8.0 (control) 3 0.9568 7.5 6 1.1416 7.3 9 1.3674 7.2 12 1.5258 6.9 20 1.6010 6.8 24 2.0939 6.7 Note: The texture analyzer is a British TA-PLUS texture analyzer, the number n of the samples to be tested is 3, the thickness is 0.75 mm-0.76 mm, and the value is an average value. [0039] It can be seen from the attached table that, the maximum load in the texture index is improved by 11.9% (keeping for 3 h) and 144.8% (keeping for 24 h) in comparison with the control noodles, the gluten network structure tends to be compact, the toughness of the fine dried noodles is enhanced prominently, and the cooking loss rate is reduced by 0.5% (keeping for 3 h) and 1.3% (keeping for 24 h) in comparison with the control noodles (refer to the attached table). [0040] It can be seen from FIG. 3 that, the arrangement of gluten network tissues of the dry-steamed fine dried noodles obtained after dry-steaming treatment becomes regular, the spacing between tissues is small, and the distribution of starch grains on the gluten film is uniform. It can be seen that the dry-steaming treatment has a function of improving the tissue structure of dried noodles, and this is consistent with the test data and the result of sensory evaluation of the texture index and cooking loss rate. The fine dried noodles are cut off, paper-packaged or plastic-packaged as required after dry-steaming treatment. Embodiment 2 [0041] In step (1) of the present invention, the raw material is composite powder of wheat flour and fruit and vegetable grains, wherein the wheat flour accounts for 92%, while the fruit and vegetable grains (sorghum flour) account for 8%. [0042] In step (2) of the present invention, the temperature is raised to 70° C. and then kept for 24 h, and the relative humidity is kept at 75%. [0043] By detecting the dry-steamed fine dried noodles, the moisture content of the dry-steamed fine dried noodles is 12.0%, the maximum load in the texture index is improved by 79.5% in comparison with the control noodles, the gluten network structure tends to be compact, the cooking loss rate is reduced by 1.1% in comparison with the control noodles, and the remaining is the same as those in embodiment 1. Embodiment 3 [0044] In step (1) of the present invention, the raw material is composite powder of wheat flour and fruit and vegetable grains, wherein the wheat flour accounts for 95%, the vegetable powder accounts for 2%, and the soybean meal accounts for 3%. [0045] In step (2) of the present invention, the temperature is raised to 75° C. and then kept for 6.5 h, and the relative humidity is kept at 78%. [0046] After the end of dry-steaming, the fine dried noodles are cooled to room temperature, wherein the cooling rate is 25° C./h and the relative humidity is kept at 75% in this embodiment. [0047] By detecting the dry-steamed fine dried noodles, the moisture content of the dry-steamed fine dried noodles is 12%, the maximum load in the texture index is improved by 34.9% in comparison with the control noodles, the gluten network structure tends to be compact, the cooking loss rate is reduced by 0.5% in comparison with the control noodles, and the remaining is the same as those in embodiment 1. Embodiment 4 [0048] In step (1) of the present invention, the raw material is composite powder of wheat flour and fruit and vegetable grains, wherein the wheat flour accounts for 92%, and the fruit and vegetable grains (buckwheat flour) account for 8%. The fine dried noodles are products after being dried, cut off and packaged with paper shrink films. [0049] In step (2) of the present invention, the temperature is raised to 80° C. and then kept for 24 h, and the relative humidity is kept at 80%. [0050] In the present invention, to enable the fine dried noodles to be heated uniformly and ensure the consistence of the quality of the fine dried noodles, the fine dried noodles are placed uniformly in the dry-steaming device. [0051] After the end of dry-steaming, the fine dried noodles are cooled to room temperature, wherein the cooling rate is 15° C./h and the relative humidity is kept at 70% in this embodiment. [0052] By detecting the dry-steamed fine dried noodles, the moisture content of the dry-steamed fine dried noodles is 11.8%, the maximum load in the texture index is improved by 21.3% in comparison with the control noodles, the gluten network structure tends to be compact, the cooking loss rate is reduced by 0.8% in comparison with the control noodles, and the remaining is the same as those in embodiment 1. Embodiment 5 [0053] In step (1) of the present invention, the raw material is composite powder of wheat flour and fruit and vegetable grains, wherein the wheat flour accounts for 95%, and the fruit and vegetable grains (green bean powder) account for 5%. The fine dried noodles are products after being dried, cut off and packaged with plastic packages. [0054] In step (2) of the present invention, the temperature is raised to 50° C. and then kept for 100 h, and the relative humidity is kept at 60%. [0055] After the end of dry-steaming, the fine dried noodles are cooled to room temperature, wherein the cooling rate is 10° C./h and the relative humidity is kept at 60% in this embodiment. [0056] By detecting the dry-steamed fine dried noodles, the moisture content of the dry-steamed fine dried noodles is 12.0%, the maximum load in the texture index is improved by 15.3% in comparison with the control noodles, the gluten network structure tends to be compact, the cooking loss rate is reduced by 0.5% in comparison with the control noodles, and the remaining is the same as those in embodiment 1 and embodiment 4. Embodiment 6 [0057] In step (1) of the present invention, the fine dried noodles are cut off and packaged in bulk after being dried. [0058] In step (2) of the present invention, the temperature is raised to 75° C. and then kept for 30 h, and the relative humidity is kept at 80%. [0059] After the end of dry-steaming, the fine dried noodles are cooled to room temperature, wherein the cooling rate is 2° C./h and the relative humidity is kept at 80% in this embodiment. [0060] By detecting the dry-steamed fine dried noodles, the moisture content of the dry-steamed fine dried noodles is 12.5%, the maximum load in the texture index is improved by 35.3% in comparison with the control noodles, the gluten network structure tends to be compact, the cooking loss rate is reduced by 1.0% in comparison with the control noodles, the fine dried noodles are paper-packaged or plastic-packaged as required after dry-steamed, and the remaining is the same as those of embodiment 1 and embodiment 4. Embodiment 7 [0061] In step (1) of the present invention, the fine dried noodles are cut off and packaged in bulk after being dried. [0062] To improve production efficiency, in step (2) of the present invention, the heating and dry-steaming method is heating the fine dried noodles by microwaves. The fine dried noodles are heated to 50° C.-80° C. (70° C. in this embodiment) and then kept for 1 h-35 h (1 h in this embodiment), and the relative humidity is kept at 60%-80% (75% in this embodiment). [0063] After the end of dry-steaming, the fine dried noodles are cooled to room temperature, wherein the cooling rate is 2° C./h and the relative humidity is kept at 75% in this embodiment. [0064] By detecting the dry-steamed fine dried noodles, the moisture content of the dry-steamed fine dried noodles is 12.0%, the maximum load in the texture index is improved by 23.7% in comparison with the control noodles, the gluten network structure tends to be compact, the cooking loss rate is reduced by 0.7% in comparison with the control noodles, the fine dried noodles are paper-packaged or plastic-packaged as required after dry-steamed, and the remaining is the same as those of embodiment 1 and embodiment 4. Embodiment 8 [0065] In step (1) of the present invention, the fine dried noodles are packaged in bulk after being dried and cut off. [0066] To improve production efficiency and reduce cost, in step (2) of the present invention, the fine dried noodles are heated to 50° C.-80° C. (50° C. in this embodiment) at first, then fed into a dry-steaming device at 50° C.-80° C. (50° C. in this embodiment) and kept for 1 h-35 h (35 h in this embodiment), and the relative humidity is kept at 60%-80% (60% in this embodiment). [0067] After the end of dry-steaming, the fine dried noodles are cooled to room temperature, wherein the cooling rate is 2° C./h and the relative humidity is kept at 70% in this embodiment. [0068] By detecting the dry-steamed fine dried noodles, the moisture content of the dry-steamed fine dried noodles is 12.0%, the maximum load in the texture index is improved by 15.4% in comparison with the control noodles, the gluten network structure tends to be compact, the cooking loss rate is reduced by 0.6% in comparison with the control noodles, the fine dried noodles are paper-packaged or plastic-packaged as required after dry-steamed, and the remaining is the same as those of embodiment 1 and embodiment 4.

The present invention discloses dry-steamed fine dried noodles. The dry-steamed fine dried noodles with a moisture content of less than or equal to 14.5% are prepared via the processes of dry-steaming, cooling and tempering by using fine dried noodles with a moisture content of 10%-16% as raw material. Compared with the control noodles, the maximum load of the dry-steamed fine dried noodles is improved by 10%-200%, and the cooking loss rate is reduced by 0.5%-1.5%. The dry-steamed fine dried noodles have good taste, boiling fastness, long shelf life, and good edible quality and cooking performance. By performing high temperature dry-steaming treatment on the prepared fine dried noodles, the present invention improves the quality of the fine dried noodles and particularly improves the hardness and toughness of the fine dried noodles while achieving sterilization and anti-insect effects, thus improving the quality guarantee period of the product, and avoiding the occurrence of quality problems such as noodle rupture and poor taste during direct high temperature drying.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of U.S. Provisional Application No. 61/896,381 filed on Oct. 28, 2013. The above identified patent application is herein incorporated by reference in its entirety to provide continuity of disclosure. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to footwear covers. More specifically, it relates to a decorative cover for boots, having optional adornments and multiple styling configurations. The cover is ideally suited for use with boots that have aesthetic damage, or are out of style. [0004] Fashion trends change with every passing season. So to does the style of footwear that is en vogue. One season, a knee high colored patent leather boots may be “all the rage”, while the next season brings with it gladiator style sandals with wedge heels. The rapidity with which trends change makes them difficult to follow and even harder to afford. Acquiring the latest and greatest footwear each season can cost hundreds if not thousands of dollars each season. Many a pocketbook, and a relationship, has been strained over the desire to have fashionable footwear at all times. [0005] In some seasons, the difference between fashion styles is subtle. A pair of boots that were fashionable last season may be essentially the same as a pair of boots that are fashionable this season, except that they lack fur trim. For many people it is difficult to justify the purchase of the newer pair of shoes if last season's fashion is already owned. People who regularly purchase new shoes to keep up with changing fashions may find themselves owning several pairs of nearly identical shoes. [0006] A shoe modification system is needed that enables users to update the appearance of footwear. The present invention solves this problem by providing a means for adding adornment to a pair of shoes. In this way, it helps users keep up with the latest footwear fashion trends while saving money. [0007] 2. Description of the Prior Art [0008] Devices have been disclosed in the prior art that relate to footwear coverings. These include devices that have been patented and published in patent application publications. These devices generally relate to protective coverings for footwear. The following is a list of devices deemed most relevant to the present disclosure, which are herein described for the purposes of highlighting and differentiating the unique aspects of the present invention, and further highlighting the drawbacks existing in the prior art. [0009] Coh, U.S. Pat. No. 5,501,022 discloses a tubular boot covering. The boot covering is a tube of material that slides down over the calf portion of the boot, covering the boot from top to ankle. Although Cohn discloses the use of several styles of tube and a variety of materials, it does not disclose additional panels, and removable elements. In this way the present invention is superior to the Cohn device because it provides users with a high degree of customization. A similar device is disclosed by Tweedie, U.S. Pat. No. 1,153,977. The Tweedie device is another boot cover and features lace façade on the front to provide the appearance of being a part of the boot. A portion of the lower edge of the boot cover may secure around the boot sole to keep the device in position during use. The Tweedie invention suffers from the same drawbacks as the Cohn device. [0010] A variation on the tubular boot covering is disclosed in Datson, U.S. Pat. No. 4,856,207. The boot covering is a protective device that reduces damage to boots during use. The device is tubular with a series of button snaps aligned in a vertical column. The snaps enable easy application and removal of the device. Datson does not disclose the use of any trim panels, additional straps, or hanging adornments. [0011] Other patents disclose single boot adornment elements. Castle, U.S. patent application publication no. 2012/0174442 discloses a clip for the upper edges f calf length boots. The clip is shaped like a bangle style bracelet. It is a solid circlet with a break in the loop at one portion. The loop can be pried apart at the break to enable insertion of the boot upper edge. The clip is then secured onto the upper edge of the boot, forming a decorative edge trim once in place. Paraszczak, U.S. patent application publication no. 8353117 teaches another edge trim decoration for a boot. The device is a strap, with a monogram plate that slides over the strap. The monogram plate can be switched out for different letters and symbols so that users can customize the displayed letters. Once the desired monogram plate(s) is affixed, the strap is buckle around the top of a boot. Unlike the present invention, these devices do not cover any portion of the calf of the boot, nor does it offer decorative elements around the ankle region. [0012] These prior art devices have several known drawbacks. None of these devices teaches a plurality of elements that can be assembled in a customizable configuration to form a decorative and protective boot cover. The present invention incldes a number of structural elements that are combined to form a boot cover with the appearance desired by the user. It substantially diverges in design elements from the prior art and consequently it is clear that there is a need in the art for an improvement to existing footwear covering devices. In this regard the instant invention substantially fulfills these needs. SUMMARY OF THE INVENTION [0013] In view of the foregoing disadvantages inherent in the known types of footwear modification devices now present in the prior art, the present invention provides a new customizable foot cover wherein the same can be utilized for providing convenience for the user when updating the look of shoes and boots [0014] It is therefore an object of the present invention to provide a new and improved customizable footwear covering device that has all of the advantages of the prior art and none of the disadvantages. [0015] It is another object of the present invention to provide a footwear cover that can be adorned with a selection of optional elements. [0016] Another object of the present invention is to provide a foot cover that removably secures to a pair of boots, covering blemishes, scratches, and imperfections that would otherwise deter the user from wearing the shoes. [0017] Yet another object of the present invention is to provide the user with a cheap and efficient way to update the look of a pair of shoes. [0018] Still another object of the present invention is to provide footwear covering that can protect the exterior of a pair of shoes or boots. [0019] A further object of the present invention is to provide a modifiable and customizable footwear covering that enables users to express personal creativity in designing the look of their shoes. [0020] A Still further object of the present invention is to provide footwear covering that may be readily fabricated from materials that permit relative economy and are commensurate with durability. [0021] Other objects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTIONS OF THE DRAWINGS [0022] Although the characteristic features of this invention will be particularly pointed out in the claims, the invention itself and manner in which it may be made and used may be better understood after a review of the following description, taken in connection with the accompanying drawings wherein like numeral annotations are provided throughout. [0023] FIG. 1 shows an overhead view of an exemplary implementation of the unassembled parts of the modifiable footwear covering device. [0024] FIG. 2 shows a perspective view of an exemplary configuration of the footwear covering decorative elements, in use. The footwear covering is wrapped around the calf portion of a knee-high boot. [0025] FIG. 3 shows a perspective view of the modifiable footwear covering being applied to the calf region of a boot. DETAILED DESCRIPTION OF THE INVENTION [0026] Reference is made herein to the attached drawings. Like reference numerals are used throughout the drawings to depict like or similar elements of the modifiable footwear covering. For the purposes of presenting a brief and clear description of the present invention, the preferred embodiment will be discussed as used for customizing the appearance of a shoe or boot. The figures are intended for representative purposes only and should not be considered to be limiting in any respect. [0027] Referring now to FIG. 1 , there is shown an exemplary implementation of the footwear covering device with its individual elements separated. The footwear covering 100 has a base panel 110 , trim panel 120 , adornment straps 130 , and hanging adornments 150 , 151 . These components may be arranged in a variety of combinations to create unique designs, as well as to add or remove functionality. By way of example, the addition of fur trim to the footwear covering may increase insulation of a user's upper calf, an advantageous feature during cold weather. Users can easily add or remove design elements from the base panel. As styles and trends change, a user can add new fashion elements and remove those that have become outdated. [0028] The base panel 110 is configured to wrap around the calf, ankle, and upper foot region of the wearer, whereby the base panel comprises side edges that fasten together. A zip fastener line of connection secures the side edges to one another, forming a substantially cylindrical shape for the wearer's leg to reside. The upper edge 111 of the base panel further comprises a fastener 111 thereon, which is used to secure the trim panel 120 thereto. The fastener 111 preferably comprises a strip of hook and loop fastening, however alternate fasteners are contemplated. [0029] One example of the assembled device in use is shown in FIG. 2 . The footwear covering 100 is removably secured over a footwear article. A trim panel 120 of faux fur is removably secured to the upper edge of the base panel 110 . This creates the appearance of a fur trim extending from the top of the boot. Trim panels 120 are attached via the upper fastener (e.g. hook and loop fasteners, buttons, snaps, or the like), and disposed along an upper edge of the base panel 110 , and on the inner or outer face thereof. Complimentary fasteners along the trim panel secure the trim panel 120 to the base panel 110 . Each hanging adornment has an attachment loop 151 disposed at one end and a distal end 130 . The loop is secured by the trim panel 120 , which is disposed through the attachment loop 151 of the hanging adornment. In this way, a hanging adornment can be incorporated into the footwear covering. In other embodiments, the hanging adornment may snap or otherwise fastener directly to the base panel 110 . [0030] An adornment strap 130 may also be affixed around the lower edge of the base panel 110 of the device 100 . The adornment straps have an adjustable length, whereby a buckle is disposed at one end of the strap 130 . The strap 130 is buckled around the ankle area, to create an aesthetically pleasing mask for the lower edge of the footwear covering. In some embodiments, the lower edge of the base panel may have snaps, hook and loop fasteners, or other fastening means that mate with corresponding fasteners disposed along all or part of the rear face of the adornment straps. Thus, the adornment strap 130 can be secured to a portion of the base panel 110 directly. This embodiment reduces shifting of the adornment straps 130 when in use, and provides a better mask for the base panel lower edge. [0031] Assembled, the footwear covering device provides the appearance of being a part of the underlying footwear 200 . In the example illustrated in FIG. 3 , the Base panel 110 covers the upper portion of a knee-high boot, including the area from the upper edge of the boot down to the user's ankle. The side edges of the base panel zip fasten together, encircling the upper portion of the boot. Once positioned, the footwear covering provides an aesthetically pleasing protective covering for the footwear, hiding any visible damage to the boot and reducing the likelihood that further damage will occur. [0032] In some embodiments, the base panel 110 is a rectangular panel of material bounded by an upper edge, a lower edge, and opposing side edges. Dimensions of the base panel will vary depending upon the type of shoe the foot cover will be used to cover. Taller shoes like boots will require larger base panels than ankle booties. A zipper, hook and eyelet closure, or similar closure means is disposed along the two side edges, each side edge having half of a mating portion of the closure means. Depicted in the figures are vertical zipper halves disposed along the length of edge side edge, the zipper halves combining in use to form a line of securement. The interior surface of the base panel may be lined or unlined depending upon the need to protect the underlying shoe from the base panel. Base panels constructed of abrasive fabrics may need to be lined to protect the underling boot. [0033] Trim panels 120 are rectangular panels having a width equal to or greater than that of the base panel 110 . Vertical height of the trim panels is significantly less than that of the base panel, as the trim panels are intended to cover only a portion near the upper edge of the base panel when in use. Each trim panel may be constructed of, or covered in a different material. One trim panel may be made of a faux fur fabric, while another is a panel of material covered in sequins. Still another panel may be plain, and made of the same material as the base panel, but in a contrasting color or pattern. The rear surface of each trim panel has a strip of hook and loop fastener or other fastening means disposed thereon, This hook and loop fastener mates with hook and loop fastener disposed along a portion of the upper edge of the base panel. The base panel hook and loop fastener may be disposed along the front face, rear face, or both. In this manner, trim panels can easily be applied and removed, giving the base panel a different appearance with each application. [0034] Adornment straps 130 are straps with buckles or snaps disposed at one end. Each strap is sized to wrap around the boot cover when in use. A variety of different types of decorations may adorn the straps. Conchos, gemstones, glitter, embossing, and other forms of decoration may be applied to the adornment straps. When these straps are fastened around the footwear covering, the overall design of the device is changed. Users may have a number of adornment straps and may switch them out for different occasions. Adornment hangers 150 are short strips of material with a securable loop at one end and one or more adornments disposed thereon. The loop is secured by the trim panels 120 or are fastened directly to the base panel, such that the adornment hanger hangs down the side of the footwear covering in use. Tassels, conchos, chain links, and the like may be used as adornment hangers, to create an attractive, dangling feature. [0035] The footwear covering device may be made form a variety of materials. Because some users may desire for the footwear covering to look like it is part of the underlying shoe, the covering may be offered in many different shades and finishes of leather. In some embodiments, the support and adornment straps are constructed of the same material as the base panel. In other embodiments, the support and adornment straps are made of contrasting leather. [0036] The present invention is a footwear covering that encircles the wear's ankle and calf regions when in use. The appearance of the footwear covering is customizable via trim panels, adornment straps, and adornment hangers. Users can modify the footwear covering as desired and place it over damaged boots to cover up deep scratches, water damage or the like. The footwear covering can also be used to update the look of older footwear. By way of illustration, boots that are several years old but in good condition may be covered with the footwear covering and adorned with rhinestones, or other fashionable embellishments. [0037] It is therefore submitted that the instant invention has been shown and described in what is considered to be the most practical and preferred embodiments. It is recognized, however, that departures may be made within the scope of the invention and that obvious modifications will occur to a person skilled in the art. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. [0038] Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Provided is footwear covering device that covers the calf and ankle region of a piece of footwear. The device has a base panel that is modifiable with trim panels, adornment straps, and adornment hangers. Trim panels may have glitter, velvet, faux fur or other material suitable for adding accent to the upper edge of a boot. The trim is removably secured to the top of the footwear covering and thus appears as edge trim for the underlying footwear when in use. Adornment straps and hangers having decorative embellishments are wrapped around the footwear covering, or allowed to hang downward form an upper edge. Thus, each user can customize the overall appearance of the footwear covering to his or her liking. The covering can be placed over old or damaged footwear to provide a fresh new appearance that protects the underlying footwear from damage.

TECHNICAL FIELD This invention relates to closed container systems for transporting and dispensing liquid chemicals, and more particularly to systems for storing, transporting and transferring toxic agrichemicals to holding tanks and to spray applicators mounted in aircraft. BACKGROUND OF THE INVENTION Because of the need to eliminate the hazards associated with the application of toxic chemicals such as pesticides and herbicides, chemical industry in general and the agricultural chemicals industry in particular have developed closed systems for shipping, transferring and applying chemicals. Typical of agrichemical systems are those described in U.S. Pat. Nos. 3,976,087 to Bolton et al. and 4,254,805 to Reeder. In these systems liquid chemical from a closed feed tank is delivered by vacuum to a holding tank for mixing or diluting or for measurement of desired volumes, the chemical then being transferred by suitable lines to spray applicator apparatus in aircraft. As shown in the Reeder patent, chemical concentrate in a supply tank is transferred by vacuum through a probe having its tip disposed below the surface of the liquid chemical to a plurality of holding tanks wherein the chemical is appropriately diluted with water for subsequent delivery to spraying apparatus such as may be contained in aircraft. The line from the probe has a conventional "quick connect-disconnect" fitting for convenience in securing the probe line to a movable chassis, upon which are mounted the various holding tanks and lines. The chassis provides convenience in moving the mixing system into position for operation. Fluid measuring circuits have been devised for use in mixing measured quantities of toxic chemicals supplied from "point-of-sale" containers. In U.S. Pat. No. 3,913,606 to Andersen, for example, a supply container is provided with a ported cover effecting a fluid-tight seal between the container and a conduit to a hermetically sealed holding tank, the tank having a sight gauge to indicate the level of toxic liquid within the tank. A flush valve and conduit connected to the bottom of the tank permits discharge through a conduit to associated tanks for mixing and/or dilution, preliminary to delivery to a spray apparatus. The connections to the supply tank include a bleeder valve for entry of atmospheric pressure into the container as and when desired. A preferred form of valve includes a ball float. The cover of the chemical supply tank is provided with a sleeve around a probe tube for fluidtight coupling of the probe tube conduit between the supply container and the holding tank. Despite advances in closed container chemical applicator systems, including apparatus and valving design as described, for example, in the foregoing patents and U.S. Pat. Nos. 3,640,319 to Hougen and 3,916,924 to McGowen, considerable risk has persisted due, in part, to use of disposable chemical supply containers or containers designed for cleaning and refill at the application site. Such container and applicator systems, even when intended for closed system use in accordance with governmental regulations, in reality have not satisfied the needs of industry. SUMMARY OF THE INVENTION It has now been found that by designing the fitting of a liquid chemical container as a single unit in the manner of the invention, chemicals can be supplied in heavy duty, returnable containers without need for cleaning and refilling by the customer at an application site and with complete avoidance of the hazards associated with disposable containers. By use of the container fitting of the invention, a chemical may be delivered to an application site in a closed, sealed condition and transferred directly to applicator apparatus such as may be mounted in an aircraft, or into an interim holding or measuring tank prior to transfer into the spray apparatus, all without operator contact with the chemical. Upon emptying of the supply container, the container is returned to the distributor where, under carefully controlled conditions, the container is cleansed, if required, and refilled. In one aspect of the invention, there is provided a fitting for a container of liquid chemical which combines, in a restricted space in the lid of the container, a tubular support member having an open end sealingly mounted in the lid of the container, a closure plate in the opposing end of the tubular support member, a liquid chemical dispensing tube sealingly mounted in the closure plate and extending axially in the tubular support member for contact with liquid chemical in the container, the upper end of the dispensing tube being capped with coupling means for connection to a liquid transfer line, and a vent tube assembly sealingly mounted adjacent the dispensing tube in the closure plate and having a pressure release or pressurization valve which is removable for filling the container with liquid chemical. In another aspect of the invention the fitting is combined with a suitable container and provides significant advantages in safety (less contamination risk because the fitting eliminates the need for other openings in the container, resulting in more restricted and controlled use of the containers), security (less opportunity and motivation for tampering), convenience (all necessary elements of the fitting are mounted in a small, restricted space, thus contributing to handling ease), and acceptable cost (high quality, returnable containers may now be used, eliminating the hazards and expense of cleaning and/or refill by the customer). The foregoing and other aspects, features and advantages of the invention will be apparent from the description which follows. DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 is a schematic view of a closed container system incorporating a liquid chemical container and fitting of the invention; FIG. 2 is a vertical, partially sectioned view of the major portions of one embodiment of a fitting of the invention shown mounted in the lid of a container; and FIGS. 3 and 4 are views similar to FIG. 2 showing other embodiments of fittings of the invention. DETAILED DESCRIPTION With reference to FIG. 1, a typical closed container liquid chemical application system 10 is illustrated. In this system, a high quality, durable container such as a drum 12 formed of stainless steel, optionally glass-lined or enclosing a plastic bottle, supplies chemical to a measuring chamber 14 in response to suction applied by a pump 16 via line 18. The liquid chemical is transferred from drum 12 to chamber 14 through a line 20 and a fitting 22 of the invention. Other components of this typical system include a transfer line 24 to spray applicator apparatus (not shown), suitable control valves 26 and 28 (which may incorporate ball check systems or similar devices for preventing reversed flow of chemical), a vent valve 30 on chamber 14 for restoration of atmospheric pressure as needed, a sight glass 32 mounted vertically on the side of chamber 14 for determining the level of liquid in the chamber, and a housing 34 on the chamber 14 for a float or similar valve for controlling the vacuum and preventing overflow of liquid into the pump 16. Except for the fitting 22 and the combination thereof with a closed container as represented by drum 12, the components of the closed container system illustrated are conventional and readily available. Optionally, the drum 12 may be a pressurized container, thus eliminating need for pump 16 (except to the extent that the pump may be useful for flushing the chamber 14 and lines 20 and 22 after disconnecting drum 12). For pressurization, an air fitting will be inserted into a wall or the lid of the drum, or the air fitting may be a part of the vent tube assembly described below. One embodiment of a fitting of the invention is shown in FIG. 2. With reference thereto, the fitting 36 includes a tubular support member here shown in two portions, an upper portion 38a and a lower portion 38b. Portion 38b is threaded on the periphery of its lower, open end for sealing engagement with a correspondingly threaded flange 40 of the container lid 42 of a drum (not shown). Portions 38a and 38b are joined by a weld ferule 39 but they can also be formed integral with one another to constitute a single member. The upper end of the tubular support member 38a may be threaded, as shown, for engagement with a correspondingly threaded tubular cap 44. Cap 44 optionally is provided with a threaded plug 46 for access to the fitting without removing the lower portion of cap 44, for example for inspection or for coupling of a line 20 in a manner to be described. A cover plate 48 is mounted in the upper, opposing end of tubular support member 38a and, as shown, is welded in place by a weld ferule 50. However, the cover plate may also be mounted by threading or other suitable means or may be formed integral with tubular member 38a. Mounted axially (concentrically or eccentrically) within the tubular support members 38a and 38b is a dispensing tube 52 shown with a threaded coupler 54 (the coupler optionally containing a check valve, not shown) and a lower extension tube 56 having a length sufficient to maintain its open end below the surface of a liquid chemical in a closed container such as drum 12 of FIG. 1. The upper end of tube 52 is threaded to receive a coupler 58 for connection with a threaded neck member 60 which is received in an opening in cover plate 48 and sealingly affixed therein as by weld ferule 62. A hydraulic coupler assembly 64 is threaded on the neck 60 and includes a crown 66 in which is mounted a spring-loaded ball 68, thus defining the male portion of a conventional "quick coupler" for connection with the female portion of a quick coupler on conduit 20 as schematically indicated in FIG. 1. Equivalent couplers may be substituted for those shown. These include "Pioneer" or "Aeroquip" brand nipple-type couplers and "Emco Wheaton" (J1302/J1401) or "OPW" (1611-A/1711-D) brand dry break-type couplers. Affixed adjacent to neck 60 in cover plate 48, as by a weld 69, is a vent tube assembly 70 which includes a tubular lower member 71, a lock nut 72 and a vacuum breaker head 74 threaded into nut 72. Tubular member 71 has an interior chamber 75 (shown in outline) of any suitable configuration for passage of air or liquid through assembly 70, optionally filtered by a filter screen 76. The assembly 70 has several functions. The first is to provide good seal of the total fitting 36 during removal of liquid chemical under suction or pressure from a container having a lid 42 via the dispensing tube 52 and its extensions. The assembly also permits venting of the container and filling after transfer of liquid chemical. Finally, one or both of elements 72 and 74 may be unscrewed to provide a port through member 71 for refill of the container or for other purposes such as insertion of a dip stick for measuring the amount of chemical remaining in the container, all without removing the total fitting 36 from the container. Of course, for good cleaning of the container or for quicker refill, it will usually be desirable to unscrew the entire fitting 36 from flange 40 on lid 42. The vent tube assembly may also include an air fitting valve (not shown), as a replacement for the vacuum breaker head 74, for pressurization of drum 12 if the chemical is to be transferred under pressure. For additional efficiency and convenience, other embodiments of the fitting are illustrated in FIGS. 3 and 4 wherein the elements, parts and features are the same as in FIG. 2 except as follows. The embodiment of fitting 80 shown in FIG. 3 includes a tubular support member having an upper portion 82a and a lower portion 82b but further including a still lower, separate section 82c threadably engagable with the flange 40 of container lid 42. The two portions 82a and 82b are shown affixed together by a weld ferule 84 but the two portions can also be formed integrally as a single section, if desired. Sections 82b and 82c of the tubular support member are sealingly connected together by means of a gasket 86 and clamping means such as a conventional circular clamp 90 of which the so-called "tri-clamp" is representative. Preferably the gasket 86 will be formed of a resilient, chemical resistant rubber such as Buna-N rubber or commercially available Viton® fluoroelastomer or Teflon® fluorocarbon materials. Still another embodiment 92 of a conveniently removable fitting of the invention is shown in FIG. 4. Here, the tubular support member of the fitting has the same configuration as in FIG. 3 except that the lower section 82d of the support member is affixed to the lid 42 as by weld ferule 88 rather than threadably engaged as in FIG. 3. This embodiment, while reducing the modes of access to the container, nevertheless improves safety because it eliminates one source of possible loose connection between the fitting and the lid 42 of the container. The various components of the fittings 36, 80 and 92 may be formed of any suitable materials depending on the type of liquid chemical and pressure/temperature requirements. For durability, metals such as stainless steel, brass and galvanized steel are preferred, including combinations thereof, but plastics can be used in some cases. Also, auxiliary gaskets and O-rings can be used for improved sealing as required. In use and operation as a vacuum system, with reference to FIGS. 1 and 2, valve 26 of the measuring chamber and the vent tube assembly 70 are closed. Line 20 is connected between the coupler assembly 64 and control valve 28, and suction line 18 from pump 16 is connected to the housing 34 on the top of chamber 14. With valve 30 closed and valve 28 open, suction is applied and chemical is drawn from drum 12 to a height in chamber 14 determined from sight glass 32. Valve 28 and the valve in housing 34 are closed and the vacuum pump stopped. Valve 30 is then opened to restore atmospheric pressure to chamber 14 and valve 24 is opened to transfer a measured amount of chemical to a spray applicator or to a holding tank therefor. When drum 12 is empty, line 20 is disconnected and drum 12 is returned to a distribution point for refill. As thus conceived and constructed, the various embodiments of the fitting eminently satisfy the objectives of safety, security, convenience and acceptable cost. In particular, the combination of a quick coupler and vent pressure tube--liquid chemical access assembly into a single unit engagable in a single opening in a liquid chemical container eliminates or reduces the possibility of contamination or hazardous contact that sometimes occurs with chemical containers of the more conventional design, usually having a fitting for dispensing the chemical and one or more other openings for refill and/or cleaning. By reducing the openings in the container to a single opening represented by the aperture in the container lid in which the fitting of the invention seats or is mounted, by controlling access to the fitting by a protective cap (such as cap 44 of FIG. 2), and optionally by use of a seal (such as a lead seal), a closed container is provided the use of which can be carefully monitored from the point of filling and shipping to the site of application, and then back to the source for refill and/or cleaning as required. Thus the customer can be assured of substantially reduced risk of operator contact with the chemical, and governmental regulations concerning closed container systems for transfer of liquid chemicals are more efficiently and economically satisfied. While the invention has been illustrated and described in what are considered to be the most practical and preferred embodiments, it will be recognized that many variations are possible and come within the scope and spirit thereof, the appended claims therefor being entitled to a full range of equivalents.

The use of liquid chemical containers in closed chemical applicator systems is made more secure, safe, convenient and cost effective by a fitting which combines a quick connect-disconnect coupler and a vent/fill tube in a single, protected assembly. The fitting eliminates the need for other openings in the containers and renders the containers returnable to distribution points for refill and/or cleaning, thereby avoiding operator contact with the chemical during transfer and minimizing unauthorized access.

BACKGROUND OF THE INVENTION [0001] There are several varieties of lighted toys that hold candies or other consumable substances. However, these toys do not allow the user to wear the toy on their finger like a ring while the consumable is lighted. Further, such toys are often large and complex and therefore may be expensive to manufacture. SUMMARY OF THE INVENTION [0002] The present invention relates to a lighted ring toy that entertains the user while a consumable supported by the toy is consumed. The user activates the lighting feature of the toy by removing a circuit-interrupting insulator. Once the insulator is removed and the circuit is closed, a power source causes a light located inside a housing to illuminate the consumable for a period of time required for the user to consume at least a portion of the consumable. The device is simple and inexpensive to manufacture. [0003] In one embodiment, the lighted ring toy of the invention has: a housing containing a power source and an electrical circuit, the housing having an upwardly extending portion for supporting a consumable portion; a finger-grasping portion extending from the housing for engagement with the finger of a user; and an illuminating element connectable to the electrical circuit and the power source to illuminate the consumable portion. In a particular embodiment, the electrical circuit may have at least one electrical contact for completing the circuit in a contacting position thereof, and the ring toy may further comprise a removable insulator disposed adjacent the electrical contact in a non-contacting position to interrupt the electrical circuit. The power source may be configured to illuminate the consumable portion for a preselected period of time sufficient to consume it, and thereafter to expire. BRIEF DESCRIPTION OF THE DRAWINGS [0004] The invention may be more readily understood from the following specification and by reference to the accompanying drawings forming a part thereof, wherein an example of the invention is shown and in which: [0005] FIG. 1 is an elevational view of a lighted ring toy according to an embodiment of the present invention; [0006] FIG. 2 is an exploded perspective view of the toy of FIG. 1 ; [0007] FIG. 3 is a vertical cross-sectional view of the toy taken along the line 3 - 3 of FIG. 1 , showing one possible internal configuration; [0008] FIG. 4 is an internal view of the toy as seen in the direction 4 - 4 of FIG. 3 , with the top portion of the housing, the batteries, and the insulator removed; [0009] FIG. 5 is a schematic of the electrical circuit of the toy of FIG. 1 in the illustrated embodiment of the invention utilizing a flashing light emitting diode (LED); [0010] FIG. 6 is a schematic of a configuration of the electrical circuit of the invention in another embodiment of the invention utilizing a non-flashing LED and a separate flasher circuit; and [0011] FIGS. 7A-7F illustrate alternative possible designs of the consumable mountable on the lighted ring of the invention. DETAILED DESCRIPTION OF THE INVENTION [0012] Referring now to the drawings, FIGS. 1, 2 and 3 illustrate a lighted ring toy 10 according to one embodiment of the invention. The ring toy 10 is constructed to be worn as a ring, rather than grasped by the user's hand, and includes a consumable 12 illuminated by a battery-powered light source 14 ( FIG. 2 ). In the illustrated embodiment, the light source 14 is contained within a ring-shaped housing 16 upon which the consumable 12 is mounted. The housing 16 contains an electrical circuit 18 and a power source 20 which cause the illumination effect to occur. The housing 16 has an opening 22 ( FIG. 3 ) through which a removable insulator 24 passes to interrupt the electrical circuit 18 . Removal of the insulator 24 allows the electrical circuit 18 to be completed, creating the illumination effect of the toy and thereby amusing a user during consumption of the consumable 12 . [0013] The consumable 12 mounted on the toy can be sucker candy, gummy candy, or any other food product through which illumination of the light source 14 can be seen to amuse the user. It can also have a wide variety of shapes and colors intended to amuse the user when it is illuminated. A few examples of the shapes for the consumable 12 are illustrated in FIGS. 7A through 7F and identified by the numerals 12 A through 12 F respectively. [0014] The consumable 12 has an opening 25 ( FIG. 3 ) that receives an upwardly-extending portion 26 of the housing 16 to hold the consumable 12 in place. The upwardly extending portion 26 preferably has a plurality of inclined ribs 26 ′ on its outer surface with undercut portions 26 ″ to ensure that the consumable 12 remains in place at the housing 16 during consumption. When a resilient material such as gummy candy is used for the consumable 12 , the opening 25 in the consumable may be somewhat smaller in diameter than the portion of the housing to be received within it to enhance friction and thereby retain the candy in place. [0015] The light source 14 can be a light emitting diode (“LED”) or any other suitable device for producing light in response to electrical power from the power source 20 . The light source 14 can be of either the flashing or non-flashing type. [0016] Referring more specifically to FIG. 3 , in the illustrated embodiment the upwardly-extending portion 26 of the housing 16 contains the light source 14 and supports the consumable 12 . While the material of the upwardly-extending portion 26 is limited by the need to transmit at least a portion of the light emanating from the light source to achieve the desired visual effect, the remainder of the housing 16 is not so limited and can be made of any other suitable material. Although the figures show a particular shape for the upwardly-extending portion 26 , alternatively, it can have any other shape suitable for supporting the consumable 12 and housing the light source 14 . [0017] As shown, the housing 16 may be made of two different parts joined together to contain the power source 20 , the electrical circuit 18 , and the light source 14 of the toy 10 . These two parts can be joined together by a snapping structure, by an adhesive, or by any other suitable method. [0018] In the illustrated embodiment, the housing 16 includes a boss 28 at the base of the upwardly-extending portion 26 for supporting the consumable 12 . The boss 28 has a peripheral lip 29 ′ that engages the outer edge of the consumable 12 , giving the combination a pleasing, uniform appearance and effectively supporting the weight of the consumable. In some cases, an interior void 28 ″ is provided adjacent the base of the stem 26 to permit expansion of the candy upon curing. The housing 16 can be shaped in any way that provides sufficient space for the electrical circuit 18 , the power source 20 , and the light source 14 . The embodiment shown in the drawings comprises a form of hexagonal pyramid whose vertex is replaced by the upwardly-extending portion 26 of the housing 16 . This gives the housing an enlarged lateral dimension. [0019] A finger-grasping portion 30 of the embodiment shown in the figures extends from the bottom of the housing 16 . The finger-grasping portion 30 includes a horizontal plate 32 that joins with the remainder of the housing to support the electrical circuit 18 and the power source 20 . A race track shaped abutment 34 extends upward from the horizontal plate 32 to hold in place the power source 20 , represented in the drawings by two button cell batteries. The abutment 34 includes two inward extensions 36 that create a pair of recesses for receiving the button cell batteries, and a narrow gap 37 ( FIGS. 2 and 4 ) along the floor of the plate 32 . [0020] First and second contact portions 38 ″ and 39 ″ are disposed within the recesses directly below the batteries. The first contact portion 38 has an finger 38 ′ which extends through the gap 37 and against a vertical tab 39 ′ of the second contact portion 39 . The two contact portions are also provided with central spring arms 38 ′ and 39 ′, respectively, which urge the batteries upwardly. The finger 38 ′ of the contact portion 38 is configured to contact and press against the tab 39 ′ of the contact portion 39 when the insulator 24 is removed from the opening 22 . [0021] In the embodiment shown in the figures, the button cell batteries are disposed in opposite directions so they are connected in series with each other and with the light source 14 when the contact portion 38 touches the contact portion 39 . To avoid shorting of the battery terminals, a ring 41 of insulating material is disposed underneath the inverted battery along its peripheral edge. The light source 14 is connected to the batteries by leads 42 and 43 , which pass through and are attached to a small circuit board or wiring board 40 for support. The ends of the leads 42 and 43 extend from the bottom of the circuit board where they make electrical contact with opposite poles of the two batteries. The electrical circuit 18 therefore comprises the light source 14 , the power source 20 , the first and second contact portions 38 and 39 , and the leads 42 and 43 . [0022] The board 40 can vary in complexity in different embodiments of the invention. In the embodiment of FIGS. 1-3 , the board 40 merely anchors the leads 42 and 43 and supports the light source 14 . In that case, the schematic of the lighted ring toy 10 can be as illustrated in FIG. 5 . The light source 14 may then be a flashing LED of the type available under the commercial designation MT-F406, which is powered by two series-connected batteries of the type identified commercially as LR 41 button cells. In this embodiment, the LED 14 is connected across the series-connected batteries 20 such that removal of the insulator strip 24 in the direction indicated completes the circuit and causes the LED to flash until the batteries are discharged. [0023] According to the schematic of FIG. 6 , which depicts an alternative embodiment of the invention ( 10 ′),the board 40 may comprise a circuit 45 that provides, in addition to physical support, lighting effects such as flashing of the light source 14 . In this embodiment, the circuit 45 may be an integrated circuit of the type available commercially under the designation A5403-01 which, in the illustrated configuration, intermittently applies the voltage of the batteries 20 across the LED 14 to produce a flashing light effect. In this embodiment, the light source may be a non-flashing LED available commercially under the designation, 3R4SDB-4. [0024] Now, considering the battery circuit in greater detail, the negative terminal of each button cell battery is the discrete circular terminal on one of its ends, and the positive terminal includes the side and bottom surfaces of the battery. One battery is inverted relative to the other, and the central spring arm 38 ″ of the contact portion 38 contacts the negative terminal of the inverted battery while the positive terminal is separated from the contact portion 38 by the insulator ring 41 . In this configuration, the finger 38 ′ of the first contact portion is urged toward the tab 39 ′, which is in contact with the positive terminal of the non-inverted battery but is initially prevented from contacting it by the insulator 24 . Removal of the insulator 24 allows the finger 38 ′ to touch the tab 39 ′, completing the circuit to apply the combined voltages of the two batteries across the leads of the light source 14 . [0025] The contact portions 38 and 39 may be made of copper, steel or other resilient conductive material, causing the finger 38 ′ to press against the insulator 24 with sufficient force to hold it in place while at the same time permitting the insulator to be removed by manually pulling it downwardly from the housing 16 . In one embodiment, the first elongated contact portion 38 is rounded or bent at its point of contact with the insulator 24 so that the insulator 24 can be removed without tearing or becoming jammed in the housing 16 . [0026] The insulator 24 and the insulating ring 41 may each be made of any suitable insulating material, such as coated paper or a sheet of suitable synthetic polymeric material. In one particular embodiment, the material may be the type available commercially under the trademark Mylar. [0027] The preceding description has been presented with reference to presently preferred embodiments of the invention. These should not be construed as limitations on the scope of the invention, but rather as examples of the embodiments thereof. Alterations and changes in the described structure may be practiced without meaningfully departing from the scope and spirit of the invention. [0028] For example, the circuit board 40 may, in its more complex embodiments, take the form of a printed circuit board having discrete electronic components mounted thereon, an integrated circuit, or a hybrid circuit comprising both discrete components and one or more integrated circuits. Accordingly, the scope of the invention should be determined not by the embodiments illustrated, but by the appended claims and their equivalents.

A housing containing a power source and an electrical circuit, the housing having an upwardly extending portion for supporting a consumable portion; a finger-grasping portion extending from the housing for engagement with the finger of a user; and an illuminating element connectable to the electrical circuit and the power source to illuminate the consumable portion.