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BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to a cartridge for applying medicament to an eye from a vial-dispenser of the type which is actuated by compression of the vial between its nozzle and its bottom wall. 2. Description of Related Art There are various dispensers which are known for applying medicament to an eye. A typical eye-drop container includes a flexible vial storage portion and a nozzle for dispensing drops of medicament into the eye by squeezing the vial between its side walls. Less common, but more precise, are accordion-like or piston-like dispensers which are actuated by squeezing the vial between a bottom wall and the nozzle so as to compress the vial in its longitudinal direction, rather than from its sides. It is these accordion-like or piston-like dispensers with which the cartridge of the present invention is particularly adapted for use. An example of a new and improved piston-like dispenser is the subject of my co-pending U.S. application Ser. No. 07/801,243 which is incorporated herein by reference. Most people encounter difficulty in applying drops to their eyes. The eye is a very sensitive body part and individuals find it difficult to control reflexive blinking when applying drops thereto. Also, eye drop users often have poor vision. Poor vision makes it difficult to position the tip of the dropper bottle over the eye and frequently causes drops to be incorrectly applied to the nose or cheek. Additionally, elderly people often have difficulty holding a dropper bottle steady or encounter difficulty in squeezing the bottle to apply a proper quantity of the medicament. Even if the liquid medicament is properly applied to the eye, the medicament's effectiveness is limited. The minimum volume of a drop of liquid medicament which can ordinarily be introduced into contact with an eye at one time is about 30 μl. Any amount which is greater than about 25 μl usually spills over the eyelid onto the cheek since this is the maximum volume which the eye can ordinarily handle. When eye drops are applied to the surface of the eyeball, blinking and natural tear flow combine to limit the time to a few minutes that liquid medicament will remain effective. On the other hand, if medicament is applied to the cul de sac of the conjunctiva, the medicament will remain effective for a longer period of time, maximizing the benefits of applying drops of liquid medicament to the eye. This is because the conjunctiva is an area of low sensitivity and low tear turnover such that blinking and tearing are avoided. However, because of the difficulty encountered in steadying the dropper and accurately positioning it over the conjunctiva, maximizing the effectiveness of the medicament remains elusive. U.S. Pat. No. 4,543,096 describes and illustrates an apparatus having finger-like projections which are attached to the front of an eye drop bottle to spread the eyelids apart during the eye drop dispensing process. One moveable finger is connected to a lever for both depressing the lever and simultaneously causing the eyelids to spread apart while forcing a drop from the dropper bottle. However, the apparatus described in U.S. Pat. No. 4,543,096 cannot be used with the accordion-like or piston-like dispensers which are actuated by compression in the longitudinal direction rather than from the sides. Furthermore, this apparatus will not properly expose the cul de sac. Similarly, U.S. Pat. No. 4,531,944 depicts an apparatus for steadying the tip of a dropper over the eye and further includes a sighting hole to distract the eye. However, this apparatus does not have a means to expose the cul de sac nor keep the lower eyelid depressed. Typical eye-drop dispensers also have the disadvantage that the force which is necessary to actuate the dispenser to emit a drop is not in the same direction as the motion which is necessary to lower the lower eyelid and expose the cul de sac. It would be desirable to have a device which actuates the dispenser with a motion which is in the same direction as that which is necessary to lower the lower eyelid. SUMMARY OF THE INVENTION It is an object of the invention to provide a device which can accurately deliver a small drop of medicament to the conjunctival cul de sac of an eye. It is a further object of the invention to provide such a device which can be used to actuate an accordion-like or piston-like vial-dispenser using minimal force. It is a further object of the invention to provide such a device wherein the motion used to actuate the dispenser to emit a drop is in the same direction as the motion which is necessary to depress the lower eyelid and expose the conjunctival cul de sac. It is a further object of the invention to provide a device having these features which has a simple construction and which is easy to manufacture. The foregoing objects are achieved by the present invention which provides a cartridge which is particularly adapted for actuating an accordion-like or piston-like dispenser-vial. The cartridge includes a generally cylindrical housing which is adapted to receive a dispenser-vial between an anterior wall of the housing and a telescoping cylinder. The anterior wall of the housing has an aperture for allowing the nozzle of the vial to project therefrom. The anterior of the housing is curved with a highly polished and smooth external surface to prevent any corneal injury in the event of accidental contact with the eye. The back of the housing is open and slidably receives the telescoping inner cylinder. When the inner cylinder is pushed toward the anterior of the housing it forces the dispenser-vial to compress in the longitudinal direction between the anterior wall of the housing and the cylinder. In the case of some dispensers which can be used with the invention, compression causes a drop of liquid medicament to enter the drop cavity of the dispenser thereby "loading" the drop cavity. The top of the inner surface of the housing is formed with a notch. The front of the telescoping inner cylinder is formed with a rearwardly and outwardly projecting extension which easily slides past an inclined side of the notch as the cylinder is pushed into the housing to load the drop cavity of the vial. However, the opposite side of the notch is angled to prevent the cylinder extension from sliding past the notch in the opposite direction, thereby locking the cylinder so that the vial is in its loaded position. The housing is formed with a trigger mechanism for unlocking the cylinder. A trigger button is disposed on the top of the housing. Depression of the trigger button forces the extension of the inner cylinder away from the notch allowing the cylinder to move past it. The compressed dispenser-vial forces the inner cylinder rearward. Upon expansion of the dispenser-vial a drop is emitted through the dispenser nozzle. The bottom of the anterior section of the housing is formed with a soft finger which is adapted to engage the lower eyelid. In order to apply a drop, the inner cylinder is pushed into its locked position to load the dispenser-vial. The nozzle projecting from the cartridge is then positioned over the eyeball with the finger pressing on the lower eyelid to expose the conjunctival cul de sac. When the trigger is depressed the resulting motion of the cartridge will be in the sam direction as the motion which causes the finger to lower the lower eyelid and expose the conjunctival cul de sac as a drop is emitted. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a cartridge in accordance with the invention. FIG. 2 is a detailed cross-sectional side view of a cartridge in accordance with the invention containing a dispenser-vial. FIG. 3 is an isolated detailed view of the trigger mechanism of the cartridge of the invention. FIG. 4 is a view of the cartridge from the anterior. DETAILED DESCRIPTION OF THE INVENTION The cartridge of the invention is specially adapted to work in conjunction with an accordion-like or piston-like dispenser-vial. An example of a new and improved piston-like dispenser which can be used in the cartridge of the invention is the subject of my co-pending application Ser. No. 07/801,243 which is incorporated herein by reference, however, the present invention is not limited to use with this particular dispenser. Parts of a dispenser described in application Ser. No. 07/801,243 which are relevant to an understanding of the present invention are illustrated in FIG. 2 and will now be described briefly to facilitate understanding of the cartridge. The dispenser-vial includes a nozzle 2, wings 3, a bellows portion 4, wings 6 and a rear vial section 8 containing a storage supply of liquid medicament. The dispenser is compressible in the longitudinal direction between its posterior wall 10 and the anterior nozzle 2. For this purpose, the bellows portion 4 is constructed of a soft flexible plastic material such as the thermoplastic resin sold under the name Kraton from the Shell Company. Resiliency of the dispenser can be provided by the spring quality of the accordion bellows made of Kraton. Kraton has an excellent memory and can be an excellent spring. Alternatively, resiliency may also be provided by a longitudinally disposed spring (not illustrated) which urges the dispenser to expand upon compression. The dispenser includes a drop cavity therein (not illustrated) which holds a predetermined volume of fluid to be emitted in the form of a drop. Compression of the dispenser in its longitudinal direction creates a drop in pressure in the drop cavity to fill or "load" the drop cavity with liquid where it is stored until it is emitted as a drop from the slit 12 (see FIG. 4) in nozzle 2. This compressed state will be referred to herein as the loaded state. Expansion of the dispenser from the loaded state (caused by the spring urges the fluid in the drop cavity under pressure toward the nozzle 2 from which it is emitted in the form of a drop. It can be seen that the force which is required to actuate this type of dispenser must ordinarily be applied in the direction of the nozzle and hence the eye. With this background information about the operation of the piston-like dispenser in mind, the cartridge of the invention will now be described. Referring to FIGS. 1 and 2, the cartridge which is generally indicated at 14 includes a cylindrical housing 16 which slidably receives an inner cylindrical member 18 through a back open end 20. Preferably, the back of the housing 16 has a wall 17 to fit around the portion of the cylinder 18 which projects outside of the housing. The wall 17 will abut a recessed portion 19 of the inner cylinder 18 to close off the housing to external vapor and moisture. The front of the housing 1 is substantially closed by an anterior wall 22 which has an aperture 24 centrally located therein allowing for the projection of the nozzle 2 of the dispenser. Preferably, the front of the housing 16 has a smooth arcuate external surface 23 (see FIG. 1) in the event that the cartridge accidentally makes contact with the face. When the dispenser is mounted in the cartridge it sits between the anterior wall 22 and the member 18 as illustrated. The inner surface of housing 16 includes an annular rim 26. Anterior wall 22 and annular rim 26 wedge wing 3 of the dispenser therebetween to prevent displacement of the dispenser within housing 14. The lower anterior section of housing 16 includes a forwardly projecting finger 28 which extends from the housing 16 beyond the tip of nozzle 2. The finger is upwardly curved to define a smooth surface 30 for engaging the lower eyelid. The finger is preferably coated with a material such as Kraton. The inner cylinder 18 has a front section 31 which is attached to the vial section 8 of the dispenser. If desired, the inner cylinder 18 may be formed integrally with the storage section 8. The front upper section of the inner cylinder 18 has an outwardly and rearwardly projecting extension 32 which engages and presses against the inner surface of housing 16. The extension 32 is flexible in the direction transverse to the longitudinal axis of the cartridge 14. The tip 34 of the extension 32 has a surface which is positioned and adapted to engage a notch 36 formed on the inside surface of housing 16. The notch 36 is inclined and smooth on its posterior side 38 but is cornered with the housing wall on its anterior side 40. The inner cylinder 18 and extension 32 are positioned in the housing such that the tip 34 of the extension is posterior to the notch 36 when the dispenser is in the non-loaded position. The cartridge 14 includes a trigger 42. The trigger 42 may be slidably positioned in an opening of an upper housing 43 (see FIG. 1) so as to be capable of inward movement toward the central longitudinal axis of the cartridge. Alternatively, the trigger 42 may be integrally formed with the housing 16 so that it pivots about a thin-walled living hinge section 44 (see FIG. 2). The inner surface of the trigger is formed with a projecting heel 46 whose function will become apparent from the following description of the operation of the cartridge. As illustrated in FIG. 2, preferably the trigger 42 and the point of attachment of the finger 28 to the housing 16 are disposed on opposite upper and lower sides of the housing, respectively, so that they are disposed along the housing 180° apart. Before positioning the cartridge 14 over the eye, the dispenser-vial in the cartridge is first loaded by pushing the inner cylinder 18 inward thereby compressing the bellows 4 of the dispenser. As the inner cylinder 18 is pushed inward the extension 32 is forced to flex as it slides over notch 36. The tip 34 of extension 32 is able to smoothly slide over the inclined surface 38 of notch 36. Once the tip 34 has passed over the notch 36 the extension 32 will snap back into engagement with the inner surface of housing 16. At this point the dispenser will be in its loaded state as previously defined. In addition, the cartridge 14 is in a locked position because the tip 34 of extension 32 will be unable to move over the cornered surface 40 of notch 36. The cartridge 14 is now ready for positioning over the eye. As discussed above, a drop of medicament is ideally deposited in the conjunctival cul de sac of the lower eyelid for maximum effectiveness. For this purpose, the engaging surface 30 of finger 28 is gently pressed on the lower eyelid. The cartridge is then moved downward slightly to expose the cul de sac and the cartridge is positioned so that the nozzle 2 will be directed toward the cul de sac. At this point the user would depress the trigger 42. Referring to FIG. 3, when the trigger 42 is depressed the heel 46 will force the extension 32 downward and the tip 34 will eventually clear the face 40 of notch 36. The spring in the dispenser will force the dispenser and the inner cylinder 18 to expand back to the non-loaded position and at this time a drop of medicament will be released from the slit 12 of nozzle 2 into the eye as discussed above. It should be appreciated that one advantage of the cartridge of the invention is that the motion which is used to depress the trigger and thereby release a drop is in the same direction as the motion used to lower the eyelid and expose the cul de sac. Therefore, more accurate delivery of the drop is possible. Furthermore, an area of low sensitivity and low tear turn over is specifically targeted by the cartridge which prevents tearing and blinking reflex for better efficacy. In addition, there is no danger of poking the eyeball with the nozzle 2 since the motion to depress the trigger is not in the direction of the eye and since the finger 28 extends beyond the nozzle. Moreover, when the trigger is depressed the return mechanism of the vial projects the inner cylinder in the direction away from the eye. The cartridge is particularly useful for arthritic patients because the trigger mechanism allows for easy release of a drop. In the foregoing specification, the invention has been described with reference to specific exemplary embodiments thereof. It will, however, be evident that various modifications and changes may be made thereunto without departing from the broader spirit and scope of the invention as set forth in the appended claims. The specification and drawings are accordingly to be regarded in an illustrative rather than a restrictive sense.

A cartridge for actuating a piston-like or accordion-like dispenser-vial for applying medicament to an eye. The cartridge includes a housing for holding the dispenser-vial and a telescoping cylinder for compressing the dispenser-vial in the longitudinal direction to actuate the vial. The cartridge includes a locking mechanism for locking the telescoping cylinder to restrict its movement and a trigger mechanism for releasing the cylinder from the locked position so that a drop is released from the dispenser. The housing includes a finger for engaging the lower eyelid and exposing the conjunctival cul de sac.

FIELD OF INVENTION [0001] The present invention relates generally to collectable helmets, and more particularly, to collectable helmets with interactive features. BACKGROUND OF THE INVENTION [0002] Collectable helmets are well known in the art and are generally comprised of replicas of helmets representing various sports teams or headgear worn by particular athletes. In some known embodiments, the collectable helmets are full-size; that is, they have substantially the same dimensions as the helmets worn by the athletes. In other known embodiments, the collectable helmets are miniature versions of actual helmets. Riddell is a manufacturer of full-size and miniature collectable helmets. [0003] One common disadvantage in these known collectable helmets is that they are generally intended for display purposes only. That is, while one can pick up the collectable helmet to examine and admire it, the collectable helmet typically does not have any other interesting features other than being a replica of the actual helmet. [0004] It is desirable, therefore, to provide a collectable helmet that can serve the basic purpose of displaying the helmet, but also includes interactive features. What is further needed is a collectable helmet that can transform into a representation of an athlete wearing the collectable helmet. What is also needed is a collectable helmet that provides a game aspect. What is still further needed is a collectable helmet that provides a game aspect associated with or related to the type or theme of the collectable helmet. SUMMARY OF THE INVENTION [0005] The present invention provides for a collectable helmet in which a figure, such as a representation of an athlete, may be compressed within the collectable helmet. In its compressed configuration, the collectable helmet may be displayed in a manner similar to traditional collectable helmets. Upon activation by a user, the representation of the athlete is released from the collectable helmet such that the representation of the athlete appears to be wearing the collectable helmet. [0006] In a preferred embodiment of the present invention, the figure is comprised of three sections: a first section resembling a head, a second section resembling a torso with arms, and a third section resembling a lower portion of a body, such as a pair of legs with feet, on a base. The figure may be compressed within the helmet such that each of the first section resembling a head, the second section resembling a torso with arms, and the portion of the third section resembling a pair of legs with feet are completely or substantially covered by the helmet. Accordingly, when the figure is compressed within the helmet, the predominant appearance is that of a collectable helmet and a base. [0007] It is another object of the present invention to provide a collectable helmet that includes an associated game play. In a preferred embodiment of the present invention, the game play is associated with or related to the type or theme of the collectable helmet. For example, in various embodiments of the present invention, a baseball-themed collectable helmet could include a moveable bat-like object attached to the base for baseball-type game play, a hockey-themed collectable helmet could include a moveable hockey stick-like object attached to the base for hockey-like game play, and a football-themed collectable helmet could include a football-like object that is struck by a moveable object attached to the base that simulates a kicking action. [0008] In a preferred embodiment of the present invention, the game play can be accomplished individually or interactively with another user. For example, for individualized play, the baseball-themed collectable helmet may be used in conjunction with a play mat, wherein such play mat resembles a baseball field. The user of the baseball-themed collectable helmet can use the moveable bat-like object attached to the base baseball-themed collectable helmet to strike a ball or disk across the mat. As another example, a user of a first baseball-themed collectable helmet could launch a ball or disk from the base of the first baseball-themed collectable helmet toward a second baseball-themed collectable helmet, and the user of the second baseball-themed collectable helmet tries to strike the ball or disk with the moveable bat-like object attached to the base of the second baseball-themed collectable helmet. In a preferred embodiment of the present invention, the game play can be accomplished whether or not the figure is compressed into the collectable helmet. [0009] A more complete understanding the collectable helmet with interactive features will be afforded to those skilled in the art, as well as a realization of additional advantages and objects thereof, by a consideration of the following detailed description of the preferred embodiment. Reference will be made to the accompanying drawings which will first be described briefly. DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a front view of a collectable helmet in its expanded position in accordance with the present invention. [0011] FIG. 2 is a side view of a collectable helmet in its collapsed position in accordance with the present invention. [0012] FIG. 3 is a front cross-sectional view of a collectable helmet in its expanded position in accordance with the present invention. [0013] FIG. 4 is a side cross-sectional view of a collectable helmet in its expanded position in accordance with the present invention. [0014] FIG. 5 is a side cross-sectional view of a collectable helmet in its collapsed position in accordance with the present invention. [0015] FIG. 6 is an exploded perspective view of a collectable helmet in accordance with the present invention. [0016] FIG. 7 is a top cross-sectional view of the base of a collectable helmet having a game play feature in accordance with the present invention. [0017] FIG. 8 is an exploded perspective view of the base of a collectable helmet having a game play feature in accordance with the present invention. [0018] FIG. 9 is a side view of a football-version of a collectable helmet in its expanded position that also includes a game play feature and a miniature football accessory in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0019] The present invention provides a collectable helmet with interactive features. In the detailed description that follows, like reference numbers are used to indicate like elements appearing in one or more of the figures. [0020] FIG. 1 shows a collectable helmet 100 in its expanded configuration having a top portion in the form of a helmet 102 , a first section 110 , a second section 112 , and a third section 114 , wherein the third section 114 comprises a base portion 104 and a lower body portion 116 . In the preferred embodiment of the present invention, when the collectable helmet 100 is in its expanded configuration, the externally visible portion of the first section 11 resembles a head, the externally visible portion of the second section 112 resembles a torso with arms, and the externally visible portion of the lower body portion 116 resembles legs with feet. [0021] The helmet 102 has an interior cavity 120 and a stem 122 extending downward from the top of the interior cavity 120 . The first section 110 and second section 112 are capable of moving longitudinally along the lower body portion 116 . The third section 114 has an interior space 124 capable of substantially receiving the stem 122 such that the stem 122 reaches into the base portion 104 of the interior space 124 . The interior cavity 120 of the helmet 102 is capable of at least substantially covering the first section 110 , the second section 112 and the lower body portion 116 when the collectable helmet 100 is in its compressed (i.e. display) configuration. FIG. 2 shows the collectable helmet 100 in it compressed configuration. [0022] FIGS. 3 and 4 show cross-sectional views of the collectable helmet 100 in its expanded configuration. The collectible helmet 100 contains a spring 140 , preferably a helical compression spring, having sufficient force to place the collectable helmet 100 into its expanded configuration when the spring 140 is substantially uncompressed. In the preferred embodiment of the present invention, the spring 140 is oriented concentrically around the stem 122 and is positioned between the top of the interior cavity 120 of the helmet 102 and a rim 142 located within the interior space 124 of the third section 114 . In another embodiment of the present invention, the spring 140 is oriented below the stem 122 such that the stem 122 compresses the spring 140 when the collectable helmet 100 is in its compressed configuration. [0023] In order to retain the collectable helmet 100 in its compressed configuration, the base portion 104 includes a plate 152 having an opening 154 and a second spring 156 , preferably a helical compression spring, wherein the plate 152 is capable of substantially lateral movement and the second spring 156 , when compressed, has sufficient force to move the plate 152 substantially laterally. The stem 122 has a groove 158 proximate to the end of the stem 122 . As the collectable helmet 100 is placed in its compressed configuration, the end of the stem 122 moves the plate 152 substantially laterally and compresses the second spring 156 sufficient to allow the end of the stem 122 to pass through the opening 154 until the groove 158 substantially aligns with the opening 154 . When the groove 158 and the opening 154 are substantially aligned, the second spring 156 moves the plate 152 (i.e., the edge of the opening 154 ) substantially laterally into the groove 158 , thereby allowing the collectable helmet 100 to be secured in its compressed configuration. In the preferred embodiment of the present invention, a spacer 190 is utilized to maintain the substantially vertical position of the stem 122 , to limit the distance in which the spring 140 can be compressed and aid in the alignment of the groove 158 with the plate 152 (i.e., the edge of the opening 154 ). The spacer 190 may be oriented concentrically around and exterior to the stem 122 and the spring 140 , or alternatively, concentrically around and between the stem 122 and the spring 140 . Furthermore, in the preferred embodiment of the present invention, the end of the stem 122 is rounded and the opening 154 has a beveled edge to allow the end of the stem 122 to pass more easily through the opening 154 . [0024] The bottom edge of the helmet 102 has a lip 170 and the top of first section 110 has a rim 172 such that the lip 170 is engageable with the rim 172 to prevent the helmet 102 from separating from the first section 110 when the collectable helmet 100 is in its expanded configuration. Also, the bottom of the first section has a second lip 174 and the top of the second section 112 has a plate 176 such that the second lip 174 is engageable with the plate 176 to prevent the first section 110 from separating from the second section 112 when the collectable helmet 100 is in its expanded configuration. Furthermore, the bottom of the second section 112 has a third lip 178 and the third section 114 has a protrusion 180 such that the third lip 178 is engageable with the protrusion 180 to prevent the second section 112 from separating from the third section 114 when the collectable helmet 100 is in its expanded configuration. [0025] FIG. 5 shows a cross-sectional view of the collectable helmet 100 in its display configuration in which the first section 110 , the second section 112 and the lower body potion 116 are all substantially received within the interior cavity 120 of the helmet 102 . In the preferred embodiment of the present invention, the helmet 102 covers substantially all of the first section 110 , the second section 112 and the lower body potion 116 , so as to not distract from the helmet 102 and to substantially appear as if the helmet is resting on the base portion 104 . When the collectable helmet 100 is in its display configuration, the spring 140 is compressed and the plate 152 has retained the stem 122 to maintain the spring 140 in its compressed state. The collectable helmet 100 expands from its display configuration when the plate 152 is moved substantially laterally toward the second spring 156 in order to compress the second spring 156 , and when the plate 152 (i.e., the edge of the opening 154 ) is removed from the groove 158 , the stem 122 is released and the spring 140 is allowed to become uncompressed thereby forcing the helmet 102 upwards and placing the collectable helmet 100 in its expanded configuration. [0026] FIG. 6 shows an exploded view of the preferred embodiment of the collectable helmet 100 . Helmet 102 , first section 110 , second section 112 and third section 114 (which includes base portion 104 and lower body portion 116 ) are separated into two parts in order to aid assembly of the collectable helmet 100 . Helmet 102 includes a rib (not shown, but similar to rib 202 ) which mates with a notch 204 in the rim 172 of the first section 110 to prevent the helmet 102 from rotating around the first section 110 . Similarly, the first section 110 includes a rib 210 which mates with a notch 212 in the plate 176 to prevent the first section 110 from rotating around the second section 112 . And the second section 112 includes a rib 220 that mates with a notch 222 in the lower body portion 116 to prevent the second section 112 from rotating around the lower body portion 116 . It should be understood that the ribs (e.g. ribs 202 , 210 and 220 ) also serve to increase the strength and rigidity of the forms (e.g. helmet 102 , first section 110 and second section 112 , respectively). [0027] FIG. 7 shows the top view of the base portion 104 and FIG. 8 shows an exploded view of the third section 114 of the collectable helmet 100 , wherein each case the base portion 104 includes features for game play. In a preferred embodiment of the present invention, the game play relates to the type or theme of collectable helmet 104 . For example, a baseball-themed collectable helmet includes features attached to the base that allow for baseball-type game play. In one embodiment of the present invention, the base portion 104 provides for baseball-like game play wherein the base portion 104 includes a bat-like object 300 that is used in conjunction with a spring 302 , preferably a torsion spring, both of which are secured to the base portion 104 with a shaft 304 . A user pulls back the bat-like object 300 thereby compressing the spring 302 and when released, the spring 302 causes the bat-like object 300 to swing forward. The bat-like object 300 is of suitable shape such that it may be used to strike a disk 306 , ball or other suitable object, without allowing such object to slide beneath the bat-like object 300 . A play mat (not shown) may be utilized to enhance the game play. For example, a play mat depicting a baseball field would be used in conjunction with the baseball-themed collectable helmet. [0028] In the preferred embodiment of the present invention, the base portion 104 includes a disk retention mechanism 310 and disk release mechanism 312 for propelling the disk 306 , ball or other suitable object. The disk retention mechanism 310 has an opening 314 and the disk 306 is retained by the disk retention mechanism 310 after the disk 306 is passed through the opening 314 . After the disk 306 is retained by the disk retention mechanism 310 , the disk release mechanism 312 is used to push the disk 306 through the opening 314 , the opening 314 being less than the diameter of the disk 306 , and once sufficient force is applied to pass the disk 306 through the opening 314 , the disk 306 is launched from the base portion 104 . [0029] As mentioned above, the collectable helmet of the present invention can vary in theme. FIG. 9 shows a football-version of a collectable helmet in its expanded position that also includes a game play feature and a miniature football accessory in accordance with the present invention. [0030] In the preferred embodiment of the present invention, the collectable helmet 10 is primarily constructed out of acrylonitrile butadiene styrene (ABS) polymer, which has the qualities of strength, rigidity and durability and is receptive to the addition of pigments. Other materials that have the ability to be injection molded or extruded may also be utilized. [0031] Having thus described a preferred embodiment of a collectable helmet with play features, it should be apparent to those skilled in the art that certain advantages of the invention have been achieved. It should also be appreciated that various modifications, adaptations, and alternative embodiments thereof may be made within the scope and spirit of the present invention. The invention is further defined by the following claims.

A collectable helmet having two states, a compressed state and an uncompressed state, such that in its compressed state, the collectable helmet appears to similar to traditional collectable helmets and may be displayed as such, and in its uncompressed configuration, appears to be a figure wearing a helmet. The collectable helmet may be designed with a particular theme and may further include features for game play associated with that theme.

BACKGROUND OF THE INVENTION The present invention relates to the art of coating edible cores, and, in particular, to a method and apparatus for continuous pan coating edible cores. The practice of applying a coating to edible particulate matter one cores by pan of coating generally includes placing the cores in a rotating drum which continuously agitates them while a solution of the coating material is applied, usually by spraying the material over the cores in the rotating drum during agitation. It is customary to coat edible cores such as nuts, chewing gum, candies, fruits, lozenges, dragees, and medicinal tablets with one or more layers of candy or sugar coating by conventional procedures using a drum or a rotatable vessel and warm air or other drying gas to evaporate and/or harden each layer in preparation for application of subsequent layers. For example, U.S. Pat. No. 4,334,493 to Okawara shows a rotary drum type apparatus for applying a coating to tablets which includes a rotary drum supported by a frame for receiving a body of tablets to be coated by spraying with a solvent. The drum which can be inclined through about 10-20° in such a manner that its front surface is turned upwardly, includes a device which supplies a coating material into the interior of the drum and an inlet tube and an outlet tube to provide a supply of drying gas such as air to the interior. The support frame cooperates with an outer periphery of the drum to define an air suction duct disposed on the front side of the support frame and an air exhaust duct disposed on the rear side of the support frame so that a smooth flow of hot blast through the drum can be obtained. Similarly, in U.S. Pat. No. 4,245,580 to Okawara, a device for coating granular solids is disclosed which has a double-cone rotary drum perforated so as to permit flow of air or gas into and out of the rotary drum, and which is tiltable about the axis at right angles to the axis of rotation of the rotary drum so that in the case of the discharge of product solids, the opening of the rotary drum may be directed downwardly. Axial annular insulating covers are providing which insure the effective thermal insulation of the rotary drum when the hot air or gas is blown thereinto. However, each of the Okawara disclosures discussed above relate to coating drums for batch operation since each body of cores to be coated must be fed into and discharged from a single opening. Similar operation and apparatus are shown in U.S. Pat. No. 3,448,718; U.S. Pat. No. 3,063,843; and U.S. Pat. No. 2,726,959. U.S. Pat. No. 3,911,860 to Nohynek discloses a coating drum for continuous coating of dragees with a coating material and for subsequent application and glossing of a protective skin over the coating by use of a co-axially connected after-treatment drum. In particular, both drums are fixed in a sealing connection to each other and may be driven at different speeds by means of a variable speed transmission rotationally interconnected. The dragee drum shown by Nohynek is a double frustum, while the after-treatment drum is cylindrical. Both drums are equipped with conveying baffles in order to push the product through from the entrance to the exit. On the inner wall of the rear frustum of the dragee drum are located conveying baffles 5 arranged in relation to the direction of rotation so that only a few dragees at a time are discharged through rear discharge opening 6. The discharge opening 6 leads to an inner drum 7 of approximately the same diameter through which the coated particles flow by means of conveying baffles 11 to radial transfer opening 17 into intermediate drum 10 on which there are also located helical screw type conveying baffles 5 and 13. The particles pass from intermediate drum 10 into the outer drum space 20 from which they emerge through discharge openings 21. In each of these disclosures, as well as general practice in the art, there is lacking a method and apparatus for continuous pan coating of edible cores in which there is a high degree of control of the coating process. Accordingly, it is an object of the present invention to overcome problems normally associated with the continuous highly controlled pan coating of edible particulate matter or cores. It is another object of the present invention to provide an apparatus for continuous pan coating of edible cores with several layers of coating material. It is a further object of the present invention to provide an apparatus whereby edible cores can be provided with a chocolate candy coating, as well as successive protective outer coatings over the chocolate coating. SUMMARY OF THE INVENTION In accordance with the present invention, an apparatus is provided which is useful for continuous pan coating of edible cores which includes, in combination, a coating drum arranged for rotation around an inclined axis and having an inlet opening at the upper axial end of the coating drum for reception of edible cores and a discharge opening at the lower axial end of the coating drum, and preferably means for controlling the incline of the drum to vary the degree of force exerted by gravity urging the cores through the drum during the panning operation. There is further included a means for continuously driving the coating drum, means for delivering coating material to the cores at a controllable rate, and means for delivering drying gas to the cores at a controllable rate while the cores are in the coating drum. Also included in the present apparatus is at least one after-treatment drum likewise arranged for rotation around an inclined axis and having an inlet opening at the upper axial end of the after-treatment drum for the reception of coated cores from the coating drum, and a discharge opening at the lower axial end for the discharge of treated coated cores. Also, a means for continuously driving said at least one after-treatment drum is provided, as well as a means for continuously conveying the coated cores from the discharge end of the coating drum to the inlet opening of the after-treatment drum. Finally, a means is provided for applying the after-treatment coating at a controllable rate to the coated cores during passage of the cores through the after-treatment drum. In a preferred embodiment of the present invention, there is further provided a second after-treatment drum arranged for rotation as in the at least one after-treatment drum and also having features or characteristics similar to those of the after-treatment drum, such as a means for continuously driving the second after-treatment drum, means for continuously conveying the cores from the discharge of the first after-treatment drum to the second after-treatment drum, as well as means for applying a second after-treatment coating to the after treated coated cores. In order to provide a means for controlled delivery of the coating in the coating drum, the present invention includes in one embodiment a coating manifold extending lengthwise in the interior of the coating drum with adjustable coating nozzles, preferably four in number, arranged along the length thereof for controlling the amount of coating material delivered to the cores. The means for delivering the coating also includes a control means for selectively adjusting each of the nozzles from a location exterior of the coating drum. The coating manifold preferably includes a continuous conduit connected for fluid communication with a source of coating material and with each of said adjustable nozzles whereby fluid coating material is provided to the nozzles. Adjustable nozzles for use in the present invention can include a nozzle housing having a coating supply bore with an exit port, a movable means for restricting the fluid flow through the exit port which is responsive to means for adjusting the flow restriction means. The adjustment means is preferably fixed to the nozzle housing at a location exterior thereto and operable to adjust the flow restriction means. The movable means for restricting flow can be a pin element slidably mounted in the bore and connected to the adjusting means for linear movement through the bore. In a preferred embodiment of the invention, the control means include nozzle adjustment stations mounted interiorly of the coating drum at positions adjacent to nozzles along the coating manifold, a rod member secured for rotation adjacent the coating manifold and parallel thereto, the rod member having fixed thereon rotating adjustors at positions on the rod member wherein each rotating adjustor can be selectively engaged with, and disengaged from, a nozzle adjustment station by linear movement of the rod member. This embodiment also contemplates use of a means for varying the position of the rod member linearly with respect to the coating manifold, as well as means for rotating the rod member which is fixed on the end of the rod member at a position exterior to the coating drum. A nozzle adjustment station which can be used with the above-described apparatus includes means for securing the rod member for rotation, an interconnecting drive means fixed to the means for securing the rod member which drives the manifold nozzle adjustment means in response to rotation of a rotating adjustor engaged therewith. The interconnecting drive means can include a drive rod with a first end adJacent to the nozzle adjustment means with a first driving gear means fixed thereon for driving the nozzle adjustment means, and a second end with a second driving gear means fixed thereon proximal to the rotating adjustor which can be selectively engaged with the rotating adjustor by linear displacement of the control rod. Thus, the interconnecting drive means and the nozzle adjustment means can be driven upon rotation of the control rod while the rotating adjustor and the second gear means are engaged. To provide a means for varying the linear position of the rod member, a linear-shift housing can be mounted at the end of the rod member exterior to the coating drum through which the rod member extends, and a linear rod control sleeve fixed around the rod at the position on such rod which extends through the housing. The control sleeve has adjusting elements formed thereon which coact with the linear-shift housing to hold the rod member in position whereby each of the rotating adjustors can selectively be engaged with a second gear means at each adjustment station. Further in accordance with the present apparatus, there is provided a means for delivering drying gas at a controllable rate which includes a drying gas manifold mounted interiorly along the length of the coating drum which has adjustable gas delivery ports provided along the length thereof, preferably four each, and means for controlling the flow of drying gas through the gas delivery ports from a location exterior of the coating drum. Preferably, each of the drying gas delivery ports includes an exit orifice having a baffle mounted therein for rotation across the orifice, while the means for controlling the flow of the drying gas includes linking means extending from a control handle exterior of the coating drum to each of the baffles for rotating such baffle so that gas flow through the respective exit orifice is controlled. As a result of the present invention, a highly controlled apparatus and method for continuously applying a candy coating, especially chocolate, is provided in which subsequent protective and appearance-improving coats can be applied on a continuous basis without interruption of flow of edible particulate matter or cores. For a better understanding of the present invention, together with other and further objects, reference is made to the following description, taken in conjunction with the accompanying drawings, and its scope will be pointed out in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention have been chosen for purposes of illustration and description and are shown in the accompanying drawings wherein: FIG. 1 is a perspective view of an overall system for continuous pan coating in accordance with the present invention; FIG. 2 is an elevated end view of the combined apparatus taken from the left hand side of FIG. 1; FIG. 3 is a plan view of the combined apparatus of a preferred embodiment of the present invention; FIG. 4 shows control apparatus mounted for operation at the discharge end of the coating drum as depicted in FIG. 1; FIG. 5 depicts a portion of the inside of a coating drum which includes a coating material recovery feature of the present invention; FIG. 6 shows a controlled coating delivery system according to the embodiment of the present invention depicted in FIG. 4. FIG. 6a is a cross-section of the coating material delivery manifold taken along lines 6a--6a; FIG. 7 is an enlarged view of a portion of the control system shown in FIG. 6; FIG. 8 is an enlarged view of a control station of FIG. 6 in partial section; FIG. 9 is a section view taken along the line 9--9 of FIG. 8; and FIGS. 10, 11, 12, 13, and 14 depict a controllable drying gas delivery system in accordance with the embodiment of the present invention depicted in FIG. 4. DETAILED DESCRIPTION OF THE INVENTION Each of the drawings depicts so much of that part of the particular embodiment of the invention which is required to provide an adequate understanding thereof. The surrounding or connected portions of the apparatus which are not shown or detailed in each drawing are understood as being part of the state of the art or are depicted in accompanying related drawings. Referring to FIGS. 1, 2 and 3, there is shown a combined apparatus in accordance with a preferred embodiment of the present invention in which a coating drum 10 is shown in series with a first after-treatment drum 100 and a second after-treatment drum 200. Particulate core material 12 is delivered from a source via conveyor means 9 into receiving end 11 of the coating drum 10. The coating drum 10 is mounted on a support 16 at an incline which is pitched downwardly from receiving end 11 towards discharge end 13. The angle or pitch of the drum, as well as the speed of rotation of the drum, provided by continuously moving drive belt or chain 19 and drive motor 18, can be varied by conventional means. The angle of the drum and the rate is generally determined by the amount of coating and the rate of product feed. Furthermore, as seen in FIG. 2, product volume control is also effected by use of a product retainer plate 6, which can be affixed to the exit end 13 of drum 10. Gravity flow, along with drum rotation, are the primary means by which the product flows through the present continuous pan coating system. Conventional conveying means, such as endless belts, can also be used between coating drums if the drums are not located one below the other. In a preferred mode of operation, a scraping and scrap removal means is also provided in the coating drum 10 to insure continual tumbling of the particulate matter being coated as well as to avoid coating build-up which requires production shut-down for clean-up. In FIG. 5 there is shown a portion of a drum interior which has a drum wall 8 having ribs 7 which effect forward travel of particles as they tumble during drum rotation. In order to prevent coating material build-up as well as particle back-flow against the particulate mass, a notched scraper 4 can be mounted along the length of the drum over several of the ribs 7 at a point which does not interfere with the coating process. These problems are associated with continuous coating processes, and are not incurred in batch operations wherein alternate or supplemental equipment usage avoids coating build-up, etc. As shown in FIG. 2, each of the drums can be mounted at a position lower than the drum before it, i.e., the treatment drum 100 is slightly below coating drum 10, and is mounted higher than second after-treatment drum 200. Each of the drums has its own source of continuous rotation, shown as motor 118 and continuous belt 119 in the case of after-treatment drum 100, and as motor 218 and continuous belt 219 for the second after-treatment drum 200. The direction of flow of particulate matter is shown in FIG. 3 as originating from conveyor belt means 9 through drum 10, and thence into drum 100 via conveyor 101. The particulate mass is passed through drum 100 where it is further coated or treated and then moved to the receiving end 113 of drum 200 via conveyor 201 and then through drum 200 to its discharge end 213. The drum 200 is mounted on a support 216 as depicted in FIG. 1. Referring specifically to FIGS. 1 and 3, a source of coating material is shown for each of the drums. Vessel 20 provides the coating material for the coating drum 10 via line 22; vessel 120 provides a source of after-treatment material via line 122, while vessel 220 is a source of material, such as a final coating, for second after-treatment drum 200 and is provided by means of supply line 222. There is also shown in FIG. 1 an overhead support means for the separate delivery systems for each of the drums. In the case of the coating drum 10, there are shown overhead support member 30 which also support scrap removal as well as the delivery system; in the case of drum 100, there are shown overhead support members 130; while for drum 200, overhead support member 230 is shown. Finally, with reference to FIG. 1, drying-gas delivery conduits 40, 140 and 240 are shown for each of the drums, as well as final product receiving conveyor means 2. FIG. 4 shows a support member 30 and the delivery control system from the discharge end 13 of coating drum 10. The control system is mounted on support member 30 by means of an angle/elevation rod 32 attached for rotation to support beam 33. As shown in FIG. 4, the rod 32 can be elevated or depressed in an angular direction by means of angle adjustment 34, while the position of the delivery control system along the length of rod 32 can be varied by means of clamping adjustment sleeve 35. Coating-supply adjustment rod 36 which can be moved longitudinally along its length and clamped to secure the coating supply system support 70, 70a at the desired position. Basically, the coating supply system should be adjusted to a position at which the coating spray is directed to the middle of the particle mass in the drum. Referring to FIGS. 4-8 inclusively there is shown the coating distribution system of the present invention which includes primarily a coating material distribution manifold 74 in combination with a control mechanism, the primary component of which is control rod 73. The coating manifold 74 is connected for fluid communication with a source of coating material and also with each of the controllable coating nozzles 75, preferably four in number. The coating manifold 74 can be constructed such that temperature control can be maintained by means of adjacent conduits 74c through which a medium, such as warm water, can be continuously passed (See FIG. 6a). Thus, a coating material such as chocolate can be continuously fed through manifold feed conduit 74b without incurring blockage due to freeze-up. For ease of assembly, the control rod 73 can be composed of rod segments which are joined at non-interferring positions along the length thereof by any conventional joining means, such as coupling 77. The control rod 73 can be mounted to the support means 70 by bearinged mounting brackets 78 which abut directly onto the mounting means 70 or, alternatively, to adjustment control station plates 70a. At the end of the control rod, exterior to the coating drum, there is shown (see FIG. 6) a linear control housing 76 and, in phantom, a linear control sleeve 79 surrounding the control rod on that portion of the control rod which passes through the housing 76. By use of this housing and sleeve combination in conjunction with the control pin 72 the control rod can be selectively displaced at different linear positions relative to the manifold 74 so that each of the nozzles can be individually adjusted to control the flow of coating material through the nozzles 75. This operation, which is relatively simple, includes extracting tensioned pin 72 away from the housing and out of a depressed portion of the sleeve 79 while the rod is moved in the linear direction to position each of the rotatable adjustors 69 next to a control station before the tensioned pin 72 is allowed to return to the fully set position. When the control rod is in the selected adjustment position, the rod may be rotated by means of control handle 71 which is exterior to the coating drum, preferably at the product exit end. The control rod is also provided with rotatable adjustors 69 which coact in cooperation with the nozzle adjustment stations, designated generally 80 to provide a means for selectively adjusting each of the nozzles 75. Focusing on the control stations 80, there can be seen linking rod 82 mounted for rotation on mounting brackets 78 generally directly below the control rod 73. The linking rod 82 has a first end which is adjacent the control mechanism on the adjustable nozzle 75 having a first gear means 83, and a second end having a second gear means 84 to which rotating adjustors 69 can be engaged by linear displacement of the control rod 73 to drive the linking rod 82 and, thus, the adjustment means 88 located on the exterior of the nozzles 75. Referring now to the adjustable nozzle 75 (see especially FIG. 8), there is depicted a nozzle having a nozzle housing 86 with a nozzle bore 87 formed therein which is in fluid communication with the coating material manifold 74. An adjustment means is provided for each of the nozzles which includes an adjustment mechanism located exterior to the nozzle, shown in FIG. 8 as an intermeshing gear means 88 connected for operation to a flow restriction pin 89 which slides linearly through the nozzle bore 87. In operation, the control rod 73 is rotated by means of handle 71 whereby a rotating adjustor 69 when engaged with a second gear means 84 of linking rod 82 is driven to turn the adjustment mechanism 88 so that the control pin 89 is raised or lowered within the bore 87, thereby controlling the flow of coating material through the nozzle orifice 81. By use of this combination adjustment means, each of the adjustment nozzles 75 can be independently adjusted to control the flow of coating material out of each station nozzle. Turning now to the drying gas controllable supply means, reference is made to FIGS. 4 and 10-14, wherein a drying gas conduit 90 is shown on support element 70 as running the length of the interior of the coating drum. Gas drying conduit 90 includes a cylindrical portion 60 extending along a lower side of conduit 90. A control panel 91 is supported from, among other means, the conduit means by a support member 92. Drying gas exit ports 93 are located along the length of the gas conduit 90. A baffle 94 is fixed for rotation across each of the exit ports 93 and is controlled by a linking means 95 connected to control rods 96, which, in turn, extend from and are mounted to control panel 91. Each of the control rods 96 are terminated at the control panel 91 by a control handle 97 which can be fixed in any position by screw down knobs 98. Each of the control handles or adjustment handles 97 can be rotated to turn the baffle 94 in each of the drying gas exit ports 93 to control the amount of drying gas, such as air, flowing therethrough. Thus, as a result of the highly controllable coating delivery system and the drying gas control system, particulate matter or edible cores can be processed through the coating drum under highly controlled and manipulable conditions in order to provide the desired amount of coating on the particulate matter. Additional coats of coating material, covering material or polish, etc. can be provided in the after-treatment drums which, in the case of chocolate coatings, can include a polish spray in the first after-treatment drum 100 and a confectioner's glaze applied in the second after-treatment drum 200. A constant flow of drying gas can also be introduced into the after-treatment drum, such as from drying gas source 140 and 240, respectively. The polish spray nozzles located in the first after-treatment drum 100 are preferably controlled in order to provide a uniform thin polish over, for example, a coated confection. Similarly, with respect to the second after-treatment drum 200, highly controlled spray nozzles can be provided to provide a uniform thin coat of glaze material. Each of the drums can also be provided with an end plate 6 in order t control the rate of product flow out of the drum, as well as the internal side scrapper to insure the tumbling effect during the coating process of the drum being rotated and for purposes of removal of excess coating material. Furthermore, while there have been described what are presently believed to be the preferred embodiments of the invention, those skilled in the art will realize that changes and modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the true scope of the invention.

An apparatus useful for continuous pan coating of edible cores which includes a coating drum arranged for rotation around an inclined axis and having an inlet opening at the upper axial end of the coating drum for reception of the edible cores, and a discharge opening at the lower axial end of the drum, so that the force of gravity urges the cores through the drum. The apparatus also includes a means for continuously driving the drum, means for providing coating material to the cores at a controllable rate, and means for delivering drying gas, such as air, to the cores also at a controllable rate while the cores are in the drum. The present invention has at least one after-treatment drum likewise arranged for rotation around an inclined axis and having an inlet opening at the upper axial end of the after-treatment drum and a discharge opening at the lower axial end, as well as a means for continuously driving the cores from the coating drum to the first after-treatment drum. In a preferred embodiment, the apparatus also includes a second after-treatment drum similar to the first after-treatment drum.

RELATED APPLICATIONS This application is a continuation-in-part of U.S. Ser. No. 10/444,663, filed May 22, 2003 now U.S. Pat. No. 6,986,240, and incorporated herein by reference. TECHNICAL FIELD This invention generally relates to a cutting unit for a turf mower. More particularly, the invention relates to a deflector assembly in selective communication with turf clippings dispersed from the cutting unit of a turf mower. BACKGROUND OF THE INVENTION Turf cutting equipment, such as rotary mowers, have a cutting deck carrying one or more turf cutting implements within a cutting chamber. Open access to the cutting chamber may be provided to allow for wide dispersal of grass clippings. Side discharge mowers have an access provided at a laterally disposed side of the cutting deck and are often equipped with a discharge deflecting chute to keep debris thrown from the mower blade at a very low altitude. Known discharge deflecting chute may be formed from metal or plastic parts. These discharge chutes are generally rigid and may be damaged during use from contact with obstacles. Additionally, debris may be deflected off the interior surfaces of the chute and thrown away from the mower at an undesirable trajectory. A common problem associated with some typical discharge deflecting chutes is that they interfere with convenient operation of the mower. Common discharge deflecting chutes are often damaged during use due to contact with obstacles. Additionally, these discharge chutes can inflict damage to trees, signposts, and other structures during contact. Areas of turf unevenness may additionally be damaged by the rigid discharge deflecting chutes contacting and scraping the turf to reveal bare soil. It is desirable to provide a mower deck which includes a side discharge chute that directs clippings during operation in the side discharge mode. It would also be desirable for such a mower to provide or hinder the chute from becoming permanently bent, deformed or warped when the discharge chute contacts obstacles. It would also be desirable for such a mower to provide or hinder the chute from causing damage to items the chute may come into contact with during operation or transport of the mower. SUMMARY OF THE INVENTION The present invention is directed to a resilient and flexible discharge deflecting chute. One embodiment of the present invention utilizes a reinforced sheet rubber form which is shaped into a chute shape by a frame. In a preferred embodiment, a flexible, resilient discharge deflecting chute is provided which has memory characteristics and returns to shape even after substantial deflection from obstacle contact. The flexible, resilient material selected for this discharge deflecting chute has sufficient stiffness to substantially maintain its shape in normal operation. The flexible, resilient material selected for this discharge deflecting chute has sufficient flexibility to deflect substantially when contacted by obstructions. The flexible, resilient material selected for this discharge deflecting chute has sufficient resiliency to substantially return to its normal shape after contact and deformation by an obstacle. Additional embodiments of the present invention include variations in construction and materials selection. The present invention may be produced as an injection molded resilient and flexible material of equivalent flexural and resiliency characteristics. Furthermore, the frame utilized to control the shape of a rubber sheet may be substantially reproduced in alternate form to provide the same function. The present invention may be produced as an injection molded resilient material of equivalent flexural and resiliency characteristics, with integral rigid plastic or steel portions to control the shape and mounting structure of the discharge deflecting chute. Another benefit of the present deflecting chute is that the resilient and flexible material may absorb a greater amount of the kinetic energy of thrown debris as compared to known generally rigid metal or plastic deflecting chutes. A variety of flexible and resilient sheet materials may be utilized to form the discharge chute of the present invention. In a preferred embodiment, the discharge deflecting chute comprises a fiber-reinforced rubber sheet. One object of the present invention is to provide an improved grass deflector attachment for a rotary lawn mower which is durable and which is inexpensive and easily manufactured. A method of providing a discharge chute is also disclosed to include the steps of providing a sheet element and deforming the sheet element into a chute-like shape with a frame. The frame preferably may include a U-shaped plate or separate brackets which engage the sheet element to generate a chute-like form. In one embodiment, a pair of plates are provided which engage the sheet element in a clamping manner. Alternative embodiments may include more than two plates or elements which engage the sheet element to form the chute shape. In accordance with these objects and other advantages which will become apparent hereinafter, the instant invention will now be described with particular reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS This invention will be described hereafter in the Detailed Description, taken in conjunction with the following drawings, in which like reference numerals refer to like elements or parts throughout. FIG. 1 is a perspective view of a mower incorporating to the invention; FIG. 2 is a perspective view of a rotary cutting unit on the mower of FIG. 1 ; FIG. 3 is a perspective view of the components of a discharge deflecting chute of FIGS. 1 and 2 . FIG. 4 is a perspective view of components of another embodiment of a discharge deflecting chute of the present invention. DETAILED DESCRIPTION The mower of this invention is referred to generally by the reference numeral 10 and is seen to be a riding lawn mower in the drawings. Although the invention described herein is ideally suited for use with a riding mower, it is believed that the invention described herein also has applicability with respect to walk-behind mowers. Mower 10 includes a frame 12 having a pair of drive wheels 14 positioned on opposite sides of the frame means 12 at the rearward end of the mower. An internal combustion engine 20 is mounted on frame 12 . Engine 20 is operatively connected to a pair of hydraulic pumps which are operatively connected to hydraulic motors operatively connected to the drive wheels 14 , respectively. Mower 10 also includes an operator's station 27 and steering controls 27 ′. Mower 10 includes a mower deck 28 at the forward end thereof which includes a top wall 30 , front wall 32 , rear wall 34 , and opposite side walls 36 and 38 . Caster wheel assemblies 39 support the forward end of deck 28 . A stabilizer rod assembly connects the rearward end of the mower deck 28 to the frame means 12 in conventional fashion. Mower deck 28 is supported by a plurality of chain members 42 which are connected to a mower deck height control mechanism generally referred to by the reference numeral 44 to enable the mower deck to be raised or lowered with respect to the frame means 12 . A rotary cutting unit is shown installed on a mower 10 . Cutting deck 28 includes a downwardly facing cutting chamber which is defined by walls 32 , 34 , 36 , and 38 that extends downwardly from top wall 30 . As is well known in rotary cutting decks, this wall arrangement provides a generally enclosed cutting chamber which is enclosed over the sides and top thereof but is open at the bottom thereof. Rotary cutting blades are carried inside this cutting chamber and rotate in a generally horizontal cutting plane about a generally vertical rotational axis. Each rotary cutting blade has sharpened cutting edges which cut the grass as blade rotates in its cutting plane. The height of cut is determined by how far the blades are positioned above the ground which is, in turn, determined by the relative position of cutting deck on roller frame. A means for rotating the cutting blade within cutting chamber is provided on cutting deck 28 . This rotating means may comprise a pulley system. Alternatively, an individual electric or hydraulic motor may be utilized to power the cutting blades. Shroud wall 36 is provided with a grass discharge opening to allow grass clippings to exit through shroud wall 36 in some desired direction, i.e. to the side of cutting deck as shown in FIG. 1 or to the rear of cutting deck 28 . Referring now to FIGS. 2 and 3 , a discharge deflector assembly is indicated as numeral 50 . Discharge assembly 50 includes a sheet 52 and a frame assembly 54 for deforming sheet 52 into a chute shape and for connecting sheet 52 to the cutting deck 28 . Discharge assembly 50 is movably connected to mower deck 28 via a hinge connection 56 which permits the discharge assembly 50 to assume a guarded position as indicated in FIG. 2 , and an unguarded position (not shown) where the discharge assembly 50 has pivoted away from the ground surface about a pivot axis. When in the guard position, discharge assembly 50 is generally aligned with side discharge opening so that clippings are directed through an interior region of discharge assembly 50 . Discharge assembly 50 includes chute having a top surface 60 and a pair of side surfaces 62 , 64 . Top surface 60 is directed downwardly at an angle of approximately 5 degrees. Side surface 62 (which is in front of side surface 64 during operation) is generally perpendicular to top surface 60 , while side surface 64 is provided at a backwardly directed angle relative to top surface 60 to facilitate dispersal of clippings. This angle, which is greater than 90 degrees, is indicated as “α” in FIG. 3 . Side surface 62 has a lower edge 66 which is substantially closer to the turf surface than a corresponding lower edge of side surface 64 . The chute can assume a variety of different shapes. For example, the chute may have a top surface 60 and only a front side surface 62 . The chute may be configured as a portion of a cylinder, etc. Sheet 52 is supported by frame assembly 54 on one end and is unsupported at a free end 72 . Structural integrity is enhanced by formation of side surfaces 62 , 64 . Sheet 52 may be manufactured by a cutting a form out of a larger sheet of rubber material. Sheet 52 may be manufactured from a wide variety of natural and/or synthetic elastomeric products. A preferred material for sheet 52 is a rubber sheet having a thickness of approximately 0.3 inch, and being manufactured by Goodyear Manufacturing, Inc. Sheet 52 preferably has a width, W, of between 4 and 16 inches. Sheet 52 may have a total surface area of between 100 to 500 square inches. In a preferred embodiment, sheet 52 has a surface area of approximately 350 square inches. Sheet 52 may be selected from a variety of known resilient materials. Reinforced or laminated sheeting may be selected. The chute may contain stiffener elements, such as wires or thickened regions of rubber. The chute may be a molded, preformed component. For example, the chute may include an injection molded or thermal formed polymer part which is secured to frame 54 to provide support and maintain the chute in shape. Sheet 52 is formed into its chute shape by engagement with plate elements 80 , 82 of frame assembly 54 . Plate element 80 is generally U-shaped while plate element 82 is generally planar. Sheet element 52 is retained between plate elements 80 , 82 by fasteners 84 . FIG. 3 illustrates the various components of discharge assembly 50 prior to assembly. As the plate elements 80 , 82 are brought together during manufacture, sheet element 52 is formed into a predetermined shape by engagement with side elements 86 of plate element 80 . Frame assembly 54 may be considered a forming element for imparting a shape upon sheet element 52 . In a preferred embodiment, frame assembly 54 provides a clamping assembly for engaging and forming sheet element 52 into its chute shape. Frame assembly 54 includes a pair of frame arms 90 each connected at one end to plate element 80 . Hinge connection 56 includes frame arms 90 , pin 92 and cutting deck supports 96 . Pin 92 generally defines a hinge or pivot axis about which chute element 52 pivots. A biasing element 102 , here in the form of a torsion spring, provides a force tending to bias the deflector assembly into the guard position as indicated in FIGS. 2 and 3 . If the discharge assembly 50 contacts an obstruction during mowing operations, hinge connection 56 allows discharge assembly 50 to pivot upward into an “unguarded” orientation. Once discharge assembly 50 is clear of the obstruction biasing element 102 helps return the chute into its guard position. Aspects of another embodiment of the present invention are illustrated in FIG. 4 . Frame 54 includes a pair of brackets 100 defining a pair of configured surfaces 102 and a pair of hinge portions 104 . In this embodiment, the hinge connection is defined by the pair of hinge portions, a pin 92 , and the cutting deck supports 96 . In comparison to the embodiment of FIG. 3 , this alternative embodiment incorporates aspects of the plate element 80 and two frame arms 90 into a pair of bracket 100 forming part of the hinge connection and also deflecting the sheet element 32 into chute shape. The term “frame” as used herein and in the appended claims is to be defined in the broadest sense. For example, the “frame” as used herein means a structure used to shape and support the resilient sheet 52 of the present invention. A frame may assume a variety of different shapes, e.g. the frame be generally U-shaped or L-shaped. A frame utilized in the present invention may or may not include planar sections, e.g., sections of the frame could be curved in form yielding a corresponding curved portion of the attached resilient sheet. A frame may be manufactured of a variety of materials, including but not limited to metals, plastics, composites, etc. Preferably, a frame is of a rigid metal (rigid, relative to the resilient chute). A frame may comprise a single part or multiple parts. Sections of the frame may be selectively movable relative to other sections of the frame, e.g. a frame may include two or more parts which are hinged together. In an illustrated embodiment, frame 54 is used to shape and support sheet 52 proximate to one end of sheet 52 . In alternative embodiments, frame 54 may include additional supporting elements which extend outwardly away from deck 28 . In such an alternative embodiment, frame 54 may include elements which engage top surface 60 and/or a bottom surface opposite the top surface. Frame 54 in alternative embodiments may have elements which pass through other apertures of sheet 52 . Frame 54 may include elements at which sheet 52 is adhesively secured thereto. One of ordinary skill in the arts would appreciate that a variety of different frame 54 devices or assemblies would be practicable to implement the present invention. Other variants are possible without departing from the scope of the present invention. For example, more than one sheet element 52 may be utilized, or the frame 54 may be differently configured to impart a different shape to the discharge chute. Thus, the scope of this invention is to be limited only by the appended claims.

A method and apparatus for a resilient and flexible discharge deflecting chute of a lawn mower. A discharge deflecting chute utilizing a flexible sheet shaped into a chute-like form by a frame is disclosed. A flexible, resilient discharge deflecting chute is provided which has memory characteristics and returns to shape even after substantial deflection from obstacle contact. Preferably, a flexible, resilient material selected for this discharge deflecting chute has sufficient stiffness to substantially maintain its shape in normal operation. The flexible, resilient material selected for this discharge deflecting chute has sufficient flexibility to deflect substantially when contacted by obstructions during mowing operations.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to and benefit of a prior U.S. Provisional Application No. 60/901,853, Medicaments for Fungal Infections, by Antonio Cassone, filed Feb. 16, 2007. The full disclosure of the prior application is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention is in the field of medicaments useful for treatment of fungal infections. Particularly, the medicaments include vaccines or antibodies directed to Candida albicans mannoprotein 65 (CAMP65). BACKGROUND OF THE INVENTION [0003] Yeasts belonging to genus Candida comprise a number of species that are major pathogens for immunocompromised hosts. For instance, Candida albicans ranks fourth among the most common agents of bloodstream infections in the hospitalized, immunocompromised patient (Pfaller et al., 1998). The same fungus is a very frequent cause of mucosal, in particular vaginal, infections in otherwise normal subjects (Fidel and Sobel, 1996). The fungal factors which express the pathogenic potential of Candida spp. have been extensively investigated, but no definite factor has emerged as being solely responsible. Rather, a team of aggressive traits appears to cooperate, to a variable extent, in the different forms of candidiasis (Calderone and Fonzi, 2001; Cutler, 1991). [0004] In the context of Candida infections, cell wall mannoproteins (MPs) have been investigated as significant players in the host-parasite relationship. Being surface-located and secreted to the external milieu, MPs are thought to be involved in cell-cell recognition and response to stress factors. Particularly, MPs warrant consideration as potential aggressive factors and as a major target of host immune responses. This dual role can be best exemplified by the recognized capacity of some MPs to favour the adhesion of the fungus to host cell surface, i.e. the essential first step in pathogenicity and disease transmission, as well as by their nature of being critical targets of both humoral and cell-mediated immune (CMI) responses by the host (Cassone, 1989). Related to this, MPs are quite versatile, bi-functional molecules with double chemical entities, the saccharide and the protein, both of which are clearly involved in host-Candida relationship, since both can work as adhesins and both elicit antibodies during colonisation and infection (Mansour and Levitz, 2003). Antibodies against some MPs have been shown to be protective (Yuan et al., 1995), though other anti-MP antibodies have been shown to actually compete with protective antibodies (Bromuro et al., 2002). On the other hand, the CMI response, which is usually directed against the protein moiety of MPs, is promptly detectable in almost all healthy subjects, and is popularly considered to play a critical role in anti-Candida defense (Romani, 1997). [0005] Camp65 is a 65 kilodalton mannoprotein that has been the subject of some research (Cassone et al., 1998). It is present in the cell wall of both yeast and hyphal forms of C. albicans (Bromuro et al., 1994) and has been shown to be a main target of cell-mediated immune response against C. albicans (Nisini et al., 2001; Gomez et al., 2000; Torosantucci et al., 1991). There are some indications that both this response and antibodies collaborate in protecting the animal from systemic or mucosal C. albicans challenge (Mencacci et al., 1994, De Bernardis, 2006 #94). The CAMP65 gene was recently cloned and a recombinant, 46 kilodalton, 6-histidine tagged protein (Camp65p) expressed, which was as extensively recognized by the human lymphocytes in vitro as the native Camp65 (Nisini et al., 2001; La Valle et al., 2000). It possesses an RGD signature putatively involved in adhesion mechanisms (Calderone et al., 2000; Gale et al., 1998). [0006] However, the biological and virulence properties, if any, of this protein have never been formally investigated. Candida infections remain a substantial and difficult to treat threat, especially in immune-compromised individuals. Moreover, options for anti-fungal treatments are quite limited and resistance is becoming more common. [0007] In view of the above, a need exists for a treatments to prevent Candida infections or to help resolve active infections. A need remains for effective treatments against Candida infections on surfaces. The present invention provides these and other features that will be apparent upon review of the following. SUMMARY OF THE INVENTION [0008] We have now surprisingly found that CAMP65 is necessary both for adhesion, thereby confirming earlier research, but also for hyphal production. Hyphae are necessary for the fungus to be able to block clearance, and we have also found that the adhesion engendered by CAMP65 is associated with virulence, and we have discovered that it is possible to block both effects, thereby both weakening the ability of C. albicans to infect and reducing the resistance of the fungus to clearance. [0009] Thus, in a first aspect, the present invention provides the use of an antibody-like molecule specific for CAMP65p of Candida albicans in the manufacture of a medicament for the treatment or prophylaxis of a fungal infection. The present invention also provides medicaments comprising such antibody-like molecules. [0010] The infecting fungus will typically be Candida and, more especially, C. albicans , but may be any related fungus which expresses the CAMP65 protein, or such a closely related protein that anti-CAMP65 antibodies bind thereto. [0011] In a particularly preferred embodiment, the medicament of the invention is for the treatment or prophylaxis of a C. albicans infection. [0012] The medicaments of the invention are useful in both early stage and late stage infection, as well as prophylaxis, as blocking CAMP65 has the dual effect of blocking both adhesion and hyphal formation, so that it acts as a preventative measure for adhesion and persistence, helping to clear established infection, and also preventing hyphal formation and adhesion of the hyphae, which helps to prevent establishment of the infection and eases subsequent clearance of the infecting fungus. [0013] In a preferred embodiment, the invention comprises a composition including an antibody specific for CAMP65 or CAMP65p in a formulation for topical administration. For example, the composition can be CAMP65 compounded in a formulation such as a suppository, cream, paste, ointment, gels, or the like, e.g., for administration to a tissue surface of a patient. In certain embodiments, the formulation does not consist of an aqueous solution, e.g., suitable for parenteral administration. [0014] In a preferred embodiment, the invention can be a method of preventing adhesion of a fungus to a surface, e.g., by contacting a Candida sp. with an antibody-like molecule specific for CAMP65 in an amount sufficient to reduce adhesion of the Candida sp. to the surface as compared to adhesion of the Candida sp. without the contacting with the antibody-like molecule. As discussed below, an “antibody-like molecule” can be, e.g., an antibody, antibody fragment or peptide having sequences of a CAMP65 antibody variable region. In a more preferred embodiment, the Candida sp. is Candida albicans . In many embodiments, the surface upon which Candida adherence is inhibited is, e.g., a polymer surface, a cell surface, a tissue surface, an organ surface, an external surface of an animal, and/or the like. [0015] The medicaments of the invention, whilst being able to be prepared as injectables, will often be prepared as external applications. Suitable external formulations include pessaries, suppositories, flushes, creams, pastes, ointments, and gels, and such formulations will typically be made up with suitable excipients, such as vehicles, bulking agents, gelling agents and sterilants. [0016] The medicaments of the present invention may also comprise a further active ingredient, such as a further anti-fungal agent, for example. [0017] Preferred medicaments of the present invention comprise at least one further antibody-like molecule to another determinant of the fungus to be treated. The preferred fungus is C. albicans. [0018] In an alternative aspect, the present invention provides a vaccine for candidiasis comprising all or part of CAMP65 in an antigenic form, optionally together with an adjuvant and/or one or more further antigenic determinants from the fungus to be treated. [0019] The nature of the antigen-presenting molecule is not important, provided that it serves to stimulate an immunogenic response, and particularly an antibody response, against the CAMP65 molecule. [0020] Such vaccines will typically be formulated as liquids for injection. The injection type is not important, but will typically be intravenous. DEFINITIONS [0021] Unless otherwise defined herein or below in the remainder of the specification, all technical and scientific terms used herein have meanings commonly understood by those of ordinary skill in the art to which the present invention belongs. [0022] Before describing the present invention in detail, it is to be understood that this invention is not limited to particular devices or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. As used in this specification and the appended claims, the singular forms “a”, “an” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to “a component” can include a combination of two or more components; reference to “feed” can include mixtures of feed, and the like. [0023] Although many methods and materials similar, modified, or equivalent to those described herein can be used in the practice of the present invention without undue experimentation, the preferred materials and methods are described herein. In describing and claiming the present invention, the following terminology will be used in accordance with the definitions set out below. [0024] The term “antibody-like molecules” is used to indicate molecules which have binding specificity for a given substance. As used hereinabove, the specificity is for CAMP65, and the molecules can be human or animal antibodies, humanized antibodies, antibody fragments, such as Fab fragments, and engineered fragments of antibodies, as well as substances incorporating a domain or region corresponding to that of a variable region of an antibody specific for CAMP65. BRIEF DESCRIPTION OF THE DRAWINGS [0025] FIG. 1A to 1D panels show gels and micrographs associated with targeted disruption of the CAMP65 gene. 1A panels show Southern blot analysis: total digested chromosomal DNA was subjected to agarose gel electrophoresis and transferred to nylon membrane. The membrane was probed with a biotin-labeled CAMP65, RPS1 and URA3 DNA fragments, hybridized and detected as detailed in Experimental Procedures. 1B panels show Northern blot analysis: total RNA was extracted from exponentially growing cells cultured for 24 h at 37° C. in modified Lee's medium. Equal amounts of RNA were subjected to denaturant electrophoresis, blotted to Hybond-N membrane and hybridized with CAMP65, URA3 and rDNA probes, as specified in Experimental Procedures. 1C panels show Western blot analysis: concentrated supernatants of exponentially growing cells cultured for 24 h at 37° C. in modified Lee's medium were used as described in Experimental Procedures. Equal amounts of secreted proteins were subjected to immuno-blot analysis, reacted with 4C8 anti-Camp 65p monoclonal antibody, anti-mannan mAb AF1 and mouse anti-Camp65p polyclonal antiserum and detected as specified in Experimental Procedures. Electrophoretic mobility of purified, recombinant Camp65p (from pRLV130) (La Valle et al., 2000) and low range pre-stained marker (Biorad) is shown. 1D panels show Immunofluorescence analysis wherein wild type and CAMP65 mutants cells were grown in Lee's medium at 37° C. for 2 h and reacted with the anti-Camp65p mAb 4C8 and FITC-conjugate goat anti-mouse IgG as described in details in Experimental procedures. [0026] FIGS. 2A and 2B show that CAMP65 is required for hyphal morphogenesis and germ-tube formation. 2A panels show colony morphology of CAMP65 mutant strains on solid media. Mutant and wild type strains were plated in Spider and modified Lee's medium supplemented with uridine and incubated at 37° C. Peripheral hyphae morphologies after 3 days of growth of each strain on Lee's and Spider media are shown. The magnification bar corresponds to 0.8 mm. The chart at 2B shows germ tube formation rates for various CAMP65 mutant strains. Wild type and mutant strains were inoculated in uridine-supplemented M199 medium, incubated at 37° C. for 2 h and the percentage of germ tubes counted under the light optical microscope. Values are mean (±SD) of triplicate independent samples. * denotes a statistically significant difference (P<0.05, Student's t test, two tailed;) as compared to the wt strain, while ** denotes a statistically significant (P as above) difference as compared to het strains. NS denotes non significant as compared to the wt strain. [0027] FIGS. 3A and 3B charts show that Camp65p is required for adherence to the plastic. FIG. 3A , shows the relative adherence properties of various CAMP65 mutant strains. Each strain was inoculated in modified Lee's medium and incubated at 37° C. for 3 h in polystyrene wells. After washing, plastic-adherent cells were incubated in solid media for 24 h, colonies were counted and the results expressed as percentage of the inoculated cells. Values are mean (±SD) of triplicate independent assays. *denotes a statistically significant difference (P<0.05, Student's t test, two tailed) as compared to the wt strain; **denotes a statistically significant difference (P as above) as compared to both het and rev strains. FIG. 3B , shows inhibition of C. albicans adherence to plastic resulting from exposure to antibodies against Camp65p along with control data. Wild type C. albicans cells were incubated with the indicated IgG-rich fractions, purified from immune and non-immune mouse sera as specified in the Experimental Procedures. Values are mean (±SD) of triplicate independent determinations. * denotes a statistically significant difference (P<0.05, Student's t test, two tailed) as compared to the treatment with the non-immune serum, while ** denotes a statistically significant difference (P as above) as compared to the anti-Scw immune serum. NS, non significant. [0028] FIGS. 4A and 4B show experimental pathogenicity of CAMP65 mutants in mouse bloodstream infections. FIG. 4A shows Kaplan-Meyer curves of mouse survival following experimentally induced candidiasis. The virulence of mutant strains was compared to that of the wild type strain in an intravenous murine model of haematogenously disseminated candidiasis. CD2F1 mice (10 mice per group) were infected via tail vein with 5×10 5 yeast-form cells of C. albicans and animal survival was monitored for 30 days. The median survival times (MST, days) of the null mutant were significantly different (P<0.01, Mann-Withney U test, two tailed) between the null mutant and both the wt strain and the heterozygous strains. There was also a significant difference (P<0.05, as above) in the MST between the null mutant and the heterozygous strains. FIG. 4B shows kidney sections of infected mice. Kidney of mice challenged with wild type and mutant strains were removed from euthanized mice, 3 days post-challenge, fixed, dehydrated and stained with Grocott as described in the Experimental Procedures. The magnification bar corresponds to 0.6 mm and 30μ for the upper and lower panels, respectively. [0029] FIGS. 5A and 5B show experimental pathogenicity of C. albicans strains in a mucosal (rat vaginal) infection model. FIG. 5A shows CFU counts in the vaginal fluid from rats intravaginally infected with each strain and monitored up to 28 days. *denotes a statistically significant difference (P<0.05, Mann-Withney U test, two tailed) between the CFUs of the null mutant and those of both the parent and revertant strains. For other technical details, see Experimental Procedures. FIG. 5B shows cytological analysis of vaginal scraping taken from infected rats. Vaginal scrapings were taken 2 days after the challenge from rats infected with wild type, homozygous and revertant cells. Slides were stained with periodic acid-Schiff-van Gieson stain and observed under a light microscope. Representative fields were randomly selected and micro-photographed as described in the Experimental procedures. The magnification bar corresponds to 60 μm. DETAILED DESCRIPTION [0030] We constructed a series of CAMP65 knockout mutants that were investigated for their phenotype, growth characteristics, morphogenesis, adherence to plastic and pathogenicity. The CAMP65 knock-out mutants that were constructed included null camp65/camp65 and CAMP65/camp65 heterozygous strains. The null strains were viable and grew well in the yeast form but they were severely affected in hyphal morphogenesis both in vitro and in vivo. Hyphae formation was restored in revertant strains. The null mutants also lost adherence to plastic, and this was in keeping with the strong inhibition of fungal cell adherence to plastic exerted by anti-Camp65p antibodies. [0031] The null mutants were also significantly less virulent than the parental strains, and this loss of virulence was observed both in systemic and in mucosal C. albicans infection models. Nonetheless, the virulence in both infectious models was regained by the CAMP65 revertants. Thus, CAMP65 of C. albicans encodes a β-glucanase adhesin, which has a dual role (hyphal cell wall construction and virulence), accounting for the particular relevance of host immune response against this mannoprotein. [0032] Camp65p is a 65 kilodalton mannoprotein of C. albicans previously discovered and characterized as a main antigen target of anti-Candida immune response in humans (Gomez et al., 1996; Bromuro et al., 1994; Torosantucci et al., 1991). The CAMP65 gene encodes a 48 kDa protein with one N- and multiple O-glycosylation sites (La Valle et al., 2000) which belongs to a family of beta-glucanase or trans-glycosidase enzymes known to play a critical function in maintaining the integrity of the cell wall and its remodelling to ensure the correct form of growth (Klis et al., 2006; La Valle et al., 2000). Although no direct demonstration of enzymatic activity of Camp65p has been provided, the protein sequence analysed here has shown typical, essential motifs of the β-glucanase family of the fungal cell wall (Sestak et al., 2004). Moreover, the presence of this protein in C. albicans cell wall, its covalent binding with β-glucan and its function as a β-glucanase enzyme has recently been confirmed by a proteomic analysis of cell wall extract (de Groot et al., 2004). However, the biological role of this component has never been properly investigated. [0033] We have used the URA3 blaster protocol to disrupt one or both CAMP65 alleles, then assessed the physiological consequences of this disruption, in terms of morphogenesis, adherence and pathogenicity of the fungus. To avoid possible bias consequent to the ectopic insertion of the URA3 gene on CAMP65 gene expression, virulence and phenotype of the fungus, we targeted reinsertion of the URA3 gene to the RPS1 locus to generate a set of isogenic wild type, heterozygous, homozygous and revertant strains. Moreover, at least two independently-generated mutants were always obtained and analysed for their genetic traits, and biological properties: they showed absolutely similar behaviour in vitro as well as in vivo. [0034] Effective and specific gene disruption, demonstrated by Southern blotting analysis, as well as by both gene and protein expression in several controlled experiments, generated a CAMP65 null mutant which was fully viable and grew well as yeast but was severely affected in its capacity to develop hyphae on solid media. Since the heterozygous camp65/CAMP65 mutant showed only partial inability to form hyphae, a gene-dosage effect is likely, as verified with other genes involved in filamentation pathways like the HWP1 gene (Tsuchimori et al., 2000; Sharkey et al., 1999) or some pH-regulated genes coding for cell wall proteins (Saporito-Irwin et al., 1995). The specificity of the functional morphogenetic defect attributable to CAMP65 deletion was demonstrated by the rescue of full capacity of hyphae formation in the revertant heterozygous strain. The defective hyphal morphogenesis was confirmed by other experiments in liquid media, where formation of germ-tubes, i.e. the hyphae precursors, was significantly delayed or arrested in the homozygous mutant strain. Overall, the data demonstrates that CAMP65 is involved in the chain of metabolic and structural events that are necessary for correct hyphal formation. [0035] The fact that CAMP65 is necessary for correct hyphal formation makes previous studies relating hyphal development with pathogenicity relevant (Davis et al., 2000; Tsuchimori et al., 2000; Gale et al., 1998; Leidich et al., 1998; Lo et al., 1997; Stoldt et al., 1997; Saporito-Irwin et al., 1995; Liu et al., 1994), and this is borne out by the fact that the CAMP65 disrupted mutants were clearly less pathogenic than the parental strain in a model of lethal systemic infection. However, this null mutant was also significantly less pathogenic in a model of mucosal infection, an observation that has never been reported with other hyphae-defective mutants and which further demonstrates the attractiveness of CAMP65 as a main target. The observation that the CAMP65 gene plays also a role in mucosal virulence is relevant since the virulence traits which allow mucosal or deep-seated invasion may not be the same, and the mechanisms of host response against the two infections are also different (De Bernardis et al., 1993). [0036] As previously demonstrated and confirmed herein by a specific reaction with a monoclonal antibody, Camp65p is present on the fungal cell surface and may contribute to the adhesive properties of the fungus. In fact, the CAMP65 null mutants did not express the protein in the cell wall and were much less adhesive to plastic than the parental strains. C. albicans hyphae have pronounced adhesive properties, and it appears that the virulence of the wild type strain may be associated with Camp65p acting as an adhesin, as also suggested by the presence of an RGD signature in its sequence. The RGD motif characterizes various proteins of eukaryotic organisms involved in adhesion mechanisms, both as adhesins and as adhesin receptors (Calderone et al., 2000; Gale et al., 1998). Besides the observation made here that anti-Camp65p antibodies inhibit adherence of the fungus to plastic, we have recently obtained strong evidence that Fc-devoid, human domain antibodies against Camp65p inhibit Candida adherence to several human tissues, in addition to plastic (De Bernardis et al., 2006). [0037] Other soluble or glucan-bound cell wall proteins (for instance, HWP1 (Tsuchimori et al., 2000; Sharkey et al., 1999) and a Candida analogue of S. cerevisiae NOT5 gene (Cheng et al., 2003)) have been implicated in adherence and/or filamentation, but this is the first report that properties such as adherence, morphogenesis and pathogenicity are directly related to a β-glucanase enzyme, the role of which was previously attributed to cell wall degradation and remodelling. By the function of this protein, hyphal cell wall construction, adherence and virulence appear to be intimately interrelated. [0038] Besides their inherent capacity of tissue damage, hyphae of C. albicans have evolved a number of mechanisms to deviate and render host response inefficient. These include enhanced secretion of virulence enzymes degrading host proteins, antigenic variations and mimicry as well as perturbance of immune response initiated by dendritic cells (Soll, 2004; Torosantucci et al., 2004; d'Ostiani et al., 2000; Romani, 1997). Recently, the expression of Dectin-1 receptor has been demonstrated to be substantially lost on hyphal cells. Since Dectin-1 is important for phagocytosis, these observations led some authors to suggest that modulation of the above receptor is a further mechanism of immuno-evasion by C. albicans (Gantner et al., 2005). Interestingly, the dectin-1 receptor has been identified as a β-glucan molecule (Brown et al., 2003). [0039] Other virulence traits are expressed by pathogenic strains of C. albicans , inclusive of production of hydrolases and phospholipases (Calderone and Fonzi, 2001; De Bernardis et al., 2001; Sugiyama et al., 1999; Leidich et al., 1998; Cutler, 1991). Camp65p is a mannoprotein which represents a main target of the anti-Candida immune response in humans (Torosantucci et al., 1991). Several Camp65p specific human T cell clones have been generated and shown to express a typical T-helper type 1 response (Nisini et al., 2001), generally considered as essential for anti-Candida protection (Romani, 1997). General Approaches and Strategies [0040] The data described below refer to strains, mutant designation and molecular reagents for mutant construction as shown in Tables 1-3 (Examples Section, below for technical details). In the strategy of targeted CAMP65 gene disruption and re-insertion, two independently-generated mutants (i.e., two isolates for each mutant strain) were always obtained and analysed for both genetic and phenotypic traits. Since all results were totally comparable for each independently derived mutant, only the one is referred to in the following description for the sake of simplicity. To knock out CAMP65 gene, a wild type strain of C. albicans (CAI4) was initially transformed with KpnI-PstI-digested pRLV140 plasmid to release the disruption cassette CAMP65::hisG-URA3-hisG and target integration to the CAMP65 locus. After the first round of transformation, the CAMP65/camp65::hisG-URA3-hisG heterozygous strain (het1) was selected for the loss of the URA3 gene by growth on medium containing 5-FOA, and transformed again with the CAMP65::hisG-URA3-hisG disruption cassette to obtain the camp65::hisG/camp65::hisG-URA3-hisG homozygous strain (hom1). A revertant strain with CAMP65 re-insertion was also constructed (rev1, Table 1). To avoid any potential bias due to the ectopic insertion of a gene into the fungal cell (Brand et al., 2004) we, therefore, generated het2, hom2 and rev2 isogenic strains by targeted integration of URA3 at the RPS1 locus. As wild type strain, we used a wt1-derived strain, obtained by integration of URA3 at RPS1 locus (wt2; Table 1; for technical details, see also Experimental Procedures) (Murad et al., 2001). Although we noticed that the morphology, adherence to plastic and experimental pathogenicity of these isogenic strains did not substantially differ in any respect from the wt1, het1, hom1 and rev1 counterparts, the results shown here, unless otherwise stated, are those obtained with the isogenic wt2, het2, hom2 and rev2 strains. For the sake of simplicity, these strains will be hereafter designated as wild type (wt), heterozygous (het), homozygous (hom) and revertant (rev) strains, respectively. Targeted Disruption of the CAMP65 Gene [0041] Effective and specific gene disruption and re-insertion was demonstrated by PCR (data not shown) and Southern blotting analysis ( FIG. 1A ). To further confirm the CAMP65 gene disruption and revertant strain construction, we performed both Northern- and Western-blot analysis with total RNA and secreted protein, respectively, purified from C. albicans cells grown in modified Lee's medium at 37° C. for 24 h. As shown in FIG. 1B , the CAMP65 gene was transcribed at a lower level in the camp65/CAMP65 heterozygous strain, and not transcribed at all in the homozygous null mutant strain which, however, expressed rRNA at a wild type level. The same pattern of CAMP65 expression was evident by testing secreted proteins of the wild type and sequential mutant strains in immuno-blotting with the anti-Camp65p polyclonal serum or the anti-Camp65 monoclonal antibody 4C8 (Gomez et al., 1996) ( FIG. 1C ), i.e. decrease and absence of Camp65p in heterozygous and homozygous strains, respectively. [0042] As a further control, and because the mutant strains were endowed with different plastic adhesive properties (see below), the extract from each strain was subjected to Western blot with a monoclonal antibody (mAb AF1) (Cassone et al., 1988) recognising a mannan epitope common to different mannoprotein adhesins of C. albicans . As shown in FIG. 1C , all strains expressed polydisperse, high molecular weight mannoprotein constituents to a comparable level. Both in Northern- and Western-blot, the revertant strain recovered the ability to express CAMP65 ( FIGS. 1B , 1 C), thus proving the re-introduction in this strain of a functional CAMP65 gene. [0043] Finally, immunofluorescence studies with the Camp65p-specific 4C8 mAb showed the expected bright cell wall fluorescence in the parental strain whereas the homozygous null strain did not show any cell wall fluorescence, despite the presence of some background, non-specific fluorescence in the cytoplasm. Conversely, some weak fluorescence was detected in the cell wall of both the heterozygous and revertant strains ( FIG. 1D ). Similar results were obtained with polyclonal anti-Camp65p serum. [0044] It has already been reported that Camp65p from C. albicans is homologous to Scw10p from S. cerevisiae (La Valle et al., 2000), a member of the GH17 glycosyl-hydrolase (1-3-β-glucanase) family. Both of the glutamate residues Glu-326 and Glu-380 are conserved in all members of the GH17 family, being crucial for enzyme activity (Sestak et al., 2004). In order to assess whether they are present in Camp65p, we performed an amino acid alignment of barley 1,3-β-glucanase (Swiss-Prot primary accession number P15737), Bgl2p (P15703), Scw1p (Q04951) and Camp65p (Q9HEP1). Two glutamate residues in Camp65p sequence at the positions 319 and 371 were indeed found in Camp65p. This suggests that this mannoprotein is indeed a β1,3-glucanase involved in cell wall morphogenesis, as further documented below. CAMP65 is Required for Hyphal Morphogenesis [0045] The CAMP65 gene is non-essential, as demonstrated by the full viability of null mutants (see also below). However, the mutations severely impaired hyphal differentiation. As shown in FIG. 2A , the camp65/camp65 homozygous strain showed suppressed hyphal formation when compared with the CAMP65/CAMP65 wild type strain, and this was observed on both Spider and Lee's solid media. The CAMP65/camp65 heterozygous strain showed an intermediate phenotype, suggesting a gene dosage effect. To confirm that the mutant phenotype was directly associated with CAMP65 loss, the revertant strain was grown in the same media. The ability of this strain to form hyphae was indeed restored to a level comparable to that of heterozygous strain ( FIG. 2A ). Wild type and mutant strains were also compared for their ability to form germ tubes, the known precursors of mature hyphae, in M199 liquid medium: the camp65/camp65 null strain was clearly impaired in germ tube formation when compared to wild type, heterozygous and revertant strains ( FIG. 2B ). As an additional control, we verified that the inability of the CAMP65 mutant cells to differentiate into hyphal forms was not due to a generally defective growth rate and viability. In fact, no appreciable difference in the rate of growth in YPD medium at 25° C., a temperature allowing growth under yeast form, could be observed among strains. The same experiment was repeated in Spider and Lee's media at 25° C. and concentrated (2×) YPD at 37° C. and, again, no growth differences between wild type and CAMP65 mutants were observed (data not shown). Therefore, the inability to differentiate into hyphal forms is unlikely to result from a generic growth defect. CAMP65 Mutants are Defective in Adherence to Plastic [0046] We next examined the plastic adherence properties of the CAMP65 mutants, being these properties also critical for C. albicans pathogenicity in catheter-bearing, immunocompromised subjects (Cutler, 1991). We found that deleting both copies of CAMP65 had a significant effect on fungal adherence to polystyrene plates ( FIG. 3A , one typical experiment out of 3 performed with similar results). Conversely, the revertant strain adhered to the plastic to the same extent as the heterozygous strain, and both strains showed an intermediate defective phenotype compared with the wild type and homozygous cells. [0047] Since germ-tubes and hyphal forms have increased adhesive properties with respect to the yeast cells (Cutler, 1991), we performed a series of experiments to demonstrate that the expression of CAMP65 itself, and not hyphal differentiation, was necessary for adherence. To this end, we generated an antiserum against a purified, recombinant Camp65p (La Valle et al., 2000) and a purified IgG-rich fraction of it was tested for the capacity to affect adherence to plastic of yeast-form cells of the wild type strain. In these experiments, the equivalent IgG-rich fraction of an immune serum against the Scmp65p, i.e. the Camp65p homologous protein of S. cerevisiae , (Scw10p) (La Valle et al., 2000) was also used. IgG-rich fractions of non-immune and irrelevant immune serum served as negative controls. As shown in FIG. 3B (which refers to the data of one experiment out of two performed with similar results), the anti-Camp65p serum almost totally inhibited the adherence of yeast cells to plastic. Also, the IgG-rich fraction of the serum against Scmp65p caused some inhibition, whereas an irrelevant IgG-rich serum fraction did not differ from the IgG-rich fraction of a non-immune mouse serum in causing a very low, background inhibition of adherence (this background inhibition level could be due to the presence in mouse serum of some antibodies directed against other C. albicans adhesins). Overall, these experiments demonstrate that Camp65p plays a functional role in the adherence of C. albicans cells to the plastic, whatever the form of fungus growth. [0000] CAMP65 Mutants have Markedly Decreased Experimental Pathogenicity [0048] The effects of CAMP65 disruption on Candida virulence were evaluated. Thus, heterozygous, homozygous and revertant strains were first compared to the wild type strain in a lethal murine model of haematogenously disseminated candidiasis. CD2F1 mice were challenged with 5×10 5 yeast-form cells of each strain by the intravenous route and mouse mortality was followed for up to 30 days. All mice infected with the wild type strain succumbed to candidal infection within 7 days with a median survival time of 4 days. In contrast, almost 100% of mice infected with either heterozygous or homozygous strains were alive on day 7. These results show that Camp65p-producing cells were more virulent than non-producing cells and the virulence was gene-dosage dependent. Indeed, the median survival time (days) of mice infected with the heterozygous and revertant strains was 7 and 8 days, respectively, while the MST of mice infected with homozygous strain was 17 days. In particular, about 60% of mice infected with homozygous mutant cells were still alive on day 15 (P<0.05, two tailed). FIG. 4A graphically summarizes the earliest and most significant differences in mouse survival rates. Similar comparative results were obtained by testing virulence through enumeration of colony-forming units (CFU) in kidneys of mice infected with the same strains. [0049] Histology of the kidneys of mice infected with the wild type strain showed multiple foci of proliferating fungal hyphae together with infiltration of host inflammatory cells. On the contrary, the kidneys of mice infected by the homozygous mutant showed a few infected foci with much fewer fungal cells, associated with little or no morphological damage to the surrounding matrix. Moreover, the homozygous mutant cells presented aberrant-thicker forms that failed to form hyphae ( FIG. 4B ). [0050] In the self-healing mucosal model of infection (De Bernardis et al., 1993), the overall kinetics of fungus clearance from rat vagina was quite similar with all mutants and wild type strain. However, the early rate of clearance (day 0-7 interval) was significantly (P<0.05, Student's t test, two tailed) more accelerated when the challenger was the homozygous strain. Moreover, all rats challenged with this strain were infection-free (less than 1 CFU/μl of vaginal fluid) on day 28, while all rats challenged with the wild type and the revertant strains were still infected ( FIG. 5A ). Histological observation of vaginal scrapings taken from rats infected with each individual strain clearly documented that the homozygous strain did not develop hyphae in the rat vagina at a time (2 days post-challenge) when both the wild type and the revertant strains had fully developed hyphae ( FIG. 5B ). EXAMPLES [0051] The following examples are offered to illustrate, but not to limit the claimed invention. Example 1 Microorganisms and Growth Conditions [0052] Escherichia coli XL1 blue (endA1, hsdR17, supE44, thi1, recA1, gyrA96, relA1, Δlac, [F', proAB, lacIqZΔM15, Tn10] and M15 (nal S , str S , rif S , lac − , ara − , gal − , mtl − , F − , recA + , uvr + , [pUHA1]) were used as host strains for recombinant plasmids. E. coli strains were grown in L-broth (1% tryptone, 0.5% yeast extract, 0.5% NaCl, pH 7.0) and Luria Bertani (LB) plates (1% tryptone, 0.5% yeast extract, 0.5% NaCl, 1.5% agar, pH 7.0) supplemented when necessary with ampicillin (100 μg/ml) or tetracycline (12.5 μg/ml) (La Valle et al., 1995). [0053] Candida albicans strains used in this study are listed in Table 1. They were routinely cultured on Yeast-peptone-dextrose (YPD; 1% yeast extract, 2% bacto-peptone, 2% glucose, all w/v) or Yeast Nitrogen Base (YNB; 2% glucose, 0.17% yeast nitrogen base without amino acids and ammonium sulphate, 0.5% ammonium sulphate, w/v) or Winge (0.3% yeast extract, 0.2% glucose) or SDB (1% bacto-peptone, 2% dextrose) media at 28° C., as indicated in specific sections. All media were solidified with 2% agar and supplemented when necessary with uridine (25 μg/ml) and 5-fluoroorotic acid (5-FOA, 1 mg/ml) and chloramphenicol (50 μg/ml) (Sharkey et al., 1999). [0000] TABLE 1 C. albicans strains described herein (all strains derived from SC5314 except ATCC20955). Nomenclature Source used in this Strain Parent Genotype or ref. study SC5314 Clinical isolate SC SC5314 collection CAI-4 CAF2-1 Δura3::imm434/Δura3::imm434 (Saporito- — Irwin et al., 1995) CAI12 CAI-4 Δura3::imm434/URA3 (Porta et al. wt1 1999) RLVCA4 CAI-4 as CAI-4 but Herein het1 camp65::hisG-URA3-hisG/CAMP65 RLVCA8 RLVCA4 as CAI-4 but Herein het1 ura3 camp65::hisG/CAMP65 RLVCA31 RLVCA8 as CAI-4 but Herein hom1 camp65::hisG/camp65::hisG-URA3-hisG RLVCA35A RLVCA31 as CAI-4 but Herein hom1 ura3 camp65::hisG/camp65::hisG RLVCA57E RLVCA35A as CAI-4 but camp65:: Herein rev1 hisG/camp65::hisG::CAMP65::URA3 NGY152 CAI-4 as CAI-4 but (Murad wt2 RPS1/rps1::CIp10 et al., 2001) RLVCA95 RLVCA8 as CAI-4 but Herein het2 camp65::hisG/CAMP65, RPS1/rps1::CIp10 RLVCA96 RLVCA35A as CAI-4 but Herein hom2 camp65::hisG/camp65::hisG, RPS1/rps1::CIp10 RLVCA97 RLVCA35A as CAI-4 but Herein rev2 camp65::hisG/camp65::hisG, RPS1/rps1::CIp10 - CAMP65 ATCC20955 Clinical isolate ATCC ATCC20955 collection [0054] Hyphae formation (filamentation) on agar-solidified media was obtained by diluting stationary-phase cells to 2×10 8 cells/ml in water, spotting 1×10 6 cells onto Medium 199, Lee's, Spider and serum plates, and incubating them at 37° C. for 7 days. Solid medium 199 (M199 cat. n o 31100-019, Invitrogen Corporation, Carlsbad, Calif.) was buffered with 150 mM Tris (pH 7) as previously described (Sharkey et al., 1999). Solid Spider, serum and modified Lee's medium were prepared as described previously (Liu et al., 1994). [0055] Germ-tube formation was assessed at 37° C. in M199, modified Lee's, Spider and serum media following inoculation of stationary-phase cells into pre-warmed broth at a density of 10 8 cells/ml. Negative controls were incubated in the same medium at 28° C. Cells were counted in a Thoma chamber. [0056] All chemicals and antibiotics were from Roche Diagnostic (Perkin Elmer Roche, Branchburg, N.J.) and Sigma-Aldrich (Milano, Italy). Microbiological powders (except M199) were from Becton Dickinson (Becton Dickinson & Co., Sparks, Md.). Example 2 Plasmid and Strain Construction [0057] To construct the CAMP65 disruption plasmid, the 3.8 kb fragment, obtained by BamHI-Bgl II digestion of p5921 (Fonzi and Irwin, 1993), was cloned into the BclI sites of pRLV139 (La Valle et al., 2000) in order to delete a 348 bp fragment of CAMP65 (spanning from nucleotide 150 to 498 of coding sequence) and insert the hisG-URA3-hisG marker thus constructing the pRLV140 plasmid. The pRLV140 construct was then digested with KpnI and PstI, and used to transform the ura− C. albicans strain CAI4 (wild type) by a lithium acetate-based transformation protocol as described elsewhere (Fonzi and Irwin, 1993). Ura+ prototrophs were selected on YNB medium. The heterozygous CAMP65/camp65::URA3 strain RLVCA4 (het1) was plated onto 5-FOA-containing YNB plates to obtain the ura3 heterozygous RLVCA8 strain (het1 ura3). A second cycle of disruption was performed to generate URA3 homozygous CAMP65 strain RLVCA31 (hom1), which was then subjected to a second cycle of 5-FOA selection to create ura3 RLVCA35A strain (hom1 ura3). [0058] To construct the revertant strain, we first produced the pRLV161 plasmid by amplifying CAMP65 locus with Ca72 and Ca73 oligonucleotides, as described below, and cloning into the pGEM-T vector (Promega, Madison, Wis.). The pRLV161 plasmid was digested with SacI restriction enzyme and the CAMP65 locus was cloned into the SacI site of the pSMS44 plasmid (Porta et al., 1999), to give pRLV162. The pRLV162 plasmid was then digested with BstXI restriction enzyme and the linearized plasmid was used to transform hom1 ura3 strain. Finally, URA3 revertant strain RLVCA57E (rev1) was selected on YNB. [0059] To construct purely isogenic strains and avoid potential problems associated with the ectopic expression of URA3strains, the het1 ura3 and the hom1 ura3 strains were transformed with NotI-digested CIp10 plasmid (GenBank accession number AF181970) (Murad et al., 2000) to create the strains RLVCA95 (het2) and RLVCA96 (hom2), respectively. To construct a revertant strain, pRLV161 plasmid was digested with ApaI and SalI restriction enzymes to excise the 2087 bp fragment containing the CAMP65 locus. This was therefore cloned into the ApaI/SalI sites of the CIp10 plasmid to obtain pRLV169 plasmid. The hom1 ura3 strain was then transformed with BglII digested pRLV169 plasmid to give pRLVCA97 revertant strain (rev2). As wild type strain, we used the NGY 152 strain (wild type2, CAI-4 transformed with StuI-digested CIp10 plasmid) (Murad et al., 2000). [0060] All recombinant plasmid inserts were fully sequenced with automated method (Genenco, Florence, Italy) by using primers flanking the poly-linker region of the vector as well as internal primers. Table 2 lists all plasmids and gene inserts used throughout this study. In the strategy of target CAMP65 gene disruption and re-insertion, at least two independently generated mutants were always obtained and analysed for both genetic and phenotypic traits. Since all results were totally comparable for each independently derived mutant, only one is referred to in the following description. Total chromosomal DNA was isolated with GFX Genomic Blood DNA Purification kit (Amersham Pharmacia Biotech Inc., Piscataway, N.J.), digested with BamHI-HindIII or BamHI to analyse CAMP65 or URA3 and RPS1 loci respectively, subjected to agarose gel electrophoresis and transferred to Hybond-N membrane (Amersham). The filters were probed with biotin-labeled DNA fragments obtained by BamHI-PvuII digestion of the pRLV130 plasmid (La Valle et al., 2000), BamHI-BglII or EcoRI-NotI digestion of Cip10 to release the 516 bp CAMP65-, 693 bp RPS1- or 586 bp URA3-fragments, respectively. The probes were labelled with North2South Biotin Random Prime Kit (Pierce, Rockford, Ill.) and purified with MicroSpin G-25 column (Amersham), while hybridisation and detection were performed with North2South Chemiluminescent Nucleic Acid Hybridisation and Detection Kit (Pierce). All enzymes were from Roche Diagnostic. [0000] TABLE 2 Plasmids used in methods described herein. PLASMID VECTOR INSERT Source or Ref. pRLV130 PDS56 (La Valle CAMP65 cds (La Valle et al., 1995) et al., 200 pRLV139 PBLUEScript CAMP65 cDNA (La Valle et al., 200 pRLV140 PBLUEScript camp65::hisG- Herein URA3-hisG pRLV161 pGEM-T CAMP65 locus Herein pRLV162 pSMS44 (Porta CAMP65 locus Herein et al., 1999) pRLV169 CIp10 (Murad CAMP65 locus Herein et al., 2000) indicates data missing or illegible when filed Example 3 Polymerase Chain Reactions (PCR) [0061] To amplify CAMP65 locus for cloning, PCR reactions were performed on a Gene Amp PCR System 9600 apparatus (Perkin Elmer Roche), in a volume of 100 μl containing 20 mM Tris-HCl pH 8.8, 10 mM KCl, 2 mM MgSO 4 , 10 mM (NH 4 ) 2 SO 4 , 1% Triton X-100, 1 mg/ml nuclease-free BSA, 200 μM of each deoxynucleotide, 0.5 μM of each primer (Table 3), 5 unit of native Pfu DNA polymerase (Stratagene, La Jolla, Calif., USA) and 100 ng of fungal DNA that was purified with GFX Genomic Blood DNA Purification kit (Amersham, Pharmacia). PCR was done using the following protocol: initial denaturation at 95° C. for 45 s followed by 25 cycles of denaturation at 95° C. for 45 s, annealing at 49° C. for 45 s, extension at 72° C. for 4 (for Ca72 and Ca73) and final extension at 72° C. for 10 min. To control the CAMP65, URA3 and RPS1 loci in wild type and mutant strains, the general protocol described above was used with the following little differences: the final volume of reaction was 20 μl; PCRs were performed with 200 ng of genomic DNA as template and Taq DNA polymerase (Invitrogen); the protocol was 2 min of denaturation at 94° C. followed by 35 cycles of denaturation at 94° C. for 45 s, annealing at 50° C. for 30 s (with Cal 16/Ca117 and Cal 16/Ca119 primers to amplify URA3 and Ura3-Rps1 loci, respectively) or at 46° C. for 2 min (with Ca64/Ca65 primers to amplify CAMP65 locus), extension at 72° C. for 2 min—followed by a final extension at 72° C. for 10 min. [0000] TABLE 3 Sequence and localisation of oligonucleotides described herein. SEQ Oligo- ID Local- nucleotide 5′ to 3′ sequence a NO isation Ca64 AACGGATCC ATGTTATTCAAGTCT 1 2067-2084 b TTC Ca65 GGGCTGCAG GTGCTTAGTTAGAGT 2 3207-3191 b AA Ca72 ATAGAGCTC GTGCGAAATTCGTCT 3 1483-1501 b AAT Ca73 CTTGGTACC CGATGACTTCTAACT 4 3483-3462 b CTTTCT Ca116 GCTGTAGTGCCATTGATTCGTAAC 5  843-866 c Ca117 CTGGATCTCTTCCTTTACCAAAC 6 1868-1846 c Ca119 CATGGAGGCCTCATGGTTTGGATT 7 2573-2548 c TC a The underlined sequences (non complementary flanking regions) contain the restriction site (in boldface) to clone the DNA fragment in the vector. b Oligonucleotide position is referred to orf 6.1672 (CAMP65 coding sequence spans from 2067 to 3203) (La Valle et al., 2000). c Oligonucleotide position is referred to CIp10 plasmid sequence (GenBank accession number AF181970) (Murad et al., 2000). Example 4 Northern Blot [0062] Total RNA from C. albicans cells grown at 37° C. for 24 h in uridine-supplemented, modified Lee's medium was isolated by RNeasy midy kit (Qiagen Hilden, Germany). Approximately 10 μg of RNA per lane was run on denaturing 1.2% formaldehyde-agarose gel, transferred to nylon membrane and probed with a biotin-labeled CAMP65 and URA3 fragments (see above) and rDNA as previously described (Sandini et al., 2002). Hybridisation and detection were performed with North2South Chemiluminescent Nucleic Acid Hybridisation and Detection Kit (Pierce). Example 5 Immunoblotting [0063] Cultures were grown at 37° C. for 24 h in 100 ml of modified Lee's medium supplemented with uridine. Supernatant from each culture was dialysed and concentrated approximately 100-fold using centrifuge filter units equipped with Biomax-5K membranes (Millipore, Bedford, Mass., USA). Concentrated samples (4 μg of proteins) were separated by SDS-PAGE on 10% polyacrylamide gels and then electro-transferred to nitrocellulose membranes (Biorad, Hercules, Calif., USA) as previously described (Sandini et al., 1999). Non-specific binding of antibodies to nitrocellulose was prevented by blocking the filters with 3% bovine serum albumin in Tris-buffered saline (TBS) for 2 h at 37° C. After three washes (10′ each) with TBS, 0.05% Tween20 (TBST), membranes were incubated with mouse anti-Camp 65p polyclonal serum (La Valle et al., 2000) (diluted 1:5.000 in TBS, BSA 3%) or anti-mannan monoclonal antibody (mAb) AF1 (Cassone et al., 1988) (diluted 1:20 in TBS, BSA 3%), overnight at 4° C. and reacted with alkaline phosphatase (AP)-conjugate goat anti-mouse IgG (1:15.000) (Sigma) or with AP-conjugate goat anti-mouse IgM (1:30.000) (Sigma), for 2 h at room temperature (RT), respectively. After rinsing three times with TBST, the membranes were placed in BCIP/NBT visualisation solution (Ausubel F M, 1996) and the reaction was stopped in distilled water. Example 5 Growth Curves [0064] 50 ml of YPD medium (1× or 2×), Spider and Lee's media supplemented with uridine were inoculated with an overnight culture of each strain (wild type and MP65-mutants strains) at 0.1 initial optical density (OD 600 ) and were shaken in an orbital incubator at 28° C. or 37° C. Growth was measured spectrophotometrically at 600 nm (Hube et al., 1997; Lo et al., 1997; Sanglard et al., 1997). Example 6 Immunofluorescence Assay [0065] The wild type and CAMP65 mutants cells were grown overnight in Winge medium at 28° C., washed twice with water, resuspended at 10 7 c/ml in LEE+U and grown at 37° C. for 2 h for hyphae induction. The cells were washed twice with PBS and resuspended in half volume in the same buffer. Then, 301 of each cell suspension were spotted onto the wells (each sample in duplicate) and dried. The cells were incubated with the anti-Camp65p mAb 4C8 (1:10) for 1 h in ice. After three washes with cold PBS, the cells were incubated in ice for 1 h in the dark, with FITC-conjugate goat anti-mouse IgG (1:64) (SIGMA). After three washes, the samples were examined under the fluorescence microscope. Negative controls consisted of cells stained in presence of a mAb with irrelevant specificity (directed against Bacteroides fragilis ) and then incubated with FITC-labeled secondary antibody or cells stained with FITC-labeled secondary antibody alone. Example 7 Microscopy and Imaging [0066] The patches and cells were imaged through the agar containing plastic petri dish and slides respectively with Nikon EclipseE800 (Nikon Corporation, Tokio, Japan). Nikon Coolpix 995 was used to capture images (Nikon Corporation). Images were imported in Adobe Photoshop 7 (Adobe System Incorporated, San Jose, Calif.), converted to grayscale, enhanced in contrast and filtered to remove noise. The size of the final image was reduced and then cropped images were assembled into figures using Canvas 9 (Deneba, Miami, Fla.). Example 8 Adherence Assay [0067] Fungal cells were grown for 24 h at 28° C. in YNB broth (0.5% glucose, 0.67% YNB dehydrated), washed twice with water and suspended at 1.5×10 3 cells/ml in modified Lee's or M199 liquid media. 1.5×10 3 cells were incubated for 3 h at 37° C. in 6-well polystyrene plates (Corning Incorporated, Corning, N.Y., USA). After extensive washing, 1 ml of Sabouraud dextrose agar was poured in each well and allowed to solidify. After incubation at 37° C. for 24 h, colonies were counted and the results expressed as percentage of the inoculum. The inoculum size of each cell suspension was confirmed by plating aliquots of the culture directly in Sabouraud dextrose agar plates. To test the inhibitory effects of antibodies on adherence, the cells were washed three times in 0.85% NaCl, then pre-incubated for 2 h at 37° C. with 50 μg of IgG-rich fractions separated (Melon Gel IgG Spin purification kit; Pierce) from non-immune, anti-Camp65p (La Valle et al., 2000), anti-Bft1p (the B. fragilis toxin)(Sandini et al., 2001) and anti-Scw10p (the S. cerevisiae homologous of Camp65p;)(La Valle et al., 2000) hyperimmune mouse antisera. The incubation mixtures were therefore transferred to polystirene wells, allowed to adhere to plastic for 3 h at 37° C., and adherence measured as reported above. Example 9 Systemic Infection of Mice [0068] Strains of C. albicans were pre-grown overnight in Winge, streaked onto SDA plates supplemented with chloramphenicol (50 μg/ml) and incubated for two days at 28° C. Cells were harvested, washed, counted and suspended to a density of 5×106 cells/ml in sterile phosphate-buffered saline (PBS) and ten CD2F1 female mice (18-21 g, Charles River Laboratories, Wilmington, Mass.) per each C. albicans strain, were administered intravenously 0.1 ml of the suspension. Seven mice of each group were observed daily for 30 days to monitor the survival. Three mice of each group were sacrificed three days post-infection, the left and right kidneys were removed and used for colony forming unit (CFU) determination and histopathological observations, respectively. The left kidneys were homogenized in 10 ml of saline and serial dilutions plated on SDA supplemented with chloramphenicol (see above). The plates were incubated at 37° C. for 48 h, after which CFU was determined. Values were expressed as log CFU/kidney of tissue homogenized. Colonies were then streaked onto CHROMagar Candida plates to confirm identification. [0069] For histological observation, the right kidneys were removed from mice and immediately fixed in 10% (vol/vol) neutral buffered formalin. After de-hydration in ethanol, clearing with Noxil (Italscientifica, Italia), and paraffin embedding, 6 μm-thick sections were stained with Grocott stain (BioOptica) and observed under a light microscope. The images were captured with Nikon Microphot-Fx and Arkon software at different magnifications, imported in Adobe Photoshop 7 and then assembled into figures using Canvas 9. Example 10 Rat Vaginal Infection [0070] Oophorectomized female Wistar rats (80-100 g, Charles River Breeding Laboratories, Calco, Italy) were used throughout this study. Animal maintenance and overall care were as described elsewhere (De Bernardis et al., 1999; Ghannoum and Abu Elteen, 1986). All rats were maintained under pseudoestrus by injection of estradiol benzoate (Amsa Farmaceutici srl, Rome, Italy). Six days after the first estradiol dose, the animals were inoculated intravaginally with 10 7 yeast cells in 0.1 ml of saline solution. The number of cells in the vaginal fluid was counted by culturing 10 μl samples (using calibrated plastic loop, Disponoic, PBI, Milan, Italy) taken from each animal, on Sabouraud agar plate containing chloramphenicol (50 μg/ml) as previously described (De Bernardis et al., 1999; Ghannoum and Abu Elteen, 1986). The rat was considered infected when at least 1 CFU was present in the vaginal lavage, i.e. a count of ≧10 3 CFU/ml. Other vaginal samples were also stained by periodic acid-Schiff-van Gieson method for microscopic examination. Example 11 Statistics [0071] Quantitative data were assessed by both parametric and non-parametric statistics, as requested, and indicated in specific experiments. The significance was set at P<0.05, two tailed. [0072] It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and scope of the appended claims. [0073] While the foregoing invention has been described in some detail for purposes of clarity and understanding, it will be clear to one skilled in the art from a reading of this disclosure that various changes in form and detail can be made without departing from the true scope of the invention. For example, many of the techniques and apparatus described above can be used in various combinations. 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J. and Brown, A. J. (2000) CIp10, an efficient and convenient integrating vector for Candida albicans . Yeast. 16: 325-327. Murad, A. M., Leng, P., Straffon, M., Wishart, J., Macaskill, S., MacCallum, D., et al (2001) NRG1 represses yeast-hypha morphogenesis and hypha-specific gene expression in Candida albicans . Embo J. 20: 4742-4752. Nisini, R., Romagnoli, G., Gomez, M. J., La Valle, R., Torosantucci, A., Mariotti, S., et al (2001) Antigenic properties and processing requirements of 65-kilodalton mannoprotein, a major antigen target of anti-Candida human T-cell response, as disclosed by specific human T-cell clones. Infect Immun. 69: 3728-3736. Pfaller, M. A., Jones, R. N., Doern, G. V., Sader, H. S., Hollis, R. J. and Messer, S. A. (1998) International surveillance of bloodstream infections due to Candida species: frequency of occurrence and antifungal susceptibilities of isolates collected in 1997 in the United States, Canada, and South America for the SENTRY Program. The SENTRY Participant Group. J Clin Microbiol. 36: 1886-1889. Porta, A., Ramon, A. M. and Fonzi, W. A. (1999) PRR1, a homolog of Aspergillus nidulans palF, controls pH-dependent gene expression and filamentation in Candida albicans . J Bacteriol. 181: 7516-7523. Romani, L. (1997) The T cell response against fungal infections. Curr Opin Immunol. 9: 484-490. Sandini, S., d'Abusco, A. S., La Valle, R. and Pantosti, A. (2001) Production of a mouse antiserum to Bacteroides fragilis enterotoxin using a recombinant enterotoxin precursor. Clin Diagn Lab Immunol. 8: 190-191. Sandini, S., Melchionna, R., Bromuro, C. and La Valle, R. (2002) Gene expression of 70 kDa heat shock protein of Candida albicans : transcriptional activation and response to heat shock. Med Mycol. 40: 471-478. Sandini, S., Melchionna, R., Arancia, S., Gomez, M. J. and La Valle, R. (1999) Generation of a highly immunogenic recombinant enolase of the human opportunistic pathogen Candida albicans . Biotechnol Appl Biochem. 29 (Pt 3): 223-227. Sanglard, D., Hube, B., Monod, M., Odds, F. C. and Gow, N. A. (1997) A triple deletion of the secreted aspartyl proteinase genes SAP4, SAP5, and SAP6 of Candida albicans causes attenuated virulence. Infect Immun. 65: 3539-3546. Saporito-Irwin, S. M., Birse, C. E., Sypherd, P. S, and Fonzi, W. A. (1995) PHR1, a pH-regulated gene of Candida albicans , is required for morphogenesis. Mol Cell Biol. 15: 601-613. Sestak, S., Hagen, I., Tanner, W. and Strahl, S. (2004) Scw10p, a cell-wall glucanase/transglucosidase important for cell-wall stability in Saccharomyces cerevisiae . Microbiology. 150: 3197-3208. Sharkey, L. L., McNemar, M. D., Saporito-Irwin, S. M., Sypherd, P. S, and Fonzi, W. A. (1999) HWP1 functions in the morphological development of Candida albicans downstream of EFG1, TUP1, and RBF1. J Bacteriol. 181: 5273-5279. Soll, D. R. (2004) Mating-type locus homozygosis, phenotypic switching and mating: a unique sequence of dependencies in Candida albicans . Bioessays. 26: 10-20. Stoldt, V. R., Sonneborn, A., Leuker, C. E. and Ernst, J. F. (1997) Efg1p, an essential regulator of morphogenesis of the human pathogen Candida albicans , is a member of a conserved class of bHLH proteins regulating morphogenetic processes in fungi. Embo J. 16: 1982-1991. Sugiyama, Y., Nakashima, S., Mirbod, F., Kanoh, H., Kitajima, Y., Ghannoum, M. A. and Nozawa, Y. (1999) Molecular cloning of a second phospholipase B gene, caPLB2 from Candida albicans . Med Mycol. 37: 61-67. Torosantucci, A., Gomez, M. J., Bromuro, C., Casalinuovo, I. and Cassone, A. (1991) Biochemical and antigenic characterization of mannoprotein constituents released from yeast and mycelial forms of Candida albicans . J Med Vet Mycol. 29: 361-372. Torosantucci, A., Romagnoli, G., Chiani, P., Stringaro, A., Crateri, P., Mariotti, S., et al (2004) Candida albicans yeast and germ tube forms interfere differently with human monocyte differentiation into dendritic cells: a novel dimorphism-dependent mechanism to escape the host's immune response. Infect Immun. 72: 833-843. Tsuchimori, N., Sharkey, L. L., Fonzi, W. A., French, S. W., Edwards, J. E., Jr. and Filler, S. G. (2000) Reduced virulence of HWP1-deficient mutants of Candida albicans and their interactions with host cells. Infect Immun. 68: 1997-2002. Yuan, R., Casadevall, A., Spira, G. and Scharff, M. D. (1995) Isotype switching from IgG3 to IgG1 converts a nonprotective murine antibody to Cryptococcus neoformans into a protective antibody. J Immunol. 154: 1810-1816.

The protein CAMP65p of C. albicans has been found to be play a significant role in both adhesion and the production of hyphae, which are important factors in both virulence and resistance to clearing. This invention provides antibodies to CAMP65p useful for administration to patients for prophylaxis and treatment of candidal infections.

TECHNICAL FIELD OF THE INVENTION [0001] This invention concerns a pharmaceutical tablet system capable of prolonged floating in or on gastric fluid for releasing therein one or more pharmaceutically active substances in the course of an alternate succession of periods of substance release and no-release, said alternate succession including at least two periods of substance release separated by one period of no-release i.e. of latency. This invention also concerns a process of producing said pharmaceutical tablet system and a process of producing a cup-shaped envelope of said pharmaceutical tablet system. BACKGROUND ART [0002] For an overall view of the field of the art to which the invention pertains, reference may be made for instance to Moës A. J., “Gastroretentive Dosage Forms”, Critical Reviews in Therapeutic Drug Carrier Systems 10(2):143-195 (1993), and also to Singh B. N. et al., “Floating drug delivery systems: an approach to oral controlled drug delivery via gastric retention”, Journal of Controlled Release 63(3):35-259 (2000). [0003] Pharmaceutical tablet systems capable of prolonged floating in or on gastric fluid e.g. so as to have a long time of residence in a patient's stomach for releasing therein a pharmaceutically active substance in sustained manner are known in the art. Generally, pharmaceutical forms having a long time of residence in a patient's stomach are of great interest, not only because they allow a local treatment of the patient's stomach wall and more particularly of the gastric mucous membrane, but also and above all because they allow to release active substance in the vicinity of the patient's duodenum, which is a very favourable location of the gastro-intestinal tract where a great many active substances are best absorbed. [0004] There are several approaches for bringing about a prolonged time of residence in the stomach. [0005] A tablet system can be formulated so as to adhere to the gastric mucous membrane (cf. for instance U.S. Pat. No. 5,213,794, U.S. Pat. No. 5,571,533, WO-A-93/24124, WO-A-98/42311, WO-A-98/52547). A major drawback of such adhering systems resides in the difficulty of bringing about that they reliably adhere and remain adherent to the gastric mucous membrane, for the latter is continually undergoing changes and replacement processes and is also subject to the peristalsis i.e. to strong contractions that take place at the stomach wall. In respect of adherence to the gastric mucous membrane no helpful knowledge can be derived from currently used pharmaceutical forms designed to adhere e.g. onto nasal or buccal surfaces, because such forms need to be pressed onto said surfaces at application time, which pressing is not possible onto a patient's gastric mucous membrane, to say nothing of the hazard of the forms getting stuck in the patient's esophagus. [0006] A tablet system can also be formulated to have a high apparent density that, following ingestion, will cause the system to settle in the stomach at the lower portion of the antrum (cf. for instance U.S. Pat. No. 4,193,985, U.S. Pat. No. 5,374,430). However, the movement of substances contained in the stomach towards the lower portion of the antrum participates in the natural sequence of events related to gastric discharge and hence, pharmaceutical forms formulated so as to settle in the antrum are likely to pass the patient's pylorus either with the bolus (during the digestion process) or together with undigested debris (in the time interval between two successive digestion processes). Thus, to secure the gastroretention of systems formulated so as to have a high apparent density, such systems must additionally be given some properties that will promote the gastroretention, which will raise again the problems already discussed above. Indeed, in EP-A-526862 a granulate is disclosed that not only has a high density but also is given muco-adhesive properties. [0007] A tablet system can also be formulated so as to grow in the stomach, following ingestion, to a size large enough to hinder the system from passing the patient's pylorus even when the latter is open. A great many of these systems are either folded at ingestion time and made to unfold and open out in the stomach following ingestion (cf. for instance EP-A-202159, U.S. Pat. No. 4,735,804, U.S. Pat. No. 4,758,436, U.S. Pat. No. 4,767,627, U.S. Pat. No. 5,002,772) or they are made to swell in the stomach following ingestion, for example as a result of gelling (cf. for instance U.S. Pat. No. 4,434,153, U.S. Pat. No. 5,651,985) or carbon dioxide emission (cf. for instance U.S. Pat. No. 4,996,058, WO-A-98/31341). However, systems formulated to swell could easily pass the patient's pylorus during the latency period that runs from ingestion time until the system has grown to a sufficient size for the gastroretention mechanism to become effective. On the other hand, systems formulated to unfold and open out in the stomach might well be retained permanently in the stomach or even in the esophagus, due to early activation of the deployment mechanism. Each of such failure cases will cause severe secondary effects. [0008] A tablet system can also be formulated with agents that delay or slow down the transit through the stomach, such as lipid-based vehicles (for instance, fatty acids) or depressors of the central nervous system (for instance, serotonine antagonists). These agents bring about a reduction of the stomach motility, which in turn slows down the gastric discharge. Such a way of bringing about gastroretention is most often used in association with other ways (cf. for instance WO-A-97/47285). However, as systems that bring about a reduction of the stomach motility interfere with the whole mechanism of gastric discharge, they are likely to cause digestion problems or worsen them, if already existing. Furthermore, the use of a serotonine antagonist has to comply with pertaining health and drug regulations. [0009] Hence, all known tablet systems of the above mentioned types must be deemed unreliable in respect of providing a prolonged time of residence in the stomach and therefore, they all are unsuitable for providing reliably an alternate succession of periods of substance release and no-release with at least two periods of substance release separated by one period of no-release e.g. when structured in accordance with the teaching of EP-A-788790. [0010] A tablet system can also be formulated to float on the content of the stomach. [0011] The buoyancy of such a tablet system may be provided by means of an initially dense matrix that undergoes gelling in the stomach following ingestion, which causes the matrix to swell and hence, reduces its density (cf. for instance GB-A-1546448, U.S. Pat. No. 4,126,672, U.S. Pat. No. 4,140,755, U.S. Pat. No. 4,167,558, U.S. Pat. No. 5,169,639, U.S. Pat. No. 5,360,793, WO-A-96/29054); or the buoyancy of such a tablet system may be provided by means of a film or coating that undergoes carbon dioxide emission in the stomach following ingestion, which causes the film or coating to foam (an effect that may be understood as a special type of swelling) and hence, reduces its density (cf. for instance U.S. Pat. No. 4,101,650, U.S. Pat. No. 4,844,905, WO-A-98/47506); or the buoyancy of such a tablet system may be obtained by providing it right from the start (i.e. before ingestion) with a density that is sufficiently low to keep the tablet system floating in the stomach following ingestion (cf. for instance JP-A-3-101615, U.S. Pat. No. 3,976,764, U.S. Pat. No. 4,702,918, U.S. Pat. No. 4,814,178, U.S. Pat. No. 4,814,179, U.S. Pat. No. 5,198,229, U.S. Pat. No. 5,232,704, U.S. Pat. No. 5,288,506, U.S. Pat. No. 5,626,876). [0012] Besides the fact that some of these tablet systems formulated to float on the content of the stomach may have their own severe drawbacks, all these systems (with the single exception of the above-mentioned U.S. Pat. No. 4,140,755) only bring about a single period of release of active substance (irrespective of the fact that the active substance may actually consist of a mixture of active compounds). As to the system disclosed in the above-mentioned U.S. Pat. No. 4,140,755, this latter system can only bring about a single immediate release of active substance followed by a single prolonged release of the same active substance. [0013] Thus, none of the above-mentioned tablet systems formulated to float on the content of the stomach is capable of providing reliably a “multipulse release” consisting of an alternate succession of periods of substance release and no-release, which alternate succession would include at least two periods of substance release separated by one period of no-release. [0014] Yet, such a multipulse release capability is highly desirable in a tablet system formulated to float on the content of the stomach, for it would allow a patient to take one single drug unit form to produce a drug plasma level scheme that can only result at present times from administering to the patient two or more standard-type fast-release drug unit forms to be taken in succession at respective predefined time instants separated by respective predefined latency or waiting periods. [0015] Pharmaceutical tablet systems having a multipulse release capability are known in the art. [0016] One type of a pharmaceutical tablet system having a multipulse release capability is known for instance from EP-A-1074249 and is constructed as a multilayered body arranged concentric about a core, which core is fully enclosed within layers that fully enclose one another in succession. The core is the last part of the tablet system that will disappear by dissolution or digestion in gastric fluid or by gastric discharge and hence, to confer prolonged buoyancy to such a tablet system and prevent any early sinking or discharge thereof, at least the core should be formed of lightweight materials. Moreover, in consideration of the possible gastric discharge of the core, a reliable administration can only be attained with a core devoid of any active substance that participates in the desired multipulse release capability, which is not an economical construction because of the necessarily large size of the core. [0017] Another type of a pharmaceutical tablet system having a multipulse release capability is known for instance from WO-A-91/04015, EP-A-631775 or EP-A-788790 and is, basically, made up of planar layers superposed in a stack that is enclosed within an envelope so as to leave at least one outer face of an outer layer of the stack uncovered and unprotected by the envelope. In particular, there is disclosed in EP-A-788790 a pharmaceutical tablet system to be administered by the oral route for releasing one or more pharmaceutically active substances in the course of an alternate succession of periods of substance release and no-release, said alternate succession including at least two periods of substance release separated by one period of no-release. This type of pharmaceutical tablet system is neither intended nor provided for prolonged floating in or on gastric fluid in a patient's stomach. [0018] To nevertheless confer buoyancy to this type of pharmaceutical tablet system, it may be envisaged to use lightweight materials to form the envelope, and this may be expected to be easiest in a tablet system having a cup-shaped envelope and a multilayered core placed therein, as disclosed in EP-A-788790. The cup-shaped envelope is the last part of the tablet system that will disappear by dissolution or digestion in gastric fluid or by gastric discharge and hence, to confer prolonged buoyancy to such a tablet system and prevent any early sinking or discharge thereof, at least the cup-shaped envelope should be formed of lightweight materials. Moreover, in consideration of the possible gastric discharge of the cup-shaped envelope, a reliable multipulse release can only be attained with a cup-shaped envelope devoid of any active substance that participates in the desired multipulse release capability. [0019] Lightweight materials, the use of which may be envisaged in pharmaceutical tablet systems of the above-mentioned type having a multipulse release capability, are known e.g. from the prior art mentioned above. Also, fatty and/or waxy lightweight materials have been used to obtain tablet systems having a low density, for instance according to JP-A-1-016715 that discloses a system having a fatty core made up of fats and oils of density — 0.98 and at least one coating layer that contains active substance. [0020] However, these known lightweight materials will not withstand a prolonged floating in or on gastric fluid, as some will dissolve in the gastric fluid, which will cause a progressive loss of buoyancy and subsequent gastric discharge of the tablet system, and others will experience a change of volume e.g. due to gelling that in turn will entail changes of shape allowing the core to eventually become detached from the cup-shaped envelope: in either case the multipulse release characteristics will be unreliable. In a pharmaceutical tablet system of the type mentioned above made up of a stack of superposed layers that is enclosed within an envelope with an outer layer of the stack having an outer face left uncovered and unprotected by the envelope, any poor contact and attachment between the stack of layers and the envelope will allow gastric fluid to infiltrate the system, causing fragility of the tablet system as well as undesirable variations more particularly of the in vivo release rate of the active substance from the innermost i.e. lowermost layer of the stack, producing the so-called “dose dumping”. In the particular tablet system having a cup-shaped envelope and a multilayered core placed therein (as disclosed in EP-A-788790) the caused fragility of the tablet system may even allow the core to detach from the cup-shaped envelope. [0021] Also, fats and oils that are currently used (alone or in mixture) in pharmaceutical tablet systems to confer them a density that is lower than unity do not allow tablet production using a compression step of the kind performed in any currently used type of tablet compression apparatus, because of feeding and sticking problems: such fats and oils (whether taken as powders or liquids) have flow properties that do not allow to reliably and evenly fill the press moulds, and during the compression step they stick to the moulding plug and die, impairing the compression efficiency and uniformity. SUMMARY OF THE INVENTION [0022] Thus, it is an object of the present invention to make available a pharmaceutical tablet system capable of prolonged floating in or on gastric fluid under conditions that are safe for a patient to whom said pharmaceutical tablet system is being administered, for releasing in the patient's stomach one or more pharmaceutically active substances in the course of an alternate succession of periods of substance release and no-release, said alternate succession including at least two periods of substance release separated by one period of no-release i.e. of latency, and which pharmaceutical tablet system does not have the drawbacks of the floating systems of the prior art mentioned above and in particular, should remain floating in or on the gastric fluid in a patient's stomach until the totality of the active substance contained in the pharmaceutical tablet system has been released, irrespective of the fact that said active substance may actually consist of a mixture of active compounds. [0023] To attain this object, according to the present invention there is provided a pharmaceutical tablet system capable of prolonged floating in or on gastric fluid for releasing therein one or more pharmaceutically active substances in the course of an alternate succession of periods of substance release and no-release, said alternate succession including at least two periods of substance release separated by one period of no-release, whereby: [0024] the tablet system is made up of a multilayered core placed in a cup-shaped envelope; [0025] the core is made up of release and no-release layers superposed in alternate succession to form a pile of layers that includes at least two release layers flanking an intermediate no-release layer, each release layer being composed of pharmaceutically acceptable excipient and/or carrier having admixed thereto at least one of said pharmaceutically active substances, each no-release layer being composed of pharmaceutically acceptable excipient and/or carrier devoid of said pharmaceutically active substance; [0026] the cup-shaped envelope covers a bottom surface and side surfaces of the core placed therein while leaving exposed an upper surface of the core; [0027] the cup-shaped envelope provides for buoyancy of the pharmaceutical tablet system with respect to gastric fluid by being formed of a compression-sintered mixture that comprises pharmaceutically acceptable hydrophobic material and pharmaceutically acceptable inert powdered filler; [0028] the hydrophobic material is composed of fatty and/or waxy material capable of being sintered by compression and whose bulk density is lower than gastric fluid density; and [0029] the powdered filler having a loose powder density that is lower than gastric fluid density. [0030] Preferably, in a pharmaceutical tablet system according to the present invention the voids may be interstices between grains of the powdered filler, and more preferably, may be generally sealed off from each other by virtue of the hydrophobic material. Also preferably, the voids may be micropores included within the hydrophobic material. Also preferably, the mixture, which the cup-shaped envelope is made of, also includes at least one or more pharmaceutically active agent different from said substances contained in one or more release layers. [0031] A process of producing the above-defined pharmaceutical tablet system involves the steps of coating the powdered filler with the hydrophobic material, preferably by spray-coating performed under vigorous stirring; granulating the resulting coated material; placing a layer of the resulting granulated material into a die; placing a core onto the layer of granulated material within the die; forcing the core into the layer of granulated material within the die, which forcing preferably involves a compression of the tablet system made up of the cup-shaped envelope having the core inserted therein to provide a snug fit between mutually facing bottom and side surfaces of the core and surface portions of the cup-shaped envelope; and removing the resulting tablet system from the die. [0032] A process of producing a cup-shaped envelope of the above-defined pharmaceutical tablet system involves the steps of coating the powdered filler with the hydrophobic material, preferably by spray-coating performed under vigorous stirring; granulating the resulting coated material; placing a layer of the resulting granulated material into a die; forming a cup-shaped recess into the layer of granulated material by forcing a correspondingly shaped body into it within the die; and removing the resulting cup-shaped envelope from the die. [0033] In the pharmaceutical tablet system of the present invention it is the cup-shaped envelope that provides for buoyancy with respect to gastric fluid. The system is constructed to float on gastric fluid at least until the core will have disappeared completely by dissolution or digestion in the gastric fluid and/or subsequent gastric discharge, which also means that all of the active substance will have been fully released. Accordingly, a pharmaceutical tablet system of the present invention will reliably bring about the desired “multipulse release” defined above, irrespective of the fact that the active substance may actually consist of a mixture of active compounds, and irrespective of the duration of the release or no-release i.e. latency periods. [0034] A great advantage of the pharmaceutical tablet system of the present invention is that it allows a patient to take one single drug unit form to reliably produce a drug plasma level scheme equivalent to that which would result from the patient's taking in succession two or more standard-type fast-release drug unit forms at respective predefined time instants separated by respective predefined no-release i.e. latency or waiting periods. [0035] It is particularly advantageous to produce the tablet system by means of the preferred process according to the present invention, which process reliably allows to obtain a snug fit between mutually facing bottom and side surfaces of the core and surface portions of the cup-hasped envelope, which snug fit in turn prevents the core from detaching too early from the cup-shaped envelope and hence, allows the tablet system to provide reliably the desired “multipulse release”. [0036] Moreover, the lightweight material used in the pharmaceutical tablet system of the present invention is advantageously well adapted to be compressed in currently used rotary or reciprocating presses without giving rise to any sticking or feeding problems. This finding is quite surprising in view of the difficulties (e.g. unreliable and irregular filling of press moulds, sticking to the moulding plug, impaired compression) that are encountered when fats and oils are used to obtain a low apparent density as taught in the prior art e.g. of JP-A-1-016715 quoted above. [0037] Also, inherent to producing the pharmaceutical tablet system of the present invention according to the above said process, the lightweight material may advantageously be imparted such appropriate hardness and friability properties that will allow an easy handling of intermediate and final products during any subsequent operations such as film coating, packaging etc. [0038] In the process of producing the pharmaceutical tablet system of the invention, the combined provision of using of a hydrophobic material composed of fatty and/or waxy material capable of being sintered by compression, using a powdered filler having a loose powder density that is lower than gastric fluid density and compressing the cup-shaped envelope having the core inserted therein is advantageous in that it results in a snug fit between the core and the cup-shaped envelope. This snug fit seals off the core from the gastric fluid except for the outer face of the core and thus, precludes any poor contact and attachment between the core and the cup-hasped envelope. As no gastric fluid is allowed to infiltrate along the interface between the core and the cup-shaped envelope, the risk of early dissolution or degradation of any other portions of the core than the vicinity if its outer surface is avoided. Such early dissolution would make the no-release or latency period unreliable and/or cause early release of active substance from lower layers of the core, which in turn would lead e.g. to a sustained release instead of a multipulse release of active substance from the pharmaceutical tablet system. [0039] It is a further advantage of the pharmaceutical tablet system of the invention that the hydrophobic material composed of fatty and/or waxy material is sintered by compression, not by melting. Both the degree of sintering and the degree of penetration of the hydrophobic material into the powdered filler can be varied by means of the sintering pressure used, which allows to vary the final properties of the cup-shaped envelope, including the latter's final porosity and thus, the overall porosity of the system. [0040] It is a still further advantage of the pharmaceutical tablet system of the invention that its mechanisms that provide for release and no-release and for buoyancy are independent from each other. This is because no hydrocolloids are used to provide for buoyancy with respect to gastric fluid, the tablet system experiences no change of volume, its buoyancy is not obtained by any gelling of hydrocolloids, and the active substance may be released by other mechanisms that diffusion through a gelled body, which latter mechanism usually leads to a sustained release. All the more, hydrocolloids have a gelling speed that, in a patient's gastric fluid, depends on physiological circumstances such as on the patient's stress, the fluid quantity available in the stomach, the instant filling state of the stomach etc., and in the pharmaceutical tablet system of the invention this is avoided. BRIEF DESCRIPTION OF THE DRAWINGS [0041] [0041]FIG. 1 illustrates an exemplary embodiment of a tablet system according to the present invention with a cylindrical tablet viewed in a schematic axial section; [0042] [0042]FIG. 2 illustrates in vitro release characteristics of a tablet system according to FIG. 1 with a composition according to Example 1. [0043] [0043]FIG. 3 illustrates in vitro release characteristics of a tablet system according to FIG. 1 with a composition according to Example 2. [0044] [0044]FIG. 4 illustrates in vitro release characteristics of a tablet system according to FIG. 1 with a composition according to Example 3. DETAILED DESCRIPTION OF THE INVENTION [0045] The present invention will now be explained in closer detail with reference to an exemplary structure of a pharmaceutical tablet system, which structure is of the kind generally known from EP-A-788790. This exemplary structure is constructed cylindrical, and an axial section thereof is illustrated schematically in FIG. 1. [0046] Generally, the tablet structure illustrated in FIG. 1 comprises a core partially enclosed within an envelope made of lightweight material that provides for buoyancy of the pharmaceutical tablet system with respect to gastric fluid e.g. in a patient's stomach. The core is made up of of three planar layers that are superposed sandwich-like in a generally cylindrical stack having a latency layer 2 located intermediate between active layers 1 and 3 . Also, the core is snugly enclosed within a cup-shaped envelope 4 that is generally shaped as a blin-dend hollow cylinder having an axial cylindrical cavity in which the core i.e. the stack of layers 1 , 2 and 3 is snugly accommodated in such manner that an outer face of the outer layer 1 of the stack remains uncovered and unprotected by the envelope 4 . [0047] The active layers 1 and 3 each are designed to provide release of one or more pharmaceutically active substances and thus, they each contain active substance that is, in the present description and by way of example, diltiazem HCl. The latency layer 2 is designed devoid of active substance so as to provide a period of no-release i.e. of latency. EXAMPLE 1 [0048] 1. Preparation of Active Layers [0049] Active layers i.e. layers containing active substance were prepared, each having a weight of 62.50 mg and the following percentage composition (by weight): diltiazem HCl 30.00% lactose (lactose pulvis H20, 200 Mesh) 59.50% from Paul Brem AG, Switzerland sodium croscarmellose Ac-Di-Sol (R) , 5.00% from FMC Corporation, USA Polyvinylpyrrolidone Plasdone (R) K29-32, 4.00% from ISP AG, Switzerland magnesium stearate from Merck, Germany 1.00% colloidal silica Aerosil (R) 200, 0.50% from Degussa AG, Hanau, Germany Total composition 100.00% [0050] Granulate was prepared in an amount appropriate to allow the production of 12000 cores of the type described above i.e. of 24000 active layers. [0051] Proper amounts of Diltiazem HCl, lactose, sodium croscarmellose and polyvinylpyrolidone were placed in a mixer (from Stephan, Switzerland) and mixed therein. Subsequently the homogeneous mixture was wetted with demineralised water and then further mixed, a process known in the art as a “wet massing” step. [0052] The paste so obtained was dried in a fluidised air bed drier (type Niro-Aeromatic Strea I, 60° C. inlet air temperature, from Aeromatic-Fielder AG, Switzerland). The resulting dried mass was then sized through a sieve granulator (type Frewitt GLA, from Frewitt Fabrique de Machines SA, Switzerland) with a sieve of 0.8 mm aperture, which step produced calibrated granulate. [0053] This calibrated granulate was then placed in a cubic mixer (type Erweka, from Mapag Maschinen AG, Switzerland), added with a proper amount of colloidal silica, and mixed for 15 min at 12 rpm. Then, a proper amount of magnesium stearate was added, and mixing was continued for 5 min. This mixture was then used for the compression step as described below. [0054] 2. Preparation of No-Release i.e. Latency Layers [0055] Latency layers i.e. layers devoid of active substance were prepared, each having a weight of 100.00 mg and the following percentage composition (by weight): dibasic calcium phosphate 45.00% from Emcompress (R) , Mendell, USA) lactose (lactose pulvis H20, 200 Mesh) 20.00% Lactose Fast Flo (R) , from Foremost, USA glyceryl behenate Compritol (R) 888 ATO, 25.00% from Gattefossé, France polyvinylpyrrolidone Plasdone (R) K29-32, 8.40% from ISP AG, Switzerland yellow ferric oxide Sicovit (R) Yellow 10E172, 0.10% from Bascom AG, Switzerland magnesium stearate from Merck, Germany 1.00% colloidal silica Aerosil (R) 200, 0.50% from Degussa AG, Hanau, Germany Total composition 100.00% [0056] Granulate was prepared in an amount appropriate to allow the production of 15000 cores of the type described above i.e. of 15000 latency layers. [0057] Proper amounts of dibasic calcium phosphate, lactose, glyceryl behenate, polyvinylpyrolidone and yellow ferric oxide were placed in a mixer (from Stephan, Switzerland) and mixed therein. The homogeneous mixture was then wetted with demineralised water and then further mixed in a “wet massing” step. [0058] The paste so obtained was dried in a fluidised air bed drier (type Niro-Aeromatic Strea I, 50° C. inlet air temperature, from Aeromatic-Fielder AG, Switzerland). The resulting dried mass was then sized through a sieve granulator (type Frewitt GLA, from Frewitt Fabrique de Machines SA, Switzerland) with a sieve of 0.8 mm aperture, which step produced calibrated granulate. [0059] This calibrated granulate was then placed in a cubic mixer (type Erweka, from Mapag Maschinen AG, Switzerland), added with a proper amount of colloidal silica, and mixed for 15 min at 12 rpm. Then, a proper amount of magnesium stearate was added, and mixing was continued for 5 min. This mixture was then used for the compression step as described below. Preparation of Buoyant Material [0060] Buoyant material was prepared, having the following percentage composition (by weight): hydrogenated castor oil Cutina HR (R) , 70.00% from Impag AG, Switzerland magnesium aluminometasilicate Neusilin UFL (R) , 12.25% from Gustav Parmentier, Germany microcrystalline cellulose Avicel (R) pH 101, 12.25% from Selectchemie AG, Switzerland gelatine from Merck, Germany 5.00% magnesium stearate from Merck, Germany 0.50% Total composition 100.00% [0061] In the above composition eventually used for preparing the cup-shaped envelope, cf. below, the hydrophobic material is hydrogenated castor oil and the inert powdered filler is magnesium aluminometasilicate. [0062] Granulate was prepared in an amount appropriate to allow the production of 1000 buoyant cup-shaped envelopes each having a weight of 500.00 mg appropriate to enclose 1000 cores so as to manufacture 1000 tablets. [0063] Proper amounts of hydrogenated castor oil, magnesium aluminometasilicate and cellulose microcrystalline were placed in a high shear mixer (type Niro-Fielder PP 1 , from Aeromatic-Fielder AG, Switzerland). The homogeneous mixture was then wetted with a gelatine solution made up of gelatine previously dissolved in demineralised water and then further mixed in a “wet massing” step. [0064] The paste so obtained was dried in a fluidised air bed drier (type Niro-Aeromatic Strea I, 50° C. inlet air temperature, from Aeromatic-Fielder AG, Switzerland). The resulting dried mass was then sized through a sieve granulator (type Frewitt GLA, from Frewitt Fabrique de Machines SA, Switzerland) with a sieve of 0.8 mm aperture, which step produced calibrated granulate. [0065] This calibrated granulate was then placed in a cubic mixer (type Erweka, from Mapag Maschinen AG, Switzerland), added with a proper amount of colloidal silica, and mixed for 10 min at 12 rpm. This mixture was then used for the compression step as described below. Preparation of Cores [0066] Cores were prepared by means of a rotating three layer press (type Manesty LP39, from Keyser Mackay, Switzerland) equipped with circular convex punches having a diameter of 7.0 mm, operating on the granulates prepared as described above with bulk active layer material in the first and third filling hoppers and bulk latency layer material in the second filling hopper. [0067] Application of buoyancy conferring layers onto cores [0068] The cores previously prepared as described above were press-coated with the buoyant material prepared as described above by means of a single punch machine (type Korsch, from Korsch Maschinenfabrik, Germany) equipped with dies and circular convex punches having a diameter of 13.0 mm. The die was filled with an exact quantity of the buoyant material and then the core was placed manually in the die and centred. Subsequently, the compression step was then performed. [0069] The resulting tablets had a thickness of 7.10 mm and a hardness of about 75N. Results [0070] To determine the in vitro release characteristics of the tablets described above, a standard equipment was used as defined and described in United States Pharmacopoeia USP XXIII, chapter 711, page 1792, paragraph “Apparatus 2”. This equipment had a stirring paddle comprised of a blade and a shaft and was operated at 100 rpm. Dissolution was investigated at 37° C. in 600 ml of a dissolution medium made up of 0.1M acetate buffer of pH 4.5. The release of the active substance (diltiazem HCl) was monitored by UV spectrophotometry at 278 nm for 6 individual samples and additionally, as a reference, for the dissolution medium taken alone i.e. devoid of any tablet material. [0071] The results are illustrated in FIG. 2 as respective time profile diagrams for the 6 tablet samples and the reference. The reference diagram showed that the dissolution medium taken alone i.e. devoid of any tablet material did not bias the results or generate any artifacts. The in vitro release characteristics of all 6 tablets appeared to form a well grouped family that was well separated from the reference characteristic which appeared in the lowest part of the diagram. [0072] In each instance, the following was observed on the in vitro release characteristics: [0073] The first release of active substance takes place within a release period of less than a one hour duration. [0074] The no-release period appears as a well-defined time interval observed between the end of the first release and the start of the second release, having a duration of more than 8 hours in each instance. [0075] The second release of active substance is observed to produce a controlled release. [0076] During the course of the dissolution the tablet system was monitored visually and observed to remain buoyant for the whole duration of the experiment. EXAMPLE 2 [0077] 1. Preparation of Active Layers [0078] Active layers i.e. layers containing active substance were prepared, each having a weight of 62.50 mg and the following percentage composition (by weight): diltiazem HCl 30.00% lactose (lactose pulvis H20, 200 Mesh) 34.50% from Paul Brem AG, Switzerland sodium croscarmellose Ac-Di-Sol (R) , 5.00% from FMC Corporation, USA sodium hydrogen carbonate 15.00% from CFS, Switzerland polyvinylpyrrolidone Plasdone (R) K29-32, 4.00% from ISP AG, Switzerland citric acid from Merck, Germany 10.00% magnesium stearate from Merck, Germany 1.00% colloidal silica Aerosil (R) 200, 0.50% from Degussa AG, Hanau, Germany Total composition 100.00% [0079] Granulate was prepared in an amount appropriate to allow the production of 11000 cores of the type described above i.e. of 22000 active layers, using the same procedure as described above under Example 1 applied to proper amounts, first of diltiazem HCl, lactose, sodium croscarmellose, sodium hydrogen carbonate and polyvinylpyrolidone, and then of colloidal silica and citric acid, placed in the respective mixer. Preparation of No-Release i.e. Latency Layers [0080] Latency layers i.e. layers devoid of active substance were prepared, each having a weight of 70.00 mg and the following percentage composition (by weight): dibasic calcium phosphate 37.50% from Emcompress (R) , Mendell, USA) lactose (lactose pulvis H20, 200 Mesh) 33.34% Lactose Fast Flo (R) , from Foremost, USA glyceryl behenate Compritol (R) 888 ATO, 20.83% from Gattefossé, France polyvinylpyrrolidone Plasdone (R) K29-32, 7.00% from ISP AG, Switzerland yellow ferric oxide Sicovit (R) Yellow 10E172, 0.08% from Bascom AG, Switzerland magnesium stearate from Merck, Germany 0.83% colloidal silica Aerosil (R) 200, 0.42% from Degussa AG, Hanau, Germany Total composition 100.00% [0081] Granulate was prepared in an amount appropriate to allow the production of 2150 cores of the type described above i.e. of 2150 latency layers, using the same procedure as described above under Example 1 applied to proper amounts, first of dibasic calcium phosphate, lactose, glyceryl behenate, polyvinylpyrolidone and yellow ferric oxide, and then of colloidal silica, placed in the respective mixer. Preparation of Buoyant Material [0082] Buoyant material was prepared, having the following percentage composition (by weight): hydrogenated castor oil Cutina HR (R) , 70.00% from Impag AG, Switzerland magnesium aluminometasilicate Neusilin UFL (R) , 22.00% from Gustav Parmentier, Germany gelatine from Merck, Germany 5.00% hydrogenated cottonseed oil from Merck, Germany 3.00% Total composition 100.00% [0083] In the above composition eventually used for preparing the cup-shaped envelope, cf. below, the hydrophobic material is a mixture of hydrogenated castor oil and hydrogenated cottonseed oil, and the inert powdered filler is magnesium aluminometasilicate. [0084] Granulate was prepared in an amount appropriate to allow the production of 300 buoyancy conferring cup-hasped envelopes each having a weight of 500.00 mg appropriate to enclose 300 cores so as to manufacture 300 tablets, using the same procedure as described above under Example 1 applied to proper amounts, first of hydrogenated castor oil and magnesium aluminometasilicate, and then of colloidal silica, placed in the respective mixer. [0085] 4. Preparation of Cores [0086] Cores were prepared by means of a single punch machine (type Korsch, from Korsch Maschinenfabrik, Germany) equipped with dies and circular flat punches having a diameter of 7.0 mm. The die was filled with exact quantities of the granulates prepared above, each corresponding to the respective layers. The compression step resulted in cores having a thickness of 3.90 mm and a hardness of about 50N. [0087] 5. Application of Buoyancy Conferring Cup-Shaped envelopes onto cores [0088] The cores previously prepared as described above were press-coated with the buoyant material prepared as described above, using the same procedure as described above under Example 1. The compression step resulted in tablets having a thickness of 7.10 mm and a hardness of about 75N. [0089] 6. Results [0090] The in vitro release characteristics of the tablets described above were determined, using the same procedure as described above under Example 1 except for monitoring the release of the active substance (diltiazem HCl) by UV spectrophotometry at 240 nm for 5 individual samples. [0091] The results are illustrated in FIG. 3 as respective time profile diagrams for the 5 tablet samples. The in vitro release characteristics of all 5 tablets appeared to form a well grouped family. [0092] In each instance, the following was observed on the in vitro release characteristics: [0093] The first release of active substance takes place within a release period of less than a one hour duration. [0094] The no-release period appears as a well-defined time interval observed between the end of the first release and the start of the second release, having a duration of more than 4 hours in each instance. [0095] The second release of active substance takes place within a release period of less than a one hour duration. [0096] During the course of the dissolution the tablet system was monitored visually and observed to remain buoyant for the whole duration of the experiment, which duration largely exceeded the time required to release the tablet system's whole content of active substance. EXAMPLE 3 [0097] 1. Preparation of Active Layers [0098] Active layers i.e. layers containing active substance were prepared, using the same procedure as described above under Example 1. [0099] 2. Preparation of No-Release i.e. Latency Layers [0100] Latency layers i.e. layers devoid of active substance were prepared, each having a weight of 100.00 mg and the following percentage composition (by weight): dibasic calcium phosphate 43.00% from Emcompress (R) , Mendell, USA) lactose (lactose pulvis H2O, 200 Mesh) 30.00% Lactose Fast Flo (R) , from Foremost, USA sodium croscarmellose Ac-Di-Sol (R) , 2.00% from FMC Corporation, USA glyceryl behenate Compritol (R) 888 ATO, 15.00% from Gattefossé, France polyvinylpyrrolidone Plasdone (R) K29-32, 8.40% from ISP AG, Switzerland yellow ferric oxide Sicovit (R) Yellow 10E172, 0.10% from Bascom AG, Switzerland magnesium stearate from Merck, Germany 1.00% colloidal silica Aerosil (R) 200, 0.50% from Degussa AG, Hanau, Germany Total composition 100.00% [0101] Granulate was prepared in an amount appropriate to allow the production of 1500 cores of the type described above i.e. of 1500 latency layers, using the same procedure as described above under Example 1 applied to proper amounts, first of dibasic calcium phosphate, lactose, sodium croscarmellose, glyceryl behenate, polyvinylpyrolidone and yellow ferric oxide, and then of magnesium stearate and colloidal silica, placed in the respective mixer. [0102] 3. Preparation of Buoyant Material [0103] Buoyant material was prepared, using the same procedure as described above under Example 1, leading to the same composition eventually used for preparing the cup-shaped envelope, cf. below, in which the hydrophobic material is hydrogenated castor oil and the inert powdered filler is magnesium aluminometasilicate. 4. Preparation of Cores [0104] Cores were prepared, using the same procedure as described above under Example 2, to result in cores having a thickness of 4.25 mm and a hardness of about 50N. [0105] 5. Application of Buoyancy Conferring Cup-Shaped Envelopes Onto Cores [0106] The cores previously prepared as described above were press-coated with the buoyant material prepared as described above, using the same procedure as described above under Example 1. The compression step resulted in tablets having a thickness of 7.05 mm and a hardness of about 105N. [0107] 6. Results [0108] The in vitro release characteristics of the tablets described above were determined, using the same procedure as described above under Example 2 except for monitoring the release of the active substance (diltiazem HCl) for 6 individual samples. [0109] The results are illustrated in FIG. 4 as respective time profile diagrams for the 6 tablet samples. The in vitro release characteristics of all 6 tablets appeared to form a well grouped family. [0110] In each instance, the following was observed on the in vitro release characteristics: [0111] The first release of active substance takes place within a release period of less than a one hour duration. [0112] The no-release period appears as a well-defined time interval observed between the end of the first release and the start of the second release, having a duration of more than 2 hours in each instance. [0113] The second release of active substance takes place within a release period of less than a one hour duration. [0114] During the course of the dissolution the tablet system was monitored visually and observed to remain buoyant for the whole duration of the experiment, which duration largely exceeded the time required to release the tablet system's whole content of active substance. SUMMARY OF EXPERIMENTAL RESULTS [0115] In each instance of the Examples, in the composition eventually used for preparing the cup-shaped envelope the inert powdered filler is magnesium aluminometasilicate and the hydrophobic material is hydrogenated castor oil (in Example 1 and Example 3) or a mixture of hydrogenated castor oil and hydrogenated cottonseed oil (in Example 2). [0116] In each instance and for all three Examples, the first release of active substance takes place within a release period of less than a one hour duration. [0117] In each instance, the no-release period appears to be a well-defined time interval observed between the end of the first release and the start of the second release, having a duration of more than 8 hours in each instance of Example 1, 4 hours in each instance of Example 2, and 2 hours in each instance of Example 3. [0118] In each instance, the second release of active substance is observed to produce a controlled release having a prolonged duration (sustained release) in each instance of Example 1, and in contrast a duration of less than one hour in each instance of Example 2 and Example 3. [0119] During the course of the dissolution the tablet system was monitored visually and observed to remain buoyant for the whole duration of the experiment, which duration largely exceeded the time required to release the tablet system's whole content of active substance in each instance of Example 2 and Example 3.

A tablet system for prolonged floating in or on gastric fluid for releasing therein pharmaceutically active substances in an alternate succession of substance release and no-release periods is made up of a multilayered core placed in a cup-shaped envelope. The core is made up of release layers and no-release layers devoid of pharmaceutically active substance, superposed in alternate succession. The cup-shaped envelope covers bottom and side surfaces of the core while leaving exposed an upper surface of the core. The cup-shaped envelope provides for buoyancy by being formed of a compression-sintered mixture comprising hydrophobic material and inert powdered filler. The hydrophobic material is composed of fatty and/or waxy material capable of being sintered by compression and whose bulk density is lower than gastric fluid density. The powdered filler has a loose powder density that is lower than gastric fluid density.

FIELD OF THE INVENTION [0001] The invention relates to methods for treatment of neurodegenerative disease and aging, and methods for delivery of therapeutic growth factor into the mammalian brain. Specifically, the invention pertains to the use of growth factors that activate the trkB nervous system growth factor receptor (including brain-derived neurotrophic factor (BDNF) and nervous system growth factor-4/5 (NT-4/5)) to stimulate neuronal activity in the entorhinal cortex (EC). HISTORY OF THE RELATED ART [0002] Neurodegeneration in Alzheimer's disease begins within the hippocampus and entorhinal cortex. In patients with even the mildest level of clinical dementia, a 30% loss of EC layer II neurons is observed. By the onset of severe AD, the loss has risen to 90%. Yet no existing therapy for AD and other neurodegenerative conditions specifically targets neurodegeneration in the EC for treatment. [0003] BDNF and NT-4/5 are neuronal growth factors which play a role in brain function through a variety of mechanisms, including stimulation of glutamate-mediated communication between cerebrocortical neurons and cortical astrocytes (Pascual, et al, Neuroreport, 12:2673-2677, 2001), and induction of dopamine formation (Theofilopoulous, et al., Brain Res. Dev. Brain Res, 127:111-122, 2001). These growth factors share functionality with other growth factors such as NT-3 and NGF, in regulating neuronal connectivities between regions of the brain implicated in cognition. [0004] Surprisingly, however, Croll, et al. (Neuroscience, 93:1491-1506, 1999) recently found that overexpression of BDNF worsened cognitive function, interfered with normal brain function, and caused excitability in the EC and hippocampal (HC) CA3 regions of the brain. Other researchers have reported similarly discouraging results from use of BDNF. For example, Blaha, et al. (Neuroscience, 99:483-493, 2000) infused BDNF into the parietal cortex (injured in rats, for the study) at “high” (12 micrograms per day) doses and at “low” (1.2 micrograms per day) doses. Before and after infusion, the researchers measured neuronal populations for loss in the hippocampus, dentate hilus, cortex and thalamic medial geniculate nucleus. Animals were also evaluated for performance in a Morris Water Maze (the same test used by the present inventors). [0005] Again, notwithstanding BDNF's role in promoting neuronal survival, Blaha, et al., concluded that “[I]in contrast to our previous studies of axotomy, ischemia and excitotoxicity, our data indicate that [BDNF] is not protective against behavioural or histological deficits caused by expermental traumatic brain injury using the delayed, post-traumatic infusion protocol examined in these studies” (from Abstract). SUMMARY OF THE INVENTION [0006] The invention provides a clinically useful protocol for improving cognitive function in primates through delivery of nervous system growth factors, such as BDNF and NT-4/5, into the entorhinal cortex (EC) of the brain. Surprisingly, and in stark contrast to results achieved previously by others, use of the invention not only encourages neuronal growth and metabolism, but also produces a demonstrable improvement in cognitive function. [0007] According to the invention, nervous system growth factors are delivered to normal, degenerated or injured tissue in the EC. In addition to the responses obtained in EC tissue, use of the invention can also exert effects on the HC and is likely to exert effects on other cortical tissues which contain trkB receptors, such as the frontal cortex, parietal cortex temporal cortex and visual cortex. [0008] Delivery is by direct infusion of the nervous system growth factor protein, or by introduction of an expressible nervous system growth factor-encoding transgene into the targeted coritcal tissue(s). In one specific embodiment of the invention, a nervous system growth factor is delivered to the EC in animals in whom spatial learning abilities and memory has been impaired by aging. Based on measures of cognitive function, including the Morris Water Maze, the impairments in spatial learning and memory are significantly ameliorated by treatment with the nervous system growth factor according to the invention. [0009] In a variation of this embodiment, the nervous system growth factor is BDNF, delivered to cortical tissues, including one or more sites in the EC, by one time infusion. [0010] In a further variation of this embodiment, the nervous system growth factor is BDNF, delivered to cortical tissues, including one or more sites in the EC, by chronic infusion. [0011] In another variation of this embodiment, measured cognitive function in treated animals improves to a level equivalent to function in unimpaired animals. DETAILED DESCRIPTION OF THE INVENTION [0012] I. Means for Delivery of Nervous System Growth Factors into the EC [0013] Practice of the invention enables one to improve cognitive function lost to neurodegeneration in the EC. The effects of the inventive method can extend to trkB receptor containing tissues other than the EC, such as the HC and the frontal, parietal and visual cortices, thereby offering the opportunity to substantially reverse the effects of neurodegeneration associated with disease (such as Alzheimer's) or aging. [0014] To these ends, direct transfer of native or recombinant BDNF, NT4/5 or other nervous system growth factors of equivalent activity into targeted cortical tissues, including the EC, may be made by infusion of the protein, or active fragments thereof, into the tissue at specified coordinates. Recombinant nervous system growth factor may also be delivered via an expressible transgene, carried in a recombinant expression vector (viral, non-viral or via a host cell, such as a fibroblast). [0015] Surgical delivery of a nervous system growth factor composition into the brain may be achieved by means familiar to those of skill in the art, including direct infusion or chronic infusion utilizing a micropump (e.g., the Alzet osmotic pumps commercially available from DURECT Corporation [10240 Bubb Road, Cupertino, Calif. 95015-0530]); microinjection through a surgical incision (see, e.g., Capecchi, Cell, 22:479-488 (1980)); electropotation (see, e.g., Andreason and Evans, Biotechniques, 6:650-660 (1988)); infusion, chemical complexation with a targeting molecule or co-precipitant (e.g., liposome, calcium), and, for expressible transgenes, microparticle bombardment of the target tissue (Tang, et al., Nature, 356:152-154 (1992)). [0016] A description of a surgical technique used to introduce rBDNF into the EC of male Fischer rats using a micropump is provided in Example I, below. Coordinates for the EC, and for specific grafting sites within the EC, are selected so as to cluster in an area of EC neuronal loss and/or loss of BDNF expression and/or loss of BDNF sensitive gene expression in the EC, such as gaba-b receptor expression (Example IV). Such areas may be identified clinically using a number of known techniques, including magnetic resonance imaging (MRI) and biopsy. In humans, non-invasive, in vivo imaging methods such as MRI will be preferred. [0017] II. Materials for use in Practicing the Invention [0018] A. Nervous system growth factors of interest. [0019] Materials useful in the methods of the invention include nervous system growth factor protein (BDNF, NT-4/5, NT-3 or a growth factor of equivalent effect on neuronal growth and activity in the EC), active protein fragments, in vivo compatible recombinant expression vectors, packaging cell lines, helper cell lines, synthetic in vivo gene therapy vectors, regulatable gene expression systems, encapsulation materials, pharmaceutically acceptable carriers and polynucleotides coding for growth factors of interest. [0020] Known nervous system growth factors include nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), nervous system growth factor-3 (NT-3), nervous system growth factor-4/5 (NT-4/5), nervous system growth factor-6 (NT-6), ciliary neurotrophic factor (CNTF), glial cell line-derived neurotrophic factor (GDNF), the fibroblast growth factor family (FGF's 1-15), leukemia inhibitory factor (LIF), certain members of the insulin-like growth factor family (e.g., IGF-1), the neurturins, persephin, artemin, the bone morphogenic proteins (BMPs), the immunophilins, the transforming growth factor (TGF) family of growth factors, the neuregulins, epidermal growth factor (EGF), platelet-derived growth factor (PDGF), and others. For their effects on synaptic transmission and plasticity in neuronal cell populations of the EC, BDNF, NT-4/5 and NT-3, especially BNDF and NT-4/5, are preferred choices for use in the invention. [0021] BDNF is a 27 kDa homodimer originally derived from human brain which shares high sequence homology (and some functionality) with NGF, NT-3 and NT-4/5, and influences many neuron types in the CNS. BDNF was first shown to promote the outgrowth of spinal sensory neurons, but has since been shown to support the survival and outgrowth of sensory neurons, ganglion neurons, dopaminergic neurons, cholinergic neurons, GABAergic neurons and motor neurons. BDNF can signal the differentiation of pluripotent neural crest cells into sensory neurons. Its effects are cell selective—BDNF exerts no supportive effect on NGF-sensitive sympathetic neurons. [0022] BDNF is produced primarily in the brain and spinal cord by glial cells, but is also produced by Schwann cells associated with peripheral motor neurons. It activates signal transduction by the dimerization and autophosphorylation of the TrkB receptor. Recombinant and native BDNF protein from different species, including humans, as well as NT-4/5 and immunoassays therefor, are commercially available from several sources, including, for rNT-4/5, Promega Corporation (2800 Woods Hollow Road Madison, Wis. 53711-5399); and, for rBNDF, Regeneron Pharmaceuticals, Inc. (777 Old Saw Mill River Road, Tarrytown, N.Y. 10591). [0023] For expression in situ, coding polynucleotides, precursors and promoters for a number of human nervous system growth factors are known, as are coding sequences for nervous system growth factors of other mammalian species. For example, GenBank M61176 sets forth the coding sequence (mRNA) for BDNF (see also, XM — 006027); BDNF precursor is set forth at BF439589; and a BDNF specific promoter is set forth at E05933. A similar range of coding sequences for other nervous system growth factors, including NT-4/5 and NT-3, are also available through GenBank and other publicly accessible nucleotide sequence databases. [0024] Human growth factors are preferred for use in therapy of human disease according to the invention due to their relatively low immunogenicity as compared to allogenic growth factors. However, growth factors of other species (e.g., non-human primates) are known which may also be suitable for use in the invention with adequate testing of the kind described herein. [0025] B. Recombinant Expression Vectors [0026] The strategy for transferring transgenes into target cells in vivo includes the following basic steps: (1) selection of an appropriate transgene; (2) selection and development of suitable and efficient vectors for gene transfer; (3) demonstration that in vivo transduction of target cells and transgene expression occurs stably and efficiently; (4) demonstration that the in vivo gene therapy procedure causes no serious deleterious effects; and (5) demonstration of a desired phenotypic effect in the host animal. [0027] The expression vector selected should meet the following criteria: 1) the vector must be able to infect targeted cells and thus viral vectors having an appropriate host range must be selected; 2) the transferred gene should be capable of persisting and being expressed in a cell for an extended period of time (without causing cell death) for stable maintenance and expression in the cell; and 3) the vector should do little, if any, damage to target cells. [0028] Because adult mammalian brain cells are non-dividing, the recombinant expression vector chosen must be able to transfect and be expressed in non-dividing cells. At present, vectors known to have this capability include DNA viruses such as adenoviruses, adeno-associated virus (AAV), and certain RNA viruses such as HIV-based lentiviruses, feline immunodeficiency virus (FIV) and equine immunodeficiency virus (EIV. Other vectors with this capability include herpes simplex virus (HSV). However, some of these viruses (e.g., AAV and HSV) can produce toxicity and/or immunogenicity. [0029] Recently, an HIV-based lentiviral vector system has recently been developed which, like other retroviruses, can insert a transgene into the nucleus of host cells (enhancing the stability of expression) but, unlike other retroviruses, can make the insertion into the nucleus of non-dividing cells. Lentiviral vectors have been shown to stably transfect brain cells after direct injection, and stably express a foreign transgene without detectable pathogenesis from viral proteins (see, Naldini, et al., Science, 272:263-267 (1996), the disclosure of which is incorporated by reference; and Example V). Following the teachings of the researchers who first constructed the HIV-1 retroviral vector, those of ordinary skill in the art will be able to construct lentiviral vectors suitable for use in the methods of the invention (for more general reference concerning retrovirus construction, see, e.g., Kriegler, Gene Transfer and Expression, A Laboratory Manual, W. Freeman Co. (NY 1990) and Murray, E J, ed., Methods in Molecular Biology, Vol. 7, Humana Press (NJ 1991)). For further review, those of ordinary skill may wish to consult Maniatis et al., in Molecular Cloning: A Laboratory Manual, Cold Spring Harbor Laboratory, (NY 1982). [0030] C. Pharmaceutically Acceptable Nervous System Growth Factor Compositions. [0031] The selected growth factor (protein or expressible transgene) will be delivered in a pharmaceutically acceptable carrier, to form a growth factor composition. A growth factor composition for use in the invention may be prepared by placing the growth factor protein or growth factor-encoding transgene (including, without limitation, those expressible in viral and non-viral vectors) into a pharmaceutically acceptable suspension, solution or emulsion. Suitable mediums include saline and liposomal preparations. [0032] More specifically, pharmaceutically acceptable carriers may include sterile aqueous of non-aqueous solutions, suspensions, and emulsions. Examples of non-aqueous solvents are propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable organic esters such as ethyl oleate. Aqueous carriers include water, alcoholic/aqueous solutions, emulsions or suspensions, including saline and buffered media. Parenteral vehicles include sodium chloride solution, Ringer's dextrose, dextrose and sodium chloride, lactated Ringer's or fixed oils. Intravenous vehicles include fluid and nutrient replenishers, electrolyte replenishers (such as those based on Ringer's dextrose), and the like. [0033] Preservatives and other additives may also be present such as, for example, antimicrobials, antioxidants, chelating agents, and inert gases and the like. Further, a composition of growth factor transgenes may be lyophilized using means well known in the art, for subsequent reconstitution and use according to the invention. [0034] IV. Dosing. [0035] As used in this disclosure, “unit dosage” refers generally to the concentration of growth factor/ml of growth factor composition. For viral vectors, the growth factor concentration is defined by the number of viral particles/ml of growth factor composition. [0036] For delivery of growth factor protein, each ml of growth factor composition will contain a concentration of protein or active peptide fragments between 1 and 25 ng/ml of carrier. Optimally, for delivery of growth factor using a viral expression vector, each unit dosage of growth factor will comprise 2.5 to 25 μl of a growth factor composition, wherein the composition includes a viral expression vector in a pharmaceutically acceptable fluid and provides from 10 10 up to 10 15 growth factor expressing viral particles per ml of growth factor composition. [0037] Startlingly, in primates, viral vectors with an operable growth factor encoding transgene have been shown to express human growth factor after delivery to the brain and to the CNS for up to 12 months (Example V). Using human growth factor protein, the exogenous growth factor can be expected to remain in the target tissue for periods somewhat shorter than may be achieved using growth factor expressible transgenes. In both instances, however, the invention provides a chronically available source for growth factor in the brain. [0038] V. Animal Models and Clinical Evaluation [0039] In non-human primate subjects, the process of aging simulates the neurological changes in the brain experienced in aging humans, including the loss of BDNF activity, EC neuronal cell populations, and loss of BDNF sensitive receptors (e.g., gaba-b). Data demonstrating the use and efficacy of the methods of the invention in aged animals are provided in the Examples. A non-aged animal model that models Alzheimer's Disease with a high degree of integrity are rats and primates in whom transection of the fornix pathway connecting the septum from the hippocampus has been performed. [0040] Clinical evaluation and monitoring of treatment can be performed using the in vivo imaging techniques described in the Examples, as well as through biopsy and histological analysis of treated tissue. In the latter respect neuronal numbers can be quantified in a tissue sample using, for example, anti-growth factor antibody (for immunoassay of secreted growth factor) (Example III), or by tracking growth factor sensitive gene expression, as demonstrated in Example IV. Of course, improved cognitive function is a clearly desirable end goal in aged, diseased or injured animals in whom such function has been impaired, and this goal may be achieved through use of the invention (Example II). [0041] The invention having been fully described, examples illustrating its practice are set forth below. These examples should not, however, be considered to limit the scope of the invention, which is defined by the appended claims. Those of ordinary skill in the art will appreciate that while the Examples illustrate one embodiment of the invention, the results achieved will be accessible through other embodiments taught herein. In the examples, the abbreviation “min.” refers to minutes, “hrs” and “h” refer to hours, and measurement units (such as “ml”) are referred to by standard abbreviations. All printed materials cited are incorporated herein by reference. EXAMPLE I Treatment of Aged Animals with BDNF Delivery to the EC [0042] Test animals underwent pre-operative water maze training, as described in Example II. Data presented in this pilot study were generated from analyzing: 10 BDNF-infused aged, 8 aged-intact, 9 vehicle-infused aged, 9 middle aged, and 20 young intact, and 2 vehicle-infused young rats. Aged (24 month-old), middle aged (11 month-old) and 10 young (5 month-old) male Fischer 344 rats were obtained from the Harlan/NIA rodent colony. [0043] Rats were anesthetized with a mixture of ketamine (50 mg/kg), acepromazine (0.5 mg/kg), and xylazine (2.6 mg/kg). After verifying that all reflex responses to cutaneous stimulation were absent, rats were implanted with following coordinates for entorhinal cortex in aged animals (relative to Bregma): −9.3 mm anterior/posterior, ±5.6 mm medial lateral, 6 mm cannula length ventral to the skull surface. Initial pilot experiments indicate that the correct EC coordinates for young (4-month old) animals are (relative to Bregma): −8.6 mm anterior/posterior, ±5.3 mm medial lateral, 5 mm cannula length ventral to the skull surface. Four-week Alzet minipumps (model number 2004) were used to deliver vehicle solution (rat artificial-cerebrospinal fluid and 1 mg/ml rat serum albumin) or 10 ng/ml of human recombinant BDNF (supplied by Regeneron Pharmaceuticals, Inc.) dissolved in vehicle solution. EXAMPLE II Pre- and Post-Operative Water Maze Testing [0044] Water maze apparatus: The first run of water maze testing was conducted in a black circular tank (diameter: 1.40 m; height: 0.60 m) filled with water (19-21° C.). A black escape platform was submerged 3 cm below the surface of the water in a specific location during training/acquisition trials. The escape platform was removed during probe testing. To provide a clear visible cue, four wooden posts were attached to the platform during cued trials. Black curtains were hung around the tank and four unique wall cues were hung to serve as environmental landmarks. For data analysis, the tank was divided into four quadrants: north, south, east, and west. Both collection and analysis of the data were performed using a San Diego Instruments (San Diego, Calif.) computer tracking system. [0045] Subsequent water maze testing was conducted in a white circular tank (diameter: 1.83 m; height: 0.70 m) filled with water made opaque by the addition of non-toxic white tempura paint (19-21° C.). A white escape platform was submerged 5 cm below the surface of the water during training/acquisition trials. The escape platform was lowered before probe trials, and raised at the end of each probe trial from outside of the tank. To provide a clearly visible cue, a black platform with a large post protruding well above the water level was used during cue learning trials. White curtains were hung around the tank and four unique wall cues were hung to serve as environmental landmarks. Collection and analysis of the data were performed using a Columbus Instruments (Columbus, Ohio) tracking system. [0046] Pre-operative testing: For all runs of water maze testing, the task consisted of 8 days of training, conducted in 4 training blocks of 6 trials (3 per day). Each training block included 5 acquisition trials (90 sec/trial max; 1 min inter-trial interval) followed by 1 probe trial (30 sec free swim). During all non-probe trials, the submerged escape platform was placed in the center of the “goal” quadrant of the pool. To begin each trial, rats were placed in the water, facing the maze wall, from one of four start positions evenly spaced around the pool (N, S, W, E). Start positions were chosen randomly at the beginning of each test day for all rats. Rats swam until they located the platform or for a maximum of 90-sec, after which the rat was guided to the platform. At the conclusion of each trial, rats remained on the platform for 30 seconds and were then removed by the experimenter and placed in a holding cage for 1 min. [0047] Cumulative search error (SE), time (latency), and distance (path length) to find the escape platform were used as measures of learning during the training trials. Every 6 th trial, rats were probed for learning of the platform location by removing (1 st run) or lowering (subsequent runs) the platform and recording the proximity average to the platform location and annulus crossings during a 30 sec free swim. Each of the learning measures from aged animals were examined and compared to young animals. Aged animals were considered aged impaired if their performance fell outside of the range of young animal performance. Acquisition data was used to form groups of aged-BDNF and aged-vehicle animals with equivalent levels of water maze performance before surgeries and post-operative testing. [0048] Post-operative testing: After a three-week delay (during which time rats were receiving either BDNF or vehicle infusions), rats were re-tested on the identical multiple-trial place learning task (8 days, 4 blocks) that was used during pre-operative testing. [0049] Cue training: Visible testing followed completion of the post-operative testing and consisted of 6 trials from different start locations. The visible platform was placed in a different location than the previously learned submerged platform location. [0050] Behavioral data analysis: Data were compiled and analyzed in Stat View 5.0 for the Macintosh (Abacus Concepts, Berkeley, Calif.). Comparisons between groups were made using repeated-measures ANOVA for the training data, whereas, factorial ANOVAs were used for probe trial data. Behavioral data are presented as mean±standard error of the mean. Criteria for significant differences were set at the 95% probability level. [0051] Based on the water maze testing results, BDNF infusions significantly improved the performance of aged animals in the final block of post-operative testing compared to vehicle-infused and intact aged groups (FIG. 3; factorial ANOVA: F5,55=18.77; P<0.0001; post hoc Fisher's tests: P<0.001 BDNF-infused vs. vehicle-infused aged and P<0.0001 for BDNF-infused vs. aged-impaired comparisons). ANOVA analysis also revealed that aged-BDNF infused animals performed at levels equivalent to aged-unimpaired (post hoc Fisher's test: P=0.99) and middle aged (post hoc Fisher's test: P=0.25) animals. As such, the results show that BDNF delivery according to the invention improved cognitive function in treated animals. EXAMPLE III BDNF Localization in the EC [0052] To determine the extent to which exogenous BDNF was retained at the infusion site in treated animals, hypothalamus, hippocampus, entorhinal cortex, prefrontal cortex, and the remainder of neocortex were sectioned from anesthesized animals, then immediately dissected and frozen in liquid nitrogen. Tissues were stored at −80° C. [0053] Immunohistochemistry for BDNF was performed using a rabbit anti-BDNF antibody at a concentration of 1:6000 and sections prepared from the treated animals. Specificity of the antibodies was verified by omitting the primary antibody with a resultant loss of cellular labeling. [0054] Levels of BDNF were determined using two-site enzyme-linked immunosorbent assays (ELISA) developed according to standard procedures (Conner et al., J. Neurosci, 17:2295, 1997). The assay was specific for BDNF and was relatively linear over the range for which it was used (1-100 pg/sample). Assays developed for BDNF showed no detectable cross-reactivity with other nervous system growth factor family members, even when these proteins were added to the assay at concentrations 20-fold in excess the upper assay limit (2000 pg/sample). [0055] After blocking non-specific binding sites on ELISA plates, plates were washed 2× with washing buffer. Known quantities of purified BDNF (1-100 pg/well), or unknown samples from tissue extracts, were then added to the wells (50 μl/well) and plates were incubated overnight at 4° C. The following day, unbound material was removed and plates were washed 5 times. Detection of bound antigens was made by sequentially adding the appropriate detection (anti-BDNF (Promega G1641; 1:2500 dilution)) and HRP-conjugated (peroxidase conjugated anti-chicken IgY (Promega G1351; 1:1000 dilution) or peroxidase conjugated anti-mouse IgG (Dako p-260; 1:1000 dilution) antibodies (each incubated overnight at 4° C.). A soluble calorimetric reaction product was then generated, and optical density measurements were made on a microplate reader at an absorbance of 490 nm. In all cases, results were corrected for nonspecific interactions by subtracting values determined in IgG coated wells from those made in anti-nervous system growth factor coated wells. [0056] Data were compiled and analyzed in Stat View 5.0 for the Macintosh (Abacus Concepts, Berkeley, Calif.). ELISA data were analyzed using factorial ANOVAs. Criteria for significant differences were set at the 95% probability level. [0057] Following perfusion and sectioning of selected pilot animals, BDNF immunolabeling confirmed the accurate location of the cannulas within entorhinal cortex (FIG. 1). ELISA for BDNF confirmed that BDNF infusions indeed raised the level of BDNF within the entorhinal cortex significantly above the endogenous level found within the brain (FIG. 2; factorial ANOVA: F4,27=11.42; P<0.0001; post hoc Fisher's tests: P<0.0001 for all comparisons of BDNF-infused to non-BDNF infused groups). EXAMPLE IV Effect of BDNF Treatment on Expression of BDNF Sensitive Receptors [0058] Total RNA was isolated from tissues by using the RNA Extraction Kit (Pharmacia-Biotech), and double-stranded DNA was synthesized from 1-5 μg of total RNA. Biotin-labeled cRNA was purified, fragmented, and hybridized to the Affymetrix Rat arrays in 100 mM Mes, pH 7.4/1 M NaCl/20 mM EDTA/0.01% Tween 20. The arrays were washed and stained with streptavidin-phycoerythrin and then scanned with an Affymetrix GeneArray Scanner. Data were analyzed with the Affymetrix Genechip Expression Analysis software (version 3.1). [0059] The arrays were analyzed using a library containing probe sets for approximately 10,000 known genes and ESTs. A summary of the number and direction of changes between groups can be found in Table 1, below. Of those, 10 were chosen to verify by RT-PCR for the entorhinal cortex, as listed in Table 2. Complete listings of the gene changes (not including ESTs) comparing BDNF-infused aged animals (n=2) to Vehicle-infused aged animals (n=2) for both EC and HC can be found in Tables 3 and 4. [0060] The analysis revealed that BDNF infusion significantly alters the expression of dozens of genes, mostly within the infusion site in EC, but also remotely in the hippocampus for a smaller number of genes. For example, expression of the gaba-b receptor was increased by greater than 50-fold after BDNF infusion. Gaba-b receptor expression is reduced in both the EC and HC of aged-impaired animals. Such an alteration of responsiveness to putatively inhibitory neuronal signaling may mediate the behavioral effect of BDNF infusion. TABLE 1 Summary of Gene Changes Comparison HC− HC+ EC− EC+ Aged-imp. BDNF vs. Aged-imp. Vehicle 16 3 6 58 Aged-imp. BDNF vs. Young 0 21 8 48 [0061] [0061] TABLE 2 Ten Selected Genes Entorhinal Cortex FC  1. GABA-B receptor 1d +53.6  2. Beta-tubulin T beta 15 +13.4  3. MAP kinase kinase kinase (MEKK-1) +3.6  4. Neuron glucose transporter +5.7  5. Fructose 2,6-bisphosphatase +16.3  6. Parathyroid hormone receptor +10.6  7. Myelin-associated oligo. basic protein +2.9  8. Brain basic helix-loop-helix factor +11.4  9. Presenilin-1 +4.4 10. Protocadherin 5 +3.0 [0062] [0062] TABLE 3 EC gene changes from aged-BDNF vs. aged-Vehicle infused rats Accession Fold Number Gene Name Change M27886 6-phosphofructo-2-kinase/fructose 2,6-bisphospha- 16.3 tase AF091561 AIV-LY1 olfactory receptor 3.2 U39609 anti-NGF30 antibody light-chain mRNA 16 X03369 beta-tubulin T beta 15 13.4 D82074 Brain basic helix-loop-helix factor (BHF-1) 11.4 D45254 cellular nucleic acid binding protein (CNBP) 5.1 M37828 Cytochrome P450 11.8 S49760 Diacylglycerol kinase 3.1 AB016161 GABAB receptor 1d 53.6 S75952 glucagon-like peptide 1 receptor 5.7 AJ224680 glutamic-acid rich protein 4.3 AF031528 green-sensitive opsin 3.3 M28671 IgG-2b 3.4 M18530 kappa-chain C-region 3.1 S59893 La = autoantigen SS-B/La 3.4 U18314 lamina associated polypeptide 2 (LAP2) 7.4 U17697 lanosterol 14-alpha-demethylase 2.8 M25823 leukocyte-common antigen (L-CA, CD45 or T200) 3.4 M13100 long interspersed repetitive DNA sequence LINE3 7.9 (L1Rn) U48596 MAP kinase kinase kinase 1 (MEKK1) 3.6 X70667 melanocortin-3 receptor 6.8 D28110 MOBP (myelin-associated oligodendrocytic basic 2.9 protein) D13962 neuron glucose transporter 5.7 L31394 parathyroid hormone receptor 10.6 AF080435 phosducin-like protein (PHLP) 5 AF030558 phosphatidylinositol 5-phosphate 4-kinase gamma 4.1 D21869 PKF-M (phosphofructokinase-M) 2.6 X62839 potassium channel protein 2.6 D82363 presenilin-1 4.4 AB004277 protocadherin 5 3 AF080468 putative glycogen storage disease type 1b protein 4.7 AF016387 retinoid X receptor gamma (RXRgamma) 3.2 X51706 ribosomal protein L9 2.8 M89646 ribosomal protein S24 3.5 U26310 tensin (Tns) 4.2 D14441 NAP-22 mRNA for acidic membrane protein −2.8 M58758 proton pump polypeptide −3.7 [0063] [0063] TABLE 4 HC gene changes from aged-BDNF vs. aged-vehicle infused (control) rats Accession Fold number EXHIBIT A GENE NAME change M25890 Somatostatin 2.8 AA945169 Transthyretin 3.1 M72711 Repressor of myelin-specific genes (SCIP) 2 M29866 Complement component C3 −41 X52477 Pre-pro-complement C3 −3.7 M15562 MHC class II RT1.u-D-alpha chain −4.3 M18527 Ig germline kappa-chain C-region −4.8 AI234828 Ig germline alpha H-chain C-region −9.4 U39609 Anti-NGF30 antibody light-chain −26 X13044 MHC-associated invariant chain gamma −13 X14254 MHC class II-associated invariant chain −35 K02815 MHC RT1-B region class II A-alpha glycoprotein −3.2 X56596 MHC class II antigen RT1.B-1 beta-chain −3.4 AA799861 Interferon regulatory factor 7 −3.5 AA800243 Cell death-inducing DNA fragmentation factor, −6.2 alpha AA894338 (H+, K+)-ATPase −3.3 AI045249 70 kd heat-shock-like protein −3 D32209 Leucine-rich acidic nuclear protein −3 AA800851 Carboxylesterase −3.5 EXAMPLE VIII Long Term GDNF Expression in Treated Animals [0064] Young adult rhesus monkeys receiving lenti-nervous system growth factor injections into the right caudate and putamen and the left substantia nigra have been demonstrated to have robust nervous system growth factor expression for as long as a year after treatment. Evaluation was performed by immunohistochemistry and enzyme-linked immunosorbent assay (ELISA) for long-term gene expression.

A protocol for use of growth factors to stimulate neuronal cell growth and activity in trkB receptor containing cortical tissues, including the entorhinal and hippocampal cortices. The method introduces exogenous growth factor, such as BDNF, NT-4/5 and NT-3, into the EC. The method is useful in therapy of defective, diseased and damaged neurons in the mammalian brain, of particular usefulness for treatment of neurodegenerative conditions such as Alzheimer's disease or for normal aging.

FIELD OF THE INVENTION The present invention relates generally to boom structure for agricultural implements such as field sprayers. BACKGROUND OF THE INVENTION The desire to increase productivity and reduce the number of passes over a field, implements with folding booms such as field sprayers have been designed for increased working widths and increased operating speeds. Booms which fold out to define a working width of up to 120 feet or more are now available. As boom size, weight and operating speed increase, large inertial loads are encountered. Building a large boom with reduced weight, easy and repeatable manufacturability and structural soundness and stiffness has become an increasing problem. The wide booms must fold to achieve a narrowed transport width. Horizontal folding reduces fold height requirements but results in extreme torsional stresses on the boom structure. For horizontal folding, the boom depth dimension is usually minimized, which results in reducing the boom strength and stiffness in the fore-and-aft direction. Over-top folding relieves the torsional stress but can result in unacceptable fold heights with large booms. A typical boom construction includes a triangular or L-shaped configuration with the base triangle or the lower leg of the L-shaped configuration at the bottom of the boom. Such structural designs that are wider at the bottom than at the top often interfere with desired spray nozzle positioning. Spray nozzle spacing options are limited or operators have to offset certain nozzles from main plumbing line, and uneven spray patterns often result. In the L-shaped designs, most fore-and-aft loads pass through to the centerframe support assembly through the two main lower beams or tubes which advantageously facilitates mounting of boom fold cylinders and tilt pivot structure at the the bottom with the cylinder located at the top. Attempts at providing alternate configurations have met with difficulties, particularly if in the alternate configuration loading is transferred towards the top of the boom. If the fold cylinder and pivot are moved towards the top of the boom and centerframe support assembly to better align with the boom loading, a large separation between the bottom of the boom and centerframe will occur when the boom section is tilted upwardly, while an overlap occurs when the section is tilted downwardly. This separation and overlap cause significant spray pattern problems. Therefore, providing such alternate boom configurations have met with significant design difficulties caused by the load transfers and tilt and fold requirements. Large booms with tubular designs are often very difficult to manufacture. Individual tube sections can have wide length and angle of cut tolerances. Where tube-to-tube connections are required, such tolerances increase the difficulty and cost of welding tube ends together, and the structural integrity of such tube end weld connections is less than optimum. In addition, conventional tubular boom construction methods require a complex and expensive boom weldment fixture. SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide an improved boom structure. It is another object to provide such a structure which overcomes one or more of the aforementioned problems. It is another object of the present invention to provide an improved boom structure which is particularly useful for use with agricultural implements such as self-propelled field sprayers. It is another object to provide such a structure which relatively light and yet is strong and has desired stiffness. It is a further object to provide such a structure which is easy and inexpensive to manufacture. It is still another object of the invention to provide an improved boom structure which reduces the cost of tooling, manufacturing and production. It is a further object to provide such a structure which reduces the amount of fixturing required during manufacture and reduces or eliminates problems associated with cut end joint tolerances and tube to tube end connections. It is another object to provide such a structure having tube support members with optimized weight and strength. It is yet another object of the present invention to provide an improved boom structure which facilitates better nozzle or dispenser and supply tube plumbing placement than at least most conventional boom structures. It is a further object to provide such a structure which is wider at the top than at the bottom and which has improved strength in the fore-and-aft direction. It is another object to provide such a structure which is particularly advantageous for an over-top wing fold configuration and which overcomes design difficulties in boom tilt and fold construction caused by boom design configurations which transfer main loading towards the top of the boom. An easily manufactured boom construction particularly useful for large agricultural folding booms includes a plurality of main tube support sections fabricated from plate material of differing thickness and section dependent on the load to be carried by the material. Thicker, higher strength, or higher grade material is used only in high stress areas so that cost and weight are reduced and weight distribution and strength are improved. The material can be laser cut from steel stock and fitted together with the use of tab-slot locators to create a section substantially more precise than is available using saw-cut pieces. The tube support sections include apertured or slotted areas which provide a preliminary snap-fit of the main tubes to significantly reduce need for additional fixturing so that tooling and manufacturing costs are reduced when compared with at least most conventional boom constructions. The opposite ends of diagonal tubes pass through apertures in the fabricated support sections, rather than mate against the surface of the plates. Therefore the diagonal tubes can be precisely located without the need for expensive and complicated weld fixtures. Diagonal tube length and cut end angle tolerances can be substantially greater than possible with structures which use tube end to flat plate mating surfaces or direct tube end to tube end connections. Since the tube ends actually pass through the support sections, each end can be welded on opposite sides of the sections at conveniently accessed locations. By eliminating most or all tube-to-tube connections and connections wherein a cut end edge has to be precisely placed against a planar surface, welds can be made more quickly, easily and reliably than with at least most previously available conventional boom constructions. By making diagonal tube connections at adjacent support sections, welds at intermediate locations on the diagonal tubes are eliminated. In the embodiment shown, the cross section of the boom is in the shape of an inverted right triangle with the base of the triangle at an uppermost portion of the boom. The apex of the triangular cross section is located at a lowermost portion of the boom, and the forwardly facing portion of the boom lies generally in an upright plane. The inverted construction provides improved nozzle and plumbing, much of which can be outside the boom cross section, and better facilitates over-top folding of a boom section compared to most previous boom designs. A unique torque-tube inner hinge design helps facilitate the inverted section and permits the boom fold cylinder and tilt pivot structure to be located near the bottom of the boom with the tilt cylinder near the top of the boom to avoid spray pattern overlaps or gaps with boom tilting. The wider upper base of the triangular cross section improves boom strength and stiffness and allows steel to be utilized throughout the boom if desired rather than more expensive, lighter materials which often increase joint fabrication difficulties. An outer wing over-top fold configuration allows for the maximum depth dimension of the wing structure and maximized strength of the structure in the fore-aft direction. These and other objects, features and advantages of the present invention will become apparent from the detailed description which follows taken in view of the drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a rear perspective view of a portion of a wide folding boom structure. FIG. 2 is an enlarged perspective view of the inner boom section of the structure of FIG. 1 . FIG. 3 is an enlarged rear perspective view of a portion of the inner boom of FIG. 2 . FIG. 4 is a front view of the portion of the inner boom shown in FIG. 3 . FIG. 5 is a left side end view of the boom portion shown in FIG. 4 . FIG. 6 is a rear view of the boom portion shown in FIG. 3 . FIG. 7 is a top view of the boom portion shown in FIG. 6 . FIG. 8 is an right side end view of the portion shown in FIG. 6 . FIG. 9 is a bottom view of the portion shown in FIG. 6 . FIG. 10 is a perspective view of one of the fabricated tube-receiving sections for the inner boom of FIG. 2 . FIG. 11 is an enlarged perspective view of the inner hinge area of the boom section of FIG. 2 showing the torque tube hinge construction FIG. 12 is an end view, partially in section, of the hinge area of FIG. 11 . DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to FIG. 1 , therein is shown a portion of an agricultural implement 10 such as a large field sprayer adapter for forward movement (F) over a field to be sprayed. The implement 10 includes right- and left-hand boom assemblies 14 and 16 supported on a vehicle or trailer (not shown) by a lift frame support or centerframe assembly 18 . The boom assemblies 14 and 16 are similar in construction and, as shown, include an inner boom section 20 connected to the support assembly 18 for pivoting about an upright axis 22 a by a structural hinge 22 for movement between an extended field working position (shown) and a forwardly folded position wherein the section 20 extends forwardly from the support assembly 18 . An intermediate boom section 24 is connected by hinge structure 26 to the outer end of the section 20 for pivoting between an outwardly extended field working position and a transport position overlying the section 20 against a stop 27 on the top of the section 20 . An outermost boom section 28 is pivotally connected to the outer end of the intermediate boom section 24 by a tip breakaway hinge structure 30 for folding about an axis to a transport position adjacent the aft side of the section 24 . The integrated breakaway of the structure 30 allows the tip of the boom assembly to move rearwardly against a spring bias upon encountering an obstacle. The tip to tip width of the structure shown in FIG. 1 can be up to 120 feet or more. Hydraulic boom fold cylinders 32 , 36 and 40 are connected at the hinge locations 22 , 26 and 30 to effect the positioning of the boom sections relative to each other and to the support assembly 18 . Boom attitude or tilt control cylinders 44 and 46 extend between the assembly 18 and the upper portions of the structural hinges 22 connecting the boom assemblies 14 and 16 to the assembly 18 . The structural hinge 22 provides joint structure at location 22 b about which the boom section both 20 tilts and folds. The location 22 b is near the bottom of the hinge and centerframe and facilitates a boom tilt of approximately 15 degrees about a tilt axis which extends horizontally in the fore-and-aft direction when the boom is in the field working position. The structural hinge 22 also provides approximately 90 degrees of fold so the boom extends transversely in the field working position and fore-and-aft in a forwardly folded transport position. Although a three section boom assembly 14 is shown, the boom construction described below for the inner boom section 20 may be utilized with other types of boom assemblies. The construction of the inner boom section 20 ( FIGS. 2–12 ) provides an inverted triangle cross section. As best seen in FIGS. 5 and 8 two main upper beams or tubes 51 and 52 define the base of the triangle and a main lower beam or tube 53 defining the inverted apex of the triangle. The beams 51 – 53 extend transversely between the hinge 22 and hinge structure 26 . As shown, the cross section is in the form of a right triangle with the upper beams 51 and 52 lying generally in a horizontal plane P 1 and with the lower beam 53 and upper beam 51 defining an upright plane P 2 . The upright plane P 2 faces the forward direction (F) or direction of travel of the machine when the boom sections are in the unfolded field working position. The triangular cross section provides a substantially unencumbered space indicated generally at 54 behind the lower beam 53 and below the beams 51 and 52 for supporting supply lines or other plumbing and material dispensers in one of a possibly infinite number of patterns. The construction of the section 20 includes a plurality beam or tube spacing members 71 – 79 ( FIG. 1 ), each of similar construction but decreasing in dimensions from the member 71 outwardly to the member 79 . Each of the spacing members 71 – 79 is fabricated as a subweldment 80 including a top web 81 , a bottom web 83 , a rear flange piece 84 , a front flange piece 85 , a central connecting piece 86 , and a top flange piece 87 . The weldment is in the form of an I-beam section which is narrow at the bottom extremity and wide at the top extremity. Laser cut tab and slot combinations with a slight interference fit at locations indicated at 90 accurately center the tab in the slot to assembly the subweldment 80 . The top and bottom webs 81 and 83 include accurately cut apertures or slots 101 , 102 and 103 conforming to a portion of the outer surface of the main beams or tubes 51 , 52 and 53 , respectively. After the flange pieces 84 , 85 and 87 are welded to the webs 81 and 83 , the slots 101 – 103 along with the slightly flared ends of the flanges define openings slightly smaller than the cross sectional dimension of the tubes 51 – 53 so that the tubes are snapped into place on the tube spacing members 71 – 79 during assembly of the section 20 and then welded to the subweldment 80 . Therefore, the amount and complexity of the weld fixturing necessary for fabrication is substantially reduced compared to most conventional boom fabrication methods. In addition, the material thickness, material grade and/or strength of each of the pieces of the subweldment 80 can be varied according to the loads encountered at the piece so that cost, weight and total area of the subweldment can be optimized. By way of example only without limitation, the top and bottom webs 81 and 83 which receive heavy loads from the main tubes 51 – 53 can be fabricated from grade 80 steel of 0.088 inch thickness while the flange pieces 84 , 85 and 87 and the connecting piece 86 , which carry much lighter loads, can be fabricated from a lower grade, thinner material such as 0.075 inch thick grade 50 steel. The upper and lower webs 81 and 83 include apertures or slots 111 and 113 for receiving diagonal tubes or brace members 121 , 122 and 123 extending between the subweldments 80 of adjacent beam spacing members. The brace members 121 – 123 extend through the apertures 111 – 113 and are fixed to the webs 81 and 83 by welds which extend partially around the circumference of the brace member ends on both sides of the webs. The brace members 121 – 123 can be precisely located without weld fixtures and without precise tube end and tube length cuts. Since the tube ends actually pass through the webs 81 – 83 , each end can be welded on opposite sides of the webs at conveniently accessed locations. Tube-to-tube connections and connections wherein a cut end edge has to be precisely placed against a planar surface can be eliminated using the above-described configuration. As shown in FIGS. 2 and 3 , a truss construction is provided with the upper brace member 122 having an outer end connected to the web 81 next to the rear upper tube 52 and an inner end connected to the next adjacent web 81 next to the front upper tube 51 . The upper innermost end of the diagonal brace member 123 is connected to the web 81 adjacent the outer end of the upper brace member 122 . Each front diagonal brace 121 has an outermost upper end connected to the web 81 adjacent the innermost end of the upper brace member 122 , and a lower innermost end connected to the web 83 adjacent the lower outermost end of the diagonal brace member 123 which extends between the lower tubes 53 and the upper front tube 51 . As shown, the diagonal brace members 121 – 123 extend between adjacent tube spacing members, and no welds are required at central locations on the brace members. End-to-end welds of the diagonal brace members 121 – 123 and direct welds of the brace members to the main tubes 51 , 52 and 53 can be eliminated. The inner structural hinge 22 transfers loading from the upper portion of the boom section 20 towards the bottom of the boom section at the hinge area and thereby permits the pivot and fold structure to remain near the bottom of the boom and the centerframe assembly 18 to avoid the problems of gapping and overlap as the boom is tilted about a fore-and-aft axis during field working operations. The outer hinge structure 26 advantageously provides hinge pivot locations 26 b which are aligned with the upper tubes 51 and 52 for providing a sturdy pivot area for upward and over center folding of the boom section 24 about the axis 26 a. As shown, the structural hinge 22 and the hinge structure 26 also use a tab and slot construction to facilitate assembly with a minimum of additional fixturing. Having described the preferred embodiment, it will become apparent that various modifications can be made without departing from the scope of the invention as defined in the accompanying claims.

An easily manufactured large boom construction includes a plurality of main tube support sections fabricated from plate material of differing material thickness, grade and section dependent on load. The tube support sections include apertured areas which provide a preliminary snap-fit of the main tubes to significantly reduce need for additional fixturing. The opposite ends of diagonal tubes pass through apertures in the fabricated support sections for accurate tube location without complicated weld fixtures or precise tube length and cut end angle tolerances. The tubes are welded on opposite sides of the sections to eliminate need for tube-to-tube connections or connections wherein a cut end edge has to be precisely placed against a planar surface. An inverted right triangle boom cross section with wing over-top fold configuration ability provides strength, stiffness and infinite nozzle placement possibilities.

RELATED APPLICATION [0001] This application claims priority to U.S. Provisional Application No. 61/101,245, filed Sep. 30, 2008, and is incorporated herein by reference in its entirety. BACKGROUND [0002] The present disclosure relates generally to medical devices and, more particularly, to surface treatments to prevent the formation of biofilms on medical devices. [0003] This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art. [0004] Advances in technology have allowed for the utilization of foreign, non-biological devices in medicine for increased external control over normal bodily functions. Such devices allow medical personnel to clearly define the environment in which the patient exists during his/her treatment as well as control, analyze, and supplement both intake and output by patients. Examples of these devices include endotracheal tubes, catheters, cardiac stunts, and the like. Endotracheal tubes may be used for patients having lengthy and complicated hospital stays to ensure adequate ventilation and/or oxygen levels for the intubated patient. Lungs have a normal microbial flora populated by both anaerobic and aerobic bacteria with a concurrent local host immune system tuned to this population and effective against normal challenges from the environment. [0005] However, the introduction of an indwelling medical device, such as an endotracheal tube, can challenge this delicate balance. The endotracheal tube introduces a new growth surface for both foreign organisms, i.e. not in the normal flora, and even organisms present in the normal flora but whose growth is normally suppressed by the restricted growth space of the lung. The new growth surface may allow for new colonization in the lungs by such bacteria, which may be pathogenic. For example, prolonged microbial colonization may lead to biofilm formation associated with the device. A biofilm is an aggregation of microorganisms that excretes an adhesive matrix that helps to anchor the biofilm onto a surface. Biofilms may represent a continuing source of infectious bacteria that can be dislodged by patient coughing, suctioning of the device, or even simple movement of the device itself. [0006] The prevention of microbial colonization of indwelling medical devices may allow medical professionals to prevent subsequent biofilm formation. This prevention may result in better outcomes for a patient with an indwelling medical device. SUMMARY [0007] Certain aspects commensurate in scope with the present disclosure are set forth below. It should be understood that these aspects are presented merely to provide the reader with a brief summary of certain forms specific embodiments might take and that these aspects are not intended to limit the scope of the disclosure. Indeed, the disclosure may encompass a variety of aspects that may not be set forth below. [0008] There is provided an airway device that includes a conduit for insertion into a patient's trachea; and an acyl-homoserine lactone analog covalently bound to the conduit, wherein the acyl-homoserine lactone analog is capable of reducing biofilm formation on the conduit when the conduit is inserted into the trachea. [0009] There is also provided a method of manufacturing an airway device that includes covalently binding an acyl-homoserine lactone analog to one or more spacer molecules bound to a surface of a conduit for insertion into a patient's trachea. [0010] There is also provided an airway device system that includes a conduit for insertion into a patient's trachea; an acyl-homoserine lactone analog covalently bound to the conduit, wherein the acyl-homoserine lactone analog is capable of reducing biofilm formation on the conduit when the conduit is inserted into the trachea; and a monitor operatively coupled to the conduit, wherein the monitor is adapted to monitor at least one characteristic of a patient. [0011] There is also provided an airway device that includes a device body having one or more surfaces, wherein at least one surface comprises one or more compounds capable of interrupting bacterial communication, and wherein the one or more compounds are covalently attached to the surface. BRIEF DESCRIPTION OF THE DRAWINGS [0012] Advantages of the present techniques may become apparent upon reading the following detailed description and upon reference to the drawings in which: [0013] FIG. 1 illustrates an exemplary endotracheal tube that includes molecules of an acyl-homoserine lactone analog covalently bound to the conduit; [0014] FIG. 2 illustrates an exploded view of the conduit with the acyl-homoserine lactone analog covalently bound; and [0015] FIG. 3 is a block diagram of a system according to the present techniques. DETAILED DESCRIPTION [0016] One or more specific embodiments of the present disclosure will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure. [0017] Certain compounds, including acyl-homoserine lactone analogs, may act to interrupt bacterial communication pathways involved in biofilm formation. Many bacteria use naturally occurring quorum-sensing compounds that include autoinducer ligands to monitor their population densities. At high cell densities, bacteria may then activate a process to promote the formation of biofilms. Synthetic analogs of chemical compounds involved in these pathways may interrupt the action of the naturally occurring compounds and prevent the signaling that leads to biofilm formation. For example, such analogs may inhibit binding of a native ligand, thus preventing activation of quorum-sensing pathways. Because such compounds inhibit biofilm formation without destroying individual bacteria in the process, these compounds are not microbicidal agents. [0018] Provided herein are airway medical devices that include acyl-homoserine lactone analogs. Covalently attaching these compounds to a surface of a medical device may prevent or reduce formation of biofilms on the device. Such compounds that are covalently bound to the device may not be eluted or otherwise leak from the device. Accordingly, covalent attachment of these compounds to a medical device provides the advantage of harnessing the chemical functionality of these compounds without their systemic administration to a patient, Synthetic acyl-homoserine lactone analogs, which are relatively large compounds, may be sterically hindered when directly attached to the surface of a medical device. In certain embodiments, the devices provided herein include a carbon tether, which spaces the acyl-homoserine lactone analog apart from the medical device and increases chemical communication with bacteria. Changing the length of the carbon tether may improve the ability of the medical device to prevent biofilm formation, [0019] It is desirable to provide an airway device, such as an endotracheal tube or other medical device, which may prevent formation of biofilms on its surface. In certain embodiments, the present techniques may be used in conjunction with any appropriate medical device, including a feeding tube, an endotracheal tube, a tracheostomy tube, a circuit, an airway accessory, a connector, an adapter, a filter, a humidifier, a nebulizer, nasal cannula, or a laryngeal mask. The present techniques may also be useful for any patient benefiting from mechanical ventilation. Further, the devices and techniques provided herein may be useful for a human patient, such as a trauma victim, an intubated patient, a patient with a tracheostomy, an anesthetized patient, a cardiac arrest victim, a patient suffering from airway obstruction, or a patient suffering from respiratory failure. [0020] FIG. 1 illustrates an embodiment in which an endotracheal tube 10 with covalently attached molecules of acyl-homoserine lactone analog 17 disposed on the outer surface of a conduit 16 and/or a cuff 12 . The endotracheal tube 10 also includes an inflatable cuff 12 that may be inflated to form a seal against the trachea walls. Typically, the cuff 12 is disposed, adhesively or otherwise, towards the distal end 13 of the conduit 16 . The cuff 12 may be inflated and deflated via an inflation lumen 15 in communication with the cuff 12 , typically through a hole or a notch in the conduit 20 . The cuff 12 has a proximal opening 20 and a distal opening 22 formed in the cuff walls to accommodate the conduit 16 . [0021] The covalently attached molecules of acyl-homoserine lactone analog 17 may be disposed on all or a portion of the outer surface or the inner surface of the conduit 16 or the cuff 12 . The conduit 16 may be formed from materials having suitable mechanical properties (such as puncture resistance, pin hole resistance, tensile strength), chemical properties, and biocompatibility. In one embodiment, the walls of the inflatable cuff 12 are made of polyurethane having suitable mechanical and chemical properties. In another embodiment, the walls of the inflatable cuff 12 are made of a suitable polyvinyl chloride (PVC). Suitable materials may also include polyethylene teraphthalate (PETP), low-density polyethylene (LDPE), polypropylene, silicone, neoprene, or polyisoprene. [0022] In certain embodiments, the covalently attached molecules of acyl-homoserine lactone analog 17 may include a compound having Formula (I), [0000] [0000] where R represents the point of covalent attachment to the conduit 16 . The attachment point R may also include other moieties bound at the carbon attachment site, including, [0000] [0000] in other embodiments, the covalently attached molecules of acyl-homoserine lactone analog 17 may be compounds such as those disclosed in U.S. patent application Ser. No. 11/275,896, entitled “COMPOUNDS AND METHODS FOR MODULATING COMMUNICATION AND VIRULENCE IN QUORUM SENSING BACTERIA,” filed on Feb. 2, 2006, the specification of which is incorporated by reference herein in its entirety for all purposes. [0023] FIG. 2 shows an exploded view of a surface of an exemplary conduit 16 with covalently attached molecules of acyl-homoserine lactone analog 17 . As shown, the acyl-homoserine Intone analog 17 may be covalently attached at points along the carbon backbone of a PVC conduit. The acyl-homoserine lactone analog 17 is shown with a three-carbon tether. In other embodiments, the carbon backbone may have acyl-homoserine lactone analog 17 covalently bound to the backbone as in Formula (II) [0000] [0000] where n or m may be any number. In certain embodiments, n is greater than m. For example, in one embodiment, n is 4 and m is 1. [0024] The conduit 16 may be functionalized with the acyl-homoserine lactone analog 17 by any suitable method. The surface treatment may include plasma treatment, corona discharge, ion implantation, ion bombardment, or treatment with chemical coupling agents (e.g. silane coupling agents, Volan), surfactants, or primers. In one embodiment, a PVC surface may be functionalized by cold plasma processing. The concentration of the acyl-homoserine lactone analog 17 added to the reactive conduit surface may be optimized for any desired spacing of the acyl-homoserine lactone analog 17 along the conduit surface. [0025] In another implementation, molecules of acyl-homoserine lactone analogs 17 may be tethered to the surface through extended spacer chains, such as carbon tethers, which may include one or more spacer chain extender molecules, covalently bound to the substrate surface. A substrate surface may first be exposed to a plasma to produce active sites, and the active sites are then reacted with a first reactant gas of spacer molecules in situ in the absence of plasma to provide surface-bound spacer chains on the substrate surface. The surface-bound spacer chains are then reacted with a second reactant gas of spacer chain extender molecules in situ in the absence of plasma to provide an extended spacer chain. The extended spacer chain may be further extended through one or more additional extension reactions by reacting the chains with additional gas-phase spacer chain extender molecules in a series of consecutive gas phase reactions. Finally, acyl-homoserine lactone analogs 17 may be immobilized on the surface of the conduit 16 by reacting them with the terminal spacer chain extender molecules. By selecting the number and length of spacer molecules and spacer chain extender molecules that go into producing the extended spacer chains, the distance between the covalently bound acyl-homoserine lactone analogs 17 and the conduit surface may be tailored to fit a selected application. [0026] The endotracheal tube 10 or airway devices as provided herein may be incorporated into systems that facilitate positive pressure ventilation of a patient, such as a ventilator. These systems may include connective tubing, a gas source, a monitor, and/or a controller. The controller may be a digital controller, a computer, an electromechanical programmable controller, or any other control system. [0027] While the disclosed embodiments may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the present disclosure is not intended to be limited to the particular forms disclosed. Rather, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims.

A surface coating for a medical device is provided that may prevent or slow the formation of medical biofilms on the surface of the device. Covalent attachment of certain analogues of N-acyl L-homoserine lactones onto a medical device may provide the advantage of slowing biofilm formation in a manner that is targeted to the surface of the medical device and not the patient. Such a device may allow healthcare providers to prevent bacterial buildups on the surfaces of the device, which may lead to biofilm formation.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This is a continuation application of U.S. patent application Ser. No. 12/744,241, filed May 21, 2010, the entire disclosure of which is hereby incorporated by reference. TECHNICAL FIELD [0002] The present invention relates to a game control technology and, more particularly, to a game control program, game device, game server, and game control method configured to control a game played by multiple players. BACKGROUND ART [0003] Match-up games that use a network are gaining popularity. Players can find an opponent in a match-up using a matching function provided by a server and enjoy a match-up game. SUMMARY OF THE INVENTION [0004] In network-based match-up games, one can experience enjoyment that cannot be experienced in a single player play. The down side of network games is that one cannot advance the game at one's own pace. [0005] The present invention addresses this drawback and a purpose thereof is to provide a game control technology capable of providing increased entertainment value. [0006] One embodiment of the present invention relates to a game control program product. The game control program product comprises: a module operative to request a game server managing multiplayer play to select a player with which to play a multiplayer play where a game is played between a game device of a requesting player and a game device of another player; a module operative to select a first mode or a second mode of multiplayer play and notify the game server accordingly, the first mode being a mode where a multiplayer play is played with a player accepting the request for a multiplayer play, and the second mode being a mode where a selected player is forced to play in a multiplayer play; and a module operative to receive notification of a player with which to play a multiplayer play from the game server and control the requested multiplayer play with a game device of the player designated by the notification. [0007] Another embodiment of the present invention also relates to a game control program product. The game control program product comprises: a module operative to acknowledge, from a game device of a player, a request for a multiplayer play where a game is played between a game device of a requesting player and a game device of another player; a module operative to select a first mode or a second mode of multiplayer play, the first mode being a mode where a multiplayer play is played with a player accepting the request for a multiplayer play, and the second mode being a mode where a selected player is forced to play in a multiplayer play; a module operative to refer to a player database storing information on players and select a player to play the requested multiplayer play; and a module operative to notify the selected player's game device of the selected mode and requests the game device thus notified to start the requested multiplayer play. [0008] Still another embodiment of the present invention also relates to a game control program product. The game control program product comprises: a module operative to control a game where a player controls a player's character and advances in a game field; a module operative to acquire play data of another player or a message, from a game server adapted to manage the play data and the message, the play data indicating the status of progress of the game in the game field, and the message being directed to another player displayed in the game field; and a module operative to display the play data or the message when the player's character is located within a predetermined range from a position where the play data or the message is registered. [0009] Yet another embodiment of the present invention also relates to a game control program product. The game control program product comprises: a module operative to acquire, from a game device adapted to control a game where a player controls a player's character and advances in a game field, play data indicating the status of progress of the game in the game field or a message directed to another player displayed in the game field; a module operative to refer to a player database storing information on positions of the player's characters of a plurality of game devices in the game field and to select a player that controls a player's character located within a predetermined range from a position in the game field where the play data or the message should be displayed; and a module operative to deliver the play data or the message to the game device of the selected player. [0010] Optional combinations of the aforementioned constituting elements, and implementations of the invention in the form of methods, apparatuses, and systems may also be practiced as additional modes of the present invention. [0011] The present invention provides a game control technology capable of providing increased entertainment value. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 shows the configuration of a game system according to an embodiment; [0013] FIG. 2 shows exemplary data stored in a player database; [0014] FIG. 3 shows exemplary data stored in a message database; [0015] FIG. 4 shows the configuration of a game device according to the embodiment; [0016] FIG. 5 shows an exemplary screen displayed by the display device; [0017] FIG. 6 shows the configuration of a game server according to the embodiment; [0018] FIG. 7 shows exemplary data stored in an attribute storage unit; [0019] FIG. 8 shows exemplary data stored in a tallying condition storage unit; [0020] FIG. 9 shows exemplary data stored in a change condition storage unit; [0021] FIG. 10 shows the configuration of a game terminal according to the embodiment; and [0022] FIG. 11 shows an exemplary screen presented by an attribute presenting unit. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS First Embodiment [0023] A description will be given of a technology according to an embodiment that provides the function of allowing players playing a game in parallel to exercise influence to each other directly or indirectly. To describe the embodiment, a role playing game will be discussed by way of example where a player controls a player's character in a hope to achieve a certain goal, traveling in a game field formed of multiple areas, fighting with an enemy character, picking up an item, clearing an event, etc. [0024] When a player's character dies by, for example, being defeated by an enemy character before achieving the goal, the game is re-started at a certain point in an area with the item that had been acquired being lost and the level of physical strength being reduced to half. The game server provides a means to allow the player to re-start the game without losing an item and so on. In other words, the player can seek relief from the game server to restore the player's character. The game server provides two methods of relief. One method is to allow the player to cooperate with a player to give relief and advance the game accordingly so that the player's character is restored by achieving the goal and clearing the area. Such a method will be referred to as “friendly mode”. Another is to restore the player's character by fighting with a player's character of a player to give relief and defeating the player. Such a method will be referred to as “hostile mode”. [0025] In the case of friendly mode, the game server requested by a player to relieve the player's character recruits a player to give relief. When a player to give relief is found, the player's character of the player to give relief is located in the game field of the player that requested the relief. In the case of hostile mode, the game server automatically selects a player to give relief and causes the player's character of the requesting player to enter the game field of the selected player. A player can choose from either of the methods when the player's character dies and attempt to restore the player's character accordingly. [0026] A player can play the game independently without connecting to the game server. By connecting to the game server to play the game, the player is given an opportunity to enjoy a multiplayer play with other players, as described above. Since a multiplayer play in the friendly mode does not occur unless the player requests relief or accepts to give relief to someone else, the player can enjoy a multiplayer play on its own pace. Sometimes, another player unexpectedly enters the player's field in the hostile mode. Therefore, the player can enjoy the playful tension. [0027] The embodiment further provides various functions designed to help players to communicate with each other indirectly. For example, the play data of another player may be played back while the game is in progress, the position where the game was over for another player may be displayed, a message for other players may be left in the field, or a message left by another player is displayed. In this way, each player can collect information that serves as a hint to the progress of the game so that the convenience for the players is improved. By seeing other players' situations or viewing messages from them, sense of solidarity is created among players, bringing refined enjoyment to the players. [0028] FIG. 1 shows the configuration of a game system 1 according to the embodiment. In the game system 1 , a game device 100 that allows a player to play a game, and a server 10 controlling the game run in multiple game devices 100 are connected by a network such as the Internet 20 . The device 100 and the game server 10 exchange data via the Internet 20 . [0029] The game server 10 is provided with a communication unit 30 , a control unit 40 , a player database 60 , a message database 62 , and a play data storage unit 64 . The configuration is implemented, in hardware components, by any CPU of a computer, a memory, and in software by a program or the like loaded into the memory. FIG. 1 depicts functional blocks implemented by the cooperation of hardware and software. Therefore, it will be obvious to those skilled in the art that the functional blocks may be implemented in a variety of manners by hardware only, software only, or a combination of thereof. [0030] The player database 60 stores information on players utilizing the service provided by the game server 10 . FIG. 2 shows exemplary data stored in the player database 60 . The player database 60 is provided with a player ID column (fields) 70 , an authentication data column (fields) 71 , an IP address column (fields) 72 , a level column (fields) 73 , an area ID column (fields) 74 , a play data column (fields) 75 , a game over position column (fields) 76 , and a status column (fields) 77 . The player ID fields 70 store player IDs. The authentication fields 71 store data for authenticating the associated players. The IP address fields 72 store the IP addresses of the game devices of the associated players. The level fields 73 store the levels of the players' characters of the associated players. The area ID fields 74 store the IDs of the areas of the game fields in which the associated players are playing. The player data fields 75 store the name of the data files storing the play data of the associated players. The game over position fields 76 store the positions where the players' characters of the associated players die. The status fields 77 store the status of the associated players in the game. The status may be “running normal mode”, “requesting friendly mode”, “running friendly mode”, “requesting hostile mode”, “running hostile mode”, etc. [0031] The message database 62 stores messages registered by players. FIG. 3 shows exemplary data stored in the message database 62 . The message database 62 is provided with a message ID column (fields) 80 , an area ID column (fields) 81 , a position column (fields) 82 , a player ID column (fields) 83 , a message column (fields) 84 , and an evaluation column (fields) 85 . The message ID fields store the IDs of messages. The area ID fields 81 store the IDs of the areas of the game fields in which the associated messages are registered. The position fields 82 store the positions in the areas in which the associated messages are registered. The player ID fields 83 store the IDs of the players registering the associated messages. The message fields 84 store the content of the associated messages. The evaluation fields 85 store the evaluation given to the associated messages by other players. [0032] The authentication unit 41 authenticates the player attempting to connect to the game server 10 . When the authentication unit 41 is requested by the game device 100 of the player to authenticate the device 100 for connection, the unit 41 demands the ID and authentication data from the player. The unit 41 refers to the player database 60 and authenticates the player ID and the authentication data thus acquired. When the player ID is not registered in the player database 60 , the authentication unit 41 acknowledges a request for registration from the player and registers the player ID and the authentication data in the player database 60 . When the authentication is successful, the authentication unit 41 acquires the IP address of the game device 100 and registers the address in the player database 60 . The unit 41 also acquires the level of the player and the ID of the area in which the player is playing and registers them in the player database 60 . [0033] A multiplayer play request acknowledging unit 42 acknowledges a request for a multiplayer play from the game device 100 of the player. As mentioned before, the embodiment provides for a multiplayer play as a means of relief when the player's character dies. The multiplayer play request acknowledging unit 42 acknowledges a request for a multiplayer play in the friendship mode or in the hostile mode from the game device 100 of the player requesting the restoration of the dead player's character. [0034] When the multiplayer play request acknowledging unit 42 acknowledges a request for a multiplayer play in the friendly mode, a friendly mode matching unit 43 selects a player with which the requesting player plays a multiplayer play. The friendly mode matching unit 43 acquires the level and the area ID of the player requesting a multiplayer play in the friendly mode from the player database 60 . The unit 43 searches the player database 60 for players playing in the same area and having a similar level. The friendly mode matching unit 43 selects players according to a predetermined condition or in a random fashion from the players identified by the search. The unit 43 transmits to the game devices 100 of the selected players data for inviting the selected players to a multiplayer play in the friendly mode. The friendly mode matching unit 43 determines a partner in the multiplayer play from the game devices 100 invited to the multiplayer play and accepting the invitation to the multiplayer play. The friendly mode matching unit 43 transmits, to the game device 100 of the player thus determined and to the game device 100 of the requesting player, the IP addresses of each other's game devices 100 . [0035] For the purpose of increasing the likelihood of success of relief of the player's character in the friendly mode, a player having a higher level than the player requesting the relief may be selected as the one to give relief. In this way, the convenience for the player is improved. Conversely, a player having a lower level than the player requesting the relief may be selected as the one to give relief. In this way, the difficulty of the game is maintained at a high level and the enjoyment of the game is improved. [0036] When the multiplayer play request acknowledging unit 42 acknowledges a request for a multiplayer play in the hostile mode, a hostile mode matching unit 44 selects a player with which the requesting player plays a multiplayer play. The hostile mode matching unit 44 acquires the level and the area ID of the player requesting a multiplayer play in the hostile mode from the player database 60 . The unit 44 searches the player database 60 for players playing in the same area and having a similar level. The hostile mode matching unit 44 selects players according to a predetermined condition or in a random fashion from the players identified by the search. The unit 44 notifies the game device 100 of the selected player of the start of a multiplayer play in the hostile mode. In other words, in the case of the hostile mode, the player's character of the requesting player enters the game field of the requested player regardless of whether the requested player likes it or not, whereupon a multiplayer play is started. The hostile mode matching unit 44 transmits, to the game device 100 of the requested player and to the game device 100 of the requesting player, the IP addresses of each other's game devices 100 . [0037] For the purpose of increasing the likelihood of success of relief of the player's character in the hostile mode, a player having a lower level than the player requesting the relief may be selected as an opponent. In this way, the convenience for the player is improved. Conversely, a player having a higher level than the player requesting the relief may be selected as an opponent. In this way, the difficulty of the game is maintained at a high level and the enjoyment of the game is improved. [0038] The friendly mode matching unit 43 or the hostile mode matching unit 44 may select multiple players as players in a multiplayer play. In this case, an upper limit may be set to the number of players that can participate in a multiplayer play in order to reduce the processing load of the game device 100 or the congestion in communication. [0039] When a player in a multiplayer play is determined, exchange of data between the game devices 100 participating in a multiplayer play may be mediated by the game server 10 . Alternatively, the data may be exchanged using P2P communication between the game devices 100 . In the latter case, the data may be directly exchanged between the participating game devices 10 . Alternatively, a given game device 100 (e.g., the game device 100 originating the request) may serve as a host to mediate data exchange between the game devices 100 . [0040] A play data acquiring unit 45 acquires data indicating the status of the game being run from the game device 100 of the player and stores the data in the play data storage unit 64 . The play data acquired may be moving image data capturing screen images and sound of the game being run, or data indicating the history of player control, or control parameters of the game. Alternatively, the play data may be replay data comprising coordinate data indicating the position of the player's character and data indicating the orientation of the player's character as recorded frame by frame or at intervals of a predetermined number of frames. What is essential is that the play data thus acquired can be played back in the game device 100 of another player. The play data includes data generated when the player's character is defeated to death by an enemy. [0041] A play data delivering unit 46 delivers the play data stored in the play data storage unit 64 to the game device 100 of the player according to a predetermined timing schedule. The play data delivering unit 46 may read the play data stored in the play data storage unit 64 , select the game device 100 that should receive the play data, and deliver the data accordingly. Alternatively, the game device 100 may first determine the game device 100 that should receive the play data, then select the play data that should be delivered to the device 100 thus determined, and deliver the data accordingly. [0042] In the former case, the play data delivering unit 46 selects and reads the play data stored in the play data storage unit 64 according to a certain condition or in a random fashion. Subsequently, the play data delivering unit 46 refers to the player database 60 , acquires the level and area ID of the player transmitting the play data thus read, and searches the player database 60 for players playing in the same area and having a similar level. Of the players identified by the search, the play data delivering unit 46 selects a player to deliver the data to according to a predetermined condition or in a random fashion. The unit 46 acquires the IP address of the game device 100 of the selected player and transmits the play data accordingly. [0043] In the latter case, the play data delivering unit 46 selects the game device 100 to deliver the play data to according to a predetermined condition or in a random fashion. Subsequently, the play data delivering unit 46 refers to the play database 60 , acquires the level and area ID of the player of the game device 100 thus selected, and searches the player database 60 for players playing in the same area and having a similar level. Of the players identified by the search, the play data delivering unit 46 selects a player according to a predetermined condition or in a random fashion. The unit 46 reads the play data of the selected player from the play data storage unit 64 and transmits the data accordingly. [0044] The play data delivering unit 46 may deliver the play data to the game device 100 periodically, deliver the data to the game device 100 of the other players when the play data acquiring unit 45 acquires the play data, or deliver the play data in an area collectively when the player starts playing in the area. The play data delivering unit 46 may provide an upper limit to the number of game devices 100 to collectively deliver the play data to, for the purpose of reducing the load of the game server 10 . [0045] A message registration acknowledging unit 47 acknowledges a request for registration of a message from the game device 100 and registers the message thus acknowledged in the message database 62 . In addition to the content of the message, the message registration acknowledging unit 47 acquires from the game device 100 the ID of and position in the area in which to register the message and registers the ID and position in the message database 62 . [0046] A message delivering unit 48 delivers the message registered in the message database 62 to the game device 100 of the player. When a player starts playing in an area, the message delivering unit 48 reads the message registered in the area from the message database 62 and delivers the message content and data indicating the position of registration to the recipient game device 100 . This allows the game device 100 to display the message in the game field. [0047] The message delivering unit may additionally read the ID of the player registering the message or the evaluation of the message from the message database 62 and deliver it to the game device 100 . This allows the player to evaluate the reliability of the registered message in an objective manner. [0048] An upper limit to the number of messages delivered may be set in consideration of the load of the game device 100 . The message delivering unit 48 may select a message to deliver by allowing for the level of the player registering the message and the level of the player to deliver the message to. For example, the unit may preferentially select a message registered by a player having a level different from that of the recipient player by a predetermined amount or less. This allows providing the player with a message such as a hint left by a player of a similar level so that the convenience for the player is improved. [0049] A message evaluation unit 49 evaluates the message registered in the message database 62 . The message evaluation unit 49 may acquire the evaluation of the message from the game device 100 when the registered message is delivered to the game device 100 . The message evaluation unit 49 calculates a numerical score indicating the evaluation of the message and registers it in the message database 62 . [0050] FIG. 4 shows the configuration of the game device 100 according to the embodiment. The game device 100 is provided with a controller 120 , an input acknowledging unit 122 , a communication unit 130 , a control unit 140 , a parameter storage unit 160 , a screen generating unit 166 , and a display device 168 . The components may be implemented in a variety of manners by hardware only, software only, or a combination of thereof. [0051] The input acknowledging unit 122 acknowledges a control signal from the controller 120 controlled by the player. The control unit 140 moves the player's character in an area forming the game field based on a control input from the player acknowledged by the input acknowledging unit 122 so as to advance the game. The parameter storage unit 160 stores various parameters necessary to advance the game such as the position of the player's character and an event flag. The screen generating unit 166 generates a screen of the game controlled by the control unit 140 and causes the display device 168 to display the screen. The communication unit 130 controls communication with the game server 10 via the Internet 20 . [0052] A single player play control unit 141 runs the game program and controls the game in the normal mode played by a single player. The single player play control unit 141 moves the player's character in an area and controls the execution of a battle with an enemy character or of an event. The single player play control unit 141 manages acquisition, disposal, and use of an item, as well as controlling increase/decrease of the physical strength level of the player's character. When the physical strength level of the player's character becomes zero, the unit deletes the item in possession of the player, sets the physical value level to half the maximum value, moves the player's character to a predetermined position in the area where the player played, and re-starts the game. [0053] A multiplayer play request transmitting unit 142 transmits data requesting a multiplayer play with another player to the game server 10 . As mentioned before, a multiplayer play is called for the purpose of restoring a dead player's character. The multiplayer play request transmitting unit 142 may request the game server 10 to run a multiplayer play when the player's character dies while the single player play control unit 141 is running a single player play. Alternatively, the unit 142 may request the game server 10 to run a multiplayer play when the game is re-started and then the player requests a multiplayer play by, for example, using an item for requesting a multiplayer play. The multiplayer play request transmitting unit 142 acknowledges a request from the player for a multiplayer play in the friendly mode or for a multiplayer play in the hostile mode. The unit 142 notifies the game server 10 of the mode of multiplayer play. [0054] A multiplayer play control unit 143 controls a multiplayer play with the game device 100 with which to play the requested multiplayer play. The multiplayer play control unit 142 runs the requested multiplayer play with the game device 100 notified by the game server 10 . A multiplayer play may be started when the player controls the multiplayer play request transmitting unit 142 to request the game server 10 to offer a multiplayer play in the friendly mode or in the hostile mode. A multiplayer play may alternatively be started when the player accepts an invitation to a multiplayer play in the friendly mode from another player, or when the player's character of another player comes entering the field for a multiplayer play in the hostile mode initiated by the entering player. [0055] When the multiplayer play request transmitting unit 142 of a device requests the start of a multiplayer play in the friendly mode, the multiplayer play control unit 143 of the requesting device terminates the multiplayer play when the player's character achieves a predetermined goal in the area. In this case, the player's character once dead is restored and the game is returned to a single player play. In the hostile mode, the multiplayer play control unit 143 terminates the multiplayer play when the player's character wins a battle with the player's character of the player in the multiplayer play. In this case, the player's character once dead is restored and the game is returned to a single player play. Second death of the player's character in a multiplayer play is processed in the same manner as death of the player's character in a single player play. [0056] A play data transmitting unit 144 transmits the play data occurring in the game to the game server 10 at a predetermined timing schedule while the game is running. The play data transmitting unit 144 may transmit the play data periodically, i.e., at predetermined time intervals. Alternatively, the unit 144 may transmit the play data when a predetermined trigger (e.g., occurrence of an event or clearing) is generated. [0057] A play data receiving unit 145 receives the play data of another game device 100 from the game server 10 . A play data playback unit 146 plays back the play data of another game device 100 received by the play data receiving unit 145 . For example, when the play data receiving unit 145 receives the play data comprising coordinate data indicating the position of the player's character of another game device 100 and data indicating the orientation of the player's character as recorded frame by frame, the play data playback unit 146 reads shape data of the player's character by referring to the data indicating the orientation so as to generate an image of the player's character and place the image on the game field by referring to the coordinate data. [0058] The play data playback unit 146 may play back the received play data when the play data receiving unit 145 receives the play data. Alternatively, the unit 146 may store the play data received in the parameter storage unit 160 and reads the data from the parameter storage unit 160 and plays back the data accordingly when the player's character passes the position where the play data is recorded. This allows the player to feel the other player is playing in parallel and develop the sense of solidarity. Therefore, the enjoyment of the game is improved. Further, the player is provided with guidance to advance the game, by playing back the play of another player. Therefore, the convenience for the player is improved. [0059] When the play data playback unit 146 receives data indicating the position where the player's character of another player dies, the unit 146 displays a mark (e.g., blood mark) at the associated position in the game field. When the player's character approaches the mark, the play data playback unit 146 inquires the player whether to play back the play data associated with the blood mark. When the unit 146 receives an instruction to play back the data, the unit 146 reads the associated play data from the parameter storage unit 160 and plays back the data. This allows the player to know where the game was over for another player and in what situation the game was over. Therefore, the convenience for the player is improved. [0060] A message registration unit 147 acknowledges a request to register a message from the player and requests the game server 10 to register the message. The message registration unit 147 presents a screen to enter a message when the unit 147 acknowledges a request to register a message from the player. A template of the message may be stored in the parameter storage unit 160 so that the template is presented to acknowledge the entry of a message. Alternatively, a free text may be acknowledged. The message registration unit 147 transmits to the game server 10 the message thus acknowledged, the area ID in the game field in which to display the message, and information indicating the position in the area. [0061] A message receiving unit 148 receives a message registered in the game server 10 from the game server 10 . The message receiving unit 148 may receive the message registered in the area before the player's character enters the area. Alternatively, the unit 148 may receive the message according to a predetermined timing schedule while the game is in progress. The message receiving unit 148 stores the received message in the parameter storage unit 160 . [0062] A message displaying unit 149 displays the message received by the message receiving unit 148 . When the screen generating unit 166 generates a screen, the message displaying unit 149 reads the position where the message is registered from the parameter storage unit 160 and notifies the unit 166 accordingly. When the screen generated by the screen generating unit 166 includes the position where the message is registered, an icon or the like indicating that the message is registered is displayed in the neighborhood of the position. When the message displaying unit 149 acknowledges a request to display the message from the player, the unit 149 reads the associated message from the parameter storage unit 160 and displays the message. This allows the player to read a message left by another player. Therefore, the player is provided with guidance to advance the game and the convenience for the player is improved. Conventionally, information exchange between players is done via a bulletin board dedicated for the purpose. By providing the function to allow messages to be exchanged within the game, however, the player is capable of reading messages without taking the trouble of opening a bulletin board while the game is in progress and reading messages related precisely to the position in the game. Therefore, the convenience is further improved. The message displaying unit 149 may display only those messages evaluated at a level higher than a predetermined value. This improves the reliability of the message. [0063] After presenting the message to the player, the message displaying unit 149 acknowledges evaluation of the message from the player and transmits the evaluation to the game server 10 . Many of the messages displayed relate to the game field ahead the point where the message is displayed. In this case, however, the player cannot evaluate the reliability of the message when the message is displayed. Therefore, the message displaying unit 149 may acknowledge from the player the evaluation of the message displayed in the past, when the player reaches a predetermined point in the game field or clears the area. In this way, the reliability of the message can be accurately reflected in the evaluation. [0064] FIG. 5 shows an exemplary screen displayed by the display device 168 . In addition to a player's character 90 and an enemy character, the screen shows a player's character 91 of another player, a blood mark 92 indicating the position where the other player's character dies, an icon 93 indicating a message left by the other player, and a blood mark 94 indicating that the other player is requesting a multiplayer play in the friendly mode. [0065] The play data playback data 146 plays back the play data of the other player in, for example, a semi-transparent fashion so that the player's character 91 of the other player is visually distinguished from the player's character 90 of the player's device. [0066] When the player's character 91 approaches the blood mark 92 , the play data playback unit 146 inquires the player whether the play data generated when the player's character associated with the blood mark 92 died should be played back. When the player requests that the data be played back, the play data playback unit 146 reads the play data from the parameter storage unit 160 and plays back the data. [0067] When the player's character 91 approaches the icon 93 indicating the message, the message displaying unit 149 inquires the player whether the message associated with the icon should be displayed. When the player requests that the message be displayed, the message displaying unit 149 reads the message from the parameter storage unit 160 and displays the message. In this process, the unit 149 may request the player to provide an evaluation of the message. The evaluation of the message provided by the player is transmitted by the message registration unit 147 to the game server 10 . [0068] When the player's character 91 approaches the blood mark 94 , the multiplayer play control unit 143 inquires the player whether the player accepts invitation to a multiplayer play in the friendly mode. When the player requests a multiplayer play, the multiplayer play control unit 143 notifies the game server 10 of the acceptance of the invitation to a multiplayer play. Upon being notified by the game device 10 of the IP address of the game device 100 of the other player in the requested multiplayer play, the multiplayer play control unit 143 starts the requested multiplayer play. [0069] Services are widely used that provide a game field where multiple players can play a game simultaneously and in parallel via a network. Examples of network games include games where multiple players match up or games where multiple players cooperate to advance a game toward a certain goal. [0070] However, the vivid pleasure of a game may be lost as the game is played repeatedly because the game itself remains unchanged even if the opponent in a match or the partner in cooperation changes. There is called for a technology to introduce a change in a game in order to prevent a user from feeling bored playing the game. [0071] The present invention addresses this goal and a purpose thereof is to provide a game control technology capable of providing increased entertainment value. [0072] One aspect of the second embodiment relates to a game control program product. The game control program product comprises: a module operative to communicate with game terminals of a plurality of players; a module operative to acquire a first parameter that varies with the progress of a game from the game terminals; a module operative to tally the first parameters from the game terminals in accordance with a tallying condition stored in a condition storage unit and calculate a second parameter indicating the overall pattern of the plurality of players; and a module operative to communicate a change of a third parameter for controlling the game to the game terminals, in accordance with a change condition stored in the condition storage unit and based on the second parameter thus calculated. [0073] Another aspect of the second embodiment also relates to a game control program product. The game control program product comprises a module operative to control the progress of a game; a module operative to transmit a parameter that varies with the progress of the game to a game server adapted to manage a plurality of game terminals; a module operative to receive notification of a change of a parameter for controlling the game from the game server; and a module operative to change a parameter used by the module for controlling the progress of the game to control the game, in accordance with the notification of a change thus received. [0074] Optional combinations of the aforementioned constituting elements, and implementations of the invention in the form of methods, apparatuses, and systems may also be practiced as additional modes of the present invention. [0075] The second embodiment provides a game control technology capable of providing increased entertainment value. Second Embodiment [0076] A description will be given of a technology according to the second embodiment whereby the game server for management of a game played by multiple players acquires and tallies event information (an example of the first parameter that varies with the progress of the game) from the game terminals of the multiple players playing the game, calculates an attribute (an example of the second parameter indicating the pattern of the game world as a whole built by the game server), and changes a control parameter (an example of the third parameter for controlling the game in the game terminals) in accordance with the attribute thus calculated. [0077] The attribute of the game world as a whole indicates “atmosphere” or “pattern” of the game world built by multiple participating players. The attribute reflects the way the game is advanced by the players connected to the game server, the progress of the game, the content, level, and nature of events, etc. For example, if there are a lot of players in a role playing game attempting to advance the game by cooperating with a friendly character and defeating an evil enemy character, the sense of justice prevails in the game world as a whole. In this case, the levels of friendly characters are increased, or a large number of valuable items are placed in the field, etc. Conversely, if there are a lot of players attempting to advance the game by diminishing a friendly character and cooperating with an evil enemy character, an evil atmosphere prevails in the game world as a whole. In this case, more evil enemy characters will present themselves, or items not available in a normal scenario are placed in the field, etc. [0078] Since each player advances the game under the influence from multiple other players playing the game simultaneously and in parallel, the player can feel a sense of involvement and experience the pleasure that cannot be experienced in related-art games. Further, since the status of each player in the game is changed in accordance with the attribute of the game world as a whole, the player can experience a game that is rich in variations. [0079] FIG. 6 shows the configuration of a game server 210 according to the embodiment. The game server 210 is provided with a communication unit 230 , a control unit 240 , an attribute storage unit 260 , a tallying condition storage unit 262 , and a change condition storage unit 264 . The configuration is implemented, in hardware components, by any CPU of a computer, a memory, and in software by a program or the like loaded into the memory. FIG. 1 depicts functional blocks implemented by the cooperation of hardware and software. Therefore, it will be obvious to those skilled in the art that the functional blocks may be implemented in a variety of manners by hardware only, software only, or a combination of thereof. [0080] In this embodiment, each game terminal 300 runs a role playing game. A role playing game comprises multiple areas. When the player clears an area, the player is capable of moving to the next area. When the player logs into the game server 210 via the game terminal 300 before playing an area, the player is presented by the game server 210 with the current attribute of the area in the game world as a whole. When the player does not wish to play in the game world with the attribute thus presented, the player can log off from the game server 210 and play on an individual basis. [0081] When the player chooses to play in the game world, the game server 210 determines control parameters of the area based on the current attribute of the area and the attribute of the player itself, and communicates the parameters thus determined to the game terminal 300 . The game terminal 300 controls the game based on the control parameters thus communicated. This allows the player to enjoy the game in which the attribute of the game world as a whole built by the game server 210 is reflected. The game terminal 300 transmits information on an event generated while the game is in progress to the game server 210 . The game server 210 calculates and records the attribute of the player by referring to the event information thus retrieved and causes the attribute to be reflected in the attribute of the game world as a whole. In this way the attribute of the game world as a whole varies minute by minute in accordance with events generated by individual players so that a change is introduced in the game. [0082] A description will now be given of the operation of individual functional blocks with reference to FIG. 6 . The communication unit 230 exchanges data with the game terminal 300 of the player via the Internet 20 , which is an example of a network. [0083] The attribute storage unit 260 stores attributes calculated by tallying the parameters retrieved from the game terminals of the players. As described below, according to the embodiment, the game parameters are changed in consideration of both the attributes of individual players and the attribute of the game world as a whole. Therefore, the attribute storage unit 260 stores the attribute of the whole and those of individual players. [0084] FIG. 7 shows exemplary data stored in the attribute storage unit 260 . The attribute storage unit 260 is provided with a player ID column (fields) 270 , a recorded date and time column (fields) 271 , an area ID column (fields) 272 , a WB attribute column (fields), and an LR attribute column (fields) 274 . The player ID fields 270 store the IDs of players for which an attribute is recorded. The recorded date and time fields 271 store the date and time that the attribute is recorded. The area ID fields 272 store the IDs of areas in which the attribute is recorded. The WB attribute fields 273 and the LR attribute fields 274 store the attribute of the game worlds as a whole and those of individual players, respectively. The WB attribute is increased as players play more in the interest of justice and is decreased as players play evil characters. The LR attribute denotes affinity with a specific character. In this embodiment, the parameters for controlling the game are determined by referring to these two attributes. Alternatively, only one or three or more attributes may be provided. [0085] The tallying condition storage unit 262 stores a tallying condition for tallying the event information and calculating the attribute. FIG. 8 shows exemplary data stored in the tallying condition storage unit 262 . The tallying condition storage unit 262 is provided with an event column (fields) 275 , an area ID column (fields) 276 , a WB attribute column (fields) 277 , and an LR attribute column (fields) 278 . For example, when the player generates an event “defeat enemy character A in the castle” in an area identified by area ID “1”, “−10” is added to the WB attribute. [0086] The change condition storage unit 264 stores a condition for changing the control parameters of the game in accordance with the attribute of the game world as a whole and the attributes of individual players. FIG. 9 shows exemplary data stored in the change condition storage unit 264 . The change condition storage unit 264 is provided with an area ID column (fields) 280 , a WB attribute column (fields) 281 , an LR attribute column (fields) 282 , and a control parameter column (fields) 283 . For example, given that the WB attribute calculated by referring to the attribute of the game worlds as a whole and the attribute of the associated player is “+50” or greater, the “enemy character level”, one of the control parameters, is increased by an increment of “+1”. [0087] An authentication unit 241 authenticates the game terminal 300 of the player. For example, the authentication unit 241 retrieves a player ID and a password for authentication from the game terminal 300 via the communication unit 230 , and authenticates the game terminal 300 of the player by referring to the player database (not shown). When the authentication is successful, the authentication unit 241 registers the IP address of the game terminal 300 of the player in the player database. The game server 210 retrieves the event information of the game from the game terminal 300 of the player successfully authenticated, as described later, and notifies the terminal of a change in the control parameters of the game. [0088] An event information retrieving unit 242 retrieves event information that varies with the progress of the game from the game terminal 300 of the player successfully authenticated by the authentication unit 241 . A tallying unit 243 calculates the attribute from the event information retrieved by the event information retrieving unit 242 in accordance with the condition stored in the tallying condition storage unit 262 and stores the attribute in the attribute storage unit 260 . A parameter change communicating unit 244 calculates the game control parameters in the individual game terminals, by referring to the attribute calculated by the tallying unit 243 , and notifies the game terminal 300 of a change in the control parameters. The parameter change communicating unit 244 may communicate the attribute calculated by the tallying unit 243 to the game terminal 300 so that the game terminal 300 can calculate the control parameters for controlling the game and change the parameters. [0089] An attribute presenting unit 245 reads the attribute of the game world as a whole from the attribute storage unit 260 and presents the attribute to the game terminal 300 . The attribute presenting unit 245 may present the attribute of the game world as a whole to the game terminal 300 before the parameter change communicating unit 244 communicates a change in the parameters to the game terminal 300 . This allows the player of the game terminal 300 to know the pattern underlying the game world as a whole beforehand and determine whether to accept the change in the parameters. [0090] FIG. 10 shows the configuration of the game terminal 300 according to the embodiment. The game device 300 is provided with a controller 320 , an input acknowledging unit 322 , a communication unit 330 , a control unit 340 , a parameter storage unit 360 , a screen generating unit 366 , and a display device 368 . The components may be implemented in a variety of manners by hardware only, software only, or a combination of thereof. [0091] The input acknowledging unit 322 acknowledges a control signal from the controller 320 controlled by the player. The control unit 340 advances the game based on a control input from the player acknowledged by the input acknowledging unit 322 . The parameter storage unit 360 stores various parameters necessary to advance the game such as control parameters for controlling the game, event information that varies with the progress of the game. The screen generating unit 366 generates a game screen controlled by the control unit 340 and causes the display device 368 to display the screen. [0092] A game control unit 341 runs the game program and controls the progress of the game. The game control unit 341 reads the control parameters of the game stored in the parameter storage unit 360 and controls the game. The game control unit 341 also stores parameters such as event information in the parameter storage unit 360 with the progress of the game. [0093] An event information transmitting unit 342 transmits the event information stored in the parameter storage unit 360 to the game server 210 according to a predetermined timing schedule. The event information transmitting unit 342 may transmit the event information to the game server 210 periodically, i.e., at predetermined time intervals. Alternatively, the unit 342 may transmit the event information to the game server 210 when the player starts playing in the area or stops playing in the area, when an event occurs, or when the game is cleared, etc. In addition to the event information or instead of the event information, the event information transmitting unit 342 may transmit other parameter that varies with the progress of the game to the game server 210 . [0094] A parameter change notification receiving unit 343 receives notification of a change of parameter from the game server 210 . A parameter changing unit 344 changes a game control parameter stored in the parameter storage unit 360 in accordance with the parameter change notification received by the parameter change notification receiving unit 343 . This changes the content of the game controlled by the game control unit 341 . Parameters changed include attributes such as the physical strength level, experience value, magic point, capability values, clothing, shape data of the player's character or the enemy character. Parameters may also or alternatively include: the configuration of the game field; the type, location, probability of occurrence of items or enemy characters located in the game field; the type, details, location, probability of occurrence of events generated in the game field; the date and time, or day of the week in the game field; or the type or brightness of the screen generated by the screen generating unit 366 . [0095] Changing the parameters for controlling the game in accordance with notification of a change from the game server 210 allows the player to enjoy a game that is rich in variations. Thereby, a game is provided which arouses the player's interest and in which it less likely that the player feels bored. [0096] An attribute presenting unit 345 retrieves from the game server 210 the attribute indicating the overall pattern of multiple game terminals 300 , which serves as a criterion to change the parameters for controlling the game and which is calculated by tallying the event information retrieved from the multiple game terminals 300 , and displays the parameter. [0097] FIG. 11 shows an exemplary screen presented by the attribute presenting unit 345 . When the game terminal 300 logs into the game server 210 , the attribute presenting unit 345 retrieves the attribute of the game world as a whole in the area in which the player attempts to play, displaying a graph representation of the attribute, plotting the WB attributes on the vertical axis and LR attribute on the horizontal axis. This allows the player of the game terminal 300 to know the pattern underlying the game world as a whole beforehand and determine whether to accept the change in the parameters. [0098] Described above is an explanation based on an exemplary embodiment. The embodiment is intended to be illustrative only and it will be obvious to those skilled in the art that various modifications to constituting elements and processes could be developed and that such modifications are also within the scope of the present invention. DESCRIPTION OF THE REFERENCE NUMERALS [0099] 10 game server, 20 Internet, 30 communication unit, control unit, 41 authentication unit, 42 multiplayer play request acknowledging unit, 43 friendly mode matching unit, 44 hostile mode matching unit, 45 play data acquiring unit, 46 play data delivering unit, 47 message registration acknowledging unit, 48 message delivering unit, 49 message evaluation unit, 60 player database, 62 message database, 64 play data storage unit, 100 game device, 140 control unit, 141 single player play control unit, 142 multiplayer play request transmitting unit, 143 multiplayer play control unit, 144 play data transmitting unit, 145 play data receiving unit, 146 play data playback unit, 147 message registration unit, 148 message receiving unit, 149 message displaying unit, 160 parameter storage unit, 166 screen generating unit, 168 display device, 240 control unit, 241 authentication unit, 242 event information acquiring unit, 243 tallying unit, 244 parameter change communicating unit, 245 attribute presenting unit, 260 attribute storage unit, 262 tallying condition storage unit 262 change condition storage unit, 300 game terminal, 330 communication unit, 340 control unit, 341 game control unit, 342 event information transmitting unit, 343 parameter change notification receiving unit, 344 parameter changing unit, 345 attribute presenting unit, 360 parameter storage unit [0100] The present invention can be used in a game device configured to control a game played by multiple players.

Methods and apparatus provide for managing multiplayer play among a first player and at least one second player, where a first mode of multiplayer play is defined such that a game server selects the second player by: (i) selecting candidates by consulting a player database of information concerning a plurality of other players, (ii) sending invitations to the selected candidates to be the selected second player, (iii) receiving acceptances of the invitations from the candidates; and (iv) selecting the second player from among the candidates from whom acceptances were received; and where a second mode of multiplayer play is defined such that the game server selects the second player by consulting a player database of information concerning the plurality of other players, without consideration of an invitation to, or an acceptance from, the selected second player.

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority under 35 U.S.C. § 119 of German Application DE 10 2004 017 403.2 filed Apr. 8, 2004, the entire contents of which are incorporated herein by reference. FIELD OF THE INVENTION The present invention pertains to a measuring device for measuring the volume flow or other substance properties of a flowing gas, whose direction of flow can reverse. Typical applications of such measuring devices are found in the area of artificial respiration, where the monitoring of various parameters of the breathing air is frequently a part of patient monitoring and/or contributes to the increase in the reliability of operation of the respirators. The present invention shall therefore be described based on the example of respiration technology. BACKGROUND OF THE INVENTION In case of mechanical respiration imitating natural respiration, the inspiration and the expiration take place via a single-channel tube introduced into the patient's trachea. Splitting into separate flow paths is performed in the vicinity of the patient via a Y-piece, and these separate flow paths can be released via actuated valves and thus make possible a desired uncoupling of the volume flows generated during expiration and inspiration, corresponding to the mode of respiration selected. The uncoupling of the volume flows can never be complete for anatomic and technological reasons. For anatomic reasons, there is a dead volume, which is determined, among other things, by the volume of the trachea, even during natural breathing. In case of artificial respiration, the volume of the tube is a technological dead volume. If additional volume areas through which both volume flows flow are present between the outer end of the tube and the beginning of the separate flow guiding, these automatically increase the dead volume during respiration. To attain a low flow resistance during respiration, the cross section is usually expanded already in the transition area between the tube and the Y-piece. As a result, the Y-piece itself may already contribute appreciably to the technological dead volume. If additional flow-carrying components, for example, sensor heads with flow sensors, are inserted between the tube and the Y-piece, these also increase the dead volume of the respiration unit. The dead volume may, as a rule, be tolerated if the tidal volume is markedly larger than the dead volume. However, cases in which a small tidal volume must suffice for complete respiration frequently occur during mechanical respiration in medicine. This may be due to various impairments in the functionality of the respiratory system or a small lung volume. The latter occurs mostly in neonatology. It is desirable in such cases to keep the dead volume as small as possible during artificial respiration. It is frequently desirable to obtain the data necessary for a “real-time monitoring” of a patient possibly in the vicinity of the patient from a measurement of the gas flows being sent through the respiration unit. If flow sensors or sensors for measuring certain properties of flowing gases are directly exposed to the gas flow to be measured, they frequently yield evaluable signals only if uniform flow conditions prevail in their immediate environment and the sensors themselves do not affect the gas flow in an undefined manner. Sensors are therefore sometimes accommodated in special components which are optimized only with the aim of guaranteeing defined flow conditions in the environment of the sensor. However, the integration of additional components implies an increased effort for installation, it possibly increases the dead volume and may lead to problems in terms of optimization in the overall system if individual components are optimized concerning their individual functions but not for an optimal cooperation. One example of such an optimization concerning individual functions is the design of conventional Y-pieces. These contain an unbranched area, which can be called a base area, which is flown through in both directions and whose dimensioning is determined essentially by the conditions of connection to the tube or to a tube adapter. Furthermore, Y-pieces comprise two outflow pipes for the connection of separate flexible tubes, which are flown through in one direction only. Flexibility problems are usually the most important aspects in designing these outflow pipes. The connection sites must have a certain minimum distance for the possibility of handling and shall permit rapid mounting. As a result, difficult-to-define flow conditions may arise in the base area of the Y-pieces, where the separate flow paths are merged. A device is known from WO 84/01704 as an example of the integration of additional components for measurement purposes, in which venturi tubes are arranged behind the Y-piece in the flow paths already extending separately, and the pressures occurring at the reduction of the area of these venturi tubes are monitored for differential pressure measurement. However, the measured values are not obtained particularly close to the patient because of the arrangement behind the Y-piece. SUMMARY OF THE INVENTION The object of the present invention is to provide a device for measuring the volume flow or the substance properties of a gas, whose direction of flow can reverse, which device makes it possible to obtain the measured data close to the patient and makes do with a very small dead volume, and wherein simple integration of the device into existing systems shall be possible. A device according to the present invention for measuring the volume flow and/or additional substance properties of a gas, whose direction of flow can reverse, contains an arrangement with a Y-piece, one end of which is connected to a gas-carrying component, in which varying directions of flow may prevail, and whose other ends are connected with gas-carrying components, in which no change takes place in the direction of flow, wherein the Y-piece has separate, essentially uncoupled flow paths for gas flows of different directions of flow, which extend at least partially in parallel to one another, are separated from one another by a flat partition in the area in which they extend in parallel to one another and are equipped with means for obtaining measured values for characterizing the flowing gas in the area in which they extend in parallel to one another. Consequently, the present invention is based, in respect to respiration technical applications, on exploring the area located in the vicinity of the tube, which is unbranched in conventional Y-pieces, as a measuring site located close to the patient, and at the same time not to allow this area to act as a dead volume any longer. The base area of the Y-piece close to the tube is divided for this purpose into two areas by a partition extending in the direction of flow. On the side facing away from the tube, each of these areas opens into the respective branch of the Y-piece, via which fresh breathing gases are supplied or the used breathing gases are removed during expiration. On the side of the Y-piece close to the tube, the partition may extend into the area of connection to the tube. The Y-piece itself does not contribute to the dead volume in this case. Due to the flow paths being separated already in the base area of the Y-piece, it is possible to increase the overall length of the Y-piece in the base area without hereby causing an increase in the dead volume. It was found that such an increase in the overall length, in conjunction with the partition according to the present invention, causes flow conditions that permit interesting measured values to be obtained in a reliable manner from the gas flows in the area close to the patient to emerge in the areas of the Y-piece that are separated by the partition and extend in parallel. The introduction of a partition according to the present invention reduces, in principle, the dead volume. It is especially advantageous for the flat partition to extend up to the area in which the connection with the gas-carrying component takes place, in which varying directions of flow may prevail. This area is determined mostly by a tube adapter. An especially good uncoupling of the separate flow paths is achieved if a movable flap, which is movable between two positions, is fastened at the end of the partition, and in case of a direction of flow from the Y-piece to the gas-carrying component, in which varying directions of flow may prevail, this flap assumes a position that reduces the flow cross section as little as possible and in the reversed direction of flow it assumes a position in which it facilitates the inflow into the flow path intended for that direction of flow. It is advantageous if at least one of the two positions of the movable flap is determined by an end stop. An especially expedient and simple embodiment of a device according to the present invention is obtained if the movable flap is fastened such that the position of the movable flap is set by the flow forces acting on the flap. The mobility of the flap can be advantageously brought about by means of elastic fastening means between the movable flap and the flat partition. Especially favorable flow conditions, which lead to good measuring results, do arise if the cross section of the Y-piece is approximately round in the area in which the separate flow paths extend in parallel to one another. This permits, in addition, an especially simple adaptation to conventional tube adapters. In another advantageous embodiment, the cross section of the Y-piece is approximately square in the area in which the separate flow paths extend in parallel to one another. This makes it possible to arrange chip sensors for measuring the flow in/at the outer wall of the Y-piece in an especially flow-neutral manner in the areas of the separate flow paths that extend in parallel to one another, because the planar geometry of the chips corresponds to the geometry of the flow-limiting surface. Another advantageous embodiment is obtained if chip sensors for measuring the flow in/at the partition are arranged in the areas of the separate flow paths that extend in parallel to one another. The electric lines necessary for the operation of the chip sensors may now be integrated in the interior of the partition. Another advantageous embodiment for flow measurement is obtained if hot wire sensors are arranged for flow measurement in the areas of the separate flow paths that extend in parallel to one another. It may be advantageous to arrange holes, through which pressure measurement can be performed if the holes are connected with pressure measuring means via pressure pipes, in the outer wall of the Y-piece in the areas of the separate flow paths that extend in parallel to one another. An especially great certainty of measurement is obtained if the holes in the outer wall lead into at least one buffer volume, whose inner pressure can be measured. The number of holes may be selected to be relatively large because the individual holes do not need to be provided with pressure pipes. As a result, there will be a high tolerance to the clogging of individual holes, and slight variations or inhomogeneities in the flow will also have only a reduced effect on pressure measurement. Such a buffer volume is advantageously associated with each pressure measuring means. In another advantageous embodiment of a device according to the present invention, openings, which can be connected with pressure measuring means via channels extending in the interior of the partition, are arranged in the partition in the areas of the separate flow paths that extend in parallel to one another. The number of flexible tubes leading into the vicinity of the patient is reduced as a result. It is especially advantageous if two means of the same type for obtaining measured values to characterize the flowing gas are coupled in the separate flow paths such that they make possible a difference measurement between the separate flow paths. It is usually possible due to the difference measurement to determine the flow component of changing direction in case a continuous basic flow is superimposed to a flow of changing direction. Dead space rinsing by a basic flow is necessary in some medical applications. The field of use of the device according to the present invention is thus expanded by the difference measurement. An especially advantageous embodiment with the possibility of measuring the pressure difference between the separate flow paths is obtained if a movable part is integrated in the partition and it is provided with measuring means, and the movable part sends a signal that depends on the pressure difference by its deflection in case of a pressure difference between the separate flow paths. This can be embodied, for example, by a piezo measuring element. An alternative embodiment with the possibility of measuring the pressure difference between the separate flow paths is obtained if windows that are permeable to ultrasound and are located approximately on a straight line that is sloped against the direction of flow are arranged in the partition and in the outer walls of the Y-piece in the area in which the separate flow paths extend in parallel to one another, and ultrasound transducers, which form a measuring section between them, via which flow measurement can be carried out by time of flight measurement, are arranged in front of the windows outside the flow paths. A further improvement of the accuracy of measurement and reproducibility is achieved if flow rectifiers are arranged in the direction of flow in front of the particular site at which measured values are obtained to characterize the flowing gas. These may be various flow guide vanes which ensure a sufficiently stable laminar flow at the particular measuring site in case of complicated incoming flow conditions. Devices according to the present invention will be described in greater detail below on the basis of exemplary embodiments. The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which preferred embodiments of the invention are illustrated. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 is a schematic sectional view of a device according to the present invention in the area of the Y-piece; FIG. 2A is a cross sectional view of a Y-piece according to the present invention in the area in which the separate flow paths extend in parallel to one another; FIG. 2B is a cross sectional view of another Y-piece according to the present invention in the area in which the separate flow paths extend in parallel to one another; FIG. 3 is a schematic sectional view of a device according to the present invention in the area of the Y-piece with holes for pressure measurement in the area of the outer wall; FIG. 4 is a schematic sectional view of a partition according to the present invention with channels milled in for pressure measurement; FIG. 5 is a schematic sectional view of a partition according to the present invention with integrated piezo pressure measuring element; FIG. 6 is a schematic sectional view of a partition according to the present invention with integrated chip sensors; FIG. 7 is a schematic sectional view of a device according to the present invention in the area of the Y-piece with integrated ultrasound measuring path; FIG. 8 is a schematic sectional view of a device according to the present invention in the area of the Y-piece with integrated hot wire sensors for flow measurement; FIG. 9 is a schematic sectional view of a device according to the present invention in the area of the Y-piece with chip sensors integrated in the outer wall; FIG. 10 is a schematic sectional view of a portion of a device according to the present invention with a movable flap at the end of the partition in the connection area to the tube adapter; FIG. 10.1 is an enlarged schematic sectional view of the device of FIG. 10 showing the movable flap at the end of the partition in the connection area to the tube adapter; FIG. 11 is a schematic sectional view of the portion of the device according to FIG. 10 showing a different position of the movable flap at the end of the partition in the connection area to the tube adapter; FIG. 11.1 is an enlarged schematic sectional view of the device of FIG. 10 showing the movable flap at the end of the partition in the connection area to the tube adapter; and FIG. 12 is a schematic sectional view of a device according to the present invention in the area of the Y-piece with buffer volume and flow guide vanes. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to the drawings in particular, FIG. 1 shows a Y-piece 2 according to the present invention connected to a tube 3 via a tube adapter 1 in a respiration unit for mechanical respiration. The base area (or parallel section) 4 of the Y-piece is divided by a flat partition 5 into two separate flow paths 6 , 7 extending in parallel to one another. During respiration, inspiration takes place via one flow path 6 , and expiration via the other flow path 7 . Both flow paths extend at first direction flow passage 66 and second direction flow passage 77 to the connection pieces (not shown here) of the Y-piece 2 , to which additional gas-carrying components, such as breathing tubes or the like, may be connected. On the patient side, the separation of the flow paths 6 , 7 ends in the area of the tube adapter 1 (ends at an opening that is a bidirectional flow passage or the bidirectional flow opening with the tube adapter forms a bidirectional flow passage). The base area 4 of the Y-piece 2 does not contribute to the dead volume of the respiration unit. The uncoupling of the separate flow paths is improved compared with respiration units with conventional Y-pieces. A flow, whose direction can reverse, prevails in the tube 3 only. The arrows shown illustrate possible directions of flow in the respective sections of the device according to the present invention. Flow conditions that permit reliable measurement of different parameters of the flowing gases prevail in the flow paths 6 , 7 extending in parallel to one another in the base area 4 of the Y-piece 2 , as a result of which a measuring site located very close to the patient is explored, at which flows without reversal of direction can be measured. The measuring technique is simplified as a result. In special embodiments of the base area 4 of the Y-piece 2 , the base area has, according to FIG. 2A a round cross section 4 ′ or according to FIG. 2B an approximately square cross section 4 ″. It is divided by a flat partition 5 , 5 in both cases. The embodiment with approximately square cross section ( FIG. 2B ) can, in particular, be advantageously combined with planar sensors (not shown). FIG. 3 shows a variant of a device according to the present invention, in which the static pressure in the flow paths 6 , 7 can be measured via holes 8 , 8 ′. A pressure measuring device 10 is connected via flexible tubes 9 , 9 ′. Measurements of the differential pressure can also be carried out with this configuration. FIG. 4 shows a modified form of a flat partition 5 according to the present invention, in which channels 11 , 11 ′ are milled, which are connected with a pressure measuring device 10 . Measurement of the static pressure can also be measured with this arrangement in the areas of the separate flow paths that extend in parallel to one another. One advantage of this design is the reduced number of flexible tubes leading into the patient's immediate vicinity and the possibility of a highly compact design. FIG. 5 shows a modified form of a flat partition 5 according to the present invention, in which a piezo pressure measuring element 12 is integrated. When a differential pressure is present, the resulting action of the force produces a deflection from the inoperative position of the piezo pressure measuring element 12 into another position 12 ′. As a result, an evaluable voltage is generated, which can be processed with a voltage measuring device 13 or corresponding evaluating units (not shown). FIG. 6 shows a modified form of a flat partition 5 according to the present invention, in which planar measuring elements 14 , 14 ′ are integrated for flow measurement. Each of these measuring elements sends a signal via electric lines 15 , 15 ′ integrated in the partition, and this signal can be processed with a voltage measuring device 13 or corresponding evaluating units (not shown). This embodiment is likewise characterized by a highly compact design and can be used to measure individual flows as well as flow differences. FIG. 7 shows a variant of a device according to the present invention, in which windows 16 , 16 ′, 16 ″, which are permeable to ultrasound and are located on a straight line that is sloped against the direction of flow, are arranged in the partition 5 and the outer walls of the Y-piece 2 in the area in which the separate flow paths 6 , 7 extend in parallel to one another. Ultrasound transducers 17 , 17 ′, which form a measuring section between them, via which flow measurement can be carried out by time of flight measurement, are arranged in front of the outer windows 16 , 16 ′ outside the flow paths 6 , 7 . The advantage of this arrangement is that no sensor needs to be directly exposed to a flow to be measured and no sensor can thus distort the flow due to geometric effects. FIGS. 8 and 9 show a schematic sectional view of a device according to the present invention in the area of the Y-piece with integrated hot wire sensors 18 , 18 ′ directly in the flow to be measured or with planar chip sensors 19 , 19 ′ for flow measurement at the outer walls of the Y-piece 2 that limit the flow paths 6 , 7 . The measured signals are sent in both cases to a voltage measuring device or a corresponding evaluating unit. Individual or difference measurements are possible. FIGS. 10 , 10 . 1 and 11 , 11 . 1 show schematic views of a device according to the present invention with a movable flap 20 at the end of the flat partition 5 in the connection area to the tube adapter 1 during inspiration ( FIG. 10 ) and during expiration ( FIG. 11 ) as well as corresponding enlarged views ( FIGS. 10.1 , 11 . 1 ) of the area of the connection between the movable flap 20 and the flat partition 5 . During inspiration, the movable flap 20 is in a position in which it reduces the flow cross section of the flow path 6 , through which the inspiration takes place, only slightly. If the direction of flow changes, the gas flow arriving at the movable flap 20 stands up the movable flap 20 until the latter assumes a position determined by a fixed stop, in which it markedly reduces the flow cross section of the flow path 6 for the inspiration. At the same time, it acts as a guide vane for the flow path 7 for the expiration and thus facilitates the inflow of the expiration flow into the flow path 7 . An especially effective uncoupling of the separate flow paths 6 , 7 is achieved as a result. FIGS. 10.1 and 11 . 1 show a design principle that makes possible a flap movement just described. The front side of the flat partition 5 has the shape of a flat notch. The flanks 22 , 23 of this notch are at an obtuse angle with one another. In areas in which the flanks 22 , 23 touch each other, the movable flap 20 is fastened to the flat partition 5 with elastic fastening means 21 . The position of the flanks 22 , 23 determines the position of two stop positions. The elastic fastening means 21 are pretensioned such that without gas flow or during inspiration, the movable flap 20 is in contact with the flank 23 in one stop position and can be moved into the other stop position, in which there is contact with the flank 22 , due to incoming flow during expiration. FIG. 12 shows a variant of a device according to the present invention, in which holes 8 , 8 ′ in the outer wall of the Y-piece lead into buffer volumes 24 , 24 ′, whose internal pressure is monitored. If an individual hole is closed due to clogging, this has hardly any effect on the pressure measurement, because each of the buffer volumes 24 , 24 ′ communicates with the gas flow to be measured via a plurality of holes 8 , 8 ′. Flow rectifiers in the form of guide vanes 25 , 25 ′, which ensure an especially uniform flow behavior, which in turn leads to especially reliable and reproducible measured values, are arranged in front of the site of pressure measurement in the direction of flow, i.e., in this case in front of the holes 8 , 8 ′, which also corresponds at the same time to the site at which measured values for characterizing the flowing gas are obtained according to claim 16 . While specific embodiments of the invention have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.

A device for measuring the volume flow or other substance properties of a gas, whose direction of flow can reverse. The arrangement contains a specially designed Y-piece, which is used for branching into direction-dependent flow paths and can be used at the same time for the measurement. Such devices can be preferably used in the area of mechanical respiration.

The present application claims priority under 35 U.S.C. §119 to United Kingdom Application Ser. No. 0524632.7, filed Dec. 2, 2005, the entire contents of which are hereby incorporated by reference herein. BACKGROUND 1. Field of the Invention The present invention relates to an apparatus in the form of a bag, and, in particular, to a stand/carry golf bag with wheels. 2. Background Information Conventionally, wheels can be provided for golf bags by providing a frame or a trolley to which the wheels are fitted and upon which a golfer places their golf bag, such that the bag can then be pulled or pushed along the ground. If a golfer uses such a frame or trolley, the golfer is restricted to transporting their bag along a designated path around a golf course. Once on a frame or trolley, the bag becomes heavy and cumbersome to carry. Although golfers who simply carry their bags are not restricted to those designated paths, they are restricted to carrying their bag around the whole course. It is therefore an object of the invention to provide a bag that can be both pulled or carried by the golfer while on the golf course by means of a simple adaptation that can be made during play. It is a further object of the invention that the bag can be placed in a free-standing position on the ground regardless of whether the bag is in the pulling or carrying mode. SUMMARY OF THE INVENTION According to one aspect of the invention there is provided an apparatus comprising a bag having a base adapted to receive a ground rolling device, and the ground rolling device being detachably connectable with the base and comprising an axle provided with a wheel at or adjacent to each end such that when the ground rolling device is connected to the base the wheels project laterally from either side of the base. According to this aspect of the invention, it is possible to provide a bag having a readily removable ground rolling device at the base of the bag, such that the golf bag can be pulled or pushed along on the wheels or carried by the golfer with or without the wheels attached. In a preferred embodiment of the invention, the axle is received within a channel which extends from one side of the base to the other, such that when the axle is connected to the base the wheels project beyond the edges of the base. In a preferred embodiment of the invention, the channel is a recess formed in the underside of the base. There are a number of suitable ways in which the axle can be retained within this recess, such as, for example, the axle can be retained as a result of “snap-fit” mechanism between the axle and the recess, although preferably the axle is retained by a latch/clip. In an alternative embodiment of the invention, a rod extends through the base such that respective opposite ends of the rod project laterally beyond respective opposite openings of the base and then one or more wheels can be connected to the projecting ends of the rod. In a further preferred embodiment of the invention, the axle is provided with an axle supporting tube, referred to as a plain bearing. When the ground rolling device is connected to the base, if the bag is to be placed in a free-standing position, there is a need for a means of stabilizing the bag. Preferably, therefore, a downwardly projecting support element, which projects from the underside of the base, is provided to perform such function. This support element extends downwardly to substantially the same level as the lowest point of the wheels when these are connected, such that when the bag is in an upright position the bag is balanced on both the support element and the wheels. Even more preferably, this element is provided in a position on the underside of the base in such a way so as to place the center of gravity of the loaded or unloaded bag on the central, vertical axis of the bag. This support element is preferably in the form of a footplate which is moveable between an open downwardly extended position when the bag is free-standing or a closed substantially flat position in which the footplate is secured in a parallel position to the underside of the base when the bag is being carried or pulled. The footplate can therefore be described as being a “fold-away” element. With wheels and footplate attached, when the bag in an upright position it is raised off the ground by approximately 50 mm. A spring foot that is connected to the stand support rods is depressed by contact with the ground as a result of rocking the bag forward. This depression causes the stand support rods to flex the stand support legs outwards and in this open position the bag can be supported at an angle on these legs. With the elevation in the height of the bag above the ground as a result of the attachment of the wheels and footplate, an extension to the spring foot is preferably provided. This extension eliminates the requirement to rock the bag too far forward in order to ensure that the spring contacts the ground as the extension extends the length of the spring foot. It is preferable that this extension can be returned to normal foot height when the bag is in “carry bag” mode, i.e., when wheels are removed and the foot plate is collapsed into the base. In a preferred embodiment of the invention, the wheels are fitted with plain bearings (referred to as “life-long bearings”) and a hub cap that can prevent entry of foreign debris, e.g., grass and mud, into the wheels, causing mechanical failure. In a further preferred embodiment of the invention, the bag is further provided with a handle in an upper region of the bag. The handle is extendable from a non-extended position. Preferably, the handle comprises a shaft and an ergonomically designed hand-grip. Preferably, at least part of the shaft is telescopic, thereby allowing the handle to be extended to any desired height. This is considered particularly advantageous if the same bag is being used by golfers of varying heights. In a further preferred embodiment of the invention, at least part of the handle is rotatable relative to the vertical axis of the bag. This rotation allows an increased degree of movement of the bag in the pulling mode, ensures that the bag is responsive to small movements by the golfer, and also improves the stability of the bag as it is maneuvered around bends or over rough terrain. There is a reduced risk of the bag become unstable as it is moved and toppling over. The shaft of the handle is preferably located within a channel or tube molded into the bag, and, even more preferably, the channel or tube extends at least part of the height of the bag. Preferably, this channel or tube extends from the base. In a further embodiment of the invention, the bag is provided with a dual-strap that is conventionally used for satchels and that enables the golfer to carry the bag and displace the weight of the bag equally across his back and shoulders. BRIEF DESCRIPTION OF THE DRAWINGS Other objects and advantages of the present invention will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments, in conjunction with the accompanying drawings, wherein like reference numerals have been used to designate like elements, and wherein: FIG. 1 illustrates a perspective view of one version of the golf bag with removable wheels, in accordance with an exemplary embodiment of the present invention. FIGS. 2A and 2B illustrate perspective views of the underside of the base of the golf bag, in accordance with an exemplary embodiment of the present invention. FIG. 3 illustrates a perspective of the inside of the base of the golf bag, in accordance with an exemplary embodiment of the present invention. FIG. 4 illustrates a schematic of the axle and wheel assembly, in accordance with an exemplary embodiment of the present invention. FIGS. 5A and 5B illustrate a schematic of the top view of the golf bag and the base of the golf bag, respectively, in accordance with an exemplary embodiment of the present invention. FIGS. 6A and 6B illustrate the foot plat structure and its actuation, in accordance with an exemplary embodiment of the present invention. FIG. 7 illustrates the foot extension, in accordance with an exemplary embodiment of the present invention. FIG. 8 illustrates the hand-grip, in accordance with an exemplary embodiment of the present invention. FIGS. 9A and 9B illustrate schematics of the internal structure of the golf bag, in accordance with an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1 , a golf bag 1 that has the same dimensions as a standard lightweight carry bag comprises conventional supporting legs 2 for supporting the bag 1 when not being supported by the golfer, and which can be stored flat against the bag when not in use. The golf bag 1 includes a handle 3 comprising a shaft 4 and a hand-grip 5 extending substantially perpendicular to the shaft 4 and being extendable from a non-extended position. The golf bag 1 includes a base 6 , and two wheels 7 a and 7 b removably detachable with the base. Referring to FIG. 2A , the underside of the base 6 is shown with a channel-shaped recess 8 extending across the width of the base 6 . The recess 8 is formed adjacent to one of the shorter sides of the base 6 . An axle (e.g., used for removably attaching wheels 7 a and 7 b to the base 6 ) is received into the recess 8 and secured by a substantially square metal clip 9 that is illustrated in FIG. 2B . The clip 9 has four sides ( 10 a - d ), with an aperture 11 being provided within the middle of one side (e.g., 10 a ) to form free ends 12 a and 12 b . These free ends 12 a , 12 b are the point at which the clip 9 is attached to the base 6 . In such an embodiment, the clip 9 is shown as being centrally located on the base 6 , although a plurality of smaller clips can be provided. The clip 9 is pivotable about its point of attachment on the base 6 and this enables the clip 9 to be moved downwards and positioned perpendicularly across the axle which is located within the recess 8 . The sides of the clip 10 b and 10 c that extend perpendicular to side 10 a are provided with central upwardly arched regions 13 a and 13 b , respectively. These arched regions 13 a , 13 b are located above the axle and urge the axle in to the recess 8 when the clip 9 is in use. As the provision of the recess 8 results in a ridge 50 (as illustrated in FIG. 2A ) being formed at the periphery of the base 8 , channels 14 a and 14 b are provided in the ridge 50 to allow the sides 10 b and 10 c to extend through the ridge 50 . FIG. 3 illustrates the inner surface of the base 6 that has a molded spigot 15 for receiving the shaft of the handle (not shown). The shaft fits over the spigot 15 and can be glued or otherwise suitably attached and pinned in place. This spigot 15 is centrally located above the recess 8 provided on the underside of the base 6 . The removable axle and wheel unit is illustrated in FIG. 4 . The axle 16 can be molded from a plastic material or the like. The axle 16 is shown with wheels 17 a and 17 b located at opposing ends of the axle 16 . Each wheel 17 a , 17 b comprises a wheel hub 18 , a tire 19 , a spring washer 20 and a hub cap 21 . An approximately 1 mm gap between the axle 16 and the hub 18 can be provided to enable the free rotation of the wheel 17 a , 17 b. As illustrated in FIG. 5A , the body portion 22 of the golf bag 1 in which the golf clubs are retained can be molded as a single unit from a rigid plastic material. The body portion 22 takes the form of a substantially hollow cylinder into which the golf clubs are placed vertically with the heads of the clubs protruding out the top of body portion 22 . FIG. 5A illustrates the top view of the body portion 22 and shows ribs 23 of a plastic material or the like dissecting the cylinder in a range of directions so as to form varying shaped and sized compartments 24 designed to accommodate an array of different clubs. The rigidity of the cylinder prevents the golf bag from twisting under load and when being towed. The body portion 22 is molded so as to have an apical region 25 that houses a substantially circular shaft 26 into which the shaft 4 of the handle 3 is inserted. As illustrated in FIG. 5B , the interior surface of the base 6 is molded to incorporate the molded spigot 15 for receiving the end portion of the shaft 4 of the handle 3 . Thus, when the base 6 and body portion 22 are connected together, an integrally molded shaft for receiving the shaft 4 of the handle 3 is formed. The outer tube is molded into the head and into the base 6 in order to create a stiff dynamic structure. FIGS. 6A and 6B illustrate the footplate 27 . FIG. 6A illustrates the mechanism of action of the footplate 27 , and FIG. 6B illustrates the operation of the foot plate 27 . The footplate 27 is a “live hinge.” As illustrated in FIG. 6B , when attaching the wheels 7 a and 7 b , the golfer can unclip the upper surface 62 of the foot plate 27 and rotate it, thereby allowing the legs 66 a , 66 b to be erected from a flat position. The “T” heads 28 a , 28 b on the legs 66 a , 66 b can be positioned in holes 29 a , 29 b on the upper surface 62 and then “clicked” into place, holding the lower surface 64 in an elevated position and hence providing the foot. After the wheels 7 a , 7 b are removed, the cycle is reversed to stow the lower surface 64 inconspicuously under the base 6 of the golf bag 1 . FIG. 7 illustrates the foot extension 30 , and the operation of the foot extension 30 is illustrated in FIGS. 9A and 9B . When the wheel unit is attached to the base 6 , the golf bag 1 is raised by about 50 mm from the ground. The foot extension 30 enables the leg actuation system 70 (illustrated in FIGS. 9A and 9B ), which is conventional to golf bags, to remain effective even when the base 6 is raised above the ground and the length of the conventional spring element used to actuate the legs is of insufficient length. As illustrated in FIG. 9A , the foot extension 30 is fitted to the lower part of the leg actuation system 70 and preferably clips on to the existing leg actuation system 70 through a suitably molded slot system such that it can be pivoted towards the ground. Since the foot extension 30 is of sufficient length to contact the ground, the foot extension 30 can replace the function of the spring element. As illustrated in FIG. 9A , the foot extension 30 is the spring foot and can swivel, clicking into place, to act as an extension. Alternatively, as illustrated in FIG. 9B , the foot extension 30 can swivel back to an un-extended position where it performs (e.g., a balancing or support function), at an appropriate length, to suit a wheel-less bag. The foot extension 30 is preferably manufactured from a plastic material or other suitable material. FIG. 8 illustrates the swan neck shape of the handle 3 . FIGS. 9A and 9B illustrate schematics of the internal structure of the golf bag 1 . It will be appreciated by those of ordinary skill in the art that the present invention can be embodied in various specific forms without departing from the spirit or essential characteristics thereof. The presently disclosed embodiments are considered in all respects to be illustrative and not restrictive. The scope of the invention is indicated by the appended claims, rather than the foregoing description, and all changes that come within the meaning and range of equivalence thereof are intended to be embraced. All United States patents and applications, foreign patents and applications, and publications discussed above are hereby incorporated herein by reference in their entireties.

A golf bag includes a base adapted to receive a ground-rolling device. The ground-rolling device is configured to be detachably connectable with the base. The ground-rolling device includes an axle provided with wheels located substantially at each end of the axle. When the ground-rolling device is connected to the base, the wheels project laterally from either side of the base.

BACKGROUND AND BRIEF SUMMARY OF THE INVENTION This invention relates to a system wherein water evaporated from salt water is used as a source of fresh water for either agriculture and/or aquaculture. Successful wide scale agriculture in arid lands which are adjacent to unlimited supplies of sea water have always presented a perplexing problem, namely the inability to use sea water for plant growth. Where sea water is used, it is typically desalinized such as by evaporation, osmosis or other separation techniques. This separation step adds considerably to the cost of the ultimate production of the crops. A further drawback is one that has been discussed in my prior patents. When plants are placed in the soil, water and nutrients are not fully utilized because of the permeability of the soil. Thus if water sufficiently pure for crops is generated from sea water and used to irrigate crops in the ground, most of the water is wasted. The aforementioned problems were overcome to a considerable degree by the invention disclosed in my prior U.S. Pat. No. 4,178,715. In that invention a plurality of channels were formed having a floor. The floor was spaced apart from a base and saline water flowed into a zone defined by the floor and the base. Temperature differences effected evaporation of pure water from the saline water. The evaporated water condensed and coalesced on the underside of the floor and permeated into the soil which the floor supported. The present invention is directed to a system which is an improvement of the basic concepts disclosed in my aforementioned patent. Further, it is believed that the prior art is still best represented by the references cited in the aforementioned patent. The present invention, relates to an apparatus and method for recovering a pure liquid vapor component from a contaminated liquid, which liquid the liquid vapor is in equilibrium with. This includes organic and inorganic wastes and aqueous wastes. More particularly the invention is directed to using water which would normally be considered contaminated for its intended use. More particularly, an apparatus and method are disclosed wherein the liquid vapor phase in equilibrium with the saline water is used to maintain the soil in which a plant is growing in a wetted condition without the saline water contacting the soil. My invention comprises a structure and method to enhance the distribution of the liquid vapor and subsequent collection of the condensate. Additionally, the invention comprises controlling the levels of salinity of the water where it can range anywhere from brackish water to potable water and additionally the recovered water may be used for aquaculture as well as agriculture. My invention includes flowing relatively contaminated water at a first higher temperature T 1 into a zone which zone is at a second lower temperature T 2 , the liquid vapor in equilibrium with the water at temperature T 2 being non-contaminated; flowing the liquid vapor from the zone into a soil bed, maintaining the liquid vapor in the soil bed and subsequently condensing the liquid vapor. The basis for the use of the normally polluted water, such as sea water, for purposes of my invention, is that in tropical areas the typical ambient temperature during the day may range from 120° to 130° F., and the surface temperature of the water from 140° to 160° F. As is well understood there always exists a relationship among temperature, both dry and wet bulb, dew point, moisture content per pound of dry air, etc. If a given volume of air is cooled, its ability to hold moisture is diminished and condensation of the moisture from the air results if the temperature reduction of the air occurs within a defined space or on an exposed surface. These relationships can be determined from any psychrometric chart. In my invention water and the air in which it is in equilibrium with is caused to pass and circulate under the floor of a soilbed. In the preferred embodiment of my invention diffuser tubes extend from a zone, defined by the upper surface of the water and the under surface of a soilbed, and into the soilbed. The sea water with the liquid vapor in equilibrium therewith, flows under and is in communication with the soilbed via the diffuser tubes during the day. The diffuser tubes allow the air containing the liquid vapor to permeate the entire soilbed. At the top surface of the soilbed the liquid vapor will essentially evaporate into the ambient. At the interface between the diffuser tubes and the soilbed and the floor of the soilbed, the liquid vapor content will essentially be the same as the liquid vapor content in equilibrium with the sea water in the zone. To maximize the amount of liquid vapor in the soilbed, i.e. prevent surface evaporation different colors of granules and sizes may be used to minimize the surface temperature. Typically, in desert-like regions, the ambient temperature during the day may be 120°-130° F., and, as is well known, within a short period of time, i.e. an hour or so, the temperature may drop to 40°-60° F. at night. In that the sandbed becomes impregnated with the air carrying liquid vapor over a long period of time during the day, when the sudden drop in temperature occurs, the liquid vapor does not escape into ambient air. Rather the liquid vapor is entrapped by the soilbed (including surfaces of the floor, walls and diffusor tubes). The particles of the soilbed and inner walls form contact or heat exchange surfaces. When the temperature drops rapidly the liquid vapor condenses, thereby saturating the soilbed. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a partially perspective view of a system embodying the invention; FIG. 2 is a front schematic of a diffuser tube gutter arrangement; FIG. 3 is a schematic view of FIG. 1; FIG. 4 is a perspective view of a solar still; FIG. 5 is a front view of an alternative embodiment of a solar still; FIG. 6 is a front view of a solar still employing an indirect heat exchange medium. FIG. 7 is a front schematic of a plurality of stills in combination; FIG. 8 is a front schematic of the system of FIG. 1 in combination with the solar still of FIG. 4; and FIG. 9 is a plan view of my system in combination with solar ponds. DESCRIPTION OF THE PREFERRED EMBODIMENTS The preferred embodiment will be described in reference to contaminated water, specifically sea water. As is well known, the moisture in the vapor phase is pure in the sense that the salts and other deleterious impurities remain in the liquid phase. Thus when the liquid phase condenses, it is pure and suitable for plant growth or for discharge to another system. In accordance with the principles of my invention, other sources of contaminated or polluted water may be used where the impurities of the liquid phase are not found in the liquid vapor in an amount sufficient to prevent plant growth. Referring to FIGS. 1 and 3 the basic system 10 is shown and comprises a lagoon 12 through which sea water may be circulated. A plant support bed 14 is spaced apart from the lagoon 12 by piles 16. The lagoon may be natural or man made, such as from thick polyethylene lining material. The bed 14 comprises a floor 18, wall 20 and plant support material 22 such as sand disposed in the bed 14. To provide for full permeation of the liquid vapor into the bed, a plurality of diffuser tubes 24 are received in the floor 18. The tubes extend into the sand 22 and into a zone 26 defined by the underside of the floor 18 and the upper surface of the water in the lagoon 12. The diffuser tubes 24 provide for the transport of the liquid vapor, upwardly through the tube whereby the liquid vapor diffuses into the plant support material as shown by the arrows in FIG. 2. Referring to FIG. 2, a diffuser tube 24 is shown in greater detail and comprises an upper sleeve 28 and a lower sleeve 30. The upper sleeve is formed of open mesh material. The liquid vapor moving through the tube will contact all exposed surfaces. Where the liquid vapor contacts the lower sleeve 30, it will condense on the surface, coalesce and flow downwardly into a gutter 32 where it is collected and recycled by a pump 34, see FIG. 7 to form a recycle stream of water as shown in FIG. 7. This recycle stream may be introduced into the plant support bed 14 in any desired manner; or it may be used for other purposes as desired. When the liquid vapor contacts the open mesh upper sleeve 28 it diffuses therethrough and permeates into the sand 22. Referring to FIG. 1, the diffuser tubes are shown in a uniform array which enhances the use of the gutters 32 (only one shown). The diffuser tubes may be disposed in any array, uniform or non-uniform; and at any depth into the bed 14. Formed in the bed 14 are a plurality of chimneys 36. The primary purpose of the chimneys is to aid in the movement of air within and through the zone 26 to enhance the overall circulation and movement of the air into and from the zone to thereby maximize the contact of the hot liquid vapor (moisture laden air) with the diffuser tubes. Additionally, screens or curtains 38 extend downwardly from the floor any desired distance for any extent along the perimeter of the system to function as baffles to enhance the movement of the air within the zone and its contact with the diffuser tubes. Referring to FIG. 4 there is illustrated a solar still 50 comprising a flume 52 having sides 54 joined to a floor 56 at fold lines 58. The floor 56 is supported on piles 60 although the floor may lie on the ground. The inner portion of the flume 52 is filled with a packing material, preferably black polyethylene perforated strips 64 to maximize the water-to-heated black surface contact area. Any suitable packing could be used such as rings, saddles, etc. commonly employed in mass transfer operations based on the usual energy and material balances. Extending outwardly and downwardly from the upper edges of the sides 54 are wings 66 made of polyethylene black lining material, which wings 66 extend downwardly and are joined to one edge of a floor 68. Superimposed over the flume 52 is a canopy 70 which extends downwardly and at its lower edge it is joined to the other edge of the floor 68 defining a dead-air zone 74 therebetween. The canopy includes a flat baffle member 72 secured thereto. Basically the packed still is configured both as to structure and in regard to its physical properties, relative to the absorption of infrared rays to maximize the use of solar energy. In the use of the solar still sea water flows into the flume 52 of the still 50 where it is heated by absorption of solar energy. The solar still functions in a similar manner as the system 10 previously described; namely, hot sea water with liquid vapor in equilibrium therewith flows into the still. The absorptive qualities of the black lining material, used for the materials of construction and the packing material, increases the amount of thermal energy or temperature within the still. At nightfall, the sharp drop in temperature results in the liquid vapor in the gaseous phase condensing and flowing onto the floor 68 between the wing 66 and depending wall of the canopy 70 which define a dead air zone 74. Supports 78 provide structural stability to the still 50. Further, the amount of heat absorbed by the packing material during the day dissipates slowly such that at nightfall liquid vapor will continue to form and subsequently condense for a considerable time after nightfall. That is, the dual wall-dead air zone concept of the solar still used in combination provides an insulated region which together with the packing in the flume retains the heat substantially beyond the time that the ambient external to the outer canopy has cooled down thus continually generating, albeit at a diminishing rate, a source of heat to continue evaporation of pure water. As shown in FIG. 4 water flows over the outer surface of the canopy 70 to aid in the condensation of the liquid vapor. The basic solar still concept embodied in FIG. 4 may be expanded to include additional dead air zones. Referring to FIG. 5, a solar still 80 is shown comprising a first square-shaped flume 82 received within and spaced apart from a second square-shaped flume 84. The second flume 84 in turn is received within and spaced apart from a third square-shaped flume 86. The flume 82 is filled with packing material 88 such as that described for the flume 50. The walls of the flume 82 define with the walls of the flume 84 a zone 90. Similarly, the walls of the flume 84 define with the walls of the flume 86 a zone 92. A canopy 94 embraces the flumes; the depending walls of the canopy defining with the outer walls of the flume 86 a trough 84 having a floor 96, for the collection of condensate. The zones 90 and 92 are enclosed to define insulated barriers or dead air zones as shown in FIG. 5. Either one or both zones 90 and 92 may be filled with packing material to retain the thermal energy acquired during the day. Alternatively, heated sea water from a lagoon could flow into one or both zones and during the day acquire thermal energy and slowly release its thermal energy commencing at dawn. Molten salt may be held in one or both of the dead air zones. This salt (an eutectic mixture) would absorb energy during the day and at night it would slowly release its thermal energy. The zones 90 and 92 are primarily designed to insulate and enhance the efficiency of the flume 82. That is the additional insulating layers or zones are provided to effectively maximize the continued condensation of liquid vapor. Referring to FIG. 6, a solar still 100 substantially as shown in FIG. 5, comprises an inner flume 102, as previously described contains packing 104 which the heated water will contact. A conduit 106 is disposed within the packing, preferably centrally, for the flow of a heat exchange fluid therethrough. This heat exchange fluid such as ethylene glycols is heated externally such as in a separate storage area, whether it be a lagoon, tank or the like, and is pumped through the conduit 106 and recycled to its storage area. The conduit places the heated fluid which may assume a temperature of between about 250° to 400° Farenheit in indirect heat exchange contact with the packing and water within the flume 102. An especially suitable heat exchange fluid is the bottom dense layer of salt water of a solar energy pond. These multi layer ponds are well known and are used as an energy source for turbines. The lowermost layers will reach temperatures of over 200° F. The specific configuration of the conduit 104 will vary depending upon the ΔF to be achieved between the heat exchange fluid and the sea water. The conduit may be fluted, finned, etc. as is well known in the heat exchange art. Alternatively, no packing need be used in the flume 102. When the heated water from a solar energy pond is used the conduit may be perforated such that at least a portion, if not all of the heat-exchange fluid may mix with the water flowing through the flume. This will aid in the evaporation of the water. With enough salt in the solar energy pond the lowermost layer conceivably could reach about 225° F. In a manner similar to the structure disclosed in FIG. 5 additinal dead air zones 108, 110 are defined by flumes 112 and 114 respectively. Either alone or in combination these zones provide the insulating function for which they are designed and may contain hot saline water, air, solar heated heat-exchange fluid such as described for the conduit 104 and/or a packing material which is particularly susceptible to absorbing solar radiation or combinations thereof. The stills 50, 80 or 100 may be used in combination with similar stills as illustrated in FIG. 7. Referring to FIG. 8 the still 50 is external to the system 10 shown in FIGS. 1 and 3. The operation of the still 50 may be either a continuous or batch operation. For the lagoon of FIGS. 1 and 3 and the flumes of FIGS. 4, 5 and 6 the source of water is preferably from preheated solar storage ponds. The ponds are allowed to increase their thermal energy from the suns rays. Referring to FIG. 9, the heated water from a first pond discharges, at a fixed rate its water into the flume 52 and is held therein assuming a batch operation and the heated water flows continuously to the lagoon 12 of the system 10. Water is held in the second pond for solar heating while the third pond is being filled. Subsequently the second pond discharges to the flume 52 and lagoon, the first pond is filled while the third pond is heated, etc. Condensate removed from the flume 50 is transferred by line 112 which communicates with the gutter 32. Alternatively the heated sea water from the flume 50 may pass into the lagoon 12.

A soil bed is spaced apart from a lagoon of saline water. The liquid vapor in equilibrium with the saline water permeates into the soilbed via diffuser tubes. At dusk the temperature of the soilbed decreases. The liquid vapor is entrapped in the soilbed and condenses. Additionally solar stills embodying flumes generate liquid vapor which is transported to the soilbed.

CROSS-REFERENCE TO RELATED APPLICATION(S) This patent application is a continuation of U.S. patent application Ser. No. 09/663,768, filed on Sep. 18, 2000, now U.S. Pat. No. 6,723,108, entitled, “Foam Matrix Embolization Device.” BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device for placement at a predetermined location within a passageway of the human body, and more particularly, relates to a flexible embolization device which may be delivered by a catheter to a pre-selected position within a blood vessel to thereby embolize a blood vessel or a defect in a blood vessel, such as an aneurysm or fistula. 2. Description of the Prior Art For many years flexible catheters have been used to place various devices within the vessels of the human body. Such devices include dilatation balloons, radiopaque fluids, liquid medications and various types of occlusion devices such as balloons and embolic coils. Examples of such catheter devices are disclosed in U.S. Pat. No. 5,108,407 to Geremia, et al., entitled, “Method And Apparatus For Placement Of An Embolic Coil” and U.S. Pat. No. 5,122,136 to Guglielmi, et al., entitled, “Endovascular Electrolytically Detachable Guidewire Tip For The Electroformation Of Thrombus In Arteries, Veins, Aneurysms, Vascular Malformations And Arteriovenous Fistulas.” These patents disclose devices for delivering embolic coils at predetermined positions within vessels of the human body in order to treat aneurysms, or alternatively, to occlude the blood vessel at a particular location. Coils, which are placed in vessels, may take the form of helically wound coils, or alternatively, may be random wound coils, coils wound within other coils or other such coil configurations. Examples of various coil configurations are disclosed in U.S. Pat. No. 5,334,210 to Gianturco, entitled, “Vascular Occlusion Assembly” and U.S. Pat. No. 5,382,259 to Phelps, et al., entitled, “Vasoocclusion Coil With Attached Tubular Woven Or Braided Fibrous Coverings.” Embolic coils are generally formed of radiopaque material, such as platinum, gold, tungsten or alloys of these metals. Often times several coils are placed at a given location in order to occlude the flow of blood through the vessel by promoting thrombus formation at the particular location. In the past, embolic coils have been placed within the distal end of a catheter and when the distal end of the catheter is properly positioned the coil may then be pushed out of the end of the catheter with, for example a guidewire, to release the coil at the desired location. This procedure for placement of the embolic coil is conducted under fluoroscopic visualization such that the movement of the coil through the vasculature of the body may be monitored and the coil may be placed in the desired location. Other embolization devices, such as detachable balloons, are placed in vessels or aneurysms. These balloons usually take the form of an inflatable elastic balloon with a valve assembly for sealing the balloon when a desired inflation is reached. Examples of various detachable balloons are disclosed in U.S. Pat. No. 4,517,979 to Pecenka, entitled, “Detachable Balloon Catheter” and U.S. Pat. No. 4,545,367 to Tucci, entitled, “Detachable Balloon Catheter And Method Of Use.” Detachable balloons are generally formed of a flexible polymer and are inflated with a radiopaque solution for visualization under fluoroscopy. Often several balloons are used to fill the aneurysm space. These balloons do not generally conform to the aneurysm space thereby leaving unoccupied space leading to an incomplete aneurysm embolization. Often times a balloon valve may leak thereby causing other balloons to shift position, which may in turn, occlude the parent artery leading to severe complications. SUMMARY OF THE INVENTION In accordance with one aspect of the present invention, the vascular embolization system comprises a catheter, a push rod and an embolization device. The embolization device takes the form of an embolization coil surrounded by a foam sleeve. The foam sleeve has a hydrated normal expanded diameter, however it may be compressed and remain compressed when constrained. When the foam sleeve is hydrated and unconstrained, the foam sleeve will return to its normal expanded diameter. The embolization device is positioned in the lumen of the catheter. The push rod is slidably received by the lumen of the catheter and engages the embolization device. Distal movement of the push rod causes the embolization device to exit the lumen of the catheter at a predetermined site within a blood vessel. In accordance with another aspect of the present invention, there is provided an embolization system comprising an embolization device, which takes the form of an embolization coil, which is impregnated and surrounded by a foam sleeve made of a moldable material. Preferably, the foam sleeve extends into the lumen of the coil. In another aspect of the present invention there is provided an embolization system, which includes an embolization device having an embolization coil and a foam sleeve bonded to the coil. The embolization device takes the form of a helix. The embolization device is positioned in the lumen of a catheter in a generally straightened configuration, however, upon exiting the distal lumen of the catheter the embolization device returns to the relaxed helical shape. Alternately, the embolization device may take the form of a convoluted shape. In accordance with another aspect of the present invention there is provided an embolization device that comprises an embolization coil with a foam sleeve disposed about the periphery of the coil. The foam may take the form of a hydrogel and in addition, the embolization device may be used to deliver a therapeutic agent to improve the efficacy of a particular treatment modality. The choice of therapeutic agent depends largely on the particular treatment chosen for a vascular abnormality. In the treatment of an aneurysm the therapeutic agent may be a growth factor such as fibroblast growth factor (FGF) or vascular endothelial growth factor (VEGF) to promote endothelialization and permanent occlusion of the aneurysm. Other therapeutic agents include radioactive materials to aid in the treatment of arteriovenous malformations. Other therapeutic agents include drugs used to obliterate tumors. In accordance with yet another aspect of the present invention, there is provided an embolization device having an embolization coil and foam sleeve disposed about the coil periphery, which is radiopaque. The embolization device may be made visible under fluoroscopy by using an embolization coil made from a radiopaque material such as a platinum or tungsten alloy. Alternatively, the foam sleeve may be made radiopaque by incorporating a radiopaque filler material such tantalum or tungsten powder or a radiopaque iodine commonly used in contrast media such as RENOGRAFFIN. This radiopaque material aids in the visualization of the embolization device during the medical procedure. In still another aspect of the present invention there is provided an embolization device that comprises an embolization coil and a foam sleeve bonded to the coil. The embolization coil may contain reinforcing fiber or fibers that are secured in at least two locations and extend through the lumen of the coil to reduce coil stretching. Alternatively, the foam sleeve may contain reinforcing material dispersed throughout the foam, such as long fibers to resist stretching or short fibers or particles to improve sponge mechanical integrity. In accordance with another aspect of the present invention there is provided an embolization device that comprises an embolization coil surrounded by a foam sleeve. The foam sleeve has a hydrated normal expanded diameter, however, it can be compressed and remain compressed when constrained. When the foam sleeve is hydrated and unconstrained the foam sleeve will return to its normal expanded diameter. Typically, the normal expanded diameter of the foam sleeve is larger than the diameter of the lumen of the catheter. In accordance with yet another aspect of the present invention there is provided an embolization device that comprises an embolization coil surrounded by a foam sleeve. The foam sleeve has a hydrated normal expanded diameter, however, it can be compressed and remain compressed when constrained. When the foam sleeve is hydrated and unconstrained the foam sleeve will return to its normal expanded diameter. Typically, the normal expanded diameter of the foam sleeve is smaller than the diameter of the catheter used to deliver the embolization device. In accordance with another aspect of the present invention there is provided a vascular embolization system comprising a push rod, a catheter and an embolization device. The embolization device takes the form of an elongated flexible cylindrical resilient foam. The foam has a normal hydrated expanded diameter and a smaller constrained diameter. When the foam is unconstrained and hydrated the foam returns to the normal expanded diameter. This elongated flexible foam has a length that is at least ten times greater than the normal hydrated diameter. In another aspect of the present invention there is provided an embolization device, which takes the form of an elongated flexible foam. The foam may take the form of a hydrogel. The foam may be used to deliver therapeutic agents to improve the efficacy of a particular treatment modality. In yet another aspect of the present invention there is provided an embolization device, which takes the form of an elongated flexible cylindrical foam. To improve the mechanical integrity of the foam, the foam may contain reinforcing materials. Reinforcing materials may take the form of long fiber or fibers incorporated within the foam or short fibers or particles dispersed throughout the foam. In still another aspect of the present invention there is provided an embolization device, which takes the form of an elongated flexible foam. The foam may be made visible under fluoroscopy by incorporating a radiopaque filler material such tantalum or tungsten powder or a radiopaque iodine commonly used in contrast media such as RENOGRAFFIN. This radiopaque material aids in the visualization of the embolization device during the medical procedure. In accordance with yet another aspect of the present invention there is provided an embolization system comprising a push rod, a catheter and an embolization device. The embolization device takes the form of an elongated resilient flexible foam having an elongated length that is at least ten times the normal hydrated diameter. The foam takes the shape of a helix. The embolization device is positioned in the lumen of the catheter in a generally straightened configuration. The push rod is slidably disposed into the catheter lumen engaging the embolization device. Distal movement of the push rod causes the embolization device to exit the lumen of the catheter. As the embolization device exits the distal section of the catheter lumen and enters the blood vessel the embolization device returns to its relaxed helical shape. Alternately, in treating a blood vessel defect such as an aneurysm, the embolization may have a preferred convoluted shape. In accordance with another aspect of the present invention there is provided an embolization system comprising a push rod, a catheter and an embolization device. The embolization device takes the form of an elongated flexible resilient cylindrical foam. The foam has a normal expanded diameter when hydrated and a smaller compressed diameter when constrained. The normal expanded diameter of the foam may be larger than the diameter of the lumen of the catheter. In accordance with another aspect of the present invention there is provided an embolization system comprising a push rod, a catheter and an embolization device. The embolization device takes the form of an elongated flexible resilient cylindrical foam. The foam has a normal expanded diameter when hydrated and a smaller compressed diameter when constrained. The normal expanded diameter of the foam material may be smaller than the diameter of the catheter used to deliver the embolization device. In accordance with yet another aspect of the present invention there is provided a vascular embolization system comprising a push rod, a catheter and an embolization device. The embolization device includes a flexible wire and a resilient foam sleeve disposed about the wire. The foam sleeve has a normal hydrated expanded diameter and a smaller constrained diameter such that when unconstrained and hydrated said foam sleeve returns to the normal expanded diameter. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a partial section view of a first embodiment of the vascular embolization system of the present invention. FIG. 2A illustrates an axial view of an embolization device according to the present invention. FIG. 2B illustrates a cross sectional view of the embolization device depicted in FIG. 2A . FIG. 3 illustrates an alternative embodiment of an embolization device according to the present invention. FIG. 4 illustrates another alternative embodiment of an embolization device having a helical shape according to the present invention. FIG. 5 illustrates yet another alternative embodiment of an elongated embolization device according to the present invention. FIGS. 6A through 6D illustrate a sequence of delivery and deployment of an embolization device in a vessel according to the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 illustrates a first embodiment of the vascular embolization system 10 . The vascular embolization system 10 includes a catheter 12 , having a proximal hub 14 , push rod 16 and embolization device 18 . Embolization device 18 is disposed within the lumen at the distal section of catheter 12 . Push rod 16 is slidably disposed within the lumen of catheter 12 , proximal to embolization device 18 . FIGS. 2A and 2B show axial and cross sectional views of embolization device 18 . The embolization device 18 comprises an embolization coil 20 surrounded by a foam sleeve 22 . The embolization coil 20 is of the type commonly used to reduce or embolize a particular blood vessel. Depending on the flexibility needed and catheter system utilized the embolization coil 20 ranges in diameter from about 0.002 inches to 0.150 inches with a preferred range of about 0.006 inches to 0.052 inches. Materials used to make the embolization coil 20 include polymers, metals or composites in filament form. A wide variety of polymers are suitable for the embolization coil such as nylons, polyesters, collagen, polyvinylalcohol or hydrogels of polyvinylalcohol or polyvinylpyrrolidone. Metals are often used to form embolization coils that are biocompatible and provide the desired flexibility like platinum, gold and nickel-titanium alloys. The preferred material being metals formed of platinum alloys. The foam sleeve 22 is a foam material that is secured using thermal, adhesive or mechanical means to the embolization coil 20 . As shown in FIG. 2B , embolization device 18 is illustrated in cross section. The foam sleeve 22 is formed of a biocompatible material. Foams for use in the preferred embodiment and alternate embodiments are generally polymeric in nature and can be formed of many materials such as collagen, polyvinylalcohol (PVA), polyvinylpyrrolidone (PVP), polyurethane or polyether-polycarbonate. In the preferred embodiment, foam sleeve 22 is molded about coil 20 using liquid components that when reacted form a solid flexible foam, such as those described in U.S. Pat. No. 4,550,126. Preferably the foam material extends within the lumen of coil 20 . To improve the integrity and mechanical properties of these foams reinforcing materials can be incorporated into the foam. Typically reinforcing material is in the form of high strength flexible fibers, however particles are also acceptable. These foams generally have a hydrated normal expanded diameter and a smaller compressed diameter when constrained. These foams are flexible and resilient, such that when unconstrained and sufficiently hydrated they return to the normal expanded diameter. The diameter of any of the foams of the preferred embodiment are largely dependent on the catheter used and the vasculature to be occluded, but generally is in the range of about 0.01 mm to 20 mm preferably in the range of about 0.1 mm to 5 mm. The structure of the foams, such as in foam sleeve 22 can be that of open celled, closed celled or a combination of both however, preferably open celled. To improve the visibility of the foams under fluoroscopy, radiopaque materials such as platinum, tungsten, tantalum, gold, barium or iodine can be incorporated within or bonded to the foam. As can be appreciated these foams can be comprised of biocompatible hydrogel materials, such as PVA, PVP, collagen, etc., making them suitable for delivery of therapeutic agents. These therapeutic agents can include radioactive particles to deliver therapeutic radiation, growth factors such as VEGF or FGF, chemotherapy agents as well as other drugs to treat tumors. FIGS. 3 and 4 illustrate alternate embodiments of the present invention. In a first alternate preferred embodiment depicted in FIG. 3 , foam sleeve elements 26 and 28 are disposed about coil 24 . The foam sleeve elements 26 and 28 are formed onto the coil 24 using aforementioned materials and methods. As can be appreciated, only their length and the length of the coil limit the number of foam sleeve elements. The foam sleeve elements 26 and 28 generally have a cylindrical shape. A variation of the first alternate preferred embodiment includes foam sleeve elements disposed about the coil, in which the length of one foam sleeve element extends far distal from the end of the coil. The length the foam element that extends from the end of the coil is in the range of 10 to 500 times the length of the coil with a preferred range of about 20 to 300 times the coil length. In a second alternate preferred embodiment shown in FIG. 4 , foam sleeve 32 is disposed about coil 30 . Coil 30 is formed into a helical shape and consequentially foam sleeve 32 also takes this helical shape. Alternatively coil 30 could be of a straight configuration, placed in a helical mold and foam sleeve 32 molded about coil 30 in a helical shape. As can be appreciated the coil 30 can be shaped complex, convoluted, spherical, conical, spiral or any other shape that is suitable for occluding the blood vessel or vascular malformation. FIG. 5 illustrates a third alternate preferred embodiment in which the embolization device of the vascular embolization system is an elongated foam material 34 . The elongated foam material 34 of the present invention is open celled, however variations could include closed cells or a combination of both. The elongated foam material 34 generally has a primary long cylindrical shape. As can be appreciated, this long cylindrical shape can have a secondary shape that is helical, conical, spherical, complex or convoluted pertinent shape to aid in delivery or occlusion. The length of the elongated foam material 34 is at least ten times its primary diameter but preferably greater than fifteen times the primary diameter. FIGS. 6A , 6 B and 6 C illustrate the sequence of positioning and deploying the vascular embolization system 10 within a blood vessel. FIG. 6A depicts catheter 12 properly positioned within a blood vessel 36 selected for embolization. Push rod 16 and embolization device 18 are introduced into the lunen of catheter 12 . Distal movement of push rod 16 advances embolization device 18 to the distal section of catheter 12 . Further distal movement of push rod 16 causes embolization device 18 to exit the lumen of catheter 12 . As shown in FIGS. 6B and 6C , the embolization device 18 exits the lumen of catheter 12 and the foam sleeve 22 expands. The foam sleeve 22 expands to its hydrated normal expanded diameter within the vessel and thereby embolizes the vessel. FIG. 6D illustrates an alternative embodiment in which the embolization device is partially deployed and has an expanded diameter smaller than the catheter 12 . As can be appreciated, numerous variations of the present invention exist to treat the limitless variations in blood vessel and vascular malformation anatomy. It is within the scope of the present invention to use various known detachable positioning mechanisms to deploy the vascular embolization device of the present invention.

The present invention relates to a medical device for placement at a predetermined location within a passageway of the human body, and more particularly, relates to a flexible expandable embolization device which may be delivered by a catheter to a pre-selected position within a blood vessel to thereby embolize a blood vessel or a blood vessel defect, such as an aneurysm or fistula.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of prior U.S. provisional application 60/810,452, entitled “Controlled Warm Air Capture, and filed Jun. 1, 2006. TECHNICAL FIELD [0002] This document relates to computing environments. BACKGROUND [0003] Computer users often focus on the speed of computer microprocessors (e.g., megahertz and gigahertz). Many forget that this speed often comes with a cost—higher power consumption. For one or two home PCs, this extra power may be negligible when compared to the cost of running the many other electrical appliances in a home. But in data center applications, where thousands of microprocessors may be operated, electrical power requirements can be very important. [0004] Power consumption is also, in effect, a double whammy. Not only must a data center operator pay for electricity to operate its many computers, but the operator must also pay to cool the computers. That is because, by simple laws of physics, all the power has to go somewhere, and that somewhere is, in the end, conversion into heat. A pair of microprocessors mounted on a single motherboard can draw hundreds of watts or more of power. Multiply that figure by several thousand (or tens of thousands) to account for the many computers in a large data center, and one can readily appreciate the amount of heat that can be generated. It is much like having a room filled with thousands of burning floodlights. The effects of power consumed by the critical load in the data center are often compounded when one incorporates all of the ancillary equipment required to support the critical load. [0005] Thus, the cost of removing all of the heat can also be a major cost of operating large data centers. That cost typically involves the use of even more energy, in the form of electricity and natural gas, to operate chillers, condensers, pumps, fans, cooling towers, and other related components. Heat removal can also be important because, although microprocessors may not be as sensitive to heat as are people, increases in temperature can cause great increases in microprocessor errors and failures. In sum, a data center requires a large amount of electricity to power the critical load, and even more electricity to cool the load. SUMMARY [0006] In some implementations, a system includes an enclosure having an exterior surface and an interior region that is characterized by a width and a length that is longer than the width; a plurality of trays mounted in racks that line a majority of each side of the length of the interior region and that define an aisle therebetween which is suitable for passage by one or more human occupants; one or more cooling coils configured to capture heat generated by the plurality of trays and exhaust the heat outside the interior region; a plurality of connections on the exterior surface including a first connection for supplying electrical power to the plurality of trays in the interior region, a second connection for supplying cooling fluid to the one or more cooling coils in the interior region, and a third connection for receiving cooling fluid discharged from the one or more cooling coils; and doors at either end of the aisle configured and positioned to facilitate emergency egress from the enclosure by a human occupant. In some implementations, each tray in the plurality of trays includes a circuit board having a microprocessor or a hard drive. [0007] The system can further include one or more lights configured to illuminate the aisle. The lights can be powered by a backup power system. The system can further include an emergency shutoff switch that, when activated, disconnects electrical power to the plurality of trays. Each door can include a crash bar. At least one door can include a door alarm that is activated when the crash bar is employed. The system can further include an exit light disposed above each door. [0008] The system can further include a fire and smoke detection system. The system can further include a fire suppression system. In some implementations, the fire suppression system is a fog based system. In some implementations, the fire suppression system includes less than ten outlets for dispersing a fire suppressing medium into the interior region. The system can further include one or more fire dampers configured to be activated in response to the fire and smoke detection system detecting fire or smoke. The system can further include fire retardant expandable foam disposed in one or more passageways in the interior region or between the interior region and a space outside of and adjacent to the enclosure. [0009] The system can further include a flood detection system. The system can further include a power-down controller configured to power down the plurality of processor boards upon detection of a flood condition by the flood detection system. The system can further include one or more overflow drains. At least one of the one or more overflow drains can be normally sealed but configured to open in the presence of liquid. At least one overflow drain can include a ball and cage construction. [0010] The system can further include one or more high temperature sensors and at least one corresponding alarm. The system can further include a thermal runaway alarm. The system can further include a power-down controller configured to power down the plurality of processor boards upon detection of a thermal runaway condition. [0011] In some implementations, the enclosure is a shipping container. The shipping container can be a 1AAA shipping container. The shipping container can be a 1CC shipping container. [0012] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. DESCRIPTION OF DRAWINGS [0013] FIG. 1 a shows a plan view of a tray in a rack-mount computer system. [0014] FIG. 1 b shows a front view of the tray in FIG. 1 a. [0015] FIG. 1 c shows a side view of the tray in FIG. 1 a. [0016] FIG. 1 d shows a plan view of a tray in a rack-mount computer system, having dual-zone power supply ventilation. [0017] FIG. 1 e shows a front view of the tray in FIG. 1 d. [0018] FIG. 1 f shows a side view of the tray in FIG. 1 d. [0019] FIG. 1 g shows a plan view of a tray in a rack-mount computer system, having dual-zone adjustable power supply ventilation. [0020] FIG. 2 a shows a plan view of a data center in a shipping container. [0021] FIG. 2 b shows a sectional view of the data center from FIG. 2 a. [0022] FIG. 2 c shows a perspective view of a modular computing environment for housing a data center or part of a data center. [0023] FIG. 3 a shows a plan view of a data center. [0024] FIG. 3 b shows a sectional view of the data center from FIG. 3 a. [0025] FIG. 4 a shows a plan view of a data center. [0026] FIG. 4 b shows a sectional view of the data center from FIG. 4 a. [0027] FIG. 5 a shows a plan view of a data center. [0028] FIG. 5 b shows a sectional view of the data center from FIG. 5 a. [0029] FIG. 5 c shows a sectional view of another implementation of a data center. [0030] FIG. 6 is a flowchart showing actions for an exemplary operation of cooling components in a data center. [0031] FIG. 7 shows plan views of two exemplary trays for use in a rack-mount computer system. [0032] Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION [0033] FIG. 1 a shows a plan view of a tray 10 in a rack-mount computer system, while FIG. 1 b shows a front view, and FIG. 1 c shows a side view, of the tray 10 in FIG. 1 a . The term “tray” is not limited to any particular arrangement, but instead includes any arrangement of computer-related components coupled together to serve a particular purpose, such as on a motherboard. Trays may be generally mounted parallel to other trays in a horizontal or vertical stack, so as to permit denser packing than would otherwise be possible with computers having free-standing housings and other components. The term “blade” may also be employed to refer to such apparatuses, though that term too should not be limited to a particular arrangement. Trays may be implemented in particular configurations, including as computer servers, switches (e.g., electrical and optical), routers, drives or groups of drives, and other computing-related devices. In general, the trays in a system take a standardized physical and electrical form to be easily interchangeable from one location in the system to another, but the trays may take other appropriate forms. [0034] In general, the tray 10 may include a standard circuit board 12 on which a variety of components are mounted. The board 12 may be arranged so that air enters at its front edge (to the left in the figure), is routed over a number of heat generating components on the board 12 , and is drawn through a power supply 14 and fan 16 before being exhausted from the tray 10 . The fan 16 may also be arranged to push air through the power supply 14 . In addition, the fan 16 may be located in other positions relative to the back edge of the tray and at locations away from a back edge of the tray 10 . The power supply 14 may likewise be positioned at other locations and need not be joined to the fan 16 . [0035] In this arrangement, the heat from power supply 14 may be picked up after the heat from other components on the board 12 is picked up by the air flow. In this manner, the speed of fan 16 may be controlled to maintain a set temperature for the air exiting the board 12 , or for temperatures at other points on the tray 10 . For example, a thermocouple or other sort of temperature sensor may be placed in the air flow, such as upstream of the power supply 14 or downstream of the fan 16 , and the fan speed may be modulated to maintain a set temperature. The temperature of the exiting air may also be highly elevated compared to systems that do not control airflow in this manner. It may be more efficient to cool this air than it would be to cool air that does not have such an elevated temperature. [0036] Air may be routed over board 12 by walls 26 a , 26 b , 26 c . Wall 26 a may block one side of board 12 , and may funnel air toward openings in power supply 14 . Where the walls 26 a , 26 c do not taper, the air may otherwise be directed to the fan 16 . Wall 26 c may block one side of board 12 , so as to prevent air from moving directly from the workspace into an area behind tray 10 (i.e., to the right in the figure). For example, a plenum may be provided behind multiple boards in the form of an open wall into which the boards may be placed, or in the form of a wall having multiple openings into which fans may be slid. In certain implementations, fully blocking or sealing of such a plenum may not be necessary, such as when the pressure difference between the plenum and the workspace is minimal. [0037] Wall 26 b separates one portion of tray 10 from another. In particular, wall 26 b separates the portion of tray 10 containing heat generating components, such as microprocessors 21 a , 21 b , from components that generate substantially less heat, such as hard drives 18 a , 18 b . In making such a separation, wall 26 b substantially blocks airflow over the components that generate less heat, and increases airflow over the heat generating components. In addition, wall 26 b is arranged to route airflow into openings in power supply 14 . Although not pictured, wall 26 b may block areas on tray 10 but may provide that each blocked area (i.e., the area on each side of wall 26 b ) may still be in fluid communication with fan 16 . For example, fan 16 may be designed to have openings that will lie on each side of wall 26 b , and the openings may be sized or otherwise tuned so as to provide for relative levels of air flow on the opposing sides of the wall 26 b . The “tuning” of the air flow may be made to match the relative thermal load of components on each side of wall 26 b , so that more air flows on the side of wall 26 b having the most thermal load, or that otherwise requires more cooling. [0038] Board 12 may hold a variety of components needed in a computer system. As shown, board 12 holds a dual processor computer system that uses processor 21 a and processor 21 b connected to a bank of memory 24 . The memory 24 may be in the form, for example, of a number of single in-line memory modules (SIMMs), dual in-line memory module (DIMMs), or other appropriate form. Other components of the computer system, such as chip sets and other chips, have been omitted for clarity in the figure, and may be selected and arranged in any appropriate manner. [0039] Board 12 may also be provided with connections to other devices. Network jack 22 , such as in the form of an RJ-45 jack or an optical networking connection, may provide a network connection for tray 10 . Other connections may also be provided, such as other optical networking connections, video output connections, and input connections such as keyboard or pointing device connections (not shown). [0040] Impingement fans 20 a , 20 b may be mounted above each microprocessor 21 a , 21 b , to blow air downward on the microprocessors 21 a , 21 b . In this manner, impingement fans 20 a , 20 b may reduce boundary layer effects that may otherwise create additional heat buildup on microprocessors 21 a , 21 b . As a result, lateral airflow across tray 10 can be reduced even further, while still adequately controlling the temperature rise to the microprocessors 21 a , 21 b. [0041] Other heat relief mechanisms may also, or alternatively, be provided for microprocessors 21 a , 21 b . For example, one or more heat sinks may be provided, such as in the form of certain finned, thermally conductive structures. The heat sinks may be directly connected to microprocessors 21 a , 21 b , or may be located to the sides of microprocessors 21 a , 21 b , and may be attached by heat pipes to plates mounted to the top of microprocessors 21 a , 21 b . Thermally conductive grease or paste may be provided between the tops of microprocessors 21 a , 21 b , and any heat sinks to improve heat flow out of microprocessors 21 a , 21 b. [0042] In operation, tray 10 may be mounted flat horizontally in a server rack such as by sliding tray 10 into the rack from the rack front, and over a pair of rails in the rack on opposed sides of the tray 10 —much like sliding a lunch tray into a cafeteria rack, or a tray into a bread rack. Tray 10 may alternatively be mounted vertically, such as in a bank of trays mounted at one level in a rack. The front of the rack may be kept open to permit easy access to, and replacement of, trays and to permit for air to flow over the tray 10 from a workspace where technicians or other professionals operating a data center may be located. In this context, the term workspace is intended to refer to areas in which technicians or others may normally be located to work on computers in a data center. [0043] After sliding a tray 10 into a rack, a technician may connect a tray to appropriate services, such as a power supply connection, battery back-up, and a network connection. The tray 10 may then be activated, or booted up, and may be communicated with by other components in the system. [0044] Although tray 10 is shown in the figures to include a multi-processor computer system, other arrangements may be appropriate for other trays. For example, tray 10 may include only hard drives and associated circuitry if the purpose of the tray is for storage. Also, tray 10 may be provided with expansion cards such as by use of a riser module mounted transversely to the board 12 . Although particular forms of tray 10 may be provided, certain advantages may be achieved in appropriate circumstances by the use of common trays across a rack or multiple racks. In particular, great efficiencies may be gained by standardizing on one or a small handful of trays so as to make interaction between trays more predictable, and to lower the need to track and store many different kinds of trays. [0045] A data center may be made up of numerous trays (hundreds or thousands), each mounted in one of numerous racks. For example, several dozen trays may be mounted in a single rack within a space, with approximately several inches between each tray. As explained in more detail below, each of the trays in a rack may back up to a warm air plenum that receives exhaust air from the trays and routes that air to a cooling unit that may re-circulate the air into the workspace in front of the racks. [0046] Trays may also be packaged in groups. For example, two stacked trays may be matched as a pair, with one fan 16 serving both trays (not shown). Specifically, the fan 16 may be approximately double the height and diameter of a single tray unit, and may extend from the lower tray in a pair up to the top of the upper tray in a pair. By such an arrangement, the slowest turning portions of the fan, in the fan center, will be near the board of the top tray, where less airflow will normally occur because of boundary layer effects. The larger and faster moving portions of the fan 11 will be located nearer to the free areas of each tray 10 so as to more efficiently move air over the trays and through the respective power supplies more freely. In addition, a double-height fan may be able to move more air than can a single-height fan, at lower rotation speeds. As a result, a fan in such an arrangement may produce less noise, or noise at a more tolerable frequency, than could a smaller fan. Parallel fans may also be used to increase flow, and serial fans may be used to increase pressure, where appropriate. [0047] Fan 16 may be controlled to maintain a constant temperature for air exiting fan 16 or at another point. By locating fan 16 downstream of power supply 14 , and power supply 14 downstream of the other components of tray 10 , the arrangement may maximize the heat rise across tray 10 , while still maintaining adequately low temperatures for heat-sensitive components mounted to board 12 , such as microprocessors 21 a , 21 b . Also, the power supply 14 may be less sensitive to higher temperatures than are other components, and so may be best located at the end of the air flow, where the temperatures are highest. [0048] Although many applications seek to substantially increase airflow across heat generating components so as to increase the rate of heat dissipation from the components, the arrangement pictured here allows airflow across tray 10 to be slowed substantially to increase the temperature rise across tray 10 . Increasing the temperature rise decreases the mass flow rate, and can make cooling across the entire system more efficient. [0049] In particular, when the temperature of the warm exiting air is increased, the difference in temperature between the warm air and any cooling water entering a cooling coil to cool the warm air, also increases. The ease of heat transfer is generally directly proportional to this difference in temperature. Also, when the difference in temperature is relatively small, increasing the difference by only one or two degrees can produce a substantial increase in the amount of heat exchange between the warm air and the cooling water. As a result, a system run at higher exhaust temperatures from board 12 can provide substantial advantages in efficiency, and lower energy consumption. [0050] In certain embodiments, the temperature rise across tray 10 may be approximately 20° C. As one example, air may enter the space above board 12 from a workspace at 25° C., and may exit fan 16 at 45° C. The entering temperature may also be about 21-30° C. (70-86° F.), and the exiting temperature 40-50° C. (104-122° F.). The 45° C. exhaust temperature or other temperature may be selected as a maximum temperature for which the components in tray 10 can be maintained without significant errors or breakdowns, or a safe temperature of operation. The 25° C. entering temperature or other temperature may be a temperature determined to create a comfortable or tolerable temperature in the workspace in a data center. The entering temperature may also be linked to a maximum allowable temperature, such as a federal or state OSHA-mandated maximum temperature. The entering temperature could be approximately 40° Celsius, which matches certain limits established by bodies governing workplace safety. [0051] In other implementations, air may enter the space above board 12 at a temperature of 50° C., where appropriate thermal removal mechanisms or methods are provided for the components on board 12 . For example, conductive and liquid-cooled components may be placed in contact with microprocessors 21 a , 21 b to increase the rate of heat dissipation from those components. Where a higher input temperature is selected, the temperature difference across tray 10 will generally be lower than if a lower input temperature is selected. However, heat will be easier to remove from such heated air when it passes through a cooling coil. Higher temperatures for expected breakdowns include components that tolerate case temperatures of 85 degrees Celsius. In addition, the exit air temperature from tray 10 may be as high as 75 degrees Celsius. An output temperature may be most easily controlled by locating a temperature sensor at the actual output (or aiming it at the actual output). Such an output temperature may also be controlled or maintained within an acceptable temperature range by placing a temperature sensor at a location away from the output, but where the difference in temperature is adequately predictable. [0052] In the front view of FIG. 1 b , one can see power supply 14 located at the back of tray 10 , and perforated to permit the flow of air through power supply 14 . In addition, one can see hard drive 18 a located in an area walled off from the heat generating components of tray 10 by wall 26 b . As noted above, the power supply 14 could also be situated so as to receive air leaving two different zones on tray 10 , with the power supply 14 or other components tuned to maintain certain relative air flow rates from each side. [0053] The side view of FIG. 1 c shows more clearly the relationship of the impingement fans 20 a , 20 b and microprocessors 21 a , 21 b . The fans 20 a , 20 b are shown schematically for clarity. Air is pulled through the tops of fans 20 a , 20 b , and driven down against the top of microprocessors 21 a , 21 b . This process breaks up layers of warm air that may otherwise form above microprocessors 21 a , 21 b. [0054] As noted above, other techniques for spot removal of heat from components such as microprocessors 21 a , 21 b may also be employed. As one example, heat sinks may be attached on top of or to the side of microprocessors 21 a , 21 b , and may be cooled by circulating air or a liquid, such as water or fluorinert liquid, or oils. Liquid supply and return tubes may be provided down each rack, with taps at which to connect pipes for cooling particular components. Circulation of liquid to the components may be driven by pressure created centrally in the system (e.g., from natural tap water pressure or large pumps) or by small pumps local to a particular tray 10 . For example, small peristaltic, centrifugal, vane or gear-rotor pumps may be provided with each tray to create liquid circulation for the tray 10 . [0055] Alternatively, a portion of a rack or a component associated with a rack may be cooled, such as by passing liquid through passages in the component. Heat sinks for each heat generating component may then be coupled physically to the cooled component in the rack so as to draw heat out of the components on the tray 10 and into the rack. As one example, a vertical runner on the rack may be provided with clamps into which heat pipes attached to heat-generating components on tray 10 are received, so that the heat pipes may pull heat away from those components and into the runner. The runner may further include fluid passages to carry cooling fluid. Thus, the runner will be kept cool, and will draw heat by conduction from the heat-generating components. [0056] FIG. 1 d shows a plan view of a tray in a rack-mount computer system, having dual-zone power supply ventilation. FIG. 1 e shows a front view of the tray in FIG. 1 d . FIG. 1 f shows a side view of the tray in FIG. 1 d . The general arrangement of components on the tray 10 here is similar to that in FIGS. 1 a - 1 c , although the particular arrangement and layout of components is not generally critical. However, in these figures, the wall 26 b has its rear edge pulled forward from the back wall of the tray 10 . Also, the power supply 14 has two areas of openings—one on its front edge, as can be seen in FIG. 1E , and one on its side edge, as can be seen in FIG. 1F . The openings on the front edge generally provide ventilation for the hot side of the tray 10 , while those on the side edge provide ventilation for the cool side of the tray 10 . [0057] The openings may be sized or otherwise organized to provide particular approximate levels of ventilation to each side of the tray 10 . As can be seen in FIGS. 1E and 1F , the front edge of the power supply 14 has more holes than does the edge; in addition, the air flow from the front edge is straight, while air coming in through the side edge needs to curve. As a result, the front edge will provide a higher level of ventilation than will the side edge, and will thus be able to carry away the higher level of heat generated on the hot side of tray 10 . The amount of air carried on a hot side might also be lower than on a cool side, such as where equipment requirements force the cool side to stay at a low temperature. In other words, in setting flow rates for each portion of tray 10 , both heat generation and desired operating temperature may be taken into account. [0058] FIG. 1 g shows a plan view of a tray in a rack-mount computer system, having dual-zone adjustable power supply ventilation. Here, the wall 26 b is positioned to direct a certain amount of ventilating air from each side of wall 26 b . The wall 26 b may be positioned on tray 10 at an appropriate position, and its terminal end may be made adjustable through pivoting or other mechanisms, so as to permit on-site adjustment of air flow. [0059] In addition, gate 27 may be provided over a front surface of power supply 14 to provide adjustment to the size of openings on the front surface via openings in the gate 27 that form an interference pattern with openings on power supply 27 (much like the openings on certain spice containers). The interference pattern may be different for each side of tray 10 , so that moving the gate 27 causes a greater effect on the airflow for one side of tray 10 than its does for the other side of tray 10 . [0060] Temperature-dependent mechanisms may also be provided to control the flow of air through power supply 14 . For example, polymer or metallic materials that change shape with temperature may be used to form openings that close as their temperature falls—thereby driving back up the exit temperature of air from a particular portion of tray 10 . As one example, the materials may produce a form of stoma that opens and closes. Also, mechanisms such as temperature-controlled louvers, or a temperature-controlled actuator on gate 27 may be used to control airflow over board 12 . Such air control mechanisms may also be located off of tray 10 . For example, a wall perforated by temperature dependent stoma (or other gates) may be placed behind a number of racks filled with trays, and may thereby control the exit temperature for all of the racks in a convenient manner. In such a situation, as in others discussed herein, fan 16 may be eliminated from tray 10 , and a central ventilation system may pull air through the various trays and racks. [0061] FIG. 2 a shows a plan view of a data center 200 in a shipping container 202 . Although not shown to scale in the figure, the shipping container 202 may be approximately 40 feet along, 8 feet wide, and 9.5 feet tall (e.g., a 1AAA shipping container). In other implementations, the shipping container can have different dimensions (e.g., the shipping container can be a 1CC shipping container). Packaging of a data center in a shipping container may permit for more flexible and automated data center manufacture, such as by having a centrally-trained crew construct a large number of such data centers. In addition, the portability offered by a shipping container permits for quicker and more flexible deployment of data center resources, and thus allows for extension and projection of a network more easily to various areas. [0062] The container 202 includes vestibules 204 , 206 at each end. One or more patch panels or other networking components to permit for the operation of data center 200 may also be located in vestibules 204 , 206 . In addition, vestibules 204 , 206 may contain connections and controls for the shipping container. For example, cooling pipes (e.g., from heat exchangers that provide cooling water that has been cooled by condenser water supplied from a source of free cooling such as a cooling tower) may pass through the end walls of a container, and may be provided with shut-off valves in the vestibules 204 , 206 to permit for simplified connection of the data center to, for example, cooling water piping. Also, switching equipment may be located in the vestibules 204 , 206 to control equipment in the container 202 . [0063] A central workspace 208 may be defined down the middle of shipping container 202 as an aisle in which engineers, technicians, and other workers may move when maintaining and monitoring the data center 200 . For example, workspace 208 may provide room in which workers may remove trays from racks and replace them with new trays. In general, workspace 208 is sized to permit for free movement by workers and to permit manipulation of the various components in data center 200 , including to provide space to slide trays out of their racks comfortably. [0064] A number of racks such as rack 219 may be arrayed on each side of workspace 208 . Each rack may hold several dozen trays, like tray 220 , on which are mounted various computer components. The trays may simply be held into position on ledges in each rack, and may be stacked one over the other. Individual trays may be removed from a rack, or an entire rack may be moved into workspace 208 . [0065] The racks may be arranged into a number of bays such as bay 218 . In the figure, each bay includes six racks and may be approximately 8 feet wide. The data center 200 includes four bays on each side of workspace 208 . Space may be provided between adjacent bays to provide access between the bays, and to provide space for mounting controls or other components associated with each bay. Various other arrangements for racks and bays may also be employed as appropriate. [0066] Warm air plenums 210 , 212 are located behind the racks and along the exterior walls of the shipping container 202 . The warm air plenums receive air that has been pulled over trays, such as tray 220 , from workspace 208 . The air movement may be created by fans such as fan 16 in FIGS. 1 a - 1 c . Where each of the fans on the associated trays is controlled to exhaust air at one temperature, such as 45° C., the air in plenums 210 , 212 will generally be a single temperature or almost a single temperature. As a result, there will be little need for blending or mixing of air in warm air plenums 210 , 212 . [0067] FIG. 2 b shows a sectional view of the data center from FIG. 2 a . This figure more clearly shows the relationship and airflow between workspace 208 and warm air plenums 210 , 212 . In particular, air is drawn across trays, such as tray 220 , by fans at the back of the trays. Although shown earlier as fans associated with single trays or a small number of trays, other arrangements of fans may also be provided. For example, larger fans or blowers, such as air induction blowers, may be provided to serve more than one tray. [0068] Air is drawn out of warm air plenums 210 , 212 by fans 222 , 224 , respectively. Fans 222 , 224 may take various forms. In one exemplary embodiment, fans 222 , 224 may be in the form of a number of squirrel cage fans. The fans 222 , 224 may be located along the length of container 202 , and below the racks, as shown in the figure. A number of fans may be associated with each fan motor, so that groups of fans may be swapped out if there is a failure of a motor or fan. [0069] An elevated floor 230 may be provided at or near the bottom of the racks, on which workers in workspace 208 may stand. The elevated floor 230 may be formed of a perforated material, of a grating, or of mesh material that permits air from fans 222 , 224 to flow into workspace 208 . Various forms of industrial flooring and platform materials may be used to produce a suitable floor that has low pressure losses. [0070] Fans 222 , 224 may blow heated air from warm air plenums 210 , 212 through cooling coils 226 , 228 . Cooling coils 226 , 228 may be sized using well known techniques, and may be standard coils in the form of air-to-water heat exchangers providing a low air pressure drop, such as a 0.1 inch pressure drop. Cooling water may be provided to coils 226 , 228 at a temperature, for example, of 20 degrees Celsius, and may be returned from coils 226 , 228 at a temperature of 40 degrees Celsius. In other implementations, cooling water may be supplied at 15 degrees Celsius or 10 degrees Celsius, and may be returned at temperatures of about 25 degrees Celsius, 30 degrees Celsius, 35 degrees Celsius, 45 degrees Celsius, 50 degrees Celsius, or higher temperatures. The position of the fans 222 , 224 and the coils 226 , 228 may also be reversed, so as to give easier access to the fans for maintenance and replacement. In such an arrangement, the fans 222 , 224 will draw air through the coils 226 , 228 . [0071] The particular supply and return temperatures may be selected as a parameter or boundary condition for the system, or may be a variable that depends on other parameters of the system. Likewise, the supply or return temperature may be monitored and used as a control input for the system, or may be left to range freely as a dependent variable of other parameters in the system. For example, the temperature in workspace 208 may be set, as may the temperature of air entering plenums 210 , 212 . The flow rate of cooling water and/or the temperature of the cooling water may then vary based on the amount of cooling needed to maintain those set temperatures. [0072] The particular positioning of components in shipping container 202 may be altered to meet particular needs. For example, the location of fans 222 , 224 and coils 226 , 228 may be changed to provide for fewer changes in the direction of airflow or to grant easier access for maintenance, such as to clean or replace coils or fan motors. Appropriate techniques may also be used to lessen the noise created in workspace 208 by fans 222 , 224 . For example, placing coils in front of the fans may help to deaden noise created by the fans. Also, selection of materials and the layout of components may be made to lessen pressure drop so as to permit for quieter operation of fans, including by permitting lower rotational speeds of the fans. [0073] Also, the fans may pull air or push air through the coils. Pushing air may have the advantage of being quieter, as the coils may block out a certain amount of the fan noise. Also pushing of air may be more efficient. Pulling of air may provide a benefit of allowing a limited number of fans to operate on a much larger bank of coils, as all the pulling fans can be connected to a plenum, and may create a relative vacuum behind the coils to pull air through. In such an arrangement, if one of the fans breaks down, the others can more easily provide support across the entire coil length. [0074] Airflow in warm air plenums 210 , 212 may be controlled via pressure sensors 209 , 211 . For example, the fans 222 , 224 may be controlled so that the pressure in warm air plenums 210 , 212 is roughly equal to the pressure in workspace 208 . The volume on one side of pressure sensors 209 , 211 may be the warm-air plenum, and the volume on the other side may be the workspace 208 ; where a common barrier between these spaces is not available, taps may be provided to permit sensing of pressure in each volume. More precisely, the pressure where the air leaves the tray 220 may be kept roughly equal to the pressure where it enters the tray, or a set difference in pressures other than zero may be maintained. Where such a pressure relationship is maintained, each of the fans that draw air across the trays 220 (where each tray may have one or more dedicated fans) may “see” a uniform and predictable world around it. As a result, the airflow across each tray 220 may likewise be more uniform and predictable, so that adequate airflow can be maintained, adequate cooling can be maintained by extension, fewer hotspots will arise, and fewer equipment failures will result. In addition, such a system may better isolate problems in one area of the system from operations in other areas, so that the system has better “diversity” of operation. [0075] Pressure sensors 209 , 211 may be, for example, differential pressure sensors such as the Setra Model 263 differential pressure transducer. Taps for the pressure sensors 209 , 211 may be placed in any appropriate location for approximating a pressure differential across the trays 220 . For example, one tap may be placed in a central portion of plenum 212 , while another may be placed on the workspace 208 side of a wall separating plenum 212 from workspace 208 . The pressure differential between workspace 208 and plenums 210 , 212 may be maintained, for example, at about 20/1000ths of an inch of static pressure, with the slight vacuum on the plenum side. In general, the sensors 209 , 221 may be operated in a conventional manner with a control system to control the operation of fans 222 , 224 . For example, variable speed drives may be used to increase or decrease the speed of the fans 222 , 224 to maintain a particular pressure differential, such as zero or nearly zero differential. One sensor may be provided in each plenum, and the fans for a plenum or a portion of a plenum may be ganged on a single control point. [0076] Controlling pressure in the warm air plenum relative to the pressure on the intake side of the racks, including when the racks are open to a workspace, can, in certain configurations, provide one or more advantages. For example, each tray can better control its own environment because it operates, airflow-wise, as if it is located in an open room—it sees a consistent and predictable pressure difference, of approximately zero in certain implementations, on each of its ends. As a result, each tray can more closely match its operation to its own heat loads. In addition, the operation of each tray is also made much less dependent on the operation of other trays. Multiple groups of trays may also be controlled together, if a particular configuration calls for such grouping. [0077] By making the entry and exit pressures for a tray or board predictable, fans for the tray or board may be run more slowly, and higher temperature rises (which can result in more efficient system-side cooling) across the tray or board may be achieved. In contrast, if the plenum fans 222 , 224 are controlled based on plenum temperatures, those fans may be run too fast. For instance, an operator of such a system may seek to prevent stagnation of airflow on any board so as to prevent component burnout. To do so, the operator may seek to ensure that the plenum does not provide backpressure to any board. And to do that, the operator may set the temperature of the warm air plenum fairly low so that more air than necessary is pulled by the plenum fans 222 , 224 . Such operation will tend to draw air out of the trays and racks, and may defeat attempts by individual racks to maintain low air flow rates and high temperature rises across the trays or boards. [0078] In addition, pressure is generally consistent across a space, whereas temperature differences may be much more localized. As a result, the location of pressure sensors 209 , 211 , may be less important than would be the particular location of temperature sensors. That may be especially true at the intake side of the trays, such as in the workspace 208 , because air velocities are relatively slow there and are likely to create higher temperature differences across space due to less blending in the slower moving air. [0079] In addition, use of pressure as a control signal for the plenum fans may permit for lower capital costs. As one example, the warm air plenum may generally be made smaller when a system is well balanced, which can save on floor space and permit more equipment to be installed in a data center. Also, with the ability to cover problems with one fan using other fans, the various fans can be sized smaller and individually less reliable, and thus acquired for less money. In addition, where the warm air plenum is roughly matched in pressure with the surrounding spaces, such as a workspace, the sealing of components for air leakage is less critical, so that savings may be achieved in labor, maintenance, and goods for such sealing. [0080] Such an implementation also permits for more flexibility in planning and operating a data center. For planning, various unmatched trays may be inserted into a system without as much concern for how each will respond to the system, or will affect each other, because each simply needs to be able to control its own individual airflow and deal with what appears to be a neutral surrounding. [0081] For operation, the system may better isolate problems in one area from other components. For instance, if a particular rack has trays that are outputting very warm air, such action will not affect a pressure sensor in the plenum (even if the fans on the rack are running at high speed) because pressure differences quickly dissipate, and the air will be drawn out of the plenum with other cooler air. The air of varying temperature will ultimately be mixed adequately in the plenum, in a workspace, or in an area between the plenum and the workspace. Also, if one plenum fan goes down, the other fans will simply speed up to maintain the pressure differential and to thereby move the same amount of air. In other words, the fans across the plenum will generally share the increased load equally. [0082] FIG. 2 c shows a perspective view of a modular computing environment 239 for housing a data center or part of a data center. The modular computing environment 239 may be housed, in whole or in part, in container 208 , which may be a standard shipping container, or may take other appropriate forms. This figure better shows features in container 208 to permit human occupancy, which may be of assistance in servicing the computing environment in the container 208 . Such human occupancy may require additional features that satisfy both physical human occupancy requirements and any legal requirements that may exist (e.g., municipal building or occupancy requirements). [0083] For example, the modular computing environment 239 provides a mechanism for human ingress into and egress out of the interior of the enclosure (e.g., by doors 258 a, b ). If necessary, stairs may be provided adjacent or near the doors to further facilitate safe ingress and egress. Lights 240 may be provided in the interior, as may be a source of fresh air and fire detection and suppression systems 242 . The interior may be further designed within certain temperature, humidity, and noise parameters, and a clearance may be provided to allow human operators to move about the interior to maintain or service various components, such as shown in FIGS. 2A and 2B . [0084] The modular computing environment 239 may further be designed to account for safety of human operators in the enclosure. For example, power sources may be covered and insulated to minimize risk of electrical shorting or shocks to human operators; fans may be enclosed within protective cages to contain fan blades that may cause injury when coming into contact with, for example, a human finger or other appendage; and the interior may be equipped with emergency lighting and exit signs 250 . [0085] The systems may require, in certain implementations, features that meet physical requirements of human occupancy (e.g., systems that regulate temperature, noise, light, amount of fresh air, etc.) Moreover, depending on its location, the modular computing environment 239 may fall under the jurisdiction of a local municipality as an inhabitable commercial or industrial structure, and various systems may be required to meet local building or occupancy codes (i.e., legal requirements of human occupancy). [0086] As shown, the systems include lighting 240 , fire/smoke detectors 242 , and a fire suppression system 246 . In some implementations, one or more of the lights are equipped with battery backup. In some implementations, the fire suppression system 246 may include an inert chemical agent or water fog fire suppressant. The chemical fire suppressant may be stored in an on-board tank 244 , or the water fog fire suppressant may be provided by a source external to the modular computing environment 239 . A controller 248 may cause the chemical fire suppressant to be released based on input from the fire/smoke detectors 242 . As shown, a number of fire suppressant heads are shown along the top of the modular computing environment 239 ; in some implementations, more or fewer heads may provided. For example, a fog-based fire suppression 246 system may only include a small number of heads. In some implementations, the fire suppression system 246 may be arranged in a different manner; for example, each rack may include its own fire suppression subsystem. [0087] Human occupancy regulations may require exit lights 250 and certain ingress and egress parameters (e.g., number, placement and size of doors 258 a , 258 b ). A fresh air circulation system 252 , 254 may also be required to supply the interior of the modular computing environment 239 with fresh air at a certain rate (e.g., 500 CFM). [0088] Other systems may be included. For example, the modular computing environment 239 may include overflow drains 256 (e.g., to dispose of water that may enter the container or may leak, such as from cooling or sprinkler piping.). The overflow drains 256 may normally be sealed, but they may allow any appreciable amount of water or other liquid to drain. In some implementations, such overflow drains 256 may have a float-ball/cage construction, as shown. As another example, various electrical shielding may be provided to reduce or control the release of electromagnetic interface (EMI) or to meet Federal Communication Commission (FCC) regulations. Power filtering or conditioning circuitry may also be included to both protect power input to the modular computing environment 239 and to prevent noise generated within the modular computing environment 239 from being coupled into the external power grid. [0089] Additional systems may be included that are not shown in FIG. 2C . For example, the modular computing environment can include one or more dampers in collapsible/extendible firewalls (e.g., included in 252 and 254 ); fire rated expanding foam can be used to seal off cable, conduit or other firewall penetrations between compartments of the modular computing environment 239 ; an emergency power off feature can be included (e.g., a single button that can cause primary power (e.g., power to circuits other than emergency lighting)) to the modular computing environment to be disconnected; and other detectors and alarms can be provided (e.g, high temperature sensors and alarms, thermal runaway sensors and alarms, flood sensors and alarms, etc.). In some implementations, a flood sensor is coupled with a power-down controller that can gracefully power down processor boards and other systems within the modular computing environment. In addition, one of the doors (e.g., door 258 b ) can be designated as an emergency-only exit and can be equipped with an alarm that is triggered upon use; one or both of the doors 258 a and 258 b can be equipped with an emergency-compatible latch (e.g., a crash bar (not shown)). Still other features and systems may be included in the modular computing environment 100 in order to meet specific, local fire or safety codes or ordinances for deployments in which the modular computing environment 239 is or could be classified as an inhabitable or commercial structure. [0090] FIG. 3 a shows a plan view of a data center 300 , and FIG. 3 b shows a sectional view of the data center 300 from FIG. 3 a . Data center 300 is similar to data center 200 from FIGS. 2 a - 2 b . However, data center 300 is shown located in a larger space, such as in a fixed building. Because of the additional space in this layout, racks of trays, such as tray 320 , are mounted back-to-back on common warm-air plenums 310 , 312 . Air from plenums 310 , 312 is routed downward below a false floor and driven back into workspace 308 by fans, such as fan 322 , and through coils, such as cooling coil 324 . [0091] Again, an open platform 326 is provided on which workers in workspace 308 may stand when monitoring or maintaining computers in the racks, such as rack servers. The rack servers may run from the floor up to or near ceiling 304 , which may be a drop tile ceiling, for example, at a height of approximately 8 feet. The ceilings may also be much higher, such as if the plenums 310 , 312 are capped. [0092] In these figures, the racks are formed in bays having four racks for each bay, and a per-bay length of approximately 6 feet. Other rack arrangements may also be employed so as to fit the needs and dimensions of a particular data center implementation. [0093] The pictured implementation and similar implementations may provide for scalability of data center 300 . For example, additional rows of computer racks may be added in parallel, either to provide for a larger data center or to expand an existing data center. Relatively simple circulation units (such as those just described) may be installed under the racks and may require only water piping connections and electrical connections for operating the fans. Thus, those components also permit for simplified maintenance and installation of components for the system. For example, standardized components such as fan coil units may be manufactured and assembled at a central location and then shipped to a data center worksite for installation. In addition, worn or broken components may be removed and switched with newer components. Moreover, use of common components permits the operation of a data center with fewer replacement components on hand and also permits use of general stock components available from many manufacturers and distributors. [0094] Pressure sensors 309 , 311 may also be provided to control the operation of fans 322 . As shown, the pressure sensors 309 , 311 are shown mounted directly in an endwall of plenums 310 , 312 , so as to provide a differential pressure between a warm air plenum 310 , 312 and a workspace 308 , but may be located in other areas, and may be provided with extension tubing so that sensing taps may be placed in any convenient location. The sensors 309 , 311 may be used to control the system 300 in ways like those discussed above for sensors 209 , 211 in FIGS. 2A and 2B . For example, fans like fan 322 may be controlled to maintain a set pressure difference, such as zero, between the plenums 310 , 312 and the workspace 308 . [0095] FIG. 4 a shows a plan view of a data center 400 , and FIG. 4 b shows a sectional view of the data center 400 from FIG. 4 a . The data center 400 is similar to data center 300 shown in FIGS. 3 a - 3 b , but with the locations of the fan-coil units changed. Specifically data center 400 is configured to be located in a fixed building and to be expandable in manners similar to data center 300 . In addition, data center 400 , like data center 300 , includes pairs of racks having trays such as tray 420 (which may include, e.g., a computer motherboard and associated components), mounted back-to-back, separated by intervening workspaces such as workspace 408 . [0096] However, in data center 400 , fan 422 and coil 424 are mounted at the top of warm air plenum 412 , as are other fans and coils. In this arrangement, air may be expelled from the fans across the ceiling and need not turn as many corners as in the implementation of FIGS. 3 a - 3 b . In other implementations, fan 422 may push air through the coil 424 . Likewise, coil 424 may be located away from the racks so as to reduce the risk that water in the coil 424 will leak onto the racks. In addition, along the length of the racks, the fans and coils may point in alternating directions, so that some fans blow into the workspace to the right of a rack and some blow into the workspace to the left of the rack. [0097] Pressure sensors 409 , 411 may also be provided to control the operation of fans 422 . In the figures, the pressure sensors 409 , 411 are shown mounted within plenums 410 , 412 to sense the pressures in the plenums 410 , 412 , and are provided with tubed extensions that sense pressure in the workspace 408 . The sensors 409 , 411 may be used to control the system 300 in ways like those discussed above for sensors 209 , 211 in FIGS. 2A and 2B . [0098] FIG. 5 a shows a plan view of a data center 500 , and FIG. 5 b shows a sectional view of the data center 500 from FIG. 5 a . In this implementation, individual fan-coil units near each rack have been replaced with a single central unit in the middle of data center 500 . The air that has warmed by passing through the racks may be drawn upward through passages in the form of chimney 504 , into an attic space 506 . The chimney 504 may be in the form of a number of passages, such as round or rectangular ducts, or may be in the form of a passage that runs the entire length of a row of trays, or may take another appropriate form. Advantageously, the attic space may be naturally warm from the outdoor environment and from radiated heat transfer from the sun, so that little to no heat will be transmitted through the roof into the attic. In appropriate circumstances, the warmed air entering the attic 506 may be at a higher temperature than the outdoor temperature, and heat transfer may occur out of the attic, rather than in. [0099] Warm air is drawn from attic space 506 by supply fan 502 , which may be located above an area near the center of data center 500 . Locating fan 502 in attic space 506 may reduce the noise level transmitted from fan 502 into workspace 508 . Other sound insulation techniques may also be used such as by insulating the ceiling of workspace 508 . Such insulation may also provide thermal insulation that prevents heat from passing downward through the ceiling. [0100] Fan 502 may connect to a plenum 514 , such as a plenum that takes the place of a pair of back-to-back bays. The plenum 514 may be formed from an enclosure that seals the plenum 514 from adjacent racks. The sides of the enclosure may be covered with cooling coils such as coil 510 . Cooling water may be passed through cooling coil 510 under conditions like those discussed above. Cooling coils 510 may be sized and selected to have relatively shallow fins, so as to present a minimal pressure drop. Fan 502 may alternatively be located, for example, in the area taken up by plenum 514 in the figure. [0101] Mechanisms for obtaining outdoor air into the attic 506 or another area may also be provided. For example, motor-controlled louvers to the outdoors may be provided and may be caused to take in outside air when atmospheric conditions are favorable (e.g., low temperature and low humidity). Air filtering may be performed on incoming fresh air. Such fresh or outside air may be blended with heated, re-circulating air from the space also. The amount of such blending may be controlled electronically to produce desired temperature or other values in the space. In addition, separate air-conditioning units may also be provided to provide supplemental or spot cooling, and to remove any built-up latent heat. When operating in such an air-side economizing mode, exhaust fans may also be provided to remove, for example, heated air, and may be controlled via differential pressure sensors to coordinate their operation with other components in the system. In addition, appropriate filtration and humidity control may be provided for air entering a system from the outdoors. [0102] Heat transfer to cooling coil 510 may be improved where heat rise through the trays is high, and air-flow volumes are therefore relatively low. As a result, the volume of air moving through cooling coils 510 will also be relatively low, so that additional heat may be transferred from the warm air into the cooling water in cooling coil 510 . Protective panel 512 , such as a louver or a protective wire mesh screen, may be provided in front of cooling coil 510 to prevent workers from accidentally bending fins in the cooling coil. In addition, redirecting vanes (not shown) may be provided in plenum 514 to direct air laterally through cooling coils 510 , 512 . [0103] Pressure sensor 505 may also be provided to control the operation of fan 502 . In the figures, the pressure sensor 505 is shown mounted within plenum 506 to sense the pressure in the plenum 506 , and is provided with a tubed extensions that passes into the workspace to sense pressure in the workspace 408 . The sensor 505 may be used to control the system 500 in ways like those discussed above for sensors 209 , 211 in FIGS. 2A and 2B . [0104] FIG. 5 c shows a sectional view of another implementation of a data center. In this implementation, a number of fan coil units 534 are provided in an attic space 536 . The units may also be located, for example in a below floor, or basement, space. As in FIG. 5B , various racks of electronic equipment, such as rack 530 , deliver warm air into the attic 536 through various chimneys 540 . The chimneys 540 and fan coil units 534 may be positioned so as to avoid interfering with each other and to avoid unwanted pressure changes in the attic 536 or elsewhere. (In addition, basements may be used in a similar manner to attic 536 described here.) [0105] The fan coil units 534 may take any appropriate form, such as commercial fan coil units containing a standard cooling coil and a centrifugal or other form of fan. The fan coil units 534 may each be connected to supply air ductwork that empties into workspace 538 . The ductwork may, for example, terminate in diffusers of various forms. The supply ductwork from multiple units 534 may be interconnected to permit for switching or for redundancy if one unit goes down. [0106] One should understand that the units 534 may be laid out in two-dimensions in the attic, so that, for example, the leftmost unit in the figure is not blocking chimney 540 . Instead, it may be in front or behind of chimney 540 in the figure. A catwalk 532 may also be provided in attic 536 so as to provide more ready access to units 534 . Alternatively, or in addition, provisions may be made to service units 534 from workspace 538 . [0107] Pressure sensors 533 a - c may also be provided to control the operation of fans coil units 534 . In the figures, the pressure sensors 533 a - c are shown mounted within a fan coil cabinet, in a plenum or an exhaust tube for a plenum, and in the open attic plenum 536 to sense the pressures in the plenums 536 and are provided with tubed extensions that sense pressure in the workspace 538 . The sensors 533 a - c may be used to control the system 300 in ways like those discussed above for sensors 209 , 211 in FIGS. 2A and 2B . [0108] FIG. 6 is a flowchart showing actions for an exemplary operation of cooling components in a data center. In general, the depicted process 600 involves steps for adding computers to a rack-mount computer system, and to control the flow of air over those computers so as to maintain temperatures and temperature changes to permit energy-efficient operation of the system. [0109] At box 602 , an operator connects one or more rack-mount servers to a warm air plenum. Such actions may occur by sliding or rolling a pre-loaded rack into the plenum, such as by placing the rack in front of an opening in one wall of the plenum. Alternatively, a rack that is empty or partially full may be moved into location, and additional trays may be added to the rack. Where appropriate, additional steps may be taken to seal around the edges of the racks or the trays in a rack. For example, blanking panels may be provided where trays are missing from a rack so as to prevent short-circuiting of air into the warm air plenum at those locations. [0110] At box 604 , the servers are started, as is a fan-coil unit or multiple fan-coil units (which may include packaged units or combinations of fans and cooling coils that are not in a pre-built unit). Starting the servers may entail powering up the various components that support the microprocessors on the servers, including chipsets and hard drives. Each server may be started at the server itself, or may be powered up remotely such as from a central control unit. Operation of the fan-coil unit or units may occur through an HVAC control system that may be configured to sense various parameters related to the controlled environment of the data center and to regulate the operation of components, such as fans and pumps that operate to regulate temperature in a space or spaces. Where multiple fan coil units are employed, they may be located in a mezzanine or attic space, which may itself serve as a warm-air plenum, and may provide cooled air to a workspace. [0111] At box 606 , a new rack is added to a warm air plenum. For example, a blanking panel may initially be located over an open space in the plenum, the panel may be removed, and a rack loaded with trays may be slid into place and sealed against the plenum. That rack may then be connected appropriately, such as by providing a power connection from a central source of power, and a networking connection (or multiple connections). Upon making the necessary connections to the trays, such as server trays, and the rack, exhaust fans for pulling air over each tray and into the warm air plenum may also be started at this point, or may be provided power but may delay their start until a particular temperature for a tray is reached. The start-up of each tray may be controlled remotely or locally, as may the control of other components in the system. [0112] At box 610 , the speeds of exhaust fans serving the various trays may be controlled to maintain a particular exit temperature at each tray. The speeds may be selected to slow the airflow to a rate lower than would typically be used to cool electronic equipment. The temperature may be selected to produce a particular temperature rise across the computers, where the input temperature is known. For example, as noted above, if the temperature of a workspace is known to be approximately 25 degrees Celsius, then a temperature rise of 20 degrees Celsius may be maintained by holding the exhaust temperature to 45 degrees Celsius. [0113] At box 612 , a fan-coil unit may likewise be controlled to maintain a temperature for the workspace. As one example, the fan in a fan-coil arrangement may be modulated using sensors that measure a pressure differential between a warm-air plenum and a workspace, such as to maintain a 0.1 or 0.002 inch pressure difference between the spaces. The pumping rate of cooling water may then be modulated to maintain a set workspace temperature. Also, multiple controls may be aggregated and controlled from a central building management system. [0114] Where pumping cannot meet the load, additional cooling may be provided, such as from a chiller or similar cooling equipment. However, such supplemental cooling will generally not be required, and may only occur on particularly hot or humid days (in which a cooling tower alone cannot sufficiently cool the cooling water), or when load is particularly high. Other free cooling sources (i.e., for cooling with no or almost no chiller operation) or air-side economizer sources other than cooling towers may also be used, such as deep lake and ocean cooling. [0115] FIG. 7 shows plan views of two exemplary trays for use in a rack-mount computer system. Tray 700 a hosts a number of storage devices, such as fixed disk drives, while tray 700 b includes a computer motherboard holding various computing components. Both trays may be centered around circuit boards, or motherboards, that hold the various components, and on which may be formed conductive traces for electrically connecting the components. Other components may also be provided on the trays, such as supporting chip sets and various forms of connectors, such as SCSI or ATA connectors that may tie tray 700 a to tray 700 b. [0116] Referring now to each tray 700 a , 700 b individually, tray 700 a contains memory 724 near its front edge, as memory generates relatively less heat than do microprocessors 721 a , 721 b located downstream. The memory 724 may be located in line with the airflow so as to permit more flow over tray 700 a . In addition, network connection 722 may also be mounted at the front edge of tray 700 a so as to permit ready connection of the tray 700 a to other portions of a rack-mount system. An electrical connector (not shown) may also be provided on the front edge of the tray 700 a. [0117] Microprocessors 721 a , 721 b may be located below impingement fans 720 a , 720 b , in a manner similar to that discussed above. Supporting chip sets and other components may be located next to or near their respective microprocessor. [0118] Walls 726 a , 726 c channel airflow over tray 700 a , and through power supply 714 and fan 716 . As arranged, components that generate more heat are placed closer to the fan, as are components (like the power supply 714 ) that are less sensitive to high temperatures. [0119] Tray 700 b holds a number of hard drives 718 a - 718 c and is dedicated to storage. Because the hard drives 718 a - 718 c generate relatively little heat, tray 700 b is not provided with a fan. Although a power supply is not shown, so that tray 700 b may share power from another source, tray 700 b may also be provided with a power supply on its back edge. The power supply may be provided with a fan or may be allowed to run hot. [0120] Cable connections (not shown) may be provided between the hard drives 718 a - 718 c on tray 700 b and the components on tray 700 a . For example, standard ATA, SATA, or SCSI cable connections, or other appropriate cable connections, including high-speed custom cable connections may be used to permit high data rate transfers from hard drives 718 a - 718 c . Serial cable connections may provide for better airflow than may ribbon-type parallel cable connections. [0121] Trays 700 a , 700 b may take on a reduced-size form factor. For example, each of trays 700 a , 700 b may be approximately 19 inches in length and approximately 6 inches or 5 inches wide. Multiple trays may be part of a single motherboard or may be connected side-by-side to fit in a wider slot in a rack. In such a situation, each tray may be self-contained, with its own power supply and fan (as shown), or the trays may share certain components. Other similar sizes may also be employed so as to fit in existing rack systems. [0122] A number of embodiments have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosures in this document. For example, additional components may be added to those shown above, or components may be removed or rearranged. Also particular values for temperatures and other such values may be varied. Moreover, steps in processes may be rearranged, added, or removed as appropriate. Accordingly, other embodiments are within the scope of the following claims.

A system can include an enclosure having an exterior surface and an interior region that is characterized by a width and a length that is longer than the width; a plurality of trays mounted in racks that line a majority of each side of the length of the interior region and that define an aisle therebetween which is suitable for passage by one or more human occupants; cooling coils configured to capture heat generated by the plurality of trays and exhaust the heat outside the interior region; a plurality of connections on the exterior surface for supplying electrical power to the plurality of trays, supplying cooling fluid to the cooling coils, and for receiving cooling fluid discharged from the cooling coils; and doors at either end of the aisle configured and positioned to facilitate emergency egress from the enclosure by a human occupant.

[0001] This application claims priority to provisional application Ser. No. 60/287,646, filed Apr. 30, 2001, incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] The present invention relates generally to articles of clothing incorporating magnet units for use in magnetic therapy. [0003] The continued use of magnetic therapy to provide relief of pain and to increase the flow of blood has been well documented. Although this proven practice has been successfully utilized throughout many countries around the world, it has only been in recent years that magnetic therapy has rapidly been gaining support in the United States. [0004] Because of the effectiveness of magnetic therapy, many permanent magnetic products for providing magnetic therapy have been developed. Sports companies such as Nike and MacGregor Sports, as well as health care clinics nationwide, are selling magnetic health products. A good example of this is the golf-industry, which has become enamored of magnetic bracelets and wraps, touting their abilities to improve a golf game. In addition, there is an array of magnetic therapy products available to the consumer. These include golf gloves, sleep pads, wraps for various parts of the body (such as the knee, ankle, back, calf and wrist), headache and stress patches, nerve patches, eye strain clothes, magnetic jewelry, equine treatments for bruises, etc. [0005] Various patents have also been granted showing magnetic therapy devices. For example, U.S. Pat. No. 5,720,046, incorporated herein by reference, discloses various articles of clothing that include permanent magnets for therapeutic purposes. According to this patent, magnets are positioned in accordance with the ancient art of applied massage therapy known as Shiatsu. Shiatsu concentrates on specific areas of the body known to provide relief from pain, which are used by acupuncture and acupressure practitioners. [0006] Other patents show the use of permanent magnets used in conjunction with other devices. For example, U.S. Pat. No. 4,509,219 teaches a sleeping mattress structure provided with permanent magnets. Similarly, U.S. Pat. No. 4,921,560 teaches a method of affixing permanent magnets to bed covering. Each of these patents is also incorporated here in by reference. SUMMARY OF THE INVENTION [0007] The present invention recognizes and addresses various disadvantages of prior art constructions and methods. [0008] In accordance with the present invention, a portable Complex Magnetic Therapy Unit (“CMU”) is provided for use in specially designed articles of clothing and therapeutic wraps. Articles of clothing utilizing the CMU include sewn pockets necessary to contain the CMUs. The pockets are positioned at specific locations as called for in accordance with the present invention so as to provide therapeutic energetic pulsed signals to the cells that need to be revitalized. [0009] As a precisely developed magnetic therapy unit, the CMU may be used in therapeutic guidance for redesigned flow of magnetized particles throughout the body. Various articles of clothing utilizing the CMU are contemplated for wear by both humans and animals, such as dogs. Such articles include men's briefs, gloves, neck supports, sock-like garments and exercise suits. Each article incorporating one or more CMUs includes a precise placement structure and systematic design for optimal effect of each magnetic unit. [0010] Advantageously, the CMU is a unique; non-invasive, non-chemical device that can be used in the treatment and/or prevention of various conditions. For example, specific embodiments of the present invention may be used in the treatment of erectile dysfunction, magnetic field deficiency syndrome, carpal tunnel syndrome, arthritis and sports injuries, along with the loss of magnetism in cells within the body. The CMU is be scientifically placed in articles of clothing worn on the areas of the body corresponding with a predetermined relief system to revitalize and separate the mass of blood cells that clump together during a loss of magnetic influence in the ions and the protons within the body. [0011] In one embodiment of the present invention, the CMU is incorporated into a unique and effective glove. Utilizing Shiatsu meridian pressure points and acupuncture pressure points, the CMU is placed in precisely the locations of the hand and wrist to best distribute the ionized particles in the cells in this area of the body to effectively contain the deterioration of the cells traumatized in the affected area. [0012] Objects, features and aspects of the present invention are provided by various combinations and subcombinations of the disclosed elements, as well as methods of utilizing same, which are discussed in greater detail below. BRIEF DESCRIPTION OF THE DRAWINGS [0013] A full and enabling disclosure of the present invention, including the best mode thereof, to one skilled in the art is set forth more particularly in the remainder of the specification, including reference to the accompanying drawings, in which: [0014] FIG. 1 illustrates the manner in which blood cells clump together when magnetism in the body cells is low, compared to how the cells circulate freely on their own when exposed to a CMU constructed in accordance with the present invention. [0015] FIG. 2 diagrammatically illustrates the manner in which lines of standard magnetic energy flow from the North Pole to the South Pole on a continual basis. [0016] FIG. 3 illustrates the manner in which lines of magnetism flow as it is conducted by the CMU. The construction of the CMU is such that it allows and encourages the re-entry of magnetic energy into the part of the body exposed to the Unit. Re-entry in and around the affected part of the body requiring additional magnetic energy for healing is critical for cells to function at their optimum level. Re-energized cells can repair themselves and stabilize the healing process. [0017] FIG. 4A is a diagrammatic plan view of a preferred base unit of the CMU showing the wave magnetization pattern. [0018] FIG. 4B is a diagrammatic plan view of the base unit of FIG. 4A with insert units. [0019] FIG. 4C is a diagrammatic plan view of insert units 3 and 4 . [0020] FIG. 4D is a diagrammatic plan view of insert unit 2 with insert unit 4 located therein. [0021] FIG. 5 is front view of a male brief constructed in accordance with one embodiment of the present invention showing the placement of multiple CMUs. In this case, the briefs are standard length low-rise briefs and CMUs are placed at the following three locations: under the waistband, and on the left and right sides of the briefs. [0022] FIG. 6 is a back view of the brief of FIG. 5 . As can be seen, a pair of CMUs is placed below the waistband in two separate pockets. [0023] FIG. 7 shows the palm side of a user's hand in open position. Placement of magnets is shown as they will come in contact with the hand and wrist when a glove constructed in accordance with a preferred embodiment of the present invention is worn. [0024] FIG. 8 shows the same view of the open hand as in FIG. 7 with glove in place. In this embodiment, the finger portion of the glove extends over the knuckle of the finger and ends between the first and second joints on each finger. The glove extends back over the palm hand and over the wrist, extending 40 mm beyond the bend of the wrist. [0025] FIG. 9 illustrates a neck support garment containing CMUs in accordance with the present invention being worn about the neck of a user. In presently preferred embodiments, the neck support garment may be approximately five inches from top to bottom edge. The garment closes in the back using a suitable attachment mechanism, such as hook and pile fasteners (i.e., Velcro). [0026] FIG. 10 illustrates the neck support of FIG. 9 removed from the wearer's neck and opened to show a preferred placement for the multiple CMUs. [0027] FIG. 11 illustrates the neck support of FIG. 9 removed from the wearer's neck and closed with Velcro fastened in the back to show the placement of the CMUs when the garment is worn. [0028] FIG. 12 illustrates a sock-like garment containing CMUs in accordance with the present invention being worn on the foot and leg of a user. [0029] FIG. 13 shows the leg of the user wearing the sock-like garment of FIG. 12 illustrating a preferred placement of CMUs. [0030] FIG. 14 shows a preferred placement of CMUs in the sole of the sock-like garment of FIG. 12 . [0031] FIG. 15 illustrates an exercise suit containing CMUs in accordance with the present invention being worn on the body of a user. [0032] FIG. 16 is a view of the exercise suit of FIG. 15 showing elastic straps sewn into the inside of the suit (the straps would not be seen from the outside of the garment). The internal straps are separated into an upper unit 1 and a lower unit 2 which are fastened together with a suitable attachment mechanism such as hook and pile fastener (i.e., Velcro) to form a complete unit. The white spots on the straps indicate a preferred placement location for the individual CMUs. [0033] FIGS. 17A and 17B are enlarged front views of upper unit 1 and lower unit 2 of the exercise garment, respectively. The units are interconnected at Velcro attachment flaps FC 1 and FC 2 . [0034] FIGS. 18A and 18B are enlarged back views of upper unit 1 and lower unit 2 of the exercise garment, respectively. The units are interconnected at Velcro attachment flaps BC 1 and BC 2 . DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0035] It is to be understood by one of ordinary skill in the art that the present discussion is a description of exemplary embodiments only, and is not intended as limiting the broader aspects of the present invention, which broader aspects are embodied in the exemplary constructions. [0036] A. Overview of CMU Therapy [0037] It should be made clear that magnets themselves do not heal anything—they only stimulate the body to heal itself. Magnetism is a wholly natural event. It is neither magic nor medicine. It merely allows body cells to exist at their optimum level. [0038] In the treatment of sprains, strains, broken bones, burns and cuts, not only does magnetic field therapy aid in the recovery, but it allows these conditions to heal better, more quickly, and with less scar tissue. Magnetic treatment has been shown to decrease healing time by half or more. [0039] In the treatment of chronic conditions such as some forms of arthritis, degenerative joint conditions, diabetic ulcers and cancer, magnetic field therapy has shown dramatic results in aiding the reduction or reversal of the condition. [0040] Another effect of a magnetic field that is well documented and supported by the laws of physics is the enhancement of blood circulation and lymphatic drainage. The circulatory effect is documented in Faraday's Law and the Hall Effect, two long-accepted laws of physics that explain the principles by which the action of the magnetic polarities create ionic currents and patterns, which in turn increase the diameter of the blood vessels and ease the movement of the blood through those vessels. [0041] According to Dr. Buryl Payne, a physicist, psychologist, and inventor of the first biofeedback instruments, sensitive research instruments have allowed scientists to document some of the ways magnetic fields affect living organisms. Among them are: [0042] (1) Increased blood flow with resultant increased oxygen-carrying capacity, both of which are basic to helping the body heal itself. [0043] (2) Magnetic fields change migration of calcium ions which can either bring calcium to heal a broken bone, or can help move calcium away from painful arthritic joints. [0044] (3) The pH (acid/alkaline) of various body fluids (often out of balance in conjunction with illness or abnormal conditions) can apparently be altered by magnetic fields. [0045] (4) Hormone production from the endocrine glands can be either increased or decreased to normal levels by magnetic stimulation. [0046] As typical examples of specific effects created when a magnetic field is applied to the body, the following changes have been documented: (a) Electricity is generated in blood vessels; (b) Ionized particles increase in the blood; (c) Autonomic nerves are excited; and (d) Circulation is improved. [0051] B. Specification for Preferred CMU [0052] FIGS. 4A, 4B , 4 C and 4 D illustrate a preferred embodiment of a CMU constructed in accordance with the present invention. This exemplary CMU pattern has the following specifications: [0053] Magnet #1 Base Unit 47 mm long with rounded corners; 25 mm wide; 3 mm thick; 850 gauss rating. [0058] Magnet #2 16 mm round; Placed in base magnet 5 mm from outside edge; Open center; 6 alternating magnetized patterns (N and S poles) around surface of magnet; 600 gauss rating. [0064] Magnet #3 6 mm round magnet placed in the center opening of magnet #2; Will be North Pole facing up; 600 gauss rating. [0068] Magnet #4 6 mm round magnet placed in the base magnet 5 mm from outside edge; Will be North Pole facing up; 600 gauss rating. [0072] C. Male Brief for Erectile Dysfunction [0073] This article of clothing will be worn, on the lower torso of the male as underwear. The brief will replace the individual's normal underwear. Illustration of the briefs with measurements can be found in FIGS. 5 and 6 . [0074] Specifically, FIGS. 5 and 6 show exact placement of the CMUs into a preferred embodiment of the men's brief. As shown, a double pocket is preferably sewn into the brief 0.5 inch below the waistband. A CMU is placed into each of the cloth pockets which is then sewn closed on all four sides and down the middle section, separating the two CMUs. This keeps the CMUs in place. [0075] FIG. 5 also shows that two additional double cloth pockets are preferably sewn into the brief, one double pocket on each side of the brief. These double pockets look and act as two single pockets just as the ones below the waistband. The CMUs are sewn next to each other with stitching around the outside edges and down the middle, separating the two CMUs. The bottom edge of the sewn pockets is pointing down toward the crotch area of the brief, as shown. [0076] In accordance with one preferred construction, each of two pockets containing the CMUs on the left side of the brief extends 37 mm per pocket, making the length of the two pockets containing the CMUs a total of 74 mm. The bottom outer corner of the lower of the two pockets on the left side may preferably be 85 mm from the seam in the crotch area. [0077] In the illustrated embodiment, the double pockets on the right side of the briefs containing the CMUs extend 37 mm per pocket, making the length of the two pockets containing the CMUs a total of 74 mm. The bottom outer corner of the lower of the two pockets on the right side may preferably be 95 mm from the seam in the crotch area. [0078] As shown, each pocket contains one complete CMU in this case. [0079] In addition, the length of the brief on both the left and right outside leg portion may preferably be exactly 125 mm from the top of the waistband to the bottom of the sewn seam at the leg opening. [0080] In addition, the length of the brief from the top of the waistband down the middle of the brief to the center seam in the crotch area may preferably be exactly 250 mm on the front side of the briefs and 230 mm on the back side. [0081] D. Glove Including CMUs [0082] FIGS. 7 and 8 illustrate one preferred embodiment of a glove constructed in accordance with the present invention. The single dotted lines represent the location of the hand where fingers join the palm. The double dotted line represents the wrinkle that forms in the hand when the thumb is bent inward toward the fingers. [0083] In this case, a CMU should preferably be placed just inside the wrinkle line on the thumb, 35 mm from the seam line. Round magnets on the fingers are placed just above the bend line on the hand between the fingers and the palm. In accordance with a preferred embodiment, the units are 10 mm round and 800 gauss each. [0084] The CMU on the wrist may preferably be placed 10 mm behind the bend of the wrist where it connects with the palm. Moreover, the section of the glove extending over the wrist area should preferably be 40 mm long. [0085] As shown, the glove extends from the base of the palm over the knuckle to halfway down the finger, ending between the first and second joint. The fingertips are cut out of the glove, providing greater use of the hand. [0086] The glove may be used for positive pain relief for arthritis, carpal tunnel syndrome and sports injuries, as well as repetitive motion syndrome and other discomforts of the hand and wrist. [0087] E. Neck Support Containing CMUs [0088] FIGS. 9 through 11 illustrate a preferred embodiment of a neck support garment including CMUs in accordance with the present invention. The illustrated neck support is designed to give substantial support to neck sprains or pain. In a preferred embodiment, the neck support is approximately six inches from top to bottom in the front and decreasing to about 2¼″ in the back where the Velcro will fasten. In this case, three CMUs are placed evenly on both the left and the right sides in the front of the neck support. One CMU may preferably be placed on both the left and right sides in the back placed evenly between the top and bottom. In a preferred embodiment, the neck support may be constructed of neoprene, open in the back with a Velcro closure which is 2¼″ wide. [0089] F. Sock-Like Garment Containing CMUs [0090] Referring now to FIGS. 12 through 14 , a sock-like garment made according to a preferred embodiment of the present invention is illustrated. In this case, the garment may preferably be approximately 22″ long in tube form with no visible “foot or heel” section. On the left side of the sock, two (2) pockets may be sewn in, one above the other, for receipt of one CMU. (The user will place the single CMU in the pocket of choice.) Two (2) pockets are also sewn in, one above the other, on the right side of the sock for receipt of a single CMU in the user's pocket of choice. [0091] Preferably, each set of pockets in the sock-like garment will be directly above the ankle, with the first pocket being 30 mm above the ankle area. In such embodiments, the bottom of the second pocket may begin 20 mm above the top of the first pocket. Preferably, each of the pockets will be approximately 53 mm by 30 mm. [0092] The inner sole insert for the foot section of the sock-like garment will preferably be provided larger than needed to each purchaser so that it can be trimmed to fit the feet of that person. Preferably, the inner sole will be magnetized at a gauss rating of 800. In this regard, three (3) CMUs will preferably be placed in the following locations: (1) a first CMU may be placed 12 mm from the outside edge of innersole on the ball of the foot; (2) a second CMU will be placed in the center of the inner sole 35 mm from the point at which the edge of the first unit stops; and (3) a third CMU will be placed in the center of the inner sole 10 mm behind the second unit and 24 mm from the outside back edge of the inner sole. [0093] Preferably, the overall sock-like garment will-be made from a suitable cotton blend material. [0094] G. Exercise Suit Containing CMUs [0095] FIGS. 15 through 18 B illustrate a preferred form of an exercise suit incorporating CMUs in accordance with the present invention. In this case, the exercise suit is constructed as a two-piece suit having a top unit and bottom unit that connect in the middle in both the front and back via Velcro closures, or other suitable attachment means. [0096] In a preferred embodiment, the top piece of the suit has 3″ wide straps running over the shoulders from front to back and meeting in the middle in the front and in the back. The straps each contain CMUs that are preferably placed according to the diagrams in FIGS. 16 , 17 A-B and 18 A-B. As shown in FIG. 16 , the straps in the bottom (pant) unit of the exercise suit will continue down the sides of the legs and cross over in the front. [0097] While preferred embodiments of the invention have been shown and described, modifications and variations may be made thereto by those of ordinary skill in the art without departing from the spirit and scope of the present invention. In addition, it should be understood that aspects of the various embodiments may be interchanged both in whole or in part. Furthermore, those of ordinary skill in the art will appreciate that the foregoing description is by way of example only, and is not intended to be limitative of the invention so further described in such appended claims.

An article of clothing adapted to be worn on a wearer's body includes at least one complex magnetic therapy unit (CMU). The CMU is carried by the article of clothing so as to be positioned at a predetermined location on the wearer's body and thereby provide therapeutic effects.

RELATED APPLICATIONS [0001] This application is related to and claims priority from U.S. Provisional application 60/554,265 (filed 18 Mar. 2004). TECHNICAL FIELD OF THE INVENTION [0002] The present invention relates hairdryers and, more particularly, to an improved hairdryer in which the air intake is cleansed of dust particles with an electrostatic precipitator. BACKGROUND OF THE INVENTION [0003] It is known in the art to filter intake air into a hair dryer in order to cleanse the air, which is to be blown upon the head and face. Prior art filters have employed various direct filter medias of various densities. However, the coarse filters remove little dust and the fine filters interfere significantly with the airflow. A clogged filter can result in hairdryers that quickly overheat and, as a result, can cycle on and off during normal use. [0004] It is known in the art to utilize electronic precipitators to cleanse air in room air cleaners by charging airborne dust particles and then collecting these charged particles in a grounded filter medium. OBJECTS AND SUMMARY OF THE INVENTION [0005] It is an object of the present invention to provide a hairdryer that overcomes the shortcomings of known hair dryers mentioned above. These and other objects are achieved by the present invention described herein. [0006] The present invention avoids the problem of passive porous filters used in a hair dryer intake by employing an electronic precipitator to more efficiently remove air contaminants such as dust, smoke and pollen particles. The active filtration allows more efficient removal of airborne particles while reducing the resistance to the airflow. [0007] A charged screen can be employed at the air intake to ionize air upstream of a grounded, porous media, with a potential between the screen and media of at least 3 to 10 KV. The collection media can made of a number of alternative porous and conductive materials, such as a carbon-loaded plastic foam, metallized glass fiber or metallic foam. The electrical activation of the downstream media allows a much coarser filter pore to be used than in a passive media. Alternatively an array of metal plates or an expanded metal or woven screen can also be used as a dust collector. Dust collecting media or plates can be designed for easy removal for cleansing. [0008] An assembly of porous, dielectric foam sandwiched closely between opposing electrode screens can be used as the charging device and as a removable collecting cartridge. The proximity of the opposing electrical fields to the insulating filter media results in the dielectric material actively and efficiently collecting dust. [0009] Alternatively, a grounded media or collection screens can be used downstream of a high Voltage, ionizing point source or a similar array of point sources. With these or similar ionizing and collection structures, intake air to a hairdryer can be efficiently cleaned with considerably less resistance to the airflow through the dryer. [0010] The precipitator device can be designed to be switched on or off, and the device can also be switched selectively through various voltage levels to increase or decrease the amount of ionization and the filtering efficiency of the aircleaner. The insulation and electrode architecture is designed to avoid visible arcs or sparkovers. [0011] The high voltage generation can be accomplished with a number of well-known electronic circuits. Coil windings and piezo crystals can generate sufficient voltage. The high voltage generator can be housed within the dryer body, within the handle of the dryer, inside the filter structure, pendant on the dryer supply cord, or at the wall plug. The generator and leads to the precipitator can be wired into the dryer or they can be designed with the generator and power supply cord independent of the hairdryer so that the active filter can be sold as an optional add on to a conventional hairdryer. [0012] In addition, when the filter media does eventually become clogged with dust particles, the increased resistance will reduce the air intake. When the air volume is significantly reduced the dryer temperatures will climb. It is common to employ a “split circuit” in hairdryers, which switches out a large portion of the heater on a thermostat, while maintaining the dropping circuit to the motor. The present invention employs a neon light wired across the temperature-limiting thermostat of the split circuit, so that when the thermostat opens, the neon will see an increased current, sufficient to light, thereby indicating the need to clean the filter. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The present invention is more fully understood by reference to the following detailed description of an illustrative embodiment with the drawings identified below. [0014] FIG. 1 is an exploded view of the preferred embodiment of a hairdryer with and electronic precipitator on the air intake. [0015] FIG. 2 is a schematic illustration, as well as a cross section, of the preferred embodiment of the electronic precipitator assembly. [0016] FIG. 3 is an orthographic illustration and a partial section of an alternative electronic precipitator filter assembly. [0017] FIG. 4 . is an orthographic illustration and a partial section of a second alternative electronic precipitator filter assembly. [0018] FIG. 5 is a circuit diagram illustrating a neon lamp used as a warning indicator for a clogged air intake filter. DETAILED DESCRIPTION OF THE INVENTION [0019] Referring to FIG. 1 , the preferred embodiment of the present invention an improved hair dryer employing an electronic precipitator, is illustrated in an exploded schematic view. The device overall is made up of a handle and barrel housing ( 10 ), a removable filter assembly ( 2 ), a precipitator housing ( 4 ), a charging screen ( 1 ), a protective rear screen ( 3 ), a rear hairdryer housing ( 5 ), a fan ( 6 ), a motor mount ( 7 ), a motor ( 8 ), a heater assembly ( 9 ), a supply cord and strain relief ( 12 ), switches ( 11 ) and an indicator light ( 13 ). [0020] FIG. 2 is a closer view of the exploded precipitator assembly as well as a schematic view of the assembled assembly. Also shown in Figure two is a cross sectional view of the assembly. The assembly is made up of a protective cover ( 3 ), a precipitator housing ( 4 ), a charging screen ( 1 ) and a grounded filter ( 2 ). [0021] FIG. 3 shows an orthographic drawing of an alternative assembly of a removable filter ( 14 ) and a partial cross section of such a filter. The alternative construction employs a sandwich of charged metallic screens, a high voltage screen ( 15 ) and a grounded screen ( 16 ). Between the two charged screens is a pad of a porous, dielectric filter material ( 17 ) and an air gap ( 19 ). The screens mount and make electrical contact inside the hairdryer between two spring contacts ( 18 ). [0022] FIG. 4 illustrates an additional alternative embodiment of an electronic precipitator employed on the intake of a hairdryer. In this alternative the ionization and charging of the intake air is accomplished with a corona discharge off a highly tensioned needlepoint ( 20 ) which is located upstream of a grounded filter ( 2 ). [0023] FIG. 5 is an illustration depicting a circuit diagram for the preferred embodiment of the improved hairdryer that illustrates how a neon lamp ( 22 ) can be switched around a temperature limiting thermostat to indicate that the normally closed thermostat ( 21 ) is open. The thermostat will generally open due to overheating of the hairdryer as a result of a dirty intake filter. The lamp thus operates as a filter cleaning indicator and warning. Such a warning light will also, in addition, indicate other, generally significant problems, if cleaning the filter fails to eliminate the warning light. Such a warning light can be used with an electronic precipitator or alternatively with a passive filter system. [0024] While a preferred embodiment of the invention has been herein disclosed and described, it is understood that various modifications can be made without departing from the scope of the invention.

A hairdryer air intake is cleansed of dust particles with an electrostatic precipitator. The precipitator consists of a charging device ( 1 ) and a grounded filter media ( 2 ) that can be removed and cleaned. A warning lamp ( 13 ) indicates the need to clean the filter.

FIELD OF THE INVENTION [0001] The present invention relates to a ventilation system. Particularly, the present system relates to a ventilation system for the oxygenation of blood and the removal of blood carbon dioxide. More particularly, the present invention relates to systems for and methods for improving automated ventilation and/or long-term ventilation to optimise patient care. BACKGROUND OF THE INVENTION [0002] Certain medical procedures require the heart or lung of a patient to be kept still. This may be necessary in order for a surgeon to perform surgical procedures, such as cardiac surgery. While the heart is unable to circulate blood or the lung is unable to re-oxygenate blood or to remove carbon dioxide, heart-lung machines are used for life support, providing extracorporeal oxygenation to maintain a supply of oxygen to a patient. [0003] More recently, extracorporeal oxygenation has been explored for the management of viral infections (such as H1N1) that affect lung function by causing pulmonary embolisms. Patients suffering from such infections may require long-term ventilation, in the region of several weeks (typically 20 days, but in severe cases ventilation may be required for several months, e.g. for up to 180 days), in order to facilitate treatment and drainage of the lung, and in order to permit the lung to rest and heal while the patient's immune system is given an opportunity to defeat the viral infection. [0004] The present invention seeks to improve ventilation management. SUMMARY OF THE INVENTION [0005] In accordance with a first aspect of the invention, there is provided an oxygenation system for a ventilation system as defined in claim 1 . [0006] The oxygenation system comprises an inlet for receiving oxygenation gas at an oxygenation gas flow rate into an oxygenator, and an exhaust gas remover to remove exhaust gas at an exhaust gas flow rate from the oxygenator. The oxygenation system further comprises one or more flow controllers for controlling the exhaust gas flow rate relative to the oxygenation gas flow rate. [0007] A ventilation system is a system for extracorporeal oxygenation of blood, also known as a “heart-lung machine” or as an extra-corporeal membrane oxygenation (ECMO) system, which may be provided on a cart. A pump circulates the blood (heart function) and an oxygenator oxygenates the blood (lung function). Oxygen-depleted blood from a patient and oxygenation gas are received into the oxygenator. In the oxygenator, oxygen is taken up by the blood from the oxygenation gas, and carbon dioxide is released from the blood. The oxygenated blood is to be circulated back into the patient. [0008] The oxygenation gas that is to be supplied into the oxygenator may have been blended (mixed) so as to have a predetermined composition of oxygen (O2), nitrogen (N2), and air (compressed air provided by hospital supplies). Traces of carbon dioxide and noble gases may be in the oxygenation gas. [0009] In the oxygenator, blood haemoglobin releases carbon dioxide and may also release other gas such as waste anaesthetic gas. This gas is removed as exhaust gas through an oxygenator exhaust port. [0010] Either the flow rate of the oxygenation gas into the oxygenator, or the flow rate of the exhaust gas out of the oxygenator, or both, may be adjusted by a flow controller. A flow controller may be provided for controlling the oxygenation gas flow rate. A flow controller may be provided for controlling the exhaust gas flow rate. The flow controller may be a high precision mass flow controller (MFC). [0011] It will be understood that the oxygenation system may comprise means for determining the flow rate of one of the oxygenation gas or the flow rate of the exhaust gas, in order to determine by which amount the other of the flow rate of the respective other gas should be changed. [0012] For instance, the oxygenation gas flow rate may be adjusted first, to ensure sufficient oxygenation gas entering the oxygenator to facilitate oxygen saturation of the blood. The oxygenation gas flow rate is then maintained at a suitable flow rate. The exhaust gas flow rate is adjusted relative to the oxygenation gas flow rate. [0013] By being able to control the flow rate of the exhaust gas relative to the flow rate of the oxygenation gas, it is possible to determine with greater accuracy the amount of total gas entering the oxygenator and the amount of total gas removed from the oxygenator. [0014] Also, this facilitates calculations that require a parameter related to the flow rate, and/or facilitates such calculations with greater accuracy. Such a parameter may be the actual flow rate of the oxygenation gas, the actual flow rate of the exhaust gas, and/or a difference between the gas flow rates. [0015] In embodiments, the one or more flow controllers are configured to maintain a predetermined flow ratio of the exhaust gas flow rate to the oxygenation gas flow rate. [0016] In embodiments, the one or more flow controllers are configured to maintain the exhaust gas flow rate at a predetermined offset level above or below the oxygenation gas flow rate. [0017] By “maintaining” it is meant that the controllers are configured to be responsive to fluctuations in a gas flow rate. The gas flow rate may fluctuate for various reasons. For instance, the oxygenator may require a higher oxygen supply and a control unit may increase the supply of oxygenation gas by increasing the flow rate. A flow controller may be configured to adjust the exhaust gas flow rate in response to the increased oxygenation gas flow, so that the exhaust gas flow rate is set to a predetermined flow ratio or a predetermined offset. [0018] Likewise, the exhaust gas flow rate may be determined by a hospital vacuum supply. The strength of the vacuum supply may vary. An exhaust gas flow controller may adjust the exhaust gas flow rate in response to a fluctuation to maintain a predetermined flow ratio or a predetermined offset. [0019] As such, the oxygenation system may be regarded as a closed-loop control system that maintains the flow rates of the oxygenation gas and of the exhaust gas relative to the other. [0020] This may also facilitate calculations, and/or improve the accuracy of calculations, by allowing simplifying assumptions to be made based on a defined flow rate ratio and/or on a defined relationship between the oxygenation gas and the exhaust gas. The controller may adjust the flow rate to a constant value. The controller may adjust the ratio to a constant value. In practice, the constant behaviour may be set for a limited period of time during which parameters for inclusion in a calculation are measured. [0021] For instance, it may be possible to use sensors for determining the fraction of oxygen and/or carbon dioxide in a gas stream. From this, the amount of oxygen provided into the oxygenator and the amount of carbon dioxide withdrawn from the oxygenator can be determined, which, in turn, may provide an indication of the amount of oxygen taken up by the blood, and the metabolic activity of the patient. However, as the metabolic activity of a patient may change, the calculations can become complex if also a change of the gas flow rates has to be considered. Thus, the ability to make an assumption about the flow rates of the gas streams allows calculations to be carried out with greater accuracy. [0022] Thus, if the flow rate of the oxygenation gas relative to the flow rate of the exhaust gas is maintained at a pre-determined ratio or at a predetermined offset, this facilitates the calculation of the uptake of oxygen by blood and of the release of carbon dioxide from the blood. [0023] In embodiments, the one or more flow controllers are configured for maintaining the exhaust gas flow rate higher than the oxygenation gas flow rate. [0024] Oxygenators are not air tight. Although connections at the supply side (the inlet for oxygenation gas into the oxygenator) are usually air tight, the outlet side typically comprises secondary outlets or safety valves that are provided for fail-safe purposes in the event that a primary outlet becomes blocked. A typical reason for a blockage is condensation. Due to the presence of secondary outlets, however, if exhaust gas is withdrawn from the oxygenator at a lower flow rate than the oxygenation gas supply, any excess oxygenation gas may pass from the oxygenator into the operating theatre (theatre=operation room) environment. Oxygenators are, therefore, also referred to as being porous. [0025] If extracorporeal ventilation is used for a patient sedated by anaesthetic gas, e.g. during surgery, the anaesthetic may be circulated with the blood stream and may also be released by the blood inside the oxygenator. In that case, waste anaesthetic gas (WAG) may pass from the oxygenator, via one of its outlets, into the operating theatre. This may adversely affect clinical staff. [0026] The ability to maintain the exhaust gas flow rate at a higher rate than the oxygenation gas rate allows ensuring that all oxygenation gas supplied into the oxygenator, as well as any gas released by the blood inside the oxygenator, is drawn out of the oxygenator and prevented from passing into the operating theatre. [0027] In such scenarios, maintaining the exhaust gas flow rate at a predetermined ratio or at a predetermined offset above the oxygenation gas flow rate ensures that the waste anaesthetic gas removal continues in the event of gas flow fluctuations. [0028] Being able to ensure that all exhaust gas is drawn away via an exhaust line is also beneficial if it is desired to relate the amount of carbon dioxide in the exhaust gas to the amount of carbon dioxide released by blood in the oxygenator. [0029] In embodiments, the exhaust gas remover is vacuum-assisted to generate a vacuum-induced flow, to assist the removal of exhaust gas from the oxygenator. The flow generated over the oxygenator is, preferably, achieved at atmospheric pressure. In other words, there is no, or substantially no, pressure gradient across the oxygenator. However, preferably, the exhaust gas flow rate is larger than the oxygenation gas flow rate. This may also be referred to as flow gradient. [0030] Using a vacuum-induced flow gradient allows the flow rate of the exhaust gas to be maintained at a higher level than the oxygenation gas flow rate even if the oxygenation gas is supplied at a low flow rate. [0031] Furthermore, a flow gradient practically eliminates the risk of exhaust gas flowing back into the oxygenator and passing into the operating theatre. [0032] In embodiments, the flow controller is configurable to maintain the flow rate of the exhaust gas removed from the oxygenator above a pre-determined threshold. [0033] While the exhaust gas is withdrawn at a higher flow rate than the oxygenation gas supply, ambient air from the operating theatre may be drawn through any secondary outlets or valve configurations of the oxygenator into the exhaust gas stream. Particularly at low flow rates, exhaust gas has insignificant positive pressure to fully exit the exhaust port and leakage through the secondary exhaust ports is possible. In that case, it is difficult to relate the fraction of carbon dioxide in the exhaust gas to the carbon dioxide released by the blood, because the fraction of carbon dioxide can only be measured in a total volume comprising a volume of exhaust gas and an unknown volume of ambient air. [0034] However, by maintaining the flow rate of the exhaust gas above a pre-determined threshold, a minimum gas flow rate and, thereby, a minimum flow rate out of the primary outlet of the oxygenator can be ensured. The minimum flow rate can be set to a level that ensures complete removal of the exhaust gas via the primary outlet. [0035] If the fraction of ambient air drawn from the oxygenator with the exhaust gas is known, this allows an assumption to be made about the fractions of carbon dioxide in the exhaust gas originating from ambient air and the fraction released by the blood. For practical purposes, it can even be assumed that the carbon dioxide fraction in air is close to 0%, for the following reason. Carbon dioxide in air typically varies between 450 ppm and 600 ppm (ppm=parts per million). Typically, the fraction of carbon dioxide in the exhaust gas is between 1% and 10%, and so an error of 0.045 to 0.06% is negligible. However, the amount of ambient air drawn into the exhaust gas may vary considerably if the exhaust gas flow rate is not adjusted relative to the oxygenation gas flow rate. [0036] Furthermore, knowledge of oxygen consumption and carbon dioxide production provides an empirical basis for optimising the composition of the oxygenation gas and for optimising the flow rates into and out of the oxygenator. This allows the composition and/or flow rate to be adjusted according to the development of a patient and helps automating the oxygenation of a patient. This is believed to be particularly useful for long-term extracorporeal ventilation. [0037] In embodiments, the oxygenation system further comprises a processor and software instructions implemented by the processor, and the flow controller is controlled by processor. [0038] In accordance with a second aspect of the invention, there is provided a blender for preparing an oxygenation gas in accordance with claim 9 . [0039] The blender comprises a first inlet for receiving gases into the blender, a blending unit for blending the gases into an oxygenation gas, a holding unit for storing the oxygenation gas after blending, an outlet to supply the oxygenation gas to an oxygenator; and a flow controller for controlling the flow rate of the oxygenation gas from the holding unit through the outlet. [0040] Oxygenation gas is typically blended from gases supplied on site, e.g., from a hospital gas supply port, to provide a desired composition or ratio of oxygen in air in the oxygenation gas. This blending process is carried out in a blending unit of a blender. The hospital-supplied gases will be provided at a given flow rate, and it is difficult to reduce the gas flow from the hospital ports below a given minimum flow rate. Furthermore, in order to achieve required mix accuracy, it may be necessary to feed hospital-supplied gases into the blending unit at a minimum flow rate. For this reason, an oxygenation gas blended from hospital-supplied gases will, in the absence of a flow controller, leave the blender at a flow rate that is influenced by the minimum flow rate of the hospital-supplied gases. [0041] A flow controller downstream of the blending unit allows the flow rate of the oxygenation gas to be adjusted to a flow rate that is lower than the sum of the flow rates of the gases blended into an oxygenation gas. More specifically, before passing through the flow controller, the oxygenation gas is buffered in a reservoir to facilitate blending. If, for any reason, more gas is blended than can be stored in the reservoir, gas that is not passed through the flow controller may be vented as excess gas into the atmosphere. [0042] The flow controller allows the output flow rate of the oxygenation gas to be set at a flow rate outside the range achievable by the blending unit. [0043] This allows the oxygenation gas to be provided at a low flow rate, while also ensuring that the components making up the oxygenation gas have been thoroughly mixed in the blender. [0044] The oxygenation gas is supplied into an oxygenator of a ventilation system. A low flow rate facilitates a flow gradient out of the oxygenator if this is intended to be combined with an exhaust gas remover withdrawing exhaust gas at a higher flow rate than that of the oxygenation gas. [0045] The embodiments of the second aspect are, therefore, directly related to embodiments of the first aspect. Embodiments of the first aspect and the second aspect may be combined. Such embodiments may be used to improve control of the flow gradient over an oxygenator in order to maintain a higher exhaust gas flow rate relative to the oxygenation gas flow rate, while also maintaining a low flow rate of the exhaust gas. [0046] For instance, a flow-controlled blender may be combined with a vacuum-assisted exhaust line in order to optimise (a) the supply of oxygenation gas at low, constant flow rates at or near atmospheric pressure, (b) the withdrawal of exhaust gas at low, constant flow rates, and (c) the maintaining a sufficient flow gradient across the oxygenator at these low flow rates, or to optimise two of (a), (b), and (c). [0047] In practice, the oxygenation gas may be supplied through the flow controller at a flow rate slightly above the required flow rate. The flow controller may be configured to bleed a marginal flow rate, e.g. in the region of 0.1 L/min, to fine-tune the required flow rate as required. However, there may be a minimum flow rate required to pass through the flow controller. For instance, it may not be possible to provide oxygenation gas below a flow rate of 1 L/min. In that case, the full difference to the required flow rate may be vented. E.g., if oxygenation gas is supplied to the flow controller at 1.0 L/min, but required at the oxygenator at only 0.6 L/min, the flow controller may vent 0.4 L/min. [0048] Thus, oxygenation gas can be provided into the oxygenator within accurate flow rate margins despite being provided at low flow rates. [0049] Embodiments may further comprise one or more sensors to measure one or more properties of the oxygenation gas indicative of its flow rate, composition, pressure, temperature, oxygen fraction, carbon dioxide fraction, or combination of two or more of these properties. [0050] This allows properties of the oxygenation gas, after blending, to be determined. Counter measures can be taken if a property is not within predetermined parameters. [0051] Also, these parameters may be used to improve the accuracy calculations to determine the amount of oxygen taken up by the blood or the amount of carbon dioxide released by the blood. [0052] In embodiments, at least one sensor is configured to measure said property downstream of the flow controller. [0053] In embodiments, at least one sensor is configured to measure said property upstream of the flow controller. [0054] This allows properties of the oxygenation gas to be determined after the flow has been adjusted by the flow controller, or before this has been adjusted, respectively. If, for any reason, the flow rate or composition of the oxygenation gas is not within predetermined parameters, countermeasures may be taken. [0055] In embodiments, the blender is configured to determine the difference between a property measured upstream of the flow controller and a corresponding property measured downstream of the flow controller, and to provide a signal if the difference exceeds a pre-determined threshold. [0056] This provides a safety mechanism in case a property of the oxygenation gas is outside predetermined parameters. The signal may be in a form suitable for alerting a staff member. The signal may be an audible signal or a visual signal. The signal may be a machine-interpretable instruction to carry out a responsive action. [0057] Embodiments may comprise a second inlet downstream of the flow controller and a bypass switch configured to receive gas from the second inlet. [0058] Although the present invention contemplates blending the oxygenation gas and adjusting the flow so as to be able to provide oxygenation gas at a predetermined flow rate, it may be desirable to bypass the blending unit and the flow controller of the blender, e.g., for testing or maintenance purposes. [0059] The gas for the second inlet may, for instance, be provided by a mechanical gas blender or by a flow-controlled emergency backup gas. [0060] This also allows for failsafe operation in case of a system failure or power loss in either of the blending unit or the flow controller. By way of the failsafe mechanism, a continuous supply of oxygenation gas can be ensured. [0061] In embodiments, the bypass switch is configured for activation to receive gas from the second inlet if the difference exceeds a pre-determined threshold. [0062] If, after the oxygenation gas was prepared in the blending unit and its flow was adjusted by the flow controller, the parameters of the oxygenation gas are outside predetermined parameters, the bypass switch allows the supply of oxygenation gas to be switched to the second inlet. [0063] In accordance with a third aspect of the invention, there is provided an oxygenation system for a ventilation system in accordance with claim 17 . [0064] The oxygenation system comprises an inlet for receiving oxygenation gas into an oxygenator and a low-pressure sub-system configured for connection to an external vacuum supply port. The low-pressure sub-system is configured to generate flow for removing exhaust gas from the oxygenator. The low-pressure sub-system is further configured for connection (a) to a venous drainage line and to generate a pressure gradient to assist blood removal via the venous drainage line, and/or to (b) to a hemo-concentrator and to generate a pressure gradient to assist the blood-concentrating by the hemo-concentrator. [0065] Typically, an oxygenator comprises a reservoir into which blood from a patient is collected via a venous drainage line before being circulated to the oxygenator. This facilitates a continuous blood circulation through the oxygenator. Being able to apply a pressure gradient induced by a vacuum allows the drainage reservoir to be positioned at any height relative to the patient. However, hospital facilities may not always provide sufficient vacuum supply connectors. Retro-fitting vacuum supply connectors may not be an available option. Thus, hospital facilities with a single vacuum supply may not be suitable for treatment requiring a plurality of vacuum supply connectors is required. [0066] It is understood that by “vacuum” supply, a supply of low pressure suitable to generate a pressure gradient below standard atmospheric pressure is meant. [0067] In such scenarios, if the available vacuum supply ports are required for critical systems, e.g. for waste anaesthetic gas removal, it may be necessary to ensure positioning of a venous drainage reservoir at a lower altitude than (i.e., below) a patient to ensure drainage. This impedes the manufacture of integrated systems. [0068] Likewise, if every available vacuum supply port is used by a more critical system, it may not be possible to use a hemo-concentrator. [0069] Providing a vacuum sub-system that generates a vacuum-induced flow for an oxygenator and a pressure gradient for venous drainage facilitates the integration of a venous drainage system. This reduces the reliance on multiple vacuum supply ports. [0070] Providing a vacuum sub-system that generates a vacuum-induced flow for an oxygenator and a pressure gradient for blood concentration facilitates the integration of a hemo-concentrator. This reduces the reliance on multiple vacuum supply ports. [0071] Embodiments of the third aspect may be combined with any of the embodiments of the first and second aspects, and combinations thereof. [0072] This allows the vacuum usage to be better coordinated between multiple systems, e.g., by using a single hospital vacuum port to supply an exhaust gas removal line, a venous drainage line and/or a hemo-concentrator. BRIEF DESCRIPTION OF THE FIGURES [0073] Exemplary embodiments of the invention will now be described with reference to the Figures, in which: [0074] FIG. 1 shows a schematic layout of components of a ventilation system in accordance with an embodiment of the invention; [0075] FIG. 2 shows a schematic illustration of a reservoir for use with a ventilation system in accordance with an embodiment of the invention; [0076] FIG. 3 shows a schematic flow analysis for the FIG. 2 reservoir; [0077] FIG. 4 shows an oxygenator of a ventilation system in accordance with an embodiment of the invention; [0078] FIG. 5 shows a schematic flow analysis for the FIG. 4 ventilation system; [0079] FIG. 6 shows a gas blender for use with a ventilation system in accordance with an embodiment of the invention; [0080] FIG. 7 shows a flow chart of the blender gas supply in accordance with an embodiment of the invention; and [0081] FIG. 8 shows a flow chart of the vacuum-assisted gas removal in accordance with an embodiment of the invention. DETAILED DESCRIPTION Components Overview [0082] FIG. 1 provides an overview of system components of a ventilation system of the present invention. By way of background, an oxygenator is a device configured to receive oxygenation gas and venous blood, to re-oxygenate the blood by exposure to the oxygenation gas, and to provide oxygenated blood as arterial blood. Unused oxygenation gas is vented as exhaust gas which will also carry any gas given away by the blood. Put simply, a pulmonary (blood) bypass loop crosses a gas (oxygen) circulation loop. The pulmonary bypass loop circulates blood from a patient in order for the blood to be oxygenated and to be returned to the patient. The gas circulation loop provides the oxygenation gas for blood oxygenation. Pulmonary Bypass Loop (Blood) [0083] Venous blood from a patient (not shown in FIG. 1 ) is circulated in the direction indicated by arrow 12 towards a reservoir 10 via a venous line V. From the reservoir 10 , the venous blood is pumped by a pump 13 in the direction indicated by arrows 14 towards an oxygenator 20 . In the oxygenator 20 , the blood is oxygenated. Blood leaves the oxygenator 20 to be supplied, as arterial blood, via an arterial line A in the direction indicated by arrow 16 towards a patient. A flow sensor 18 is provided to measure the flow rate of the re-oxygenated blood exiting the oxygenator 20 . A temperature sensor 22 is provided to measure the temperature of the re-oxygenated blood exiting the oxygenator 20 . Water lines 21 connect the oxygenator 20 to a water bath for maintaining a predefined temperature. Oxygenation Gas Circulation/Supply Line [0084] A gas circulator 35 comprises a blender 30 for preparation of oxygenation gases and a vacuum subsystem 40 for removal of exhaust gases. [0085] Gases, such as nitrogen (N2) and oxygen ( 02 ) of predetermined purity levels are supplied from hospital supply lines 32 into a gas mixer 52 of the blender 30 . Compressed air with a composition of about 79% nitrogen and 21% oxygen may be supplied. Hospital-supplied gases may contain traces of carbon-dioxide and/or noble gases. The hospital mains also provide a source of low pressure or vacuum. The hospital supplies may also include oxygenation gas of a predetermined composition or oxygen at a predetermined purity level, which may be supplied via a supply line 57 to the blender 30 . [0086] In the blender 30 , the gases are mixed to a composition that is to be supplied to the oxygenator 20 and fed in the direction indicated by arrow 34 via a supply line 24 . In the oxygenator 20 , the haemoglobin molecules of the venous blood are to take up oxygen and to release carbon dioxide. In the oxygenator 20 , other gases, such as waste anaesthetic gases, may be released from or not be taken up in the oxygenator. Any gases released in or passing through the oxygenator 20 and gas components not taken up from the inlet gas are collected as waste gas or exhaust gas and leave the oxygenator 20 via an exhaust line 26 in the direction of arrow 36 and are transported away. The gas flow via the exhaust line 26 is assisted by a vacuum subsystem 40 that is part of the gas circulator 35 . Components Operation [0087] The operation of the reservoir 10 , the oxygenator 20 , the blender 30 and the vacuum subsystem 40 will now be described in more detail with reference to FIGS. 2, 3, 4, 5, 6, 7 and 8 . Reservoir 10 [0088] Venous blood from a patient is collected in a cardiotomy reservoir (reservoir 10 ), shown in more detail in FIGS. 2 and 3 . Blood drainage from a patient into the venous line V is improved by the vacuum-assisted venous drainage (VAVD) line 28 . As indicated in FIG. 3 , a pressure gradient 38 applied via the drainage pressure line 28 improves the drainage of blood via venous line V independent of the altitude of the reservoir 10 relative to a patient. Oxygenator 20 [0089] Venous blood carrying CO2 and waste anaesthetic gas (WAG) enters the oxygenator 20 via venous line V (in direction 14 ), as shown in detail in FIGS. 4 and 5 . Venous blood enters the oxygenator 20 in a condition indicated herein by the symbol BI. In particular, the blood transports an amount of oxygen BIO2 and an amount of carbon dioxide BICO2 per unit of time. [0090] FIG. 4 illustrates the uptake of oxygen by the blood in the oxygenator 20 . The venous blood is transported within the oxygenator 20 along line 15 and exposed to the gas mixture, inlet gas GI from the blender 30 , that is transported along the line 25 . The gas mixture GI has a higher oxygen partial pressure and a lower carbon dioxide partial pressure than the haemoglobin in the blood, causing the haemoglobin to release CO2 and take up O2. Although FIG. 4 indicates, schematically, a concurrent exchange, oxygenators use, in practice, a countercurrent exchange. [0091] FIG. 5 illustrates a flow diagram. In the oxygenator 20 , CO2 is released from the blood into the gas stream, as indicated by arrow 42 . The blood stream takes up O2 in a reaction indicated by arrow 44 . Other components, such as waste anaesthetic gas, may not be taken up by the blood and enter or remain in the exhaust gas stream as indicated by arrow 46 . Oxygenated blood is referred to as arterial blood. Blood is assumed to remain in the oxygenator for long enough to reach equilibrium oxygen saturation, so blood exiting the oxygenator via arterial line A in direction 16 is saturated with oxygen. I.e., the oxygen supplied with the oxygenation gas exceeded the oxygen-carrying capacity of the haemoglobin molecules in the blood. [0092] The oxygenator 20 is not an air-tight unit. It may comprise one or more secondary exhaust ports 27 as a failsafe measure, to avoid pressure build-up within the oxygenator 20 if the exhaust line 26 is blocked. As or if a vacuum-induced flow is applied via exhaust line 26 , this draws, therefore, not only exhaust gas GE from the oxygenator 20 , but also ambient air 48 via secondary exhaust ports 27 . To provide an illustrative example, for every 2 L of gas mixture supplied into the oxygenator 20 via supply line 24 , 2.1 L of exhaust gas may be drawn through exhaust line 26 . [0093] The difference in flow rates that causes ambient air 48 to be drawn into the oxygenator 20 can also be used to ensure that any waste anaesthetic gas 46 is removed via the exhaust line 26 . Thus, waste anaesthetic gas 46 is prevented from seeping out of the oxygenator 20 , as indicated by arrows 49 , into the operating theatre, where anaesthetic gases could affect staff. [0094] Arterial blood leaves the oxygenator 20 in a condition BE. The amount of oxygen of the arterial blood BEO2 is related to the arterial oxygen saturation SaO2 and also depends on the haemoglobin concentration in the blood. [0095] Exhaust gas GE which carries components released from the blood, such as CO2 from transfer 42 or waste anaesthetic gas that has not been taken up inside the oxygenator 20 , is drawn via exhaust line 26 towards the vacuum sub-system 40 of gas circulator 35 . Blender 30 [0096] In FIG. 6 , the blender 30 is drawn enlarged as part of the gas circulator 35 . Gas components supplied via inlets 32 are mixed to provide a supply gas for the oxygenator 20 . The processing steps in the blender 30 are set out in FIG. 7 . Hospital-supplied gases 32 are fed first into a gas mixer 52 , and then passed through a flow control 54 , a failsafe control 56 , and sensors 58 , before being supplied via supply line 24 to the oxygenator 20 . Gas Mixer 52 [0097] The gas mixer 52 comprises a mixing chamber into which component gases are received via an inlet and mixed to an oxygenation gas. The mixing chamber constitutes a blending unit in which the component gases are blended into an oxygenation gas. The mixing chamber also constitutes a holding unit or reservoir in which component gases may homogenise. The gas pressure may be controlled via a back pressure regulator. Excess gas may be vented into the atmosphere. From the mixing chamber of the gas mixer 52 , the oxygenation gas passes through the blender flow control 54 . Blender Flow Control 54 [0098] The blender flow control 54 allows the flow rate of the gas mixture, the oxygenation gas, to be adjusted to a pre-determined flow rate. The blender flow control 54 controls the flow rate of the oxygenation gas from the holding unit, or mixing chamber, and thus constitutes a flow controller of the invention. This allows the amount of gas supplied to the oxygenator to be set, and allows this to be used in the calculation of oxygenation-related parameters. [0099] A flow control unit in the blender allows the flow rate of the gas mixture to be set to low rates after it has been mixed as required. This improves the accuracy of the composition particularly at low flow rates, which are preferred in pulmonary systems. [0100] It is difficult to achieve a good quality mixture of the oxygenation gas when throttling the flow rate of the hospital-supplied gas. Thus, to obtain an accurate mixture, the hospital-supplied gas is fed at a suitably high flow rate. The flow control therefore addresses the problem of how to obtain an accurately mixed oxygenation gas, while also providing the oxygenation gas to the oxygenator 20 at a low flow rate. [0101] To illustrate this with an example, both oxygen and nitrogen may be supplied at 1.05 L/min. A 50%/50% mixture of these two gases would create a volume flow of 2.1 L/min (1.05 L/min+1.05 L/min=2.1 L/min). If, for instance, it is desired to supply only 2.0 L/min oxygenation gas to the oxygenator, the excess of 0.1 L/min (2.1 L/min−0.1 L/min=2.0 L/min) is vented, or “bled”, into the atmosphere. Any suitable mixing ratios may be used in practice. Failsafe Control 56 [0102] The failsafe control 56 provides an additional safety feature, by providing an option to switch to an external gas supply 57 . In particular, the failsafe control 56 may be responsive to the gas mixer 52 , the blender flow control 54 , and/or sensors 58 , and is configured to switch to the external gas supply 57 oxygen in the event one of the gas mixer 52 or the blender flow control 54 fail to provide oxygenation gas of pre-determined composition or flow rate. [0103] The gas supplied via the external gas supply 57 may be pure oxygen. The gas supplied may be provided by a mechanical blender, or an emergency backup gas supply. Sensors 58 /Output Measurement [0104] The sensors 58 are configured to measure parameters of the supply gas mixture. The parameters include the flow rate of the gas mixture, the pressure of the gas mixture, the temperature of the gas mixture, the oxygen concentration, the carbon dioxide concentration, or combinations thereof. [0105] The values obtained by the output measurement can be checked against expected values and countermeasures can be taken in the event of any discrepancy. For instance, the flow rate as determined by sensors 58 can be compared to the flow rate set by the blender flow control 54 . In the event of any discrepancy, countermeasures can be taken. Countermeasures include the generation of a notification signal, the increase or decrease of the flow rate by the blender flow control 54 , or the switching to an external gas supply 57 by the failsafe control 56 . [0106] The sensors 58 allow the composition, pressure, temperature, and flow rate to be monitored regardless of the source, e.g., whether this is from gas mixer 52 or from an external gas supply 57 . [0107] The oxygenation gas of known properties leaves the blender 30 via an outlet to be supplied to the oxygenator 20 . Vacuum Subsystem 40 [0108] Vacuum may be used to create a flow gradient to assist gas flow. The vacuum pressure gradients are controlled by a vacuum subsystem 40 which in turn is supplied from a single vacuum supply, e.g. from a hospital. [0109] The flow gradient in the exhaust line 26 is indicated by arrow 36 and pulls exhaust gas from the oxygenator 20 to the gas circulator 35 . As indicated, the vacuum subsystem also generates and applies a pressure gradient in the direction indicated by arrow 38 in the drainage line 28 connecting the reservoir 10 to the gas circulator 35 . The vacuum subsystem 40 may also provide a pressure gradient for the operation of a hemo-concentrator. [0110] As illustrated in FIG. 8 , the vacuum subsystem 40 comprises a WAG sensor 60 for the measurement of waste anaesthetic gas, and an exhaust flow control 62 . The exhaust flow control 62 constitutes a flow controller of the invention and allows the flow of the exhaust gas GE drawn into exhaust line 36 to be determined or controlled. For example, this allows the amount of ambient air 48 that may be drawn into exhaust line 36 via oxygenator 20 to be modulated. Preferably, the flow rate of the exhaust gas relative to the flow rate of the oxygenation gas is controlled by one or both of the blender flow control 54 and the exhaust gas flow control 62 . [0111] To illustrate this with an example, supply gas GI may be supplied to the oxygenator 20 at a rate of 2 L/min. The rate of 2 L/min may be set in the blender 30 by flow control 54 and monitored by one of sensors 58 . The exhaust flow control 62 may be set to a flow rate of 2.1 L/min. Thus, it can be assumed that, absent any influences by the blood oxygenation processes, 0.1 L/min (0.1 L/min=2.1 L/min exhaust gas−2.0 L/min inlet gas) of ambient air were drawn in via the oxygenator. [0112] The vacuum subsystem 40 further comprises a vacuum pressure control 64 providing for the controlled depressurisation of the cardiotomy reservoir in order to improve the drainage of patient blood into the extracorporeal bypass. [0113] Optionally, the vacuum subsystem 40 may generate a pressure gradient for use by a hemo-concentrator. The optional hemo-concentrator functionality is indicated in FIG. 8 by a dashed line. To this end, the vacuum sub-system comprises a vacuum pressure control 70 for a hemo-concentrator line 72 . A hemo-concentrator is a device for extracting fluid from the blood, and is used, typically at the end of a surgical intervention, to remove excess fluid from the blood without removing wasting blood cells. This is achieved by a selectively permeable membrane between the blood and an outer chamber. The selectively permeable membrane is permeable for excess fluid but retains blood cells, and so the removal of fluid results in a relatively higher concentration of blood cells in the blood after removal of fluid. A vacuum-assisted pressure differential is applied via a hemo-concentrator line 72 creating a flow in the direction of to the outside in order to assist the removal of fluid. [0114] All vacuum lines may comprise a mechanical pressure limit protection. This may be used to set a maximum positive (or upper) pressure close to atmospheric pressure. This may be used to set a maximum negative (or lower) pressure to prevent the building up of a pressure gradient across the oxygenator 20 in the event of a valve failure. [0115] Pressure sensors may be provided to measure the pressure of the flow lines, the vacuum lines, and/or at vacuum connections. If a pressure value measured by one of these sensors is outside a predetermined threshold, e.g. outside a safe pressure range, a notification signal may be generated. For instance, the pressure of the hospital supply lines 32 and/or 57 may be monitored and the flow rates may be adjusted by blender flow control 54 and/or exhaust flow control 62 , to maintain a predetermined flow rate or flow ration independent of any fluctuations. [0116] Likewise, if the vacuum supplying the vacuum-assisted venous drainage fails, a notification signal may be generated that the drainage may need to be effected by other means than an assisted drainage, e.g., by positioning the reservoir below a patient. [0117] The combination of the blender 30 and the vacuum sub-system 40 in a gas circulator 35 facilitates the integration of sensor and the evaluation of measured properties of the oxygenation gas and the exhaust gas (e.g., flow rate, pressure, temperature, composition, oxygen fraction, carbon dioxide fraction, and combinations thereof). [0118] Furthermore, this facilitates taking into account certain maintenance functions. For instance, condensation may build up on a gas/blood membrane inside an oxygenator. In order to remove condensation, the gas flow of the oxygenation gas into the oxygenator may be moderately increased to blow out the condensation. The increased gas flow to blow out condensation is referred to as “sighing”. [0119] The gas circulator 35 may comprise, or be connected to, a controller that is configured to carry out a sighing procedure in regular intervals/at regular frequencies, or dependent on the flow rate. The parameters for sighing may be programmable into the controller. [0120] Automating the sighing procedure by coordinating the oxygenation gas flow rate and the exhaust gas flow rate reduces the likelihood of condensation occurring and blocking the exhaust port of the oxygenator 20 . This increases the period of time during which the oxygenation system may be operated without supervision. [0121] The saturation of the arterial blood leaving the oxygenator 20 via line A may be measured by an oxygen sensor. Using calculations not specified herein, a determination can be made whether or not blood is fully (100%) saturated. During normal operation, the oxygenation gas flow rate is maintained to ensure 100% blood saturation. [0122] However, over time, efficiency of an oxygenator may decline due to antibody (blood protein) build-up at the gas/blood membrane, clogging the gas/blood membrane and reducing the gas exchange capacity of the membrane. This may reduce blood oxygenation to below 100%. However, blood oxygenation may be reduced for other, e.g., medical, reasons. In order to determine whether a declining blood oxygenation is due to an oxygenator efficiency drop, the oxygenation gas flow rate may be temporarily and gradually reduced so as to reduce the blood oxygenation below the saturation value. Once this value has been determined, the oxygenation gas flow rate is increased to maintain full saturation. [0123] The saturation value can be monitored over time. A decline in blood oxygenation may be indicative of an efficiency loss, and helps determining the oxygenator life span. This allows the replacement of oxygenators, or components such as its membrane, to be scheduled. Furthermore, if the efficiency loss occurs more rapidly than anticipated in view of comparable systems, this may be indicative of a catastrophic oxygenator failure. Thus, if a rapid efficiency loss is determined, a notification signal may be generated. [0124] Although the gas supply 32 and 57 is described herein as being provided by a hospital, this is exemplary for a typical setting. The gas supply may be provided by another source. Any number and type of supply gases may be used, according to requirements.

An oxygenation system for a ventilation system comprises an inlet for receiving oxygenation gas at an oxygenation gas flow rate into an oxygenator, and an exhaust gas remover to remove exhaust gas at an exhaust gas flow rate from the oxygenator, and one or more flow controllers for controlling the exhaust gas flow rate relative to the oxygenation gas flow rate. This allows the amount of total gas entering the oxygenator and the amount of total gas removed from the oxygenator to be controlled with greater accuracy.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 U.S.C. §119 to Japanese Patent Application No. 2008-003810 filed on Jan. 11, 2008. The entire disclosure of Japanese Patent Application No. 2008-003810 is hereby incorporated herein by reference. BACKGROUND OF THE INVENTION Field of the Invention The present invention generally relates to a game program, and more specifically to a game program for realizing a game of causing a character to release a moving object. In addition, the present invention relates to a game device allowed to execute the game program, and a game control method controlled by a computer based on the game program. A variety of video games have been conventionally proposed. The video games are executed in a game device. For example, a game device generally includes a monitor, a game console, and an input unit (e.g., a game controller). Here, the game console is provided separately from the monitor. The input unit is provided separately from the game console. A plurality of input buttons are arranged on the game controller. Also, a portable game device includes a game console, a liquid-crystal display (LCD) monitor, and input units (e.g., a plurality of input buttons). In this case, the LCD monitor is arranged in the approximately center part of the game console. The input units are arranged on the both sides of the LCD monitor. There are various types of baseball video games. For example, in some baseball video games, a game player selects a baseball team and operates baseball player characters of the selected team by operating a game controller. The baseball team selected by the game player competes with an opponent team for getting scores. Also, in some baseball video games, a baseball match is automatically performed, and a game player enjoys the match as the manager of a baseball team. An example of the former typed baseball video game is software for PLAYSTATION® 3, “Pro Yakyu Spirits 4” of Konami Digital Entertainment Co., Ltd. on sale in Apr. 1, 2007. In the baseball video game, when a game player operates a baseball player character with a game controller while one's baseball team takes an offensive/defensive position, the game player is capable of causing a baseball player character to throw/hit a ball object. For example, when a game player operates a pitcher character with the game controller, the game player is required to give the pitcher character a command of releasing the ball object along a desired pitching trajectory through the game controller. In this case, the game player generally selects a pitching trajectory that a batter character is bad at hitting the ball object. Then, when an opponent game player moves a cursor of a bat of the batter character for determining a ball-hitting point, a ball-hitting zone is displayed in a small size in the pitching trajectory that the batter character is bad at hitting the ball object. On the other hand, the ball-hitting zone is displayed in a large size in a pitching trajectory that the batter character is good at hitting the ball object. Based on the information (i.e., the ball-hitting zone's size), the game player operating the pitcher character is capable of distinguishing whether the batter character is good at or bad at hitting the ball object in a pitching trajectory. In conventional baseball video games, when a game player operates the pitcher character (i.e., a first character), the game player is capable of distinguishing whether or not the batter character (i.e., a second character) is bad at hitting the ball object in a pitching trajectory based on the ball-hitting zone's size. Therefore, a game player tends to often select a pitching trajectory that the batter character is bad at hitting the ball object for the purpose of making the batter character out. In this case, operation of the pitcher character tends to be monotonous. Accordingly, a game player may not feel amused for operating the pitcher character. Also, if the game player operating the pitcher character recognizes a pitching trajectory that the batter character is bad at hitting the ball object, the pitcher character comes to easily make the batter character out. Thus, the game player operating the pitcher character will be in more advantageous position than the other game player operating the batter character. In order to solve the problem, the following system is installed in the above-mentioned baseball video game. The system reduces the extent that a batter character is bad at hitting the ball object in a pitching trajectory. According to the system, if the game player operating a pitcher character often selects a pitching trajectory that a batter character is bad at hitting the ball object, the extent that the batter character is bad at hitting the ball object in the pitching trajectory will be gradually reduced. Therefore, it becomes difficult for the pitcher character to make the batter character out. Accordingly, advantageous level for the pitcher character will be reduced. In this way, imbalance of the baseball video game is to be solved between the pitcher character and the batter character. Thus, the system is installed in the conventional baseball video game for reducing the extent that a batter character is bad at hitting the ball object in a pitching trajectory (i.e., an element that a batter character comes to be used to a pitching trajectory that the batter character is bad at hitting the ball object). Because of this, if a game player operating a pitcher character wants to effectively make a batter character out, the game player is required to give a pitcher character a command of pitching while considering the pitching trajectory. On the other hand, in the real baseball, a pitcher may make a batter out by changing ball velocity in every pitching. In this case, whether or not the pitcher is capable of making the batter out depends on whether the batter is accustomed to the fast ball or the slow ball. In other words, whether or not the pitcher is capable of making the batter out depends on the batter's adaptability level for velocity of the ball released by the pitcher. As described above, the element that the batter character comes to be used to a pitching trajectory has been installed in the conventional baseball video games. However, the conventional baseball video games do not evaluate the element that the batter character comes to be used to velocity of the ball object released by the pitcher character. Therefore, in the conventional baseball video games, a game player operating the pitcher player has not given the pitcher character a command of pitching while considering velocity of the ball released by the pitcher character. In other words, the game player operating the pitcher character has not been required to give the pitcher character a command of pitching while having a pitcher's feeling in the real baseball. Accordingly, aspects of the present invention have been created to solve the above-mentioned problems occurring in the conventional practice, and to enable a game player to have a real world's sport player's feeling in a video game by changing a property of a second character in accordance with a property of a moving object to be released by a first character. SUMMARY OF THE INVENTION According to a first aspect of the present invention, a game program is for causing a computer to realize the following functions, and the computer is capable of realizing a game for causing a character to release a moving object. The functions are: (1) A character display function for displaying a first character and a second character on an image display unit. (2) A character property recognition function for causing a control unit to recognize second character's property data corresponding to a property of the second character. (3) A character property display function for displaying a property indicator for informing the property of the second character on the image display unit based on the second character's property data. (4) A moving object property recognition function for causing the control unit to recognize moving object's property data corresponding to a property of the moving object to be released by the first character. (5) A moving object display function for displaying the moving object released by the first character on the image display unit by causing the control unit to issue a command for causing the first character to release the moving object. (6) A character property change function for causing the control unit to change the second character's property data based on the moving object's property data after the moving object released by the first character is displayed on the image display unit. (7) A character property re-recognition function for causing the control unit to re-recognize the changed second character's property data. (8) A character property redisplay function for redisplaying the property indicator on the image display unit based on the changed second character's property data. According to the game program, in the character display function, the first character and the second character are displayed on the image display unit with the first character's image data and the second character's image data. In the character property recognition function, the second character's property data corresponding to a property of the second character is recognized by the control unit. In the character property display function, the property indicator for informing the property of the second character is displayed on the image display unit with property indicator's image data based on the second character's property data. In the moving object property recognition function, the moving object's property data corresponding to the property of the moving object to be released by the first character is recognized by the control unit. In the moving object display function, the moving object released by the first character is displayed on the image display unit with the moving object's image data by causing the control unit to issue a command for causing the first character to release the moving object. In the character property change function, the second character's property data is changed by the control unit based on the moving object's property data after the moving object released by the first character is displayed on the image display unit. In the character property re-recognition function, the changed second character's property data is re-recognized by the control unit. In the character property redisplay function, the property indicator is redisplayed on the image display unit with property indicator's image data based on the changed second character's property data. For example, when a baseball video game is executed with the present game program, a pitcher character and a batter character are displayed on the image display unit with pitcher character's image data and batter character's image data. Then, the batter character's property data is recognized by the control unit. Here, the batter character's property data corresponds to a property of the batter character (e.g., batter character's adaptability with respect to velocity and variation of the ball object). Then, the property indicator for informing a batter character's property is displayed on the image display unit with the property indicator's image data based on the batter character's property data. Then, the ball object's property data corresponding to a property of the ball object to be released by the pitcher character (e.g., velocity or variation of the ball object) is recognized by the control unit. Then, when a command for causing the pitcher character to release the ball object is issued by the control unit, the ball object released by the pitcher character is displayed on the image display unit with the ball object's image data. Then, when the ball object released by the pitcher character is displayed on the image display unit, the batter character's property data is changed by the control unit based on the ball object's property data. Accordingly, the changed batter character's property data is re-recognized by the control unit. Then, the property indicator is redisplayed on the image display unit with the property indicator's image data based on the changed batter character's property data. In this case, when the ball object released by the pitcher character is displayed on the image display unit, the batter character's property data is changed by the control unit based on the ball object's property data corresponding to velocity or variation of the ball object, for instance. Accordingly, the property indicator is redisplayed on the image display unit with the property indicator's image data based on the changed batter character's property data. As described above, according to the first aspect of the present invention, when the ball object is released by the pitcher character, it is possible to evaluate the batter character's adaptability with respect to velocity or variation of the ball object depending on velocity or variation of the released ball object. Generally speaking, this means that it is possible to evaluate the second character's (i.e., batter character's) adaptability with respect to the moving object's (i.e., the ball object's) property by setting a second character's property to be changed depending on a property of the moving object released by the first character (i.e., the pitcher character). Also, it is possible to inform the batter character's adaptability with respect to velocity and variation of the ball object released by the pitcher character and the like by displaying the property indicator on a pitching-to-pitching basis. Also, a game player is capable of judging a condition of the opponent second character's (i.e., the batter character's) adaptability by watching the property indicator displayed on a pitching-to-pitching basis. Also, a game player is capable of giving the pitcher character a command of pitching while judging a condition of the batter character's adaptability, and is capable of acquiring a variety of pitching methods. When a game player is capable of acquiring a variety of pitching methods, the game player is capable of effectively making the batter character out. Accordingly, the game player will reconfirm amusement of the baseball video game. Generally speaking, this means that a game player is capable of effectively acquiring a method of giving the first character a command, and reconfirms amusement of the video game. Furthermore, according to the present invention, the batter character's adaptability is changed depending on velocity, variation, and the like of the ball object released by the pitcher character. Therefore, a game player will give the pitcher character a command of pitching while considering velocity, variation, and the like of the ball object to be released. Accordingly, a game player is capable of experiencing a feeling of a real baseball pitcher releasing a ball toward a batter in the video game. Generally speaking, this means that a game player is capable of experiencing a feeling of a real world's athlete in the video game. For example, it is possible to set the property indicator to be a line-shaped velocity indicator. Here, it is possible to set a portion of the property indicator to be thick for associating the thick portion with high adaptability of the batter character (i.e., batter character's accustomed ball velocity). Here, the pitcher character (i.e., game player) is capable of confirming that a batter character hits the ball object with high possibility when the game player gives the pitcher character a command of releasing the ball object at velocity corresponding to the thick portion of the property indicator. In other words, watching the property indicator makes it possible for a game player to preliminarily judge risky velocity of the ball object to be released by the pitcher character (i.e., risky portion of the property indicator). A second aspect of the present invention relates to the game program of the first aspect. The game program of the second aspect is related to causing a computer to further realize the following function. (9) A character motion display function for displaying a series of second character's motions on the image display unit by causing the control unit to issue a command for controlling the second character's motion. According to the game program, in the character motion display function, a series of second character's motions are displayed on the image display unit with the second character's image data by causing the control unit to issue a command for controlling the second character's motion. Also, in the moving object display function, the moving object released by the first character is displayed on the image display unit with the moving object's image data by causing the control unit to issue a command for causing the first character to release the moving object based on an input signal from an input unit. For example, when a baseball video game is executed with the present game program, a series of batter character's motions are displayed on the image display unit with the batter character's image data by causing the control unit to issue a command for controlling the batter character's motion. Also, the moving object released by the pitcher character is displayed on the image display unit with the moving object's image data by causing the control unit to issue a command for causing the pitcher character to release the moving object based on an input signal from the input unit. In this case, the batter character's motion is controlled by the control unit, and the pitcher character's motion is controlled based on a game player's command. Specifically, the batter character's motion is controlled based on an artificial intelligence (AI) program while the pitcher character's motion is controlled based on a game player's command. Therefore, when a game player operates a pitcher character, the game player is capable of grasping adaptability of a batter character controlled by the AI program on a pitching-to-pitching basis by watching the property indicator. Accordingly, the game player is capable of acquiring a pitching method in a match-up game with the AI program. Also, a game player is capable of effectively making the batter character out. Generally speaking, this means that a game player is capable of effectively acquiring a method of giving the first character a command. Here, the above-mentioned AI program is prepared for causing the control unit to automatically issue a variety of commands in the baseball video game. A third aspect of the present invention relates to the game program of the first aspect or the second aspect. The game program of the third aspect is related to causing a computer to further realize the following function. (10) A character property non-display function for causing the control unit to issue a command for clearing the property indicator displayed on the image display unit when the moving object released by the first character is displayed on the image display unit. According to the game program, in the character property non-display function, the command for clearing the property indicator displayed on the image display unit is issued by the control unit when the moving object released by the first character is displayed on the image display unit. For example, when a baseball video game is executed with the present game program, a command for clearing the property indicator displayed on the image display unit is issued by the control unit when the ball object released by the pitcher character is displayed on the image display unit. In this case, when the ball object is released by the pitcher character and the ball object is displayed on the image display unit, display of the property indicator on the image display unit will be prohibited. According to the third aspect, when the ball object is released by the pitcher character, non-display of the property indicator is performed. Thus, a game player is capable of easily viewing the ball object hit by the batter character. Accordingly, a game player is capable of concentrating subsequent play after the ball object is released by the pitcher character. Generally speaking, this means that a game player is capable of concentrating the game by performing non-display of the property indicator when the property indicator is not necessary. A fourth aspect of the present invention relates to the game program of one of the first to third aspects. The game program of the fourth aspect is for causing a computer to further realize the following function. (11) A data association function for causing the control unit to execute processing of associating the second character's property data and the moving object's property data. According to the game program, in the data association function, processing of associating the second character's property data and the moving object's property data is executed by the control unit. Here, in the character property change function, the second character's property data corresponding to the moving object's property data is changed by the control unit after the moving object released by the first character is displayed on the image display unit. For example, when a baseball video game is performed with the present game program, processing of associating the batter character's property data and the ball object's property data is executed by the control unit. Then, the batter character's property data corresponding to the ball object's property data is changed by the control unit after the ball object released by the pitcher character is displayed on the image display unit. In this case, it is possible to change the batter character's property data in conjunction with the ball object's property data by causing the control unit to execute processing of associating the batter character's property data and the ball object's property data. Accordingly, a game player operating the pitcher character is required to give the pitcher character a command of pitching while having tension of a real baseball's pitcher. Therefore, a game player is capable of effectively acquiring a pitching method. Generally speaking, this means that a game player is capable of effectively acquiring a method of giving the first character a command. A fifth aspect of the present invention relates to a game program of one of the first to fourth aspects. The game program of the fifth aspect is related to causing a computer to further realize the following function. (12) A change frequency recognition function for causing the control unit to recognize change frequency of the second character's property data. According to the game program, in the change frequency recognition function, change frequency of the second character's property data is recognized by the control unit. Here, the second character's property data is changed by the control unit based on weighted data corresponding to the moving object's property data and change frequency after the moving object released by the first character is displayed on the image display unit. For example, when a baseball video game is executed with the present game program, change frequency of the batter character's property data is recognized by the control unit. Then, the batter character's property data is changed by the control unit based on the weighted data corresponding to the ball object's property data and change frequency after the ball object released by the pitcher character is displayed on the image display unit. In this case, the batter character's property data is changed by the control unit based on the weighted data corresponding to change frequency of the ball object's property data and that of the batter character's property data. For example, as change frequency of the batter character's property data is increased, weight for the batter character's property data is increased. Accordingly, the batter character's adaptability for velocity, variation, and the like of the ball object is evaluated. Thus, the batter character's property data also reflects the change frequency and the weighted data corresponding to it. Accordingly, when the ball object of 150 km/h is released a plurality of times, a portion of the property indicator corresponding to 150 km/h is displayed with thickness greater than that when the ball object of 150 km/h is released only once. Also, when the ball object of 120 km/h is released once after the ball object of 150 km/h is released three times, thickness of the portion of the property indicator corresponding to 150 km/h is not restored to the default thickness but is slightly reduced. In addition, thickness of a portion of the property indicator corresponding to 120 km/h is increased by a predetermined amount corresponding to a single pitch. In this example, thickness of portions of the property indicator corresponding to 150 km/h and 120 km/h are increased, and the property indicator in this condition is displayed on the television monitor 20 . Here, thickness of the portion of the property indicator corresponding to 150 km/h is greater than that corresponding to 120 km/h. Accordingly, it is possible to more realistically evaluate the batter character's adaptability with respect to velocity, variation, and the like of the ball object. Generally speaking, this means that it is possible to more realistically evaluate the second character's property with respect to the moving object's property. A sixth aspect of the present invention relates to a game program of one of the first to fifth aspects. In the game program of the sixth aspect, second character's property data corresponding to second character's property having a plurality of levels. This is realized in the character property recognition function. In the moving object property recognition function, moving object's property data corresponding to moving object's property having any one of a plurality of levels is recognized by the control unit. In the character property change function, the second character's property data corresponding to the moving object's property data recognized by the control unit is changed by the control unit after the moving object released by the first character is displayed on the image display unit. For example, when a baseball video game is executed with the present game program, the batter character's property data having a plurality of levels is recognized by the control unit. Here, the batter character's property data corresponds to the batter character's adaptability with respect to velocity, variation, and the like of the ball object. Also, the ball object's property data corresponding to velocity, variation, and the like of the ball object of one of the plurality of levels is recognized by the control unit. Also, the batter character's property data corresponding to the ball object's property data recognized by the control unit is changed by the control unit after the ball object released by the pitcher character is displayed on the image display unit. In this case, the ball object's property data corresponding to velocity, variation, and the like of the ball object of a predetermined level is recognized by the control unit. Then, the better character's property data corresponding to the ball object's property data of a predetermined level recognized by the control unit is changed by the control unit after the ball object released by the pitcher character is displayed on the image display unit. Accordingly, it is possible to cause the control unit to change the batter character's property data corresponding to the batter character's adaptability depending on velocity, variation, and the like of the ball object released by the pitcher character. Specifically, when velocity of the ball object released by the pitcher character is 150 km/h, it is possible to change the batter character's property data for enhancing the batter character's adaptability with respect to the ball object of 150 km/h. Generally speaking, this means that it is possible to evaluate the second character's adaptability with respect to the moving object's property. Also, a game player is capable of effectively acquiring a method of giving the first character a command when giving the first character a command while confirming the second character's adaptability by watching the property indicator. Accordingly, a game player is capable of experiencing a feeling of a real world's athlete in the game. A seventh aspect of the present invention relates to a game program of the sixth aspect. In the game program of the seventh aspect, second character's property data corresponding to the moving object's property data recognized by the control unit is changed by the control unit after the moving object released by the first character is displayed on the image display unit. Then, second character's property data of the rest of the plurality of levels excluding the level of the second character's property data corresponding to the moving object's property data recognized by the control unit is changed by the control unit based on the second character's property data corresponding to the moving object's property data recognized by the control unit. These are realized in the character property change function. For example, when a baseball video game is executed with the present game program, batter character's property data (i.e., main-property data) corresponding to the ball object's property data recognized by the control unit is changed by the control unit after the ball object released by a pitcher character is displayed on the image display unit. Then, batter character's property data of the rest of the plurality of levels (i.e., sub-property data) excluding the level of the batter character's property data corresponding to the ball object's property data recognized by the control unit is changed by the control unit based on the batter character's main-property data. In this case, the batter character's main-property data and the batter character's sub-property data are changed by the control unit. Especially, the batter character's sub-property data is changed by the control unit based on the batter character's main-property data. Accordingly, it is possible to change the batter character's property data of a plurality of levels depending on velocity, variation, and the like of the ball object released by the pitcher character. Specifically, when velocity of the ball object released by the pitcher character is 150 km/h, it is possible to change the batter character's property data for enhancing batter character's adaptability with respect to the ball object of 150 km/h. Also, it is possible to change the batter character's property data for setting the batter character's adaptability with respect to the ball object of any velocity excluding 150 km/h to be lower than the batter character's adaptability with respect to the ball object of 150 km/h. Generally speaking, this means that it is possible to more realistically evaluate the second character's adaptability with respect to the moving object's property. Also, when giving the first character a command while confirming the second character's adaptability by watching the property indicator, a game player is capable of effectively acquiring a method of giving the first character a command. Accordingly, a game player is capable of experiencing a feeling of a real world's athlete in the game. An eighth aspect of the present invention relates to the game program of the sixth aspect or the seventh aspect. The game program of the eighth aspect is related to a computer to further realize the following function. (13) A level setting function for causing the control unit to set all of the levels of the second character's property so as to make the number of levels of the second character's property equal to or greater than the number of levels of the moving object's property. According to the game program, in the level setting function, all of the levels of the second character's property are set by the control unit so as to make the number of levels of the second character's property equal to or greater than the number of levels of the moving object's property. For example, when a baseball video game is executed with the present game program, all of the levels of a batter character's property is set for making the number of levels of the batter character's property equal to or greater than the number of levels of the ball object's property. In this case, a game player is capable of confirming batter character's adaptability with respect to velocity, variation, and the like of the ball object by watching a property indicator, even if arbitrary values are set for velocity, variation, and the like of the ball object released by a pitcher character. Accordingly, a game player is capable of giving a pitcher character a command of pitching while watching the property indicator to be displayed on a pitching-to-pitching basis. Furthermore, a game player is capable of acquiring a variety of pitching methods. Generally speaking, this means that a game player is capable of effectively acquiring a method of giving the first character a command. A ninth aspect of the present invention relates to the game program of one of the first to eighth aspects. The game program of the ninth aspect is related to causing a computer to further realize the following function. (14) A moving object property display function for displaying a mark for informing the second character's property data corresponding to the moving object's property data recognized by the control unit on the property indicator. According to the game program, in the moving object display function, the mark for informing the second character's property data corresponding to the moving object's property data recognized by the control unit is displayed on the property indicator with mark's image data. For example, when a baseball video game is executed with the present game program, a mark for informing the ball object's property data recognized by the control unit (e.g., ball velocity and variation of breaking ball) is displayed on a property indicator. Note that the ball velocity will be hereinafter used as a representative of the ball object's property data recognized by the control unit. Here, the mark will be displayed on a corresponding portion of the property indicator when the ball velocity is replaced by the batter character's property data. Thus, when a game player refers to the mark displayed on the property indicator when selecting a pitch before causing a pitcher player to release a ball object, the game player is capable of grasping a batter character's accustomed velocity level by watching the corresponding portion of the property indicator. Also, a game player is capable of simultaneously confirming velocity of a currently selected pitch by watching the same property indicator. Thus, a game player is capable of easily comparing a batter character's accustomed portion (e.g., ball velocity) and a game player's currently selecting portion (e.g., ball velocity). Therefore, a game player is capable of promptly selecting velocity of the ball object released by a pitcher character and the like without any erroneous operation. A tenth aspect of the present invention relates to a game device. The game device is capable of executing a game for causing a character to release a moving object. The game device includes: character display means for displaying a first character and a second character on an image display unit; character property recognition means for causing a control unit to recognize second character's property data corresponding to a property of the second character; character property display means for displaying a property indicator for informing the property of the second character on the image display unit based on the second character's property data; moving object property recognition means for causing the control unit to recognize moving object's property data corresponding to a property of the moving object to be released by the first character; moving object display means for displaying the moving object released by the first character on the image display unit by causing the control unit to issue a command for causing the first character to release the moving object; character property change means for causing the control unit to change the second character's property data based on the moving object property data after the moving object released by the first character is displayed on the image display unit; character property re-recognition means for causing the control unit to re-recognize the changed second character's property data; and character property redisplay means for redisplaying the property indicator on the image display unit based on the changed second character's property data. An eleventh aspect of the present invention relates to a game control method. The game control method is executed by a computer being capable of realizing a game for causing a character to release a moving object. The game control method includes the steps of: displaying a first character and a second character on an image display unit; causing a control unit to recognize second character's property data corresponding to a property of the second character; displaying a property indicator for informing the property of the second character on the image display unit based on the second character's property data; causing the control unit to recognize moving object's property data corresponding to a property of the moving object to be released by the first character; displaying the moving object released by the first character on the image display unit by causing the control unit to issue a command for causing the first character to release the moving object; causing the control unit to change the second character's property data based on the moving object's property data after the moving object released by the first character is displayed on the image display unit; causing the control unit to re-recognize the changed second character's property data; and redisplaying the property indicator on the image display unit based on the changed second character's property data. As described above, according to the present invention, the second character's property is changed depending on the property of the moving object to be released by the first character, and the second character's adaptability with respect to the moving object's property is accordingly evaluated. Also, according to the present invention, a game player is capable of effectively acquiring a method of giving the first character a command, and will reconfirm amusement of the game. Furthermore, a game player is also capable of having an athlete's feeling of the real world in the game. BRIEF DESCRIPTION OF THE DRAWINGS Referring now to the attached drawings which form a part of this original disclosure: FIG. 1 is a block diagram for illustrating a basic configuration of a video game device in accordance with an embodiment of the present invention; FIG. 2 is a functional block diagram for illustrating an example of the video game device; FIG. 3 is a table for illustrating relations among levels, velocity, and velocity adaptability data; FIG. 4 is a table for illustrating relations among levels, velocity data of a ball object, and velocity adaptability data; FIGS. 5( a ) and 5 ( b ) are diagrams for explaining overview of an ability indicator; FIG. 6 is a table for illustrating relations between change-frequency data and weighted data; FIGS. 7( a ) to 7 ( c ) are diagrams for illustrating detail of the ability indicator; FIG. 8 is a schematic flowchart for illustrating the entire flow of a baseball video game; FIG. 9A is a flowchart for illustrating an ability informing system in a baseball video game; and FIG. 9B is a flow chart for illustrating an ability informing system in a baseball video game. DETAILED DESCRIPTION OF THE EMBODIMENTS Selected embodiments of the present invention will now be explained with reference to the drawings. It will be apparent to those skilled in the art from this disclosure that the following descriptions of the embodiments of the present invention are provided for illustration only and not for the purpose of limiting the invention as defined by the appended claims and their equivalents. Configuration and Operation of Game Device FIG. 1 illustrates the basic configuration of a game device in accordance with an embodiment of the present invention. As an example of a video game device, a home video game device will be hereinafter explained. The home video game device includes a home video game console and a home television set. A recording medium 10 is configured to be allowed to be loaded in the home video game console. Game data is arbitrarily read out of the recording medium 10 and a game is executed. The content of the game executed herewith is displayed on the home television set. The game system of the home video game device is made up of a control unit 1 , a storage unit 2 , an image display unit 3 , an audio output unit 4 , and an operation input unit 5 . These units are connected to each other through a bus 6 , respectively. This bus 6 includes an address bus, a data bus, a control bus, and the like. Here, the control unit 1 , the storage unit 2 , the audio output unit 4 , and the operation input unit 5 are included in the home video game console of the home video game device, and the image display unit 3 is included in the home television set. The control unit 1 is provided for mainly controlling the progress of the entire game based on the game program. For example, the control unit 1 is made up of a CPU (Central Processing Unit) 7 , a signal processor 8 , and an image processor 9 . The CPU 7 , the signal processor 8 , and the image processor 9 are connected to each other through the bus 6 . The CPU 7 interprets a command from a game program and executes a variety of data processing and data control. For example, the CPU 7 commands the signal processor 8 to provide the image data to the image processor. The signal processor 8 mainly executes computations in the three-dimensional space, position conversion computations from the three-dimensional space to a virtual three-dimensional space, light source computation processing, and data generation and data processing of image data and audio data. The image processor 9 mainly executes processing of writing image data on a RAM (Random Access Memory) 12 based on the computation results and processing results of the signal processor 8 . Note that the image data written in the RAM 12 will be subsequently rendered. The memory unit 2 is provided mainly for storing the program data, various types of data used for the program data, and the like. For example, the storage unit 2 is made up of the recording medium 10 , an interface circuit 11 , and the RAM 12 , for instance. The interface circuit 11 is connected to the recording medium 10 . The interface circuit 11 and the RAM 12 are connected through the bus 6 . The recording medium 10 stores program data of the operation system, game data made up of image data, audio data, and various types of program data, and the like. For example, the recording medium 10 is a ROM (Read Only Memory) cassette, an optical disk, a flexible disk, or the like. The program data of the operating system, the game data, and the like are stored in this recording medium 10 . Note that a card memory is also included in the category of the recording medium 10 . The card memory is mainly used for storing various game parameters at the point of interruption of the game. The RAM 12 is used for temporarily storing various types of data read out of the recording medium 10 , and for temporarily recording the processing results of the control unit 1 . The RAM 12 stores address data as well as various types of data. Note that the address data indicates the memory location of various types of data. The RAM 12 is configured to be allowed to specify an arbitrary address and read/write data from/onto the address. The image display unit 3 is provided for mainly outputting various types of image data as an image. For example, the various types of image data include the image data written onto the RAM 12 by the image processor 9 and the image data read out of the recording medium 10 . For example, the image display unit 3 is made up of a television monitor 20 , an interface circuit 21 , a D/A converter (Digital-to-Analog converter) 22 . The D/A converter 22 is connected to the television monitor 20 , and the interface circuit 21 is connected to the D/A converter 22 . In addition, the bus 6 is connected to the interface circuit 21 . Here, the image data is provided to the D/A converter 22 through the interface circuit 21 , and is converted into an analog image signal in the D/A converter 22 . Then, the analog image signal is outputted to the television monitor 20 as an image. Here, the image data includes polygon data, texture data, and the like. The polygon data is the coordinate data of vertices forming a polygon. The texture data is used for setting texture with respect to the polygon. The texture data is made up of texture specifying data and texture color data. The texture specifying data is used for associating the polygon and the texture, and the texture color data is used for specifying the texture color. Here, the polygon data and the texture data are associated with polygon address data and texture address data, respectively. The polygon address data and the texture address data include storage locations of the polygon data and the texture data, respectively. As to the image data of this type, the signal processor 8 performs coordinate conversion and perspective projection conversion with respect to the polygon data in the three-dimensional space (i.e., the three-dimensional polygon data) specified by the polygon address data based on the displacement data and the rotation amount data of the screen itself (i.e., point of sight). Accordingly, the polygon data is converted into the polygon data in the two-dimensional space (i.e., the two-dimensional polygon data). Then, a polygon outline is constituted with a plurality of two-dimensional polygon data, and texture data specified by the texture address data is written onto the internal area of the polygon. Thus, it is possible to express a variety of objects (i.e., characters) made by applying texture to each polygon. The audio output unit 4 is provided mainly for outputting the audio data read out of the recording medium 10 as audio. For example, the audio output unit 4 is made up of a speaker 13 , an amplifier circuit 14 , a D/A converter 15 , and an interface circuit 16 . The amplifier circuit 14 is connected to the speaker 13 . The D/A converter 15 is connected to the amplifier circuit 14 . The interface circuit 16 is connected to the D/A converter 15 . In addition, the bus 6 is connected to the interface circuit 16 . Here, the audio data is provided to the D/A converter 15 through the interface circuit 16 and is converted into an analog audio signal. The analog audio signal is amplified by the amplifier circuit 14 , and is outputted from the speaker 13 as audio. For example, ADPCM (Adaptive Differential Pulse Code Modulation) data, PCM (Pulse Code Modulation) data, and the like are included in the category of the audio data. In the case of the ADPCM data, it is possible to output the audio from the speaker 13 with almost the same type of the above-mentioned processing method. In the case of the PCM data, if the PCM data is converted into the ADPCM data in the RAM 12 , it is possible to output the audio from the speaker 13 with almost the same type of the above-mentioned processing method. The operation input unit 5 is mainly made up of a controller 17 , an operation information interface circuit 18 , and an interface circuit 19 . The operation information interface circuit 18 is connected to the controller 17 , and the interface circuit 19 is connected to the operation information interface circuit 18 . In addition, the bus 6 is connected to the interface circuit 19 . The controller 17 is an operation unit used by the video game player (user) for the purpose of inputting various operation commands, and transmits operation signals to the CPU 7 according to the video game player's operation. The controller 17 is provided with a first button 17 a , a second button 17 b , a third button 17 c , a fourth button 17 d , an up key 17 U, a down key 17 D, a left key 17 L, a right key 17 R, a L 1 button 17 L 1 , a L 2 button 17 L 2 , a R 1 button 17 R 1 , a R 2 button 17 R 2 , a start button 17 e , a select button 17 f , a left stick 17 SL, and a right stick 17 SR. For example, the up key 17 U, the down key 17 D, the left key 17 L, and the right key 17 R are used for providing the CPU 7 with a command to cause the characters and a cursor to move up, down, left, and right on the screen of the television monitor 20 . For example, the start button 17 e is used for commanding the CPU 7 to load the game program from the recording medium 10 . For example, the select button 17 f is used for commanding the CPU 7 to execute various selections with respect to the game program loaded from the recording medium 10 . The left stick 17 SL and the right stick 17 SR are stick-shaped controllers with approximately the same configuration as a so-called joystick. This stick-shaped controller includes an upright stick. The stick is configured to be allowed to lean from the upright position to 360-degree directions including front, back, left, and right directions, centering around the fulcrum. The left and right sticks 17 SL and 17 SR respectively transmit their positional information as an operation signal to the CPU 7 through the operation information interface circuit 18 and the interface circuit 19 . Here, their upright positions are defined as the origin of the x-y coordinate, and their positions are accordingly expressed with values in the x-y coordinate. When the left and right sticks 17 SL and 17 SR are leaned, their positions are determined depending on their leaned directions and angles. Various functions are allocated to the first button 17 a , the second button 17 b , the third button 17 c , the fourth button 17 d , the L 1 button 17 L 1 , the L 2 button 17 L 2 , the R 1 button 17 R 1 , and the R 2 button 17 R 2 depending on the game program to be loaded from the recording medium 10 . Here, excluding the left and right sticks 17 SL and 17 SR, the buttons and the keys provided in the controller 17 are configured to function as ON/OFF switches. Specifically, they are switched to an on-state when pressed from the neutral position by the external pressure. On the other hand, when the pressure is released, they return to the neutral positions and are switched to an off-state. The general operations of the above-configured home video game device will be hereinafter explained. When a power switch (not illustrated in the figure) is turned on and the game system 1 is powered on, the CPU 7 reads out image data, audio data, and program data from the recording medium 10 based on the operating system stored in the recording medium 10 . All or part of the read-out data including the image data, the audio data, and the program data are stored in the RAM 12 . Then, the CPU 7 issues commands for data stored in the RAM 12 (e.g., the image data and the audio data) based on the program data stored in the RAM 12 . In a case of the image data, the signal processor 8 firstly performs a variety of computations (e.g., positional computation and light source computation for a character in the three-dimensional space) based on the command from the CPU 7 . Next, the image processor 9 executes a variety of processing (e.g., processing for writing the image data (to be rendered) onto the RAM 12 ) based on the computation results by the signal processor 8 . Then, the image data written onto the RAM 12 is provided to the D/A converter 22 through the interface circuit 21 . Here, the image data is converted into an analog image signal by the D/A converter 22 . The image data is subsequently provided to the television monitor 20 and is displayed as an image. In a case of the audio data, the signal processor 8 firstly executes processing to generate and process audio data based on the command from the CPU 7 . Here, a variety of processing (e.g., pitch conversion, noise addition, envelope setting, level setting, and reverb addition) are executed for the audio data. Next, the audio data is outputted from the signal processor 8 , and is provided to the D/A converter 15 through the interface circuit 16 . Here, the audio data is converted into an analog audio signal. Then, the audio data is outputted as the audio from the speaker 13 through the amplifier circuit 14 . Summary of Various Processing in Game Device For example, a baseball video game is executed in the present game console. The present game console is configured to realize a game for causing a pitcher character to release a ball object. FIG. 2 is a functional block diagram for explaining functions playing major roles in the present invention. Character display means 50 has a function of displaying a pitcher character and a batter character on the television monitor 20 . In the character display means 50 , a pitcher character and a batter character are displayed on the television monitor 20 with character's image data. For example, in the character display means 50 , pitcher character's image data and pitcher character's position coordinate data are recognized by the CPU 7 . Here, the pitcher character's image data and the pitcher character's position coordinate data are stored in the RAM 12 . Also, batter character's image data and batter character's position coordinate data are recognized by the CPU 7 . Here, the batter character's image data and the batter character's position coordinate data are stored in the RAM 12 . Then, based on a command of the CPU 7 , the pitcher character's image data and the batter character's image data are provided to the television monitor 20 through the image processing circuit 14 . Accordingly, the pitcher character and the batter character are respectively displayed on predetermined positions (i.e., the pitcher's mound for the pitcher character and the batter's box for the batter character) based on the pitcher character's position coordinate data and the batter character's position coordinate data. Here, when the game program is loaded, the character's image data and the character's position coordinate data are provided from the recording medium 10 to the RAM 12 , and is then stored in the RAM 12 . Pitch informing means 51 has a function of displaying an image for informing a game player of a pitch type that the pitcher character is capable of releasing on the television monitor 20 . In the pitch informing means 51 , an image for informing a game player of a pitch that the pitcher character is capable of releasing is displayed on the television monitor 20 with pitch information's image data. Here, based on a command of the CPU 7 , the pitch information's image data is provided to the television monitor 20 through the image processing circuit 14 . Then, the pitch information's image is displayed on a predetermined position on the television monitor 20 based on the pitch information's position coordinate data. Here, when the game program is loaded, the pitch information's image data and the pitch information's position coordinate data are provided from the recording medium 10 to the RAM 12 , and is then stored in the RAM 12 . Level setting means 52 has a function of causing the CPU 7 to set a level of batter character's velocity adaptability. Here, the number of levels of the batter character's velocity adaptability is equal to or greater than the number of levels of the ball object's velocity. In the level setting means 52 , the level of the batter character's velocity adaptability is set by the CPU 7 while the number of levels of the batter character's velocity adaptability is equal to or greater than the number of levels of the ball object's velocity. Here, “the ball object's velocity” means velocity assigned to each of pitches that the pitcher character is capable of releasing. Also, the number of levels of the ball object's velocity corresponds to the number of kinds (i.e., levels) of the ball object's velocity assigned to each of pitches that the pitcher character is capable of releasing. Here, both of the ball object's velocity and the number of kinds of the ball object's velocity are preliminarily determined in the game program. For example, when one of pitcher characters is capable of releasing a curveball of 100 km/h, a screwball of 120 km/h, and a fastball of 150 km/h, the number of levels of the ball object's velocity is set to be “3”. Also, when another pitcher character is capable of releasing a slow ball of 90 km/h, a curveball of 120 km/h, a screwball of 120 km/h, and a fastball of 150 km/h, the number of pitches is four. However, velocity of the curveball and that of the screwball is the same. Therefore, the number of levels of the ball object's velocity is set to be “3”. The maximum level of the ball object's velocity is set in the game program. The following relation is established between the maximum level of the ball object's velocity and the number of levels of the ball object's velocity: “(the maximum level of the ball object's velocity)≧(the number of levels of the ball object's velocity). Also, the number of levels of the batter character's velocity adaptability is set to be the maximum level of the ball object's velocity. In other words, the following relation is established between the number of levels of the batter character's velocity adaptability and the maximum level of the ball object's velocity: “(the number of levels of the batter character's velocity adaptability)=(the maximum level of the ball object's velocity). Thus, the condition, “the number of levels of the batter character's velocity adaptability is equal to or greater than the number of levels of the ball object's velocity”, is satisfied by setting the number of levels of the batter character's velocity adaptability to be the maximum level of the ball object's velocity. When the number of levels of the batter character's velocity adaptability is set to be the maximum of the predetermined ball object's velocity, velocity corresponding to each level of the batter character's velocity adaptability (i.e., velocity of each level) is recognized by the CPU 7 . Accordingly, the velocity level that the batter character is capable of adapting is set by the CPU 7 . Here, velocity corresponding to each level of the batter character's velocity adaptability (i.e., velocity of each level) is set by the CPU 7 based on velocity of the ball object that the pitcher character is capable of releasing. For example, velocity of each level is set based on the maximum velocity of the ball object that the pitcher character is capable of releasing. Specifically, the maximum velocity of the ball object that the pitcher character is capable of releasing is used as velocity of the maximum level. Also, the maximum velocity is used as a benchmark, and any velocity less than the maximum velocity are used as velocity of the other levels. Accordingly, based on the maximum velocity corresponding to the maximum level, it is possible to cause the CPU 7 to recognize velocity corresponding to the other levels. Batter character property recognition means 53 has a function of causing the CPU 7 to recognize batter character's property data corresponding to the batter character's velocity adaptability. Specifically, the batter character property recognition means 53 has a function of causing the CPU 7 to recognize the batter character's property data corresponding to multiple-level velocity adaptability of the batter character. In the batter character property recognition means 53 , the batter character property data corresponding to multiple-level velocity adaptability of the batter character is recognized by the CPU 7 . For example, velocity corresponding to each level of the batter character's velocity adaptability (i.e., velocity of each level) is expressed by “V”, and the batter character's property data corresponding to multiple-level velocity adaptability of the batter character is expressed by “DT (V)”. Thus defined batter character's property data DT (V) of each level is recognized by the CPU 7 . Data association means 54 has a function of causing the CPU 7 to execute processing of associating the batter character's property data with the ball object's property data. In the data association means 54 , processing of associating the batter character's property data with the ball object's property data is executed by the CPU 7 . For example, a level of the ball object's velocity is expressed by “n”, and the ball object's property data corresponding to multiple-level velocity of the ball object is expressed by “BT (n)”. Here, when the number of levels of the ball object's property data is set to be “n_max”, “n” is set to be any of natural number ranging from “1” to “n_max”. Processing of associating thus defined ball object's property data BT (n) with the batter character's property data DT (V) is executed by the CPU 7 . Specifically, when the ball object's property data BT (n) is corresponded to the ball object's velocity V, it is possible to evaluate the batter character's property data DT (V) corresponding to the ball object's property data BT (n) with the expression “DT (BT (n))”. Thus, the batter character's property data DT (V) and the ball object's property data BT (n) are associated by the CPU 7 . Batter character property display means 55 has a function of displaying a velocity ability indicator on the television monitor 20 based on the batter character's property data. Here, the velocity ability indicator is used for informing a game player of the batter character's velocity adaptability. In the batter character property display means 55 , the velocity ability indicator for informing a game player of the batter character's velocity adaptability is displayed on the television monitor 20 with ability indicator's image data based on the batter character's property data DT (V). For example, the ability indicator's image data is provided to the television monitor 20 through the image processing circuit 14 based on a command of the CPU 7 . Accordingly, the velocity ability indicator is displayed on a predetermined position on the television monitor 20 based on ability indicator's position coordinate data. Here, when the game program is loaded, the ability indicator's image data and the ability indicator's position coordinate data are provided from the recording medium 10 to the RAM 12 , and is then stored in the RAM 12 . Ball object property recognition means 56 has a function of causing the CPU 7 to recognize the ball object's property data corresponding to velocity of the ball object released by the pitcher character. Specifically, the ball object property recognition means 56 has a function of causing the CPU 7 to recognize the ball object's property data corresponding to any one of the multiple-level velocity of the ball object. In the ball object property recognition means 56 , the ball object's property data corresponding to any one of the multiple-level velocity of the ball object is recognized by the CPU 7 . For example, a game player selects a pitch of the ball object to be released by the pitcher character by operating the controller 17 , while watching the pitch information's image displayed on the television monitor 20 . Accordingly, the ball object's velocity assigned to the selected pitch (i.e., the ball object's property data) is recognized by the CPU 7 . Ball object property display means 57 has a function of displaying a mark for informing a game player of the batter character's property data corresponding to the ball object's property data recognized by the CPU 7 on the television monitor 20 . In the ball object property display means 57 , a mark for informing a game player of the batter character's property data corresponding to the ball object's property data recognized by the CPU 7 is displayed on the television monitor 20 with mark's image data. For example, when a game player selects a pitch of the ball object to be released by the pitcher character by operating the controller 17 , the batter character's property data corresponding to the ball object's property data assigned to the selected pitch is recognized by the CPU 7 . Accordingly, the mark for informing a game player of the level of the batter character's property data is displayed on the ability indicator. Here, the mark's image data is provided to the television monitor 20 through the image processing circuit 14 based on a command of the CPU 7 . Accordingly, the mark is displayed on a predetermined position on the television monitor 20 based on mark's position coordinate data. Also, when the game program is loaded, the mark's image data and the mark's position coordinate data are provided from the recording medium 10 to the RAM 12 , and are then stored in the RAM 12 . Ball object display means 58 has a function of displaying the ball object released by the pitcher character on the television monitor 20 by causing the CPU 7 to issue a command for causing the pitcher character to release the ball object. Specifically, the ball object display means 58 has a function of displaying the ball object released by the pitcher character on the television monitor 20 by causing the CPU 7 to issue a command for causing the pitcher character to release the ball object based on an input signal from the controller 17 . In the ball object display means 58 , when a command for causing the pitcher character to release the ball object is issued by the CPU 7 based on an input signal from the controller 17 , the ball object released by the pitcher character is displayed on the television monitor 20 . For example, when a game player operates the controller 17 for giving a command for causing the pitcher character to release the ball object, an input signal is transmitted from the controller 17 to the CPU 7 . Then, when the input signal is received by the CPU 7 , a command for causing the pitcher character to release the ball object is issued by the CPU 7 . Accordingly, a series of pitcher character's motions from the start of a pitching motion to the release of the ball object are displayed on the television monitor 20 based on the command for causing the pitcher character to release the ball object. Then, the ball object released by the pitcher character is displayed on the television monitor 20 with the ball object's image data. Here, the above-mentioned command for causing the pitcher character to release the ball object includes a variety of commands such as a command for causing the pitcher character to start a pitching motion, a command for determining a pitching trajectory, and a command for causing the pitcher character to release the ball object. These commands are given when a game player operates the controller 17 . Batter character property non-display means 59 has a function of causing the CPU 7 to issue a command for clearing the ability indicator displayed on the television monitor 20 when the ball object released by the pitcher character is displayed on the television monitor 20 . In the batter character property non-display means 59 , a command for clearing the ability indicator displayed on the television monitor 20 is issued by the CPU 7 when the ball object released by the pitcher character is displayed on the television monitor 20 . For example, when a command for displaying the ball object on the television monitor 20 is issued by the CPU 7 , a command for clearing the ability indicator displayed on the television monitor 20 is issued by the CPU 7 . Accordingly, the ability indicator currently displayed on the television monitor 20 is cleared. Batter character motion display means 60 has a function of displaying a series of swinging motions by a batter character on the television monitor 20 by causing the CPU 7 to issue a command for controlling the batter character's swing motion after the ball object released by the pitcher character is displayed on the television monitor 20 . In the batter character motion display means 60 , when the command for causing the batter character to perform a swing motion is issued by the CPU 7 after the ball object released by the pitcher character is displayed on the television monitor 20 , a series of swinging motions by the batter character are displayed on the television monitor 20 . For example, when a command for causing the batter character to perform a swing motion is issued by the CPU 7 based on an AI (artificial intelligence) program after a command for displaying the ball object on the television monitor 20 is issued by the CPU 7 , a series of swinging motions by the batter character are displayed on the television monitor 20 with batter character's movie data. Change frequency recognition means 61 has a function of causing the CPU 7 to recognize frequency of changing the batter character's property data. In the change frequency recognition means 61 , frequency of changing the batter character's property data (i.e., change frequency) is recognized by the CPU 7 . Here, the change frequency to be recognized by the CPU 7 is set as follows. For example, the default value of the change frequency is set to be “0”. The change frequency (i.e., the default value) is recognized by the CPU 7 before after-mentioned batter character property change means 62 is performed. After the after-mentioned batter character property change means 62 is performed, processing of incrementing the change frequency is executed by the CPU 7 and the incremented change frequency is recognized by the CPU 7 . Batter character property change means 62 has a function of causing the CPU 7 to change the batter character's property data to the changed property data based on the ball object's property data after the ball object released by the pitcher character is displayed on the television monitor 20 . Specifically, the batter character property change means 62 has a function of causing the CPU 7 to change the batter character's property data corresponding to the ball object's property data recognized by the CPU 7 after the ball object released by the pitcher character is displayed on the television monitor 20 . More specifically, the batter character property change means 62 has a function of causing the CPU 7 to change the batter character's property data (i.e., main-property data) corresponding to the ball object's property data recognized by the CPU 7 in consideration of the weighted data corresponding to the change frequency after the ball object released by the pitcher character is displayed on the television monitor 20 . Also, the batter character property change means 62 has a function of causing the CPU 7 to change the batter character's property data of the other levels (sub-property data) excluding the batter character's main-property data, while the batter character's main-property data is used as a benchmark. In the batter character property change means 62 , the batter character's main-property data is changed by the CPU 7 in consideration of the weighted data corresponding to the change frequency after the ball object released by the pitcher character is displayed on the television monitor 20 . Then, the batter character's sub-property data is changed by the CPU 7 based on the batter character's main-property data. Here, relation between the change frequency and the weighted data is preliminarily determined in the game program. Batter character property re-recognition means 63 has a function of causing the CPU 7 to re-recognize the changed batter character's property data. In the batter character property re-recognition means 63 , the changed batter character's property data of each level (i.e., the main-property data and the sub-property data) are re-recognized by the CPU 7 . Batter character property redisplay means 64 has a function of redisplaying the velocity ability indicator for informing the batter character's velocity adaptability on the television monitor 20 based on the changed batter character's property data. In the batter character property redisplay means 64 , the velocity ability indicator for informing the batter character's velocity adaptability is redisplayed on the television monitor 20 with the ability indicator's image data based on the changed batter character's property data of each level (i.e., the main-property data and the sub-property data). Summary of Ability Informing System in Baseball Video Game Next, contents of the ability informing system in the baseball video game will be hereinafter specifically explained. In addition, processing flows illustrated in FIGS. 8 and 9 will be explained. FIG. 8 is a processing flow for illustrating the summary of the entire baseball video game. FIG. 9 is a processing flow for explaining the above-mentioned system. First, when the game console is powered on and is started, a baseball video game program stored in the recording medium 10 is loaded into the RAM 12 , and is then stored in the RAM 12 . Also, the recording medium 10 stores a variety of basic game data necessary for executing the baseball video game. Here, the variety of basic game data are simultaneously loaded into the RAM 12 , and are then stored in the RAM 12 (Step S 1 ). For example, the basic game data includes a variety of image data for the three-dimensional game space (e.g., image data of baseball stadiums, baseball player characters, and a variety of objects). The variety of image data are recognized by the CPU 7 . Also, the basic game data includes position coordinate data for arranging the variety of above-mentioned image data in the three-dimensional game space. Furthermore, the basic game data includes the data to be used for the ability informing system. Next, the baseball video game program stored in the RAM 12 is executed by the CPU 7 based on the basic game data (Step S 2 ). Accordingly, the start-up screen of the baseball video game is displayed on the television monitor 20 . Also, a variety of setting screens are displayed on the television monitor 20 for executing the baseball video game. For example, a mode selection screen (not illustrated in the figure) is displayed on the television monitor 20 for selecting a playing mode of the baseball video game. A game player selects a playing mode through the mode selection screen by operating the controller 17 (Step S 3 ). For example, a match-up mode, a pennant-race mode, and a developing mode are prepared as the playing modes. In the match-up mode, a game player selects one of 12 baseball teams, and enjoys playing a match-up game. In the pennant-race mode, a game player selects one of 12 baseball teams and enjoys playing baseball matches in the pennant race. In the developing mode, a game player develops baseball player characters as a manager of a baseball team. Next, a variety of events are performed by the CPU 7 in the playing mode selected through the mode selection screen (Step S 4 ). For example, the events include an event automatically controlled by the CPU 7 based on the AI program, and an event manually controlled by a game player based on an input signal from the controller 17 . Also, controls of player characters are classified into the automatic control and the manual control. The automatic control automatically gives a baseball player character a command based on the AI program. On the other hand, the manual control directly gives a baseball player character a command based on an input signal from the controller 17 . Thus, according to the present baseball video game, an event is controlled and a command is given to a baseball player character in accordance with commands from the controller 17 and the AI program. Next, it is judged by the CPU 7 whether or not the selected playing mode was terminated (Step S 5 ). Specifically, it is judged by the CPU 7 whether or not a command for indicating the end of the playing mode was issued. If it was judged by the CPU 7 that the command for indicating the end of the playing mode was issued (Yes in Step S 5 ), processing of storing data for continuing the game in the RAM 12 is executed by the CPU 7 . After the data for continuing the game is stored in the RAM 12 , a selection screen is displayed on the television monitor 20 for selecting whether or not a game player stops playing the baseball video game (Step S 6 ). Then, if a game player selected an item for stop playing the baseball video game through the selection screen by operating the controller 17 (Yes in Step S 6 ), processing for terminating the baseball video game is executed by the CPU 7 (Step S 7 ). On the other hand, if a game player selected an item for continuing playing the baseball video game through the selection screen by operating the controller 17 (No in Step S 6 ), the mode selection screen in Step S 3 is redisplayed on the television monitor 20 . Unless it was judged by the CPU 7 that the command for terminating the playing mode was issued (No in Step S 5 ), a variety of events are performed by the CPU 7 in the playing mode selected through the mode selection screen (Step S 4 ). Next, the ability informing system will be hereinafter explained in detail. The following is an example of the ability informing system functioning in the match-up mode. For example, when the match-up mode is selected through the mode selection screen and a game event is executed in the match-up mode, the ability informing system functions. In the match-up mode, a team A is controlled by the AI program and a team B is controlled by a game player. Also, the team A is set to bat first while the team B is set to take the field first. Especially, the following example relates to the ability informing system functioning when the game player gives a command to a pitcher character 70 of the team B. When a game player selects the match-up mode through the mode selection screen, a game event is performed by the CPU 7 (Step S 401 ). Then, in Step S 402 , the teams (i.e., teams A and B) are selected through a team selection screen (not illustrated in the figure). In addition, baseball player characters of the both teams (i.e., the teams A and B) are selected through a player selection screen (not illustrated in the figure). Accordingly, the basic settings for determining a variety of abilities of the selected baseball player characters are performed by the CPU 7 (Step S 403 ). For example, the maximum “n_lim” for a level “n” of the ball object's velocity is set by the CPU 7 . Specifically, the maximum n_lim is set to be “10”. Here, the maximum n_lim is preliminarily determined in the game program. Here, “the ball object's velocity” means velocity assigned to a pitch of each pitcher character, that is, velocity assigned to a pitch that each pitcher character is capable of releasing. Therefore, in the present embodiment, the ball object's velocity is treated as one of the pitcher character's abilities. Also, the number of levels “m_max” of the batter character's velocity adaptability is set by the CPU 7 , for instance. Specifically, the number of levels m_max is set to be the maximum n_lim (i.e., 10) by the CPU 7 . Accordingly, the level “m” of the batter character's velocity adaptability is set to be any of 10 levels (i.e., levels “1” to “10”). Thus, when the level m of the batter character's velocity adaptability is set, it is possible to constantly set the number of levels m_max of the batter character's velocity adaptability to be equal to or greater than the number of kinds of the ball object's velocity that the pitcher character is capable of releasing (i.e., equal to or greater than the number of levels, n_max) by setting the level m of the batter character's velocity adaptability. Furthermore, velocity V (m) corresponding to each level m of the batter character's velocity adaptability (i.e., velocity of each level) is set by the CPU 7 , for instance. Specifically, velocity V (m) of each level is set based on the maximum velocity V_max of the ball object that each pitcher character is capable of releasing. Here, the maximum velocity V_max is assigned to the velocity of the maximum level (e.g., velocity V (10) of level 10) by the CPU 7 . Also, the maximum velocity V (10) of the ball object is used as a benchmark, and any velocity less than the maximum velocity V (10) (i.e., V_max) are assigned to velocity of the other levels (e.g., velocity V (m) of levels 1 to 9, note that “m” is natural number ranging from 1 to 9) by the CPU 7 . Specifically, when a level of the batter character's velocity adaptability, velocity of each level, and the maximum velocity of the ball object that the pitcher character is capable of releasing, are respectively set to be “m” (m is natural number ranging from 1 to m_max), “V (m)”, and “V_max”, velocity of each level is calculated based on the equation “V (m)=V_max−α×(10−m)”. Here, “α” is coefficient for regulating velocity corresponding to each level, and is set to be “5.0”. Also, the maximum “m_max” for “m” corresponds to the number of levels of the batter character's velocity adaptability. In other words, the following relation is established: “m_max=10”. For example, when the maximum velocity V_max is set to be 150 km/h, the relation between each level and velocity of each level is established as illustrated in FIG. 3 . Next, the property data corresponding to abilities of the selected baseball player character is recognized by the CPU 7 . Here, the property data corresponding to the batter character's velocity adaptability (i.e., velocity adaptability data) and velocity data corresponding to velocity of the ball object to be released by the pitcher character are recognized by the CPU 7 . For example, when velocity corresponding to each level of the batter character's velocity adaptability (i.e., velocity of each level) is set to be “V (m)” and the batter character's velocity adaptability data corresponding to multiple-level velocity adaptability of the batter character is set to be “DT (V (m))”, the batter character's velocity adaptability data DT (V (m)) of each level stored in the RAM 12 is recognized by the CPU 7 (Step S 404 ). Here, a predetermined value DT 0 is used as the default value of the batter character's velocity adaptability data DT (V (m)) of each level. Here, the following relation is established: “DT 0 =1.0”. Therefore, when a game event is started, the default value DT 0 (=1.0) of the batter character's velocity adaptability data of each level is recognized by the CPU 7 as the batter character's velocity adaptability data DT (V (m)) of each level. Also, when a ball object's velocity level is set to be “n” (n is natural number ranging from 1 to n_max) and the ball object's velocity data corresponding to multiple-level velocity of the ball object is set to be “BT (n)”, the velocity data BT (n) stored in the RAM 12 corresponds to velocity of a pitch of the ball object that the pitcher character is capable of releasing. In Step S 405 , the velocity of a pitch of the ball object that the pitcher character is capable of releasing is recognized by the CPU 7 . Here, the maximum of “n” (i.e., n_max) corresponds to the number of kinds (i.e., levels) of velocity of the ball object that the pitcher character is capable of releasing. For example, as illustrated in FIG. 4 , when the pitcher character is capable of releasing a slow ball of 105 km/h, a curveball of 120 km/h, a screwball of 120 km/h, and a fastball of 150 km/h (=V_max), the number of levels n_max of the ball object's velocity is set to be “3” by the CPU 7 . In this case, the following relation is established: “n_max=3”. Accordingly, the ball object's velocity data BT (n) corresponds to “BT(1)=105 (km)”, “BT (2)=120 (km)”, and “BT (3)=150 (km)”. Next, processing of associating the batter character's velocity adaptability data DT (V (m)) with the ball object's velocity data BT (n) is executed by the CPU 7 (Step S 406 ). Specifically, the ball object's velocity data BT (n) is considered as the ball object's velocity V (m), and accordingly the batter character's velocity adaptability data DT (V (m)) corresponding to the ball object's velocity data BT (n) is evaluated. In other words, as illustrated in FIG. 4 , it is also possible to evaluate the batter character's velocity adaptability data DT (V (m)) corresponding to the ball object velocity data BT (n) as “DT (BT (n))”. As described above, the CPU 7 is caused to evaluate the batter character's velocity adaptability data DT (V (m)) corresponding to the ball object's velocity data BT (n) with “DT (BT (n))”, and accordingly the CPU 7 is caused to associate the ball object's velocity data BT (n) with the batter character's velocity adaptability data DT (V (m)). When the batter character's velocity adaptability data DT (V (m)) and the ball object's velocity data BT (n) were recognized and associated by the CPU 7 as described above, a variety of basic images are displayed on the television monitor 20 with corresponding image data as illustrated in FIG. 5 (Step S 407 ). For example, a pitcher character 70 , a batter character 71 , and a fielder character (not illustrated in the figure) are displayed on the television monitor 20 with the corresponding image data. Also, a pitch informing image KH is displayed on the television monitor 20 with the corresponding image data. Here, the pitch informing image KH is displayed for informing a game player of a pitch that the pitcher character 70 is capable of releasing. Furthermore, a ball-hitting zone (not illustrated in the figure) is displayed on the television monitor 20 with the corresponding image data. Here, the batter character 71 is capable of hitting the ball object when the ball object exists in the ball-hitting zone. Next, a velocity ability indicator NM is displayed on the television monitor 20 with the corresponding image data (Step S 408 ). Here, the velocity ability indicator NM is displayed for informing a game player of velocity adaptability of the batter character 71 . For example, the velocity ability indicator NM is displayed on the television monitor 20 with the corresponding image data based on the velocity adaptability data DT (V (m)) of the batter character 71 . Here, the velocity ability indicator NM is formed in a rectangular shape. Also, the velocity ability indicator NM is sectioned in ten portions corresponding to levels 1 to 10. The velocity adaptability level of the batter character 71 is expressed by the thickness of the sectioned portion. As illustrated in FIG. 5 , the velocity ability indicator NM has constant thickness in the initial state. In the initial state of the velocity ability indicator NM, the velocity adaptability data DT (V (m)) of the batter character 71 of each level is set to be “DT 0 ” (=1.0) as a benchmark. In the condition, when a game player pressed a direction key of the controller 17 (i.e., the up key 17 U, the down key 17 D, the left key 17 L, and the right key 17 R) while watching the pitch informing image KH displayed on the television monitor 20 , a pitch assigned to the pressed direction key is selected (Step S 409 ). As illustrated in FIG. 5 , the pitch informing image KH is formed in a cross shape. When the up key 17 U of the controller 17 was pressed, an upper protruding portion of the pitch informing image KH is highlighted and characters “FASTBALL” are displayed in the vicinity of the upper protruding portion. In other words, a fastball is assigned to the up key 17 U of the controller 17 . Also, when the left key 17 L of the controller 17 was pressed, a left protruding portion of the pitch informing image KH is highlighted and characters “CURVEBALL” are displayed in the vicinity of the left protruding portion. In other words, a curveball is assigned to the left key 17 L of the controller 17 . Also, when the right key 17 R of the controller 17 was pressed, a right protruding portion of the pitch informing image KH is highlighted and characters “SCREWBALL” are displayed in the vicinity of the right protruding portion. In other words, a screwball is assigned to the right key 17 R of the controller 17 . Furthermore, when the down key 17 D of the controller 17 was pressed, a lower protruding portion of the pitch informing image KH is highlighted and characters “SLOW BALL” are displayed in the vicinity of the lower protruding portion. In other words, a slow ball is assigned to the down key 17 U of the controller 17 . When the controller 17 is thus operated, the pitch selected through the controller 17 and the velocity of the pitch selected through the controller 17 are recognized by the CPU 7 . For example, the pitch data corresponding to the pitch selected through the controller 17 and the ball object's velocity data BT (ns) corresponding to the ball object's velocity assigned to the selected pitch are recognized by the CPU 7 (Step S 410 ). Here, “ns” corresponds to a level for determining the ball object's velocity to be determined when a pitch is selected. For example, FIG. 4 illustrates that the pitcher character 70 is capable of releasing a slow ball of 105 km/h, a curveball of 120 km/h, a screwball of 120 km/h, and a fastball of 150 km/h (=V_max). When the slow ball is selected, “n=1 (=ns)” is recognized by the CPU 7 , and accordingly the ball object's velocity data BT (1) (=105 (km/h)) is recognized by the CPU 7 . Also, when the curveball or the screwball is selected, “n=2 (=ns)” is recognized by the CPU 7 , and accordingly the ball object's velocity data BT (2) (=120 (km/h)) is recognized by the CPU 7 . Furthermore, when the fastball is selected, “n=3 (=ns)” is recognized by the CPU 7 , and accordingly the ball object's velocity data BT (3) (=150 (km/h)) is recognized by the CPU 7 . Next, the velocity adaptability data DT (V (ms)) of the batter character 71 (=DT (BT (ns))) is recognized by the CPU 7 (see FIG. 4 ). Here, the velocity adaptability data DT (V (ms)) corresponds to the ball object's velocity data BT (ns) recognized by the CPU 7 . Accordingly, a level “ms” corresponding to the velocity adaptability data DT (V (ms)) is recognized by the CPU 7 (Step S 411 , see FIG. 3 ). Here, “ms” indicates a level for determining the velocity adaptability data DT (V(ms)). Then, a mark MK is displayed on the television monitor 20 with mark's image data (Step S 412 ). Here, the mark MK is used for informing a game player of the level ms of the velocity adaptability data DT (V(ms)) of the batter character 71 . For example, the mark MK is displayed on the velocity ability indicator NM (see FIG. 5 ). Accordingly, a game player is capable of selecting a desired pitch while referring to the mark MK. For example, when the pitcher character 70 is capable of releasing a slow ball of 105 km/h, a curveball of 120 km/h, a screwball of 120 km/h, and a fastball of 150 km/h (=V_max) and the slow ball is selected, the velocity adaptability data DT (V (1)) of the batter character 71 (=DT (BT (1))=105) is recognized by the CPU 7 . Accordingly, the level “ms=1” corresponding to the velocity adaptability data DT (V (1)) of the batter character 71 is recognized by the CPU 7 . Then, the mark MK for informing a game player of velocity adaptability of the batter character 71 is displayed on a portion “level 1” of the velocity ability indicator NM. Also, when the curveball or the screwball is selected, the velocity adaptability data DT (V (4)) of the batter character 71 (=DT (BT (2))=120) is recognized by the CPU 7 . Then, the level “ms=4” corresponding to the velocity adaptability data DT (V (4)) of the batter character 71 is recognized by the CPU 7 . Accordingly, the mark MK for informing a game player of velocity adaptability of the batter character 71 is displayed on a portion “level 4” of the velocity ability indicator NM. Furthermore, when the fastball is selected, the velocity adaptability data DT (V (10)) of the batter character 71 (=DT (BT (3))=150) is recognized by the CPU 7 . Accordingly, the level “ms=10” corresponding to the velocity adaptability data DT (V (10)) of the batter character 71 is recognized by the CPU 7 . As illustrated in FIG. 5 , the mark MK for informing a game player of velocity adaptability of the batter character 71 is then displayed on a portion “level 10” of the velocity ability indicator. In the selection of a pitch, the mark MK is thus allowed to be displayed on the velocity ability indicator NM. Therefore, a game player is capable of confirming a batter character 71 's accustomed ball object's velocity level by watching the thickness of the mark MK. At the same time as this, the game player is capable of recognizing his/her currently selecting pitch's velocity with the mark MK. Accordingly, a game player is capable of easily comparing the batter character's accustomed ball object's velocity with his/her currently selecting pitch's velocity. As a result, a game player is capable of promptly selecting velocity of the ball object to be released by the pitcher character 70 without an erroneous operation. Next, when a game player operated a predetermined button of the controller 17 in the above-mentioned condition, a command for a pitching motion is given to the pitcher character 70 (Step S 413 ). The command for a pitching motion is issued by the CPU 7 , and includes a command for causing the pitcher character 70 to start a pitching motion, a command for determining a pitching trajectory, a command for causing the pitcher character 70 to release the ball object, and the like. Accordingly, a series of pitching motions of the pitcher character 70 are displayed on the television monitor 20 . Then, the ball object 72 released by the pitcher character 70 is displayed on the television monitor 20 as illustrated in FIG. 5 (Step S 414 ). When the ball object 72 released by the pitcher character 70 was displayed on the television monitor 20 , a command for clearing the velocity ability indicator NM is issued by the CPU 7 . Accordingly, the currently displayed velocity ability indicator NM is cleared from the screen of the television monitor 20 (Step S 415 ). In this condition, the pitch informing image KH is not displayed on the television monitor 20 . Next, it is judged by the CPU 7 whether or not a command for batting was given to the batter character 71 based on the AI program (Step S 416 ). The command for batting includes a command for moving the ball-hitting zone and a command for causing the batter character 71 to start swinging a bat. Then, when it was judged by the CPU 7 that the command for batting was given to the batter character 71 based on the AI program (Yes in Step S 416 ), a series of swinging motions of the batter character 71 are displayed on the television monitor 20 . Also, when the command for causing the batter character 71 to start swinging was given based on the AI program (Yes in S 416 ), it is judged by the CPU 7 whether or not the ball object was hit by the batter character 71 (Step S 417 ). For example, it is judged by the CPU 7 whether or not the ball-hitting zone was overlapped with the ball object. Specifically, it is judged by the CPU 7 whether or not at least one coordinate data within the ball-hitting zone was matched with at least one coordinate data within the ball object. Then, when it was judged by the CPU 7 that the ball object was not hit by the batter character 71 (No in Step S 417 ), in other words, when the ball object reached the position of a catcher character's mitt, processing for changing velocity adaptability of the batter character 71 is executed by the CPU 7 . For example, processing for incrementing change frequency data ih (m) is executed by the CPU 7 (Step S 418 ). Here, the change frequency data ih (m) corresponds to change frequency of velocity adaptability of the batter character 71 . The processing is expressed by the equation: “ih (m)=ih (m)+1”. Then, the processed change frequency data ih (m) is recognized by the CPU 7 . Accordingly, the weighted data DW (ih (m)) corresponding to the change frequency data ih (m) is recognized by the CPU 7 based on a correspondence table for indicating correspondence relation between the change frequency data ih (m) and the weighted data DW (ih (m)) (Step S 419 ). FIG. 6 illustrates an example of the correspondence table, and the correspondence table is preliminarily determined in the game program. Here, the change frequency data ih (m) corresponds to frequency that the batter character 71 encounters the ball object of the same velocity. In the real baseball video game, the more a batter encounters balls of the same velocity, the more the batter easily adapts oneself to the ball velocity. For the purpose of replicating this effect in the baseball video game, the value of the weighted data DW (ih (m)) is increased as the value of the change frequency data ih (m) is increased. This is illustrated in FIG. 6 . Accordingly, the more the batter character 71 encounters the ball objects of the same velocity, the more the batter character 71 easily adapts oneself to the ball object's velocity. Then, the velocity adaptability data DT (V (m)) of the batter character 71 is changed by the CPU 7 depending on the ball object's velocity data BT (ns) recognized by the CPU 7 (Step S 420 ). For example, the batter character 71 's velocity adaptability data DT (V (ms)) (i.e., main-velocity adaptability data) corresponding to the ball object's velocity data BT (ns) recognized by the CPU 7 is changed by the CPU 7 in consideration of the weighted data DW (ih (m)) corresponding to the change frequency data ih (m). The batter character 71 's velocity adaptability data DT (V (mf)) of the other levels (i.e., sub-velocity adaptability data) excluding the batter character 71 's main-velocity adaptability data DT (V (ms)) is changed by the CPU 7 based on the batter character 71 's main-velocity adaptability data DT (V (ms)). Here, “mf” is natural number ranging from 1 to m_max (excluding “ms”). The following example explains that the batter character 71 's velocity adaptability data (i.e., the main-adaptability data and the sub-adaptability data) is changed. For example, the batter character 71 's main-velocity adaptability data DT (V (ms)) is changed by the CPU 7 with the equation “DT (V (ms))=DT (V (ms))+DW (ih (ms))×k”. On the other hand, the batter character 71 's sub-velocity adaptability data DT (V (mf)) is changed by the CPU 7 with the equation “DT (V (mf))=DT (V (mf))+(K−|ms−mf|×kc)”. Here, “k” is correction coefficient for correcting the batter character 71 's main-velocity adaptability data. On the other hand, “kc” is correction coefficient for correcting the batter character 71 's sub-velocity adaptability data based on the main-velocity adaptability data of the batter character 71 . Also, “k” and “kc” are constant numbers. In this case, “k” and “kc” are respectively set to be “1.0” and “0.25”. When the batter character 71 's velocity adaptability data is thus changed by the CPU 7 , it is judged by the CPU 7 whether or not a match-up between the pitcher character 70 and an arbitrary batter character 71 was finished (Step S 421 ). For example, it is herein judged by the CPU 7 whether or not a flag for indicating finish of the match-up between the pitcher character 70 and the batter character 71 was turned on. In other words, it is judged by the CPU 7 whether or not the flag value is “1”. Then, when it was judged by the CPU 7 that the match-up between the pitcher character 70 and the batter character 71 had not finished yet, in other words, when the flag value is not “1” but “0” (No in Step S 421 ), the changed batter character 71 's velocity adaptability data of each level (i.e., main-velocity adaptability data and sub-velocity adaptability data) is re-recognized by the CPU 7 (Step S 422 ). Accordingly, in Step S 408 , the velocity ability indicator NM for informing a game player of the batter character 71 's velocity adaptability is redisplayed on the television monitor 20 with the ability indicator's image data based on the changed batter character 71 's velocity adaptability data of each level (i.e., the main-velocity adaptability data and the sub-velocity adaptability data). On the other hand, when it was judged by the CPU 7 that the ball object was hit by the batter character 71 (Yes in S 417 ), processing for incrementing the change frequency data ih (m) corresponding to the change frequency of the batter character 71 's velocity adaptability data will not be executed by the CPU 7 . In addition, processing for changing the batter character 71 's velocity adaptability data will not be executed by the CPU 7 . In this case, processing in Step S 421 is executed by the CPU 7 . Also, when a command for causing the batter character 71 to start a swinging motion was not given based on the AI program (No in Step S 416 ), a series of swinging motions of the batter character 71 are not displayed on the television monitor 20 . This corresponds to a case that the batter character 71 did not swing a bat. Also, in this case, processing for incrementing the change frequency data ih (m) corresponding to change frequency of the batter character 71 's velocity adaptability data is executed by the CPU 7 when the ball object reaches the position of the catcher character's mitt (Step S 418 ). Then, the processed change frequency data ih (m) is recognized by the CPU 7 . Next, the above-mentioned Steps S 419 and S 420 are performed by the CPU 7 . Accordingly, the batter character 71 's main-velocity adaptability data is changed by the CPU 7 in consideration of the weighted data DW (ih (m)) corresponding to the change frequency data ih (m). Also, excluding the main-velocity adaptability data of the batter character 71 , the batter character 71 's sub-velocity adaptability data is changed by the CPU 7 based on the batter character 71 's main-velocity adaptability data. Accordingly, subsequent processing after the above-mentioned Step S 421 are executed by the CPU 7 . Next, when it was judged by the CPU 7 that the match-up between the pitcher character 70 and an arbitrary batter character 71 was finished, in other words, when the flag value is “1” (Yes in Step S 421 ), the batter character 71 's velocity adaptability data of each level is reset by the CPU 7 (Step S 423 ). In other words, the batter character 71 's velocity adaptability data of each level is changed into the default value DT 0 by the CPU 7 . Next, it is judged by the CPU 7 whether or not the game event was finished (Step S 424 ). For example, it is judged by the CPU 7 whether or not a flag for indicating finish of the game event is turned on. In other words, it is judged by the CPU 7 whether or not the flag value is “1”. Next, when it was judged by the CPU 7 that the game event had not finished yet, in other words, when the flag value is not “1” but “0” (No in Step S 424 ), processing in Step S 404 with respect to the next batter character 71 is executed again by the CPU 7 . On the other hand, when it was judged by the CPU 7 that the game event was finished, in other words, when the flag value is “1” (Yes in Step S 424 ), processing for finishing the game event (e.g., processing for storing a variety of data in the RAM 12 ) is executed by the CPU 7 (Step S 425 ). Finally, the ability indicator NM will be hereinafter explained in detail with reference to FIG. 7 . Note that the mark MK is not illustrated in FIG. 7 for better view of the ability indicator NM. As illustrated in FIGS. 5 and 7( a ), the ability indicator NM displayed on the television monitor 20 has constant thickness in the default state. In this case, the batter character 71 's velocity adaptability data DT (V (m)) of each level is set to be “DT 0 ” (=1.0). In other words, when the velocity adaptability data DT (V (m)) is “DT 0 ” (=1.0), the constant-thickness ability indicator NM is displayed on the television monitor 20 as illustrated in FIGS. 5 and 7( a ). On the other hand, when the velocity adaptability data DT (V (m)) is changed, value of the velocity adaptability data DT (V (m)) becomes greater than or less than “DT 0 ” (=1.0). Accordingly, as illustrated in FIGS. 7( b ) and 7 ( c ), thickness of the ability indicator NM displayed on the television monitor 20 is changed depending on the changed velocity adaptability data DT (V (m)). In the example of FIG. 7( b ), the velocity adaptability data DT (V (m)) is changed when fastballs of 150 km/h (m=10) are successively released three times. In FIG. 7( b ), the batter character 71 came to be used to the fastball of 150 km/h, and a portion of the ability indicator corresponding to the level 10 reflects its influence. When a game player watches the ability indicator illustrated in FIG. 7( b ), he/she is capable of confirming that the batter character 71 is accustomed to the fastball of 150 km/h. In other words, FIG. 7( b ) indicates that the batter character 71 hits the ball object with high possibility when the pitcher character 70 releases the ball object of approximately 150 km/h in the next at-bat. Therefore, a game player is capable of judging that the pitcher character 70 has greater risk of being got hammered when releasing the ball object of the velocity level corresponding to the ability indicator NM's thicker portion. In general, the more the ball velocity becomes fast, the more the pitcher character 70 becomes advantageous over the batter character 71 . However, a game player may choose a strategy for causing the pitcher character to throw a slow ball based on the above-mentioned information. Thus, the present baseball video game is provided with useful information for a pitching plan while the conventional baseball video games have not been provided with the information. Accordingly, the present baseball video game is capable of highly entertain a game player. Also, in the example of FIG. 7( c ), the velocity adaptability data DT (V (m)) is changed when the pitcher character 70 released a curveball of 120 km/h (m=4) after consecutively releasing fastballs of 150 km/h (m=10) three times. In FIG. 7( c ), the batter character 71 came to be used to a curveball of 120 km/h, and a “level 4” portion of the ability indicator reflects its influence. In addition, the batter character 71 also came to be used to a fastball of 150 km/h, and a “level 10” portion of the ability indicator reflects its influence. Thus, before the match-up between the pitcher character 70 and the batter character 71 is finished, the ability indicator is configured to reflect influence of the immediately-preceding ball object's velocity and is also configured to keep influence of the past-released ball object's velocity. When a game player watches the ability indicator illustrated in FIG. 7( c ), he/she is capable of confirming that the batter character 71 is accustomed to the ball object of 120 km/h and is still accustomed to the ball object of 150 km/h. Thus, according to the present embodiment, the ability indicator is configured to reflect the batter character 71 's velocity adaptability data for the past pitching results based on the change frequency ih (m) of the velocity adaptability data and the weighted data DW (ih (m)) corresponding to the change frequency. Therefore, it is possible to visually express the remaining influence of the past released ball experienced by a real baseball's batter in the video game. Thus, according to the present embodiment, the ability indicator is configured to inform a game player of the batter character 71 's velocity adaptability for the ball object's velocity from the start till the end of the match-up between the pitcher character 70 and the batter character 71 . Based on the information of the ability indicator NM, a game player is capable of giving the pitcher character 70 a command of pitching. Then, a game player is capable of effectively obtaining a pitching method for a pitcher character. Accordingly, a game player is able to effectively make a batter character out, and further enjoys amusement of the baseball video game. Furthermore, a game player is capable of experiencing a feeling of a real baseball's pitcher in the baseball video game. Other Example Embodiment (a) In the above-mentioned embodiment, the home video game device is used as an example of a computer that the game program is allowed to be applied. However, the game device is not limited to the above-mentioned embodiment. The game device may be applied to a game device that a monitor is separately provided, a monitor-integrated game device, a personal computer or a workstation functioning as a game device when a game program is executed therein, and the like, as well. (b) The present invention includes a program for executing the above-mentioned game and a computer-readable recording medium storing the program. For example, a computer-readable flexible disk, a semiconductor memory, a CD-ROM, a DVD, a MO, and a ROM cassette may be suggested as the recording medium other than the cartridge. (c) In the above-mentioned embodiment, the velocity data relating to the ball object's velocity is used as the ball object's property data. However, the ball object's property data is not limited to the above-mentioned embodiment, and may be any type of data as long as the data relates to a ball object's property. For example, variation data relating to the ball object's variation may be used instead of the ball object's velocity data. Also, both of the ball object's velocity data and the ball object's variation data may be used. In this case, the television monitor 20 displays an ability indicator for informing a game player of batter character's variation adaptability, that is, an ability indicator for informing a game player of batter character's adaptability for breaking-ball. Therefore, a game player is capable of evaluating the batter character's variation adaptability and effectively giving a pitcher character a command while watching the ability indicator. Accordingly, a game player is capable of effectively acquiring a pitching method. Furthermore, a game player is capable of realistically having a feeling of a real baseball's pitcher. General Interpretation As used herein, the following directional terms “forward, rearward, above, downward, vertical, horizontal, below and transverse” as well as any other similar directional terms refer to those directions of a device equipped with the present invention. Accordingly, these terms, as utilized to describe aspects of the present invention, should be interpreted relative to a device equipped with the present invention. The term “configured” as used herein to describe a component, section or part of a device includes hardware and/or software that is constructed and/or programmed to carry out the desired function. Terms that are expressed as “means-plus function” in the claims should include any structure that can be utilized to carry out the function of that part of the present invention. The term “comprising” and its derivatives, as used herein, are intended to be open ended terms that specify the presence of the stated features, elements, components, groups, integers, and/or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers and/or steps. The foregoing also applied to words having similar meanings such as the terms, “including,” “having,” and their derivatives. Also, the term “part,” “section,” “portion,” “member,” or “element” when used in the singular can have the dual meaning of a single part or a plurality of parts. The terms of degree such as “substantially”, “about” and “approximately” as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. While only selected embodiments have been chosen to illustrate the present invention, it will be apparent to those skilled in the art from this disclosure that various changes and modifications can be made herein without departing from the scope of the invention as defined in the appended claims. Furthermore, the foregoing descriptions of the embodiments according to the present invention are provided for illustration only, and not for the purpose of limiting the invention as defined by the appended claims and their equivalents. Thus, the scope of the invention is not limited to the disclosed embodiments.

The present invention is related to controlling a video game in which ability of a game character is adjusted on the basis of events in the video game. For example, in a baseball video game, if the game player operating a pitcher character keeps selecting a pitching trajectory that a batter character is bad at hitting the ball object, the extent that the batter character is bad at hitting the ball object in the pitching trajectory will be gradually reduced. Therefore, it becomes difficult for the pitcher character to make the batter character out. Accordingly, advantageous level for the pitcher character will be reduced. Therefore, imbalance of the baseball video game is to be solved between the pitcher character and the batter character.

FIELD OF THE INVENTION This application relates to a novel device having particular utility for the storage of liquids and/or the controlled, delivery of stored liquids to a plant growth environment over a period of time. BACKGROUND OF THE INVENTION In the cultivation of plant life, it is essential that they be timely provided with water and/or other liquid nourishment. Traditionally, the gardener relies upon nature to provide periodic rainfall for plants under cultivation but, when nature doesn't respond or cultivation is undertaken in an area unaffected by rainfall, the gardener must provide water and/or other liquid nourishment to the plants. Typically, water and/or other liquids are provided by portable sprayers or cans or even spraying from hoses driven from feeding water. Such methods are time consuming and can involve heavy and tiring labor. In addition the spraying of plants directly involves the use of significantly more liquid than may be necessary and can cause damage to plants. Thus it is preferred to apply the water and/or liquid directly to the roots or the soil adjacent the roots of a plant to allow the most efficient utilization of the liquid. There is a continuing need for an efficient means to provide water to the roots of a plant over a prolonged period of time. There is also a continuing need to provide liquids containing nutrients and the like to the plant root structure. An object of the present invention is to provide a novel device for providing liquids such as water, with or without added nutrients and the like, to a plant. Another object of the invention is to provide a novel device that will store liquids and the like and provide same to the plant in a controlled manner. A still further object of the invention is to provide a device which allows minimal maintenance and will automatically provide liquids to a plant in preset volumes. These and other objects of the invention will become apparent from the following description of the invention. SUMMARY OF THE INVENTION The instant invention features a novel plant watering system arranged in a combination comprising a container for storing a fluid; a hollow, fluid distribution member that has an inlet in fluid communication with a lower portion of the storage container and contains a plant feeder outlet and a fluid transmission outlet; and a remote plant feeder member. The fluid transmission outlet is configured to have an interior surface that engages the exterior surface of a fluid transmission tube that can be inserted through the fluid transmission outlet into the distribution member. The fluid distribution member also contains a plant feeder outlet, an opening of which is arranged along the path the fluid transmission tube follows into the distribution member, such that the opening is partially or fully closed by the surface of the tube in response to the distance the tube is inserted through the fluid transmission outlet into the distribution member. Thus, as fluid flows from the storage container to the distribution member it will flow out the plant feeder outlet in an amount controlled by the distance the tube is inserted into the distribution member. In one embodiment, the tube extends from the fluid transmission outlet to a remote plant feeder member. The remote plant feeder member has a fluid transmission inlet with an interior surface configured to engage the exterior surface of the tube and a plant feeder outlet, arranged in the manner of the plant feeder outlet of the distribution member such that the amount of fluid flowing from the outlet is controlled by varying the distance the tube is inserted through the fluid transmission inlet into the remote plant feeder member. In another embodiment of the invention the plant feeder member also comprises a fluid transmission outlet for distribution of fluid to a further plant feeder member or the like. The fluid transmission outlet of the plant feeder member may be configured to engage the exterior surface of a tube so that fluid flow through the plant feeder outlet can be controlled by the distance the tube is inserted into the outlet and/or the insertion of the tube through the inlet. In still another embodiment of the invention a fluid transmission tube may be blocked or comprise a rod, plug or the like, such that liquid flow through the plant feeder outlet in a plant feeder member or distribution member can be controlled but fluid does not flow through the fluid transmission outlet. In typical operation of the invention the liquid storage container is positioned such that the bottom portion thereof is at or above soil level, with the plant feeder outlet of the hollow distribution member being proximate the area where the stem of a plant emerges from the soil. A fluid transmission tube is arranged to extend from the fluid transmission outlet of the hollow distribution member to a remote plant feeder member positioned proximate a second plant where fluid is desired to be delivered and so forth. It should be understood that the distribution member, tubes and plant feeder members can also be arranged below soil level if desired. The tube may also comprise one or more diverter or other couplings that allow division of the fluid flow through the fluid transmission tube to other plant feeder members. Thus, fluid flows freely from the container through the distribution member and the fluid transmission tube to the various remote plant feeder members, controlled by the size of the tubing and the fluid transmission inlets and outlets. The volume of fluid flow, through the plant feeder outlet of the hollow distribution member or a remote plant feeder member is controlled by varying the distance that the tube inserts into the member. Thus, insertion of the tube to various prescribed distances can allow controlled partial or full closure of a plant feeder outlet as desired for the particular area receiving the liquid. For example, the plant feeder outlet at the distribution member can be adjusted to allow more or less fluid flow than a remote plant feeder member or other plant feeder members. It should be understood that fluid flow can be the same, different, full, partial or even blocked at each plant feeder outlet. A plant feeder member may also contain a fluid transmission outlet configured to engage the exterior surface of the tube and/or a further tube to allow transmission of fluid to a further plant feeder member and the like. The storage container, distribution member and plant feeder members are generally manufactured to a desirable ornamental appearance. Thus, the storage compartment may be in the form of a plant or any other desirable ornamental object. Generally the storage container, distribution member and plant feeder members are manufactured from a ceramic or plastic material or the like. The tubing is generally formed from a flexible plastic material such as neoprene or the like. The lower portion of the container is typically formed with the hollow distribution member being an integral part thereof but such may be a separate member. The placement of the outlet to the distribution member is typically at a lower portion of the container reservoir to allow gravity flow of the liquid in the container thereto. It should be understood that it is contemplated as within the invention to include pressurized flow of fluid through the system. Generally it is desirable to have a means for indicating the level of fluids in the container. The container may be transparent to allow visual observation of the fluid level and/or may contain a float indicator or the like. One particularly desirable indicator is a float comprising a rod that extends through the top of the container. The amount of rod extending from the container provides convenient visual indication of fluid level BRIEF DESCRIPTION OF THE DRAWINGS FIG.1 is a perspective view of a plant watering system of the invention in an operating position. FIG. 2 is a sectional view of a liquid storage container with elongated member and fluid transmission tube. FIGS. 3 through 7 are sectional views of various plant feeder members identified in FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the FIG. 1 wherein is illustrated an embodiment of the plant watering system of the invention, comprising storage container 1, ornamentally illustrated in the general form of a mushroom. The storage container comprises an upper reservoir portion 20, middle reservoir portion 21, lower reservoir portion 22 and bottom spike 23. In the illustrated embodiment hollow distribution member 2 is configured as integral with lower reservoir portion 22 of the storage container. The upper reservoir portion has a filling inlet with removable cover 24. Float stick 26, is illustrated as having indicator knob 28, and extends through hole 29 in cover 24 to the exterior of the storage container. Transmission tube 3 extends from hollow distribution member 2 to first plant feeder member 4. Tube 3a extends from plant feeder member 4 to diverter coupling 5 whereupon tubes 3b and 3c extend to second and third plant feeder members 6 and 7 respectively. Tube 3d extends from third plant feeder member 7 to fourth plant feeder member 8 comprising plug 9. In the illustrated system, storage container 1 is arranged in an embodiment such that lower reservoir 22 is below soil level 11, with hollow distribution member 2 being arranged proximate the roots of plant 10a. Plant feeder members 4,6,7 and 9 are similarly arranged proximate the roots of plants 10b-10e below soil level. It should be understood that it is contemplated as within the invention that lower reservoir 22 and/or hollow distribution member 2 be also arranged above soil level 11 and that plant feeder members 4,6,7 and 9 be arranged above or below soil level as desired. In the operation of the system of the invention, it is not necessary for plant feeder members to be at the same level with each other or the hollow distribution member. Preferably, the system will rely upon gravity flow of fluid from storage of fluids at a higher level to plant feeder outlets of plant feeder members arranged at lower levels. It is, however, contemplated that pressure can be imposed upon the system for fluid flow that does not rely upon gravity alone. FIG. 2 provides a sectional view of storage container 1 with integral hollow distribution member 2. Therein, float stick 26 is illustrated as extending through hole 29 and having float 27 attached thereto. Float 27 is comprised of a material which will float on the surface of fluids in the container such that upward and downward movement of the float causes the stick to move upwardly and downwardly through hole 29 in response to the fluid level within upper reservoir 20. Fluid is added to storage container 1 through inlet 12 which has a removable cover 24. Fluid flows from upper reservoir portion 20 to middle reservoir portion 21 and lower reservoir portion 22, through inlet 30 to hollow distribution member 2. Hollow distribution member 2 contains a plant feeder outlet which comprises a series of holes 25. An end of fluid transmission tube 3 is inserted into fluid transmission outlet 13 of hollow distribution member 2 such that the exterior surface of tube 3 engages an interior surface of the hollow distribution member to form a fluid seal. Holes 25 are arranged such that the number of holes covered and/or the opening of said holes varies with the distance said end of said tube is inserted into said fluid transmission outlet. Thus, the opening of the plant feeder outlet varies with the distance said end of said tube is inserted into said fluid transmission outlet. It should be understood that it is also contemplated as within the invention that the plant feeder outlet comprise one or more slots, elongated holes or the like that may be similarly fully or partially covered. FIGS. 3-7 illustrate various embodiments of plant feeder members of the invention. In FIG. 3, plant feeder member 4 comprises an elongated hollow member having slot 36 therein. Incoming fluid transmission tube 31 inserts into inlet 33 and engages an interior surface of the plant feeder member such that the opening of the slot varies with the distance the incoming tube inserts into the member. Outgoing tube 32 is inserted in outlet 34. In FIG. 4, plant feeder member 4 comprises an elongated hollow member having a series of holes 35 therein. Incoming fluid transmission tube 31 inserts into inlet 33 and engages an interior surface of the plant feeder member such that the number of holes covered and/or the extent of covering a hole, varies with the distance the incoming tube inserts into the member. Outgoing tube 32 is inserted in outlet 34. In FIG. 5, plant feeder member 7 comprises an elongated hollow member having a series of holes 35 therein. Incoming fluid transmission tube 31 inserts into inlet 33 and outgoing tube 32 is inserted in outlet 34 which engages an interior surface of the plant feeder member such that the number of holes covered and/or the extent of covering a hole, varies with the distance the outgoing tube inserts into the member. In FIG. 6, plant feeder member 8 comprises the plant feeder member of FIG. 4 being an elongated hollow member having a series of holes 35 therein. Incoming fluid transmission tube 31 inserts into inlet 33 and engages the interior surface of the plant feeder member such that the number of holes covered and/or the extent of covering a hole, varies with the distance the outgoing tube inserts into the member. Outlet 34 comprises plug 9. In FIG. 6, plant feeder member 6 comprises an elongated hollow member having a series of holes 35 therein. Incoming fluid transmission tube 31 inserts into inlet 33 and engages the interior surface of the plant feeder member such that the number of holes covered and/or the extent of covering a hole, varies with the distance the outgoing tube inserts into the member.

The invention comprises a liquid storage container having a plant feeder outlet and a fluid transmission outlet arranged to accept a tube, the distance it inserts into the fluid transmission outlet determining the volume of fluid which is allowed to flow from the plant feeder outlet. The invention includes a system of remote plant feeder members connected through said tube and allowing delivery of controlled volumes of fluid to one or more plants.

BACKGROUND OF THE INVENTION This invention relates generally to devices providing for the carrying of an infant by an adult. More specifically, the invention relates to a flexible infant carrier which may be adjusted to accommodate several different configurations, including one configuration orienting the infant carrier such that the infant is facing the adult, another configuration wherein the infant is facing the adult draped with a sling to serve as an additional protector, yet another configuration wherein the infant is facing outward, in the direction the adult is facing, and finally, two sling configurations, one wherein the infant is cradled in a sling attached to the harness at five points to facilitate private nursing and another wherein the sling is attached to the harness at four points to facilitate carrying the infant. The demands of today's fast-paced society have created a need for an device by which an adult attendant may carry an infant without compromising the free and independent movement and volition of the adult's shoulders and arms. In order to accomplish the everyday tasks associated with caring for a child, an adult must oftentimes take the infant on errands and chores. Responding to this problem, many devices have been created to provide an adult with hands-free carriage of an infant, thereby allowing the adult to perform routine tasks while still caring for the infant. Numerous devices have been developed over the years for providing a carrier for an infant which is supported by the body of the wearer. Perhaps the most prevalent type of carrier is the so-called backpack type which supports the infant from the shoulders of the wearer and positions the infant on the back of the wearer, much like a conventional backpack. For example, U.S. Pat. No. 3,179,100 to Thompson discloses a backpack carrier for carrying a child in a piggy-back fashion comprising a unitary flexible body of elongated generally rectangular form defining front and rear end portions at opposite ends, including a pair of shoulder encircling loops connected to opposite sides of the front end portion for application to the shoulders of the person carrying the child. Back carriers of this type present several disadvantages among which it is noted that after the carrier is positioned on the shoulders, it is difficult to get the child into the carrier and remove him therefrom. The difficulty and awkwardness associated with mounting and dismounting a backpack type infant carrier presents serious problems. Also, back-worn infant carriers do not provide the wearer with face-to-face contact with the infant or the ability to observe the infant. Although front-worn carriers address some of these problems, the known front-worn carriers may oftentimes prove to be cumbersome and awkward to use. In many cases, mounting and dismounting the infant is difficult as well as awkward, more often than not requiring assistance. For example, U.S. Pat. No. 4,724,988 to Tucker discloses an infant carrier which provides for the forward facing carriage of an infant at the front of an adult. The device includes panels and shoulder harnesses configured so that when the infant carrier is worn, the infant is received within the carrier with its buttocks resting against the region where the front and back panels are attached and with the back of its thighs supported by the front panel. The carrier also provides a four way restraint system for the infant, comprised of two shoulder straps and two lateral restraints. However, the multiplicity of straps and restraints associated with this invention make mounting and dismounting cumbersome and time consuming. Akin to backpack type carriers, the difficulty and awkwardness is primarily attributable to the fact that the infant must remain in the carrier during mounting and dismounting of the carrier from the shoulders of the wearer unless assistance is available. There are carriers which may carry the infant on the wearer's back as well as the wearer's front and which may permit the infant to be carried either forward facing (away from the wearer) or rearward facing (toward the wearer). For example, U.S. Pat. No. 4,402,440 to Purtzer et al. discloses an infant carrier with two major components, a harness and a pouch. The harness has a generally rectangular fabric panel which is strapped to the body by means of shoulder straps and waist straps. The harness has a pair of upper and lower dowel receiving rings. The pouch has two leg holes and a back and head support section. The pouch is detachably engaged with the harness by means of four dowels which mate with the dowel receiving rings of the harness. The harness can be mounted on the front of the person or the back of the person depending on where the child is to be carried, either front or back respectively. The pouch can also be mounted to the harness in either a forward facing or rearward facing orientation. However, this carrier suffers the disadvantage that the pouch portion is not easily and conveniently detachable from, or attachable to, the harness portion with the infant in the pouch, since it requires the wearer to disengage, or engage, each of the dowel and ring connections at four attachment points. Carriers of a sling type have also been provided, generally supported from a shoulder of the attendant. The infant is retained in position by virtue of the sling support depending from the wearer's shoulders. For example, U.S. Pat. No. 4,986,458 to Linday discloses an infant carrier adaptable to support an infant selectively and interchangeably on the front or on the side of an adult. The carrier includes a child supporting flexible pouch and an integral harness, wherein the harness includes adjustable shoulder straps and an adjustable girth strap and the pouch has draw cord means for adjusting the configuration of the pouch. The girth strap has complimentary coupling members adjustably located toward the outer free ends thereof to permit the girth to be coupled to provide a lower torso encircling loop. Sling carriers have the notable disadvantage of being limited for use with only small infants and generally are incapable of adjusting for an infant's growth. Moreover, the attendant's hands sometimes must be used to cradle the child while in the sling, as the sling sometimes does not provide for adequate support of the child. The foregoing demonstrates a need for a front infant carrier which (1) allows for quick and easy removal of the infant from the carrier; (2) allows the child to be oriented either forward-facing or rearward facing; (3) distributes the weight of the infant for the comfort of the wearer; and (4) provides a sling that can support the infant. SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to overcome the deficiencies noted above. The front infant carrier of the invention meets these needs and overcomes the disadvantages and drawbacks of the prior art by providing a front infant carrier which includes a vest-like harness that is worn by the attendant, a detachable infant shell, and a sling. The vest-like harness includes a rear belt portion which provides for distribution of the infant's weight to the wearer's lower back. The detachable infant shell attaches to the harness at three attachment points, either in a forward-facing or rearward-facing orientation. In the rearward-facing position, the shell attaches to the harness by a peg/button mounted at the crotch of the shell which snaps into a socket centrally mounted at the lower front of the harness, and by a pair of upper clips on the shell which engage clips on the upper front of the harness. In the forward-facing position, the shell attaches using a second peg/button at the lower back portion of the shell, instead of the crotch peg/button, and attaches in a similar fashion, whereby the second peg/button snaps into the socket centrally mounted at the lower front of the harness, and the pair of upper clips on the shell engage the clips on the upper front of the harness. A sling may also be attached to the harness at five points, the sling having a third peg/button which mates with the socket centrally mounted at the lower front of the harness, a pair of upper clips which engage rings located on the upper front of the harness just above the harness mounting clips and straps on the lower corners of the sling that clip to side clips or the waist belt of the harness. The sling also may be attached with both upper clips mounted to one of the rings, so that the disengaged shell and carried infant may be rested sideways within the sling. The sling is reinforced with sewn-in battens to help provide support for the infant to rest in the sling alternatively without the shell. In another configuration, the sling surrounds the outside of the shell and serves as a weather guard or privacy element. When the sling is used as a weather guard to surround the shell attached to the harness, then the third peg/button is not used, since one of the shell pegs/buttons is connected to the socket. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a perspective view of the front infant carrier constructed in accordance with a preferred embodiment the invention when in its rearward facing position; FIG. 2A shows a perspective view of the front infant carrier when in its rearward facing position; FIG. 2B shows a perspective view of the front infant carrier when in its rearward facing position with the sling serving as a weather protector; FIG. 2C shows a perspective view of the front infant carrier when in its forward facing position; FIG. 2D shows a perspective view of the front infant carrier when utilizing the sling as a privacy shield; FIG. 2E shows a perspective view of the front infant carrier when utilizing the sling as a carrier; FIG. 3 is a front view of the harness; FIG. 4 shows a perspective view of the socket; FIG. 5 is a rear view of the harness; FIG. 6 is a front view of the shell; FIG. 7 is a rear view of the shell; FIG. 8 is a front view of the sling; FIG. 9A illustrates the interaction between the infant and the shell; FIG. 9B illustrates the interaction between the socket and the shell when the shell is oriented facing the wearer; FIG. 9C illustrates the interaction between the harness and the shell when the shell is oriented facing the wearer; FIG. 9D illustrates the interaction between the support belt and the sling when the sling is utilized as a weather protector; FIG. 9E illustrates the interaction between the D-clips on the harness and the J-hooks on the sling when the sling is used as a weather protector; FIG. 10A illustrates the interaction between the socket and the shell when the shell is oriented away from the wearer; FIG. 10B illustrates the interaction between the harness and the shell when the shell is oriented away from the wearer; FIG. 11 illustrates the interaction between the socket and the sling when the sling is used as a carrier with the shell not attached to the harness; FIG. 12 illustrates the interaction between the D-clips on the harness and the J-hooks on the sling when the sling is utilized as a carrier in an of itself; FIG. 13 is a front view of the bib portion. DETAILED DESCRIPTION The invention is described and illustrated below in the context of an infant carrier, although the invention may be applicable to other devices. Referring to FIGS. 1 to 13 of the attached drawings, preferred embodiments of the present invention will now be described. A front infant carrier 10 is illustrated generally in FIG. 1 and FIGS. 2A through 2E. The major components of the front infant carrier are a harness 100, a shell 200, a sling 300 and a bib attachment 400. As further described below, the shell 200 releasably attaches to the harness 100 in one of two ways, either facing forward (away from the wearer) or facing rearward (toward the wearer). In addition, the sling 300 may be attached to the harness 100 with or without the shell 200 attached to the harness 100. As shown in detail in FIGS. 3 and 5, the harness 100 includes first and second shoulder straps 102, 104 integrally connected and worn in a criss-crossed fashion. The first and second shoulder straps 102, 104 terminate in front of the wearer to form a u-shaped generally flat lower front portion 106. Centered within and permanently affixed to the u-shaped generally flat lower front portion 106 is a socket 108, the socket 108 serving as one of three attachment points for either the shell 200 or the sling 300. As illustrated in detail in FIG. 4, the socket 108 is generally u-shaped having flared upper ends 110 and terminating in a generally circular cavity 112, whose use will become apparent below. Laterally existing on both sides of the socket 108 are first and second waist receiving tethers 114, 116 terminating in first and second waist strap receiving buckles 118, 120. Traversing upward on the front of the harness 100 are first and second pockets 122, 124 followed by first and second shell receiving tethers 126, 128. The first and second shell receiving tethers 126, 128 terminate in first and second shell receiving buckles 130, 132. Directly above the attachment points for the first and second shell receiving tethers 126, 128 are first and second bib receiving snaps 134, 136 for receiving the detachable bib 400. Traversing further up the first and second shoulder straps 102, 104, permanently affixed above the first and second bib receiving snaps 134, 136, are first and second D-rings 138, 140. Permanently affixed to the second shoulder strap 104 is a shoulder tether 142, serving to hold the second shoulder strap 104 in a criss-cross position in relation to the first shoulder strap 102. As best illustrated in FIG. 5, the first and second shoulder straps 102, 104 terminate behind the wearer in first and second shoulder adjustment buckles 144, 146. As discussed in more detail below, the first and second shoulder adjustment buckles 144, 146 exist to adjust the length of the first and second shoulder straps 102, 104. First and second support belt connection straps 148, 150, which interact with the first and second shoulder adjustment buckles 144, 146, serve both to connect the first and second shoulder straps 102, 104 to the support belt 152 and to adjustably fit the harness 100 to its wearer. Referring back to FIG. 3, permanently attached along the lateral expansion of the support belt 152 are first and second waist straps 154, 156. The first and second waist straps 154, 156 terminate in first and second waist strap buckles 158, 160, which mate with the first and second waist strap receiving buckles 118, 120 attached to the front of the harness 100. First and second sling receiving tethers 162, 164, terminating in first and second sling receiving buckles 166, 168 (shown in FIG. 9D) are permanently attached to the support belt 152 at the same location as the first and second waist straps 154, 156. The shell 200 is the enclosure in which the infant resides. Reference is now made to FIGS. 6, 7 and 9A wherein the shell 200 of the present invention is illustrated. The shell 200 includes lower, center and upper portions 202, 204, 206, the center portion 204 separating the upper and lower portions 202, 206, much like a conventional diaper. The shell 200 further includes a front surface 208 and a rear surface 210. The front surface 208, shown in detail in FIG. 6, has a lower portion 202 with upper attributes shaped to accommodate the infant's legs and lower attributes to cover the infant's torso when the infant is secured in the shell 200. The lower portion 202 includes first and second side flap fasteners 212, 214, whose use will become apparent below. Along the periphery of the upper portion 206 are first and second cushion ears 216, 218, which serve to protect and comfort the infant while nestled within the shell 200. Attached near the attachment points of the first and second cushion ears 216, 218 are first and second chest straps 220, 222. The first and second chest straps 220, 222, having first surfaces 224, 225 and second surfaces 226, 227, include first and second chest strap fastening means 228, 230. In a preferred embodiment, the first and second chest strap fastening means 228, 230 are comprised of a conventional hook and loop fastener construction. Located on the first surface 224 of the first chest strap 220 is the first chest strap fastening means 228. Located on the second surface 227 of the second chest strap 222 is of the second chest strap fastening means 230. Commencing near the attachment points of the first and second chest straps 220, 222 and traversing the upper periphery of the upper portion 206 of the shell 200 is a padded infant head support portion 236. Included within the upper portion 206 of the shell 200 is a rigid battens 238 (shown in hidden lines), which serves to reinforce the structure of the shell 200 and to provide additional comfort to the infant. Illustrated in detail in FIG. 7 is the rear surface 210 of the shell 200, which is described below. Permanently attached to the lower portion 202 of the rear surface 210 of the shell 200 are first and second side strap tethers 213, 215 to which are attached first and second side strap slip buckles 216, 218. Located near the intersection between the lower portion 202 and the center portion 204 is a first attachment button 240. Permanently attached to the lower aspects of the upper portion 206 are first and second elongated side flap receiving fasteners 242, 244. The first and second elongated side flap receiving fasteners 242, 244 are affixed to the shell 200 and shaped to mate with the first and second side flap fasteners 212, 214 in an adjustable manner. Centered and permanently attached to the lower aspects of the upper portion 206 is a second attachment button 246, which may be identical in shape to the first attachment button 240. Above the second attachment button 246, and attached to the upper portion 206 by third and fourth side strap tethers 248, 250 are first and second side strap receiving buckles 252, 254. Located near the attachment points of the first and second cushion ears 216, 218 and spanning the distance therebetween is a shell tether 256. The shell tether 256 is permanently attached to the fabric comprising the upper portion 206 of the shell 200 and terminates at either end in first and second shell buckles 258, 260. With reference to FIG. 8, the sling 300 will now be described. The sling 300 is generally rectangular in shape, having first and second vertical edges 302, 304, upper and lower horizontal edges 306, 308, and an upper sling portion 310. Integrated along the first and second vertical edges 302, 304 are first and second drawstring 311, 312. Similarly, a horizontal drawstring 314 is integrated along the upper horizontal edge 306. Permanently affixed at the intersection between the upper and lower vertical edges 302, 304 and the upper horizontal edge 306 are first and second J-hooks 316, 318. In close proximity to the upper horizontal edge 306 is the upper sling portion 310. The upper sling portion 310 is generally semi-elliptical in shape and is separated at its midpoint into two halves. The upper sling portion 310 is reinforced by stitching to provide for a more rigid structure. Residing along the lower horizontal edge 308 is a sling tether 322. Located at the terminal ends of the sling tether 322 are first and second sliding sling buckles 324, 326. Located slightly above the second horizontal edge 308 is a sling attachment button 328. The sling 300 is reinforced with sling battens 330 (shown in hidden lines) which provides additional support and shape to the sling to permit the infant to safely and comfortably rest in the sling 300 without the sling folding over or buckling when the infant is placed in the sling 300 without being in the shell 200. The sling 300 is an optional component of the invention. Accordingly, one embodiment of the invention is possible without the sling 300 and the D-rings 138, 140 and the sling receiving buckles 166, 168. OPERATION The operational characteristics of this invention will now be described. In general, the operative configurations, illustrated in FIGS. 2A through 2E, require the attendant to wear the harness 100. Referring back to FIGS. 3 and 5, the first and second shoulder straps 102, 104 are draped over the attendant's shoulders, allowing the u-shaped generally planar portion 106 to rest near the attendants waistline. The harness 100 is positioned such that the first and second waist straps 154, 156 are around the attendant's waist and the support belt 152 rests on the attendant's lower back. The first and second waist strap receiving buckles 118, 120 are then mated with the first and second waist strap buckles 158, 160. The interaction between the first and second waist straps 154, 156 and the first and second waist strap buckles 158, 160 allow the attendant to adjust the harness 100 to fit the attendant. In order to adjust the length of the harness 100 to the length of the attendant's torso, the attendant pulls on the terminal ends of the first and second support belt connection straps 148, 150, causing the first and second support belt connection straps 148, 150 to slide in relation to the first and second shoulder adjustment buckles 144, 146. Referring back to FIGS. 6, 7 and 9A, the method of placing the infant in the shell will now be described. The shell 200 is placed on a level surface, orienting the shell 200 such that the front surface 208 is visible and the padded infant head support portion 236 is at the top. The infant is placed on the shell 200 so that the infant's head is resting just below the padded infant head support portion 236. The first and second chest straps 220, 222 are connected across the infant's chest, below the infant's arms, by mating the first chest strap fastening means 228, located on the first surface 224 of the first chest strap 220, with the second chest strap fastening means 230, located on the second surface 226 of the second chest strap 222 (designated by Arrow X in FIG. 9A). The lower portion 202 of the shell 200 is lifted between the infant's legs, much like a conventional diaper, so that the rear surface 210 of the lower portion 202 is now visible (designated by Arrow Y in FIG. 9A). The first and second side strap slip buckles 216, 218 are inserted into the first and second side strap receiving buckles 252, 254, effectively securing the lower portion 202 of the shell 200 around the infant's torso. The interaction between the first and second side strap tethers 213, 215 and the first and second side strap slip buckles 216, 218 allows the attendant to adjust the size of the shell to fit the infant therein. Completing the process, the first and second side flap fasteners 212, 214, permanently affixed to the front surface 202 of the shell 200, are mated with the first and second elongated side flap receiving fasteners 242, 244, permanently affixed to the rear surface 210 of the shell 200. The elongated aspects of the first and second elongated side flap receiving fasteners 242, 244 allow the attendant to adjustably fit the lower portion 202 of the shell 200 around the infant. The interaction between the harness 100 and the shell 200 will now be described. The attendant has the option of orienting the infant so that he is either facing the attendant or facing the direction in which the attendant is traversing. When orienting the front infant carrier so that the infant is facing the attendant, the attendant may want to attach the optional bib portion 400 to the harness 100 to prevent the attendant's clothing from getting soiled, as infants up through the teething stage tend to drool almost continuously and also regurgitate small amounts of their food or milk, especially following a feeding. The bib portion 400, illustrated in FIG. 13, is attached by mating the first and second bib receiving snaps 134, 136 with the first and second bib snaps 402, 404. The infant, already fitted within the shell 200 in the manner described above, is held by the attendant so that the attendant and the infant are face-to-face. As illustrated by Arrow A in FIG. 9B, while supporting the infant's back and bottom, the attendant inserts the first attachment button 240, located near the intersection between the lower portion 202 and the center portion 204 of the shell 200, into the top of the socket 108 (shown in detail in FIG. 4), which is affixed to the u-shaped generally planar portion 106 on the front of the harness 100. The first attachment button 240 is slid down within the socket 108 until it rests within the generally circular cavity 112 (shown in FIG. 4). Cradling the infant with one arm, the attendant further secures the shell 200 to the harness 100 by mating the first and second shell buckles 258, 260 with the first and second shell receiving buckles 130, 132 (as shown in FIG. 9C). The interaction between the first and second shell receiving buckles 130, 132 and the first and second shell receiving tethers 126, 128 allows for adjusting the distance between the attendant's torso and the infant. Orienting the infant so that the infant faces the attendant provides the attendant with the option of attaching the sling 300 to the harness 100, utilizing the sling 300 as a weather protector. As illustrated in FIG. 9D, to secure the lower aspects of the sling 300 to the harness 100, the first and second sliding sling buckles 324, 326, located on the sling 300 at the second horizontal edge 308, are mated with the first and second sling receiving buckles 166, 168, which are attached to the support belt 152. Since the first shell attachment button 240 of the shell is mounted in the socket 108, the sling attachment button 328 is not used. The upper aspects of the sling 300 are secured to the harness 100 by attaching the first and second J-hooks 316, 318, which are permanently affixed at the intersection between the first and second vertical edges 302, 304 and the first horizontal edge 306, to the first and second D-rings 138, 140 on the harness 100, as illustrated in FIG. 9E. To gather the sling 300 (serving as a weather protector in this instance) around the infant as shown in FIGS. 2B and 9E, the attendant pulls and ties the first and second drawstrings 310, 312 which are integrated along the first and second vertical edges 302, 304. To gather the sling 300 over the top of the infant's head, the attendant pulls and ties the horizontal drawstring 314 which is integrated along the first horizontal edge 306. In an effort to allow the infant to interact directly with the outside environment, the shell alternatively may be positioned so that the infant is facing the direction the attendant is traveling. The infant, already fitted within the shell 200 in the manner described above, is held by the attendant so that file infant is facing away from the attendant. As illustrated by Arrow B in FIG. 10A, while supporting the infant with one arm, the second attachment button 246, which is attached to the rear surface 210 of the upper portion 206 of the shell 200, is inserted into the top of the socket 108, which is affixed to the u-shaped generally planar portion 106 on the front of the harness 100. The second attachment button 246 is slid down within the socket 108 until it rests within the generally circular cavity 112. Cradling the infant with one arm, the attendant further secures the shell 200 to the harness 100 by mating the first shell buckle 258 with the second shell receiving buckle 132 and mating the second shell buckle 260 with the first shell receiving buckle 130 (as shown in FIG. 10B). The interaction between the first and second shell receiving buckles 130, 132 and the first and second shell receiving tethers 126, 128 allows for adjusting the distance between the attendant's torso and the infant. In addition to using the sling 300 as a weather protector when the shell 200 is attached to the harness 100, it may be used as a carrier in and of itself. Referring to Arrow C in FIG. 11, the sling attachment button 328, permanently attached to the sling 300 near the second horizontal edge 308, is inserted into the socket 108, which is affixed to the u-shaped generally planar portion 106 on the front of the harness 100. The sling attachment button 328 is slid down within the socket 108 until it rests within the generally circular cavity 112. First and second pockets 122, 124 (shown in FIG. 3) are provided to place the first and second shell receiving buckles 130, 132 when the shell 200 is not in use. To secure the lower corners of the sling 300 to the harness 100, the first and second sliding sling buckles 324, 326, located on the sling 300 at the second horizontal edge 308, are mated with the first and second sling receiving buckles 166, 168 (shown in detail in FIG. 9D), which are attached to the support belt 152. As illustrated in FIG. 12, the upper aspects of the sling 300 are secured to the harness 100 by attaching the first and second J-hooks 316, 318, which are permanently affixed at the intersection between the first and second vertical edges 302, 304 and the first horizontal edge 306, to the first and second D-rings on the harness 138, 140. Attaching the first J-hook 316 to the first D-ring 138 and the second J-hook 318 to the second D-ring 140 allows the attendant to privately nurse the infant (as shown in FIG. 2D). The first and second J-hooks 316, 318 may also be attached to the same D-ring 138, 140 to facilitate carrying the infant in the sling 300 (as shown in FIG. 2E and FIG. 12). When the carrier is used in the configuration shown in FIG. 2E and FIG. 12, the infant may rest in the sling 300 either while resting in the shell 200 (the shell 200 is not attached to the harness 100 but rests in the sling 300) or the infant may rest in the sling 300 without the shell 200. The sling 300 is reinforced with sling battens 330 (shown in hidden lines in FIG. 8), providing the sling 300 with structural reinforcement to aid in supporting the infant residing therein.

A front infant carrier which includes a vest-like harness that is worn by the attendant, a detachable infant shell, and a sling. The detachable infant shell attaches to the harness at three attachment points, either in a forward-facing or rearward-facing orientation. In the rearward-facing position, the shell attaches to the harness by a peg/button mounted at the crotch of the shell which snaps into a socket centrally mounted at the lower front of the harness, and by a pair of upper clips on the shell which engage rings on the upper front of the harness. The forward-facing attachment uses a second peg/button at the lower back portion of the shell, instead of the crotch peg/button, and attaches in a similar fashion, whereby the second peg/button snaps into the socket centrally mounted at the lower front of the harness, and the pair of upper clips on the shell engage the rings on the upper front of the harness. A sling may also be attached to the harness at three points, the sling having a third peg/button which mates with the socket centrally mounted at the lower front of the harness and has a pair of upper clips which engage the rings on the upper front of the harness. The sling may be attached so that the disengaged shell and carried infant may be rested sideways within the sling. The sling is reinforced with sewn-in battens to help provide support for the infant to rest in the sling alternatively without the shell.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to snow skiing implements such as snowboards and snow skis, and more particularly to an improved boot scraper of novel design and shape and incorporating a novel boot scraping surface for cleaning the undersurfaces of ski and snowboard boots. 2. Background Art Accumulated snow and other foreign matter on the undersides of ski and snowboard boots prevents proper seating of the boots in ski boot and snowboard boot bindings. Improperly seated boots may lead to premature binding release and loss of control. Accordingly, it is important that snow and other foreign matter be removed from the undersurfaces of ski and snowboard boots prior to mounting the boots in ski and snowboard boot bindings. Cleaning snow off the undersides of ski and snowboard boots prior to putting on skis or snowboards is usually awkward and inconvenient, especially if a ski or snowboard has become loose after a fall and the skier or snowboarder is attempting to remount the ski or snowboard. Skiers are forced to balance on one ski and one ski pole, using the other pole to clean the bottom of the loose boot while simultaneously balancing on the snow covered slope and retaining the loose ski in a position that will allow the loose boot to be inserted in the binding. Snowboarders have similar problems. Prior art attempts at ski boot sole cleaning devices have included ski-mounted scraping devices such as those disclosed in U.S. Pat. Nos. 3,826,518, 3,975,036, 3,976,304, 3,999,773, 5,156,418, 5,147,098 and Des. 305,270, and ski pole-mounted scraping devices such as those disclosed in U.S. Pat. Nos. 4,000,909, 4,145,063 and 5,358,277. These prior art cleaning devices have been excessively complex and/or expensive, have interfered with the operation of the skis, have not been robust enough to hold up to the rigors of skiing use, have been awkward to use, or were otherwise unsatisfactory. Accordingly there remains a need for an effective boot underside cleaning device that is robust, effective, non-intrusive, easy to use and inexpensive to make. SUMMARY OF THE INVENTION The present invention consists of a boot scraper of novel design and shape and incorporating a novel boot scraping surface that can be mounted to, or incorporated in, skiing implements such as skis and snowboards, as well as ski boot bindings, snowboard boot bindings, and ski boots and snowboard boots. In one embodiment, the boot scraper of the present invention comprises an elongated polygonal molded rigid ABS plastic block that is mounted to the top surface of a ski. The block is mounted to the ski by an adhesive or by mechanical means such as screws. The top surface of the boot scraper incorporates a two-dimensional grouping of adjacent polyhedrons extending in an upward direction. Each polyhedron generally has a quadrilateral base and a pointed tip. The tips of the polyhedrons form a scraping surface consisting of a multi-dimensional array of spaced, generally rigid pointed surfaces. The underside of the block contains hollowed out cavities that reduce weight but maintain strength and rigidity of the block. The scraper is used by drawing the sole of the ski boot to be cleaned over the scraper. The array of pointed surfaces forming the scraping surface quickly and omnidirectionally removes snow and foreign matter from the bottom of the boot. The scraper may be molded in a variety of colors so as to be decorative as well as utilitarian. The scraper may also be fabricated using a variety of plastics or other light weight materials, such as composites or metals. Another embodiment of the invention, intended for mounting on snowboards, comprises a polygonal cylinder with polyhedral projections extending from portions of the cylinder's exterior surfaces, forming a scraping surface consisting of a generally semi-cylindrical array of pointed surfaces. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top view of one embodiment of a boot scraper of the present invention. FIG. 2 is a side view of the embodiment of FIG. 1. FIG. 3 is a front view of the embodiment of FIG. 1. FIG. 4 is a back view of the embodiment of FIG. 1. FIG. 5 is a perspective view of the embodiment of FIG. 1. FIG. 6 is a side view of a second embodiment of a boot scraper of the present invention. FIG. 7 is a front view of the embodiment of FIG. 6. FIG. 8 is a top view of the embodiment of FIG. 6. FIG. 9 is a perspective view of a third embodiment of a boot scraper of the present invention. FIG. 10 is a bottom view of the embodiment of FIG. 1. DETAILED DESCRIPTION OF THE INVENTION A boot scraper incorporating a novel boot scraping surface is disclosed. In the following description, numerous specific details such as dimensions, materials, shapes, mounting methods, etc. are described in detail in order to provide a thorough description of the present invention. It will be apparent to one skilled in the art, however, that the invention may be practiced without these specific details. In other instances, well-known features have not been described in detail so as not to obscure the present invention unneccessarily. FIGS. 1-5 are top, side, front, back, and perspective views, respectively, of one embodiment of the present invention. This embodiment consists of a boot scraper that is intended to be mounted on the top surface of a ski, typically in front of the toe plate or behind the heel plate of a ski boot binding. This embodiment may be molded from a durable plastic material that is able to withstand freezing temperatures without becoming brittle, that is impact and abrasion resistant, that does not absorb water, that exhibits low thermal expansion, and that exhibits good color retention under long term exposure to sunlight. Plastic materials that may be used include ABS, polypropelene, and formion. The plastics used may have a variety of decorative colors. Logos, trademarks or other graphics or text may be imprinted on or molded into the boot scraper as desired. As shown in FIGS. 1 and 5, boot scraper 100 of this embodiment has a plan shape generally in the form of a polygon. As shown more clearly in FIG. 1, in this embodiment the polygon is an irregular heptagon with a front vertex 105 and sides 115, 120, 125, 130, 135, 140, and 145, respectively. When mounted to a ski, boot scraper 100 is typically oriented such that front vertex 105 points to the front tip of the ski. Front vertex 105 and sides 115 and 145 of boot scraper 100 present a wedge-shaped profile towards the front of the ski, reducing air and snow resistance of boot scraper 100 and aiding the shedding of snow from the ski forward of the location at which boot scraper 100 is mounted. In this embodiment, the overall length of boot scraper 100 from front vertex 105 to rear side 130 is approximately 3 1/2 in. The width between sides 120 and 140 is approximately 2 1/2 in. As shown in FIG. 5, the top surface of boot scraper 100 features a two-dimensional grouping of adjacent polyhedral projections 500. These projections are identified individually in FIG. 1 as projections 150a, 150b, 155a, 155b, 155c, 160a, 160b, 160c, 160d, 160e, 160f, 160g, 160h, 165a, 165b, 165c, 170a, 170b, and 175, respectively. As shown in FIG. 1, the bases of these projections, except for front projection 175, are quadrilaterals. The projections can be divided into three groups: front projections 165a-c, 170a-b, and 175; central projections 160a-h; and rear projections 150a-b and 155a-c. The bases of central projections 160a-hare squares with approximately 1/2 in. long sides. The height of projections 160a-h is approximately 5/8 in. above the plane 210 shown in FIG. 2. Projections 160a-160hform a set of eight adjacent pyramid shaped projections arranged in two rows of eight projections each. The first row of front projections immediately adjacent to central projections 160a-d consists of three projections 165a-c, respectively. Middle projection 165bhas a rectangular base approximately 1/2 in. deep and 5/8 in. wide. Right and left projections 165a and 165c are mirror images of each other. Each has a rhombus shaped base approximately 1/2 in. deep, 11/16 in. wide on the side adjacent to center projections 160a-d, and 5/16 in. wide on the opposite side. The next row of front projections consists of two projections 170a-b. Right and left projections 170a-b are mirror images of each other. Each has a rhombus shaped base approximately 1/2 in. deep, 3/4 in. wide on the side adjacent to projections 165a-c, and 3/8 in. wide on the opposite side. The final row of front projections consists of a single projection 175. Projection 175 has a triangular base approximately 1/2 in. deep and 3/4 in. wide. The first row of rear projections immediately adjacent to central projections 160e-h Consists of three projections 155a-c, respectively. Middle projection 155bhas a rectangular base approximately 1/2 in. deep and 5/8 in. wide. Right and left projections 155a and 155c are mirror images of each other. Each has a rhombus shaped base approximately 1/2 in. deep, 11/16 in. wide on the side adjacent to center projections 160e-h, and 1/2 in. wide on the opposite side. The second row projections consists of two projections 150 a-b. Right and left projections 150a-b are mirror images of each other. Each has a rhombus shaped base approximately 1/2 in. deep, 11/16 in. wide on the side adjacent to projections 155a-c, and 1/2 in. wide on the opposite side. Like central projections 160a-h, each of projections 150a-b, 155a-c, 165a-c and 170 a-b forms a generally pyramid shaped projection approximately the same 5/8 in. high. In this embodiment, as shown in FIG. 2, front projection 175, though also pyramid shaped, is somewhat smaller than the other projections, having a height of approximately 3/8 in. The tips of the projections are rounded off to provide additional strength. As shown in FIG. 2, below projections 500, boot scraper 100 consists of a midsection 215 and a bottom section 220. Midsection 215 is also visible in FIG. 1. As shown in FIGS. 1 and 2, midsection 215 has a beveled edge 225 that extends from the heptagon formed by the bases of projections 500 to the heptagon formed by the outside edges 115, 120, 125, 130, 135, 140 and 145. In this embodiment, midsection 215 is approximately 5/16 in. high, and beveled edge 225 extends approximately 1/4 in. outwardly from the heptagon formed by the bases of projections 500. Bottom section 220, visible in FIG. 10 as well as in FIG. 2, is a mirror image of midsection 215, having a beveled edge 230 that extends inwardly from the heptagon formed by the outside edges 115, 120, 125, 130, 135, 140 and 145 to a approximately equal in size to the heptagon formed by the bases of projections 500. In this embodiment, bottom section 220 is approximately 5/16 in. high, and beveled edge 230 extends approximately 1/4 in. inwardly from the heptagon formed by outside edges 115, 120, 125, 130, 135, 140 and 145. In another embodiment of boot scraper 100, the front diagonal sides 115 and 145 of mid section 215 and bottom section 220 are not beveled but are vertical. The other sides remain beveled as above. The vertical sides can be used to imprint a logo or tradename onto boot scraper 100. The embodiment of boot scraper 100 shown in FIG. 1 includes mounting holes 180 and 185 and recessed shoulders 190 and 195. Mounting holes 180 and 185 extend through the bottom of boot scraper 100. Recessed shoulders 190 and 195 extend below the bases of projections 500. In this embodiment, mounting holes 180 and 185 are approximately 1/8 in. in diameter and spaced one inch apart, while recessed shoulders 190 and 195 are approximately 3/16 in. in diameter. Mounting holes 180 and 185 can be used to mount boot scraper 100 to the top surface of a ski. In one embodiment, stainless steel threaded inserts are installed in the ski at positions corresponding to the position of mounting holes 180 and 185 when boot scraper 100 is located at the desired mounting location. Boot scraper 100 is placed in the desired location, and fastened to the top surface of the ski by means of stainless steel screws inserted through mounting holes 180 and 185 and screwed into the threaded inserts that have been installed in the ski. In one embodiment, 8-15×11/16 in. Philips pan head stainless steel passivated 18-8 screws are used. Boot scraper 100 may also be adhesively fastened to the top of a ski, or any of a variety of other well known mechanical and/or adhesive fastening means may be used. To save weight while maintaining structural integrity, a number of cavities may be formed in the bottom of boot scraper 100 as shown in FIG. 10. Cavities 1005a-f shown in FIG. 10 are approximately 5/8 in. deep and are dimensioned and shaped so that a web 1010 approximately 3/16 in. thick remains around the edges of the base of boot scraper 100, around mounting holes 180 and 185, and across the inside of boot scraper 100 as shown in FIG. 10. In addition, drainage openings 1015a-f, shown in FIG. 10 and also in FIG. 2, may be formed through web 1010 along the bottom edge of bottom section 220 of boot scraper 100 so as to allow water formed by melting snow and ice to drain out from cavities 1005a-f. A second embodiment of the boot scraper of the present invention is shown in FIGS. 6-8. In this embodiment, as shown in FIGS. 6-8, boot scraper 600 consists of a molded rectangular block 605 with a three-by-four grid of polyhedral projections 610 extending from its top surface and two triangular mounting flanges 620 extending from its base. In this embodiment, projections 610 are approximately equal to each other in size and shape, having a generally square base and symmetrical sides such that each projection 610 is in the form of a four-sided pyramid. The base of each projection 610 is approximately 9/16 by 9/16 in. in size, and the height of each projection 610 is approximately 3/4 in. Mounting flanges 620 are approximately 3/8 in. thick, are approximately 3/4 in. wide at their base, and extend approximately 3/8 in. outwardly from rectangular block 605. Each mounting flange 620 contains a mounting hole 810 through which a screw can be inserted to mount boot scraper 600 to the top surface of a ski. Boot scraper 600 may also contain a hollowed-out inside cavity, the outline of which is indicated by dotted line 625 in FIG. 6 and 710 in FIG. 7. An embodiment of the present invention intended for mounting on snowboards is shown in FIG. 9. Because a snowboard is much wider than a ski, a wider boot scraper can be used with a snowboard than with a ski, providing a larger scraping surface. In addition, because only a single board is used in snowboarding, a snow scraper for a snowboard may project a substantial distance above the snowboard surface without interfering with the operation of the snowboard. In the embodiment shown in FIG. 9, boot scraper 900 has the form of an elongated octagonal prism containing polyhedral projections on each of its end faces 910 and along its exposed longitudinal sides, which in this embodiment are upper horizontal side 915, upper diagonal sides 920 and 925, and vertical sides 930 and 935. Each face 910 contains nine polyhedral projections: five full projections 940 and four half projections 950. Each full projection 940 has an approximately square base with sides of length approximately between 3/8 and 3/4 in. Each projection 940 is approximately 1/2 to 3/4 in. high. Each half projection 950 is approximately equal in size to a full projection 940 that has been bisected diagonally across its square base. Each of the exposed longitudinal sides, such as upper horizontal side 915, contains a row of adjacent polyhedral projections 960 approximately equal in size to full projections 940. In the embodiment shown in FIG. 9, there are eleven projections 960 along a side. Boot scraper 600 is mounted to the top surface of a snowboard by means of polygonal mounting blocks 970 that extend downwards from boot scraper 900. In the embodiment shown in FIG. 9, mounting blocks 970 are generally hexagonal and extend downwards approximately 1/2 to 1 in. The mounting blocks may be adhesively affixed to the snowboard, or any of a variety of other well known fastening means may be used. Boot scraper 900 may be transversely mounted on the snowboard in front of or behind the snowboard's boot bindings. To use boot scraper 900, a snowboarder draws the underside of a snowboard boot in any direction across boot scraper 900 such that it engages any portion of the multi-faceted, three dimensional snow scraping surface formed by the tops of the polyhedral projections of boot scraper 900. Because boot scraper 900 features scraping surfaces oriented at a variety of angles all around its exposed surfaces, effective cleaning of a snowboard boot underside can be achieved at a variety of boot orientations with respect to boot scraper 900. In other embodiments, the snow scraping surface of the present invention, comprising a two or three dimensional groupings of spaced, rigid pointed surfaces formed by the tips of two and three dimensional arrays of projections, are directly incorporated in a ski or, snowboard surface, a boot, or a binding, or are incorporated in boot scrapers designed to be mounted to ski and snowboard boots and bindings. In one example embodiment, a scraping surface comprising an array of polyhedral projections similar to the array extending from the top surface of boot scraper 100 of FIG. 1 is integrally formed with the top surface of a ski. In another embodiment, an array of such projections is integrally formed on an exposed surface of a ski or snowboard boot, for example adjacent to the heel, the toe, or the side of the boot. In a further embodiment, the scraping surface of the present invention is incorporated in the heel or toe plate of a ski boot binding, or in a separate boot scraper designed to be mounted on the heel and/or toe plate of the ski boot binding. Thus, a boot scraper incorporating a novel boot scraping surface has been presented. Although the invention has been described with respect certain detailed embodiments, the invention is not limited to the specific embodiments and details presented. For example, the projections forming the scraping surface of the present invention have been described as polyhedrals. However, other projections, for example conical projections, may be used. The boot scrapers of the present invention have been described as being formed of plastic. However, other materials, including, without limitation, aluminum and other metals, ceramics, or composite materials may be used. The boot scraper of the present invention may have any of a variety of shapes and forms, and the projections forming the scraping surface may be arranged in a variety of configurations. For example, the projections may be arranged around the perimeters of concentric circles. Other variations of the present invention will be evident to those skilled in the art.

A boot scraper of novel design and shape and incorporating a novel boot scraping surface that can be mounted to, or incorporated in, skiing implements such as skis and snowboards, as well as ski boot bindings, snowboard boot bindings, and ski boots and snowboard boots. In one embodiment, the boot scraper comprises an elongated polygonal molded rigid ABS plastic block that is mounted to the top surface of a ski. The block is mounted to the ski by an adhesive or by mechanical fasteners such as screws. The top surface of the boot scraper incorporates a two-dimensional grid of adjacent polyhedrons extending in an upward direction. The tips of the polyhedrons form a scraping surface consisting of a multi-dimensional array of spaced, generally rigid pointed surfaces. The underside of the block contains hollowed out cavities that reduce weight but maintain strength and rigidity of the block. The scraper is used by drawing the sole of the ski boot to be cleaned over the scraper. The array of pointed surfaces forming the scraping surface quickly and omnidirectionally removes snow and foreign matter from the bottom of the boot.

BACKGROUND OF THE INVENTION The invention is concerned with an apparatus for the cutaneous determination of the partial pressure of gases in blood with a heated polarographic blood gas electrode and an arrangement for the determination of the blood gas availability at the contact surface. The term "cutaneous" used herein denotes a bloodless measurement recording by a an electrochemical sensor placed on the skin. It is well known that the pO 2 -value measured with heated cutaneous oxygen electrodes does not always correlate with the arterial pO 2 -value, since other parameters such as, for example, the microcirculation, diffusion resistance of the skin and the circulatory condition can also influence the cutaneous pO 2 -value. Thus, for example, some medicaments which have vasodilating or vasoconstricting activity, used in intensive care cause fluctuations in the cutaneous pO 2 -value while the central-arterial pO 2 -value remains constant. Likewise, it is known that fluctuations in the blood pressure (especially in the case of patients with a variable circulatory condition) can influence the cutaneous pO 2 -value. For these reasons a satisfactory interpretation of the cutaneous pO 2 -value is not always possible. This restriction has contributed materially to the fact that the method for cutaneous pO 2 -measurement in the supervision of adult intensive care patients has hitherto not succeeded. Experiments have already been carried out to couple a perfusion measurement with the cutaneous pO 2 -measurement in order to enable an improved interpretation of the cutaneous pO 2 -value. This has hitherto exclusively been carried out using methods which rely on the determination of the heat transport at the measurement position. The method described by Lubbers and co-workers, U.S. Pat. No. 3,918,434, relies on the measurement of the heat energy which is required to heat the oxygen electrode to a constant temperature. With increased local perfusion a greater heat energy is consumed. One disadvantage of this method is, however, that only a small heat energy (according to recently published estimates 25%) is removed by the blood flow. The rest of the heat energy is used to heat non-perfused tissues as well as the surroundings of the electrode. For this reason the method according to Lubbers et al. is relatively unsensitive and, moreover, requires a high expenditure for the heat isolation of the electrode against the surroundings. It is, however, accepted that in principle the validity of the cutaneous pO 2 -observation is increased by a simultaneous measurement of the perfusion. Apart from the method described by Lubbers by determining the heat energy for the maintenance of a constant temperature at the measurement position there are still other methods which rely on the measurement of the heat transport. Another method consists, for example, in applying heat at one position and measuring the temperature at a second position situated at a determined distance therefrom. The temperature difference produced is likewise a measurement of the perfusion. The previous discussions of the state of the art relate almost exclusively to the measurement of the pO 2 in blood. This is attributed to the fact that until now only the pO 2 -measurement has found acceptance in clinical practice. It is, however, known to the person skilled in the art that the partial pressure of other blood gases, especially the pCO 2 , can be measured in principally the same manner. In so doing, such measurements can be carried out either separately or combined with one another. With regard to this, the present invention is not limited to the measurement of a particular blood gas concentration; it can be used not only in the measurement of pO 2 but also of other gases in blood which are to be determined electro-chemically, especially the pCO 2 . SUMMARY OF THE INVENTION The aim of the present invention is to provide an improved method for the simultaneous cutaneous measurement of the partial pressure of a gas in blood and the perfusion, which does not have the disadvantages of the known methods, i.e. which can be carried out with especially higher accuracy. In accordance with the present invention the foregoing aim is achieved in that the arrangement for the determination of the blood gas availability includes a second polarographic electrode with maximum regular gas consumption in structural unity with the first polarographic blood gas electrode. As already mentioned, the correlation of the cutaneous measured blood gas value with the actual arterial value can be observed with such an electrode arrangement, in that the measurement value for the gas availability at the contact surface can serve for the interpretation of the measured concentration values. In other words, a correction factor for the measurement value of the cutaneous pO 2 can be determined from the measurement value of the gas availability. Moreover, the simultaneously measured value of the gas availability can serve as the function control for the apparatus. Thus, for example, errors in the application such as the use of too much contact gel, the detachment of the sensor, the presence of air bubbles between the skin and the sensor, burn blisters and other skin damage etc, can be detected. On the other hand, variations in the circulatory activity can be included in the safeguarding of accurate functions. In particular, the effects of medicaments on the circulation can be included so that, inter alia, their influence on the measurement of the blood gas circulation can be taken into consideration. Finally, above all in the case of neonates in which usually no influence of medicaments is present, a qualitative observation of the blood pressure is possible using the measurement of the gas availability, which is also dependent on the blood pressure. BRIEF DESCRIPTION OF THE DRAWING An embodiment of the present invention is described hereinafter in connection with the accompanying drawing, in which: FIG. 1A illustrates in a cross-sectional side view the depicted embodiment of the invention; and FIG. 1B illustrates a view of the contact surface of the device of FIG. 1A without a membrane. DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1A shows a section through an oxygen electrode according to this invention and thereunder a view of the contact surface without a membrane. In this embodiment, an essentially cylindrical silver electrode 1 is provided with a heating arrangement. The surface of the silver electrode 1 has a circular recess in which is situated a heating coil 2. Two eccentric concentrically arranged continuous bores in the silver electrode serve for the reception of two platinum electrodes 3 and 4. The ends of the platinum electrodes lie in one plane with the corresponding face of the silver electrode. One of the two platinum electrodes, i.e. electrode 3, consists of very thin platinum wire and has a diameter of about 25 μm. The other platinum electrode 4 consists of a platinum pin of ca 2 mm diameter. The side lying opposite this face carries two further borings in the silver block in which are situated in each case a temperature measuring element 5. Instead of platinum, the electrode material may be another precious metal (e.g. gold) which is customary in the case of polarographic electrodes. All conductors are led away laterally and connected into a cable (not particularly shown). The entire arrangement is surrounded with a flat-cylindrical capsule 6 of synthetic material, one face of the capsule leaving the electrodes free. For the measurement, the face is coated with an electrolyte film 7 and covered with a membrane 8 which is held by an elastic O-ring 10. The membrane consists of polytetrafluoroethylene (Teflon) of 25 μm thickness. The membrane can consist of other materials and thicknesses. It is only important that the membrane must be relatively well permeable for oxygen. In operation, the electrodes are connected so that the two platinum electrodes 3 and 4 serve as cathodes, while the silver electrode 1 serves as the anode. The microcathode 3, which has a diameter of ca 25 μm, possesses a very much lower oxygen consumption. It is consequently suitable for the measurement of the oxygen partial pressure. The large-surface cathode 4, which has a diameter of ca 2 mm, accordingly consumes practically the entire oxygen arriving at the contact surface. Consequently, it can serve for the determination of the oxygen availability. In this manner there can also be obtained, simultaneously with the cutaneous pO 2 -measurement, a prediction concerning the blood perfusion in the surroundings of the measurement position. The advantage of the oxygen-flow measurement vis-a-vis the heat-flow measurements used hitherto in this connection consists in that the perfusion measurement is not disturbed by removal of heat in the surroundings. No expensive thermal isolation of the measurement arrangement is therefore necessary. Moreover, the measurement of the oxygen flow has a higher sensitivity. In addition to the previously described preferred embodiment of the invention, other embodiments with various constructive solutions are also conceivable. Thus, for example, the heating can be arranged, instead of at the anode, at the large-surface cathode 4 which, for this purpose, would be appropriately enlarged. Another possibility consists in providing a heating element independent of the electrodes. A further possibility, to obtain the differentially high oxygen consumption of the two cathodes, consists in providing two similarly sized so-called macrocathodes and to cover these with differentially permeable membranes. The one of the two cathodes, which serves for the perfusion measurement, can have a Teflon membrane whose permeability is high, while the other cathode, which serves for the pO 2 -measurement, must be covered with a relatively less permeable membrane (e.g. Mylar). This arrangement would tend to be more complicated regarding construction and application than the previously described preferred embodiment.

An apparatus for the simultaneous determination of the cutaneous blood gas concentration and of the blood gas availability for the correction of physiologically caused errors of the measured value of the cutaneous blood gas concentration by means of two heated blood gas electrodes in structural unity, of which one is distinguished by maximum gas consumption.

FIELD OF THE INVENTION [0001] The present invention relates to an electric locomotion means, more particularly relates to an electric locomotion means suitable for people with walking problems and/or paraplegics. BACKGROUND OF THE INVENTION [0002] As is known, there are locomotion means for people with walking problems such as wheelchairs for example, which can be manual or electric. [0003] There are also dynamically stabilised vehicles that have a control system that actively maintains the stability of the vehicle, which normally only have two wheels. Appropriate sensors continuously control vehicle orientation and the control circuit determines the necessary corrections for maintaining stability by suitably commanding the wheel motors. For example, the vehicles shown in documents US 2011/303475 A1 and WO 2009/054344 A1 are known in the prior art. [0004] Disadvantageously, none of the devices described in the documents of the prior art are suitable for transporting a person with a disability of the lower limbs, as some of these devices require that the user stand up. Other devices allow the user to sit, but still require the use of the legs to steer, as they require a rotation of the seat with respect to a vertical axis. FIELD OF THE INVENTION [0005] The aim of the present invention is to provide for a new concept electric locomotion means, in particular suitable for people with walking problems and/or paraplegics, which allows the person position themselves at a height equal to that of a standing person, and which can also move at the same time. [0006] Another aim is to provide for an electric locomotion means that can allow the user, through a specific seated position, to unload part of their own weight onto the knees thus lightening the load on the coccyx, which using the muscles of the lower limbs. [0007] Another aim is to provide for an electric locomotion means that can be used in both indoor and outdoor environments and that can vary its height to adapt to the altered conditions. [0008] A further aim is to provide for an electric locomotion means that can adapt to different user dimensions in a simple way. [0009] These problems are overcome by an electric locomotion means according to the present invention. This locomotion means comprises a dynamically stabilised vehicle comprising two wheels. The vehicle has a transverse axis that is defined by an axis of rotation of the wheels. The vehicle also has a longitudinal axis that is perpendicular to the transverse axis and that defines a direction of advancement of the vehicle. [0010] The vehicle comprises a pivot arranged along the longitudinal axis and that is rotatable about the longitudinal axis. The pivot is configured to transfer a steering command to the wheels. The locomotion means further comprises a seat positioned on the vehicle. The seat is configured to accommodate a user affected by motor disability of the lower limbs. The seat is laterally tiltable by a lateral displacement of the user's weight. The locomotion means further comprises transmission means arranged between the seat and the pivot. The transmission means are configured to transfer a tilting movement of the seat to the pivot. [0011] Advantageously, in the locomotion means according to the present invention, a slight lateral displacement of the user's weight is sufficient to control the steering of the locomotion means. This movement can also be easily performed by people affected by disability of the lower limbs, making the locomotion means suitable for their transport. [0012] Further characteristics of the invention are described in the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS [0013] Further characteristics and advantages of the present invention will become apparent from the following detailed description of a practical embodiment thereof, illustrated by way of non-limiting example in the accompanying drawings, in which: [0014] FIG. 1 shows a schematic side view of an electric locomotion means according to the present invention; [0015] FIG. 2 schematically shows a front view of an electric locomotion means according to the present invention; [0016] FIG. 3 schematically shows a side view of a lower portion, without the wheels, of an electric locomotion means according to the present invention; [0017] FIG. 4 schematically shows a front view of a lower portion of an electric locomotion means according to the present invention; [0018] FIG. 5 schematically shows a side view of a seating system of an electric locomotion means according to the present invention; [0019] FIG. 6 schematically shows a portion of an electric locomotion means, a side view of which is shown in FIG. 3 , according to the present invention. DETAILED DESCRIPTION OF THE INVENTION [0020] With reference to the accompanying figures, an electric locomotion means, according to the present invention, comprises a dynamically stabilised vehicle 10 having two wheels 11 . [0021] A base plate 13 is superposed to the upper surface 12 of the vehicle 10 . [0022] The plate 13 is in rest position, raised from the surface 12 due to the presence of elastic dampers 14 . [0023] On the surface 12 are the switches 15 (usually four) that enable the vehicle 10 to start. Shims suitable for facilitating the pressure of the switches 15 can be found opposite the switches 15 . [0024] The plate 13 further comprises an actuator, anteriorly and posteriorly. Preferably, this actuator is a hydraulic piston 16 , electrically or manually controlled by a hydraulic system. [0025] The hydraulic pistons 16 extend to touch the ground and to stabilise the vehicle so that the user can get on, indeed the pistons 16 and the two wheels 11 form four ground points. [0026] Anteriorly and posteriorly from the surface 12 rise two support plates, respectively 20 and 21 , which are substantially triangular in shape frontally and L-shaped laterally. [0027] The rear plate 21 supports a further plate 23 by means of a pivot 22 . The plate 23 can rotate about the pivot 22 with respect to the plate 21 . [0028] The front plate 20 supports a further plate 25 by means of a pivot 24 . The plate 25 can rotate about the pivot 24 with respect to the plate 20 . In this case, however, the plate 25 is fixed to the pivot 24 and thus a rotation of the plate 25 rotates the pivot 24 . [0029] The rotation of the plates 25 and 23 is, however, limited to small angles by the presence, between the base of the L, of the plates 25 and 23 , and the base plate 13 of the elastic shims 26 and 27 , which allow rotation in that they are deformable, being made of rubber. [0030] There are two shims 26 and 27 per plate, positioned laterally thereto. [0031] Moreover, for a greater adjustment of the sensitivity to rotation, the elastic shims 26 and 27 can be fixed to the plates 25 and 23 in different positions, by means of screws, i.e. more or less sideways with respect to the pivot 24 , by means of an arrangement of holes 28 in the plates 25 and 23 . [0032] It is alternatively possible to use other mechanisms to adjust the sensitivity to rotation, by using a knob that shifts the position of the elastic shims 26 and 27 , for example. [0033] The plates 25 and 23 supporting a guide 31 within which a feed screw 30 can rotate. [0034] Fixing of the guide 31 onto the plates 25 and 23 can be performed so as to adjust the relative position thereof in order to maintain the user's centre of gravity (associated with that of the seat) in the correct position with respect to the dynamically stabilised vehicle 10 . [0035] The feed screw 30 is electrically driven by a motor 32 . It is alternatively possible to use other mechanisms such as a hydraulic piston or linear actuators. [0036] On the feed screw 30 is a movable slider 33 . [0037] The slider 33 comprises in its interior a bearing 34 and a spring 35 to ensure an elastic force reaction to possible thrusts contrary to the movement. [0038] A movable plate 36 comprising a series of holes 37 is arranged on the slider 33 . [0039] A fixed back plate 38 having at least one hole 39 is fixed to the guide 31 , posteriorly to the portion of feed screw 30 on which the slider 33 can slide. [0040] A front rod 40 is movably pivoted in one of the holes 37 . [0041] A rear rod 41 is movably pivoted in the hole 39 . [0042] The two rods 40 and 41 are movably joined together by means of a pivot 42 passing through both the rods at a point that is intermediate thereto. [0043] The rods 40 and 41 have a plurality of holes so that the pivot 42 can be inserted into the most suitable hole. [0044] A knee/shin rest 43 is positioned on the front end of the rod 41 , opposite to the pivot 39 . Two short bars (lengthways-adjustable) fixed to the front end of the rod 41 is support two folding anatomical half-shells that support the knees/shins of the user. [0045] A seat 44 can slide along the rod 40 itself on the rear end of the rod 40 , opposite the slider 33 . Its position is optimally determined by means of a first bar 45 that is fixed on to the seat 44 on one side and to a second bar 46 on the other side that is fixed to the rod 41 in the central portion thereof. The second bar 46 comprises a plurality of holes 47 . The first bar 45 is pivoted with the second bar 46 in one of the holes 47 . [0046] The seat 44 also has the ability to tilt with respect to the rod 40 . Indeed, underneath it and passing through the rod 40 , it comprises a threaded bar 48 having an adjustment knob 49 . Other movement means of the seat 44 can be used. [0047] In addition to the control system for the dynamically stabilised vehicle 10 , the vehicle preferably comprises a further battery (not shown), as well as a control (not shown) for operating the motor 32 in one direction and in the opposite direction, operating means (not shown) of the hydraulic cylinders 16 . [0048] The operation of the invention is apparent, to a person skilled in the art, from what has been described and is, in particular, as follows. [0049] Depending on his overall size, the size of his femur and other considerations, the user suitably fixes all the present adjustments onto the locomotion means. [0050] The user in particular fixes the elastic shims 26 and 27 in a position according to his weight and according to the desired steering sensitivity; he positions the pivot 42 between the two rods 40 and 41 to adjust the height of the seat 44 and optimise motor torque (if the pivot 42 is moved towards the slider 33 , uphill speed is increased but the motor struggles more and vice versa); position the rod 45 on the second bar 46 to maintain the correct proportion of movements with respect to the seat 44 during movement of the rods 40 and 41 ; arrange the positioning of the rod 40 on the slider 33 to adjust the maximum lowering of the rod 40 ; adjust the tilt of the seat 44 by means of the knob 49 . [0051] The user operates the hydraulic pistons 16 by lowering them and stabilising the locomotion means. He can then get on and sit on the seat 44 and rest his knees on the knee/shin rest 43 without any problem. [0052] The user's weight sufficiently lowers the base plate 13 , as permitted by the elastic dampers 14 , towards the surface 12 and the switches 15 are pressed and the dynamically stabilised vehicle can then be started. [0053] The user starts the motor 32 , which drives the feed screw, bringing the motor 32 closer to the slider 33 and the entire rod system rises and consequently raises the seat 44 , until the desired height is reached. [0054] He starts up the dynamically stabilised vehicle 10 in the usual way and then raises the hydraulic pistons 16 . [0055] The electric locomotion means is thus ready to be used. [0056] If the user needs to go forward or reverse, he pushes his body forward or backward as in the case of usual dynamically stabilised vehicle 10 . [0057] For bends, instead of operating the normal handlebar present in all dynamically stabilised vehicles, the user tilts sideways to the left or right, by the same almost imperceptible amount as when moving forward or backward, and the vehicle will steer accordingly. [0058] Moving to the left or right, the body's weight rotates the plates 23 and 25 . The plate 25 rotates the pivot 24 which is nothing other than the pivot that is normally fixed to the steering wheel of dynamically stabilised vehicles. [0059] To descend from the locomotion means, the user sits in the most vertical position possible in order to stop the locomotion means, then the hydraulic pistons 16 are lowered. The plate 13 is raised from the surface 12 and the switches 15 are released. The dynamically stabilised vehicle is completely switched off and the user gets off directly or the motor 32 is started so as to lower the seat 44 . [0060] We thus have an electric locomotion means that makes use of a dynamically stabilised vehicle that comprises a horizontally-pivoted platform that is adapted and pivoted to the steering head, which eliminates the steering rod, so as to permit the user to steer using body weight alone, thus freeing the hands. Special mechanisms allow a manual and/or motorised micrometric adjustment, to adjust steering according depending on user weight, user height, seat height, user asymmetries. [0061] The seat on the electric locomotion means is ergonomic and dynamic, i.e. its height is adjustable. This allows a relational symmetry of the user i.e. the user is at the same height as the people in front of him, and thus improves interpersonal relations, improves blood circulation, improves the functioning of the digestive system, limits compression of the diaphragm, eliminates overloading of the lumbosacral region, prevents pressure sores, osteopenia and osteoarthritis, promotes musculoskeletal elasticity, permits passive exercise therapy (by operating the motor 32 for example), limits overloading of the musculoskeletal system. [0062] The dynamic ergonomic seat is always balanced and constantly maintains the user's centre of gravity in axis, allowing movement in any direction at any height selected. [0063] The seat is also damped, with respect to ground roughness, thanks to the springs 35 . [0064] The geometry of the electric locomotion means adapts to the user's skeletal measurements. [0065] The seat can be varied through a micrometric adjustment on the basis of the length of the femur, the shin, the delta (femur/shin ratio and geometry of the centre of gravity), longitudinal axis, steering sensitivity and LH and RH asymmetry corrections. [0066] An application for Apple and Android devices that can wirelessly control suitable physical exercises for the user can be envisaged, by raising and lowering the seat, or other arranged movements for example, so as to prevent related diseases.

Electric locomotion means comprising a dynamically stabilised vehicle ( 10 ) comprising two wheels ( 11 ), said vehicle ( 10 ) having a transverse axis defined by an axis of rotation of said wheels ( 11 ) and a longitudinal axis that is perpendicular to said transverse axis and defines a direction of advancement of said vehicle ( 10 ), said vehicle comprising a pivot ( 24 ) arranged along said longitudinal axis and rotatable about said longitudinal axis, said pivot ( 24 ) being configured to transfer a steering control to said wheels ( 11 ); a seat ( 44 ) positioned on said vehicle; characterised in that said seat ( 44 ) is configured to accommodate a user affected by motor disability of the lower limbs, said seat ( 44 ) being tillable sideways by a lateral shift of the user's weight; said locomotion means further comprising transmission means ( 25 ) arranged between said seat ( 44 ) and said pivot ( 24 ), said transmission means ( 25 ) being configured to transfer a tilting movement of the seat ( 44 ) to said pivot ( 24 ).

BACKGROUND A. Field of the Invention This invention relates to timing and alarm devices, and further relates to timing and alarm devices as applied to the field of medicine. Many prescribed medicines need to be taken at regular times or time intervals so that a known percentage presence of the medicine can be maintained within the bloodstream. For instance, those medicines used to combat urinary tract infections, heart disease and in control of diabetes must all be taken at prescribed intervals. If such medicines are not taken at time intervals predetermined by the health practitioner, then the health of the patient could be seriously affected. To keep a medicine user as healthy as possible during times when he or she is not directly supervised by doctors or nurses, a convenient reminder is useful to indicate to the use when to self-administer medicaments prescribed by the health practitioner. B. Prior Art In the past there have been devices for recording how much medicine was taken in any given dosage or for indicating by a pre-set indicator dial time a dosage should be taken. Multipurpose timers are known which exist apart from the prescription bottle. However, the multipurpose timer's need for winding or time setting attentions is frequently forgotten by the medicine users and, not being incorporated into the container, are frequently not available for use at the time the timer is needed. As a result, most self-administered medicaments are ingested at an irregular schedule, often adversely affecting the efficacy of the medicament. In some instances the health and well-being of the patient are thereby adversely affected. C. Objects of the Invention It is an object of this invention to provide a combined medicament-timer mechanism for storing a medicament and indicating an elapsed time interval for administration of the medicament. It is another object of this invention to provide a timer mechanism in conjunction with a medicament bottle or container which timer incorporates, in one embodiment, a mechanical clock escapement mechanism for timing a set time interval together with audible alarm means. It is a further object of this invention to provide a timer and medicament bottle of the nature described in which the timer mechanism is an electronic device having a minimum of moving parts. It is a still further object of this invention to provide a timer mechanism for use with a medicament container in which the timer mechanism may be set for intervals usually encountered in the self-administration of medicaments to the patients of health practitioners. SUMMARY A timing and alarm device contained within a medicine bottle cap is provided wherein the timer is adapted to measure an interval suitable for the repeated administration of drugs. The purpose of the alarm device is to signal the medicine user, both visually and audibly, when a prescribed medicine dosage should be taken. The timer may be either the well-known escapement-type mechanical clock means having a unique alarm mechanism as described more in detail below or may be a solid state electronic device containing any one of a number of well-known timing circuits and devices adapted to time an elapsed period of rather short duration. As is well known in the administration of medicaments, the usual time periods prescribed are four, six, eight, twelve, or 24 hours, depending on the nature and dosage rates of the material being administered. In the self-administration of such medicines, a timer adapted to sound an audible signal and otherwise warn the user of the need to administer the next dosage is incorporated directly into the top or cap of the bottle. The timer is activated by manipulative movement of the act of closing the container to initiate the timing cycle. In the embodiment utilizing a clock escapement or mechanical timing device, the invention utilizes the interengagement of the top and container to perform the function of winding the mainspring of the clock device. The winding functions for both winding the mainspring on its arbor post and presetting the time interval are performed by placing a torque on the medicine bottle cap contained on the medicine bottle, which is equal to the direction and placement of torque needed to rotatively secure the medicine bottle cap on complementary threads on the medicine bottle. In other words, the medicine bottle cap is first screwed onto the medicine bottle and any further turning of the medicine bottle cap iin the same direction performs a winding of the timing and alarm device contained therein. When it is desired by the medicine user to wind and set the timing and alarm device for a prescribed time interval, the medicine bottle cap is wound or screwed onto the medicine bottle until the point at which the threads contained within the medicine bottle cap have received their full complement of threads contained on the medicine bottle, at which point cogs on the inner circumference of the medicine bottle cap engage a winding wheel which winds the mainspring of a timer on its arbor post. In one embodiment the time interval of the fully wound timer bottle cap is preset at the point of manufacture by a specific construction of the clock escapement. In the alternative, means are provided by which the duration of the timed sequence may be preset by the pharmacist and the medicine user need only wind the timer fully by turning the timer bottle cap until a stop is reached for the preset time interval. A more universally useful timer may also be provided in which the time interval is indicated on the timer and set by the user to establish each timer interval. This more universal arrangement permits reusage by the patient for various prescriptions to be administered on different time cycles. The alarm portion of this invention signals the medicine user at the prescribed time for medicine dosage with both audible and visual signals. The audible signal is preferably a mechanically operated bell sounded by a spring-driven rotating mechanism. Preferably, the device provides for disengagement of the mainspring from the clock escapement at the end of the timer cycle with the remaining force of the mainspring being then applied to the alarm sounding mechanism. Prior to the alarm bell sounding the center wheel teeth are engaged with the movement wheels and escapement through respective pinions and movement wheels. At the end of the prescribed time interval, whether this interval has been predesignated as the only interval for a timer or whether the medicine user can set different time intervals at their own discretion, a gap in the toothed portion of the center wheel reaches the escapement drive pinion. As a result, the center wheel disengages from the escapement drive pinion and, urged by the now unrestrained mainspring, the center wheel spins rapidly on its arbor post causing an alarm drive pinion, also engaged with the teeth of the center wheel, to spin rapidly. Alarm arms attached to the alarm wheel extend centrifugally and repeatedly strike the alarm bell. A visual indicator appears through an aperture in the top at the end of the prescribed time interval. The indicator is a color dot which appears in a view window aperture in the timer bottle cap at the prescribed time for medicine dosage. After the center wheel has spun rapidly to ring the alarm bell and the center wheel teeth once again become engaged with the first movement wheel pinion, the center wheel is stopped in its rotative movement and the visual indicator appears in the view window in the timer bottle cap. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view of one embodiment of the invention. FIG. 2 is a cross sectional view of the cap. FIG. 3 is a view showing a second embodiment of the invention showing a functional block diagram. FIG. 4 is a view of the cap of FIG. 3 for a four hour interval. DESCRIPTION OF THE PREFERRED EMBODIMENT As shown in FIG. 1, one preferred embodiment of this invention consists of a bottle 8 having a container neck 9 with container neck threads 10 contained thereon and an outer cap 1 having a timer escapement 48 and an inner cap 7 contained therein. A bottom bearing plate 5 retains the timer works 48 within the outer cap 1 and atop the inner cap 7. Support legs 4 are fixed to the bottom bearing plate 5 and support a top bearing plate 3. Flexible standoffs 2 attached to the outer cap 1 separate the outer cap 1 from the top bearing plate 3. An uninterrupted circumferential flange 44 is attached to the outer surface of the inner cap 7 and the outer cap 1 has a circumferential guideway 46 which receives the flange 44 of the inner cap 7. The inner gap 7, bottom bearing plate 5, support legs 4, top bearing plate 3 and the timer works 48 therebetween are retained in the outer cap 1 by means of the interengagement of the guideway 46 and the flange 44. Cog teeth 11 fixed to the inner wall of the outer cap 1 are unidirectional ratchet teeth which engage the winding wheel 12 of the timer works 48. When the outer cap 1 is rotated in a clockwise direction relative to the inner cap 7 and timer works 48, the mainspring 13 is wound up to operate the timer works 48. The arbor 16 of the winding wheel 12 is journaled for rotation in the top bearing plate 3 and in the bottom bearing plate 5. Mainspring 13 is fixed to the arbor 16 with a spring hook 15 and the mainspring 13 is attached to the winding wheel 12 at spring post 14. Elevated from the mainspring 13 and attached to the arbor 16 is center wheel 17. Center wheel 17 is in toothed engagement with a second movement wheel pinion 19. The second movement wheel pinion 19 has an arbor 18 which is journaled for rotation in both the top and bottom bearing plates 3 and 5, respectively. Common to the arbor 18 is a second movement wheel 20 which is in toothed engagement with a third movement wheel pinion 22. The third movement wheel pinion 22 has an arbor 21 which is journaled for rotation in the top and bottom bearing plates 3 and 5, respectively. Common to the arbor 21 is a third movement wheel 23 which is in toothed engagement with an escape wheel pinion 25. The escape wheel pinion 25 has an arbor 24 which is journaled for rotation in the top and bottom bearing plates 3 and 5, respectively. Common to the arbor 24 is an escape wheel 26 which is in toothed engagement with an escapement 36 as shown in FIG. 2. As shown in FIG. 2, the center wheel 17 has a center wheel gap 30 extending from the minor diameter of the center wheel 17 to the major diameter of the center wheel 17. In toothed engagement with the center wheel 17 is an alarm wheel 40 and attached in opposing radial directions from the arbor 39 of the alarm wheel 40 are hinged arms 42. An alarm bell 38 is fixed to the bottom bearing plate 7 within striking distance of the hinged arms 42 when fully extended. The timer works 48 is wound when the winding wheel 12 is caused to turn mainspring 13 about its arbor post 16. The winding wheel 12 is turned in the following manner: the medicine user rotates the outer cap 1 with the fixed cog teeth 11 in a clockwise direction relative to the inner cap 7 and the timer works 48. The cog teeth 11 engage the teeth of the winding wheel 12 in this relative clockwise direction and the torque of the rotating outer cap 1 is transmitted through to the center wheel 12 as it acts on the mainspring 13. Until the inner cap and container are secured the mainspring 13 will not be wound on its arbor post 16, because the torque required for rotatively securing the inner cap 7 to the medicine container 9 is less than that torque needed to wind the mainspring 13 of the timer works 48. Once the inner cap 7 is rotatively secured to the container neck 9 so that the top of the container neck 9 abuts the bottom bearing plate 5, the torque required for any further rotative securing of the container neck 9 into the inner cap 7 becomes greater than that torque needed for winding the mainspring 13 on the arbor 16 by means of the toothed engagement of the outer cap cogs 11 and the winding wheel 12, and, as a result, the mainspring 13 is wound. The torque applied to winding wheel 12 by unwinding the mainspring 13 will cause the winding wheel 12 to rotate in a counterclockwise direction relative to the cog teeth 11 of the outer cap 1. In this counterclockwise direction, the winding wheel 12 disengages from the one-way ratchet teeth of the cog teeth 11. The torque applied by unwinding the mainspring 13 is also transmitted through the arbor 16 to the center wheel 17 and thence through the timer works 48 in a manner commonly known in the prior art. From the center wheel 17, the torque goes through the pinion 19, through the second movement wheel 20, through the pinion 22, through the third movement wheel 23, through the pinion 25, and through the escape wheel 26 to the escapement 36, which escapement serves as a speed governor for the timer works 48. The diameters and toothed arrangement of the center wheel 17 and the second and third movement wheels 20 and 23, respectively, and the second and third movement wheel pinions 18 and 22 respectively will have been predetermined such that when the container neck 9 is rotatively secured to the bottom bearing plate 5 and when the mainspring 13 is completely wound on the arbor 16, the timer works 48 will time an interval coincident with a prescribed interval separating medicine dosages and such an interval being predetermined by varying the characteristics of the timer works 48. The user is made aware of the proper time for medicine dosage by both audible and visual signals. The audible signal is produced in the following manner: Once the prescribed and predetermined time interval has passed, the center wheel gap 30 of the center wheel 17 having no gear teeth, as shown in FIG. 2, reaches the second movement wheel pinion 19. The center wheel 17 disengages from pinion 19 and the center wheel 17 rotates rapidly from the torque of mainspring 13. Being in toothed engagement with the center wheel 17, the alarm wheel 40 with hinged arms 42 will spin rapidly about its arbor 52 and the hinged arms 42 will extend and strike the alarm bell 38, thus signalling the user to self-administer a medicine dosage. The visual indicator of the preferred embodiment consists of a visual indicator arm 28, as shown in FIGS. 1 and 2, which is fixed for rotation on the arbor 16 above the top bearing plate 3. The indicator arm 28 and indicator viewing aperture 34 are arranged such that the indicator arm 28 is visible to the medicine user through the aperture 34 when the gap 30 of the center wheel 17 has completely tangentially traversed the pinion 19 and the torque of the wound spring 13 is exhausted. To unscrew the outer cap 1 and inner cap 7 from the container neck 9 the user presses downwardly on the outer cap 1 thus bending the flexible standoffs 2 and engaging pegs 32 with peg slots 50 in the bearing plate 3 so that the outer cap 1 is firmly engaged with the inner cap 7 and so that the inner cap 7 may be rotatably separated from the inner neck 9 and the medicine obtained. The circumferential flange 44 and circumferential guideway 46 assure that the inner cap 7 and the timer works 48 will not fall from the outer cap 1 when the outer cap is removed from the container 8. The width of the outer cap cogs 11 and the guideway 46 assure that the outer cap with pegs 32 may be pressed downwardly for the engagement of pegs 32 with peg slots 50 without loosing the engagement of the flange 44 with the guideway 46 and the center wheel 12 with the outer cap cog 11. FIG. 3 shows a second embodiment of this invention in which an electronic timing means shown generally at 70 is used to control the duration of the timing cycles for this invention. An alarm mechanism 74 having an audible sounding means 76 and a mechanically operated visual indicator 80 visible through aperture 78 is shown. The timing device 70 and the alarm device 74 are both driven by a suitable power supply 82 such as a miniaturized nickel-cadmium battery or the like. The elements are all enclosed within cap 66 adapted to rotatively engage container 68. The upper lip of container 68, when fully engaged with cap 66, presses timer-actuator 72 into timer means 70 to initiate the timing of an interval preset by timer 70. Timer 70 may be any of a number of well-known timing devices, suitable for timing intervals from two to 24 hours. For example, a charged capacitor with a controlled decay rate could be utilized. Similarly, digital timing techniques, quartz crystals, resonant circuitry or the like may be utilized, all as is well known in the timer arts. While the inventor has described his invention in terms of specific preferred embodiments, it is apparent that various minor modification and changes are well within the scope of this invention and may be made without departing from the spirit and scope hereof.

A combined timer and container for dispensing medicaments is provided wherein a predetermined timer cycle set to coincide with dosage intervals is utilized to activate an audible signal and a visible signal in the cap of the container. The container and cap coact to initiate the timer cycle upon interengagement of the cap and container.

CROSS-REFERENCED TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. application Ser. No. 12/832,277 filed Jul. 8, 2010 by Studer et al and entitled “PEST CONTROL DEVICE WITH GLUEBOARD GUIDE”. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable. BACKGROUND OF THE INVENTION I. Field of the Invention The present invention relates to pest control devices, and more particularly to pest control devices which incorporate a replaceable glueboard to immobilize pests. II. Related Art Historically, a variety of pest control devices have been employed to trap rodents, insects and other pests. Such pest control devices have typically employed some attraction mechanism for luring pests to the pest control device. Such attraction mechanisms have included baits such as food, pheromones or other odorous materials found attractive by the pest. Such mechanisms have also included light sources. Ultraviolet lamps have proven to be a useful and effective lure when trapping flying insects. Pest control devices have likewise historically included an immobilization mechanism preventing the pest from exiting the pest control device. One type of immobilization mechanism commonly used is substrate such as a board, paper or other medium having a surface coated with an adhesive. Pests attracted to the pest control device or incidentally coming into contact with the adhesive become trapped by adhesion. One type of adhesively-coated substrate is commonly referred to as a “glueboard”. As the name suggests, a glueboard is a disposable board made of stiff paper, cardboard, corrugated plastic or other suitable material with an adhesive layer on one of the surfaces. For packaging and shipping purposes, the adhesive layer is covered by a release paper. The release paper is, of course, removed prior to use to expose the adhesive layer so pests can come into contact with the adhesive layer and become entrapped. Such disposable glueboards are routinely replaced to ensure the continued efficacy of the pest control device and to dispose of the pests immobilized by the glueboard. While the adhesives employed when manufacturing glueboards have proved to be highly effective for trapping insects and other small animals, the nature of the adhesive is such that insertion and removal of the glueboard from the pest control device can be problematic. If the adhesive surface of the glueboard accidently comes into contact with other surfaces of the pest control device, the adhesive will cause the glueboard to stick to those surfaces. Likewise, if the skin or clothing of a person installing or removing glueboard comes into contact with the adhesive surface, the glueboard will stick to the person or the person's clothing. Efforts have been made in the past to address such concerns. By way of example, various cartridges have been developed to enclose a substrate having a surface coated with an adhesive. See, for example, U.S. Pat. No. 6,871,443 granted to Lambert et al on Mar. 29, 2005 and U.S. Pat. No. 5,651,211 to Regan et al granted Jul. 29, 1997. While such cartridges do prevent the adhesive surface from coming into contact with the outer surface of the light sources and other surfaces of the trap and are also useful in diminishing the risk an installer or the installer's clothing will come into contact with the adhesive surfaces, such cartridges tend to be relatively expensive and complicated to assemble. Likewise, they often incorporate bracing or grids reducing the size of the area of the adhesive surface which is exposed and thus capable of trapping pests. Prior to the invention disclosed and claimed herein there existed a real need for an inexpensive solution to reduce the risk that the adhesive surface of a glueboard will come into contact with the other surfaces of the insect trap or the skin or clothing of a person installing or removing a glueboard. SUMMARY OF THE INVENTION A unique and novel pest control device is described below. The pest control device comprises replaceable glueboards of a defined thickness each having at least one edge extending between back and front surfaces, the front surface having a peripheral section adjacent the at least one edge and a central section, and an adhesive coating covering the central section. The pest control device further comprises a housing having a space which reserves and retains one or more replaceable glueboards. This space is defined by at least one channel, the channel having an opening into which the at least one edge of the glueboard(s) is inserted and a lip for retaining the at least one edge of the glueboard(s) within the channel. The lip of the channel and the peripheral section of the glueboard(s) are dimensioned so the adhesive coating of the glueboard(s) does not come into contact with the lip as a glueboard is inserted into and retained within or removed from the space of the housing. The pest control device also includes a guide engaging and guiding the glueboard(s) during insertion of the glueboard(s) into and removal of the glueboard(s) from the space of the housing. The guide engages the front surface of a glueboard as the glueboard is inserted into and removed from the space to prevent the adhesive coating covering the central section of front surface of the glueboard from coming into contact with other surfaces of the pest control device. The guide has an edge engaging the front surface of a glueboard. This edge of the guide is sufficiently narrow to prevent the guide from sticking to the adhesive coating. In certain embodiments, the guide comprises an axle supported by one or more bearings having at least one wheel mounted thereon. In these embodiments the edge(s) of the guide coming into contact with the front surface of a glueboard is the periphery of the wheel(s). A plurality of such guides may be provided. The axle of the guides may be made flexible to accommodate glueboards having differing defined thicknesses or a plurality of glueboards. The axle of the guides may also be resilient so the wheel(s) mounted thereon slightly pinch the glueboard(s) between the wheel(s) and a portion of the housing. Also, the wheel(s) mounted on the axle of a guide may rotate during insertion and removal of the edges of glueboards from the channels and glueboards from the space. While the pest control device may include a pest attractant incorporated into the glueboard(s), the pest control device may either alternatively or additionally include a separate pest attractant in a second space which is located adjacent the space in which at least one replaceable glueboard is located. This separate pest attractant can be of any suitable type—one example being a light source. One of the functions of the guide is to ensure the adhesive surface of the glueboard does not come into contact with the separate attractant (or other surfaces) as the replaceable glueboard is inserted or removed. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a flying insect trap. FIG. 2 is a perspective view of the housing of the flying insect trap shown in FIG. 1 . FIG. 3 is a partial perspective view showing the bearing and axle assembly of the housing of FIG. 2 . FIG. 4 is a partial front elevational view of the bearing, axle and wheel assembly of the housing of FIG. 2 . FIG. 5 is a partial perspective view of the glueboard of the flying insect trap of FIG. 1 . FIG. 6 is a perspective view showing the glueboard partially inserted into the housing showing how the glueboard interacts with the channels and the axle and wheel assemblies of the housing. Two of the light sources are not shown in the drawing to make it easier for one to view the axle and wheel assemblies. FIG. 7 is a perspective view like FIG. 6 , but with the glueboard fully inserted into the housing. FIG. 8 is a perspective view like FIGS. 6 and 7 , but with all three light sources in place. FIG. 9 is a partial front elevational view of the bearing, axle and wheel assembly of the housing of FIG. 2 together with a plurality of glueboards. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The concepts of the present disclosure may be employed in various alternative forms. The following description of specific exemplary embodiments shown by way of the drawings is provided to meet the disclosure requirements of the patent laws. However, the reader should understand that the present invention is not limited to the embodiment shown in the drawings or described herein. FIG. 1 shows one of many different flying insect traps which may be made in accordance with the present invention. The flying insect trap shown includes a glueboard 10 , a housing 30 , three ultraviolet light sources 56 , 57 and 58 , a removable pan 80 , and a removable cage 82 . The removable cage 82 prevents people from inadvertently coming into contact with and being potentially burned by the light sources 56 , 57 and 58 while at the same time permitting ingress of flying insects into the caged area. Glueboards 10 of the type used may be of a variety of shapes. As shown in the drawings, the glueboard 10 is rectangular in shape having a first edge 12 ( FIG. 6 ) parallel to a second edge 14 and a third edge 16 parallel to a fourth edge 18 extending between first and second surfaces. The first or back surface has no adhesive coating. The second or front surface 20 has a peripheral section 22 adjacent the edges 12 , 14 , 16 and 18 and a center section 24 . The center section 24 is coated with a suitable adhesive known in the art for immobilizing the pests to be captured by the pest control device. The peripheral section 22 is typically not coated with such an adhesive to promote ease of handling. FIG. 5 also shows a release paper 26 which covers the adhesive layer of the center section 24 during shipping and handling to prevent unintended items from sticking to the center section 24 . The release paper 26 is removed at the time the glueboard 10 is placed into service as illustrated in FIGS. 1 and 6 - 8 . As best shown in FIGS. 2 and 6 , the housing 30 includes a space 32 in which a glueboard 10 is received and retained. As shown in the drawings, the space 32 is defined by a first channel 34 , a second channel 40 , and a support surface 46 . Alternatively, a single U-shaped channel could be employed. The first channel 34 has at least one open end 36 and a lip 38 for retaining edge 18 of the glueboard 10 . The second channel 40 has at least one open end 42 and a lip 44 for retaining edge 16 of the glueboard 10 . The dimensions of the lips 38 and 44 and the peripheral section 22 are such that the adhesive coating of the glueboard 10 never comes into contact with lips 38 and 44 . When the glueboard 10 is located within the space 32 , the front surface 20 of the glueboard 10 and adhesive coating over the center section 24 face away from a support surface 46 of the housing 30 . As such, the back surface of the glueboard 10 , which is not coated with adhesive, is in face-to-face registration with the support surface 46 . As shown in FIGS. 1-3 and 6 - 8 , the housing 30 also includes electrical fittings 50 - 55 for physically and electrically coupling three ultraviolet (UV) light sources 56 - 58 to the housing. The UV light sources, when energized, give off UV light which is known to be attractive to insects. As shown, the UV light sources 56 - 58 are positioned in front of and spaced from the channels 34 and 40 and the glueboard 10 and extend across the support surface 46 and glueboard 10 . When the UV light sources 56 - 58 are illuminated, insects attracted by the UV light will fly about the light sources 56 - 58 , come into contact with the adhesive and adhere to the glueboard 10 . Of course, if the glueboard 10 is not replaced regularly, the adhesive can dry out and loose its adhesive properties in which case any dead insects will fall into pan 80 . While the drawings show UV light sources being employed, other types of attractants can be employed either in lieu of or in addition to such light sources. The drawings also show a pair of guides 60 and 62 . As shown, each guide includes a first bearing 64 and a second bearing 66 which support opposite end sections of an axle 68 . Mounted along each axle 68 between the two bearings 64 and 66 are narrow wheels 70 and a plurality of stops 72 . The stops 72 prevent the axle 68 from unintentionally becoming disconnected from the bearings 64 and 66 and the wheels from sliding along the axle. The wheels 70 have an axis of rotation along the same longitudinal line as the axle 68 . The wheels 70 can either be fixed to the axle 68 , in which case the bearings 64 and 66 permit the axle to rotate, or the wheels can rotate about the axle 68 . The wheels 70 terminate in a narrow outer edge to ensure the adhesive of the glueboard 10 does not cause the wheels 70 to stick to the glueboard 10 . The wheels 70 of guide 60 provide at least two very important functions when the edges 16 and 18 of a replaceable glueboard 10 are being inserted into or removed from the channels 34 and 40 of the housing 30 . Specifically, the wheels 70 guide the glueboard 10 so the edges 16 and 18 enter the channels 34 and 40 . The wheels 70 also prevent the adhesive-coated center section of the glueboard from coming into contact with the outer surfaces of bulbs 56 - 58 or other surfaces of the housing 30 . Guides having other configurations can also provide this function without deviating from the invention so long as any edge of the guide coming into contact with the adhesive coating is thin enough to prevent an adhesive bond from being formed between the glueboard and the guide. A second guide 62 may be added at the opposite end of space 32 and channels 34 and 40 for additional security. When a second guide 62 is provided, the guides 60 and 62 cooperate with the lips 38 and 44 of the channels 34 and 40 to ensure the glueboard 10 does not move, warp or otherwise change position in a fashion which could permit the adhesive of glueboard 10 to come into contact with the outer surfaces of light sources 56 - 58 or other surfaces of the housing 30 . From FIGS. 1-8 of the drawings, it should be appreciated that the thickness of the glueboard 10 , at least at the peripheral section 22 , should be less than the distance between the lips 38 and 44 and the support surface 46 so the edges 12 and 14 of the glueboard 10 can be slid between the lips 38 and 44 and the support surface 46 . As noted above, the depth of the lips 38 and 44 and the peripheral section 22 of the glueboard 10 should be dimensioned so adhesive from the glueboard 10 does not come into contact with the lips 38 and 41 . The axles 68 may also be made of a flexible yet resilient material to allow for variations in the thickness of the replaceable glueboard 10 and provide a slightly-pinching force against the glueboard 10 between the wheels 70 and the support surface 46 . The arrangement of the present invention cannot only be employed to position and retain a glueboard being used to capture pests attracted to the trap, but also to store a plurality of replacement glueboards. As shown in FIG. 9 , glueboard 10 A is positioned to capture pests while glueboards 10 B and 10 C are being stored for future use. One should recognize that suitable steps should be taken to ensure that the glueboards 10 A, 10 B and 10 C do not adhere to each other when stored as shown in FIG. 9 . One such suitable step is to employ release paper 26 of the type shown and described with reference to FIG. 5 . As used herein, “release paper”, irrespective of the specific material from which the panel is made, is used to identify any panel of material which can be releasably applied to the adhesive layer of a glueboard to selectively cover the adhesive layer and thereby prevent the adhesive layer from contacting other items that may stick to the adhesive layer. Rather than using a separate release paper or panel, the back surface of each glueboard 10 A, 10 B and 10 C may have characteristics similar to release paper 26 . A spacer or sleeve arrangement (not shown) may likewise be employed to keep the adhesive layer of one glueboard from contacting the adjacent glueboard of the stack. Also, the walls of the channel may comprise a plurality of grooves such that a separate glueboard can be stored in each groove. The spacing between the grooves of the channel keeps the adhesive layer of one glueboard from coming into contact with the adjacent glueboard. When a plurality of glueboards are to be retained and stored as shown in FIG. 9 , the housing 30 and guide 60 must be arranged to permit such storage. Specifically, the distance between the support surface 46 and the wheels 70 of guide 60 must be sufficient to accommodate the number of glueboards to be stored. This can be achieved by changing the distance between the support surface 46 and the point of intersection between the bearing 64 and the axle 68 . This can also be achieved by providing an axle 68 which is sufficiently flexible such that it flexes to accommodate different numbers of glueboards. The size of the channel and its openings (e.g., opening 36 ) must also accommodate the size of the stack of glueboards as shown in FIG. 9 . The drawings and the description provided above are designed to meet the disclosure requirements of the patent laws, but the invention is not limited to the embodiment disclosed. Variations can be made without deviating from the invention. By way of example, a different number or type of lights may be employed as the pest attractant. Pest attractants other than light sources may be employed including, but not limited to, pheromones and other odorous materials embedded in the glueboard or positioned adjacent to the glueboard. The housing may also include various grills, grates or decorative panels to prevent people from coming into contact with the adhesive coating of glueboard 10 , to prevent viewing of the glueboard 10 and any pests trapped by the glueboard 10 , or to prevent people from coming into contact with either the glueboard or light sources. Also, the housing 30 and glueboard 10 may have a variety of different shapes without deviating from the invention. Thus, it is intended that the invention only be limited by the language of the claims which are intended to cover what the claims literally describe and a fair range of equivalents.

A pest control device uses a replaceable glueboard to immobilize pests attracted to the pest control device. A unique guide is provided to help prevent the adhesive surface of the glueboards from coming into contact with other surfaces of the pest control device during installation and removal of such glueboards.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is a continuation of application U.S. Ser. No. 11/163,648 filed Oct. 26, 2005, now U.S. Pat. No. 7,387,208 issued Jun. 17, 2008. FIELD OF THE INVENTION [0002] This invention relates to the field of medication dosage tracking, and in particular, to a system which allows the user of medication to readily track both the dosages that need to be taken as well as those that have already been taken. BACKGROUND OF THE INVENTION [0003] Most practitioner-prescribed medication, as well as over-the-counter medication, requires regimented usage for optimal results. In our fast paced society, it is difficult for most people to maintain a medication-related schedule and to remember what has been taken and what still needs to be taken. [0004] A survey of approximately one hundred people who take or have taken medication (the survey included pharmacists) was conducted by applicant to substantiate the belief that most people forget, or have forgotten to take their medication. The results of the survey was that ninety-nine percent of those people surveyed forget to take their medication, and that the majority of people forget to take their medications, more often than not. Not only do most people forget to take their medication, but just as important, most people, while in the process of remembering to take their medication, often forget if they have taken their last scheduled dose or not. [0005] It is therefore desirable to have a reminder system which indicates not only when the medication is scheduled to be taken according to the medication schedule, but also contains some visible evidence attesting to the day-schedule on which the doses were to be taken and have already been taken. [0006] In particular, it is desirable for such reminder system to confirm that a particular medication dose has been taken as a consequence of removing reminder tabs from the system at the time a medication is taken, as well as to indicate what dosages still need to be taken. [0007] In other words, there should be no doubt for the user, about when the medication should be taken. And, there should be no confusion for the user, as to whether or not the medication has been taken. SUMMARY OF THE INVENTION [0008] This invention relates to a system of Day/Dose tear-off tabs, which allows the user of medication to adhere to a medication schedule, with respect to dates or days of any calendar day, week, or month, in any sequence that is determined by the medication schedule. The invention also allows the user to easily determine if the scheduled dose or doses have been taken on the scheduled date/day, and indicates when the next scheduled dose is due to be taken, by viewing the visible residue Day tabs, and removing/tearing off the Dose tabs appropriately. [0009] This Med-Sked™ Tab System is used in conjunction with the consumption of any type of medication produced. The Tab System can also be used in accordance with over-the-counter medication. The System has specific Day/Dose tabs, which can be used for any prescribed schedule, but not limited to, numbering anywhere from, or numbering anywhere in between, or any combination of numbers and dates, the numbers corresponding to calendar days one through thirty one. These Day/Dose tabs correspond with the prescribed Day/Dose dosage of any type of medication. The tab system is specifically designed for, but not limited to, a medication schedule wherein one or more doses of meds are to be taken within the course of one day, for any number of days. While the dose tabs are torn off as each dose is taken, a corresponding Day Tab Residue remains adhered to the bottle or package, to indicate to the user both what has been taken, and also whether or not there are more doses to be taken that day or on a later day, until the medication is taken in its entirety. The innovative feature of this invention is in its simplicity. It is revolutionary in that it requires no electronic equipment, requires no complicated mechanics and requires no maintenance to perform its function. And, it not only tell the user what needs to be taken next, but also confirms for the user what has been taken by virtue of the tab “residue.” [0010] The function of the Med-Sked™ Tab System is to keep the users of medically prescribed medication on their medication-taking schedule. The Med-Sked™ Tab System is a series of Day/Dose tabs that indicate the medication schedule or calendar and confirms that the schedule has been adhered to, when the appropriate tabs are removed. This procedure eliminates the confusion associated with the taking of medication. It assists the user in complying with, and with specificity to prescription and non-prescription medication scheduling. Using a tab residue, It confirms that this has been accomplished when the appropriate Day/Dose Tab has been removed. [0011] The Med-Sked™ Tab System may be affixed to, or incorporated into, any medication packaging. [0012] The Med-Sked™ Tab System reduces or eliminates the possibility of overdose or under-dose. [0013] The Med-Sked™ Tab System may be manufactured in a variety of materials. [0014] The Med-Sked™ Tab System's dimensions may be adjusted accordingly to accommodate a variety of medication containers. [0015] The Med-Sked™ Tab System may be affixed, through the use of adhesives, magnets, or other attachment/adhering devices and methods known or which may become known in the art, to a multitude of surfaces. [0016] Disclosed is a device, system, method, and product-by-process for tracking consumption of a medication which is taken N doses per day where N>1, for a plurality of days, the system comprising: a top tab layer comprising a plurality of top layer day-dose tabs, each top layer day-dose tab comprising a top layer day-day indicator designation and a top layer dose number designation; a bottom tab layer comprising a plurality of bottom layer day-dose tabs, each bottom layer day-dose tab comprising a bottom layer day-day indicator designation and a bottom layer dose number designation; if N>2, N-2 intermediate tab layers between the top and bottom tab layers, comprising a plurality of intermediate layer day-dose tabs, each intermediate layer day-dose tab comprising an intermediate layer day-day indicator designation and an intermediate layer dose number designation; each of the top and bottom tab layers, and all of the intermediate layers, if any, comprising tearable perforation lines between the layer's day-day indicator designations, and the layer's dose number designations; and the top layer day and day indicator designations adhered over the bottom layer day and day indicator designations, and if there are any intermediate layers, via being adhered over the day but not day indicator designations of the intermediate layers; wherein: when a dose number designation portion of a tab of the top or bottom tab layers, or, if any, the intermediate layers, is pulled with a force sufficient to cause a tear along the perforation line, the pulled tab tears along the perforation line and the adhesion causes the day-day indicator designation of the pulled tab to remain adhered in place to the next-lower tab layer as a residue while the dose number designation of the pulled tab is torn away, the residue thereby indicating that the dose number for the day has been consumed and the remaining unpulled tabs indicating what doses still remain to be taken. [0017] Also disclosed is a device, system, method, and product-by-process for tracking consumption a medication which is taken one dose per day for a plurality of days, the system comprising: a top tab layer comprising a plurality of top layer day tabs, each top layer day tab comprising a top layer day-day indicator designation; a bottom tab layer comprising a plurality of bottom layer day tabs, each bottom layer day tab comprising a bottom layer day-day indicator designation; each of the top and bottom tab layers comprising tearable perforation lines between the layer's day designation, and the layer's day indicator designation; the top layer day but not day indicator designations adhered over the bottom layer day but not day indicator designations; wherein: when a tab of the top or bottom tab layers is pulled with a force sufficient to cause a tear along the perforation line, the pulled tab tears along the perforation line and the adhesion causes the day designation of the pulled tab to remain adhered in place to the next-lower tab layer as a residue while the day indicator of the pulled tab is torn away, the residue thereby indicating that the dose for the day corresponding to the torn-off day indicator has been consumed and the remaining unpulled tabs indicating the days for which doses still remain to be taken. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The features of the invention believed to be novel are set forth in the appended claims. [0019] The invention, however, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawing(s) summarized below. [0020] FIGS. 1 and 2 illustrate the right/left alignment of three layers of tabs in accordance with an embodiment of the invention, as well as a fourth, underlying affixation layer for affixing the tab system to medication packaging. FIG. 1 exemplifies a ten-day system for three doses per day. FIG. 2 exemplifies a thirty-day system for one dose per day. These are by way of illustration only, and these illustrated examples do not in any way serve to limit the range of medication dosage calendars that can be represented in accordance with the invention. [0021] FIGS. 3 and 4 respectively illustrate the up/down alignment of the exemplary three layers of tabs illustrated in FIGS. 1 and 2 . [0022] FIGS. 5 and 6 illustrate the manner in which the exemplary tabs illustrated in FIG. 1 through 4 are overlaid onto one another and affixed together to assemble the embodiment of FIGS. 1 through 4 . [0023] FIGS. 7 and 8 illustrate the embodiments of the preceding figures, with all layers of tabs assembled and affixed together, as well as the manner in which tabs are removed to indicate that a particular dose has been taken. These two figures illustrate the manner in which various embodiments of the invention would typically be provided to the medication consumer for use with a medication, whereas FIGS. 1 through 6 illustrate “pre-assembled” representations of invention embodiments. [0024] FIG. 9 illustrates last dose and next-to-last-dose indicators for reconfiguring one or two of the first day tabs into last day tabs, for the common situation where all daily dosages of a medication are not consumed in the first day. [0025] FIG. 10 illustrates the one or two of the first day tabs reconfigured into last dose and next-to-last-dose tabs, using the last dose and next-to-last-dose indicators of FIG. 9 . [0026] FIG. 11 illustrates the invention embodiment of FIG. 7 , as mounted on medication packaging. [0027] FIGS. 12 and 13 illustrate sample, for illustration not limitation, of directions for using the Med-Sked™ tab systems of FIGS. 1 , 3 , 5 , 7 and 2 , 4 , 6 , 8 , respectively. DETAILED DESCRIPTION [0028] Referring to FIGS. 1 and 2 , it is seen that that the top tab layers 11 and 21 are slightly narrower than the middle tab layers 12 and 22 , which in turn are slightly narrower than the bottom tab layers 13 and 23 . It is also seen in FIG. 1 that the underlying affixation layer 14 is approximately equal in width to that of the “day tab” portion of the top 11 , middle 12 and bottom 13 tab layers, including a day indicator for the day (e.g., number of the day or day of the week, etc.), while in FIG. 2 , the underlying affixation layer 24 is approximately equal in width to that of the “day tab” portion of the top 21 , middle 22 and bottom 23 tab layers, excluding the day indicator, (e.g., number of the day, day of the week). Note that affixation layer 14 in the FIG. 1 embodiment is preferably wider than narrower affixation layer 24 in the FIG. 2 embodiment, as will be elaborated below. Affixation layers 14 and 24 adhere on both sides (preferably, beneath 14 and 24 is a peel-off protective sheet), and the adhesive on the underside of 14 and 24 is used to adhere these to a mounting location, e.g., the medicine container, box, etc. (packaging). [0029] For the multidose-per-day embodiment of FIG. 1 , there is a tearable perforation line 15 between the day portion of the tab including the day indicator, and the dose portion of the tab. For the single-dose-per day embodiment of FIG. 2 , there is a tearable perforation 25 between the word “day” and the day indicator so that when an upper 21 or middle 22 tab is removed, the day indicator on the middle 22 or bottom 23 tab, respectively, is readily revealed to visual inspection. [0030] The dimensions of the tab system may readily be varied. For illustration, and not limitation, in a preferred embodiment the top-to-bottom length of the entire system is approximately 2 3/16″. Similarly, it is preferred, but not at all limiting, for the top layers 11 and 21 to be 13 / 16 ″ in width, for the middle layers 12 and 22 to be 15/16″ in width, and for the bottom layers 13 and 23 to be 1 1/16″ in width, all approximately. For the FIG. 1 system, which illustrates multiple doses per day (and in this specific, non-limiting illustration, three doses per day for each of ten days), perforation 15 is preferably approximately 7/16″ from the left edge of each layer (and wider affixation layer 14 correspondingly, is preferably approximately 7/16″ in width), and between each tab, there are horizontal cuts 16 . For the FIG. 2 system, which illustrates a single dose per day (and in this specific, non-limiting illustration, one dose per day for each of thirty days), perforation 25 is preferably approximately 4/16″ from the left edge of each layer (and narrower affixation layer 24 correspondingly, is preferably 4/16″ in width). Between each tab, again, are horizontal cuts 26 . Because perforation 15 in the FIG. 1 embodiment is between the day/day indicator and the dose number, when a tab is removed from this system, the day indicator remains intact. Because perforation 25 in the FIG. 2 embodiment is between the word “day” and the day indicator, when a tab is removed from this system, the day indicator is also removed, so that a different day indicator just beneath becomes exposed to view. [0031] FIGS. 3 and 4 illustrate the same as FIGS. 1 and 2 respectively, except that here the tabs are shown in a right-to-left placement for comparison of how the vertical elements align, whereas FIGS. 1 and 2 illustrate the horizontal alignment. FIGS. 5 and 6 similarly illustrate the way in which the layers are overlaid, resulting in the configuration of FIGS. 7 and 8 . [0032] In relation to the illustrative embodiment of FIGS. 1 , 3 , 5 , and 7 , top layer 11 is adhered to middle layer 12 beneath where the word “day” (or a similar suitable indicator for a day) as well as beneath the day indicator; middle layer 12 is adhered to bottom layer 13 also beneath where the word “day” and the day indicator; and bottom layer 13 is adhered to wider affixation layer 14 , also beneath where the word “day” and the day indicator. All of these are adhered with sufficient strength such that, when a dose is taken and the dose tab is torn along perforation 15 , the word “day” and the day indicator both remain intact as an indicator “residue.” In this way, the user can keep track both that a dose has been taken together with what dose needs to be taken next. For example, as illustrated in FIG. 7 , once the “dose 1 ” and “dose 2 ” tabs are torn at perforation 15 , the user visually sees only “day 1 , dose 3 ” remaining. This tells the user not only that day 1 , dose 3 is the next dose, but also, by virtue of the day 1 residue which contains an affirmative indicator which was formerly part of (a residue from) the indictor from dose that has now been consumed, that the first two doses from day 1 have already been consumed. Note, this “residue” is more than just the tape or glue or the nub from a removed tab, which can be inconclusive in its meaning. This residue, again, contains an affirmative remaining (unremoved) indicator which was earlier associated with a dose that has now been consumed. Thus, the indicators which are displayed to visual inspection once doses have been taken relate to and originate from both doses which have already been taken as well as doses which still need to be taken. [0033] In relation to FIGS. 2 , 4 , 6 , and 8 , top layer 21 is adhered to middle layer 22 beneath the word “day,” but not beneath the day indicator. Middle layer 22 is adhered to bottom layer 23 also beneath the word “day” but not beneath the day indicator; and bottom layer 23 is adhered to wider affixation layer 24 , also beneath the word “day” but not the day indicator. All of these are adhered with sufficient strength such that, when a dose is taken and the dose tab is torn along perforation 25 , the word “day” remains intact, again, as a “residue.” But, in contrast to FIGS. 1 , 3 , 5 , and 7 , the day indicator from the next lower layer is exposed. Again, this enables the user to keep track both that a dose has been taken together with what dose needs to be taken next, by maintaining an affirmative visual indicator—more than tape or glue or nub—from doses already taken as well as doses still to be taken. For example, as illustrated in FIG. 8 , when the “1” from day 1 is torn away along perforation 25 together with the dose 1 indicator, the “11” for day 11 is exposed. It is clear to the user from both the day 1 residue (here, the word “day”) as well as the now-visible “11” that the day 1 dose has been consumed, and that the day 2 dose is next to be consumed. When all of the dosages for days 1 through 10 are completed, the user will see all of day indicators 11 through 20 exposed, and will begin to cycle through the second layer 22 , see FIGS. 1 , 3 and 5 . Completion of the second layer cycle then leaves the third layer 23 for days 21 through 30 , again, see FIGS. 1 , 3 and 5 . [0034] The directions for using the tab system, for the example of a medication that is taken three times per day for 10 days, would be as follows: [0035] On day 1 , consumer takes Dose 1 of medication from the bottle or box, then lifts and tears off the tab for Dose 1 adjacent to Day 1 , at the perforation line 15 . [0036] Later on day 1 , consumer takes Dose 2 of medication from the bottle or box, then lifts and tears off the tab for Dose 2 adjacent to Day 1 , again at the perforation line 15 . [0037] Consumer continues this medication schedule, tearing off all dose tabs from top 11 , middle 12 , and bottom 13 layers, for the prescribed 10 days, until the medication is taken in its entirety. [0038] For the example of one dose per day for 30 days, the consumer removes tabs so as to cycle through the first 10 days, which exposes days 11 through 20 . Then, the consumer cycles through and removes tabs for the next 10 days, exposing days 21 through 30 . Finally, the consumer cycles through and removes tabs for the final 10 days. [0039] In all cases, there is never any doubt whether a dose has been taken, nor is there any doubt which dose needs to be taken next. [0040] While the examples used here are for ten days at three doses per day and thirty days at one dose per day, this is exemplary and not limiting. For one week of medication taken four times per day, one would have seven tabs per layer, and four layers. For two weeks of medication taken twice a day, one might have seven tabs per layer and four layers, but differently marked so that when the day 1 dose 1 is taken, a day 1 dose 2 tab is exposed, and when that is taken a day 8 dose 1 tab is next exposed, followed by a day 8 dose 2 tab. Whether one elongates the top-to-bottom length of this system and thus uses more tab per layer, or adds additional layers, will depend on the particulars of the dosage schedule to be represented, as well as how much physical space is expected to be available on the mounting surface to which the system is to be mounted. Other combinations will become readily apparent to someone of ordinary skill, and are envisioned to be within the scope of this disclosure and its associated claims. [0041] Similarly, the use of “day 1 ,” “day 2 ” etc, is illustrative, but not limiting. For example, not limitation, the days can simply be represented by calendar numbers, e.g., 1 through 31. Or, by days of the week such as “Sunday” through “Saturday” which may employ a seven-tab-per-layer embodiment. Then, if the user starts consuming medication on, e.g., a Wednesday, the first tear-off will occur for the Wednesday tab in the middle of top layer of the tab system, and will cycle back to the Tuesday tab also in the middle of the first layer, before staring the second layer on its Wednesday tab. For a 30-day calendar month, for example, one might have 30 distinct embodiments, so that if a medication is begun on the 23 rd of the month, the number “23” appears as the first tab, the top layer contains all of 23 through 30 and 1 and 2 (ten tabs per layer), the middle layer contains all of 3 through 12, and the bottom layer all of 13 through 22. In sum, the day indicator designations may comprise a sequence of numbers beginning at 1, or a sequence of numbers representing days on a calendar, or a sequence of markings representing days of the week, or any other suitable representation of specific days. Again, other variations of this nature will become apparent to someone of ordinary skill based on this disclosure, and are regarded to be within the scope of this disclosure and its associated claims. [0042] As a more detailed example of use, consider the example of Amoxicillin, prescribed to be taken three times a day, for ten days. The consumer receives the Amoxicillin from the pharmacy, then affixes the Med-Sked™ Tab System to the medication package/container. The consumer takes the first dose of Amoxicillin, then tears off the Dose 1 tab (adjacent to the Day 1 tab). The remaining Dose 2 and Dose 3 tabs, along with the corresponding Day 1 tab is left adhered to the medication package/container to indicate that the user has taken Dose 1 , but has yet to take Dose 2 and Dose 3 for the remaining Day 1 . The user then takes the second dose of Amoxicillin, according to the medication schedule, and tears off the Dose 2 tab adjacent to the Day 1 tab. The remaining Dose 3 tab, along with the Day 1 tab is left adhered to the medication package/container to indicate that the user has taken Dose 2 , but has yet to take Dose 3 for the remaining Day 1 schedule. The user then takes the third and final dose of Amoxicillin for Day 1 . The user tears of the Dose 3 tab. There are no more Dose tabs left for Day 1 , which indicates that the user has taken all 3 doses for Day 1 . [0043] The Day 1 tab is left adhered to the package/container as a residue to act as confirmation that all doses for Day 1 were taken according to the medication schedule. [0044] The above procedure is repeated for (but not limited to) the 10 day medication schedule. [0045] To manufacture the embodiments described above for use by a consumer, one first cuts and prints/marks a plurality of tab layers along the lines of FIGS. 1-4 . This includes making horizontal cuts 16 , 26 , as well as, e.g., scoring the perforations 15 , 25 . Then, the top layers 11 , 21 are adhered to the middle layers 12 , 22 , the middle layers 12 , 22 are adhered to the bottom layers 13 , 23 , and the bottom layers 13 , 23 are adhered to the “top” side of the affixation layers 14 and 24 . All of this is done such that the tabs will tear properly along the perforation lines and leave the required residues through which the consumer can be reminded what doses have been taken and what doses need to next be taken. As noted above, affixation layers 14 and 24 also contain, for example, an adhesive on their underside, protected, for example, by a peel-off protective sheet. When manufactured, the protective sheet remains adhered. The consumer peels off this sheet to expose the underside adhesive, and uses this to affix the entire Med-Sked™ system to the mounting surface, e.g., medication packaging. [0046] Frequently, when a consumer begins a prescription for a medication that is taken two or more times per day, not all of the daily doses are consumed on the first day, and this will leave extra doses to be consumed following the last day. For example, for the three-dose-per-day, ten-day prescription (30 doses total) illustrated in FIGS. 1 , 3 , 5 and 7 , the consumer may pick up the prescription from the pharmacy on the afternoon of the first day and so skip the morning dose for that day. Or, the consumer may pick up the prescription from the pharmacy on the evening of the first day and so skip both the morning and afternoon doses for that day. In the former case the consumer takes two doses (afternoon and evening) the first day, and has one dose left over which will actually need to be consumed on the morning of the 11 th day. In the latter case, the consumer takes only one dose (evening) the first day, and so has two doses left over which will need to be consumed on the morning and afternoon of the 11 th day. [0047] FIGS. 9 and 10 illustrate an example of how to employ the Med-Sked™ to deal with this type of situation. Fundamentally, one addresses this situation by redesignating the “day 1 /dose 3 ” tabs, and possibly the “day 1 /dose 2 ” tabs, respectively, into next-to-last-dose and last-dose tabs. For example, if the consumer only takes two doses the first day, then the unused day “day 1 /dose 3 ” tab is redesignated into a “last dose” tab. If the consumer only takes one dose the first day, then the unused “day 1 /dose 3 ” tab is redesignated into a “last dose” tab, and in addition, the unused “day 1 /dose 2 ” tab is redesignated into a “next-to-last dose” tab. If there are more than three doses per day, then one would need to further redesignate others of the day 1 tabs into “third-from-last dose,” “fourth-from-last dose,” etc. [0048] A particular embodiment for managing this redesignation is illustrated, for example but not limitation, in FIGS. 9 and 10 . In this embodiment, the Med-Sked™ system comprises two extra redesignation tabs (for three doses per day) with adhesive backing (and a removable protective layer over the adhesive) which can be adhered to the “day 1 /dose 2 ” and the “day 1 /dose 3 ” tabs as needed, to redesignate the meaning of these tabs as just discussed. One of these redesignation tabs is a “next-to-last dose” tab 91 . The other is a “last dose” tab 92 . For N doses per day, a total of N-1 such redesignation tabs are provided. [0049] However, one can employ other devices and methods for doing this as well. The consumer, for example, might simply use a marking pen or pencil to redesignate these tabs. The “day 1 /dose 2 ” and the “day 1 /dose 3 ” tabs might be manufactured wider (left-to-right in the drawings) than all of the other tabs, with a scoring line along which they may be reduced by tearing down to their original, illustrated widths. By leaving these tabs elongated, that would mean that these are to be regarded as “last dose” and “next-to-last dose” tabs. By removing the extra width before use, this would mean that these continue to be first day dose tabs. Other methods that may become apparent of ordinary skill for redesignating certain tabs from one indication to another indication are considered to be within the scope of this disclosure and its associated claims. [0050] While FIGS. 2 , 4 , 6 , and 8 all illustrate “day,” the “day indicator,” and the “dose number,” it is recognized that the dose number tab may actually be superfluous and thus omitted, because this is a one-dose-per-day system and the dose taken on any given day will always be “dose 1 ,” and indeed the only dose, for that day. The presence of the “dose 1 ” tab section illustrated in FIGS. 2 , 4 , 6 , and 8 , therefore, serves to elongate the tab to make it easier to pull, but this printed matter can also be omitted and the tab simply provided in elongated form to facilitate pulling and separation. What is most important for this one-dose-per-day embodiment, is the tearing between the “day” and the “day indicator,” so as to expose the underlying day indicator, that is, for example, to tear off the “1” of day 1 so as to expose the “11” of day 11 , again, see FIG. 8 . [0051] It is not strictly necessary, but is preferred, that this system be mounted on a mounting location on the medication packaging 110 as illustrated in FIG. 11 . A consumer might wish, for example, not limitation, to affix the Med-Sked™ system to a counter space, or a sheet of paper, or to a wall (in which case a Post-It® type of adhesive backing is preferred for affixation layers 14 and 24 ), or to a refrigerator (in which case a magnetic backing is suitable), or to an automobile dashboard or visor, or to any other mounting location that suits the consumer's convenience. Irrespective of the exact mode of affixation, or what mounting location the consumer chooses to affix the Med-Sked™ to based on personal preference and convenience, it is understood that the means is provided for the consumer to affix the Med-Sked™ to a suitable location that will often be the medicine packaging. And, it is understood that affixation means which employ other than glue or tape may alternatively be provided within the scope of this disclosure and its associated claims. [0052] While the tabs illustrated here use the word “day” together with a day indicator, and the word “dose” together with a dose number, to remind the user of what medication have been taken and still need to be taken, it will be understood by someone of ordinary skill that other words or indicators may be used. Any word, coloration, marking, shape, or other visual indicator which the user understands to mean “day,” and/or “dose,” with or without the actual words “day” and/or “dose” or synonyms therefore, is understood to fall within the scope of this disclosure and its associated claims. [0053] Similarly, while the ends of the tabs are all shown to be squared off, these can also be rounded, or have some other shape. That is, the particular squared shape illustrated in the various drawings is to be understood as exemplary, and not limiting. [0054] Further, while the bottom layers 13 and 23 are illustrated to be the widest, and the top layers 11 and 21 are illustrated to be the narrowest, this is exemplary, not limiting. For example, it is possible to have a reverse scheme in which the top layers are the widest and the bottom layers narrowest. Also, for example, it is possible for all of the widths to be substantially the same. Also, it is possible for the widths to be varied in any other way consistent with space requirements, ease of removing tabs, and reliability of the indication that a does has been or still needs to be consumed. [0055] While only certain preferred features of the invention have been illustrated and described, many modifications, changes and substitutions will occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

Disclosed is a medical scheduling system to keep the users of medically prescribed medication on their medication-taking schedule. The Med-Sked™ Tab System is a series of Day/Dose tabs that indicate the medication schedule or calendar and confirms that the schedule has been adhered to, when the appropriate tabs are removed. This procedure eliminates the confusion associated with the taking of medication. It assists the user in complying with, and with specificity to prescription and non-prescription medication scheduling. Using a tab residue, It confirms that this has been accomplished when the appropriate Day/Dose Tab has been removed.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is a divisional application of U.S. patent application Ser. No. 11/853,713, filed Sep. 11, 2007. [0002] The entire disclosure of the prior application, from which a copy of the oath or declaration is supplied, is considered to be part of the disclosure of the instant application and is hereby incorporated by reference therein. TECHNICAL FIELD [0003] This invention relates to electrical testing equipment, and, more particularly to an apparatus and method for preventing accidental electric shock in testing equipment having exposed contact posts. BACKGROUND OF THE INVENTION [0004] Medical equipment must be carefully tested and calibrated in order to ensure that it will function properly in critical situations. Electrocardiogram (ECG) testers are an example of such test equipment. As shown in FIG. 1 , an ECG tester 10 typically includes a number of contact posts 12 that may be coupled to electrode leads of an ECG monitor by means of clips 14 . The ECG tester 10 must be able to test ECG monitors having a wide variety of electrode lead clips. Some of these lead clips normally clip to electrodes having exposed terminals. Therefore, the contact posts 12 , like the electrode terminals, must be exposed rather than insulated from external contact by an insulating structure. [0005] Hospital equipment, including ECG monitors, must be tested to ensure that they do not pose a shock hazard resulting from short circuits to an AC line power lead. The ECG leads, as well as cases of ECG monitors, are normally isolated from AC line voltage by suitable insulation, which can become damaged. ECG testers check electrical isolation of ECG monitors by applying line voltage to the contact posts 12 . The exposed contact posts 12 in prior art systems can be hazardous inasmuch as they can be inadvertently touched and cause electrocution. Accordingly, it would be an advancement in the art to provide a conveniently used apparatus and method for shielding the contact posts of ECG testers and like equipment when they are not covered by an electrode clip. SUMMARY OF THE INVENTION [0006] In one aspect of the invention, an electronic device, such as an ECG tester, includes a contact post having first and second ends mounted on a housing having the first end exposed and the second end electrically coupled to a circuit board operable to apply signals to and receive signals from the contact post. An insulative sleeve is slidably mounted on the contact post and engages a latching mechanism that secures the sleeve in either of two positions, an extended position in which the sleeve is positioned over the contact post in order to protect and insulate the post and a retracted position in which the first end of the contact post is exposed. [0007] In another aspect of the invention the latching mechanism is a push-push latch. An engagement member may be secured to the sleeve to enable a user to push the sleeve into the retracted and extended positions. [0008] In another aspect of the invention, the sleeve has an aperture extending transversely through a wall thereof such that a clip, such as a banana plug, may engage the first end of the contact post when the sleeve is in the extended position. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is an isometric view of an ECG tester in accordance with the prior art. [0010] FIGS. 2A-2B are isometric views of an ECG tester having contact post shields in accordance with an embodiment of the invention. [0011] FIG. 3 is an exploded view of a contact post shield in accordance with an embodiment of the present invention. [0012] FIG. 4 is a cutaway isometric view of a contact post shield mounted within an ECG tester in accordance with an embodiment of the present invention. [0013] FIG. 5 is an isometric view of a housing suitable for mounting a contact post shield in accordance with an embodiment of the present invention. [0014] FIGS. 6A-6C are bottom plan views of a latching mechanism in accordance with an embodiment of the present invention. [0015] FIG. 7 is bottom isometric view of an alternative embodiment of a shield having a truncated indexing member in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0016] Referring to FIGS. 2A and 2B , in one embodiment of the invention, an ECG tester 16 includes a plurality of insulating shields 18 positioned around respective contact posts 20 . The shields 18 are in the form of cylindrical sleeves 30 that are slidably positioned around respective contact posts 20 , but other configurations can be used. The shields 18 are positionable in a retracted position leaving an upper end 22 of the contact post 20 extending from the shield 18 and an extended position in which the upper end 22 is positioned within the shield 18 . The upper end 22 of the contact post 20 is shaped to be engaged by conventional ECG electrode clips. In some embodiments, in the extended position, the shield 18 extends beyond the top of the contact post 20 a substantial distance, such as a distance about equal or greater than the extent the top of the shield 18 is below the top of the contact post 20 in the retracted position. The shield 18 may be coupled to the housing 24 by means of a push-push latching system such that an operator may push a retracted shield 18 to cause it to spring back to the extended position and push an extended shield 18 to lock it in the retracted position. [0017] In some embodiments, the shield 18 includes an aperture 26 that extends through a wall of the shield 18 . When the shield 18 is retracted slightly, but not enough to expose the upper end 22 of the contact post 20 , the aperture 26 is aligned with an aperture 27 formed in the contact post 20 . As shown in FIG. 2B , when the shield 18 is retracted slightly further from the position shown in FIG. 2A , a banana plug 14 b may be inserted through the aperture 26 in the shield 18 and the aperture 27 in the contact post 20 . The contact post 20 may include a narrowed upper portion 28 sized to receive a connector, such as an ECG clip 14 a when the shield 18 is in the fully retracted position. [0018] An engagement member 32 may be secured to the sleeve 30 and provide an area for a user to safely press to move the sleeve 30 into the extended and retracted positions of FIGS. 2A and 2B . In the illustrated embodiment, the engagement member 32 has a cross section that is constant for a portion of its length along a direction of movement 34 of the shield 18 as it moves between the retracted and extended positions. For example, the engagement member 32 is substantially cylindrical in the illustrated embodiment, however many other cross sectional shapes may be used such as rectangular, hexagonal, I- or H-shaped, or some other shape having a keyway, or any polygon offering sufficient structural shape. The engagement member 32 may be secured to the sleeve 30 by a web 36 of material, which may serve to increase the separation between the engagement member 32 and the contact post 20 to reduce the risk of accidental electrical shocks to an operator. [0019] Referring to FIGS. 3 and 4 , a latching mechanism 38 , such as a push-push latching mechanism, secures the shield 18 in either the extended or retracted position. The latching mechanism may be any push-push type latching mechanism or other latching mechanism known in the art. In the illustrated embodiment, the latching mechanism 38 includes indexing members 40 secured to the sleeve 30 . The indexing members 40 may include pointed ends formed by intersecting sloped surfaces 42 . The indexing members 40 are distributed evenly around the sleeve 30 and may be positioned slightly radially outwardly from the sleeve 30 with a gap between each adjacent members 40 . [0020] The indexing members 40 engage arms 44 formed on a ratchet 46 . The arms 44 include sloped surfaces 48 , such that pressing the indexing members 40 against the arms 44 causes the ratchet to rotate in direction 50 ( FIG. 4 ). In the illustrated embodiment, there are twice as many indexing members 40 as arms 44 , that is, eight indexing members 40 and four arms 44 . The arms 44 may bear another sloped surface 52 sloping in the opposite direction from the sloped surface 48 such that the sloped surfaces 48 , 52 form a point. The surface 52 is preferably substantially narrower than the surface 48 , however they may also be of equal width. The arms 44 secure to a ratchet hub 54 having an aperture 56 for receiving the contact post 20 . A biasing member 58 , such as a spring or other resilient member, engages the ratchet hub 54 and urges the sloped surfaces 48 against the indexing members 40 . In the illustrated embodiment, the biasing member 58 extends between the arms 44 of the ratchet hub 54 and a printed circuit board 60 ( FIG. 4 ) to which the contact post 20 is mounted. The circuit board 60 may be an ECG tester control circuit for applying line voltages to the contact posts 20 and receiving signals from the contact posts 20 . The engagement member 32 may slide within a channel 62 . Slidable engagement of the engagement member 32 within the channel 62 may advantageously fix the rotational position of the indexing members 40 relative to the ratchet 46 . [0021] Referring to FIG. 5 , the sleeve 30 and ratchet 46 may mount within a channel 64 having vertical guides 66 formed therein. The vertical guides 66 may be equal in number to the arms 44 of the ratchet 46 and sized to slidably receive the arms 44 . The vertical guides 66 constrain the ratchet to movement in the vertical direction when the arms 44 are positioned therein. Stops 68 are positioned between the vertical guides 66 and likewise may be equal in number to the arms 44 of the ratchet 46 . The stops 68 prevent upward movement of the arms 44 when the arms 44 are aligned therewith. The stops 68 may have a sloped surface such that when the arms 44 are urged against the stops 68 , they are urged against a raised area 70 that prevents further rotation until the arms 44 are pushed away from the stops 68 . Grooves 72 may be formed in the stops 68 to receive the indexing members 40 . In the illustrated embodiments, the vertical guides 66 are formed by gaps between the stops 68 . [0022] Referring to FIGS. 6A-6C , while referring generally to FIGS. 4 and 5 , the function of the illustrated latching mechanism 38 will be more particularly pointed out. When the shield 18 is in the extended position, the arms 44 are positioned within the vertical guides 66 , as shown in FIG. 6A , such that the biasing member 58 is able to urge the shield 18 upwardly. To move the shield 18 into the retracted position, the operator pushes downwardly on the engagement member 32 , which causes the indexing members 40 to press against the sloped upper surface 48 of the ratchet 46 , causing the arms 44 rotate over the edges of vertical guide 66 , as shown in FIG. 6B . Upon release of the engagement member 32 , the biasing member 58 urges the sloped upper surface 48 against the sloped surface of stop 68 , causing the ratchet and arms 44 to rotate and move into alignment with another of the indexing members 40 , stopping against the raised portion of 70 , as shown in FIG. 6C . As is apparent in FIG. 6C , the arms 44 are positioned over the stops 68 such that they are constrained from moving upwardly. To move from the retracted position to the extended position, the operator pushes downwardly on the engagement member 32 , the indexing members 40 are again urged against the sloped upper surfaces 48 , causing the arms 44 to rotate over the raised portion of 70 and into alignment with the vertical guides 66 , as shown in FIG. 6A , where they are allowed to move vertically upward upon release of the engagement member 32 . [0023] Referring to FIG. 7 , in embodiments where the engagement member 32 is secured to the shield 18 , pressing on the engagement member may result in a rotational moment 74 being exerted on the shield 18 inasmuch as the engagement member 32 is offset from the shield 18 . As a result, the indexing members 40 may tend to become misaligned from the sloped upper surfaces 48 . In particular, indexing member 76 that is located about 90 degrees from the engagement member moving along the direction of rotation 78 may tend to move over the surface 52 such that it will exert a force on the surface 52 opposite the direction of rotation 78 of the ratchet 46 . Accordingly, the indexing member 76 may be truncated such that it does not have sloped surfaces 42 . The indexing member 76 may have instead a flat upper surface 80 that is offset from the pointed ends of the other indexing members 40 along the direction 82 of movement of the sleeve 18 such that the flat upper surface 80 does not contact the sloped surfaces 48 , 52 of the ratchet 46 . In the illustrated embodiment, a portion of the indexing member 76 remains and aids in registering the shield 18 within a vertical guide 66 or groove 72 . In an alternative embodiment, there is no indexing member located in the position of indexing member 76 . In yet another alternative embodiment, the sloped surfaces 42 of the indexing member 76 may be of different lengths such that the point formed by the surfaces 42 is shifted opposite the direction of rotation 78 in order to compensate for shifting caused by the rotational moment 74 . [0024] Although the present invention has been described with reference to the disclosed embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention. Such modifications are well within the skill of those ordinarily skilled in the art. Accordingly, the invention is not limited except as by the appended claims.

An electronic device having one or more contact posts is disclosed having a sleeve slidably mounted around the contact post and lockable by a push-push latching system in a retracted position in which the sleeve is below an upper end of the contact post and an extended position in which the sleeve extends around and covers the upper end of the contact post. The sleeve and contact post may have respective apertures extending transversely therethrough, which are aligned when the sleeve is slightly retracted to receive a probe. Alternatively, an ECG electrode clip may engage an end of the contact post when it is exposed by the sleeve being in the retracted position.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to stents of improved configuration. 2. Brief Description of the Prior Art Stents are radially expandable endoprosthesis which are typically intravascular implants capable of being implanted transluminally and enlarged radially after being introduced percutaneously. They have also been implanted in urinary tracts and bile ducts. They are used to reinforce body vessels and to prevent restenosis following angioplasty in the vascular system. They may be self-expanding or expanded by an internal radial force, such as when mounted on a balloon. In the past, stents have been generally tubular but have been composed of many configurations and have been made of many materials, including metals and plastic. Ordinary metals such as stainless steel have been used as have shape memory metals such as Nitinol and the like. Stents have also been made of biodegradable plastic materials. Such stents have been formed from wire, tube stock, etc. Some stents are self-expanding and some are expanded by an interior radial force. SUMMARY OF THE INVENTION This invention provides new configurations of the segments making up stents which may be adapted to all of the various types of prior art stents described above and/or known previously in the art. There are numerous advantages to the new configurations. For example, the configurations of the invention limit recoil and add resistance to compression for an expanded stent, among other things. Also, the stents of this invention are longitudinally flexible. The inventive stents comprise a plurality of annular elements aligned to form a cylindrical stent body. Each annular element, in turn, is comprised of a plurality of open, generally boomerang-shaped segments. The segments are interconnected top-to-bottom around each of the annular elements. Adjacent annular elements are interconnected by one or more interconnecting elements. Each interconnecting element extends from an end of a boomerang-shaped segment in one annular element to an end of a boomerang-shaped segment in an adjacent annular element. In a preferred embodiment an interconnecting element extends from each boomerang-shaped segment in an annular element to a neighboring boomerang-shaped segment in an adjacent annular element. Interconnecting elements joining adjacent annular elements are desirably U-shaped or zig-zag shaped, although other curvilinear and rectilinear interconnecting elements may also be used. Adjacent boomerang-shaped segments in an annular element may be interconnected via a link extending from the top of a segment to the bottom of an adjacent segment. The links may range in design from a short, straight connector to any of the shapes described below for the interconnecting elements. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 is a schematic showing boomerang shapes; FIG. 2 is a flat plan view of an embodiment of a stent configuration of the invention in the unexpanded condition; FIG. 3 is a longitudinal view of the stent of FIG. 2 in its normal tubular unexpanded condition; FIG. 4 is a flat plan view of an embodiment of a stent configuration of the invention in the unexpanded condition; FIG. 5 is a longitudinal view of the stent of FIG. 3 in its tubular, expanded condition; FIG. 6 is an interconnecting element that may be used to join adjacent annular elements in another embodiment of the invention; and FIG. 7 is a view of the stent of FIG. 3 after being bent. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS For the purposes of this invention, the term boomerang is used to describe the shape of certain stent segments and is used in the sense as described in the Websters New Collegiate Dictionary with reference to FIG. 1 hereof: “boomerang 1: A bent or angular throwing club which can be thrown so as to return near the starting point.” An embodiment of a generally cylindrical stent according to the invention is illustrated in the flat at 110 in FIG. 2 or FIG. 4 . The stent may be formed of a metal tube such as nitinol, or stainless steel preferably, which has been etched or preferably laser cut to the configuration shown in the flat plan view of FIGS. 2 or 4 . The configuration may be formed in flat sheet and rolled into a cylinder with a welded seam or the like joining together edges 112 and 114 , or the configuration may be formed directly in a small tube such as a hypotube. A tubular form of the stent is shown generally at 210 in FIG. 3 . The configurations shown in FIGS. 2-4 are made up of a plurality of aligned annular elements 114 aligned as shown to provide a generally cylindrical stent body. Each annular element 114 is comprised of a series of generally boomerang shaped segments indicated at 118 (see darkened segment in the Figures for clarity) having an open structure joined top 120 to bottom 122 at segment junction 124 . Segments 118 are arranged or networked as shown in the Figures with ends 126 of neighboring segments on adjacent annular elements joined by interconnecting elements 128 . In FIGS. 2-4, interconnecting element 128 is a U-shaped element which is a partly open curve. Alternative interconnecting elements including zig-zag shaped element 228 as shown in FIG. 6, which may be used in place of U-shaped element 128 to join adjacent annular elements 114 together. The configurations of FIGS. 2 and 4 are substantially similar to one another, differing principally in the presence of a dimple 130 in each bottom 122 of each segment 118 in the configuration of FIG. 4 . Without being bound by a particular theory, it is believed that the presence of the dimple limits the extent to which the stent buckles out of the plane on expansion. It is desirable that the boomerang-shaped segments be at least substantially symmetric about a midline 138 extending from the top 120 of the segment to the bottom 122 of the segment. Midline 138 is situated midway between ends 126 of the segment. When the stent of FIG. 2 is expanded, as shown generally at 310 in FIG. 5 on a balloon for example, the boomerang-shaped segments 118 of the unexpanded stent take on a new configuration. The segments 318 take on the shape of rounded triangles with bulging bottoms 322 . It is desirable that the interconnecting elements be U-shaped as shown in FIGS. 2 and 4 or zig-zag shaped as shown in FIG. 6 . However, in a more general sense, the invention contemplates the use of curvilinear as well as rectilinear interconnecting elements, including straight elements. Examples of other suitable connectors are disclosed in U.S. patent application Ser. No. 09/111,531 filed Jul. 8, 1998, U.S. patent application Ser. No. 08/846,164 filed Apr. 25, 1997, WO 97/32543 to Divysio Solutions LTD. and WO 97/40780 to David G. Jang, all of which are incorporated herein by reference. Of course, adjacent boomerang-shaped segments may also be joined side-by-side with a region of overlap between adjacent boomerang-shaped segments. It is also desirable that interconnecting elements be flexible so as to accommodate bending of the stent without substantial distortion of the boomerang-shaped segments. FIG. 7 shows the stent of FIG. 3 having been bent. As shown in FIG. 7, as the stent is bent, interconnecting elements in tension open while interconnecting elements in compression close to accommodate bending of the stent. Although as shown in the Figures an interconnecting element extends from each boomerang-shaped segment in an annular element to a nearest neighboring boomerang-shaped segment in an adjacent annular element, the invention further contemplates the possibility of an interconnecting element extending from each boomerang-shaped segment in an annular element to a next-nearest neighboring boomerang-shaped segment in an adjacent annular element. In the latter case, the first end 140 and second end 144 of each interconnecting element 128 would be circumferentially offset along the stent. In a more general sense, the invention further contemplates a stent in which each adjacent annular element is interconnected by one or more interconnecting elements and each interconnecting element extends from an end of a boomerang-shaped segment in one annular element to an end of a boomerang-shaped segment in an adjacent annular element. As such, an interconnecting element need not extend from each boomerang-shaped segment. An example of this is a stent in which interconnecting elements extend from every second or third boomerang-shaped segment in an annular element. The invention also contemplates the possibility of altering the orientation of some of the annular elements. In one such embodiment, adjacent annular elements in the flat pattern are rotated by 180° relative to one another so that adjacent annular elements point in opposite directions. Although the ends of nearest neighboring segments in adjacent annular elements are shown in the figures as aligned with one another along the circumference of the stent, the invention further contemplates embodiments of the stent in which nearest neighboring segments in adjacent annular elements are circumferentially displaced relative to one another. In yet another series of embodiments, adjacent (or non-adjacent) annular elements may be formed of different sized boomerang-shaped elements. As such, adjacent (or non-adjacent) annular elements may span different lengths. Alternatively, adjacent (or non-adjacent) annular elements may comprise different numbers of boomerang-shaped segments. Although in the embodiment of FIGS. 2-4, segment junction 124 is shown as a small, straight link extending from the top of one segment to the bottom of an adjacent segment, the invention also contemplates the possibility of adjacent boomerang-shaped segments within an annular element being connected by U shaped links, zig-zag shaped links or any of the shapes disclosed above for the interconnecting elements. Additionally, other shaped segments may be interspersed among the boomerang-shaped segments. The inventive stent may be self-expanding or mechanically expandable such as by balloon. The stent may be made of a variety of suitable bio-compatible materials including metal, plastic and any other material capable of functioning as an expandable stent. For example, the stent may be of metal wire or ribbon such as tantalum, stainless steel or the like or of metal sheeting or metal tubing. It may be thin-walled. It may be of shape memory alloy such as Nitinol or the like. The above Examples and disclosure are intended to be illustrative and not exhaustive. These examples and 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 attached claims. 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 attached hereto.

Improved stent configurations exhibiting limited recoil, resistance to compression and improved longitudinal flexibility are disclosed. The stent comprised of a plurality of annular elements aligned to form a cylindrical stent body. The annular elements are comprised of a plurality of open, generally boomerang-shaped segments interconnected top-to-bottom around each of the annular elements. Adjacent annular elements are interconnected by interconnecting element.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a medical apparatus and systems and more particularly to introducing and supporting a plurality of tubes extending in side-by-side relation into a patient through the patient's mouth, when the patient is unconscious as during surgery, or during other procedures referred to as endotracheal intubation. 2. History of the Prior Art While carrying out both surgical and examination procedures on a patient, it is often necessary to introduce a variety of tubes simultanously through the mouth and throat of the patient. At the same time that anesthesia is being administered to the patient, such procedures as microlaryngeal surgery and examination procedures such microlaryngoscopy may be performed on a patient. To simultaneously give anesthesia and perform an examination or surgery through the throat of a patient, it is desirable to have means for separately supporting tubes in parallel relationship extending into the patient's mouth and downwardly through the pharynx, the upper part of the esophagus, the larynx, and the trachea. It is desirable that such tubes extend through separate defined passageways so that one may be easily inserted or removed without disturbing the other. Such procedures involve the use of either a straight or a curved cannula, depending upon the particular procedures performed. A straight cannula may be used for cases under direct vision like microlaryngeal surgery. A curved cannula may be used with fibre optic light devices as in microlaryngoscopy. Both straight and curved cannula provide the opportunity to achieve endotracheal intubation with the fibre optic aid of the bronchoscope with a light. A number of devices are known for supporting and guiding one or more tubes through the throat of a patient for a variety of purposes. Examples of various types of such devices are shown in the following U.S. patents: U.S. Pat. No. 1,498,810 issued June 24, 1924 to J. G. Poe; U.S. Pat. No. 2,127,215 issued Aug. 16, 1938 to J. T. Gwathmey; U.S. Pat. No. 2,599,521 issued June 3, 1952 to R. A. Berman; U.S. Pat. No. 2,705,959 issued Apr. 12, 1955 to Cal Elmore U.S. Pat. No. 3,756,244 issued Sept. 4, 1973 to John M. Kinnear, et al; U.S. Pat. No. 3,908,665 issued Sept. 30, 1975 to John A. Moses; U.S. Pat. No. 4,198,970 issued Apr. 22, 1980 to Raymond Luomanen; U.S. Pat. No. 4,256,099 issued Mar. 17, 1981 to Gale E. Dryden; and U.S. Pat. No. 4,363,320 issued Dec. 14, 1982 to Michael Cossove. While these patents show a variety of cannula designs, none of them show or suggest the specific designs of the present invention and methods and apparatus for adjustably and securely supporting the devices while they are being used for both surgery and examination. Such apparatus as face plates has been used to hold a cannula in place. SUMMARY OF THE INVENTION In accordance with the invention, there is provided an endotracheal cannula and a system for supporting the cannula during intubation of a patient. One form of cannula comprises a curved portion joined with an integral straight portion. Another form is straight. Both cannulas are provided with side-by-side passageways for tubes. One side of the cannula housing around one of the passage openings is shorter than the other side at the straight end portion end of the curved form. One end of the straight form is tapered. The system for supporting the cannula includes a bridge assembly spanning an operating table supporting the cannula above a patient from an adjustable mounting assembly permitting the cannula to be aligned at a plurality of angles relative to the vertical for a variety of surgical and examination procedures. It is a principal object of the invention to provide a new and improved endotracheal cannulas. It is an other object of the invention to provide a system for supporting an endotracheal cannula above a patient on an operating table. It is another object of the invention to provide an supporting structures for an endotracheal cannula above a patient on an operating table by angular and lateral movement to facilitate introduction of an endotracheal cannula into a patient's throat. The above and other objects and features of the invention will be apparent to those skilled in the art from the following detailed description of the invention taken in conjunction with the accompanying drawings in which preferred embodiments of the devices of the invention are shown. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view in elevation of a patient on an operating or examination table showing an endotracheal cannula supported in the mouth and throat of the patient by a system including the features of the invention: FIG. 2A is a side view along line 2A--2A of FIG. 2. FIG. 2 is a head end view in elevation of the patient and apparatus of the invention as shown in FIG. 1; FIG. 3 is a fragmentary exploded view in perspective of the devices of the invention including the curved endotracheal cannula and the support system; FIG. 4 is an enlarged side view in section of the adjustable features of the support for the cannula; FIG. 5 is an enlarged side view in section of the cannula and mounting block for the cannula as seen in FIG. 3; FIG. 6 is a side view in elevation of the curved cannula shown in FIG. 5; FIG. 7 is a top view of the cannula as shown in FIG. 6; FIG. 8 is a right end view of the cannula in FIGS. 6 and 7; and FIG. 9 is a side view in elevation of a straight cannula in accordance with the invention. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. 1, a curved endotracheal cannula 10 is illustrated suspended from a support system 11 in the mouth and throat of a patient 12 resting on an operating or examination table 13. As shown in FIGS. 1 and 2 the support system 11 includes a mounting body 14 adjustably secured on an inverted U-shaped bridge formed by a horozontal bar 15 and legs 16 having end mounting sleeves 20 secured on pins 21 permitting angular adjustment of the bridge over the patient. The bar 15 is mounted in sleeves 17 on legs 16. Screws 18 in sleeves 17 secure the bar in the sleeves and allow the bar to be adjusted horizontally. Referring to FIGS. 3-5, the body 14 is formed by two longitudinal halves 14a and 14b held together by screws 20 threaded through the body member 14a into the body member 14b. The body 14 has a front opening slot 21 having an enlarged central portion defined between opposite side edges 22. The slot 21 extends into the body curving upwardly generally along the vertical axis of the body terminating in a cylindrical transverse slot portion 23. As seen in FIGS. 3 and 4, the slot 21 opens through the opposite side faces of the body halves 14a and 14b. The configuration of the slot 21 is designed particularly to permit the body 14 to be installed on the bar 15 for pivotal movement thereon. The body 14 is mounted on the bridge on a tubular shaped gear 24 locked on the central portion of the bar 15 by a key 25. The key 25 fits into corresponding keyways within the gear and along the central portion of the bridge. The diameter of the gear 24 is slightly less than the diameter of the slot portion 23 to permit the body 14 to freely rotate on the gear. The length of the gear is less than the transverse distance across the body between the slot internal side faces 22. The design of the gear and the internal slot 21 in the body 14 permits the body to freely rotate on the bar 15 while being locked at a near central position on the bridge as shown. The design of the bridge, gear, and body 14 can be such as to allow axial or lateral movement of the body on the horizontal part of the bridge to facilitate alignment between patient and cannula. For example, the key 25 and key slots in the bar 15 may be lengthened to allow the gear and body 14 to slide along the bar for lateral adjustment across the table to the patient position. An indexing locking latch 30 is mounted in a bore 31 extending from the body back face intersecting the cylindrical portion 23 of the slot 21. The indexing latch has an inward enlarged forked head 32 configured to engage the teeth on the gear 24 for releaseably locking the body 14 at different angular positions on the bridge 15. A coil spring 33 around the indexing latch within the bore 31 urges the indexing latch inwardly into meshing, locking relationship with the teeth on the gear 24. The outward end portion of the indexing latch is pinned to an operating handle 34 for retracting the indexing latch to release the latch from the gear. The handle 34 is pinned between side brackets 35 connected on the back face of the upper end of the body 14 so that the handle 34 may pivot on the brackets 35 to engage and disengage the indexing latch 30. An operating handle 40 is secured into the top of the body 14 for changing the angular position of the body on the bridge when the latch is disengaged. As viewed in FIG. 4, the indexing latch handle 34 may be moved clockwise to disengage the indexing latch 30 from the gear 24 releasing the body 14 so that the operator may grasp the handle 40 on the body to change the angular position of the body 14 on the bridge. When the desired position is reached the indexing handle 34 is released allowing the spring 33 to move the indexing latch inwardly reengaging the gear and locking the body 14 on the bridge. A rod 41 is secured at an upper end into the bottom of the body 14. A downwardly opening U-shaped bracket 42 having downwardly extending opposite side legs 43 is secured on the lower end of the rod 41. The two bracket legs 43 are each provided with a pair of vertically spaced holes 44 aligned horizontally with each other to receive mounting pins 45 for connecting a cannula mounting block 50 in the bracket. As seen in FIG. 3, the cannula mounting block 50 is formed by a T-shaped back member 51 and a front plate 52 secured by screws 53 to the back member. Some lateral movement of the block 50 along the pins 45 may be provided for further horizontal adjustment of the cannula 10. The reduced portion of the back member 51 has horizontal holes 54 for the pins 45 so that the mounting block is secured with the bracket 42 by the pins 45 extending through the bracket legs 43 and horizontal holes 54 in the reduced portion of the back member. The inside contacting surfaces of the mounting block members 51 and 52 are configured to provide a vertical slot 55 in the mounting block through which the straight upper end portion of the cannula 10 fits. The straight portion of the cannula as seen in FIG. 5 is clamped in the mounting block when the two portions of the mounting are screwed together as illustrated. In accordance with the invention, two forms of endotracheal cannulas may be used for operating on and examining a patient. Both of curved cannula 10 shown in FIGS. 1-3, 7, and 6-8 and the straight cannula shown in FIG. 9 may be supported by the system 11, depending upon the particular surgical operation or examination to be performed. Referring to FIGS. 6-8, the curved cannula 10 has a curved portion 10a and an integral straight portion 10b. As evident in FIGS. 7 and 8, the cannula is provided with parallel side-by-side passageways 10c and 10d extending throughout the length of the cannula to accommodate two tubes, surgical instruments, and the like. As illustrated in FIGS. 6 and 7, the straight end 10d of the cannula has one side shortened so that the passage 10c is not as long as the passage 10d, opening in the straight end inwardly from the opening of the passage 10d. The curved portion of the cannula fits through the mouth into the throat of the patient as evident in FIG. 1, while the straight portion is clamped in the support block 50 for supporting the cannula in place in the patient from the system 11. A straight form of cannula 60 is illustrated in FIG. 9. The cannula 60 has parallel side by side passages 60a and 60b extending throughout the length of the cannula. As shown, one end of the cannula is tapered so that the passage 60b at such end is shorter than the passage 60a. The provisions of the shorter passage in both the cannula 10 and the straight cannula 60 facilitates the extraction of the cannula while leaving in place an endotracheal tube. Both cannulas are preferrably made of plastic so that they are less expensive, disposable, and less traumatic for a patient. The curved cannula 10 or the straight cannula 60 is used to perform such operative procedure or examination upon a patient as is desired or necessary. The straight end portion of the curved cannula or the tapered end of the straight cannula is clamped in the mounting block 50 which is then secured by the pins 45 in the bracket 42. The body 14 may already be on the bar 15 or may now be installed on the bar. The body is mounted on the bar by manipulating the body over the bar along a path to guide the bar and the gear 24 into the slot 21 to the position illustrated in FIG. 4. When placing the body on the bar, the indexing latch 30 should be retracted with the handle 34. With the patient in position below the bridge, the cannula 10 is inserted into the mouth and throat of the patient to the desired position. The handle 34 is then released allowing the spring 33 to press the latch 30 inwardly until the head of the latch engages the teeth on the gear 24 to lock the body 14 with the cannula 10 at the desired operating position. The necessary tubes and/or instruments then may be inserted into the patient through the cannula 10. The straight cannula 60 is installed using the same procedural steps. The angular and lateral adjustablity of both the body 14 on the bar 15 and of the bar on the operating or examination table permits maximum flexibility of the positioning of the cannula with respect to the patient. The many different applications of the cannula and the support system will be evident. For example, the straight cannula can be used advantageously for removal of laringeal tumors with microscopical help using long alligator forceps. The curved cannula can be used for the removal laringeal tumors through indirect vision using a fibreoptic broncoscope. Both of the cannulas permit the introduction of a naso-gastric tube in cases of abdominal surgery. The mounting system permits both vertical and horizontal adjustment. The angular adjustment features allows for positioning the cannulas to obtain an optimum field in microlaryngoscopy.

An endotracheal intubation system including straight and curved cannulas, and cannula support apparatus comprising a bridge connectable over a patient table, and an adjustable mounting block assembly for supporting a cannula over the table in position in the mouth and throat of a patient.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a device for storing various media and a classification system therefor. [0003] 2. Description of the Prior Art [0004] In this era of technology, media of all sorts are present in every aspect of today's lifestyle. Whether it is for leisure or for work, the amount of media handled daily by the typical person has increased impressively over the past few years. The format of the media has also taken a plurality of shapes. For instance, compact disks, videodisks, computer diskettes, are just a few examples of the media being used daily. [0005] Accordingly, plural storage devices, e.g. trays, have emerged to provide ways to store the media. As changes and novelties often occur in the media formats, it is frequent to have storage devices that are not ideally suited to comply with the storing requirements of the media. Among familiar occurrences are oversized storage systems in the wait of a person's media library to build up, a plurality of generally empty adjacent storage devices for each medium, storage devices filled to an extent where it is quite hard to find a given medium. As an example of a more specific case, compact disk racks often have slots for receiving single compact disk casings. However, double compact disk casings do not fit in these slots. SUMMARY OF THE INVENTION [0006] It is therefore an aim of the present invention to provide a storage device that is versatile. [0007] It is also an aim of the present invention to provide a multi-media storage device that is modular, [0008] It is a further aim of the present invention to provide a multi-media storage device that has an indexing system to facilitate the finding of a given medium stored in the device. [0009] Therefore, in accordance with the present invention, there is provided a device for storing media, comprising; [0010] a frame module having a support surface adapted for receiving media thereon, a peripheral ledge around said support surface for preventing the media on said support surface from sliding off therefrom, said frame module having also a support structure for allowing said frame module to receive thereon another frame module similar thereto in a stacked relationship, such that said device is expandable; and [0011] a cover module for covering the support structure of an uppermost one of said frame modules. [0012] Also in accordance with the present invention, there is provided a device for storing and classifying media, said device comprising: [0013] a casing having a support surface adapted for receiving media thereon; [0014] labels each having respective reference indicia thereon and each adapted for being secured to a respective one of the media; and [0015] a reference list provided on said casing, said reference list being adapted to receive information thereon relating to a content of each one of the media in said casing in relation to said reference indicia of said label secured thereto, whereby the media in said device are classified. [0016] Further in accordance with the present invention, there is provided a device for storing media, comprising: [0017] a frame module having a support surface adapted for receiving media thereon and having end walls, and a cover module disposed on top of said end walls and at a distance from said support surface such that media is received between said support surface and said cover module, said device being open along both sides thereof extending between said end walls such that media can be removed from or inserted in said device from two opposite sides. BRIEF DESCRIPTION OF THE DRAWINGS [0018] Having thus generally described the nature of the invention, reference will now be made to the accompanying drawings, showing by way of illustration a preferred embodiment thereof and in which: [0019] [0019]FIG. 1 is a partly exploded view of a storage device in accordance with the present invention having two storage trays; [0020] [0020]FIG. 2 is a perspective view of a storage device of the present invention that has one storage tray shown here with media stored therein; [0021] [0021]FIG. 3 is a top plan view of the device of FIG. 2 but without a cover thereof for illustration purposes; [0022] [0022]FIG. 4 is a vertical transversal cross-sectional view illustrating a medium being removed from the storage device; [0023] [0023]FIG. 5 is a vertical longitudinal cross-sectional view, fragmented, of the storage device having multiple trays; and [0024] [0024]FIGS. 4A and 5A are similar to FIGS. 4 and 5, hut show a variant of the storage device. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0025] Referring now to FIG. 1, a multimedia storage device in accordance with the present invention is generally shown at 10 . The storage device 10 consists essentially of at least one frame module 12 and one cover module 14 . As will be described in detail hereinafter, the number of frame modules 12 in the storage device 10 depends on the number of storage levels or trays desired by a user. On the other hand, the storage device 10 always has one cover module 14 , notwithstanding the number of frame modules 12 . Therefore, the storage device 10 may expand with a person's media library. [0026] As shown in FIGS. 1 and 5, the storage device 10 has two frame modules 12 that are identical. Each frame module 12 has a base 20 and a pair of end structural walls 36 , The base 20 is formed by a rectangular panel 22 with lateral edge walls 24 disposed perpendicularly on lateral side edges of the panel 22 . The base 20 further has end edge walls 26 on end edges of the panel 22 . The lateral edge walls 24 and the end edge walls 26 form an upper peripheral ledge 28 projecting perpendicularly from a top surface 30 of the panel 22 , and a lower peripheral ledge 32 projecting perpendicularly from a bottom surface 34 of the panel 22 . The structural walls 36 extend upwardly from the upper surface 30 of the panel 22 . The structural walls 36 are received in abutment against a portion of the lateral edge walls 24 and are spaced from the end edge walls 26 , such that channels 38 are defined therebetween. Four slots 39 are formed in the upper peripheral ledge 28 (three of which are visible in FIG. 1) such that the channels 38 extend from side-to-side of the base 20 . The structural walls 36 are parallel one to another and are generally perpendicular to the panel 22 , Four slots 37 (two of which are visible in FIG. 1) are symmetrically formed in the lower peripheral ledge 32 and are positioned similarly to the position of the slots 39 in the upper peripheral ledge 28 , i.e. vertically opposite thereto. [0027] The cover module 14 is like a frame module 12 without the structural walls 36 . Therefore, the cover module has a rectangular-shaped panel 42 , with lateral edge walls 44 and end edge walls 46 forming an upper peripheral ledge 48 perpendicular to a top surface 50 of the panel 42 , and a lower peripheral ledge 52 perpendicular to a bottom surface 54 of the panel 22 . It is pointed out that, as the cover module 40 does not have structural walls, the cover module 14 does not have channels similar to the channels 38 of the frame module 12 . However, the cover module 14 has four slots 59 therein (two of which are visible) equivalent to the slots 39 of the frame module 12 . Similarly to the slots 39 of the frame module 12 , the slots 59 of the cover module 14 are defined in the lateral edge walls 44 . The cover module 14 could also be made identical to the base 20 , i.e. also with slots on both sides of its panel 42 , [0028] Now that the physical configurations of the frame modules 12 and the cover module 14 of the storage device 10 have been described in detail, the assembly for functional use of the storage device 10 will now be described. FIGS. 1 and 5 illustrate a storage device 10 assembled from two frame modules 12 and a cover module 14 . For clarity purposes, a first one (i.e. the lower one) of the frame modules 12 of FIG. 1 will be identified as “A” and another one (i.e. the upper one) will be identified as “B”. Therefore, letters “A” and “B” will be affixed to the reference numerals in the description. For instance, the frame module 12 A will designate the frame module 12 identified by “A” in FIG. 1. The frame module 12 B is positioned on top of the frame module 12 A, which rests on a floor F, by upper free ends of the structural walls 36 A being nested in a corresponding shape defined by the lower peripheral ledge 32 B and the bottom surface 34 B. [0029] The cover module 14 is positioned on the frame module 12 B in a similar fashion. Free ends of the structural walls 36 B will be nested in a corresponding shape defined by the lower peripheral ledge 52 and the bottom surface 54 of the cover module 14 . The cover module 14 is shown at 14 ′ in broken lines in FIG. 1 to illustrate how it is disposed on the frame module 12 B (see arrows 70 ). Therefore, the storage device 10 has two levels or trays of media storage, i.e. one for the upper surface 30 of each frame module 12 , along with a level of storage for other items on the upper surface 54 of the cover module 14 . [0030] [0030]FIG. 2 illustrates a storage device 10 ′ having a single storage level, but with various items J (compact disk circular magazines, pens, diskette boxes, etc.) stored on the upper surface 54 of the cover module 14 and restrained from falling by the upper peripheral ledge 48 . It is obvious that the storage device 10 may consist of one, two or more than two frame modules 12 . [0031] Returning to FIG. 1, a panel 66 is shown being slid into the channels 38 of the frame module 12 B of the storage device 10 . The panels 66 are sized so as to be slidably received in the slots 59 of the cover module 14 at the same time, Accordingly, the panels 66 are co-planar against outer surfaces of the structural walls 36 B. Although not shown, the channels 38 of the frame module 12 A may also receive such panels 66 therein, with atop portion of the panels 66 being slidably received in out that other suitable ways may be used to removably secure the panels 66 to the structural walls 3 A, such as fasteners like Velcro™, magnets, etc. The panels 66 , as will be explained hereinafter, will be used to display the media contents of the various levels or trays of the storage device 10 . [0032] Referring now to FIGS. 2 and 3, a storage device 10 having one storage level or tray is shown storing various media conventional single compact-disk casings are shown at CD 1 , casings having two or more compact disks are shown at CD 2 , and typical compact disk collection box-sets are shown at CD 3 . Video-disk and CD-ROM casings are also shown stored in the storage device 10 and are illustrated by DVD. The above enumerated media are upstanding in the storage 10 , and are sized so as to be kept in the storage device 10 by abutting laterally against the upper peripheral ledge 28 which extends on both sides of the frame module 12 . [0033] On the other hand, media of smaller dimensions than the above-mentioned media may also be stored in the storage device 10 . For instance, audiocassettes in their casings, which are generally illustrated at T as best shown in FIG. 3, are positioned upstanding in the frame module 12 of the storage device 10 , and are paired up in side-by-side relationship so as to be immobilized laterally by the upper peripheral ledge 28 of the storage device 10 . Similarly, as also best shown in FIG. 3, computer diskettes H are immobilized laterally in the storage device 10 by having a diskette box G filling an empty space caused by the width of the diskettes H with respect to the width of the frame module 12 . Other media (not shown) can also be received in the device 10 , such as compact disks in their flexible cardboard or cellophane sleeves. [0034] Referring to FIGS. 2 to 4 , a classification system is illustrated for keeping track of what is stored in the storage device 10 . Labels 60 (see FIG. 4) are provided in order to identify the media in the storage device 10 . The labels 60 may be of various types, but preferably have a tab portion 62 having an identification character, such one or many letters, or a numeral as shown in FIGS. 2 and 4. The tab portions 62 extend outwardly from the media so as to be visible when the media are stored in the storage device 10 . It is also preferred to provide each label 60 with an adhesive portion 64 , whereby the labels 60 may be stuck to the media. It is preferable to have the labels 60 positioned at various heights on the various media in order to avoid visual interference created by the label 60 of a first medium being too close to the label 60 of an adjacent medium. The tab portions 62 may also be transparent (e.g. except at their identification characters) to help see tab portions 62 located behind a given tab portion 62 . [0035] The labels 60 are used in conjunction with the panel 66 , which, as shown in FIG. 2, illustrates a chart with numerals thereon corresponding to the numerals on the labels 60 and with user-added information being provided on the chart or panel 66 opposite the numerals thereof, the information associated with a given numeral being indicative/descriptive of the media stored in the storage device 10 and bearing this given numeral on its label 60 . [0036] The panel 66 may have an ink-erasable surf ace such that the chart thereon may be hand-filled with the information concerning the media corresponding to the numerals, and erased when changes in the stored contents of the storage device 10 occur. It may also be a computer printout that is replaced and kept up-to-date. Although not shown in FIG. 1, each storage level of the storage device 10 has its own panel 66 , which can be inserted at either end of the frame module 12 . It is also pointed that the panels 66 may be folded so as to have a greater area for information to be filled thereon. [0037] As shown in FIG. 4, a single compact disk casing CD 1 is shown being removed from the storage device 10 by a person P grasping the tab portion 62 of the label 60 and lifting it upwardly (see arrow 72 ) such that the casing CD 1 is above the upper peripheral ledge 28 of the frame module 12 . The casing CD 1 is then pulled outwardly (see arrow 74 ) of the storage device 10 by its tab portion 62 . These steps are repeated in order to remove any other media from the storage device 10 , and are reversed to put a medium back into the device 10 . [0038] As seen from the top view of FIG. 3, labels 60 may be provided on both sides of the wider media such that there are labels 60 on either side of the storage device 10 . This allows formats such as the compact-disk casings CD 1 to be removed from either side, On the other hand, media only exposed on one side of the storage device 10 because of their small width are removed from one of the sides of the storage device 10 , and labels 60 are positioned on these media in order to comply with the side they are to be removed from. The fact that the storage device 10 is open on both sides offers the advantage that there is no need for a first medium to be displaced in order for a second medium to be pulled out of the storage device 10 , as is the case with, for instance, the audiocassettes T. Also, it allows the device 10 to put up against a wall, or the like, on any of the two open sides thereof while allowing media to be removed therefrom through its unobstructed side, i.e. its side opposite the side located against the wall. [0039] The storage device 10 may consist in a plurality of materials. For instance, various metals and woods may be used, in which case the storage device 10 will be able to sustain the weight of various storing levels. Plastics and various polymers may be used in serial production of the storage devices 10 of the present invention and present characteristics which comply with the use of the storage device 10 . [0040] The device 10 is thus modular as the number of levels or trays thereof can be modified by adding or removing frame modules 12 from its stacked attitude. As the frame modules are exempt of partitions, the device 10 is versatile in being able to accommodate various articles of various sizes in customized arrangements in the frame module 12 . [0041] [0041]FIGS. 4A and 5A illustrate a variant storage device 10 ′, wherein each storage module (two such modules being shown in FIG. 5A) is identical and includes the base 20 and a cover module 14 ′ that are fixedly secured respectively at lower and upper ends of the structural end walls 36 . In the device 10 , the cover module 14 is not fixed to the walls 36 . Therefore, in the storage device 10 ′, each module is stand-alone and can thus be used on its own, separately or in stacked relationship. [0042] In a further variant (not shown), the ends walls 36 could be detachable from both the base 20 and the cover module 14 / 14 ′ so that the storage device is more compact for packaging, or storage.

A device for storing media comprises at least one frame module having a support surface adapted for receiving media thereon, a peripheral ledge around the support surface for preventing the media on the support surface from sliding off therefrom. The frame module also has a support structure for allowing the frame module to support another frame module similar thereto in a stacked relationship, such that the device is modular and expandable. The device also includes a cover module for covering the support structure of an uppermost one of the frame modules. Labels each having respective reference indicia thereon are each adapted to be secured to a respective one of the media, with a reference list being provided to receive information relating to a content of each one of the media in relation to the reference indicia on the label secured thereto, whereby the media in the device are classified. The device is open along both sides thereof extending between end walls of the frame module such that media can be removed from or inserted in the device from two opposite sides.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is divisional of U.S. patent application Ser. No. 12/452,926, filed on 29 Jan. 2010, which is a 35 U.S.C. §371 national stage entry of PCT/IL2008/001056, which has an international filing date of 31 Jul. 2008 and claims priority to U.S. Provisional Patent Application Nos. 60/963,045, filed on 1 Aug. 2007 and 60/999,654, filed on 19 Oct. 2007; the contents of which are incorporated herein by reference in their entireties. FIELD OF THE INVENTION [0002] A system, device and a method for sustained medical infusion of fluids are described. Some embodiments relate generally to a miniature portable infusion device that can be attached to and detached from a patient's body and that is configured to accurately dispense fluids. Some embodiments relate to a skin securable infusion device that can be periodically disconnected from and reconnected to the body of the patient. Some embodiments relate to a skin securable infusion device that can be disconnected from and reconnected to the body and to a method for detecting whether the infusion device is disconnected or reconnected to the body and for controlling the device's operation accordingly. BACKGROUND OF THE INVENTION [0003] Medical treatment of several illnesses requires continuous drug infusion into various body compartments, such as subcutaneous and intra-venous injections. Diabetes mellitus patients, for example, require administration of varying amounts of insulin throughout the day to control their blood glucose levels. In recent years, ambulatory portable insulin infusion pumps have emerged as a superior alternative to multiple daily syringe injections of insulin. These pumps, which deliver insulin at a continuous basal rate as well as in bolus volumes, were developed to liberate patients from repeated self-administered injections, and allow them to maintain a near-normal daily routine. Both basal and bolus volumes must be delivered in precise doses, according to individual prescription, since an overdose or under-dose of insulin could be fatal. [0004] A first generation of portable infusion pumps refers to “pager-like” devices with a reservoir contained within the device's housing. In the first generation devices, a long tube delivers insulin from the pump, which is attached to a belt on the patient, to a remote insertion site. Such devices are disclosed, for example, in U.S. Pat. Nos. 3,771,694, 4,657,486 and 4,498,843. These devices represent a significant improvement over multiple daily injections, but nevertheless, they all suffer from several major drawbacks, among which are the large size and weight of the device, long tubing and lack of discreetness. [0005] To avoid consequences associated with employing a long delivery tube, a new concept was proposed, which was implemented in second generation pumps. The second generation pumps concept relates to a remote controlled skin adherable device with a housing having a bottom surface adapted for contact with the patient's skin, a reservoir disposed within the housing, and an injection needle adapted for communication with the reservoir. This paradigm was described, for example, in U.S. Pat. Nos. 5,957,895, 6,589,229, 6,740,059, 6,723,072 and 6,485,461. The second generation devices also have several limitations: they are bulky, the remote control unit should always be at hand, and they are expensive because the entire device should be discarded every 2-3 days. [0006] Third generation skin adherable devices were devised to avoid the cost issues of the second generation devices and to extend patient customization. An example of such a device was described in the co-owned, co-pending U.S. patent application Ser. No. 11/397,115 and co-owned International Application No. PCT/IL06/001276, the disclosures of which are incorporate herein by reference in their entireties. The third generation devices contain a remote control unit and a skin adherable patch unit (also referred to as a “dispensing patch unit”) that includes two parts: (1) a reusable part containing driving and pumping mechanisms, electronics and other relatively expensive components, and (2) a disposable part containing a reservoir and, in some embodiments, batteries. A tube can also be provided which delivers the fluid from the reservoir to an outlet port that contains a connecting lumen. [0007] This concept can provide a cost-effective skin adherable infusion device and allow diverse usage of the device, such as using it with various reservoir sizes, various needle and cannula types, etc. [0008] In the co-pending, co-owned U.S. patent application Ser. No. 12/004,837, and co-owned International Patent Application No. PCT/IL07001578, both filed Dec. 20, 2007, and both claiming priority to U.S. Provisional Patent Application No. 60/876,679, filed Dec. 22, 2006, the disclosures of which are incorporated herein by reference in their entireties, a fourth generation patch unit that can be disconnected from and reconnected to a skin adherable cradle unit was disclosed. In the fourth generation the patch unit, after reservoir filling, is mounted on the body by the following steps: [0009] 1) Cradle unit is adhered to the skin; [0010] 2) Cannula is inserted through a cradle unit passageway (also referred to as a “well”) into the subcutaneous tissue. The cannula, including a rubber septum, can be connected to the cradle unit's “well”; [0011] 3) The patch unit is connected to the cradle unit, The connecting lumen pierces a rubber septum allowing fluid communication between the reservoir, cannula and the body. [0012] In the co-pending, co-owned U.S. patent application Ser. No. 11/706,606, the disclosure of which is incorporated herein by reference in its entirety, a device containing a dispensing patch unit (called also “insulin dispensing patch”) and an analyte sensing means (i.e., continuous glucose monitor) was disclosed. This dual function device is configured to have similar configuration to the one outlined above and can also be disconnected from and reconnected to a cradle unit upon patient discretion. [0013] In some conventional systems, although basal delivery should be continuously administered, it is often interrupted due to periodic pump disconnection. In some situations, pump disconnection is mandatory, for example during sauna and hot bath because insulin cannot tolerate high temperatures. However, there are occasions in which a short time disconnection can substantially improve daily activity and patient satisfaction. If the operation of the patch unit's driving mechanism is not suspended prior to disconnection (for example, the user forgets to do so, the disconnection is unintentional, etc.), the patch unit will continue to dispense insulin even though it is not connected to the cradle unit, thus wasting precious insulin and battery power. Moreover, the patient's ability to control the precise amount of delivered insulin will be diminished, SUMMARY OF THE INVENTION [0014] An apparatus and a method for delivering a therapeutic fluid into a body of a patient are provided. In one aspect the device and the method can be implemented using a patch unit removably attachable to a cradle unit, said cradle unit removably attachable to the body of the patient; a position detector comprising a patch portion and a cradle portion, said patch portion coupled to the patch unit, said cradle portion coupled to the cradle unit; a processor adapted for receiving a position indication signal from the at least one position detector, said position indication signal corresponding to a physical proximity of the patch portion to the cradle portion; the processor is further adapted for receiving at least one command from the patient; and, wherein the portable therapeutic device is adapted for at least one therapeutic function selected from the group consisting of delivering a therapeutic fluid into the body of the patient and sensing a bodily analyte. [0015] For example, the patch unit can comprise a reusable part and a disposable part; the disposable part can comprises a reservoir for storing the therapeutic fluid, and, the reusable part can comprise a metering portion for delivering the therapeutic fluid from said reservoir into the body of the patient. The patch unit can be configured to be remotely controlled. In some implementations, the therapeutic fluid can be insulin. [0016] The processor can be adapted to control an operation of the patch unit based on the connection status signal received from the position detector. The processor can further be adapted to control the delivery of the therapeutic fluid into the patient based on the connection status signal. The processor can also be adapted to record commands received from the patient in a memory component. The processor is further adapted to deactivate at least one component of the apparatus based on the connection status signal received from the position detector. The processor can also be configured to initiate a notification to the patient, said notification corresponding to the connection status signal. [0017] In some implementations, the cradle unit can have a cradle base configured as a flat sheet with an adhesive layer facing a skin of the patient and having anchoring means for connection and disconnection of said patch unit; and, a well configured to protrude upwardly from said cradle base to allow alignment and appropriate connection of said patch unit. For example, the well can be adapted for insertion of a cannula into the body of the patient. [0018] In some implementations, the patch unit can be configured to use peristaltic pump to deliver the therapeutic fluid into the body of the patient. It can also be configured to use a piston to deliver the therapeutic fluid to the body of the patient. [0019] In some implementations the position detector can comprise an optical sensor having a light source component and a light detector component. The position detector can also comprise an electro-magnetic detector and/or a magnetic proximity detector. [0020] In another aspect, a method for activating a device for delivering a therapeutic fluid into a body can also be provided. For example, the method can comprise attaching a patch unit to a cradle unit; attaching the cradle unit to the body; generating an activation request for at least one component of at least one of the patch unit and the cradle unit based on a connection status signal generated by a position detector, said position detector comprising a patch portion and a cradle portion, the patch portion coupled to the patch unit, the cradle portion coupled to the cradle unit, said connection status signal corresponding to a physical proximity of the patch portion to the cradle portion. [0021] A device is disclosed that can deliver therapeutic fluid into the body and/or monitor analyte concentration levels. For example, the device can include the following units: A patch unit, which can be remotely controlled or manually controlled by operating buttons. In some embodiments, the patch unit can include two parts: reusable and disposable. The disposable part can be configured to include a reservoir and an outlet port with a connecting lumen. The reusable part can be configured to include electronics and at least a portion of a dispensing mechanism. A cradle unit, which can be adherable to the patient's skin, e.g., by an adhesive. [0024] After attaching the cradle unit to the skin, a cannula can be inserted into the subcutaneous compartment of the patient's body through a dedicated passageway (“well”) provided in the cradle unit. During patch-cradle connection, the connecting lumen pierces a self-sealable rubber septum that seals the “well”. Thus, fluid communication is established between the patch unit and the cannula. The patch unit can be connected to and disconnected from the cradle unit upon patient's discretion, [0025] According to some embodiments, the device can be configured to include a position detector configured to detect whether the patch unit is connected to or disconnected from the cradle unit. The position detector, according to some embodiments, includes two parts, one of them being located on the patch unit (“patch portion”) and the other on the cradle unit (“cradle portion”). A central processing unit (“CPU”)/processor can be provided, which receives the position detector's output (connected/disconnected) and controls the patch unit's operation and fluid delivery, accordingly. For example, when the patch is disconnected, fluid delivery can be terminated and after reconnection, it can be resumed. [0026] In some embodiments, the position detector's operation can be based on optical-type detectors or other means. For example, a light emitting diode (“LED”) and a light detector can be adjacently located on the patch unit and the cradle unit can be provided with a reflective surface. Upon disconnection or reconnection, the CPU receives no/yes light inputs from the position detector and accordingly assigns the patch unit a “disconnected” or “connected” position status. [0027] In some embodiments, the position detector is configured to operate as an electronic switch. For example, two conductive surfaces (in some embodiments, the surfaces can be fabricated from gold, nickel, or any other suitable material) can be attached to the lower surface of the patch unit's housing, and a third conductive surface can be attached to the cradle unit. The CPU is configured to assign the patch a certain position status according to whether the patch-cradle conductive surfaces are connected or disconnected (“ON-OFF” state). [0028] Some embodiments include a device that includes a dispensing and/or sensing patch unit that can be disconnected from and reconnected to a skin adherable cradle unit, and that further includes a position detector, while the operation of the device can be controlled according to position detection. [0029] Some embodiments include a device that can includes a miniature patch unit that can be configured to continuously dispense insulin and/or monitor glucose levels, and that further incorporates a position detector, and whose operation can be controlled according to position detection. [0030] Some embodiments include a patch unit that can be disconnected from and reconnected to a cradle unit and enables users to safely disconnect the patch unit for a certain period of time. [0031] Some embodiments include a device that includes a patch unit that can be remotely controlled and can be disconnected from and reconnected to a skin adherable cradle unit and that includes a position detector, and whose operation can be controlled according to position detection. [0032] Some embodiments include a device that includes a patch unit having two parts, e.g., a reusable part and a disposable part, and that can be disconnected from and reconnected to a skin adherable cradle unit, and that further includes a position detector, and whose operation can be controlled according to position detection. [0033] Some embodiments include a device which is miniature, discreet, economical for the users and highly cost effective for the payer, and that incorporates a position detector, and whose operation can be controlled according to position detection. [0034] Some embodiments include a patch unit that continuously monitors body glucose (e.g., blood, ISF) levels and can concomitantly deliver insulin into the body, and that incorporates a position detector, and whose operation can be controlled according to position detection. [0035] Some embodiments include a semi closed-loop system that monitors glucose levels and dispenses insulin according to sensed glucose levels, and incorporates a position detector and operation of the device can be controlled according to position detection. [0036] Some embodiments describe a device that includes a dispensing and/or sensing patch unit (hereinafter, referred to generally as a “patch” or a “patch unit”) that can be disconnected from and reconnected to a skin adherable cradle unit, and that includes a detector device that is configured to detect whether the patch is connected or disconnected (hereinafter, referred to as “position detector”). It is also desirable to provide a method for controlling patch operation according to a position of the patch that has been detected by the position detector. [0037] It is desirable to provide a device that includes a miniature patch that can continuously dispense insulin and/or monitor glucose levels and incorporates a position detector and its operation is controlled according to position detection. [0038] It is also desirable to provide a dispensing patch that can be disconnected from and reconnected to a cradle unit and that enables users to safely disconnect the patch unit for a period of time. [0039] It is desirable to provide a device that contains a patch unit that can be remotely controlled and can be disconnected from and reconnected to a skin adherable cradle unit and that further includes a position detector, whose operation can be controlled according to position detection. [0040] It is desirable to provide a device that contains a patch unit, which includes two parts, e.g., a reusable part and a disposable part, and which can be disconnected from and reconnected to a skin adherable cradle unit, and incorporates a position detector, whose operation can be controlled according to position detection. [0041] It is desirable to provide a device that is miniature, discreet, economical for the users, and cost effective for the payer and that incorporates a position detector, whose operation can be controlled according to position detection. [0042] It is desirable to provide a device that can continuously monitor body glucose (e.g. blood glucose, ISF glucose) levels and concomitantly deliver insulin into the body, and that incorporates a position detector, while the operation of the device can be controlled according to position detection. [0043] It is desirable to provide a device that constitutes a semi closed-loop system that monitors glucose levels and dispenses insulin according to sensed glucose levels, and that incorporates a position detector, while the operation of the device can be controlled according to position detection. [0044] The foregoing and other features, aspects, and advantages of the present invention will be more apparent from the following detailed description, which illustrates exemplary embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS [0045] FIGS. 1 a - b illustrate an exemplary device having a patch unit and a remote control unit. [0046] FIGS. 2 a - b illustrate an exemplary device having a patch unit provided with operating buttons and a display. [0047] FIGS. 3 a - c illustrate an exemplary cradle unit having a cradle base and a well. [0048] FIGS. 4 a - d illustrate an exemplary connection of a patch unit to a skin adherable cradle unit [0049] FIGS. 5 a - d illustrate exemplary patch units that can be configured to be connected to a skin adherable cradle unit. [0050] FIGS. 6 a - c illustrate various optional locations of a two-part position detector. [0051] FIG. 7 illustrates an exemplary scheme of the components associated with the patch unit's position status setting and operation control. [0052] FIGS. 8 a - c and 9 a - b illustrate exemplary optical position detectors. [0053] FIGS. 10 a - b illustrate an exemplary magnetic position detector. [0054] FIGS. 11 a - b illustrate an exemplary electro-mechanical position detector. [0055] FIGS. 12 a - b illustrate an exemplary electronic switch position detector. [0056] FIG. 13 is a flow chart of exemplary position settings and CPU-controlled patch operations. [0057] FIGS. 14 a - c are flow charts of exemplary processes following position detector indications or inputted commands. [0058] FIGS. 15 a - e illustrate an exemplary two-part patch unit provided with manual bolus buttons and a position detector. [0059] FIGS. 16 a - d illustrate an exemplary two-part patch unit provided with operating buttons, a display and a position detector. DETAILED DESCRIPTION OF THE INVENTION [0060] FIGS. 1 a - b illustrate a device having a patch unit ( 10 ) capable of dispensing and/or sensing (hereinafter referred to generally as “patch” or “patch unit”) and a remote control unit ( 40 ). In some embodiments, the patch unit ( 10 ) can include a single part ( FIG. 1 a ) or two parts ( FIG. 1 b ), e.g., reusable part ( 100 ) and disposable part ( 200 ). [0061] In some embodiments, fluid delivery can be programmed solely by the remote control unit ( 40 ) and/or by manual buttons (not shown) which could be provided on the patch unit ( 10 ). An embodiment of this arrangement is disclosed in our co-owned International Patent Application No. PCT/IL08/001001, filed Jul. 20, 2008, claiming priority to U.S. Provisional Patent Application No. 60/961,527, filed Jul. 20, 2007, and titled “Manually Operable Portable Infusion Device”, the disclosure of which is incorporated herein by reference in its entirety. [0062] FIGS. 2 a - b illustrate another embodiment of the device having a patch unit ( 10 ) provided with operating buttons ( 12 ) (e.g., keypad) and a display ( 14 ). In some embodiments, fluid delivery programming can be carried out by the operating buttons ( 12 ). In other embodiments, the device can include also a remote control unit. The patch unit ( 10 ) can include a single part ( FIG. 2 a ) or two parts ( FIG. 2 b ), e.g., reusable part ( 100 ) and disposable part ( 200 ). In these embodiments, the operating buttons ( 12 ) and the display ( 14 ) can be located on the reusable part ( 100 ). An embodiment of this arrangement is disclosed in a co-owned International Patent Application No. PCT/IL08/001057, entitled “Portable Infusion Device with Means for Monitoring and Controlling Fluid Delivery”, filed on Jul. 31, 2008, claiming priority to U.S. Provisional Patent Applications No. 60/963,148, filed Aug. 1, 2007, and No. 61/004,019, filed Nov. 21, 2007, both entitled “Portable Infusion Device with Means for Monitoring and Controlling Fluid Delivery”, the disclosure of which is incorporated herein by reference in its entirety. [0063] In some embodiments, the device can include a cradle unit ( 20 ) that can be adhered to the skin of the patient, so that the patch unit ( 10 ) can be connected to and/or disconnected from the cradle unit ( 20 ) as desired. An embodiment of the device employing the cradle unit is disclosed in co-owned, co-pending U.S. patent application Ser. No. 12/004,837, and International Patent Application No. PCT/IL07001578, both filed Dec. 20, 2007, and both claiming priority to U.S. Provisional Patent Application No. 60/876,679, filed Dec. 22, 2006, the disclosures of which are incorporated herein by reference in their entireties. [0064] FIGS. 3 a - b illustrate side and upper views (respectively) of an exemplary cradle unit ( 20 ). The cradle unit ( 20 ) can include the following elements: Cradle base ( 300 )—configured as a flat sheet with an adhesive layer facing the skin ( 5 ) and with anchoring latches ( 302 , 304 ) on its upper side for connection and disconnection of the patch unit. Well ( 310 )—configured as a tubular protrusion emerging upwardly from the cradle base ( 300 ) to allow alignment with and appropriate connection of the patch unit. The well ( 310 ) constitutes a passageway through which a cannula (not shown) can be inserted into the patient's body for fluid (e.g. insulin) delivery and/or for analyte (e.g. glucose) sensing. The cradle unit ( 20 ) can be configured to have more than one “well”. For example, in case when two cannulae are employed, one for fluid delivery and the other for analyte sensing. [0067] FIG. 3 c illustrates an exemplary embodiment of the cradle unit ( 20 ) having a cradle base ( 300 ) with anchoring latches ( 302 , 304 ) and a well ( 310 ). Upon attachment of the cradle unit ( 20 ) to the patient's skin ( 5 ), a cannula (not shown) can be inserted into the subcutaneous compartment of the patient's body through the well ( 310 ) of the cradle unit ( 20 ). The insertion of the cannula into the subcutaneous compartment can be carried out by a dedicated inserter (not shown), e.g., an embodiment of which is disclosed in a co-owned International Patent Application No. PCT/IL08/000859 and co-owned, co-pending U.S. patent application Ser. No. 12/215,219, filed Jun. 25, 2008, claiming priority to U.S. Provisional Patent Application No. 60/937,155, entitled “Protector for Cannula and Penetrating Member Insertable in the Body of a Patient”, and filed Jun. 25, 2007, and co-owned International Patent Application No. PCT/IL08/000860 and co-owned, co-pending U.S. patent application Ser. No. 12/215,255, filed Jun. 25, 2008, claiming priority to U.S. Provisional Patent Application No. 60/937,214, entitled “Insertion Device for Inserting a Cannula into a Body”, and filed Jun. 25, 2007, disclosures of which are incorporated herein by reference in their entireties. Following cannula insertion, a patch unit can be connected to the cradle unit, and fluid delivery and/or analyte sensing can be established. [0068] FIG. 4 a illustrates the cradle unit ( 20 ) being adhered to the patient's skin ( 5 ). FIG. 4 b illustrates an exemplary connection of the patch unit ( 10 ) to the adhered cradle unit ( 20 ) (after cannula insertion). FIG. 4 c illustrates the patch unit ( 10 ) being connected to the cradle unit ( 20 ) and ready for operation. FIG. 4 d illustrate the patch unit ( 10 ) being disconnected from the cradle unit ( 20 ). [0069] FIGS. 5 a - d illustrate exemplary patch units that are configured to be attached to the cradle unit ( 20 ). FIG. 5 a illustrates an exemplary fluid delivery device having a cradle unit ( 20 ) and a two-part dispensing patch unit ( 10 ) that employs a peristaltic pumping mechanism. Rotation of a rotary wheel ( 110 ) and pressing of rollers ( 101 ) against a delivery tube ( 230 ) periodically positively displaces fluid from a reservoir ( 220 ) into the delivery tube ( 230 ) by virtue of a peristaltic motion. The fluid is then delivered via a cannula ( 330 ) into the subcutaneous compartment ( 4 ) within the patient's body. An exemplary two-part dispensing patch unit employing a peristaltic pumping mechanism is disclosed in co-pending, co-owned U.S. patent application Ser. No. 11/397,115 and co-owned International Application No. PCT/IL06/001276, the disclosures of which are incorporated herein by reference in their entireties. FIG. 5 b illustrates an exemplary fluid delivery device having a cradle unit ( 20 ) and a two-part dispensing patch unit ( 10 ), which employs instead of a peristaltic pumping mechanism a syringe-type pumping mechanism. A plunger ( 210 ) is displaced within a reservoir ( 220 ) and forces fluid towards the cannula ( 330 ). An exemplary embodiment of this arrangement is disclosed in a co-owned International Patent Application No. PCT/IL08/000641, filed May 11, 2008, claiming priority to U.S. Provisional Patent Application No. 60/928,815, filed May 11, 2007, the disclosure of which is incorporated herein by reference in its entirety. FIG. 5 c illustrates an exemplary analyte sensing device having a two-part sensing patch unit ( 10 ) and a cradle unit ( 20 ). In an embodiment of FIG. 5 c , an optical sensor for analyte sensing can be employed. One or more optical means ( 106 , 106 ′) (e.g., reflectors) can be used for creating an optical path between a light source ( 102 ) and a sample. In some embodiments, the optical path can be located in the subcutaneous portion of the cannula ( 330 ). In some embodiments, the optical path terminates at a light detector ( 104 ). An embodiment of this arrangement is disclosed in co-owned, co-pending U.S. patent application Ser. No. 11/989,678, filed Jan. 28, 2008, and co-owned International Patent Application No. PCT/IL07/001096, filed Sep. 5, 2007, both claiming priority to U.S. Provisional Patent Application No. 60/842,869, filed Sep. 6, 2006, and U.S. patent application Ser. No. 11/989,665, filed Jan. 28, 2008 and International Patent Application No. PCT/IL07/001177, filed Sep. 25, 2007, both claiming priority to No. 60/848,511, filed Sep. 29, 2006, the disclosures of which are incorporated herein by reference in their entireties. FIG. 5 d illustrates an exemplary dual function device having a cradle unit ( 20 ) and a patch unit ( 10 ) that can be configured to dispense therapeutic fluid (e.g., insulin) and sense analyte (e.g. glucose). This device can be configured to employ a single cannula shared for both fluid delivery and analyte sensing. The dispensing and sensing functions can be independent from one another, or as an alternative, the device may operate in a semi or fully closed-loop mode. An embodiment of this arrangement is disclosed in a co-pending, co-owned U.S. patent application Ser. No. 11/706,606, the disclosure of which is incorporated herein by reference in its entirety. [0070] Although basal delivery can be continuously administered to the patient, nevertheless in practice it is often interrupted due to periodic patch unit disconnections, whether mandatory (e.g., during sauna and hot bath), voluntary (e.g., when going to the beach), or accidentally. According to some embodiments, a dedicated position detector can be provided within the device for detecting whether the patch unit is connected or disconnected. For example, the position detector can be configured to generate a signal output, which can be received at the central processing unit (CPU). The position detector's signal output can correspond to the current position status of the patch unit, i.e., whether it is connected to the cradle unit or disconnected therefrom. Upon receiving the output signal, the CPU can assign the patch unit the appropriate position status. Some embodiments implement a method for controlling the patch unit's operation according to the position status of the patch unit assigned by the CPU upon receiving the position detector's signal output. [0071] The position detector according to some embodiments comprises two parts one of which being located on the patch unit (“patch portion”) and the other on the cradle unit (“cradle portion”). It should be borne in mind that according to other embodiments the position detector may comprise only a single part. [0072] FIGS. 6 a - c illustrate various locations of parts of a position detector ( 1000 ) on the cradle unit ( 20 ) and on the patch unit ( 10 ). FIG. 6 a illustrates an embodiment in which one part, namely a cradle portion ( 800 ), is located on the upper side of a cradle base ( 300 ) while the other part, namely a patch portion ( 900 ), is located on the bottom side of the patch unit ( 10 ). In case of a two-part patch unit ( 10 ), the patch portion ( 900 ) can be located on the reusable part ( 100 ). However, the patch portion ( 900 ) can be located on the disposable part ( 200 ) as well. When the patch portion is located on the reusable part, a printed circuit board (“PCB”) can be used for electrical connection of the patch portion to the CPU. In some embodiments, the PCB can be made available in the reusable part. When the patch portion is located on the disposable part, a dedicated electrical means (e.g., wires, metal tabs, etc.) can be used to electrically connect the patch portion to the PCB. FIG. 6 b illustrates an exemplary embodiment in which the cradle portion ( 800 ) of the position detector ( 1000 ) is located on one of the cradle unit's anchoring latches (e.g., on the latch designated by numeral 302 ) and the patch portion ( 900 ) of the position detector ( 1000 ) is located in close proximity. FIG. 6 c illustrates an exemplary embodiment in which the cradle portion ( 800 ) of the position detector ( 1000 ) is located on the well ( 310 ) and the patch portion ( 900 ) of the position detector ( 1000 ) is located on the patch unit's outlet port ( 213 ). In some embodiments, where the patch unit ( 10 ) includes two parts, the outlet port ( 213 ) could be located in the disposable part ( 200 ), and, thus, the patch portion ( 900 ) will be provided with dedicated means ( 902 ) (e.g. wires, metal tabs) for electrical connection to the PCB ( 130 ) located in the reusable part ( 100 ). [0073] FIG. 7 illustrates exemplary components associated with the patch unit's position status setting and operation control. The output of the position detector's patch portion ( 900 ), which, in the embodiment of FIG. 7 can be located in the reusable part ( 100 ), is received at the CPU ( 140 ). The CPU ( 140 ) can assign the patch unit a “connected” or “disconnected” position status according to received output, and then control the operation of the pump driving mechanism ( 146 ) and/or sensing apparatus ( 147 ) according to the detected patch unit position status (e.g., deactivation of pump driving mechanism ( 146 ) and/or sensing apparatus ( 147 ) when the patch unit is disconnected from the cradle unit ( 20 )). The CPU ( 140 ) can be configured to notify the user via an indication means ( 145 ) for indicating the current position status. [0074] FIGS. 8-12 illustrate exemplary cross-sectional views of a two-part patch unit ( 10 ) and a cradle unit ( 40 ) employing various types of position detectors. For illustrative purposes only, in the figures the cradle portion of the position detector is located on the upper side of the cradle base ( 300 ) and the patch portion of the position detector on the patch unit's ( 10 ) bottom side. As can be understood by one skilled in the art, both detector portions can be located adjacently at any other location of patch and cradle units. [0075] FIGS. 8 a - c illustrate an embodiment of a position detector that can be configured to use optical sensing. In this embodiment, the position detector can be configured to include a light emitting diode (LED) ( 112 ) and a light detector ( 114 ). The LED ( 112 ) and light detector ( 114 ) are configured to be adjacent to the bottom side of the PCB ( 130 ) (e.g., the side of the PCB ( 130 ) that faces the cradle unit ( 20 )). The LED ( 112 ) and the light detector ( 114 ) may be separately located items, as shown in FIGS. 8 a - b , or they may be fixed adjacent to each other being deployed on a common support frame ( 115 ), as shown in FIG. 8 c . The LED ( 112 ) and the light detector ( 114 ) can be configured to have leads (not shown), which can be soldered to the PCB ( 130 ), thereby establishing electrical connection. In some embodiments, at least a portion ( 11 ) of the housing of the reusable part ( 100 ), which is located beneath the LED ( 112 ) and the light detector ( 114 ), can be fabricated from a transparent material so that light could pass through it. The cradle base ( 300 ) can be provided with a reflective surface ( 311 ), which is located opposite to the transparent portion ( 11 ) of the reusable part ( 100 ) housing. The reflective surface ( 311 ) can be embedded in the cradle base ( 300 ) or alternatively it can protrude from the cradle base ( 300 ). FIG. 8 a illustrates exemplary patch unit ( 10 ) and cradle unit ( 20 ), when they are not connected. In this case the light emitted by the LED ( 112 ) passes through the transparent portion ( 11 ) of the reusable part's housing and it is not sensed by the light detector ( 114 ). FIG. 8 b illustrates exemplary patch unit ( 10 ) being connected to the cradle unit ( 20 ). The light emitted by the LED ( 112 ) passes through the transparent portion ( 11 ) of the reusable part ( 100 ) housing, is reflected by the reflective surface ( 311 ) of the cradle unit ( 20 ), and is then sensed by the light detector ( 114 ). It will be noted that in case the cradle unit ( 20 ) is transparent, the patient's skin may act as a reflective surface, in which case the transparent configuration of the cradle unit can act as the cradle unit portion of the position detector. In some implementations, the cradle unit ( 20 ) can be fabricated entirely from a reflective material, or it can be painted in a bright color. In these cases, the reflective qualities of the cradle unit can represent the cradle portion of the position detector. [0076] The CPU ( 140 ) is configured to receive “yes”/“no” light detection signals, set the patch unit's position status to “connected” or “disconnected” based on the received signal, and control the patch unit's operation accordingly. [0077] The LED ( 112 ) can be configured to emit light continuously, periodically (e.g. every 1 sec for a period of 1 μsec), or in any other fashion. This can be done to save energy supplied by at least one battery ( 240 ) located in the disposable part ( 200 ) or in the reusable part ( 100 ). [0078] FIGS. 9 a - b illustrate another exemplary embodiment of the position detector the operation of which is based on optical sensing, according to the present invention. In this embodiment, the bottom side of the reusable part's ( 100 ) housing is configured to have a depression ( 13 ). At least two walls ( 132 , 134 ) of the depression ( 13 ) can be fabricated from a transparent material so that light could pass through them. The PCB ( 130 ) in this embodiment is configured such that a LED ( 112 ) and a light detector ( 114 ) can be soldered to the PCB ( 130 ) and be situated on opposite sides of the depression ( 13 ) thus facing each other. The cradle base ( 300 ) is provided with a protrusion ( 313 ) configured to fit inside the depression ( 13 ) provided in reusable part's ( 100 ) housing. FIG. 9 a illustrates the patch unit ( 10 ) and the cradle unit ( 20 ) when they are not connected. In this case, the light emitted by the LED ( 112 ) passes through the transparent walls ( 132 , 134 ) of the depression ( 13 ) in the reusable part's ( 100 ) housing and is collected by the light detector ( 114 ). FIG. 9 b shows the patch unit ( 10 ) connected to the cradle unit ( 20 ). The cradle base's protrusion ( 313 ) is located inside the depression ( 13 ) in the reusable part's ( 100 ) housing, thus preventing light from passing from the LED ( 112 ) to the light detector ( 114 ). The light emitted by the LED ( 112 ) is either absorbed by the protrusion ( 313 ) or it is reflected by it, depending on the material it is fabricated from and its color, but in either case no light is collected by the light detector ( 114 ). The CPU (not shown) is configured to receive “yes”/“no” light detection signals and accordingly set the patch status to “disconnected” or “connected”. [0079] FIGS. 10 a - b illustrate another exemplary embodiment of the position detector, according to the present invention. A magnetic field applied by a magnet ( 316 ), which is provided in the cradle base ( 300 ), affects a magnetic component ( 16 ), which is attached to the PCB ( 130 ). The magnetic component ( 16 ) can be any component that is affected by a magnetic field, for example, an electrical “ON/OFF” Reed switch or a Hall Effect sensor with varying voltage output. The signals generated by the magnetic component are interpreted by the CPU ( 140 ) as “connected”/“disconnected” positions and the patch's operation is controlled by the CPU ( 145 ) accordingly. FIG. 10 a illustrates the patch unit ( 10 ) and the cradle unit ( 20 ) when they are not connected, and FIG. 10 b illustrates the patch unit ( 10 ) connected to the cradle unit ( 20 ). [0080] FIGS. 11 a - b illustrate an exemplary embodiment of an electro-mechanical position detector, according to the present invention. In this embodiment, an electronic switch ( 17 ) is provided, which can be a commercially available tactile switch (e.g., a tact switch manufactured by Alps Electric Co., Ltd., Japan), or any other electronic switch. The switch can be attached to the PCB ( 130 ) and connected to the CPU ( 140 ). A portion ( 117 ) of the reusable part ( 100 ) housing, which is located directly beneath the electronic switch ( 17 ), may be fabricated from a resilient material, e.g. rubber, preferably using a dedicated molding process so that the patch unit ( 10 ) remains water-tight. FIG. 11 a and FIG. 11 b illustrate the patch ( 10 ) and cradle ( 20 ) units in “disconnected” and “connected” positions respectively. A protrusion ( 317 ) which is provided in the cradle base ( 300 ) pushes the resilient portion ( 117 ) of the reusable part ( 100 ) housing against the electronic switch ( 17 ) and turns it in ON or OFF state (depending whether the switch is normally closed or normally open). The state of the electronic switch ( 17 ) (ON or OFF) is interpreted by the CPU as “connected”/“disconnected” patch unit position. [0081] FIGS. 12 a - b illustrate another exemplary embodiment of the position detector, which can operate as an electronic switch, according to the present invention. In this embodiment, two electrically conductive surfaces (e.g. fabricated from gold or nickel) ( 18 , 19 ) can be provided in the reusable part's ( 100 ) housing. The conductive surfaces ( 18 , 19 ) are either embedded in the bottom side of the housing of the reusable part ( 100 ), or they are secured thereon by any other suitable method. The conductive surfaces ( 18 , 19 ) can be configured to be electrically connected to the PCB ( 130 ) by appropriate wires ( 180 , 190 ). A third conductive surface ( 318 ) can be either embedded in the cradle base ( 300 ) or protruding from the cradle base ( 300 ). The area of the third conductive surface ( 318 ) can be configured to be large enough to ensure that it contacts both conductive surfaces ( 18 , 19 ) upon connection of the patch unit ( 10 ) and the cradle unit ( 20 ). The three conductive surfaces ( 18 , 19 and 318 ) together constitute an electronic switch. FIG. 12 a illustrates the patch unit ( 10 ) and the cradle unit ( 20 ) when they are not connected. The switch in this case is in an “OFF” state, thus the CPU assigns the patch unit ( 10 ) a “disconnected” status. FIG. 12 b illustrates the patch unit ( 10 ) connected to the cradle unit ( 20 ). In this case electrical contact is established between the conductive surfaces ( 18 , 19 ) and the conductive surface ( 318 ), thus the switch is in an “ON” state, and the CPU assigns the patch unit ( 10 ) a “connected” status. [0082] It will be noted, that the switch may alternatively be set up such that establishing contact between the reusable part's conductive surfaces ( 18 , 19 ) and the cradle base's conductive surface ( 318 ), would place the switch in an “OFF” state. In such a case, the CPU will assign the patch unit ( 10 ) a “connected” status when the switch is in an “OFF” state and a “disconnected” status when the switch is in an “ON” state. [0083] Another embodiment of the present invention may employ a proximity sensor (e.g. an inductive proximity sensor) as a position detector. In case an inductive proximity sensor is employed, the sensor is attached to the PCB, and the cradle base can be provided with a surface fabricated from a magnetic material (e.g., ferromagnetic material), which could be either embedded in the cradle base or protruding from it. The sensor can use a coil or an inductor as a transducer to produce a magnetic field. When the patch unit is in close proximity to the cradle unit, the magnetic surface would be exposed to the sensor's magnetic field. Electrical currents (i.e., Eddy currents) would then build up in the magnetic surface and dampen the sensor's magnetic field. Changes in the magnetic field would result in changes in the sensor's signal output sent to the CPU, and the patch unit's status would be set accordingly. An output threshold can be preprogrammed such that the CPU will set the patch unit's status to “connected” only when the distance between the sensor and the magnetic surface is at its minimum corresponding to a situation when the patch unit is connected to the cradle unit. [0084] FIG. 13 is a flow chart illustrating exemplary method for setting and controlling operation of the patch unit. Position indication ( 702 ) is provided by the position detector ( 143 ). Position indication ( 702 ) can be generated, for example, upon request ( 704 ) of the CPU ( 140 ), or automatically when the patch unit is being connected/disconnected, or periodically according to a predetermined time schedule. As can be understood by one skilled in the art, other ways of generating position indication signals are possible. [0085] Some steps may be carried out automatically when the patch unit's position is changed. Such steps may include, for example, deactivation or activation ( 706 , 707 ) of the patch unit's driving mechanism ( 146 ) and deactivation or activation of one or more sensing apparatuses ( 147 ), as will be demonstrated below. The sensing apparatus ( 147 ) can be, for example, a sensor for detecting occlusion in the fluid delivery tube, as described in co-pending, co-owned U.S. patent application Ser. No. 11/810,854 and co-owned International Patent Application No. PCT/IL07/000684, both filed Jun. 6, 2007, disclosures of which are incorporated herein by reference in their entireties. Other sensing apparatuses may include a sensor for monitoring analyte (e.g., glucose) concentration levels in the patient's body, as disclosed, for example, in co-pending, co-owned U.S. patent application Ser. No. 11/706,606, filed Feb. 14, 2007, disclosure of which is incorporated herein by reference in its entirety. [0086] A notification (as shown in step 705 ) may be sent to the user via an indication means ( 145 ) (e.g. buzzer, visual display) upon position status change and upon activation/deactivation of a patch unit component based on a position status change. The current position (designated by numeral 702 ′ in FIG. 14 a ) may also be checked after a command ( 701 ) has been generated by a user by an input means ( 142 ) (e.g. remote control unit or operating buttons provided on the patch unit) and received at the CPU ( 140 ). If there is a mismatch between a command ( 701 ) and the patch position status (hereinafter “inexecutable command”) (e.g. a bolus delivery command is generated when the patch unit and cradle unit are not connected), the command ( 701 ) is stored in the storage means ( 144 ). The stored command ( 701 ′) may include additional data, such as command timing ( 703 ) provided by a clock ( 141 ). [0087] FIG. 14 a is a flow chart of an exemplary process ( 730 ) that takes place after command ( 701 ) is received by the CPU. The command ( 701 ) is checked (as shown in step 732 ) in accordance to a current patch position. If the command can be executed, then the execution can be immediately performed (as shown in step 733 ). If the command cannot be executed, then it can be stored (as shown in step 734 ) for a later execution. The user can be notified accordingly, as shown in step 735 . For example, a bolus delivery command can be received while the patch unit's current status ( 702 ′) is “disconnected”. The command cannot be executed and thus it is stored for a later execution, i.e., upon reconnection of the patch unit to the cradle unit. Appropriate notification can be sent to the patient. [0088] The execution of some commands does not depend on the patch unit's status, i.e., the command can be executed whether the patch is connected or disconnected. An example of such a command is a “set clock” command, which sets the clock of the patch unit according to user input. Some inexecutable commands are not stored for later execution but they are cancelled once they are determined “inexecutable”, e.g., a periodical command to sample the occlusion sensor. [0089] FIG. 14 b is a flow chart of an exemplary process ( 750 ) taking place after receiving position indication ( 702 ) from the patch portion of the position indicator ( 143 ). If there is a mismatch (as shown in step 751 ) between the received position ( 702 ) and the current position ( 702 ′), the following exemplary steps can be carried out in any suitable order: Step 752 : update current position ( 702 ′); Step 753 : activate or deactivate patch components based on the current position ( 702 ′); Step 754 : store relevant data (e.g., position change timing); Step 755 : process and execute previously stored commands ( 701 ′) (e.g., using process 730 ) according to patch position. [0094] When the patch unit is being disconnected from the cradle unit its position is set to “disconnected” status, the driving mechanism can be deactivated, and timing and amount of undelivered volume can be recorded. If the patch unit is provided with operating buttons and a display, the operating buttons may be unlocked and the display may be activated upon disconnection. After reconnection the patch position can be set to “connected” status, timing is recorded, fluid delivery is resumed, the operating buttons may become locked, and the display may be deactivated. [0095] FIG. 14 c is a flow chart of an exemplary process ( 760 ) for position checking after every command ( 701 ) is received. The following exemplary steps can be performed by process ( 760 ) in any suitable order: Step 761 : send a position status request ( 704 ) from the CPU to the position detector, and receive position status indication ( 702 ); Step 762 : check command ( 701 ) in accordance with received patch position status ( 702 ), Step 763 : execute the command if it is executable; Step 764 : store the command if it is inexecutable; Step 765 : notify the patient [0101] In some embodiments, a bolus delivery command generated by the user can be received at the CPU, and a “disconnected” position status indication ( 702 ) can be generated by the position detector. The command cannot be executed, it is therefore stored for later execution, and notification (as shown in step 765 ) can be sent to the patient. Some inexecutable commands are not stored for a later execution but they are cancelled once they are determined “inexecutable”, e.g., a periodical command to sample the occlusion sensor. [0102] As explained above, various position detectors can allow the user to safely disconnect and reconnect the patch unit from and to the cradle unit without using the remote control for suspension or resumption of patch operation, because these actions can be done automatically upon disconnection/reconnection of the patch unit to the cradle unit. The position detector can also prevent the patch unit from operating in case of unintentional disconnection. [0103] A co-owned International Patent Application No. PCT/IL08/001001, filed Jul. 20, 2008, claiming priority to U.S. Provisional Patent Application No. 60/961,527, filed Jul. 20, 2007, and titled “Manually Operable Portable Infusion Pump” discloses a patch unit having manual button(s) allowing the user to initiate bolus delivery without using the remote control unit. In some embodiments, a dedicated position detector for detecting whether the patch unit is connected to or disconnected from the cradle unit can be used. In other embodiments, a method for controlling the patch unit's operation accordingly can be implemented. [0104] One of the advantages of using some implementations of the detector can be that the user can press the bolus button(s) in a situation when the patch unit is disconnected from the cradle unit and bolus delivery will commence only after the patch unit has been reconnected to the cradle unit. [0105] FIGS. 15 a - d illustrate an exemplary two-part patch unit ( 10 ) provided with manual buttons ( 15 ) and with a position detector (not shown in the Figures). FIG. 15 a illustrates an exemplary patch unit ( 10 ) connected to a cradle unit ( 20 ). FIG. 15 b illustrates the patch unit ( 10 ) being disconnected from the cradle unit ( 20 ). FIG. 15 c illustrates the user simultaneously pressing two bolus buttons ( 15 ). FIG. 15 d illustrates the patch unit ( 10 ) being reconnected to the cradle unit ( 20 ). FIG. 15 e illustrates an exemplary embodiment of a two-part patch unit ( 10 ) provided with manual bolus buttons ( 15 ) and a display ( 50 ) on the reusable, part's ( 100 ) housing. In this exemplary embodiment, the patch unit ( 10 ) includes a single part, the display ( 50 ) can be positioned anywhere on the patch unit's housing. The display ( 50 ) can be configured to show a programmed bolus dosage. In some embodiments, the display ( 50 ) can be configured to show additional data, such as the amount of fluid left in the reservoir, the battery status, etc. According to the present invention, if the user presses the bolus buttons ( 15 ) when the patch unit ( 10 ) is not connected to the cradle unit ( 20 ), bolus delivery will not commence until the patch unit ( 10 ) is reconnected to the cradle unit ( 20 ). The user can therefore attach the cradle unit ( 20 ), and consequently the patch unit ( 10 ), to the body at remote locations, e.g. the back or buttocks, and still be able to look at the display ( 50 ) while pressing the bolus buttons. [0106] A co-owned International Patent Application No. PCT/IL08/001057, entitled “Portable Infusion Device with Means for Monitoring and Controlling Fluid Delivery”, filed Jul. 31, 2008, claiming priority to U.S. Provisional Patent Applications No. 60/963,148, filed on Aug. 1, 2007, and No. 61/004,019, filed on Nov. 21, 2007, both entitled “Portable Infusion Device with Means for Monitoring and Controlling Fluid Delivery”, discloses an exemplary embodiment of a patch unit provided with operating buttons and a display which allow the user to control all aspects of both basal and bolus delivery, as well as analyte monitoring in some embodiments, directly from the patch unit without use of a remote control unit. [0107] FIGS. 16 a - d illustrate an exemplary two-part patch unit ( 10 ) provided with operating buttons (the buttons are designated as a group by numeral 12 ), a display ( 14 ) and a position detector (not seen). In this embodiment the user can disconnect the patch unit ( 10 ) from the cradle unit ( 20 ), issue the necessary fluid delivery and/or sensing commands using the operating buttons ( 12 ) and the display ( 14 ), and then reconnect the patch unit ( 10 ). In some implementations, the programmed commands can be executed only after the patch unit ( 10 ) is reconnected to the cradle unit ( 20 ). [0108] Various implementations of the subject matter described herein may be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof. These various implementations may include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device. [0109] These computer programs (also known as programs, software, software applications or code) include machine instructions for a programmable processor, and may be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the term “machine-readable medium” refers to any computer program product, apparatus and/or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term “machine-readable signal” refers to any signal used to provide machine instructions and/or data to a programmable processor. [0110] To provide for interaction with a user, the subject matter described herein may be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user and a keyboard and a pointing device (e.g., a mouse or a trackball) by which the user may provide input to the computer. Other kinds of devices may be used to provide for interaction with a user as well; for example, feedback provided to the user may be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user may be received in any form, including acoustic, speech, or tactile input. [0111] The subject matter described herein may be implemented in a computing system that includes a back-end component (e.g., as a data server), or that includes a middleware component (e.g., an application server), or that includes a front-end component (e.g., a client computer having a graphical user interface or a Web browser through which a user may interact with an implementation of the subject matter described herein), or any combination of such back-end, middleware, or front-end components. The components of the system may be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include a local area network (“LAN”), a wide area network (“WAN”), and the Internet. [0112] The computing system may include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. [0113] Although particular embodiments have been disclosed herein in detail, this has been done by way of example for purposes of illustration only, and is not intended to be limiting with respect to the scope of the appended claims, which follow. In particular, it is contemplated that various substitutions, alterations, and modifications may be made without departing from the spirit and scope of the invention as defined by the claims. Other aspects, advantages, and modifications are considered to be within the scope of the following claims. The claims presented are representative of the inventions disclosed herein. Other, unclaimed inventions are also contemplated. The applicant reserves the right to pursue such inventions in later claims. [0114] Any and all of the foregoing patents, applications, and publications referenced in this specification are hereby incorporated by reference herein in their entireties.

A portable therapeutic apparatus and a method for controlling the apparatus are provided. In one aspect the apparatus and the method can be implemented using a patch unit ( 100, 200 ) removably attachable to a cradle unit ( 20 ), said cradle unit removably attachable to the body of the patient; a position detector ( 1000 ) comprising a patch portion ( 900 ) and a cradle portion ( 800 ), said patch portion coupled to the patch unit, said cradle portion coupled to the cradle unit; a processor adapted for receiving a position indication signal from the at least one position detector, said position indication signal corresponding to a physical proximity of the patch portion to the cradle portion, and, wherein the portable therapeutic apparatus is adapted for at least one therapeutic function selected from the group consisting of delivering a therapeutic fluid into the body of the patient and sensing a bodily analyte.

RELATED APPLICATIONS This application is a continuation under 35 U.S.C. 111(a) of PCT/CN2005/000333, filed Mar. 17, 2005 and published as WO 2005/087242 A1, filed Sep. 22, 2005, which claimed priority under 35 U.S.C. 119 to Chinese Application No. 200410018758.4, filed Mar. 17, 2004, which applications and publication are incorporated herein by reference and made a part hereof. TECHNICAL FIELD The invention relates to a medicine, and in particular, to a traditional Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular diseases. BACKGROUND ART Cardiovascular and cerebrovascular diseases are common ones which do great harm to health of human beings. Recently, such diseases have an increasing occurrence due to the changes of works, livings, diet patterns, environments and the like with social development. The traditional Chinese medicine (TCM), in spite of its lower activity toward a single target relative to the Western medicine, is characterized by its multiple routes and targets, dynamic and holistic treatment, and low side effects, which are far beyond the effects of the Western medicine. The TCM preparation with definite therapeutic effect will have an overall therapeutic effect superior to that of the Western medicine. There have been now a plurality of TCM preparations for the treatment of cardiovascular and cerebrovascular diseases, such as compound Danshen tablets and its TCM preparations, Guanxin Danshen drop pills, and Xinkeshu tablets etc. These TCM preparations, all of which contain Radix Salviae Miltiorrhizae (also known as danshen) and Radix Notoginseng , have different therapeutic effects for their different formulations, proportions of ingredients, extraction and purification processes, or dosage forms. In addition, these TCM preparations can hardly be controlled in quality, since no effective quality detection method is available at present for completely characterizing the physical and chemical properties of these medicines, and instead, only one or two compounds, such as Danshensu or Tanshinone IIA, are used to represent the complex biologically active ingredients in these medicines. Therefore, it is necessary to improve the process for extracting and purifying such TCM preparations and also the method for controlling their qualities. SUMMARY OF THE INVENTION It is an object of the present invention to provide a more effective TCM preparation for the treatment of cardiovascular and cerebrovascular diseases. Also provided herein is a detection method for relatively complete and exact characterization of the physical and chemical properties thereof. It is another object of the present invention to provide a process for preparing the above TCM preparation. The objects of the present invention are achieved through the following embodiments. The TCM preparation according to the present invention can be prepared through a process comprising the following steps of: mixing Radix Salviae Miltiorrhizae and Radix Notoginseng with sodium hydroxide, sodium bicarbonate, sodium carbonate, potassium hydroxide, potassium bicarbonate, potassium carbonate or a mixture thereof in an amount of 0.5%-4.0% based on the total weight of said medicinal materials to obtain a mixture; boiling the mixture out in 3-6 folds of water for 2-4 times; subjecting the mixture to filtration and concentrating the combined filtrates; adding an ethanol with a high concentration (above 70%) in an amount sufficient to obtain a 65-70% content of the ethanol; allowing the mixture to stand and separating the supernatant; recovering the ethanol from the supernatant and concentrating the residue until it has a relative density of 1.20-1.50 (55-60° C.), which is an extract of Radix Salviae Miltiorrhizae - Radix Notoginseng; mixing the above extract with Borneol (or an oil of Lignum Dalbergiae Odoriferae ); and adding one or more pharmacological excipients, such as starch, dextrin, lactose, microcrystalline cellulose, hydroxypropyl methyl cellulose, polyethylene glycol, magnesium stearate, micro silicon gel, xylitol, lactitol, glucose, glycine, mannitol, methyl starch sodium, cross-linked sodium carboxyl methyl cellulose, cross-linked polyvinylpyrrolidone etc., to formulate the mixture into various dosage forms, such as injection, tablet, sustained-release tablet, drop pill, granule, injection powder, capsule, microgranule, oral disintegrant. Preferably, the above TCM preparation is prepared through a process comprising the following steps of: weighing Radix Salviae Miltiorrhizae and Radix Notoginseng; adding sodium bicarbonate in an amount of 1.4%-1.9% based on the total weight of said medicinal materials to obtain a mixture; boiling the mixture out in 4-5 folds of water for 2-3 hours, and then in 3-4 folds of water for another 1-2 hours; subjecting the mixture to filtration and concentrating the combined filtrates until a specific gravity of 1.16-1.20 (80±5° C.) is achieved; adding an ethanol with a high concentration (above 70%) in an amount sufficient to obtain a 65-70% content (20° C. of the ethanol; allowing the mixture to stand for 8-12 hours and separating the supernatant; recovering the ethanol from the supernatant and concentrating the residue until it has a relative density of 1.32-1.40 (55-60° C.), which is an extract of Radix Salviae Miltiorrhizae - Radix Notoginseng ; mixing the above extract with Borneol (or an oil of Lignum Dalbergiae Odoriferae ); and adding one or more pharmacological excipients selected from the group consisting of starch, dextrin, lactose, microcrystalline cellulose, hydroxypropyl methyl cellulose, polyethylene glycol, magnesium stearate, micro silicon gel, xylitol, lactitol, glucose, glycine, mannitol, methyl starch sodium, cross-linked sodium carboxyl methyl cellulose, cross-linked polyvinylpyrrolidone etc. to formulate the mixture into tablet, drop pill, injection powder, capsule, granule, microgranule, or oral disintegrant. The Borneol used herein can be a naturally occurring or synthesized one. The oil of Lignum Dalbergiae Odoriferae used herein is obtained through distillation of Lignum Dalbergiae Odoriferae. The above TCM preparation is preferably in the dosage form of drop pill. The TCM preparation according to the present invention is characterized using the following physical and chemical parameters: in the HPLC spectrum, there are 8 peaks which have a ratio of single peak area to total peak area greater than 2%; the average retention time of these 8 peaks is 6.04, 9.90, 16.89, 17.84, 20.31, 23.74, 27.73 and 31.02 respectively, and the RSD % of the retention time is 0.31, 0.25, 0.61, 0.70, 0.96, 0.76, 0.50 and 1.18 respectively; their average peak area is 1627.92, 2575.54. 366.89, 381.40, 186.08, 555.35, 281.91 and 1852.33 respectively, and the RSD % of the peak area is 5.91, 13.53, 10.92, 13.81, 12.04, 10.48, 18.08 and 14.84 respectively; and the ratio of single peak area to total peak area accounts for 19.6%-22.0%, 28.5%-37.4%, 4.2%-5.2%, 4.2%-5.5%, 2.1%-2.7%, 6.4%-7.8%, 3.0%-4.3% and 20.2%-27.2% respectively. The above physical and chemical parameters were obtained under the following detection conditions: (1) High Performance Liquid Chromatography Octadecylsilyl-silica gel was used as a filler for the chromatography column, with flow rate of 1.000 ml/min and detection wavelength of 280 nm. The Elution was carried out under the following conditions: mobile phase A being a 0.02% aqueous phosphoric acid solution, mobile phase B being a 80% acetonitrile-0.02% aqueous phosphoric acid solution, mobile phase A being changed from 90% to 78% homogeneously and mobile phase B being changed from 10% to 22% homogeneously during 0 to 8 min; mobile phase A from 78% to 74% and mobile phase B from 22% to 26% during 8 to 15 min; and mobile phase A from 74% to 48% and mobile phase B from 26% to 52% during 15 to 55 min. (2) Preparation and Determination of Sample Solution 10 pills of the TCM preparation according to the present invention are weighed accurately, and then, added into a 10 ml measuring bottle. Distilled water was added in an amount sufficient to dissolve the pills through shaking with ultrasound for 15 minutes. And more distilled water was then added to achieve a volume of 10 ml. The resultant solution was subjected to centrifugation or filtration to obtain a sample solution. An accurate 10 μl of the sample solution was injected into a HPLC apparatus, and then determined by way of HPLC chromatography to obtain a HPLC spectrum. With the aid of an analysis method, such as a comparison with a standard sample and Mass Spectra, the above 8 peaks with an average retention time of 6.04, 9.90, 16.89, 17.84, 20.31, 23.74, 27.73 and 31.02 were identified to correspond with Danshensu, Protocatechualdehyde, Isolithospermic acid A, Isolithospermic acid B, Salvianolic acid D, Rosmarinic acid, Salvianolic acid B and Salvianolic acid A, respectively (see FIG. 1 ). Using a particular HPLC-MS method, the TCM preparation of the present invention was determined to comprise Danshensu, Protocatechualdehyde, Isolithospermic acid A, Isolithospermic acid B, Salvianolic acid D, Salvianolic acid E, Rosmarinic acid, Salvianolic acid B, Salvianolic acid G, Salvianolic acid A, Tanshinone I , Tanshinone II A, Notoginsenoside R 1 , Ginsenoside Re, Ginsenoside Rg1, Ginsenoside Rb1, Notoginsenoside R2, Notoginsenoside R2 iso., Ginsenoside Rg2, Ginsenoside Rh1, Ginsenoside Rh1 iso., Ginsenoside Rd, Ginsenoside Rd iso., Ginsenoside Rf-H2O, Notoginsenoside R2-H2O, Ginsenoside Rg6 or F4, Ginsenoside Rk3, Ginsenoside (Rh4), Ginsenoside 20(R)-Rg3, Ginsenoside 20(S)-Rg3, Ginsenoside (Rk1), Ginsenoside (Rg5) and the like. 1 2 3 4 5 6 7 8 9 10 11 1. Danshensu MW = 198 2. Protocatechualdehyde MW = 138 3. Salvianolic acid A MW = 494 4. Salvianolic acid B MW = 718 5. Salvianolic acid C MW = 492 6. Salvianolic acid D MW = 418 7. Salvianolic acid E MW = 718 8. Salvianolic acid G MW = 340 9. Isolithospermic acid A MW = 538 10. Isolithospermic acid B MW = 538 11. Rosmarinic acid MW = 360 Structure Type A Ginsenoside R 1 R 2 Molecular Weight (MW) Ginsenoside Rb 1 Glc-Glc Glc-Glc 1108 Ginsenoside Rd Glc-Glc Glc 946 Ginsenoside Rg 3 Glc-Glc H 784 Ginsenoside F 2 Glc Glc 784 Structure Type B Ginsenoside R 1 R 2 R 3 MW Ginsenoside Re H Glc O-Glc-Rham 946 Ginsenoside Rf H H O-Glc-Glc 800 Ginsenoside Rg 1 H Glc O-Glc 800 Ginsenoside Rg 2 H H O-Glc-Rham 784 Ginsenoside Rh 1 H H O-Glc 638 Notoginsenoside R 2 H H O-Glc-Xyl 770 Notoginsenoside R 1 H Glc O-Glc-Xyl 932 Ginsenoside F 1 H Glc OH 638 Structure Type C Ginsenoside R 1 R 2 MW Ginsenoside Rg 5 Glc-Glc- H 766 Ginsenoside Rh 4 H Glc-O— 620 Ginsenoside F 4 H Rham-Glc-O— 766 Structure Type D Ginsenoside R 1 R 2 MW Ginsenoside Rg 6 H Rham-Glc-O— 766 Ginsenoside Rk 1 Glc-Glc H 766 Ginsenoside Rk 3 H Glc-O— 620 Glc = β-D-glucose Rham = α-L-rhamnose Xyl = β-D-xylose In the extraction process and analysis method of the present invention, fingerprint atlas was used for completely characterizing the physical and chemical properties of the Radix Salviae Miltiorrhizae and the Radix Notoginseng in the TCM preparation. Compared to the prior art in which only one or two compounds are used to represent complex biologically active ingredients in TCM preparations, this characterization means is more suitable for controlling the quality of the TCM preparations. The biologically active ingredients in the present TCM preparations were detected using the HPLC-MS analysis method according to the present invention. As a result, 12 components from Radix Salviae Miltiorrhizae and 21 components from Radix Notoginseng have been identified in total. The compounds were identified mainly based on an analysis of the MS n data and comparison with data from literature. Finally, a large number of the components were completely confirmed with respect to their structures through comparison with the control samples. It can be concluded thereby that the analysis for the chemical composition of the present TCM preparation using the HPLC-MS method of the present invention can produce abundant information on the structure of the biologically active ingredients. The characterization by these information for the physical and chemical properties of Radix Salviae Miltiorrhizae and Radix Notoginseng in the present TCM preparation has consequently a much better effect than those methods in the prior art. The following tests demonstrate that the present TCM preparation has an effect on the treatment of cardiovascular and cerebrovascular diseases. 1. Effects of the TCM Preparation on Myocardial Ischemia and Myocardial Infarction in Anaesthetized Dog An epicardial electrogram was used to map a range of myocardial ischemia and to indicate the extent thereof. Quantitative histology (N-BT staining method) was used to determine an area of myocardial infarction. Also determined were changes of blood flow of coronary artery, myocardial oxygen consumption, and activities of serum CK and LDH, and blood plasma ET, TXB 2 , and 6-Keto-PGF 1a . The TCM preparation according to the present invention was studied upon alimentary administration with regard to its effect on acute myocardial ischemia, myocardial infarction, and related indicators in test dogs. The test results show that the TCM preparation according to the present invention has a significant effect in improving acute myocardial ischemia and myocardial infarction of dogs. It can lead to a reduced extent of myocardial ischemia (Σ-ST) indicated by the epicardial electrogram (P<0.001 relative to the control group using normal saline), a significantly reduced area of infarction indicated through N-ST staining (P<0.001 relative to the control group using normal saline), and a significantly increased blood flow of coronary artery in an ischemic heart (P<0.001 relative to the control group using normal saline). It has an inhibitory action against the release of serum lactate dehydrogenase (LDH) resulted from myocardial ischemia and myocardial infarction (with a relative change ratio significantly lower than that of the control group using normal saline, P<0.001), as well as against the increase of the activity of creatine phosphokinase (CK) (with a relative change ratio significantly lower than that of the control group using normal saline, P<0.05). It has also an effect in reducing blood plasma ET (P<0.001 relative to the control group using normal saline)and TXB 2 level (P<0.001 relative to the control group using normal saline, P<0.05 relative to the group using a TCM preparation) of blood plasma, and improving the ratio of 6-Keto-PGF 1a /TXB 2 (P<0.001 relative to the control group using normal saline, P<0.05 relative to the group using a TCM preparation). 2. Effects of the TCM Preparation on Myocardial Infarction Caused by Ischemic Reperfusion It was found through an observation on a rat model with the damage of myocardial ischemia reperfusion that, the TCM preparation according to the present invention could lead to a significantly reduced extent of myocardial damage, a decreased area of myocardial infarction (p<0.05-0.01 relative to the model group), and a less weight of an infarction part (p<0.05 relative to the model group). It has also an effect in significantly increasing the activity of superoxide dismutase (SOD) (p<0.01 relative to the model group). 3. Effects of the TCM Preparation on Dynamics of Cardiac Blood Flow and Myocardial Oxygen Consumption in Dogs The TCM preparation of the present invention was evaluated with respect to its effect on dynamics of cardiac blood flow and myocardial oxygen consumption in anaesthetized normal dogs. The results show that the TCM preparation according to the present invention can lead to a significantly improved blood flow of coronary artery (p<0.01-0.001 relative to the group before administration and the control group using normal saline), an expanded coronary vessel, an increased oxygen content in coronary vein sinus (p<0.05-0.001 relative to the group before administration and the control group using normal saline), a reduced myocardial oxygen consumption indicator, an improved supply of blood and oxygen to cardiac muscle, and an increased output per heartbeat and cardiac output (p<0.05-0.01 relative to the group before administration and the control group using normal saline) without enhancing left ventricular work. The present TCM preparation has also an effect in adjusting cardiac complaisance, and thus, in adapting and improving a cardiovascular system. 4. Effects of the TCM Preparation on Platelet Agglutination in Rabbits The TCM preparation of the present invention was evaluated through Born nephelometry with respect to its effect on platelet agglutination in rabbits. The results show that the TCM preparation can, upon an intragastric administration for 7 successive days, lead to a significant reduction of the platelet agglutination in rabbits induced by arachidonic acid (AA) (p<0.05-0.01 relative to the control group using distilled water) and collagen (p<0.01 relative to the control group using distilled water). This indicates that the TCM preparation according to the present invention has an inhibitory effect on platelet agglutination. 5. Effects of the TCM Preparation on Thrombogenesis in Vitro and Blood Viscosity in Rats The TCM preparation of the present invention was evaluated with respect to its effect on thrombogenesis in vitro and blood viscosity in rats. The results show that the TCM preparation can, upon an intragastric administration for 7 successive days, lead to a considerably shortened thrombus (p<0.01 relative to the control group using distilled water), a decreased wet and dry weight of the thrombus (p<0.05 relative to the control group using distilled water), a reduced viscosity of blood plasma (p<0.001 relative to the control group using distilled water), and a decreased whole blood viscosity at various shear rates (p<0.05 relative to the control group using distilled water). This indicates that the TCM preparation according to the present invention has an effect in inhibiting thrombogenesis, and reducing viscosity of blood plasma and of whole blood. 6. Effects of the TCM Preparation on Hyperlipidemia and Atherosclerosis in Rabbits A hyperlipidemia and atherosclerosis (AS) model for test was established through feeding fodder with a high content of cholesterol to a rabbit. The TCM preparation of the present invention was evaluated with respect to its effect on this model. The results show that the TCM preparation according to the present invention can lead to a significantly decreased concentration of TC, TG, LDL-C, VLDL-C in serum and a decreased TC/HDL-C ratio (p<0.05-0.001 relative to the control group suffering from Hyperlipidemia) in rabbits, a significantly increased HDL-C concentration (p<0.05 relative to the control group suffering from Hyperlipidemia), a decreased content of TC in the aorta (p<0.05 relative to the control group suffering from Hyperlipidemia), a decreased content of TG in the liver (p<0.05 relative to the control group suffering from Hyperlipidemia), and a decreased content of MDA in the liver (p<0.001 relative to the control group suffering from Hyperlipidemia). The present TCM preparation has a significant effect in improving the activity of SOD in the liver (p<0.01 relative to the control group suffering from Hyperlipidemia). Furthermore, it has a significant effect in reducing the thickness of aorta plaque and the amount of the foam cells formed in the aorta (p<0.05 relative to the control group suffering from Hyperlipidemia). It also leads to a decreasing tendency of the area of the aorta plaque. These indicate that the TCM preparation according to the present invention has an effect in adjusting blood fat, and at the same time, a certain effect of the anti-peroxidation of lipid and prevention of arteriosclerosis. 7. Effects of the TCM Preparation on Localized Cerebral Ischemia in Rats Using a rat model with a middle cerebral artery thrombosis (MCAT), the TCM preparation of the present invention was determined with respect to its effect on an area of cerebral infarction in MCAT rats. The results demonstrate that the TCM preparation according to the present invention has a significant effect of anti-cerebral ischemia. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 is a fingerprint atlas of the components of the Radix Salviae Miltiorrhizae in the drop pills as one of the dosage forms of the present TCM preparation. In this figure, peak 1 represents Danshensu; peak 2 represents Protocatechualdehyde; peak 3 represents Isolithospermic acid A; peak 4 represents Isolithospermic acid B; peak 5 represents Salvianolic acid D; peak 6 represents Rosmarinic acid; peak 7 represents Salvianolic acid B; and peak 8 represents Salvianolic acid A. FIG. 2 is a HPLC spectrum of the water-soluble components of the Radix Salviae Miltiorrhizae in the present TCM preparation. In this figure, peak 1 represents Danshensu; peak 2 represents Protocatechualdehyde; peak 3 represents Isolithospermic acid A; peak 4 represents Isolithospermic acid B; peak 5 represents Salvianolic acid D; peak 6 represents Salvianolic acid E; peak 7 represents Rosmarinic acid; peak 8 represents Salvianolic acid B; peak 9 represents Salvianolic acid G; and peak 10 represents Salvianolic acid A. FIG. 3 is a MS-TIC spectrum of the water-soluble components of the Radix Salviae Miltiorrhizae in the present TCM preparation. FIG. 4 is a HPLC spectrum of the liposoluble components of the Radix Salviae Miltiorrhizae in the present TCM preparation. In this figure, peak 1 represents Tanshinonel; and peak 2 represents Tanshinone IIA. FIG. 5 is a MS-TIC spectrum of the liposoluble components of the Radix Salviae Miltiorrhizae in the present TCM preparation. FIG. 6 is a MS-TIC spectrum of the components of the Radix Notoginseng in the present TCM preparation. DETAILED DESCRIPTION OF THE EMBODIMENTS The invention will be further illustrated in details by reference to the following examples. The examples are for illustrative purpose and are not intended to limit the scope of the invention. EXAMPLES Example 1 Preparation Example 41.06 g of Radix Salviae Miltiorrhizae and 8.03 g of Radix Notoginseng were weighed out, to which sodium bicarbonate was added in an amount of 1.8% based on the total weight of said medicinal materials. The resulting mixture was boiled out in 4 folds of water for 2 hours, and then in 3 folds of water for another 1 hour. After filtration, the combined filtrates were concentrated until a specific gravity of 1.19-1.20 (75±1° C.) was achieved. Then, a 95% ethanol was added in an amount sufficient to obtain a 65% content of the ethanol (20° C.). The mixture was subsequently allowed to stand for 12 hours, and the supernatant was separated. The ethanol was recovered from the supernatant, and the residue was concentrated until it had a relative density of 1.37 (55-60° C. ), which was an extract of Radix Salviae Miltiorrhizae - Radix Notoginseng. The above extract was then mixed uniformly with 0.46 g of Borneol and 18 g of polyethylene glycol-6000. The mixture was melted at a temperature of 85° C. for 80 mins. The melting liquor was then introduced into the dropping tank of a drop-pill machine with the tank temperature being maintained at 86° C., in which the liquor was dropped into a liquid paraffin at 8° C. The obtained drop pills were taken out, subjected to an oil removal and then screened through a sieve to obtain the desired preparation. Example 2 Preparation Example 59.36 g of Radix Salviae Miltiorrhizae and 6.38 g of Radix Notoginseng were weighed out, to which potassium carbonate was added in an amount of 1.0% based on the total weight of said medicinal materials. The resulting mixture was boiled out in 4 folds of water for 2.5 hours, and then in 3 folds of water for another 1.5 hours. After filtration, the combined filtrates were concentrated until a specific gravity of 1.19-1.20 (75±1° C.) was achieved. Then, a 85% ethanol was added in an amount sufficient to obtain a 70% content of the ethanol (20° C.). The mixture was subsequently allowed to stand for 10 hours, and the supernatant was separated. The ethanol was recovered from the supernatant, and the residue was concentrated until it had a relative density of 1.35 (55-60° C. ), which was an extract of Radix Salviae Miltiorrhizae - Radix Notoginseng. The above extract was then mixed uniformly with 0.34 g of Borneol and 23 g of polyethylene glycol-6000. The mixture was melted at a temperature of 89° C. for 100 mins. The melting liquor was then introduced into the dropping tank of a drop-pill machine with the tank temperature being maintained at 85° C., in which the liquor was dropped into a methyl silicone oil at 8° C. The obtained drop pills were taken out, subjected to an oil removal and then screened through a sieve to obtain the desired preparation. Example 3 Preparation Example 12.60 g of Radix Salviae Miltiorrhizae and 56.15 g of Radix Notoginseng were weighed out, to which potassium bicarbonate was added in an amount of 1.0% based on the total weight of said medicinal materials. The resulting mixture was boiled out in 4 folds of water for 2.5 hours, and then in 3 folds of water for another 1.5 hours. After filtration, the combined filtrates were concentrated until a specific gravity of 1.19-1.20 (75±1° C.) was achieved. Then, a 95% ethanol was added in an amount sufficient to obtain a 70% content of the ethanol (20° C.). The mixture was subsequently allowed to stand for 10 hours, and the supernatant was separated. The ethanol was recovered from the supernatant, and the residue was concentrated until it had a relative density of 1.35 (55-60° C.), which was an extract of Radix Salviae Miltiorrhizae - Radix Notoginseng. The above extract was then mixed with 0.34 g of Borneol and 23 g of polyethylene glycol-6000. The mixture was melted at a temperature of 89° C. for 100 mins. The melting liquor was then introduced into the dropping tank of a drop-pill machine with the tank temperature being maintained at 85° C., in which the liquor was dropped into a methyl silicone oil at 8° C. The obtained drop pills were taken out, subjected to an oil removal and then screened through a sieve to obtain the desired preparation. Example 4 Preparation Example 31.12 g of Radix Salviae Miltiorrhizae and 9.21 g of Radix Notoginseng were weighed out, to which sodium hydroxide was added in an amount of 0.5% based on the total weight of said medicinal materials. The resulting mixture was boiled out in 4 folds of water for 1.5 hours, and then in 3 folds of water for another 1.5 hour. After filtration, the combined filtrates were concentrated until a specific gravity of 1.19-1.20 (75±1° C.) was achieved. Then, a 88% ethanol was added in an amount sufficient to obtain a 66% content of the ethanol (20° C.). The mixture was subsequently allowed to stand for 10 hours, and the supernatant was separated. The ethanol was recovered from the supernatant, and the residue was concentrated until it had a relative density of 1.40 (55-60° C. ), which was an extract of Radix Salviae Miltiorrhizae - Radix Notoginseng. The above extract was then mixed uniformly with 0.50 g of Borneol, 90 g of mannitol, 15 g of calciumedetate sodium and 15 ml of distilled water. The resultant mixture was lyophilized, and finally formulated into injection powders. Example 5 Preparation Example 116.35 g of Radix Salviae Miltiorrhizae and 58.21 g of Radix Notoginseng were weighed out, to which sodium bicarbonate was added in an amount of 2.0% based on the total weight of said medicinal materials. The resulting mixture was boiled out in 4 folds of water for 2 hours, and then in 3 folds of water for 1.5 hour. After filtration, the combined filtrates were concentrated until a specific gravity of 1.19-1.20 (75±1° C.) was achieved. Then, a 88% ethanol was added in an amount sufficient to obtain a 66% content of the ethanol (20° C.). The mixture was subsequently allowed to stand for 10 hours, and the supernatant was separated. The ethanol was recovered from the supernatant, and the residue was concentrated until it had a relative density of 1.40 (55-60° C. ), which was an extract of Radix Salviae Miltiorrhizae - Radix Notoginseng. The above extract was then mixed uniformly with 1.80 g oil of Lignum Dalbergiae Odoriferae and 40 g of microcrystalline cellulose. A 3% solution of polyvidone in ethanol was added to soften the mass. The softened mass was then sieved through an 18-size mesh to form granules. The granules were dried at a temperature of 60° C. for 35 mins, trimmed, and then mixed uniformly with 4 g of talcum powders. The mixture obtained was encapsulated to obtain the desired preparation. Example 6 Preparation Example 116.35 g of Radix Salviae Miltiorrhizae and 58.21 g of Radix Notoginseng were weighed out, to which sodium bicarbonate was added in an amount of 2.0% based on the total weight of said medicinal materials. The resulting mixture was boiled out in 4 folds of water for 2 hours, and then in 3 folds of water for 1.5 hour. After filtration, the combined filtrates were concentrated until a specific gravity of 1.19-1.20 (75±1° C.) was achieved. Then, a 88% ethanol was added in an amount sufficient to obtain a 66% content of the ethanol (20° C.). The mixture was subsequently allowed to stand for 10 hours, and the supernatant was separated. The ethanol was recovered from the supernatant, and the residue was concentrated until it had a relative density of 1.40 (55-60° C. ), which was an extract of Radix Salviae Miltiorrhizae - Radix Notoginseng. The above extract was then mixed uniformly with 0.90 g of Borneol, 120 g of microcrystalline cellulose, 40 g of hydroxypropyl methyl cellulose, 5 g of xylitol, and 2 g of magnesium stearate. The obtained mixture was compressed into tablets to obtain the desired preparation. Example 7 Preparation Example 140.35 g of Radix Salviae Miltiorrhizae and 36.42 g of Radix Notoginseng were weighed out, to which sodium bicarbonate was added in an amount of 2.5% based on the total weight of said medicinal materials. The resulting mixture was boiled out in 4 folds of water for 2 hours, and then in 3 folds of water for 1.5 hour. After filtration, the combined filtrates were concentrated until a specific gravity of 1.19-1.20 (75±1° C.) was achieved. Then, a 90% ethanol was added in an amount sufficient to obtain a 65% content of the ethanol (20° C.). The mixture was subsequently allowed to stand for 8 hours, and the supernatant was separated. The ethanol was recovered from the supernatant, and the residue was concentrated until it had a relative density of 1.35 (55-60° C. ), which was an extract of Radix Salviae Miltiorrhizae - Radix Notoginseng. The above extract was then mixed uniformly with 1.00 g of Borneol and 46 g of microcrystalline cellulose. A 3% solution of polyvidone in ethanol was added to soften the mass. The softened mass was then sieved through an 18-size mesh to form granules. The granules were dried at a temperature of 60° C. for 30 mins, trimmed, and then mixed uniformly with 4 g of talcum powders. The mixture obtained was compressed into tablets to obtain the desired preparation. Example 8 Detection Example for Active Component 1. Preparation of Sample (1) The Water-Soluble Components of the Radix Salviae Miltiorrhizae in the Present TCM Preparation 148.4 mg was weighed out each for the TCM drop pills from example 1, 2 and 3, the TCM injection powders from example 4, the TCM capsules from example 5, the TCM oral disintegrant tablets from example 6, and the TCM tablets from example 7. Said preparations were dissolved in 6 ml of water through ultrasound for 15 mins, and then filtered through a 0.45 μm nylon film to obtain a yellow sample solution, respectively. (2) The Components of the Radix Notoginseng and Liposoluble Components of the Radix Salviae Miltiorrhizae in the Present TCM Preparation 1003.8 mg was weighed out each for the TCM drop pills from example 1, 2 and 3, the TCM injection powders from example 4, the TCM capsules from example 5, the TCM oral disintegrant tablets from example 6, and the TCM tablets from example 7. Said preparations were dissolved in 10 ml of 4% aqueous ammonia through ultrasound for 15 mins, and then filtered through a 0.45 μm nylon film, respectively. The filtrate was pretreated on an Extract-Clean C 18 (Alltech Associates, Inc, U.S.) column. This sample, upon loaded into the column, was washed with 10 ml of water, and then eluted with 2 ml of methanol to obtain the test sample as a yellow eluent, respectively. 2. Analysis of Sample (1) Instruments and Agents Agilent Series-1100 Liquid Chromatograph (Agilent); G1315A Diode Array Detector G1313A Automatic Sample Injector; G1316A Thermostat; G1322A Deaerator and Duplex Pump; HP Instrument Chromatographic Work Station. Type G2445A Series 1100 LC-MSD/Trap Mass Spectrograph (Bruker); Ionization was carried out by means of electro-spraying; Extract-Clean C 18 Column(100 mg/ml, Alltech Associates, Inc, U.S.), acetonitrile being chromatographically pure (TEDIA), water being redistilled water , and acetic acid being analytically pure. (2) Detection Conditions of Instruments Agilent Zorbax SB-C18 chromatographic column (5 μm, 4.6 mm×25 cm , Agilent, SN USCL009296) was used for HPLC analysis. The gradient elution and mass spectrum detection of each sample were performed under following conditions. {circle around (1)} The Water-soluble Components of the Radix Salviae Miltiorrhizae in the TCM Preparation from Each Example HPLC Elution Conditions: time (min) mobile phase A (%) mobile phase B (%) 0 95.0 5.0 15 78.3 21.7 33 78.3 21.7 38 65.0 35.0 mobile phase A: acetic acid:water = 0.01:100 mobile phase B: acetic acid:acetonitrile = 0.01:100 flow rate: 0.5 ml/min temperature: 30° C. detection wavelength: multiple wavelength (280 nm of indicated wavelength) MS Analysis Conditions: HPLC-MS HPLC-MS n Ion detection manner negative ion detection Dry gas flow rate (L/min) 10 10 Nebulizer pressure (psi) 60 60 Dry temperature (° C.) 350 350 Capillary voltage (v) 3500 3500 Mass scan range (m/z) 100-1200 100-800 Fragment amplitude (ev) 1.5-3.0 {circle around (2)} The components of the Radix Notoginseng in the TCM Preparation from Each Example HPLC Elution Conditions: time (min) mobile phase A (%) mobile phase B (%) 0 80 20 15 65 35 25 65 35 40 57 43 50 54 46 65 42 58 75 25 75 mobile phase A: acetic acid:water = 0.01:100 mobile phase B: acetic acid:acetonitrile = 0.01:100 flow rate: 0.8 ml/min temperature: 30° C. detection wavelength: multiple wavelength (203 nm of indicated wavelength) MS Analysis Conditions: HPLC-MS HPLC-MS n Ion detection manner negative ion detection Dry gas flow rate (L/min) 10 10 Nebulizer pressure(psi) 60 60 Dry temperature (° C.) 350 350 Capillary voltage (v) 3500 3500 Mass scan range (m/z) 400-1500  400-1200 Fragment amplitude (ev) 1.2-1.5 3. Analysis Results and Peak Identification The components were identified in the following two aspects: (1) using control samples; (2) using the UV absorption properties and ion fragment information from MS n in combination with literature data 4. Identification Results (1) The Water-soluble Components of the Radix Salviae Miltiorrhizae in the Radix Salviae Miltiorrhizae Preparation from Each Example of the Present Invention (see tables 1 and 2, and FIGS. 2 and 3 ). TABLE 1 HPLC-MS Data and Identification Results Max. Quasi-Molecular Absorption Peak Retention Ion Mass Peak Wavelength No. Time m/z [M−H] − Identity λmax 1 12.73 197 Danshensu 280 2 19.69 137 Protocatechual- 231, 280, dehyde 310 3 22.99 537 Isolithospermic 327 acid A 4 23.83 537 Isolithospermic 327 acid B 5 24.89 417 Salvianolic acid D 247, 321 6 26.70 717 Salvianolic acid E 330 7 28.51 359 Rosmarinic acid 329 8 31.93 717 Salvianolic acid B 254, 286, 309 9 34.86 339 Salvianolic acid G 395 10 44.64 493 Salvianolic acid A 288 TABLE 2 HPLC-MS n Data Peak No. Identity Fragment ion m/z 3 Isolithospermic Second(537): 493[M-H—CO 2 ] − , acid A 295[M-CO 2 —R—H 2 O] − Third (295): 159, 109 4 Isolithospermic Second (537): 493[M-H—CO 2 ] − , acid B 295[M-CO 2 —R—H 2 O] − Third (295): 159, 109 5 Salvianolic Second (417): 175[M-CO 2 —R—H 2 O] − , acid D 373[M-H—CO 2 ] − Third (175): 147, 157, 133 6 Salvianolic Second (717): 519[M-R—H 2 O] − , acid E 321[M-2R—2H 2 O] − Third (519): 321[M-R—H 2 O] − , 339[M-R] − Third (321): 279, 293, 249, 223, 185 7 Rosmarinic Second (359): 161[M-R—H 2 O] − , acid 179[M-R] − , 195 8 Salvianolic Second (717): 519[M-R—H 2 O] − , acid B 321[M-2R—2H 2 O] − Third (519): 321[M-R—H 2 O] − , 339[M-R] − Fourth (321): 279, 293, 249, 233, 185 9 Salvianolic Second (339): 321[M-H—H 2 O] − , acid G 295[M-H—CO 2 ] − Third (295): 279, 267 Fourth (279): 251 10 Salvianolic Second (493): 295[M-R—H 2 O] − acid A Third (295): 159, 109 it can be seen from the MS n results that the second and third peak have very similar structures as that of lithospermic acid. They are considerably different from lithospermic acid, however, with respect to UV absorption. Lithospermic acid has a relatively strong absorption near 253 nm due to its phenyl coumaran backbone, while the second and third peak do not have such a absorption property. Both of these peaks have UV absorption very similar with that of Salvianolic acid E, which demonstrates that the two compounds corresponding to these two peaks are likely to have the same backbone as Salvianolic acid E, i.e. the structure of carboxyl diphenyl ethylene backbone. It is thereby concluded that they have structures as those of Isolithospermic acids A and B shown in the above structure formula for components. These two structures have never been reported, and are therefore named as Isolithospermic acids A and B herein. (2) The Liposoluble Components of the Radix Salviae Miltiorrhizae in the TCM Preparation of the Present Invention (see table 3, and FIGS. 4 and 5 ). TABLE 3 HPLC-MS Data and Identification Results Peak Retention Quasi-Molecular No. Time Ion Mass Peak m/z − Identity 1 24.36 277 [M + H] + , Tanshinone I 575 [2M + Na] + 2 34.85 295 [M + H] + , Tanshinone IIA 611 [2M + Na] + (3) The Components of the Radix Notoginseng in the Radix Salviae Miltiorrhizae Drop Pills of the Present Invention (see tables 4 and 5, and FIG. 6 ). TABLE 4 HPLC-MS Data and Identification Results Quasi-Molecular Peak Retention Ion Mass Peak No. Time m/z [M-H] − Identity 1 11.27 931 Notoginsenoside R 1 2 12.38 945 Ginsenoside Re 2 12.53 799 Ginsenoside Rg 1 3 20.81 1107  Ginsenoside Rb 1 4 21.25 769 Notoginsenoside R 2 5 22.53 769 Notoginsenoside R 2 iso. 6 22.85 783 Ginsenoside Rg 2 7 23.77 637 Ginsenoside Rh 1 8 25.00 637 Ginsenoside Rh 1 iso. (F 1 ) 9 30.05 945 Ginsenoside Rd 10 34.81 945 Ginsenoside Rd iso. 11 40.00 781 Ginsenoside Rf-H 2 O 12 41.57 751 Notoginsenoside R 2 —H 2 O 13 43.72 751 Notoginsenoside R 2 —H 2 O 14 44.89 765 Ginsenoside Rg 6 /F 4 15 46.43 619 Ginsenoside Rk 3 /Rh 4 (Rk 3 ) 16 48.68 619 Ginsenoside Rk 3 /Rh 4 (Rh 4 ) 17 54.97 783 Ginsenoside 20(R)Rg 3 18 56.48 783 Ginsenoside 20(S)Rg 3 19 68.35 765 Ginsenoside Rk 1 /Rg 5 (Rk 1 ) 20 69.53 765 Ginsenoside Rk 1 /Rg 5 (Rg 5 ) TABLE 5 HPLC-MS n Data Retention Quasi-Molecular Ion Time Identity Mass Peak m/z − 11.27 Notoginsenoside R 1 799[M-H-Xyl] − ; 637[M-H-Xyl-Glc] − ; 475[M-H-Xyl-2Glc] − 12.38 Ginsenoside Re 799[M-H-Rham] − ; 783[M-H-Glc] − ; 637[M-H-Rham-Glc] − ; 475[M-H-Rham-2Glc] − 12.53 Ginsenoside Rg 1 637[M-H-Glc] − ; 475[M-H-2Glc] − 20.81 Ginsenoside Rb 1 945[M-H-Glc] − ; 783[M-H-2Glc] − ; 621[M-H-3Glc] − ; 459[M-H-4Glc] − 21.25 Notoginsenoside R 2 637[M-H-Xyl] − ; 475[M-H-Xyl-Glc] − 22.53 Notoginsenoside R 2 iso. 637[M-H-Xyl] − ; 475[M-H-Xyl-Glc] − 22.85 Ginsenoside Rg 2 637[M-H-Rham] − ; 475[M-H-Rham-Glc] − 23.77 Ginsenoside Rh 1 475[M-H-Glc] − 25.00 Ginsenoside Rh 1 iso. (F 1 ) 475[M-H-Glc] − 30.05 Ginsenoside Rd 783[M-H-Glc] − ; 621[M-H-2Glc] − ; 459[M-H-3Glc] − 34.81 Ginsenoside Rd iso. 783[M-H-Glc] − ; 621[M-H-2Glc] − ; 459[M-H-3Glc] − 40.00 Ginsenoside Rf-H 2 O 619[M-H-Glc] − ; 457[M-H-2Glc] − 41.57 Notoginsenoside R 2 —H 2 O 619[M-H-Xyl] − 43.72 Notoginsenoside R 2 —H 2 O 619[M-H-Xyl] − 44.89 Ginsenoside Rg 6 /F 4 619[M-H-Rham] − ; 457[M-H-Rham-Glc] − 54.97 Ginsenoside 20(R)Rg 3 621[M-H-Glc] − ; 459[M-H-2Glc] − 56.48 Ginsenoside 20(S)Rg 3 621[M-H-Glc] − ; 459[M-H-2Glc] − 68.35 Ginsenoside Rk 1 /Rg 5 (Rk 1 ) 603[M-H-Glc] − ; 441[M-H-2Glc] − 69.53 Ginsenoside Rk 1 /Rg 5 (Rg 5 ) 603[M-H-Glc] − ; 441[M-H-2Glc] − Based on the above research, the extraction process and analysis method for the TCM preparation of the present invention are established, which include: (1) A Solid-Phase Process for Extracting the Liposoluble Components of Radix Salviae Miltiorrhizae and the Components of Notoginsenoside from the Drop Pills of Radix Salviae Miltiorrhizae; (2) a Method of HPLC-MS Analysis for Each Sample 12 components from Radix Salviae Miltiorrhizae and 21 saponin components from Radix Notoginseng have been identified in total. Among them, 4 water-soluble components of Radix Salviae Miltiorrhizae, 2 liposoluble components of Radix Salviae Miltiorrhizae and 9 components of saponin have been identified through comparison with the control samples, while other compounds were identified mainly based on an analysis of MS n data and comparison with data from literature. Example 9 Detection Example of the Fingerprint Atlas for the Components of Radix Salviae Miltiorrhizae in the TCM Preparation 1. Instruments and Agents Instruments: Agilent 1100 Liquid Chromatograph, comprising: quad-pump, online deaerating system, automatic sample injector, DAD detector, column temperature tank, Chemstation work station; BS210S electronic balance (1/10 −4 g) (Beijing Sartorius Company), METTLER AE240 electronic balance ((1/10 −4 g or 1/10 −5 g) (Mettler-Toledo Corporation, Shanghai), LD4-2 centrifuge (4000 r/min) (Beijing Medical Centrifuge Factory), Digital thermostatic water-bath kettle (Tianjing Changfeng Corporation), RE-52AA rotary evaporator (Shanghai Yarong Biochemical Instrumentation Factory), SHE-(III) water-circulating vacuum pump (Gongyi Yingyuyuhua Instrumentation Factory), KQ-250B ultrasonic cleanser (Kunshan Ultrasonic Instrumentation Corporation), HENGAO T&D filter(HENGGAO T&D), synthetic fiber membrane filter (aperture 0.45 μm)(Shanghai Xingya Purifying Materials Factory). Agents: acetonitrile (chromatographically pure, Merck Company, US), phosphoric acid (top grade), Wahaha pure water. 2. Preparation of Test Sample 10 pills of the TCM preparation from each batch of Example 1 were weighed accurately and then introduced into a 10 ml measuring bottle. Distilled water was added to in an amount sufficient to dissolve the pills through shaking with ultrasound for 15 mins. And more distilled water was then added to achieve a volume of 10 ml. The obtained solution was subjected to centrifugation or filtration to obtain a sample solution. 3. HPLC Analysis Conditions Agilent ZoRBAx SB-C18 (4.6×250 mm, 5 μm) chromatographic column; Mobile phase: mobile phase A being a 0.02% aqueous phosphoric acid solution, mobile phase B being a 80% acetonitrile-0.02% aqueous phosphoric acid solution; flow rate: 1.000 ml/min; detection wavelength: 280 nm , column temperature: 30° C.; injected sample volume: 10 μl. Elution Gradient of Mobile Phase: Retention time Mobile Phase A(v/v) Mobile Phase B(v/v)  0 min 90% 10%  8 min 78% 22% 15 min 74% 26% 55 min 48% 52% 4. Detection Results (see table 7) TABLE 7 Detection Results for Components of Radix Salviae Miltiorrhizae in 200 Batches of Above TCM Drop Pills Average RSD % of Average RSD % Percentage of Single Percentage Range of Peak Retention Retention Peak of Peak Peak Area to Total Single Peak Area to No. Time Time Area Area Peak Area Total Peak Area 1 6.04 0.31 1627.92 5.91 20.80% 19.6%-22.0% 2 9.90 0.25 2575.54 13.53 32.90% 28.5%-37.4% 3 16.89 0.61 366.89 10.92 4.69% 4.2%-5.2% 4 17.84 0.70 381.40 13.81 4.87% 4.2%-5.5% 5 20.31 0.96 186.08 12.04 2.38% 2.1%-2.7% 6 23.74 0.76 555.35 10.48 7.09% 6.4%-7.8% 7 27.73 0.50 281.91 18.08 3.60% 3.0%-4.3% 8 31.02 1.18 1852.33 14.84 23.66% 20.2%-27.2% Note: Peak 1 represents Danshensu; peak 2 represents Protocatechualdehyde; peak 3 represents Isolithospermic acid A; peak 4 represents Isolithospermic acid B; peak 5 represents Salvianolic acid D; peak 6 represents Rosmarinic acid; peak 7 represents Salvianolic acid B; and peak 8 represents Salvianolic acid A (see FIG. 1). Table 7 shows the relative positions and ratios of area (retention time and peak area) of 8 peaks, wherein 3 peaks have a ratio of single peak area to total peak area greater than 10% and all the 8 peaks have a ratio of single peak area to total peak area greater than 2%. All publications, patents and patent applications are incorporated herein by reference. While in the foregoing specification this invention has been described in relation to certain preferred embodiments thereof, and many details have been set forth for purposes of illustration, it will be apparent to those skilled in the art that the invention is susceptible to additional embodiments and that certain of the details described herein may be varied considerably without departing from the basic principles of the invention.

The present invention discloses a traditional Chinese medicine preparation for cardio-cerebral blood vessel diseases, it is prepared through extracting danshen and Notoginseng by lye, precipitating with alcohol, concentrating, and adding other medicine and excipients. Then using the HAPLY-MS and HAPLY fingerprint Atlas to characterize its Physicochemical properties completely. Using the fingerprint Atlas analysis method of the present invention, the structure and comparative content of biologically active component can be known. Characterization of the physical chemical properties of danshen and Notoginseng of traditional Chinese medicine preparation with this way is better than other methods of the prior art.

RELATED APPLICATIONS This is a U.S. national stage application of PCT/DK2008/050310, filed Dec. 16, 2008, which claims priority to Danish Application No. 2007 01831, filed Dec. 20, 2007, both of which are incorporated herein by reference. FIELD OF THE INVENTION The present invention relates to the field of adhesive patches, which can detect and record acoustic signals from the body. BACKGROUND A widely used tool used by medical professionals for performing relatively simple diagnostic tasks is the stethoscope, which is used to listen to a variety of internal bodily functions through the skin of a human or animal patient. The conventional stethoscope has been used for hundreds of years for assisting the medical professional in providing diagnostics for a vide range of illnesses. A significant problem when using a conventional stethoscope is that the sound captured by the stethoscope is not actively amplified, only conveyed via flexible or stiff tubular material to the ears of the medical professional, which means that very subtle sounds within the body cannot be identified using the stethoscope in real time. One way of solving this problem is through the invention of the electronic digital stethoscope, which is capable of amplifying the sound levels from the body and processing the sound for optimal listening, such that a medical professional is capable of listening to sounds, which are hardly conceivable using a conventional stethoscope. The traditional digital stethoscope and the conventional stethoscope both have the same drawback, which is that a medical professional is required to listen to the sounds collected by the stethoscope in real time, and make a judgment based on what he hears. However, recent digital stethoscopes have been provided with the capability to store a few seconds of recorded sound, such that the medical professional may choose to listen again to the sounds stored in the digital stethoscope. US Patent Application No. US 2007/0276270 attempts to solve this problem by describing a health care monitoring system, which describes one or more wireless nodes forming a wireless mesh network, where the mesh network communicates with a base station in the form of a computer server, where the nodes transmit patient data to the base station to detect a heart attack or a stroke attack. One described embodiment of the aforementioned system describes collection of wireless nodes having different functions where one wireless node is an electronic stethoscope where heart sounds are transmitted from the wireless node to a base station, using sounds recorded from the wrist of the patient. The collection of wireless nodes is required to communicate continuously with the base station when in range. A serious drawback to this health care monitoring system is that the wireless node has to communicate the signals to a base station to be capable of performing any analyzing tasks. This means that the user or a health care professional is required to communicate with the base station to obtain or access any information about the recorded patient data. Furthermore, as the wireless communication is continuously with the base station when in range, the power consumption is significant, as the collection of node would have to check continuously if the base station is in range and receive a confirmation thereof in addition to the continuous data transmission of the recorded patient data. Coronary artery disease (CAD) is a continuously increasing threat to the public health in western society, where tobacco smoking, increased stress, lack of exercise, fat saturated diets, obesity, etc. are reported to be significant direct or indirect risk factors for the development of blockages in the coronary arteries, resulting in coronary artery disease. Currently, the present methods for assisting in the diagnostics and/or diagnosis of CAD are expensive and require complicated equipment, such as an electrocardiogram, nuclear scanning, angiography or coronary angiography, CAT scans and MRI scans. Furthermore, these methods require that the subject spend a considerable amount of time in hospital laboratories. The execution of the previously mentioned methods may be very expensive, which means that the methods are rarely used for preventive diagnostics and subjects are usually subjected to CAD diagnostics subsequent to physical problems indicating the presence of CAD, such as chest pains, etc. Therefore, there is a need for an improvement in monitoring the physical signs of CAD, using acoustic signals from the human or animal body, where the acoustic signals are selectively or continuously recorded and/or transmitted to a peripheral device. The selective transmission means that normal signals would not be transmitted while abnormal signals could trigger a transmission. SUMMARY OF THE INVENTION An object of the present invention is to provide an adhesive patch, which can continuously monitor acoustic signals from the human body. Another object of the present invention is to provide an adhesive patch, which can alert the user if the monitored acoustic signals change in a predefined manner from predefined normal acoustic signals. A further object of the present invention is to provide an adhesive patch that can process the acoustic signals in a predefined manner and compare the processed signals to standard values and store the acoustic signals for subsequent transmission to a peripheral device. A yet further object of the present invention is to provide an adhesive patch that is suitable for detecting early signals of coronary artery disease. The present invention discloses an adhesive patch for monitoring acoustic signals from a human or animal body, comprising a skin contact surface; converting means for recording the acoustic signals and converting it to a first electric output signal; an adhesive element for attaching the converting means to the skin surface; transmitting means for transmitting the electric output signal to a peripheral device; and means for managing the pressure between the converting means and the skin contacting surface. The adhesive patch is provided with an adhesive layer on the skin contact surface, where the adhesive layer ensures that the patch stays in place after it has been placed onto the skin surface of a user. It has been shown during testing of one embodiment that if the acoustic recordings are obtained while the converting means are held in position by the user or a healthcare professional, which often is done using an analog or digital stethoscope, the converting means collect a mechanical noise which is caused by minute vibrations originating from the hand or the human extremity which holds it in place. Although it appears that some people have a very steady hand, it is physically impossible to remove all vibrations as skeletal muscles are stimulated using periodical nerve signals, which cause very small vibration in the muscle as each muscle fiber contracts. The vibration caused by the hand becomes a significant noise factor when the converting means are held in position using the arm and/or the hand for recording the acoustic signals from the body and the converting means are very sensitive and capable of recording extremely vague signals. This type of noise can be reduced drastically using an embodiment where the converting means are adhered to the skin surface using an adhesive patch, such that the converting means are not affected by vibrations in the hand of the medical professional. It should be understood that the term ‘acoustic’ should be interpreted broadly as a difference, typically a change, in pressure, which for example is conveyed through the air and/or the human or animal body from a target area, e.g. a coronary artery, to a detecting unit, for example the human ear or the converting means. For example the above described mechanical noise caused by minute vibration originating from the hand is not audible to the human ear without being processed, e.g. by amplification and/or frequency manipulation. Another advantage of adhering the converting means to the skin surface is that the user can wear the adhesive patch for a longer period of time, such that acoustic signals may be recorded over a longer time period, if deemed necessary for diagnostic purposes. The recorded acoustic signals are converted into a first electric output signal, which may be transmitted directly via wireless or wired transmitting means to a peripheral device. It should be understood that a peripheral device is a stand-alone unit separate from the patch, for example a personal computer (PC), a mobile telephone or a PDA (personal digital assistant). In the peripheral device the signals may be further processed, or used unprocessed by a medical professional for assessing the acoustic content of the signals by listening to it using a loudspeaker, headphones or similar electrical signal converting means. The acoustic signals are recorded by placing the converting means, or the microphone, in direct contact with the skin surface of the user or by positioning an acoustic conducting layer between the converting means and the skin surface, the acoustic conducting layer functioning as a means for sound propagation. It has been discovered that any change in pressure between the converting means and the skin surface, may influence and/or reduce the transmission of the sound between the skin surface and the converting means. The acoustic conductivity, transmission and/or contact between the conducting means and the skin surface is optimized by maintaining the pressure between the converting means and the skin surface as stable as possible, i.e. that the pressure does not vary significantly during the use time of the adhesive patch or that the pressure applied is significantly higher than any variation in pressure. This may be achieved by having a resilient material that supports the side of the converting means that faces away from the skin surface and maintains the converting means at a constant pressure to the skin surface, and if there are any changes in the force that is applied from the converting means to the skin or from the skin surface to the converting means, the resilient material absorbs at least the majority of the force but maintains the pressure between the skin surface and the converting means. Another means for the management of pressure between the converting means and the skin surface may be to provide a compression structure at the skin contacting surface. The compression structure may be in the form of one or more protrusions that project out from the skin contacting surface. The protrusions may form a circle, an ellipse or any suitable shape in a closed line where the converting means is placed inside the closed line shape, or may be in the form of a number of suitably placed protrusions that are positioned close to and/or around the converting means. When the skin contacting surface of the adhesive patch is placed on the skin, the protrusions apply an increased pressure onto the areas of the skin which are in contact with the protrusions and inside the area that is defined by the protrusions. This means that while the skin contacting surface of the adhesive patch maintains its contact with the adhesive patch, the skin surface inside the area defined by the protrusions maintains an increased tension. The tension of the skin surface does not vary significantly when the user moves or changes his/her posture as the compression structure maintains the tension of the skin inside the area defined by the protrusions. Within the skin contacting area defined by the area in a inwards radial direction from the protrusions, an acoustic medium can be applied to increase the tension at the skin surface further. By positioning the conversion means onto the skin surface inside the area defined by the protrusions, such that the conversion means maintain its relative position in all directions with regards to the protrusions, it is ensured that the pressure of the converting means and the tension of the skin surface are managed and maintained during the use of the adhesive patch and thus the pressure between the converting means and the skin surface is managed effectively. Another means for managing the pressure between the converting means and the skin surface may be to position the converting means inside a pressure cavity arranged in the adhesive patch. The skin contacting surface of the adhesive patch operates as the gas and/or liquid impermeable barrier between the adhesive patch and the skin surface. The pressure cavity may comprise an external wall which creates a gas- and/or liquid impermeable barrier to the atmosphere, which ensures that any gas or liquid contained or introduced into the cavity may be sealed inside the cavity. The adhesive patch may be provided with a one and/or two way valve which may be used to introduce or remove gas and/or liquids into the cavity to manage the pressure inside the cavity. The converting means may be placed inside the pressure cavity providing a direct or indirect contact with the skin surface of the user, where the pressure inside the cavity would ensure that any movement or change in the user's posture would not alter the pressure between the converting means and the skin surface. In one embodiment of the present invention the patch may further comprise processing means for processing the first electric output signal and converting it to at least a second electric output signal. For this purpose, the patch may be provided with processing means in the form of a microprocessor, microcontroller, A/D converter, digital signal processor and/or the necessary electrical circuitry such that the acoustic recording may be partly processed within the adhesive patch into a second electric output signal. In the context of the present invention the term partly processed acoustic signal means an acoustic signal which may be processed with analog or digital signal processing in the form of filtering, analog to digital conversion, digital or analog amplification, differential amplification, voltage amplification, output amplification and similar signal processing methods. In one embodiment of the present invention the patch may further comprise analyzing means for processing the first or the second electric output signal and converting it to a third electric output signal. This means that the recorded acoustic signal may be fully processed within the adhesive patch. The term fully processed acoustic signal means in the context of the present application an acoustic signal that has been fully processed within the adhesive patch, such that all signal-processing steps, which are deemed necessary to provide an indication of an abnormal signal, are taken. The signal processing steps are similar to the abovementioned steps defined in context of the partly processed acoustic signal. Additionally, the fully processed signal has been processed into values or a mathematical representation, which may be compared to standard values or fed into a mathematical model such that the processing means can be instructed to indicate if there are some unusual elements in the recorded acoustic signal. In one embodiment of the present invention the processing means can statistically determine in what way the recorded signals deviate from the predefined standard values. If the adhesive patch uses standard values for comparison purposes, the standard values are selected based on which body acoustic signals are to be monitored and what ailment is to be monitored, as acoustic heart signals and acoustic respiratory signals are not suitable for comparison. In one embodiment of the present invention the patch may further comprise storing means for storing at least one of the first, second or third electric output signals. This means that a health care professional can review parts of or all of the recorded acoustic signals after a user has been wearing the adhesive patch for monitoring purposes for a period of time. This also means that the user may not be required to be in a clinic when a monitoring task is being performed. The user might be provided with one or more patches and subsequently return to his normal routine wherein the adhesive patch is recording acoustic signals from the body while the user is acting in his normal fashion. In one embodiment of the present invention the converting means may include at least one microphone, where the microphone is used to record the acoustic signals from the body. The microphone produces the first electrical output signal which may be stored within the adhesive patch, transmitted to a peripheral device, processed and/or analysed within the adhesive patch. In another embodiment of the present invention the converting means may include at least two microphones, where the first microphone is used to record the acoustic signals from the body and the at least second microphone is used to record environmental noise signals. By using two microphones, which are recording acoustic signals synchronously, the noise signal acquired from the second microphone can be used to remove the environmental noise recorded by the first microphone, which ideally reduces the noise level significantly and the remaining acoustic signal is the primary acoustic signal from the body, which is interesting for the diagnostic procedure. A number of different types of microphones may be used for the purpose of recording acoustic signals from the body, where in one embodiment the at least one microphone may be a silicon microphone and in another embodiment the at least one microphone may be a pressure sensitive contact microphone. In alternative embodiments of the present invention where the adhesive patch includes more than one microphone, the microphones may be of different types. This might be advantageous as one type of microphone might be better suited for noise recording and another type might be better suited for the recording of acoustic signals from the body. It is obvious to the skilled person based on the teachings of the present invention that any type of microphone suited for recording noise, acoustic signals from the body or similar might be used in the adhesive patch of the present invention. In an attempt to increase the quality of the acoustic recording of acoustic signals from the body, the adhesive patch may further comprise sound focusing means. The sound focusing means may be used to collect acoustic signals from a skin surface area that is larger than the collecting area of the converting means. The sound focusing means focus the acoustic signals towards one or more collecting areas, as might be done with a funnel like structure where the wide end collects the acoustic signals and gathers the acoustic signals in the narrow end. By adding sound focusing means the converting means are subjected to more acoustic signals than when directly using the converting means. This increases the sensitivity of the converting means and the acoustic patch is capable of acquiring more subtle or vague sounds than when not using sound focusing means. In one embodiment of the present invention the sound focusing means may include a bell shaped compartment, where the converting means are positioned at a central position of the compartment. The bell shaped compartment allows the collected sound waves to bounce of the walls and reflect in a direction towards the converting means. In another embodiment of the present invention the focusing means may include a diaphragm, where the diaphragm vibrates when the diaphragm is subjected to sound waves or vibrations due to pressure difference affecting the skin surface area in communication with the diaphragm. A diaphragm operates as a filter as the physical size of the diaphragm affects the responsiveness of the diaphragm. In order to reduce the environmental noise affecting the converting means that record or monitor acoustic signals from the body, the adhesive patch may include an acoustic absorbing layer. The acoustic absorbing layer may be used to isolate the converting means from the external environment, reducing the environmental noise significantly. In one embodiment of the present invention the acoustic absorbing layer may comprise a high-density material, such as a hydrocolloid material, where the hydrocolloid material may be a layer of the adhesive patch or an integral part of the adhesive patch. The isolating capabilities of the hydrocolloid material are dependent on the thickness and the chemical composition of the material, where a thicker material isolates more than a thin material and material containing high-density particles might dampen the noise and provide increased isolation. The hydrocolloid material is permeable to water vapor, which means that any water vapor introduced into the adhesive patch from the skin surface may escape the patch through the hydrocolloid layer. The water vapor permeability of the hydrocolloid material may protect the electrical circuitry within the patch such that the risk of moist damage to the electrical compounds is reduced. In order to facilitate the acoustic transmission between the converting means and the skin surface, the adhesive patch may comprise an acoustic conducting layer. The acoustic conducting layer increases the conducting capabilities between the converting means and the skin surface, as the acoustic impedance is reduced between the layers. By reducing the acoustic impedance the conducting layer maintains the velocity of the received sound waves substantially. This means that the sound waves will cross more easily between the skin surface and the converting means, as the sound velocity of the sound waves in the conducting layer is kept close to the sound velocity within the body, by mimicking the acoustic impedance of the skin layers. Direct contact between the converting means and the skin surface might reduce the acoustic quality of the acquired signals, as the increased acoustic impedance could filter some elements of the sound when the sound crosses from the skin surface towards the converting means. In one embodiment of the present invention the acoustic conducting layer may be formed of an acoustic conducting gel. The sound velocity of the gel is similar to the sound velocity of the skin layers. This means that the sound communicates from the skin layers via the conductive gel towards the converting means without a significant loss of quality due to the aforementioned acoustic impedance. In one embodiment of the present invention, the acoustic conducting layer may be formed of an acoustic conducting material that may be provided as a coating that envelopes at least a part of an external surface of the converting means. The acoustic conducting material may be in the form of a solid layer enveloping a part of the external surface of the converting means or the entire external surface of the converting means. Advantageously, the acoustic conducting material covers at least the external area of the converting means that is suitable for acquiring the acoustic signal from the body. The acoustic conducting material may envelope the entire external surface of the converting means, where the acoustic conducting material provides an increased acoustic conductivity between the converting means, the skin surface and the acoustic conducting material. Furthermore it may be used to protect or shield the converting means from any harmful contaminants that may reduce the lifespan of the converting means or may reduce the converting means capability to record acoustic signals from the body, such as particles, moisture and other contaminants that may be considered as harmful. In one embodiment of the present invention the adhesive patch may further comprise visual means for indicating placement of the adhesive patch according to anatomic landmarks on the human or animal body. The visual means may be used to facilitate the positioning of the adhesive patch according to predetermined anatomic landmarks, where the anatomical landmarks are dependent on what acoustic monitoring task is being performed. This means that the physical positioning of the patch may facilitate for a specific type of acoustic monitoring task. This might also be important in the case were the acoustic patch has more than one converting means for recording acoustic signals from the body, for example an 1D, 2D or 3D array of converting means and the exact placement and the spatial positioning of the array is important or even vital for the outcome of the acoustic recording, depending on the application of the adhesive patch. The adhesive patch may further be used to monitor other acoustic signals from the body, such as respiratory signals, digestive signals, bowel signals, joint signals, urinary signals and other acoustic signals from the body. The present invention also describes an adhesive patch kit comprising an adhesive part and a converting part. The adhesive part is a disposable part that can be thrown out after use, such that every time an adhesive part is used the adhering properties are optimal. The converting part comprises the electrical circuitry and the converting means required to record acoustic signals according to the present invention. The individual parts of the converting part, such as the converting means, transmission means and/or the processing means might be very expensive compared to the adhesive part, and by reusing the converting part multiple times it might be possible to reduce the overall cost of a single diagnostic procedure. The converting part can be secured to the adhesive part using temporary connection means, such as hook and loop connection means, adhesive means or by other mechanical connection means between the adhesive part and/or the converting part. When the adhesive part and the converting part are secured to each other, the two parts form an adhesive patch according to the present invention. The adhesive part may be a sterile or non-sterile adhesive patch which has a first connection means for temporary connection to a second connection means provided on the converting part. Thus, the kit may be used so that the adhesive part is positioned on the skin surface of the user and where the converting part is subsequently temporarily connected to the adhesive part or by combining the adhesive part and the converting part prior to positioning the adhesive patch on the skin surface of the user. After the adhesive patch kit has been used to monitor acoustic signals from the body, the adhesive part and the converting part may be removed from the skin surface in one piece or as one part after the other. The adhesive part may subsequently be disposed in a trash bin or similar, while the converting part may be prepared for the next user by cleaning, disinfecting, refurbishing and other steps deemed advantageous by a medical professional for optimal security and/or hygiene for the next user. The use of a disposable adhesive part ensures the adhesive qualities of the adhesive surface are optimal for application to the skin surface of the user from the start and the risk of inadvertent detachment is reduced. It is also to be understood that the adhesive part may also be a reusable part, where the adhesive surface may be of the kind that can be refurbished and prepared so that the adhesive surface has enough adhesive properties to achieve the necessary adherence to last throughout the use of the adhesive patch kit. The present invention further describes a method for monitoring acoustic signals from the human body using an adhesive patch comprising converting means, processing means and transmission means. The adhesive patch is positioned on the skin surface of a user, such that the converting means are in direct or indirect communication with the skin surface. The converting means convert the recorded acoustic signals into an analog electrical signal, which in turn is converted into digital form using an A/D converter. In order to be able to reduce the size of the analog or digital signal, the signals are filtered using a bandpass filter having a predefined upper and lower frequency limit. The predefined upper and lower frequency limits are chosen based on what acoustic signals in the body are being monitored. In one embodiment of the present invention where the converting means comprise two microphones and the first microphone records acoustic signals from the body and the second records noise, the two resulting signals may be fed into a differential amplifier. The differential amplifier compares the input signals and reduces the magnitude of the first microphone signal by the magnitude of the synchronous second microphone signal. This results in the reduction of noise in the first microphone signal, which means that the underlying acoustic signal from the body becomes clearer in the output signal of the differential amplifier. In one embodiment of the present invention, the output signal may be transmitted to a peripheral device using transmitting means, where further processing of the signal may be performed. In another embodiment the output signal is fed into processing means where one or more signal processing methods may be applied to the signal. The choice of methods depends on the type of acoustic signal from the body and the choice might be between methods such as time-frequency analysis, statistical analysis and other methods known in the art of signal processing. The processing means may be supplemented with analyzing means, where the processed signals or their mathematical representation may be compared to standard values, such that any deviation of standard values may be detected by the analyzing means. At any point in time, from the acquisition of the acoustic signals using the converting means, may the resulting signals be stored in a memory bank, such as flash memory or be transmitted to a peripheral device. The choice of at which point in time storage or transmission is performed may be taken by a technician or a medical professional. Furthermore, the transmitting means may be used to program the adhesive patch and provide the patch with appropriate instructions for each monitoring task. BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described in further detail below with reference to the schematic drawings in which, FIG. 1 is an exploded view of an adhesive patch for monitoring acoustic signals from the body according to the present invention, and FIG. 2 is a sectional view of the same taken along line II-II in FIG. 1 FIG. 3 is a sectional view of an adhesive patch comprising a adhesive part and a separate converting part, FIGS. 4 a and 4 b are sectional views of adhesive parts having compression structures, and FIG. 5 is a sectional view of an adhesive patch according to the present invention applied on the skin surface of a user. DETAILED DESCRIPTION FIG. 1 is an exploded view of an adhesive patch 1 for monitoring acoustic signals in the body according to the present invention. The adhesive patch 1 comprises a protective layer 2 , which may also be seen as an enclosing layer. The protecting layer 2 is provided with a projection area 3 , which is located substantially in the central area of the protective layer and projects axially away from the distal edges of the protective layer 2 . The protective layer 2 is provided with an adhesive layer 4 , which ensures that the adhesive patch 1 can be adhered to the skin surface of the subject which is to be monitored. The adhesive layer 4 extends from the distal edges of the protective layer and radially inwards towards the central area of the protective layer 2 . In this embodiment the adhesive layer 4 extends from the distal area and radially inwards to the area where the projection area 3 starts. A microphone 5 is positioned on the inner surface, i.e. the surface that is adjacent to the adhesive layer 4 , of the projection area 3 . This microphone 5 has, in this embodiment, direct access to the skin surface of the subject, where none of the patch layers separate the microphone and the skin surface when the adhesive patch 1 is adhered to the skin surface. This can be seen as the adhesive layer has an opening in the central area, which corresponds in size to the projection area 3 . Furthermore, on the inner surface of the projection area 3 , between the protective layer 2 and the microphone 5 a pad 6 or block of resilient material is placed, which provides support to the microphone 5 . The resilient pad 6 ensures that the microphone is optimally pressed to the skin surface when the patch adhered on the skin surface of the user. The choice of resilient material for the pad 6 may be varied, such that the contact between the skin surface and the microphone is always at an optimal pressure in different situations. The microphone 5 is in electrical communication with a controlling unit 9 via an electrical lead 7 , which is fed through a small opening 8 in the protective layer 2 , to the external surface of the protective layer 2 . In this view the electrical lead 7 is not connected to the controller unit 9 , but in an assembled state the lead is connected and in communication with the controller unit 9 . The opening 8 is large enough for the lead to pass through, but small enough to ensure a snug fit, such that excessive noise does not pass through the hole to interfere with the recordings made by the microphone 5 . In one embodiment the controller unit 9 may be permanently connected to the protective layer 2 , while in another embodiment the controller unit 9 may be temporarily connected to the external surface of the protective layer 2 , such that the controller unit 9 may be removed if the protective layer 2 is to be discarded. In this embodiment of the present invention, a second microphone 10 is placed on the external surface of the protective layer 2 , where the second microphone 10 is used to record environmental noise, from the surrounding environment. The second microphone 10 is in electrical communication with the controller unit via an electrical lead 11 . In another embodiment of the adhesive patch the protective layer 2 might be an adhesive material, which means that no specific adhesive layer 4 is needed to adhere the patch to the skin surface of the user. In this case, the outer surface of the patch may be provided with a protecting film, such that the outer surface of the adhesive patch 1 is not adhesive. FIG. 2 shows a sectional view of the adhesive patch 1 taken along line II-II in FIG. 1 , where the different parts of the adhesive patch are assembled. It can be seen in this assembled state that the first microphone 5 , protrudes from a plane defined by the adhesive layer 4 , such that when the patch is adhered to the skin surface, the microphone becomes depressed into the skin surface and the resilient pad 6 and the pad 6 provides optimal pressure between the first microphone 5 and the skin surface. Furthermore, in this configuration, the first microphone 5 is in electrical communication with the controller unit 9 where an electrical lead 7 passes through opening 8 from the inner volume 12 of the patch to the external surface of the patch. In the present invention, the controller unit 9 , comprises the electrical circuitry necessary to convert, process, transmit, store and analyze the electrical signals acquired from the first 5 and the second microphone 10 . The electrical circuitry for processing the signals may be chosen from the group of: a filter component, an A/D converter, a microprocessor, a wireless transmission module, a flash memory chip, a USB controller or similar electronic components known in the art. The controller unit 9 may further be provided with an on/off switch, which may be used to trigger the adhesive patch into a functional state or out of a functional state to a passive state. Furthermore, the controller unit 9 comprises a power source, such as a single use or a rechargeable battery, kinetic power converter or similar in order to provide electrical current to the electrical circuitry and the electrical or electronic components of the adhesive patch. FIG. 3 shows a schematical view of one embodiment of an adhesive patch 30 according to the present invention where the adhesive part 31 and the converting part 32 may be releasably connected to each other via a first connecting means 33 and a second connecting means 34 . The adhesive part 31 is provided with an adhesive surface 35 providing the skin contacting surface and a non-adhesive outer surface 36 which faces away from the skin contacting surface 35 . The adhesive part has a through-going opening 37 which provides communication from the outer surface 36 of the adhesive part 31 to the skin contacting surface 35 . The converting part 32 comprises a housing 38 having a cylindrical wall 39 and a back wall 40 where the walls define an inner cavity 41 housing a pressure management element 42 , in the form of resilient foam or similar material, and converting means 43 in the form of a microphone or a sound transducer. The converting part 32 may be connected to the first connecting means 33 , which is in the form of a coupling ring, encircling the opening 37 , where the ring 33 is permanently attached to the outer surface 36 of the adhesive part 31 . The free end of the housing 38 is provided with a second connecting means 34 in the form of a first radial protrusion 44 that is capable of snap locking into a second protrusion that is provided as a protrusion 45 or a rim on the free end of the coupling ring 33 . As the converting part is attached to the adhesive part, the skin contacting surface 46 of the converting means 43 is substantially parallel to the skin contacting surface of the adhesive part 31 , which means that the converting part comes into contact with the skin surface as the adhesive patch 40 is attached to the skin surface of the user. Any modifications to the size, shape, material choice are obvious to the skilled person based on the teachings of the present invention. FIG. 4 a shows a schematical view of an adhesive part 31 having a compression structure 47 on the skin contacting surface 35 of the adhesive part 31 . The compression structure 47 is formed as a tapered surface area 48 of the skin contacting surface 35 which protrudes in a direction away from the adhesive part 31 . The tapered surface may be seen as an increase in thickness of the adhesive part 31 where the adhesive part is thinner in the area in a radial direction away from the opening 37 and increases in thickness the closer the area 49 is to the opening 37 . FIG. 4 b shows a schematical view of an adhesive part 31 having a compression structure 50 in the form of a circular protrusion 51 on the skin contacting surface 35 of the adhesive part 31 . FIG. 5 shows an adhesive patch 60 according to the present invention applied on the skin surface 61 of a user, having a compression structure 62 as shown in FIG. 4 a , where the compression structure 62 encircles the opening 63 and the tapered surface 64 or the protrusion shown in FIG. 4 b increases the surface tension and/or stretches the skin surface 65 inside the opening 63 of the user upon application of the adhesive patch 60 and maintain the tension on the skin surface 63 during the continued application of the adhesive patch 60 . In this embodiment, it may be seen that even if the skin surface 66 surrounding the adhesive patch 60 is stretched, deformed or moved in any way, the surface tension of the skin surface 65 inside the opening 63 is maintained, and thus the pressure between the converting means 67 and the skin surface 65 is managed. In this embodiment, a layer of acoustic conducting layer 68 is applied between the skin surface 64 and the converting means 67 . The acoustic conducting layer 68 , may in some embodiments stretch throughout the entire opening 63 or just a part of the opening. The layer 68 may be a layer having an adhesive skin contacting surface and have an adhesive layer on the opposite surface. The layer 68 may be a gel like layer or in some embodiments it may be a layer of a gas, such as air. Any suitable acoustic conducting material known in the art may be used to facilitate acousting transmission or transfer between the skin surface and the converting means. The embodiments shown in FIGS. 4 and 5 are shown as being a part of a two-part device, where the converting part can be releasably connected to the adhesive part. In other embodiments having the same or similar compression structure, the adhesive part may be permanently connected to the converting part, such as shown in the embodiment of FIG. 2 . Any modification made in the shape, form, size and structure of the compression structure shown in FIGS. 4 and 5 to obtain similar or the same functionality is obvious to the skilled person based on the present disclosure.

An adhesive patch for monitoring acoustic signals from a human or animal body, comprising a skin contact surface, converting means for recording the acoustic signals and converting it to a first electric output signal, and an adhesive element for attaching the converting means to the skin surface, the patch further comprises transmitting means for transmitting the output signal to a peripheral device.

BACKGROUND OF THE INVENTION This invention pertains to grips, such as a golf club grip, and more particularly to apparatus and a method for facilitating the removal of a grip from its associated handle. Hand grips are used in a variety of applications such as tools and sporting goods. The use of grips, particularly in the sporting goods field such as a golf grip, presents problems during the removal process. In the past the grip is usually removed by scoring the grip proper with a knife blade, razor blade or other cutting utensil. If penetration is too deep the cutting tool may score the underlying handle and/or shaft. In connection with graphite-type of handles, such as a golf club shaft or the like, this scoring may lead to a subsequent, undesirable fracture of the shaft during use. Such a fracture necessarily leads to an expensive replacement of the golf club or the like. In response thereto we have invented a cutting tool for facilitating the removal of a used grip from a handle such as a golf club or the like. In our first embodiment we utilize a double-sided tape having a cutting wire longitudinally extending therethrough. The tape is positioned about the handle/shaft to serve as a base for the overlying grip with the wire extending along the length of the underlying handle/shaft. Upon fixation of the grip atop the tape with a conventional adhesive, at least one end of the wire projects beyond the affixed grip. For removing the grip this wire is grasped by the user and pulled along the length of the shaft. This action causes the wire to sever the overlying grip which facilitates the removal of the grip from the handle/shaft without the need for exterior cutting of the grip and possible scoring of the underlying handle/shaft. In the second embodiment of our invention the cutting wire is embedded in the grip and longitudinally extends along the length of the grip. An end of the wire is made available for subsequent user manipulation at the time of a desired grip removal. Such manipulation causes the wire to sever the grip and facilitate removal of the grip from the underlying handle/shaft. It is therefore a general object of the invention to provide apparatus for facilitating the removal of a grip from an underlying handle. Another object of this invention is to provide a grip structure which includes an associated cutting tool to sever the grip. A still further object of this invention is to provide a grip structure, as aforesaid, in which the grip is severed from the interior surface thereof. Another particular object of this invention is to provide apparatus, as aforesaid, which precludes the need to score the exterior surface of the grip for removal. Still another important object of this invention is to provide a grip, as aforesaid, which has the cutting tool embedded in the grip structure. A still further object of this invention is to provide an underlying base for said grip structure which incorporates said cutting tool in the form of an elongated cutting wire embedded therein. Still another further object of this invention is to provide a method of affixing a grip to a handle which provides for an easy subsequent separation of said grip from said handle. Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein is set forth by way of illustration and example, embodiments of this invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a fragmentary view of one end of a golf club shaft, the shaft end being foreshortened for purposes of illustration; FIG. 2 is a view, as in FIG. 1, illustrating a first embodiment of the invention, i.e. a cutting wire tape, prior to placement about the shaft; FIG. 3 is a view, as in FIGS. 1 and 2, illustrating the placement of the cutting wire tape about the shaft with a cap/plug being exploded from its nested position within the proximal end of the shaft; FIG. 4 is a view of the shaft, as in FIGS. 1-3, illustrating a grip positioned about the tape; FIG. 5 is a view of the shaft, as in FIG. 4, illustrating the severing action of the cutting wire along the grip proper; FIG. 6 is a view, taken along lines 6--6 in FIG. 3, illustrating the relationship among the shaft, tape, cutting wire and grip; FIG. 7 is a view, as in FIG. 1, illustrating a second embodiment of the invention, i.e. a cutting wire embedded in a grip on the shaft; FIG. 8 is a view illustrating the severing action of the cutting wire along the extent of the grip; FIG. 9 is a view, taken along lines 9--9 in FIG. 7, illustrating the relationship among the shaft, grip and cutting wire. DESCRIPTION OF THE PREFERRED EMBODIMENT Turning more particularly to the drawings, FIGS. 1-6 illustrate a first embodiment 100 of the invention in use with a grip 800 on a golf club shaft 900. Therein is shown a tape 100 having first and second adhesive-laden surfaces 110, 120. A cutting wire 150 is embedded within the tape 100 or otherwise associated with the tape 100 by adhesive or the like. The wire 150 extends along the length of the tape between the proximal 160 and distal 170 ends of the tape 100. The width of the tape is such that it encompasses the diameter of the shaft 900 of the golf club as fragmentarily shown in FIG. 1. As shown in FIG. 2 the tape 100 is positioned so that a multi-strand wire 150 runs along the extent of the shaft 900. Once wrapped, as shown in FIG. 3, the tape 150 serves as a base for the overlying grip 800 as well as an anchor for the cutting wire 150. The cutting wire 150 preferably extends beyond the proximal 160 and/or distal 170 ends and presents a proximal wire end 152 and/or a distal wire end 154. The proximal end 152 of the wire may be tucked into the free proximal end 952 of the shaft 900 and held in place thereat by a cap/plug 300 nesting therein. Alternatively, the distal end 154 of the wire 150 may extend beyond the distal end 170 of the tape 100 as shown in FIGS. 3 and 4. A tab (not shown) or the like may be attached to this distal wire end 154 for subsequent grasping/purchase by the user. Subsequent to affixing the tape 100 about the shaft 900, the grip 800 is ready to be positioned about the shaft 900. An adhesive is placed about the tape 100. The grip 800 is then positioned about shaft 900 as shown in FIG. 4. Once the adhesive sets the grip 800 is affixed to the shaft 900 for subsequent use. During subsequent golf club use, wear and tear will require replacement of the grip 800 with a new grip. The proximal end 810 of the grip 800 which extends beyond the shaft 900 may be removed so as to expose the cap 300. Cap 300 removal will expose the proximal end 152 of the wire for gripping/purchase by the user. Alternatively, the distal wire end 154 of the cutting wire may be grasped/purchased by the user. Subsequent to said grip/purchase of a wire end 152 or 154 the user pulls the wire end along the length of the golf shaft 900 towards the opposed end either from the proximal end 810 to distal end 820 or vice versa. As shown in FIG. 5 the distal end 154 of cutting wire 150 has been selected by the user and pulled along shaft 900 towards the proximal end 810 of grip 800. This action causes the wire 150 to be pulled from its anchored tape 100 position so as to sever the overlying grip 800 into flaps 840, 850. Continuing the wire 150 movement along the length of shaft 900 will sever the grip 800 into folds 840, 850 entirely extending along its length so as to facilitate the removal of the grip 800 from the underlying golf shaft 900 or the like. Depending on the relative position of the wire 150 within tape 100, the underlying tape 800 may also be severed. Accordingly, it can be seen that the above structure precludes the need to score the exterior surface of grip 800 along the length of the underlying shaft 900 so as to facilitate grip 800 removal. Such preclusion eliminates the need to use an exterior cutting device and the possible undesirable scoring of the underlying shaft 900 and fracture thereof as discussed above. A second embodiment of our invention is as shown in FIGS. 6-9. Therein is shown the use of the cutting wire 150' embedded or otherwise affixed to the grip 800' along the length thereof. Again the wire 150' presents proximal 152' and distal 154' ends. The grip 800' is affixed to the shaft 900 in a conventional manner which normally comprises pouring an adhesive over the end of the shaft as covered by a tape 990 and then positioning the grip 800' thereon. Once the adhesive sets the grip 800' is firmly affixed to the shaft 900. When replacement is desired the user again grips or otherwise obtains a purchase on an end 152' or 154' of grip 800' as above described. The wire end 152' or 154' is pulled along the length of grip 800' towards its opposite end. Again this action severs the grip 800' into flaps 840', 850' to facilitate grip 800' removal from the underlying shaft 900. Thus, no exterior scoring of the grip 800' positioned above shaft 900 is required. It can also be seen that alternatively the wire 150 may be laid in the adhesive before placing the grip 800 thereon. As such, the wire 150 will be positioned between the tape 100 and grip 800 upon setting of the adhesive. Upon grip 800 removal the wire 150 is pulled along the length of the shaft 900 as above described. Again the wire 150 action severs the grip 800 from the interior surface thereof so as to facilitate grip removal. Accordingly, our disclosure will lead to many variations of the inventive concept in our invention including various new methods of applying grips to handles in connection with a cutting tool so as to facilitate subsequent grip removal. Such methods include extending the cutting wire 150 along the shaft 900 and between the shaft 900 and grip 800. This relative position allows the grip 800 to be subsequently severed from the interior thereof by grasping a wire 150 end and manipulating the wire 150 along the shaft 900 encompassed by the overlying grip 800. Although certain embodiments of this invention have been described and illustrated herein it is understood that the scope of our invention need not be restricted thereto except as set forth in the following claims and allowable functional equivalents thereof.

Apparatus for facilitating the removal of a grip from a handle, such as a golf club, comprises a double side tape wrapped about the handle with a cutting wire embedded therein. Adhesive is placed about the tape with the grip placed thereon. For removal one end of the cutting wire is grasped by a user and pulled along the length of the handle to sever the overlying grip. An alternative embodiment embeds the cutting wire in the grip proper for subsequent manipulation and grip severance.

This application is a continuation-in-part of my copending application Ser. No. 604,709, filed on Apr. 27, 1984. BACKGROUND OF THE INVENTION This invention relates to highly absorbent and retentive materials for absorbing aqueous based fluids and more particularly for absorbing body fluids in such.products as sanitary napkins, diapers, bandages and the like. Specifically, this invention is related to compositions and methods for preparing crosslinked polyelectrolytes capable of absorbing and retaining many times their weight of such aqueous fluids. Highly absorbent crosslinked polyelectrolytes and methods of preparing the same are already known. U.S. Pat. Nos. 3,669,103 and 3,670,731 teach use of these materials in diapers and dressings. U.S. Pat. Nos. 2,988,539; 3,393,168; 3,514,419 and 3,557,067 teach methods of making such absorbents and in particular are related to water swellable crosslinked carboxylic copolymers that are either crosslinked during copolymerization or crosslinked after polymerization and then neutralized to result in pendant ionic moieties capable of imparting water retention properties to the finished material. Additionally polyelectrolytes have been prepared which are cured or crosslinked employing epihalohydrine. For example, U.S. Pat. No. 3,980,663 employ epihalohydrines but has been found to be unacceptably slow and inefficient as a method for crosslinking such polymers. In U.S. Pat. No. 4,076,673 an improvement in the rate and efficiency of curing polyelectrolytes has been accomplished by employing as a crosslinking agent a polyamidepolyamine epihalohydrine adduct of the kind commercially available from Hercules, Incorporated and sold by them under the Trademark Polycup®. A still further improvement in the choice of crosslinking agent is disclosed in U.S. Pat. No. 4,310,593 which teaches the use of monomeric amine epihalohydrine as a crosslinker which is said to have greater efficiency, longer shelf life and the convenience of being capable of shipping as a concentrate. The above disclosures notwithstanding, there is still a need for improvement in crosslinked polyelectrolyte technology and in particular there is a need to improve the efficiency of the crosslinking reaction, the shelf life of the crosslinker and its convenience in use. SUMMARY OF THE INVENTION It has now been discovered that a crosslinker may be employed to cure or crosslink polyelectrolytes which exhibits significantly greater efficiency, faster reaction rate and greater shelf life without sacrificing any of the advantages of prior suggested processes. In particular it has been discovered that these desirable attributes may be achieved by employing in such compositions and methods a crosslinking agent which is a water soluble, relatively low molecular weight compound having at least two 1-aziridinyl groups bonded thereto. Preferably, such groups have the general formula: ##STR1## wherein each R group is independently selected from the group consisting of H, alkyl having from one to three carbon atoms, or alkylene having from one to three carbon atoms. Preferably the compound has a molecular weight of less than 1000. Of choice the functional groups are bonded to aliphatic or substituted aliphatic groups sufficiently small enough to maintain the compound soluble in water. The crosslinkers of choice are di- and tri-functional aziridine several of which are commercially available. It has been found that employment of the crosslinking agents of this invention results in the ability to use only minimal amounts of crosslinking agents, that the curing rates of these agents are demonstratably faster than prior agents and that the shelf life of these agents, notwithstanding their higher reactivity, are substantially longer than prior agents. DETAILED DESCRIPTION OF THE INVENTION The carboxylic polyelectrolytes capable of being crosslinked in accordance with the teachings of this invention are well-known and are described in detail in U.S. Pat. No. 4,310,593 which is incorporated herein by reference. The essence of usable polyelectrolytes is that they comprise, at least in the salt form, sufficient carboxylate moieties to render them water soluble. Usable polymers, capable of being prepared from readily available monomers and converted into their salt form include for example, acrylic acid-acrylate copolymers; acrylic acid-acrylamide copolymers; acrylic acid-olefin copolymers; polyacrylic acid; acrylic acid-vinyl aromatic copolymers; acrylic acid-styrene sulfonic acid copolymers; acrylic acid-vinyl ether copolymers; acrylic acid vinyl acetate copolymers, acrylic acid-vinyl alcohol copolymers; copolymers of methacrylic acid with all of the above comonomers; copolymers of maleic acid, fumaric acid and their esters with all of the above comonomers; copolymers of maleic anhydride with all of the above comonomers. The conversion to the salt form may take place either before or after the crosslinking reaction, but in any event, the crosslinked polyelectrolyte should have at least 25% of the carboxyl groups, on a molar basis, in the salt form. Generally described, the crosslinking agents of this invention are low molecular weight, water soluble compounds having at least two 1-aziridinyl groups bonded thereto which groups preferably have the general formula: ##STR2## wherein the R groups may be independently selected from the group comprising H, alkyl having from one to three carbon atoms or alkenyl having from two to three carbon atoms. The functional groups are preferably bonded to an aliphatic chain or a substituted aliphatic chain with the essential criterion that such chains be small enough to insure that the compound is water soluble. Preferably the compound has a molecular weight of less than 1000. Such aliphatic or substituted aliphatic chains may include olefinic groups from 2 to 12 carbon atoms; substituted olefinic groups such as olefinic hydroxides, e.g., butylenehydroxide or butylenedihydroxide; mercaptans of olefins such as mercaptobutylene; ethers of aliphatic compounds such as diethylene glycol or triethylene glycol; esters of aliphatic compounds such as triglycerides or esters of trimethylpropane and pentaerythritol. Several such compounds are already commercially available and it will be understood by one skilled in the art that a great many variations of these commercially available compounds can be synthesized while still conforming to the general description given above. A particularly effective group of compounds are the triaziridines based on trimethylolpropane tripropionates having the formula: ##STR3## and sold by the Aceto Chemical Company under the trade name TAZ. Another effective compound, based on pentaerythritol tripropionate adduct, has the formula: ##STR4## and is sold by Aceto Chemical Company under the trade name TAZO. Similar materials conforming to the general description given above are available from Cordova Chemical Company under the trade name XAMA. Additionally, other polyfunctional aziridines that have triazine or phosphate backbones are also available. Such are, for example, tris(1-aziridinyl)phosphine oxide, tris(1-aziridinyl)-phosphine sulfide; 2,4,6,trisaziridinyl-s-triazine. The reaction of the functional group of the aziridine with the carboxyl group of a carboxylic polyelectrolyte proceeds rapidly at temperatures of from room temperature or less to about 150° C. with, of course, increasing reaction rate the highest temperatures. The reaction proceeds through ring opening as follows: ##STR5## Crosslinking takes place when a polyfunctional aziridine molecule reacts as above with carboxyl groups of adjacent polyelectrolytes to form bridges between these molecules. In the general method of carrying out this invention, a solution is prepared comprising from 5 to 60% by weight of a carboxylic polyelectrolyte, e.g., polyacrylic acid or salts thereof having molecular weights which may vary from 10,000 to 4,000,000 or more. Preferably such molecular weights should range from 10,000 to 1,000,000. As used in this connection, the term "molecular weight" is meant to denote the weight average molecular weight of the polymer. The choice of molecular weight for the polyelectrolyte may vary over this wide range depending on the desired properties of the finished crosslinked product. For example, extremely low weight polyelectrolytes will go into solution easily and hence highly concentrated solutions may be prepared which will require less drying to produce the final product. Low weight polyelectrolytes however require a higher ratio of crosslinking agent to insolubilize. On the other hand, extremely high molecular weight polyelectrolytes form very viscous solutions which are difficult to handle in their pre-crosslinked form but require lower concentration of crosslinking agent to insolubilize. The solvent of choice is water although other solvents such as alcohol or mixtures of water and alcohol may be employed. The solution may be maintained in the acid state and neutralization may take place after crosslinking or the solution may be neutralized to as high a pH as 12 or more utilizing a strong base such as sodium hydroxide. Preferably the reaction is best controlled when preparing a relatively neutral solution in the range of from 5 to 10 pH and still more preferably in the range of from 6 to 8. The polyfunctional aziridine is dissolved into the solution at a concentration which may vary from about 0.2 to about 20% by weight, based on the weight of the carboxylic polyelectrolyte. Preferably, the concentration should range from 0.5 to 15% and still more preferably from 1 to 10%. For a given polyelectrolyte, too low a concentration of aziridine will result in a failure to render the polyelectrolyte insoluble. On the other hand, too high a concentration of aziridine will result in a crosslinked product which exhibits relatively low swelling and hence low absorption capacity. These properties also vary with the molecular weight of the uncrosslinked polymer wherein a greater concentration of crosslinking agent is required to insolubilize a low molecular weight polyelectrolyte and a lesser quantity of crosslinker may be employed with higher molecular weight polyelectrolytes. In general, to obtain best absorption properties, the minimum quality of crosslinking agent capable of insolubilizing the polyelectrolyte should be employed. The solution may be cast onto a release substrate to produce a highly absorbent film upon drying. The film may then be crushed to form an absorbent powder, the common form of highly absorbent materials suggested for use in such body fluid absorbent products as diapers, sanitary napkins, tampons, dressings or the like. A particularly useful material may be produced by employing, as the neutralizing base, a carbonate compound such as Na 2 CO 3 , K 2 CO 3 or ammonium bicarbonate. The neutralization of the carboxylic polyelectrolyte will release carbon dioxide gas and foam the mixture which, on drying, produces a cellular, foam-like material having high volume and enhanced absorbency. Ordinarily, it would be difficult to use such a system to foam the polymers as the cells tend to collapse too quickly. However, because of the rapidity of reaction with the crosslinking agents of this invention this is now possible. Another method of utilizing the compositions and methods of the invention is to spray the solution of polyelectrolytes and crosslinkers onto the surface of a substrate such a tissue which when dried will exhibit good absorption properties. Alternatively, the solution may be applied by padding or saturating a substrate such as a pad of cellulose fibers or the like which then may be dried, with the highly absorbent crosslinked polyelectrolyte distributed throughout the pad. Vacuum suction means can be employed to control the solution add-on as is currently employed for producing suction bonded nonwoven fabrics. The dried crosslinked polyelectrolyte adheres to most surfaces with sufficient tenacity to preclude problems such as sifting or dislocation typically encountered when attempting to combine absorbent powders with nonwoven fabrics or pads of cellulosic materials. EXAMPLE 1 A composition is prepared by mixing a 25%, by weight, aqueous solution of poly (sodium acrylate) having a molecular weight of 100,000 with a sufficient quantity of 50% by weight of aqueous sodium hydroxide to neutralize to a pH of from 7 to 8. The triaziridine based on trimethylolpropane tripropionate, TAZ, and obtained from the Aceto Chemical Company, is dissolved into the solution in various concentrations, as are set out in Table 1 below in percent by weight, based on the weight of the poly(sodium acrylate). A film of the solution, 30 mils thick is cast onto silicon coated paper and dried in an oven at 110° C. for 30 minutes. The films are peeled from the paper and ground to 20 mesh powders. The weighed powders are saturated with test fluids (deionized water and a 1% by weight aqueous NaCl solution), excess fluid is absorbed with paper towels and the weight gain of water is measured as the Free Absorbency. The results are reported below in Table 1. TABLE 1______________________________________ Free Absorbency, g/gCrosslinker (TAZ), % Water 1% NaCl______________________________________0.5 soluble --1.2 75 122.0 128 224.0 70 107.0 10 --______________________________________ can be seen from the above table, this relatively low molecular weight polyelectrolyte reached an optimum Free Absorbency value at approximately 2% crosslinker concentration and thereafter exhibited reduced absorbency. EXAMPLE 2 The procedure of Example 1 is followed with the exception that a 200,000 molecular weight poly (sodium acrylate) was employed. The crosslinker used for this Example 2 is the triaziridine based on pentaerythritol tripropionate adduct, TAZ-0, sold by the Aceto Chemical Company. The results are shown in Table 2 below. TABLE 2______________________________________ Free Absorbency, g/gCrosslinker (TAZ-0), % Water 1% NaCl______________________________________8 60 --4 70 --2 140 351 330 45 0.6 --soluble--______________________________________ As can be seen, this relatively high molecular weight polyelectrolyte exhibited optimum absorbency at about 1% crosslinker concentration. EXAMPLE 3 The procedure of Example 1 is repeated with the exception that the polyelectrolyte employed was poly(acrylic acid) neutralized with sodium hydroxide and having varying molecular weights as set out in Table 3 below and the crosslinking agent employed is TAZ-0 at a constant concentration of 1%. As in Example 1 a 25% solution of the polyelectrolyte is employed with the exception that, for the 400,000 molecular weight polyacrylic acid, a 12.5% solution is used. The results are reported below in Table 3. TABLE 3______________________________________Poly(acrylic acid) Free Absorbency (g/g)Molecular Weight Water 1% NaCl______________________________________ 25,000 --soluble-- 60,000 130 29200,000 360 40400,000 435 43______________________________________ As can be seen from this example, for the constant value of crosslinker concentration, absorbency increased with increasing molecular weight. EXAMPLE 4 A crosslinked absorbent polyelectrolyte foam is prepared. A mixture of three grams of sodium hydroxide, three grams of potassium carbonate, and one gram of ammonium bicarbonate are dissolved in 80 grams of water and one gram of the TAZ triaziridine crosslinking agent. The solution is poured on 10 grams of 450,000 molecular weight polyacrylic acid powder obtained from Polysciences, Inc. and hand mixed thoroughtly for three minutes. The mixture has a dough-like consistency due to the carbon dioxide released from the carbonate compounds. The mixture is heated for 30 seconds in a microwave oven and then kept for 15 minutes in a hot air oven at 120° C. The resulting dry material is fluffy and cellular and demonstrates a very high absorption rate. The material is crushed manually and the free absorbency is measured as described above. The material is found to absorb 480 grams per gram of deionized water and 55 grams per gram of one percent, by weight, sodium chloride aqueous solution. EXAMPLE 5 A crosslinked polyelectrolyte absorbent film is produced. A 25 percent aqueous solution of polyacrylic acid having a molecular weight of 100,000 and obtained from the North Chemical Inc. Company in the quantity of 26.4 grams was neutralized with four grams of potassium carbonate and two grams of ammonium bicarbonate. Two drops of a surfactant, pluronic L-62, was added to break up the foam. The crosslinker, TAZ triaziridine, was mixed into the solution and a film was cast on a silicone coated paper. After 15 minutes, at 110° C., a strong but brittle film was obtained that swelled instantly when wetted by water. The film was crushed in a mortar and the powder had a free absorbency of 128 grams per gram of water and 22 grams per gram of one percent sodium chloride solution. Measurements for absorption retention under pressure were taken using the gravimetric absorbency tester (GAT) instrument, described in U.S. Pat. No. 4,357,827. The absorption using this instrument was found to be 20.8 grams per gram with a retention of 14.8 grams per gram using a 1%, by weight, aqueous sodium chloride test fluid. EXAMPLE 6 The formulation of Example 5 was diluted with water to give a 10 percent by weight solid solution. Solution was sprayed onto a non-woven fabric of cellulosic fibers while vacuum was applied on the opposite side of the fabric to suck the excess fluid through the fabric. The solution was also sprayed onto a tissue paper. Both impregnated substrates were dried for 10 minutes at 110° C. Similar samples were prepared and were dried overnight at room temperature. The absorption characteristics of these impregnated substrates varied with the amount of solution applied thereto but all exhibited enhanced absorbency. EXAMPLE 7 This example illustrates the importance of having at least 25% of the carboxyl groups (on a molar basis) converted to the salt form in the crosslinked polyelectrolyte. A series of 12.5% by weight solutions of polyacrylic acid in water is prepared wherein the polyacrylic acid employed has a molecular weight of 400,000. The solutions are neutralized to varying degrees as shown in Table 4 below. The XAMA-7, a polyfunctional aziridine obtained from the Cordova Chemical Company, is employed as the crosslinking agent by adding an amount equal to 1% of the weight of the polyelectrolyte to the solution. A film is cast from the solution onto a silicon coated release paper. The film is dried for 10 minutes at 130° C. and then ground to pass through a 20 mesh screen. The absorption capacity is measured by following the procedure described in Example 1 and the results are reported in Table 4 below. The same procedure is followed for another series with the exception that an 11.1%, by weight, aqueous solution of 200,000 molecular weight polymethacrylic acid is employed as the polyelectrolyte. The results are also reported in Table 4 below. TABLE 4______________________________________Acid % Carboxyl in AbsorbencyType pH Salt Form gm/gm______________________________________Polyacrylic 3 0 4 5 30 35 7 85 56Polymethacrylic 3.5 0 3 5.0 25 30 7.5 85 37______________________________________ As can be seen from the above table, as the percentage of carboxyl groups converted to the salt form increases beyond about 25% there is a marked increase in the absorbency. EXAMPLE 8 This example illustrates the advantages of employing the aziridinyl crosslinking agents to prepare the products of this invention, as contrasted with the materials prepared by the teachings of U.S. Pat. No. 4,310,593 mentioned above. Following the procedure of U.S. Pat. No. 4,310,593 an amine/epichlorohydrin adduct crosslinker was prepared by dissolving one gram of diethylenetriamine in 16 ml. of methanol. To this was added, with mixing, 1.8 grams of epichlorohydrin. The mixture, in a sealed bottle, was placed in a 65° C. water bath for one hour. A series of samples were prepared wherein the crosslinking reactions were carried out using an aqueous solution containing 12.5% by weight of a 400,000 molecular weight polyacrylic acid obtained from the Rohn Haas Company and sold by them under the trademark Acrysol A-5. In all cases the solution was neutralized to a pH of 7 and crosslinked with the amount of various crosslinking agents illustrated in Table 5 below, as expressed as weight % of crosslinking agent, based on the total weight of the neutralized acid. A 30 mil film was cast on release paper and allowed to dry, at room temperature for 18 hours. The resulting material was tested for absorbency in accordance with the test described in Example 1. The results are reported in the Table 5 below. TABLE 5______________________________________ Absorbency (gm/gm)Crosslinking Agent Amine(weight %) XAMA-2 TAZ-O Epichlorohydrin______________________________________0.5 31 -- Soluble Polymer1.0 26 29 Soluble Polymer______________________________________ As can be seen, the amine/epichlorohydrin adduct is not reactive enough to crosslink to a sufficient degree under these conditions. EXAMPLE 9 This example illustrates the surprisingly greater reactivity of the crosslinking agents taught by this invention in making the products taught herein. The same neutralized acid employed in Example 8 in a 6% by weight, aqueous solution was mixed with 1% by weight of various crosslinkers, based on the weight of the neutralized acid and cured at 25° C. The time for gelation was recorded. TABLE 6______________________________________Crosslinker Gelation Time______________________________________TAZ-O 45 MinutesXAMA-2 3 HoursAmine/Epichlorohydrin 72 Hours______________________________________ EXAMPLE 10 The same aqueous mixtures of neutralized acid and 1% crosslinker employed in Example 9 were used to treat 15 denier polyester fibers to attempt to render them absorbent and usable in absorbent products and, in particular, products for absorbing body fluids. The polyester fibers were dipped into the solution and excess solution was removed to the point that the remaining solution corresponded to a 50% weight gain of solution based on the weight of the dry fibers; i.e., 0.5 grams of solution per gram of dry fiber. Samples of the fibers were dried and the polyelectrolyte cured, at room temperature for three hours and for 18 hours. The absorbency of the samples for both water and a 1% by weight aqueous NaCl solution, was tested using the method of Example 1. TABLE 7______________________________________ Absorbency gm/gmCrosslinking 3 Hours 18 HoursAgent Water 1% NaCl Water 1% NaCl______________________________________XAMA-2 30 9 33 12Amine/Epichloro- 4.5 1.7 5 5hydrin______________________________________ EXAMPLE 11 Twenty grams of the 12.5% solution of polyacrylic acid of Example 8 are neutralized with 2 grams of potassium carbonate and 0.5 grams of ammonium bicarbonate. The carbon dioxide generated in this reaction foamed the system. The foamed system is crosslinked with 1% TAZ-O crosslinking agent, based on the weight of the neutralized acid, for one minute in a microwave oven and for an additional three minutes at 110° C. in a hot air oven. When tested by the method of Example 1, the resulting cellular, fluffy material absorbed 400 grams of water per gram of material and 55 grams of 1% aqueous NaCl solution per gram of material in 30 seconds without further grinding. The same procedure was followed using, as the crosslinking agent, the amine/epichlorohydrin adduct. Gelation was slow and no cellular material was formed. The product absorbed only 10 grams of NaCl per gram of material after 30 seconds.

Crosslinked water absorbent carboxylic polyelectrolytes and articles made therefrom are provided. The polyelectrolytes are crosslinked using a di- or tri-functional aziridine crosslinking agent.

[0001] The present patent document claims the benefit of DE 10 2009 009 616.7, filed Feb. 19, 2009, which is hereby incorporated by reference. BACKGROUND [0002] The present embodiments relate to a capsule for use in endoscopic examinations. [0003] Classical endoscopy is a widely established method in medicine, both for examining or diagnosing, as well as for treating or administering therapy to a patient. In classical endoscopy, an endoscope or a catheter is introduced into a hollow organ of the patient (e.g., the stomach or the intestine) via a bodily orifice of the patient (e.g., the mouth or anus). [0004] Conventional endoscopes do, however, have disadvantages. For example, conventional endoscopes have a limited range extending from the bodily orifice to the interior of the body of the patient or a limited flexibility when it comes to following curves or loops of hollow organs. [0005] The small intestine of a patient may have a length of 7 to 8 m and is, for example, not fully accessible using a conventional endoscope with a limited range or limited flexibility. [0006] Endoscopy systems employing magnetically controlled endoscopic capsules (e.g., endorobots) have been proposed to allow better investigation over the entire length of the intestinal tract. A magnetically controlled endoscopic capsule is described in DE 101 42 253 C1, for example. Magnetic guidance is achieved using magnetic forces that result from magnetic gradient fields that act on a permanent magnet in the capsule, the magnetic gradient field being generated by using an external guidance magnet. The external guidance magnet is an electromagnet such as is described, for example, in DE 103 40 925 B3 or WO 2006/092421 A1. In another embodiment, the guidance magnet includes one or more mechanically movable permanent magnets. As an alternative to magnetic guidance using magnetic forces, the capsule can, as described in US 2003/0181788 A1, be provided externally with a kind of thread and moved according to the principle of an Archimedes screw through a section of the intestine, while magnetic torques that are produced due to the interaction of a rotating external magnetic field with a permanent magnet fixedly incorporated into the capsule act on the capsule. The magnetization direction of the permanent magnet of the capsule may lie normal to the longitudinal axis of the capsule. The position and orientation of the capsule can be measured partially electromagnetically, as described, for example, in WO 2005/120345 A2. [0007] Typically, the endorobot is navigated using a force input device, (e.g., a 6D mouse). The gradient direction, which corresponds to the superposition of the three individual systems, can be determined by tilting an input lever forward/back and right/left, as well as by pressing or lifting the input lever; the amplitude can be determined by turning the input lever. The forces applied to the input device may be proportional to the force applied to the instrument. [0008] When performing methods in capsule endoscopy, obstacles may be created due to the position of the patient such that there are intestinal loops in a section of the intestine lying in a way that cannot be overcome by the endoscopic capsule or can be overcome only with great difficulty. Such obstacles include, for example, kinks in the intestine, very tight curves, polyps, or the compression of portions of the intestine due to organs lying on the intestine (e.g., other intestinal loops). The rubbing of the capsule against the interior wall of body cavities may lead to problems with movement or to blockages of movement. The problems with movement and blockages of movement can be removed by application of proportionally great magnetic forces onto the capsule, which constitutes a very complex and involved solution. SUMMARY AND DESCRIPTION [0009] The present embodiments may obviate one or more of the drawbacks or limitations inherent in the related art. For example, in one embodiment, the movement of an endoscopic capsule during the examination of patients may be improved. [0010] The present embodiments may provide, in addition to the advancement of the capsule with the aid of an advancing device (e.g., by using an integrated magnet and external magnetic fields), the generation of a movement through which obstructions (e.g., severe edge friction or jamming of the capsule) in the course of the advancement or navigation of the capsule through organs may be counteracted more effectively. The advancement of the capsule, with the aid of the advancing device, is facilitated in the event of movement-inhibiting edge friction or edge contact occurring. The generation of the movement may also assist the capsule to overcome inhibiting frictional forces. [0011] The movement may include, for example, a jerking, a vibrating, a pulsating or an oscillating action, thereby increasing the freedom of movement of the capsule (e.g., as a result of the induced lessening of the friction with organ walls) and a further advancement with the aid of the advancing device. [0012] The movement may be situationally triggered (e.g., when an obstruction of the capsule occurs). Parameters of the advancing device, for example, may be used as a criterion for the situational triggering of the movement. In one embodiment, the forces to be applied for the advancement with the aid of the advancing device (e.g. magnetic forces) may be used as a criterion for triggering or activating the movement. In one embodiment, the criterion may include a predefined maximum force not being able, or no longer being able to move the capsule a defined extent (e.g., a minimum speed or distance). [0013] If a path through an organ under investigation or the position of the capsule in the organ is visualized externally (e.g., outside of the patient under examination) so that the capsule may be controlled by the operating personnel, then a decision concerning an activation of the movement may be made on the basis of the visualization or on the basis of an evaluation of optical information transmitted by the capsule. The operating personnel can see (e.g., on a monitor) that the capsule is not moving forward as desired and can activate an additional movement of the capsule to reduce the frictional forces acting on the capsule. [0014] Manual or automatic activation is possible. Manual activation may also be provided in addition to automatic activation. [0015] In addition to the advancing device for conveying the capsule through an organ under investigation, the capsule according to the present embodiments is provided with a device for generating movements to reduce edge friction or edge contact impeding the advancement of the capsule. [0016] In one embodiment, the device is configured for generating movements, for example, using an ultrasonic resonator, a bobbin arranged in a coil, or an unbalanced motor. In one embodiment, the device for generating movements may use the physical effect of magnetostriction or electrostriction. In one embodiment, the capsule walls may be configured to generate movement using the effect of magnetostriction or electrostriction. [0017] The activation of the device for generating movements or the triggering of the generation of a movement by the device is effected using an external (e.g., initiated from outside the patient under examination) irradiation of electromagnetic radiation. [0018] In one embodiment, the irradiation of the electromagnetic radiation may directly cause energy to be supplied to the device for generating movements. In other words, the irradiated radiation represents energy that quickly feeds the device for generating movements. In one embodiment, the length of time during which the device will generate movements may be specified using the period of time the irradiation lasts. Thus, for example, a criterion for terminating the generation of movements may be specified (e.g., analogously to a criterion for the activation, using forces to be applied or an external visualization of the advancement or position of the capsule). Upon the criterion being fulfilled, the irradiation will be terminated, the energy supply to the capsule will be cut off, and the additional movement generation will be terminated. [0019] In one embodiment, the capsule may include an energy store (e.g., a battery). The electromagnetic radiation irradiated for activation purposes represents a signal through which a supply of energy from the energy store to the device for generating movements is effected or triggered. In one embodiment, the irradiation of a second signal will stop the device for generating movements or terminate the supplying of energy from the energy store. In one embodiment, the energy store is configured for being charged using energy transmitted wirelessly from an external source. [0020] Other combinations of energy supply to and activation of the device for generating movements may be found. For example, in one embodiment, an external irradiation of energy may be provided to supply the device for generating movements with energy (e.g., additional energy) only in a specific mode (e.g., boost mode) that is provided for overcoming obstructions during the advancement of the capsule. In another mode, the irradiated energy will be used, for example, for supplying energy to other parts of the capsule. The switching between modes may be effected using externally transmitted control signals. BRIEF DESCRIPTION OF THE DRAWINGS [0021] FIG. 1 shows an endoscopic capsule, [0022] FIG. 2 shows the navigation of an endoscopic capsule through an intestinal system, [0023] FIG. 3 shows one embodiment of an endoscopic capsule having a device for generating vibrations, [0024] FIG. 4 shows one embodiment of an endoscopic capsule having a device for generating vibrations, [0025] FIG. 5 shows one embodiment of an energy supply to a device for generating vibrations, [0026] FIG. 6 shows one embodiment of an energy supply to a device for generating vibrations. DETAILED DESCRIPTION [0027] FIG. 1 shows an endoscopic capsule as described in DE 101 42 253 C1 (e.g., an endorobot). [0028] A capsule 1 has an ellipsoid-shaped housing in which a bar magnet 3 is aligned collinearly to a principal axis 2 . A video camera 6 may include a lens 4 and a CD sensor 5 , and records images, which are transmitted externally using an RF transmitter 7 and an antenna 8 . Different measuring instruments, biopsy instruments or treatment instruments may also be controlled via radio (e.g., via the antenna 8 ). As shown in FIG. 1 , one embodiment may include a biopsy pistol 9 controlled via the antenna 8 . [0029] FIG. 2 shows the capsule 1 shown in FIG. 1 in action. FIG. 1 schematically illustrates a patient 11 who has been brought into a working room 12 of a magnetic coil system 13 . A capsule endoscopy is to be performed on the patient 11 . An endoscopic capsule 1 is therefore administered orally to the patient 11 . The capsule 1 contains at least one permanent magnet 3 , a camera 6 that includes a lens 4 with a CCD sensor 5 , and an antenna 8 for communication by radio with a remote station (not shown) outside of the patient 11 . [0030] In FIG., 1 the capsule 1 is shown three times, namely at different times T 1 , T 2 and T 3 . At time T 1 , the patient 11 has just swallowed the capsule 1 , which is why the capsule is situated on the path through an esophagus 28 in the direction of a stomach 30 . At time T 1 , the capsule 1 may still be inactive if a gastrointestinal tract is to be investigated. [0031] At time T 2 , the capsule 1 has reached the stomach 30 . Examinations are carried out in the stomach 30 . The direction of movement and speed of movement of the capsule 1 , for example, are controlled by application of a force F and a torque M onto the capsule 1 using the magnetic coil system 13 , which interacts with the permanent magnet 3 . During this process, the camera 6 permits navigation by sight. [0032] After time T 2 , the capsule 1 is navigated by sight through a pyloric orifice 40 and through a duodenum 42 as far as a small intestine 44 . In the small intestine 44 , the capsule 1 is depicted once again at time T 3 . Particularly on a path through the pyloric orifice 40 , the duodenum 42 and the small intestine 44 , obstructions of the capsule 1 may result due to friction against the walls or the capsule 1 becoming stuck in the gastrointestinal tract before the investigation has been completed and the capsule 1 is egested naturally from the patient 11 in the direction of an arrow 46 . The present embodiments may enable the obstructions to be overcome more effectively. In one embodiment, an additional, brief movement (e.g., vibration or oscillation) of the capsule 1 is generated from outside. The additional movement supports the magnetic forces used for advancing the capsule 1 by effecting, for example, a breaking away from an organ wall. In one embodiment, movement is generated by changing a length of an exterior shell of the capsule 1 . [0033] In the embodiments described below, the additional movement is vibration for clarity of illustration. However, other additional movement of the capsule 1 may be provided in alternative embodiments. [0034] In one embodiment, the vibrations are generated using a device for generating vibrations that is contained in the capsule 1 . Embodiments of the device for generating vibrations are shown in FIG. 3 and FIG. 4 . [0035] FIG. 3 shows an endoscopic capsule having, for example, ultrasonic resonators or transducers 21 for generating ultrasound. The ultrasonic resonators are driven using a circuit 22 . [0036] If an external controller detects that the capsule is blocked, the ultrasonic resonators are activated in accordance with one embodiment of a method illustrated below with reference to FIG. 5 and FIG. 6 . As a result of the interaction of the ultrasonic resonator waves with the walls of the organ (e.g., intestine) in which the capsule is located, the capsule is set into motion until the blockage has been overcome. [0037] FIG. 4 schematically illustrates one embodiment of the device for generating vibrations. A circuit 23 is connected to a coil 24 , which surrounds a bobbin or coil carrier 25 . If the capsule becomes blocked or gets stuck, the circuit 23 is supplied with energy according to one of the above-mentioned methods. By reversal of the polarity of the coil 24 , vibrations are induced in the bobbin 25 , and as a result, the capsule vibrates. This manner of operation is related to that of a doorbell or door chime, which is actuated using a relay. [0038] In one embodiment not shown in the figures, a type of wobble-plate motor or unbalanced motor is arranged in the capsule, the motor serving to set the capsule into motion using internal forces acting asymmetrically. [0039] In one embodiment, an outer shell of the capsule 1 is configured to undergo a change in length or shape induced by magnetostriction or electrostriction. In the event of problems in advancing the capsule, an electric or magnetic field is applied to change the shape. As a result of the change in shape, external forces (e.g., friction, normal advancement, gravitational force) come into play at other points of the capsule 1 . Accordingly, a movement is generated, which counteracts obstructions during the advancement of the capsule. [0040] FIG. 5 and FIG. 6 show two different embodiments for supplying energy to generate vibrations. For each embodiment, the figures show a device 20 for generating vibrations, an antenna 8 , a receiver 10 for electromagnetic radiation and a camera 6 . [0041] According to one embodiment shown in FIG. 5 , electromagnetic radiation received by the antenna 8 is used directly for generating vibrations. The radiation is forwarded by the receiver 10 to the device 20 for generating vibrations, where the device 20 feeds, for example, a circuit as shown in FIG. 3 or FIG. 4 . [0042] In FIG. 6 , an energy store 15 (e.g. a battery) is shown. In response to a signal received from the antenna 8 and the receiver 10 , the supply of energy from the energy store 15 to the device 20 is activated in order to generate vibrations. In one embodiment, logic may be provided, which evaluates received signals and interprets a correspondingly formed signal as a command to generate vibrations. [0043] In one embodiment, the capsule may be configured to enable the energy store 10 to be charged using irradiated electromagnetic waves during an examination without causing vibrations to be triggered. The vibrations are dependent on an associated trigger signal. [0044] In one embodiment, the duration of the vibrations may be limited. The duration of the vibrations may be limited, for example, by supplying the device with energy for the purpose of generating vibrations only for a desired time period. In one embodiment having an energy store as shown, for example, in FIG. 6 , a timer or time recorder may be provided, which starts to run in response to the trigger signal for the vibrations. After the timer has timed out, the energy supply to the device for generating vibrations is interrupted again. After the limited time in which the capsule vibrates, the capsule is subject only to the influence of magnetic forces and may be navigated by the magnetic forces more effectively than if other movements (e.g., vibration) were to be superimposed on the navigation movements. The extraction of energy from the energy store is limited. In one embodiment, a termination of the vibrations or the energy supply required for the vibrations may be provided using an externally transmitted control signal. [0045] While the present invention has been described above by reference to various embodiments, it should be understood that many changes and modifications can be made to the described embodiments. It is therefore intended that the foregoing description be regarded as illustrative rather than limiting, and that it be understood that all equivalents and/or combinations of embodiments are intended to be included in this description.

A capsule for endoscopic examinations and a method for assisting the advancement of the capsule through organs are provided. In addition to a device for advancing the capsule through an organ under investigation, the capsule is also provided with a device for generating movements of the capsule to reduce the edge friction impeding the advancement of the capsule. The device for generating movements of the capsule is activated using electromagnetic radiation irradiated from outside to a receiving system of the capsule. The device generates a movement, which helps overcome inhibiting frictional forces.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to an anti-intoxication preparation and, more particularly, to a compound position made of herbal extracts to be taken orally to overcome the unpleasantness inherent in excessive consumption of ethyl alcohol. 2. Brief Statement of the Prior Art Certain herbal substances have been known in oriental countries, in particular China, for their beneficent properties in overcoming, or at least easing, the unpleasant side-effects resulting from excessive consumption of ethyl alcohol, C 2 H 5 OH. Foremost among them is a substance prepared from radix as well as flos puerariae, i.e., respectively, the root and the blossom of pueraria lobota, commonly known as kudzu, a leguminous vine. Indeed, documentation of its use in alcohol-related illness has been found as early as about 600 A.D. in the Chinese pharmacopoeia Beiji-Qianjin-Yaofang. U.S. Pat. No. 5,324,516 discloses a Galenic composition said to increase, in vivo, the metabolic activity of alcohol dehydrogenase and aldehyde dehydrogenase enzymes and a pharmaceutically acceptable carrier, adjuvant or excipient therefor, including an extract of the pueraria flower, phaseoli radiati semen, pinelliae tuber and fructose in certain proportional ranges. Keung and Vallee, in an article in Proc. Natl. Acad. Sci. USA, Vol. 90, pp. 10008-10012, November 1993, Biochemistry, have reported experiments they conducted with Syrian Golden hamsters, ascribing alcohol-suppressant effects of such herbal compositions to daidzin and daidzein, respectively a glycosylated isoflavone and a aglycone thereof. But they do not know whether these substances per se are the pharmacologically active molecules which directly suppress ethanol intake or whether they act as prodrugs converted in vivo to pharmacologically active species. To date, none of the information available on the effects of kudzu vine extracts on alcohol consumption indicates any great success in combatting a significant social disease. OBJECTS OF THE INVENTION It is, therefore, an object of the present invention to provide an herbal composition including an extract of the kudzu vine which can be used as a food supplement to overcome the effects of alcoholic intoxication in humans. Another object is to provide a composition of the general kind which can easily be made from vegetable sources. A still further object of the invention is to provide a composition based on vegetable or herbal extracts which act on gastric and hepatic metabolisms and which provides quick physical recuperation after excessive alcohol consumption. Other objects will in part be obvious and will impart appear hereinafter. SUMMARY OF THE INVENTION These and other objects will be accomplished by a currently preferred composition including, without being thus limited, an extract of the kudzu vine blossom, starch extracted from the kudzu vine root, an extract prepared from American ginseng, an extract of ginger root, extracts of tangerine and green lemon peel, an extract of magnolia tree bark, and thiamine, in proportions hereinafter set forth. The novel features which are considered to be characteristic of the invention are set forth with particularity in the appended claims. The invention itself, however, in respect of its composition and manufacturing techniques, together with other objects and advantages thereof, will be best understood from the following description of preferred embodiments. DETAILED DESCRIPTION OF THE INVENTION The moderate consumption of alcohol, in private or in public, appears generally to have been accepted or condoned as an integral element of civilized and cultured human activities. Indeed, "drinking" in responsible quantities is seen as contributing to the well-being of individuals and to conviviality, at least until post festum. Ethyl alcohol is one of a few intoxicating drugs widely and legitimately available for consumption by humans generally anywhere. It is offered in a dazzling variety of distilled liquors and brewed or fermented beverages, ranging in strength from 4 to more than 75 volume-% of alcohol. While its consumption may be tolerated and condoned, the drinking of ethyl alcohol can lead to serious physical, mental and social illnesses, cirrhosis of the liver being an example of the former and disrupted families and drunken driving examples of the latter kind. Attempts to combat the consumption of alcohol have not been lacking, the most serious and concerted, albeit unsuccessful one, being that increment of American history known as Prohibition. For an understanding of the invention, a detailed description of the metabolism of alcohol is not thought to be necessary. Generally, however, alcohol metabolizes in vivo in two stages: First, in the alcohol dehydrogenase (ADH) converting the alcohol into acetaldehyde and, second, in the aldehyde dehydrogenase (ALDH) converting the CH 3 CHO into acetate. They occur gastrally as well as hepatically, with the liver supplying the co-enzyme NAD+ required in the process. In the stomach, the acetate is broken down into water and carbon dioxide, both of which are secreted. The liver converts the acetate, in separate metabolic pathways, into energy by way of the citric acid cycle and into fat through the fatty acid synthesis. The processes may be schematized as follows: ##STR1## As can be seen, both gastric and hepatic metabolisms require the NAD+ (nicotine-adenine-dinucleotide) co-enzyme to break down ethanol. In the absence of this co-enzyme ethanol cannot be metabolized. In any event, the reaction of ethanol by alcohol dehydrogenase into acetaldehyde is a rate limiting reaction, and while in the presence of NAD+ large quantities of ethanol can quickly be converted into acetaldehyde, the remaining NAD+ is very likely of insufficient quantity to convert the acetaldehyde into acetate. Excess acetaldehyde will thus accumulate, enter the blood stream and the brain. Being a toxic substance, acetaldehyde will cause headaches, nausea, vomiting, diarrhea, upset stomach, dizziness, ataxia, confused consciousness--in short, all the symptoms associated with being inebriated. In acute cases, a social drinker may additionally suffer from numbness of the limbs, and in chronic cases it may progress to the Wernicke-Korsakoff syndrome, to wit, numbness of limbs, depression of the central nervous system, restlessness, ocular problems, amnesia, and coma. Social drinkers as a rule have insufficient quantities of the enzyme and co-enzyme referred to supra. As a consequence, they become quickly inebriated and suffer from the mentioned symptoms in proportion to the amount of ethanol consumed. Since ethanol also suppresses anti-diuretic hormones (ADH), social drinkers tend to urinate excessively and become dehydrated and, consequently, thirsty. The concentration of electrolytes in their blood changes; acidosis may occur. Alcohol addicts, however, have increased gastric and hepatic dehydrogenase and NAD+ than "social" drinkers. The constant onslaught of ethanol forces the liver to reconvert NADH to NAD+ on rather a larger scale. The result is an excessive accumulation of fatty acid, and eventually hepatic cirrhosis will set in. Alcohol also depletes thiamine (vitamin B 1 ). It has been recognized by the present inventor that the problems associated with the consumption of alcohol can be alleviated generally by diverting some of the conversion of acetate from the liver to the stomach and, more particularly, by additionally supporting this gastral process by providing ingestible substances reducing the rate of alcohol conversion into acetaldehyde. Therefore, in accordance with the invention, ethanol is to be retained in the stomach for as long a period as possible so that it can be converted into CO 2 and H 2 O by gastric metabolism. Ideally, and to avoid the build-up of acetaldehyde, the conversion ratio of ethanol into acetaldehyde and of acetaldehyde into acetate should be 1:1. While the controlled breakdown of alcohol within the system of the body is an important element in its recuperation, it has been found that an adequate simultaneous supply of nourishment is of equal importance and must not, therefore, be neglected. These objects are accomplished by food intake to reduce the gastric discharge and, additionally, by an agent inhibiting the alcohol dehydrogenase to slow the reaction of ethanol into acetaldehyde. Daidzin and daidzein are such agents occurring in nature in a source which is fairly common, the kudzu plant. As alcohol acts as an irritant on the gastric mucosa, an agent to protect the mucosa should preferably also be administered. Finally, to substitute for, or complement, the energy typically lost by drinking persons, certain herbs should be provided as well. It has surprisingly been found that these requirements can be met by a composition containing the following ingredients: 1) an extract of kudzu blossom (flos puerariae) as a source of daidzin and daidzein to inhibit alcohol and acetaldehyde dehydrogenase; 2) starch derived from the kudzu root (radix puerariae) as nourishment and coating for the gastric mucosa *); 3) extract of American ginseng (panax quinquafolium) as a source of quick energy (tonic); 4) an extract of ginger root (radix zingiberis officinalis) against vomiting; 5) extracts of tangerines peel and green lemon peel in equal proportions against stomach upset; 6) extract of magnolia tree bark against stomach upset; and 7) thiamine (vitamin B 1 ) against numbness. The above ingredients, all of which are either commercially in Oriental natural food shops and pharmacies or apopthecaries available, or can at any rate easily be prepared from the plants referred to by extraction processes well known to those skilled in the art as dry powders, should be thoroughly mixed in the following preferred quantities: 1)--about 0.5 to about 2.5 g; 2)--about 5 to 25 g; 3)--about 0.5 to about 2.5 g; 4)--about 0.5 to about 2.5 g; 5)--about 0.5 to about 2.5 g; and 6)--about 0.5 to about 2.5 g; and 7)--about 50 mg. After mixing, the composition may be left in its powdery state. Preferably, however, it is pressed into tablets or lozenges weighing about 20 g each. It may be found to be advantageous to add an inert or base binder matrix material of the kind well known to persons skilled in the art to the compound to improve its compaction into tablets, without, however, interfering with the defined relative and absolute quantities of its ingredients. Alternatively, the powder may be packaged in small pouches or capsules of suitable digestible materials. Another possibility of packaging the compound would be its suspension in candy bars to accommodate the craving of inebriated persons for sugar. It may, optionally, also have flavoring agents added, provided, however, they do not render the composition acidic. It has been found that if the composition is taken before drinking alcohol, the usual symptoms accompanying alcoholic intoxication are substantially avoided. Taken after drinking, the composition will also prevent the occurrence of the mentioned symptoms and it will inhibit or suppress, or at any rate quickly overcome the sensation colloquially known as hang-over. It will be appreciated by those skilled in the art that the quantitative ranges set forth above in respect of the ingredients used in the compound of the present application are intended as examples only, certain ideal absolutes being believed possible but dependent upon the amount of alcohol consumed by a person and the general physical constitution of such person.

An anti-intoxication compound for combatting the side-effects of an excessive consumption of alcohol may be taken orally as a food supplement before or after drinking, and comprises a plurality of herbal or vegetable extracts in defined quantities, at least one of them containing naturally occurring daidzin and daidzein in sufficient quantities to control the gastric and hepatic metabolism of alcohol.

DESCRIPTION This invention relates to an attachment device for skis. Safety attachment A is disclosed that allows disengagement of the boot from the ski when certain stress values are exceeded in case of lateral or front falls of the skier. In the known attachment devices, the skier's boots are secured to the known skis by sprung devices fitted on the skis themselves. These sprung devices exert their action both on the skier's boots and, by suitable intermediate controls, on the rear part of the skier's calf and contemplate means apt to secure the boot on the ski in normal use, while the boot can be detached from the ski in case of accident. The purpose of this invention is to improve the detachment safety of the boot from the ski, both when the ski is loaded or unloaded, reducing, in particular to adjustable uniform values the rotating moment necessary to effect said disengagement with a minimum torsional effort applied to the shin bone of the skier. The ski attachment device in which the sprung means secured to the ski are also secured both to the calf and rear of the heel of the skier's boots and in which a horizontal thrust is applied to the boot by rear sprung means apt to urge the boot against a front stop plate secured to the ski, is characterized in that said front stop is engaged by a grooved rotatable element, secured to the boot to maintain its sole uplifted from the ski. A longitudinally grooved base is provided around the mid position between said rotatable element and the application point of the thrust of the rear sprung means. Said groved base is secured to the sole and within his longitudinal groove is inserted a pin integral with the ski and projecting from a plate rotatable coaxially with said pin. The bottom lateral surface of the base rests on said plate, and the groove of the base constitutes, together with the pin, a longitudinal slidable guideway to keep the boot centered with ski and acts as a fulcrum apt to normalize the disengagement of the boot from the ski in a torsional direction before the torque becomes dangerous for the safety of the skier's legs. The invention will now be described, by way of example, in conjunction with the attached drawings in which: FIG. 1 is a side elevation view showing parts in cross section of the attachment according to the invention. FIG. 2 is a top view of the ski according to FIG. 1, but without the boot. FIG. 3, similar to FIG. 1 shows the conjunction between boot and ski on a larger scale. FIGS. 4 and 5 are axial and transversal sections of the sprung assembly of the ski. FIG. 6 is a sketch showing the kinematic connection of the sprung devices of FIG. 4. With reference to the drawings, in particular to FIG. 1, the ski is identified by letter A and B is the skier's boot retained on said ski by device C. The device is comprised of a front stop plate 10, provided with a "V" shaped seat, the plate 10 being secured to ski A by a spacer 12 apt to maintain the sole of boot B conveniently spaced from the ski. A grooved roller 14 engages with the profiled edge of plate 10; pin 15 of the roller is suitably secured and housed in the bottom of sole 16 of boot B so as to be contained in a cavity of said sole without projecting from the surface of the sole itself. The substantially middle part of sole 16 of boot B, corresponding with the arch of the skier's foot, is provided with a base 17 integral with the sole. The center part of base 17 has a groove 22, substantially parallel to the axis of the ski and which houses a pin 24 apt to slide along the walls of groove 22, said pin 24 forming an integral part of ski A through a shaped element 25. Groove 22, allows therefore a suitable mobility to boot B on the longitudinal axis of the ski during use. A truncated cone shaped associated element 26 is rotatably movable on element 25, the bottom of base 17 being supported on said element 26. Again in relation to the connection of boot B to ski A, the rear part of the boot adjacent to the lower part of the heel, is provided with a block 27 having a suitably shaped seat 28 apt to engage ball head 29 fitted on the end of a slider 30. A spring 32 (see FIG. 4)is inserted on a rod 34 integral with said slider 30; the spring is retained on the perforated bottom of a bushing 36 in which the rod 34 operates. The action of spring 32 can be neutralized by means of a lever 38 which is pivoted on the threaded free end of the rod 34 and cooperates with the end of said bushing 36 to maintain slider 30 in a retracted position, to disengage it from seat 28 of block 27. When lever 38 is actuated, the slider 30 is disengaged from the seat of block 27 to free the boot B from ski A; on the other hand, when said lever 38 is free, the spring 32 acts on slider 30 and maintains roller 14 of boot B engaged with the V shaped profile of plate 10 of ski A. Bushing 36 is provided, on one of its ends, with a tab 40 engaging with an eccentric pin 42, the ends 44 of which engage inturn with the holes of a support 46 secured to ski A. A rod 48 is attached to one of the ends 44 of eccentric pin 42; said rod 48 extends upwardly and terminates with an arched element 50 (FIG. 1) apt to engage with the skier's calf. As a result of the action of spring 32 on eccentric 42-44, it ensures that during use of the ski the arched element 50 is maintained in engagement with the skier's calf and follows the movements of the leg during use of the ski. The upper end of rod 48 (see FIG. 1) is secured, by a universal joint at a point close to the connection of the arched element 50, to the movable part 52 of a pneumatic spring 54 the other end of which is joined by a hinge 55 to bushing 36. Therefore the movements of the skier's legs are favoured and followed by the springing action of pneumatic spring 52-54 and by the action of spring 32 on the boot. Moreover, the action of spring 32 on boot B is also affected by eccentric 42 which is rotatably joined with bushing 36. The behaviour of device C during use is illustrated in FIG. 6 which shows schematically the extreme positions of eccentric 42-44 of FIG. 4 in different way of use. In the rest position the rod 48, under the action of pneumatic spring (52-54), is urged against ski A showed in the figure by line X--X. More specifically when rod 48 is in its rest or idle position (i.e. when the boot is disengaged form the ski) it can be stated that the rod assumes the position identified by horizontal line X--X. In the initial working position I at an angle of approximately 30° from the preceeding position the eccentric 42, which rotates around pin 44, assumes the position shown in the figure identified by continuous line 42'. From this position onward, the rod can reach position II by performing an angular movement of approximately 60°, corresponding to the excursion required in normal sking, followed by a further complementary maximum shift of 15° up to line III, where the eccentric sets itself in position 42'" designated by the dotted line. In brief, rod 48 can perform a shifting movement starting from initial working position I up to position III, a maximum angular shift of 75°, while eccentric 42 performs a corresponding horizontal shift "S" equal to approximately six millimeters computed on the actual dimensions of the device according to the invention, thereby varying in said measure the compression of spring 32 when the ski is in use. Referring again to FIG. 1, in order to control the mobility of the foot, a shaped reinforcement lamina 60 is inserted in the boot at the height of skier's ankle. Said shaped lamina 60 is made of plastic material of adequate thickness which can vary between 0.5 and 2.5 millimeters and which is shaped so as to adapt itself conveniently to the part of the skier's foot. In addition to providing the best possible protection against impact, the in question in question makes it possible to control the thrusts of spring rod 48 and thereby eliminate a part of the muscular strain. Shaped lamina 60 may be provided with perforations or apertures for ventilation and its ends may be either in the front or rear, depending on use requirements. It clearly emerges from what hereinabove described and illustrated that the scope proposed by the invention has been achieved. In fact, in the devices known heretofore, disengagement of the boot from the ski, especially during excessive torsional stresses which are the cause of most accidents to the tibia of the skier, still remains impredictably influenced by the friction conditions between the sole and the ski. In the device according to this invention, the front part of the sole remains lifted from the ski the boot being engaged with the throat of grooved roller 14 against V shaped plate 10 and set at a suitable height to maintain the surface of the sole lifted from that of the ski. Said position can be maintained becausethe boot B is freely urged against plate 10 by the thrust exerted by the rear sprung means which discharge the thrust on roller 14 without being opposed by any impediment. In fact the sole is free to float in the longitudinal direction with respect to the ski, since pin 24 can run in said direction, being contained only transversally by the walls of groove 22 of plaque 17. Also the heel on the boot rests slightly on the ski, being supported by rotary element 26 on which the lower face of base 17 rests. In this way the detachment of the boot by torsion is ensured, in that the boot itself, pivoted on pin 24, can be disengaged beyond an expected stress limit both from plate 10 and from slider 30 said limit being comprised and adjustable within the limits allowed by the safety test regulations.

A ski attachment device having a safty feature that allows disengagement of the boot from the ski in the case of lateral or front falls of the skier. The device comprises a rear unit adapted to be attached to the ski and including a spring for applying a longitudinal forward thrust to the rear of the boot. A front unit includes a plate having a "V" shaped seat to be engaged by a grooved rotatable roller housed in a cavity in a sole of the boot.

BACKGROUND OF THE INVENTION Field of the Invention This invention relates generally to surgical prostheses for the enhancement of appearance and operation of organs, and more particularly to a penile prosthesis enabling a damaged penis or poor penis function to be restored to a satisfactory sexual function. Description of Related Art A prosthesis for implantation into a penis to provide rigidity and improve dimensions is known in the art. Such a prosthesis may include an elongated, malleable rod portion which is housed within a generally tubular, physiologically inert plastic body. The malleable rod portion enables the prosthesis to conform to a variety of shapes by bending or twisting it. During intercourse the prosthesis will maintain the penis in an erect state, and afterwards the penis may be positioned and maintained in a more convenient and comfortable position. Finney, U.S. Pat. No. 4,204,530 describes a prosthesis with a sleeve for increasing the penile diameter, and which includes a flexible sheet of soft, physiologically acceptable material, the sheet being of sufficient length when formed in the general shape of a cylindrical sleeve to extend from the glans penis to the base of the penis and of a width which is insufficient to completely encircle the penis, but is sufficient to cover the corpora cavernosa. Improved rod-type penile prostheses may have a relatively stiff proximal portion for positioning inside the corpora cavernosa adjacent the pubis for supporting the prosthesis, a longer relatively stiff distal portion for positioning in the corpora cavernosa of the pendulous penis, and a hinge separating the distal and proximal portions. Masters, U.S. Pat. No. 4,669,456 describes a penile prosthesis which comprises an elastomeric rod and a metal wire coil coaxially imbedded within at least a portion of the rod. Subrini, U.S. Pat. No. 6,015,380 describes a prosthesis which can be used to increase penile volume. Moreira de Azeredo, WO 86/01398 describes a penile rigidity prosthesis for the treatment of erectile impotence in men including at least one penile prosthesis comprising an elongated malleable cylindrical body adapted to be surgically placed in the corpora cavernosa. The prior art teaches the use of a subcutaneously placed prostheses to rigidize the penis, but does not teach the use of certain contours that provide structural advantages nor a means for restricting flow through the dorsal vein, or a means for preventing axial movement or sliding of the prosthesis relative to the penis' long axis. The present invention fulfills these needs and provides further related advantages as described in the following summary. SUMMARY OF THE INVENTION The present invention teaches certain benefits in construction and use which give rise to the following objectives. A penile prosthesis may have a cylindrical, elongated body providing a wall thickness varying circumferentially from a maximum thickness at its top surface, to a minimum thickness along its bottom surface. The wall thickness may further vary longitudinally from a maximum thickness at a proximal end of the device to a minimum thickness at a distal end. The apparatus is preferably made of silicone rubber and has a length and size enabling subcutaneous implantation around the corpora cavernosa providing sufficient rigidity for enabling coitus while still being flexible enough to be conveniently positioned when the penis is flaccid. An objective of the described and claimed prosthesis is to provide rigidity to the human penis so as to enable coitus. A further objective is to provide an appropriate tapered appearance. A still further objective is to enable surgical implantation without removal of existing organ portions or related tissues. A yet further objective is to prevent the prosthesis from moving axially after being implanted. A further objective is to provide a means for anchoring the distal end of the prosthesis. An important objective is to stem the flow of blood out of the penis during coitus. Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings illustrate the present invention. In such drawings: FIG. 1 is a perspective view of the described and illustrated prosthesis; FIG. 2 is a perspective view of a left half thereof; FIG. 3 is a perspective view of a gauze sheath thereof; FIG. 4 is a side elevation view thereof; FIG. 5 is a rear elevation view thereof; FIG. 6 is a distal elevation view thereof; FIG. 7 is a proximal elevation view thereof shown with a flaccid penis; FIG. 8 is a further proximal elevation view thereof shown with engorged penis; and FIG. 9 is a cross-sectional view of the human penis. DETAILED DESCRIPTION OF THE INVENTION The above described drawing figures illustrate the invention in at least one of its preferred embodiments, which is further defined in detail in the following description. The invention is a penile prosthesis, of silicone rubber or an equivalent material, which may be implanted subcutaneously in the human penis 5 . FIG. 9 is a section illustrating the anatomy of penis 5 and showing in particular, the dorsal vein 6 a , the deep dorsal vein 6 b , the dorsal artery and nerve 6 c , the corpus cavernosum penis 6 d , the profunda artery 6 e , the corpus spongiosum and urethra 6 f , the tunica albuginea 6 g , the intercavernous septum of buck's fascia 6 h , the tunica albuginea of corpus caversosum penis 6 i , the buck's fascia 6 j , the dartos fascia 6 k , and the skin 6 l which is the outer layer of penis 5 . The prosthesis may have a cylindrical body 10 of a selected longitudinal length aligned with the long axis 4 of penis 5 , and may be open at both its proximal end 20 (nearest to the testacies), as well as at its opposite distal end 30 (nearest to the glans penis) as shown in FIG. 1 . Body 10 may have an inside surface 50 and an outside surface 60 and may be formed as a single integral part with two joined halves 10 A, 10 B or alternately it may be formed as two separate halves 10 A, 10 B which may be later joined together as shown in FIG. 1 . Halves 10 A, 10 B may be mirror images of each other as shown and may be joined prior to or during implantation into penis 5 . The prosthesis implantation process is taught in Finney, U.S. Pat. No. 4,202,530 which is hereby incorporated into the present application by reference. Thus, it is clear that the prosthesis can be formed to have a size and shape adapted for subcutaneous implantation below exterior skin 6 l and adjacent to buck's fascia 6 h . The prosthesis may extend from the base of penis 5 at its proximal end 20 to the glans penis (not shown) at distal end 30 . Both inside surface 50 and outside surface 60 may have a silicon net sheeting 70 imbedded just under these surfaces as shown in FIGS. 1 and 2 , wherein net sheeting 70 may extend continuously over and/or under both halves 10 A, 10 B and thus function as a hinge between the halves along joining line 100 . Halves 10 A and 10 B may therefore move between the two attitudes shown in FIGS. 7 and 8 . The prosthesis, when in place around buck's fascia 6 j , may be anchored using sutures joining net sheeting 70 to buck's fascia 6 j or to tunica albuginea 6 g , or both. As shown in FIGS. 1 and 2 , a press-rib 15 , of silicone rubber or equivalent material, may be joined to body 10 and, or to net sheeting 70 , or both, along joining line 100 . Press-rib 15 may extend only partially or fully over the length of body 10 . The hardness of the material of press-rib 15 is selected to be effective in the compressing action shown in FIG. 8 . The function of press-rib 15 will be discussed below in conjunction with descriptions of FIGS. 6-8 . Body 10 may have a wall thickness that varies circumferentially from a maximum thickness along joining line 100 in FIG. 1 , to a minimum thickness along bottom edges 90 . It should be clear that FIG. 1 represents body 10 when the two halves 10 A, 10 B are joined along joining line 100 . The wall thickness of body 10 further may vary longitudinally from a maximum thickness at proximal end 20 , to a minimum thickness at distal end 30 . Edges 90 may be spaced apart as shown in FIGS. 1 and 6-8 and this gap may extend the full length of body 10 . The thicker wall at proximal end 20 , when placed adjacent to the base of the penis provides the advantage of improved rigidity of the prosthesis, and the thinner wall at distal end 30 , adjacent to the glans penis, allows for improved movement of the glans penis. The uniform taper from proximal end 20 to distal end 30 provides improved flexibility of the penis when flaccid. The thicker wall along joining line 100 provides greater structural strength where the highest compressive forces occur during coitus. The circumferential taper provides improved flexibility of the penis and a more natural penile conformation and appearance as well as improved blood flow in general since the prosthesis wall may be quite thin near the glans penis. The important overall result of the conformation of the prosthesis is that it uses a relatively small amount of material while achieving sufficient rigidity and blood flow. The use of net sheeting 70 provides a wide range of choices as to placement of sutures. The use of split halves 10 A, and 10 B facilitates implantation and provides the opportunity to use asymmetrical halves as may be necessary for repair of damaged or misshaped organs. The space between the bottom longitudinal edges 90 allows the penis to expand without restraint, see FIG. 8 . The interior space within body 10 is preferably oblate, as is the human penis 5 with height greater than width as shown in FIGS. 6 and 7 with a preferred ratio of height to width of approximately 1.12. It has been found that this form enables improved blood flow as well as a more comfortable fit to the shape of the penis. As shown in FIG. 1 , body 10 may be fitted with a gauze sheath 110 at distal end 30 and it may be fixed thereto by sutures 112 as also shown. FIGS. 3-5 show that gauze sheath 110 may have the same shape as the distal end 30 of body 10 so that gauze sheath 110 may be fitted up against the terminal edge of distal end 30 and may lay against both inner surface 50 as well as outer surface 60 of body 10 so that it does not produce a bulky area adjacent to the glans penis and provides an improved implantation. Gauze sheath 110 provides a functional means for suturing the distal end 30 of body 10 to the buck's fascia 6 h so that body 10 is unable to move longitudinally. FIG. 6 shows the prosthesis as viewed from the distal end 30 looking toward the proximal end 20 while FIGS. 7 and 8 show the prosthesis as viewed from the proximal end 20 looking toward the distal end 30 and additionally show buck's fascia 6 h in dashed outline. Skin 6 l is not shown in FIG. 6, 7 , or 8 . Deep dorsal vein 6 b is shown located at the 12 o'clock position (under joining line 100 ) in FIGS. 7 and 8 , whereas FIG. 7 represents a flaccid penis 5 while FIG. 8 represents an erect or engorged penis 5 . It is shown that press-rib 15 compresses deep dorsal vein 6 b to slow outward blood flow during the erection process and in order to maintain the erect condition. While the invention has been described with reference to at least one preferred embodiment, it is to be clearly understood by those skilled in the art that the invention is not limited thereto. Rather, the scope of the invention is to be interpreted only in conjunction with the appended claims.

A subcutaneous prosthesis for a penis provides two sides of an elongated cylinder, the sides hinged along a top longitudinal edges of the sides. One end of the prosthesis has a gauze sheath providing a means to secure the prosthesis from moving relative to the corpora cavernosa around which it is placed. When the penis is erect it grows in girth thereby causing the two sides of the cylindrical prosthesis to spread divergently and forcing a press-rib against the deep dorsal vein of the penis, thereby restricting blood flow.

SUMMARY OF THE INVENTION According to the invention, the harvester is provided with coupling means by which it can be coupled with the front of a tractor such as disclosed in U.S. Pat. Nos. 3,721,077; 3,720,047 and 3,878,956 the disclosures of which are incorporated by reference. In operation, the machine is located in front of the tractor and further coupling means are provided for transporting the machine in a position differing by at least substantially 90° from the operational position of the machine. By means of this construction the machine in operation as a whole can be arranged in front of the tractor, whereas for transport purposes the machine can be located to the rear of the tractor and transported lengthwise. For a better understanding of the invention and to show how the same may be carried into effect, reference will be made by way of example to the accompanying drawing. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a harvester attached to the front of the tractor; FIG. 2 is a side elevational view in the direction of the arrow II in FIG. 1; FIG. 3 is a plan view of the harvester in the transport position; FIG. 4 is an enlarged elevational view taken on the line IV--IV in FIG. 1; FIG. 5 is an enlarged elevational view taken on the line V--V in FIG. 1; and FIG. 6 is a fragmentary plan view in section of the coupling gear between an outermost and a central unit of the machine. DESCRIPTION OF THE PREFERRED EMBODIMENT The harvester 1 shown in the Figures, forming a combine harvester, is attached in operation to the lifting device at the front of a tractor 2. The tractor 2 has three pairs of aligned wheels 3, the foremost and hindmost wheels being steerable wheels. The tractor 2 comprises a cabin 4 at the front. The harvester 1 comprises four identically constructed units 5 arranged side-by-side. The units cooperate with one another in operation and each includes a crop moving, threshing and cleaning mechanism. One of the units will be described more fully hereinafter. Referring to FIG. 1, two units 5 are arranged on either side of the longitudinal center line a of the tractor 2. Each unit 5 comprises at least one substantially horizontal, hollow frame beam 6 extending in operation transversely of the intended direction of movement of the machine and having in this embodiment a square section (FIG. 5). To the frame beam 6 are fastened longitudinal beams 7 extending in operation in the intended direction of movement A and having, in plan, a straight shape, but viewed from aside, they are bent near the centers, the foremost portion being inclined downwardly. The front ends of the beams 7, which are also hollow, are interconnected by means of a hollow transverse beam 8 of square section. The frame formed by the beams 6, 7 and 8 is provided on its sides with vertical walls 9 of sheet material, which are, viewed from aside, inclined at the front from top to bottom and which are slightly rounded off on the bottom side to the rear. At the top side the sidewalls 9 of a unit 5 are interconnected by a plate forming a top wall 10. The wall 10 is bent at the front in a downward direction over a given distance and joins a transverse joint 11 between the walls 9. Between the walls 9, at the front, just behind the bent-over front end of the top wall 10 a threshing drum 12 is arranged with its rotary shaft 13 extending in operation transversely of the direction of movement A. A threaded jacket or concave 14 co-operates with the threshing drum 12. Behind the threshing drum 12 and above the concave 14 a straw deflector 15 is provided. A shaker 16 is arranged behind the concave 14. Beneath the shaker 16 a cleaning device 17 is arranged. The air is supplied to the cleaning device through a transverse chute 18 located in front of the cleaning device and opening out beyond the sidewall of the unit and terminating in an upwardly extending channel 19, which joins the housing of a blower 20, which is arranged near the top side on the unit. It is apparent from FIG. 1 that with the units located on either side of the longitudinal center line a of the tractor 2 the respective blowers 20 are located on the sides remote from the longitudinal center line. A plate 21 joins the threshing concave 14 and extends substantially in the form of an S inclined downwardly and forwardly, viewed from aside. The bottom edge the plate 21 is provided with a cutting mechanism 22 comprising a finger bar 23 with which part of a cutter bar 24 common to all units is adapted to co-operate. Above the cutting mechanism 22 a reel 26 is arranged by means of arms 25. The arms 25 are adapted to pivot about axes coinciding with the rotary axis 13 of the threshing drum 12. The reel 26 can be displaced vertically by means of the pivotable arms 25 with the aid of a hydraulic setting cylinder (not shown). Near the ends of the transverse beam 8 pairs of plates 27 extend upwardly and forwardly, between which parallel arms 30 forming a parallelogram structure are pivotally arranged by means of pins 28. The arms 30 have their other ends pivotally connected by means of pins 28 with an upright sleeve 31. The sleeve 31 accommodates a pivotable shaft 32. At the lower end the shaft 32 is provided with a downwardly inclined bracket 33, between the limbs of which is arranged a ground wheel 34. In this way two castor ground wheels 34 are fastened at a given distance from one another near the ends of the beam 8. In a similar manner castor ground wheels 34 are arranged by means of pairs of plates 35 on the hindmost frame beam 6. Between the arms 30 an upright hydraulic setting cylinder 36 is arranged between the lower arm 30 of the respective parallelogram structures 29 and the top side of a supporting plate 27 or 35 respectively, for adjusting the position of the ground wheels 34 with respect to the respective beams 6 and 8 and hence for regulating the height of the cutting mechanism 22 above the ground. On the facing sides, at the level of the beams 6 and 8, between the walls 9 of adjacent units 5 pairs of tags 37 and 38 respectively are arranged so that they overlap over a given distance and are interconnected by means of pivotal pins 39, whose longitudinal center lines are in line with one another (FIG. 4). The longitudinal center lines b of the pins constitute in operation pivotal axes extending parallel to a plane in the direction of movement A between the respective units 5, said axes being inclined to the rear. The cutting mechanism 22 comprising for each unit 5 a finger bar 23 with which the common cutter bar 24 is adapted to co-operate, is constructed so that it is flexible at least in the junctions of the parts because the common cutter 24 is made from flexible material. The resultant flexibility of the cutting mechanism 22 is sufficient for enabling a restricted deflection about the aforesaid pivotal axes between the respective units 5 in operation so that despite the large working width of the machine an effective adaptation to any unevennesses of the ground can be obtained. On the side remote from the longitudinal center line a of the tractor 2 the central units are provided with an endless belt-type elevator 41 accommodated in a housing 40. On the lower side, the housing 40 joins, through a flexible connection 42, an auger conveyor receiving housing 43 extending in operation transversely of the direction of movement A and located beneath the cleaning mechanism 17 of an outermost unit, which housing accommodates an auger delivery conveyor 44 (FIGS. 5 and 6). The housing 40 comprising elevator 41 opens out on the top side in a pipe 45 extending in operation transversely of the direction of movement and accommodating a auger conveyor 46. The pipe 45 opens out above a trough-shaped part 47 holding a worm conveyor 48 and joining the housing of a blower 49 located on the bottom side of an outlet conduit 50. On the other side the housing of the blower 49 is joined by a pipe 51 holding a worm conveyor 52, said pipe joining by its other end the top side of the housing 40 of elevator 41 located on the side of the longitudinal center line a of the tractor 2. The housing 40 of the elevator communicates with the space 43 beneath a central unit. The housing of the blower 49 communicates on the top side through a rotatable member 53 with the outlet conduit 50 comprising an upwardly extending part 54, which terminates at an area at a higher level than the cabin 4 of the tractor in a substantially horizontal part 55, which is slightly inclined downwardly and rearwardly and opens out above the top side of a container 56, which is connected with the three-point lifting device on the rear side of the tractor 2. (FIG. 2). FIG. 1 shows that a delivery structure of the kind described above is provided for each pair of units 5 located on one side of the longitudinal center line of the tractor. The outlet conduits 50 leading to the container 56 are adapted to be turned by means of the rotatable member 53 about an axis which at least substantially coincides with the longitudinal center line of the upright part 54. By turning about said axis through about 90° said outlet conduits 50 can be moved into a position as shown in FIG. 3, which they occupy during the transport of the machine. The container 56 attached to the rear lifting device of the tractor extends downwardly in the form of a funnel, the bottom side being provided with a worm conveyor 57 extending in operation in the direction of movement as far as into the lower end of an upwardly and rearwardly inclined pipe 58 holding a worm conveyor 59 for delivering in conjunction with the worm conveyor 57 the produce fed into the container. For driving the movable parts of the respective units 5 a shaft 60 extending in the direction of movement is arranged at the front between the central units; near its end located on the side of the tractor said shaft is held in a bearing 61, whereas the other end is journalled in a gear box 62, in which the shaft is drivably connected through a bevel gear wheel 63 with a bevel gear wheel 64 on a telescopic shaft 65, which interconnects the rotary shafts 13 of the threshing drums 12 of the central units (FIG. 4). The shafts 13 of the threshing drums 12 of the central units are connected through universal joints and telescopic shafts with the rotary shafts of the threshing drums 12 of the outermost units. The shafts 13 of the threshing drums of the respective units 5 provide for each of the movable parts of the units a drive as shown schematically in FIG. 5. Through endless members and pulleys the straw deflector 15, the shaker 16 and the sieves of the cleaning mechanism 17, the blowers 20 near the top side, the reel 26 and the elevator 41 and the blower 49 are driven for the delivery of the gathered produce. For driving the common, flexible cutter 24 of the cutter mechanism 22 the outer side of one of the outermost units is provided with a transmission also drivably connected with the rotary shaft of a threshing drum 12. The beams 6 of the central units have near the center an opening receiving a pin 66 arranged on a transverse beam 67, which is provided near its center with a trestle 68 for coupling with the three-point lift of the tractor 2. The pins 66 are locked in the apertures of the beams 6 by means of safety pins 69 (FIG. 5). The beam 67 is provided for each of the central units with a screening plate 70, which is bent over on the top side towards the interior of a unit. The plates 70 prevent tailings emanating from the shaker 16 from striking the tractor cabin. In operation, the machine is coupled by the coupling means formed by the trestle 68 on the longer side of the machine with the three-point lift on the front side of the tractor, while the driving shaft 60 is connected through an auxiliary shaft 71 with the power take-off shaft of the tractor for driving the respective movable parts of the units via the transmissions described above. By means of the hydraulic setting cylinders 36 of the parallelogram structures 29, which cylinders like the hydraulic cylinders of the respective reels 26 communicate in a manner not shown with the hydraulic system of the tractor, the position of the ground wheels 34 can be adjusted with respect to the frame formed by the beams 6 to 8, the height of the cutting mechanism 22 above the ground being thus determined. During the movement of the machine in the direction of the arrow A it is completely located in front of the tractor and a strip of crop having a width four times the width of one unit, hence a width of 12 meters is cut by the respective cutting mechanisms of the units relatively movable by means of the pins 66 with respect to the transverse beam 67 and by means of the pins 39 relative to one another. The cut crop is conducted by the respective reels 26 along the upwardly extending plate 21 within reach of the respective threshing drums 12. The threshed produce is cleaned by means of the straw shaker 16 and cleaning device 17 of each unit and collected in the spaces 43 located beneath the respective units, in which the worm conveyors 44 discharge the produce via elevator 41 and the delivery device into the container 56 on the rear side of the tractor. When the container 56 is filled it is discharged into a wagon via the aforesaid worm conveyors 57 and 59, which may be driven by the power take-off shaft of the tractor, after which the harvesting operation can be continued. In operation, the assembly is readily steerable owing to the steerability of the front and rear wheels 3 of the tractor 2. The cabin 4 at the front of the tractor allows the driver to have a satisfactory survey of the operations to be carried out. If the machine described above has to be transported, the container 56 is disengaged from the rear side of the tractor and after the respective outlets 50 have been turned into the position shown in FIG. 3 the machine is discoupled from the front of the tractor. Subsequently, the rear side of the tractor is coupled with the tiltable coupling means 72 arranged on a sidewall of one of the outermost units so that the machine may be transported in its direction of length as is shown in FIG. 3. The castor ground wheels 34 near the front and rear sides of each unit automatically turn into a position differing by 90°. If desired, locking means may be provided for fixing at least the hindmost pairs of ground wheels of the unit which is hindmost in operation after having been turned through 90°. For transporting the machine the container 56 may be provided on the rear side with a draw hook with which the machine can be attached. In this case the container need not be disengaged. The construction depicted above provides a harvester, particularly a combine harvester of large working width, comprising a plurality of--preferably four--units located side-by-side in operation and being capable in operation of effectively matching unevennesses of the ground by turning about the aforesaid pins 39 with respect to one another, the cutting mechanism 22 comprising the flexible cutter 24 allowing such a turn. The machine can be transported along the road without causing any danger to the further traffic. The invention is not restricted to the foregoing specification but also relates to all details and equivalents thereof whether described or not described.

A harvester machine includes a plurality of harvester units that can be positioned side-by-side in a row that extends across the direction of operative travel in front of a tractor. The tractor is connected to a first coupling to push the machine when processing crop and a second coupling at one side of the machine can be used to tow the machine during transport; the units then being located one behind the other. Each unit includes cutting, threshing and cleaning means and a delivery device communicates with the units to remove grain through one or more outlets that extend over the tractor to a rear container. The units are interconnected by pivot connections at their sides with pivot axes extending in the direction of operative travel. Adjustable castor wheels support the units at the desired height and a common drive from the tractor engages the various threshing, cleaning, mowing and delivery devices including blowers.

FIELD OF THE INVENTION [0001] The present invention generally relates to clothing, and more particularly to garments having an inside-out appearance. BACKGROUND OF THE INVENTION [0002] Garments can be made using many different fabric types and can come in a variety of styles. Fabrics used in garments often have a so-called right side and a so-called wrong side, the right side indicating the side of the fabric normally shown on the outside of the garment when worn and the wrong side indicating the side normally hidden from view. [0003] When making a garment, the fabric can be laid out and pattern pieces can be cut from the fabric. Multiple pattern pieces of various sizes and shapes can be created from the fabric, usually by cutting the fabric along a predetermined path. The pattern pieces are used to create the shape of the garment by attaching the pattern pieces together at predefined locations. A variety of attachment mechanisms can be used, including numerous stitching techniques, as is known in the art. [0004] As mentioned above, garments are usually created with the right side of the fabric displayed on the outside of the garment. Fasteners are used on the garment to facilitate wearing and are oriented to encourage wear of the garment wherein the right side of the fabric is shown on the outside of the garment. Some fasteners useful in wearing garments include buttons, zippers, and belt carriers. Any given garment can be made having a combination of various fasteners. [0005] Some garments can also be made having a number of functional elements such as pockets and belt carriers. Pockets can be made having a number of different configurations, such as a panel pocket, pocket bag, and coin pocket. The pockets can be attached by sewing and/or or can be riveted. Likewise, belt carriers can be sewn, stitched or otherwise attached to add to the functionality or appearance of the garment. [0006] When a garment is turned inside-out it can become difficult to continue full use of the garment. For example, in some garments fasteners are meant to be used when a person wears the garment conventionally and are not intended to be functional when the garment is worn inside-out. Likewise, features such as pockets or belt carriers can be difficult or impossible to fully use when the garment is worn inside out. Because of this, it can sometimes be difficult to properly wear a garment inside-out. [0007] In view of this background, the need remains for garments intended to be worn with an inside out appearance. The present invention is addressed to these needs. BRIEF DESCRIPTION OF THE DRAWINGS [0008] Although the characteristic features of this invention will be particularly pointed out in the claims, the invention itself, and the manner in which it may be made and used, may be better understood by referring to the following description taken in connection with the accompanying figures forming a part thereof. [0009] FIG. 1 a depicts the front view of a pair of pants. [0010] FIG. 1 b depicts the back view of a pair of pants. [0011] FIG. 2 depicts a close-up view of the top of the pair of pants of FIG. 1 a. [0012] FIG. 3 depicts another close up view of the top of the pair of pants of FIG. 1 a. [0013] FIG. 4 a depicts another close up view of the top of the pair of pants of FIG. 1 a. [0014] FIG. 4 b depicts another close up view of the top of the pair of pants of FIG. 1 a. DETAILED DESCRIPTION [0015] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, and alterations and modifications in the illustrated devices, and further applications of the principles of the invention as illustrated therein are herein contemplated as would normally occur to one skilled in the art to which the invention relates. [0016] Certain embodiments of the present invention provide novel arrangements of garments having an inside out appearance and/or provide for inside-out fashion. Furthermore, certain embodiments of the present invention provide an aesthetic appearance and feel which are pleasing to some people and can be unisex or designed specifically for men, women, or children. Novel approaches to providing fasteners on the wrong side of fabric on the outside of garments provide useful garments having an inside-out appearance. As used herein, the term ‘garments’ includes but is not limited to pants, slacks, jeans, shirts, blouses, skirts, jackets and hats. Also as used herein, the term ‘fasteners’ includes but is not limited to buttons, rivets, zippers, hooks, hook and loop fasteners sometimes referred to as VELCRO, snaps, and belt carriers. [0017] Turning now to FIGS. 1 a and 1 b, a pair of pants 100 is shown having the appearance of a conventional pair of pants which have been turned inside-out. Pants 100 of the illustrated embodiment are constructed from conventional denim fabric. In other embodiments, however, the pants or other garments may be formed from another fabric type. As used herein, the term ‘fabric’ includes but is not limited to woven or knitted fabrics such as denim, duck cloth, cotton and cotton blends, corduroy, velveteen, linen and linen blends, wool and wool blends, double knits and canvas. The pants 100 are constructed such that the right side of the fabric faces the inside of pants 100 . Additionally, the seams facing the inside of the pants 100 appear as they would appear on the outside of a conventional pair of pants. As used herein, ‘conventional pair of pants’ and ‘conventional pair of jeans’ is intended to encompass a pair of pants such as standard jeans and DOCKERS manufactured by LEVI STRAUSS that are constructed using the right side of fabric showing on the outside of the pants, as is well known in the art. Also as used herein, the term ‘conventional garment’ means a garment that is constructed using the right side of fabric showing on the outside of the garment. The pants 100 are also constructed such that the wrong side of the fabric faces the outside of the pants, giving the pants 100 the appearance of being inside out even though they are not. [0018] Pants 100 include features similar to conventional pants such as pant legs 110 , front pockets 120 , back pockets 130 , coin pocket 140 , fly guard 150 and belt carriers 160 . Some of these features such as coin pocket 140 and belt carriers 160 are attached to the outside of pants in the illustrated embodiment to add functionality and usability even though the pants provide the illusion of being inside-out. If the pants 100 were merely conventional pants turned inside out, these features would be situated on the inside of the pants 100 . As used herein, the term ‘attached’ includes but is not limited to sewn, stitched, glued, and riveted. When pattern pieces are attached to one another a variety of seams can be created, some of which include flat felled seams and serged seams. [0019] In the illustrated embodiment, side seams 170 are finished having serged seam stitching shown on the outside of pants 100 , contrasted with a conventional pair of pants where the serged seam would be hidden on the inside of the pants. Constructing pants having the serged seam visible on the outside is useful in creating the illusion that a conventional pair of pants has been turned inside out. [0020] In the illustrated embodiment the inseams 180 , crotch seam 190 and back yoke seam 200 utilize a flat felled seam application. It will be understood that inseams 180 , side seams 170 , crotch seam 190 and back yoke seam 200 are created when two pattern pieces are attached together and thus can take on a variety of forms as discussed above. Thus, in other embodiments a crotch seam can be created using a serged seam application to name just one example. Likewise, a back yoke seam can be created by attaching pattern pieces using double chain stitching to name just one example. [0021] Back pocket 130 is attached in an inside out manner to the outside of pants 100 to add functionality and usability. The use of back pockets in the illustrated embodiment can be contrasted with a conventional pair of pants that have been turned inside-out. When conventional pants are turned inside-out the back pockets would face the inside and thus be inaccessible to the wearer when the pants are worn. Embodiments of the present invention, however, provide for back pockets useable in a pair of pants having an inside-out appearance. [0022] The pair of back pockets 130 in the illustrated embodiment are patch pockets attached with the wrong side of denim facing the outside of the pants 100 . The inside-out illusion is thus maintained while at the same time maintaining the utility of back pockets. The back pocket hem 220 is turned away from pants 100 thus exposing the right side of the denim of back pocket 130 . Exposing the right side of the fabric in the back pocket hem 220 is also useful to highlight the outline of back pocket 130 and provide visual contrast. The back pocket 130 is thus constructed the same way a back pocket on a conventional pair of jeans would be constructed, but it is attached to the pants 100 with the conventional inside of the pocket facing outward. Providing back pocket 130 as described in the illustrated embodiment is similar to removing a back pocket from a conventional pair of pants and reattaching the pocket to the pants. In other embodiments, back pocket hem 220 can be turned toward the inside of pants 100 , much as the hem would be created on a conventional pair of pants. [0023] To further create the appearance of an inside-out pair of pants, the pant leg hem 230 is turned toward the outside of pants 100 with the right side of the fabric showing. Exposing the right side of the fabric in the pant leg hem 230 is useful to, among other things, highlight the bottom of pant leg 110 as well as to provide visual contrast. Because the pant leg hem 230 is turned away from pants 100 , pant leg hem 230 creates the illusion of having been created by simply turning a pair of conventional pants inside-out. The pant leg hem 230 is thus constructed the same way the pant leg hem on a conventional pair of jeans would be constructed, except that the hemmed material is turned to the outside of the pants 120 instead of the inside, as is done with conventional pants. In other embodiments, pant leg hem 230 can be turned toward the inside of pants 100 , much as the pant leg hem would be created on a conventional pair of pants. [0024] Turning to FIG. 2 and examining the illustrated embodiment in more detail, pants 100 include a pair of front pockets 120 comprising front pocket bags 250 as found on the inside of a conventional pair of pants. Front pocket bags 250 are depicted as partially showing on the outside of pants 100 , the remainder of the bag is hidden from view much like a pocket bag of a conventional pair of pants. In a conventional pair of pants, the upper portion 255 of front pocket bag 250 would be concealed by a flap of fabric, typically matching the fabric from which the remainder of the pants 100 are constructed, as is known in the art. Allowing a portion of the front pocket bags to show at the top of the pocket 120 further reinforces the illusion that the pants 100 are inside out. In other embodiments, however, front pocket bags 250 can be attached similar to pocket bags in conventional jeans wherein the bag is hidden from view. [0025] Front pocket hem 260 is formed at the top edges of the pocket 120 opening. Front pocket hem 260 is turned toward the inside of pants 100 , much as the front pocket hem would be created on a conventional pair of pants. In other embodiments, front pocket hem 260 can be turned toward the outside of pants 100 . Exposing the right side of the fabric in other embodiments is useful to, among other things, highlight the front pockets 120 as well as to provide visual contrast. [0026] Front pocket rivets 270 are affixed to each end of front pocket hem 260 in the same areas where rivets are normally found on a conventional pair of jeans. As is known in the art, the front pocket rivets 270 comprise a rivet front and a rivet back which are mechanically coupled to one another with material thereby secured therebetween. Front pocket rivets 270 are attached in an inside out configuration wherein the back side of the rivet normally hidden from view on the inside of a conventional pair of pants is now shown on the outside of the illustrated embodiment. This effect can be created by actually riveting the pants with the rivet back on the outside of pocket 120 and the rivet front on the inside of pocket 120 , or the rivet back may be on the inside pocket 120 and the rivet back may be on the outside of pocket 120 (i.e. the same orientation used in conventional pants), except that the rivet front is flipped over before securing it to the rivet back, such that the rear side of the rivet front faces outward from the outside of the pants 120 . Placing rivets in the same orientation as conventional pants provides the protruding piece of the rivet to face out and provide maximum comfort and wear Because front pocket rivets 270 are attached backwards compared to a conventional pair of pants, the illustrated embodiment creates the illusion of having been created by turning a conventional pair of pants inside-out. In other embodiments, either the rivet front or the rivet back could be attached to the outside of pants 100 thus creating the impression that a rivet has been mechanically coupled. [0027] Coin pocket 140 is sewn as a patch pocket and is attached to front pocket bag 250 with the wrong side of the fabric showing on the outside. The inside-out illusion is thus maintained while at the same time providing for the usefulness of coin pockets. Coin pocket hem 280 is turned away from the pants 120 thereby exposing the right side of the fabric on the outside. Exposing the right side of the fabric in the coin pocket hem 280 is useful to, among other things, highlight the outline of coin pocket 140 as well as to provide visual contrast. In other embodiments, coin pocket hem 280 can be turned toward the inside of pants 100 , much as the coin pocket hem would be created on a conventional pair of pants. Coin pocket 140 is attached to pants using coin pocket rivets 290 attached to the top comers of coin pocket hem 280 . Furthermore, three sides of coin pocket 140 are attached to pants 100 by stitching. In some embodiments, only one rivet may be used if only one corner of the top of the coin pocket were normally visible in any given design of pants 100 . [0028] Coin pocket rivets 290 are attached in an inside out configuration wherein the side of the rivet normally hidden from view on the inside of a conventional pair of pants is now shown on the outside of the illustrated embodiment, as discussed hereinabove with respect to the front pocket rivets 270 . Because coin pocket rivets 290 are attached backwards compared to a conventional pair of pants, the illustrated embodiment creates the impression of having been created by turning a conventional pair of pants inside-out. Coin pocket rivets can be oriented similar to front pocket rivets discussed above. The coin pocket 140 is thus constructed the same way a coin pocket on a conventional pair of jeans would be constructed, but it is attached to the pants 100 with the conventional inside of the pocket facing outward. [0029] Turning now to FIG. 3 , waistband 300 displays a single chain stitch on the outside of pants 100 as would be found on the inside of the waistband of conventional denim pants. Waistband 300 in the illustrated embodiment shows the right side of fabric. Exposing the right side of the fabric in waistband 300 is useful to, among other things, highlight the outline of waistband 300 as well as to provide visual contrast. In addition, because the waistband 300 displays the right side of the fabric it creates the illusion of having been created by simply turning a pair of conventional pants inside-out. In other embodiments, waistband 300 can be attached to pants 100 showing the wrong side of the fabric. In some embodiments waistband 300 can display stitching on the outside similar to the outside of a conventional pair of pants. In other embodiments waistband 300 can display stitching on the inside similar to the inside of a conventional pair of pants. In other embodiments, waistband stitching can include single chain stitching, double chain stitching, or any other types of stitching. [0030] Belt carriers 160 are shown in the illustrated embodiment sewn onto the outside of waistband 300 . Belt carriers in the illustrated embodiment are made having the wrong side of fabric shown on the outside of pants 100 creating the appearance of an inside-out pair of pants. In addition, belt carrier tab 305 is shown oriented away from waistband 300 in contrast to a conventional pair of pants where belt carrier tab 305 would be oriented toward waistband 300 . Orienting belt carrier tabs 305 away from the waistband also contributes to the inside-out appearance. In other embodiments, carrier tab 305 can be oriented toward waistband 300 . In still other embodiments, belt carriers 160 can be provided using the same configuration as found on a conventional pair of pants wherein the right side of the fabric is shown on the outside of the pants and wherein carrier tab 305 is oriented towards waistband 300 and therefore hidden from view. Exposing the right side of the fabric in belt carriers 160 is useful to, among other things, highlight the outline of belt carriers 160 as well as to provide visual contrast. Although the belt carriers in this embodiment appear conventional, the pants maintain an overall appearance of inside-out and are not detracted by belt carriers in this embodiment. In still further embodiments, belt carriers 160 can be provided using a similar configuration as found on a conventional pair of pants wherein the right side of the fabric is shown on the outside of the pants but wherein carrier tab 305 is oriented away from waistband 300 and therefore hidden from view. [0031] Belt carriers 160 are attached in the illustrated embodiment to allow for functionality and usability, such as for use with a belt, as contrasted to a conventional pair of pants turned inside-out wherein the belt carriers would be located on the inside of the pants thus impeding and/or preventing use of a belt. Carriers provided in this way permit normal use of pants 100 such that the pants may be readily worn by threading a belt through the carriers as can be done in a conventional pair of pants. As used herein, the term ‘normal use’ refers to, among other things, the use that is typical of a conventional pair of pants such that pockets, belt carriers, buttons, and zippers are readily accessible from the outside. For example, if a conventional pair of pants are turned inside-out it can be difficult and/or impossible to continue use of items such as pockets, belt carriers, buttons and zippers because these items have been turned towards the inside of the pants and are not readily accessible with a person's hands or fingers. To continue use of these items in a conventional pair of pants turned inside-out therefore requires changes in the normal use of the pants. Embodiments of the invention described herein, however, provide normal use of pants wherein pockets, belt carriers, buttons, and zippers can be readily accessible from the outside. [0032] Carrier hem 310 is folded toward waistband 300 in the illustrated embodiment. In some embodiments, carrier hem 310 can be folded away from the waistband. Stitching 315 is added to the outside of belt carriers 160 to provide the appearance of a belt carrier hem folded away from waistband 300 . Because belt carrier hems are normally configured towards waistband 300 and therefore hidden from view, providing stitching in this way mimics the appearance of a carrier hem folded away from the waistband and therefore contributes to the illusion of inside-out pants. [0033] With regards to belt carriers, it will be understood that any combination of right side/wrong side fabric, orientation of carrier tabs towards or away from waistband, and/or additions of hem stitching, can be made within the scope of the invention. [0034] Turning now to FIGS. 4 a and 4 b, a close up view of the fly and button region of pants 100 is shown. Button 320 is attached to the outside of waistband 300 similar to buttons attached to conventional pairs of pants. Buttonhole 330 is created in the complementary side of the waistband to receive button 320 . Button 320 and buttonhole 330 are positioned for functionality and usability so as to permit fastening of the pants around a person's waist as contrasted to a conventional pair of pants turned inside-out wherein the button would then be facing the inside of the pants, creating difficulties in fastening the pants. Buttons attached to pants as described herein thus provide for pants having the illusion of being inside-out but having the usefulness of a conventional pair of pants. [0035] Fly guard 150 , traditionally found on the inside of conventional pairs of pants, is exposed on the outside of the garment 100 . The fly guard 150 is configured showing the right side of the fabric on the outside of pants 100 and is attached with bar tack 152 to hold fly guard 150 in place. In other embodiments fly guard 150 can be constructed showing the wrong side of fabric. Fly guard 150 is finished with serged seam 156 . Because fly guard 150 displays the right side of fabric as well as the fly guard construction on the outside of pants 100 , the illustrated embodiment provides the impression of a conventional pair of pants turned inside-out. [0036] Zipper 340 is turned out in a normal manner and is attached to fly guard 150 . Zipper 340 is positioned for functionality and usability such that zipper pull 350 can be used to open the fly of pants 100 as contrasted to a conventional pair of pants turned inside-out wherein the zipper pull would be located on the inside of the pants thus impeding and/or preventing use of the fly. Therefore, while the zipper of the pants 100 is positioned and used the same as a conventional pair of pants, placement of the fly guard on the outside of the pants 100 and having the right side of the fly guard fabric facing the outside of the pants 100 creates the impression of a conventional pair of pants turned inside out. [0037] Other types of garments can be created using the invention as disclosed herein. For example, blouses and jackets could be made having seams and fabric constructed to provide an inside-out appearance while maintaining the functionality of a blouse or jacket having fasteners such as buttons which are oriented to the outside of the inside-out appearing garment. Some garments could also be made using non-traditional attachment methods as described above. [0038] While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. Only certain embodiments have been shown and described, and all changes, equivalents, and modifications that come within the spirit of the invention described herein are desired to be protected. Any experiments, experimental examples, or experimental results provided herein are intended to be illustrative of the present invention and should not be considered limiting or restrictive with regard to the invention scope. Further, any theory, mechanism of operation, proof, or finding stated herein is meant to further enhance understanding of the present invention and is not intended to limit the present invention in any way to such theory, mechanism of operation, proof, or finding. Thus, the specifics of this description and the attached drawings should not be interpreted to limit the scope of this invention to the specifics thereof. Rather, the scope of this invention should be evaluated with reference to the claims appended hereto. In reading the claims it is intended that when words such as “a”, “an”, “at least one”, and “at least a portion” are used there is no intention to limit the claims to only one item unless specifically stated to the contrary in the claims. Further, when the language “at least a portion” and/or “a portion” is used, the claims may include a portion and/or the entire items unless specifically stated to the contrary. Finally, all publications, patents, and patent applications cited in this specification are herein incorporated by reference to the extent not inconsistent with the present disclosure as if each were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.

Garments having an inside-out appearance are disclosed and are designed to be inside-out and fashionable. Unique fasteners, belt carriers and modifications of pockets make possible wearing a garment having an inside-out appearance. When a conventional garment is turned inside out many features such as belt carriers, zippers, and pockets become difficult or impossible to use when the garment is worn. Garments disclosed herein permit full use of features such as belt carriers, buttons, zippers, and pockets.

TECHNICAL FIELD [0001] This invention relates a therapeutic patch for ophthalmologic and cosmetic use that provides therapy to the region where the patch is provided, specifically, the eye region; the therapeutic patch provides at least one therapeutic delivery layer for placement against, for example, the eye region including, e.g., the peri-orbital tissues of a patient, and a non-contacting layer that can be used, for example, to generate heat or moisture for transmission to the surface to which therapy is being applied. As contemplated by the invention, the patches can be pre-packaged in either sterile or non-sterile packing. The invention also includes a kit for at-home care of a region requiring therapy, in a manner that inhibits transmission of infectious agents. BACKGROUND [0002] Eye patches are known in the art. For example, U.S. Pat. No. 4,682,371 discloses a protective eye patch. The '371 patch has several tabs for securing the patch to a patient's eye. U.S. Pat. No. 3,068,863 discloses a patch designed to keep the eye closed. U.S. Pat. No. 3,092,103 discloses a patch with a cushion material at the edge that allows the patient's eye to move underneath the eye patch. U.S. Pat. No. 3,908,645 for an ophthalmic therapeutic pressure bandage with a conformable, permeable carrier tape. [0003] U.S. Pat. No. 6,409,746 discloses an eye pillow that releases steam from its surface applied to the eyes and the area around the eyes. The temperature is 50° C. or lower and has a total weight of 50 g or more. [0004] Several conditions exist for which medical and cosmetic therapy is appropriate. For example, blepharitis, meibomitis, chalazia, and/or styes are common disorders of the eyelids that cause chronic inflammation in the peri-orbita, and are often associated with ocular tear film abnormalities resulting in dry eye symptoms. Symptoms of blepharitis include burning, itching, light sensitivity, and foreign body sensation. Signs include eyelash crusting, ocular discharge, eyelid scaling and swelling, and redness. For example, staphylcoccal blepharatis can have scaling and crusting along the eye lashes. There is no cure for blepharitis and long term treatment is required to keep it under control. Warm compresses, such as a warm washcloth, are used to heat the debris and crust on the lid for 5-10 minutes. After the lid has been warmed, a lid scrub is performed by using a suitable soap, such as Neutrogena or diluted Johnson's Baby Shampoo. Commercially available cleansing pads are available to assist in performing the lid scrub, for example OCuSOFT® Lid Scrubs or Novartis Ophthalmics Eye Scrub®. Following the eye scrub, antibiotics, such as polysporin, tobramycin, or erythromycin can be applied, to alleviate patient discomfort. Another condition for which therapy is appropriate is meibomitis, also known as the meibomian gland dysfunction. Meibomitis is a dysfunction of the meibomian gland that provides an oily layer as a critical component of the eye's natural tear film. [0005] As reported by Olson et al, of the Schephens Eye Institute in Boston, warm moist compress therapy applied to the skin of the closed eyelids increases tear-film lipid layer thickness for subjects with meibodian gland dysfunction by more than 80% 5 minutes after initiating treatment and an additional 20% after 15 minutes of treatment. (See, PMID 12695712, Abstract: “Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction.”). [0006] What is needed is a device that conveniently delivers heat and moisture to at least one eye region, including the eyelids, and is held in place over one or both eyes with a biocompatible adhesive. Furthermore, this device, or an alternative embodiment of the device, can act as a platform for delivery of baby shampoo and any other therapeutic agent based on the type of treatment desired and the severity of the disease process, including for example, steroids, antibiotics and anti-wrinkle and anti-eye bag cosmetic formulations. Additionally, the device can provide a mechanism for easily determining when therapy is being delivered and when therapy is no longer being delivered. SUMMARY OF THE INVENTION [0007] A variably configurable patch for delivering therapy to an eye region is provided that comprised: therapy delivery layer; an aperture for accessing the therapy layer; and an adhesive layer for adhering the patch to a surface. The patch can have a plurality of therapy delivery layers associated therewith. Additionally, the patch can comprise a therapeutic substance within the therapy delivery layer. Therapeutic substances can, for example, be selected from the group consisting of: baby shampoo, antibiotics, polysporin, tobramycin, steroids, prednisone, and anti-aging formulations. Additionally, a heat delivery layer can be provided. In the configuration with a heat delivery layer, it is contemplated that a non-permeable or permeable layer will separate the heat delivery layer from the therapy delivery layer. Additionally, a moisture delivery layer can be provided. As described above, a non-permeable or permeable layer can be provided to separate the moisture delivery layer from the heat delivery layer. Additionally, it is contemplated that layers, either permeable or non-permeable, can separate each of the layers, e.g., one or more therapeutic layers, one or more heat delivery layers, and one or more moisture delivery layers. One or more heat and/or moisture delivery layers might be desirable where heat and/or moisture is to be delivered on, for example, a time released scheduled. The patch of the invention can further comprise a non-irritating, hypoallergenic material which includes sterile or non-sterile water or saline or a therapeutic substance. Additionally, it is contemplated that the therapeutic substance might be activated by the application of heat from the heat delivery layer or moisture from the moisture delivery layer. It is also contemplated that the patch can include a mechanism for displaying, for example, heat delivery status, heat delivery temperature, absence of heat delivery, cooling delivery status, cooling delivery temperature, absence of cooling delivery, etc. [0008] A pre-configured patch for delivering therapy to an eye is disclosed comprising: a layer selected from the group consisting of a heat delivery layer, a moisture delivery layer, and a therapy delivery layer; a skin contacting layer; an adhesive layer covering a portion of the skin contacting layer; and an exterior layer. As disclosed it is contemplated that the second layer is selected from the group consisting of a heat delivery layer, a moisture delivery layer, and a therapy delivery layer. Additionally, a plurality of therapy delivery layers can be provided. The patch can further comprise a therapeutic substance within the therapy delivery layer. Suitable therapeutic substances can include, for example, baby shampoo, antibiotics, polysporin, tobramycin, steroid creams or ointments, such as prednisone, and anti-aging formulations. This patch can, include a heat delivery layer and/or a moisture delivery and a non-permeable or permeable layer to separate the heat delivery layer from either the therapy delivery layer or the moisture delivery layer, or both. As contemplated, the therapeutic layer can be activated with the application of heat and/or moisture provided from either of the heat layer or the moisture layer of the patch. In any configuration, the therapy delivery layer, in contact with the skin, can contain any suitable therapeutic substance, including water or saline. [0009] Kits are also provided for providing ophthalmologic or cosmetic treatment to an eye region housed in a container comprising: an eye patch; a therapeutic layer for an eye patch; an adhesive layer for an eye patch; a therapeutic substance provided within a container. Alternative kit compositions include a kit for providing ophthalmologic and/or cosmetic treatment to an eye region housed in a container comprising: a first eye patch for delivering heat and moisture to the eye region; and a second eye patch for delivering therapeutic substances to the eye region. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a top view of a patch according to the invention; [0011] FIG. 2 is a lower view of a patch according to the invention; [0012] FIGS. 3 A-D are alternative cross-sectional views of the patch taken along the lines 3 - 3 in FIG. 1 , wherein each figure illustrates an alternative embodiment; [0013] FIG. 4 is a block diagram showing the steps of making a patch; [0014] FIG. 5 is a top view of a patch, according to the invention, contained in packaging. [0015] FIG. 6 is a top view of a patch, according to the invention, further including a display capable of indicating delivery of therapeutic temperature range. DETAILED DESCRIPTION [0016] The following description is presented to enable any person skilled in the art to make and use the invention. Various modifications to the embodiments described will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other embodiments and applications without departing from the spirit and scope of the present invention as defined by the appended claims. Thus, the present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein. To the extent necessary to achieve a complete understanding of the invention disclosed, the specification and drawings of all issued patents, patent publications, and patent applications cited in this application are incorporated herein by reference. [0017] FIG. 1 illustrates a top view of a patch 100 according to the invention. As illustrated, the patch 100 can take on a tear-drop shape. Alternatively, the exterior perimeter of the patch 100 can take on other shapes, such as circular, substantially circular, oval, or substantially oval. The shape can be optimized for use on either the right or left eye, or the shape can be optimized for use with either eye. The overall width (measured along the x axis) and height (measured along the y axis) of the patch 100 will vary depending on the size of the patient for which the patch is intended. As shown here, the upper surface of the patch 102 , which is not in contact with the patient, can be selected from the following materials: cotton, synthetic fibers, and/or suitable lint-free material. As will be appreciated by those of skill in the art, depending upon the contents of the various layers of the patch, it may be desirable for the upper surface 102 to be flexible while remaining fairly impermeable. [0018] FIG. 2 illustrates a bottom view of a patch 100 , showing the surface of the patch that is in contact with a patient's eyelid and periorbital skin, according to the invention. As illustrated, the patch 100 has a therapy delivery surface 120 and an adhesive edge 122 for adhering the patch to the skin surface of a patient. The adhesive can be formed of any suitable material that enables the patch 100 to adhere to the skin of the patient, including, for example, hypo-allergenic and latex free adhesive. [0019] As will be appreciated by those of skill in the art, the patch can be assembled in a variety of configurations to achieve the intended result. [0020] As shown in FIG. 3A , an upper surface 102 is provided which can provide a permeable or non-permeable seal for a delivery layer 104 . The delivery layer 104 can be preformed to include, for example, water, polyethylene glycol, butylenes glycol, propylene glycol or iron powder. Alternatively, the delivery layer 104 can be a moisture delivery layer or a heated moisture delivery layer. In that event, the delivery layer 104 , may be formed from two layers, one for generating heat and one for delivering moisture. As will be appreciated by those of skill in the art, delivery layer 104 can, in turn be formed of a plurality of components or layers enabling delivery of more than one therapy to be achieved. The mechanism of heat generation in layer 104 can be accomplished through several approaches. The heat can be generated as a byproduct of an exothermic chemical reaction. Reactants can include various combinations of Butylene Glycol, Sodium Silicoaluminate, Kaolin, PEG 8, Methyl Gluceth 20, Hydroxypropylcellulose, Talc, Acrylates Copolymer, Polyethylene, Methylcellulose, Ethylcellulose, BHT, Tetrasodium EDTA, and Ultramarines. Reactants such as these could be activated by exposure to water. An alternative approach could use iron filings, and could be activated by exposure to the oxygen in air. Another approach could be an external pouch that is activated via a microwave oven and inserted into layer 104 . This pouch could be single or configured for multiple use. [0021] Depending upon the contents of the delivery layer 104 , a permeable or non-permeable layer 110 can be optionally provided. Where the delivery layer 104 is a heat layer, the optional layer 110 would most likely be non-permeable to the materials provided to generate heat. In that instance, the optional layer 110 would be formed of, for example, a water resistant material such as cellophane. Where the delivery layer 104 is designed to deliver only moisture, the optional layer 110 , if present, would most likely be permeable to allow the moisture to reach the eye. In that instance, the optional layer 110 would be formed of any suitable material including, for example, cotton. [0022] Depending upon the intended therapeutic application of the patch 100 , the therapy delivery layer 120 could comprise a variety of materials. For example, a layer of hypoallergenic and/or non-irritating material with sterile or non-sterile water or saline could be provided; a layer of non-irritating material impregnated with a therapeutic substance could be provided; a layer of non-irritating material impregnated with a therapeutic substance activated with the application of heat could be provided; or a layer of non-irritating material impregnated with a therapeutic substance activated with the application of moisture could be provided. The non-irritating material could be any suitable material that is sterile or non-sterile, such as gauze. The impregnating substance could be, for example, baby shampoo; antibiotic, e.g., polysporin, tobramycin, etc.; steroids, e.g. prednisone; anti-aging treatment formulations, e.g., Eyeliss by Sederma, used to prevent puffiness and reduce bags under the eye, Drmazyl by Sederma, used as an anti-aging wrinkle smoothing and cutaneous barrier repair, Sudden Change Eye Gel with Green Tea by Sudden Change, Sudden Change Under-Eye Firming Serum, by Sudden Change, Bio-Performance Super Eye Contour Cream, an anti-wrinkle and anti-dark circle formulation by Shiseido, to name a few. [0023] As illustrated in FIGS. 3 A-B the adhesive edge 122 can be configured such that it encircles a portion of the outer edge of the patch 100 (shown in FIG. 3A ). Alternatively, the adhesive layer 122 can be configured such that it forms a complete layer between the optional layer 110 and the delivery layer 120 (as shown in FIG. 3B ). [0024] In an alternative embodiment, shown in FIG. 3C , a receiving mechanism 140 is provided for filling the delivery layer 120 . Such a mechanism is, for example, an aperture capable of enabling materials to be integrated into the layer 120 . Ideally, the aperture would be sealable such that once the desired material is delivered to the therapeutic delivery layer 120 , the aperture can be sealed to prevent ingress or egress of materials from the delivery layer 120 . In this scenario, the delivery layer 120 could initially be dry and the user would inject, or otherwise permeate, the delivery layer 120 with the substance desired to come into contact with the skin surface. Alternatively, the layer could contain a fluid, such as water, or a catalyst for reacting with the materials delivered. Suitable substances are, for example, those listed above. [0025] In an alternative embodiment, shown in FIG. 3D , a receiving mechanism 142 is provided for filling the delivery layer 104 . Similar to the receiving mechanism 140 described above, a suitable mechanism is, for example, an aperture capable of receiving materials. In this scenario, the delivery layer 104 could be dry and the user would inject, or otherwise permeate, the delivery layer 104 with a substance capable of delivery heat, moisture or both to the patch. Suitable substances are, for example, those listed above. [0026] In the embodiments described above it is contemplated that the filled materials can be inserted in a manner whereby the materials do not come in contact with the patient's skin, e.g., some of the filled materials used for generating heat and/or filled material that are not biocompatible. Additionally, it is contemplated that the patch 100 can be configured such that steam and/or heat is delivered for a prescribed period of time followed by delivery of therapeutic material. In this instance a degradable layer could be provided such that delivery of steam or heat degrades the layer of time such that the degraded layer allows for the delivery of therapeutic material. In this instance, the delivery of the therapeutic layer could occur some time after the beginning of delivering steam and/or heat or some time after the conclusion of delivering steam and/or heat. Persons of skill in the art would be familiar with materials suitable for achieving this objective. [0027] Turning now to FIG. 4 , a flow chart is provided that illustrates the process for determining the configuration of a patch 100 . The first step is to assess the eye and peri-orbital structures including the eye lids, eye lashes, and tear film 400 . A variety of conditions suitable for use of an eye patch of this invention includes, for example, blepharitis, meibomitis, dry eye, rosacea, chalazia and conditions of aging of the peri-orbital structures such as eyelid wrinkles (including the condition commonly known as “crows' feet”) and eyelid “bags” or puffiness. In assessing the eye 400 , a practitioner will determine the amount, if any, and duration of any heat to be applied 410 or steam to be applied 411 . If heat is to be applied, then a suitable heat delivery mechanism or layer will be chosen 420 . Alternatively, if steam is to be applied then a suitable steam delivery mechanism or layer will be chosen 421 . As will be appreciated by those of skill in the art, theses steps can be skipped 422 without departing from the scope of the invention. Additionally, following the step of selecting a heat layer 420 or steam layer 421 the assembled eye patch can be applied to the eye 450 (steps 424 or 426 ) [0028] In another process, after the eye is assessed 400 , a therapy layer can be selected 430 , and then applied to the eye patch 440 . The assembled patch can then be applied to the eye 450 . [0029] When it is determined that both heat and therapy are required, the eye is assessed 400 as described above. The practitioner will then determine the amount and duration of heat to be applied 410 and will select a suitable heat delivery mechanism or layer 420 . Thereafter, the practitioner can select a therapy layer 430 and apply the therapy layer to the eye patch 440 . Once the eye patch has been configured, the assembled eye patch can then be applied to the eye 450 . As will be appreciated by those of skill in the art, a practitioner can perform the process of selecting the therapy layer prior to selecting the heat layer without departing from the scope of the invention. Additionally, the process of selecting the layer and assembling the patch can be performed by the practitioner, e.g., physician or nurse treating a patient, or can be performed in a factory, or using a suitable manufacturing process, such that the practitioner selects a pre-made eye patch containing the desired heat layer and therapy layer and then applies the pre-assembled patch to the patient's eye. Alternatively, the process of selecting and assembling the patch can be performed by the patient. Additionally, whether selected by patient or practitioner, the patch can be self-applied by the patient. [0030] FIG. 5 illustrates a patch 100 which has been preconfigured and placed into a package 150 for delivery to a patient. The package can be sterile or non-sterile in configuration. The patch can be adhered using the adhesive edge 122 to the interior of the package 150 or can be placed on a removable insert within the package. [0031] A variety of kits are contemplated with the invention. In a first kit, one or more patches 100 having the same therapeutic benefit can be provided, e.g. providing heat to warm the moisture and baby shampoo that are in the therapy delivery layer and intended to be in contact with the peri-orbital surfaces. Alternatively, a kit can be provided that provides one or more patches 100 having more than one benefit: e.g., a first type of patch with a first function, such as providing warmth and moisture to the eye, and a second type of patch with a second function, such as providing additional therapy to the surface. Yet another kit contemplated includes a plurality of blank patches 100 which can be loaded with a variety of materials, as described above, to achieve the intended therapeutic benefit. [0032] Turning now to FIG. 6 , an alternative embodiment of a therapeutic patch 100 of the invention is shown. In this embodiment, a therapy indicator 160 is provided. The therapy indicator can be, for example, a thermometer or decal with a temperature sensor that displays an indication of therapy status. Temperature sensing devices come in a variety of forms, and are known in the art. Temperature sensing devices include, for example, thermochromic liquid crystals (TLC), capable of changing colors in response to temperature. TLCs typically show color by selectively reflecting incident white light. The temperature sensitive mixtures in films then reflect colors as they turn from colorless (black against black background) to, for example, red at a given temperature or pass through other colors of the visible spectrum as the temperature increase. See, for example, U.S. Pat. No. 6,257,759. Where the patch 100 includes a therapy indicator 160 , it is contemplated that the therapy indicator is adhered in a manner that protects the therapy indicator from ambient temperature and results in the indicator 160 providing an indication of the temperature of the therapy being delivered or the status of the therapy being delivered. The indicator 160 can, for example, provide a display that indicates the temperature, in either Celsius or Fahrenheit, of the therapy being delivered, or can indicate to the user the status of the patch in a “go-no go” fashion. If the go-no go indication is used, then the use of iconography, such as a “thumbs up” sign when the temperature is in the therapeutic range, and/or an “X” can be used to indicate that the therapy delivery cycle has completed (to accommodate non-English speaking patients), or the use of appropriate words, for example: Done, Fin, etc. [0033] It is also contemplated that the therapy delivery indicator could function as a therapy delivery timer. In that instance, the indicator would indicate completion of therapy at the end of a prescribed period of time. [0034] The foregoing description of embodiments of the present invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations will be apparent to the practitioner skilled in the art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention and the various embodiments and with various modifications that are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and its equivalence.

This invention is directed to a therapeutic patch for ophthalmologic and cosmetic use that provides therapy to the region where the patch is provided; the therapeutic patch provides a therapeutic delivery surface for placement against, for example, the eyelid and peri-orbital structures of a patient, and a non-contacting surface that can be used, for example, to generate heat and/or moisture for transmission to the surface to which therapy is being applied. The invention also includes a kit for at-home care of a region requiring therapy, in a manner that inhibits transmission of infectious agents.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part application of copending and commonly assigned U.S. application Ser. No. 742,720, now U.S. Pat. No. 4,802,486, entitled Improved Method and Apparatus For Detecting Optical Pulses, filed June 7, 1985 in the names of James E. Corenman and David E. Goodman, which is a continuation of U.S. application Ser. No. 718,525, entitled Improved Method and Apparatus For Detecting Optical Pulses, filed Apr. 1, 1985 in the names of James E. Corenman and David E. Goodman, now abandoned. This invention relates to non-invasive pulse oximetry and specifically to an improvement on the method and apparatus for photoelectric determination of blood constituents disclosed in U.S. applications Ser. No. 742,720 and 718,525. This specification is accompanied by software appendices A and B. BACKGROUND OF THE INVENTION Non-invasive photoelectric pulse oximetry has been previously described in U.S. Pat. Nos. 4,407,290, 4,266,554, 4,086,915, 3,998,550, 3,704,706, European patent application No. 102,816 published Mar. 13, 1984, European patent application No. 104,772 published Apr. 4, 1984, and European patent application No. 104,771 published Apr. 4, 1984. Pulse oximeters are commercially available from Nellcor Incorporated, Hayward, Calif., U.S.A., and are known as, for example, Pulse Oximeter Model N-100 (herein "N-100 oximeter"). Pulse oximeters typically measure and display various blood flow characteristics including but not limited to blood oxygen saturation of hemoglobin in arterial blood, volume of individual blood pulsations supplying the flesh, and the rate of blood pulsations corresponding to each heartbeat of the patient. The oximeters pass light through human or animal body tissue where blood perfuses the tissue such as a finger, an ear, the nasal septum or the scalp, and photoelectrically sense the absorption of light in the tissue. The amount of light absorbed is then used to calculate the amount of blood constituent being measured. The light passed through the tissue is selected to be of one or more wavelengths that is absorbed by the blood in an amount representative of the amount of the blood constituent present in the blood. The amount of transmitted light passed through the tissue will vary in accordance with the changing amount of blood constituent in the tissue and the related light absorption. For example, the N-100 oximeter is a microprocessor controlled device that measures oxygen saturation of hemoglobin using light from two light emitting diodes ("LED's"), one having a discrete frequency of about 660 nanometers in the red light range and the other having a discrete frequency of about 925 nanometers in the infrared range. The N-100 oximeter microprocessor uses a four-state clock to provide a bipolar drive current for the two LED's so that a positive current pulse drives the infrared LED and a negative current pulse drives the red LED to illuminate alternately the two LED's so that the incident light will pass through, e.g., a fingertip, and the detected or transmitted light will be detected by a single photodetector. The clock uses a high strobing rate, e.g., one thousand five hundred cycles per second, to be easily distinguished from other light sources. The photodetector current changes in response to the red and infrared light transmitted in sequence and is converted to a voltage signal, amplified, and separated by a two-channel synchronous detector--one channel for processing the red light waveform and the other channel for processing the infrared light waveform. The separated signals are filtered to remove the strobing frequency, electrical noise, and ambient noise and then digitized by an analog to digital converter ("ADC"). As used herein, incident light and transmitted light refers to light generated by the LED or other light source, as distinguished from ambient or environmental light. The light source intensity may be adjusted to accommodate variations among patients' skin color, flesh thickness, hair, blood, and other variants. The light transmitted is thus modulated by the absorption of light in the variants, particularly the arterial blood pulse or pulsatile component, and is referred to as the plethysmograph waveform, or the optical signal. The digital representation of the optical signal is referred to as the digital optical signal. The portion of the digital optical signal that refers to the pulsatile component is labeled the optical pulse. The detected digital optical signal is processed by the microprocessor of the N-100 oximeter to analyze and identify arterial pulses and to develop a history as to pulse periodicity, pulse shape, and determined oxygen saturation. The N-100 oximeter microprocessor decides whether or not to accept a detected pulse as corresponding to an arterial pulse by comparing the detected pulse against the pulse history. To be accepted, a detected pulse must meet certain predetermined criteria, for example, the expected size of the pulse, when the pulse is expected to occur, and the expected ratio of the red light to infrared light of the detected optical pulse in accordance with a desired degree of confidence. Identified individual optical pulses accepted for processing are used to compute the oxygen saturation from the ratio of maximum and minimum pulse levels as seen by the red wavelength compared to the maximum and minimum pulse levels as seen by the infrared wavelength. Several alternate methods of processing and interpreting optical signal data have been disclosed in the patents and references cited above. A problem with non-invasive pulse oximeters is that the plethysmograph signal and the optically derived pulse rate may be subject to irregular variants in the blood flow, including but not limited to motion artifact, that interfere with the detection of the blood flow characteristics. Motion artifact is caused by the patient's muscle movement proximate to the oximeter sensor, for example, the patient's finger, ear or other body part to which the oximeter sensor is attached, and may cause spurious pulses that are similar to pulses caused by arterial blood flow. These spurious pulses, in turn, may cause the oximeter to process the artifact waveform and provide erroneous data. This problem is particularly significant with infants, fetuses, or patients that do not remain still during monitoring. A second problem exists in circumstances where the patient is in poor condition and the pulse strength is very weak. In continuously processing the optical data, it can be difficult to separate the true pulsatile component from artifact pulses and noise because of a low signal to noise ratio. Inability to reliably detect the pulsatile component in the optical signal may result in a lack of the information needed to calculate blood constituents. It is well known that electrical heart activity occurs simultaneously with the heartbeat and can be monitored externally and characterized by the electrocardiogram ("ECG") waveform. The ECG waveform, as is known to one skilled in the art, comprises a complex waveform having several components that correspond to electrical heart activity. The QRS component relates to ventricular heart contraction The R wave portion of the QRS component is typically the steepest wave therein, having the largest amplitude and slope, and may be used for indicating the onset of cardiovascular activity. The arterial blood pulse flows mechanically and its appearance in any part of the body typically follows the R wave of the electrical heart activity by a determinable period of time that remains essentially constant for a given patient. See, e.g., Goodlin et al., "Systolic Time Intervals in the Fetus and Neonate", Obstetrics and Gynecology, Vol. 39, No. 2, February 1972, where it is shown that the scalp pulse of fetuses lag behind the ECG "R" wave by 0.03-0.04 second, and U.S Pat. NO. 3,734,086. In prior U.S. application Ser. No. 742,720, copending and commonly assigned, the disclosure (including the software appendix) of which is hereby expressly incorporated by reference, and in corresponding International PCT Application publication No. WO 86/05674 published Oct. 9, 1986, also commonly assigned, there is disclosed an invention for measuring the patient's heart activity and correlating it with the patient's detected blood flow signal to calculate more accurately the patient's oxygen saturation and pulse rate. The correlation includes auto- and cross correlation techniques to enhance the periodic information contained in each individual waveform as well as determine the time relationship of one waveform to another. Correlating the occurrence of cardiovascular activity with the detection of arterial pulses occurs by measuring an ECG signal, detecting the occurrence of the R-wave portion of the ECG signal, determining the time delay by which an optical pulse in the detected optical signal follows the R-wave, and using the determined time delay between an R-wave and the following optical pulse so as to evaluate arterial blood flow only when it is likely to present a true blood pulse for waveform analysis. The measured time delay is used to determine a time window when, following the occurrence of an R-wave, the probability of finding an optical pulse corresponding to a true arterial pulse is high. The time widow provides an additional criterion to be used in accepting or rejecting a detected pulse as an optical pulse. Any spurious pulses caused by motion artifact or noise occurring outside of that tie window are typically rejected and are not used to calculate the amount of blood constituent. Correlating the ECG with the detected optical pulses thereby provided for more reliable measurement of oxygen saturation. That application and publication refers to a modified N-100 oximeter (the "enhanced N-100 oximeter") whereby the device is provided with an additional heart activity parameter in the form of a detected R-wave from the patient's ECG waveform, in addition to the N-100 pulse oximeter functions, and the microprocessor is modified to include software and memory for controlling and processing the optical signal and heart activity information. The additional heart activity parameter is independent of the detection of peripheral arterial pulses, e.g., ECG signals, ultrasound, ballistocardiogram, and maybe, accelerometers, nuclear magnetic resonators, electrical impedance techniques, and the like, and provides an identifiable and detectable signal in response to each heartbeat for use by the signal processing of the oximeter. It is an object of this invention to provide for improved processing of the detected optical signal containing periodic information corresponding to arterial pulsatile blood flow and aperiodic information corresponding to noise, spurious signals, and motion artifact unrelated to the beating heart and arterial pulsatile blood flow, to improve further the reliability and accuracy of the determination of blood constituent, particularly oxygen saturation of hemoglobin by a non-invasive oximeter device. lt is another object of this invention to provide an improved method and apparatus for collecting successive portions of detected optical signals encompassing periodic information for more than one heartbeat and processing the collected portions to attenuate and filter therefrom aperiodic signal waveforms to provide enhanced periodic information from which the patient's blood constituent can be accurately determined. It is another object to maintain the enhanced periodic information updated by continuing to add new portions of detected optical signals as they are obtained. It is another object of this invention to create enhanced periodic information by collecting and processing successive portions of detected optical signals wherein the periodic information corresponding to the optical pulses have been added together in phase, synchronized to the occurrence of the patient's ECG and preferably the R-wave signal. It is another object of this invention to add synchronized periodic information in a weighted fashion so that the most recent portion of detected optical signal is accorded a greater weight in the collected sum than any one prior portion of periodic information data. lt is another object of this invention to create the enhanced periodic information by adding together a predetermined number of the most recent successive portions of detected optical signal, whereby each portion corresponds to a heartbeat event and is given a weight according to its relative age so as to emphasise the newest information in the resultant weighted collective sum. It is another object of this invention to correlate the periodic information with the ECG R-wave by using a waveform product technique to identify the occurrence of the heartbeat and the optical pulse corresponding to that heartbeat. It is another obJect of this invention to evaluate the collected periodic information for a predetermined number of successive portions of the detected optical signal corresponding to a predetermined number of heartbeats in the frequency domain to obtain enhanced periodic information. It is another object of this invention to Fourier transform a time-measure of detected optical signals including periodic information for N heartbeats to determine the relative maxima at the fundamental frequency N and the minima at the zero frequency for use in determining the light modulation ratio for the amount of blood constituents. It is another object of this invention to correlate the Fourier Transform of the time-measure of detected optical signals with the Fourier Transform of a time-measure of the ECG signal, and more particularly the R-wave events of the ECG signal, to determine the maxima at the fundamental heart frequency. It is another object of this invention to correlate the periodic information in a time-measure of the detected optical signal with a time-measure of the detected heart activity, preferably in the form of the ECG signal and more preferably in the form of the R-wave of the ECG signal, to define a predetermined number of samples in a data set and use frequency domain analysis techniques to evaluate the collected predetermined number of sample data sets to determine the relative maxima at the fundamental frequency. SUMMARY OF THE INVENTION This invention provides enhanced periodic information with improved rejection of noise, spurious pulses, motion artifact, and other undesired aperiodic waveforms and thereby improves the ability of oximeters to accurately determine amounts of blood constituents. The present invention provides methods and apparatus for collecting a time-measure of the detected optical signal waveform containing a plurality of periodic information corresponding to arterial pulses caused by the patient's heartbeat and aperiodic information unrelated to pulsatile flow, and processing the collected time-measure of information to obtain enhanced periodic information that is closely related to the most recent arterial pulsatile blood flow. The time-measure may comprise a continuous portion of detected optical signals including a plurality of periodic information from successive heartbeats, or a plurality of discrete portions of detected optical signals including a corresponding plurality of periodic information. By updating the time-measure of information to include the most recently detected periodic information, and processing the updated measure collectively, an updated enhanced periodic information is obtained (including the new and historical data) from which aperiodic information (including any new aperiodic information) is attenuated. In some embodiments, the updating process includes subtracting detected signals older than a certain relative time from the collected time-measure. Applicants have discovered that by collectively processing a time-measure including successive periodic information to obtain the enhanced periodic information, and using the enhanced periodic information as the basis for making oxygen saturation calculations, the accuracy and reliability of oxygen saturation determinations can be significantly increased. Applicants also have discovered that the time-measures may be collectively processed in either the time domain or the frequency domain. The amount of a blood constituent, for example, oxygen saturation, can be then determined from this enhanced periodic information (also referred to as composite signal information) by determining the relative maxima and minima in the enhanced periodic information for the respective wavelengths for use in determining the modulation ratios of the known Lambert-Beers equations. In the preferred embodiment, the detected optical signals are conventionally obtained by passing red (660 nanometers) and infrared (910 nanometers) light through a patient's blood perfused tissue, detecting the transmitted light which is modulated by the blood flow, and providing red and infrared detected optical signals that are preferably separately processed and optionally converted from analog to digital signals, for example, as described above for the Nellcor N-100 oximeter. Portions of the corresponding red and infrared digital signals are then collectively processed in accordance with the present invention and the light modulation ratios are determined based on the resulting enhanced periodic information and used to calculate oxygen saturation. In the time domain analysis embodiment, the invention provides a method and apparatus for adding together a plurality of successive portions of the detected optical signal waveform whereby one portion of the detected optical signal waveform is added to the following selected portion so that their respective periodic information is added in synchrony, i.e., in phase. The synchronized sum thus forms a composite portion of detected optical signal information having enhanced periodic information. The following portion is then added to the composite portion so that the new periodic information is added to the prior composite periodic information in synchrony, forming an updated composite portion with updated enhanced periodic information. Thereafter, subsequent successive portions of detected optical signal are added to the prior updated composite portion, one at a time, so that the composite and enhanced periodic information are updated with each new portion and corresponding heartbeat event. Weighting functions are applied to the two portions before they are added each other. This provides a .scaled or weighted sum that can be adjusted, by selection of the respective weighting functions, to more closely reflect the patient's current condition, rather than the historical condition. In the preferred embodiment, the weighting functions are fractional multipliers which sum to one to provide a stable filter, and are discussed in greater detail below. The periodic information (optical pulse) generally has the same pulse shape, height, and duration from heartbeat to heartbeat and, as is described in U.S. Ser. No. 742,720, follows heart activity by a determinable period of time. Applicants have discovered that by synchronizing the occurrence of successive R-waves, it becomes possible to add the corresponding successive portions of the detected optical signal together so that the periodic information (optical pulses) corresponding to the arterial pulse in each portion will add in phase. The weighted magnitude of the new periodic information is reinforced by the existence of the weighted enhanced periodic information at the same time location in accordance with the degree of synchrony. If the new optical pulse is identical to the composite pulse, then the updated result is a composite optical pulse having the same magnitude. If the magnitudes differ, the additive result will differ according to the relative weights. As a result of the collected, synchronized additive process, any aperiodic information that may be present in the portions of the detected optical signals also are weighted and added to the weighted composite portion waveform. However, because aperiodic signals differ in pulse shape, duration, height-, and relative time of occurrence within each portion, and are not synchronous with heart activity, they do not add in phase. Rather, they add in a cancelling manner whereby their weighted sum is spread across the relative time frame of the composite portion. Applicants have discovered that by processing portions including the periodic information collectively, aperiodic information is attenuated by the absence of any corresponding historical aperiodic signal in the prior composite portion or any subsequent aperiodic at that relative time following heart activity. Further, because the new information can be given a small weight when compared to the absolute weight given the prior composite (as distinguished from the effective lesser weight given to any single prior portion of optical signals as explained below) new aperiodic information is quickly and effectively attenuated, and thus filtered out of the resultant additive portions. To the extent that any aperiodic information would overlap and thereby obscure some periodic information in a portion, then that aperiodic information would be reinforced by the existing periodic information in the prior composite portion; but only to the extent there was overlap. Thus, the collective processing does not lose optical pulse information hidden by an artifact. Subsequent periodic information lacking "identical" aperiodic information would attentuate any overlapping aperiodic pulse over time. The collective additive sum having synchronized periodic information waveforms thus presents enhanced periodic information that is a composite data set that corresponds to a composite optical pulse from which noise, spurious signals, and motion artifact, have been filtered out. By weighting the collective additive process to favor the most recent information and processing this weighted composite portion as it is updated, an accurate estimated optical pulse (enhanced periodic information) that closely reflects the actual conditions is maintained. Basing oxygen saturation determinations on this enhanced optical pulse as it is updated thus provides a more accurate measure than was available by conventional and prior processing techniques. As discussed in application Ser. No. 742,720, the determinable time period between the R-wave and the optical pulse makes it possible to determine a time window whose time length is long enough to include any likely periodic information, and short enough to exclude detected optical signals that are not of any significant or clinical use in making the determination of the selected blood constituent A time window can be used in the present invention, following the occurrence of heart activity, to select a portion of detected optical signals for processing in accordance with this invention to reduce the amount of detected optical signal information that must be processed, to improve the rejection of aperiodic signals not proximate to the optical pulse, and to improve the resolution of the oximeter. The timing of the portion can be selected empirically, by considering the time length of the heartbeat pulse and how long it takes for the pulse to travel to the optiCal detection site so that the window is opened before the optiCal pulse maximum occurs at the optical detection site. In the preferred embodiment, the portion of signal is portion that begins 40 ms after the detection of an R-wave event, based on experimentation, and ends after the relative minimum of the optical pulse is detected, which ending time can vary from portion to portion, and may be, for example, about 230 ms after the R-wave event. The time domain processing of collective weighted portions of the detected optical signal waveforms synchronized by the R-wave of the ECG waveform provides the equivalent of an optimal filter in the frequency domain, whose band-pass elements are those of an ideal heartbeat for the patient under examination. All frequencies which are found in a normal heartbeat are passed with weights of one, and all nonsynchronous frequencies are rejected with attenuation depending on the degree of asynchrony, and the time length of the filter (the effective number of portions processed collectively). As the weight of the periodic information corresponding to the current heartbeat is decreased, greater rejection of low-frequency aperiodic artifacts occurs, but the delay in reporting the most accurate arterial pulsatile flow increases. The weighting functions also assure that the new periodic information is not absorbed into the time and amplitude average of the old data. Using fractional weights provides scaling of the new and old composite information sum, and when the fractional weights add to one, stable performance of the filter is assured. Repeated multiplication of the old data by weights less than one accomplish the effective removal of older data, thus limiting in effect the number of periods processed collectively. In the preferred embodiment, the detected optical signal information is processed in digitized form. Because the successive digitized information is weighted and added, the amount of digital computer memory required to contain the historical and updated composite periodic information only need be as long as the time period for a relative typical heartbeat, so that it can contain the entire time for a selected portion including an optical pulse. This simplifies oximeter operation. In the preferred embodiment, applicants have found that optimal performance occurs when the most recent information is accorded a weight of 1/6 and the historical weight-averaged composite information is accorded a weight of 5/6. Weights which are in powers of 2, e.g., 1/2, 1/4, 1/8, etc., are attractive to use with binary digital computers because they require simpler mathmatical operations, however, they do not necessarily provide the optimal time and noise attenuation tradeoff in selecting weighting functions. The resultant enhanced periodic information is a weighted composite optiCal pulse that is evaluated in the same manner that prior oximeters evaluated individual pulses they determined were appropriate optical pulses for determining blood constituents, whether or not the criteria included use of a time window. The relative maxima and minima for each of the red and infrared composite optical pulses are separately determined and used in the modulation ratios for determining amounts of blood constituents, e.g., in the modulation ratio R of the Lambert-Beers equations that are commonly used to determine oxygen saturation of arterial hemoglobins as described below. As additional data sets are taken, the collective set of periodic information is updated. Consequently, the most recent waveform data representing the actual amount of blood constituent is included in the updated composite optical pulse from which the updated oxygen saturation can be determined and displayed. Although the foregoing and following discussions generally discuss only a detected optical signal, it should be understood that both the red and infrared signal are separately obtained and processed by these techniques, except as indicated. In another embodiment of the time domain embodiment, the time-measure of the detected optical signal is collected in a different manner. The digitized portions of information that are to be weighted, synchronously added together, and processed collectively are accumulated in a memory device having sufficient memory locations for storing separately the raw data for a predetermined number of portions of the detected optical signal. The time of occurrence of the R-wave also may be stored in memory as a pointer for the raw data. This filter embodiment permits assigning a different weighting function to each raw data set corresponding to a different heartbeat in the memory, to improve the attenuation of artifacts and reduce the time needed to estimate the actual arterial pulsatile flow in the detected optical signal. In this embodiment, for N predetermined heartbeats, the average value of the detected optical signal for those N heartbeats is computed by assigning a weight to each data set and adding the weighted data for each heartbeat synchronously into a buffer with a weight of 1, then dividing by N. After each computation, the data set from the oldest stored heartbeat is subtracted from the buffer. As a new R-wave is detected, the incoming data is added to the buffer, and the result is divided by N for computation of relative amplitudes of the two wavelength (red and infrared) periodic information. Thus, the equivalent delay in determining the arterial oxygen saturaton is N/2 times the heartbeat interval. The stored R-wave pointer may be used to correlate the weighting function with the raw data so that the oldest data is given the smallest weight and the most recent data is given the greatest weight, and after each composite heartbeat computation, the oldest data set can be subtracted from the buffer before the following newest data is added. In an alternate embodiment of the time domain analysis techniques, the ECG and periodic information can be correlated by using a waveform product of the ECG signal and the detected optical signal to determine the location of the optical pulse from which oxygen saturation and heart rate values may be computed. The R-wave of the ECG has the largest slope component within the ECG waveform. In the optical pulse waveform in the portion of detected optical signal, the largest slope is created when the heart contracts to expell blood and thereby produce the arterial pulse. Thus, because of the determinable time interval between the ECG R-wave and the appearance of the optical pulse at the detection site, the detected optical signal can be moved backwards in time, relative to the ECG waveform, an amount equal to the determined time interval so that the portions of maximum slope in the two signals will be aligned, and their product will be at a maximum. Aperiodic signals, such as motion artifact, having high slopes will not occur synchronously on the ECG and the detected optical signals. Therefore, once the two periodic waveforms are aligned, the largest slope product of the two will occur at the heart rate interval. Detection of the maximum slope product can be used to pinpoint the occurrence of a heartbeat, and the portion of the detected optical signal that is associated with that maximum slope product can be used for calculating oxygen saturation. In this embodiment, the time interval between the R-wave and the optical pulse can be determined by collecting a predetermined time measure history of optical and ECG waveform data comprising n seconds. The time interval must be long enough for the samples to include at least one R-wave and one pule respectively, given that the heartbeat may vary from 20-30 beats per minute at the slowest rates. A measure of six seconds is acceptable. The samples are conventionally digitized and stored in memory. An array of sample-to-sample slopes is obtained for each n second sample of the ECG waveform and for the second half of each optical pulse waveform sample. The first half of the optical pulse sample is discarded so that when the first optical pulse in the second half is slid backwards, the first R-wave peak it will come upon will be its corresponding R-wave, and also so that the most recent heartbeat data is detected. An optical pulse in the first half of the sample could miss its R-wave. The number of slope values in the second half of the optical waveform, i.e. the number of data points minus 1 at the given sampling rate of 57 samples per second (every 17.5 msec), is taken as m, which corresponds to n/2 seconds of data. A slope product is obtained by multiplying each element of the optical slope array by its corresponding three and one-half points in the ECG slope array (the ECG signal is sampled every 5 msec) and summing the products. This process is repeated for each of the m optical sample points as the optical waveform slope array is moved backwards relative to the ECG slope array, one optical waveform sample at a time. The backwards slide terminates when the first sample of the ECG waveform is aligned with the first sample of the second half of the optical waveform. The maximum slope product is found to occur after the optical waveform slope array has been slid x optical sample points backwards. This establishes the time interval t between the detection of the ECG R-wave and the detection of the optical pulse produced by the same heart contraction. This time interval t is expressed in terms of a number of waveform samples, and is used in the determination of heartbeat occurrence. Computation of the aligned waveform slope product will yield a slope product value for each optical waveform sample. A percentage of the maximum slope product produced during the establishment of the time interval component can be used to compute a maximum product threshold. For example, a percentage of 75% of the maximum slope product may be used. Thus, when the ECG and optical signal waveform slope product exceeds the maximum product threshold, it is likely that a true pulse has been located. The "true" pulse, as it appears the detected optical signal, can then be validated and processed using known techniques for calculating oxygen saturation from detected optical signals. For example, the slope product could be used to synchronize the R-wave events so that the corresponding periodic information can be added in phase in accordance with the preferred embodiment of this invention, or the slope product could be used as an additional criterion for accepting the corresponding optical pulse as valid, and the oxygen saturation determination could be based only on the corresponding optical pulse. Alternately, the waveform product for the maximum and minimum values for the red and infrared waveforms could be used as the maximum and minimum values in calculating saturation. Also, one could integrate some portion of the selected waveform product waveform and compare the area of the change to the area of the total signal to obtain the relative transmittance for use in determining saturation. For example one could integrate the portion above a selected threshold and compare that area to the integral of the entire pulse. Qualified "true" pulses are then used to update the slope product threshold value so that it will change as the patient's condition changes or as the quality of the received signals changes. Applicants also have discovered that a time-measure of detected optical signals containing a plurality of periodic information corresponding to successive heartbeats can be collectively processed and analyzed using frequency domain techniques. These frequency domain techniques utilize the synchronous nature of the heartbeat and the asynchronous characteristics of noise, spurious signals, and motion artifacts. In the frequency domain, the optical signals for a given wavelength corresponding to the pulsatile arterial blood flow have spectral components including a zero frequency at the background intensity level, a fundamental frequency at the frequency of the beating heart, and additional harmonic frequencies at multiples of the fundamental frequency. Noise, spurious signals, and motion artifact that appear in the detected optical signal have frequencies that spread across the spectrum. Transient changes in the average background intensity level have frequencies that appear spread out between the zero frequency and the fundamental frequency. The frequency domain embodiment of the present invention provides a method and apparatus for collecting a time-measure of detected optical signals including a predetermined number of optical pulses, converting the collected detected optical signals into the frequency domain, and analyzing the spectral components of the frequency spectrum thereby to determine the red and infrared relative maxima intensity at the fundamental frequency, and relative minima at the background intensity zero frequency, for use as maxima and minima in the percentage modulation ratio for calculating oxygen saturation. Applicants have discovered that if the digitized values of the time domain detected optical signals are stored in memory for a period of N heartbeats, and the stored data set is transformed into the frequency domain using Fourier Transforms, the amplitude of the fundamental heartrate is summed for the N heartbeats and appears in the frequency spectrum at a location of N cycles. In contrast, the amplitude of asynchronous signals is 1/m where m is the number of data pints in the digitized stored data set, and appear spread across the frequency domain spectrum. The average intensity of the detected optical signal background intensity appears at the spectral line corresponding to zero cycles and corresponds to the average background intensity for that wavelength. If the detected optical signal for the red and infrared signals is considered as a single complex data set, i.e., having real and imaginary components, only a single Fourier transform is required to analyze the spectral contents of the collective time-measure of the two signals. If F(s) represents the Fourier Transform of the complex data set f(t)=Red(t)+jIR(t) (for Red(t) being the red detected optical signal and IR(t) being the infrared detected optical signal), the Fourier Transform of the real component of f(t) is found by F{Re[f(t)]}=1/2{F(s)+F*(-s)}. Similarly, the Fourier transform of the imaginary component of f(t) is found by F{Im[f(t)]}=1/2{F(s)-F*(-s)}. F*(-s) is the complex conjugate of F(s) with the indexes reversed. The relative amplitudes of the red and infrared fundamentals at the heartrate has been found to be equivalent to the foregoing time domain techniques for computation of arterial oxygen saturation. The amplitude data may be found by searching the frequency spectrum in the region of expected heart rates for a relative maximum and insuring that this is the fundamental by determining the existence of another relative maximum at twice this rate. This provides a technique for obtaining relative modulation data to calculate arterial oxygen saturation without the need to identify the heart rate independently, e.g., by detecting the ECG. Alternately, the amplitude data at the fundamental may be found by the use of independent heart rate determining mechanism such as ECG or phonoplethysmography or the like to determine a heart rate. However, unlike the time domain techniques, the precise time of occurrence of each heartbeat need not be determined and the optical signal and a heart rate parameter need no be correlated to obtain accurate saturation values. Rather, it is sufficient to obtain an approximate indicator of heart rate, which will facilitate identification of the fundamental frequency and improve saturation reliability. The number of spectral lines computed is preferably optimized to include the expected range of clinically applicable heartbeats (from 20-250 beats per minute), while the length of the data set is selected by the allowable equivalent delay in displaying measured arterial oxygen saturaton. A time-measure of data of, for example, 9-10 seconds represent delays of only 4-5 seconds in the display of computed saturations, and, depending upon the computational speed of the oximeter microprocessor, the time-measure can be updated in a timely fashion every 1 to 2 seconds. In the preferred embodiment, the optical signal is digitized at 57 samples per second for each red and infrared signal. When 512 data points are accumulated, the data is Fourier transformed, and the red and infrared fundamental maxima are located. The percentage modulation ratio (red/infrared) is computed by dividing the energy at each maxima by the zero cycle background intensity for that wavelength, then dividing the red modulation by the infrared modulation. The resultant ratio, R, is the used in the manner set forth in the Lambert-Beers equations for calculating arterial saturation of hemoglobin. The collective data can be updated so that new data points replace the oldest data points by using a push down stack memory or equivalent so that the transform, evaluation and saturation calculation could be made after each new data set was obtained. An alternative embodiment of the frequency domain analysis technique includes sampling the real tim ECG waveform and the real time detected optical signal at high rates, e.g., 1000 samples per second. By examining the ECG wave, the time of occurrence for each heartbeat and the appropriate sample rate to obtain m samples during that heartbeat could be determined. Thus, the data set for each heartbeat can be selected to contain the same number of m samples, where each sample is a fraction of the heartbeat period and N heartbeats contains mxN samples. Taking the Fourier transform of this mxN data set and processing the spectral components of the transform in the same manner as described previously, results in a spectral analysis having several additional advantages. First, the fundamental maximum would always occur at the spectral line for N cycles in "heartbeat" space. Second, any signal present in the data set which did not remain synchronous with the heart, including noise, artifact and transient background intensity changes, would be spread over the heartbeat spectrum. Third, the enhancement in signal-to-noise would be the same for all heart rates. Fourth, because only two spectral lines are of interest, the zero spectral line corresponding to the zero frequency background intensity and the N spectral line corresponding to the number of heartbeats for the data set, the Fourier Transform need only be made at the two frequency components and not of the entire spectrum, and the computation efforts required by the microprocessor are significantly diminished. The apparatus of the present invention can be used for either time domain or frequency domain analyses, and includes inputs for the plethysmographic detected optical signals and ECG signals of a patient, an analog to digital converter for converting the analog plethysmographic signal to the digital optical signals and for converting the analog ECG signals into digital ECG signals (unless the plethysmographic or ECG signals are provided in digital form), and a digital signal processing section for receiving the digital signals and processing the digital detected optical signal in accordance with one of the foregoing analysis techniques of the present invention, including a microprocessor, memory devices, buffers, software for controlling the microprocessor, and display devices. In its context, the apparatus of the present invention is a part of an oximeter device which has the capability to detect the red and infrared light absorption, and receive at ECG signal from the patient. In the preferred embodiment, the apparatus of this invention is a part of the Nellcor N-200 Pulse Oximeter (herein the "N-200 oximeter"), a commercially available noninvasive pulse oximeter device manufactured and sold by Nellcor, Incorporated, Hayward, Calif. U.S.A. The N-200 oximeter is an improved version of the enhanced N-100 oximeter described above and in the prior application Ser. No. 742,720. The N-200 includes circuits that perform many of the same functions as in the N-100 device, but includes some changes, for example, to expand the dynamic range of the device over the N-100 device and to include a 16 bit microprocessor manufactured by Intel Corporation, Model No. 8088. The N-100 oximeter uses an 8 bit microprocessor manufactured by Intel Corporation, Model 8085. The N-200 oximeter includes software for controlling the microprocessor to perform the operations of the preferred embodiment of the time domain analysis techniques of present invention in addition to the conventional oximeter functions, and has some structure and processing methods that are unrelated to the present invention, and therefore are not discussed herein. The software could be modified to perform any of the other time domain or frequency domain analysis techniques of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1A and 1B are a block diagram of the apparatus of this invention and the apparatus associated with the present invention. FIG. 2A is a detailed circuit schematic of the saturation preamplifier in the patient module of FIG. 1. FIG. 2B is a detailed circuit schematic of the ECG preamplifier and input protection circuit in the patient module of FIG. 1. FIGS. 3A and 3B are a detailed circuit schematic of the saturation analog front end circuit of FIG. 1. FIG. 4 is a detailed circuit schematic of the LED drive circuit of FIG. 1. FIG. 5 is a detailed circuit schematic of the ECG analog front end circuit of FIG. 1. FIGS. 6A and 6B are a detailed circuit schematic of the analog to digital converter section of FIG. 1. FIGS. 7A, 7B, and 7C are a detailed circuit schematic of the digital signal processing section of FIG. 1. FIG. 8 is a detailed circuit schematic of the external ECG circuitry of FIG. 1. FIGS. 9A, 9B, 9C, 9D, 9E and 9F are flow charts for the time domain ECG and optical signal processing of this invention. FIG. 10 is a flow chart for the frequency domain optical pulse processing of this invention. FIGS. 10A, 10B, 10C, 10D and 10E are a series of waveforms corresponding to the flow chart of FIG. 10. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGS. 1A and 1B, the preferred embodiment of the present invention relates to the apparatus for processing the detected analog optical signal and the analog ECG signal and comprises portions of analog to digital conversion section ("ADC converter") 1000 and digital signal processing section ("DSP") 2000, including the software for driving microprocessor 2040, which processes the digitized optical signals and ECG signals to determine the oxygen saturation of hemoglobin in arterial blood. Associated with the invention, but not forming a part of the invention, is the apparatus for obtaining the detected analog optical signals and the analog ECG signals from the patient that is part of or is associated with the commercially available Nellcor N-200 Pulse Oximeter. Such apparatus include plethysmograph sensor 100 for detecting optical signals including periodic optical pulses, patient module 200 for interfacing plethysmograph sensor 100 and the conventional ECG electrodes with saturation analog front end circuit 300 and ECG analog front end circuit 400 respectively, saturation analog circuit 300 for processing the detected optical signals into separate red and infrared channels that can be digitized, and ECG analog front end circuit 400 for processing the ECG signal so that it can be digitized. The N-200 oximeter also includes external ECG input circuit 500 for receiving an external ECG signal and processing the signal so that it is compatible with the N-200 processing techniques (as explained below), LED drive circuit 600 for strobing the red and infrared LEDs in plethysmograph sensor 100 at the proper intensity to obtain a detected optical signal that is acceptable for processing, and various regulated power supplies (not shown) for driving or biasing the associated circuits, as well as ADC 1000 and DSP 2000, from line current or storage batteries. The associated elements are straightforward circuits providing specified functions which are within the skill of the ordinary engineer to design and build. The associated elements are briefly described here, and reference is made to the corresponding detailed schematics in the Figures and circuit element tables set forth below, to place the apparatus for using the present invention in its operating context in the preferred embodiment. In the preferred embodiment, the invention requires three input signals, the two plethysmograph or detected optical signals (e.g., red and infrared) and the ECG signal of the patient. If analog signals are provided, they must be within or be adjusted by, for example, offset amplifiers, to be within the voltage input range for the ADC. In circumstances where the signals have been digitized already, they must be bit compatible with the digital signal processing devices, DSP. The plethysmograph signal is obtained in a conventional manner for a non-invasive oximeter, typically by illuminating the patients tissue with red and infrared light in an alternating fashion, in the manner described above for the N-100 oximeter. Referring to FIGS. 1A and 1B, sensor circuit 100 has red LED 110 and infrared LED 120 connected in parallel, anode to cathode, so that the LED drive current alternately illuminates one LED and then the other LED. Circuit 100 also includes photodetector 130, preferably a photodiode, which detects the level of light transmitted through the patient's tissue, e.g., finger 140, as a single, analog optical signal containing both the red and infrared light plethysmographic, detected optical signal waveforms. Referring to FIGS. 1A, 1B, 2A, and 2B, patient module 200 includes preamplifier 210 for preamplifying the analog detected optical signal of photodetector 130, ECG preamplifer 220 for preamplifying the analog ECG signal detected from the ECG electrodes that would be attached to the patient in a conventional manner, and protection circuitry 250 interposed between instrumentation amplifier 220 and inverter 230 and the three ECG signal leads, to prevent high voltage transients from damaging the ECG preamplifier electronics. Preamplifier 210 may be an operational amplifier configured as a current to voltage converter, biased by a positive voltage to extend the dynamic range of the system, thereby converting the photocurrent of photodiode 130 into a usable voltage signal. ECG preamplifier 220 is preferably a high quality instrumentation amplifier which amplifies the differential signal present on the two ECG signal electrodes. The common-mode signal present on the two signal electrodes is inverted by inverter 230 and returned to the patient by the third ECG lead, effectively nulling the common-mode signals. A biasing network on tee two ECG signal leads is provided to aid in the detection of when an ECG electrode lead becomes disconnected from patient module 200 or the patient. Patient module 200 also includes leads for passing the LED drive voltages to LEDs 110 and 120. Referring to FIGS. 1A, 1B, 3A and 3B, saturation analog front end circuit 300 receives the analog optical signal from patient module 200 and filters and processes the detected signal to provide separate red and infrared analog voltage signals corresponding to the detected red add infrared optical pulses. The voltage signal is passed through low pass filter 310 to remove unwanted high frequency components above, for example, 100 khz, AC coupled through capacitor 325 to remove the DC component, passed through high pass filter 320 to remove any unwanted low frequencies below, for example, 20 hertz, and passed through programmable gain stage 330 to amplify and optimize the signal level presented to synchronous detector 340. Synchronous detector 340 removes any common mode signals present and splits the time multiplexed optical signal into two channels, one representing the red voltage signals and the other representing the infrared voltage signals. Each signal is then passed through respective filter chains having two 2-pole 20 hertz low pass filters 350 and 360, and offset amplifier 370 and 380. The filtered voltage signals now contain the signal information corresponding to the red and infrared detected optical signals. Additionally, circuits for use in preventing overdriving the amplifiers in saturation circuit 300 may be applied, for example, level-sensing circuits 312 and 314 (located after low pass filter 310) for indicating unacceptable LED drive current, and level sensing circuit 315 (located after programmable gain amplifier 330) for indicating unacceptable input amplifier gain setting. Referring to FIGS. 1A, 1B, and 8, ECG analog front end circuit 400 receives the preamplified ECG signal from patient module 200 and processes it for use with the present invention. The analog ECG signal is passed through 2-pole 40 hertz low pass filter 410 for removing unwanted frequencies above 40 hertz, and programmable notch filter 420 for removing unwanted line frequency components. Optionally, circuitry may be provided to measure the line frequency and to select an appropriate clock frequency for the notch filter. The ECG signal is then passed through low pass filter 430, preferably configured to remove further unwanted components above about 40 hertz, and in particular any frequency components that may have been generated by notch filter 420. Thereafter, the ECG signal is passed through 2-pole 0.5 hertz high pass filter 440 to remove any low-frequency baseline shifts present in tee original ECG signal, and then passed through offset amplifier 450 to add an offset voltage that the voltage is within the input signal specifications of the analog to digital converter device and the complete waveform will be properly digitized. It also is desirable to pass the signal output from low pass filter 410 into a circuit that detects whether or not the ECG signal is being detected to identify a "leads-off" condition. The signal voltage is passed through absolute value circuit 480 to take the absolute value of the low pass filter output voltage and sends the value to comparator 490. Comparator 490 compares the absolute value voltage to a reference threshold or range and, when the absolute value voltage is not within the acceptable range, comparator 490 changes state which change is input to latch 495, to indicate this condition to, for example, the microprocessor. Referring to FIGS. 1A, 1B and 8, the Nellcor N-200 device also is equipped with external ECG circuit 500 for receiving the ECG signal of a stand alone ECG detector device and processing the ECG signal so that it can be used with the N-200 oximeter and the present invention. Circuit 500 receives the external analog ECG signal, passes it across capacitor 510 to remove any DC offset voltage and then passes the signal through peak detection circuit 530. A portion of the AC coupled signal also is passed through buffer amplifier 520 and input to comparator 570. The held peak voltage is used as the reference threshold voltage that is fed to the other input of comparator 570 so that subsequent QRS complexes in the ECG signal that rise above the threshold generate a trigger signal that is transferred to DPS 2000 by an electrically isolated optical serial communication link comprising serial driving opto-isolator 580, electrically isolated optical link 590, and corresponding serial driving opto-isolator 2590 in DSP 2000. Referring to FIGS. 1A, 1B, 6A and 6B, ADC 1000 provides the analog to digital conversions required by the N-200 oximeter. The aforementioned three voltage signals, the red detected optical signal, the infrared detected optical signal, and the ECG signal (preferably the ECG signal from patient module 200), are input to ADC 1000. These three signals are conventionally multiplexed and digitized by an expanded range 12-bit analog to digital conversion technique, yielding 16-bit resolution. The input signals are passed through multiplexor 1010 and buffer amplifier 1020. The converter stage includes offset amplifier 1030, programmable gain circuitry 1040 which allows a portion of the signal to be removed and the remainder to be further amplified for greater resolution, sample and hold circuit 1050, comparator 1060, and 12-bit digital to analog converter 1080. The buffered signal is passed through offset amplifier 1030 to add a DC bias to the signal wherein a portion of the signal is removed and the balance is amplified by being passed through programmable gain circuitry 1040 to improve the resolution. The amplified signal is then passed through sample and hold circuit 1050, the output of which is fed to one input of comparator 1060. The other input of comparator 1060 is the output of digital to analog ("DAC") converter 1080 so that when the inputs to comparator 1060 are the same, the analog voltage at the sample and hold circuit is given the corresponding digital word in DAC converter 1080 which is then stored in an appropriate memory device as the digitized data for the sample, and the next sample is sent to sample and hold circuit 1050 to be digitized. Referring to FIGS. 1A, 1B, 4, 6A, 6B, 7A, 7B, and 7C, DAC 1080 also generates the sensor LED drive voltages, under the control of microprocessor 2040, using analog multiplexor 610, which separates the incoming analog signal into one of two channels for respectively driving the red and infrared LEDs, having respective sample and hold circuits 620 and 630, and LED driver circuit 640 for converting the respective analog voltage signal into the respective positive and negative bipolar current signals for driving LEDs 110 and 120. Alternate techniques of converting the analog signals to digital signals could be used, for example, a 16-bit analog to digital converter. Referring to FIGS. 1, 7A, 7B, and 7C, DSP 2000 controls all aspects of the signal processing operation including the signal input and output and intermediate processing. The apparatus includes 16-bit microprocessor 2040 and its associated support circuitry including data bus 10, random access memory (RAM) 2020, read only memory (ROM) 2030, a conventional LED display- device 2010 (not shown in detail), system timing circuit 2050 for providing the necessary clock synchronizing and notch filter frequency signals. In the preferred embodiment, microprocessor 2040 is a model 8088 microprocessor, manufactured by Intel Corporation, Santa Clara, Calif. Alternate microprocessors may be used, such as any of model nos. 8086, 80186, and 80286, also made by Intel Corporation. Referring to FIGS. 9A, 9B, 9C, 9D, 9E, and 9F and software Appendix A, the flowcharts for the software operation of the preferred embodiment are shown and described. Software appendix A is written in the standard programming language for Intel Model 8088 microprocessor devices. Similar to the enhanced N-100 oximeter described in U.S. application Ser. No. 742,720, the N-200 oximeter incorporating the present invention is designed to determine the oxygen saturation in one of two modes, an unintegrated mode wherein the oxygen saturation determination is made on the basis of pulses detected in the optical pulse signal that are determined to be optical pulses in accordance with conventional pulse detection techniques, and in an ECG synchronization mode wherein the determination is based on the synchronized additive, composite optical signal information in accordance with the preferred embodiment of the present invention. In an alternate embodiment of the present invention, the determination of saturation in the unintegrated mode may be based on the frequency domain analysis techniques in accordance with this invention with or without the ECG synchronization feature of the time domain analysis techniques. Referring to FIG. 9F, interrupt programs control the collection and digitization of incoming optical and ECG data. As particular events occur, various software flags are raised which transfer operation to various routines that are called from the Main Loop Processing routine. For example, Main Loop Processing calls the ECG routine at 3600, calls a routine that checks the LED levels at 3610 to make sure that there is enough and not too much light being transmitted, looks for the presence of new data at 3615, and if there is new data, calls the MUNCH routine at 3620, looks for processed pulse data at 3635 and passes such data to the Leve13 routine that calculates saturation at 3640, and also runs various maintenance routines related to the oximeter functions which are not pertinant to the present invention, e.g., at 3625, 3630, 3645, 3650, 3655, and 3660 and are not discussed herein. The routines pertinent to the present invention are discussed here. Examples of similar and peripheral other routines may be found in the software appendix to application Ser. No. 742,720. The detected optical signal waveform is sampled at a rate of 57 samples per second. When the digitized red and infrared signals for a given portion of detected optical signals are obtained, they are stored in a buffer called DATBUF and a software flag indicating the presence of data is set at 3615. This set flag calls a routine referred to as MUNCH at 3620, which processes each new digitized optical signal waveform sample. The MUNCH routine is called once per data point and determines pairs of maximum and minimum amplitudes in the detected signal data and presents the pairs to the Leve13 routine. The Leve13 routine evaluates the pair of maximum and minimum amplitudes determined by MUNCH, preferably utilizing conventional techniques for evaluating whether a detected pulse is acceptable for processing as an arterial pulse and performs the saturation calculation based on accepted pulses. The MUNCH routine first queries whether or not there is ECG synchronization. If there is ECG synchronization, then the MUNCH routine obtains from the SLIDER routine the enhanced pulse data on which the ECG synchronized saturation calculation will be mad. If there is not synchronization, MUNCH obtains the sample stored in DATBUF on which the unintegrated saturation calculation will be made. Referring to FIG. 9A, the SLIDER routine processes each new digitized sample portion of detected optical signal containing the optical pulse to create and maintain the enhanced composite red and infrared optical pulse waveforms, synchronized with the occurrence of successive ECG R-wave events. The SLIDER routine first inquires whether there is an ECG signal at 3100. If there is not, then the routine aborts to exit at 3160 to main line operation. If there is an ECG signal, then the SLIDER routine continues and checks the validity of the optical signal at 3110. If the digitized sample in the buffer DATBUF for either of the red or infrared channels contains an invalid datapoint, the full content of the slider buffer (SLIDEBUF) is erased and the routine exited. The validity of the data is checked by looking for zeros placed in the buffer. Zeros are placed in the buffer when the signal level of the LEDs changes to permit the 20Hz filters to settle, or if the signal exceeds the voltage limits of the processing electronics. This prevents processing of data known to be bad. If the data are determined to be valid, then the SLIDER routine queries whether or not the data should be skipped at 3120. The optical signal sampling and data collection and processing of the sampled data are asynchronous processes. On occasion, the data buffer will have several unprocessed samples of data by the time the ECG R-wave event trigger occurs (described below). The R-wave event resets the slider buffer pointer to the beginning of the slider buffer and marks the R-wave data sample in DATBUF SLIDER will not process a data point if the slider buffer pointer is reset already to the beginning of the slider buffer and if the incoming data point was digitized in DATBUF before the data point marked by the R-wave event. Data in the DATBUF buffer prior to the R-wave event are to be skipped. If the data are to be skipped, SLIDER is exited. If the data are to be processed, SLIDER calculates the updated value for the composite portion waveform sample as "slider data" using the following formula: ##EQU1## where "WEIGHT" is the aforementioned fractional weighting fraction; "new data" is the data point taken from the incoming sample in DATBUF, and "slider data" is the pre-existing data point in the composite waveform in the slider buffer (SLIDEBUF) before the new data point is added and becomes the updated data point after the computation. The computation is performed for each data point in DATBUF and any corresponding pre-existing data in the slider buffer. The occurrence of an R-wave event indicates the beginning of the heartbeat sample. Before making the computation, SLIDER checks the slider buffer to see if there is any existing data at 3130. If there are data, then at 3150 SLIDER calculates the new value for the composite optical signal. If, however, the slider buffer is empty, then the WEIGHT value is assigned a numerial value of 1 at 3140, and subsequent new data points will be weighted 100% and the routine continues to calculate a new value for the composite optical signal at 3150 until the occurrence of the next R-wave event corresponding to the following heartbeat and portion of detected optical signal. The SLIDER routine also performs other housekeeping chores for the processing associated with the slider buffer. First, in the preferred embodiment, the slider buffer is given a specific length and is able to store about three seconds worth of data. If, for whatever reason, the microprocessor does not receive or recognize an R-wave for more than three seconds, the pointer of the slider buffer is set to point to the last location and does not get incremented beyond that location. Subsequently processed samples are each placed in the last location of the buffer until the next accepted R-wave occurs or a time-out condition occurs. Time-out occurs when no further R-wave events are accepted for a predetermined time of, e.g., five seconds. After time out has occurred, MUNCH is notified that ECG synchronization is lost so that saturation calculations will be based only on the optical signals in DATBUF in the unintegrated mode. Second, SLIDER continuously compares the updated composite waveform in the slider buffer to the previous composite waveform. If there is a large discrepancy, for example, during electromechanical disassociation, SLIDER takes immediate action to disregard the slider buffer data. Third, to avoid corrupting the integrity of the waveform data in the slider buffer whenever the apparatus hardware or software triggers a change that influences the signal level of the detected optical signal or the optical pulse waveform, the content of the slider buffer is erased. Referring to FIG. 9B, the ECG BOX routine processes the ECG signal obtained through patient module 200 and analog ECG front end circuit to detect ECG R-wave events. The ECG signal is digitized every 5 msec and the digitized values are maintained in a circular buffer. The R-wave event is detected by observing the derivative of the ECG signal. The derivative is obtained at 3200 by application of the following algorithm: ##EQU2## where "ecg data[n]" is the digitized value for the ECG signal at sample location n and "abs[]" is the absolute value of the bracketed quantity. The largest magnitude spike in the derivative buffer marks the R-wave. Because the algorithm generates the absolute value of the derivative, the derivative buffer contains two spikes very close to each other, one for the positive-going portion and the other for the negative-going portion of the R-wave. After the first spike is recognized, a timer ecg block is set at 3250 to cause ECG BOX to ignore the second spike. Once the derivative value is obtained, and if the ecg block timer is not active, then the derivative value is compared to the ECG threshold at 3240. The ECG threshold is a value that is set at about 75% of the previous maximum derivative value. If the derivative is greater than the threshold, ECG BOX starts the ecg block timer by setting ecg block equal to true at 3250, and it replaces the maximum derivative value with the current derivative value at 3260, and calls the R-WAVE CHECKING routine at 3270. After the R-WAVE CHECKING routine is completed (as discussed below), ECG BOX is exited at 3280. If the derivative is not greater than the threshold, then ECG BOX is exited at 3280. Once the ecg bock timer is activated, ECG BOX will continue to calculate the derivative and compare the derivative to the prior maximum derivative value ay 3220. If the calculated derivative is greater, then the maximum derivative value is set equal to the current derivative ecg data[n]at 3230 and the routine is exited. Otherwise the routine is exited. Referring to FIG. 9E, the R-WAVE CHECKING routine receives the detected R-wave event at 3500 and checks the elapsed time since the last R-wave at 3510. If the elapsed time is less than the minimum internal time limit, preferably set at about 200 msec, the R-wave event is marked as a false R-wave event at 3520. If the elapsed time is greater than the minimum limit, then the routine starts a phasedelay timer/counter at 3530. The purpose of the phase-delay counter is to ensure that the optical data is placed into the beginning of the slider buffer after the optical signal minimum from the preceding pulse, but before the signal maximum of the next pulse. The preferred phase-delay period is 40 msec, based on the results of experimentation, and corresponds to the opening of the time window. It may be desirable to have a phase delay period that can be adjusted to accommodate varying optical signal detection conditions for different patients. The Nellcor N-200 device is equipped with an external ECG input circuit as described above. The main line operating system controlling the operation of the N-200 device receives an interrupt when the external circuit 500 detects an R-wave. On receipt of the interrupt, a message is sent across isolated optical data transmission path 580-590-2590 (FIGS. 1A and 1B) to microprocessor 2040. The microprocessor then indicates to the ECG processing routines that an externally detected R-wave event has occurred, and the R-wave event is passed to the R-WAVE CHECKING routine. The external ECG analog circuit 500 thus performs the same function as the ECG BOX routine, i.e., determination of an R-wave event followed by the R-WAVE CHECKING routine. The ECG BOX routine is given priority over external ECG circuit 500 in passing signals to R-WAVE CHECKING. Referring to FIG. 9C, the ECG routine provides for ECG synchronization, the initialization for slider buffer use, and various other tasks associated with ECG enhancement of the detected optical signal. The ECG routine is entered from the Main Loop Processing system (FIG. 9F, at 3600). Its first task is to maintain the ECG related counters/timers, such as ecg block and phase-delay, at 3300. Next, at 3310, it checks whether or not the ECG leads from patient module 200 are present, and if not, it checks at 3320 for the presence of an external R-wave event trigger from external ECG circuit 500. If no R-wave event is detected, then the ECG routine is exited at 3370. At this point in the processing, the main line processing system is receiving R-wave events, either from external circuit 500 or from patient module 200 and ECG BOX. Regardless of the source of the R-wave event, the subsequent processing of the R-wave event is the same. When an external R-wave event is detected or the ECG leads are present, the ECG routine calls the ECG LV3 routine, shown in FIG. 9D. ECG LV3 runs through a similar patient module 200 lead checking at 3410 or external circuit 500 trigger at 3420 as the ECG routine and if no R-wave event has occurred the routine is exited at 3480. If an R-wave event is detected, it is first checked at 3425 to determine whether or not it is a new R-wave event, and if it is not, the ECG LV3 routine is exited. If it is a new R-wave event, 3430 uses the false R-wave flag (set by the R-WAVE CHECKING routine) to determine whether or not it was a true or false R-wave event. False R-waves will cause the routine to be exited at this point. If the R-wave event is determined not to be a false R-wave, then the ECG-LV3 routine builds up a history of R-wave events based on the R-wave to R-wave interval at 3435. The criteria for accepting an R-wave includes the R-R period and the amplitude of the R-wave. For external ECG circuit 500 triggers, the R-wave even is a uniform pulse resulting from a comparison of the R-wave amplitude to a determined threshold signal. After computing the R-R interval (or R-R delta) and history, the ECG LV3 routine checks to see if the ECG is synchronized at 3440. The ECG is synchronized after receiving the predetermined number, preferably five, acceptable R-wave triggers. For example, the ECG synch counter is initialized at five. The routine tests the ECG synch counter 3440 so that if it is greater than zero, the ECG is determined to be not synched, and then the ECG synch counter is decreased by one at 3455. Thus, when the ECG synch counter is at zero at 3440, indicating that the required prior five acceptable R-wave event have successively occurred, then it is determined that there is ECG synchronization and the device will proceed through MUNCH to calculate oxygen saturation based on the enhanced composite slider buffer calculations. Whether or not there is EC synchronization, any R-wave event is checked again at 3450 against the history and R-R interval, if any, to determine whether there is an error in synchronization. If there is an error, the ECG LV3 routine is exited. If there is no synchronization error, a routine is called at 3460 to compute the maximum length of time after which data in the slider buffer (SLIDEBUF) is disregarded. For example, if there is no prior R-R interval or history, then there will be no error for the first R-wave event. Subsequent true R-wave events will be compared to the prior R-R interval and history and if it appears to be a valid true pulse, then a routine is called to reset slider buffer pointers. However, the saturation calculation will be based upon the slider buffer data only after five R-waves have passed in synch and the synchronization flag is raised. Loss of synchronization resets the ECG synch counter to five. The ECG LV3 routine also calculates the maximum length of the slider buffer based on the heart rate, which length is preferably 3 seconds or 2.5 times the determined R-R interval, whichever is the smaller. The ECG LV3 routine also maintains the slider pointers and counters, resetting them or clearing them as necessary, resets the ecg timeout and bad R-wave counter, computes and displays heart rate based on the R-R interval at 3465, updates the history buffers and sets the trigger for the MUNCH routine to calculate pulse data for determining oxygen saturation based on the updated slider buffer data at 3470, sets and computes windows for selecting the portion of detected optical signal to be processed for each heartbeat, based on the history and the most recent data at 3475. In the preferred embodiment, the windows are set to open by the R-WAVE CHECKING routine phase-delay counter/timer 40 ms after the R-wave occurs and before the maximum optical pulse wave has occurred at the detection site, and set to close by the MUNCH routine after a maximum and minimum pair has been found. Upon exiting ECG LV3, the program returns to the ECG routine and checks the threshold of the derivative buffer of ECG BOX. If the maximum derivative value is changed substantially, which indicates that the R-wave slope is changing, then the threshold is adjusted. Referring to FIGS. 10, 10A, 10B, 10C, 10D, 10E and the software appendix B, the flow chart for the software operation of the frequency domain embodiment of the present invention are shown. Software appendix B is written is the Asyst computer language which is a commercially available language. The routine begins at 4000 with the acquisition of 512 data points for each of the digitized red and infrared optical signals, which are shown graphically at FIG. 10A. At 4010, the complex data set, f(t)=Red(t)+jIR(t), is formed. At 4020, the "D.C." component is formed by summing all of the data points, and the "D.C." component is then removed from the complex data set by subtraction at 4030, which is graphically shown at FIG. 10B. The resulting data is then decimated in time to 64 samples at 4040, which is illustrated in FIG. 10C, and the time decimated data is then processed by the Hamming Window function at 4050, which result is illustrated in FIG. 10D. Thereafter, the Fourier Transform is taken at 4060. The spectral components of the transform are shown in FIG. 10E. The Fourier Transforms of the red and infrared components are then calculated at 4070 in accordance with the aforementioned equations, and at 4080 the maximum value at the fundamental heart rate and the minimum value at the zero frequency are determined for each of the red and infrared transforms. The saturation ratio R is calculated as: ##EQU3## The minimum values for the red and infrared waveforms are taken from the respective real and imaginary components of the "D.C." component. Thereafter, the pulse data is declared ready and saturation is calculated in accordance with the foregoing saturation formula. With each occurrence of the heartbeat, new data is acquired, the 512 data point set is updated and the routine operates to determine the saturation ratio R. In the preferred embodiment, the blood constituent measured is the oxygen saturation of the blood of a patient. The calculation of the oxygen saturation is made based on the ratio of the pulse seen by the red light compared to the pulse seen by the infrared light in accordance with the following equation: ##EQU4## wherein BO1 is the extinction coefficient for oxygenated hemoglobin at light wavelength 1 (Infrared) BO2 is the extinction efficient for oxygenated hemoglobin at light wavelength 2 (red) BR1 is the extinction coefficient for reduced hemoglobin at light wavelength 1 BR2 is the extinction coefficient for reduced hemoglobin at light wavelength 2 light wavelength 1 is infrared light light wavelength 2 is red light and R is the ratio of the optical density of wavelength 2 to wavelength 1 and is calculated as: ##EQU5## wherein I max2 is the maximum light transmitted at light wavelength 2 I min2 is the minimum light transmitted at light wavelength 2 I max1 is the maximum light transmitted at light wavelength 1 I min1 is the minimum light transmitted at light wavelength 1 The various extinction coefficients are determinable by empirical study as is well known to those of skill in the art. For convenience of calculation, the natural log of the ratios may be calculated by use of the Taylor expansion series for the natural log.

A method and apparatus for improving the calculation of oxygen saturation and other blood constituents by non-invasive pulse oximeters. The method and apparatus permit more accurate determination of blood flow by collecting time-measures of the absorption signal at two or more wavelengths and processing the collected time-measure to obtain composite pulsatile flow data from which artifacts have been filtered. The processing may occur in the time domain or in the frequency domain. In the preferred time domain embodiment, successive portions of periodic information are weighted and added together in synchrony to obtain the composite pulse information. In the preferred frequency domain embodiment, the time-measure is Fourier transformed into its spectral components to form the composite information. A new method and apparatus for correlating the heartbeat and optical pulse is provided whereby a product of the ECG R-wave and optical pulse signals corresponding to the same heartbeat is obtained, and one signal is time shifted relative to the other until a maximum waveform product corresponding to the heartbeat is determined.

FIELD OF THE INVENTION [0001] This invention relates to devices for securing mobility devices and, more particularly, to an apparatus for securing a mobility device such as a scooter to the inside of a vehicle. BACKGROUND OF THE INVENTION [0002] Many people with limited physical capabilities transport themselves around using a mobility scooter or similar mobility device. A typical scooter will have four wheels, an electric motor, bicycle style handlebars, a large padded seat and a footplate. The rear wheels are driven and the front wheels steer. It is commonly driven or moved into a wheelchair access vehicle via a lift or ramp and, the disabled person alights the scooter and moves into the driver seat to drive the vehicle or into a passenger seat. Once inside the vehicle, it is desirable to secure or tie down the scooter, so that it does not move around while the vehicle is moving and, worse, become a massive and dangerous projectile in the event a sudden deceleration or accident. SUMMARY OF THE INVENTION [0003] Generally speaking, there is provided an apparatus for securing a mobility device such as a scooter to the inside of a vehicle. [0004] The present invention is directed to an apparatus that is operable to anchor a mobility scooter or similar mobility device into a position from which it cannot move inside of a vehicle. When a mobility scooter is located in the desired position the user will actuate a switch which will lower a powered arm from a vertical parked position into a horizontal position across the middle of a mobility scooter. The powered arm will locate either into the floor or latch to a post secured into the floor (depending on the variant fitted to the vehicle) thereby restricting the movement of the mobility scooter in the event of an accident. [0005] In one embodiment, an apparatus is provided for securing a scooter with a footplate to a vehicle having a floor. The apparatus includes a main beam having proximal and distal ends and being connectable to the vehicle floor to move between an up, rest position and a down, locking position, the down, locking position including a portion of the main beam extending generally laterally over and across the footplate of a scooter positioned thereunder; actuator means including a follower pin received for limited movement in a slot defined by guide means connected to the main beam, the actuator means being for moving the main beam between the up, rest position and down, locking positions; and latch means for securing the distal end of the main beam to the vehicle floor when in the down, locking position. [0006] It is an object of the present invention to provide an improved device for securing mobility devices such as scooters on the inside of a vehicle. [0007] Other objects and advantages will become apparent from the following description of the preferred embodiment. BRIEF DESCRIPTION OF THE DRAWINGS [0008] FIG. 1 is a side, elevational view of an apparatus 10 for securing a scooter in a vehicle in accordance with one embodiment of the present invention, with apparatus 10 shown in the generally vertical up and resting position 14 as it would appear when it is not in use. [0009] FIG. 2 is perspective view of the apparatus 10 of FIG. 1 [0010] FIG. 3 is a side, elevational view of the apparatus 10 of FIG. 1 , with its central beam 18 shown in the generally horizontal position, apparatus 10 being nearly in the fully down, locking position 15 , and showing in phantom the scooter footplate 71 that it would be locking down. [0011] FIG. 4 is an enlarged view of a portion of the apparatus 10 of FIG. 3 at detail A and showing the foot beam 19 as its locking knob 52 is nearly fully latched into the keyhole opening 59 of floor socket 3 . [0012] FIG. 5 is perspective view of the portion of apparatus 10 of FIG. 3 . [0013] FIG. 6 is an enlarged view of a portion of the apparatus 10 of FIG. 5 at detail B and showing the foot beam 19 as its locking knob 52 is nearly fully latched into the keyhole opening 59 of floor socket 3 . [0014] FIG. 7 is a perspective view of the floor socket 3 of the apparatus 10 of FIG. 6 showing the underside of the floor socket. [0015] FIG. 8 is a side, elevational view of the apparatus 10 of FIG. 1 shown in the fully down, locking position 15 . [0016] FIG. 9 is a perspective view of the apparatus 10 of FIG. 8 . DESCRIPTION OF THE PREFERRED EMBODIMENT [0017] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, and any alterations and further modifications in the illustrated device and further applications of the principles of the invention as illustrated are being contemplated as would normally occur to one skilled in the art to which the invention relates. [0018] Referring to the FIGS. 1 , 2 , 8 and 9 , there is shown an apparatus 10 for securing a mobility device such as a scooter to the inside of a vehicle. A typical scooter (not shown) has four wheels, an electric motor, bicycle style handlebars, a large padded seat and a footplate. The rear wheels are driven by the electric motor, and the front wheels are steered by the user via the handlebars. Other configurations of scooters are known and/or contemplated (having only three wheels, for example), but the present invention is directed to all such mobility devices that have a footplate connecting the front and rear portions of the mobility device and being located near to the ground. [0019] Briefly, FIG. 1 illustrates the device in the vertical position as it would be when not in use. It is bolted to the floor of an adapted vehicle through a plate 2 . A main beam 1 is raised and lowered via a toggle switch 78 and powered by a motor 5 with joint at the end of the beam so it pivots using a gas strut 7 . The device locks into floor socket 3 by the locating pin 4 latching into it. [0020] Apparatus 10 generally includes a main beam 1 , plate 2 , a floor socket (or latch) 3 and an actuator assembly 11 that articulates (that is, one or more of components are moved via hinged interconnections) apparatus 10 between an up, resting position 14 ( FIGS. 1 and 2 ) and a down, locking position 15 ( FIGS. 8 and 9 ). Main beam 1 (or arm) includes a base beam 17 , a central beam 18 , a foot beam 19 (or arm) and proximal and distal hinge members 21 and 22 . Base beam 17 is connected to plate 2 , which is mounted to the floor of the vehicle in any appropriate manner [0021] Central beam 18 is hingedly connected to base beam 17 by hinge member 21 to pivot about a pin 25 . Hinge member 21 is fixedly connected to base beam 17 and includes a stop plate 26 that extends about 90 degrees (that is, generally horizontally) from the generally vertically extending base beam 17 . [0022] Foot beam 19 is hingedly connected to central beam 18 by hinge member 22 to pivot about an axis 27 via a pin 28 . Hinge member 22 is fixedly connected to foot beam 19 and includes a stop plate 29 that extends about 90 degrees from the length (that is, the long axis) of foot beam 19 . [0023] Actuator assembly 11 includes a motor 5 with linearly extending/retracting output rod 33 (i.e. a linear actuator), the motor 5 being pivotally mounted to the base beam 17 via a bracket member 34 , which is fixed to base beam 17 , and whereby motor 5 is pivotally mounted to bracket member 34 by a pin 35 . At the distal end of the motor's output rod 33 is a follower in the form of a pin 38 that rides within slots 39 and 40 defined by guide plates 41 and 42 , respectively, that are fixed to extend upwardly (as shown in FIG. 9 ) from central beam 18 . A connector rod 45 is connected to and extends from the distal end of output rod 33 , the two here being connected together by the pin 38 , and toward the distal end of central beam 38 where it is pivotally connected via a pin 46 to a bracket 47 that is fixedly connected to foot beam 19 , as shown. [0024] Referring to FIG. 4 , at the distal end 50 of foot beam 19 is the locating pin 4 (a first member) that is sized and configured to engage and releasably lock with the floor socket 3 (a second member). Locating pin 4 has a main shank 51 connected to and extending from distal end 50 , and then at the distal end of shank 51 is a larger sized locking knob 52 . Knob 52 has a generally flat surface (or ledge) 55 extending radially outwardly from its junction to shank 51 and has a rounded outer surface 56 at its outermost side. [0025] Referring to FIGS. 4 , 6 , 7 , 10 and 11 , floor socket 3 is a plate defining a keyhole shaped opening 59 that is sized, at its outer end 60 (that is, the end to be the farthest away from the mounting of base beam 17 (here, via plate 2 ) to the vehicle floor), large enough for locking knob 52 to pass therethrough, and that is sized, at its inner end 61 (the end closest to the mounting of base beam 17 to the vehicle floor), only wide enough for the narrower diameter shank 51 to be received therein. Floor socket 3 also is thinner at its outer end 64 than at its inner end 65 , and at a portion near the junction 66 of the thinner/thicker portions 64 / 65 . And, on opposite sides of the opening 59 and at its underside, floor socket 3 is ramped (at 68 / 69 ) to facilitate a smooth entry of the shank 51 from the larger outer end 60 into the smaller inner end 61 of opening 59 as the flat surface ledge 55 engages ramps 68 / 69 on the underside of floor socket 3 and slides to a snug locking position at the inner opening end 61 . [0026] Referring to FIGS. 8 and 9 , apparatus 10 further includes two gas struts (or gas shocks) 72 and 73 to dampen the articulating movement of the base, central and foot beams 17 - 19 . Inner gas strut 72 is connected at one end 74 to bracket 34 and at its opposite end 75 to central beam 18 , and outer gas strut 73 is connected at one end 76 to the outer end of central beam 18 and at its opposite end 77 to rod 45 . [0027] In assembly, apparatus 10 is installed by mounting the base beam 17 via its plate 2 to the vehicle floor and by mounting floor socket 3 also to or in the vehicle floor (preferably flush with the floor) at such distance from the mounting of plate 2 so as to leave the desired gap between beams 17 and 19 to accommodate the intended scooter and as defined by the length of central beam 18 . Where the lengths of central beam 18 and the actuator assembly 11 are adjustable, the positionment of floor socket 3 is selected within the range of such adjustability and the width of the scooter. [0028] In use, once the scooter is maneuvered into position, as shown at 71 in FIG. 3 , the user activates motor 5 (via an appropriate switch, such as toggle switch 78 or a remote or other device), which causes output rod 33 to extend, its outer end being guided by the pin 38 riding within slots 39 and 40 , and central beam 18 is forced to pivot down about its hinged connection at pin 35 . Likewise, as pin 38 moves within slots 39 and 40 , connector rod 45 moves outwardly, and foot beam 19 is forced to bend at its hinge axis at pin 28 . As beams 18 and 19 bend, central beam 18 swings down over the scooter 71 , and locating pin 4 approaches floor socket 3 until: central beam 18 has reached it pivot limit (via hitting stop plate 26 ); foot beam 19 has reached its pivot limit (via stop plate 29 hitting central beam 18 ; and locating pin 4 has entered all the way into a snug locking engagement within the small, inner end 61 of keyhole opening 59 , as shown in FIGS. 8 and 9 , which constitutes the down, locking position 15 . To unlock the scooter, the toggle switch 78 or similar switch is activated to reverse the motor 5 , which retracts output rod 33 , and central and foot beams 18 and 19 are pivoted in the opposite directions until apparatus 10 is in its up, resting position ( FIGS. 1 and 2 ) and now stowed out of the way. [0029] While electric motor 5 minimizes the effort required by the operator to use apparatus 10 , alternative embodiments are contemplated wherein apparatus 10 lacks a motor, and the beams 17 - 19 are manually moved between the up, resting and down, locking positions 14 and 15 . In this configuration, the gas struts 72 and 73 are particularly helpful to avoid damage to the scooter or user from inadvertently dropping the assembly 10 before it has reached a position resting on and locking with the vehicle floor. Likewise, the gas struts can be omitted from the assembly 10 or such dampening action can be achieved in other means, such as friction bushings or similar elements at the hinged connections between the beams. [0030] Alternative embodiments are contemplated wherein central beam 18 and some portion of the actuator assembly 11 (that is, one or more of motor 5 , output rod 33 , connector rod 45 and other components connected thereto) are made for their length to be adjustable. That is, apparatus 10 is intended for use with scooters and/or similar mobility devices which might be of varying widths. The gap between base beam 17 and foot beam 19 in the down, locking position 15 is therefore contemplated to be made to readily accommodate such mobility device therebetween, but to not be too wide where apparatus 10 takes up more space than is necessary. Alternative embodiments are also contemplated wherein the base and foot beams 17 and 19 are made to be vertically adjustable to likewise readily accommodate the scooter or other mobility device contemplated for use therewith. [0031] Alternative embodiments are contemplated wherein the main beam 1 is mounted, not to the vehicle floor, but to any other part of the vehicle, so long as it moves between an up, rest position out of the way and a down, locking position securing the scooter. For example, main beam 1 could lack a base beam 17 , and the central beam 18 would be movably (e.g. pivotally) connected to some structure of or connected directly to the vehicle's side wall. [0032] While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.

An apparatus for securing a scooter with a footplate to a vehicle having a floor includes a main beam having proximal and distal ends and being connectable to the vehicle floor to move between an up, rest position and a down, locking position, the down, locking position including a portion of the main beam extending generally laterally over and across the footplate of a scooter positioned thereunder; actuator means including a follower pin received for limited movement in a slot defined by guide means connected to the main beam, the actuator means being for moving the main beam between the up, rest position and down, locking positions; and latch means for securing the distal end of the main beam to the vehicle floor when in the down, locking position.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation application of U.S. patent application Ser. No. 12/122,880, filed on May 19, 2008, which application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/930,547, filed May 17, 2007, the contents of which are incorporated herein by reference in their entirety. BACKGROUND OF THE INVENTION Field of the Invention The present invention is related generally to tampon pledgets. More particularly, the present invention is related to tampon pledgets that exhibit increased bypass leakage protection. Description of Related Art Both in-vivo and in-vitro testing has shown that current tampon pledgets do not protect well against bypass leakage. In-vivo testing shows that the typical woman places the tampon too deep into the vaginal canal and is not optimally placed to absorb fluid. In-vitro testing confirms that pledget expansion is not optimal. With both of these insights it is known that there is a propensity for the tampons to leak prematurely, i.e., bypass leakage. There have been many attempts in the prior art to address bypass leakage. Examples include providing a tampon pledget with various pre-expanded, compressed shapes designed to conform to a user's anatomy upon insertion into the vagina. One particular drawback with the pledget having a pre-expanded shape is that it may be difficult to house the pre-shaped pledget in a typical cylindrical applicator tube due to its shape. Also, once housed in the applicator, the pledget having the pre-expanded shape may exert additional forces on the walls of the barrel due to its shape, which in turn could cause excess friction during expulsion, requiring additional force to expel the pledget from the applicator. The additional required force could make using the applicator difficult and in some cases actually cause deformation of the applicator, making its use extremely difficult. Therefore, there remains a need in the tampon art for a tampon pledget that mitigates or all together prevents bypass leakage, while also avoiding the drawbacks associate with the prior art. The present invention meets this need. SUMMARY OF THE INVENTION The novel tampon pledget according to the present invention includes one or more of the following properties: increased absorbency rate; high absorbent capacity and fluid retention; rapid expansion potential; and ease of ejection of the pledget from the applicator. Surprisingly, the one or more properties are achieved by using a modified dual cross-pad, folded, compressed tampon pledget design. In one aspect of the invention, the cross pads are nearly identical in area prior to forming. It has been found that this feature provides the correct tampon length in body and the proper diameter for insertion into a woman's vagina. Additionally, it provides a more uniform fiber weight distribution across the entire length of the formed pledget, which unexpectedly results in improved absorption and reduced pledget ejection forces. In another aspect of the present invention the one or more bottom pads 12 is thicker, hence statistically heavier, than the one or more top pads 14 . The one or more bottom pads have a pad weight that is statistically greater than 50% of the total weight of the tampon pledget. The one or more top pads 14 have the remaining weight of the tampon pledget, namely a pad weight that is less than 50% of the total tampon pledget weight. Without being constrained by theory, these features together unexpectedly result in an increase in both the rate of absorbency and the absorbent capacity. The fluid intake rate is faster through the lighter, one or more top pads, while fluid is more efficiently stored in the thicker, one or more bottom pads, which form the absorbent core of the formed tampon pledget. Thus, relative to conventional prior art tampon pledgets, the tampon pledgets of the present invention not only absorb liquid faster and provide more rapid expansion, they also allow for lower pledget weights overall in order to achieve the required syngyna absorbency specifications, as regulated by the FDA Federal Register 821.430. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is top view of a tampon pledget prior to formation according to the present invention; FIG. 2 is a side view of a formed tampon pledget according to the present invention; FIG. 3 is a cut away view of the tampon pledget of FIG. 2 taken along line A-A; and FIG. 4 is a graph depicting tampon slice density data for a Regular absorbency, non-deodorant pledget according to the present invention versus a prior art pledget; FIG. 5 is a graph depicting tampon slice density data for a Regular absorbency, deodorant pledget according to the present invention versus a prior art pledget; FIG. 6 is a graph depicting tampon slice density data for a Super absorbency, non-deodorant pledget according to the present invention versus a prior art pledget; FIG. 7 is a graph depicting tampon slice density data for a Super absorbency, deodorant pledget according to the present invention versus a prior art pledget; FIG. 8 is a graph depicting tampon slice density data for a Super Plus absorbency, non-deodorant pledget according to the present invention versus a prior art pledget; and FIG. 9 is a graph depicting tampon slice density data for a Super Plus absorbency, deodorant pledget according to the present invention versus a prior art pledget. DETAILED DESCRIPTION OF THE INVENTION The present invention provides a unique tampon pledget designed for various tampon sorts with one or more enhanced features including, but not limited to, increased absorption potential, increased absorbency rate, increased expansion rate, improved fiber weight distribution along the length of the formed pledget, or any combinations thereof. These enhanced features are achieved by constructing the tampon pledget with certain pad lay-up ratios, fiber weight distributions, fibers and/or fiber blends, or any combinations thereof. As a result of these one or more enhanced features, a tampon pledget having increased bypass leakage protection results. Additionally, the enhanced features do not compromise the desired pledget geometry, pre-expansion. Therefore, applicator modifications are not required to house the pledget of the present invention. Referring to FIG. 1 , the present invention is exemplified by the pad lay-up represented generally by reference numeral 10 . Pad lay-up 10 includes one or more bottom pads 12 and one or more top pads 14 . While pad lay-up 10 depicts the one or more bottom pads 12 and one or more top pads 14 in a cross-pad configuration, it should be understood that the pad lay-up can be configured in any suitable shape, including, but not limited to cross, chevron, diamond, circular, oval, square, rectangle, or any combinations thereof, that achieve one or more of the desired properties according to the present invention. It has been surprisingly found that by providing one or more bottom pads 12 with one or more top pads 14 in certain pad lay-up ratios, based on their respective areas, desirable tampon pledget configurations can be achieved that provide enhanced bypass leakage protection. The pad lay-up ratio is defined as the ratio of the area of one or more bottom pads 12 to the area of one or more top pads 14 . The area of the one or more pads is calculated in a single plane. Therefore, while stacking of multiple pads may be done, it does not increase the calculated area of the one or more pads. Again referring to FIG. 1 , the one or more top pads 14 each has a length dimension 15 and a width dimension 16 . The one or more bottom pads 12 each have a length dimension 17 and a width dimension 18 . The one or more top pads 14 each have a length dimension 15 between about 2 inches and about 6 inches. In another embodiment, the one or more top pads 14 each have a length between about 3.5 inches and about 5 inches. In yet another embodiment, the one or more top pads 14 each have a length about 4 inches. The one or more top pads 14 each have a width dimension 16 between about 1 inches and about 4 inches. In another embodiment, the one or more top pads 14 each have a width between about 1.5 inches and about 3 inches. In yet another embodiment, the one or more top pads 14 each have a width about 2 inches. The one or more bottom pads 12 each have a length dimension 17 between about 2 inch and about 6 inches. In another embodiment, the one or more bottom pads 12 each have a length between about 3.5 inches and about 5 inches. In yet another embodiment, the one or more bottom pads 12 each have a length about 4 inches. The one or more bottom pads 12 each have a width dimension 18 between about 1 inch and about 4 inches. In another embodiment, the one or more bottom pads 12 each have a width between about 1.5 inches and about 3 inches. In yet another embodiment, the one or more bottom pads 12 each have a width about 2 inches. In one embodiment of the present invention, the pad lay-up ratio is between about 1:1.2 to about 1.2:1. In another embodiment of the present invention, the pad lay-up ratio is about 1:1. By providing the pad lay-up ratio, as described, the formed pledget has a more uniform fiber weight distribution across its entire length. As a result, the more uniform diameter of the pledget results in lower ejection forces. Additionally, the pledget absorbs more evenly across the length of the formed pledget. Another important aspect of the present invention is that the one or more bottom pads 12 are thicker, hence statistically heavier, than the one or more top pads 14 . The one or more bottom pads 12 have a pad weight that is statistically greater than 50% of the total weight of the tampon pledget. The one or more top pads 14 have the remaining weight, namely a pad weight that is less than 50% of the total tampon pledget weight. Without being constrained by theory, these features together unexpectedly result in an increase in both the rate of absorbency and the absorbent capacity. The fluid intake rate is faster through the lighter, one or more top pads 14 , while fluid is more efficiently stored in the one or more bottom pads 12 , which form the inner absorbent core of the tampon pledget when formed. Thus, the tampon pledgets of the present invention have enhanced absorption capacity, absorbent rates, and expansion rates, which lead to better bypass leakage protection. Suitable materials for use in forming the one or more bottom pads and/or the one or more top pads include, but are not limited to, cellulosic, rayon, cotton, pulp, superabsorbent, absorbent foam, multilobal fiber, or any combinations thereof. The tampon pledget may include a liquid permeable coverstock or overwrap material, if desired. Suitable coverstock materials may include, but are not limited to, rayon, cotton, bicomponent fibers, or other suitable natural or synthetic fibers known in the art. Rayon, polyethylene, polypropylene and blends of these are particularly suited for use as coverstock material. Referring to FIGS. 2 and 3 , a formed tampon pledget according to the present invention is depicted generally by reference numeral 20 . When forming tampon pledget 20 , the one or more bottom pads and one or more top pads are arranged in a cross pattern, then centered, as depicted in FIG. 1 . The pads are then folded using an auger provided in a tampon-forming machine like that which is commercially available from Playtex Hauni Machines (Richmond, Va.) such that the one or more bottom pads form an inner core 26 and the one or more outer pads form an outer layer 28 . The folded pads are then transferred into heated oven tubes, which compress the pads into the final self-sustaining cylindrical shape for assembly into a tampon applicator. Typically a withdrawal cord 22 is added to pledget 20 by means of threading a needle to the base 24 of the pledget during tampon assembly. Withdrawal stings are typically made of mercerized cotton treated with an anti-wick (a Nalan hydrophobic wax) coating to reduce string absorbency and wicking. Tampon strings are commercially available from Coats LLC (UK). Strings are typically threaded through a hole and then a loop is tied into a knot such that the final string hangs down about 4.5 inches from the base of the tampon pledget to allow the string to be easily located by the tampon wearer. Tampon pledgets may be either scented or unscented. Scented pledgets are typically obtained by spraying on a mix of deodorant (typically a proprietary mixture comprised of one or more fragrances, available from a fragrance house such as Givaudan (Switzerland)) blended together with a nonionic surfactant (e.g. the Tween 20 described above). When desired, about 0.125 g of blend may be sprayed on the one or more top pads and/or one or more bottom pads of each pledget just prior to pledget forming. The following examples demonstrate various embodiments according to the present invention. These examples are not intended to limit the scope of the present invention. Example 1 A Regular absorbency pledget is comprised of two fibrous nonwoven pads, both about 2″×4″, oriented perpendicular to each other. The nonwoven inner absorbent core pad (bottom pad in cross-pad configuration) is 100% viscose rayon fiber having a multilobal (“Y-shaped) geometry, marketed by Kelheim Fibres GmbH (Kelheim, Germany) under the Galaxy™ tradename. The outer pad (top pad in the cross-pad configuration) is formed with a blend of 60% viscose staple rayon (such as the P-1 fiber that is available from Lenzing Fibers, Austria) and 40% multilobal rayon fiber, as described above. The fiber typically may include a small percentage of a finish, such as sorbitan monolaurate nonionic surfactant (Tween 20), although a variety of finish chemistries may be used. The Regular pledget weight is about 1.52 grams (g) (at 14% moisture). The inner, absorbent core pad weight is about 0.63 g to about 1.25 g. In one preferred embodiment, the absorbent core pad weight is about 0.84 g (at 14% moisture). The outer pad is thinner and has a pad weight of about 0.51 g to about 1.05 g (at 14% moisture). In one preferred embodiment, the outer pad has a pad weight of about 0.68 g (at 14% moisture). The final pledget length for a Regular absorbency tampon pledget according to the present invention is about 1.875 inches. Example 2 A Super absorbency pledget is formed from two fibrous nonwoven pads, both about 2″×4″, oriented perpendicular to each other. The nonwoven inner absorbent core pad (bottom pad in cross-pad configuration) is 100% viscose rayon fiber having a multilobal (“Y-shaped) geometry, marketed by Kelheim Fibres GmbH (Kelheim, Germany) under the Galaxy™ tradename. The outer pad (top pad in the cross-pad configuration) is formed with a blend of 60% viscose staple rayon (such as the P-1 fiber that is available from Lenzing Fibers, Austria) and 40% multilobal rayon fiber, as described above. The fiber typically may include a small percentage of a finish, such as sorbitan monolaurate nonionic surfactant (Tween 20), although a variety of finish chemistries may be used. The pledget weight is about 2.27 g (at 14% moisture). The inner pad weight is between about 0.94 g to about 1.78 g (at 14% moisture). In one preferred embodiment, the inner pad weight is about 1.26 g (at 14% moisture). The outer pad weight is between about 0.76 g to about 1.46 g (at 14% moisture). In one preferred embodiment, the outer pad weight is about 1.01 g (at 14% moisture). Example 3 A Super Plus absorbency pledget is formed from two fibrous nonwoven pads, both about 2″×4″, oriented perpendicular to each other. Super Plus tampons are formed with 100% multilobal Galaxy rayon in both inner and outer pads. The total pledget weight is about 3.14 g (at 14% moisture). The inner pad has a weight between about 1.27 g to about 2.33 g (at 14% moisture). In one preferred embodiment, the inner pad has a weight of about 1.70 g (at 14% moisture). The outer pad has a weight between about 1.08 g to about 2.00 g. In one preferred embodiment, the outer pad has a pad weight of about 1.44 g (at 14% moisture). Example 4 Webs were formed in an engineering trial using Rando Machines. The Super absorbency webs formed were a wide web (a 60% viscose rayon/40% multilobal blend) and a narrow web targeted for the outer pads, with 100% ML Galaxy fiber wide webs targeted for the inner absorbent core pads. The Super Plus absorbency webs formed, both wide and narrow, were both made of 100% ML. Roll weights were targeted to achieve the desired pad weights for 2″×4″ inner and outer pads. Regular, Super and Super Plus absorbency tampon pledgets were formed on a Hauni forming machine. The formed pledgets were then tested in the laboratory. Results of the testing are summarized below in the Tables. Table 1 shows the individual pad weights for the tampons made according to this invention. Note the differences in individual pad weights. TABLE 1 Summary of Pad, String, and Tampon Weights for Regular, Super and Super Plus Absorbency Tampons of this Invention Regular Super Super Plus Formed Formed Formed Formed Tampon Inside Formed Tampon Formed Tampon Formed Key Statistics for a Weight Narrow Outside Weight Inside Formed Weight Inside Formed Set of 45 to 50 Including Pad Wide Pad String Including Narrow Outside String Including Narrow Outside String Tampons of Each String Weight Weight Weight String Pad Wide Pad Weight String Pad Wide Pad Weight Sort (gms.) (gms.) (gms.) (gms.) (gms.) Weight Weight (gms.) (gms.) Weight Weight (gms.) Average 2.02 1.05 0.87 0.10 2.73 1.39 1.23 0.11 3.34 1.79 1.44 0.11 (of all 45-50) Standard Deviation 0.086 0.065 0.066 0.015 0.099 0.051 0.084 0.014 0.103 0.062 0.082 0.044 Number Tested 50 50 50 50 50 50 45 50 50 50 45 45 Maximum 2.22 1.18 1.00 0.15 2.99 1.51 1.43 0.13 3.51 1.95 1.68 0.36 Minimum 1.79 0.89 0.71 0.08 2.52 1.28 1.03 0.05 3.09 1.68 1.25 0.01 Table 2 provides a summary of results for Super absorbency tampons roughly in accordance with the present invention. As you can see, the average absorbency for the Super sort was 10.79 grams, which meets the specification of 9-12 grams. The average ejection force for the Super sort was 16.61 oz. TABLE 2 Summary of Weights, Ejection Forces, Moisture Levels and Absorbencies for Super Absorbency Tampons of this Invention (2″ × 4″ Inside Pads and 4″ × 2″ Outside Pads) Tampon Moisture, % g per g Weights Ejection Loss on Syngyna Absorbency Key Statistics (dry), gms. Forces (oz.) Drying Absorbency Capacity Average (of all tested) 2.34 16.61 11.29 10.79 4.48 Standard Deviation 0.108 2.087 1.150 0.371 0.169 Number Tested 30 30 5 30 30 Maximum 2.58 20.27 13.11 11.36 4.82 Minimum 2.13 11.46 10.00 9.88 4.10 Note: Tampons Made on an HP Machine Made (Nov. 11, 2006) Target weight: 2.35 gm. Super Wide Target Outside Pad (1.05 gm.) & Super Narrow Target Inside Pad (1.30 gm.) (GG Phase 1 - P13AT24 Web Made on Nov. 10, 2006) 225° F. Oven Temperature, Standard Super White Barrels Table 3 provides results for Super Plus tampons made roughly in accordance with this invention. As you can see, the average absorbency for the Super Plus sort was 13.01 grams, which meets the specification of 12-15 grams. The average gm/gm for the Super Plus sort was 4.19 grams. The average ejection force for the Super Plus sort was 24.82 oz. TABLE 3 Summary of Weights, Moisture Levels and Absorbencies for Super Plus Absorbency Tampons of this Invention (2″ × 4″ Inside Pads and 4″ × 2″ Outside Pads) g per g Ejection Tampon Dry Moisture, % Syngyna Absorbency Key Statistics Forces, oz. Weights (gms.) Loss on Drying Absorbency Capacity Average (of all tested) 24.82 3.01 11.15 13.01 4.19 Standard Deviation 5.641 0.142 0.370 0.521 0.130 Number Tested 30 30 5 30 30 Maximum 36.22 3.32 11.68 14.01 4.43 Minimum 14.93 2.71 10.77 12.02 3.96 Note: Tampons Made on HP Machine Made (Nov. 11, 2006) 3.05 gm. Super Plus Wide Target Outside Pad (1.39 gm.) & Super Plus Narrow Target Inside Pad (1.66 gm.) (Web Made on Nov. 10, 2006) 260° F. Oven Tubes, Standard Super White Barrels Results reported in Tables 2 and 3 above are for tampon pledgets made with standard barrels. A subsequent study was done on 33 super and 33 super plus tampons made with barrels containing erucamide. This provided not only comparable results in terms of absorbency but also significantly lower ejection forces. Tables 4 and 5 provide a summary of those results for Super and Super Plus non-deodorant (non-deo) tampons respectively. As you can see, results are favorable for ejection force, absorbency and gram per gram absorbency capacity relative to results for comparable prior art tampons. TABLE 4 Super Results 06-0251 GG Phase 1 Super ND (Dec. 5, 2006) Input/Output Pledget Study Dec. 5, 2006 GG PHASE 1 MEASUREMENT Spec. Range SUPER ND Narrow Pad Dimension 2 ± .25″ AVERAGE 1.861 (Width) (1.75-2.25) STDEV 0.0459 Narrow Pad Dimension 4 ± .25″ AVERAGE 3.922 (Length) (3.75-4.25) STDEV 0.0499 Narrow Pad (Weight) NA AVERAGE 1.235 STDEV 0.1102 Wide Pad Dimension 2 ± .25″ AVERAGE 3.713 (Width) (1.75-2.25) STDEV 0.1264 Wide Pad Dimension 4 ± .25″ AVERAGE 1.981 (Length) (3.75-4.25) STDEV 0.0324 Wide Pad (Weight) NA AVERAGE 0.838 STDEV 0.1042 Pledget Initial 25 oz. Max AVERAGE 18.44 Ejection Force STDEV 1.1404 Pledget Dry Weight 2.60 ± .25″   AVERAGE 2.40 (1.65-2.15) STDEV 0.2246 Pledget Corrected AVERAGE 2.57 Weight (14%) STDEV 0.2405 Pledget Absorbency 9-12 grams AVERAGE 10.16 STDEV 0.7919 Pledget Gm/Gm NA AVERAGE 3.96 STDEV 0.0953 TABLE 5 Super Plus Results 06-0257 GG Phase 1 Super Plus ND (Dec. 8, 2006) Input/Output Pledget Study GG PHASE 1 Dec. 8, 2006 SUPER MEASUREMENT Spec. Range PLUS ND Narrow Pad 2 ± .25″ AVERAGE 1.931 Dimension (Width) (1.75-2.25) STDEV 0.0357 Narrow Pad 4 ± .25″ AVERAGE 3.909 Dimension (Length) (3.75-4.25) STDEV 0.0619 Narrow Pad (Weight) 1.27-2.33 AVERAGE 1.600 grams STDEV 0.0935 Wide Pad Dimension 4 ± .25″ AVERAGE 3.834 (Width) (3.75-4.25) STDEV 0.0583 Wide Pad Dimension 2 ± .25″ AVERAGE 1.955 (Length) (1.75-2.25) STDEV 0.0469 Wide Pad (Weight) 1.08-1.80 grams AVERAGE 1.388 STDEV 0.1291 Pledget Initial 25 oz. Max AVERAGE 25.21 Ejection Force STDEV 2.2750 Pledget Dry Weight 3.31 ± .25″   AVERAGE 3.19 (1.65-2.15) STDEV 0.1906 Pledget Corrected AVERAGE 3.37 Weight (14%) STDEV 0.2017 Pledget Absorbency    12-15 grams AVERAGE 12.86 STDEV 0.5045 Pledget Gm/Gm NA AVERAGE 3.82 STDEV 0.1358 Additional absorbency rate testing of the tampon pledgets made above and described in the Tables above against some competitive, commercially available tampons was conducted. Since the test was not standard, the detailed protocol is provided below. Test Method: Protocol for Gravimetric Absorption Testing System (GATS) Testing GATS uses a patent-based method to reliably determine absorption characteristics. By employing a sensitive scale, slide, and software, the GATS can run either horizontal or vertical absorption studies by manipulating test plates. Either or both the capillary and structural liquid intake of a desired substrate can be assessed by GATS. The GATS is commercially available form MK Systems. The GATS is widely used in the many industries, including nonwoven, tissue, paper towel, textile, and powder based areas. Any solid material that absorbs liquid can be measured with the GATS, using a method that takes user-variability out of testing. After each test has been completed, data is then downloaded to a PC. The liquid source is automatically refilled. Briefly, the GATS monitors the rate at which a liquid is absorbed onto a test plate. Tests are started either by solenoid action or by the placement of a sample onto the plate. An internal microprocessor takes several readings of the scale's output every second. The test stops when the flow rate drops below a predetermined rate or a predetermined time. Typically, the test plate is attached to a vertical leveling mechanism. This prevents the formation of excess hydrostatic head during a test. The test plate is lowered at the same rate at which the liquid level in the reservoir drops. This eliminates the effects of gravity, providing a truer profile of the material's absorptive characteristics. The balance is very accurate (+/−0.001 g). This accuracy and precision provides the necessary discrimination for an accurate profiling of the absorbency of a given material. Key External References Pertaining to the GATS System The American Society for Testing and Materials (ASTM) actually suggests using the GATS for standard absorption testing. A key ASTM reference is: American Society for Testing and Materials (ASTM) D 5802-95, Standard Test Method for Sorption of Bibulous Paper Products (Sorptive Rate and Capacity Using Gravimetric Principles). Test method ASTM D5802-95 was followed, except as noted on the next page. Modifications for the Study of Rate of Absorbency by Tampons The dry mass of the tampon is the mass of the fiber capsule with the string cut flush to the tampon. (The strings were cut, because it interfered with absorption measurements, by becoming immersed in the fluid.) All tests were made at zero hydrostatic head, which means that the test stopped automatically when the product was saturated and did not absorb fluid further. The fluid used was 1% saline. The fluid was allowed to be absorbed from the end that enters the body cavity first, i.e. from the end opposite to the one that has the string attached. The tests were performed on GATS with a special attachment that held the tampon vertically over the fluid hole and imposed lateral pressure over much of their periphery, using four curved pieces of Teflon connected arranged at 90 degrees with respect to one another and connected to a larger Plexiglas enclosure by a spring. The pressure applied was such that the tampon could expand somewhat during absorption of fluid. The applied pressure was to mimic the pressure typically exerted by the vaginal walls. This provided an absorptive capacity comparable to what is seen in a typical syngyna absorbency test. Results were then summarized in a series of excel spreadsheets. Tables 6 through 6f provide a summary of the results for rates of absorbency estimated at the five-second mark after tampon absorption had started. Results were comparable at the 2 and 10 second marks as well. Rates of absorbency of tampons are most relevant at the shorter times. If the rates are too slow at these times, bypass leakage becomes more likely. As you can see from the Tables, rates of absorbency for the tampon pledgets according to the present invention at these times are faster and thus superior to those rates for commercially available prior art tampon pledgets. TABLE 6 Comparison of Absorbency Rates (g per g per sec) at the 5 second mark to Various Commercial Tampons Absorbency Brand Super Super Plus Comments Gentle Glide Average 0.265 0.252 10-20 tampons were tested for each Standard Dev. 0.045 0.031 brand/absorbency The tampons of the previous invention were those described above. Tampons of the Present Invention Average 0.321 0.257 Overall, the Tampons of the Standard Dev. 0.022 0.019 present invention are fastest absorbing. Tampax Pearl Average 0.192 0.145 somewhat low relative to Gentle Standard Dev. 0.023 0.022 Glide and those of present invention. Kotex Average 0.156 0.116 lowest overall Standard Dev. 0.022 0.018 TABLE 6a Absorbent Capacity, gram per gram absorbent capacity, Super Absorbency Tampons Brand Kotex Playtex Playtex Tampons Tampax Secu- Gentle Gentle of this Pearl, Tampax rity Glide, Glide, Invention, unscent- Pearl, (no non- Deodor- unscented ed scented scent) deodorant ant 6.243 4.64 4.47 4.32 4.29 4.87 5.947 4.44 4.89 4.25 4.98 4.80 5.930 4.50 4.70 3.66 4.92 5.17 5.679 4.68 4.72 4.17 5.31 5.27 6.344 4.69 4.65 4.08 5.28 5.17 5.759 4.61 4.30 3.80 4.91 5.25 6.328 4.24 4.33 3.70 5.53 5.16 5.793 4.32 4.79 4.36 5.59 5.23 6.149 4.50 4.67 4.40 5.73 5.03 5.789 4.54 4.53 4.04 5.24 4.94 3.84 4.66 3.64 5.83 4.07 4.15 3.99 3.98 4.14 3.84 3.79 4.20 4.54 3.91 4.27 3.97 Average 5.996 4.516 4.606 4.079 5.176 5.104 Std. Dev. 0.250 0.149 0.192 0.272 0.420 0.169 Probability that t test is 0.00 0.00 0.00 0.00 0.00 significantly different (I.e. higher) for tampons of this invention vs. competitive offering ---> TABLE 6b Absorbent Capacity, gram per gram absorbent capacity, Super Plus Absorbency Tampons Brand Kotex Playtex Playtex Tampons Tampax Secu- Gentle Gentle of this Pearl, Tampax rity Glide, Glide, Invention, unscent- Pearl, (no non- Deodor- unscented ed scented scent) deodorant ant 6.383 4.403 4.258 4.269 6.111 6.178 6.164 4.640 4.177 3.318 6.008 6.335 6.124 4.273 3.957 4.079 6.511 6.276 6.075 4.495 3.785 4.039 6.228 6.484 5.510 4.271 4.328 3.399 6.144 6.212 5.864 4.240 4.626 3.947 6.590 5.995 6.260 4.083 4.370 3.916 6.078 6.583 5.927 4.183 4.240 3.983 6.377 6.612 6.623 4.347 4.400 3.939 6.260 6.138 6.472 4.283 4.449 4.193 6.121 6.393 4.391 4.294 3.628 6.455 6.163 4.273 4.400 3.768 6.062 6.189 3.826 4.073 4.123 3.831 3.642 4.002 4.149 4.077 4.223 3.735 4.136 3.969 Average 6.140 4.322 4.259 3.908 6.243 6.321 Std. Dev. 0.323 0.159 0.243 0.311 0.193 0.200 Probability that t test is 0.00 0.00 0.00 0.38 0.20 significantly different (I.e. higher) for tampons of this invention vs. competitive offering ---> TABLE 6c Rate of Absorbency, at 2 seconds, gram per gram per second, Super Absorbency Tampons Brand Kotex Playtex Playtex Tampons Tampax Secu- Gentle Gentle of this Pearl, Tampax rity Glide, Glide, Invention, unscent- Pearl, (no non- Deodor- unscented ed scented scent) deodorant ant 0.373 0.195 0.189 0.194 0.182 0.194 0.388 0.178 0.195 0.181 0.288 0.182 0.382 0.177 0.215 0.122 0.199 0.200 0.336 0.150 0.232 0.156 0.304 0.214 0.347 0.191 0.224 0.155 0.317 0.227 0.325 0.217 0.216 0.166 0.305 0.231 0.398 0.221 0.209 0.179 0.346 0.232 0.345 0.194 0.233 0.237 0.364 0.235 0.351 0.154 0.242 0.200 0.331 0.226 0.320 0.223 0.232 0.191 0.322 0.196 0.256 0.163 0.200 0.196 0.240 0.109 0.376 0.159 0.195 0.170 0.160 0.164 0.149 0.150 0.168 0.206 0.163 0.197 0.165 Average 0.362 0.190 0.219 0.178 0.296 0.211 Std. Dev. 0.027 0.026 0.017 0.031 0.060 0.020 Probability that t test is 0.00 0.00 0.00 0.02 0.00 significantly different (I.e. faster) for tampons of this invention vs. competitive offering ---> TABLE 6d Rate of Absorbency, at 2 seconds, gram per gram per second, Super Plus Absorbency Tampons Brand Kotex Playtex Playtex Tampons Tampax Secu- Gentle Gentle of this Pearl, Tampax rity Glide, Glide, Invention, unscent- Pearl, (no non- Deodor- unscented ed scented scent) eodorant ant 0.256 0.141 0.174 0.122 0.260 0.239 0.279 0.160 0.163 0.101 0.256 0.240 0.333 0.153 0.140 0.078 0.210 0.305 0.253 0.155 0.134 0.107 0.235 0.281 0.272 0.128 0.126 0.125 0.114 0.255 0.270 0.168 0.159 0.138 0.308 0.251 0.259 0.192 0.096 0.131 0.274 0.295 0.291 0.184 0.138 0.134 0.293 0.283 0.269 0.148 0.162 0.268 0.310 0.293 0.209 0.156 0.238 0.296 0.180 0.124 0.305 0.294 0.180 0.106 0.331 0.298 0.117 0.123 0.126 0.108 0.092 0.138 0.130 0.124 0.138 0.111 0.158 Average 0.277 0.160 0.149 0.122 0.246 0.276 Std. Dev. 0.024 0.021 0.030 0.024 0.054 0.027 Probability that t test is 0.00 0.00 0.00 0.29 0.88 significantly different (I.e. faster) for tampons of this invention vs. competitive offering ---> TABLE 6e Rate of Absorbency, at 5 seconds, gram per gram per second, Super Absorbency Tampons Brand Kotex Playtex Playtex Tampons Tampax Secu- Gentle Gentle of this Pearl, Tampax rity Glide, Glide, Invention, unscent- Pearl, (no non- Deodor- unscented ed scented scent) deodorant ant 0.335 0.180 0.176 0.174 0.241 0.231 0.344 0.165 0.182 0.168 0.238 0.222 0.340 0.166 0.199 0.115 0.199 0.244 0.303 0.142 0.213 0.146 0.221 0.256 0.317 0.177 0.206 0.145 0.175 0.280 0.295 0.200 0.200 0.148 0.284 0.285 0.355 0.204 0.193 0.155 0.254 0.293 0.310 0.181 0.213 0.204 0.271 0.295 0.318 0.144 0.221 0.178 0.250 0.284 0.290 0.204 0.212 0.169 0.223 0.182 0.234 0.146 0.281 0.182 0.221 0.104 0.300 0.148 0.171 0.158 0.149 0.153 0.139 0.140 0.157 0.190 0.151 0.181 0.154 Average 0.322 0.176 0.201 0.160 0.236 0.238 Std. Dev. 0.021 0.023 0.015 0.024 0.033 0.015 Probability that t test is 0.00 0.00 0.00 0.00 0.00 significantly different (I.e. faster) for tampons of this invention vs. competitive offering ---> TABLE 6f Rate of Absorbency, at 5 seconds, gram per gram per second, Super Plus Absorbency Tampons Brand Kotex Playtex Playtex Tampons Tampax Secu- Gentle Gentle of this Pearl, Tampax rity Glide, Glide, Invention, unscent- Pearl, (no non- Deodor- unscented ed scented scent) deodorant ant 0.241 0.134 0.162 0.116 0.260 0.281 0.259 0.141 0.153 0.097 0.256 0.262 0.303 0.121 0.133 0.075 0.210 0.238 0.236 0.131 0.127 0.102 0.235 0.234 0.251 0.134 0.120 0.116 0.114 0.274 0.250 0.151 0.150 0.128 0.308 0.264 0.243 0.145 0.093 0.121 0.274 0.285 0.267 0.146 0.141 0.124 0.293 0.274 0.252 0.124 0.141 0.146 0.268 0.271 0.272 0.157 0.193 0.143 0.238 0.274 0.179 0.168 0.114 0.305 0.170 0.168 0.101 0.331 0.111 0.117 0.120 0.103 0.088 0.130 0.124 0.118 0.130 0.105 Average 0.257 0.138 0.141 0.110 0.246 0.266 Std. Dev. 0.019 0.012 0.027 0.018 0.054 0.017 Probability that t test is 0.00 0.00 0.00 0.93 0.50 significantly different (I.e. faster) for tampons of this invention vs. competitive offering ---> Example 5 The tampon pledgets according to the present invention were tested to determine the fiber weight distribution across the entire length of the formed pledget. Test Method for Tampon Cross-Section Slicing Equipment EdgeCraft electric food slicer or equivalent, electronic or dial calipers, tampon barrel-pledget holding device(s) (1-Regular & 1-Super), Sartorius BP110 Digital Scales or equivalent, and pin gauges. Procedure Using the EdgeCraft 662 Electric Slicer and Holder, remove the tampon plunger and cut the string flush with the bottom edge of the finger grip portion of the barrel. Insert the finger grip end of the barrel into the slide portion of the holding fixture up to the second ring from the top. Insert the slide portion to be sliced into the mounted holder base. Set the slicer thickness control knob setting to the number 5 to start. This setting will yield an approximate slice thickness of ⅛″. With the carriage-holder assembly positioned to the left, and hands away from the blade, turn on the “ON/OFF” power switch(s) as described. To minimize the possibility of accidentally powering the slicer, it is designed with a double switch system. The left-on/off power switch must be pushed first. To start the blade, next push the right spring-loaded safety switch (the switch will return instantly to a “neutral” position). When the slicer blade is rotating, an indicator light positioned to the right of the switches will be on. To stop the slicing blade, press the top of the left switch. Cross-Section Slicing With the slicer blade now operating, grasp the slicer carriage with the left hand and the tampon holder with the right hand. Advance the tip of the tampon applicator into contact with the rotating blade. After each slice, the slice part(s) will drop into the tray placed on the slicer base on the opposite side of the blade. After each slice, return the carriage to the left and press the tampon forward preparing for the next slice. (First 2 slices will usually remove only the petals). Upon making the first whole slice consisting of a solid ring of plastic and rayon, remove this piece and verify the thickness using electronic or dial calipers. The key to a good even slice is to cut slowly and with even pressure. The slice thickness should be no less than ⅛″ of an inch or greater if specified. If the part is too thick or thin, readjust the “Thickness Control Knob” as necessary (higher the setting, the thicker the part and vise-versa). Upon making the first acceptable slice, you must keep each slice positioned on the tray in the order in which it was sliced (required for proper density identification throughout the entire pledget). The last slice should end approximately at the barrel parting line. The first full slice ring to start with, will be just below the petal slots. This will be the start of the procedure and will require the following: Remove the rayon from the plastic slice ring and weigh and document the rayon weight. Utilizing the appropriate size “Pin Gage”, measure the inside diameter of the plastic ring and document. In the order of slicing, each ring-rayon slice must be correlated and documented together (in sliced order) throughout the entire individual tampon slicing. Calculation Pledget ⁢ ⁢ Density = Mass ⁢ ⁢ of ⁢ ⁢ Pledget Cross ⁢ ⁢ Section ⁢ ⁢ Area ( Pin ⁢ ⁢ Gage ⁢ ⁢ Meas . ) × Plastic ⁢ ⁢ Ring ⁢ ⁢ Thickness ( 0.125 ″ ) Report Record the individual weight of each piece of rayon and measure and record the inside diameter of each sliced plastic ring in the order that they were sliced. The results of this study are set forth in FIGS. 4 through 9 . While the present invention has been described with reference to one or more exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the disclosure without departing from the scope thereof.

The present invention provides a tampon pledget with one or more of the following properties: increased absorbency rate; high absorbent capacity and fluid retention; rapid expansion potential; and ease of ejection of the pledget from the applicator. Surprisingly, the one or more properties are achieved by using a modified dual cross-pad, folded, compressed tampon pledget design.

BACKGROUND OF THE INVENTION The invention concerns a drum for the production of drageees. Such a drum is for instance already known under DE-OS No. 33 15 223 from the same applicant. A feature of this known arrangement is that the spray arm is so formed that the cleaning process for the spray jets can be carried out during the short intervals between coatings without interrupting the complete program. To this point this publication explained that the spray arm is fitted in a closed housing in which the spraying and cleaning arrangements are fixed. In the operating mode, the spray arrangement is folded out by specific apertures opened and closed by slides in the housing, thus carrying out the coating of the kernels. In the cleaning mode, the complete jet arrangement in the closed housing is swung in and the recesses in the housing are covered by a covering slide so that the housing is hermetically sealed and the jets are thus now arranged directly opposite the cleaning jets which carry out the cleaning of the spray jets. This continuous operation of the drum enabling cleaning of the drum during the coating intervals without stopping it has proved itself to be unusually satisfactory. However, with such a known drum only one single load of the same type of kernels can be coated. If differing coatings are required a further drum is required with all fitments for air and water techniques which leads to high equipment resources. BRIEF SUMMARY OF THE INVENTION The present invention has as its object the further development of a drum of the type mentioned in the foregoing so that with one and the same drum differing loads of kernels can be coated with different materials. To solve this problem, the present invention is characterized in that the drum is divided axially into several separate coating chambers (drum sections) for the separate treatment of the kernels, and that several parallel partitions each dividing a section of the drum extend diametrically from the inner circumference of the drum radially inwards in the direction of the drum axis, and that in each drum section a separate spray arm section is arranged. A fundamental feature of the current invention is therefore that in one and the same drum, various kernels can be simultaneously treated. This is particularly advantageous in the case of kernels which are to be coated in differing colours. Previously, for example, for six different colours six different drums were required with all their necessary attachments such as supply fixtures, air and water fittings, drive, control and the like. In the case of the present invention these resources in materials are rendered superfluous as in this case only one single drum is required,and, naturally the technical air equipment acts simultaneously on all sections of the drum thus producing further savings in resources. A drum according to the invention therefore functions substantially more economically than the currently known drums which require a number of drums for the different treatment of the kernels. Also made similarly redundant are transport problems, material treatment problems, intermediate storage, and cleaning and rinsing problems in that the materials to be treated undergo differing treatments in the area of the different drum. sections. A requirement for such a partitioning of a drum is that one can treat relatively large loads. This is achieved in that the air from the exterior of the drum is blown in radially towards the drum axis and thus the kernels are lifted on an air cushion and essentially do not move, so that even in the case of large load sizes, the kernels will not be damaged. In the case of the drum divided into sections according to the invention, the air stream in the individual drum sections is so directed that each kernel to be coated is led towards the middle of the drum section so that they do not remain on the partition thus possibly passing through a central aperture in the partition through which the spray arm protrudes, and thus landing in the adjacent section. The annular air flow in each drum section ensures that the spray cloud created in the respective drum sections cannot penetrate into the adjacent section. The air streams in each drum section are so directed that they are always concentrated in the direction of the longitudinal axis, so that a specific screening action in the direction of the partition is available because the partition itself is not acted upon by the air current. In the following the invention will be further explained by means of drawings illustrating only one application method. Herewith further fundamental features and advantages of the invention arise from the drawings and their descriptions. Brief description of the various views of the drawings: FIG. 1: Section through a drum according to the invention. FIG. 2: Face view of the drum shown in FIG. 1 in the direction of arrow II. FIG. 3: Front view of the partition shown in FIG. 2. FIG. 4: Section IV--IV in FIG. 3 through the attachment of the partition. FIG. 5: Section V--V in FIG. 3 FIG. 6: Schematic perspective illustration of a spray arm divided into sections. DETAILED DESCRIPTION FIG. 1 shows a schematic illustration of a drum (1) whose mountings and external housing have been dispensed with in the interests of clarity. In that matter the specific publication DE-OS No. 33 15 223 is to be referred to, in which it can be seen that the drum (1) is mounted in a machine frame together with the drive system and the complete drum with the drive fittings is enclosed in a (not illustrated) housing. On the face of the drum (1) a flow distributor is fitted from which connection channels (3) extend parallel and equidistant in the direction of the longitudinal axis of the drum (Ref. FIG. 2). The drying air is fed into the connection channels (3) through the flow distributor (4) and reaches the interior of the drum (1) through apertures in the outer wall of the drum (1). In the embodiment example in accordance with the drawings, the drum (1) is divided into two drum sections (10)(11), in which the division is formed by a partition (12) diametric to the drum axis(2). A spray arm (6) extends parallel to the drum axis (2) in the direction of the longitudinal axis of the drum (1) which can be seen from the face view of the spray arm in FIG. 2. The spray arm (6) in accordance with FIGS. 2 and 6 consists of a closed housing (15) in which a jet carrier (16) extending axially into the housing (15) is available. In the jet (16) two separate jet tubes (19)(20) are arranged which are led off to the exterior of the drum (1) by a connector piece (21). In this fashion it is possible to connect the spray jets (17) of the left hand spray arm section (13) to a different spray medium as that of the spray jets (17) in the right hand spray arm section (14) as shown in FIG. 6. On the underside of the spray arm (6) are spray jets on bars for chocolate (36) to coat kernels as required with chocolate. The cleaning fixtures are shown in FIG. 2 only and not in FIG. 6 in the interests of clarity. They consist of a cleaning spray jet bar (34) fitted in the upper inner side of the housing (15) from which a cleaning agent, usually warm water can be directed onto the spray jets (17). The cleaning of the spray jets (17) during the intervals between coatings is achieved in that the complete jet carrier (16) is swivel mounted in the direction of arrow (38) in the housing (15) and the spray jets (17) in accordance with FIG. 2 are swung clockwise back into the housing (15) so that their openings lie directly opposite to the respective cleaning jets of the cleaning spray jet bar (34). During the spraying phase the spray jets (17) are swung out of the housing (15) through apertures in this housing taking the position shown schematically in FIG. 2. During the cleaning phase the spray jets (17) are swung back into the housing by rotating the jet tube (19) in a clockwise direction (arrow direction 38) and the apertures in the housing are sealed by a slide so that the housing is hermetically sealed. The water sprayed on the spray jets (17) from the cleaning spray jet bar (34) is trapped in a floor channel (18) of the spray arm (6) and directed to the exterior. For the purposes of powder coatings a powder injection fitting (35) can be provided on the underside of the spray arm (6) whereby, as before, a powder injection fitting for each drum section (10)(11) can be driven separately. In order that the method of operation may be observed, lighting (33) is fitted on the upper side of the spray arm (6). The jet arrangement (9) of the spray jets (17) on the common jet carrier (16) in the embodiment example is random. In other, not illustrated, embodiment examples the described cleaning fixture can naturally be dispensed with and the cleaning of the spray jets can be carried out in the usual way. The important thing is, therefore, that in the drum one or more parallel and equidistant partitions (12) are arranged which, between themselves and as required form, together with the end faces of the drum (1), specific drum sections (10)(11) in each of which is arranged a spray arm section (13)(14) for the separate treatment of kernels to be coated in each respective drum section (10)(11). In accordance with FIGS. 2 and 3, the partition (12) consists of several segment shaped partition sections (37) which are held together in a radially inwards position by a U-shaped channel attachment ring (32). In accordance with FIG. 5 the attachment ring (32) consists of two handed ring halves (29)(31) which have their flat sides fitted together, and which have an attachment bolt (22) fitted in one ring half (31) which extends through a corresponding hole in the other ring half (29) where it is secured on this side by a cap nut (not illustrated). Both ring halves (29)(31) form a circular peripheral slot (40) in which is gripped the internal circumference of the respective partition sections (37). On their longitudinal sides, the partition sections (37) meet tightly together and are connected on their external circumference to the inner side of the drum (1) by means of the attachment shown in FIG. 4. For this purpose attachment angles (23) are screwed onto the inner side of the drum (1), each attachment angle being connected by a threaded bolt (25) which extends through the wall of the drum (1) and which is secured on the other side by a nut (26). The legs of the attachment angle (23) standing radially outwards from the inner wall of the drum are tilted towards each other, so that they grip and retain the respective inserted partition sections (37). At a distance from the wall attachment of the partition sections (37) air guide plates (30) are connected to the partition sections (37) by corresponding attachment angles (24). The attachment angles (24) are welded to the partition section (37) at their points of contact, the other leg of the attachment angle (24) laying flush with the air guide plates (30). In accordance with FIG. 3 the air guide plates (30) have the task of redirecting in the direction of arrow (27) the air streams entering the drum(1) through the aperture (8) in the direction of arrow (28) to achieve a circular airflow along the inner side of the respective drum sections. This air flow holds the material to be coated away from the drum wall and directs it to the middle of each respective drum section in the direction of the drum axis where it falls back again in the direction of the inner wall of the drum (1). It is important here that the drum rotates in the direction of arrow (39) so that the air flowing in the direction of arrow (27) is able to pick up kernels laying on the floor of the drum and to lead the circulation to the next air guide plate (30). A partial vacuum is created in each drum section (10)(11) thus avoiding air passing from one drum section (10)(11) to another section (10)(11) through the radial clearance (41) of the attachment ring (32) to the outer circumference of the spray arm. In a further development of the present invention a wedge-shaped partition profile (42) is provided in place of the straight partition profile (Ref.FIG. 1) as shown by the dotted lines in FIG. 1. The partition in this case extends from the radially inwards situated attachment ring (32) in a radially outwards direction to approximately the middle in a straight form (as in FIG. 1) and then, from the middle, directed radially outwards, to form wedge-shaped radially outwards spreading surfaces. In this fashion it is ensured that material falling against the partitions is again directed towards the middle of the respective drum sections (10)(11).

A spray arm (6) is arranged parallel to the axis (2) of a drum with a multi-spray system for the production of dragees, on which a jet arrangement (9)(36) for the spraying of kernels, together with, as necessary a cleaning fixture for cleaning the jet arrangement is provided. So that in one and the same drum, several kernels can be treated with different materials, the drum (1) is divided axially into several separate coating chambers, whereby several parallel partitions, each dividing a section of the drum, extend diametrically from the inner circumference of the drum (1) radially inwards in the direction of the drum axis and in each drum section (10)(11) a separate spray arm section (13)(14) is arranged.

BACKGROUND OF THE INVENTION [0001] The classic game of “checkers” has been varied in many ways over the years. It is usually a two-person game in which one-half of the classic checkerboard comprising 32 squares—16 of one color (usually black) and 16 of another color (usually red)—is the domain of one player and the other one-half is the domain of a second player. [0002] There are variations of checkers for more than two players, but few are for three players. [0003] There are variations of checkers and other board games that have been implemented on personal computers, on a host network or in an integral small device for a single player, typically, to play against the device. It is contemplated that the version of checkers disclosed herein may also be so implemented using appropriate software or a suitable microchip to allow the device to take the part of two of the three players. [0004] The present variation of the classic checkers board game makes changes in the game and how it is played, but includes the possibility of using conventional checker pieces (albeit in three colors instead of two) or using other types of pieces as “checkers.” BRIEF DESCRIPTION OF THE INVENTION [0005] This invention consists of a game board and rules that allow three players simultaneously to play a game based on the traditional game of checkers. The game board provides a Home Base for each of three players (instead of two, as in traditional checkers) separated by a triangular Battle Zone in which the game pieces are allowed more freedom of movement than in their Home Bases. The object of the game is, as in traditional checkers, to avoid capture so that you have pieces remaining on the gameboard after all pieces of both opponents have been captured. The invention includes a second variation that uses a gameboard in which the Battle Zone is configured in a different manner. BRIEF DESCRIPTION OF THE DRAWINGS [0006] FIG. 1 is a topside view of the game board for three players according to claim 1 of the present invention. [0007] FIG. 2 is a schematic view of the moves that may be made by an unimpeded game piece to enter the Battle Zone according to claim 1 or claim 2 of the present invention. [0008] FIG. 3 is a schematic view of the moves that may be made by a game piece to enter the Battle Zone by jumping and capturing an opponent's game piece according to claim 1 or claim 2 of the present invention. [0009] FIG. 4 is a schematic view of the moves that may be made by an unimpeded game piece inside the Battle Zone according to claim 1 of the present invention. [0010] FIG. 5 is a schematic view of the moves that may be made by a game piece to jump and capture an opponent's game piece inside the Battle Zone according to claim 1 of the present invention. [0011] FIG. 6 is a schematic view of the moves that may be made by an unimpeded game piece to exit the Battle Zone and enter an opponent's Base according to claim 1 or claim 2 of the present invention. [0012] FIG. 7 is a schematic view of the moves that may be made by a game piece to jump and capture an opponent's game piece to exit the Battle Zone and enter an opponent's Base according to claim 1 of the present invention. [0013] FIG. 8 is a schematic view of the moves that may be made by a game piece located on the outer row of Battle Zone discs to “jump” an opponent's piece and move into an opponent's Base according to claim 1 of the present invention. [0014] FIG. 9 is a schematic view of the configuration of the gameboard according to claim 2 of the present invention. [0015] FIG. 10 is a schematic view of moves that may be made by an unimpeded game piece inside the Battle Zone according to claim 2 of the present invention. [0016] FIG. 11 is a schematic view of the moves that may be made by a game piece to jump and capture an opponent's game piece to exit the Battle Zone and enter an opponent's Base according to claim 2 of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0017] The present game features a gameboard made up of three equivalent rectangles, each attached along their longer axes to a side of an equilateral triangle that forms the center of the board. Each rectangle, called a “Base,” is divided into four rows of eight squares, one-half of which are the same “dark” color and the other half of which are the same “light” color. The squares alternate by color so that no dark square is adjacent to another dark square. The squares of each Base are marked with a device in a color to identify that Base with the pieces for which that Base is “Home” and to differentiate that Base from the Home Base of the other players. The triangle at the center of the board, called the “Battle Zone,” is composed of three concentric equilateral triangles made up of discs the color of the dark squares in the Bases. The background of the Battle Zone is the same color as the light squares in the Bases. Each of the discs is approximately the same diameter as the length of a side of the squares. There are 36 discs in the Battle Zone, with the outermost triangle having eight discs to a side, the central triangle being made up of only three discs, and the remaining triangle having four discs to the side. ( FIG. 1 ). (In an alternate version of the game, described below, the three-disc central triangle is eliminated and there are only 33 discs in the Battle Zone, contained in an outer triangle with eight discs to the side and an inner triangle with four discs to the side.( Fig. 10 ).) [0018] A set of twelve game pieces, or “checkers” is assigned to each player. The checkers are all the same color, but each set of twelve is marked with a device in the same color as the identifying color of one of the three Bases to identify that set of pieces as belonging to that Base. The pieces can resemble classical checkers—cylinders with a diameter approximately three times their height—or other objects, so long as the design and/or color device of each set of twelve pieces is sufficient to identify the members of that set of twelve pieces with each other, to differentiate them from the members of the other two sets, and to allow for signification that a piece has attained the status of a “King.” The sets of pieces, or checkers, can be made of wood, plastic, metal or other materials. [0019] In playing, each player sits directly behind the Base whose pieces he or she is to play. The player's pieces are aligned, one to a square, on the dark squares of the three rows of the Base closest to the player, leaving the row of each Base adjacent to the Battle Zone empty at the beginning of play. Inside the Bases, the game is played only on the dark squares, and no player's pieces can ever occupy the the light squares. [0020] The players select the method by which they will determine which of them plays first, with one method being the rolling of dice, with the player rolling the highest number beginning play. After the beginning player's turn, play passes to the next player in a counterclockwise direction. During a turn, a player may move only one of the player's pieces. [0021] Unless the piece has been “crowned” or attained the status of a “King,” as hereinafter described, a piece while inside a Base (either the player's Home Base or the Home Base of another player), may be moved only in a forward direction, that is, away from the player. While inside a Base, and except when executing a “jump” or series of “jumps,” a piece may move only to an unoccupied dark square diagonally adjacent to and forward from the dark square occupied by that piece. If a dark square diagonally adjacent to and forward from the square occupied by the piece is occupied by a piece of an opponent, the player may capture the opponent's piece, if the dark square diagonally adjacent to and forward of the the opponent's piece and on the same diagonal with the player's piece, is unoccupied. The player achieves this capture by moving the piece across the opponent's piece diagonally to the unoccupied dark square, a move called a “jump.” The player then removes the captured opponent piece from the board. If immediately after an initial jump, the jumping piece occupies a square that is diagonally adjacent to a forward square occupied by an opponent's piece and the next forward square on the same diagonal is not occupied, the player may continue his move by jumping the second opponent piece, a move called a “double jump.” [0022] In addition to the fact that there can be three players, the primary difference between the present game and traditional checkers is the presence of the Battle Zone and the method of play therein. [0023] A player's piece enters the Battle Zone from the player's Home Base by moving forward to any unoccupied directly or diagonally adjacent dark disc ( FIG. 2 ) or by jumping and capturing an opponent's piece that occupies a diagonally adjacent dark disc or the adjacent disc directly forward of the square occupied by the jumping piece ( FIG. 3 ). Inside the Battle Zone, the player may move the player's piece in any direction, but may not return that piece to its Home Base unless the piece has been “crowned.” ( FIG. 4 ). The piece proceeds though the Battle Zone by moving one disc per move or jumping an opposing player's piece that occupies an adjacent disc ( FIG. 5 ). A player's piece leaves the Battle Zone by entering an opponent's Base and occupying an adjacent dark square that is directly or diagonally forward of the Battle Zone disc occupied by the piece ( FIG. 6 ) or by jumping an opponent's piece that occupies a diagonally adjacent forward disc on the outer row of Battle Zone discs ( FIG. 7 ) or by jumping an opponent's piece that occupies a dark square diagonally adjacent to the disc on the outer row of Battle Zone discs that is occupied by the player's piece ( FIG. 8 ). [0024] Inside an opponent's Base, the piece moves forward only, in the same manner as inside its Home Base, toward the last row of the opponent's Base. Upon reaching this last row, piece is “crowned” and becomes a “King.” To signify that a piece has been crowned, one of that player's pieces that has been captured by an opponent and removed from play is stacked atop or otherwise attached to the piece being crowned and thereafter the attached or stacked pieces are moved together. The movements of a King differ from those of other pieces only in that a King may move diagonally forward or backward inside any Base that it occupies. This ability to move forward or backward on the diagonal makes it possible for a King to execute a Triple Jump or Quadruple Jump or even more complex moves so long as opponents' pieces are aligned to allow such moves. Inside the Battle Zone, the King moves in the same manner as any other piece. A King can only be jumped by an opposing King. [0025] Play continues until only one player has pieces remaining on the board. [0026] In a second version of this game, the Battle Zone is comprised of only two concentric equilateral triangles, one with eight dark discs to a side and the other with five dark discs to a side. The central area framed by these triangles is empty and is called the “Mine Field.” ( FIG. 9 ). The gameboard is otherwise the same for this version as for the first version. [0027] Play of the game differs for the second version only with regard to movements related to the Mine Field. Because a player's piece in the Battle Zone cannot be moved parallel to the long side of the Player's Base, each piece must pass through the Mine Field on its way to an opponent's Base. A piece may not come to rest in the Mine Field, but must pass into and out of it in a single move. ( FIG. 10 ). Thus, a piece located on the exterior triangle of the Battle Zone (the row next to the Player's Base) may jump an opponent's piece located directly or diagonally in front of it, touch down in the Mine Field and move immediately out of it, landing on an unoccupied disc on the interior triangle or again jumping an opponent's piece located on the interior triangle and ending the move by landing on a disc on the exterior triangle. ( FIG. 11 ). Play of the game in this second version is otherwise identical to that in the first version. [0028] Play of the second version is more difficult than the first version because the Battle Zone is more constricted.

A game board and rules that allow three players to play a game based on traditional checkers but requiring additional moves through a triangular central field of play. In one version, the central field is composed of three concentric equilateral triangles made up of discs. In another version there are two concentric equilateral triangles of discs arranged around a triangular central void. The rules of play differ between the two versions because of the difference in configuration of the game board.

FIELD OF THE INVENTION [0001] The present invention relates generally to dispensing arrangements. Stated more particularly, this patent discloses and protects a device for dispensing game projectiles to enable the practice and development of sports skills. BACKGROUND OF THE INVENTION [0002] The ability to play a given sport with proficiency is an integral element to a player's enjoyment and success in playing the game. Of course, it will also be appreciated that practice and skill development are inherently necessary to improving one's proficiency in any sport including, for example, hockey. Even further, one knowledgeable in the art will be well aware that skill proficiency can be achieved most readily by the efficient and constructive use of the time that is dedicated to skill practice and development. As one would expect, therefore, athletes expend significant time and effort in honing their skills. For example, hockey players engage in countless repetitions of varied types of practicing passing, receiving, handling, and shooting. [0003] Advantageously, numerous prior art inventors and substantially innumerable coaches have contributed usefully to the present state of the art by providing drills, devices, and systems for enabling players to practice and improve their skills. For example, a number of devices have been disclosed for dispensing game projectiles, such as hockey pucks, for being handled and struck by a player. Such devices are of undeniable utility in their general ability for making game projectiles available to a user for being struck and otherwise handled. [0004] Unfortunately, however, these devices suffer from a number of disadvantages. For example, prior art devices typically can dispense game projectiles in only one direction whereby they are suitable for players of only one type of hand dominance. Furthermore, even where the player's hand dominance corresponds to the design of the machine, the player may have difficulty practicing certain types of shots that would normally demand that the puck be dispensed from an opposite direction. By way of example, the same player may find the direction of puck dispensing to be proper when practicing slap shots but opposite to what he or she would want for practicing backhanded passes and shots. Even further, many dispensing devices of the prior art are unable to supply multiple hockey pucks or other game projectiles in a rapid and efficient manner without a need for electricity or other power. [0005] For these and further reasons, it is clear that there is a need for a device for dispensing game projectiles that overcomes one or more of the deficiencies left by the prior art. It is still more clear that a device for dispensing game projectiles that overcomes all of the known disadvantages of the prior art while providing a plurality of heretofore unrealized advantages thereover would represent a marked advance in the art. SUMMARY OF THE INVENTION [0006] Advantageously, the present invention sets forth with the broadly stated object of providing a dispensing device for game projectiles that solves each of the problems left by the prior art while providing a number of heretofore unrealized advantages thereover. [0007] Stated more particularly, one basic object of the invention is to provide a dispensing device for game projectiles that can dispense game projectiles in more than one direction. [0008] A related object of the invention is to provide a game projectile dispensing device that can accommodate players of both hand dominances while allowing players of each hand dominance to strike projectiles with forehand and backhand striking movements. [0009] A further object of the invention is to provide a game projectile dispensing device that can retain and dispense multiple game projectiles to enable extended practice sessions to be carried out in an efficient and convenient manner. [0010] Yet another object of the invention is to provide a game projectile dispensing device that is durable in construction and reliable in performance. [0011] These and further objects and advantages of the present invention will become obvious both to one who reviews the present specification and drawings and to one who has an opportunity to make use of an embodiment of the present invention. [0012] In accomplishing the aforementioned objects, a most basic embodiment of the present invention for a game projectile dispensing device is founded on a dispensing housing with a first side and a second side. A game projectile retaining member, which can take the form of a game projectile retaining cylinder, can retain a plurality of game projectiles in a stack relative to the dispensing housing. A first game projectile emission chute can be disposed in the first side of the dispensing housing, and a second game projectile emission chute can be disposed in the second side of the dispensing housing. An actuating means, such as an actuating lever, can enable a player to cause a game projectile to be dispensed from the dispensing housing. A selection means, such as a game projectile supply ramp, can enable a player to select between emitting game projectiles through the first game projectile emission chute or through the second game projectile emission chute. [0013] Where the selection means comprises a game projectile supply ramp, it can be tiltable from a first orientation wherein it provides a ramp sloped toward the first game projectile emission chute and a second orientation wherein it provides a ramp sloped toward the second game projectile emission chute. To accomplish this, the game projectile supply ramp can be pivotally supported by at least a first axle rod. A control knob can be operably coupled to the first axle rod so that a player can rotate the control knob in a first rotational direction to cause the game projectile supply ramp to provide a ramp sloped toward the first game projectile emission chute and in a second rotational direction to cause the game projectile supply ramp to provide a ramp sloped toward the second game projectile emission chute. [0014] Where an actuating lever acts as the actuating means, it can be pivotable about a pivot axis and can have a first arm for being engaged by a player and a second arm for engaging a game projectile and inducing the game projectile to be dispensed from the dispensing housing. The second arm of the actuating lever can be generally L-shaped with a proximal leg of the L disposed generally perpendicularly to the first arm and a distal leg of the L disposed generally perpendicularly to the proximal leg and collinear with the first arm. The distal leg of the second arm can be disposed adjacent to the lower-most game projectile when the actuating lever is in a non-actuated orientation. Under such an arrangement, a player can press on the first arm of the actuating lever to cause it to pivot thereby inducing the distal leg of the second arm to drive the lower-most projectile from the stack of game projectiles. With this, the lower-most game projectile will be allowed to be dispensed from the dispensing housing. [0015] Where a game projectile supply ramp acts as the selection means, it can be disposed below the means for retaining the plurality of game projectiles. With this, upon being driven from the stack of game projectiles, a game projectile will drop onto the game projectile supply ramp for being dispensed from either the first game projectile emission chute or the second game projectile emission chute, depending on the orientation of the game projectile supply ramp. Where the game projectile is a hockey puck, it can drop onto the game projectile supply ramp on its edge whereby it will roll down the ramp and through the emission chute for being struck or otherwise manipulated by a player. [0016] The game projectile retaining member can have a body portion, a first end, a second end, and an open inner volume for retaining a plurality of game projectiles. Preferably, the game projectile retaining member will be removably and replaceably received relative to the dispensing housing. A base retainer member can be disposed at the first end of the game projectile retaining member for preventing game projectiles from being inadvertently dislodged from within its open inner volume. With this, the game projectile retaining member can be used in retrieving, retaining, storing, and dispensing game projectiles. The base retainer member can have an open mouth for allowing game projectiles to pass therethrough. Where the actuating means comprises a lever, the base retainer member can have an aperture disposed opposite to the open mouth for allowing the entry and operation of the actuating lever. Still further, a handle can be coupled to the body portion of the game projectile retaining member generally in line with the open mouth of the base retainer member for further ensuring that game projectiles do not fall during a carrying of the game projectile retaining member. [0017] With a plurality of embodiments of the present invention for a game projectile dispensing device described, one will appreciate that the foregoing discussion broadly outlines the more important features of the invention merely to enable a better understanding of the detailed description that follows and to instill a better appreciation of the inventors' contribution to the art. Before an embodiment of the invention is explained in detail, it must be made clear that the following details of construction, descriptions of geometry, and illustrations of inventive concepts are mere examples of the many possible manifestations of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0018] In the accompanying figures: [0019] [0019]FIG. 1 is a perspective view of a game projectile dispensing device according to the present invention; [0020] [0020]FIG. 2 is an exploded perspective view of the game projectile dispensing device of FIG. 1; [0021] [0021]FIG. 3 is a cross sectional view of a game projectile retaining cylinder according to the present invention; [0022] [0022]FIG. 3A is a bottom plan view of the game projectile retaining cylinder of FIG. 3; [0023] [0023]FIG. 4 is a perspective view of a game projectile supply ramp under the present invention; [0024] [0024]FIG. 5 is a view in side elevation of a game projectile dispensing housing half according to the present invention; [0025] [0025]FIG. 6 is a view in side elevation of an actuating lever according to the present invention; [0026] [0026]FIG. 7A is a partially dismantled and cross sectioned view in side elevation of a game projectile dispensing device according to the present invention in operation; and [0027] [0027]FIG. 7B is a further partially dismantled and cross sectioned view in side elevation of the game projectile dispensing device in operation. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0028] As is the case with many inventions, the present invention for a game projectile dispensing device is subject to a wide variety of embodiments. However, to ensure that one skilled in the art will be able to understand and, in appropriate cases, practice the present invention, certain preferred embodiments of the broader invention revealed herein are described below and shown in the accompanying drawing figures. [0029] With this in mind and looking more particularly to the accompanying figures, a preferred embodiment of the game projectile dispensing device is indicated generally at 10 in FIG. 1 where the device is designed particularly for dispensing hockey pucks. There, one sees that the game projectile dispensing device 10 is founded on a flat base portion 12 . A dispensing housing 14 is fixed to the base portion 12 , such as by being secured thereto or by being formed integrally therewith. A game projectile retaining cylinder 16 is removably and replaceably received relative to the dispensing housing 14 and can be lifted and held by a retaining handle 24 . An actuating lever 22 is pivotally retained relative to the dispensing housing 14 for dispensing game projectiles, which are not shown in this drawing, as will be discussed more fully below. Finally, a control knob 18 is rotatably retained relative to the dispensing housing 14 for controlling the supply orientation of a game projectile supply ramp 20 and thus the direction in which game projectiles are dispensed from the dispensing device 10 . [0030] Turning to FIG. 2, the game projectile dispensing device 10 is shown in an exploded view such that the dispensing housing 14 is shown to comprise first and second dispensing housing halves 14 A and 14 B that are secured together by a plurality of fasteners 30 . The actuating lever 22 , which is shown alone in FIG. 6, is interposed between the first and second dispensing housing halves 14 A and 14 B to pivot about a pivot axis 38 . The actuating lever 22 is biased to the non-pivoted position depicted in FIGS. 1 and 2 by a coil spring 26 . A first arm 36 of the actuating lever 22 is generally straight and projects from between the dispensing housing halves 14 A and 14 B. An engaging notch 37 is disposed at a distal end of the first arm 36 for engaging a striking implement 200 as is shown in FIGS. 7A and 7B. A second arm 34 of the actuating lever 22 is L-shaped with a proximal leg 39 of the L disposed generally perpendicularly to the first arm 36 and a distal leg 35 of the L disposed generally perpendicularly to the proximal leg 39 and collinear with the first arm 36 . [0031] The first and second dispensing housing halves 14 A and 14 B are essentially identical. As FIG. 5 shows relative to the first dispensing housing half 14 A, each housing half 14 A has a semicircular retaining wall 42 for receiving and retaining the game projectile retaining cylinder 16 . A support base 45 is fixed below the retaining wall 42 for supporting the game projectile retaining cylinder 16 . An angled slide wall 44 descends from the support base 45 and leads to a game projectile emission chute 46 . As FIGS. 1 and 2 show most clearly, the game projectile emission chute 46 extends entirely through each of the first and second dispensing housing halves 14 A and 14 B and thus entirely through the dispensing housing 14 . [0032] By combined reference to FIGS. 1, 2, and 4 , one sees that the game projectile supply ramp 20 is formed by a generally flat, rectangular base plate 34 that is fixed to first and second triangular side walls 29 and 31 . A first axle rod 32 projects from a first side wall 31 while a second axle rod 33 , which is coaxial with the first axle rod 32 , projects from a second side wall 29 . A retaining rod 40 is disposed through the second axle rod 33 while the first axle rod 32 has a flattened portion for engaging the control knob 18 . When the game projectile dispensing device 10 is fully assembled, the first and second axle rods 32 and 33 are sandwiched within corresponding notches in the first and second dispensing housing halves 14 A and 14 B. With that, the control knob 18 can be employed to control the orientation of the game projectile supply ramp 20 such that it could provide a ramp sloped toward either the side of the first dispensing housing half 14 A or toward the side of the second dispensing housing half 14 B as is shown in FIGS. 1 and 2. [0033] As shown most clearly in FIGS. 3, 3A, 7 A, and 7 B, the game projectile retaining cylinder 16 has a base retainer member 25 coupled to what can be considered its first or base end. The base retainer member 25 has a cylindrical sidewall 28 that entirely surrounds the base end of the game projectile retaining cylinder 16 but that becomes only semicircular where it extends beyond the base end of the game projectile retaining cylinder 16 . A semicircular base plate 29 is fixed to the most distal end of the cylindrical sidewall 28 . With this, an open mouth 21 is left for allowing the dispensing of game projectiles as will be discussed more fully hereinbelow. Furthermore, an aperture 27 is provided in the cylindrical sidewall 28 and the base plate 29 opposite to the open mouth 21 for allowing the entry and operation of the actuating lever 22 as will also be discussed below. [0034] It will, of course, be appreciated that the game projectile dispensing device 10 and its constituent elements could be formed from a variety of materials and with a variety of dimensions. In this presently preferred embodiment wherein the game projectile dispensing device 10 is designed for dispensing hockey pucks 100 , the first and second dispensing housing halves 14 A and 14 B can be formed from gray anodized aluminum such that they will demonstrate the durability required for sports related applications and so that they will resist rust and corrosion. The game projectile retaining cylinder 16 and the base retainer member 25 can each be formed from a polymer, such as polyvinylchloride or PVC, while the retaining handle 24 can be formed from a metal, such as stainless steel or aluminum. The actuating lever 22 can be crafted from a metal, such as black anodized aluminum, and the game projectile supply ramp 20 and the first and second axle rods 32 and 33 can be formed from stainless steel. The control knob 18 can be plastic. [0035] The game projectile retaining cylinder 16 preferably will have an overall length of approximately 19 inches and an outside diameter of approximately 3.5 inches. The cylindrical sidewall 28 of the base retainer member 25 has an inside diameter of approximately 3.5 inches and an outside diameter of approximately 4 inches. The preferred game projectile supply ramp 20 can have an overall length of approximately 3 and ⅝ inches and a width of about 1 and ½ inches. The game projectile emission chute 46 can have a width of approximately 2 inches, and the angled slide wall 44 can be disposed at an angle of approximately 45 degrees from horizontal. The first arm 36 of the actuating lever 22 can have a length from the pivot axis 38 to its end of approximately 8 inches, and the engaging notch 37 can be disposed approximately 1 inch from the end of the first arm 36 . The proximal leg 39 of the second arm 34 can have a length from the pivot axis 38 to its end of 3 and ⅜ inches. The distal leg 35 preferably will have a length of 3 and ½ inches while its distal tip will be laterally spaced approximately 2 inches from the pivot axis 38 . [0036] Turning to FIGS. 7A and 7B, one sees an embodiment of the game projectile dispensing device 10 in operation. There, just the first dispensing housing half 14 A is shown, and the second dispensing housing half 14 B is removed for clarity. A plurality of game projectiles 100 , namely hockey pucks 100 , are retained in the game projectile retaining cylinder 16 , and the game projectile retaining cylinder 16 is retained and supported by the semicircular retaining wall 42 . The base retainer member 25 cups the hockey pucks 100 and rests on the support base 45 of the first dispensing housing half 14 A with the mouth 21 of the base retainer member 25 facing the angled slide wall 44 and the game projectile emission chute 46 . The distal leg 35 of the actuating lever 22 passes through the aperture 27 , and the most distal end of the distal leg 35 contacts the lower-most hockey puck 100 . A striking implement 200 , namely a hockey stick 200 , is engaged with the engaging notch 37 on the first arm 36 as the case would be where a player would employ the actuating lever 22 to dispense a hockey puck 100 . [0037] As FIG. 7B illustrates, the player can continue the process of dispensing a hockey puck 100 by pressing the first arm 36 of the actuating lever 22 downwardly with the hockey stick 200 thereby causing a pivoting of the actuating lever 22 . The distal leg 35 of the second arm 34 then drives the lower-most hockey puck 100 laterally through the mouth 21 of the base retaining member 25 whereupon it will pass by the angled slide wall 44 and drop into the game projectile emission chute 46 . If necessary to allow the hockey puck 100 to leave the mouth 21 of the base retaining member 25 , the actuating lever 22 can be pressed further whereupon the distal leg 35 of the second arm 34 will engage and lift the remaining hockey pucks 100 as FIG. 7B shows such that the lower-most hockey puck 100 will be better able to drop from the mouth 21 of the base retaining member 25 . [0038] Once the lower-most hockey puck 100 falls into the game projectile emission chute 46 , it will drop on its edge onto the base plate 34 of the game projectile supply ramp 20 . Since the hockey puck 100 is round, it will tend to roll down the game projectile supply ramp 20 , out of the game projectile emission chute 46 , and onto a surrounding ground surface. Once so dispensed from the game projectile dispensing device 10 , the hockey puck 100 can be struck or otherwise manipulated by the player with the hockey stick 200 . When one hockey puck 100 has been shot or otherwise disposed of, the player can readily dispense a second and further hockey pucks 100 by a simple operation of the actuating lever 22 . [0039] Advantageously, the player can control the direction in which the hockey puck 100 is dispensed from the game projectile dispensing device 10 by use of the control knob 18 to control the orientation of the game projectile dispensing ramp 20 . Where the player seeks to have the hockey puck 100 roll from the game projectile emission chute 46 to the side of the first dispensing housing half 14 A, he or she can rotate the control knob 18 counter-clockwise such that the game projectile dispensing ramp 20 will provide a ramp sloped toward the side of the first dispensing housing half 14 A. Where the player seeks to have the hockey puck 100 roll from the game projectile emission chute 46 to the side of the second dispensing housing half 14 B, he or she can rotate the control knob 18 clockwise until the game projectile dispensing ramp 20 provides a ramp sloped toward the side of the second dispensing housing half 14 A. [0040] It should be clear that, although the game projectile emission chute 46 is shown and described as a single passageway, it can be formed and/or considered to be two separate, opposed passageways. With this, as FIG. 2 shows, the game projectile emission chute 46 can be formed and described as a first game projectile emission chute 46 A disposed in the first dispensing housing half 14 A for enabling a game projectile to be dispensed from the first side of the dispensing housing 14 and as a second game projectile emission chute 46 B disposed in the second dispensing housing half 14 B for enabling a game projectile 100 to be dispensed from the second side of the dispensing housing 14 . [0041] Under this arrangement, the game projectile dispensing device 10 can accommodate players of left and right hand dominances. Furthermore, players of each hand dominance can practice forehand shots where, for example, the hockey puck 100 is dispensed from the side of the first dispensing housing half 14 A and backhand shots where, for example, the hockey puck 100 is dispensed from the side of the second dispensing housing half 14 B. A plurality of further advantages are derived from the ability of the game projectile retaining cylinder 16 to be removed and replaced relative to the dispensing housing 14 . For example, a player can lift and carry the game projectile retaining cylinder 16 to retrieve a number of hockey pucks 100 that have been dispensed by the game projectile dispensing device 10 and shot or otherwise manipulated. In doing so, the player can drop a plurality of hockey pucks 100 into the upper end of the game projectile retaining cylinder 16 to create a stack of hockey pucks 100 . [0042] Advantageously, the base plate 29 of the base retainer member 25 will retain the stack of hockey pucks 100 securely within the game projectile retaining cylinder 16 until they are to be dispensed as previously described. In this regard, one will note that the retaining handle 24 is disposed to the same side of the game projectile retaining cylinder 16 as the open mouth 21 of the base retainer member 25 such that hockey pucks 100 will not tend to slide through the open mouth 21 inadvertently. Additionally, the game projectile retaining cylinder 16 can be removed to allow for storage, packaging, and transportation of the game projectile dispensing device 10 . Still further, an entire stack of hockey pucks 100 or other game projectiles can be stored in and/or shipped with the game projectile retaining cylinder 16 and the game projectile dispensing device 10 . [0043] From the foregoing, it will be clear that the present invention has been shown and described with reference to certain preferred embodiments that merely exemplify the broader invention revealed herein. Certainly those skilled in the art can conceive of alternative embodiments. For instance, those with the major features of the invention in mind could craft embodiments that incorporate those major features while not incorporating all of the features included in the preferred embodiments. [0044] With the foregoing in mind, the following claims are intended to define the scope of protection to be afforded the inventors, and the claims shall be deemed to include equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. A plurality of the following claims express certain elements as a means for performing a specific function, at times without the recital of structure or material. As the law demands, these claims shall be construed to cover not only the corresponding structure and material expressly described in the specification but also equivalents thereof.

A game projectile dispensing device with a dispensing housing, a game projectile retaining member for retaining a plurality of game projectiles in a stack, first and second game projectile emission chutes, an actuating lever with a first arm for being engaged by a player and a second arm for engaging a game projectile whereby a player can press on the first arm of the actuating lever to induce the actuating lever to drive the lower-most projectile from the stack of game projectiles. A game projectile supply ramp can enable a player to select between emitting the game projectile from the first and second game projectile emission chutes. The game projectile supply ramp can be disposed below the game projectile retaining member whereby, when driven from the stack of game projectiles, a game projectile will drop onto the game projectile supply ramp for being dispensed.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims the priority right from the U.S. provisional patent application No. 61/695,540 that was filed on Aug. 31, 2012, the content of which is herewith incorporated in its entirety by reference. FIELD OF THE INVENTION [0002] The present invention generally relates to cyanocobalamin containing medications that are placed in the mouth, dissolved and swallowed for the prevention and treatment of headaches and body pains in humans and for enhancing the normal functioning of the human body by boosting the human defense against headaches and body pains. BACKGROUND OF THE INVENTION [0003] Human brains are one fiftieth of our body's weight, and yet consume up to one fifth of the body's energy. Two thirds of the brain's energy consumption goes into making nerve cells fire, and one third into cell maintenance. Most of the brain's energy is chemical energy manufactured in the mitochondria and stored in the form of ATP. Mitochondria live as organelles within cells, including brain cells. The number of mitochondria per cell can range from one to thousands, depending on the energy needs of the cell. Energy-hungry brain cells contain thousands of mitochondria. Once inside the body cyanocobalamin is converted to adenosylcobalamin and methylcobalamin. Adenosylcobalamin is critical to the health and functioning of the brain's mitochondria while methylcobalamin is critical to the health and functioning of the rest of the brain's and body's cells. [0004] Muscle cells have a large energy demand and require lots of ATP. Muscle cells also have a correspondingly high number of mitochondria, and are often the site of the body's soreness and pain. The current invention focuses on musculoskeletal pain. [0005] The current invention discloses novel approaches to prevent and treat the malfunctioning or underperformance of the body's mitochondria and cells with methylcobalamin, and adenosylcobalamin, and their chemical precursor, cyanocobalamin, especially in the central and peripheral nervous systems. The inventor of the current invention puts forth the theory that by providing cyanocobalamin, methylcobalamin, and/or adenosylcobalamin in therapeutic doses to headache and body pain sufferers that their mitochondria will attain sufficient therapeutic concentrations of these essential micronutrients to survive, increase in number and function properly, thereby not creating the symptoms of certain types of headache and body pain. [0006] The current invention differs substantially from prior uses of cobalamins, such as hydroxycobalamin to take up excess nitric oxide, or cobalamins to prevent IgE-mediated allergic diseases, neurogenic inflammation or cobalamins to repair nerve cell-insulating myelin sheath. [0007] Cyanocobalamin, methylcobalamin, adenosylcobalamin and hydroxocobalamin each contain a biologically rare cobalt metal atom as a central feature. Around that cobalt is the active part of each molecule (i.e. the moiety) which is the location responsible for the unique type of chemical reactions that molecule causes to make happen. Attached to their central cobalt atoms; cyanocobalamin has a cyano group, methylcobalamin has a methyl group, adenosylcobalamin has an adeno group, and hydroxocobalamin has a hydroxyl (OH) group. Because of these distinct electromagnetic properties, each of these compounds plays a distinct biochemical role. [0008] Cyanocobalamin, methylcobalamin, and adenosylcobalamin (the three chemicals pertaining to the current patent) differ in some important ways from hydroxocobalamin (which does not pertain to the current patent). [0009] Once inside the body cyanocobalamin is converted to methylcobalamin and adenosylcobalamin, but not to hydroxocobalamin. [0010] Hydroxocobalamin is known to scavenge nitric oxide (NO) which is associated with migraine. Hydroxocobalamin does this scavenging by trading its OH group connected to its central cobalt with the nitric oxide molecule. Because neither cyanocobalamin, nor methylcobalamin, nor adenosylcobalamin have the ability to scavenge nitric oxide, their ability to lessen the frequency and severity of headaches cannot be ascribed to nitric oxide scavenging. [0011] In 1999 Merkus disclosed in U.S. Pat. No. 5,925,625 a method and composition for the prophylaxis and treatment of headaches using intranasal hydroxocobalamin. The current invention can be distinguished from Merkus' patent because the current invention discloses the use of different chemical entities, namely cyanocobalamin, methylcobalamin, and adenosylcobalamin. The current invention can be distinguished from Merkus' patent because Merkus describes a short-term treatment while the current patent describes a long-term treatment. The current invention can be further distinguished from U.S. Pat. No. 5,925,625 because Merkus states that “Oral, sublingual as well as nasal administration of vitamin B12 appeared to be ineffective treatments . . . ” while the current patent teaches away from Merkus because the current patent discloses that buccal and sublingual administration do indeed yield effective treatments for headache. [0012] In 2001 Ernest T. Armstrong (the inventor of the current invention) disclosed in U.S. Pat. No. 6,255,294 a method to treat allergy using cobalamins. However, in U.S. Pat. No. 6,255,294 there is no mention of headache or migraine. In U.S. Pat. No. 6,255,294 the invention relied on a method for treating Immunoglobulin E (IgE) mediated atopic disease including allergic rhinitis and asthma. Such atopic diseases are a completely different class of disease and human condition with different causations and modes of action than the headaches and body pains disclosed in the current invention. The claims of U.S. Pat. No. 6,255,294 were approved with cyanocobalamin, methylcobalamin, and hydroxocobalamin, but not with adenosylcobalamin. [0013] In 2002 van der Kuy showed in an unblinded, open-label study on 19 migraine patients that intranasal hydroxocobalamin can have an effect on migraine. The authors of the van der Kuy study hypothesize that hydroxocobalamin might be effective in migraine because of its nitric oxide-scavenging activity. Flaws in the van der Kuy study include the lack of a placebo group as a comparator, and the lack of any follow up after the last day the subjects received their last dose of medication which could have demonstrated (or not demonstrated) a persistence of effect. The current invention can be distinguished from van der Kuy's research because van der Kuy used hydroxocobalamin while the current invention discloses the distinct chemical entities of cyanocobalamin, methylcobalamin, and adenosylcobalamin. The current invention can be distinguished from van der Kuy's research because van der Kuy's treatment has a short-term persistence of effect while the current invention has a long-term effect. The current invention can be distinguished from van der Kuy's research because for all subjects van der Kuy showed essentially no reduction in severity (mean of 2.2 at baseline versus 2.1 at the end of the study, on a 0-3 scale). The current invention can be further distinguished from van der Kuy's research because van der Kuy's mechanism of action describes hydroxocobalamin as a nitric oxide (NO) scavenger. Nitric oxide is created and excreted by the body within a matter of hours. The important distinguishing point is that the current invention's mechanism of action most certainly is different than that of van der Kuy's invention because the scavenging of nitric oxide lasts only hours while the current invention has a persistence of effect lasts weeks, and perhaps months or years. (Van der Kuy, H et al. Hydroxocobalamin, a nitric oxide scavenger, in the prophylaxis of migraine: an open, pilot study. Cephalalgia, 2002, 22, 513-519.) [0014] Dalsgaard-Nielsen performed a double-blind, placebo-controlled study on 29 patients (active n=15 and placebo n=14). During two months every two weeks 2 mg of cyanocobalamin were administered intramuscularly. The patients reported a: “Good result” active n=4 versus placebo n=2, and “Considerable improvement” active n=2 versus placebo n=5. The authors concluded that no therapeutic effect attributable to cyanocobalamin was demonstrated. (Dalsgaard-Nielsen A T, Trautmann J. Profylaktisk behandling of migraene med vitamin B12. Almindelige Danske Laegeforening 1970; 132:339-41.) [0015] The authors of the van der Kuy study also hypothesize that since cyanocobalamin has no nitric oxide-scavenging activity, in contrast to hydroxocobalamin, it is not surprising that in the Dalsgaard-Nielsen trials on cyanocobalamin no effect was seen in migraine patients. Van der Kuy was correct about the lack of cyanocobalamin's nitric oxide-scavenging activity, but they missed another flaw in the Dalsgaard-Nielsen trials: Dalsgaard-Nielsen administered cyanocobalamin only once every two weeks. Based on the current inventor's original clinical research, the current invention teaches away from Dalsgaard-Nielsen and discloses a particularly preferred embodiment of daily administration of cyanocobalamin, with repeated delivery ranging from about 15 days to about 60 days. [0016] The non-obviousness of the instant claims can be established by considering that oral (buccal) dissolving strip, sublingual lozenges and other disclosed means of introducing the headache and body pain opposing medications orally provide significant improvements over the prior art in that the dissolving strip are more convenient for the headache patient than a series of injections, or a nasal spray. Compared to an injection, or nasal spray, a dissolving strip or a sublingual lozenge is much more convenient because it takes from between one minute and five minutes to inject oneself or to administer a nasal spray. These few minutes may not seem like much, but to the headache patient, time is of the essence. [0017] Another advantage is that people in pain do not want something stuffed up their nose or an injection in the body. [0018] Among the surprising advantages of the dissolving strip and sublingual lozenge over the injection and nasal spray is that the headache patient would not be further irritated by a painful injection process or by a nasal spray up a sensitive nostril. This is an important aspect of the oral strip which comes in an easy to use soft plastic container because headache patients are often hypersensitive to bright lights (photophobia), shrill sounds (phonophobia), smells (osmophobia), and metallic objects touching the body. Such extraneous irritations are the last thing a headache sufferer would want at the time he or she is experiencing an episode of headache, thus the strips and sublingual lozenge differ in a significant way. [0019] The significance of the difference between the oral dissolving medication and other delivery means becomes apparent when one examines the large numbers of people and money involved. There are between 30 and 50 million headache sufferers in the United States, thus if only ten percent can be provided an improvement, then some 3 to 5 million people will be helped. According the American Academy of Pain Medicine, pain affects more Americans than does diabetes, heart disease, and cancer combined. Back pain problems in the United States are reported to cost more than $100,000,000,000 annually. [0020] Many large pharmaceutical companies have spent millions of dollars over many years investigating new medications for headache sufferers, but none of them have developed any medication with the safety profile, efficacy and ease of use afforded by the current invention. EXAMPLE 1 [0021] This clinical study was designed and directed by the inventor of the current patent. Methods: 162 human subjects with demonstrated seasonal allergic rhinitis (hay fever) in the Pacific Northwest region of the United States were split into two groups with approximately 50 percent in the active group and 50 percent in the placebo group. Subjects were given their study medication, either Cyanocobalamin, USP or placebo in the a.m. and p.m. every day for 21 consecutive days. Data on adverse events including headache was captured throughout the ten-week duration of the study. Week One was a baseline during which time no medication was administered; Weeks Two, Three and [0022] Four were the weeks during which time the subjects received their study medication; and Weeks Five through Ten were a post-treatment period during which time no medication was administered but observations of symptoms and adverse events were documented. Each time a subject felt a “Headache”, he or she reported its occurrence. [0023] Results: The subjects' post-treatment reports of “Headache” decreased from baseline in the following surprising and unexpected results: Week Five −1.4 active vs. −0.9 placebo, Week Six −1.6 active vs. −2.0 placebo, Week Seven −1.4 active vs. −0.1 placebo, Week Eight −2.1 active vs. −1.2 placebo, Week Nine −3.4 active vs. −1.8 placebo, and Week Ten −3.2 active vs. −0.3 placebo. [0024] The results also demonstrated a persistence of effect of at least six weeks after finishing the treatment. The results also demonstrated that there was a greater reduction in the frequency of headache in the active group versus placebo in five out of six post-treatment weeks. Additionally, almost one year later a follow-up questionnaire was completed by 43 active and 49 placebo subjects, the results of which suggest a persistence of effect lasting almost one year. EXAMPLE 2 [0025] This clinical study was designed and directed by the inventor of the current patent. A large, multi-center, Phase 3, randomized, placebo-controlled clinical study on 1,551 patients was designed and directed by the inventor of the current patent. Methods: The study was titled: “A Phase 3, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of pre-seasonal sublingual cyanocobalamin lozenges on moderate to moderately severe seasonal allergic rhinitis in humans”. The study took place before and during the ragweed pollen season at 23 study sites in the Midwest, Northeast and Central Texas regions of the United States. Essentially all of the 23 investigators were Board Certified in Allergy/Immunology. Qualified subjects were randomized into an active or placebo group (approximately 50% and 50%) using an interactive voice recognition system (IVRS). All subjects (or their guardians) signed an Informed Consent form approved by the IRB. Each subject had three visits to the clinic. At Visit 1 and at Visit 3, they were given a physical exam (HEENT, chest, lungs, heart, vital signs, height and weight); and donated blood and urine samples for laboratory analysis. CBC and chemistry panels were run for safety analyses. The blood samples were analyzed by chemiluminescent immunoassay for the presence of ragweed specific immunoglobulin epsilon (IgE), and were assayed for cobalamins (cyanocobalamin, methylcobalamin and adenosylcobalamin) levels. [0026] Subjects self-rated the severity their allergy symptoms in the morning (a.m.) and in the evening (p.m.) by entering a numeric score in a keypad of a telephone (IVRS) or in a computer connected via the Internet to a database. [0027] Subjects were given their study medication, either 3.3 mg Cyanocobalamin, USP or placebo in the a.m. and p.m. Subjects were instructed to let the study drug “dissolve completely in your mouth, especially under your tongue, then swallow.”. Subjects self-administered the study medications for six consecutive weeks. For the next four weeks subjects did not take any study medications. [0028] Any adverse event (AE) or serious adverse event (SAE) was documented by the subject in a paper diary and then transcribed to the appropriate case report form (CRF) page. All SAEs were attended to by the investigator, and reported to the FDA by the sponsor. All sites were monitored multiple times by qualified monitors. [0029] Results: There was a total enrollment of 1,551 subjects (RA5555 n=763 and RA3333 n=788). The total number of doses possible was 84 doses. Over 50 percent (n=766) of the 1474 subjects who reported taking at least one dose, took at least 80 doses of study medication. [0030] The allergy symptom scores were derived by summing and averaging all a.m. plus all p.m. scores for the symptoms of sneezing, runny nose, nasal congestion, nasal itch and eye itch. The primary comparison of interest was the scores across Weeks 4, 5 and 6 (i.e. during the pollen season). All randomized subjects who took at least one dose were included in this intent-to-treat (ITT) analysis. The reduction in symptom severity from baseline was greater for the active group than the placebo group for all five composite symptoms: sneezing, runny nose, nasal congestion, nasal itch and eye itch. [0031] In terms of safety, the active study medication was well tolerated. [0032] As per the laboratory results, a significant average increase of more than 250 percent in post-treatment blood serum cobalamin (cyanocobalamin, methylcobalamin and adenosylcobalamin) levels was reported in the cyanocobalamin-treated subject groups compared with essentially no increase in placebo-treated subjects. [0033] The following types of headaches were self-diagnosed and documented by subjects in the study: tension headache, headache, migraine, increased frequency of headaches, worsening sinus migraine headache, increased headache, headache worsening, worsening of migraine, sinus headache, severe sinus headache, and sinus pressure headache. [0034] The following types of body pains and myasthenia were self-diagnosed and documented by subjects in the study: ear pain, earache, sore throat, sore muscles, leg cramps, myalgia, back pain, sprained ankle, ache, toothache, hip pain, finger pain, knee pain, pulled back muscle, shoulder pain, pulled hamstring, neck pain, femur pain, gum pain, sore muscle, toenail pain, sore foot, and pulled neck muscle. [0035] Of the 294 documented reports of some type of headache and of body pain, the study yielded the following surprising and unexpected frequencies demonstrating positive results: 137 reports in the active group compared to 157 reports in the placebo group. The severities of those headaches and body pains were rated in the following surprising and unexpected intensities: “Mild” 63 reports (or 46.0%) in the active group versus 71 reports (or 45.2%) in the placebo group; “Moderate” 68 reports (or 49.6%) in the active group versus 68 reports (or 43.3%) in the placebo group; and “Severe” 6 reports (or 4.4%) in the active group versus 18 reports (or 11.5%) in the placebo group. EXAMPLE 3 [0036] The current invention was successfully tested in humans with a history of headache and/or body pains in a variety of formulas. These formulas comprised dissolving medications containing combinations of cyanocobalamin, methylcobalamin, adenosylcobalamin, magnesium, coenzyme Q10, L-carnitine, and riboflavin. [0037] Formula 1 was a dissolving medication with 3.3 mg of cyanocobalamin. [0038] Formula 2 was a dissolving medication with 6.6 mg of cyanocobalamin. [0039] Formula 3 was a dissolving medication with 3.3 mg of methylcobalamin. [0040] Formula 4 was a dissolving medication with 3.3 mg of adenosylcobalamin. [0041] Formula 5 was a dissolving medication with 2.2 mg of cyanocobalamin, 2.2 mg of methylcobalamin, and 2.2 mg of adenosylcobalamin. [0042] Formula 6 was a dissolving medication with 3.3 mg of adenosylcobalamin. [0043] Formula 7 was a dissolving medication with 5.6 mg of cyanocobalamin, 0.5 mg of methylcobalamin, and 0.5 mg of adenosylcobalamin. [0044] Formula 8 was a dissolving medication with 1.1 mg of cyanocobalamin, 1.1 mg of methylcobalamin, and 1.1 mg of adenosylcobalamin. [0045] Formula 9 was a dissolving medication with 2.2 mg of cyanocobalamin, 2.2 mg of methylcobalamin, 2.2 mg of adenosylcobalamin, 15 mg of coenzyme Q10, and 2.1 mg of riboflavin. [0046] Formula 10 was a dissolving medication with 1.1 mg of cyanocobalamin, 1.1 mg of methylcobalamin, 1.1 mg of adenosylcobalamin, 18 mg of coenzyme Q10, and 2.1 mg of riboflavin. [0047] Formula 11 was a dissolving medication with 1.1 mg of cyanocobalamin, 1.1 mg of methylcobalamin, 1.1 mg of adenosylcobalamin, 5 mg magnesium, 9 mg of coenzyme Q10, 5 mg L-carnitine, and 2.1 mg of riboflavin. [0048] Formula 12 was a dissolving medication with 5.6 mg of cyanocobalamin, 0.5 mg of methylcobalamin, 0.5 mg of adenosylcobalamin, 15 mg of coenzyme Q10, and 1 mg of riboflavin. [0049] Formula 13 was a dissolving medication with 5.6 mg of cyanocobalamin, 0.5 mg of methylcobalamin, 0.5 mg of adenosylcobalamin, 5 mg magnesium, 10 mg of coenzyme Q10, and 2.1 mg of riboflavin. [0050] Formula 14 was a dissolving medication with 5.6 mg of cyanocobalamin, 0.5 mg of methylcobalamin, 0.5 mg of adenosylcobalamin, 10 mg of coenzyme Q10, and 1 mg of riboflavin. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0051] Headaches, such as tension headache and sinus headache, are painful and can rob individuals of quality of life. Headache symptoms include a pounding headache, nausea, vomiting, and light sensitivity. Body soreness is a pain in the body. Conventional headache and body pain remedies include various types of pain relievers, pain killers, and analgesics, including COX-1, COX-2, opioids, and NSAIDs; none are without side-effects, including drug addiction, liver damage and cardiovascular events; and none get to the truly underlying causes of pain and neurological health, as does the current invention. [0052] The International Classification of Headache Disorders (ICHD) is a classification of headaches published by the International Headache Society. The current patent applies to primary headaches which the ICHD-2 classification defines as migraines, tension-type headaches, cluster headache and other trigeminal autonomic cephalalgias stabbing headaches, headaches due to cough, exertion and sexual activity (coital cephalalgia), continuous headache on one side of the head (hemicrania continua), paroxysmal hemicrania, daily-persistent headaches along with the hypnic headache and thunderclap headaches. [0053] Vitamin B12 or simply B12 are unspecific terms often used casually for a variety of cobalamins, including cyanocobalamin, methylcobalamin, and adenosylcobalamin. [0054] All other headache remedies with adequate research proving their efficacy have safety profiles that contrast sharply with cyanocobalamin, methylcobalamin, and adenosylcobalamin which are considered by the nutritionists and the FDA to have excellent safety profiles, they are so safe and vital to health, that—like exceedingly few other products—they are recommended to women who are pregnant and lactating! The metal cobalt plays a central role in these molecules with its unique electrochemical bounding abilities. These molecules are the only molecules in the human body to utilize these special properties of cobalt, are difficult to absorb from food, and cannot be manufactured by the body. [0055] Cyanocobalamin (also known as CNCbI, or 5,6-dimethylbenzimidazolyl cyanocobamide) has the molecular formula C63H88CoN14O14P. Cyanocobalamin is a manufactured commercial form of a cobalamin, and not native to the human body. Once inside the body cyanocobalamin is converted to methylcobalamin and adenosylcobalamin, but not to hydroxocobalamin. [0056] Methylcobalamin (also known as mecobalamin, or MeCbl) has the molecular formula C63H91CoN13O14P and is notable as a rare example of an enzyme that contains metal-alkyl bonds. Methylation is the donation of a methyl group to a substrate, and methylcobalamin can function as the donor molecule. Proper DNA replication and cell division require methylation. For this reason, and others, the current invention includes cyanocobalamin and methylcobalamin. [0057] Adenosylcobalamin (also known as cobamamide, AdCbl, or dibencozide) comprises more than 70 percent of the cobalamins in the brain. Adenosylcobalamin functions in reactions in which hydrogen groups and organic groups exchange places. Adenosylcobalamin is the major form in cellular tissues, especially energy-hungry muscles, where it is retained in the mitochondria. Adenosylcobalamin is the coenzyme for the mitochondrial enzyme methylmalonyl CoA mutase. Problems with methylmalonyl CoA mutase can lead to methylmalonic aciduria and dysfunction of the mitochondria. In one preferred embodiment of the current invention, adenosylcobalamin is included to prevent dysfunction of the mitochondria in the brain. [0058] The mitochondrion (plural mitochondria) is the “cell's powerhouse”. Most of the organism's stored energy is converted into a usable chemical energy known as adenosine triphosphate (ATP) in the mitochondria. The citric acid cycle or Krebs cycle generates GTP which becomes ATP. Problems with the mitochondria can cause them to die. Problems with the mitochondria, which are also involved in cell signaling, cell death, and cell differentiation, can disrupt the functioning of the cell, tissue and organ in which they survive. It is an organelle with its own strand of DNA, distinct from DNA in the nucleus. Mitochondria are found inside most animal cells. Populations of mitochondria per cell range from one to thousands. Mitochondria living in our cells may be hitch-hiking, symbiotic descendants of bacteria that provided some benefits to us, indeed mitochondrial DNA resembles bacterial DNA. We certainly provided a safe living cell as home with all the warmth and nutrients to these bacteria. When one realizes that the basic chemical structure of cobalamins can only be synthesized by bacteria, it is not hard to see a critical connection and history between mitochondria and cobalamins. [0059] Consistent with the idea that certain types of headache are a result of insufficient energy production by the mitochondria are reports of headache remedies that lessen the brain's demand for energy including relaxation techniques, meditation, and calming affirmations while hypnotized. Also consistent are reports that providing more oxygen to an individual can ameliorate headaches, such treatments include repeated deep breathing and hyperbaric oxygen. Other consistent findings are that regular exercise can both prevent headaches and that exercise can increase the number of mitochondria in the brain. Conversely, strenuous physical activity by people who are not accustomed to it can reduce oxygen concentrations in the brain and have been reported to trigger a benign exertion headache. Likewise carbon monoxide (which binds up hemoglobin) and tobacco smoke can reduce oxygen and are associated with headache. Brain scans called fMRI detect where there is increased blood flow in the brain, which is a surrogate indicator for where there is increased brain activity. Such fMRI scans show that three of the highest energy demanding functional areas of our brains are those areas which process vision, smell and hearing. Accordingly the mitochondrial dysfunction theory of headache is consistent with the hypersensitivity of headache sufferers to bright lights, bad smells, and loud noises. Indeed, visual disturbances known as aura can occur an hour or so prior to the onset of a headache. [0060] The brain's electrical activity correlates to changes in cerebral blood flow and cerebral metabolic rate of oxygen. Rises in cerebral metabolic rate of oxygen are controlled by the ATP turnover, which depends on the energy used for the Na, K-ATPase to re-establish ionic gradients, while cerebral blood flow responses are controlled by mechanisms that depend on Ca(2+) rises in neurons. (Lauritzen M, Neuroimage, 2012 Aug. 15;62(62(2):1040-50.) Caffeine acts as a stimulant because it constricts the brain's blood vessels and many analgesics contain caffeine to fight headaches, especially vascular headaches including migraines. Other products, such as adenosine, have the opposite effect because they dilate blood vessels in the brain and the increased blood flow can lead to a headache. Vasodilation may be part of a headache, yet it is not required for migraine symptoms to manifest. Vasodilation and the brief vasoconstriction that generally precedes it are not the root causes of vascular headaches, as once believed. [0061] The current invention teaches away from the prior art in its findings. The seemingly contradictory idea that headaches are caused by insufficient metabolism of oxygen in the mitochondria, and that increasing blood flow is also a cause of headaches can be reconciled as follows: Blood vessels over essentially all of the brain are normally constricted in a resting, non-headache state, and it is only at the local functional area(s) in the brain where current neurological processing is taking place that momentary vasodilation of the blood vessels (i.e. increases in local cerebral blood flow) occur. (This increased local blood flow can be seen in fMRI images that detect the iron in hemoglobin being fed to the high activity locations.) This local spike in cerebral blood flow delivers a quick, just-in-time oxygen supply to permit a local increase in the cerebral metabolic rate of oxygen. Ameliorating headaches by restricting blood flow all over the brain (increasing mean arterial pressure) is analogous to keeping all the fire hydrants in a city sealed shut except that one hydrant in front of a burning building where opening just that one hydrant provides sufficient pressure to blast the water out. [0062] Hours or days prior to the onset (aura) of a migraine attack, a headache sufferer often experiences a set of symptoms known as prodrome consistent with the current invention's teachings of mitochondrial dysfunction or underperformance in the brain and muscles. Prodrome's symptoms include mood changes, muscle stiffness, yawning (which is a call for more oxygen), fatigue and food (nutrition) cravings. [0063] The current inventor contends that the root cause of many headaches and body pains is inadequate energy (ATP) production in the mitochondria needed to fuel the energy-hungry brain and muscle cells (and not the inflammatory response as per conventional wisdom), and that surprisingly the current invention can provide the micronutrients needed as raw materials to permit the optional functioning of mitochondria. [0064] A non-obvious mechanism of action disclosed in the current invention is that increased mitochondrial concentrations of adenosylcobalamin (and also coenzyme Q10, magnesium, L-carnitine, and riboflavin) prevent or lessen the severity of a cellular energy crisis in which mitochondrial function declines. Such a decline can be due to alternating inner membrane potential, imbalanced trans-membrane ion-transport, and an overproduction of free radicals. (Zhuo M L, Huang Y, Liu D P, Liang C C (April 2005). “KATP channel: relation with cell metabolism and role in the cardiovascular system”. Int. J. Biochem. Cell Biol. 37 (4): 751-64.) In such a situation, mitochondrial K(ATP) channels open and close to regulate both internal Ca2+ concentration and the degree of membrane swelling. This helps restore proper membrane potential, allowing further H+ outflow, which continues to provide the proton gradient necessary for mitochondrial ATP synthesis. Without aid from the potassium channels, the depletion of high energy phosphate would outpace the rate at which ATP could be created against an unfavorable electrochemical gradient. (Xu M, Wang Y, Ayub A, Ashraf M (September 2001). “Mitochondrial K(ATP) channel activation reduces anoxic injury by restoring mitochondrial membrane potential”. Am. J. Physiol. Heart Circ. Physiol. 281 (3): H1295-303.) [0065] An ATP-sensitive potassium channel is a type of potassium channel that is gated by ATP. Simply stated, levels of ATP influence constriction and dilation of blood vessels which have receptors for ATP known as P2x-R. Many vascular headaches, including migraine, begin with a brief vasoconstriction immediately followed by vasodilation, resulting in a throbbing headache. The current invention therefore surprisingly prevents headaches by providing the micronutrients needed for the mitochondria to function properly. [0066] Any shortage or deficiency of adenosylcobalamin and/or the other micronutrients disclosed in the current invention will impair or inhibit mitochondrial functioning. Additionally, increasing amounts of adenosylcobalamin and/or the other micronutrients disclosed herein will accelerate the chemical reactions in the mitochondria, thereby permitting the mitochondria to metabolize more chemical energy over a given period of time. [0067] One example of the utility of the current invention is its amelioration of mitochondrial dysfunction in the hypothalamus, a hormone secreting region of the brain which is associated with cluster headaches. [0068] One especially preferred embodiment of the current invention is a once-daily dissolving that is placed on the tongue and swallowed, and contains combinations of cyanocobalamin, methylcobalamin, and adenosylcobalamin in amounts that are effective in defending the individual against headache and body pain; and the current invention also includes one or more of the following substances or metabolites and salts thereof: magnesium, coenzyme Q10, L-carnitine, and riboflavin. [0069] Magnesium ions are important to the production of nucleic acid, DNA, and RNA, and the catalytic action of many enzymes. Of special relevance to the current invention are the magnesium-dependant enzymes associated with the conversion of adenosine triphosphate (ATP) into adenosine diphosphate (ADP) in the mitochondria. Phosporylation is an important process that occurs in the mitochondria. For this reason, one particularly preferred embodiment of the current invention includes elemental magnesium, magnesium oxide, magnesium gluconate, magnesium citrate, magnesium oxide, magnesium orotate, magnesium malate, and combinations thereof in the formulation in amounts ranging from about 10 mg to about 500 mg per portion. [0070] Proper functioning of the mitochondria requires coenzyme Q10 (CoQ10), also known as ubiquinone or 1-4-benzoquinone. In one preferred embodiment, coenzyme Q10 is included in the formulation in amounts ranging from about 10 mg to about 500 mg per portion. [0071] Riboflavin (vitamin B2) has an important function in energy metabolism. Flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD) function as coenzymes for a wide variety of oxidative enzymes and remain bound to the enzymes during the oxidation-reduction reactions. Reduction of isoalloxazine ring (FAD, FMN oxidized form) yields the reduced forms of the flavoproteins (FMNH2 and FADH2). For this reason, one particularly preferred embodiment of the current invention includes riboflavin in the formulation in amounts ranging from about 0.1 mg to about 300 mg per portion. [0072] Levocarnitine (or L-carnitine) plays an important role in energy metabolism by helping the transport of fatty acids from the cytosol into the mitochondria. Also, it helps remove toxic chemical byproducts from the mitochondria so they do not accumulate. In one preferred embodiment of the current invention, L-carnitine, acetyl-L-carnitine (L-acetylcarnitine), L-propionyl carnitine, or L-carnitine fumarate, and combinations thereof is included in doses between 1 mg and 400 mg per portion. [0073] One especially preferred embodiment of the current invention is a once-daily dissolving medication that is placed on the tongue and swallowed, and contains combinations of cyanocobalamin, methylcobalamin, adenosylcobalamin, magnesium, coenzyme Q10, and riboflavin in amounts that are effective in defending the individual against headache and body pain. [0074] One particularly preferred embodiment of the current invention is a once- or twice-daily dissolving that is placed on the tongue and swallowed. Each dosage's approximate contains are: 1.1 mg of cyanocobalamin, 1.1 mg of methylcobalamin, 1.1 mg of adenosylcobalamin, 5 mg of coenzyme Q10, and 1.2 mg of riboflavin. [0075] In one preferred embodiment, the current invention includes one or more of the following plants or extracts thereof: feverfew ( Tanacetum parthenium, Chrysanthemum parthenium, Pyrethrum parthenium ), kudzu ( Pueraria lobata ), capsicum ( solanaceae ), butterbur ( Petasites hybridus ), ginger ( zingiber officinale ) and ginko ( ginko biloba ). [0076] In the current invention, formulation of dissolving medication can employ hydrophilic polymers that rapidly dissolve in the mouth, preferably on top of the tongue. The cyanocobalamin, methylcobalamin, and adenosylcobalamin permeate the skin of the mouth and, in a certain percentage, are ingested for absorption by the gut, especially the ileum. In one preferred embodiment of the current invention, formulation of dissolving medication involves the application of both aesthetic and performance characteristics such as polymers, plasticizers, active pharmaceutical ingredients, sweetening agents, saliva stimulating agents, flavoring agents, coloring agents, stabilizing and thickening agents. In the current invention, formulation of dissolving medication can employ polymers such as maltodextrin, microcrystalline cellulose and piroxicam made with a hot extrusion technique. To make the medication more flexible; plasticizer excipients such as propylene glycol, glycerol, dimethyl phthalate, diethyl phthalate, dibutyl phthalate, triacrtin, castor oil, triethyl citrate, tributyl citrate, acetyl citrate in the current invention. In one preferred embodiment of the current invention Stevia (steviol glycoside) is used to sweeten the medications. [0077] In one particularly preferred embodiment, the headache medication is delivered to the headache sufferer in a dissolving medication placed in the mouth. The dissolving medication is a thin film delivery technology, and is also referred to as a dissolving film or an oral strip. The current invention defines a dissolving strip as a thin film delivery means to administer active agent(s) via absorption in the mouth. This absorption can be in the mouth as a whole (buccally) on top of the tongue (supralingually), or under the tongue (sublingually) followed up by swallowing. [0078] The skin, including the surface of the tongue, provides a physical barrier that can interfere with the absorption of active drug ingredients. Although cyanocobalamin, methylcobalamin, and adenosylcobalamin are known to permeate the skin in the mouth, a penetration enhancer can increase their transdermal delivery in one preferred embodiment. Penetration enhancers that can increase transdermal delivery and can be used preferably in various embodiments of the current invention include but are not limited to: dimethyl isosorbide, alpha bisobola, sulphoxides (e.g. dimethylsulphoxide), azones (e.g. laurocapram), pyrrolidones (e.g. 2-pyrrolidone), alcohols and alkanols (e.g. ethanol and decanol), glycols (e.g. propylene glycol), surfactants, terpenes, fatty acids, fatty acid esters, fatty alcohols, fatty alcohol esters, biologics, enzymes, amines, amides, complexing agents, macrocyclics, classical surfactants and the like. Gels and creams with a Lamellar or liquid crystal structure also enhance penetration of active ingredients. [0079] When considering the various embodiments of the invention described herein, those knowledgeable in the art will appreciate that these are illustrative only. Such embodiments do not limit the scope of the invention. Those knowledgeable in the art involved will appreciate that many variations, substitutions, equivalents, and like modifications may be made within the scope of the present invention. SUMMARY OF THE INVENTION [0080] Consistent with original study findings on almost 2,000 people, most of whom were in a Phase III placebo-controlled clinical study, the present invention is directed to safe and effective cyanocobalamin, methylcobalamin, and/or adenosylcobalamin containing, orally-dissolving medications to reduce the frequency and severity of pains in the head and body in humans and for enhancing the normal functioning of the human body by boosting the human defense against headaches and body pains. [0081] A non-obvious mechanism of action disclosed in the current invention is that higher concentrations of adenosylcobalamin (and other disclosed compounds) in the mitochondria prevent or lessen the severity of a cellular energy crisis in which

The current invention discloses novel approaches to help individuals defend against headaches and body pains with orally-delivered cyanocobalamin, methylcobalamin, adenosylcobalamin, and combinations thereof. Original clinical research conducted by the inventor on almost 2,000 humans yielded surprising and unexpected results showing differences in the frequency and severity of pains in the head and the body favoring cyanocobalamin patients over placebo. In one FDA-approved Phase III study on 1,551 patients, 4.4 percent of headaches and body pains were rated as “Severe” in the cyanocobalamin, group versus 11.5 percent in the placebo group. Once inside the body, cyanocobalamin is converted to methylcobalamin and adenosylcobalamin, but not to hydroxocobalamin. The current invention provides the patient's mitochondria with sufficient concentrations of essential micronutrients to survive, increase in number and manufacture the chemical energy (ATP) that is required to prevent the brief vasoconstriction followed by vasodilation associated with headache and body pain.

FIELD OF THE INVENTION [0001] The present invention in general relates to non-acetylated salicylate compounds, and in particular to delivery of such compounds under conditions to enhance therapeutic efficacy. BACKGROUND OF THE INVENTION [0002] Choline salicylate is a well-known analgesic that met with limited acceptance owing to a foul taste associated with oral delivery and perturbations to endogenous choline levels after discontinuation of the drug. The attractive attributes of salicylates have been slow metabolic clearing and less of a propensity to induce gastric irritation and bleeding. These attributes of salicylates are in marked contrast to acetylated salicylates, of which aspirin is the preeminent member. [0003] Choline salicylate became a more attractive oral analgesic after compounding with salicylate salts such as magnesium salicylate. The resulting mixed choline-salt salicylate can take various forms such as choline magnesium salicylate and choline magnesium trisalicylate. Regardless of stoichiometry of the choline-metal salt salicylate, the resulting compound is a powder amenable to forming into tablets. Formulation as a tablet addresses in part the limitations of choline salicylate, yet retains a comparatively high concentration of choline. While choline is generally considered to have mild side effects, cholinergic receptors associated with peripheral tissues such as stomach fundus, urinary bladder, trachea and nicotinic receptors throughout an individual potential concern as side effects and an interference to simultaneous treatments. I.H. Ulus et al., Biochemical Pharmacology, 37(14):2747-55 (1988). Additionally, high choline dosing in some individuals has been associated with symptoms of clinical depression. [0004] Thus, there exists a need for salicylate-containing therapeutic compositions for indications such as osteoarthritis, rheumatoid arthritis, muscle pain, anti-inflammatories, analgesics, antipyretics and in the treatment of traumatic brain injury with superior control over elimination half-life, mode of delivery, and the amount of choline relative to salicylate in a formulation. SUMMARY OF THE INVENTION [0005] A therapeutic composition includes a salicylate administering concert with at least one salicylate excretion compound of a glycine salicylate conjugate and a gluconoride salicylate conjugate. A therapeutic composition is provided that has an extended excretion half-life for a salicylate that includes the administration of the salicylate in concert with an enzymatic substrate competitor, the enzymatic substrate competitor being competitive with salicylate or gluconoride. Salicylate enzymatic substrate competitors include benzoate or other aromatic derivatives, while gluconoride enzymatic substrate competitors include an active phenolic unit. [0006] A process for treating a human or nonhuman subject includes administering to a subject a therapeutically effective amount of a salicylate and a salicylate pharmacokinetics modifier of glycine salicylate conjugate, gluconoride salicylate conjugate, benzoate, an aromatic derivative and an active phenolic unit, along with a pharmaceutically acceptable carrier. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0007] The present invention has utility as a therapeutic composition indicated for chronic and acute pain associated with ailments illustratively including osteoarthritis, rheumatoid arthritis, as a general analgesic, and as antipyretic. The inventive compositions have the attribute of not affecting platelet aggregation and as such are also indicated in instances of cerebrospinal swelling associated with traumatic brain injury. [0008] An inventive salicylate composition includes a mixture of salicylates that allows one to adjust the time of peak dosage after administration, the half-time elimination or a combination thereof. In another embodiment, the present invention affords a single salicylate compound, or a mixture of salicylates in a hydrophilic polymer matrix, that shifts the peak dosage after administration to a latter time relative to the comparable dose absent the matrix. The present invention yields a tunable dosing profile. [0009] As used herein, “bioequivalence” is defined to mean the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. See Code of Federal Regulations, Title 21, Apr. 1, 1997 edition, Part 320.1, Definitions (e) Bioequivalence, page 195. [0010] While the present invention is principally disclosed herein with respect to solid oral delivery dose, it is appreciated that inventive salicylate compositions are readily prepared in forms other than a solid oral delivery dose to treat a subject. As used herein, a “subject” is defined to include mammals and birds inclusive of humans. Examples of nonhuman subjects illustratively include cows, dogs, cats, sheep, goats, pigs, and chickens. One skilled in the art will readily appreciate that an inventive mixture of salicylates, alone or in combination with enzymatic substrate competitors, are readily formulated as a topical rubefacient, transdermal patch, intravenous solution, intramuscular solution, intrathecal solution, intraventricular solution, a suppository, an oral solution, and a nasal spray. Such delivery forms typically include a physiologically acceptable sterile aqueous or non-aqueous solution, dispersion, suspension or emulsion or a sterile powder for reconstitution into a sterile injectable solution or dispersion. Examples of suitable aqueous and non-aqueous carriers, diluents, solvents and vehicles illustratively include water; ethanol; polyols such as propylene glycol, polyethylene glycol, and glycerol; suitable mixtures thereof; vegetable oils such as olive oil; and injectable organic esters such as ethyloleate. Adjuvants are typically provided to facilitate delivery and storage. Typical adjuvants illustratively include osmolarity buffers such as saline; pH buffers; antioxidants; and antimicrobials: the identity and typical quantities of such adjuvants are detailed in Remington's Pharmaceutical Sciences, 20 th Edition, pp. 240-241, 1015-1017, 1510-1530, and 1551-1555. [0011] An inventive salicylate composition exhibits an approximate in vivo hysteresis profile when the plasma curves at less than saturation dosing for salicylate is deconvoluted. J.G. Wagner et al., J. Pharm. Sciences, 52:610-611 (1963). The absorption profile for an inventive formulation is approximately characterized by three general phases; I, II, and III. Phase I is characterized by the initial time period where minimal absorption of salicylate occurs. In conventional salicylate dosing such as with choline magnesium salicylate tablets, phase I is on the range of 15 to 30 minutes. Phase II is an exponential period, following phase I during which most of the absorption of salicylate occurs. In conventional salicylate dosing such as with choline magnesium salicylate tablets, phase II yield as peak dose after 1 to 2 hours. Phase III involves the time period when salicylate absorption ends and is treated theoretically as asymptotically diminishing to a complete absorption. In conventional salicylate dosing such as with choline magnesium salicylate tablets, complete absorption is obtained in 10 to 20 hours. [0012] Through the use of a hydrophilic polymer matrix as part of the present invention, phase I is extended to occur from 1 to 5 hours with a mean of about 2.7 hours after ingestion. Phase II is adjusted to occur from S to 12 hours with a mean of about 8 hours after phase II. Phase III is adjusted to occur from 12 to about 16 hours with a mean of about 14 hours after ingestion. The net result is that salicylate in conventional form that typically is predominantly absorbed from the stomach, is absorbed according to the present invention predominantly in the duodenum. The actual time being modified by factors illustratively including subject mass, stomach contents, metabolic rate, age, and dose. A typical daily dose of salicylate according the present invention for an adult is between 300 and 900 milligrams (mg) per day exclusive of the weight of counter ions, and for children a typical dose ranges from 12 to 50 mg/kilogram (kg)/day exclusive of the weight of counter ions. In terms of weight percentages, up to 25% and preferably about 8% of the total dose is absorbed during phase I. During phase II between about 75% and 100% and preferably about 90% is absorbed during phase II, with the remainder, if any, being absorbed during phase III. It is appreciated that salicylate excretion is via a renal glycine conjugate (salicyluric acid) and a renal phenolic glucuronide conjugate. Excretion is rate limited by the hepatic formation of the excretion conjugates. Glucuronide conjugate in bile is capable of reabsorption, thereby slowing the net rate of excretion. As a result of the known excretion pathways and kinetics, one skilled in the art will appreciate that there is a dose dependency to the excretion metabolite ratio of glycine: glucuronide conjugates, as well as the amount of glucuronide reabsorption. [0013] In a first inventive embodiment, one or more soluble salicylate therapeutic species is combined in an oral drug delivery form with a hydrophilic polymer matrix swelling agent that extends the duration of drug release profile phases compared to the bare one or more soluble salicylate therapeutic species. Oral drug delivery forms operative herein illustratively include tablets, capsules, and dragees. It is appreciated that the specific salicylate and the amount of swelling agent are preselected in order to control the time profile release of the salicylate. It is appreciated that the amount of the hydrophilic polymer matrix swelling agent varies depending upon factors such as the nature of the salicylate, grain size of the salicylate, the physical properties of the swelling agent, and the desired the time release profile, it is preferred to employ amounts of the salicylate to provide the desired dosing effect. Optionally, a hydrophilic polymer matrix swelling agent is replaced with or used in combination with a gel, permeable membrane, osmotic system such as those of Alza Corp. (Mountain View, Calif.), microparticles, liposomes, or microspheres. As is known in the art, such hydrophilic polymer matrix swelling agents and amounts thereof, are preselected in order to control the time release of salicylate. [0014] Hydrophilic polymer matrix swelling agents operative herein illustratively include polymers such as carboxy C 1 -C 8 alkylcelluloses; C 1 -C 8 alkylcelluloses; and waxes such as beeswax; and natural materials such as gums or gelatins or mixtures of any of the above. A preferred swelling agent is hydroxypropyl methylcellulose, in an amount ranging from about 5% to about 50% parts by weight per 100 parts by weight of salicylate, where the salicylate weight is determined independent of counter ion or conjugate moiety. The preferred quantity is chosen to afford sustained time release over a period corresponding to phase II of 8 to 12 hours as demonstrated by in vitro dissolution techniques known to the art. [0015] A binder is optional included in an inventive composition. While any known binding material is operative herein, a preferred binder is a polymer incorporating the repeating unit of 1-ethenyl-2-pyrrolidinone. These polymers generally have molecular weights of from 10,000 and 700,000, and are also known as commercially as povidones. Typically, povidones are present from 1 to 5 % parts by weight per 100 parts of salicylate, where the salicylate weight is determined independent of counter ion or conjugate moiety. [0016] Conventional processing aids such as lubricants and desiccants are appreciated to be operative herein. Typical lubricants illustratively include stearic acid and salts thereof and are used in a manner as known to the art. Remington's Pharmaceutical Science, 20 th Edition. Desiccants are also conventional to oral solid dose compounding and illustratively include silicon dioxide and starches. Lubricants and desiccants are typically present from 0.05 to 2 % parts by weight per 100 parts of salicylate, where the salicylate weight is determined independent of counter ion or conjugate moiety. [0017] Salicylates operative in the present invention include a variety of physiologically compatible counter ions and conjugates and illustratively include alkali metal ion salicylates such as lithium, sodium, and potassium; alkali earth ion salicylates such as magnesium, and calcium; transition metal salicylates such as iron; other metal ions such as aluminum; quaternary alkyl ammoniums such as tetra (C 2 -C 8 ) ammoniums; organics such as choline; amino acids such as glycine (synonymously known as salicyluric acid), alanine, valine, leucine, isoleucine, serine, methionine, threonine, phenylalanine, tyrosine, tryptophan, cysteine, proline, histidine, aspartic acid, asparagine, glutamic acid, glutamine, γ-carboxyglutamic acid, arginine, omithine and lysine, hydroxylysine, citrulline, kynurenine, (4-aminophenyl)alanine, 3-(2′-naphthyl)alanine, 3-(1+-naphthyl)alanine, methionine sulfone, (t-butyl)alanine, (t-butyl)glycine, 4-hydroxyphenyl-glycine, aminoalanine, phenylglycine, vinylalanine, propargyl-gylcine, 1,2,4-triazolo-3-ala, 3-aminotyrosine, trifluoromethylalanine, 2-thienylalanine, (2-(4-pyridyl)ethyl)cysteine, 3,4-dimethoxy-phenylalanine, 3-(2′-thiazolyl)alanine, ibotenic acid, 1-amino-1-cyclopentane-carboxylic acid, 1-amino-1-cyclohexanecarboxylic acid, quisqualic acid, 3-(trifluoromethylphenyl)alanine, (cyclohexyl)glycine, thiohistidine, 3-methoxytyrosine, norleucine, norvaline, alloisoleucine, homoarginine, thioproline, dehydroproline, hydroxyproline, homoproline, indoline-2-carboxylic acid, 1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid, 1,2,3,4-tetrahydroquinoline-2-carboxylic acid, a-amino-n-butyric acid, cyclohexylalanine, 2-amino-3-phenylbutyric acid; oligopeptides composed of from 2 to 5 of the above amino acids; heterocyclics such as glucuronide, glucuronamide, aminopyridines, and endocannibinoids, endorphins, enkephalins and dynorphins; multiple species adducts such as choline magnesium salicylate, and choline magnesium trisalicylate; and combinations thereof. Particularly preferred salicylates according to present invention include choline magnesium salicylate, choline magnesium trisalicylate, glycine salicylate and glucuronide salicylate. [0018] In an alternate embodiment, the half-life of excretion is adjusted independent of the release rate as modified by the addition of a swelling agent. Excretion half-life is modified according to the present invention through a recognition that hepatic capacity to modify a salicylate into one of the two predominant excreted forms of a glycine salicylate or glucuronide salicylate is limited. Further, it is appreciated that the glucuronide salicylate excretion pathway is slowed by reabsorption of glucuronide salicylate from bile. [0019] According to the present invention, excretion rates are increased by the administration of glycine with a therapeutic quantity of salicylate. Without intending to be bound to a particular theory, the addition of glycine appears to assure that serum glycine level is not the rate-limiting step in formation of the salicyluric acid. In a particular embodiment having a reduced half-life of excretion, the salicylate is administered in concert with free glycine or a glycine-rich protein such as gelatin. Typically, a molar stoichiometric ration of glycine:salicylate of between 0.2-2:1 is used in the present invention with greater relative quantities of glycine being used in instances where high end doses are administered and/or rapid excretion is desired. According to the present invention, a single 570 mg dose of salicylate with a 2:1 molar ratio of glycine:salicylate is cleared in 40 to 70% of the time required for the same salicylate dose given independent of glycine, with the variability in excretion half-life being related to those factors such as subject mass, stomach contents, metabolic rate, and age. It is appreciated that the presence of glucuronide in a form illustratively including a glucuronate acid or salt, such as sodium glucuronate within an inventive composition further facilitates excretion via the secondary glucuronide pathway, notwithstanding the partial reabsorption noted in bile. Maximal rates of excretion are noted in the present invention when glucuronide is present at from 10 to 20 molar percent of the quantity of glycine present in an inventive therapeutic dose. It is appreciated that a rapid excretion form of the present invention is well suited for a subject having an indication justifying salicylate therapy yet is under a complex regimen of pharmaceutical treatments with concerns about possible drug interactions. By way of example, an inventive salicylate composition taken in the evening that affords pain relief to allow a restful night and clearance by morning to facilitate the ingestion of a secondary therapeutic is a value in the treatment of a subject suffering multiple chronic ailments. It is appreciated that a rapid excretion clearance composition according to the present invention is readily coupled with a swelling agent as detailed above to induce a delayed release, thereby affording a delayed release and rapid clearance formulation. [0020] In a long-acting embodiment of the present invention, a competitive substrate is provided for hepatic enzymes that form salicylate excretion products. A preferred competitive substrate for both glycine- and glucuronide-renal clearance conjugates is a benzoate ion derivative. Benzoate derivatives operative herein include benzoate salts, benzalkoniums, phthalates, benzaldehydes, and substituted forms thereof where a hydryl moiety attached to the phenyl ring is substituted with a substitute including C 0 -C 4 hydroxyl, C 0 -C 4 sulfonyl, C 0 -C 4 carboxyl, C 1 -C 4 trialkyl C 0 -C 4 amino and C 2 -C 8 quaternary C 0 -C 4 amino. Without intending to be bound by a particular theory, it is believed that benzoate aromatic derivatives compete effectively with salicylate as a substrate for enzymatic modification thereby slowing the rate of modification of salicylate to an excretable glycine or glucuronide conjugate. Benzoate counter ions operative herein illustratively include alkali metal ion salts such as lithium, sodium, and potassium; and alkali earth ion salts such as magnesium, and calcium and other biocompatible counter ions and conjugates. [0021] Typically, a molar stoichiometric ratio of benzoate derivative:salicylate of between 0.3-10:1 is used in the present invention with greater relative quantities of benzoate being used in instances where slower excretion is desired. Preferably, the molar stoichiometric ratio of benzoate derivative:salicylate is between 0.5-4:1. According to the present invention, a single 570 mg dose of salicylate with a 3:1 ratio of benzoate derivative:salicylate is cleared in 140 to 340% of the time required for the same salicylate dose given independent of benzoate derivative, with the variability in excretion half-life being related to those factors such as subject mass, stomach contents, metabolic rate, and age. [0022] It is appreciated that an independent and less pronounced competitive substrate according to the present invention as compared to benzoate derivative is a phenolic compound containing active phenolic unit. As used herein “an active phenolic unit” is defined to include a molecule or a subunit of polymeric molecule containing a six-membered aromatic ring moiety having at least one hydroxyl substituent thereon, and having an in vivo solubility sufficient to allow interaction with hepatic enzymes that bind phenol. [0023] Without intending to be bound by a particular theory, it is believed that active phenolic units compete effectively with glucuronide as a reagent for enzymatic coupling to salicylate thereby slowing the rate of modification of salicylate to an excretable glucuronide conjugate. Phenolic compounds operative herein illustratively include phenolates; flavenols, flavanones, catechins; anthrocyanins, such as fruit and vegetable colorings; isoflavones, such as genistein, diadzein; dihydroflavonols; chalcones; quercetins; phenolic acids, such as ellagic acid, tannic acid, and vanillin; hydroxycinnamic acid derivatives, such as caffeic acid, chlorogenic acid, ferulic acid, curcumins, and courmarins; and lignans. It is appreciated that phenolic compounds according to the present invention are routinely found as phytochemicals. As such, it is appreciated that diet and nutritional supplements are implicated in the importance of the glucuronide renal excretion pathway. Exemplary phenol compounds used herein include tyrosine and virgin pressed olive oil containing the non-polar phenols oleuropein- and ligstroside- aglycones and the polar phenols, hydroxytyrosol and tyrosoll. Typically, a phenolic competitive substrate is provided at a molar stoichiometric ratio of active phenolic unit: salicylate of between 0-3:1 with greater relative quantities of phenolics being present in instances where slower excretion is desired. Preferably, the molar stoichiometric ratio of active phenolic unit:salicylate is between 0.05-0.8:1. The variations in ratio of active phenolic unit to salicylate are a result in part of: the competitive bind rate of the active phenolic unit relative to glucuronide as measured by the Michaelis-Menten equation, and the salicylate dosing since excretion kinetics vary in the exponent dependency on salicylate concentration as a function of the salicylate concentration. [0024] It is appreciated that benzoate derivatives and phenolic competitive substrates are optionally combined within a therapeutic dose with the understanding that benzoate tends to slow excretion by both glycine and glucuronide conjugate renal pathways, while an active phenolic unit functions preferentially to slow excretion by the glucuronide pathway. Maximal rates of excretion are noted in the present invention when glucuronide is present at from 10 to 20 molar percent of the quantity of benzoate derivatives present in an inventive therapeutic dose. [0025] An additional aspect involves formulating granules of inventive compositions that vary between granules in at least one dose profile parameter of absorption onset, peak dose, or steady state excretion half-life. It is appreciated that combining such granules into a delivery device affords tunable control over the dose profile parameters of the aggregated dose within the delivery device. [0026] An inventive salicylate composition, alone or in combination with enzymatic substrate competitors for delivery by a variety of routes, including topical, intravenous, intramuscular, intraspinal, intraventricular, anal or intranasal through the use of conventional pharmaceutical formulary. By way of example, injectable forms of an inventive composition range from soluble to highly soluble in aqueous solution and as such, are readily dissolved in sterile saline or other physiological solutions for injectable routes including intravenous, intramuscular, intrathecal and intraventricular. [0027] An inventive salicylate composition, alone or in combination with enzymatic substrate competitors, is readily formulated as a suppository through compounding with a suitable base as detailed in Remington's Pharmaceutical Sciences, 20 th Edition, pp. 852-856. [0028] An inventive salicylate composition, alone or in combination with enzymatic substrate competitors, is also recognized to be readily formulated into a topical delivery composition. Suitable bases for inclusion of the inventive composition active ingredients include essentially any base topical formulation. Representative base formulations for an inventive topical composition are found in U.S. Pat. Nos. 3,880,996; 4,775,667; 5,223,257; and 5,223,267. Additional topical base formulations are also disclosed in WIPO Publication WO 02/098404 A1. [0029] An inventive mixture of salicylates alone or in combination with enzymatic substrate competitors or a single salicylate in combination with an enzymatic substrate competitor is also readily formulated into a transdermal patch. A representative transdermal delivery system suitable for delivery of an inventive composition is detailed in U.S. Pat. No. 5,658,587, column 15, line 23 -column 22, line 53. EXAMPLES [0030] In order to demonstrate the effectiveness of the compositions and method of the present invention over known conventional salicylate compositions, a number of compositions are prepared according to the invention as oral tablets and compared to action of a conventional formulation in a model human adult subject. The bioequivalence of soluble salicylates used herein is assumed for the purposes of the subsequent calculations. Dosing data for a single dose of each composition is also provided, where times are provided in hours. Excretion half-life is calculated based on the steady state administration of 4 doses administrated once daily for 4 consecutive days. The compositions are summarized in Table 1 where quantities are provided in milligrams. TABLE 1 Test Tablet Composition FORMULATION INGREDIENT A B C D E F G Comparative Salicylate 570 570 570 570 570 570 570 570 Salicylate conjugate Choline Mg CM CM CM CM Glycine CM CM (identity and weight) (CM) 180 180 180 180 308 180 180 180 Hydroxypropyl 205 — — — — 205 205 methylcellulose Sodium benzoate — 1500 1500 1500 Tyrosine — — 371 371 Povidone 26 26 26 26 26 26 26 26 Stearic Acid 10 10 10 10 10 10 10 10 Other Glycine Glycine — — 467 467 Sodium glucuronate 145 TOTAL 991 2286 2657 1253 1398 1120 2862 786 Absorption Onset 1-2 0.3-0.5 0.4-0.6 0.3-0.5 0.3-0.5 1-2  1-2 0.3-0.5 (Phase I) (hours) Peak Dose (hours)  5-12 1-2 1-2 1-2 1-2 5-12 17-33 1-2 Steady State Excretion 10-17 15-29 17-33  6-14  5-14 9-16  9-17 Half-life (hours) [0031] Patent documents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. These documents and publications are incorporated herein by reference to the same extent as if each individual document or publication was specifically and individually incorporated herein by reference. [0032] The foregoing description is illustrative of particular embodiments of the invention, but is not meant to be a limitation upon the practice thereof. The following claims, including all equivalents thereof, are intended to define the scope of the invention.

A therapeutic composition includes a salicylate administering concert with at least one salicylate excretion compound of a glycine salicylate conjugate and a gluconoride salicylate conjugate. A therapeutic composition is provided that has an extended excretion half-life for a salicylate that includes the administration of the salicylate in concert with an enzymatic substrate competitor. The enzymatic substrate competitor being competitive with salicylate or gluconoride. Salicylate enzymatic substrate competitors include benzoate or other aromatic derivatives, while gluconoride enzymatic substrate competitors include an active phenolic unit. A process for treating a human or non-human subject includes administering to a subject a therapeutically effective amount of a salicylate and a salicylate pharmacokinetics modifier of glycine salicylate conjugate, gluconoride salicylate conjugate, benzoate, an aromatic derivative and an active phenolic unit, along with a pharmaceutically acceptable carrier.

FIELD The present invention relates to games using a tangible projectile. More specifically, the present invention relates to a device for developing or enhancing consistent motor movements, such as a club stroke for golfing or batting swing in baseball. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic view of a training device in one embodiment. FIG. 2 is an external schematic view of the embodiment of FIG. 1 . FIG. 3 is a perspective view of the external case of a second embodiment. FIG. 4 is a perspective view of a charging dock used with the embodiment of FIG. 3 . FIGS. 5-8 are perspective views of pad and cam kits for use with the embodiment of FIG. 3 . FIGS. 9A-9Q are a series of perspective views of various embodiments with various swingable items described herein. DESCRIPTION For the purpose of promoting an understanding of the principles of the present invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will, nevertheless, be understood that no limitation of the scope of the invention is thereby intended; any alterations and further modifications of the described or illustrated embodiments, and any further applications of the principles of the invention as illustrated therein are contemplated as would normally occur to one skilled in the art to which the invention relates. One form of the present device is a training device that is removably attachable to the shaft of a swingable implement, such as a golf club or baseball bat, as illustrated in FIGS. 1-2 . The device 100 includes a small, brushless motor 140 attached to a cam 150 that is approximately the height of the motor. Cam 150 is designed with its weight off-center so it produces vibration when it is rotated by motor. In one embodiment, shown in FIG. 1 , the motor 140 is a Traxxas model 3975 Titan® 550 motor with a custom fabricated and welded eccentric cam 150 . Power for this embodiment is provided by a 9-volt cell 110 placed within housing 120 , though other attached or detached power systems are used in other embodiments. Motor 140 is placed within the main portion of plastic tube 130 and wired in series with 9-volt cell 110 and switch 160 . The battery housing 120 is secured to the main portion 130 of the housing screws through holes 180 or other attachment methods as will occur to those skilled in the art. Turning to FIG. 2 , vent holes 170 through the plastic tube 130 allow ventilation for motor 140 and passive cooling of the device 100 . Plastic cap 195 seals the end of plastic tube 130 opposite housing 120 , while rubber gasket 105 seals the juncture between the housing components 120 and 130 . Gasket 105 also extends radially beyond the diameter of plastic tubing 130 to provide additional friction and inhibit slippage when the device is attached to something. Fastener straps 125 are preferably made from a hook-and-loop material such as Velcro® and affixed permanently in at least one location to plastic tube 130 or battery housing 120 . When the device is in use, the fastener straps 125 are wrapped around something that a person holds or moves during an activity. For example, in one mode of use the device is attached to a golf club on or near the handle. The device is switched on and vibrates the golf club during a rest break, practice or exercise. The vibration induces improved muscle control and muscle memory and, therefore, accuracy by improving positioning and motion of the club during the user's swing. Another application of the device is for batting practice. The device is strapped to a baseball bat using fastener straps 125 , then is turned on using switch 160 during training and practice swings. Yet another application of the device is for relaxation or to decrease discomfort. Vibration imparted by the device is perceived by the skin and joints. The device is attached directly to an implement held in the hands or applied to the muscles targeted for relaxation. For instance, a tennis player feeling tight or tense because of pain or nervousness attaches the device to the racquet handle. The player relaxes, holds the racquet lightly, and the device is turned on imparting a gentle massage to the hands. A runner uses the device in a similar fashion by attaching the device to her feet or legs. A soccer player preparing to take a penalty kick attaches the device to the surface of his soccer boot to help aid in relaxation, while a basketball player applies the device to her hands during a time out immediately prior to shooting free throws. A golfer suffering from discomfort secondary to arthritis in his hands applies the device to his golf club, turns it on and swings his club while waiting to tee off to relieve discomfort. A gymnast attaches the device to a pole or cane and turns the device on while performing a stretching program to enhance muscle and joint flexibility and mobility. This also applies to many other activities and settings. Yet another application of the device is for acute/transient muscle stimulation. The user engages in a short bout (2-10 minutes) of training immediately prior to participating in activity. This preparation may enhance muscle fiber activity during and after submaximal isometric and dynamic contractions. The device may be attached to almost any sporting device to facilitate increased performance. For example, a baseball player who is “on deck” waiting for his turn to bat may attach the device to his bat. The batter then may perform static and/or dynamic movements with the bat while the device is turned on. A static movement may consist of simply holding the bat at impact position or at full backswing. A dynamic movement may be gently swinging the bat as the baseball player would normally swing when he is at the plate. When it is his turn to bat, the player removes the device from his bat. This mode of use could be applied to many sports (cricket, golf, etc.). In addition, a sprinter could apply the device (in its present form in a suitably modified case, such as an arm or leg wrap housing that might double as an ice pack housing) to his calves prior to sprinting, a discus thrower to the disc, a javelin thrower to the javelin, a golfer to the golf club, a rock climber to their ice pick or training board, etc. A golfer may attach the device (in some form or modified casing, such as a specialized housing belt) to his back, thus stimulating muscles involved in stabilization of the trunk or generation of speed via rotation utilizing the muscles of the back and trunk. Still another use of this device is to help decrease the risk of certain sports injuries via stimulation of muscles. One use in this setting is to decrease the likelihood of suffering an ankle inversion sprain by stimulating the muscles on the outside of the lower leg (peroneus longus and brevis). For example, a football player who suffers from chronic inversion ankle sprains may have the device applied to the outside of his lower leg during rest periods. In addition to a physical stimulation of the muscles, this use may provide a reminder to the user to utilize proper form and thus avoid injury. Another use in this vein is to enhance stretching and/or warm-up exercise. For example, a pair of devices could be placed on the user's arms using arm bands while the user does push-ups or stretches. This application is believed to enhance joint and muscle flexibility. Once a muscle group becomes fatigued (and thus theoretically more susceptible to injury), it may be possible to overcome this fatigue to some degree with application of a vibratory stimulus. If a tennis athlete, for example, suffering from sensations of forearm fatigue, is sitting on the side of the court during a change of sides in a tennis match, the athlete may be able to apply the vibration by holding the racquet and thus re-invigorate the fatigued forearm muscles. When rehabilitating from an injury, the device may be utilized in a sport-specific manner to regain strength and neuromuscular coordination. A tennis player recovering from tennis elbow or lateral epicondylalgia may perform upper extremity exercises using the tennis racquet with the device attached. A soccer player who is rehabilitating from an inversion sprain may train by attaching the device to his foot or lower leg and performing ankle exercises. The device might be used by individuals undergoing bed rest in a hospital. The individual might practice moving their limbs with the vibration device either attached to the limb or to an instrument held in the hand or foot. By performing these actions, the expected decline in muscle output may be diminished. Usage of this device may also be incorporated into regularly scheduled training multiple times per week to enhance strength. A golfer may attach the device to the handle of her golf club, and after turning the device on, may practice bringing the club into the impact position and holding it there for 30 seconds followed by 30-second holds in the full backswing and follow-through positions. She may then decide to perform four repetitions of this pattern and conclude the vibration portion of her exercise session with two minutes of full swings with the device turned on. She may then continue with her usual exercise routine whether it includes weight training, cardiovascular conditioning, stretching, and the like. Likewise, a bicyclist may use vibrating pedals to improve performance in cycling and with stationary bikes or elliptical trainers. A waterproof version is suitable for swimmers in arm band form or for surfers, either as an ankle band or incorporated into surfboards, while another version works within a ski boot, within a snowboard, or with ski poles. Use of this device may also be a pain-free way for individuals suffering from bone loss to exercise in a way that is low-impact and therefore less likely to cause injury due to bone fracture. These individuals may strap the device to a cane or other implement and practice various exercises with their extremities. In another application, the device may induce positive adaptations in peripheral blood circulation. Use of the device by placement either directly on or attached to implements held by the hands or feet could result in increased activation of muscles of those extremities. This leads to increased perfusion of those muscles and, therefore, increased circulation to the extremities. Use in this manner may be of benefit for those suffering from peripheral circulatory derangement such as Type II diabetes mellitus. Attaching the device to the shoe of an older individual and having that individual move their leg through some range of motion with the device turned on may enhance proprioception of the joints of the lower extremity through training of the muscle spindles and joint receptors. This increased awareness of body position in space or kinesthetic awareness may decrease risk of future falls. An alternative design for the device includes a microcontroller programmed to generate a simple square wave, which is supplied as a DC voltage signal to the DC brushed motor at a software-determined frequency (i.e., a software controlled motor speed). A simple cam system is then connected to the shaft of the motor. The frequency of the vibration could then be controlled by the software or ultimately by a user of the device through a microcontroller-sampled user interface device such as an encoder, potentiometer, or buttons. The software could then be customized to accommodate the appropriate range of frequencies desired. Software algorithms to implement these applications will occur to those skilled in this area of technology. Other implementations of this device include embedding the device (electro-mechanical system) or building the device into an athletic implement such as a golf club or baseball bat as opposed to strapping a separate chassis to an existing athletic implement. Another implementation is shown in FIG. 3 and allows the user to exchange cams ( 150 in FIG. 1 ) for cams of alternative shape, mass, and/or relative center of mass. This embodiment of device 200 includes enclosure 210 and has a main lower shell 213 , a control shell 216 , and a battery compartment cover 218 . Motor ventilation holes 217 in battery compartment cover 218 enable airflow for cooling of the components internal to enclosure 210 . Control shell 216 includes a depression and defines an opening for power button 220 , defines an opening for frequency selector 222 , and includes an indentation 224 next to the edge of battery compartment cover 218 to facilitate the removal by users of battery cover compartment 218 . On the opposite side of device 200 from control shell 216 and battery cover compartment 218 is pad 230 , which is removably connected to lower shell 213 by pad anchors 232 . Finger pull tab 234 rests in depression 215 in lower shell 213 when device 200 is in use, and facilitates removal of pad 230 from lower shell 213 for replacement by a replacement pad or a pad of a different configuration. FIG. 4 illustrates a docking station and battery component of a rechargeable variation 300 of the embodiment in FIG. 3 . In this variation, battery pack 318 is removed from the remainder of the device and placed in contact with charging station 370 so that mating structures mate. In particular, electrical contacts 360 on battery pack 318 meet with electrical contacts 362 on charging station 370 so that power coming to charging station 370 through cord 345 can be passed into an energy storage device (such as a battery) in battery pack 318 . In some embodiments, cord 345 connects to a wall outlet or DC converter, while in others cord 345 connects to a powered USB port or similar connection to a personal computer, while in still others another source of energy is used. Then, in preparation for use, battery pack 318 rests in lower shell 310 so that electrical contacts 360 of battery pack 318 meet with electrical contacts 364 inside lower shell 310 . A variety of suitable pads 230 and cams 150 are shown in FIGS. 5-8 . FIG. 5 , for example, illustrates a kit of replacement parts for device 100 or 200 . Pad 230 a defines groove 235 a , which is configured to receive the shaft of golf club when pad 230 a is attached to lower shell 213 , and one of golf cams 250 a is attached to axle 355 to be driven by motor 340 (see FIG. 4 ). Likewise, pad 230 b is configured for use with a baseball bat matching that configuration of groove 235 b , in connection with use of cams 250 b . Pad 230 c is configured with groove 235 c , which is adapted to receive the handle of a racquet (such as a tennis or racquetball racquet), and cams 250 c are attachable to axle 355 to be driven by motor 340 to provide a suitable speed, magnitude or range of vibration. Pad 230 d is configured for use with device 200 as a massager, where surface 235 d directly contacts the skin of the user, and one of cams 250 d provides suitable speed, magnitude or range of vibration. Other pad designs and cam configurations will occur to those skilled in the art. FIGS. 9A-9Q illustrate various embodiments of the present system, where the swingable item is a golf club, tennis racquet, racquetball racquet, squash racquet, baseball bat, cricket bat, hockey stick, lacrosse stick, jai alai basket, fishing rod, javelin, pole-vaulting pole, runner's baton, broom, shovel, mitt, and glove, respectively. All publications, prior applications, and other documents cited herein are hereby incorporated by reference in their entirety as if each had been individually incorporated by reference and fully set forth. While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. While the inventions have been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that the preferred embodiment has been shown and described and that changes and modifications that come within the spirit of the invention are desired to be protected.

Embodiments of a portable vibration device are disclosed, along with their use in enhancing performance for athletic and other processes requiring precise body control. A small portable housing is removably attachable to an athletic implement such as the shaft of a golf club. A battery-operated vibration mechanism within the housing operates at a frequency suitable for enhancing muscle performance through stimulation. A frequency control circuit operable by the user enables adjustment of the frequency for various circumstances. A removable pad attaches to the vibration mechanism and defines features adapted to match a particular intended implement, and a removable cam attached via an axle to a motor can be replaced by a cam adapted for use with that same type of implement.

FIELD OF THE INVENTION The present invention relates in general to a vehicle seat and more particularly to a seat backrest whose contour is adjustable to conform to the lumbar contour of a particular occupant in a vehicle. BACKGROUND OF THE INVENTION Throughout the specification, the terms "forward" and "rearward" are to be understood as referring to "in the direction to the front of the subject seat" and "in the direction to the rear of the subject seat", respectively and "upward" and "downward" to be taken as upward and downward with respect to the subject seat, respectively. For increased riding comfort and for minimum occupant fatigue, a vehicle seat backrest must support the lumbar area of the seat occupant's back. But, it is recognized that the construction of universally satisfactory permanent seat structures can not be effected because of difference in individual body sizes and proportions. In view of the above, it has become popular to equip a vehicle seat with a so-called "adjustable lumbar supporter" held in the backrest of the seat. However, such an adjustable lumbar supporter conventionally used still has a limitation in setting a plurality of positions. In fact, the adjustment of the supporter is limited to either forward-rearward positioning or upward-downward positioning. More specifically, the positioning of the lumbar supporter is made by moving it monodirectionally. Thus, the most desired and effective positioning of the supporter for properly supporting the lumbar area of the seated occupant has not been obtained. SUMMARY OF THE INVENTION Therefore, an object of the present invention is to provide a seat which is equipped at the backrest thereof with an improved adjustable lumbar supporter which is adjustable in both forward-rearward directions and upward-downward directions for the proper supporting of the seated occupant's lumbar area irrespective of differences in individual body sizes and proportions. According to the present invention, there is provided a seat backrest having two parallel but spaced frame members by which a contourable portion constituted by padding means is supported, and a lumbar supporter for imparting a curvature to the contourable portion to produce a desired contour, the lumbar supporter comprising: a rod transversely passing the frame members and rotatable about the axis thereof relative to the frame members, an arm member secured at its one end to the rod and located between the frame members, a support member pivotally connected to the arm member, lumbar pressing means connected to the support member, first control means for permitting the support member to rotate about its pivoted portion relative to the arm member when operated, and second control means for permitting the arm member and thus the rod to rotate about the axis of the rod relative to the frame members when operated. SUMMARY OF THE DRAWINGS Other objects and advantages of the present invention will become apparent from the following description when taken in conjunction with the accompanying drawings, in which: FIG. 1 is a perspective but partially broken view of a seat according to the present invention; FIG. 2 is an enlarged partial view taken on the line II-II of FIG. 1; FIG. 3 is a view taken on the III-III of FIG. 2; FIG. 4 is an exploded view of a part of the seat of the invention; FIGS. 5A and 5B are views each taken on the line V-V of FIG. 3, showing respectively lower and upper section supporting conditions of a lumbar supporter equipped in the seat of the invention; and FIGS. 6A and 6B are views similar to FIGS. 5A and 5B, each showing front and rear section supporting conditions of the lumbar supporter in case of the respective lower and upper section supporting conditions thereof. DESCRIPTION OF THE PREFERRED EMBODIMENTS In the drawings, the points denoted by "GW" and "SW" are to be understood as "gas welding point" and "spot welding point", respectively. Referring to FIG. 1 of the drawings, there is illustrated a seat of the present invention, as being generally designated by numeral 10. The seat 10 generally comprises a seat proper 12 mounted through suitable supporting means on the floor (not shown) of a vehicle, and a backrest 14 pivotally connected to a rear portion of the seat proper 12 in a manner as will be apparent from the following. The backrest 14 comprises an archshaped tubular frame 16 having foot portions pivotally connected via pivot pins 18 to rear portions of side frames (not shown) of the seat proper 12. A tubular lower frame 19 is secured via welding to lower sections of leg portions of the frame 16 to span the same. Side brackets 20 and 22 are secured via welding to the leg portions of the tubular frame 16 to permit each longitudinal edge to evenly project forwardly as shown. The respective edges of the side brackets 20 and 22 are formed with flanges 25 and 26 extending toward each other. Bridged between the side brackets 20 and 22, more particularly the flanges 24 and 26 are alternately curved spring wires 28 which are parallel with each other. These elements, such as the tubular frame 16 and side brackets 20 and 22, are wrapped by conventional padding means which is indicated by a phantom line 30. Denoted by numeral 31 (shown in FIG. 3) is a substantially rectangularly formed spring wire which is fixedly connected via welding to the tubular frame 16 and the tubular lower frame 19. Within the backrest 14, an adjustable lumbar supporter constituting an important part of the invention is disposed, which is generally designated by numeral 32. Description on the detailed construction of the adjustable lumbar supporter 32 will be made with the aid of FIGS. 2 to 4. In FIG. 4, an exploded view of the lumbar supporter 32 is illustrated with omission of several parts. As shown, the lumbar supporter 32 comprises an elongate rod 34 having ends rotatably disposed in holes 36 and 38 formed in lower portions of the respective side brackets 20 and 22. The elongate rod 34 shown includes an offset portion (no numeral). Helical springs 39 are arranged on end portions of the elongate rod 34 to bias the same to rotate in a direction as viewed by an arrow A. A pair of triangular arms 40 and 42 are firmly connected via welding at their apex sections to the elongate rod 34 being parallel with and spaced from each other. Each of the arms 40 and 42, or at least the arm 40 has a flange 44 (or 46) which extends toward the adjacent side bracket 20 (or 22). A pair of spring supporters 48 and 50 are pivotally connected to inboard surfaces of the triangular arms 40 and 42 via respective pins 52 and 54. Each of the spring supporters 48 and 50 is formed with two spaced hook portions 56a and 56b or 58a and 58b. These hook portions are used for arranging alternately curved two springs 60 and 62 between the spring supporters 48 and 50 in parallel relation, as well shown in FIG. 3. For the reason which will become clear hereinlater, the hook portions of the spring supporters 48 and 50 are such constructed as to permit the parallelly arranged springs 60 and 62 to face substantially forwardly. Each of the spring supporters 48 and 50 is further formed with a downwardly extending arm section 64 (or 66) in which a longitudinally extending elongate slot 68 (or 70) is provided. A control arm 72 having rectangularly bent ends 74 76 is arranged between the arm sections 64 and 66 in a manner that pins 78 and 80 which extend from the respctive bent ends 74 and 76 are slidably disposed in the elongate slots 68 and 70 of the arm sections 64 and 66 of the spring supporters 48 and 50. As is best seen from FIG. 3, a control shaft 82 passing through the triangular arm 40 via a bushing 83 is firmly connected at one end thereof to the outboard wall surface of the bent end 74 of the control arm 72. A pin 84 loosely passing through the bent end 76 is firmly fixed to the triangular arm 42. Thus, it will be appreciated that the rotation of the control shaft 82 about the axis thereof in clockwise direction in FIG. 4 induces the clockwise rotation of the control arm 72 about an imaginary axis passing through the axes of the control shaft 82 and the pin 84 thereby simultaneously permitting the spring supporters 48 and 50 to swing counterclockwise about an imaginary axis passing through the pins 52 and 54. The other end of the control shaft 82 is slidably disposed in an arcuate opening 89 formed in the side bracket 20. The opening 89 is arranged to form a part of an imaginary circle which has the center thereof at the center of the hole 36 for the elongate rod 34. The triangular arm 40 is formed with an arcuate opening 86 at its generally middle section, the opening being so constructed as to form a part of an imaginary circle which has the center thereof at the center of the opening of the arm 40 through which opening the elongate rod 34 is passed. Slidably disposed in the arcuate opening 86 is an end of a control shaft 88 on which a cam member 90 with first, second and third cam surfaces 90a, 90b and 90c is securely mounted through a collar 92. As will be seen from FIG. 5A, the first and second cam surfaces 90a and 90b intersect at 45-degree angles, and the second and third cam surfaces intersect at 45-degree angles, also. A snap ring 94 (shown in FIG. 3) is fixed to one end of the control shaft 88 for retaining the same to the triangular arm 40. The connection of the control shaft 88 with the triangular arm 40 is so made that the cam surfaces 90a, 90b and 90c of the cam member 90 are brought into contact with an inner surface portion 95 of the flange 44 of the triangular arm 40 upon rotation of the shaft 88 about the axis thereof. As is well shown in FIG. 5A, the distance from the axis of the control shaft 88 to the cam surface 90a is shorter than that to the cam surface 90b, while the distance to the latter is shorter than that to the cam surface 90c. The other end of the control shaft 88 is rotatably disposed in a bracket 96 which is tightly disposed in a hole 98 formed in the side bracket 20 at a position above the hole 36. Bolts 100, though only one is illustrated, are used for connecting the bracket 96 to the side bracket 20, as shown in FIG. 4. A height control lever 102 and a fore-and-aft control lever 104 are respectively fixed to the shaft 82 and the shaft 88 so as to rotate their corresponding shafts when handled. Preferably, these levers 102 and 104 are such arranged that the respective longitudinal axes thereof are perpendicular to the axes of the corresponding shafts 82 and 88. With the above-described construction, the operation of the adjustable lumbar supporter 32 is as follows Explanation on handling the height control lever 102 will be made with the aid of FIGS. 5A and 5B. When the height control lever 102 (not shown in these figures) is rotated about 180-degree angles rotating the control shaft 82 clockwise, that is in a direction as shown by arrow B, the control arm 72 is simultaneously rotated with its bent end 74 in the same direction while rotating, via the pin 78, the downwardly extending arm section 64 of the supporter 48 about the pin 52 in a counterclockwise direction and finally setting the supporter 48 in a position shown in FIG. 5B. With this, the parallelly arranged springs 60 and 62 on the spring supporters 48 and 50 move from a position denoted by "C" to another position denoted by "D", as viewed in FIG. 5A. It should be now noted that in the position of "C", the lower end of the spring 62 is most projected forwardly thus strongly pressing a predetermined lower portion of the padding means 30 forwardly as viewed in FIG. 2, while in the position of "D", the upper end of the spring 60 is most projected forwardly thus strongly pressing a predetermined upper portion of the same forwardly. In other words, a forwardly projected part of the padding means 30 which contributes substantially to lumbar supporting moves upwardly or downwardly by a distance of "Y" upon handling of the height control lever 102. It should be noted that under the handling of the height control lever 102, the triangular arms 40 and 42 and the elongate rod 34 remain stationary. Explanation on handling of the fore-and-aft control lever 104 will be made by the aid of FIGS. 6A and 6B. FIG. 6A shows the fore-and-aft movements of the lumbar supporter under a condition in which the lower end of the spring 62 is most projected forwardly, and FIG. 6B shows the fore-and-aft movements of the lumbar supporter under a condition in which the upper end of the spring 60 is most projected forwardly. When, in either cases of FIGS. 6A and 6B, the fore-and-aft control lever 104 (not shown in these drawings) is rotated about 45-degree angles rotating the control shaft 88 in a direction as indicated by an arrow "E", the cam member 90 securedly mounted on the shaft 88 is simultaneously rotated in the same direction from a position as indicated by "C" or "D", where, as shown by a solid line, the cam surface 90a engages the inner surface portion 95 of the flange 44 of the triangular arm 40 to a position where the cam surface 90b engages the inner surface 44. With this, the triangular arm 40 and thus the arm 42 are rotated forwardly with the elongate rod 34 allowing the parallely arranged springs 60 and 62 on the spring supporters 48 and 50 to take a position indicated by "C'" or "D'". When the fore-and-aft control lever 104 is rotated further about 45-degree angles, the cam surface 90c is brought into contact which the inner surface section 94 thus setting the springs 60 and 62 in a position indicated by "C"" or "D"". Now, it should be noted that in the case of FIG. 6A, the most forwardly projected portion of the springs 60 and 62, that is the lower end of the spring 62, is moved forwardly by a distance of "X 1 " by the first 45-degree angle rotation of the lever 104 and moved further forwardly by a distance of "X 2 " by the further 45-degree angle rotation of the same, and in the case of FIG. 6B, the most forwardly projected portion of the springs 60 and 62 is moved forwardly by a distance of "X 3 " by the first 45-degree angle rotation of the lever 104 and moved further forwardly by a distance of "X 4 " by the further 45-degree angle rotation of the same. In either cases of FIGS. 6A and 6B, a forwardly projected portion of the padding means 30 moves forwardly or rearwardly upon handling of the fore-and-aft control lever 104. Although not shown in the drawings, the hook portions 56a and 58a (see FIG. 4) may be constructed separated from their corresponding spring supporters 40 and 42 and pivotally connected to the same respectively. In this case, the spring 60 can normally face forwardly irrespective of the angular position of the spring supporters 48 and 50. It should be noted that the foregoing description shows only one exemplary embodiment. Various modifications are apparent to those skilled in the art without departing from the scope of the present invention which is only limited by the appended claims.

Herein disclosed is a seat backrest with an adjustable lumbar supporter which comprises a rod transversely crossing frame members of the seatback to be rotatable about the axis thereof relative to the frame members, an arm member secured to the rod, a support member pivotally connected to the arm member, lumbar pressing means such as spring connected to the support member, first control means for permitting the support member to rotate about its pivoted portion relative to the arm member when operated, and second control means for permitting the arm member and thus the rod to rotate about the axis of the rod relative to the frame members when operated.

CROSS-REFERENCE TO RELATED APPLICATIONS This is a division of Application Ser. No. 09/504,830, filed Feb. 16, 2000, now U.S. Pat. No. 6,340,672. BACKGROUND OF THE INVENTION The present invention relates to a parasiticidal formulation and a method for making the formulation. More specifically, the present invention relates to a parasiticidal formulation for use in veterinary applications. Currently, closantel, a parasiticidal agent, is available in an injectable form or as an oral drench. One disadvantage with these closantel parasiticidal formulations is that they are not available in a pour-on form. Ivermectin, another parasiticidal agent which kills different parasites from closantel, may be purchased in an injectable form, as a pour-on formulation, in a paste form, as an oral drench, or in a chewable form. The ivermectin injectable formulations currently available contain glycerol formal or propylene glycol to dissolve the ivermectin. The ivermectin pour-on formulations currently available contain isopropyl alcohol or a mixture of caprylic acids and caprylic esters to dissolve the ivermectin. One disadvantage with both injectable and pour-on ivermectin formulations currently available is that none of these formulations will dissolve closantel and like parasiticidal formulations in concentrations sufficient to be useful. Another disadvantage with the ivermectin pour-on formulations available is that they only have up to a 0.5% weight per volume (w/v) concentration of ivermectin. Additionally, a disadvantage with parasiticidal formulations currently available is that closantel and ivermectin are not available in a single formulation, and therefore a broadened spectrum of parasite protection is not available in a single formulation. Still further, parasiticidal agents, including, but not limited to closantel and ivermectin, cannot be combined in pour-on formulations currently available in a manner that keeps both parasiticidal agents in solution. In order to overcome these disadvantages, a parasiticidal formulation containing an effective solvent delivery system that allows one or more parasiticidal agents to dissolve, especially closantel and ivermectin in combination, is needed. In addition, the resulting parasiticidal formulation should be usable in a pour-on or an injectable form. Still further, the solvent delivery system should be able to hold larger amounts of parasiticidal agents than prior formulations. SUMMARY OF THE INVENTION It is an object of the present invention to provide a parasiticidal formulation containing more than one parasiticidal agent or a larger amount of a single parasiticidal agent than conventional formulations that may be a administered as a pour-on product in order to facilitate easier administration of the parasiticidal formulation. It is another object of the present invention to provide a parasiticidal formulation that contains at least two different parasiticidal agents so as to obtain a broadened spectrum of parasite protection. It is a further object of the present invention to provide a method of making a parasiticidal formulation that achieves the foregoing objects. Still another object of the present invention is to provide a method for administering a parasiticidal formulation that achieves the foregoing objects. According to the present invention, the foregoing and other objects are achieved by a pour-on or an injectable parasiticidal formulation that includes a mixture of a pyrrolidone solvent, a bridging solvent and at least one parasiticidal agent. One or more parasiticidal agents may be included in the formulation. Preferably, the formulation contains both closantel and ivermectin. Another aspect of the present invention is a method of making this parasiticidal formulation. This method includes mixing a pyrrolidone solvent and a bridging solvent to form a solvent solution and adding one or more parasiticidal agents to the solvent solution. A further aspect of the present invention is a method for administering the parasiticidal formulation of the present invention to an animal. This method of administration includes providing the parasiticidal formulation described above and applying this formulation to the skin of an animal, wherein the formulation may be absorbed through the animal's skin. Additional objects, advantages and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned from the 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. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The parasiticidal formulation of the present invention is an effective pour-on or injectable formulation for protection against parasites. The formulation includes a solvent delivery system and one or more parasiticidal agents. The solvent delivery system includes a mixture of a pyrrolidone solvent and a bridging solvent. This mixture provides a unique solvent system which allows one or more parasiticidal agents to dissolve effectively when added to the solvents. The pyrrolidone solvent that may be used in the formulation of the present invention includes, but is not limited to, N-methyl-2-pyrrolidone, 2-pyrrolidone, N,5-dimethyl-2-pyrrolidone, 3,3-dimethyl-2-pyrrolidone, N-ethyl-2-pyrrolidone, N-ethoxy-2-pyrrolidone, N-ethylene-2-pyrrolidone, 1-pyrrolidone, or any combinations thereof. Preferably, the pyrrolidone solvent is N-methyl-2-pyrrolidone or 2-pyrrolidone. The pyrrolidone solvent desirably is present in the solvent delivery system in an amount effective, in combination with a bridging solvent, for dissolving a therapeutic amount of one or more parasiticidal agents. The bridging solvent that may be used in the formulation of the present invention includes, but is not limited to, diethylene glycol monobutyl ether (DGME), benzyl benzoate, isopropyl alcohol, xylenes, or any combinations thereof. If xylenes are used, usually a combination of ortho-xylene, meta-xylene and para-xylene is used. The bridging solvent aids in dissolving the parasiticidal agents and acts to carry the formulation through an animal's skin once it is applied to the skin. If 2-pyrrolidone is used as the pyrrolidone solvent, then preferably xylenes are used as the bridging solvent. If a pyrrolidone solvent other than 2-pyrrolidone is used, then the preferred bridging solvent is DGME. In any event, the solvent delivery system must include an amount of the bridging solvent that is effective, in combination with the pyrrolidone solvent, to dissolve a therapeutic amount of the active parasiticidal agent or agents. The combination of a pyrrolidone solvent and a bridging solvent to form the unique solvent delivery system of the present invention allows one or more parasiticidal agents to dissolve. The solvent system dissolves the parasiticidal agents and keeps them in solution. The solvent delivery system also functions to transport one or more parasiticidal agents into an animal so that the agent or agents may interact therapeutically with parasites in the animal. The parasiticidal agents that may be used in the formulation of the present invention include, but are not limited to, closantel, oxyclozanide, praziquantel, pyrantels, tetrahydropyrimidines, probenzimidazoles, imidazothiazoles, macrocyclic lactones, benzimadizoles, tetramisoles, avermectins, epsiprantel, morantel, febantel, netobimin, clorsulon, bunamidine, nitroscanate, melarsomine, amidines, benzoyl urea derivatives, carbamates, nitroquanidines, pyrazoles, pyrethrins, pyrethroids, pyriproxyfen, acylhydrazones and any combinations thereof. An example of a pyrantel that may be used is pyrantel pamoate. Examples of benzimadizoles that may be used include, but are not limited to, mebendazole, oxibendazole, fenbendazole, oxfendazole, triclabendazole, flubendazole, ricobendazole, thiabendazole, and albendazole. Preferably, if a tetramisole is used, it is levamisole. Examples of avermectins that may be used include, but are not limited to, ivermectin, moxidectin, doramectin, eprinomectin, and milbemycin. Preferably, a combination of ivermectin and closantel is used as the parasiticidal agent in the formulation. Ivermectin kills a variety of internal and external parasites; a number of worms including stomach worms, intestinal worms, lungworms, barber's pole worms, lice, and mites. Closantel kills adult and immature barber's pole worms, liver flukes, and all stages of nasal bot in sheep. Most preferably, the formulation contains ivermectin and closantel in about a 1:10 ratio. As discussed above, closantel and ivermectin each provide protection against different species of parasites. Thus, when closantel and ivermectin are combined in a single parasiticidal formulation, the formulation provides protection against a broader spectrum of parasites than a formulation containing either parasiticidal agent alone. Additionally, because the solvent delivery system of the present invention effectively dissolves both closantel and ivermectin, if either active ingredient is used in the absence of the other, the solvent delivery system of the present invention may still be used. When used with a single parasiticidal agent, including, but not limited to ivermectin or closantel, the solvent delivery system of the present invention may allow the parasiticidal agent to dissolve at a higher concentration than formulations currently available. For example, an ivermectin formulation with a concentration of ivermectin from about 1-5% w/v or higher may be made. Thus, the solvent delivery system of the present invention allows for several formulations, each manufactured to provide protection against a targeted parasite population. The preferred total amount of parasiticidal agent in the formulation of the present invention may be about 0.1-15% w/v, whether used singularly or in combination. Preferably, the formulation of the present invention includes about 1-8% w/v parasiticidal agent. When using closantel and ivermectin in combination, the parasiticidal formulation of the present invention preferably may include about 1-10% w/v closantel and about 0.1-5% w/v ivermectin. More preferably, the formulation of the present invention may include about 3-7% w/v closantel and about 0.3-0.7% w/v ivermectin. Most preferably, the formulation of the present invention may include about 5% w/v closantel and about 0.5% w/v ivermectin. If the chosen pyrrolidone solvent is N-methyl-2-pyrrolidone, the parasiticidal formulation of the present invention preferably may include about 5-90% w/v N-methyl-2-pyrrolidone. More preferably, it includes about 30-50% w/v N-methyl-2-pyrrolidone. Most preferably, it may include about 40-45% w/v N-methyl-2-pyrrolidone. However, when increased amounts of closantel are used in the formulation, the amount of N-methyl-2-pyrrolidone may also be increased to ensure that the closantel dissolves. Thus, amounts at the higher ends of the ranges given are used. If the chosen pyrrolidone solvent is 2-pyrrolidone, the parasiticidal formulation of the present invention preferably may include about 15-90% w/v 2-pyrrolidone. More preferably, it may include about 50-80% w/v 2-pyrrolidone. Most preferably, it may include about 70% w/v 2-pyrrolidone. If any pyrrolidone solvent other than N-methyl-2-pyrrolidone or 2-pyrrolidone is chosen, the parasiticidal formulation of the present invention preferably may include about 10-90% w/v pyrrolidone solvent. More preferably, it may include about 30-70% w/v pyrrolidone solvent. If the chosen bridging solvent is DGME, the parasiticidal formulation of the present invention may preferably include about 10-90% w/v DGME. More preferably, it may include about 25-75% w/v DGME. Most preferably, it may include about 50% w/v DGME. If any bridging solvent other than DGME is chosen, either singularly or in combination, the parasiticidal formulation of the present invention preferably may include about 10-90% w/v bridging solvent. More preferably, it may include about 30-70% w/v bridging solvent. Most preferably, it may include about 50% w/v bridging solvent. While the solvent delivery system and a parasiticidal agent are the only components necessary in the formulation of the present invention, a number of optional ingredients may be added to enhance certain properties of the formulation. One such optional ingredient is a stabilizer which acts to enhance the stability of the parasiticidal formulation. Stabilizers that may be used in the formulation of the present invention include, but are not limited to, vitamin B 12 , vitamin E acetate, niacinamide, ascorbic acid, butylated hydroxyaniline, thioctic acid, sorbic acid, sodium formaldehyde sulfoxylate, butylated hydroxytoluene, or any combinations thereof. Preferably, vitamin B 12 and vitamin E acetate, either singularly or in combination, are used as stabilizers in the formulation of the present invention because they are the most effective in preserving the active ingredients. If vitamin B 12 is chosen as a stabilizer for the formulation, the parasiticidal formulation of the present invention preferably may include about 0.005-1% w/v vitamin B 2 . More preferably, it may include about 0.01-0.5% w/v vitamin B 12 . Most preferably, it may include about 0.1% w/v vitamin B 12 . If vitamin E acetate is chosen as a stabilizer for the formulation, the parasiticidal formulation of the present invention preferably may include about 0.05-5% w/v vitamin E acetate. 16-4 More preferably, it may include about 0.5-1.5% w/v vitamin E acetate. Most preferably, it may include about 1% w/v vitamin E acetate. If any stabilizer other than vitamin B 12 or vitamin E acetate is used in the formulation, the formulation of the present invention preferably may include about 0.005%-15% w/v stabilizer. More preferably, it may include about 0.05-3% w/v stabilizer. These ranges of stabilizers also may apply if two or more of the stabilizers are used in combination, such as when vitamin B 12 and vitamin E acetate are used in combination. Another optional ingredient that may be included in the formulation of the present invention is a solubility agent. Solubility agents of the present invention may include, but are not limited to, mixtures of caprylic acids and esters, ethyl oleate, propylene glycol, Arachis oil (peanut oil), or any combinations thereof. The mixtures of caprylic acids and esters may contain from about 99% acids to about 99% esters. Solubility agents aid in dissolving the active ingredients of the formulation, but also aid in spreading the formulation across an animal's skin once it has been poured over the skin, making the formulation less aggressive to the skin. Still further, because each of these solubility agents are oily substances used in the formulation, they help the skin retain moisture. The parasiticidal formulation of the present invention preferably may include about 5-50% w/v solubility agent. More preferably, the formulation of the present invention may include about 10-35% w/v solubility agent. Most preferably, the formulation of the present invention may include about 20% w/v solubility agent. Another ingredient that optionally may be added to the formulation of the present invention is a colorant. Colorants give the formulation a more consistent color and aid an observer in determining what areas of an animal's skin have been treated. A colorant may be added to the parasiticidal formulation of the present invention in an amount sufficient that the formulation poured onto the animal's skin can be seen. In addition, water may be added to the formulation of the present invention. In fact, it may be necessary to add water to the formulation if a colorant is added so that the colorant is adequately dispersed. Further, a pH stabilizer may be added to the parasiticidal formulation of the present invention to prevent hydrolysis. Examples of pH stabilizers that may be used in conjunction with the present invention include, but are not limited to, triethanolamine and diethanolamine. One preferred formulation of the present invention includes N-methyl-2-pyrrolidone, DGME, closantel, and ivermectin. Another preferred formulation of the present invention includes 2-pyrrolidone, xylenes, closantel, and ivermectin. A highly preferred formulation of the present invention is described in Example 1. The parasiticidal formulation of the present invention is made by combining a pyrrolidone solvent, a bridging solvent, and one or more parasiticidal agents to form a mixture. Preferably, closantel and ivermectin may be used in combination as the parasiticidal agents. The order in which components are added in making the formulation is not critical. The formulation may optionally be heated to between about 40° and 80° C. continuously or intermittently during its preparation in order to dissolve the components more quickly. If vitamin B 12 is used as a stabilizer, it is recommended that the formulation may be heated to about 500° C. prior to adding the vitamin B 12 . Preferably, a portion of the pyrrolidone solvent, the bridging solvent, or the solubility agent may be added last so that a specific quantity of parasiticidal formulation may be obtained and to ensure that all ingredients dissolve. This process can be scaled to make any desired quantity of the formulation. One preferred method of making the parasiticidal formulation of the present invention includes placing a quantity of pyrrolidone solvent in a vessel and warming it to about 50° C. Next, a stabilizer is added, and the resulting solution is cooled to room temperature. The bridging solvent is then added and mixed into the solution for an effective period of time. Optionally, a second stabilizer may then be added and mixed until all ingredients are adequately dissolved. Following this, ivermectin is added and mixed into the solution until it is dissolved. Closantel is then added, and the mixture is agitated until a portion of the closantel is dissolved. The closantel likely will not completely dissolve. Thus, it will be necessary to add an additional portion of pyrrolidone solvent to ensure that all components adequately dissolve. The parasiticidal formulation of the present invention may be administered as a pour-on product or as an injectable formulation to any animal. Preferably, it is administered as a pour-on product. It is especially useful for cattle, horses, sheep, goats, and pigs. Most preferably, it is administered to cattle. It may be poured over an animal's back or may be poured on any other body part of an animal that needs treatment. Preferably, it may be administered in a dosage of about 0.020.4 milliliters of formulation per kilogram of animal. More preferably, it may be administered in a dosage of about 0.02-0.3 milliliters of formulation per kilogram of animal. Most preferably, it may be administered in a dosage of about 0.02-0.25 milliliters of formulation per kilogram of animal. The following are examples of various parasiticidal formulations and methods of making these formulations that are within the scope of this invention. These examples are not meant in any way to limit the scope of this invention. EXAMPLE 1 N-methyl-2-pyrrolidone was added to a vessel and warmed to 500° C. Agitation began. With continued agitation, a quantity of vitamin B 12 amounting to 0.1% w/v of the final formulation was added to the solvent and mixed with it until the vitamin B 12 dissolved. The resulting solution was then cooled to room temperature. A quantity of DGME amounting to 50% w/v of the final formulation was then added and mixed into the solution. Next, vitamin E acetate was added in a quantity amounting to 1% w/v of the final formulation, and the resulting solution was mixed until all ingredients were adequately dissolved. With continued agitation, a quantity of ivermectin amounting to 0.5% w/v of the final formulation was added and mixed into the solution until dissolved. Closantel was then added in a quantity amounting to 5% w/v of the final formulation, and the mixture was agitated to dissolve a portion of the closantel. With continued agitation, a supplemental amount of N-methyl-2-pyrrolidone was added in an amount sufficient to completely dissolve the closantel. The total amount of N-methyl-2-pyrrolidone used made up the balance of the formulation. EXAMPLE 2 A quantity of xylenes was added to a vessel. To the xylenes, a quantity of 2-pyrrolidone amounting to 70% w/v of the final formulation was added and agitation began. With continued agitation, a quantity of ivermectin amounting to 0.5% w/v of the final formulation was added and mixed into the solution until dissolved. Next, closantel was added in a quantity amounting to 5% w/v of the final formulation, and the mixture was agitated to dissolve a portion of the closantel. With continued agitation, a supplemental amount of xylenes was added in an amount sufficient to completely dissolve the closantel. The total amount of xylenes used made up the balance of the formulation. EXAMPLE 3 A quantity of xylenes was added to a vessel. Agitation began. With continued agitation, a quantity of N-methyl-2-pyrrolidone amounting to 18.2% w/v of the final formulation was added. Next, a quantity of a mixture of caprylic acids and esters (obtained from Croda, Inc. of Parsippany, New Jersey under the tradename Crodamol Cap™) amounting to 18.2% w/v of the final formulation was added and mixed with the solution until the Crodamol Cap™ dissolved. Subsequently, a quantity of vitamin E acetate amounting to 0.93% w/v of the final formulation was added. With continued agitation, diethanolamine was added in a quantity amounting to 0.16% w/v to the solution and mixed until dissolved. Next, a quantity of Arachis oil amounting to 16% w/v of the final formulation was added and mixed until dissolved. Following this, a quantity of ivermectin amounting to 0.45% w/v of the final formulation was added and mixed into the solution until dissolved. Closantel was then added in a quantity amounting to 4.5% w/v, and the mixture was agitated for a time sufficient to dissolve a portion of the closantel. With continued agitation, a supplemental amount of xylenes was added in an amount sufficient to completely dissolve the closantel. The total amount of xylenes used made up the balance of the formulation. EXAMPLE 4 A quantity of N-methyl-2-pyrrolidone was added to a vessel. Agitation began. With continued agitation, a quantity of isopropyl alcohol amounting to 20% w/v of the final formulation was added, and the two solvents were mixed into solution. Next, a quantity of ethyl oleate amounting to 20% w/v of the final formulation was added, and the mixture was agitated until all ingredients were adequately dissolved. Subsequently, a quantity of DGME amounting to 20% w/v of the final formulation was added. Next, a quantity of benzyl benzoate amounting to 20% w/v of the final formulation was added. Following this, a quantity of vitamin E acetate amounting to 1% Age w/v of the final formulation was added, and the solution mixed until all components adequately dissolved. With continued agitation, a quantity of ivermectin amounting to 0.5% w/v of the final A formulation was added. Subsequently, a quantity of closantel amounting to 5% w/v of the final formulation was added, and the mixture was agitated to dissolve a portion of the closantel. With continued agitation, a supplemental amount of N-methyl-2-pyrrolidone was added in an amount sufficient to completely dissolve all of the closantel. The total amount of N-methyl-2-pyrrolidone used made up the balance of the formulation. EXAMPLE 5 A quantity of N-methyl-2-pyrrolidone was added to a vessel. Agitation began. To the N-methyl-2-pyrrolidone, a quantity of benzyl benzoate amounting to 44.3% w/v of the final formulation was added, and the mixture was agitated to ensure all ingredients dissolved. With continued agitation, a quantity of ethyl oleate amounting to 30% w/v of the final formulation was added. Next, a quantity of ivermectin amounting to 0.5% w/v of the final formulation was added, and the mixture was agitated until all of the ivermectin had dissolved. Next, a quantity of closantel amounting to 5% w/v of the final formulation was added, and the mixture was agitated to dissolve a portion of the closantel. With continued agitation, a supplemental amount of N-methyl-2-pyrrolidone was added in a quantity sufficient to dissolve all of the closantel. The total amount of N-methyl-2-pyrrolidone made up the balance of the formulation. EXAMPLE 6 A quantity of N-methyl-2-pyrrolidone was added to a vessel. Agitation began. With continued agitation, a quantity of a mixture of caprylic acids and esters (obtained from Croda, Inc. of Parsippany, New Jersey under the tradename Crodamol Cap™) amounting to 18% w/v of the final formulation was added, and the mixture was agitated to ensure that all ingredient dissolved. Next, a quantity of isopropyl alcohol amounting to 30% w/v of the final formulation was added and the mixture was agitated until all ingredients were adequately dissolved. Following this, a quantity of diethanolamine amounting to 0.05% w/v of the final formulation was added. Next, a quantity of ivermectin amounting to 0.5% w/v of the final formulation was added and the mixture was agitated until all components were adequately dissolved into solution. With continued agitation, a quantity of closantel amounting to 5% w/v of the final formulation was added, and the mixture was agitated to dissolve a portion of the closantel. With continued agitation, a supplemental amount of N-methyl -2 -pyrrolidone was added in an amount sufficient to completely dissolve all of the closantel. The total amount of N-methyl-2-pyrrolidone made up the balance of the formulation. EXAMPLE 7 A quantity of propylene glycol was added to a vessel. Agitation began. With continued agitation, a quantity of N-methyl-2-pyrrolidone amounting to 20% w/v of the final formulation was added. Next, a quantity of ethyl oleate amounting to 20% w/v of the final formulation was added, and the mixture was agitated until all ingredients were adequately dissolved. Following this, a quantity of vitamin E acetate amounting to 1% w/v of the final formulation was added. With continued agitation, a quantity of diethanolamine amounting to 0.17% w/v of the final formulation was added. Next, a quantity of xylenes amounting to 40% w/v of the final formulation was added. Next, a quantity of ivermectin amounting to 0.5% w/v of the final formulation was added. Next, a quantity of closantel amounting to 5% w/v of the final formulation was added, and the mixture was agitated to dissolve a portion of the closantel. With continued agitation, a supplemental amount of propylene glycol was then added in an amount sufficient to completely dissolve all of the closantel. The total amount of propylene glycol made up the balance of the formulation. EXAMPLE 8 A quantity of N-methyl-2-pyrrolidone was added to a vessel. Agitation began. With continued agitation, a quantity of DGME amounting to 40% w/v of the final formulation was added. Next, a quantity of propylene glycol amounting to 10% w/v of the final formulation was added, and the mixture was agitated until all components were adequately dissolved. Subsequently, a quantity of vitamin E acetate amounting to 1% w/v of the final formulation was added. With continued agitation, a quantity of a mixture of caprylic acids and esters (obtained from Croda, Inc. of Parsippany, N.J. under the tradename Crodamol Cap™) amounting to 20% w/v of the final formulation was added. Next, a quantity of diethanolamine amounting to 0.05% w/v of the final formulation was added. Following this, a quantity of FD&C Blue #1 amounting to 0.02% w/v of the final formulation was added. A quantity of sterile water amounting to 0.2% w/v of the final formulation was then added. With continued agitation, a quantity of ivermectin amounting to 0.5% w/v of the final formulation was added. Next, a quantity of closantel amounting to 5% w/v of the final formulation was added, and the mixture was agitated to dissolve a portion of the closantel. With continued agitation, a supplemental amount of N-methyl-2-pyrrolidone was then added in an amount sufficient to completely dissolve all of the closantel. The total amount of N-methyl-2-pyrrolidone made up the balance of the formulation. From the foregoing, it will be seen that this invention is one that is well adapted to attain all the ends and objects herein above set forth together with other advantages which are obvious and inherent to the formulation. 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 claims. 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 is to be interpreted as illustrative and not in a limiting sense.

A parasiticidal formulation is provided. This formulation includes a pyrrolidone solvent, a bridging solvent, and an parasiticidal agent. One or more parasiticidal agents may be included in the formulation. Preferably, the formulation contains both closantel and ivermectin. Another aspect of the present invention is a method of making this parasiticidal formulation. This method includes mixing a pyrrolidone solvent and a bridging solvent to form a solvent solution and adding one or more parasiticidal agents to the solvent solution. A further aspect of the present invention is a method for administering the parasiticidal formulation of the present invention to an animal. This method of administration includes providing the parasiticidal formulation described above and applying this formulation to the skin of an animal, wherein the formulation is absorbed through the animal's skin.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an antler composition and, more particularly, to an antler composition comprising a special matrix. The present invention further relates to a special antler extract mixture, and to a process to produce the antler extract mixture. 2. Description of Related Art There are extensive amount of polymeric materials such as proteins and peptides in velvet antler extract. These polymers are said to play important roles in various function in human body, including anti-aging, boosting immune system, and anti-disease etc. Oral administration is the most popular and convenient way for taking such products, however, the nutriment may be degrade by the strong acid in our stomach, and some polymer molecules will lose their activities to lower the efficiency of velvet antler. Therefore, the non-oral administration, which delivers the active molecules into blood directly, becomes more important. The non-oral administrations are usually nasal or sublingual administration. The most effective non-oral administration method for nutriment is the mucosa spray method, which perform good bioavailability and pharmadynamics. Because the large surface area under the tongue and intranasal areas, where has less enzymatic activity, so the degradation of polymeric material such as velvet antler is less. In addition, the spray form is very convenient and popular to consumers. However, there are also many disadvantages for mucosa spray. For example, plenty of fluid flows through the mucus surface, therefore the time period available for the therapeutic absorption is relatively short. Another question is that the peptides or proteins with higher molecule weight are not easily adsorbed through the tongue or nasal membrane due to poor permeability. Furthermore, most medicine without coating matrix loses their activity rapidly. In order to prolong the release of therapeutic agent to 24–48 hours, the development of a suitable polymeric matrix is necessary. Many patents in polymer matrix advocate the use of various biopolymers for the releasing control, but most of these polymers are not suitable to be used in velvet antler extract. The reasons are: (1) There are many polymeric materials in velvet antler extract which needs a special elastic polymer with strong adsorption property to form an encapsulated complex in order to prolong the residence time of them, so as to enhance the absorption of antler extract and other gradients in the composition. (2) The polymer complex used in an antler extract should be insoluble in water and with right size to accommodate the antler extract and other ingredients in the composition. (3) The polymer must be pharmaceutically acceptable and free of toxicity. In addition, the final product is sterilized under high temperature and high pressure, so these ingredients must be chemically stable. In order to enhance the permeability of the polymeric matrix and the active polymer complex in antler extract, it needs a special solvent with dual hydrophilic and hydrophobic function. Furthermore, for avoiding the degradation of the active factor in antler extract, the proteinase activity should be inhibited. Therefore, an enzymatic inhibitor should be added to the composition. U.S. Pat. No. 4,702,923 discloses a yogurt composition with 7–15% velvet antler powder enriched. The yogurt composition is considered inferior in medicinal value because the low content of antler powder. Because there are many polymers in velvet antler extract, the antler extract becomes water-insoluble when the amount of antler extract is high. So the antler composition comprising high amount of antler extract is usually hard to be packed as solution or spray, and it confines the application of aqueous antler composition. Therefore, products comprising high amount of velvet antler has not been developed in the market. In traditional method, the active compound of velvet antler was obtained by extracting with alcohol or water, and then lyophilizing the active compound and grounding into powder. But this method cannot afford high quality and quantity active compound and costs a lot. U.S. Pat. No. 6,099,867 teaches a new processing method to heat the velvet antler at 100 to 120° C. for 2 hour, then go through several steps of separation, homogenization, filtering, mixing, and lyophilization. This method includes severe heating for extended time, and it ineluctably triggers chemical reactions which could significantly reduce the medicinal value of velvet antlers. Therefore, it is desirable to provide a novel antler composition and producing method to mitigate and/or obviate the aforementioned problems. SUMMARY OF THE INVENTION The object of the present invention is to provide an antler composition which is parenteral and released steadily. Another subject of the present invention is to provide a novel process for producing the antler composition which comprising active compounds encapsulated in a matrix. Another subject of the present invention is to provide a novel antler composition comprising high quality and quantity antler extract, which is obtained by addition of special additives and special process. The composition keeps water-soluble for a long period to maintain stability of the active compound therein. To achieve the object, the antler extract mixture of the present invention comprises 70 to 90 wt % of velvet antler powder, 2 to 10 wt % of amino acid, 1 to 5 wt % of carbohydrate, 0.1 to 2 wt % of vitamin, 0.1 to 3 wt % of minerals. Said antler extract mixture can optionally comprises 0.1 to 1.5 wt % of emulsifier, 0.1 to 1.0 wt % of stabilizer, and 0.005 to 0.2 wt % additive. To achieve another object, the antler composition of the present invention comprises an antler extract mixture and a matrix which comprises β-cyclodextrin, a higher ester compound, a proteinase inhibitor, and an organic solvent; wherein the weight ratio of said matrix to said antler extract mixture is between 1:1.5 and 1:2.7. Said weight ratio of β-cyclodextrin to said higher ester compound to said proteinase inhibitor to said organic solvent is between 1:0.01:0.02:0.45 and 1:0.20:0.18:0.55. Said antler mixture has been described above. Other objects, advantages, and novel features of the invention will become more apparent from the following detailed description. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The main purpose of the present invention is to provide a novel antler composition and the method for producing it. The antler composition comprises an antler extract mixture and a matrix which comprises β-cyclodextrin, a higher ester compound, a proteinase inhibitor, and an organic solvent. Preferably, the weight ratio of β-cyclodextrin to said higher ester compound to said proteinase inhibitor to said organic solvent is between 1:0.01:0.02:0.45 and 1:0.20:0.18:0.55, and the weight ratio of said matrix to said antler extract mixture is between 1:1.5 and 1:2.7. All materials used in the present invention are all pharmaceutically acceptable. Preferably, the higher ester compound mentioned above is obtained by reacting alcohol with 12 to 18 carbon atoms and carboxylic acid with 8 to 18 carbon atoms while said proteinase inhibitor is mucus proteinase inhibitor, and said organic solvent is propylene glycol. The antler composition is produced by the following steps: (a) mixing said β-cyclodextrin, said higher ester compound, said proteinase inhibitor, and said organic solvent with a specific ratio mentioned above, (b) then adding the mixture into pure water wherein the preferable weight ratio of the mixture to the water is 1:3, and blending the mixture at room temperature for 18 to 36 h to form a suspension comprising the matrix; (c) adding the antler extract mixture aforementioned to the suspension and keep agitating the suspension with low speed at room temperature for about 18 to 24 hour until microcapsules performs, (d) subsequently incubating the mixture at 4° C. for 24 to 48 hour until the precipitate forms, and finally (e) filtering obtained mixture to get the precipitate. The step (d) can be repeated three or four times and the precipitate can be washed by cold water. The final precipitate can be optionally added into three fold of pure water, and the mixture is mixed in a homomixer for about 15 to 20 minutes until it is homogenized. The homogenized mixture is then disinfected and packed with a spray aerosol or pulverized into powder for longtime storage. The whole packing process is sterile and the package is suitable for nasal or sublingual delivery. As mentioned above, velvet antlers contain many water-insoluble polymers so that conventional antler composition comprises only low amount of antler extract. Therefore, the present invention offers an emulsification method to dissolve this problem. Accordingly, the antler extract mixture comprises two parts: one is antler mixture and the other part is emulsifying part. The antler mixture contains 70 to 90 wt % of velvet antler powder, 2 to 10 wt % of amino acid, 1 to 5 wt % of carbohydrate, 0.1 to 2 wt % of vitamin, and 0.1 to 3 wt % of minerals. All contents are provided as powder and mixed well. The emulsifying part comprises 0.1 to 1.5 wt % of emulsifier, 0.1 to 1.0 wt % of stabilizer, and 0.005 to 0.2 wt % additive. Preferably, the antler powder is lyophilized antler powder; and one or more amino acids are selected from alanine, arginine, asparigine, aspartic acid, cystine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, or valine. In addition, one or more fatty acids preferably select from the group consisted of stearic acid, oleic acid, linoleic acid, lauric acid, caprylic acid, capric acid, myristic acid, or palmitic acid; and one or more carbohydrates preferably select from the group consisted of starch, maltose, fructose, sucrose, glucose, sorbitol, arabinose, xylose, lactose, corn syrup solid, maltodextrins, dextrine, and dextrose. One or more vitamins preferably select from vitamin A, vitamin B 1 , vitamin B 2 , vitamin B 6 , vitamin B 12 , vitamin C, vitamin D, vitamin E, vitamin K, folic acid, biotin, or pantothenic acid; and one or more minerals preferably select from zinc, calcium, phosphorus, potassium, cobalt, manganese, iron, copper, sodium, magnesium, iodine, chlorine, or fluorine. Preferably, one or more emulsifiers select from Mono and Diglycerides, Sorbitan, Monostearate, Polysorbate 60, Polysorbate 80, Lecithin, Emplex, Caprol, or Myyerol; and one or more stablizers select from Xanthan gum, CMC gum, Carageenan, Methocol, Klucel, Guar gum, Locus bean gum, and Alginates. One or more additives select from the buffering agent, sequestraut, preservative, or food pigment; wherein said buffering agent is potassium phosphate and/or sodium phosphate; said sequestraut is EDTA, citric acid, and/or polyphosphate; said preservative is potassium propionate and/or potassium sorbate; and said food pigment selects is yellow No. 5, yellow No. 6, red No. 2, red No. 40, or β-carotene. The antler extract mixture of the present invention is prepared as the following steps: (a) adding 70 to 80° C. hot water to said antler extract mixture in a mixer speed and agitating with high at 60° C. for 10 minutes; (b) subsequently adding said emulsifying agents to the mixture, heating at 50 to 70° C. for 10 to 20 minutes, and mixing well; (c) subjecting the mixture obtained from step (b) in another mixture, mixing well with low speed and heating at 60 to 65° C. for 30 minutes; (d) degassing the mixture with a vacuum pump and repeating for one to four times until the foams are disappeared; (e) homogenizing said mixture under the pressure between 1,000 and 1,500 psi followed by under the pressure between 1,500 and 3,000 psi to form an emulsified mixture; (f) chilling the emulsified mixture to 3 to 6° C. rapidly wherein the chilling process is preferably a HTST chilling process; and finally (g) transferring the cool emulsified mixture to an maturing vat and agitating the mixture with low speed at 4° C. for 24 hour to complete the degassing and maturing process. The obtained products are homogenized and degassing thoroughly, and stored in a cold plastic bottle. Said “mature” step indicates that the mixture is mixed well and incubated until the all reactions occurring in the mixture reach equilibrium. The velvet antler powder contained in the antler extract mixture is prepared by soaking the antler in hot water wherein the water temperature is preferably between 80 and 90° C., and more preferably, 85° C.; after 30 minutes, separating the skin part and the other tissue part; then homogenizing said skin part and tissue part separately and removing the hair portion from the homogenized skin part subsequently. Next, to recombine said homogenized skin part and said tissue part to obtain a suspension, and then separate the water-soluble and water-insoluble parts of the suspension. Finally, pulverize said water-insoluble part and said water-insoluble part into powder in a fluidized bed dryer with an temperature between 75 and 90° C., wherein the temperature of the fluidized bed dryer is between 70 and 95° C., and preferably, 60 and 85° C. to obtain an antler powder which contains water less than 6%. In one embodiment, the water-insoluble portion is dried in an agitated swirl fluidized bed dryer at 60 to 85° C., and the obtained powder contains only 7% of water. The powder from water-soluble part and that from water-insoluble part can be used together or separately. The present invention will be further illustrated by the following examples. EXAMPLE 1 Preparation of Velvet Antler Powder The frozen deer antlers were cut into 5 cm long strips by using electric saw. The antler strips were then cleaned in warm water and soaked in 65° C. water for 30 minutes. The skin part was then separated from other tissue parts. The antler skin was homogenized in a Waring blender at high speed for 5 minutes, the skin homogenate was then filtered through three layers of cheesecloth, and the filtrate was washed with some distilled water. The hair portion was discarded. The other tissue parts of deer antler were gone through the same homogenization and filtration steps as above. The two filtrates were combined and homogenized in Waring blender at high speed for another 5 minutes. The combined homogenate was then centrifuged at 1000×g for 15 minutes. Both the supernatant and precipitate were separately dried. The supernatant portion (water-soluble part) was placed in a fluidized bed dryer, and dried for 20 minutes with an outlet temperature of 80° C., and the resulting solid contains water less than 7%. The precipitate portion (water-insoluble part) was placed in an agitated swirl fluidized bed dryer, and dried for 20 minutes with an outlet temperature of 78° C. and the resulting solid contains water less than 6%. The resulting solids were then pulverized into fine powder and mixed well. EXAMPLE 2 Preparation of the Antler Extract Mixture A. The formula of the antler mixture lists below: B. TABLE 1 Material % (W/W) Weight (g) Velvet antler 86.495 864.95 Lysine 0.500 5.00 Histidine 0.400 4.00 Proline 0.800 8.00 Tryptophan 0.400 4.00 Isoleucine 0.300 3.00 Leucine 0.500 5.00 Threonine 0.600 6.00 Methionine 0.200 2.00 Arginine 0.800 8.00 Phenylalanine 0.600 6.00 Stearic acid 0.700 7.00 Oleic acid 0.800 8.00 Linoleic acid 0.800 8.00 Lauric acid 0.800 8.00 Palmitic acid 0.900 9.00 Corn syrup solid 1.500 5.00 Lactose 0.500 5.00 Glucose 0.500 5.00 Dextrose 0.500 5.00 Ascorbic acid 0.500 5.00 Calcium carbonate 0.800 8.00 Magnesium oxide 0.100 1.00 Zinc oxide 0.005 0.05 Total 100.00 1,000.00 (Sample No.: AE-792) * All amino acids in this formula are essential amino acids. C. The formula of the emulsifying agents listed below: TABLE 2 Materials % (W/W) Weight (Kg) Antler extract sample No. 69.37 69.37 AE-792 Distilled water (80° C.) 30.00 30.00 Lecithin 0.08 0.08 Mono-glyceride 0.03 0.03 Di-glyceride 0.01 0.01 Sorbitan monoglycerate 0.10 0.10 Carageenan GP-713 0.10 0.10 Xanthan gum (Kelco) 0.04 0.04 Potassium phosphate 0.10 0.10 Salts 0.15 0.15 β- Carotene 0.02 0.02 (Sample No. HL-483) The contents mentioned above were added in a mixer and mixed with high speed as the steps of: (1) adding the 80° C. distilled water; (2) adding the lecithin, mono-glyceride, di-glyceride, and sorbitan monoglycerate slowly into the warm water; (3) adding potassium phosphate into the mixture above subsequently; (4) adding Carageenan GP-713 followed by adding Xanthan gum which is dissolved in propylene glycol with the weight ratio of 1:10; (5) adding salts and β-carotene to the mixture above; and (6) finally adding the antler extract mixture AE-792 to said mixture. All contents mentioned above were placing in a mixer and agitated with high speed for 10 minutes, and the mixture was then transferred to another mixer and agitated with mediate speed at 60° C. for about 30 minutes. All the solid contents were evaluated to confirm the formula. After heating, the mixture was drawn to a deaerator by a vacuum pump and deaerated for four times for eliminating foam. After foam eliminated, the mixture was transferred in a homogenizer for homogenizing under 1,200 psi followed by homogenizing under 3,500 psi to emulsify the mixture, wherein the emulsification was carried out at about 55° C. After complete emulsification, the mixture was transferred in an cooler for rapid cooling to 4° C., and transferred in an maturing vat. Agitate the mixture with low speed to deaerate for maintaining the homogenized state of the mixture, and keep it at 4° C. for storage. Store the suspension obtained from aforementioned treatments in a sterile bottle and refrigerate it for a long time to observe the stability of the suspension. After five months, surprisingly, only 1% of the suspension performs water-insoluble. This indicates that the stability of suspension diluted to one tenth can reaches to 99%, and the shelf life is about 6 months. EXAMPLE 3 Preparation of the Antler Composition The formula of the antler composition lists below: TABLE 3 Contents Weight (Kgw) β-cyclodextrin 6.18 Sec-Butyl-3-pentaoate 0.916 Mucus proteinase inhibitor 0.124 Propylene glycol 2.78 Total 10.00 The contents on table 3 were added in 30 Kg of distilled water, and the mixture was then agitated with low speed for 18 to 36 hour to form a suspension contained the matrix. 5.5 Kg of antler extract mixture (HL-483) was added into the suspension, and the mixture was agitated with low speed at room temperature for 18 to 24 hour until the microcapsules performs. The obtained mixture was incubated at 4° C. to form precipitates followed by filtering off the mixture, and the solid filtrates was washed with distilled water for three times. The final solid product was about 18 Kg, and it is added into 55 Kg of distilled water in a homomixer to stir for 15 minutes. After mixing well, the mixture was heated dramatically at 212° F. for about 2 minutes, then chilled to 4° C. and stored in a sterile glass bottle attached an aerator. The whole processing processes were disinfected. EXAMPLE 4 Storage Test of the Antler Composition The antler composition produced from the steps of example 2 was compared with the following comparative examples in stabilities Comparative Example 1 All the contents in comparative example 1 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the antler mixture (AE-792) is added into distilled water first and then the lecithin and amino acids are added to the mixture. Comparative Example 2 All the contents in comparative example 2 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the heating step is heated at 80° C. for 30 minutes. Comparative Example 3 All the contents in comparative example 3 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the aerating step is omitted. Comparative Example 4 All the contents in comparative example 4 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the emulsifying step is carried out under the pressure of 500 psi followed by under the pressure of 2,000 psi. Comparative Example 5 All the contents in comparative example 5 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the emulsifying step is carried out under the pressure of 1,000 psi followed by under the pressure of 2,500 psi. Comparative Example 6 All the contents in comparative example 6 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the heating step is heated at 80° C. for 30 minutes. Comparative Example 7 All the contents in comparative example 7 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the deaeration step is only repeated once. Comparative Example 8 All the contents in comparative example 8 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the emulsifying step is carried out at 45° C. Comparative Example 9 All the contents in comparative example 9 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the emulsifying step is carried out at 65° C. Comparative Example 10 All the contents in comparative example 7 are the same as example 2 (HL 483), and the producing steps are also similar to example 2, except that the maturing step is omitted. The samples mentioned above were incubating at room temperature and observed the water-insolubility for six months. The results list below: TABLE 4 The percentage of hydrophobious portion to whole weight. Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Example 2  0  0  0  0  1  1 Comparative 26 29 30 33 36 45 example 1 Comparative  5  7  7  7  8  8 example 2 Comparative 17 20 26 26 28 32 example 3 Comparative 45 59 62 64 64 65 example 4 Comparative 27 28 29 29 31 34 example 5 Comparative  4  5  6  6  7  8 example 6 Comparative 11 14 21 21 23 24 example 7 Comparative 47 50 53 53 54 56 example 8 Comparative 33 33 33 35 35 36 example 9 Comparative 71 72 73 73 75 76 example 10 TABLE 5 The percentage of water-insoluble portion to whole weight. Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Examle 2 0 0 0 0 0 1 Comparative 62  62  62  62  63  63  example 1 Comparative 100  100  100  100  100  100  example 2 Comparative 58  59  59  59  59  60  example 3 Comparative 100  100  100  100  100  100  example 4 Comparative 95  96  96  96  96  96  example 5 Comparative 100  100  100  100  100  100  example 6 Comparative 47  48  48  51  51  51  example 7 Comparative 0 0 0 0 1 2 example 8 Comparative 0 0 0 1 2 3 example 9 Comparative 0 0 4 4 4 5 example 10 The results suggest that the adding sequence of the antler mixture (comparative example 1), the temperature (comparative example 2), the frequency of deaeration (comparative example 3 and 7), the emulsifying pressure (comparative example 4 and 5), and maturing step (comparative example 10) are important factors which influence the hydorphilicity or water-solubility of the antler composition strongly. People who are skilled in this field know that the hydrophilicity and the water-solubility determine the bioavailibility and the potency of the composition. Therefore, the present invention provides a novel and special process to produce a stable and homogenized antler liquid composition contained high amount the antler. EXAMPLE 5 The Effects of the Antler Composition on Animal Model The effects of the traditional antler compositions on rats are compared with the antler composition of the present invention. The rats of experimental group is feed with the antler composition of the present invention while the rats of the comparative group is feed with the traditional antler composition. The control group is feed with the normal feed. Said traditional antler composition comprises 20 g of conventional antler power, 10 g of Herba Corydalis Bungeanae, 3 g of Squama Manitis, 4 g of Radix Scutellariae, 4 g of Curcuma aromatica salisp, 4 g of Semen Vaccariae, 4 g of Liquoric Root, 5 g of Japanese Honeysuckle Stem, 5 g of Fructus Forsythiae, 5 g of Angelica, 5 g of Red Paeony Root, 5 g of Gardenia jasminoides, 5 g of Nutgrass Galingale Rhizome, 5 g of Uniflower Swisscentaury Root. Said mixture is extracted by three fold boiling water. Said extract and the antler composition of the present invention were evaluated by the following experiments. Experiment A The Growth State of Rats The effects of sample HL-483 on the growth state of rats is compared with traditional lyophilized antler composition. 60 six week-old Wistar male rats whose weights are about 100 g are treated with these samples. The rats are arranged in cages, and each cage accommodates 4–6 rats. The rats are feed with distilled water and Adlibitum, a purified casein. The samples are added in the daily feed with a dosage of 200 mg separately. The results list as table 6: TABLE 6 The influence of different antler compositions on growth state of rats. (All data are average values) Weight (g/) Week /Duration 0 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Control group 100.0 102.3 104.7 105.3 107.7 108.1 109 HL-483 100.0 105.3 106.2 108.4 110.8 113.4 114.2 Traditional 100.0 102.2 104.7 104.9 106.7 108.7 109.3 antler composition The results suggest that the antler composition of the present invention (HL-483) can benefit the rats' growth state. Experiment B The Anti-Aging Effects on Rats The sample and experimental condition are all the same as experiment A except the rats are feed with distilled water and Adlibitum, a purified casein. The samples are added in the daily feed with a dosage of 200 mg separately. The results list as table 7 and 8: TABLE 7 The influence of different antler compositions on rat's testosterone concentration. (All data are average values) Groups Concentration of testosterone (pg/100 1 plasma) Control group 42 HL-483 (example 2) 95 Conventional antler 71 composition * The anti-aging effect increases when the testosterone concentration decreases. TABLE 8 The influence of different antler compositions on rat's MAO-B activities. (All data are average values) Activity of MAO-B * Groups Liver Barin Control group 5.7 2.4 HL-483 (example 2) 2.5 0.5 Conventional antler composition 4.3 1.3 * The anti-aging effect increases when the activity of MAO-B decreases. The results suggest that the anti-aging effect of IL-483 is much better than that of conventional antler composition. Experiment C The Anti-Inflaming Effects on Rats The sample and experimental condition are all the same as experiment A except the rats of control group are feed with conventional antler composition. The samples are added in the daily feed with a dosage of 200 mg separately. The results list as table 9: TABLE 9 The influence of different antler compositions on rat's leukocyte numbers. (All data are average values) Number of rat leukocyte */ ml × 10 −5 Control group 36 HL-483  6 Conventional antler 17 composition *The anti-inflaming effect increases when the number of leukocyte decreases. The results suggest that the anti-aging effect of HL-483 is much better than that of conventional antler composition. EXAMPLE 6 Pharmaco-Kinetics Study of the Antler Composition Comprising the Matrix The present experiment will study the effects of the administration way on the bioavalibility of the antler composition of the present invention. The conventional antler composition was a powdered mixture which packed in a capsule and was delivered by oral administration, while the antler composition of the present invention was delivered by spray. Human growth hormone (HGH), which is abundant and stable in antler composition, is a marker representing the active compounds in antler composition. So we compare the HGH amount of various samples to determine the effects of different administration way. Experiment A In Vitro Releasing Rate of the Antler Composition in the Present Invention The antler composition capsule without polymer matrix (control group) is compared with the antler composition of the present invention wherein the weight ratio of the antler extract to the β-cyclodextrin lists in table 10: TABLE 10 The weight ratio of the antler mixture to the β-cyclodextrin Weight part of Group antler extract Weight part of β-cyclodextrin Group 1 1 1 Group 2 1 1.5 Group 3 1 2.0 Group 4 1 2.7 Group 5 1 3.5 The samples mentioned above all comprise 150 mg of HGH, which is determined by IRMA (RADZM Co.). Other components are the same as example 1. The mixture mentioned above is put into a vial containing 10 ml of PBS buffer and stirred steadily. After 24 hours, the mixtures are transferred to another vial for the HGH amount analyzation. Repeat these steps until 144 hour. The results list as table 11: TABLE 11 The HGH amount in antler composition changes by time HGH amount (mg) Control Time (h) group Group 1 Group 2 Group 3 Group 4 Group 5  0 150  150  150 150  150  150  24 35  75 135 129  123  98 48 12  54 114 107  109  73 72 0 17  80 81 77 28 96 0  3  56 52 53  9 120  0  0  32 27 25  0 144  0  0  4  5  2  0 The results suggest that the releasing state of group 2 and group 4 are better than other groups. Experiment B In Vivo Releasing Rate of the Antler Composition of the Present Invention in Human Body The treatment and the experimental conditions are similar to experiment A, but the antler composition is packed in a bottle with an aerosol. The experimental group was sublingual administration while the control group was oral administration. The weight ratios of the antler mixture to the β-cyclodextrin are as table 12: TABLE 12 The weight ratio of the antler mixture to the β-cyclodextrin Weight part of Group antler extract Weight part of Group β-cyclodextrin Group 1 1 1 Group 2 1 1.5 Group 3 1 2.0 Group 4 1 2.7 Group 5 1 3.5 The samples mentioned above all comprise 150 mg of HGH, which is determined by IRMA (RADZM Co.). Other components are the same as example 3. The mixture mentioned above is put into a vial containing 10 ml of PBS buffer and stirred steadily. After 24 hours, the mixtures are transferred to another vial to analyze the HGH amount. Repeat these steps until 144 hour. The results list as table 13: TABLE 13 The HGH amount in antler composition changes by time HGH amount (mg) Control Time (h) group Group 1 Group 2 Group 3 Group 4 Group 5  0 150  150 150 150 150 150  24 23  105 127 132 130 112  48 0  83 109 115 117 87 72 0  50  81  87  89 62 96 0  17*  52*  59  58 24 120  0  0  29  33  37  3 144  0  0  3  5  9  0 *These groups are not patent in statistics (p > 0.05). The results suggest that the releasing state of group 2 and group 4 are better than other groups, so the weight ratio of antler extract to matrix is preferred in the range of 1:1.5 to 1:2.7. In addition, the antler composition of the present invention can release steadily and be stable in human body for six days. From the descriptions mentioned above, it is known that the antler composition of the present invention absorbed nasally or sublingually comprises contact active compounds. The present invention provides a matrix containing β-dextrin, which is elastic, water-soluble and non-toxic. Furthermore, the present invention provides a proper ratio of said polymers, which is suitable to pack the antler extract into microcapsules and optimize the pore size (2 to 10 micrometer) of the microcapsules. So the matrix of the present invention has a good performance of releasing the antler composition packed in the microcapsules into blood, thus maintains the potency until 24 to 48 hours. In addition, for improving the permeability of the matrix, the present invention provides a new formula which contains propyl ethylene, a stable and non-toxic solvent suitable for using in antler composition. It is deserved to notice that composition of the present invention also comprises higher ester and mucus proteinase inhibitor, which inhibit the proteinase efficiently, and thus protect the active compound in the antler composition and keep the stability of the matrix. For comparing with the traditional antler composition for oral administration or nasal or sublingual delivery, the antler composition of the present invention can provide more active compounds, prolong the potency, and improve the permeability, thus improve the bioavalibility and release the active compounds steadily. This is what the prior art cannot achieve. Although the present invention has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the scope of the invention as hereinafter claimed.

An antler composition and its manufacturing process are disclosed, the composition comprises an antler extract mixture and a matrix which comprises β-cyclodextrin, a higher ester compound, a proteinase inhibitor, and an organic solvent; wherein the weight ratio of the matrix to the antler extract mixture is between 1:1.5 and 1:2.7. The antler composition poses excellent activities and stable properties to be released steadily in human body. The present invention also relates to the antler extract mixture and the process for preparing the antler composition and the antler extract mixture.

The present application is a Continuation In Part of: [0000] U.S. patent application Ser. No. 12/610,181 filed Oct. 30, 2009; U.S. patent application Ser. No. 12/620,584 filed Nov. 17, 2009; U.S. patent application Ser. No. 12/762,262 filed Apr. 16, 2010; and U.S. patent application Ser. No. 14/222,333 filed Mar. 21, 2014, which applications are incorporated in their entirety herein by reference. BACKGROUND OF THE INVENTION [0005] The present invention relates to coffee makers and in particular to a method for using a brewing material holder which tamps brewing material. [0006] Coffee is generally prepared in a coffee maker by measuring an amount of ground coffee into a coffee filter, closing a lid over the ground coffee, and providing a stream of hot water through the loosely packed ground coffee. Unfortunately, water passes freely through the loosely packed ground coffee and does not obtain the full flavor which might otherwise be obtained. [0007] U.S. patent application Ser. No. 11/777,831 filed Jul. 13, 2007 for “Pod Adapter System for Single Service Beverage Brewers” by the present applicant overcomes this problem by packaging the coffee in closed filter paper commonly called a pod, and inserting the closed pod into a pod holder including a tamping spring and bottom tamper for tamping the pod between the bottom tamper and a coffee holder lid. While the pod adapter of the '831 application works well for some applications, it does not facilitate the simple use of bulk ground coffee in all general coffee makers. BRIEF SUMMARY OF THE INVENTION [0008] The present invention addresses the above and other needs by providing a self-tamping brewing material holder which tamps loose ground brewing material obtaining richer flavor. The brewing material holder includes a holder base and a holder lid. Brewing material is loosely deposited in the brewing material holder base and the holder lid is attached to the holder base. Cooperation of the holder base and holder lid biases a tam per against the brewing material to tamp the brewing material. The tamping may be biased by a spring or by a resilient solid material attached to the brewing material holder lid and push the brewing material down inside the base or may be biased by a spring or by a spring or resilient solid material attached to the brewing material holder base and push the brewing material up against the holder lid. Heated water is pumped through the lid and into the brewing material during brewing. [0009] In accordance with one aspect of the invention, there is provided a coffee making system including tamping coffee. The holder receives a portion of untamped brewing material and a holder lid closes the holder after receiving the untamped brewing material. A tamper resides inside the brewing material holder and tamps the coffee as the holder lid is closed. After tamping, the brewing material holder is engaged with a suitable coffee maker. Water is heated and pumped into the holder under pressure to mix with the tamped brewing material to make a brewed drink. [0010] In accordance with another aspect of the invention, there is provided a self tamping brewing material holder. The holder includes a reusable holder lid and a reusable holder base containing a single serving of brewing material. A tamper is attached to the holder lid and biased into the holder base by an urging member comprising a spring, a compressible member, or a resilient member to tamp the brewing material. The brewing material holder engages a coffee maker including a coffee maker pump and water heater. The coffee maker pumps heated water into the reusable brewing material holder and into the brewing material to prepare a serving of brewed drink. [0011] In accordance with yet another aspect of the invention, there is provided a self tamping brewing material holder. The holder includes a reusable holder lid and a reusable holder base containing a single serving of brewing material. A tamper is attached to the holder base and biased toward the holder lid by an urging member comprising a spring, a compressible member, or a resilient member to tamp the brewing material. The brewing material holder engages a coffee maker including a coffee maker pump and water heater. The coffee maker pumps heated water into the reusable brewing material holder and into the brewing material to prepare a serving of brewed drink. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING [0012] The above and other aspects, features and advantages of the present invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings wherein: [0013] FIG. 1A is a front view of a coffee maker according to the present invention. [0014] FIG. 1B is a side view of the coffee maker according to the present invention. [0015] FIG. 1C is a top view of the coffee maker according to the present invention. [0016] FIG. 2 is a side view of the coffee maker with an open lid allowing placement of a brewing material holder according to the present invention inside the coffee maker. [0017] FIG. 2A is a functional diagram of the coffee maker. [0018] FIG. 3 is a side view of a first brewing material holder according to the present invention. [0019] FIG. 4 is a cross-sectional side view of the first brewing material holder according to the present invention taken along line 4 - 4 of FIG. 3 . [0020] FIG. 5A is a cross-sectional side view of the first brewing material holder according to the present invention taken along line 4 - 4 of FIG. 3 showing an empty brewing material holder with the tamping spring and the bottom tamper according to the present invention. [0021] FIG. 5B is a cross-sectional side view of the first brewing material holder according to the present invention taken along line 4 - 4 of FIG. 3 showing the brewing material holder with the tamping spring and bottom tamper, a portion of brewing material, and the holder lid ready to attach to a holder base according to the present invention. [0022] FIG. 5C is a cross-sectional side view of the first brewing material holder according to the present invention taken along line 4 - 4 of FIG. 3 showing the brewing material holder with the tamping spring and bottom tamper, the portion of brewing material in the brewing material holder, and the holder lid ready to attach to the reusable holder base according to the present invention. [0023] FIG. 5D is a cross-sectional side view of the first brewing material holder according to the present invention taken along line 4 - 4 of FIG. 3 showing the brewing material holder with the tamping spring and bottom tamper, the portion of brewing material in the brewing material holder, and the holder lid attached to the brewing material holder base, according to the present invention. [0024] FIG. 6 is a top view of the first holder lid. [0025] FIG. 7A is a side view of a filter paper cup according to the present invention. [0026] FIG. 7B is a top view of the filter paper cup according to the present invention. [0027] FIG. 7C is a second embodiment of the filter paper cup with a lid. [0028] FIG. 8A shows the first brewing material holder ready for insertion into the coffee maker. [0029] FIG. 8B shows the first brewing material holder inserted into the coffee maker before tamping the coffee. [0030] FIG. 8C shows the first brewing material holder inserted into the coffee maker after tamping the coffee. [0031] FIG. 9 is a side view of a second brewing material holder according to the present invention. [0032] FIG. 10 is a cross-sectional side view of the second brewing material holder according to the present invention taken along line 10 - 10 of FIG. 9 . [0033] FIG. 11A is a cross-sectional side view of the second brewing material holder according to the present invention taken along line 10 - 10 of FIG. 9 showing an empty brewing material holder with the tamping spring and the top tamper according to the present invention. [0034] FIG. 11B is a cross-sectional side view of the second brewing material holder according to the present invention taken along line 10 - 10 of FIG. 9 showing the brewing material holder with the holder lid, tamping spring and top tamper, and a portion of brewing material, ready to attach according to the present invention. [0035] FIG. 11C is a cross-sectional side view of the second brewing material holder according to the present invention taken along line 10 - 10 of FIG. 9 showing the portion of untamped brewing material in the brewing material holder, and the holder lid, tamping spring and top tamper, ready to attach to the reusable holder base, according to the present invention. [0036] FIG. 11D is a cross-sectional side view of the second brewing material holder according to the present invention taken along line 10-10 of FIG. 9 showing the portion of brewing material in the brewing material holder and the tamping spring, top tamper, and the holder lid attached to the brewing material holder, according to the present invention. [0037] FIG. 12 is a top view of the second holder lid. [0038] FIG. 13 is a top view of the bottom tamper. [0039] FIG. 14A shows the second brewing material holder ready for insertion into the coffee maker. [0040] FIG. 14B shows the second brewing material holder inserted into the coffee maker before tamping the coffee. [0041] FIG. 14C shows the second brewing material holder inserted into the coffee maker after tamping the coffee. [0042] FIG. 15 is a side view of a third brewing material holder according to the present invention. [0043] FIG. 16 is a cross-sectional side view of the third brewing material holder according to the present invention taken along line 16 - 16 of FIG. 15 . [0044] FIG. 17A is a cross-sectional side view of the third brewing material holder according to the present invention taken along line 16 - 16 of FIG. 15 showing the portion of brewing material above the brewing material holder and the top tamper and the holder lid ready to attach to the brewing material holder, according to the present invention. [0045] FIG. 17B is a cross-sectional side view of the third brewing material holder according to the present invention taken along line 16 - 16 of FIG. 15 showing the portion of brewing material in the brewing material holder, and the top tamper and the holder lid ready to attach to the brewing material holder, according to the present invention. [0046] FIG. 17C is a cross-sectional side view of the third brewing material holder according to the present invention taken along line 16 - 16 of FIG. 15 showing the portion of brewing material in the brewing material holder, and the bottom tamper, the top tamper, and the holder lid attached to the brewing material holder, according to the present invention. [0047] FIG. 18A shows the third brewing material holder ready for insertion into a second coffee maker according to the present invention. [0048] FIG. 18B shows the third brewing material holder inserted into the coffee maker before tamping the coffee. [0049] FIG. 18C shows the third brewing material holder inserted into the coffee maker after tamping the coffee. [0050] FIG. 19 is a side view of a fourth brewing material holder according to the present invention. [0051] FIG. 20 is a cross-sectional side view of the fourth brewing material holder according to the present invention taken along line 20 - 20 of FIG. 19 . [0052] FIG. 21A is a cross-sectional side view of the fourth brewing material holder according to the present invention taken along line 20 - 20 of FIG. 19 showing the brewing material holder with the bottom tamper, a portion of brewing material, and the holder lid ready to attach, according to the present invention. [0053] FIG. 21B is a cross-sectional side view of the fourth brewing material holder according to the present invention taken along line 20 - 20 of FIG. 19 showing the brewing material holder with the bottom tamper, a portion of brewing material in the brewing material holder, and the holder lid ready to attach, according to the present invention. [0054] FIG. 21C is a cross-sectional side view of the fourth brewing material holder according to the present invention taken along line 20 - 20 of FIG. 19 showing the brewing material holder with the bottom tamper, a portion of brewing material in the brewing material holder, and the holder lid attached, according to the present invention. [0055] FIG. 22A shows the fourth brewing material holder ready for insertion into the coffee maker. [0056] FIG. 22B shows the fourth brewing material holder inserted into the coffee maker before tamping the coffee. [0057] FIG. 22C shows the fourth brewing material holder inserted into the coffee maker after tamping the coffee. [0058] FIG. 23A shows the fourth brewing material holder ready for insertion into the coffee maker having a tamping block according to the present invention. [0059] FIG. 23B shows the fourth brewing material holder inserted into the coffee maker having the tamping block before tamping the coffee. [0060] FIG. 23C shows the fourth brewing material holder inserted into the coffee maker having the tamping block after tamping the coffee. [0061] FIG. 24 is a side view of a fifth brewing material holder according to the present invention. [0062] FIG. 24 is a cross-sectional side view of the fifth brewing material holder according to the present invention taken along line 25 - 25 of FIG. 24 . [0063] FIG. 26A is a cross-sectional side view of the fifth brewing material holder according to the present invention taken along line 25 - 25 of FIG. 24 showing the portion of brewing material above the brewing material holder base, and the holder lid with the top tamper and tamping spring, ready to attach to the brewing material holder base, according to the present invention. [0064] FIG. 26B is a cross-sectional side view of the fifth brewing material holder according to the present invention taken along line 25 - 25 of FIG. 24 showing the brewing material holder with the portion of brewing material in the brewing material holder, and the holder lid with the top tamper and tamping spring ready to attach to the brewing material holder base, according to the present invention. [0065] FIG. 26C is a cross-sectional side view of the fifth brewing material holder according to the present invention taken along line 25 - 25 of FIG. 24 showing the portion of brewing material in the brewing material holder, and the holder lid with the top tamper and tamping spring attached to the reusable holder base, according to the present invention. [0066] FIG. 27 is a side view of a sixth brewing material holder according to the present invention. [0067] FIG. 28 is a cross-sectional side view of the sixth brewing material holder according to the present invention taken along line 28 - 28 of FIG. 27 . [0068] FIG. 29A is a cross-sectional side view of the sixth brewing material holder according to the present invention taken along line 28 - 28 of FIG. 27 showing the portion of brewing material above the brewing material holder, and the holder lid ready to attach to the reusable holder base, according to the present invention. [0069] FIG. 29B is a cross-sectional side view of the sixth brewing material holder according to the present invention taken along line 28 - 28 of FIG. 27 showing the portion of brewing material in the brewing material holder, and the holder lid ready to attach to the reusable holder base, according to the present invention. [0070] FIG. 29C is a cross-sectional side view of the sixth brewing material holder according to the present invention taken along line 28 - 28 of FIG. 27 showing the portion of brewing material in the brewing material holder, and the holder lid attached and tam ping the coffee, according to the present invention. [0071] FIG. 30 is a side view of a seventh brewing material holder according to the present invention. [0072] FIG. 31 is a cross-sectional side view of the seventh brewing material holder according to the present invention taken along line 31 - 31 of FIG. 30 . [0073] FIG. 32A is a cross-sectional side view of the seventh brewing material holder according to the present invention taken along line 31 - 31 of FIG. 30 showing the portion of brewing material above the brewing material holder, and the holder lid ready to attach to the reusable holder base, according to the present invention. [0074] FIG. 32B is a cross-sectional side view of the seventh brewing material holder according to the present invention taken along line 31 - 31 of FIG. 30 showing the portion of brewing material in the brewing material holder, and the holder lid ready to attach to the reusable holder base, according to the present invention. [0075] FIG. 32C is a cross-sectional side view of the seventh brewing material holder according to the present invention taken along line 31 - 31 of FIG. 30 showing the portion of brewing material in the brewing material holder, and the holder lid attached to the reusable holder base and the coffee tamped between the bottom tamper and spring and the holder lid, according to the present invention. [0076] FIG. 33 is a side view of an eighth brewing material holder according to the present invention. [0077] FIG. 34A is a cross-sectional side view of the eighth brewing material holder taken along line 34 - 34 of FIG. 33 showing a portion of brewing material for placing inside the brewing material holder and the holder lid with an insertable portion and an O-Ring inside the brewing material holder for sealing according to the present invention. [0078] FIG. 34B is a cross-sectional side view of the eighth brewing material holder taken along line 34 - 34 of FIG. 33 showing the portion of brewing material inside the brewing material holder and the holder lid with the insertable portion inserted into the brewing material holder and cooperating with the O-Ring inside the brewing material holder for sealing. [0079] FIG. 35 is a side view of a ninth brewing material holder according to the present invention. [0080] FIG. 36A is a cross-sectional side view of the ninth brewing material holder taken along line 36 - 36 of FIG. 35 showing a portion of brewing material for placing inside the brewing material holder and a holder lid with a threaded portion for screwing inside the reusable holder base for sealing according to the present invention. [0081] FIG. 36B is a cross-sectional side view of the ninth brewing material holder taken along line 36 - 36 of FIG. 35 showing the portion of brewing material inside the brewing material holder and a holder lid with the threaded portion screwed into the reusable holder base and tam ping the coffee according to the present invention. [0082] FIG. 37A shows a third coffee maker having a brewing material holder for receiving a portion of brewing material and tamping spring according to the present invention for tamping the coffee when the coffee maker lid is closed. [0083] FIG. 37B shows the third coffee maker with the brewing material holder holding the portion of brewing material and the tamping spring under the brewing material holder according to the present invention for tamping the coffee when the coffee maker lid is closed. [0084] FIG. 37C shows the third coffee maker with the brewing material holder holding the portion of tamped brewing material with the coffee maker lid closed for tamping the coffee according to the present invention. [0085] FIG. 38A shows a third coffee maker having a brewing material holder for receiving a portion of brewing material and tamping spring attached to the coffee maker lid according to the present invention for tamping the coffee when the coffee maker lid is closed. [0086] FIG. 38B shows the third coffee maker with the brewing material holder holding the portion of untamped brewing material according to the present invention for tamping the coffee when the coffee maker lid is closed. [0087] FIG. 38C shows the third coffee maker with the brewing material holder holding the portion of tamped brewing material with the coffee maker lid closed to push the tamping spring into the brewing material holder for tamping the coffee according to the present invention. [0088] FIG. 39A shows a fourth coffee maker having a brewing material holder for receiving a packet containing untamped brewing material, a knife for cutting the packet open, and tamping spring attached to the coffee maker lid according to the present invention for tamping the coffee when the coffee maker lid is closed. [0089] FIG. 39B shows the fourth coffee maker with the brewing material holder holding the packet of untamped brewing material according to the present invention for tamping the coffee when the coffee maker lid is closed. [0090] FIG. 39C shows the fourth coffee maker with the brewing material holder holding the packet of tamped brewing material with the coffee maker lid closed to push the tamping spring into the brewing material holder for tamping the coffee according to the present invention. [0091] FIG. 40A shows a fifth coffee maker accepting a horizontal brewing material holder and tamping spring residing horizontally in a brewing material holder cavity according to the present invention for tamping the coffee when the coffee maker lid is closed. [0092] FIG. 40B shows the fifth coffee maker with the brewing material holder residing horizontally in the brewing material holder cavity according to the present invention for tamping the coffee when the coffee maker lid is closed. [0093] FIG. 40C shows the fifth coffee maker with the brewing material holder residing horizontally in the brewing material holder cavity with the coffee maker lid closed and the brewing material holder pushed against the tamping spring for tamping the coffee, according to the present invention. [0094] FIG. 41 is a side view of a tenth brewing material holder with straight walls according to the present invention. [0095] FIG. 42 is a cross-sectional view of the tenth brewing material holder taken along line 42 - 42 of FIG. 41 showing an empty brewing material holder. [0096] FIG. 43 is a cross-sectional view of the tenth brewing material holder taken along line 42 - 42 of FIG. 41 showing a full and tamped brewing material holder. [0097] FIG. 44 is a side view of an eleventh brewing material holder with straight walls according to the present invention. [0098] FIG. 45 is a cross-sectional view of the eleventh brewing material holder taken along line 45 - 45 of FIG. 44 showing an empty brewing material holder. [0099] FIG. 46 is a cross-sectional view of the eleventh brewing material holder taken along line 45 - 45 of FIG. 41 showing a full and tamped brewing material holder. [0100] FIG. 47A is a side view of a top tamper. [0101] FIG. 47B is a top view of the top tamper. [0102] FIG. 47C is a side view of a top tamper with a seal according to the present invention. [0103] FIG. 47D is a top view of the top tamper with a seal. [0104] FIG. 48 is a perspective view of a filter paper cup with a folding cup lid. [0105] FIG. 49 is a side view of a twelfth brewing material holder with straight walls according to the present invention. [0106] FIG. 50 is a cross-sectional view of the twelfth brewing material holder taken along line 50 - 50 of FIG. 49 showing an empty brewing material holder. [0107] FIG. 51A is a cross-sectional view of the twelfth brewing material holder taken along line 50 - 50 of FIG. 49 showing a lid, coffee, a filter paper cup, above the base, and the brewing material holder base. [0108] FIG. 51B is a cross-sectional view of the twelfth brewing material holder taken along line 50 - 50 of FIG. 49 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base. [0109] FIG. 51C is a cross-sectional view of the twelfth brewing material holder taken along line 50 - 50 of FIG. 49 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base with a filter paper cover folded over the coffee in the filter paper cup. [0110] FIG. 51D is a cross-sectional view of the twelfth brewing material holder taken along line 50 - 50 of FIG. 49 showing the lid attached to the base with the coffee and the filter paper cup residing in the brewing material holder base with the coffee tamped. [0111] FIG. 52 is a side view of a thirteenth brewing material holder with a releaseable tamping latch according to the present invention. [0112] FIG. 53 is a cross-sectional view of the thirteenth brewing material holder taken along line 53 - 53 of FIG. 52 showing an empty brewing material holder. [0113] FIG. 54A is a cross-sectional view of the thirteenth brewing material holder taken along line 53 - 53 of FIG. 52 showing a lid, coffee, a filter paper cup, above the base, and the brewing material holder base, with the tamping latch retaining the bottom tamper. [0114] FIG. 54B is a cross-sectional view of the thirteenth brewing material holder taken along line 53 - 53 of FIG. 52 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base, with the tamping latch retaining the bottom tamper. [0115] FIG. 54C is a cross-sectional view of the thirteenth brewing material holder taken along line 53 - 53 of FIG. 52 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base with the tamping latch retaining the bottom tamper. [0116] FIG. 54D is a cross-sectional view of the fourteenth brewing material holder taken along line 53 - 53 of FIG. 52 showing the lid attached to the base with the coffee and the filter paper cup residing in the brewing material holder base with tamping latch released and the coffee tamped. [0117] FIG. 55 is a side view of a fourteenth brewing material holder with a releaseable tamping latch according to the present invention. [0118] FIG. 56 is a cross-sectional view of the fourteenth brewing material holder taken along line 56 - 56 of FIG. 55 showing an empty brewing material holder. [0119] FIG. 57A is a cross-sectional view of the fourteenth brewing material holder taken along line 56 - 56 of FIG. 55 showing a lid, coffee, a filter paper cup, above the base, and the brewing material holder base, with the tamping latch retaining the bottom tamper. [0120] FIG. 57B is a cross-sectional view of the fourteenth brewing material holder taken along line 56 - 56 of FIG. 55 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base, with the tamping latch retaining the bottom tamper. [0121] FIG. 57C is a cross-sectional view of the fourteenth brewing material holder taken along line 56 - 56 of FIG. 55 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base, with the tamping latch released but just prior to tam ping. [0122] FIG. 57D is a cross-sectional view of the fourteenth brewing material holder taken along line 56 - 56 of FIG. 55 showing the lid attached to the base with the coffee and the filter paper cup residing in the brewing material holder base with tamping latch released and the coffee tamped. [0123] FIG. 58 is a side view of a fourteenth brewing material holder with a releaseable tamping lock according to the present invention. [0124] FIG. 59 is a cross-sectional view of the fourteenth brewing material holder taken along line 59 - 59 of FIG. 58 showing an empty brewing material holder. [0125] FIG. 60A is a cross-sectional view of the fourteenth brewing material holder taken along line 59 - 59 of FIG. 58 showing a lid, coffee, a filter paper cup, above the base, and the brewing material holder base, with the tamping lock retaining the bottom tamper. [0126] FIG. 60B is a cross-sectional view of the fourteenth brewing material holder taken along line 59 - 59 of FIG. 58 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base, with the tamping lock retaining the bottom tamper. [0127] FIG. 60C is a cross-sectional view of the fourteenth brewing material holder taken along line 59 - 59 of FIG. 58 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base prior to tamping. [0128] FIG. 60D is a cross-sectional view of the fourteenth brewing material holder taken along line 59 - 59 of FIG. 58 showing the lid attached to the base with the coffee and the filter paper cup residing in the brewing material holder base with tamping lock released and the coffee tamped. [0129] FIG. 61 is a top view of a lock according to the present invention. [0130] FIG. 62 is a bottom view of a second bottom tamper with cooperates with the tamping lock according to the present invention. [0131] FIG. 63A is a side view of a filter cup according to the present invention. [0132] FIG. 63B is a top view of the filter cup according to the present invention. [0133] Corresponding reference characters indicate corresponding components throughout the several views of the drawings. [0134] FIG. 64 shows a brewing material holder with a second embodiment of a lid. DETAILED DESCRIPTION OF THE INVENTION [0135] 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 one or more preferred embodiments of the invention. The scope of the invention should be determined with reference to the claims. [0136] A front view of a coffee 10 maker according to the present invention is shown in FIG. 1A a side view of the coffee maker 10 is shown in FIG. 1B , and a top view of the coffee maker 10 is shown in FIG. 1C . The coffee maker 10 includes a base 12 , an opening lid 14 , a lid handle 16 , a water container 18 , a display 20 , controls 22 , and platform 24 . A cup 26 rests on the platform 24 . The coffee maker 10 provides a flow of hot water through brewing material to produce a brewed drink. The flow of water may be heated by one of any known means, for example, an electrical heating coil, inductive heating, or a conductive coating on tubing carrying the water. [0137] A side view of the coffee maker 10 with an open lid 14 allowing placement of a brewing material holder 30 according to the present invention inside the coffee maker 10 is shown in FIG. 2 . The lid 14 includes a lid hinge 14 a and a water tube 15 carries heated water into the lid 14 . A pad 17 resides on a bottom surface of the lid 14 and presses against the brewing material holder 30 when the lid 14 is closed, and in cooperation with other means discloses hereafter, tamps coffee contained in the brewing material holder 30 . A nozzle 19 extending down from the closed lid 14 directs the flow of hot water into the brewing material holder 30 . [0138] A functional diagram of the coffee maker 10 is shown in FIG. 2A . The preferred coffee (or brewing material) maker 10 includes the water tank 18 , water pump 21 , a heater 13 , check valve 23 and the nozzle 19 . The pump 21 preferably provides at least one PSI water pressure. The water heater 13 may include a heating coil, inductive heating, or a resistive coating or any other means for heating water. The check valve 23 limits the water pressure at the nozzle 19 by returning some of the water flow to the water tank 18 . While the water pump 21 is a preferred method for providing a flow of water to the nozzle 19 , other methods include placing the water in the water tank 18 under pressure, and a coffee maker using any means to provide a forced flow of water at above ambient air pressure is intending too within the scope of the present invention. The nozzle 19 provides a closed fluid path 19 ′ from the water pump 21 into the holder 30 . The fluid path 19 ′ has an entry end 19 ″ in fluid communication with the pressurized water from the water pump 21 and a release end 19 ″′ residing inside the holder 30 , and is otherwise closed (i.e., not in fluid communication with ambient air pressure) between the entry end 19 ″ and the release end 19 ′″. The release end 19 ′″ resides in the holder interior and the pressurized flow of water is above ambient pressure at entry into the holder interior. [0139] A side view of a first brewing material holder 30 a according to the present invention is shown in FIG. 3 and a cross-sectional side view of the first brewing material holder 30 a including a holder base 31 , a first holder lid 32 a, a bottom tamper 34 , and a tamping spring 36 according to the present invention taken along line 4 - 4 of FIG. 3 is shown in FIG. 4 . A volume (or brewing material holder interior) 38 is provided inside the brewing material holder 30 a to receive brewing material 41 . A passage 33 in the lid 32 a is provided for the nozzle 19 (see FIG. 2 ). [0140] Those skilled in the art will recognize that the spring 36 may be replaced by any urging member, for example a compressible member (for example a compressible fluid held inside a membrane), a solid resilient material, or the like, and a brewing material holder including any form of urging member exerting force against a tamper is intended to come within the scope of the present invention. [0141] A cross-sectional side view of the first brewing material holder 30 a taken along line 4 - 4 of FIG. 3 showing an empty brewing material holder 30 a with the tamping spring 36 and the bottom tamper 34 ready for filling are shown in FIG. 5A . A cross-sectional side view of the first brewing material holder 30 a taken along line 4 - 4 of FIG. 3 showing the brewing material holder 30 a with the tamping spring 36 and bottom tamper 34 , a portion of brewing material 41 , and the holder lid 32 a ready to attach is shown in FIG. 5B . A cross-sectional side view of the first brewing material holder 30 a taken along line 4 - 4 of FIG. 3 showing the brewing material holder 30 a with the tamping spring 36 and bottom tamper 34 , a portion of brewing material in the volume 38 , and the holder lid 32 a ready to attach is shown in FIG. 5C . A cross-sectional side view of the first brewing material holder 30 a taken along line 4 - 4 of FIG. 3 showing the brewing material holder 30 a with the tamping spring 36 and bottom tamper 34 , a portion of brewing material 41 in the volume 38 , and the holder lid 32 a attached to the brewing material holder 30 a, is shown in FIG. 5D . [0142] A top view of the first holder lid 32 a showing the passage 33 provided for the nozzle 19 (see FIG. 2 ) is shown in FIG. 6 . [0143] A side view of a filter paper cup 40 according to the present invention is shown in FIG. 7A and a top view of the filter paper cup 40 is shown in FIG. 7B . The filter paper cup 40 includes a bottom 40 b, sides 40 a, and a rim 40 c. The filter paper cup 40 may be used with the brewing material holder 30 a with the rim 40 c resting on a top edge of the reusable holder base 31 and held between the holder lid and base when the lid is placed on the base, thereby preventing or restricting the escape of brewing material 41 from the cup 40 when hot water flows into the brewing material holder 30 a. [0144] A second embodiment of the filter paper cup 40 ′ with a folding paper lid 40 d is shown in FIG. 7C . The lid 40 d of the filter paper cup 40 ′ may be folded over the cup 40 ′ after brewing material is poured into the cup. The lid 40 d preferably includes a perforation 40 e centered on the lid 40 d allowing the nozzle 19 to enter and/or inject the hot flow of water into the brewing material 41 . [0145] The filter cups may be made from several materials including filter paper, nylon mesh, steel mesh, or any material suitable for filtration. [0146] The first brewing material holder 30 a is shown ready for insertion into a first coffee maker 10 a in FIG. 8A , the first brewing material holder 30 a is shown inserted into the coffee maker 10 before tamping the brewing material 41 in FIG. 8B , and the first brewing material holder 30 a is shown in the coffee maker 10 after tamping the brewing material 41 in FIG. 8C . The coffee maker includes a cavity 11 for accepting the brewing material holder and has walls 11 a for aligning the brewing material holder in the coffee maker. When the lid 14 is closed, the pad 17 on the bottom of the lid 14 and/or arms 25 attached to the bottom of the lid 25 , push the brewing material holder 30 a down over the tamping spring 36 and the brewing material 41 is tamped between the lid 32 a and the bottom tamper 34 . The arms 25 push the brewing material holder 30 a down ahead of the nozzle 19 thereby seating the brewing material holder 30 a in the cavity 11 for alignment of the nozzle 19 with the passage 33 in the lid 32 a. [0147] A side view of a second brewing material holder 30 b according to the present invention is shown in FIG. 9 and a cross-sectional side view of the second brewing material holder 30 b taken along line 10 - 10 of FIG. 9 is shown in FIG. 10 . The brewing material holder 30 b includes the reusable holder base 31 , a second holder lid 32 b, a tam ping spring 36 , a spring washer 35 a, and a top tamper 35 b. [0148] A cross-sectional side view of the second brewing material holder 30 b taken along line 10 - 10 of FIG. 9 showing an empty brewing material holder 30 b is shown in FIG. 11A . A cross-sectional side view of the second brewing material holder 30 b taken along line 10 - 10 of FIG. 9 showing the holder lid 32 b and a loose portion of brewing material 41 above the empty brewing material holder 30 b is shown in FIG. 11B . A cross-sectional side view of the second brewing material holder 30 b taken along line 10 - 10 of FIG. 9 showing the holder lid 32 b above the brewing material holder 30 b with the portion of brewing material 41 in the brewing material holder 32 b is shown in FIG. 11C . A cross-sectional side view of the second brewing material holder 32 b taken along line 10 - 10 of FIG. 9 showing the brewing material holder with the holder lid 32 b attached to the brewing material holder 30 b and a portion of brewing material 41 in the brewing material holder 30 b is shown in FIG. 11D . The tamping spring 36 extends upward out of the brewing material holder 30 b for tamping the brewing material as disclosed hereafter. The top tamper 35 b includes a passage 35 ′ allowing heated water to be introduced by a coffee maker into the brewing material holder 30 b under pressure. [0149] A top view of the second holder lid 32 b is shown in FIG. 12 . The holder lid 32 b includes a larger passage 33 a allowing passage of the tamping spring 36 through the holder lid 32 b. [0150] A top view of the bottom tamper 34 is shown in FIG. 13 . The bottom tamper 34 includes perforations 34 a to allow coffee drink to pass through the bottom tamper 34 . [0151] The second brewing material holder 30 b is shown ready for insertion into the coffee maker 10 in FIG. 14A , the second brewing material holder 30 b is shown inserted into the coffee maker 10 before tamping the brewing material 41 in FIG. 14B , and the second brewing material holder 30 b is shown in the coffee maker 10 after tamping the brewing material 41 in FIG. 14C . The coffee maker 10 may include a long nozzle 19 a to reach the top tamper 35 b for “injection” of the heated water into the tamped brewing material, but the heated water may pass through the brewing material 41 under the pull of gravity. [0152] A side view of a third brewing material holder 30 c according to the present invention is shown in FIG. 16 and a cross-sectional side view of the third brewing material holder 30 c taken along line 16 - 16 of FIG. 15 is shown in FIG. 16 . The brewing material holder 30 c includes the reusable holder base 31 , the second holder lid 32 b, the bottom tamper 34 , and the top tamper 35 b. [0153] A cross-sectional side view of the third brewing material holder 30 c taken along line 16 - 16 of FIG. 15 showing the brewing material holder 30 c with the holder lid 32 b, the top tam per 35 b, and a portion of brewing material, ready to attach to the holder 31 , is shown in FIG. 17A . A cross-sectional side view of the third brewing material holder taken along line 16 - 16 of FIG. 15 showing the brewing material holder 30 c with the holder lid 32 b and the top tam per ready to attach, and a portion of brewing material 41 in the brewing material holder, is shown in FIG. 17B . A cross-sectional side view of the third brewing material holder 30 c taken along line 16 - 16 of FIG. 15 showing the brewing material holder with the holder lid and the top tam per attached and a loose portion of brewing material 41 in the brewing material holder is shown in FIG. 17C . The brewing material holder 30 c is configured to use with a coffee make 10 b (see FIGS. 18A-18C ) including apparatus for entering the brewing material holder for tamping the brewing material 41 . [0154] The third brewing material holder 30 c ready for insertion into a second coffee maker 10 b in FIG. 18A , the third brewing material holder 30 c is shown residing in the coffee maker 10 b before tamping the brewing material 41 in FIG. 18B , and the third brewing material holder 30 c is shown residing in the coffee maker 10 b after tamping the brewing material 41 in FIG. 18C . The coffee maker 10 b includes the tamping spring 36 attached to the pad 17 on the bottom of the lid 14 . When the lid 14 is closed the tamping spring 36 enters the brewing material holder 30 c through the lid passage 33 a (see FIG. 12 ) and pushes the top tamper 35 b against the brewing material 41 to tamp the brewing material 41 . [0155] A side view of a fourth brewing material holder 30 d according to the present invention is shown in FIG. 19 and a cross-sectional side view of the fourth brewing material holder 30 d taken along line 20 - 20 of FIG. 19 is shown in FIG. 20 . The brewing material holder 30 d includes the reusable holder base 31 , the first holder lid 32 a, and the bottom tamper 34 . [0156] A cross-sectional side view of the fourth brewing material holder 30 d taken along line 20 - 20 of FIG. 19 showing the brewing material holder with the bottom tamper 34 , and a portion of brewing material 41 and the holder lid ready to attach is shown in FIG. 21A . A cross-sectional side view of the fourth brewing material holder 30 d taken along line 20 - 20 of FIG. 19 showing the brewing material holder 30 d with the bottom tamper 34 , the portion of brewing material 41 in the brewing material holder 30 d, and the holder lid 32 a ready to attach is shown in FIG. 21B . A cross-sectional side view of the fourth brewing material holder 30 d taken along line 20 - 20 of FIG. 19 showing the brewing material holder 30 d with the bottom tamper 34 , a portion of brewing material in the brewing material holder 41 , and the holder lid 32 a is shown in FIG. 21C . [0157] The fourth brewing material holder 30 d ready for insertion into another embodiment of the second coffee maker 10 b in FIG. 22A , the fourth brewing material holder 30 d is shown residing in the coffee maker 10 b before tamping the brewing material 41 in FIG. 22B , and the fourth brewing material holder 30 d is shown residing in the coffee maker 10 b after tamping the brewing material 41 in FIG. 22C . The coffee maker 10 b may include the tamping spring 36 residing in the bottom of the brewing material holder cavity 11 . When the lid 14 is closed, the pad 17 pushed the brewing material holder 30 d down over the tamping spring 36 and the tamping spring 36 enters the brewing material holder 30 c through the bottom of the reusable holder base 31 and pushes the bottom tamper 34 against the brewing material 41 to tamp the brewing material 41 . [0158] The fourth brewing material holder 30 d ready for insertion into another embodiment of the second coffee maker 10 b in FIG. 23A , the fourth brewing material holder 30 d is shown residing in the coffee maker 10 b before tamping the brewing material 41 in FIG. 23B , and the fourth brewing material holder 30 d is shown residing in the coffee maker 10 b after tamping the brewing material 41 in FIG. 23C . The coffee maker 10 b may include a resilient block 42 residing in the bottom of the brewing material holder cavity 11 . When the lid 14 is closed, the pad 17 pushed the brewing material holder 30 d down over the resilient block 42 and the resilient block 42 enters the brewing material holder 30 c through the bottom of the reusable holder base 31 and pushes the bottom tamper 34 against the brewing material 41 to tamp the brewing material 41 . [0159] A side view of a fifth brewing material holder 30 e according to the present invention is shown in FIG. 24 and a cross-sectional side view of the fifth brewing material holder 30 e taken along line 25 - 25 of FIG. 24 is shown in FIG. 25 . The fifth brewing material holder 30 e includes the reusable holder base 31 , the holder lid 32 b, the tam ping spring 36 and the top tamper 35 b attached to the holder lid 32 a. The top tamper 35 b includes a passage 35 ′ allowing heated water to be introduced by a coffee maker into the brewing material holder 30 b under pressure. [0160] A cross-sectional side view of the fifth brewing material holder 30 e taken along line 25 - 25 of FIG. 24 showing the brewing material holder 30 e with a portion of brewing material 41 , and the holder lid 32 b with the top tamper 35 b and tamping spring 36 attached, above the reusable holder base 31 , is shown in FIG. 26A . A cross-sectional side view of the fifth brewing material holder 30 e taken along line 25 - 25 of FIG. 24 showing the brewing material holder with the portion of brewing material 41 in the brewing material holder, and the holder lid 32 b with the top tamper 35 b and tamping spring 36 attached, above the reusable holder base 31 , is shown in FIG. 26B . A cross-sectional side view of the fifth brewing material holder 30 e taken along line 25 - 25 of FIG. 24 showing the brewing material holder 30 e with the portion of brewing material 41 in the brewing material holder 30 e, and the holder lid 32 b with the top tamper 35 b and tamping spring 36 attached to the reusable holder base 31 is shown in FIG. 26D . The tamping spring 36 and top tamper 35 b tamp the brewing material 41 to provide a tamped brewing material when the holder lid 32 b is attached to the reusable holder base 31 . [0161] A side view of a sixth brewing material holder 30 f according to the present invention is shown in FIG. 27 and a cross-sectional side view of the sixth brewing material holder 30 f taken along line 28 - 28 of FIG. 27 is shown in FIG. 28 . The sixth brewing material holder 30 f includes the reusable holder base 31 and a third holder lid 32 c. The third holder lid 32 c includes a recessed portion 32 ′ which reaches into the interior of the sixth brewing material holder 30 f. The recessed portion 32 ′ is preferably a solid resilient material. [0162] A cross-sectional side view of the sixth brewing material holder 30 f taken along line 28 - 28 of FIG. 27 showing the sixth brewing material holder 30 f with a portion of brewing material 41 , and the holder lid 32 c, above the reusable holder base 31 , is shown in FIG. 29A . A cross-sectional side view of the sixth brewing material holder 30 f taken along line 28 - 28 of FIG. 27 showing the brewing material holder 30 f with the portion of brewing material 41 in the brewing material holder, and the holder lid 32 c above the reusable holder base 31 , is shown in FIG. 29B . A cross-sectional side view of the sixth brewing material holder 30 f along line 28 - 28 of FIG. 27 showing the sixth brewing material holder 30 f with the portion of brewing material 41 in the brewing material holder 30 e, and the holder lid 32 e attached to the reusable holder base 31 is shown in FIG. 26D . The recessed portion 32 ′ tamps the brewing material 41 to provide a tamped brewing material when the holder lid 32 e is attached to the reusable holder base 31 . The recessed portion 32 ′ is preferably made from a resilient material to cushion the tamping of the brewing material. [0163] A side view of a seventh brewing material holder 30 g according to the present invention is shown in FIG. 30 and a cross-sectional side view of the seventh brewing material holder 30 g taken along line 31 - 31 of FIG. 30 is shown in FIG. 31 . The seventh brewing material holder 30 g includes the reusable holder base 31 , the holder lid 32 b, the tam ping spring 36 , and the bottom tamper 34 inside the reusable holder base 31 . [0164] A cross-sectional side view of the seventh brewing material holder 30 g taken along line 31 - 31 of FIG. 30 showing the seventh brewing material holder 30 g with a portion of brewing material 41 and the holder lid 32 a above the reusable holder base 31 , and with the bottom tamper 34 and tamping spring 36 inside the reusable holder base 31 , is shown in FIG. 32A . A cross-sectional side view of the seventh brewing material holder 30 g taken along line 31 - 31 of FIG. 30 showing the brewing material holder with the portion of brewing material 41 in the filter paper 40 in the reusable holder base 31 resting on the bottom tamper 34 supported by the tamping spring 36 , and the holder lid 32 a above the reusable holder base 31 , is shown in FIG. 32B . A cross-sectional side view of the seventh brewing material holder 30 g taken along line 31 - 31 of FIG. 30 , showing the seventh brewing material holder 30 g with the portion of brewing material 41 in the brewing material holder 30 e, and the holder lid 32 a attached to the reusable holder base 31 , is shown in FIG. 32C . The tamping spring 36 and bottom tamper 34 tamp the brewing material 41 upward against the holder lid 32 a to provide a tamped brewing material when the holder lid 32 a is attached to the reusable holder base 31 . [0165] A side view of an eighth brewing material holder 30 h according to the present invention is shown in FIG. 33 , a cross-sectional side view of the eighth brewing material holder 30 h taken along line 34 - 34 of FIG. 33 showing a portion of brewing material 41 for placing inside the brewing material holder and a fourth holder lid 32 d with an insertable portion and an O-Ring 50 inside the brewing material holder for sealing is shown in FIG. 34A , and a cross-sectional side view of the eighth brewing material holder taken along line 34 - 34 of FIG. 33 showing the portion of brewing material 41 inside the brewing material holder 30 h and the holder lid 32 d with the insertable portion inserted into the brewing material holder base 31 a is shown in FIG. 34B . The filter paper 40 extends up above the O-ring 50 and the O-Ring 50 cooperates with the holder lid 32 d to sandwich the top edge of the filter paper 40 for sealing the filter paper 40 to reduce or prevent the brewing material 41 from escaping when the flow of hot water is provided to the brewing material holder 30 h. The reusable holder base 31 a is preferably cylindrical but may also be conical in shape. [0166] A side view of a ninth brewing material holder 30 i according to the present invention is shown in FIG. 35 , a cross-sectional side view of the ninth brewing material holder 30 i taken along line 36 - 36 of FIG. 35 showing a portion of brewing material 41 for placing inside the brewing material holder and a fifth holder lid 32 e with a threaded portion for screwing inside the reusable holder base 31 b for sealing is shown in FIG. 36A , and a cross-sectional side view of the ninth brewing material holder 30 i taken along line 36 - 36 of FIG. 35 showing the portion of brewing material 41 inside the brewing material holder and the holder lid 32 e with the threaded portion screwed into the brewing material holder and tamping the brewing material 41 is shown in FIG. 36B . The threads both provide tamping and sealing the coffee to reduce or prevent the brewing material 41 from escaping when the flow of hot water is provided to the brewing material holder 30 h. The reusable holder base 31 b is preferably cylindrical to facilitate having internal threads, and at least the threaded portion is preferably cylindrical. [0167] A third coffee maker 10 c having a brewing material holder 30 according to the present invention for receiving a portion of brewing material, and a tamping spring 36 for tamping the coffee, is shown in FIG. 37A , the third coffee maker 10 c with the brewing material holder 30 holding the portion of brewing material 41 is shown in FIG. 37B , and the third coffee maker 10 c with the brewing material holder 30 holding the portion of brewing material 41 with the coffee maker lid 14 closed for tamping the brewing material 41 is shown in FIG. 37C . When the coffee maker lid 14 is closed, the pad 17 pushes the brewing material holder 30 down and the tamping spring 36 enters the bottom of the brewing material holder 30 to tamp the brewing material 41 . While attaching the lid 32 a to the holder 30 is preferred in order to prevent coffee grounds from escaping the holder 30 , the coffee maker 10 c may also be used without the lid 32 a and the pad 17 may serve to seal the brewing material 41 in the holder 30 . In this instance, the coffee maker lid 14 serves as a brewing material holder lid. [0168] A third coffee maker 10 c having a brewing material holder for receiving a portion of brewing material, and tamping spring 36 attached to the coffee maker lid 14 , according to the present invention for tamping the brewing material 41 when the coffee maker lid 14 is closed is shown in FIG. 38A , the third coffee maker 10 c with the brewing material holder 30 holding the portion of brewing material 41 is shown in FIG. 38B , and the third coffee maker 10 c with the brewing material holder 30 holding the portion of brewing material 41 with the coffee maker lid 14 closed to push the tam ping spring 36 into the brewing material holder 30 for tamping the brewing material 41 is shown in FIG. 38C . [0169] A fourth coffee maker 10 d having a third holder base 31 c for receiving a packet 41 a containing untamped brewing material, a knife 50 for cutting the packet 41 a open, and tam ping spring 36 under the reusable holder base 31 c , according to the present invention, for tamping the brewing material when the coffee maker lid is closed, is shown in FIG. 39A , the fourth coffee maker 10 d with the reusable holder base 31 c holding the packet 41 a of untamped brewing material is shown in FIG. 39B , and fourth coffee maker with the reusable holder base 31 c holding the packet of tamped brewing material 41 c with the coffee maker lid 14 closed to push the reusable holder base down over the tamping spring 36 for tamping the brewing material is shown in FIG. 39C . The coffee maker 10 d includes a somewhat pointed nozzle 19 a to puncture the packet 41 a to provide the flow of hot water to the tamped brewing material in the packet 41 a . Known brewing material packets include internal filters to allow a flow of hot water through the packet to make the brewed drink while preventing brewing material grounds from escaping. The cut in the packet 41 a made by the knife 50 allows the brewed drink to escape from the packet while filter material in the packet 41 a prevents brewing material grounds from escaping. The tamping spring 36 may also be attached to the lid 14 as in FIGS. 38A-38C . [0170] The packet 41 a may be an air tight pod containing brewing material in filter paper and positioning the knife on the side of the reusable holder base 31 c results in less likelihood of the knife 50 cutting the filter paper. The packet 41 a is preferably air tight to maintain coffee freshness and may be plastic, metal foil, or other air tight material which is sufficiently flexible to allow the coffee contained in the packet 41 a to be tamped. Alternatively, the knife 50 may be eliminated when the packet 41 a is configured to burst under pressure to expose the brewing material, for example, when the coffee maker tamps the brewing material, the packet 41 a also bursts. In one embodiment, filter paper 41 is inserted into the reusable holder base 31 c without the knife 50 , and the packet 41 a bursts during compacting to release the brewed drink into the filter paper. [0171] Known coffee makers use a sealed cup or capsule having a somewhat ridged cup with a foil cover. Such cups might be compressible and used in the coffee maker 10 d, however, a similar cup or capsule having a less ridged cup which may be compressed in the coffee maker 10 d are more suitable for use in the coffee maker 10 d to allow tamping of the brewing material contained in the cup or capsule. [0172] A fifth coffee maker 10 e for horizontally receiving the brewing material holder 30 is shown in FIG. 40A , the fifth coffee maker with the brewing material holder 30 residing in the coffee maker is shown in FIG. 40B , and the fifth coffee maker with the coffee maker lid 14 closed and the tamping spring 36 entering the brewing material holder 30 for tamping the brewing material 41 is shown in FIG. 40C . The fifth coffee maker 10 d may alternatively include a tamping spring entering the brewing material holder top, or a resilient solid block pushed into the brewing material holder 30 to tamp the brewing material. Preferably, a horizontal ram 42 a is actuated when the lid 14 is closed and pushed the brewing material holder 30 against the spring 36 to tamp the brewing material. The horizontal ram 42 a may be actuated by an electrical solenoid, by pressure, or by mechanical levers connected to the lid 14 . The fifth coffee maker 10 e may further include any of the features described above for other embodiments of the coffee maker according to the present invention and may be configured to use any of the brewing material holders described above according to the present invention. [0173] A side view of a tenth brewing material holder 30 j with straight walls according to the present invention is shown in FIG. 41 , and a cross-sectional view of the tenth brewing material holder 30 j taken along line 42 - 42 of FIG. 41 showing an empty brewing material holder is shown in FIG. 42 . The brewing material holder 30 j provides straight cylindrical inside walls allowing a better fit between the top tamper 35 b and the inside walls to reduce or eliminate brewing material 41 escaping past the top tamper 35 b during tamping. [0174] A cross-sectional view of the tenth brewing material holder 30 j taken along line 42 - 42 of FIG. 41 showing a full and tamped brewing material holder is shown in FIG. 43 . The tamping spring 36 has been pushed down by the lid 32 b to tamp the brewing material 41 . [0175] A side view of an eleventh brewing material holder 30 k with straight walls according to the present invention is shown in FIG. 44 , a cross-sectional view of the eleventh brewing material holder 30 k taken along line 45 - 45 of FIG. 44 showing an empty brewing material holder is shown in FIG. 45 , and a cross-sectional view of the eleventh brewing material holder 30 k taken along line 45 - 45 of FIG. 41 showing a full and tamped brewing material holder 30 f is shown in FIG. 46 . As with the brewing material holder 30 j, the brewing material holder 30 k provides straight cylindrical inside walls allowing a better fit between the lid 32 f and the inside walls to reduce or eliminate brewing material 41 escaping past the lid 32 f during tamping. The lid 32 f may be used with or without the top tamper 35 b. [0176] A side view of a top tamper 35 b is shown in FIG. 47A and a top view of the top tamper 35 b is shown in FIG. 47B . A side view of a top tamper 35 b ′ with a seal 60 according to the present invention is shown in FIG. 47C and a top view of the top tamper 35 b ′ with the seal 60 is shown in FIG. 47D . In some instances, for example with a very fine ground coffee, an amount of coffee may escape past the top tamper 35 b. In such instances, a user may prefer to use the top tamper 35 b ′ with the seal 60 to reduce or eliminate the escape of the coffee. [0177] A perspective view of a filter paper cup 40 ′ with a folding cup lid 40 d is shown in FIG. 48 (also see FIG. 7C ). The cup lid 40 d may be folded over the rim 40 c to reduce or prevent coffee from escaping during tamping of subsequent processing. The lid 40 d may also include a perforation 40 e centered on the lid 40 d allowing the nozzle 19 to enter and/or inject the hot flow of water into the tamped brewing material 41 , but in some embodiments, the lid 40 d does not include the perforation 40 e. The filter paper cup 40 ′ may be used in the coffee containers described herein, and may be used in a coffee machine having a cavity for receiving the filter paper cup 40 ′. While the cup 40 ′ is preferably made from filter paper, the cup may also be made from a reusable mesh. [0178] A side view of a twelfth brewing material holder 30 I with straight walls according to the present invention is shown in FIG. 49 , and a cross-sectional view of the twelfth brewing material holder 30 I taken along line 50 - 50 of FIG. 49 showing an empty brewing material holder is shown in FIG. 50 . The twelfth brewing material holder 301 includes a straight walled base 31 a and the tam ping spring below the brewing material, and additionally uses the filter paper cup 40 ′ with the folding lid 40 d. [0179] A cross-sectional view of the twelfth brewing material holder 30 I taken along line 50 - 50 of FIG. 49 showing the lid 32 a, brewing material 41 , the filter paper cup 40 ′ with lid 40 d, above the brewing material holder base 31 a is shown in FIG. 51A , a cross-sectional view of the twelfth brewing material holder 30 I taken along line 50 - 50 of FIG. 49 showing the lid 32 a, above the brewing material 41 , and the filter paper cup 40 ′ resting in the brewing material holder base 31 a is shown in FIG. 51B , a cross-sectional view of the twelfth brewing material holder 30 I taken along line 50 - 50 of FIG. 49 showing the lid 32 a, above the brewing material 41 and the filter paper cup 40 ′ resting in the brewing material holder base 31 a with the filter paper cover 40 d folded over the brewing material 41 in the filter paper cup 40 ′ is shown in FIG. 51C , and a cross-sectional view of the twelfth brewing material holder 30 I taken along line 50 - 50 of FIG. 49 showing the lid 32 a attached to the base 31 a with the brewing material 41 and the filter paper cup 40 ′ residing in the brewing material holder base 31 a with the brewing material 41 tamped is shown in FIG. 51D . In embodiments with the brewing material 41 partially exposed above the base 31 a, some brewing material 41 may escape during tamping. Using the filter paper cup 40 ′ having the fold over paper lid 40 d reduces or eliminates such escape of brewing material 41 . [0180] A side view of a thirteenth brewing material holder 30 m with a releaseable tamping latch 64 according to the present invention is shown in FIG. 52 and a cross-sectional view of the thirteenth brewing material holder 30 m taken along line 53 - 53 of FIG. 52 showing an empty brewing material holder 30 m is shown in FIG. 53 . The latch 64 is held in a latched position by a spring loaded lever 62 on the exterior of the base 31 a . [0181] A cross-sectional view of the thirteenth brewing material holder 30 m taken along line 53 - 53 of FIG. 52 showing the lid 32 a, brewing material 41 , the filter paper cup 40 , above the base 31 a, with the tamping latch 64 retaining the bottom tamper 34 , is shown in FIG. 54A , a cross-sectional view of the thirteenth brewing material holder 30 m taken along line 53 - 53 of FIG. 52 showing the lid 32 a above the brewing material 41 and the filter paper cup 40 resting in the brewing material holder base 31 a, with the tamping latch 64 retaining the bottom tamper 34 is shown in FIG. 54B , a cross-sectional view of the thirteenth brewing material holder 30 m taken along line 53 - 53 of FIG. 52 showing the lid 32 a attached to the base 31 a above the brewing material 41 , and the filter paper cup 40 resting in the brewing material holder base 31 a with the tamping latch 64 retaining the bottom tamper 34 is shown in FIG. 54C , and a cross-sectional view of the fourteenth brewing material holder 30 m taken along line 53 - 53 of FIG. 52 showing the lid 32 a attached to the base 31 a with the brewing material 41 and the filter paper cup 40 residing in the brewing material holder base 31 a with tamping latch 64 released and the brewing material 41 tamped, is shown in FIG. 54D . The lever 62 thus holds the latch 64 until the lever 62 is pushed to release the latch 62 to release the bottom tamper 34 to tamp the brewing material 41 . [0182] A side view of a fourteenth brewing material holder 30 n with a releaseable tamping latch 64 according to the present invention is shown in FIG. 55 and a cross-sectional view of the fourteenth brewing material holder taken along line 56 - 56 of FIG. 55 showing an empty brewing material holder 30 n is shown in FIG. 56 . The lever 62 holds the latch 64 until the arm 66 attached to the lid 32 g pushes the lever 62 to release the latch 64 . [0183] A cross-sectional view of the fourteenth brewing material holder 30 n taken along line 56 - 56 of FIG. 55 showing the lid 32 g, brewing material 41 , and the filter paper cup 40 , above the brewing material holder base 31 a, with the tamping latch 64 retaining the bottom tamper 34 is shown in FIG. 57A , a cross-sectional view of the fourteenth brewing material holder 30 n taken along line 56 - 56 of FIG. 55 showing the lid 32 g above the brewing material 41 and the filter paper cup 40 resting in the brewing material holder base 31 a, with the tamping latch 64 retaining the bottom tamper 34 is shown in FIG. 57B , a cross-sectional view of the fourteenth brewing material holder 30 n taken along line 56 - 56 of FIG. 55 showing the lid 32 g, above the brewing material 41 and the filter paper cup 40 resting in the brewing material holder base 31 a with the tamping latch 64 released but just prior to tam ping (the bottom tamper has been released but has not moved upward against the brewing material 41 ) is shown in FIG. 57C , and a cross-sectional view of the fourteenth brewing material holder 30 n taken along line 56 - 56 of FIG. 55 showing the lid 32 g attached to the base with the brewing material 41 and the filter paper cup 40 residing in the brewing material holder base 31 a with tamping latch 64 released and the brewing material 41 tamped is shown in FIG. 57D . The lever 62 thus holds the latch 64 until the lever 62 is pushed by the arm 66 to release the latch 62 to release the bottom tamper 34 to tamp the brewing material 41 . [0184] A side view of a fourteenth brewing material holder 30 o with a releaseable tamping lock according to the present invention is shown in FIG. 58 and a cross-sectional view of the fourteenth brewing material holder 30 o taken along line 59 - 59 of FIG. 58 showing an empty brewing material holder is shown in FIG. 59 . The brewing material holder 30 o includes a tamping lock 70 which engages a second bottom tamper 34 ′ to hold the second bottom tamper in a down position for filling the brewing material holder with coffee and releases the bottom tamper 34 ′ to be pushed upwards by the tamping spring 36 to tamp the coffee after the holder lid 32 b is attached to the base 31 a . [0185] A cross-sectional view of the fourteenth brewing material holder 30 o taken along line 59 - 59 of FIG. 58 showing a lid 32 b, brewing material 41 , a filter paper cup 40 , above the brewing material holder base 31 , with the tamping lock 70 retaining the bottom tamper 34 ′ is shown in FIG. FIG. 60A , cross-sectional view of the fourteenth brewing material holder taken along line 59 - 59 of FIG. 58 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base, with the tamping latch retaining the bottom tamper 34 ′ is shown in FIG. FIG. 60B , a cross-sectional view of the fourteenth brewing material holder taken along line 59 - 59 of FIG. 58 showing the lid, above the coffee and the filter paper cup resting in the brewing material holder base prior to tamping is shown in FIG. 60A , and a cross-sectional view of the fourteenth brewing material holder taken along line 59 - 59 of FIG. 58 showing the lid 32 b attached to the base 31 a with the brewing material 41 and the filter paper cup 41 residing in the brewing material holder base 31 a with tamping lock released and the coffee tamped is shown in FIG. 60D . [0186] A top view of a tamping lock 70 according to the present invention is shown in FIG. 61 and a bottom view of a second bottom tamper 34 ′ which cooperates with the tamping lock 70 according to the present invention is shown ion FIG. 62 . The tamping lock 70 includes teeth 72 which are inserted between and turned to engage lips 74 on the bottom of the bottom tamper 34 ′ to hold the bottom tamper in the down position for filling the brewing material holder 30 o with brewing material 41 . After the brewing material holder 30 o is filled with brewing material and the holder lid 32 b attached, the tam ping lock is twisted to release the bottom tamper 32 b to tamp the brewing material. [0187] A side view of a filter cup 80 according to the present invention is shown in FIG. 63A and a top view of the filter cup 80 is shown in FIG. 63B . The filter cup 80 includes a ring 84 made of a material sufficiently strong to hold shape in the proposed use. Filter material 82 is attached to the ring 84 . The filter cup 80 is insertable into the brewing material holder and in many embodiments is a replacement for the filter paper cup 40 . [0188] A brewing material holder 30 p with an embodiment of a lid 32 h is shown in FIG. 64 . The lid 32 h includes a downward reaching cylindrical portion 90 insertable into a brewing material holder base 31 c. The cylindrical portion 90 may include an O-ring 92 for sealing the lid 32 h to the brewing material holder base 31 c. [0189] While the present invention is described above as placing brewing material in a brewing material holder, the invention may also be practiced by placing prepackaged coffee, for example coffee pods, into the brewing material holder. Further, while the brewing material holder is generally described as having a snap on lid, a screw on lid may also be used, and in general the various elements of different embodiments described above may be mixed to provide new embodiments and such new embodiments are intended to come within the scope of the present invention. [0190] Further, many embodiments are described as including a coffee chamber comprising a filter paper cup. In many cases, a filter cup made of nylon mesh or metal mesh is equally suitable, and any brewing material holder or combination of coffee maker and brewing material holder including a filter chamber which holds coffee and allows the coffee to be tamped as described above is intended to come within the scope of the present invention regardless of the specific filter material. [0191] While the invention herein disclosed has been described by means of specific embodiments and applications thereof, numerous modifications and variations could be made thereto by those skilled in the art without departing from the scope of the invention set forth in the claims.

A self-tamping brewing material holder tamps loose ground brewing material obtaining richer flavor. The brewing material holder includes a holder base and a holder lid. Brewing material is loosely deposited in the brewing material holder base and the holder lid is attached to the holder base. Cooperation of the holder base and holder lid biases a tam per against the brewing material to tamp the brewing material. The tamping may be biased by a spring or by a resilient solid material attached to the brewing material holder lid and push the brewing material down inside the base or may be biased by a spring or by a spring or resilient solid material attached to the brewing material holder base and push the brewing material up against the holder lid. Heated water is pumped through the lid and into the brewing material during brewing.

BACKGROUND 1. Field of the Invention [0001] The present invention relates to a fluid heat exchanger assembly and more particularly to a personal cooling device. The invention utilizes commercially available thermoelectric heat transfer devices having the capability to concurrently provide heating and cooling on opposing sides of the device. [0002] 2. Description of the Related Art [0003] The heating and/or cooling of fluid (i.e., gases or liquids) in transmit or at a point of accumulation has been effected in a multitude of fashions dating back as far as the origin of the very reasons for such heat transfer. A majority of the pieces of prior art typically center around heat transfer from or to a fluid by the circulation of currents from one region to another. [0004] In the area of vehicle racing in particular, special suits are used by individuals in an attempt to maintain a cooler epidermal temperature while performing various strenuous or dangerous acts. One such product, in particular, the K&P Temp Suit, is a hooded vest made from a loose-knit cotton fabric with a nylon inner liner worn by a driver while competing in an automobile race. The system is supplied with the suit, an ice with chest with a pump, a timer, fittings, wire connecters and enough hose and wires to mount the components almost anywhere in the vehicle. The cooling system, in particular, consists of either a 16-quart or 8-quart ice chest with a built-in pump and attached hose. The manufacturer of this device indicates that using the 16-quart chest the ice load will last up to four hours depending upon the cooling line insulation, test location and heat load. Temperature control is accomplished by a variable timer. This timer cycles the pump on and off at various rates thereby controlling the temperature. The suit, in particular, has a chin strap which keeps a cooling tube against the back of the neck thereby cooling the back of the neck. The chin strap and the vest front are fastened by velcro, thereby making fastening or unfastening simple. The suit is connected to the cooling system by a quick release or dry brake connecter. [0005] Other designs of racing suits have centered around various forms of fabric which are considered to “breath.” These fabrics allow water vapor emitted from the epidermal layer to pass through the fabric thereby taking heat from the epidermal layer to the environment. Additionally, body-suits worn by those involved in hazardous activities typically provide regions or layers which are impervious to air flow for various safety reasons. However, these safety reasons often conflict with the ability of the wearer to stay relatively cool in performing their duties by inhibiting air flow for cooling the epidermal region of the wearer, thus generally inhibiting the stamina of the wearer. These systems have compromised the cooling capabilities of various fabrics directly to inhibit the very air flow which could present a danger to the wearer. Other body-suits have been developed in which cool liquids are circulated throughout a particular apparel, only to be refrigerated and reticulated again. [0006] Additionally, racing helmets for stock car drivers have been fitted with built-in side ports to accommodate air conditioning hoses or ventilation hoses. An example of such a ventilation hose attachment may be seen on NASCAR Winston Cup type vehicles where a duct is placed in the driver's window opening, which is cupped inward toward the driver, pulling air into an attached ventilation hose which flows into a side port on the driver's helmet. Additionally, these helmets have various vents which can be opened to provide variable flow, thus directing the air flow to a particular region(s) that the driver desires. Helmets worn by open wheel racers or motorcycle racers, in general, typically have vents which can be opened in a variable fashion or completely closed thereby directing airflow into the helmet in various orientations. These helmets need not use the duct and ventilation hose used by stock car drivers, because in large part their helmet is directly in the line of fluid or air flow over the cockpit. SUMMARY [0007] The present invention relates to a heat transfer system for cooling fluids utilizing one or more thermoelectric devices being made up of two ceramic wafers and a series of P and N doped semi-conductor blocks positioned there between. The ceramic wafered thermoelectric devices are used to cool a conduit(s) through which the fluid is passed. Effective heat transfer is brought about when the fluid moves through the conduit enabling conduction between the ceramic wafered thermoelectric device and the particles of the conduit. [0008] Advantageously, the ceramic wafered thermoelectric devices operate on relatively low power and voltages and are relatively durable. Because the ceramic wafered thermoelectric devices emanate thermal energy on the side of the devices opposite that of the cooling side, the exemplary embodiment of the present invention may utilize a plurality of conduits for fluid flow enabling the heat withdrawn from a first conduit to be distributed to at least a second conduit. [0009] It is a first aspect of the present invention to provide a fluid heat exchanger assembly comprising: a fluid inlet; a cooler fluid conduit in fluid communication with the fluid inlet having a cooler fluid outlet; a warmer fluid conduit in fluid communication with the fluid inlet and having a warmer fluid outlet; and at least one ceramic wafered thermoelectric device having a cooling wafer surface and an opposed warming wafer surface, positioned between the warmer fluid conduit and the cooler fluid conduit, such that the cooling wafer surface faces the cooler fluid conduit and the warming wafer surface faces the warmer fluid conduit; where upon electrical activation of the ceramic wafered thermoelectric device the cooling wafer becomes relatively cool in comparison to the warming wafer surface becoming relatively warm. [0010] It is a second aspect of the present invention to provide a method of exchanging heat between at least two fluid conduits comprising the steps of: providing at least one ceramic wafered thermoelectric device having at least a cooling wafer surface and a warming wafer surface opposing the cooling wafer surface; and positioning the ceramic wafered thermoelectric device to develop a thermal gradient between fluid within a conduit to be cooled and the cooling wafer surface of the ceramic wafered thermoelectric device, and to develop a thermal gradient between fluid within a conduit to be heated and the warming wafer surface of the ceramic wafered thermoelectric device. [0011] It is a third aspect of the present invention to provide a fluid heat exchanging assembly comprising: a fluid inlet; a cooler fluid conduit in fluid communication with the fluid inlet and splitting into at least two parallel conduits between the fluid inlet and at least one cooler fluid outlet; at least one warmer fluid conduit in fluid communication with the fluid inlet; at least two ceramic wafered thermoelectric devices each having a cooling wafer surface opposing a warming wafer surface, a first one of the ceramic wafered thermoelectric wafer devices being positioned between the warmer fluid conduit and a first one of the parallel conduits, such that the cooling wafer surface faces the first one of the parallel conduits and the warming wafer surface faces a section of the warmer fluid conduit, the second ceramic wafered thermoelectric device being positioned between the warmer fluid conduit and a second one of the parallel conduits such that the cooling wafer surface faces the second one of the parallel conduits and the warming wafer surface faces a section of the warmer fluid conduit; a power source operatively coupled to the ceramic wafered thermoelectric device; and a warmer fluid outlet in fluid communication with the warmer fluid conduit. [0012] It is a fourth aspect of the present invention to provide a fluid heat exchanging assembly comprising: a fluid inlet; a warmer fluid conduit in fluid communication with the fluid inlet and splitting into at least two parallel conduits between the fluid inlet and at least one warmer fluid outlet; at least one cooler fluid conduit in fluid communication with the fluid inlet; at least two ceramic wafered thermoelectric devices each having a cooling wafer surface opposing a warming wafer surface, the first one of the ceramic wafered thermoelectric devices being positioned between the cooler fluid conduit and a first one of the parallel conduits such that the warming wafer surface faces the first one of the parallel conduits and the cooling wafer surface faces a section of the cooler fluid conduit, the second ceramic watered thermoelectric device being positioned between the cooler fluid conduit and a second one of the parallel conduits such that the warming wafer surface faces the second one of the parallel conduits and the cooling wafer surface faces a section of the cooler fluid conduit; a power source operatively coupled to the ceramic wafered thermoelectric device; and a cooler fluid outlet in fluid communication with the cooler fluid conduit. [0013] It is a fifth aspect of the present invention to provide a method of cooling the epidermis of a human being comprising the steps of: providing at least one ceramic wafered thermoelectric device having at least a cooling wafer surface and an opposed warming wafer surface; developing a thermal gradient between the fluid to be cooled and the cooling wafer surface of the ceramic wafered thermoelectric device by the ceramic wafered thermoelectric device; and directing the cooled fluid through a region in fluid communication with the epidermis of a human being. [0014] It is a sixth aspect of the present invention to provide a method for protecting the epidermis of a human being comprising the steps of: providing at least one ceramic wafered thermoelectric device having at least a cooling wafer surface and an opposed warming wafer surface; developing a thermal gradient between the fluid to be cooled and the cooling wafer surface of the ceramic watered thermoelectric device by the ceramic wafered thermoelectric device; directing the cooled fluid to a region approximate the epidermis of a human being; and selectively dispersing a combustion suppression fluid in place of, or in combination with, the cooled fluid when conditions for combustion are present or are detected. [0015] It is a seventh aspect of the present invention to provide a method of cooling the epidermis of a human being comprising the steps of: providing at least one ceramic wafered thermoelectric device having at least a cooling wafer surface and an opposed warming wafer surface; utilizing the ceramic wafered thermoelectric device to develop a thermal gradient between the fluid to be cooled and the cooling wafer surface of the ceramic wafered thermoelectric device; donning hazardous duty apparel by a human being, the apparel having a plurality of conduits for cooling fluid flow; and directing the cooled fluid to the plurality of conduits in the apparel. [0016] It is an eighth aspect of the present invention to provide a personal cooling device for use with hazardous duty equipment and/or apparel (such as racing equipment and/or apparel), comprising: an air conduit having an inlet and an outlet, the outlet being in fluid communication with an item of racing apparel, an item of hazardous duty apparel, a protective helmet, a harness, a belt, a shoe, a sock, a glove, and/or a body suit; and at least one ceramic wafered thermoelectric device having a warming wafer surface opposing a cooling wafer surface, positioned in close proximity to the air conduit and such that the cooling wafer surface faces the air conduit so as to allow heat transfer between the air conduit and the cooling wafer surface. [0017] It is a ninth aspect of the present invention to provide a personal cooling system for a racecar driver, comprising: a protective helmet having at least one coolant air path extending therein in fluid communication with an inlet; an air intake mounted to the racecar adapted to receive at least a portion of air flowing past the racecar; a coolant conduit coupled between, and providing fluid communication between the inlet of the protective helmet and the air intake; at least one ceramic wafered thermoelectric device having a warming wafer surface opposing a cooling wafer surface, positioned in close proximity to the coolant conduit and oriented such that the cooling wafer faces the coolant conduit; and a power supply operatively coupled to the ceramic wafered thermoelectric device, whereby the ceramic wafered thermoelectric device promotes heat transfer between the coolant conduit and the cooling wafer surface. BRIEF DESCRIPTION OF THE DRAWINGS [0018] [0018]FIG. 1 is a perspective view of an exemplary fluid heat exchanger apparatus according to certain aspects of the present invention; [0019] [0019]FIG. 2 is a cross-sectional view of the fluid heat exchanger apparatus of FIG. 1, taken along lines 2 - 2 of FIG. 1; [0020] [0020]FIG. 3 is a perspective view of an optional blower for use with the fluid heat exchanger apparatus of FIG. 1; [0021] [0021]FIG. 4 is a schematic representation of a cooled racing jumpsuit for use with the fluid heat exchanger apparatus of FIG. 1; [0022] [0022]FIG. 5 is a perspective view of a 3-way valve assembly coupled between the fluid heat exchanger apparatus, the cooled jumpsuit and a source of flame suppression fluid; and [0023] [0023]FIG. 6 is a schematic representation of a cooled racing helmet assembly utilizing a fluid heat exchanger apparatus according to an aspect of the present invention. DETAILED DESCRIPTION [0024] A method and apparatus for heating and/or cooling fluids in transit is disclosed. More particularly, a personal cooling device for use with hazardous duty equipment or apparel, or for use with racing equipment or apparel is disclosed. In the following description, for purposes of explanation, specific references are set forth to provide a thorough understanding of exemplary embodiments of the present invention. However, those of ordinary skill in the art will understand these detailed explanations to be non-limiting and encompassing obvious variations of the detailed description. [0025] The ceramic wafered thermoelectric devices (CWTD) utilize two thin ceramic wafers with a series of bismuth telluride semi-conductor blocks sandwiched therebetween which are sufficiently doped to exhibit an excess of electrons (P) or a deficiency of electrons (N). The ceramic wafer material provides an electrically-insulated and mechanically rigid support structure for the thermoelectric device. The “P&N” type semiconductor blocks are electrically interconnected such that, upon electrical activation and depending upon the polarity, heat is transferred from one ceramic wafer to the opposite wafer causing a first ceramic wafer to become cooled while the opposing ceramic wafer becomes hot. The CWTDs are commercially available, for example, as the ZMAX® (line from Tellurex Corporation, Traverse City, Mich. (www.tellurex.com). [0026] The structure of an exemplary embodiment of the present invention may be assembled utilizing 1.5 inch aluminum tubing, 0.375 inch polymer tubing, two ceramic wafered thermoelectric devices having wafer surface area approximately measuring 2.25 inches squared, and two aluminum conduits for distributing the fluid flow between the sections of 0.375 inch polymer tubing. [0027] As shown in FIGS. 1 and 2, an exemplary embodiment of a fluid heat exchanger assembly 10 for use with the present invention includes a primary fluid conduit 12 having a fluid inlet 14 and a fluid outlet 16 , and a secondary fluid conduit 18 having a fluid inlet 20 and a fluid outlet 22 . In this exemplary embodiment, the secondary fluid conduit 18 branches from, and is in fluid communication with, the primary fluid conduit at a point 24 upstream from a heat exchange section 26 such that fluid flowing into the inlet 14 of the primary fluid conduit 12 will flow into the fluid inlet 20 of the secondary fluid conduit 18 . At a point 24 upstream from the heat exchanger section 26 , the secondary fluid conduit 18 branches into a pair of parallel (in a flow sense), conduit branches 28 A and 28 B, each of which are coupled to a respective pair of heat exchange conduits 30 A and 30 B. [0028] Each heat exchange conduit 30 A, 30 B is a fluid conduit of heat transfer material, such as aluminum, having an inlet 32 A, 32 B, an outlet 34 A, 34 B and a substantially planar heat exchange segment 36 A, 36 B positioned therebetween. Each heat exchange conduit 30 A, 30 B is positioned on opposite radial sides of the primary fluid conduit 12 in the heat exchange section 26 , and each sandwiches a ceramic wafered thermoelectric device 38 therebetween. As discussed above, each CWTD 38 includes a ceramic wafer 40 A, 40 B that becomes relatively hot and a ceramic wafer 42 A, 42 B that becomes relatively cool when power is supplied to the leads 44 of the CWTD 38 . A power source (not shown) provides 12VDC to the leads 44 when activated. In the present exemplary embodiment, the hot wafer 40 A, 40 B faces the primary fluid conduit 12 and the cool wafer 42 A, 42 B faces the heat exchange segment 36 A, 36 B of the heat exchange conduit 30 in fluid communication with the secondary fluid conduit 18 . In the exemplary embodiment, the heat exchange segment 36 A, 36 B of the heat exchange conduit 30 A, 30 B is divided into a plurality of discrete paths 46 A, 46 B to increase surface area contact between the heat exchange material of the heat exchange conduit 30 A, 30 B and the fluid flowing therethrough (See FIG. 2 in particular). [0029] As power is delivered to the CWTDs 38 by leads 44 , the hot ceramic wafer 40 A, 40 B becomes relatively hot by drawing the thermal energy away from cold ceramic wafer 42 A, 42 B and the thermal energy generated by the semiconductors as a result of current flow therethrough. The difference in temperature between the hot ceramic wafer 40 A, 40 B and the temperature of the fluid within the primary fluid conduit 12 establishes a gradient for thermal energy transfer to the fluid in the primary fluid conduit from the hot ceramic wafer 40 A, 40 B. Concurrently, the cold ceramic wafer 42 A, 42 B becomes relatively cold as thermal energy is drawn away from its surface. The difference in temperature between the cold ceramic wafer 42 A, 42 B and the fluid within heat exchange conduit 30 A, 30 B establishes a gradient for thermal energy transfer from the fluid flowing within heat exchange conduit 30 A, 30 B to the cold ceramic wafer 42 A, 42 B. In sum, the result is fluid passing within primary fluid conduit 12 being heated or increased in temperature by operation of the CWTDs 38 ; and, simultaneously, the fluid passing within secondary fluid conduit 18 is cooled or decreased in temperature by operation of the CWTDs 38 . [0030] After the fluid within primary fluid conduit 12 has passed through the heat exchange section 26 , the warmer fluid is expelled via the fluid outlet 16 . Concurrently, cooler fluid within secondary fluid conduit 18 , after having passed through the heat exchange section 26 , is thereafter expelled via the fluid outlet 22 . [0031] As will be described in a first exemplary application of this heat exchanger assembly 10 , the fluid outlet 22 from the secondary fluid conduit 18 provides a source of cooled air to an apparel item of a race-car driver and the fluid outlet 16 from the primary fluid conduit 12 is in fluid communication with an exhaust port or channel. [0032] If the orientation of the CWTDs 38 are switched, or if the polarity of the power supplied to the leads 44 of the CWTDs 38 were reversed, then the fluid flowing through the primary fluid conduit 12 would be cooled and the fluid flowing through the secondary fluid conduit 18 would be heated. Thus, as will be described below in a second exemplary application of this heat exchanger assembly 10 , the CWTDs 38 are reversed as described, the fluid outlet 16 from the primary fluid conduit 12 provides a source of cooled air to a helmet of a race-car driver and the fluid outlet 22 from the secondary fluid conduit 18 is in fluid communication with an exhaust port or channel. [0033] As shown in FIG. 3, it is within the scope of the present invention to utilize a fluid pump, such as a blower 48 , to accelerate the fluids flowing through the primary and/or secondary conduits 12 , 18 . The blower 48 of FIG. 3 is coupled in fluid communication with the primary conduit 12 , upstream from the heat exchange section 26 , by a fluid conduit 50 that branches from the primary fluid conduit 12 . As the blower 48 operates, fluid is drawn from the environment into the blower 48 and pushed through the branch conduit 50 , thereafter arriving in primary fluid conduit 12 . The fluid flow generated by blower 48 results in a decrease in fluid pressure in the inlet 14 upstream from primary conduit 12 . This decrease in pressure results in a pressure differential between the fluid source and fluid at the entrance of the inlet 14 , thus inducing fluid flow into the inlet 14 and directionally toward primary fluid conduit 12 . It is within the scope of the present invention to provide a pump with more than one fluid outlet, or provide a plurality of pumps with one or more fluid outlets for generating flow in the direction of the primary conduit 12 . It is within the scope of this aspect of the present invention that the blower 48 be substituted with any type of pump which can create a pressure differential in the fluid, thereby promoting fluid flow in a desired direction. Examples of pumps which may be used with the present invention include, without limitation, fans, positive displacement pumps, gear pumps and centrifugal pumps. [0034] As shown in FIG. 4, a first exemplary application for the fluid heat exchanger assembly 10 is to cool a jumpsuit 52 worn by a race-car driver. The jumpsuit 52 includes a plurality of conduits 54 extending into various regions of the jumpsuit 52 , where the conduits 54 include air exit ports 56 that allow cool air to be released in the respective region of the jumpsuit 52 . Each of the conduits 54 are coupled for fluid communication with an inlet conduit 57 that, in turn, includes a quick-disconnect coupling 58 for providing fluid communication with a source of cooled air, such as the fluid outlet 22 of the fluid heat exchanger assembly 10 . [0035] The plurality of conduits 54 are a structure of flexible hoses divided into five sections for total body cooling. The sections are: left front lower conduit 54 A, right front lower conduit 54 B, right front upper conduit 54 C, left front upper conduit 54 D and a conduit 54 E for the neck and/or head cooling, or for leading to the rear of the jumpsuit 52 . Inlet conduit 57 may be secured to the jumpsuit (Kevlar Safety Suit) 52 . The user may additionally have a mechanism (not shown) conveniently placed in relation to the position of the user's appendages thereby enabling the user to provide restriction of the fluid flow if the desired cooling effect is being or has been achieved. [0036] In addition to the jumpsuit 52 , it is also within the scope of the present invention to provide conduits for fluid flow within a protective harness, a belt, a shoe, a sock, a glove, hazardous duty apparel (such as firefighting apparel) and/or racing apparel. [0037] As shown in FIG. 5, a three-way valve 60 may be provided in fluid communication between the source of cooled air 62 , a source of combustion suppression fluid 64 and a fluid outlet 65 , which includes a quick-disconnect coupling 66 adapted to mate with the quick-disconnect coupling of the jumpsuit 52 . The source of cooled air 62 may be the fluid outlet 22 of the fluid heat exchanger assembly 10 . The three-way valve 60 may be operated in such a manner so as to selectively provide fluid communication between the fluid outlet 65 and the source of the cooled air 62 to the exclusion of combustion suppression source 64 , or to selectively provide fluid communication between the fluid outlet 65 and the combustion suppression source 64 to the exclusion of the source of cooled air 62 . The three-way valve 60 may be electrically connected via leads 68 to a power source (not shown) in which case the user may utilize a manual switch 70 or an automatic switch (not shown) to option between the fluid communication possibilities offered. [0038] The combustion suppression source 64 may be continuously in fluid communication with a combustion suppression hose 72 . Combustion suppression fluid may be any available combustion suppression agent having as a suppression ingredient fluid or solid matter disbursed utilizing a fluid medium. Examples of such suppression ingredients include water, carbon dioxide, sand and dry powders. [0039] As shown in FIG. 5, a second exemplary application for the fluid heat exchanger assembly 10 is to provide cooling air to a racer's helmet 74 . In this application, the polarity of the CWTDs 38 are reversed so that the air in the primary conduit 12 is cooled and the air in the secondary conduit 18 is heated. A duct 76 , positioned at the inlet 14 of the primary conduit 12 , may be mounted, for example, in a driver's door window opening in the lower comer closest to the front of the vehicle to receive air flowing thereover. As the velocity of the air passing by the duct 76 increases, more and more air is drawn into the duct 76 , and, in turn, the inlet 14 . The duct 76 may be cupped in shape to induce air to be drawn into the duct 76 and thereby push air into primary conduit 12 . At the cupped based of duct 76 , an interface 78 is formed between primary conduit 12 and duct 76 . The interface 78 is the point at which the air becomes axially surrounded by primary conduit 12 . The continual flow of air into the duct 76 provides the driving force to move the air from the duct 76 into primary conduit 12 . Commercially available ducts can be ordered as part number FA-NACA from helmetcity.com. [0040] The helmet 74 includes a built in side helmet port 80 for mating with the outlet 16 of the primary conduit 12 . The side helmet port 80 is in fluid communication with an inner conduit or bladder 82 for distributing the cooled air about and/or onto the wearer's head. The construction of such an inner bladder 82 or conduit will be readily ascertained by those of ordinary skill in the art. The fluid outlet 18 , in this application, is coupled to an exhaust port or conduit (not shown) for removing the heated air. [0041] While exemplary applications for the fluid heat exchanger assembly 10 utilize cooled fluid expelled within a hazardous duty/racing suit or helmet, it is also within the scope of the present invention to provide a similar apparatus which expels heated fluid in situations in which such heated fluid is desired by the user in either a suit or helmet. [0042] With each of the embodiments disclosed herein, it is within the scope of the invention to incorporate a feedback control system with power supplied to the CWTDs 38 for regulating the temperature of the fluid being heated or cooled. Such a control system would be easily available to one of ordinary skill in the art. [0043] Following from the above description and invention summaries, it should be apparent to those of ordinary skill in the art that, while the processes and systems herein described constitute exemplary embodiments of the present invention, it is understood that the inventions contained herein are not limited to these precise processes and systems and that changes may be made to them without departing from the scope of the inventions as defined by the claims. [0044] Additionally, it is to be understood that the invention is defined by the claims and it is not intended that any limitations or elements describing the exemplary embodiments set forth herein are to be incorporated into the meanings of the claims unless such limitations or elements are explicitly listed in the claims. Likewise, it is to be understood that it is not necessary to meet any or all of the identified advantages or objects of the inventions disclosed herein in order to fall within the scope of any claims, since the invention is defined by the claims and since inherent and/or unforeseen advantages of the present invention may exist even though they may not have been explicitly discussed herein.

The present invention is directed to a fluid heat exchanger assembly comprising: a fluid inlet; a cooler fluid conduit in fluid communication with the fluid inlet having a cooler fluid outlet; a warmer fluid conduit in fluid communication with the fluid inlet and having a warmer fluid outlet; and at least one ceramic wafered thermoelectric device having a cooling wafer surface and an opposed warming wafer surface, positioned between the warmer fluid conduit and the cooler fluid conduit, such that the cooling wafer surface faces the cooler fluid conduit and the warmer wafer surface faces the warmer fluid conduit; whereupon electrical activation of the ceramic wafered thermoelectric device the cooling wafer becomes relatively cool in comparison to the warmer wafer surface becoming relatively warm. Additionally, the heat exchanger assembly may receive ambient air flowing through a fluid inlet positioned within or on a vehicle such that the cooler fluid is directed into at least one item taken from the group of: a body-suit worn by a driver of a vehicle, apparel worn by a driver of a vehicle and protective equipment worn by a driver of a vehicle.

BACKGROUND OF THE INVENTION [0001] This invention provides stable pharmaceutical compositions of the N-methyl-D-aspartic acid (NMDA) receptor antagonist, (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol, methods of preparing such pharmaceutical compositions and methods of treating stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases such as Alzheimer's disease, senile dementia of the Alzheimer's type, Huntington's disease, Parkinson's disease, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and an ischemic event arising from CNS surgery, open heart surgery or any procedure during which the function of the cardiovascular system is compromised, using the pharmaceutical compositions of this invention. [0002] (1S,2S)-1-(4-Hydroxyphenyl)-2-(4-hydroxy4-phenylpiperidin-1-yl)-1-propanol (hereafter referred to as the “Compound”) is a neuroprotecting agent that is useful for the treatment of stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases such as Alzheimer's disease, senile dementia of the Alzheimer's type, Huntington's disease, Parkinson's disease, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and an ischemic event arising from CNS surgery, open heart surgery or any procedure during which the function of the cardiovascular system is compromised. The Compound exhibits activity as an NMDA receptor antagonist. NMDA is an excitatory amino acid involved in excitatory neurotransmission in the central nervous system. NMDA antagonists are compounds that block the NMDA receptor by interacting with the receptor's binding site. [0003] Antagonists of neurotransmission at NMDA receptors are useful therapeutic agents for the treatment of neurological disorders. U.S. Pat. No. 4,902,695 is directed to series of competitive NMDA antagonists useful for the treatment of neurological disorders, including epilepsy, stroke, anxiety, cerebral ischemia, muscular spasms, and neurodegenerative disorders such as Alzheimer's disease and Huntington's disease. U.S. Pat. No. 4,968,878 is directed to a second series of competitive NMDA receptor antagonists useful for the treatment of similar neurological disorders and neurodegenerative disorders. U.S. Pat. No. 5,192,751 discloses a method of treating urinary incontinence in a mammal, which comprises administering an effective amount of a competitive NMDA antagonist. [0004] Commonly assigned U.S. Pat. No. 5,272,160 and commonly assigned U.S. Pat. No. 5,710,168 (the disclosures of which are hereby incorporated by reference) disclose the Compound and methods of using the Compound for treatment of diseases or conditions that are susceptible to treatment by blocking NMDA receptor sites, including stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and ischemic events. [0005] Commonly assigned U.S. Pat. No. 6,008,233 (the disclosure of which is hereby incorporated by reference) discloses the methanesulfonate trihydrate of the Compound and uses thereof for treatment of the aforesaid diseases and conditions. [0006] The Compound is preferably administered as an intravenous infusion lasting many hours. Such administration is intended to maintain a desired blood level of the compound for the duration of the therapy. Typically, therapy with the Compound is initiated in the hospital emergency room and continues for a desired time in the ICU or other critical care units. [0007] Formulations and dosage presentations of the Compound should be designed for convenient and efficient administration and should be especially suited for the emergency setting. Degradation of the Compound in such formulations should be minimized. SUMMARY OF THE INVENTION [0008] This invention provides relatively stable formulations of the Compound in aqueous solutions made by reducing or removing the presence of trace metal ions in the solutions. Stability is further improved through the use of a pharmaceutically acceptable buffer. Additional stability is afforded by reducing the presence of oxygen in the formulations. [0009] One aspect of the present invention is pharmaceutical compositions comprising a pharmaceutically effective amount of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof and water, wherein said compositions contain less than about 2 parts per million of free copper ion and less than about 2 parts per million of free iron ion. [0010] Another aspect of the present invention is pharmaceutical compositions comprising (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof, water and a pharmaceutically acceptable chelating agent, preferably ethylenediaminetetraacetic acid, citric acid, succinic acid or tartric acid or a pharmaceutically acceptable salt thereof, at a concentration effective to chelate with trace metal ions present in said composition. [0011] A further aspect of the present invention is pharmaceutical compositions comprising (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof in an aqueous solution, wherein the percent of the degradation product, 4-hydroxybenzaldehyde, is no more than about 0.15 percent of said composition following storage at 50° C. for 12 weeks, preferably no more than about 0.07 percent and most preferably no more than about 0.04 percent. [0012] An additional aspect of this invention is pharmaceutical compositions comprising (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof in an aqueous solution, wherein the percent of the degradation product, 4-hydroxy-4-phenylpiperidine, is no more than about 0.2 percent of said composition following storage at 50° C. for 12 weeks, preferably no more than about 0.1 percent and most preferably no more than about 0.05 percent. [0013] An additional aspect of this invention is methods of treating stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases such as Alzheimer's disease, senile dementia of the Alzheimer's type, Huntington's disease, Parkinson's disease, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and an ischemic event arising from CNS surgery, open heart surgery or any procedure during which the function of the cardiovascular system is compromised, in mammals, comprising administering to a mammal in need of such treatment a pharmaceutical composition of this invention. [0014] In a preferred embodiment of the composition aspects of this invention, the compositions are substantially free of free copper ion and free iron ion. [0015] In another preferred embodiment of the composition aspects of this invention, the compositions contains less than about 2 parts per million of any free trace metal ion, and more preferably is substantially free of any free trace metal ion. [0016] Another preferred embodiment of the composition aspects of this invention provides that the compositions comprise a pharmaceutically acceptable buffer at a concentration effective to maintain the pH of the compositions at between about 3.8 to about 5.0 and more preferably at between about 4.0 to about 4.5. In a more preferred embodiment, the anion of the buffer is selected from acetate, citrate, tartrate, formate and lactate, most preferably lactate. [0017] A further preferred embodiment of the composition aspects of this invention provides that the compositions are substantially free of oxygen. [0018] In a preferred embodiment of the method of treatment aspects of this invention, the mammal is a human. [0019] The term “chelating agent” as used herein means any compound that sequesters, forms a complex or otherwise interacts with trace metal ions such that the destabilizing effect of such metal ions to the Compound in aqueous solution is minimized. Exemplary chelating agents include ethylenediaminetetra-acedic acid (EDTA) and its salts, trans-1,2-diaminocyclohexanetetra-acedic acid (DCTA) and its salts, bis-(2-aminoethyl)ethyleneglycol-NNN′N′-tetraacetic acid (EGTA) and its salts, diethyllenetriamineepenta-acetic acid (DTPA) and its salts, tri-(2-aminoethyl)amine (tren), NNN′N′-tetra-(2-aminoethyl)ethylenediamine (penten), nitrilotriacedic acid (NTA) and its salts, 2,3-dimercapto-1-propanesulfonic acid (DMPS) and its salts, meso-2,3-dimercaptosuccinnic acid (DMSA) and its salts, hydroxyl acids such as citric, tartaric, lactic, succinic, etc. and their salts, and certain amino acids such as glycine, histidine, and glutamic acid and their salts. [0020] The term “Degradant 1” as used herein refers to the degradation product of the Compound, 4-hydroxybenzaldehyde. [0021] The term “Degradant 2” as used herein refers to the degradation product of the Compound, 4-hydroxy-4-phenylpiperidine. [0022] The terms “free copper ion”, “free iron ion” and “free trace metal ion” as used herein means copper ions, iron ions or trace metal ions, respectively, that when present in an aqueous composition comprising the Compound are in a form or state as to enable them to cause, initiate, encourage or catalyze degradation of the Compound. [0023] “Headspace” refers to the difference in volume between a closed container (e.g., a vial) and the volume of liquid contained in that container. The headspace can be quantified as a percent of the total volume of the closed container. [0024] The expression “means to remove trace metal ions” as used herein means any means that may be used to remove trace metal ions from an aqueous solution. For example, such means can include the use of metal chelating resins or other chelating reagents that are known to those skilled in the art. [0025] The term “non-reactive gas” as used herein means any gas that does not react or interact chemically with a pharmaceutical composition or any of its components. Such gas is preferably nitrogen, but may be argon, helium, or any other gas known by those skilled in the art for its non-reactive properties. [0026] The expressions “percent of Degradant 1” and “percent of Degradant 2” means the percent of the applicable degradation product present in a pharmaceutical composition of the Compound in weight versus weight (w/w) terms. The percent is calculated from peak areas derived from HPLC analysis according to the formula: Percent of Degradant=[( A SAMP ×D SAMP )/( R AVG ×C LAB )]×100 [0027] where: [0028] A SAMP =impurity peak area [0029] D SAMP =dilution factor, calculated as: D SAMP =C LAB /C SAMP [0030] where: [0031] C LAB =label concentration of the Compound in the formulation being-tested (free base concentration) [0032] C SAMP =concentration of the free base of the Compound in the sample tested (based upon dilution of the label concentration used to make the sample) [0033] R AVG =is the average standard response factor (“R”) obtained from analysis of a standard solution, calculated as: R=A STD /( C STD ×PF ) [0034] where: [0035] A STD =peak area of the Compound in the standard solution [0036] C STD =concentration of the Compound in the standard solution [0037] PF=potency factor of the Compound in the standard solution, calculated as the molar weight of the free base of the compound divided by the molar weight of the actual compound in the standard solution. [0038] The dilution factor, D SAMP , accounts for dilution that may be necessary so that the sample tested is within the validated concentration limits of the HPLC method. [0039] The expression “pharmaceutically acceptable” as used herein refers to carriers, diluents, excipients, buffers and/or salts that are compatible with the other ingredients of the formulation and are not deleterious to the recipient thereof. [0040] The term “substantially free” as used herein with respect to the presence of trace metal ions in pharmaceutical compositions comprising the Compound, means a quantity that is less than that which would have a substantial effect on degradation of the Compound in such compositions. Notwithstanding the foregoing, such an amount is less than about 2 ppm for any applicable trace metal ion. The term “substantially free” as used herein with respect to the presence of oxygen in or in contact with pharmaceutical compositions comprising the Compound, means a quantity of oxygen that is less than that which would have a substantial effect on degradation of the Compound in such compositions. For example, in compositions packaged in closed containers or vials having a headspace wherein such headspace is 25% or less of the volume of the container or vial, the term “substantially free” means that there is less than 10% oxygen in such headspace. [0041] The term “trace metal ion” as used herein means any metal ion that, when present in an aqueous pharmaceutical composition comprising the Compound, causes, initiates, encourages or catalyzes degradation of the Compound, especially ions of transition metals and most especially iron and copper ions. DETAILED DESCRIPTION OF THE INVENTION [0042] The active ingredient in the present pharmaceutical compositions is (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol, which may be present as its free base or as a pharmaceutically acceptable salt, preferably the methanesulfonate (mesylate) salt. The preparation of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol is described in U.S. Pat. No. 5,272,160 and in U.S. Pat. No. 6,008,233. The preparation of the mesylate salt trihydrate is described in U.S. Pat. No. 6,008,233. [0043] In a representative example, (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol is administered to a stroke or head trauma patient at the emergency site or in the hospital emergency room by intravenous infusion. Therapy would continue in the ICU or other critical care units. The amount of the compound to be administered would, in part, depend on the body weight of the patient. [0044] A concentrated solution of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol that can readily be diluted according to the needs of the patient provides the required dosing flexibility. The concentrated solution would, if necessary, be diluted to the appropriate concentration for administration to the patient. [0045] Formulations of the present pharmaceutical compositions may be in the form of concentrated solutions intended to be diluted in a suitable IV diluent prior to administration. The formulations may also be prepared as ready to use forms that are at concentrations that can be administered without further dilution. The preferred concentration of the compositions in concentrate form is 10 milligrams of the free base of the active compound, (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol, per 1 milliliter of solution (i.e., 10 mgA/mL). The preferred concentration of the ready to use forms is 1.25 mgA/mL. [0046] The composition is administered full strength or is diluted as required. A preferred dosage concentration for administration to the patient is 0.1 mgA/mL to 10 mgA/mL. A more preferred dosage for administration is at a concentration of 0.5 mgA/mL to 2.0 mgA/mL. An even more preferred dosage concentration is 1.25 mgA/mL. The preferred IV diluent of the composition is normal saline solution (0.9% NaCl). [0047] Two degradants produced by the chemical degradation of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol in aqueous solutions are the compounds 4-hydroxybenzaldehyde (hereafter “Degradant 1”) and 4-hydroxy-4-phenylpiperidine (hereafter “Degradant 2”). While not essential to the practice of this invention and not intending to be limited in any manner thereby, it is believed that such degradation is the result of oxidation of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol. [0048] Trace metal ion contamination has been found to be a critical factor in the degradation of the Compound. Such effects are exemplified by spiking experiments of solutions containing the Compound with iron or copper ions. Table 1 shows the effect of iron and copper ions in unbuffered water for injection (WFI) solution on degradation product formation. TABLE 1 Effect of Fe 2+ and Cu + spiking on degradation of the Compound. Numbers represent percent of Degradant 1 (w/w). Days at 70° C. WFI only Fe 2+ (20 ppm) Cu + (20 ppm) Day 0 0.002% 0.024% 0.085% Day 3 0.007% 0.061% 0.107% Day 7 0.009% 0.110% 0.128% [0049] An, effective, means of improving the chemical stability of the Compound is achieved by removing trace metal ions from the aqueous formulation. One method of metal ion removal is by employing agents specifically designed for this purpose. Exemplary metal ion removing agents include chelating resins such as Chelex® (Chelex is a trademark of Bio-Rad Laboratories, Inc., Hercules, Calif.). However, other pharmaceutically acceptable chelating resins or reagents performing the same function would be acceptable so long as they do not detrimentally affect the Compound or other components of the formulation. [0050] Treatment for removal of trace metal ions may be performed on individual components of the formulation prior to final formulation or such treatment may be performed on the formulation itself. For example, water that is to be used in the formulation may be treated to remove trace metals. Alternatively, concentrated buffer solutions may be treated prior to dilution with water and formulation with the active ingredient. In another alternative, the aqueous solution containing all components of the formulation except for the active pharmaceutical ingredient may be treated to remove metal ions. A still further alternative is to treat the complete formulation that contains all components, including the active ingredient. [0051] An alternative to removal of trace metal ions is to incorporate certain compounds in the formulation that will form a chelate with the trace metal ions, thereby minimizing their degradation effect. Examples of such chelating agents include ethylenediaminetetraacetic acid (EDTA) disodium and citrate and tartrate buffers. The preferred concentration of EDTA disodium, citrate buffer and tartrate buffer is 10 mM each. Citrate and tartrate are believed to act as chelating agents for trace metal ions. In addition, succinate is believed to act as a chelating agent. Other chelating agents will be apparent to those skilled in the art in light of this disclosure. [0052] Aqueous solutions of the Compound are susceptible to pH shift. The compound is believed to exhibit its best chemical stability between pH 4.0 and 4.5. When the Compound is formulated with only water, the pH of the formulation increases above 5. This pH shift results in conditions favorable to the oxidative degradation reaction, thus accelerating the degradation of the aqueous formulation. The increase in pH also decreases the solubility of the compound, thereby increasing the possibility of precipitation out of solution. [0053] The pH shift may be minimized by using a suitable buffer. Those skilled in the art will appreciate that any pharmaceutically acceptable buffer that maintains the pH of the formulation within a certain range may be used. The pH range of such buffer is preferably between about 3.8 and about 5.0, and most preferably between 4.0 and 4.5. Suitable buffers include, but are not limited to, acetate, benzoate, citrate, formate, lactate and tartrate buffers, preferably lactate. [0054] Table 2 exemplifies the use of various buffers to stabilize the pH of formulations containing 10 mgA/ml of the Compound. TABLE 2 pH at 70° C. Initial Buffer lot (post-TS) 2 days 4 days 7 days 21 days 10 mM acetate 4.16 N/T 4.14 4.14 4.17 10 mM benzoate 4.21 N/T 4.16 4.20 N/A 10 mM citrate 4.16 4.16 N/T 4.17 4.11 10 mM formate 4.17 4.18 N/T 4.16 4.13  3 mM lactate 4.24 4.21 N/T 4.20 4.14 10 mM tartrate 4.15 4.17 N/T 4.17 4.07 [0055] In order to further improve stability of the active compound, it is preferable that the oxygen content in the formulation be reduced. This can be done by sparging the formulation solution with nitrogen, argon or other non-reactive gas and, when the compositions of the invention are packaged in vials or similar containers containing a headspace, using such inert gas for the headspace. When the compositions of the invention are packaged so that they contain a headspace, it is preferable that the oxygen content in the headspace be less than about 12% and most preferably less than about 8%. Oxygen may be removed by other methods, including the use of a vacuum to remove air and oxygen. Other methods of oxygen removal will be apparent to those skilled in the art. [0056] A preferred presentation of the composition aspects of the invention comprises the Compound at a concentration of 10 mgA/mL. This concentration is near the maximum solubility of the Compound (about 12 mgA/mL at 5° C.). The preferred solution of the composition is 10 mM lactate buffer. However, those skilled in the art will appreciate that buffer solutions of other anions may be used, including, but not limited to, buffer solutions of the anions acetate, citrate, tartrate and formate. [0057] A preferred packaging of the compositions is a 40 cc, Flint Type I molded glass vial with rubber stopper and aluminum shell. Alternative presentations can include other vial or container types, pre-filled syringes or pre-filled IV bags. Other packaging presentations will be apparent to those skilled in the art. [0058] Vials are preferably sterilized by terminal sterilization methods employing an autoclave. Preferably, sterilization is for 8 minutes at 121° C. Sterilization may cause a slight shift of pH. In the lactate buffered formulation, pH shifted slightly down. In order to achieve a mid-point in the preferred pH range, the initial pH is preferably set to 4.5. The terminal sterilization cycle reduces the pH to about 4.2. EXPERIMENTAL EXAMPLES [0059] The present invention is illustrated by the following examples, but is not limited to the details thereof. [0060] Percentages of Degradant 1 and Degradant 2 where measured using reverse-phase HPLC analysis on a Kromasil® C4 column, 5 μm, 25 cm length×4.6 mm ID (EKA Chemicals, Bohus Sweden). Column temperature was 30° C.±5° C. Mobile phase A: water/acetonitrile/trifluoracetic acid, 90/10/0.1 (v/v/v). Mobile phase B: water/acetonitrile/trifluoracetic acid, 40/60/0.1 (v/v/v). Gradient profile: linear. Detection: UV @215 nm. Flow rate: 1.5 mL/min. Injection volume: 10 μL. Example 1 [0061] Effect of Treatment with a Chelating Resin. [0062] Solutions of sodium chloride of 0.3, 0.6 and 0.9% were treated with 5% w/w of Chelex® resin and stirred slowly for 1 hour. The pH of the solutions was adjusted to 4.6 while stirring with the Chelex resin. The mixture was then filtered. Control samples of sodium chloride solutions of 0.3, 0.6 and 0.9% were prepared which were not treated with the Chelex resin. Treated and untreated solutions were combined with (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol at a concentration of 1.25 mgA/ml and stored in sealed 5 cc Flint type I molded vials containing 4.0 ml solution fill and 2.0 ml air headspace at 70° C. for 7 days. The results of this experiment are represented in Table 3. TABLE 3 Numbers represent percent of Degradant 1 (w/w). % NaCl Untreated Treated 0.3 0.034% 0.004% 0.6 0.038% 0.003% 0.9 0.033% 0.003% Example 2 [0063] Effect of Formulating with a Chelating Agent. [0064] The following solutions were made to a concentration of 10 mM each at pH 4.2: [0065] 1. Unbuffered normal saline (0.9% NaCl); [0066] 2. 10 mM Citrate buffer in normal saline (0.9% NaCl); [0067] 3. 10 mM Tartrate buffer in normal saline (0.9% NaCl); and [0068] 4. 10 mM EDTA disodium in normal saline (0.9% NaCl); [0069] Solutions of each were combined with (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol to a concentration of 1.25 mgA/ml and the pH was adjusted to 4.2. Each formulation was subjected to an 8 minute autoclave cycle at 121° C. and then stored at 70° C. The results of this experiment are represented in Table 4 below. TABLE 4 Numbers represent percent of Degradant 1 (w/w). 0.9% NaCl 10 mM 10 mM 10 mM Saline Tartrate Citrate EDTA Day 0 N/A 0.002% 0.000% 0.000% Day 3 N/A 0.003% 0.001% 0.000% Day 7 0.033% 0.006% 0.001% 0.002% Example 3 [0070] 4-Hydroxybenzaldehyde (Degradant 1). [0071] NMR analysis was performed at ambient temperature on a Bruker Avance DRX 500 MHz NMR spectrometer using a Bruker 5mm gradient broadband inverse probe (Bruker Instruments, Inc., Billerica, Mass.). Sample was dissolved in 99.9% deuterated dimethyl sulfoxide (DMSO). 13 C-NMR 1 H-NMR Carbon (PPM) H's Attached Proton (PPM) δ Proton Multiplicity 115.84 1 6.92 doublet 128.43 0 132.10 1 7.74 Doublet 163.32 0 190.95 1 9.77 Singlet Example 4 [0072] 4-Hydroxy-4-phenylpiperidine (Degradant 2). [0073] NMR analysis was performed at ambient temperature on a Bruker Avance DRX 500 MHz NMR spectrometer using a Bruker 5 mm gradient broadband inverse probe. Sample was dissolved in 99.9% deuterated dimethyl sulfoxide (DMSO). 13 C-NMR 1 H-NMR Carbon (PPM) H's Attached Proton (PPM) δ Proton Multiplicity 39.05 2 1.49 doublet 1.77 triplet 42.03 2 2.70 doublet 2.92 triplet 70.41 0 124.70 1 7.46 doublet 125.97 1 7.18 triplet 127.76 1 7.30 triplet 150.76 0 Example 5 [0074] Formulation of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol in lactate buffer. Weight Concentration Component Grade Function (mg/vial) (mg/ml) (1S,2S)-1-(4- Pharm Active 586.01 14.577 hydroxyphenyl)-2- ingredient (equal to (4-hydroxy-4- 10 mgA/ml) phenylpiperidin-1- yl)-1-propanol mesylate trihydrate Lactic Acid USP Buffer 41.12 1.023 Sodium Hydroxide NF pH modifier Ca 13.87 Ca 0.345 Hydrochloric Acid NF pH modifier 0 0 Water for Injection USP Vehicle 39711.76 987.855 [0075] USP=United States Pharmacopoeia [0076] NF=National Formulary [0077] The pH of the initial formulation is set at pH 4.5 to accommodate the slight pH down-shifting upon terminal sterilization. The terminal sterilization cycle lowers the pH to about 4.2. Sodium hydroxide and hydrochloric acid are used as needed to adjust the solution to the desired pH. Example 6 [0078] Accelerated Stability Study. [0079] A-10 mgA/ml solution of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol in 10 mM lactate buffer was prepared. The pH of three separate portions was adjusted so that the initial post terminal sterilization pH was 3.9, 4.2 or 4.6. The formulation was packaged in vials containing varying concentrations of oxygen or in air. Terminal sterilization was by autoclave at 121° C. for 8 minutes. Samples were stored in 40 ml Flint type I vials with 40 ml fill and 10 ml headspace for 12 weeks at 30° C., 40° C. and 50° C. [0080] The results of this experiment are presented in Table 5 and Table 6 below. TABLE 5 Numbers represent percent of Degradant 1 (w/w). Head space, pH Initial Post T.S. 30° C. 40° C. 50° C.  4% O 2 , pH 4.2 0.002% 0.004% 0.003% 0.005% 0.009%  6% O 2 , pH 4.2 0.002% 0.004% 0.004% 0.005% 0.011% 10% O 2 , pH 4.2 0.004% 0.003% 0.004% 0.006% 0.015% Air, pH 4.6 0.003% 0.003% 0.008% 0.015% 0.033% Air, pH 4.2 0.003% 0.004% 0.004% 0.006% 0.032% Air, pH 3.9 0.003% 0.003% 0.009% 0.019% 0.040% [0081] [0081] TABLE 6 Numbers represent percent of Degradant 2 (w/w). Head Space, pH Initial Post T.S. 30° C. 40° C. 50° C.  4% O 2 , pH 4.2 0.003% 0.006% 0.008% 0.010% 0.017%  6% O 2 , pH 4.2 0.003% 0.006% 0.008% 0.010% 0.019% 10% O 2 , pH 4.2 0.002% 0.006% 0.009% 0.013% 0.024% Air, pH 4.6 0.002% 0.005% 0.012% 0.018% 0.043% Air, pH 4.2 0.001% 0.005% 0.008% 0.012% 0.042% Air, pH 3.9 0.001% 0.003% 0.013% 0.023% 0.051%

This invention relates to stable pharmaceutical compositions of the NMDA receptor agonist, (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol], methods of preparing such pharmaceutical compositions and methods of treating stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases such as Alzheimer's disease, senile dementia of the Alzheimer's type, Huntington's disease, Parkinson's disease, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and an ischemic event arising from CNS surgery, open heart surgery or any procedure during which the function of the cardiovascular system is compromised using the pharmaceutical compositions.

BACKGROUND OF THE INVENTION The invention relates to a toothbrush according to those having interchangeable brush heads for ready replacement when the brush head is worn or for insertion of differing brush heads for use by plural users, and to a brush head for the toothbrush. Toothbrushes and brush heads of this type are known and are available on the market in a variety of designs. Illustrative of prior art constructions are seen in the U.S. patents to Hansen et al U.S. Pat. No. 4,80,924 or Arsenault et al U.S. Pat. No. 5,224,234, for example. The object of the present invention is to provide a toothbrush and a brush head which, in addition to ensuring that used-up brush heads can be exchanged in a straightforward manner, also ensure that the brush head is fastened securely when the toothbrush is used. BRIEF SUMMARY OF THE INVENTION This object is achieved according to the invention by a toothbrush and a brush head having the unique axial insertion and removal of a brush head from the toothbrush handle which insures releasable latching of the head to the handle. Preferred developments of the toothbrush according to the invention and of the brush head form the structure seen in the drawings and include the flat groove in the handle cooperating with the flat tongue spaced from the base of the brush head, including parallel resilient latches on the brush head detachably interengaging with recesses on the handle adjacent the groove therein. DESCRIPTION OF THE DRAWINGS An exemplary embodiment of the toothbrush according to the invention and of the brush head according to the invention is described in more detail hereinbelow and is illustrated in the drawing, in which: FIG. 1 shows a side view of a toothbrush with a handle and a brush head attached; FIG. 2 shows the toothbrush according to FIG. 1 as seen in arrow direction A; FIG. 3 shows a plan view of the brush head and the handle of the toothbrush according to FIG. 1 in the separated state; FIG. 4 shows, on a larger scale than in FIG. 1, a side view of the brush head and the front part of the handle in the separated state; FIG. 5 shows the brush head and the front part of the handle according to FIG. 4 as seen in arrow direction A; FIG. 6 shows a plan view of the brush head and the front part of the handle according to FIG. 4; and FIG. 7 shows the brush head according to FIG. 6 as seen in arrow direction B. FIG. 8 is similar to FIG. 5 showing a modification wherein the centering protrusion and recess arrangements are in a reversed position from that of FIG. 6 . DESCRIPTION OF THE PREFERRED EMBODIMENTS According to FIGS. 1 to 3 , a toothbrush 1 has a handle 2 with an exchangeable brush head 4 , which can be attached to a front part 3 of the handle 2 . The brush head 4 comprises a bristle carrier 5 and bristles 6 which are anchored in the bristle carrier 5 and of which the free ends form a brushing surface 7 (FIG. 1 ). The bristle carrier 5 is provided with bristles up to its border, as can be seen from FIGS. 3 and 6. The longitudinal axis of the toothbrush is designated by la in FIGS. 2 and 3; it has a plane of symmetry E of the toothbrush 1 running through it. The bristle carrier 5 and the brushing surface 7 are preferably of oval shape in plan view, as is illustrated in FIGS. 2 and 3; the front part 3 of the handle 2 is also adapted to this shape in plan view. A base surface of the bristle carrier 5 , from which the bristles 6 project, is designated by 9 in FIG. 1 . The way in which the brush head 4 is retained in a removable manner in the front part 3 of the handle 2 can easily be seen, in particular, from FIGS. 4 to 6 , in which the brush head 4 and the handle 2 are shown in a state in which they have been separated from one another. The front part 3 of the handle 2 , said front part being offset by a step from the rest of the handle 2 (cf. FIG. 4 ), has a recess 8 which is defined by a base 11 , a rear wall 10 and two side walls 12 , 13 . The inner surfaces 12 ′, 13 ′ of the side walls 12 , 13 are slightly inclined with respect to the plane of symmetry E and converge rearward toward the wall 10 . The inner surfaces 12 ′, 13 ′ of the side walls 12 , 13 are each provided with a longitudinal groove 14 , 15 , which runs in the longitudinal direction of the toothbrush (arrow direction S according to FIGS. 2 and 4 ), and with a latching groove 16 , 17 . The latching grooves 16 , 17 are located in the rear region, in the vicinity of the rear wall 10 . The top surface of the side walls 12 , 13 form guide surfaces which are designated by 18 , 19 in FIGS. 6 and 7. A rounded step surface between the front part 3 , which is of spoon-like design, and the rest of the handle 2 is designated by 20 in FIGS. 4 to 6 . The step surface 20 is provided with a centering recess 22 which is parallel to the base 11 and of which the side surfaces 23 , 24 are inclined with respect to the plane of symmetry E such that the centering recess 22 tapers rearward. The bristle carrier 5 of the brush head 4 has a front part 30 , a handle-side, rear part 31 and a retaining part 32 , which is provided on the underside of the rear part 31 . The retaining part 32 is provided on both sides with a guide strip 34 , 35 running in the longitudinal direction S of the toothbrush, the shape and width of the retaining part 32 and of the guide strips 34 , 35 corresponding to the longitudinal grooves 14 , 15 . On the handle-side, rear, free end, the retaining part 32 is provided with two resiliently elastic latching tongues 37 , 38 which can be deformed elastically transversely with respect to the longitudinal direction S, are arranged parallel to the base surface 9 , and to a bottom guide surface 33 of the rear part 31 , and have in each case one latching protrusion 39 , 40 on their outsides. The latching protrusions 39 , 40 correspond to the latching grooves 16 , 17 in terms of shape and arrangement. Provided on the rear part 31 of the bristle carrier 5 is a centering protrusion 42 which is designed to mate with the centering recess 22 , provided in the handle 2 , and has two rearwardly converging side surfaces 43 , 44 which are inclined with respect to the plane of symmetry E. The front part 30 of the bristle carrier 5 has a rounded, bottom step surface 45 at the rear (see FIGS. 4 and 5 ), and this step surface 45 is configured to mate with a rounded end surface 46 of the front handle part 3 . A rear stop surface 47 of the rear bristle-carrier part 31 , said stop surface being provided with the abovementioned centering protrusion 42 , is likewise rounded such that it corresponds to the step surface 20 of the handle 2 . When a new brush head 4 is attached to the handle 2 , the bristle carrier 5 is pushed in the longitudinal direction of the toothbrush (arrow direction S according to FIG. 4 ), by way of its guide surface 33 , onto the top guide surfaces of the front handle part 3 , the retaining part 32 being introduced into the recess 8 . The guide strips 34 , 35 pass into the mating longitudinal grooves 14 , 15 and wedge slightly with respect to the same; at the end of this pushing movement, in an end position of the bristle carrier 5 , the latching tongues 37 , 38 latch into the latching grooves 16 , 17 by way of their latching protrusions 39 , 40 . In this case, the step surface 45 of the bristle carrier 5 comes to rest against the end surface 46 of the handle 2 and the stop surface 47 comes to rest against the step surface 20 , it also being the case that the centering protrusion 42 is introduced into the centering recess 22 and wedges with respect to the same. In order to remove a used-up brush head 4 , the bristle carrier 5 is manually forced forward in the longitudinal direction of the toothbrush (direction counter to arrow S according to FIG. 4 ), for example by exerting force on the slightly upwardly projecting stop surface 47 . This overcomes the wedging action of the centering elements (centering recess 22 , centering protrusion 42 ) and the latching tongues 37 , 38 are forced together elastically transversely with respect to the longitudinal direction S; the latching protrusions 39 , 40 are unlatched from the latching grooves 16 , 17 , and the brush head 4 is pushed out of the recess 8 . This achieves, in a straightforward manner, a fastening for the exchangeable brush head 4 which can easily be released by hand—without using an additional tool—but is nevertheless secure. The additional locking of the two toothbrush parts, said locking being ensured by the centering protrusion 42 and the centering recess 22 , improves the hold of the brush head 4 in the handle 2 when one is cleaning one's teeth, i.e. it prevents the brush head 4 from being loose or even from being released from the handle 2 in an undesired manner. This eliminates any risk of injury when the toothbrush is being used. Moreover, in the case of the inventive design of the brush head 4 and of the handle 2 , interspaces in which water and extraneous particles could penetrate are advantageously filled well when the two toothbrush parts are joined together; deposits of dirt in the recess 8 are largely prevented, which makes it easier to maintain the toothbrush and is highly advantageous from the point of view of hygiene. It would, in fact, be possible for the plug-in connection of the brush head and the handle to be such that the handle is provided with deformable latching tongues with latching protrusions and the bristle carrier is provided with latching recesses. It may, however, be more expedient for parts such as the latching tongues, which are likely to show signs of wear as time progresses, to be assigned to the toothbrush part which can be disposed of once it has been used up. A converse configuration of the additional centering means (centering protrusion on the handle, centering recess in the bristle carrier) is likewise conceivable. Such an arrangement is shown in FIG. 8, wherein the protrusion 42 ′ similar to protrusion 42 in FIG. 6 is on handle 2 extending forwardly from the arcuate surface 20 , and the receiving centering recess 22 ′ similar to recess 22 in FIG. 5 is provided on the rear part 31 of bristle carrier 4 and extending thereinto. In like manner, protrusion 42 ′ has converging tapering side surfaces 43 ′ and 44 ′ and which are complementary to like converging tapered side surfaces 23 ′ and 24 ′ of recess 22 ′ to assist centering of the bristle carrier on the handle. The longitudinal guide for the exchangeable brush head, said longitudinal guide extending in the longitudinal direction S of the toothbrush, could also be formed by guide strips in the handle, in which mating longitudinal grooves in the bristle carrier engage. The inventive embodiment of the toothbrush and the exchangeable brush head is advantageous not just from an aesthetic point of view but also from an ecological point of view since a comparatively small amount of material is required for the disposable parts.

A toothbrush and replaceable brush head wherein the brush head is easily and positively inserted and removed by axial motion along the axis of the handle. The handle and head have cooperating tongue and groove configurations providing parallel guides to receive and retain the members in assembled relation by virtue of handle recesses and resilient catches on the brush head, while permitting ready disassembly to remove and replace the brush head. Further, the handle and brush head have cooperating wedge formations to insure positive centering of the brush head along the axis of the handle. The assembly is snug and leaves no room for dirt, thereby enhancing hygiene during repeated use.

FIELD OF THE INVENTION [0001] This invention relates to novel apparatus and methods which use specific wavelengths of visible light to manipulate the behavior of stored product insect pests in the order Lepidoptera. The invention pertains primarily to the Indian meal moth, Plodia interpunctella , but also is directed at other stored product insect pests, including (but not limited to) the Mediterranean flour moth, Ephestia kuhniella , the tobacco moth, Ephestia elutella , the almond moth, Cadra cautella , the raisin moth, Cadra figulilella and the Angoumois grain moth, Sitotroga cerealella. BACKGROUND OF THE INVENTION [0002] The Indian meal moth (IMM) is one of the worst insect pests of stored foods. Larvae infest many food products (Williams 1964; Doud and Phillips 2000), and have even been reported to infest bee hives feeding on pollen (Kwon et al. 2003). This wide variety of resources used by IMM for oviposition and larval development poses a great challenge for pest managers to control IMM damage. [0003] Indoors, IMMs have a continuous life cycle with multiple generations per year. A gravid female lays 200-400 eggs. Hatching larvae develop through five instars and then wander away from the resource for pupation. [0004] Sex pheromone components of female IMM have been identified (Zhu et al. 1999), and synthetic replica could be developed for monitoring populations or for pheromone-based mass trapping or disorientation of mate-foraging males (Foster and Harris 1997). However, there are problems with the use of just synthetic sex pheromones for IMM control. Pheromone-baited traps target only males. Moreover, males not captured in traps or not affected by pheromone-based disorientation will mate with females, and thus maintain populations at high densities (Olsson et al. 2006). Thus, a method of controlling female IMMs has been suggested. Various food sources and their semiochemicals (message bearing chemicals) have been investigated as attractants or oviposition stimulants for gravid female IMMs. Sources shown to induce upwind flight and oviposition by female IMMs, and closely related moths, include nuts and almonds (Hoppe 1981), walnut oil (Nansen and Phillips 2003), acetic acid and isoamyl alcohol (Tóth et al. 2002), wheat odors (Barrer 1977; Barrer and Jay 1980) chocolate products with nuts or rum (Olsson et al. 2005a) or their semiochemicals, such as cyclohexanone, α-pinene, phenylacetaldehyde, cyclohexanol, 3-ethyl-2,5dimethyl-pyrazine, nonanal, vanillin and ethyl vanillin (Olsson et al. 2005b). However, none of these substances induces sufficient attraction to be used in suppression of a pest population. [0005] Stored product insects are also attracted to light. Stermer (1959) released insects into a large chamber, and trapped them at either end after they responded to light sources. The IMM strongly responded to traps associated with ultraviolet light (334 and 365 nm). The almond moth and the Angoumois grain moth were less attracted to traps associated with ultraviolet light and more attracted to traps associated with blue (475 nm), blue-green (500 nm) and yellow (546 nm) than the IMM. Stermer (1959) describes violet-blue light (404.7 nm) as being an “unattractive waveband”. In contrast to Stermer's (1959) behavioral data, Marzke et al. (1970) used electrophysiological recordings to show that the eyes of IMM males and females were least responsive to ultraviolet light (350 nm) and most responsive to yellow light (550-575 nm). Kirkpatrick et al. (1970) found no significant difference in the captures of almond moths, Angoumois grain moths and IMMs to traps emitting green light, ultraviolet light, or both together, whether the traps were offered simultaneously or separately. Soderstrom (1970) found significantly more Mediterranean flour moths and IMMs were captured in suction traps associated with green than ultraviolet light, while almond moths and Angoumois grain moths showed no preference. Finally, Sambaraju and Phillips (2006) tested the response of IMMs released in a shed with one side dark and the other illuminated by white, ultraviolet or green wavelengths. Both sexes responded to the lighted side of the shed, but males responded equally to all three light sources, while females were more attracted to ultraviolet light than to green or white light. However, shining either green or ultraviolet light on traps baited with sex pheromone caused catches to be reduced compared to pheromone-baited control traps, and few moths were captured on sticky traps illuminated with ultraviolet light. [0006] Integrated pest management programs for stored product Lepidoptera, such as the IMM, commonly employ pheromone-baited traps to detect the occurrence and estimate the severity of infestations (Nansen et al. 2004). However, a recent review on the biology and management of the IMM fails to list a single reference on the use of light in the sampling or manipulation of IMM populations (Mohandass et al. 2007). Given the variable and conflicting data cited above, this is not surprising. [0007] The foregoing examples of the related art and limitations related thereto are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the drawings. SUMMARY OF THE INVENTION [0008] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above-described problems have been reduced or eliminated, while other embodiments are directed to other improvements. [0009] This invention relates to a novel apparatus and methods which use specific wavelengths of visible light, or specific wavelengths of visible light in combination with specific wavelengths of ultra-violet light, to manipulate the behavior of stored product insect pests, including moths and Indian meal moths. [0010] In one embodiment, the invention is a 405 nm (±5 nm) wavelength, or a 405-nm (±5-nm) wavelength in combination with other specific wavelengths of visible or ultra-violet light produced from light-emitting-diodes (LED) or other light sources, to attract males and females of the Indian meal moth, Plodia interpunctella . The LED light sources can be deployed in trapping devices that retain attracted insects. [0011] In another embodiment, the invention can be deployed in combination with other attractants, including (but not limited to) synthetic sex pheromones, natural or synthetic food semiochemicals, and bioacoustic signals. [0012] The invention in broad terms is directed to a method of inducing orientation by stored product insect pests to a light source. The stored product insect pests can be moths, including the Indian meal moth, Plodia interpunctella. [0013] In the method, the effective wavelength range can be 400-475 nm, and the effective intensity ranges can be 50-5000 lux, or 3.8-380 μW measured at 12 cm from the source. In one preferred embodiment, the effective wavelength is about 405 nm. In another preferred embodiment, the effective wavelength is about 405 nm in combination with 350±10 nm. In the method, the light source can be a light emitting diode or narrow band filter. [0014] The stored product moth pests include (but are not limited to) males and females of the following species: the Indian meal moth, Plodia interpunctella , the Mediterranean flour moth, Ephestia kuhniella , the tobacco moth, Ephestia elutella , the almond moth, Cadra cautella , the raisin moth, Cadra figulilella and the Angoumois grain moth, Sitotroga cerealella. [0015] In the method, the light source can be placed in or on a trap. In the method, the stored product moths can be induced to land on or enter the trap, in which they are captured on a sticky surface or inside a receptacle from which they cannot escape. [0016] In the method, the trap can also contain a moth-sound emitting device, and an attractive chemical lure, including (but not limited to) one or more of the following chemicals: (Z,E)-9,12-tetradecadienyl acetate; (Z,E)-9,12-tetradecadienol; (Z,E)-9,12-tetradecadienal; (Z)-9-tetradecenyl acetate; (Z)-11-hexadecenyl acetate; acetic acid; isoamyl alcohol; benzyl alcohol; nonanal; phenylacetaldehyde; hexanol; (E)-2-heptenal; 2-phenylethanol; ethyl decanoate; and geranyl acetone. [0017] In another embodiment, the invention includes an apparatus for attracting stored product insect pests, including (but not limited to) the Indian meal moth, Plodia interpunctella , the Mediterranean flour moth, Ephestia kuhniella , the tobacco moth, Ephestia elutella , the almond moth, Cadra cautella , the raisin moth, Cadra figulielella , and the Angoumois grain moth, Sitotroga cerealella , consisting of a light source placed in a trap. [0018] In a further embodiment of the apparatus, the light source in the trap can be a light emitting diode or narrow band filter. In the apparatus, the insect pest can be Indian meal moth, Plodia interpunctella , and the light source can have an effective wavelength of about 405 nm. The effective light source may also be a wavelength of about 405 nm in combination with other specific wavelengths of visible or ultra-violet light. In the apparatus, the insects that orient to and land on or enter the trap can be captured on a sticky surface or inside a receptacle from which they cannot escape. [0019] In the apparatus, the trap can also contain a moth-sound emitting device, and an attractive chemical lure, including (but not limited to) one or more of the following chemicals: (Z,E)-9,12-tetradecandienyl acetate; (Z,E)-9,12-tetradecadienol; (Z,E)-9,12-tetradecadienal; (Z)-9-tetradecenyl acetate; (Z)-11-hexadecenyl acetate; acetic acid; isoamyl alcohol; benzyl alcohol; nonanal; phenacetaldehyde; hexanol; (E)-2-heptenal; 2-phenylethanol; ethyl decanoate; and geranyl acetone. [0020] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed descriptions. DRAWINGS [0021] Exemplary embodiments are illustrated in referenced figures of the drawings. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive. [0022] FIG. 1 illustrates the scheme of the experimental design employed in two-choice or four-choice experiments. [0023] FIG. 2 illustrates graphical data of mated female Indian meal moths responding in still-air, two-choice laboratory Experiments 1-3 to various light sources, each tested at a light intensity of 53-170 lux. [0024] FIG. 3 illustrates graphical data of male, mated female and virgin female Indian meal moths responding in still air, four-choice laboratory Experiments 4-6 to various light sources, each emitting 15 μW per 1 cm 2 . [0025] FIG. 4 illustrates graphical data of mated female Indian meal moths responding in still-air, two-choice laboratory Experiments 4-6 to blue light (400-475 nm) of different intensities. [0026] FIG. 5 illustrates graphical data of mated female Indian meal moths responding in still-air, four-choice laboratory Experiment 10 to specific wavelengths (405, 435, 450 or 470 nm) in the blue-light wavelength range (400-475 nm). [0027] FIG. 6 illustrates graphical data of mated female Indian meal moths responding in still-air, four-choice laboratory Experiment 11 to specific wavelengths (405, 435, 450 or 470 nm) in the blue-light wavelength range (400-475 nm), each tested at 200 μW per 1 cm 2 . [0028] FIG. 7 illustrates graphical data of male, virgin female and mated female Indian meal moths responding in still-air, two-choice laboratory Experiments 12-14 to a source of blue light (400-475 nm) and a specific wavelength (405 nm) each tested at an intensity of 1,000 lux. [0029] FIG. 8 illustrates graphical data of male, virgin female and mated female Indian meal moths responding in still-air, four-choice laboratory Experiments 15-17 to Light Emitting Diodes (LEDs) emitting at 30 μW per 1 cm 2 a peak wavelength of 505, 525, 565 or 572 nm. [0030] FIG. 9 illustrates graphical data of mated female Indian meal moths responding in still-air, two-choice laboratory Experiment 18 to a single wavelength (405-nm LED) or to a wavelength combination (405-nm LED plus 350-nm LED), with single or combined wavelength stimuli tested at identical light intensity (200 μW per 1 cm 2 ). DETAILED DESCRIPTION OF THE INVENTION [0031] Throughout the following description specific details are set forth in order to provide a more thorough understanding to persons skilled in the art. However, well known elements may not have been shown or described in detail to avoid unnecessarily obscuring the disclosure. Accordingly, the description and drawings are to be regarded in an illustrative, rather than a restrictive, sense. Experimental Insects [0032] Indian meal moth (IMM) larvae, Plodia interpunctella , were obtained from infested cereal bars provided by Pherotech International Inc. Larvae were reared at 27° C. at a photoperiod of 17 hours light and 7 hours dark. The rearing medium was modified from Le Cato (1976) and consisted of whole wheat flour (27.5% by volume), yellow cornmeal (27.5%), Purina One dog food (13.5%), brewers yeast (6.9%), honey (6.9%), glycerine (6.9%; 96% pure), Quaker rolled oats (6.8%) and wheat germ (3.4%). [0033] Fifth instar larvae were separated by sex and placed in groups of 12-15 specimens into Petri dishes (10 cm diam), containing corrugated cardboard as pupation sites. Eclosed adults were kept under the same conditions as larvae (see above). To obtain gravid females, 3-4 virgin males and 2-3 virgin females were kept together during the dark phase in small cages (10×10×10 cm). The next day, females were assumed mated and were used for colony rearing or laboratory experiments. All adult moths used in laboratory experiments were 2-5 days old. General Experimental Design [0034] Still-air, two- or four-choice laboratory bioassays (Experiments 1-10) were conducted in a modified wind tunnel (1×1×3 m long) with air entry and exit sections covered by mesh screens, and also by black paper in Experiments 4-10 to minimize light reflection ( FIG. 1 ). [0035] FIG. 1 illustrates the scheme of the experimental design employed in two-choice or four-choice experiments. Traps, the platform for releasing moths and Light-Emitting-Diodes (LED) are drawn not to scale. [0036] For each replicate, two Petri dishes with ≦5 insects each were placed on a 50-cm tall, black felt-covered platform (23×30 cm) in the centre of the tunnel. In two-choice experiments, a green Delta trap (Pherotech International Inc.) was affixed to a metal pole at a height of 50 cm, and was positioned to the left and right of, and 1.5 m apart from, the release platform. In four-choice Experiment 7, the design was identical except that one trap was near (30 cm; 45° angle) each corner of the tunnel. Light sources as test stimuli were randomly assigned to, and mounted within, traps. All experiments were conducted in the first 2 hours of the 7-hour dark phase, when IMMs forage for mates or suitable oviposition sites. [0037] An experimental replicate was initiated by lifting the lid of each Petri dish on the release platform, and was terminated by scoring the number of moths captured in each trap two hours later. All moths not responding were removed from the wind tunnel prior to initiating a new experimental replicate. After each set of three replicates, the wind tunnel was wiped with 70% ethanol and left to “aerate” overnight. Experiments 1-3 Relative Attractiveness of White, Red, Green and Blue Light Sources to Mated Females Tested in Two-Choice Experiments [0038] To determine the spectrum of visible light that is most effective in attracting IMMs, a 6-volt light bulb connected to a 9-volt power source was placed inside a 2-ml glass vial (10×28 mm) which filtered out ultraviolet light. The glass vial, in turn, was surrounded by a cylindrical (5.5×10.5 cm diam) flexible filter (Lee Filters, Hamshire, England) that generated light spectra in the blue range (400-475 nm, peaking at 400, 425 and 450 nm; referred to as “Rose Purple 7”), green range (475-600 nm, peaking at 510 nm, 545 nm, and 575 nm; “lime 8”) and red range (575-750, peaking at 610 nm and 655 nm; “orange 9”). A clear filter (heat shield #269) was used to generate white light. Light intensities were measured with a Mastersix photometer (Gossen Foto- und Lichtmesstechnik, Nürnberg, Germany) with the diffuser removed so that low-light levels could be measured. All light sources were tested at an intensity of 53-170 lux. [0039] In two-choice Experiments 1-3, it was found that gravid female IMMs preferred blue light over red light (Experiment 1), and white light (containing blue light) over red light (Experiment 2), but failed to show a significant preference for red or green light, which were equally unattractive (Experiment 3) (see FIG. 2 ). This unexpected result shows for the first time a preference for visible light of a defined wavelength over white light that includes that defined wavelength. Sambaraju and Phillips (2006) showed this for ultraviolet, but not visible, light. [0040] FIG. 2 illustrates graphical data of mated female Indian meal moths responding in still-air, two-choice laboratory Experiments 1-3 to various light sources, each tested at a light intensity of 53-170 lux. In each experiment, an asterisk (*) indicates a statistically significant preference for the respective test stimulus; Wilcoxon paired-sample test, P<0.05. Experiments 4-6 Relative Attractiveness of Various Wavelength Ranges to Males, Virgin Females and Mated Females Tested in Four-Choice Experiments [0041] To further determine the spectrum of visible light that is most effective in attracting IMMs, four-choice experiments were conducted. Modified desk lamps (Espressivo, Ikea) with 20-watt halogen bulbs were used as light sources to test the response of males (Experiment 4), virgin females (Experiment 5) and mated females (Experiment 6). Each desk lamp was connected to a rheostat to adjust light intensity, and the halogen bulb was fitted with a black cardboard cylinder (8×12 cm wide), with the light filter mounted at the front 8 cm apart from the bulb. The cylinder projected the light in one direction. Flexible filters (Lee Filters, Hamshire, England) that generated light spectra in the blue range (400-475 nm, referred to as “Rose Purple 7”), green range (475-600 nm, “lime 8”), orange range (525-750 nm, “orange 9”) or red range (590-800 nm, “light Red”). Filter spectra and light intensities were measured with an HR4000 high-resolution spectrometer (Ocean Optics Dunedin Fla.). All light sources were tested at an intensity of 15 μW/cm 2 integrated from 350-700 nm measured at the filter, 8 cm from the halogen light source. [0042] In four-choice Experiments 4-6, it was found that males and mated females showed a significant preference for blue light over red, green and orange light, but that virgin females had no preference for any wavelength range ( FIG. 3 ). [0043] FIG. 3 illustrates graphical data of male, mated female and virgin female Indian meal moths responding in still air, four-choice laboratory Experiments 4-6 to various light sources, each emitting 15 μW per 1 cm 2 . In each experiment, bars with different letters are significantly different; analysis of variance with Tukey's test for multiple comparison of means, P<0.05. Experiments 7-9 Effect of Intensity of Blue Light (400-475 Nm) to Attract IMMs [0044] To determine the intensity of blue light (400-475 nm) most effective in attracting gravid female IMMs, light intensities of 50 versus 200 lux (Experiment 7), 200 versus 1,000 lux (Experiment 8), and 1,000 versus 3,000 lux (Experiment 9) were tested in two-choice experiments. In all three experiments, the filter “Rose Purple 7” (see above) was used to generate blue light, but the light sources differed. In Experiment 7, the light source consisted of a 6.4-volt bulb connected to a 100-ohm adjustable resistor powered at 9 volts. Experiments 8 and 9 deployed a modified desk lamp (Espressivo, Ikea) with a 20-watt halogen bulb to generate light intensities of 1,000 lux and 3,000 lux. The desk lamp was connected to a rheostat to adjust light intensities. The halogen bulb was fitted with a black cardboard cylinder (8×12 cm wide), with the filter “Rose Purple 7” mounted at the front, 8 cm apart from the bulb. The cylinder projected the light in one direction. [0045] In each of Experiments 7-9, it was found that mated female IMMs preferred the blue light of greater intensity over that of lower intensity ( FIG. 4 ). [0046] FIG. 4 illustrates graphical data of mated female Indian meal moths responding in still-air, two-choice laboratory experiments 7-9 to blue light (400-475 nm) of different intensities. In each experiment, an asterisk (*) indicates a statistically significant preference for the respective test stimulus; Wilcoxon paired-sample test, P<0.05. Experiment 10 Attractiveness of Specific Wavelengths in the Blue Light Spectrum (400-475 nm) Each Tested at a Light Intensity of 200 lux [0047] To determine the wavelength in the blue light spectrum (400-475 nm) most effective in attracting mated female IMMs, Light-Emitting-Diodes (LED; Roithner Lasertechnik, Vienna, Austria) with peak wavelengths of 405 nm (range: 400-410 nm), 435 nm (range: 410-470 nm), 450 nm (range: 440-460 nm) and 470 nm (range: 465-475 nm) were tested in four-choice Experiment 10. For each replicate, one of the four LEDs was randomly assigned to, and mounted within, one of four Green Delta Traps (see general experimental design; FIG. 1 ), using a resistor to adjust the intensity of each LED to 200 lux. [0048] In Experiment 10, it was found that the LED with peak wavelength 405 nm was significantly more effective than LEDs with peak wavelength 435 nm, 450 nm or 470 nm in attracting gravid female IMMs. The latter three peak wavelengths were equally unattractive to female moths (see FIG. 5 ). [0049] FIG. 5 illustrates graphical data of mated female Indian meal moths responding in still-air, four-choice laboratory experiment 10 to specific wavelengths (405, 435, 450 or 470 nm) in the blue-light wavelength range (400-475 nm). Bars with different letters are significantly different; analysis of variance with Tukey's test for multiple comparison of means, P<0.05. Experiment 11 Attractiveness of Specific Wavelengths in the Blue-Light Spectrum (400-475 nm) Each Tested at a Light Intensity of 200 μW Per 1 cm 2 [0050] To further determine the wavelength in the blue light spectrum most effective in attracting mated females, an additional four-choice experiment (Experiment 11) was conducted. The experimental design was identical to that of Experiment 10 except that the LEDs were calibrated to emit 200 μW per 1 cm 2 , integrated from 350-550 nm using a HR4000 high-resolution spectrometer (Ocean Optics Dunedin Fla.). [0051] In Experiment 11, it was found that the LED with peak wavelength 405 nm was significantly more effective in attracting gravid females than were LEDs with peak wavelength 435 nm, 450 nm or 470 nm. The latter three peak wavelengths were equally unattractive to female moths ( FIG. 6 ). [0052] FIG. 6 illustrates graphical data of mated female Indian meal moths responding in still-air, four-choice laboratory Experiment 11 to specific wavelengths (405, 435, 450 or 470 nm) in the blue-light wavelength range (400-475 nm), each calibrated at 200 μW per 1 cm 2 . Bars with different letters are significantly different; analysis of variance with Tukey's test for multiple comparison of means, P<0.05; LED=Light Emitting Diode. Experiments 12-14 Attractiveness of “LED 405” and the Blue-Light Spectrum 400-475 nm to Males, Virgin Females and Mated Females [0053] To compare the relative attractiveness of blue light (400-475 nm) and specific wavelength 405 nm (+/−5 nm), both light sources at 200 lux each were tested in two-choice experiments 8-10, with males (Experiment 12), virgin females (Experiment 13) and mated females (Experiment 14) as bioassay insects. The blue-light spectrum was generated from a desk lamp (Espressivio, Ikea) with a Halogen bulb, fitted with a cardboard cylinder (8×12.5 cm diam) for projecting the light and carrying the filter “Rose Purple 7” (as described for experiments 4-6). To standardize visual stimuli, the same set-up was used for the “405-nm LED” which was mounted just in front of the turned-off Halogen bulb. [0054] In two-choice Experiments 12-14, it was found that males (Experiment 12), virgin females (Experiment 13) and mated females (Experiment 14), all preferred the LED with peak wavelength 405 nm over the blue-light spectrum 400-475 nm ( FIG. 7 ). This result was surprising and unexpected, given that Indian meal moths, and other stored product moths, were not highly attracted to light of an almost identical wavelength (404.7 nm), which was described by Stermer (1959) as an “unattractive waveband”. [0055] FIG. 7 illustrates graphical data of male, virgin female and mated female Indian meal moths responding in still-air, two-choice laboratory Experiments 12-14 to a source of blue light (400-475 nm) and a specific wavelength (405 nm) each tested at an intensity of 200 lux. In each experiment, an asterisk (*) indicates a significant preference for the respective test stimulus; Wilcoxin paired-sample test, P<0.05. Experiment 15-17 Attractiveness of Specific Wavelengths in the Green-Light Spectrum (505-572 nm) Each Tested at a Light Intensity of 30 μW Per 1 Cm 2 [0056] Considering that green light (475-600 nm) was somewhat attractive (although not statistically significant) to males, virgin females and mated females in Experiments 4-6 (see FIG. 3 ), and that attraction of IMM to green light is reported in the literature (Stermer 1959; Soderstrom 1970; Kirkpatric and Marzke 1970), four-choice bioassays (Experiments 15-17) were designed to determine the specific wavelength(s) responsible for the attractiveness. Light-Emitting-Diodes (LED) with peak wavelengths of 505 nm, 525 nm, 565 nm or 572 nm (Roithner Lasertechnik, Vienna, Austria) were deployed to test the response of males (Experiment 15), virgin females (Experiment 16) and mated females (Experiment 17). For each replicate, one of the four LEDs was randomly assigned to, and mounted within, one of four Green Delta Traps (see general experimental design; FIG. 1 ), adjusting with a resistor the intensity of each LED to 30 μW per 1 cm 2 . [0057] In Experiments 15-17, it was found that there was a weak preference by males, virgin females and mated females to LEDs emitting a peak wavelength of 505 nm or 525 nm ( FIG. 8 ). In Experiment 15, the 525-nm LED attracted significantly more males than did the 572-nm LED. In Experiment 17, the 525-nm LED attracted significantly more mated females than did the 565-nm LED ( FIG. 8 ). [0058] FIG. 8 illustrates graphical data of male, virgin female and mated female Indian meal moths responding in still-air, four-choice laboratory Experiments 15-17 to Light Emitting Diodes (LEDs) emitting at 30 μW per 1 cm 2 a peak wavelength of 505, 525, 565 or 572 nm. Bars with different letters are significantly different; analysis of variance with Tukey's test for multiple comparison of means, P<0.05. Experiment 18 Attractiveness of Wavelength 405 nm (+/−5 nm) Tested Alone or in Combination with Wavelength 350 nm (+5/−nm) [0059] To determine whether attraction of mated female IMMs to the wavelength 405 nm would increase in the presence of another specific wavelength, two-choice experiment 18 (see FIG. 1 ) tested a single LED emitting peak wavelength 405 nm at 200 μW per 1 cm 2 versus two LEDS, one of which emitting the peak wavelength 405 nm at 180 μW per 1 cm 2 and the other LED emitting the peak wavelength 350 nm at 20 μW per 1 cm 2 . Great care was taken to adjust to 200 μW per 1 cm 2 the total light intensity emitted from either the single LED or the paired LEDs. For each replicate, the paired LEDs were positioned on top of each other and mounted within a green delta trap, using a resistor to adjust the intensity of each LED. The position of test stimuli (see FIGURE 1) was alternated between replicates. [0060] In experiment 18, it was found that the paired 405-nm and 350-nm LEDs attracted more mated females than did the single 405-nm LED ( FIG. 9 ). This indicates that attraction of IMMs to a 405-nm LED can be improved by addition of other specific wavelengths. [0061] FIG. 9 illustrates graphical data of mated female Indian meal moths responding in still-air, two-choice laboratory Experiment 18 to a single wavelength (405-nm LED) or to a wavelength combination (paired 405-nm LED and 350-nm LED), with single or combined wavelength stimuli tested at identical light intensity (200 μW per 1 cm 2 ). [0062] In all experiments which tested the effective wavelength 405±5 nm, a large proportion of all moths released into the modified wind tunnel (see FIG. 1 ) were captured within just two hours, indicating that this technology has great potential for suppression of IMM populations in private households and industrial settings. [0063] While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope. REFERENCES [0000] Barrer, P. M. (1977) Influence of airborne stimulation from conspecific adults on site of oviposition of Ephestia cautella (Lepidoptera-Phycitidae). Entomologia Experimentalis et Applicata 22: 13-22. Barrer, P. M., Jay, E. G. (1980) Laboratory observations on the ability of Esphestia cautella (Walker) (Lepidoptera, Phycitedaeo) to locate and to oviposit in response to a source of grain odor. Journal of Stored Product Research 16: 1-7. Doud, C. W. and Phillips, T. W. (2000) Activity of Plodia interpunctella (Lepidoptera: Pyralidae) in and around flour mills. Journal of Economic Entomology 93: 1842-1847. Foster, S. P. and Harris, M. O. (1997) Behavioral manipulation methods for insect pest-management. Annual Review of Entomology 42: 123-46. Hoppe, T. (1981) Food preference, oviposition and development of the Indian meal moth Plodia interpunctella (Hubner) on different products of the chocolate industry. Zeitschrift für Angewandte Entomologie 91: 170-179. Kirkpatrick, R. L., Yancey, D. L. and Marzke, F. O. (1970) Effectiveness of green and ultraviolet light in attracting stored-product insects to traps. Journal of Economic Entomology 63: 1853-1855. LeCato, G. L. (1976) Yield, development, and weight of Cadra cautella (Walker) and Plodia interpunctella (Hubner) on 21 diets derived from natural products. Journal of Stored Product Research 12: 43-47. Mohandass, S., Arthur, F. H., Zhu, K. Y. and Throne, J. E. (2007) Biology and management of Plodia interpunctella (Lepidoptera: Pyralidae) in stored products. Journal of Stored Products Research 43: 302-311. Marzke, F. O., Street, M. W., Mullen, M. A. and McCray, T. L. (1973) Spectral responses of six species of stored-product insects to visible light. Journal of the Georgia Entomological Society 8: 195-200. Nansen, C. and Phillips, T. W. (2003) Ovipositional responses of the Indian meal moth, Plodia interpunctella (Hubner) (Lepidoptera: Pyralidae), to oils. Annals of the Entomological Society of America 96: 524-531. Nansen, C., Phillips, T. W. and Sanders, S. (2004) Effects of height and adjacent surfaces on captures of Indianmeal moth (Lepidoptera: Pyralidae) in pheromone-baited traps. Journal of Economic Entomology 97: 1284-1290. Olsson, P. O., Anderbrant, O. and Löfstedt, C. (2006) Attraction and oviposition of Ephestia kuehniella induced by volatiles identified from chocolate products. Entomologia Experimentalis et Applicata 119: 137-144. Olsson, P. O., Anderbrant O., Löfstedt, C. (2005a) Flight and oviposition behavior of Ephestia cautella and Plodia interpunctella in response to odors of different chocolate products. Journal of Insect Behavior 18: 363-380. Olsson, P. O., Anderbrant O., Löfstedt C., Borg-Karlson, A. and Liblikas I. (2005b) Electrophysiological and behavioral responses to chocolate volatiles in both sexes of the pyralid moths Ephestia cautella and Plodia interpuntcella . Journal of Chemical Ecology 31. Sambaraju, K. R. and Phillips, T. W. (2006) Behavioral responses of Plodia interpunctella (Lepideroptera: Pyralidae) to light. Poster presented at the annual meeting of the Entomological Society of America, Indianapolis, Ind., 10-13 Dec. 2006. Soderstrom, E. L. (1970) Effectiveness of green electroluminescent lamps for attracting stored-product insects. Journal of Economic Entomology 63: 726-731. Stermer, R. A. (1959) Spectral response of certain stored-product insects to electromagnetic radiation. Journal of Economic Entomology 52: 888-892. Tóth, M., Repasi, V. and Szöcs, G. (2002) Chemical attractants for females of pest pyralids and phycitids (Lepidoptera: Pyralidae, Phycitidae). Acta Phytopathologica et Entomologica Hungarica 37: 375-384. Williams, C. G. (1964) Life-History of Indian meal moth Plodia interpunctella (Hubner) (Lep.: Pycitidae) in warehouse in Britain and on different foods. Annals of Applied Biology 53: 459. Yong Jung, K., Shafqat S. and Marie Jose, D. (2003) Control of Plodia interpunctella (Lepidoptera: Pyralidae), a pest in Bombus terrestris (Hymenoptera: Apidae) colonies. The Canadian Entomologist 135: 893-902. Zhu J., Ryne C., Unelius C. R., Baleru P. G. and Löfstedt C. (1999) Re-identification of the female sex pheromone of the Indian meal moth, Plodia interpuctella : evidence for a four-component blend. Entomologica Experimentalis et Applicata 92: 137-146.

This invention relates to novel apparatus and methods which use specific wavelengths of visible light, or combinations of specific wavelengths of visible light with specific wavelengths of ultra-violet light, to manipulate the behavior of stored product insect pests, including moths and Indian meal moths. The apparatus for attracting stored product insect pests, including (but not limited to) the Indian meal moth, Plodia interpunctella , the Mediterranean flour moth, Ephestia kuhniella , the tobacco moth, Ephestia elutella , the almond moth, Cadra cautella , and the raisin moth, Cadra figulielella , consists of a light source placed in a trap.

BACKGROUND [0001] The present application generally relates to a food processor. [0002] Food processors, such as those employed in the home environment for food preparation such as slicing, chopping, cubing, and dicing of food items, typically have a work bowl with a cylindrical projection extending upwardly from the floor and surrounding a drive shaft to which different implements can be attached for the different processes as desired. The processed food is typically directed to the sides via an impeller or the like and then resides in the work bowl. The work bowl has a cover with a feed chute and pusher member to force the food being processed into the processing implement. With respect to such conventional food processors where food is thrown to the side outlet via an impeller, one drawback is that the food typically is redirected downwards via an angled wall. With the food being ejected at high velocity, this angled wail can tend to cause extra vibration to the machine and can also bruise or damage softer foods. [0003] When using such a conventional food processor, it is necessary to transfer the processed food from the work bowl to whatever cooking or further food processing container is being employed with the recipe being used. Additionally, it is difficult for the user to be able to inspect processed ingredients between runs for desired thickness or size, unless the cover is removed and the processing disk is removed. The work bowl, the cover, and the processing implement, together with the drive mechanism, frequently become covered with residue which can be difficult to clean. Also, due partly to the design of the work bowl and its drive mechanism, conventional food processors are somewhat bulky and heavy. Such large food processors typically do not reside on a countertop but must be stored, occupying significant cabinet space. [0004] Reducing the size, weight, and cost of such food processors, as well as facilitating not only their use but the cleaning of their components, would be a significant improvement to existing designs. The linear path food processor also provides the benefit of reduced machine vibration without bruising of the food. SUMMARY [0005] A food processor of one design includes a housing including a motor and a coupling for rotating a food processing implement. The housing receives a feed chute assembly with a receiving chute for food to be processed. The feed chute assembly also includes an axially aligned discharge chute and a processing implement, such that food is processed linearly from the receiving chute to the discharge chute. The housing has an open front for receiving containers for food processed by said food processor. This results in a smaller food processor which is capable of directly feeding processed food into a container separate from the food processor itself. Also, it is easy to inspect ingredients during or between processing runs, either into a collection bowl or onto the hand of a user. More specifically, the legs of the food processor define a concave curved space between them. The space allows for the discharge of processed food into the hand of a user for inspection of the processed ingredient. [0006] These and other features, advantages, and objects of the design will be further understood and appreciated by those skilled in the art upon studying the following specification, claims, and appended drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0007] In the drawings: [0008] FIG. 1 is a frontal perspective view of a food processor embodying the present design; [0009] FIG. 2 is a front elevational view of the food processor shown in FIG. 1 ; [0010] FIG. 3 is a left side elevational view of the food processor shown in FIGS. 1 and 2 ; [0011] FIG. 4 is a top plan view of the food processor shown in FIGS. 1-3 ; [0012] FIG. 5 is an exploded perspective view of the housing for the food processor shown in the previous figures; [0013] FIG. 6 is an exploded perspective view of the feed chute assembly for the food processor shown in FIGS. 1-4 ; [0014] FIG. 7 is a vertical cross-sectional view of the food processor, taken along section lines VII-VII of FIG. 2 ; and [0015] FIG. 8 is a side elevational view of alternative accessories which can be associated with the housing of the food processor. DETAILED DESCRIPTION OF EMBODIMENTS [0016] For purposes of description herein the terms “upper,” “lower,” “right,” “left,” “rear,” “front,” “vertical,” “horizontal,” and derivatives thereof shall relate to the present application as oriented in FIGS. 1-4 . However, it is to be understood that the application may assume various alternative orientations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification are exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise. [0017] Referring initially to FIGS. 1-4 , there is shown a linear food processor 10 embodying the present design. The food processor has two major components, a housing 20 comprising upper and lower sections 22 and 24 , respectively, and a removable feed chute assembly 30 . Housing 20 is shown in the exploded view shown in FIG. 5 , while the removable feed chute assembly is illustrated in the exploded view of FIG. 6 . Details of both components are shown in the cross-sectional view of FIG. 7 . [0018] The housing 20 of the food processor includes a base plate 26 ( FIG. 5 ) with four feet 27 for providing support for the food processor during use and storage. The base plate, together with lower housing 24 , defines, as best seen in FIGS. 1-4 , a pair of outwardly diverging legs 50 and 52 with a concave wall 51 therebetween for receiving, as an example, a container, such as a bowl 53 (shown in phantom form in FIG. 3 ). As also illustrated in FIG. 3 , as well as FIG. 5 , the lower housing 24 has a concavely curved wall 55 , while the upper housing 22 has concave, upwardly curved edges 56 covered by bezel 18 as described below. This shape allows the entry of a container, such as bowl 53 , to be positioned in an operative position, as seen in FIG. 3 , for receiving processed food in a generally linear vertical path from feed chute assembly 30 through the discharge chute 40 . The linear path is illustrated by the axis A shown in FIG. 7 and is a direct path from feed chute 34 to discharge chute 40 with at least one processing implement 46 ( FIG. 6 ) interposed in the pathway. The housing 20 has a curved rear surface 13 , such that the food processor 10 can be conveniently positioned in the corner of a wailed countertop. [0019] The base plate 26 , as illustrated in FIG. 5 , includes mounting ferrules 28 for receiving fasteners, such as threaded screws, which extend upwardly through plate 26 through similar mounting ferrules 29 in the lower housing section 24 , which are aligned with mounting ferrules 28 . Lower housing 24 includes mounting ferrules 29 for receiving fasteners which extend upwardly through lower housing 24 through similar mounting ferrules (not shown) in upper housing 22 , which are aligned with mounting ferrules 29 . It being understood that there are four such threaded mounting bosses aligned with ferrules 28 and that there are four such threaded mounting bosses aligned with ferrules (not shown) to secure the upper and lower housings together with their operating mechanism for driving a food processing implement. Bezel 18 includes ferrules 18 A of a similar arrangement which are aligned with mounting ferrules 25 in upper housing 22 . Lower plate 26 also includes a motor fan-receiving vented cylindrical housing 21 having vents 23 through the bottom, as illustrated in FIG. 5 . Printed circuit board 63 is provided for motor power control and includes heat sink 64 mounted to the printed circuit board 63 in the conventional manner. A mounting ferrule extends downwardly from lower housing 24 for receiving threaded fastener 62 for mounting printed circuit board 63 to lower housing 24 . [0020] As seen in FIGS. 5 and 7 , a drive motor 60 with a rotary drive shaft 62 is secured to the upper housing 22 by fasteners that extend upwardly through multiple mounting holes 70 A in motor mounting bracket 70 . The drive shaft 62 of motor 60 extends through a lower bearing 66 ( FIG. 7 ) and to a fan 68 mounted in the vented cylindrical housing 21 to provide cooling through openings in the floor of base plate 26 upwardly and around the motor and motor 60 and heat sink 64 . The motor mounting bracket 70 is secured to the upper end of motor 60 , as best seen in FIGS. 5 and 7 . Bracket 70 is conventionally secured to the housing of motor 60 by fasteners (not shown) and to mounting flanges (not shown) within housing 24 to secure the motor in place. Bracket 70 includes mounting bosses 72 for receiving fasteners 74 ( FIG. 7 ) for securing a drive plate 80 to the mounting bracket 70 . The drive plate 80 serves to provide mounting for bushing 81 . An offset drive for the lower drive coupling 90 for the food processing implement is now described. [0021] Motor drive shaft 62 is secured to a first drive gear 82 , and the same shaft is rotatably mounted to a bushing 81 ( FIG. 7 ) in drive plate 80 . Gear 82 has teeth coupled to teeth of a drive belt 84 , in turn, coupled to a second drive gear 86 . Gear 86 is threadably coupled to the lower drive coupling 90 extending through opening 91 in upper housing 22 and a surrounding cylindrical clearance opening 93 , as best seen in FIG. 7 . Gear 86 is mounted to drive shaft 87 , which is supported at its lower end by a bushing 88 in mounting bracket 70 . Thus, rotation of motor drive shaft 62 rotates the lower coupling 90 of the housing 20 which drives, as described below, a food processing implement, such as a cutter disk 46 , of feed chute assembly 30 . [0022] The upper housing 22 likewise has a pair of spaced-apart curved edges 56 corresponding to the curvature of wall 55 of lower housing 24 and joining walls 51 of the base plate 26 to provide a generally concave curvilinear front surface for the food processor 10 . The upper housing 22 includes a recess 92 surrounded by a rim 94 for receiving the feed chute assembly 30 . Upper housing 22 also includes a generally oval-shaped aperture 96 for receiving the discharge chute 40 of the feed chute assembly 30 when positioned on housing 20 , as seen in FIGS. 1-4 and 7 . [0023] The upper housing 22 includes a forward upper projection 11 for receiving a touch switch control pad 15 associated with the electronic control 17 for controlling the operation of the drive motor 60 from off to low and high speeds or pulsed operation. The electrical circuit 17 is enclosed by a bezel 18 having an aperture 19 aligned with aperture 96 for the food discharge chute 40 . Bezel 18 has a curvature conforming to the curved edges 56 of the upper housing and is mounted thereto in a conventional manner. [0024] The feed chute assembly 30 ( FIGS. 6 and 7 ) includes a lid 32 having a food feed chute 34 and a removable food pusher 36 . A telescoping secondary food pusher 36 A extends into t central area of food pusher 36 . Lid 32 is removably locked to a generally cylindrical base 38 with a bayonet-type mount including L-shaped slots 37 in base 38 and mating tabs 35 in lid 32 . The base 38 includes a downwardly projecting food discharge chute 40 , having an open mouth 42 within base 38 for receiving processed food. Chute 40 extends through aperture 96 in the upper housing 22 and aperture 19 in bezel 18 and has a lower output end 41 , as seen in FIGS. 3 and 7 , which positions the lower or exit end of food discharge chute 40 immediately above an awaiting container, such as 53 shown in FIG. 3 , for food which is processed linearly along an axis identified by arrow A in FIG. 3 and axis A in FIG. 7 , such that food entering the feed chute 34 is processed and directly flows along the axis A in a linear direction to the output 41 of food discharge chute 40 . Bet the base 38 and lid 32 of feed chute assembly 30 are food processing implements, such as a rotating cutter disk 46 , which includes a cutter knife 43 adjacent an inclined ramp 44 , with a blade depth adjustment knob 47 which may be of the type disclosed in U.S. Publication No. 2011/0265666, published Nov. 3, 2011, and entitled ADJUSTABLE FOOD PROCESSOR WITH GUIDE RAMP, the disclosure of which is incorporated herein by reference. [0025] In addition to the cutting disk 46 , the processor may include a cubing and dicing grid 100 which has a central aperture 102 extending over a drive bushing 104 which is keyed to the drive shaft 106 as described below. The cubing and dicing grid 100 includes a cubing side 101 with larger opening grates and a dicing side 105 with smaller grates to cube or dice food being sliced by the cutting disk 46 . The cubing/dicing grid 100 is keyed to the base 38 by slots 107 A in the outer diameter of grid 100 which align and engage inwardly extending ribs 39 on the inner diameter of base 38 so that the cubing grid is indexed in the cubing or dicing position under cutting disk 46 . Apertures 107 are provided as finger-holes to aid in insertion and removal of grid 100 from base 38 . [0026] The rotary motion from the lower coupling 90 of the housing 20 is applied to the drive shaft 106 through a mating upper coupling 110 , which is fixedly coupled by threads to the lower end of shaft 106 . A Teflon® washer 111 is interposed between coupling 110 and a threaded nut 126 secured to a feed-through bushing 120 . Bushing 120 extends through an aperture 48 in base 38 and is sealed by means of a rubber seal 121 to the floor 49 of base 38 . The threaded lower end 122 of bushing 120 extends through aperture 48 and through a stainless steel flat washer 124 and is secured to the base 38 by a threaded nut 126 . The upper end of drive shaft 106 extends through the bushing 120 through a rubber seal 128 and into a drive bushing 104 having a flat 108 thereon for keying to the drive hub 48 of cutting disk 46 . The drive hub 48 includes a keyed slot for receiving the bushing 104 , as best seen in FIGS. 6 and 7 . The drive bushing can be locked to the flat 103 on the upper end of drive shaft 106 by means of a suitable set screw. The lower end of drive bushing 104 includes an annular flange 109 to affect the seal between the rotary shaft 106 , the stationary bushing 120 , the rotary drive bushing 104 , and rubber seal 128 . [0027] The food processor of this application can also be employed with a variety of food processing implements, such as slicing disks, shredding disks, dough blades, multipurpose blades, and the like. In addition, it is particularly well adapted for other implements which can employ conventional bowls positioned in the area between the legs 50 and 52 of the housing in the concave area 51 . FIG. 8 illustrates one appliance, such as a stirring unit 130 having a stirring rod 131 coupled to a stirring implement 132 and driven by a right-angle power beater head 134 having a coupler 136 which mates with the lower coupling 90 . Thus, the stir unit 130 can be lowered onto the base to the housing 20 and controlled with the same control panel 15 as employed with the food processor described earlier. Additionally, the open area between legs 50 and 52 can accommodate a resistance-type heater or a Peltier-type hot or cold plate 140 coupled by a power supply through contacts 142 which may optionally be included in the lower housing 24 for either heating or cooling items being stirred by stirring implement 132 . For example, an ice cream bowl 144 for mixing ice cream may be placed on plate 140 in the cold mode of operation and the stirring unit 130 lowered onto the housing 20 and actuated for making ice cream, as only an example of the universal applicability of the linear feature of the processor 10 . [0028] It will be understood by one having ordinary skill in the art that construction of the described food processor and other components is not limited to any specific material. Other exemplary embodiments disclosed herein may be formed from a wide variety of materials, unless described otherwise herein. [0029] For purposes of this disclosure, the term “coupled” (in all its forms, couple, coupling, coupled, etc.) generally means the joining of two components (electrical or mechanical) directly or indirectly to one another. Such joining may be stationary in nature or movable in nature. Such joining may be achieved with the two components (electrical or mechanical) and any additional intermediate members being integrally formed as a single unitary body with one another or with the two components. Such joining may be permanent in nature or may be removable or releasable in nature unless otherwise stated. [0030] It is also important to note that the construction and arrangement of the elements as shown in the exemplary embodiments is illustrative only. Although only a few embodiments of the present innovations have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter recited. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of the interfaces may be reversed or otherwise varied, the length or width of the structures and/or members or connector or other elements of the system may be varied, the nature or number of adjustment positions provided between the elements may be varied. It should be noted that the elements and/or assemblies of the system may be constructed from any of a wide variety of materials that provide sufficient strength or durability, in any of a wide variety of colors, textures, and combinations. Accordingly, all such modifications are intended to be included within the scope of the present innovations. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the desired and other exemplary embodiments without departing from the spirit of the present innovations. [0031] It will be understood that any described processes or steps within described processes may be combined with other disclosed processes or steps to form structures within the scope of the present application. The exemplary structures and processes disclosed herein are for illustrative purposes and are not to be construed as limiting. [0032] It is also to be understood that variations and modifications can be made on the aforementioned structures and methods without departing from the concepts of the present application, and further it is to be understood that such concepts are intended to be covered by the following claims unless these claims by their language expressly state otherwise. [0033] The above description is considered that of the illustrated embodiments only. Modifications will occur to those skilled in the art and to those who make or use the food processor. Therefore, it is understood that the embodiments shown in the drawings and described above is merely for illustrative purposes and not intended to limit the scope of the application, which is defined by the following claims as interpreted according to the principles of patent law, including the Doctrine of Equivalents.

A food processor of one design includes a housing including a motor and a coupling for rotating a food processing implement. The housing receives a feed chute assembly with a receiving chute for food to be processed. The feed chute assembly also includes an aligned discharge chute communicating with a processing implement, such that food is processed linearly from the receiving chute to the discharge chute. The housing has an open front for receiving containers for food processed by said food processor. This results in a smaller food processor which is capable of directly feeding processed food into a container separate from the food processor itself.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 13/679,816, filed Nov. 16, 2012, which is a continuation of U.S. application Ser. No. 11/924,014, filed Oct. 25, 2007, now U.S. Pat. No. 8,349,298, which is a division of copending U.S. application Ser. No. 10/870,293, filed Jun. 17, 2004, now U.S. Pat. No. 7,862,801, which is a continuation of U.S. application Ser. No. 10/715,003, filed Nov. 17, 2003, now U.S. Pat. No. 7,128,899, which is a continuation of U.S. application Ser. No. 10/288,239, filed Nov. 5, 2002, now U.S. Pat. No. 6,730,316, which is a continuation-in-part of US. application Ser. No. 09/770,489, filed Jan. 27, 2001, now U.S. Pat. No. 6,500,408. The foregoing patents and applications are incorporated herein in their entirety. BACKGROUND OF THE INVENTION [0002] 1. The Field of the Invention [0003] Dental bleaching and dental bleaches are disclosed. Discussion is provided concerning viscous dental bleaches which may be placed into a tray or otherwise held against a patient's teeth in order to cause a lightening, whitening and stain removal effect without damaging the enamel of the patient's teeth. [0004] 2. The Relevant Technology [0005] The ability to whiten both vital and non-vital teeth with peroxides has been known for well over 40 years. By nature, the human race is very diversified genetically as to tooth shape and color. The color of teeth within the human race usually ranges from whites, blacks, greys, browns and yellows. Environment, nutrition, medication and diet can affect tooth color. Some foods such as blueberries, cranberries, coffee and tea can significantly alter a person's tooth color from its original state. Other habits like smoking or chewing of tobacco can darken a person's teeth over a period of time. Tetracycline and other medications can have a darkening or graying effect on teeth. Children born to women who ingested tetracycline during pregnancy often have permanently stained teeth. Tetracycline staining may come in definite unsightly bands on the teeth. [0006] A desire among the populace for bright white teeth has increased as economic stature and standards of living have improved. In developing and developed nations, social standing, personal relations and career opportunities can be positively or negatively influenced by the appearance of one's teeth. Generally, it is preferred to have white teeth rather than to have dark teeth. Since whiter teeth are generally more desirable, many materials have been devised to whiten an individual's teeth by chemical means. [0007] The most commonly accepted chemicals used in teeth whitening today are peroxides. Peroxides are known in the art as oxidizing agents and are highly reactive. Organic molecules that reflect specific wavelengths of light back to our eyes are usually very complex molecules. These colorful substances are usually called dyes and pigments. Oxidation of these organic dyes and pigments usually destroys their ability to absorb light and therefore renders them white. For example, the paper industry uses hydrogen peroxide to bleach brown wood pulp to white wood pulp. [0008] Peroxides are a safe teeth whitener, because they are generally deemed safe from a physiological standpoint as compared to other oxidizing agents. The peroxides of choice for teeth whitening are: hydrogen peroxide, carbamide peroxide, sodium perborate, and sodium percarbonate. When these peroxides are in appropriate contact with teeth they will usually oxidize both internal and external organic stains, rendering the teeth whiter. In contrast, inorganic stains are usually not affected by peroxides. Individuals with predisposed inorganic stains usually will not experience a whitening effect with the application of peroxides. However, the majority of the world's human population will experience a whitening effect through the application of peroxides to teeth. [0009] Since the use of peroxides has been generally accepted for use in teeth whitening, a multitude of methods for applying peroxides have been devised. One method of application is to paint a peroxide in water solution directly on the teeth. A problem with water solutions of peroxides is that they are too thin or runny. This causes them to run off of the teeth due to the force of gravity and run onto the soft tissues of the mouth. High concentrations of peroxides are painfully irritating to soft tissue, causing serious discomfort to a patient. The method of painting a water solution of peroxide on a person's teeth is usually an “in-office” procedure, because of the inherent difficulties associated with patients applying it to their own teeth. In most cases, the patient's lips are painfully retracted during the entire treatment, and the patient is confined to sitting in the dental chair. The danger of the peroxide solution running off the teeth and contacting soft tissue is always present when peroxide and water bleaching solutions are used. [0010] Patient comfort during the bleaching treatment may be improved by shortening the time of bleaching. In general there are three ways to bleach teeth faster. The first is to increase the concentration of the peroxide. The second is to increase the pH of the peroxide with a basic substance. Basic substances such as sodium hydroxide will destabilize peroxide solutions, therefore making the peroxide more reactive so that it carries out its whitening effect more quickly. The third way to bleach teeth more quickly is to speed up the reaction process by heating the peroxide solution. Heat accelerates almost all chemical reactions, including bleaching. In order to reduce bleaching treatment time, any one or combination of the above methods can be implemented or augmented. [0011] There are physiological problems associated with speeding up the bleaching process, however. First, as peroxide concentration in the bleach is increased, the bleach is more irritating to soft tissues. Second, as the pH level is increased in the bleach, the bleach becomes more caustic to soft tissue. Third, as temperature of the bleach is increased, the bleaching process is more likely to burn soft tissue or even kill teeth. [0012] The runniness of aqueous peroxide solutions and the problems associated with accelerating the bleaching process incentivized the dental care provider to isolate soft tissues from the dental bleach. This can be accomplished by methods known in the dental profession such as use of a rubber dam. First, the patient's lips are painfully retracted, followed by placing a pre-punched rubber sheet or dam over each individual tooth. Placing a rubber dam on each tooth is slow and does not guarantee a perfect seal against leakage of the peroxide solution onto soft tissue. In order to satisfy patient demand for rapid and complete bleaching of teeth, the dental practitioner must increase risk to the patient by use of more concentrated bleaches. In order to treat teeth with a bleach that would essentially be non-irritating to soft tissues would take 2-5 full days of bleaching to see significant improvement in whitening. A patient would be very uncomfortable sitting in a dental chair with their cheeks retracted for that period of time, and the cost of such treatment would be prohibitive. [0013] Recognition of these inherent problems associated with the “paint-on” method of bleaching with aqueous peroxides brought about significant improvements in the art of tooth bleaching. The improvements came by adding viscosity-building chemicals to the peroxide solutions. By increasing the viscosity of bleaching solutions, the ability of the bleach to flow, run or drip decreased. Substances such as glycerin, high molecular weight polyethylene glycol, fumed silica, high molecular weight polypropylene glycol, xanthan gum, hydroxy propyl cellulose and carbomer (marketed under the trade name CARBOPOL®), have generally been used to increase the viscosity of peroxide solutions. [0014] In order to also reduce the detrimental effects of bleaching gels coming into contact with soft tissues, the pH of the peroxide solution was adjusted to around pH=7. When the concentration of peroxide was reduced, patients were required to keep the bleaching gel in contact with their teeth for a longer period of time in order to achieve the desired whitening result. This consideration was addressed by use of a dental tray which holds the bleach in contact with teeth, but which prevents the bleach from flowing away from the teeth to contact soft tissues. Use of a dental tray permits the bleach to remain in intimate contact with teeth for long periods of time without requiring the patient to sit in a dental chair with retracted cheeks. When a dental tray is used to accommodate long periods of exposure of bleach to teeth, lower concentrations of peroxides in bleach may also be used, therefore reducing the risk to soft tissue. A dental tray is an arch-shaped container which holds the bleaching material against the teeth. The dental tray also acts as a barrier against dilution of the bleach by saliva and the eventual swallowing of the bleaching material in a short period of time. [0015] The viscosity-building material used in almost all bleaching gels today is carbomer (CARBOPOL®), manufactured by B.F. Goodrich. CARBOPOL® is a modified polyacrylic acid hydrophilic polymer, capable of forming viscous gels at concentrations above as little as 5% by weight. CARBOPOL® is the material of choice for current bleach manufacturers because it thickens peroxide solutions to a point where they will not run out of a dental tray or away from the teeth to soft tissue areas. This allows the bleach to stay in contact with the teeth for extended periods of time and protects soft tissues. The use of a dental tray and a viscous bleach allows a low concentration bleach to effectively whiten a person's teeth over a 1-2 week period of time with minimal risk to the patient. CARBOPOL® is generally the only material of choice that delivers the required high viscosity properties for a 4-8 hour bleaching period. [0016] Fumed silica is an alternative thickening agent, but it is considered a poor choice for use in dentistry. Fumed silica is not soluble in peroxide solutions; therefore, it only suspends in the solution. At higher loadings of silica, peroxide solutions turn into a putty instead of a viscous gel. A putty suffers from not being able to flow freely around the teeth to adequately bleach them. Silica also absorbs peroxide solutions, thus binding the peroxide so that it is not as available for bleaching. Silica can also act disadvantageously as a wick to peroxide solutions. Silica-thickened bleaches dry up very quickly when placed on the teeth, and it is well known that dry peroxides do not bleach as effectively as aqueous peroxides. It is therefore generally concluded that silica is a poor choice as a thickener for tray bleaching. [0017] There are other natural gums that could also be considered as a thickener for tray bleaching. Materials such as xanthan gum, pectin, guar gum and hydroxy propyl cellulose have been considered in the past. Natural gums are also poor materials of choice for use as thickeners in dental bleaching, although they are used widely in the food industry as thickeners. Natural gums at low concentrations are adequate for thickening bleaches that are still runny and able to drip when poured. Natural gums at high concentrations tend to turn into gelatinous masses. Gelatin does not flow and tends to clump together, thus limiting its ability to adequately flow around the teeth to effectively bleach. For this reason it is not used as the sole thickener in viscous bleaches. It has generally been concluded by the industry that natural gums are not desirable for use in tray bleaching. [0018] Other thickening agents used in the dental industry are high molecular weight water soluble waxes, such as polyethylene glycol and polypropylene glycol. Water soluble waxes are not used as the sole thickener for peroxide solutions, however, because they do not thicken adequately. At high loadings of water soluble waxes, bleaches are still runny and maintain no gel-type properties. Bleaches made from water soluble waxes are not highly viscous and can easily escape out of the tray. It is generally known that water soluble waxes used to thicken peroxide solutions are not desirable for tray bleaching. [0019] Considering the shortcomings of the various thickeners, CARBOPOL® remains the best compromise as a thickener for tray bleaching. CARBOPOL® has more or less the desired thickening properties to deliver a viscous bleaching gel. For this reason it is widely used as the thickener of choice in almost all currently marketed available tray bleaching materials. [0020] CARBOPOL®, though popular, has shortcomings as well. CARBOPOL® is a cross-linked polyacrylic acid. A polyacrylic acid has the structure —CH 2 CH(CO 2 H)—. When CARBOPOL® is dispersed in water, the resulting mixture becomes acidic. Acidic substances have the ability to remove cations from inorganic matrixes to form a salt. The enamel that covers the outer portion of human teeth is composed of calcium hydroxyl apatite. Calcium hydroxyl apatite is a crystalline material similar to bone ceramic. Acidic substances like vinegar or lemons can remove enamel by forming a salt with the calcium in our enamel. It is well known in the dental industry that individuals who suck on lemons can literally etch large portions of enamel off their teeth. [0021] Similarly, CARBOPOL® is a long chain of repeating acids, and when dispersed in an aqueous solution, it can acidically remove calcium from teeth and therefore remove tooth enamel. Since CARBOPOL® bleaches are intended for long-term bleaching regimes, keeping the bleach in contact with the tooth for more than just a few minutes, they may remove enamel during these extended bleaching sessions. It is accepted in the dental industry that the removal of layers of enamel is harmful to an individual's dental health and can lead to mottling (wearing away) of the teeth. [0022] Manufacturers of dental bleach containing CARBOPOL® use bases to raise the pH of the bleaching material. The bases of choice generally have been sodium hydroxide, potassium hydroxide and triethanolamine. Bases are used to raise the pH of the dental bleach to less acidic levels to reduce removal of enamel by acidic etching. Since CARBOPOL® is known to be more stable in acidic ranges, almost all manufacturers of tray bleaching systems adjust their CARBOPOL® bleaches to a pH range of 5.5-6.5. The lower the pH of the bleach, the more enamel is removed by acidic etching. Long-term bleaching only lengthens out the acidic etching process. Even a bleach pH of 6.0 can remove tooth enamel during bleaching. [0023] Additionally, it is difficult to achieve consistent pH from batch to batch of dental bleach. Because of the variations in the average molecular weight of CARBOPOL®, specially tailored quantities of base must be added to separate batches to attain a constant pH level in the dental bleach product. But it is a common practice for manufacturers to add a standard amount of base to each batch of bleach, resulting in pH variability from batch to batch. This variability will always exist even if the manufacturer intends his bleach to be at pH 7. [0024] Another problem in using CARBOPOL® is that it has long chains of polyacrylic acid that sometimes fold around themselves to form a ball. When this happens, the inner protected parts of the CARBOPOL® chain wet at a much slower rate than the outer parts of the chain. This means that the pH of the CARBOPOL® and hence the dental bleach will vary with the total wetting time. Consequently, CARBOPOL® bleaches may have a different pH at one week after manufacture than on the day of manufacture. The only way to rectify this problem is for the dental bleach manufacturer to keep the CARBOPOL® bleach in storage for a period of time to allow pH stabilization, followed by a final pH adjustment. Such a practice is not economical. All these factors make it extremely difficult to manufacture CARBOPOL® dental bleach that has a consistent pH level both from batch to batch and over time. [0025] Acidic etching, as explained above, is not the only cause of calcium being removed from tooth enamel. Organic acids can also remove cations by the process of chelation. Carboxylic acids have an affinity to form a salt with cations. This affinity for cations varies by the type of cations. For example, a carboxylic acid can form a salt with an element in the alkaline family, such as lithium, sodium, or potassium. The affinity to form an ionoic bond with an alkaline element is moderate. This we know because most organic acid-alkaline salts will ionize (dissolve) in water. However, the affinity of a carboxylic acid to an alkaline earth element such as beryllium, magnesium or calcium is much stronger. The affinity of an alkaline earth element to an organic acid is very strong, because most organic acid-alkaline earth salts do not readily ionize in water. Organic acids therefore have a higher affinity to bind with calcium than they do to sodium or potassium. This same principle is used during crown cementation with glass ionomer cements. Crown cementation is achieved because the polyacrylic acid (whether neutralized or un-neutralized) reacts with the alkaline earth cations of the ion leaching glass. Thus, organic acids, initially neutralized with sodium hydroxide to form a sodium salt, would switch to a calcium salt if calcium hydroxide were added to the mixture. [0026] CARBOPOL® dispersed into water cannot be neutralized by calcium hydroxide without precipitating the polymer. Therefore, there are no CARBOPOL® bleaches neutralized with calcium hydroxide. Almost all CARBOPOL® bleaches are pH adjusted with sodium or potassium hydroxide. [0027] There is a constant battle going on between the alkaline salts of CARBOPOL® and the calcium of the enamel. The carboxylic acid-alkaline salts of the CARBOPOL® have a higher binding power for the calcium of the enamel. Therefore, through the process of chelation, calcium is constantly being removed from the tooth enamel by CARBOPOL®-based bleaches. [0028] Although CARBOPOL® is very effective in creating viscous gels for tray bleaching of teeth, its side effects in acid etching of tooth enamel and chelation are damaging to the very teeth that it is desired to restore to a more aesthetic condition. Information concerning the detrimental effects of prior art dental bleaches on tooth enamel can be found in the following articles: (i) Perdigao, J., et al., “Ultra-Morphological Study of the Interaction of Dental Adhesives with Carbamide Peroxide-Bleached Enamel”, American Journal of Dentistry, vol. II, No. 6, pp. 291-301, December 1998; (ii) Pinheirojunior, E. C., et al., “In Vitro Action of Various Carbamide Peroxide Gel Bleaching Agents on the Microhardness of Human Enamel”, Braz. Dent. J., 7(2): 75-79 (1996); (iii) Shannon, et al., “Characterization of Enamel Exposed to 10% Carbamide Peroxide Bleaching Agents”, Quintessence International, vol. 24, no. 1, pp. 39-44 (1993); (iv) Bitter, N., “A Scanning Electron Microscope Study of the Long-Term Effect of Bleaching Agents on the Enamel Surface In Vivo”, General Dentistry, pp. 84-88, (January-February 1998). The prior art shows a need for dental bleach and a method for its use that includes a thickener or gelling agent that does not attack or react with tooth enamel. SUMMARY OF THE INVENTION [0029] Improved dental bleaches are disclosed. Some of the embodiments include bleaches that do not attack or react with tooth enamel. The dental bleaches have a tendency to lighten, whiten and remove stains and oxidize complex organic molecules from the teeth. [0030] These and other advantages and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS [0031] To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: [0032] FIG. 1 depicts the chemical structure of polyvinyl pyrrolidone. [0033] FIG. 2 depicts a series of steps that can be performed to bleach teeth using a one part bleaching system. [0034] FIG. 3 depicts placing a one-part bleach into a bleaching tray for use in bleaching teeth. [0035] FIG. 4 depicts a series of steps that can be performed to bleach teeth using a two-part bleaching system. [0036] FIG. 5 depicts placing a two-part bleach into a bleaching tray for use in bleaching teeth [0037] FIG. 6 is a perspective view of a substantially flat strip of material having rounded corners. [0038] FIG. 7 is a perspective view of a bleaching system, disclosing the flat strip of FIG. 6 coated with a tooth whitening substance. [0039] FIG. 8 is a cross-sectional view thereof, taken along section line 8-8 of FIG. 7 , disclosing an example of the flat strip having a thickness less than that of the substance coated thereon. [0040] FIG. 9 is a cross-sectional view showing another bleaching system, showing shallow pockets in the strip of material, which act as reservoirs for additional substance coated on the strip. [0041] FIG. 10 is a cross-sectional view showing adjacent teeth having the strip of material conforming thereto and adhesively attached to the teeth by means of a substance located between the teeth and the strip of material. [0042] FIG. 11 is a cross-sectional elevation view of a tooth and adjoining soft tissue, taken along section line 11-11 of FIG. 10 , disclosing the strip conforming to and adhesively attached to the tooth by means of the substance located between the tooth and the strip of material. [0043] FIG. 12 is a cross-sectional view, similar to FIG. 10 , showing a strip of material conforming to the teeth and the adjoining soft tissue and adhesively attached to both sides of the teeth by means of the substance located between the teeth and the strip of material. [0044] FIG. 13 is a cross-sectional elevation view, taken along section line 13-13 of FIG. 12 , showing the strip of material conforming to both the tooth and the adjoining soft tissue and adhesively attached to both sides of the tooth by means of the substance located between the tooth and the strip of material. [0045] FIG. 14 is a perspective view of a bleaching system disclosing the flat strip coated with a tooth whitening substance of FIG. 7 with a release liner. [0046] FIG. 15 is a cross-section view taken along section line 15-15 of FIG. 14 , showing a release liner attached to the strip of material by the substance on the strip of material. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0047] A. Materials for Use in Dental Bleach [0048] A dental bleach may have several components including a bleaching agent, a basic agent, a thickening agent, a flavoring agent, a desensitizing agent, and others, or a subset thereof. [0049] 1. Bleaching Agent [0050] Suitable bleaching agents will include any material capable of releasing an oxidizing agent such as free radical oxygen ions for contacting teeth and removing stains therefrom via an oxidation process. Most common bleaching agents at this time are peroxides, including but not limited to hydrogen peroxide, carbamide peroxide, sodium perborate, and sodium percarbonate. Other peroxides and other oxidizing agents and bleaching agents may be utilized in addition to or in substitution of these materials. [0051] 2. Thickening Agent [0052] Dental bleaches can include a thickening agent in order to avoid runoff of the dental bleach and consequent contact with sensitive soft tissues, and in order to keep the bleach in contact with teeth. A suitable thickening agent will serve to increase viscosity of the dental bleach while avoiding substantial interference with the release of oxygen ions from the bleaching agent or the contact of those oxygen ions with teeth to be bleached. In some embodiments, the thickening agent used will include polyvinylpyrrolidone. FIG. 1 depicts the chemical structure of polyvinylpyrrolidone. Polyvinylpyrrolidone is also referred to as “povidone”. [0053] Polyvinylpyrrolidone has the advantage of serving as a thickening agent or gelling agent while failing to: (i) interfere with release of oxygen ions from the bleaching agent or contact of those oxygen ions to the teeth to bleached, (ii) chemically etch tooth enamel, (iii) remove calcium from tooth enamel by chelation, and (iv) solidify the dental bleach. [0054] Polyvinylpyrrolidone is a tertiary amide based polymer. It contains no organic acid in its structure and therefore cannot acid etch or chelate teeth. Polyvinylpyrrolidone based bleaches are enamel safe and therefore will present a significant improvement over the prior art. Polyvinylpyrrolidone is easily dispersed into water to make highly viscous gels for tray bleaching at around 5-40% by weight. Polyvinylpyrrolidone may also be considered a tackifying agent because the increased viscosity of dental bleach that it produces has a sticky or tacky feel enabling it to adhere to teeth for the time required to carry out the bleaching process. [0055] The most desirable molecular weights for the thickener used in the bleach is from about 90,000-1,500,000. Molecular weight may be determined by light scattering methods, size exclusion chromatography and other methods. Thickeners with a molecular weight outside that range can be used as well, as illustrated by the examples. As a general rule, the lower the molecular weight of the polyvinylpyrrolidone used, the more polyvinylpyrrolidone that is required to achieve the desired thickening. [0056] 3. Liquid Component [0057] In its raw form, polyvinylpyrrolidone is a white powder. In order to form a gel useful in a dental bleach, a liquid component must be added to it. In some embodiments, suitable liquid components of the gel include water, glycerin, propylene glycol, liquid polyethylene glycol, liquid polypropylene glycol, ethanol, and other suitable liquid components. Any of the liquid components can be used singly or in combination. [0058] 4. Basic Substance [0059] In some embodiments, it will be desirable to include a basic substance in the dental bleach. Use of a basic substance can destabilize the bleaching agent such as a peroxide, facilitating release of oxygen ions for dental bleaching. This is particularly desirable if a two-part bleaching system is utilized such as depicted in FIGS. 4 and 5 and as described in their accompanying text. A list of basic substance which may be used in the bleach includes sodium hydroxide, potassium hydroxide, calcium hydroxide and triethanol amine. [0060] 5. Flavoring Agent [0061] In some embodiments, it may be desired to add flavorings or sweeteners to the dental bleach. Examples of appropriate sweeteners include aspartame, sodium saccharin, mannitol, fructose, sorbitol, xylitol and the like. Flavorings which may be used include mint, wintergreen, spearmint, berry, lemon, lime, and the like. [0062] 6. Desensitizing Agent [0063] Even when they have not been exposed to caustic prior art dental bleaches, some patients experience chronic sensitivity of the teeth and gums. This sensitivity may be alleviated in part by including a desensitizing agent in the dental bleach so that the patient will not experience discomfort or develop apprehension during the bleaching process. Examples of desensitizing agents include fluoride, potassium nitrate, sodium citrate, aloe vera and the like. [0064] 7. Other Components [0065] As desired, other components may be included in the bleach as well, including anticariogenic agents and antimicrobial agents which are already known in dentistry. [0066] 8. Examples of the Inventive Dental Bleach [0067] The following are some sample compositions of the invented dental bleach. Weight percentages provided indicate the presence of a component as its percentage of the total resulting bleach. [0000] Exemplary Dental Bleaches Bleaching Liquid Basic Flavoring Desensitizing EX. Agent Thickening Agent Component Substance Agent Agent 1 carbamide Polyvinylpyrrolidone Water about 35% by none aspartame about none peroxide 1,000,000 to 1,500,000 weight; 0.5% by weight; about 11% by molecular weight glycerin about 29% peppermint oil weight about 25% by weight by weight about 0.5% by weight 2 carbamide Polyvinylpyrrolidone Water about 54% by none None none peroxide 1,000,000 to 1,500,000 weight about 16% by molecular weight weight about 30% by weight 3 carbamide Polyvinylpyrrolidone glycerine about 49% none None none peroxide 44,000 to 54,000 by weight about 21% by molecular weight weight about 30% by weight 4 carbamide Polyvinylpyrrolidone Water about 10% by none None none peroxide 1,000,000 to 1,500,000 weight; about 25% by molecular weight glycerin about 10% weight about 30% by weight by weight 5 hydrogen Polyvinylpyrrolidone Water about 15% by none none none peroxide 28,000 to 34,000 weight; about 3% by molecular weight glycerin about 10%; weight about 40% by weight polyethylene glycol (600 molecular weight) about 42% by weight 6 hydrogen Polyvinylpyrrolidone water about 56.39% none none none peroxide 1,000,000 to 1,500,000 by weight; about 5% by molecular weight polyethylene glycol weight about 25% by weight (600 molecular weight) about 10% by weight 7 sodium Polyvinylpyrrolidone propylene glycol none none none perborate 44,000 to 54,000 about 50% by about 25% by molecular weight weight weight about 25% by weight 8 sodium Polyvinylpyrrolidone anhydrous glycerin none none none perborate about 1,000,000 to 1,500,000 about 55% by 25% by weight molecular weight weight about 10% by weight; Polyvinylpyrrolidone 44,000 to 54,000 molecular weight about 10% by weight 9 carbamide Polyvinylpyrrolidone water about 35.69% none aspartame about sodium fluoride peroxide 100,000 to 150,000 by weight; 0.5% by weight; about 0.25% by about 10.5% by molecular weight ethanol about 2% by wintergreen oil weight; weight about 10% by weight weight; about 1% by potassium nitrate polyethylene glycol weight about 0.1% by (300 molecular weight weight) about 10% by weight; polyethylene glycol (8000 molecular weight) about 30% by weight 10 carbamide Polyvinylpyrrolidone water about 20% by sodium none none peroxide 1,000,000 to 1,500,000 weight; hydroxide about about 15% by molecular weight anhydrous glycerin 0.2% by weight weight about 25% by weight about 39.8% by weight 11 carbamide Polyvinylpyrrolidone water about 15% by sodium none none peroxide 1,000,000 to 1,500,000 weight; hydroxide about about 25% by molecular weight anhydrous glycerin 0.2% by weight weight about 25% by weight about 34.8% by weight 12 carbamide Polyvinylpyrrolidone water about 10% by sodium none none peroxide 1,000,000 to 1,500,000 weight; hydroxide about about 35% by molecular weight anhydrous glycerin 0.2% by weight weight about 30% by weight about 24.8% by weight 13 carbamide Polyvinylpyrrolidone water about 15% by sodium none none peroxide 1,000,000 to 1,500,000 weight; hydroxide about about 15% by molecular weight anhydrous glycerin 0.2% by weight weight about 35% by weight about 34.8% by weight 14 carbamide Polyvinylpyrrolidone water about 10% by sodium none none peroxide 1,000,000 to 1,500,000 weight; hydroxide about about 15% by molecular weight anhydrous glycerin 0.2% by weight weight about 60% by weight about 14.8% by weight 15 carbamide Polyvinylpyrrolidone water about 3% by sodium none none peroxide 1,000,000 to 1,500,000 weight; hydroxide about about 8% by molecular weight anhydrous glycerin 0.2% by weight weight about 90% by weight about 4.8% by weight 16 carbamide Polyvinylpyrrolidone water about 2% by sodium none none peroxide 1,000,000 to 1,500,000 weight; hydroxide about about 10% by molecular weight anhydrous glycerin 0.2% by weight weight about 85% by weight about 2.8% by weight 17 carbamide Polyvinylpyrrolidone Purified water about sodium 0.6% peppermint none peroxide about about 23% by weight 30% by weight; hydroxide about oil; 31% by weight anhydrous glycerin 0.18% by weight sodium saccharin, about 14.5% by about 0.7% by weight weight 18 carbamide Polyvinylpyrrolidone Purified water about Sodium 0.6% peppermint none peroxide about about 28% by weight 26.1% by weight; hydroxide about oil; 16% by weight anhydrous glycerin 0.11% by weight sodium saccharin, about 28.59% by about 0.6% by weight weight [0068] In some embodiments, percentages of various components can vary as follows: [0000] Component of Dental Broad Typical More Typical Bleach Range Range Range Bleaching Agent 0.1-80% 0.5-60%  1-50% Bleaching Agent if 0.5-80%   1-50%  3-25% Carbamide Peroxide Bleaching Agent if 0.1-50% 0.5-25% 1-5% Hydrogen Peroxide Liquid Component   0.1-99.8% 0.2-80% 10-50% Polyvinylpyrrolidone 0.1-90%  25-60% 25-35% Basic Substance   0-10% 0.1-9%  0.2-6%   Flavoring Agent  0-5% 0.5-3%  1-2% [0069] Other ranges of components of dental bleach are possible as well. [0070] The pH ranges of the mixed gel can be as desired, and in many instances may be in the range of 5 to 8, or in the range of 4 to 10. Other pH ranges are possible. [0071] A completed dental bleach of the invention may be a viscous gel that is thick enough that it does not drip out of a syringe of the size typically used in clinical or home dental bleaching where the syringe has a tip aperture that measures from about 2 mm to about 10 mm in diameter. Dental bleaches of other viscosities may be made according to the invention as well. [0072] B. Methods for Performing Dental Bleaching [0073] Referring to FIG. 2 , a method for performing dental bleaching of a patient's teeth is depicted. First, a dental bleach containing polyvinylpyrrolidone is obtained or created 201 such as by utilizing one of the formulas above. A patient or dental practitioner of patient would likely obtain a dental bleach in a dispenser ready to use as depicted in FIGS. 3 and 5 . [0074] Second, the dental bleach is placed into a dental tray 202 . The bleach should be spread evenly in the tray and should be of sufficient quantity to cover the exterior surfaces of all teeth. The dental tray may be of a design that does not exert any or much mechanical pressure on a patient's teeth or gums. [0075] Third, the dental tray containing bleach is placed onto the teeth to be bleached, causing the bleach to contact teeth 203 . A combination of suction created by placing the tray onto the teeth plus the viscosity of the dental bleach serves to hold the dental tray in place on the teeth during bleaching. [0076] Next, optionally, the dental bleach can be exposed to light or heat in order to accelerate release of its oxidizing agent such as oxygen ions 204 . Heat will accelerate any chemical reaction including the reactions of dental bleaching. Some practitioners may use a light to create heat. Some lights that can be used include halogen bulb lights, xenon bulb lights, plasma arc bulb lights, ion gas lasers, semiconductor lasers and light emitting diodes. [0077] Regardless of whether light or heat is used, next, the dental bleach will release an oxidizing agent 205 such as oxidizing ions. The oxidizing agent, when in contact with teeth, will bleach and lighten, whiten or remove stains from the teeth 206 . The time that is required for steps 205 and 206 varies, but 1 to 8 hours is common. Shorter and longer times are possible. By utilizing more basic substance or applying heat or a light to the dental bleach, these steps may be accelerated. Alternatively, by using a stronger concentration of bleaching agent, these steps may be accelerated. [0078] Next, the dental tray is removed 207 and the teeth are rinsed 208 . This sequence may be performed once in a dental practitioner's office if a strong bleaching agent is used. Or it may be performed several times by a patient in his or her own home. Patients will typically perform the bleaching steps once per day for a couple of weeks, optionally followed by a maintenance regimen. [0079] Referring to FIG. 3 , placement of dental bleach 305 into a dental tray 303 , and placing the dental tray 303 onto a patient's teeth 301 is depicted. The dental tray 303 has an arch 304 matching the arch of the patient's teeth for containing the dental bleach 305 and keeping it in close contact with the patient's teeth 301 while not placing it against a significant amount of soft tissue 302 . If high concentration peroxides are used for bleaching, then a dental dam, rubber protector or fluid light-cured acrylic barrier may be used to keep the dental bleach from contacting soft tissues. Generally, at a concentration of greater than 15% hydrogen peroxide or greater than 40% carbamide peroxide, some type of additional soft tissue protector is desired. The dental tray may be flexible or rigid, and may be made from a suitable material such as plastic or rubber. The tray can be formed in a dental lab to cause it to precisely conform to a patient's teeth, it can be a universal tray such that one size fits all, or it can be a tray that a patient molds himself such as by heating the tray in hot water and then pressing his teeth into it. [0080] A single chamber syringe 307 is provided having a chamber 307 a containing dental bleach. A plunger 307 b is used to expel a desired quantity of dental bleach 305 from the syringe tip 307 c. In some embodiments, the pH of the dental bleach 305 within the syringe will not exceed pH=7, or the bleaching agent may become destabilized prior to use. [0081] Referring to FIG. 4 , another method for performing dental bleaching of a patient's teeth is depicted. This method is intended when a two-part dental bleach is utilized. First, a two-part dental bleach containing polyvinylpyrrolidone is obtained or created 401 such as by utilizing one of the formulas above. A patient or dental practitioner of patient would likely obtain a dental bleach in a dispenser ready to use as depicted in FIG. 5 . Note that the syringe has two barrels for the two parts of the dental bleach. The components of the two-part dental bleach must be mixed for use 402 . Second, the mixed two-part dental bleach is placed into a dental tray 403 . Third, the dental tray containing bleach is place onto teeth to be bleached, causing the bleach to contact teeth 404 . Next, optionally, the dental bleach can be exposed to light or heat in order to accelerate release of its oxidizing agent such as oxygen ions 405 . Regardless of whether light or heat is used, next, the dental bleach will release an oxidizing agent 406 such as oxygen ions. The oxidizing agent, when in contact with teeth, will bleach and lighten, whiten or remove stains from the teeth 407 . Next, the dental tray is removed 408 and the teeth are rinsed 409 . [0082] Referring to FIG. 5 , use of a dental bleach dispenser 507 such as a double barrel syringe is depicted. The double barrel syringe 507 has a first chamber 507 a and a second chamber 507 b. Both chambers may be of equal volume for ease of determining the final mixture of the dental bleach, although double barrel syringes with two chambers of unequal volumes can be used as well Likewise, multi-chamber syringes may be used for multi-component bleaches. The two chambers 507 a and 507 b may also contain gels of approximately equal viscosities for ease and efficiency of mixing. The first chamber 507 a may contain an oxidizing agent such as a peroxide in a concentration such that when the two components of the bleach are mixed from the two chambers, the resulting bleach 505 has the desired concentration of bleaching agent. The chamber 507 a containing the bleaching agent 507 a may have a pH=7 or less for stability of the bleaching agent. The contents of the second chamber 507 b will include a basic substance and will have a pH in the range of about 7 to 12. However, the second chamber 507 b will typically not include a bleaching agent. The remainder of the components of the dental bleach may be equally present in both chambers of the syringe, although other pre-dispensing mixes are possible. [0083] As the plunger 507 d of the dental bleach dispenser 507 is depressed, the contents of the first chamber 507 a and the second chamber 507 b are forced through a mixing tip 507 c where they are mixed. This mixing contacts the basic substance with the bleaching agent. As the basic substance will tend to destabilize the bleaching agent, the bleaching agent will generate oxygen radicals more rapidly. The pH of the resulting mixed dental bleach 505 may be greater than the pH of the dental bleach dispensed from the syringe of FIG. 3 . [0084] The mixed bleach 505 is placed into the arch 504 of a dental tray 503 , and the dental tray 503 is placed over teeth 501 . The bleach 505 with destabilized bleaching agent will release large quantities of oxidizing agent quickly to perform rapid and thorough bleaching of the teeth 501 . The dental tray 503 serves to retain the bleach 505 on the teeth 501 and to keep the bleach 505 away from most soft tissue 502 . [0085] Referring now to the drawings, and more particularly to FIGS. 11 and 12 , there is shown a device which is generally indicated as 1010 . Embodiment 1010 represents a delivery system for a tooth whitening substance. Delivery system 1010 has a strip of material 1012 , which may be initially substantially flat with rounded corners. [0086] Applied or coated onto strip of material 1012 , or embedded into the strip of material 1012 if the material is porous, is a tooth whitening substance 1014 . Substance 1014 maybe homogeneous, uniformly and continuously coated onto strip of material 1012 , as shown in FIG. 8 , or embedded into the strip of material if the material is porous. However, substance 1014 may alternatively be a laminate or separated layers of components, an amorphous mixture of components, separate stripes or spots or other patterns of different components, or a combination of these structures, including a continuous coating of oral care substance 1014 along a longitudinal axis of a portion of strip of material 1012 . [0087] As shown in FIG. 9 , an alternative embodiment, a strip of material 1012 may have shallow pockets 1018 formed therein. When substance 1014 is coated on a substance-coated side of strip of material 1012 , additional substance 1014 fills shallow pockets 1018 to provide reservoirs of additional substance 1014 . [0088] FIGS. 10 and 11 show a delivery system 1024 applied to a plurality of adjacent teeth and the surface of a tooth. Embedded in adjacent soft tissue 1020 is a plurality of adjacent teeth 1022 . Adjacent soft tissue is herein defined as soft tissue surfaces surrounding the tooth structure including: papilla, marginal gingiva, gingival sulculus, inter dental gingiva, gingival gum structure on lingual and buccal surfaces up to and including muco-gingival junction and the pallet. [0089] In both FIGS. 10 and 11 , delivery system 1024 represents strip of material 1012 and substance 1014 , with substance 1014 on the side of strip of material 1012 facing adjacent teeth 1022 . Substance 1014 may be pre-applied to strip of material 1012 or applied to strip of material 1012 by the delivery system user. In either case, strip of material 1012 has a thickness and flexural stiffness which enable it to conform to the contoured surfaces of adjacent teeth 1022 and to adjacent soft tissue 1020 . The strip of flexible material has sufficient flexibility to form a curved shape around a plurality of adjacent teeth. The strip of material is also readily conformable to tooth surfaces and to the interstitial tooth spaces without permanent deformation when the delivery system is applied. The delivery system is applied without significant pressure. [0090] FIGS. 12 and 13 show delivery system 1024 applied to both front and rear surfaces of a plurality of adjacent teeth 1022 as well as to adjacent soft tissue 1020 located by the front surfaces of the teeth. Delivery system 1024 represents strip of material 1012 and substance 1014 , with substance 1014 on the side of strip of material 1012 facing adjacent teeth. [0091] FIGS. 14 and 15 shows an optional release liner 1027 . Release liner 1027 is attached to strip of material 1012 by substance 1014 . Substance 1014 is on the side of strip of material 1012 facing release liner 1027 . This side is applied to the tooth surface once release liner 1027 is removed. [0092] The strip of material serves as a protective barrier to substantially prevent saliva contacting the tooth whitening substance and leaching and/or erosion of the tooth whitening substance from the surface of the teeth by the wearer's lips, tongue, and other soft tissue. In order for an active in tooth whitening substance to act upon the surface of tooth over an extended period of time, from several minutes to several hours, it is important to minimize such leaching and/or erosion. The term “act upon” is herein defined as bringing about a desired change. For example, if the substance is a tooth whitener, it bleaches color bodies to bring about whitening. [0093] The strip of material may comprise materials such as polymers, natural and synthetic wovens, non-wovens, foil, paper, rubber, and combinations thereof. The strip of material may be a single layer of material or a laminate of more than one layer. Generally, the strip of material is substantially water impermeable. The material may be any type of polymer that meets the required flexural rigidity and is compatible with tooth whitening actives, such as peroxide. The material may comprise a single polymer or a mixture of polymers. Suitable polymers include, but are not limited to, polyethylene, ethylvinylacetate, ethylvinyl alcohol, polyesters such as Mylar® manufactured by DuPont, fluoroplastics such as Teflon® manufactured by DuPont, and combinations thereof. The material may be polyethylene. The strip of material is generally less than about 1 mm thick, or less than about 0.05 mm thick, or from about 0.001 to about 0.03 mm thick. A polyethylene strip of material may be less than about 0.1 mm thick or from about 0.005 to about 0.02 mm thick. [0094] The shape of the strip of material may be any shape that has rounded corners. “Rounded corners” is defined as not having any sharp angles or points. The conformable strip of material may be of a size that individually fits the row of teeth desired to be bleached. Generally, this is the front 6-8 teeth of the upper or lower rows of teeth that are visible when the wearer is smiling. Optionally, the strip of material may fit the entire upper or lower rows of teeth when positioned against the teeth. The size of the strip of material depends upon many factors, including the number of teeth to be bleached, the size of the teeth, and personal preference of the wearer. In general, the length of the strip of material is from about 2 cm to about 12 cm, or from about 4 cm to about 9 cm. The width of the strip of material will also depend upon many factors, including whether or not the strip of material wraps around the teeth and covers both surfaces of the tooth. In a general application, the width of the strip of material is from about 0.5 cm to about 4 cm, or from about 1 to about 2 cm. [0095] The strip of material may contain shallow pockets. When the substance is coated on a substance-coated side of strip of material, additional substance fills shallow pockets to provide reservoirs of additional substance. Additionally, the shallow pockets help to provide a texture to the delivery system. The film may have an array of shallow pockets. Generally, the shallow pockets are approximately 0.4 mm across and 0.1 mm deep. When shallow pockets are included in the strip of material and substances are applied to it in various thicknesses, the overall thickness of the delivery system is generally less than about 1 mm. The overall thickness may be less than about 0.5 mm. [0096] Flexural stiffness is a material property that is a function of a combination of strip thickness, width, and material modulus of elasticity. This test is a method for measuring the rigidity of polyolefin film and sheeting. It determines the resistance to flexure of a sample by using a strain gauge affixed to the end of a horizontal beam. The opposite end of the beam presses across a strip of the sample to force a portion of the strip into a vertical groove in a horizontal platform upon which the sample rests. A micrometer, wired to the strain gauge, is calibrated in grams of deflection force. The rigidity of the sample is read directly from the microammeter and expressed as grams per centimeter of sample strip width. In some embodiments, the strip of material has a flexural stiffness of less than about 5 grams/cm as measured on a Handle-O-Meter, model #211-300, available from Thwing-Albert Instrument Co. of Philadelphia, Pa., as per test method ASTM D2923-95. The strip of material may have a flexural stiffness less than about 4 grams/cm, or less than about 3 grams/cm, or from about 0.1 grams/cm to about 1 grams/cm. The flexural stiffness of the strip of material may be substantially constant and not significantly change during normal use. For example, the strip of material does not need to be hydrated for the strip to achieve the low flexural stiffness in the above-specified ranges. [0097] This relatively low stiffness enables the strip of material to drape over the contoured surfaces of teeth with very little force being exerted; that is, conformity to the curvature of the wearer's mouth and gaps between adjacent teeth is maintained because there is little residual force within strip of material to cause it to return to its substantially flat shape. The flexibility of the strip enables the strip of material to contact adjoining soft tissue over an extended period of time without physical irritation. The strip of material does not require pressure forming it against the teeth. [0098] The strip of material is held in place on a plurality of adjacent teeth by adhesive attachment provided by the substance. The viscosity and general tackiness of the substance cause the strip of material to be adhesively attached to a plurality of adjacent teeth without substantial slippage under the potential friction from the lips, tongue, and other soft tissue rubbing against the strip of material during mouth movements associated with talking, drinking, etc. However, this adhesion to the teeth is low enough to allow the delivery system to be easily removed by the wearer by peeling off the strip of material using one's finger or fingernail. The delivery system is easily removable from the surfaces of the teeth without the use of an instrument, a chemical solvent, or undue friction. Chemical solvents include any organic solvents commonly used in oral care products such as alcohol and other safe solvents such as water, which could be used to dilute the gelling agent. Undue friction is described as any type of rubbing with one's finger or a soft implement, such as cotton balls, swabs, or gauze pads. [0099] A peel force of from about 1 gram to about 50 grams for a 1.5 cm strip width (approximately 17 grams/cm) is all that is required. The peel force may be from about 5 grams to about 40 grams, or from about 10 grams to about 30 grams. The low peel force is desired for consumer handling purposes. The low peel force is possible because of the non-aggressive nature of a gel substance. Only when the flexural stiffness of the strip is low can the adhesion of the substance also be low. The adhesion of a stiffer strip would have to be greater in proportion to the strip stiffness in order to prevent the strip from returning to its flat condition and pulling away from the contoured surface of a plurality of teeth. [0100] The strip of material may be formed by several of the film making processes known in the art. A strip of material made of polyethylene may be made by a blowing process or a cast process. Processes, such as extrusion and other processes that do not affect the flexural rigidity of the strip of material, are also feasible. Additionally, the substance may be incorporated onto the strip during the processing of the strip. The substance may be a laminate on the strip. [0101] While the present embodiments have been described and illustrated in conjunction with a number of specific embodiments, those skilled in the art will appreciate that variations and modifications may be made without departing from the principles as herein illustrated, described and claimed. The devices may be embodied in other specific forms without departing from their spirit or characteristics. The described embodiments are to be considered in all respects as only illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

A dental bleaching composition comprises a dental bleaching agent, polyvinylpyrrolidone, and at least 0.1% water. The bleaching composition may include a liquid component, flavoring agent, basic substance, and/or desensitizing agent as desired. Polyvinylpyrrolidone avoids acid etching and chelation of teeth that were problematic in bleaches using carbomer as a thickener. A delivery system for delivering the bleaching composition comprises the aforementioned dental bleaching composition in combination with a moisture-resistant barrier layer such as a dental tray or a flexible strip of material.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority of provisional application Serial No. 60/087,661, filed Jun. 2, 1998. TECHNICAL FIELD [0002] This invention relates to medical devices, more particularly, to intraluminal devices. BACKGROUND OF THE INVENTION [0003] As minimally invasive techniques and instruments for placement of intraluminal devices have developed over recent years, the number and types of treatment devices have proliferated as well. Stents, stent grafts, occlusion devices, artificial valves, shunts, etc., have provided successful treatment for a number of conditions that heretofore required surgery or lacked an adequate solution altogether. Minimally invasive intravascular devices have especially become popular with the introduction of coronary stents to the U.S. market in the early 1990s. Coronary and peripheral stents have been proven to provide a superior means of maintaining vessel patency, however, they have subsequently been used in conjunction with grafts as a repair for abdominal aortic aneurysm, fibers or other materials as occlusion devices, and as an intraluminal support for artificial valves, among other uses. [0004] Some of the chief goals in designing stents and related devices include providing sufficient radial strength to supply sufficient force to the vessel and prevent device migration. An additional concern in peripheral use, is having a stent that is resistant to external compression. Self-expanding stents are superior in this regard to balloon expandable stents which are more popular for coronary use. The challenge is designing a device that can be delivered to the target vessel in as small of a configuration as possible, while still being capable of adequate expansion. Self-expanding stents usually require larger struts than balloon expandable stents, thus increasing their profile. When used with fabric or other coverings that require being folded into a delivery catheter, the problem is compounded. [0005] There exists a need to have a basic stent, including a fabric covering, that is capable of being delivered with a low profile, while still having a sufficient expansion ratio to permit implantation in larger vessels, if desired, while being stable, self-centering, and capable of conforming to the shape of the vessel. SUMMARY OF THE INVENTION [0006] The foregoing problems are solved and a technical advance is achieved in an illustrative multiple-sided intraluminal medical device comprised of a single piece of wire or other material having a plurality of sides and bends interconnecting adjacent sides. The bends can be coils, fillets, or other configurations to reduce stress and fatigue. The single piece of wire is preferably joined by an attachment mechanism, such as a piece of cannula and solder, to form a closed circumference frame. The device has a first configuration wherein the sides and bends generally lie within a single, flat plane. In an embodiment having four equal sides, the frame is folded into a second configuration where opposite bends are brought in closer proximity to one another toward one end of the device, while the other opposite ends are folded in closer proximity together toward the opposite end of the device. In the second configuration, the device becomes a self-expanding stent. In a third configuration, the device is compressed into a delivery device, such as a catheter, such that the sides are generally beside one another. While the preferred embodiment is four-sided, other polygonal shapes can be used as well. [0007] In another aspect of the present invention, one or more barbs can be attached to the frame for anchoring the device in the lumen of a vessel. The barbs can be extensions of the single piece of wire or other material comprising the frame, or they can represent a second piece of material that is separately attached to the frame by a separate attachment mechanism. An elongated barb can be used to connect additional devices with the second and subsequent frames attached to the barb in a similar manner. [0008] In still another aspect of the present invention, a covering, such as DACRON, PTFE, collagen, or other flexible material, can be attached to the device with sutures or other means to partially, completely, or selectively restrict fluid flow. When the covering extends over the entire aperture of the frame, the frame formed into the second configuration functions as an vascular occlusion device that once deployed, is capable of almost immediately occluding an artery. A artificial valve, such as that used in the lower legs and feet to correct incompetent veins, can be made by covering half of the frame aperture with a triangular piece of material. The artificial vein traps retrograde blood flow and seals the lumen, while normal blood flow is permitted to travel through the device. In related embodiments, the device can be used to form a stent graft for repairing damaged or diseased vessels. In a first stent graft embodiment, a pair of covered frames or stent adaptors are used to secure a tubular graft prosthesis at either end and seal the vessel. Each stent adaptor has an opening through which the graft prosthesis is placed and an elongated barb is attached to both frames. In another stent graft embodiment, one or more frames in the second configuration are used inside a sleeve to secure the device to a vessel wall. BRIEF DESCRIPTION OF THE DRAWING [0009] [0009]FIG. 1 depicts a top view of one exemplary embodiment of the present invention; [0010] [0010]FIG. 2 depicts a pictorial view of the embodiment of FIG. 1; [0011] [0011]FIG. 3 depicts a top view and enlarged, partial cross-sectional views of a second exemplary embodiment of the present invention; [0012] [0012]FIG. 4 depicts a side view of the embodiment of FIG. 3 deployed in a vessel; [0013] [0013]FIG. 5 depicts a enlarged partial view of the embodiment of FIG. 1; [0014] [0014]FIG. 6 depicts a partially-sectioned side view of the embodiment of FIG. 1 inside a delivery system; [0015] [0015]FIG. 7 depicts a top view of a third embodiment of the present invention; [0016] [0016]FIG. 8 depicts a side view of the embodiment of FIG. 7 deployed in a vessel; [0017] FIGS. 9 - 11 depict enlarged partial views of other embodiments of the present invention; [0018] [0018]FIG. 12 depicts a top view of a fourth embodiment of the present invention; [0019] FIGS. 13 - 14 depicts side views of the embodiment of FIG. 12; [0020] [0020]FIG. 15 depicts a top view of a fifth embodiment of the present invention; [0021] [0021]FIG. 16 depicts a side view of the embodiment of FIG. 15; [0022] [0022]FIG. 17 depicts a side view of a sixth embodiment of the present invention; [0023] [0023]FIG. 18 depicts an enlarged pictorial view of a seventh embodiment of the present invention; and [0024] [0024]FIG. 19 depicts a top view of an eighth embodiment of the present invention. DETAILED DESCRIPTION [0025] The invention is further illustrated by the following (preceding) pictorial embodiments, which in no way should be construed as further limiting. The present invention specifically contemplates other embodiments not illustrated but intended to included in the appended claims. [0026] [0026]FIG. 1 depicts a top view of one embodiment of the medical device 10 of the present invention comprising a frame 11 of resilient material, preferably metal wire made of stainless steel or a superelastic material (e.g., nitinol). While round wired is depicted in each of the embodiments shown herein, other types, e.g., flat, square, or triangular, may be used to form the frame. In the illustrative embodiment, the frame comprises a closed circumference 62 of a single piece 59 of material that is formed into a device 10 having a plurality of sides 13 interconnected by a series of bends 12 . The depicted embodiment includes four sides 13 of approximately equal length. Alternative embodiment include forming a frame into any polygonal shape, for example a pentagon, hexagon, octagon, etc. One alternative embodiment is shown in FIG. 19 that includes a four-sided frame 11 having the general shape of a kite with two adjacent longer sides 66 and two adjacent shorter sides 67 . In the embodiment of FIG. 1, the bends 12 interconnecting the sides 13 comprise a coil 14 of approximately one and a quarter turns. The coil bend produces superior bending fatigue characteristics than that of a simple bend 40 , as shown in FIG. 9, when the frame is formed from stainless steel and most other standard materials. The embodiment of FIG. 9 may be more appropriate, however, if the frame is formed from nitinol (NiTi) or other superelastic alloys, as forming certain type of bends, such as coil 14 , may actually decrease fatigue life of a device of superelastic materials. Therefore, the bend 12 should be of a structure that minimizes bending fatigue. Alternative bend 12 embodiments include a outward-projecting fillet 41 as shown in FIG. 10, and an inward-projecting fillet 42 comprising a series of curves 63 , as shown in FIG. 11. Fillets are well known in the stent art as a means to reduce stresses in bends. By having the fillet extend inward as depicted in FIG. 11, there is less potential trauma to the vessel wall. [0027] When using stainless steel wire, the size of the wire depends on the size of device and the application. An occlusion device, for example, preferably uses 0.010″ wire for a 10 mm square frame, while 0.014″ and 0.016″ wire would be used for 20 mm and 30 mm frames, respectively. Wire that is too stiff can damage the vessel, not conform well to the vessel wall, and increase the profile of the device. [0028] Returning to FIG. 1, the single piece 59 of material comprising the frame 11 is formed into the closed circumference by securing the first and second ends 60 , 61 with an attachment mechanism 15 such as a piece of metal cannula. The ends 60 , 61 of the single piece 59 are then inserted into the cannula 15 and secured with solder 25 , a weld, adhesive, or crimping to form the closed frame 11 . The ends 60 , 61 of the single piece 59 can be joined directly without addition of a cannula 15 , such as by soldering, welding, or other methods to join ends 61 and 62 . Besides, joining the wire, the frame could be fabricated as a single piece of material 59 , by stamping or cutting the frame 11 from another sheet (e.g., with a laser), fabricating from a mold, or some similar method of producing a unitary frame. [0029] The device 10 depicted in FIG. 1 is shown in its first configuration 35 whereby all four bends 20 , 21 , 22 , 23 and each of the sides 13 generally lie within a single flat plane. To resiliently reshape the device 10 into a second configuration 36 , shown in FIG. 2, the frame 11 of FIG. 1 is folded twice, first along a diagonal axis 24 with opposite bends 20 and 21 being brought into closer proximity, followed by opposite bends 22 and 23 being folded together and brought into closer proximity in the opposite direction. The second configuration 36 , depicted in FIG. 2, has two opposite bends 20 , 21 oriented at the first end 68 of the device 10 , while the other opposite bends 22 , 23 are oriented at the second end 69 of the device 10 and rotated approximately 180° with respect to bends 20 and 21 when viewed in cross-section. The medical device in the second configuration 36 can be used as a stent 44 to maintain an open lumen 34 in a vessel 33 , such as a vein, artery, or duct. The bending stresses introduced to the frame 11 by the first and second folds required to form the device 10 into the second configuration 36 , apply radial force against the vessel wall 70 to hold the device 10 in place and prevent vessel closure. Absent any significant plastic deformation occurring during folding and deployment, the device in the second configuration 36 when removed from the vessel or other constraining means, will at least partially return to the first configuration 25 . It is possible to plastically form the device 10 into the second configuration 36 , such that it does not unfold when restraint is removed. This might be particularly desired if the device is made from nitinol or a superelastic alloy. [0030] The standard method of deploying the medical device 10 in a vessel 33 , depicted in FIG. 6, involves resiliently forming the frame 11 into a third configuration 37 to load into a delivery device 26 , such as a catheter. In the third configuration 37 the adjacent sides 13 are generally beside each other in close proximity. To advance and deploy the device from the distal end 28 of the delivery catheter 26 , a pusher 27 is placed into the catheter lumen 29 . When the device 10 is fully deployed, it assumes the second configuration 36 within the vessel as depicted in FIG. 2. The sides 13 of the frame, being made of resilient material, conform to the shape of the vessel wall 70 such that when viewed on end, the device 10 has a circular appearance when deployed in a round vessel. [0031] A second embodiment of the present invention is depicted in FIG. 3 wherein one or more barbs 16 are included to anchor the device 10 following deployment. As understood, a barb can be a wire, hook, or any structure attached to the frame and so configured as to be able to anchor the device 10 within a lumen. The illustrative embodiment includes a first barb 16 with up to three other barbs 17 , 71 , 72 , indicated in dashed lines, representing alternative embodiments. As depicted in detail view A, the barb combination 38 that comprises barbs 17 and 18 , each barb is an extension of the single piece 59 of material of the frame 11 beyond the closed circumference 59 . The attachment cannula 15 secures and closes the single piece 59 of material into the frame 11 as previously described, while the first and second ends 60 , 61 thereof, extend from the cannula 15 , running generally parallel with the side 13 of the frame 11 from which they extend, each preferably terminating around or slightly beyond respective bends 20 , 23 . To facilitate anchoring, the distal end 19 of the barb 16 in the illustrative embodiment contains a bend or hook. [0032] Optionally, the tip of the distal end 19 can be ground to a sharpened point for better tissue penetration. To add a third and fourth barb as shown, a double ended barb 39 comprising barbs 71 and 72 is attached to the opposite side 13 as defined by bends 21 and 22 . Unlike barb combination 38 , the double barb 39 , as shown in detail view B, comprises a piece of wire, usually the length of barb combination 38 , that is separate from the single piece 59 comprising the main frame 11 . It is secured to the frame by attachment mechanism 15 using the methods described for FIG. 1. FIG. 4 depicts barb 17 (and 18 ) engaging the vessel wall 70 while the device 10 is in the second, deployed configuration 36 . While this embodiment describes up to a four barb system, more than four can be used. [0033] [0033]FIG. 7 depicts a top view of a third embodiment of the present invention in the first configuration 35 that includes a plurality of frames 11 attached in series. In the illustrative embodiment, a first frame 30 and second frame 31 are attached by a barb 16 that is secured to each frame by their respective attachment mechanisms 15 . The barb 16 can be a double-ended barb 39 as shown in FIG. 3 (and detail view B) that is separate from the single pieces 59 comprising frames 30 and 31 , or the barb may represent a long extended end of the one of the single pieces 59 as shown in detail view A of FIG. 3. Further frames, such as third frame 32 shown in dashed lines, can be added by merely extending the length of the barb 16 . FIG. 8 depicts a side view of the embodiment of FIG. 7 in the second configuration 36 as deployed in a vessel 33 . [0034] FIGS. 12 - 18 depict embodiments of the present invention in which a covering 45 comprising a sheet of fabric, collagen (such as small intestinal submucosa), or other flexible material is attached to the frame 11 by means of sutures 50 , adhesive, heat sealing, “weaving” together, crosslinking, or other known means. FIG. 12 [0035] depicts a top view of a fourth embodiment of the present invention while in the first configuration 35 , in which the covering 45 is a partial covering 58 , triangular in shape, that extends over approximately half of the aperture 56 of the frame 11 . When formed into the second configuration 36 as shown in FIGS. 13 - 14 , the device 10 can act as an artificial valve 43 such as the type used to correct valvular incompetence. FIG. 13 depicts the valve 43 in the open configuration 48 . In this state, the partial covering 58 has been displaced toward the vessel wall 70 due to positive fluid pressure, e.g., normal venous blood flow 46 , thereby opening a passageway 65 through the frame 11 and the lumen 34 of the vessel 33 . As the muscles relax, producing retrograde blood flow 47 , as shown in FIG. 14, the partial covering 58 acts as a normal valve by catching the backward flowing blood and closing the lumen 34 of the vessel. In the case of the artificial valve 43 , the partial covering 58 is forced against the vessel wall to seal off the passageway 65 , unlike a normal venous valve which has two leaflets, which are forced together during retrograde flow. Both the artificial valve 43 of the illustrative embodiment and the normal venous valve, have a curved structure that facilitates the capture of the blood and subsequent closure. In addition to the triangular covering, other possible configurations of the partial covering 58 that result in the cupping or trapping fluid in one direction can be used. [0036] Selecting the correct size of valve for the vessel ensures that the partial covering 58 properly seals against the vessel wall 70 . If the lumen 34 of the vessel is too large for the device 10 , there will be retrograde leakage around the partial covering 58 . [0037] [0037]FIG. 15 depicts a top view of a fifth embodiment of the present invention in the first configuration 35 , whereby there is a full covering 57 that generally covers the entire aperture 56 of the frame 11 . When the device 10 is formed into the second configuration 36 , as depicted in FIG. 16, it becomes useful as an occlusion device 51 to occlude a duct or vessel, close a shunt, repair a defect, or other application where complete prevention of flow is desired. As an intravascular device, studies in swine have shown occlusion to occur almost immediately when deployed in an artery or the aorta with autopsy specimens showed thrombus and fibrin had filled the space around the device. The design of the present invention permits it to be used successfully in large vessels such as the aorta. Generally, the occlusion device should have side 13 lengths that are at least around 50% or larger than the vessel diameter in which they are to be implanted. [0038] FIGS. 17 - 18 depict two embodiments of the present invention in which the device 10 functions as a stent graft 75 to repair a damaged or diseased vessel, such as due to formation of an aneurysm. FIG. 17 shown a stent graft 75 having tubular graft prosthesis 54 that is held in place by a pair of frames 11 that function as stent adaptors 52 , 53 . The tubular graft prosthesis 54 Each stent adaptor 52 , 53 has a covering attached to each of the frame sides 13 which includes a central opening 55 through which the graft prosthesis 54 is placed and held in place from friction or attachment to

A multiple-sided medical device comprises a closed frame of a single piece of wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration that comprises a self-expanding stent. The stent is pushed from a delivery catheter into the lumen of a duct or vessel. One or more barbs are attached to the frame of the device for anchoring or to connect additional frames. A covering of fabric or other flexible material such as DACRON, PTFE, or collagen, is sutured or attached to the frame to form an occlusion device, a stent graft, or an artificial valve such as for correcting incompetent veins in the lower legs and feet. A partial, triangular-shaped covering over the lumen of the device allows the valve to open with normal blood flow and close to retrograde flow.

FIELD OF THE INVENTION [0001] The present invention relates to devices having a sheet usable to clean a floor or other hard surfaces and more particularly to such devices having a removably attachable sheet. BACKGROUND OF THE INVENTION [0002] Cleaning of hard surfaces, such as floors (vinyl, linoleum, tile, cement), countertops, showers, etc. is well known in the art. Cleaning may be accomplished using cellulosic paper towels and non-woven sheets, as are well known in the art. Nonwoven sheets may be made according to commonly assigned U.S. Pat. Nos. 6,936,330 and/or 6,797,357. Cellulosic paper towels may be made according to commonly assigned U.S. Pat. Nos. 4,191,609 and/or 4,637,859. [0003] Such sheets have been removably attached to manual implements. The implements increase reach, and improve ergonomics. For example, when the hard surface to be cleaned is a floor, the implement allows the user to clean from a standing position, improving comfort over cleaning from a crouched position or on the knees. Manual implements may be made according to commonly assigned U.S. Pat. Nos. 8,684,619; 6,305,046 and/or D588,770. [0004] One problem encountered when cleaning floors is that a user can encounter tacky soils, which tend to stick to the floor, and/or encounter a variety of fine soils, such as dust, granular soils, dried food debris, plants, mud, etc. which tend to stick to the floor less. To improve cleaning of soluble and tacky stains, wetted and wettable floor sheets have been used. Pre-wetted floor sheets include those having APG polymers, as disclosed in commonly assigned U.S. Pat. No. 6,716,805. Wettable floor sheets have been used with the commercially available Swiffer WetJet® device. This device sprays cleaning solution onto the floor from a replaceable reservoir, as described in commonly assigned U.S. Pat. No. 8,186,898. Cleaning solution chemistry and a reservoir therefor may be made according to commonly assigned U.S. Pat. No. 6,386,392. Floor sheets which absorb cleaning solution from the floor may be made according to commonly assigned U.S. Pat. Nos. 5,960,508, 6,101,661 and/or 7,144,173. [0005] But these attempts do not always sufficiently clean the entire range of soils encountered, particularly large particles, such as cereal and chunks of mud from the floor. To overcome the problem of loose, large particle cleaning, rotatable beater bars have been utilized, as disclosed in U.S. Pat. No. 9,783, reissued Jun. 28, 1881; U.S. Pat. No. 306,008 issued Sep. 30, 1884; U.S. Pat. No. 329,257 issued Oct. 27, 1885; U.S. Pat. No. 4,654,927 issued Apr. 7, 1987; U.S. Pat. No. 7,134,161 issued Nov. 14, 2006. The beater bars in these teachings are driven by the wheels. Particularly, each of these references teaches plural wheels contacting the floor to be cleaned. The wheels drive the beater bar, obviating the need for a separate electric motor. Electric motors add cost and weight to the device. Split beater bars have also been used, as shown in 2005/0055792 and U.S. Pat. No. 7,134,161. [0006] Many mechanical sweepers use beater bars comprising nylon bristles. Bristles may also be used on carpets, where bristles can help loosen hair. Bristles can be prone to hair/lint/thread wrapping which may degrade performance. Since mechanical sweepers rely on momentum for pick-up, contaminated bristles reduce cleaning capability. Additionally, bristles can separate, requiring higher rotational speed to reduce bristle separation, and minimize particles passing through the bristles. Accordingly, some beater bars use fins or blades. [0007] Powered devices may have a beater bar which is battery powered or AC line powered to aid in picking up soil. These devices have higher rotational speeds and can be more effective than mechanically driven beater bars at picking up particles. But powered devices can be inconvenient if battery life is depleted or cord length is insufficient. [0008] Devices which also use a disposable sheet to assist in cleaning are known as illustrated by EP 1027855; US 2009/0077761; U.S. Pat. No. 7,013,528; U.S. Pat. No. 7,346,428 and commonly assigned U.S. Pat. No. 7,676,877. The disposable sheet may be attached to the implement using grippers, as described in commonly assigned 2014/0026344. Exemplary 2009/0077761, U.S. Pat. No. 7,013,528, U.S. Pat. No. 7,346,428 and EP 1027855 show the common arrangement of having a sheet attached to the bottom of the device. Commonly assigned U.S. Pat. No. 7,676,877 teaches a cleaning implement having a pivotable bottom wall to which a cleaning substrate may be attached. Commonly assigned 2013/0333129 teaches a device having a rotary beater bar and a cleaning sheet proximate thereto. [0009] But even with dual mode pickup devices, having a beater bar followed by a cleaning sheet, not all debris may be captured from the target surface. One problem with devices having dual mode pickup is that debris may pass between the two pickup modes. E.g. debris not captured by the beater bar may bypass the cleaning sheet, and more specifically, debris may pass between a beater bar and sheet. If such debris is not captured, that debris remains on the floor and the cleaning task may be unsatisfactory. [0010] One potential solution would be to provide a lip at the entrance to the beat bar pathway. The lip could drag on the floor similar to a dustpan. But this attempt at a solution may lead to drag in use and/or scratches on a wood floor. Clearly a better approach is needed to prevent bypass debris from remaining on the floor following cleaning. SUMMARY OF THE INVENTION [0011] The invention comprises a foot which accepts a removable sheet. The foot is movable on a surface and comprises a housing for holding a beater bar in a portion of the foot. A lip defines a rearward edge of the portion of the housing holding the beater bar. The foot also has a sole plate joined to the housing. The sole plate removably receives a disposable cleaning sheet thereon. The sole plate optionally pivots about a pivot axis between an open position for servicing of the cleaning sheet and optionally to a closed position for cleaning tasks. The sole plate has a distal edge proximate the lip. The lip and the distal edge defines predetermined gap therebetween, ranging from about −8 mm to about +8 mm. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1A is a side elevational view of a device of the present invention, with the sole plate shown in a closed position and shown with the front of the device facing right. [0013] FIG. 1B is a side elevational view of the device of FIG. 1A , with the sole plate shown in an intermediate position and showing the cleaning sheet in phantom. [0014] FIG. 1C is a side elevational view of the device of FIG. 1A , with the sole plate shown in a fully open position and showing the cleaning sheet in phantom. [0015] FIG. 2A is a front perspective view of an alternative embodiment of a device according to the present invention having a beater bar and raised head, with the sole plate shown in a closed position. [0016] FIG. 2B is a front perspective view of the device of FIG. 2A with the sole plate shown in a fully open position and showing the cleaning sheet in phantom. [0017] FIG. 2C is a rear perspective view of the device of FIG. 2B with the sole plate shown in a fully open position and showing the cleaning sheet in phantom. [0018] FIG. 3A is a rear perspective view of an alternative embodiment of a device according to the present invention having an optional dirt bin, dual gripper pairs to attach different cleaning sheet lengths, with the sole plate shown in a closed position. [0019] FIG. 3B is a side elevational view of the device of FIG. 3A and showing the cleaning sheet in phantom attached to two different sets of grippers. [0020] FIG. 4 is a vertical fragmentary sectional view of a device having a gap with an overlap and shown with the front of the device facing left. [0021] FIG. 5 is a graphical representation of the effect of the gap between the forward distal edge of the sole plate and the lip of the portion of the beater bar housing on debris pickup, showing the performance of an exemplary dual mode cleaning device. DETAILED DESCRIPTION OF THE INVENTION [0022] Referring to FIGS. 1A-1C , the invention may comprise a dual mode surface cleaning device ( 10 ) for cleaning hard surfaces, such as floors, countertops, etc. The device ( 10 ) may comprise a handle ( 12 ) and a foot ( 14 ) mounted thereto in pivoting relationship. The pivoting relationship may include single axis pivoting relationship as occurs with a hinge or multi-axis pivoting relationship as occurs with a universal joint. Alternatively, if a small hand-held device ( 10 ) is desired, the handle ( 12 ) and foot ( 14 ) may be disposed in fixed relationship, so that countertops, showers and similar surfaces may be cleaned. The handle ( 12 ) and foot ( 14 ) may be permanently or removably connected together. Or a small hand held device ( 10 ) may comprise only a foot ( 14 ) and no handle ( 12 ). [0023] The foot ( 14 ) may comprise a beater bar ( 44 ) on the bottom thereof, to provide a first mode of cleaning for crumbs, large particulates, etc. The foot ( 14 ) may removably receive a sheet ( 20 ) on the bottom thereof, to provide a second mode of cleaning, for dusts and smaller debris not captured by the first mode of cleaning. [0024] Referring particularly to FIGS. 1B-1C , the floor sheet ( 20 ), or other cleaning cloth, usable with the present invention may comprise a textured nonwoven and more particularly a hydroentangled nonwoven. The nonwoven may comprise a single ply having three layers. The three layers may comprise a layer of carded fibers interposed between two layers of spunbonded fibers. The sheet ( 20 ) may be made according to commonly assigned U.S. Pat. Nos. 6,561,354; 6,645,604 and/or 2002/0042962. [0025] Optionally, the sheet ( 20 ) may comprise a laminate construction, particularly if wet cleaning is contemplated with the present invention. The laminate may comprise at least one floor contacting layer and at least one absorbent, reservoir storage layer. A third, dedicated foot ( 14 ) contacting layer is optional and can be used for attachment to the device ( 10 ). Thus, the sheet ( 20 ) of the present invention may comprise 1, 2, 3, 4 or more layers. [0026] In one embodiment, the fibers can be an airlaid nonwoven web comprising a combination of natural fibers, staple length synthetic fibers and a latex binder. The dry fibrous web can be about 20 to 80 percent by weight wood pulp fibers, 10 to 60 percent by weight staple length polyester fibers, and about 10 to 25 percent by weight binder. The dry sheet ( 20 ) can have a basis weight between about 30 and about 1000 grams per square meter. [0027] Pre-moistened sheets ( 20 ) used in the system of the present invention may be advantageous in that they are always ready for use, and simple to use without special dosing. The user does not have to worry about applying too much cleaning solution, leading to waste, or too little cleaning solution to be efficacious. A pre-moistened sheet ( 20 ) may be made according to the teachings of commonly assigned U.S. Pat. No. 6,716,805. The sheet ( 20 ) may comprise a perforate or imperforate film, such as is known in the art for wetted floor sheets ( 20 ). An imperforate film will inhibit, if not prevent, transmission of steam or liquid therethrough, potentially reducing efficacy of the cleaning system. [0028] The sheet ( 20 ) may be disposable after a single use. By disposable, it is meant that the sheet ( 20 ) is discarded after a single use of cleaning at least 5, 10, 15, 20 or more square meters and is not laundered or restored. Alternatively the sheet ( 20 ) may be laundered and restored for subsequent use. The sheet ( 20 ) can function as a scrubbing material and/or have additional materials added for scrubbing. [0029] The sheet ( 20 ) may be generally rectangular, and sized to removably fit on the sole plate ( 70 ) of the device ( 10 ). The sheet ( 20 ) may have two opposed faces, an upper face for attachment to the sole plate ( 70 ) of the device ( 10 ), and a lower face which contacts and cleans the target surface. The sheet ( 20 ) may be removably attachable to the foot ( 14 ), and particularly to the sole plate ( 70 ) thereof using grippers ( 74 ) as described herein. [0030] Referring to FIGS. 2A-2C , the foot ( 14 ) may comprise a footprint large enough to accommodate the sheet ( 20 ). The foot ( 14 ) may be generally rectangular, having a front ( 52 ), rear ( 53 ) and two spaced apart sides ( 54 ). The foot ( 14 ) may comprise two mirror images, symmetrically opposite about a longitudinal centerline. The user may generally push the device ( 10 ) from front ( 52 ) to rear ( 53 ), and back, in a series of strokes. [0031] The device ( 10 ) may comprise an axially rotatable beater bar ( 44 ), to remove debris from the floor. The beater bar ( 44 ) may be manually driven from a wheel or may be electrically powered, from an AC motor or DC motor as is known in the art. The beater bar ( 44 ) may sweep loose debris into a dirt bin ( 58 ), as described in 2010/0287716. [0032] The optional beater bar ( 44 ) may be parallel to the widthwise direction of the foot ( 14 ) and parallel to the axle. The beater bar ( 44 ) may axially rotate about its axis on the forward stroke. Such rotation will collect large particles in an optional dirt bin ( 58 ). Smaller particles, not collected by the rotation of the beater bar ( 44 ), may be captured by the sheet ( 20 ) which trails the beater bar ( 44 ) on a forward stroke. [0033] The beater bar ( 44 ) may be contained within a housing ( 50 ) for safety. The beater bar ( 44 ) may be parallel to the front ( 52 )/rear ( 53 ) of the foot ( 14 ) and perpendicular to the longitudinal centerline. The device ( 10 ) may comprise two or more co-linear beater bars ( 44 ). The two beater bars ( 44 ) may be disposed with one on each side of the longitudinal centerline. Each beater bar ( 44 ) may be disposed on and rotate about an axle. Each axle may extend from the respective side ( 54 ) of the housing ( 50 ) to a trunnion juxtaposed with the longitudinal centerline. The axles may be locked in place by protrusions in the axles which fit into complementary detents in the trunnions. The beater bar ( 44 ) thus may be easily and conveniently removed and replaced, without having to undo belts, screws, etc. [0034] Referring to FIG. 2B , the beater bar ( 44 ) may be disposed in a portion of the housing ( 50 ) defined in part by a lip ( 45 ). The lip ( 45 ) may be disposed on, or proximate to, the floor during use. The lip ( 45 ) may be parallel to and generally correspond in width to the beater bar ( 44 ). The lip ( 45 ) may scrape the floor and provide for the foot ( 14 ) to collect debris in use. The lip ( 45 ) may also provide an entrance for debris to enter a collection system, as discussed below relative to an exemplary dirt bin ( 58 ). The lip ( 45 ) may also define a rearward edge of the portion of the housing ( 50 ) which holds the beater bar ( 44 ). [0035] Referring to FIG. 2A , the foot ( 14 ) may comprise an optional dirt bin ( 58 ) to receive debris from the beater bar ( 44 ) or other cleaning mode. At the end of the cleaning task, or when filled, the dirt bin ( 58 ) may be removed from the foot ( 14 ) through a cover in the housing ( 50 ) or by pivoting the housing ( 50 ) to an open position or by other access. Upon removal, the dirt bin ( 58 ) may be emptied or replaced. If desired, the dirt bin ( 58 ) may comprise part of the housing ( 50 ). [0036] Referring to FIG. 2B , the foot ( 14 ) may comprise one or more wheels ( 40 ). A single wheel ( 40 ) may be disposed on the longitudinal centerline of the foot ( 14 ) as described in commonly assigned US 2013/0333129A1. The wheel ( 40 ) may be mounted towards the front ( 52 ) or rear ( 53 ) of the foot ( 14 ). The axis and axle may be parallel to the width direction of the foot ( 14 ), and perpendicular to the longitudinal centerline of the foot ( 14 ). The wheel ( 40 ) may have a diameter ranging from 18 to 63 mm and particularly be 43 mm. The wheel ( 40 ) may be relatively narrow at the circumference, to improve maneuverability. The wheel ( 40 ) may have a rubber periphery, to provide traction sufficient to drive each optional beater bar ( 44 ), if present. The beater bar(s) ( 44 ) may be driven in a 1:1 ratio with the wheel ( 40 ) or may be geared to be rotationally driven faster than the wheel ( 40 ), at a ratio ranging to 3, 4, 5 or 6:1 or more. [0037] Referring to FIGS. 2A-2B , the foot ( 14 ) may further comprise an optional plow ( 56 ). The plow ( 56 ) may be chevron-shaped, arcuate, diagonally oriented with respect to the front ( 52 ) of the device, etc. The plow ( 56 ) may divert debris from the wheel to more directly be intercepted by the beater bar ( 44 ) and or sheet ( 20 ). [0038] Referring to FIGS. 1A-1C , the housing ( 50 ) may have a removable or hingedly attached sole plate ( 70 ). Removal/pivoting of the sole plate ( 70 ) from/relative to the housing ( 50 ) may allow access to the, beater bars ( 44 ), dirt bin ( 58 ) and/or particularly the sheet ( 20 ). This arrangement allows the replacement of a beater bar ( 44 ) to occur without the use of tools, such as a screwdriver or pliers. The pivoting relationship of the sole plate ( 70 ) relative to the housing ( 50 ) described herein does not require 360 degree rotation of one relative to the other. Pivoting/articulation or other temporary removal of the sole plate ( 16 ) from the housing ( 50 ), need only intercept an angle/position sufficient to allow servicing [mounting/removal] of the sheet ( 20 ) in an open position and placement of the sheet ( 20 )/sole plate ( 70 ) in the foot ( 14 ) in the closed position for cleaning tasks. [0039] The entire sole plate ( 70 ) may hinge to an open position. As used herein, a housing ( 50 ) and sole plate ( 70 ) may be movable relative to each other. One may be held stationary, while the other is articulated or translated to/from a closed position to an open position and back. While a sole plate ( 70 ) hingedly attached to a housing ( 50 ) is shown, one of skill will recognize the invention is not so limited. [0040] The sole plate ( 70 ) and housing ( 50 ) may be distinguished from each other by the housing ( 50 ) generally being larger and heavier than the sole plate ( 70 ). The housing ( 50 ) may serve as a frame for and provide attachment of components such as the wheel ( 40 ), beater bar ( 44 ) dirt bin ( 58 ) and/or other components. [0041] The sole plate ( 70 ) may pivot about a pivot axis. This axis may be perpendicular to the longitudinal centerline and extend between the two spaced apart sides ( 54 ). The sole plate ( 70 ) has a forward portion ( 173 ) and rearward portion ( 172 ) opposingly disposed about the axis. The forward portion ( 173 ) and rearward portion ( 172 ) rotate about the axis in synchronus relationship, in response to manipulation by the user. If the user grasps either the forward portion ( 173 ) or rearward portion, and manipulates one portion ( 172 , 173 ) to move relative to the housing ( 50 ), the other portion ( 172 , 173 ) will likewise and simultaneously move an equal amount relative to the housing ( 50 ) and around the pivot axis. The forward portion ( 173 ) and rearward portion ( 172 ) may be joined in rigid relationship, to assure synchronus movement as the sole plate ( 70 ) rotates about the pivot axis relative to the housing ( 50 ). [0042] The forward portion ( 173 ) may have a distal edge ( 175 ). The distal edge ( 175 ) of the forward portion ( 173 ) of the sole plate ( 70 ), and particularly of the panel ( 73 ) thereof, may be straight, parallel to and correspond in width to, the beater bar ( 44 ). The distal edge ( 175 ) may also be angled and/or tapered to direct particles to a specific portion of the beater bar ( 44 ). [0043] Each of the forward portion ( 173 ) and rearward portion ( 172 ) of the sole plate ( 70 ) may have one or more grippers ( 74 ). This arrangement allows the sheet ( 20 ) to be attached to the sole plate ( 70 ) without attachment to or interference from the housing ( 50 ). The sheet ( 20 ) may be attached to the upwardly facing surfaces of both the forward portion ( 173 ) and rearward portion ( 172 ). The grippers ( 74 ) may be disposed on the upwardly facing surfaces, oriented away from the floor, of both the forward portion ( 173 ) and rearward portion ( 172 ). [0044] This arrangement advantageously allows the sheet ( 20 ) to wrap both the front edge of the forward portion ( 173 ) and rear edge of the rearward portion ( 172 ). By wrapping both edges of the pivotable sole plate ( 70 ), snowplowing of debris in both the forward stroke direction and reverse stroke direction is reduced. Likewise dislodging of the free edge of the sheet ( 20 ) which wraps the sole plate ( 70 ) is less likely to occur than if a free edge of the sheet ( 20 ) is disposed on the bottom of the sole plate ( 70 ) and rubs on the floor or other surface being cleaned. Such benefits are not expected or predicted in the devices known in the prior art. [0045] The sole plate ( 70 ) may comprise a generally planar panel ( 73 ), having the forward portion ( 173 ) and rearward portion ( 172 ) in generally mutually coplanar relationship. Alternatively the sole plate ( 70 ) may be curved, particularly convex outwardly. This geometry provides the benefit of concentrating pressure from the user onto a smaller portion of the sheet ( 20 ) and reducing snowplowing of debris in front of the sheet ( 20 ). [0046] One or more grippers ( 74 ) may be disposed on the head ( 72 ) of the sole plate ( 70 ). One or more grippers ( 74 ) may be disposed on the panel ( 73 ) of the sole plate ( 70 ), and particularly may be disposed on the inner face thereof, as disclosed in commonly assigned application Ser. No. 13/947,501, filed Jul. 22, 2013. This arrangement provides for all grippers ( 74 ) to be disposed on the articulable sole plate ( 70 ). In this arrangement, no grippers ( 74 ) are disposed on the housing ( 50 ). [0047] The sheet grippers ( 74 ) may comprise resilient fingers as shown in commonly assigned U.S. Pat. No. 6,305,046, U.S. Pat. No. 6,484,346 and U.S. Pat. No. 6,651,290 and US 20140026344. The grippers ( 74 ) may also or alternatively comprise hook and loop fasteners, adhesive, friction grips, clamps, etc. The grippers ( 74 ) may be exclusively disposed on the sole plate ( 70 ), as described herein. That is, the housing ( 50 ) may be free of grippers ( 74 ) and/or not require the use of grippers ( 74 ) to secure a sheet ( 20 ) to the foot ( 14 ). This arrangement provides the benefit that all grippers ( 74 ) can rotate together, and without relative movement between individual grippers ( 74 ) and be synchronously rotated together independent of the housing ( 50 ). [0048] Referring to FIGS. 2A-2C , in a particular embodiment, the sole plate ( 70 ) may comprise a panel ( 73 ) and optional head ( 72 ) extending therefrom and particularly outwardly and/or upwardly therefrom. The head ( 72 ) may be disposed on the rearward portion ( 172 ) of the sole plate ( 70 ). The panel ( 73 ) may be disposed on or comprise the forward portion ( 173 ) of the sole plate ( 70 ). A large portion of the panel ( 73 ) may have a generally flat shape, and be generally planar. The panel ( 73 ) may have an interior face and exterior face opposed thereto. Such panel ( 73 ) portion of the sole plate ( 70 ) need not be flat, as shown, but may have a convex or other arcuate shape, as helpful. The panel ( 73 ) may have a proximal end near the head ( 72 ) and a distal end remote therefrom. The distal end of the panel ( 73 ) may have an edge for convenient wrapping of the sheet ( 20 ) therearound. [0049] The head ( 72 ) may be integral with and/or rigidly attached to the panel ( 73 ). This arrangement provides the benefit, not found in the art, that as the sole plate ( 70 ) is moved, such during rotated to the open/closed positions, the head ( 72 ) and panel ( 73 ) are synchronized and move together without independent movement therebetween. Synchronus, simultaneous movement of the head ( 72 ) and panel ( 73 ) provide the benefit of less manipulation of the foot ( 14 ) during sheet ( 20 ) installation/replacement. [0050] The head ( 72 ), and rearward portion ( 172 ) in particular, may be disposed at the back of the foot ( 14 ). The sole plate ( 70 ) may partially wrap the housing ( 50 ), providing for advantageous placement of the grippers ( 74 ) on the sole plate ( 70 ). One or more grippers ( 74 ) may be disposed on the inside of the sole plate ( 70 ), and particularly the inside of the panel ( 73 ). Similarly, one or more grippers ( 74 ) may be disposed on the top of the sole plate ( 70 ), and particularly the top of the head ( 72 ). [0051] Referring to FIGS. 3A and 3B , the head ( 72 ) may comprise grippers ( 74 ) which are disposed on the top thereof, and may be generally horizontally oriented. Alternatively or additionally, the grippers ( 74 ) may be disposed on the rear ( 53 ) of the head ( 72 ). This arrangement disposes the grippers ( 74 ) in a vertical orientation although one of skill will recognize the grippers ( 74 ) may be disposed in an orientation between vertical and horizontal. The dual sets of grippers ( 74 ) provides for the head ( 72 ) to accommodate different sheet ( 20 ) sizes. [0052] The head ( 72 ) of FIGS. 3A and 3B has a generally vertically oriented surface. This surface provides the benefit that a portion of the sheet ( 20 ) may be vertically oriented for cleaning of baseboards, lower walls, etc. If desired, the rear ( 53 ) of the head ( 72 ) may be made of or lined with sponge, rubber, or other resiliently compliant material to conform to the profile of baseboards, molding, etc. [0053] While the foot ( 14 ) is illustrated with the pivot axis near the center of the sole plate ( 70 ) and widthwise oriented, one of skill will recognize the invention is not so limited. The axis about which the sole plate ( 70 ) articulates may be parallel to the longitudinal centerline or skewed relative thereto, including being skewed relative to the horizontal plane. For example, the axis may be disposed on a side ( 54 ) of the sole plate ( 54 ). Of course, the side ( 54 ) of the sole plate ( 70 ) may be generally coplanar with the side ( 54 ) of the housing ( 50 ). Or the side ( 54 ) of the sole plate ( 70 ) may be inboard of the side ( 54 ) of the housing ( 50 ), or may be outboard thereof, so that the sole plate ( 70 ) and housing ( 50 ) have mutually different widths. [0054] The foot ( 14 ) may further comprise a hinge, universal joint, ball and socket joint, etc. or portion thereof to pivotally receive a handle ( 12 ). Optionally and if small enough, the foot ( 14 ) may be used without a handle ( 12 ). [0055] In yet another embodiment, the device ( 10 ) may optionally spray cleaning solution onto the floor or other target surface. This arrangement provides the benefit that the user can see where the cleaning solution is being applied, with it being blocked under the sheet ( 20 ). The cleaning solution may be any of the liquid solutions described above, aqueous or otherwise. The sprayer may be a pump system, as described with respect to commonly assigned U.S. Pat. No. 8,186,898, or a gravity feed system, either permanently/removably attached to the device ( 10 ) or a part thereof. Or a separate aerosol or trigger pump sprayer may be utilized, as are well known in the art. A spray system may be advantageously used with a single-use sheet ( 20 ), which is discarded after one cleaning event or with reusable sheets ( 20 ), such as microfiber sheets ( 20 ). If spray is used it will be advantageous to use dry absorbent sheets ( 20 ) such those described in commonly assigned U.S. Pat. No. 6,101,661; U.S. Pat. No. 7,144,173 and U.S. Pat. No. 7,163,349, [0056] In yet another embodiment, the device ( 10 ) may optionally apply steam to the floor. The steam may be applied through a dry sheet or a pre-wetted sheet as disclosed in commonly assigned US 2013/0319463. [0057] Referring to FIG. 4 , the lip ( 45 ) may be tapered to provide a flow path for debris to intercept the portion of the sheet ( 20 ) which wraps the top of the sole plate ( 70 ) and/or a flow path towards the dirt bin ( 58 ). In use, the lip ( 45 ) may be spaced a predetermined distance away from the floor to provide an efficacious flow path as shown by distance A, to provide for an efficacious flow path and provide protection for the floor. Likewise, the distal edge ( 175 ) of the sole plate ( 70 ) may be spaced rearward of the axis of the beater bar ( 44 ) a predetermined distance as shown by distance C. If desired, the sheet ( 20 ) may wrap the edge ( 45 ) for attachment thereto, in lieu of attachment to the sole plate ( 70 ). [0058] The lip ( 45 ) and the distal edge ( 175 ) of the sole plate ( 70 ) may be both substantially straight and substantially mutually parallel. By substantially straight it is meant that deviations beyond that which occur in ordinary manufacture, and typically less than 1 mm across the width of the foot ( 14 ), do not occur. By substantially parallel it is meant that deviations beyond that which occur in ordinary manufacture, and typically less than 2 degrees across the width of the foot ( 14 ), do not occur. [0059] Referring to FIGS. 1A , 2 A, 3 A and 3 B and 4 , a gap (G) may separate the edge of lip ( 45 ) of the first cleaning mode and the distal edge ( 175 ) of the sole plate ( 70 ) which holds the sheet ( 20 ) for the second cleaning mode. The gap (G) is measured with the sole plate ( 70 ) in the in-use position. By in-use position it is meant that the device ( 10 ) has the housing ( 50 ) and sole plate ( 70 ) held in stationary, fixed relationship, corresponding to that position used during a routine cleaning task. Typically this position yields the smallest measurement of gap (G). [0060] Gap (G) is then measured to yield the smallest gap (G) of the device ( 10 ), in a generally forward-backward direction and perpendicular to the width of the foot ( 14 ) and parallel to the beater bar ( 44 ). The gap (G) is measured using only the device ( 10 ), without having a sheet ( 20 ) in place. [0061] If the gap (G) is not constant, the gap (G) is measured as the portion of the distal edge ( 175 ) having the most width which is constant and contiguous. If there is not a portion of the distal edge ( 175 ) which is constant, e.g. a sinusoidal or sawtooth distal edge ( 175 ), the measurement is taken at the midpoint thereof. If the gap (G) extends for at least 25, 50 or 75 percent of the width of the foot ( 14 ), or for at least 10, 15, or 20 cm in the width direction, the gap (G) is considered to provide for efficacious, dual mode pickup of debris during cleaning and to meet the limitations of the following claims. The gap (G) may be measured using a Series 500 handheld depth gauge or dial calipers as are commonly available from Mitutoya America of Aurora, Ill. [0062] If the distal edge ( 175 ) of the sole plate ( 70 ) barely intercepts the lip ( 45 ) of the housing ( 50 ), the gap is defined as 0. If there is an open space between the distal edge ( 175 ) and the lip ( 45 ), the gap (G) is defined as positive. If there is overlap between the distal edge ( 175 ) and the lip ( 45 ), the gap (G) is defined as negative. [0063] Referring to FIG. 5 , it can be seen that the gap (G) directly affects the performance of the cleaning device ( 10 ). The performance in FIG. 5 was measured using a commercially available Swiffer® Sweep & Trap™ device ( 10 ) sold by the instant assignee for control and using this same Swiffer® Sweep & Trap™ device ( 10 ) modified for purposes of this testing. A commercially available control device ( 10 ) is understood to have a gap (G) ranging from a space of +5.6 mm to +6.6 mm. The test devices ( 10 ) had gaps (G) ranging from −9 mm to +15 mm. A single device ( 10 ) was used to control for extraneous variables. [0064] All devices ( 10 ) were tested on a tile floor with grout using 0.5 grams/sq. meter large particle debris. A new Swiffer® Sweeper sheet ( 20 ) was used for each trial. [0065] Thirteen different gap (G) dimensions were tested. Each gap (G) was tested for n=3 trials, for a total of 39 different tests. But not all gap (G) dimensions performed equally well. [0066] Referring to FIG. 5 , it can be seen that performance unexpectedly was greater than 90% total debris pickup for a gap (G) ranging from −1 to +1 mm, was greater than 85% total debris pickup for a gap (G) ranging from −3 to +3 mm, and was greater than 80% total debris pickup for a gap (G) ranging from −7 to +5 mm. For greater gap (G) dimensions, in either the positive or negative senses, performance rapidly decreased. These data are illustrated in Table 1 below. [0000] TABLE 1 Minimum Total Debris Pickup Gap Overlap Gap Space (percentage) (mm) (mm) 90 −1 +1 85 −3 +3 80 −7 +5 [0067] Thus a foot ( 14 ) according to the present invention may have a gap (G) ranging from an overlap of about −1, −3, −5, −7 or −9 mm, to a space of about +1, +3, or +5 mm, inclusive of any value therebetween, and using any cited endpoint for the range. If measured to a sufficient degree of precision, a foot ( 14 ) according to the present invention may have a gap (G) ranging from an overlap of about −1.0, −3.0, −5.0, −7.0 or −9.0 mm, to a space of about +1.0, +3.0, or +5.0 mm, inclusive of any value therebetween, and using any cited endpoint for the range. Or the gap (G) may be 0 mm in a degenerate case, with the distal edge ( 175 ) and lip ( 45 ) barely in mutual contact. [0068] The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Instead, unless otherwise specified, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as “40 mm” is intended to mean “about 40 mm”. It should be understood that every maximum numerical limitation given throughout this specification includes every lower numerical limitation, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this specification includes every higher numerical limitation, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this specification includes every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein. [0069] All parts, ratios, and percentages herein, in the Specification, Examples, and Claims, are by weight and all numerical limits are used with the normal degree of accuracy afforded by the art, unless otherwise specified. [0070] Except as otherwise noted, the articles “a,” “an,” and “the” mean “one or more.” All documents cited in the Background and the Detailed Description of the Invention are, in relevant part, incorporated herein by reference; the citation of any document is not to be construed as an admission that it is prior art with respect to the present invention. To the extent that any meaning or definition of a term in this written document conflicts with any meaning or definition of the term in a document incorporated by reference, the meaning or definition assigned to the term in this written document shall govern. [0071] While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

A foot for a device and a related device for cleaning a target surface and which can accept a sheet for contact with the target surface. The device also has a rotatable beater bar. The beater bar and sheet provide two cleaning modes for the device. The device has a foot which comprises a housing and forward lip for the beater bar and further has a sole plate for accepting the cleaning sheet. The lip and proximate edge of the sole plate are in spaced in relationship to each other. The proper spacing between the portion of the housing with the beater and sole plate holding the sheet, provides for improved dual mode cleaning performance. The cleaning system may be used to clean hard surfaces, such as a floor.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to the German application No. 10 2004 030 833.0, filed Jun. 25, 2004 which is incorporated by reference herein in its entirety. FIELD OF INVENTION [0002] The invention relates to an x-ray diagnostics method (in particular a digital method) and an X-ray device, especially for use in angiography and cardiology. BACKGROUND OF INVENTION [0003] A method of this type and a device associated therewith are known from DE 199 19 423 A1. In particular the mAs product can hereby be adjusted as a control variable which is definitive for the image quality. In the course of the known method, operating parameters such as tube current and scan time are varied such that unreliable operating states are avoided without significantly reducing the mAs product and thus the image quality. [0004] With x-ray examinations in angiography and cardiology an outstanding image quality is of particular significance in order to be able to clearly distinguish between the comparatively weakly absorbent bodily structures examined here, in particular tissue and vessels, and if necessary catheters and stents. At the same time however, it must be ensured that the patient and the medical staff are exposed to the smallest possible x-ray dose. SUMMARY OF INVENTION [0005] It is thus usual to operate a generic x-ray device in two operating modes, namely fluoroscopy and acquisition. In this way, in the course of the fluoroscopy with preparatory steps using comparatively small x-ray doses, e.g. the position of the patient in the desired exposure position, the selection of a specific recording segment or the selection of specific recording parameters are carried out. The actual recording of the x-ray image used for diagnosis purposes subsequently takes place in the course of the acquisition with comparatively high radiation intensity on the other hand. [0006] A method of this-type is known for example from EP 1 322 143 A2. For both operating modes, the tube current is adjusted as a function of the tube voltage on the basis of a controlling curve assigned in each instance, with which the controlling curve is modified in accordance with the method such that a predetermined maximum input dose is not exceeded when radiation is applied to an object. [0007] Furthermore, methods are known for example from U.S. Pat. No. 6,222,907 B1 or U.S. Pat. No. 6,233,310 B1, in which the image quality of an x-ray recording or the detector input dose are controlled or regulated, in which as a function of the depth of the transilluminated body tissue (or how fat the patient is) and as a function of the distance between the x-ray emitter and the detector of the x-ray device, said distance being referred to as SID (source image distance), predefined recording parameters, in particular the tube voltage (kV), tube current (mA), exposure time (ms) as well as the setting of an x-ray filter preceding the x-ray emitter are set such that a constant image quality and/or detector input dose is achieved with the smallest possible patient dose. [0008] An object of the invention is to specify an x-ray diagnostic method particularly suited to use in angiography and cardiology, by means of which a particularly good image quality can be achieved in an easily manageable manner at the same time as particularly low x-ray exposure for the patient and the medical personnel. Furthermore, the object of the invention is further to specify an x-ray device particularly suited to implementing the method. [0009] The object is achieved by the claims. Accordingly a control parameter is provided which is linked to a number of recording parameters such that it functions as a gauge for the image quality, the detector input dose or the contrast noise ratio. The control parameter can thus be continuously varied, so that the image quality, the detector input dose and/or the contrast noise ratio can be directly and continuously adjusted by means of varying the control parameter. The control parameter is linked to the recording parameters optionally by specifying a set of functional dependencies, in other words mathematical functions, characteristics fields, etc, by means of which each recording parameter is assigned a value dependent on the value of the control parameter, while the control parameter is optionally provided in the course of control as a target value of the detector input dose or of the contrast noise ratio. [0010] As a result of the facilities for continuous adjustment according to the invention, a attending doctor who considers it expedient to adapt the image quality and/or detector input dose can quickly and directly do so by activating an individual opera ting element. In accordance with the method, the recording parameters linked to the control parameter are automatically adjusted in the background such that the increase or reduction in the image quality, the detector input dose and/or the contrast noise ratio predetermined by the control parameter is implemented. The attending doctor is thereby able to set an image quality at any time during an x-ray examination which is sufficiently good to satisfy the current requirements. On the other hand, the doctor is able to restrict the image quality at any time to the level required at that time, thereby simultaneously minimizing the radiation exposure for the patient and him/herself. [0011] Tube voltage, tube current, exposure time and/or the adjustment of an x-ray filter, in particular the filter thickness are preferably considered as recording parameters. In an advantageous embodiment of the method, the recording parameters are not only controlled as a function of the control parameter but also as a function of at least one further input variable. How fat the patient is, the SID and/or an image enlargement factor are thereby preferably considered here as input variables. [0012] Provision is advantageously made in that the control parameter can be varied at any point during the x-ray examination, in other words particularly also during an exposure phase, so that the attending doctor is also able to match the recording conditions to the current requirements during the image recording. This prevents doctors from making wrong diagnoses as a result of image quality problems and having to amend or even discontinue their treatment. Furthermore, the doctor thus has direct control over patient dosage and can significantly reduce this at any time by foregoing above-average image quality. [0013] In an advantageous embodiment of the invention, provision is made that several alternative sets of functional dependencies are provided in order to link the control parameter with the recording parameters, from which the attending doctor can make his/her selection. In this way, the definition of various objects or structures to be examined, e.g. iodine as a contrast medium, vessels, stents etc is particularly enabled, in relation to which the image quality is optionally optimized. By way of example, a corresponding set of functional dependencies can be selected that depicts stents in a particularly contrasting manner etc. [0014] In terms of the x-ray device, the object is achieved according to the invention by the features of claim 8 . The device accordingly comprises an x-ray emitter, a digital x-ray detector and a control unit for controlling the x-ray emitter. The control unit is here assigned an operating element, by means of which the control unit can be assigned a continuously adjustable control parameter, as a function of which the control unit adjusts a number of recording parameters whilst implementing the method described above. [0015] The operating element is preferably designed as a joystick, foot pedal, rotary knob or rotary wheel or as a trackball. A virtual operating element can nevertheless be provided instead of a physical operating element, said virtual operating element being implemented within a graphic user interface of an operating software. BRIEF DESCRIPTION OF THE DRAWINGS [0016] Exemplary embodiments of the invention are described below with reference to a drawing, in which: [0017] FIG. 1 shows a schematic representation of an x-ray device with an x-ray emitter, an x-ray detector, a control unit and a control element assigned to one of these, [0018] FIG. 2 shows the control unit of the device according to FIG. 1 in a schematic flow diagram, and [0019] FIG. 3 shows a modified design of the control unit in a representation according to FIG. 2 DETAILED DESCRIPTION OF INVENTION [0020] Components and variables corresponding to one another are always provided with the same reference characters in all the figures. [0021] The X-ray device 1 represented schematically in FIG. 1 comprises an X-ray emitter 2 , a digital x-detector (abbreviated below as detector) 3 and a control and evaluation system 4 . A multileaf collimator 6 and a scattered ray raster 7 are interposed in the direction of radiation 5 between the x-ray emitter 2 and the detector 3 . [0022] The multileaf collimator 6 also serves to cut out a partial beam of a desired variable from the x-ray radiation R generated by the x-ray emitter 2 , which falls on the detector 3 through a patient P to be examined or an object to be examined and the scattered ray raster 7 . The multileaf collimator 6 additionally contains a filter arrangement 8 , by means of which the x-ray radiation R generated by the x-ray emitter 2 can be diminished and/or can be modified in terms of its spectral distribution. The filter arrangement 8 can be adjusted particularly in terms of its filter thickness F ( FIG. 2 ). [0023] The scattered ray raster 7 serves to mask out scattered radiation hitting the detector 3 at a low angle and which would corrupt an x-ray image B recorded by the detector 3 . [0024] The x-ray emitter 2 and the detector 3 are fixed to a stand 9 in an adjustable manner, or above or below an examination table. [0025] The control and evaluation system 4 comprises a control unit 10 for controlling the x-ray emitter 2 and/or the detector 3 . To control the x-ray emitter 2 , the control unit 10 is linked to an x-ray generator 12 by means of a data line 11 , said x-ray generator generating an electrical supply voltage V for radiation generation and outputting this to the x-ray emitter 2 . The voltage rate (subsequently referred to as tube voltage U) and the current strength (subsequently referred to as tube current I) of the supply voltage V are set together with the exposure time by means of the control unit 10 and are given to the x-ray generator 12 as a recording parameter. In a similar manner, the control unit 10 adjusts the filter thickness F and is given to the depth parameter 6 as a recording parameter. [0026] The control unit 10 is a software component of a data processing system 13 , which preferably comprises further software components for preparing and evaluating x-ray images B, which are generated by the detector 3 and transmitted to the data processing system 13 by way of the data line 11 . [0027] The data processing system 13 is linked to peripheral devices 14 , such as a screen and a keyboard for example for the purpose of inputting and outputting data. The data processing system 13 is additionally linked to an operating element 15 , which is preferably designed as a joystick and by means of which the control unit 10 is given a control parameter S for adjusting the image quality or the detector input dose. [0028] FIG. 2 shows a schematic representation of a first embodiment of the control unit 10 and the variables supplied thereto and/or output therefrom. The display shows that the control unit 10 is fed, in addition to the control parameter S, the distance SID between the x-ray emitter 2 and the detector 3 and how fat the patient is D, in other words the depth of the transilluminated tissue of the patient P, as input variables. The output variables of the control unit 10 are, as already mentioned, the tube voltage U, the tube current I, the exposure time t and the filter thickness F. [0029] The control parameter S is a signal, the rate of which can be adjusted b y the attending doctor by actuating the operating element 15 continuously at any time within predetermined limits, e.g. between 0 and 1. The adjustability of the control parameter S is thus also understood as ‘continuous’, if the control parameter S, particularly with digital information processing, comprises a multiplicity of discrete, narrowly distanced adjustment facilities. The adjusted value of the control parameter S is shown on the screen 14 , so that the attending doctor is able to read off his current settings at all times. [0030] In the control unit 10 , a corresponding function dependency U (S,D,SID), I(S,D,SID), t(S,D,SID) and F(S,D,SID) is deposited for each recording parameter U,I,F,t, by means of which a value dependent on the rate of the control parameter S and the further input variables D, SID is assigned to the corresponding recording parameter U, I, t and/or F. The functional dependencies U(S,D,SID), I(S,D,SID), t(S,D,SID) and F(S,D,SID) are deposited in the form of mathematical model functions or in the form of supporting defined characteristic fields. The functional dependencies U(S,D,SID), I(S,D,SID), t(S,D,SID) and F(S,D,SID) are thus selected such that with the variation of the control parameter S between its minimum value and its maximum value, the set of recording parameters U, I, t, F output is varied such that the image quality of a recorded x-ray image is varied correspondingly between a minimum state and a maximum state. In this way, the control parameter S represents a direct gauge for the image quality. The respective ratio of the recording parameters U,I,t,F with a predetermined value of the input variables S,D,SID is thus selected such that the patient dose is minimized with a constant image quality. The form of the functional dependencies U(S,D,SID), I(S,D,SID), t(S,D,SID) and F(S,D,SID) is to be determined from the empirical series of tests on the x-ray device 1 , by means of model calculations. [0031] Optionally several alternative sets of functional dependencies U i (S,D,SID), I i (S,D,SID) t i (S,D,SID) and F i (S,D,SID) are deposited in the control unit 10 , in which i=1,2,3, . . . represents the number of the set to be selected. The control unit 10 defines this number 1 for the selection of a specific set of functional dependencies. [0032] This method allows several alternative definitions of the image quality to be available for selection, e.g. to allow a specific object to be examined or a specific structure to come to light in a particularly clear manner. By way of example, provision is made that a first set U 1 (S,D,SID), I 1 (S,D,SID), t 1 (S,D,SID) and F 1 (S,D,SID) of functional dependencies is optimized for the representation of iodine as the contrast medium used. A second set of functional dependencies U 2 (S,D,SID), I 2 (S,D,SID), t 2 (S,D,SID) and F 2 (S,D,SID) represents for instance a form of the image quality optimized for the representation of stents. [0033] In a modification of the control unit 10 represented in FIG. 3 , the control parameter S is not considered as a gauge for the image quality, but as a gauge for the detector input dose, which represents an objectively measurable variable in contrast to the image quality. In this embodiment, the control unit 10 is designed as a closed-loop control and acquires the continuously measured value of the detector input dose DE as an actual value, which is compared with the control parameter S as a target value for the purpose of carrying out a target/actual value comparison. If the measured detector input dose DE falls short of the rate of the control parameter S, the recording parameters U, I, t, F are controlled such that the detector input dose DE is accordingly increased. The detector input dose DE is similarly lowered by a corresponding control of the recording parameters U, I, t, F, if the measured detector input dose DE exceeds the control parameter S. The respective ratio of the recording parameters U, I, t, F is in turn determined based on deposited characteristics such that the patient dose is always minimized with a given detector input dose DE. [0034] In place of the detector input dose DE, a further modification of the control unit 10 (not shown in more detail) provides for the contrast noise ratio to be considered as a control variable. Furthermore, the two variants of the control unit 10 shown in FIGS. 2 and 3 can also be simultaneously implemented for the selection with the same x-ray device 1 , so that the attending doctor can select whether the operating element 15 can be used to control the image quality, the detector input dose or if necessary the contrast noise ratio. Optionally, the settings of image processing software are automatically adjusted as a function of the control parameter S. By way of example, setting a low detector input dose allows for stronger low pass filtering to be set than in the case of a high detector input dose. [0035] In place of a joystick, further possible embodiments of the operating element 15 are alternatively provided, in particular a foot pedal functioning in a similar manner to a gas pedal, a rotary knob or a rotary wheel with the possibility of a positive or negative deflection, as well as a trackball.

An x-ray diagnostics method is specified, in particular for use in angiography and cardiology, by means of which a particularly good image quality can be achieved in an easily manageable manner for the patient (P) and the medical personnel, at the same time as a comparatively low radiation exposure. Furthermore, a specific x-ray device ( 1 ) for implementing the method comprising an x-ray emitter ( 2 ), an x-ray detector ( 3 ) and a control unit ( 10 ) is specified to control the x-ray emitter ( 2 ). In this way the control unit ( 10 ) is allocated an operating element ( 15 ), by means of which a control parameter (S) characterizing the image quality, the detector input dose or the contrast noise ratio can be continuously varied, as a function of which a number of recording parameters (U,I,t,F) are set by means of the control device ( 10 ).

RELATED APPLICATION [0001] This application claims the benefit of the filing date pursuant to 35 U.S.C. §119(e) of Provisional Application Ser. No. 60/137,830, filed Jun. 6, 1999, the disclosure of which is hereby incorporated by reference. FIELD OF THE INVENTION [0002] The present invention relates to the field of storage devices. More particularly, the invention relates to a storage device having improved stability with easy access from two opposing sides. BACKGROUND OF THE INVENTION [0003] In many work environments, two employees work in closely spaced adjacent work areas. These works areas often include elements such a desk or a meeting table. However, many times a worker needs additional space for the storage of materials such books or papers. While two storage devices such as traditional book shelves can be positioned adjacent each other such that each user can place work objects therein, this configuration can involve a somewhat wasteful use of space if only one bookshelf is necessary. Yet, two bookshelves have previously been necessary because they are not designed to provide access from two opposing directions. Rather, traditional bookshelves generally include a rear panel that prevents access to the bookshelf from the rear. This rear panel is necessary to provide the bookshelf with the required stability. [0004] Therefore, there is a need for an improved storage device which has the required stability while also being capable of being accessed from two opposing directions. This storage device must also be capable of easy assembly while being easily constructed in a cost-efficient manner. SUMMARY OF THE INVENTION [0005] The present invention is directed to an improved storage device that provides easy access from two opposing sides while also capable of being easily reconfigured and assembled. [0006] According to a first aspect of the present invention, a storage device is provided. The storage device includes two opposing side panels, a plurality of shelves and a plurality of crossed support devices. The plurality of shelves interconnect the side panels. The plurality of crossed support devices are capable of being attached to one of a first opening and a second opening. The first opening and the second opening are located opposite one another and provide access to an interior cavity capable of supporting storage materials. [0007] According to another aspect of the invention, a storage device is provided. The storage device includes two opposing side panels, a plurality of shelves and a plurality of crossed support cables. The plurality of crossed support cables are capable of being attached to one of a first opening and a second opening. The first opening and the second opening are located opposite one another and provide access to an interior cavity capable of supporting storage materials. The cables can be adjustably secured to impart a tension to the side panels thereby providing an improved stability to the storage device. [0008] According to a further aspect of the invention, a storage device is provided. The storage device includes two opposing side panels, a plurality of shelves and a plurality of crossed support cables. The two opposing side panels have a vertical channel extending along the ends thereof. A plurality of shelves interconnect the side panels. A plurality of crossed support devices are capable of being attached to one of a first opening and a second opening. The first opening and the second opening are located opposite one another and provide access to an interior cavity capable of supporting storage. [0009] The present invention, together with attendant objects and advantages, will be best understood with reference to the detailed description below in connection with the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0010] [0010]FIG. 1 is a perspective view of a storage device constructed in accordance with a first preferred embodiment; [0011] [0011]FIG. 2 is a partially exploded view of the preferred embodiment illustrated in FIG. 1; [0012] [0012]FIG. 3 is an exploded view of the embodiment illustrated in FIGS. 1 and 2; [0013] [0013]FIG. 4 is an exploded view of the shelves and support cables in accordance with a preferred embodiment; [0014] [0014]FIG. 5 is an inner perspective view of a side panel in accordance with a preferred embodiment; [0015] [0015]FIG. 6 is a cross-section taken along the lines 6 - 6 of FIG. 4; [0016] [0016]FIG. 6 is a perspective view of a preferred embodiment of an insert; and [0017] [0017]FIG. 7 is a partially broken away view of the preferred embodiment of the cable connection assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0018] [0018]FIG. 1 is an illustration of a storage device 10 constructed in accordance with a first preferred embodiment of the invention. It should be recognized that the storage device 10 can be constructed in a wide variety of sizes and alternate configurations without departing from the spirit of the present invention. For example, while the storage device 10 illustrated in the drawings includes four shelves and a top work surface, the present invention may also be embodied with two, or three shelves. The present invention could also be constructed without the top work surface. In addition, the shelves may be constructed to have a wide variety of widths. [0019] With reference to FIG. 1, storage device 10 is shown having feet 12 . The feet 12 are preferably manufactured from a thermoplastic polymer material. In the alternative, the feet 12 could be constructed using casters to provide the storage device 10 with easier movability. The feet 12 are connected to side panels 14 . The feet 12 include a threaded top portion that is fit within a leg 16 extending from a lower portion 18 of the side panel 14 . [0020] The side panel 14 is preferably manufactured from a thermoplastic polymer. A low-pressure gas assist molding press is preferably used to manufacture the side panels 14 . The side panels 14 include a plurality of vertically aligned pairs of apertures 20 . The apertures 20 are adapted to receive an attachment portion of a utility piece, such as a paper tray. This feature is particularly useful when the storage member 10 is positioned adjacent the work surface of a user. [0021] The side panels 14 include an inner side 30 that is best illustrated in FIGS. 3 & 5. The inner side 30 includes a plurality of crisscrossed ribs 32 that provide support the storage device 10 . A plurality of spaced pairs of horizontally extending ribs 34 extend intermittently between a top portion 40 and the lower portion 18 of the side panel 14 . The horizontal ribs 34 include end portions 44 . A plurality of passageways 46 extend coaxially with the apertures 20 . [0022] Inserts 50 are best illustrated in FIGS. 5 and 6. The inserts 50 are positioned adjacent to each end portion 44 of the horizontal ribs 34 . The inserts 50 are molded into the side panel 12 during manufacture thereof. There are two inserts 50 molded into each side panel 14 at each tier such that four inserts 50 are adjacent each shelf 54 . In the preferred embodiment, the insert 50 is formed from an alloy material and manufactured using a permanent mold. [0023] With particular reference to FIG. 6, the insert 50 includes a double keyhole opening 60 , a screw boss 62 and a utility hole 64 . The double keyhole opening 62 includes a central and generally circular opening 66 with the narrow channels 68 extending above and beneath the circular opening 66 . The screw boss 62 includes an interior surface to receive a thread-cutting screw (not shown). The utility hole 64 is a smooth passageway adapted to receive the attachment portion of a utility member that extends through a coaxial aperture 20 . The double keyhole opening 60 serves as the attachment point for the support cables 70 . [0024] The support cables 70 are best illustrated in FIGS. 1 - 4 , and 7 . With particular reference if FIG. 7, the support cables 70 include a first piece 72 and a second piece 74 . At each end of each piece 72 , 74 , a rounded end portion 76 is fixedly attached to the cable. The rounded end portion 76 is preferably formed from an alloy material and die cast onto an end of the cable. In the preferred embodiment, a steel wire body 80 interconnects the end portions 76 . The length of the body 80 can be adjusted to suit the varying widths of the storage devices 10 that can be constructed in accordance with the present invention. The first piece 72 is approximately 4″ long in the preferred embodiment. The second piece 74 extends the balance of the length from the first side of the storage device 10 to the second side of the storage device 10 . [0025] A bullet-shaped connector 90 interconnects the first piece 72 and the second piece 74 . The connector 90 provides for a connection between the first piece 72 and second piece 74 . The connector 90 includes a first member 92 having a threaded end 94 adapted to be received within the second member 96 . The first member 92 and second member 96 can rotate with respect to the bodies 80 of the first piece 72 and the second piece 74 . The threaded end 94 is adapted to be screwed into a boss 98 within the second member 96 . As a result, the support cables 70 impart the required stress to the storage device 10 to thereby improve its stability. The connector 90 is preferably formed from cold rolled steel with a plated finish. The first member 92 and the second member 96 are slid onto the cable during manufacture thereof and retained by the end portions 76 . [0026] Shelves 54 interconnect the side panels 14 . Shelves 54 are preferably manufactured from a steel material. The shelves 54 include a plurality of apertures 102 as shown in FIG. 3. The apertures 102 provide the passageway for screws (not shown) which pass through the shelves 54 and into the screw bosses 62 within the inserts 50 . In this manner, the shelves 54 are attached to side panels 14 of the storage device 10 . A second set of apertures 104 are aligned with the utility holes 64 for use with a utility member. The shelves 54 include a ridge 106 that passes horizontally along end portions 108 thereof. Support cables 70 are aligned with the ridges 106 . The ridge 106 can also be used as a mounting feature for a tool or prevent a work object from being pushed off the shelf 54 . [0027] A top work surface portion 110 is illustrated in the FIGURES of this preferred embodiment. The work surface 110 is attached to the support rods 112 . The support rods 112 are mounted to aluminum mounting members 114 which are attached to an upper portion of the side panels 14 . The work surface 110 includes a bottom portion having a steel plate 116 extending thereacross. The steel plate 116 is welded to the support rods 112 . The steel plate 116 further includes additional openings that allow fasteners to passed into the work surface 110 . The work surface 110 can be constructed from a wide variety of materials including wood. [0028] The storage device 10 is assembled securing the shelves 54 to the side panels 14 using screws which pass through apertures 102 into the screw bosses 62 in the inserts 50 . Feet 12 are secured to the lower portion 18 of the side panel 14 . The round end portions 76 of the cables 70 are fit within the double keyhole opening 60 of the inserts 50 , The body portion 80 passes through one of the narrow channels 68 . The first member 92 are the second member 96 are connected by threading the threaded end 94 into the boss 98 . The body portions 80 are sized such that when the first member 92 and the second member 96 are screwed together that the proper tension is imparted to the storage device 10 . The work surface 110 is screwed to steel plate 116 which is welded to the support rods 112 . [0029] The storage device 10 is designed such that a user could remove the support cables 70 from one opposing side of the storage device and reattach the support cables 70 to an opposing side. The support cables 70 would then be located on opposite sides of the storage device such that the storage device 10 could be used by two workers in adjacent work spaces. [0030] The embodiments described above and shown herein are illustrative and not restrictive. The scope of the invention is indicated by the claims rather than by the foregoing description and attached drawings. The invention may be embodied in other specific forms without departing from the spirit of the invention. For example, the storage device may be configured to provide a wide variety of vertical and horizontal sizes without departing from the claimed invention. Accordingly, these and any other changes which come within the scope of the claims are intended to be embraced herein.

A storage device including two opposing side panels, a plurality of shelves and a plurality of crossed support devices. The plurality of shelves interconnect the side panels. The plurality of crossed support devices are capable of being attached to one of a first opening and a second opening. The first opening and the second opening are located opposite one another and provide access to an interior cavity capable of supporting storage materials.

This is a continuation-in-part of Ser. No. 07/949,013, filed Sep. 21, 1992, now abandoned. BACKGROUND OF INVENTION 1. Field of Invention This invention relates in general to household item and in particular to the hanging of clothing onto a non-destructive device on the hinge pin of a door hinge. 2. Prior Art I have been a renter for over 20 years now and I have been faced with security deposit deductions because of objects left behind after relocating to another residence. One item in particular, the hangers, (screws, nails, hooks, etc.) that are fastened onto doors on which to hang clothing. As a renter you either leave the hangers on the doors when you move, or remove them and be faced with repairing the holes in the door. I feel it's cheaper to leave the hangers on the door but your next place of residence might need them and you have to purchase them again. There are other instances in which you can't or don't want to attach hangers on the doors because of door construction--hollow door, uniqueness of door--nicely finished wood--both of which could result in expensive repairs. You do not necessarily need to be a renter to be faced with these last two circumstances. A home owner might not want to attach a hanger to a nicely finished door. This is one of the advantages of this present invention. It is a non-destructive support on which to hange clothes. You simply remove the existing hinge pin and install the hinge pin clothes hanger in its place. It's that simple. All of the examples of the prior art related to door or hinge attached hangers are set forth in the patents described below: U.S. Pat. Nos. Des. 170,725 Stahl: This is an ornamental design for a hinge. Des. 197,702 Loeb: This is an ornamental design for a cabinet hinge. 2,509,502 Hunt: This hanger is not a unitary part of the hinge pin. It could interfere with the full operation of the hinge. 2,684,225 Johnson: This support is much too complicated for a simple means of hanging clothes. 2,895,698 Palmer: This clothes hanger is much too large to use as a simple alternate support on which to hang clothes. 2,896,791 Raber: These portable supports seem to be permanently attached to the hinge and are too complicated for a simple non-destructive attachment to the hinge. 3,044,630 Szabo: This hinge pin hook is not a unitary part of the hinge pin and is made to fit between the head of the hinge pin and the top of the hinge. This shortens the hinge pin and makes for a sloppy fit when weight is hung on the hooks. It is a filmsy arrangement. 3,145,849 Hanson: This hanger bracket is much too long for a clothes hook. It appears to be made for clothes hung on hangers. 3,175,696 Melbourne: The hanger structure also seems to be set up for clothes hung on hangers and is much too large for a simple clothes support. 3,200,435 Hemmeter et al: This hanger is designed to have shoes and clothes on hanger's hung onto it. 3,294,248 Olson: This clothes hanger is similar to Hanson, Hemmeter et al, described above. Again, it appears to be designed for clothes hung on hangers. 3,825,127 Morrison et al: The hinge hanger is made for clothes hung on hangers. This is similar in design to Olson, Hemmeter et al, Hanson referenced above. Norwegian patent: 57,263: This device and its construction do not appear sturdy. Whatever the precise merits, features, and advantages of the above cited references, none of them achieves, or fulfills the purposes of the hinge pin clothes hanger, this present invention. The principal effect and objective of this present invention is to furnish a quality product made to last. Another accomplishment of this present invention is to provide a sturdy support which replaces the hinge pin of any door hinge. Additionally this present invention quickly attaches a non-destructive support on which to hang clothes, towels, or anything similar, on any door, in any room in which it would be useful. Furthermore, this present invention is easily installed or removed without any damage to the door or hinge. SUMMARY OF THE INVENTION The principal effect and objective of this present invention is to furnish a quality product made to last, that replaces the hinge pin of any door hinge with a hinge pin clothes hanger that, when properly installed, does not effect the operation of the door or hinge into which it is being used. The hangers are an integral part of the body of the hinge pin clothes hanger. The head of the hinge pin is extended above the top of the hinge to carry the hangers. This appliance is of one piece construction. Additionally this present invention is a non-destructive device which can be easily removed to restore the hinge to its original condition with the original hinge pin. Furthermore when in use this present invention will provide years of reliable service and will blend into the decor of the room into which it is being used. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1. This is a complete two hanger version of the hinge pin clothes hanger. It is shown in a side view. FIG. 2. This is a detail of the longer of the two hangers. It shows the overall length of the part. It is shown in a side view. FIG. 3. This is a detail of the shorter of the two hangers. It shows the overall length of the part. It is shown in a side view. FIG. 4. This is a complete variation of the hinge pin clothes hanger. It is shown in a side view. FIG. 5. This is a detail of a variation of the longer of two hangers. It shows the overall length of the part. It is shown in a side view. FIG. 6. This is a detail of a variation of the shorter of two hangers. It shows the overall length of the part. It is shown in a side view. FIG. 7. This is a detail of the radius of a variation of the hanger as it should be made onto the end of parts "4" and "5". It is shown in a side view. FIG. 8. This is a complete two hanger version showing the position of the metal pin. It is shown in a side view. FIG. 9. This is a detail of the metal pin. It shows the knurling in two places. DETAILED DESCRIPTION OF THE INVENTION Refer now to FIG. 1 which is an overall drawing of a preferred embodiment of the invention. The number of hangers and shape of support are preferred because of their simplicity of appearance and symmetry of design. It is suggested that, because of maintenance free characteristics, the entire invention--parts "1", "2", "3" and "6"--be constructed of stainless steel and be T.I.G. welded for a clean appearance and for sturdy heavy duty construction. Parts "1" and "6" are of one piece construction, or are attached to each other or made in a way that they become a unitary, inseparable part of each other. It is essential that part "6", the hinge pin part, be machined or made to duplicate the diameter and length of the hinge pin it is to replace, so the hinge pin clothes hanger does not effect the operation of the door or the hinge into which it is positioned. It is important that part "1", the body of the hinge pin clothes hanger, is to be similar to the diameter of the hinge pin head, as illustrated in FIG. 1. It is suggested that the length of part "1" be approximately four inches. Again, it is suggested that part "1" has two holes made into its body to accept parts "2" and "3" respectively. These holes are made into part "1" to put the hangers on approximately a 45 degree angle as seen in FIG. 1. It is further suggested that these holes be approximately 1/4" deep. Furthermore, these holes made into part "1" should be larger than the diameter of parts "2" and "3" to allow for a snug fit. It is suggested that the centerline of the hole for part "2" is 11/4" from the top of part "1", and the centerline of the hole for part "3" is 2 9/16"from the top of part "1". It is shown in FIGS. 2 and 3 that parts "2" and "3" are 3/8" in diameter. It is suggested that a round end be shaped onto the end of part "2" and "3" to make the end of the hanger. After the hangers are fitted into their respective holes or the hangers are attached or made to the body, part "1", in a way that they become a unitary part of each other, with hanger ends facing up, as shown in FIG. 1, the lower hanger is always shorter in length than the hanger above it, parts "1", "2", and "3" now become the clothes hanger part of the hinge pin clothes hanger, as shown in FIG. 1. The overall length of part "2" is noted in FIG. 2. The overall length of part "3" is noted in FIG. 3. When all of the above mentioned components are machined, cut, fitted and T.I.G. welded together, the outcome will be the hinge pin clothes hanger which the hinge pin part, body, and the hangers are attached to each other or made in a way that they become a singular, unitary, inseparable part of each other, comprised of one or more hangers, hanger ends facing up, and provide a substantial means of support which will give the consumer years of reliable service. Another suggestion for construction of the hinge pin clothes hanger is by the injection molding process. The body and hangers, parts `1`, `4` and `5` are injection molded around the metal pin, part `7`. This metal pin, part `7` as shown in FIG. 9, is knurled in two places to allow the material, plastic or nylon for example, a rough surface on which to grip as it cools and shrinks around the pin. This allows the material to permanently and solidly bond to the pin. This metal pin, part `7`, extends into the body and becomes unitary with the body and hangers, parts `1`, `4` and `5` as shown in FIG. 8. Parts `1`, `4` and `5`, the body and hangers become a singular, unitary, inseparable part of each other through the injection molding process. The injection molding process eliminates the necessity for the holes to be formed into the body for the positioning of the hangers. The machining of the tooling or mold allows the body and hanger, parts `1`, `4` and `5`, to be molded as one piece around the pin. Yet another suggestion for making the hinge pin clothes hanger is to cast or pour a molten material, such as brass, bronze, aluminum or even stainless steel for example, into a mold. When the metal has hardened and taken out of the mold it is a completed hinge pin clothes hanger. The pin, part `6`, the body, part `1` and the hooks, parts `4` and `5` can be cast at the same time into this mold. An alternative method would be to insert the pin, part `7`, into the casting and pour the molten material around the pin. Again when the metal has hardened and taken out of the mold it is a completed hinge pin clothes hanger. ALTERNATIVES Refer now to FIG. 4 which is an overall drawing of a variation of the preferred embodiment of the invention. It is also suggested that parts "1", "4", "5", "6" be constructed of stainless steel and be T.I.G. welded for a clean appearance and for sturdy heavy duty construction. It is also important that part "1", the body of the hinge pin clothes hanger, is made to be similar to the diameter of the hinge pin head, as illustrated in FIG. 4. Again, it is suggested that part "1" has two holes made into its body to accept parts "4" and "5" respectively. These holes are made into part "1" on the vertical plane. It is further suggested that these holes be approximately 1/4" deep. Furthermore, these holes made into part "1" should be larger than the diameter of parts "4" and "5" to allow for a snug fit. It is suggested that the centerline of the hole for part "4" be 13/16" from the top of part "1", and the centerline of the hole for part "5" be 2 3/16" from the top of part "1". It is shown in FIGS. 5 and 6 that parts "4" and "5" are 3/8" in diameter, and a hook be made onto the end of parts "4" and "5" to make the end of the hanger. A detail of the hook for parts "4" and "5" is shown in FIG. 7. After the hangers are fitted into their respective holes or the hangers are attached or made to the body, part "1", in a way that they become a unitary part of each other, with hanger ends facing up, as shown in FIG. 4, the lower hanger always shorter in length than the hanger above it, parts "1", "4" and "5" now become the clothes hanger part of the hinge pin clothes hanger, as shown in FIG. 4. The overall length of part "4" is noted in FIG. 5. The overall length of part "5" is noted in FIG. 6. As disclosed in the Detailed Description of the invention, stainless steel is the preferred material because of its maintenance free characteristics. Other metals or materials may be selected for their ability to be easily plated or colored, to enhance the decor of a room. An example would be a brass plated hinge pin clothes hanger to match the rest of the hinge or other trim in a bathroom. Another example would be to anodize the hinge pin clothes hanger to match the trim in a room. The number, shape and length of the hangers, FIGS. 1, 2, and 3 as presented in the Detailed Description of the invention is the preferred embodiment of the invention because of its simplicity and appearance. A one hanger hinge pin clothes hanger, or a three or more hanger "Hinge Pin Clothes Hanger", may be desired, the shape of the hangers can also be altered, as shown in FIGS. 4, 5 and 6. As revealed in the Detailed Description of the invention and in FIG. 1, the individual diameter of parts "1" and "6" will vary to duplicate and replace the hinge pin of different size hinges. It is important that the diameter of part "1" be similar to the diameter of the hinge pin head it is to replace and it is essential that the diameter and length of part "6" duplicate the diameter and length of the same hinge pin As cited above, it is preferred that the parts of the hinge pin clothes hanger be machined, cut, fitted and T.I.G. welded together. There are other methods of achieving the same end result. These practices, processes, or materials do not limit the way this present invention should or could be made. The foregoing descriptions of the two embodiments of the invention have been presented for the purpose of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention be limited not by this Detailed Description, but rather by the Claims appended hereto.

The principal effect and objective of the hinge pin clothes hanger is to furnish a quality product made to last, that replaces the hinge pin of any door hinge with a hinge pin clothes hanger that, when properly installed, does not effect the operation of the door or the hinge into which it is being used. The hinge pin clothes hanger is a non-destructive support on which to hang clothes, towels or anything similar, on any door hinge, in any room in which it would be useful. It is easily installed or removed without any damage to the door or hinge. You simply remove the existing hinge pin and install the hinge pin clothes hanger in its place, or simply remove the hinge pin clothes hanger to restore the hinge to its original condition with the original hinge pin. It's that simple. Furthermore, when in use the hinge pin clothes hanger will provide a substantial means of support which will give the consumer years of reliable service and will blend into the decor of the room into which it is being used.

BACKGROUND OF THE INVENTION [0001] This invention relates generally to the field of cataract surgery and more particularly to a handpiece for practicing the liquefaction technique of cataract removal. [0002] The human eye in its simplest terms functions to provide vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of the lens onto the retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and lens. [0003] When age or disease causes the lens to become less transparent, vision deteriorates because of the diminished light which can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens (IOL). [0004] In the United States, the majority of cataractous lenses are removed by a surgical technique called phacoemulsification. During this procedure, a thin phacoemulsification cutting tip is inserted into the diseased lens and vibrated ultrasonically. The vibrating cutting tip liquifies or emulsifies the lens so that the lens may be aspirated out of the eye. The diseased lens, once removed, is replaced by an artificial lens. [0005] A typical ultrasonic surgical device suitable for ophthalmic procedures consists of an ultrasonically driven handpiece, an attached cutting tip, and irrigating sleeve and an electronic control console. The handpiece assembly is attached to the control console by an electric cable and flexible tubings. Through the electric cable, the console varies the power level transmitted by the handpiece to the attached cutting tip and the flexible tubings supply irrigation fluid to and draw aspiration fluid from the eye through the handpiece assembly. [0006] The operative part of the handpiece is a centrally located, hollow resonating bar or horn directly attached to a set of piezoelectric crystals. The crystals supply the required ultrasonic vibration needed to drive both the horn and the attached cutting tip during phacoemulsification and are controlled by the console. The crystal/horn assembly is suspended within the hollow body or shell of the handpiece by flexible mountings. The handpiece body terminates in a reduced diameter portion or nosecone at the body's distal end. The nosecone is externally threaded to accept the irrigation sleeve. Likewise, the horn bore is internally threaded at its distal end to receive the external threads of the cutting tip. The irrigation sleeve also has an internally threaded bore that is screwed onto the external threads of the nosecone. The cutting tip is adjusted so that the tip projects only a predetermined amount past the open end of the irrigating sleeve. [0007] In use, the ends of the cutting tip and irrigating sleeve are inserted into a small incision of predetermined width in the cornea, sclera, or other location. The cutting tip is ultrasonically vibrated along its longitudinal axis within the irrigating sleeve by the crystal-driven ultrasonic horn, thereby emulsifying the selected tissue in situ. The hollow bore of the cutting tip communicates with the bore in the horn that in turn communicates with the aspiration line from the handpiece to the console. A reduced pressure or vacuum source in the console draws or aspirates the emulsified tissue from the eye through the open end of the cutting tip, the cutting tip and horn bores and the aspiration line and into a collection device. The aspiration of emulsified tissue is aided by a saline flushing solution or irrigant that is injected into the surgical site through the small annular gap between the inside surface of the irrigating sleeve and the cutting tip. [0008] Recently, a new cataract removal technique has been developed that involves the injection of hot (approximately 45° C. to 105° C.) water or saline to liquefy or gellate the hard lens nucleus, thereby making it possible to aspirate the liquefied lens from the eye. Aspiration is conducted with the injection of the heated solution and the injection of a relatively cool solution, thereby quickly cooling and removing the heated solution. This technique is more fully described in U.S. Pat. No. 5,616,120 (Andrew, et al.), the entire contents of which is incorporated herein by reference. The apparatus disclosed in the publication, however, heats the solution separately from the surgical handpiece. Temperature control of the heated solution can be difficult because the fluid tubings feeding the handpiece typically are up to two meters long, and the heated solution can cool considerably as it travels down the length of the tubing. [0009] One handpiece that heats the working fluid internally is described in U.S. Pat. No. 6,398,759 B1 (Sussman, et al.) and is commercially available from Alcon Laboratories, Inc., Fort Worth, Tex. Other handpieces are described in U.S. Pat. Nos. 5,865,790 and 6,527,766 (both to Bair) and U.S. Pat. No. 6,440,103 (Hood, et al.). These handpieces all require an external source of the working fluid. [0010] Therefore, a need continues to exist for a surgical handpiece that has an integral source for the fluid solution used to perform the liquefaction technique. BRIEF SUMMARY OF THE INVENTION [0011] The present invention improves upon the prior art by providing a liquefaction handpiece having an internal or integral reservoir for the working fluid. The reservoir may either feed the heater/pump by gravity or may use capillary or wicking action to feed the heater pump. [0012] Accordingly, one objective of the present invention is to provide a handpiece suitable for practicing the liquefaction technique of lens removal. [0013] Another objective of the present invention is to provide a handpiece suitable for practicing the liquefaction technique of lens removal and having an integral source for the working fluid. [0014] These and other advantages and objectives of the present invention will become apparent from the detailed description and claims that follow. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is an enlarged cross-sectional view of a first embodiment of the handpiece of the present invention. [0016] FIGS. 2A-2B are enlarged cross-sectional views of a first embodiment of the handpiece of the present invention. [0017] FIGS. 3A-3B are enlarged cross-sectional views of a second embodiment of the handpiece of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0018] As best seen in FIG. 1 , in general, pumping chamber 42 contains a relatively large pumping reservoir 43 that is sealed on both ends by electrodes 45 and 47 . Electrical power is supplied to electrodes 45 and 47 by insulated wires, not shown. In use, surgical fluid (e.g. saline irrigating solution) enters reservoir 43 through tube 34 and check valve 53 , check valves 53 being well-known in the art. Electrical current (preferably Radio Frequency Alternating Current or RFAC) is delivered to and across electrodes 45 and 47 because of the conductive nature of the surgical fluid. As the current flows through the surgical fluid, the surgical fluid boils. As the surgical fluid boils, it expands rapidly out of pumping chamber 42 through tube 30 (check valve 53 prevents the expanding fluid from entering tube 34 ). The expanding gas bubble pushes the surgical fluid in tube 30 downstream of pumping chamber 42 forward. Subsequent pulses of electrical current form sequential gas bubbles that move surgical fluid down tube 30 . The size and pressure of the fluid pulse obtained by pumping chamber 42 can be varied by varying the length, timing and/or power of the electrical pulse sent to electrodes 45 and 47 and by varying the dimensions of reservoir 43 . In addition, the surgical fluid may be preheated prior to entering pumping chamber 42 . Preheating the surgical fluid will decrease the power required by pumping chamber 42 and/or increase the speed at which pressure pulses can be generated. [0019] In a first embodiment of the handpiece of the present invention, seen in FIGS. 2A-2B , handpiece 100 has body 110 containing pumping chamber 42 connected to tip 120 in the manner generally described in U.S. Pat. No. 6,579,270 B2 (Sussman, et al.). Tip 120 may have a construction similar to the tips described in this reference, FIGS., 23 and 24 and the discussion at column 7, lines 31-45 of U.S. Pat. No. 6,579,270 B2 specifically being included by reference. Attached to or integrally formed within body 110 is fluid reservoir 130 , containing a surgical irrigating solution, or liquefaction working fluid 140 . Fluid 140 is supplied to pumping chamber 42 by fluid line 150 . Handpiece 100 in FIG. 2A relies on gravity pressure to feed fluid 140 to pumping chamber 42 while handpiece 100 in FIG. 2B relies on pressurized gas 160 , such as CO 2 , to force fluid 140 through line 150 . [0020] In a second embodiment of the handpiece of the present invention, seen in FIGS. 3A-3B , handpiece 200 has body 210 containing pumping chamber 42 connected to tip 220 in the manner generally described in U.S. Pat. No. 6,579,270 B2 (Sussman, et al.). Tip 220 may have a construction similar to the tips described in this reference, FIGS., 23 and 24 and the discussion at column 7, lines 31-45 of U.S. Pat. No. 6,579,270 B2 specifically being included by reference. Attached to or integrally formed within body 210 is fluid reservoir 230 , containing a surgical irrigating solution, or liquefaction working fluid 240 . Fluid 240 is supplied to pumping chamber 42 by fluid line 250 . Fluid reservoir 230 may be a rigid container, as shown in FIG. 3A , or a collapsible bag, as shown in FIG. 3B . Fluid 240 flows to pumping chamber 42 by capillary or wicking action through line 250 . [0021] This description is given for purposes of illustration and explanation. It will be apparent to those skilled in the relevant art that changes and modifications may be made to the invention described above without departing from its scope or spirit.

A liquefaction handpiece having an internal or integral reservoir for the working fluid. The reservoir may either feed the heater/pump by gravity or may use capillary or wicking action to feed the heater pump.

This Application is a continuation of application Ser. No. 09/148,567 filed Sep. 4, 1998 now U.S. Pat. No. 5,955,102. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention provides a nutritional supplement containing docosahexaenoic acid (DHA), lutein and anthocyanosides. The supplement is useful for improving night vision acuity, field of vision and adaptation to light. 2. Discussion of the Background Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are omega-3 (ω3) polyunsaturated fatty acids (PUFA) found naturally in marine oils. Both DHA and EPA have beneficial pharmacological effects on the human cardiovascular system, the auto-immune system and the development and maintenance of the brain and retina functions. DHA is present in large amounts in the outer segments (phospholipids) or photoreceptor cells of the retina (Murphy M G, J. Nutr. Biochem . 1990, 1: 69-70). Although the role of DHA in retinal function has been questioned (See Leaf et al., Early Human Dev . 1996, 45:35-53; Weisinger et al., Lipids 1996, 31:65-70), it is widely believed to be beneficial (See Noble et al., U.S. Pat. No. 5,484,611). DHA is critical for normal retinal development, and continues to accumulate in the retina even after birth, suggesting that it is a vital nutrient Conner WE et al., World Review in Nutrition and Dietetics 1991, 66:118-32). Antioxidants are believed to extend normal vision by preventing cataract formation (See Taylor, J. Am. Coll. Nutr . 1993, 12:138-46) and other visual disorders (Richer, J. Am. Optom. Assoc . 1996, 67:30-49). Lutein and zeaxanthin are antioxidants, belonging to a class of lipid-soluble yellow-to-red pigments known as carotenoids. In humans, lutein and zeaxanthin are major constituents of the macula lutea region of the retina, which is responsible for sharp, detailed viewing (Bone R A et al., Invest. Ophthalmol. Vis. Sci . 1993, 34:3033-40). Anthocyanosides are a group of red to blue plant pigments, which exist as condensed products (glycosides) of anthocyanins or anthocyanidins combined usually with sugar, such as glucose, arabinose or galactose. Bilberry contains a variety of anthocyanosides including cyanidine, malvidine, delphynidine, petunidine and peonidiene. Anthocyanosides are similar in structure and function to bioflavonoids. In particular, anthocyanosides enhance the regeneration of rhodopsin or visual purple, an eye protein necessary for vision in dim light or at night. Anthocyanosides may also improve vision by enhancing the activity of metabolic enzymes in the retina. (See De Smet, P. (1983) “Vaccinium myrtillus,” In Adverse Effects of Herbal Drugs , De Smet et al. eds., pp. 307-314, Berlin: Springer-Verlag; Cunio, L. Austrian J. Medicinal Herbalism 1993, 5(4):81-85; Mowrey, E. (1990) “Bilberry: For veins, eyes and nerves.” In Guaranteed Potency Herbs: Next Generation Herbal Medicine , pp. 14-24, New Canaan: Keats Publishing Inc.). Despite the recognition of the beneficial properties of DHA, antioxidants such as lutein and anthocyanosides, the American diet contains few foods which supply these nutrients. Thus, a nutritional supplement comprising these is desirable. Such a nutritional supplement is particularly useful for preventing visual disorders and for improving vision. SUMMARY OF THE INVENTION The present invention provides a nutritional supplement useful for preventing visual disorders and for improving vision. The nutritional supplement comprises DHA, antioxidants including at least lutein, and anthocyanosides. The present invention also provides a method of correcting, improving, preventing, or delaying various visual disorders such as myopia, hemeralopia, eye strain, night vision, retinal and macular degeneration. DETAILED DESCRIPTION OF THE INVENTION In accordance with the present invention, a nutritional supplement is provided which includes at least DHA, lutein and anthocyanosides as active ingredients. As used herein, an “anthocyanoside” is a flavonoid plant pigment which accounts for most of the red, pink, and blue colors in plants, fruits, and flowers. A “carotenoid” is a class of pigments occurring in the tissues of higher plants, algae, bacteria and fungi. They are usually yellow to deep red, crystaline solids, soluble in fats and oils, insoluble in water, highmelting, stable to alkali, unstable to acids and oxidizing agents, their color is easily destroyed by hydrogenation or by oxidation, and some are optically active. A “flavonoid” is a group of aromatic, oxygen-containing, heterocyclic pigments widely distributed among higher plants. They constitute most of the yellow, red, and blue colors in flowers and fruits, excluding the carotenoids. The flavonoids include the following subgroups: (1) catechins, (2) leucoanthocyanidins and flavanones, (3) flavanins, flavones, and anthocyanins, and (4) flavonols. The nutritional supplement of the present invention is preferably provided as a capsule and includes a liquid or dry inner filling and an outer shell. In the preferred embodiment, the inner filling is a liquid mixture which is contained within a gelatin capsule, such as a “softgel” type capsule. The inner filling includes at least DHA, lutein and at least one anthocyanoside. “DHA” refers to the free acid form of docosahexaenoic acid, not the phospholipid form or the ester form. One naturally occurring source of DHA is fish oil. Fatty fish such as salmon, mackerel, sardines, ocean trout and herring contain the highest amounts of DHA (about 600-800 mg/3 oz). Other sources of DHA include fin fish such as whiting and flounder (about 200-400 mg/3 oz), plants such as seaweeds, and many microorganisms. The nutritional supplement of the present invention preferably contains about 25 to 900, preferably 25 to 140, mg/day of DHA. Alternatively, the nutritional supplement contains 10 to 15% by weight of DHA. EPA, another ω3 PUFA, is commonly found in sources of DHA. When EPA is present, the ratio of DHA:EPA in the nutritional supplement is greater than 1.1:1, preferably greater than 2:1, and more preferably greater than 4:1. Tuna oil is the preferred source of DHA as it contains about 25% DHA and about 6% EPA. Lutein and zeaxanthin are both carotenoids and structural isomers of one another. They can be extracted in crystalline form from marigolds. Dietary sources of lutein and zeaxanthin include mustard greens, spinach, kale, broccoli, leaf lettuce, green peas, brussel sprouts, corn, some squash and green beans. The nutritional supplement of the present invention preferably contains about 1 to 6 mg/day of lutein. Alternatively, the nutritional supplement contains 0.1 to 0.5% by weight of lutein. The nutritional supplement of the present invention preferably contains about 0 to 0.15 mg/day of zeaxanthin. Alternatively, the nutritional supplement contains 0 to 0.05% by weight of zeaxanthin. In addition to lutein and zeaxanthin, other antioxidants may also be present in the nutritional supplement of this invention. These may include vitamins such as vitamin A, vitamin C, and vitamin E (∝-tocopherol) or lemon bioflavonoids. The nutritional supplement may contain 0 to 10% by weight of one or more antioxidants. Any source of anthocyanosides can be used in accordance with the present invention. Bilberry extract is preferred. “Bilberry” refers to berries of Vaccinium myrtillus , a small, perennial scrub that is native to northern Europe and Asia. Other names include blueberry, whortleberry, black whortles, shinberry, trackleberry, hurts, bleaberry, hurtleberry and airelle. The nutritional supplement of the present invention preferably contains about 3 to 200, preferably about 30 to 200, mg/day of an anthocyanoside such as bilberry extract. Alternatively, the nutritional supplement contains 5 to 10% by weight of an anthocyanoside such as bilberry extract. The components of the inner filling are preferably solubilized in a liquid to form a liquid mixture (i.e., not an emulsion). Suitable liquids include vegetable oils such as soybean oil. The inner filling can other components, including fillers, components useful for adjusting the isotonic properties of the filling (such as glycerol), and components useful for adjusting the stability of the inner filling such as amino acids and carbohydrates (such as fructose, glucose, dextrose, etc.). When the inner filling of the nutritional supplement of the present invention is a liquid, the outer shell is preferably composed of gelatin as well as other optional components such as glycerol and coloring agents (such as caramel). Such a nutritional supplement can be obtained by filling the outer shell with the premixed inner filling. In one particularly preferred embodiment, the nutritional supplement is a softgel capsule comprising (i) about 70% by weight, based on the total weight of the capsule, of an inner filling comprising: about 8% by weight of bilberry extract, about 0.3% by weight of lutein, about 0.01% by weight of zeaxanthin, about 12% by weight of DHA, about 3% by weight of EPA, about 6% by weight of vitamin C, and about 6% by weight of lemon bioflavonoids; and (ii) about 30% by weight, based on the total weight of the capsule, of an outer shell comprising about 20% by weight, based on the total weight of the capsule, of gelatin. Having generally described this invention, a further understanding can be obtained by reference to the following example which is provided herein for purposes of illustration only and is not intended to be limiting. EXAMPLE Formulation of a Softgel Capsule The following softgel capsule is one embodiment of the present invention. To provide a benefit to vision, two such softgel capsules would be ingested per day. ingredient mg/ Ingredient genus/species breakdown softgel Inner filling bilberry extract Vaccinium myrtillus 90% Bilberry 40 extract 7% Fructose 3% Dextrsoe marigold extract Tagetes Erecta 20% Lutein 7.5 0.86% Zeaxanthin 79.14% Corn oil tuna oil 25% DHA 200 6% EPA 0.2% Spearmint acerola concentrate Malpighia emarginata 25 lemon biflavonoids Citrus limon 25 soy lecithin 12 vegetable oil 61.52 (soya) ∝-tocopherol 67% 1 ∝-tocopherol 33% soy oil yellow beeswax 41 Outer shell gelatin 134.98 glycerin 59.72 caramel color 4.98 *  *  *  *  * Having now fully described the invention, it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the spirit or scope of the invention as set forth herein.

This invention provides a nutritional supplement containing docosahexaenoic acid (DHA), antioxidants and anthocyanosides. The supplement is useful for improving night vision acuity, field of vision and adaptation to light.

The present invention is related to the plants in the following co-pending applications: ______________________________________Application no. Filing Date Title______________________________________09/149,300 09/09/98 Refocus09/149,299 09/09/98 Pink Refocus09/149,657 09/09/98 White Refocus______________________________________ BACKGROUND OF THE INVENTION The present invention comprises a new a distinct cultivar of chrysanthemum plant that is a natural occurring sport of a parent chrysanthemum named Refocus. Parent chrysanthemum Refocus is also described in this application. The new cultivar was discovered as a whole plant mutation in May, 1993 by Rob Noodelijk in a greenhouse in Ter Aar, Holland. The first act of asexual reproduction of Red Refocus was accomplished when vegetative cuttings were taken from the initial selection in August 1993 in a controlled environment in Ter Aar, Holland. SUMMARY OF THE INVENTION The present invention is a new and distinct variety of chrysanthemum bearing small sized blooms with red ray florets and green-yellow disc florets. BRIEF DESCRIPTION OF THE DRAWINGS The present invention of a new and distinct variety of chrysanthemum is shown in the accompanying drawings, the color being as nearly true as possible with color photographs of this type. FIG. 1 shows the stem of the cultivar in full bloom. FIG. 2 shows the various stages of bloom and foliage of the new cultivar. DESCRIPTION OF THE INVENTION This new variety of chrysanthemum is of the botanical classification Dendranthema grandiflora. When grown in the vicinity of Ter Aar, Holland, it has a response time of approximately 8 weeks. This new variety produces small sized blooms with red ray florets and green-yellow disc florets having a 3 week performance (i.e., vase life of 21 days). This new variety of chrysanthemum has been found to retain its distinctive characteristics throughout successive propagations. However, the phenotype may vary significantly with variations in environment such as light intensity and temperature. To show the phenotype as described Red Refocus may be planted year round under greenhouse conditions in Holland. The following is a description of the plant and characteristics that distinguish Red Refocus as a new and distinct variety. The color designations are taken from the plant itself. Accordingly, any discrepancies between the color designations and the colors depicted in the photographs are due to photographic tolerances. ______________________________________CULTIVAR RED REFOCUS Parent Cultivar REFOCUS______________________________________BudSize small cross section + 1.0 medium, cross section ± cm, height ± 1.2 cm 1.2 cm, height ± 1.2 cmOutside Color red 46B red-purple 70ABloomSize small smallFully Expanded 4-41/2 cm 4-41/2 cmBorne upper portion single flower upper portion single flower per peduncle, lower portion per peduncle, lower portion plural flower per peduncle plural flower per peduncleNumber of average of 10 average of 10Blooms (persingle stem)Peduncle near the top ±10 cm, near near the top ±10 cm, nearLengths the middle 20 cm, near the the middle 20 cm, near the bottom 20 cm. bottom 20 cm.Peduncle medium mediumLateral Shoot,AttachmentPeduncle 30° 30°-35°Lateral Shoot,AngleForm single (daisy) single (daisy)Performance good, 21 days (18°-20° C.) good, 21 days (18°-20° C.)(bloomingperiod)ColorCenter of yellow-green 144B at an yellow-green 15A at anFlower/disc early stage of inflorascence, early stage of inflorascence,floret mature yellow-orange 14B mature yellow-orange 14BColor of upper red 45A red-purple 71Csurface of themajority of theray-floretsColor of the red 45C purple violet 80Dlower surfaceof the majorityof the ray-floretsTonality from a small red daisy a small purple daisyDistanceDiscoloration ray-florets to red 45C ray-florets to red-purple disc-floret to yellow-orange 72D disc-floret to yellow- 14B orange 14BPollen yellow-orange 14A yellow-orange 14ARay floretsTexture upperside smooth, under- upperside smooth, under- side smooth side smoothNumber 35-40 (2-3 rows) 35-40 (2-3 rows)Cross-section concave concaveLongitudinal straight straightaxis of majorityShape of tip pointed pointedFragrance typical chrysanthemum typical chrysanthemumDisc Diameter small to medium (1.0-1.2 small to medium (1.0-1.2 cm) cm)ReproductiveOrgansStamen yellow-green, thin, ± yellow-green, thin, ±(present in disc mm in length mm in lengthflorets only)Pollen present, abundant present, abundantStyles (present yellow-green, thin yellow-green, thinin both ray anddisc florets)Style Length ±4 mm ±4 mmStigmas yellow yellowStigma Width ±1 mm ±1 mmOvaries enclosed in calyx enclosed in calyxPlantForm spray mum meant for erect spray mum meant for erect culture. Herbaceous culture. HerbaceousGrowth short to medium short to mediumHeight ±95-100 cm ±95-100 cmStem Color yellow-green 146B yellow-green 146BStem Strength strong strongStem Brittle- absent presentnessStem present absentAnthocyaninColorationInternodes short (1.5-2.0 cm) short (1.5-2.0 cm)Flowering 8 weeks 8 weeksResponse(photoperiodiccontrolledcrop, no naturalgrowing)FoliageColor upperside yellow-green upperside yellow-green 147A 147A underside yellow-green underside yellow-green 147B 147BSize length 10 cm; width 7 cm length 9 cm; width 6 cmQuantity (per 28-32 28-32single stem)Shape egg-shaped egg-shapedTexture fleshy fleshyRibs and Veins both ribs and veins well both ribs and veins well developed developedEdge crenated crenatedShape of Base round roundof SinusBetweenLateralLobesMargin of converging convergingSinus BetweenLateral LobesShape of Base truncated roundedApex mucronate mucronateYear of 1993 1992Discovery______________________________________CULTIVAR PINK REFOCUS WHITE REFOCUS______________________________________BudSize medium, cross section ± medium cross section ± 1.2 cm, height ±1.2 cm 1.5 cm, height ±1.0 cmOutside Color red-purple 58B yellow-orange 20DBloomSize small smallFully Expanded 41/2-5 cm 31/2-4 cmBorne upper portion single flower upper portion single flower per peduncle, lower portion per peduncle, lower portion plural flower per peduncle plural flower per peduncleNumber of average of 10 average of 10Blooms (persingle stem)Peduncle near the top ±10 cm, near near the top ±10 cm, nearLengths the middle 20 cm, near the the middle 20 cm, near the bottom 20 cm. bottom 20 cm.Peduncle medium to strong mediumLateral Shoot,AttachmentPeduncle 30°-35° 30°-35°Lateral Shoot,AngleForm single (daisy) single (daisy)Performance good, 21 days (18°-20° C.) good, 21 days (18°-20° C.)(bloomingperiod)ColorCenter of yellow-green 144B at an yellow-green 144A at anFlower/disc early stage of inflorescence, early stage of inflorescence,floret mature yellow-orange 14B mature yellow-orange 14BColor of upper near red-purple 58C pure white 155D (butsurface of the whiter)majority of theray-floretsColor of the red-purple 58C pure white 155D (butlower surface whiter)of the majorityof the ray-floretsTonality from a small pink/purple daisy a clear white small daisyDistanceDiscoloration ray-florets to red-purple Ray florets none, disc 58D disc-floret to yellow- florets to yellow-orange orange 14B 14BPollen Yellow-orange 14A noneRay floretsTexture upperside smooth, under- upperside smooth, under- side smooth side smoothNumber 38-45 (3 rows) 22-26 (2 rows)Cross-section concave convex (no keels)Longitudinal straight reflexingaxis of majorityShape of tip pointed roundedFragrance typical chrysanthemum typical chrysanthemumDisc Diameter mall to medium (1.0-1.2 small to medium (1.2-1.5 cm) cm)ReproductiveOrgansStamen yellow-green, thin, yellow-green, thin,(present in disc ±4 mm in length ±4 mm in lengthflorets only)Pollen present, abundant noneStyles (present yellow-green, thin yellow-green, thinboth ray anddisc florets)Style Length ±4 mm ±4 mmStigmas yellow yellowStigma Width ±1 mm ±1 mmOvaries enclosed in calyx enclosed in calyxPlantForm spray mum meant for erect spray mum meant for erect culture. Herbaceous culture. HerbaceousGrowth short to medium short to mediumHeight ±100-105 cm ±100-105 cmStem Color yellow-green 146B yellow-green 147BStem Strength strong strongStem Brittle- absent presentnessStem present presentAnthocyaninColorationInternodes short (1.5-2.0 cm) short (1.5-2.0 cm)Flowering 8 weeks 8 weeksResponse(photoperiodiccontrolledcrop, no naturalgrowing)FoliageColor upperside yellow-green upperside yellow-green 147A 147A underside yellow-green underside yellow-green 147B 147BSize length 9 cm; width 6 cm length 9 cm; width 6 cmQuantity (per 28-32 30-35single stem)Shape egg-shaped egg-shapedTexture fleshy fleshyRibs and Veins both ribs and veins well both ribs and veins well developed developedEdge crenated crenatedShape of Base round roundof SinusBetweenLateralLobesMargin of converging convergingSinus BetweenLateral LobesShape of Base obtuse truncatedApex cuspidate mucronateYear of 1993 1995Discovery______________________________________

A chrysanthemum plant named `Red Refocus` characterized by its small sized blooms with red ray florets and green-yellow disc florets.

SUMMARY OF THE INVENTION This invention relates to a new and distinct Lantana camara cultivar which is outstanding because of its very compact growth habit, strong tendency to self branching, dramatic tri-colored, continuous bloom display, dense forest green leaves and tendency to set seed infrequently. The claimed Lantana camara plant was primarily selected for these characteristics. This selection was made from a specially designed Lantana hybridizing program with said hybrid cultivars being planted and grown in Grain Valley, Mo. ORIGIN AND ASEXUAL REPRODUCTION Asexual reproduction of this cultivar by tip cuttings was directed by me, such reproduction establishing that the plant does in fact maintain the characteristics described, in successive generations. Vegetative tip cuttings were taken in January from the original “Mother” plant (produced from seed) and rooted and grown in a greenhouse. These were planted outside as a 2 inch plug size in USDA Zone 5 in the first week of May and grown and observed through September. This outdoor evaluation process was conducted for at least two or more summer growing seasons to observe descriptive characteristics. It should be noted that the plant was initially selected from a Lantana planting being grown near Grain Valley, Mo. in a cultivated area and has since been reproduced by tip cuttings in the vicinity of Grain Valley, Mo. with the new and distinct characteristics stated herein, found to be stable and reproduce true to type in successive generations as before recited. Lantana camara is native to the subtropics and tropical North and South America. They are woody ornamentals which are not usually winter hardy North of USDA horticulture Zone 9. The roughish leaves range from yellow-green to green to blue-green and the two basic growth forms are mounding and trailing (weeping). Bloom color usually include yellow, white, cream, pink, or orange. The cultivar of Lantana camara ‘Robpatcow’ may further be described as having a number of distinctive characteristics which are enumerated in the succeeding specific description but broadly stated as comprising a very compact growth habit of only 8-12 inches in height and width in one season, a strong tendency to self branching, a tri-colored bloom display which transitions from yellow (PMS #108) to buff-gold (PMS #1235) and then to orange (PMS #1655), dense forest-green (PMS #343) leaves with blue overtones, and reduced tendency to set seed. The continuous color display begins blooming at 6-7 weeks after cutting are made, or four weeks after potting. Almost no pinching is needed due to this cultivar's tendency to self-branching. I have chosen to identify this new cultivar as Lantana camara ‘Robpatcow’. This cultivar is being marketed in the United States under the name of Patriot™ Cowboy. BRIEF DESCRIPTION OF THE DRAWING The accompanying photographs show as nearly true as it is reasonably possible to make the same, in color illustrations of this character, typical leaves and flowers of the new variety. The photographic drawings illustrate the flower form, the distinctive color transitions of the flowers, and the very compact growth habit. FIG. 1 illustrates the bloom cluster with varying maturity of the flowers (to display the color range as well as possible). FIG. 2 illustrates the compact growth habit of the mature plant. DETAILED DESCRIPTION In order to more specifically identify the cultivar, descriptive details are set forth hereinafter, along with related aspects of the plant which serve to distinguish the same, all colors being noted as compared with the Pantone Matching System (PMS). The measurements and colors were recorded from mature 8 month old (from the time tip cuttings were taken) plants grown in the vicinity of Grain Valley, Mo. Parentage: Seed parent.—Lantana camara ‘Robcomplan’ (U.S. Plant Pat. No. 9,837) in a semi-controlled open pollination. Pollen parent.—Lantana camara ‘Robcomplan’ (U.S. Plant Pat. No. 9,837). Propagation: Asexual reproduction by tip cuttings started near Grain Valley, Mo. Plant descriptions: Inflorescence and reproductive parts.— The inflorescence is a flat topped round cluster of 25-30 flowers. The individual clusters are determinate and arise from the leaf axils. Each individual flower is slightly un-symmetrical with a bilateral symmetry and is subtended by a single bract. The bract has a length of ⅜″; width is {fraction (1/32)}″ at the widest point; shape is lanceolate; apex is acute; base is truncate; margin is smooth with slight pubescence; color of both upper and lower surfaces is PMS #370 at the base blending to PMS #357 at the apex; lower surface has stronger pubescence. The perianth consist of: the Calyx (5 united sepals) and the Corolla (5 united petals with narrow tube). The flowers are zygomorphic, hermaphroditic, and have 4 introrse stamens which are didynamous. Single pistil which is usually vestigal and somewhat deformed. The ovary is superior, the style is terminal, and the stigma is lobed. The ovary is 2 locular, but is divided into 4 locules by a false septum in each locule. The placentation is axile with 2 ovules per carpel. The sepals, though not perceivable by the naked eye, when magnified can be observed and described as fused and comprising a short tubular calyx approximately {fraction (1/32)}″ long. Slightly translucent in appearance, they have a coloration of PMS #370 on both surfaces. Petals have a fused corolla with fingerlike projections and have a length of ⅝″ from base to tip; width of {fraction (5/16)}″; funnel shape; apex is irregular with 4-5 lobes; base is fused. Ultimate plant height is 12″ when measured from the soil to the top of the inflorescence; ultimate plant diameter is 12″. The fruit classification is drupe and potentially contains 2 seeds {fraction (3/16)}″ in diameter. When fruit forms, it is green (PMS #363); then matures through a deep purple (PMS #533) to a near black (PMS #532). Inflorescence dimensions.— Bloom cluster — 1.5″ in diameter. Single Flower — 0.25″. Pedicel length — 1.1″; color is green (PMS #370). Corolla tube — 0.375″. Inflorescence colors.— Buds — Cream (PMS #607); length is {fraction (1/16)}″; diameter is {fraction (1/32)}″. The petals color at first opening — Upper surface is Bright yellow (PMS #108); lower surface is pale yellow (PMS #120); Transitions through to an upper surface of buff gold (PMS #1235); lower surface is cream-yellow (PMS #1205); Mature — Upper surface is Orange (PMS #1655); lower surface is pale gold-orange (PMS 1345). Transition Time — 24 hours (approximately). Tube — Exterior color is Salmon in all stages (PMS #170); interior color is pale yellow (PMS #127). Developmental pattern.— First flowers develop in a circular pattern on the periphery of the inflorescence. The average plant grown outdoors for 6-8 months will typically produce 70-100 inflorescences at peak blooming. Lastingness of individual blooms: From early bud stage to the aborting of the last flower is typically 8-12 days. Leaves and stems.— Leaf Shape: Ovate. Leaf Margins: Serrate. Leaf Tip: Acute. Leaf Base: Obtuse. Leaf Veins: Pinnate. Leaf Surface: Rough due to bristly hairs. Leaf Arrangement: Opposite. Leaf Color: Immature leaves — upper surface is forest green (PMS #349); lower surface is green (PMS #378) maturing to an upper surface color of blue green (PMS #343); lower surface color of green (PMS #378). Leaf Size: Length 2″. Petiole Length is 0.5″; diameter is {fraction (1/16)}″; color is green (PMS #370). Width 1.25″. Peduncle: Color is green (PMS #370); length is ⅞-1¼″; diameter is {fraction (1/16)}″ at midpoint. Stem: Square in youth becoming round and woody with age; length is 6-8″; diameter is ⅛″ at midpoint on the stem; internode length is ¼-1″; immature color is green (PMS #370) and mature color is (PMS #147). Roots: Highly branched and fibrous. Flowering time: The color display begins blooming at 6-7 weeks after cuttings are made, or 4 weeks after potting, and continue until temperatures drop below 45 degrees Fahrenheit. Fragrance: The flowers have a medium to strong minty fragrance in the early yellow and buff gold stages and have little to no fragrance in the orange stage before aborting. Diseases: No known diseases noted to date. General observations: Lantana camara ‘Robpatcow’, with its dwarf and very compact growth habit is ideal for the smaller garden and landscape designs and the patio/pot culture trend. The lack of need to pinch for compact growth and the self-branching quality is a very time saving feature for the home gardener. For the purpose of ornamental horticulture in our present living environments which include smaller yards and patio gardening, Lantana camara plant ‘Robpatcow’ is ideal due to several characteristics: A. It is an excellent plant for mass planted ground covers, low borders, hanging baskets or floral short (12-15 inches) specimen standards. Lantana camara ‘Robpatcow’ will produce a continuous display of bright colors throughout the summer. B. Self-branching is spontaneous, so almost no pinching is necessary. This growth habit, atypical in lantanas, produces a full compact display plant with little care or attention on the part of the gardener. C. The leaves are smaller and more closely arranged than other lantanas, which enhances the “compact” display. It forms a compact mound 12″×12″ in one season. Its very compact growth habit with small leaf size, short internode spacing and tendency toward self-branching places ‘Robpatcow’ in a category all its own, as this “compact habit” is not typical for any other lantana, other than the parent plant, that we are aware of. D. Lantana camara ‘Robpatcow’ has a reduced tendency to set seed, therefore the inflorescence gives a longer display of color to the garden. COMPARISON TO KNOWN VARIETIES Lantana camara plant ‘Robpatcow’ should be compared with Lantana camara ‘Robcomplan’ (U.S. Plant Pat. No. 9,837) for its compact habit, growth rate, mature size, foliage color and shape. However, ‘Robpatcow’ is a new color in the compact Lantana plants. The only other compact Lantana plant that applicant is aware of is the patented parent, ‘Robcomplan’. The most distinguishing characteristic which differentiates ‘Robpatcow’ from, the parent, ‘Robcomplan’, is the bloom color. ‘Robcomplan’ transitions from yellow, to sienna and orange, then to fuscia pink and displays a bloom with a multi-color effect in appearance. Robpatcow's blooms transition from yellow, a very brief buff-gold, and then quickly mature to a bright orange giving the appearance of being bi-colored in mass rather than tri-colored.

This invention relates to a new and distinct Lantana camara cultivar which is outstanding because of its very compact growth habit, strong tendency to self branching, dramatic tri-colored, continuous bloom display, dense forest green leaves and tendency to set seed infrequently.

BACKGROUND OF THE INVENTION [0001] The invention herein disclosed describes an ophthalmic marker identified as the ‘Melki Marker’, and relates to opthalmology, and specifically to retinal surgical vitreous procedures for marking positions for incision/injection sites on the scleral tissue. The types of ophthalmic vitreous surgical procedures for which the ‘Melki Marker’ are applicable include but not limited to, vitrectomies performed in hospital operating rooms and in doctor's offices where vitreous injections are routinely performed for a variety of procedures to treat abnormal eye conditions. [0000] In executing surgical complicated procedures on tissue within the human eye, and for other animals such as horses, domestic cats and dogs, it is necessary to accurately locate the position of incision locations on the scleral surface of the eye. [0002] In order to prevent having surgical intervention taking place too far from the location to be operated on, or at a wrong angle or in an improper plane or inclination, it is necessary to mark the location as accurately and precisely as practical. BRIEF SUMMARY OF THE INVENTION [0003] The specific procedure is an ophthalmic procedure wherein it is essential to locate the point of incision on the sclera limbal tissue surface to ensure that the location is safe to enter the Pars Plana region. In the event that the location is outside the Pars Plana region serious medical complications could result, such as lens damage, and thus creating a cataract. Another complication can be a retina tear or detachment. For the adult human eye the safe Pars Plana region is at a fixed dimension of 3.5 mm from the outer edge of the iris, also known as limbus. [0004] The procedure using existing caliper markers consists of defining an incision site on the surface of the eyeball by initially drying the surface of the eye with sterilized disposable “Q” tip cotton swabs and marking the incision point with caliper pointers set by thumbscrew setting caliper scale at the required position to suit the patient. The set pointers are applied with ink by a nurse using sterilized blue pen from an epidermic labeler, such as #150 available from Devon Inc., or equivalent non-toxic, waterproof, absorbable ink or stain. In this manner the ink soaked pointers can be placed on the eye ball to mark the incision site. [0005] It will be evident that in such a procedure, it is essential that the caliper pointers are correctly set by a nurse in attendance, further checked by the surgeon before carefully aligning caliper mechanism on the scleral in each instance and that the whole procedure is time consuming. [0006] The marker types that have been used in these ophthalmic procedures are disclosed for example, by Simon in U.S. Pat. No. 5,090,955, and by manufacturer Storz Gmbh in Germany in the Model # E2404—Castroviejo Caliper. These markers are based on a caliper adjustment range of between 0 mm to 20 mm in 1 mm increments with a scale reading settings. The mode of operation is to use a thumbscrew setting to position the tips of the caliper pointers at the desired setting. In practice it is possible that errors result in the desired pointer-to-pointer setting due to haste in setting the pointers, wear and tear of the marker components and misreading of the scale reading setting. In addition, surgical tools of these types have non-smooth surfaces and hide-out areas that are required to be sterilized before reuse. [0007] Simplicity is the essential feature of the Melki Marker invention in that it prevents the need for the surgeon to double-check the prior art ophthalmic markers caliper point settings that have been fixed by others. In addition, prior art caliper markers are subject to wear and tear of the setting mechanism that leads to caliper setting gauge inaccuracies after a period of time. By means of using a Melki Marker with a fixed pointer setting the surgeon saves time. The Melki Marker pointer setting is dependent on the type and age of the patient, for example, for an adult, the marker setting points are 3.5 mm apart and for premature infants and infants less than 3 months old, 1.0 mm apart, and for animals, such as racing horses, domestic pets, in the range 2.8 mm to 4.7 mm. These pointer settings are based on the need to ensure that the location of the incision point is in the safe Pars Plana region of the eye. [0008] It is clear to one of ordinary skill in the art that there is a need for an error free, accurate and easy to use marker instrument that ensures the safety of ophthalmic procedures that require marking on the scleral surface of the eye. [0009] In the preferred embodiment of the invention, the Melki Marker, the pointer set points are fixed for each category of patient whereby errors in pointer setting are eliminated and operating surgeon's time is reduced. [0010] In the preferred embodiment the Melki Marker pointer settings are clearly identified on the instrument distel portion by engraving, imprinting or equal means, as a quality assurance feature to ensure that there is no possibility of using pointer settings in error. [0011] In the preferred embodiment of the Melki Marker the material selected is one from a range of metal materials that are readily sterilizable and designed with smooth, shiny surfaces. [0012] In a further preferred embodiment of the invention, the Melki Marker is made from materials of reinforced plastics, such as fiber glass, glass reinforced plastic or equal materials, that are less costly to make and can therefore be disposable after use. [0013] In yet a further embodiment of the invention, the Melki Marker is arranged as a disposable once only use instrument having the pre-set pointer positions provided with pre-inked pointer tips with protector thimbles enclosing the ink-tips, and sealed in a sterilized see-through package, ready for immediate use by the operating surgeon pointer settings that are clearly identified on the instrument distel portion by engraving, imprinting or equal identification means. BRIEF DESCRIPTION OF THE DRAWINGS & TABLE [0014] Various features, aspects, and advantages of the present invention will become more apparent with reference to the following Figures and Table accompanying this application, wherein: [0015] FIG. 1 —This Figure illustrates the fundamental eye elements for the purposes of performing vitreous retinal surgical procedures for marking incision/injection sites on the sclera limbal tissue. [0016] FIG. 2 —This Figure illustrates the marking on the scleral surface of the eye at a distance of 3.5 mm from the edge of the iris. [0017] FIG. 3 —This Figure shows vitrectomy instrument positions. [0018] FIG. 4 —This Figure shows an example of prior art used in scleral marking procedures. [0019] FIG. 5 —This Figure shows a further example of prior art used in scleral marking procedures. [0020] FIG. 6 —This Figure shows a practical example of the Melki Marker. [0021] FIG. 7 —This Figure shows image of Melki Marker with pointer distances for different patients. [0022] FIG. 8 —This Figure shows image of Melki Marker made in plastic or equal material with ink dipped pointers in sealed package. [0023] TABLE 1—Depicts typical steps performed by a surgeon in marking the scleral of the human eye. LIST OF REFERENCE NUMBERS FOR THE ELEMENTS IN THE DRAWINGS [0024] The following is a list of the elements in the drawings in numerical order. 1 Pupil 2 Iris 4 Vitreous 5 Retina 6 Sclera 10 Surgical Marker 12 Proximal End 14 Distel End 16 Bend Portion 18 Pointer 20 Pointer 22 Eyeball 24 Incision Spot 26 Caliper 28 Protector Thimbles for Pre-Inked dipped Pointers 30 Vacuum Sealed see-through Package DETAILED DESCRIPTION OF THE INVENTION [0041] The object of the present invention is therefore to provide a marker for ophthalmic surgical procedures which permits the operating physician to effect a precise marking of the location to be operated upon with accuracy, safety and a reduction in the surgeon's operating time. [0042] For such procedures, the Melki Marker is held by the surgeon in one hand and brought into contact with the sclera limbal tissue of the eye by means of the operating physician taking hold of a tubular marker at the distel handle end and presenting the two sharp marker pointers at the proximal end so that two dots may be made on the scleral surface at for example, 3.5 mm apart and in a manner that uses the edge of the iris, also known as limbus, as reference point and ensures that the Pars Plana safety region is maintained. The novel feature of the ‘Melki Marker’ is that by having a fixed distance between the marker points it is ensured that incision spots 24 made by the pointers are always 3.5 mm apart for adult human procedures. [0043] The key embodiment of the Melki Marker is that it is a simple and easy to use surgical instrument that has no moving parts that are intrinsic to prior art caliper markers. The absence of moving parts prevents marker manipulation position settings errors, errors in settings due to wear and tear of the caliper mechanism moving parts, and saves the surgeon the need to double-check the caliper setting for inaccuracies. [0044] There are several ophthalmic procedures that require the surgeon to locate precise incision points on the scleral surface of the eye. For example, for vitrectomies performed in hospital operating rooms, and in out-patient surgical facilities, it is necessary to locate up to three incision spots 24 on the scleral surface wherein each location is required to be in the Pars Plana safety region at exactly 3.5 mm from the edge of the iris as shown in FIG. 2 . [0045] The sharp marker pointer ends 12 and 18 are applied with ink by a nurse using sterilized blue ink pen from an epidermic labeler, such as #150 available from Devon Inc., or equivalent non-toxic, waterproof, absorbable ink or stain. In this manner the ink soaked pointers can be placed on the eye ball to mark multiple incision/injection spots 24 on scleral surface in such Operating Room settings where for example, vitrectomy ophthalmic procedures are performed. [0046] There are other ophthalmic surgical procedures that are performed in doctor's offices where the treatment requires the injection of medications such as steroids, anti-biotics, and anti-VEGF and requires similar procedures/injections for the location of injection spots 24 . [0047] In a preferred embodiment of the surgical marker the Melki Marker is made from stainless steel or equal material in the form of a solid smooth surface tubular metal rod and arranged with the marker points at exactly 3.5 mm apart for use on adult human eyes as disclosed in FIG. 7 . This embodiment can be provided with an identification marker (such as “Melki Marker 3.5 mm, or “M-M 3.5 mm”) on the handle of the instrument to indicate the pointer setting distance in mm's and this can be applied by engraving, imprinting, stamping, stenciling or other equal identification method. [0048] In a further preferred embodiment the Melki Marker is made from reinforced plastics, such as fiber glass, glass reinforced plastic or equal light weight, high tensile strength materials in the form of a solid smooth surface tubular rod, that is less costly to make than metallic forms and can be disposable after use. This embodiment can also be provided with an identification marker on the handle of the instrument to indicate the pointer setting in mm and this can be applied by engraving, imprinting, stamping, and stenciling or other equal identification method. [0049] In yet a further preferred embodiment the distel ends of the sharp pointers 18 , 20 , markers are pre-soaked in ink dye from an approved epidermic labeler and protected by rubber, polystyrene or other equal type of material thimbles 28 , and packaged for use in a sterilized sealed see-through package 30 , as disclosed in FIG. 8 . In this embodiment the material selection makes it suitable for disposal after use. In addition, in this embodiment the handle portion of the instrument is engraved, stamped, imprinted or other identifying means, with the pointer distances in mm. In addition, the see-through sealed package can also be imprinted, stamped, or with equal identification means to indicate to the surgeon the marker pointer distance in mm's. [0050] FIG. 7 shows a specific embodiment of a surgical marker made from high tensile strength material, such as stainless steel, alloy steel, titanium or equal material that can be sterilized. The surgical marker 10 has a tubular distel end 14 with a means for readily handling and a bend portion 16 at an included angle of approximately 150 degrees for an ergonomic configuration, a proximal end 12 with two sharp-ended pointers 18 and 20 arranged in a vee formation and set at a fixed distance of 3.5 mm between said pointers 18 , 20 in a preferred embodiment for adult patients. [0051] The invention described herein is for a surgical instrument used primarily intended for surgical retinal surgeons. However, the basic concept of the invention could have other applications in other medical specialties with different proximal end pointer settings in excess of 5.00 mm. [0052] Table 1 shows typical steps performed by the physician for scribing the eye sclera incision/injection site(s). [0053] The Melki Marker invention incorporates a number of alternative embodiments for the material for making the marker. For example, a preferred embodiment of the surgical marker the material of the marker can be made of alloy steels, stainless steel, nickel-chromium steels, or titanium that can be readily sterilized in the hospital or doctor's office facilities. A further preferred embodiment of the invention incorporates a disposable material, such as fiber-glass, glass reinforced plastic (GRP) or equal light weight high strength materials, for the Melki Marker wherein the marker can be disposed in licensed disposal equipment. [0054] The above developments of the marker tool are indicative of use in medical procedures wherein the marker can be used in both hospital and doctor's office settings. It will be clear from the foregoing specification disclosure and drawings, that the invention of the Melki Marker provides a simple and reliable means for marking incision/injection spots on the scleral libel tissues of the human and other animal eye surfaces that is easy to use, exactly accurate, not prone to operating room setting errors, and not subject to inaccuracies due to wear and tear of existing caliper marker setting appliances. [0055] The preferred Melki Marker embodiment is made of materials such as stainless steels, alloy steels, titanium or equal high tensile strength materials that provide for instrument re-use after sterilization, is particularly suitable for hospital operating room settings, as disclosed for example, in FIG. 7 . [0056] In a further preferred embodiment the Melki Marker made out of low cost, light weight, high tensile strength plastic materials, and disposable after use is suitable for doctor's office settings. This particular embodiment in the form of a pre-packaged instrument as disclosed in FIG. 8 is ideal for use in doctors' offices. [0057] While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiments, it is understood that the invention is not limited to the foregoing Detailed Description Drawings of the Invention, and disclosed preferred embodiments, but it will be appreciated by those skilled in the art that the Invention is not limited to the embodiments disclosed, but is capable of numerous rearrangements, modifications, and substitutions of parts or elements without departing from the spirit and scope of the appended Claims. DESCRIPTION OF TABLE [0058] TABLE 1—Depicts typical steps performed by a surgeon in marking eye scleral surface. TABLE 1 STEP NUMBER DESCRIPTION STEP 1 Prepare the patient by administering eye drops/ medication for dilation, sedation, anesthesia STEP 2 Prepare surface of the sclera conjunctive tissue of the eye by drying with sterilized “Q” tips cotton swabs STEP 3 Select specific Melki Marker with indicator confirming that the pointers are at fixed distances apart to suit patient Alternative Select specific disposable Melki Marker in vacuum STEP 3 sealed see-through package with pre-inked pointer tips STEP 4 Soak the pointers by application of approved disposable blue ink pen STEP 5 Present ink-tipped pointers to the surface of the scleral surface to make incision/injection mark(s) within the Pars Plana safety region DESCRIPTION OF FIGURES [0059] FIG. 1 —This Figure illustrates the fundamental eye elements for the purposes of performing vitreous retinal surgical procedures for marking incision sites on the sclera limbal tissue. [0060] FIG. 2 —This Figure illustrates the marking on the scleral surface of the eye at a distance of 3.5 mm from the edge of the iris. [0061] FIG. 3 —This Figure shows vitrectomy instrument positions. [0062] FIG. 4 —This Figure shows an example of prior art used in scleral marking procedures. [0063] FIG. 5 —This Figure shows a further example of prior art used in scleral marking procedures. [0064] FIG. 6 —This Figure shows a practical example of the Melki Marker. [0065] FIG. 7 —This Figure shows the image of the Melki Marker with pointer distances for different patients. [0066] FIG. 8 —This Figure is a further preferred embodiment of the Melki Marker invention using plastic or equal material and wherein the end-pointers are soaked in FDA approved ink, protected by thimbles and the vacuum sealed in see-through package.

The invention relates to opthalmology surgical procedures, and specifically to vitreous retinal surgical procedures for marking positions for incision/injection sites on the scleral surface of the eye. The types of ophthalmic vitreous surgical procedures for which are applicable include but not limited to, vitrectomies performed in hospital operating rooms and vitreous injections are routinely performed in doctor's offices for a variety of procedures to treat abnormal eye conditions. The invention discloses a range of scleral limbal marker for adult human patients, pediatric patients, and domestic and other animals. The invention discloses markers in materials capable of sterilization and for markers in materials suitable for disposal and packaged in vacuum sealed packages.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This patent application is a divisional application of U.S. patent application Ser. No. 11/506,619, filed Aug. 17, 2006, for Neural Stimulator for Increased Persistence, which is a divisional application of U.S. patent application Ser. No. 11/044,761, filed Jan. 26, 2006 for Neural Stimulator for Increased Persistence, the disclosures of which is incorporated herein by reference. GOVERNMENT RIGHTS NOTICE [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. FIELD OF THE INVENTION [0003] 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 [0004] 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. [0005] 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. [0006] 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. [0007] 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. [0008] 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. [0009] 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. [0010] 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. [0011] 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). [0012] 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. [0013] 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. [0014] 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. [0015] 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. [0016] 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. [0017] 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. [0018] The ability to perceive a constant image or image persistence is necessary to the design of a visual prosthesis. SUMMARY OF THE INVENTION [0019] 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. [0020] 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 [0021] FIG. 1 is a perspective view of the implanted portion of the preferred retinal prosthesis. [0022] FIG. 2 is a side view of the implanted portion of the preferred retinal prosthesis showing the fan tail in more detail. [0023] FIG. 3 depicts a flow chart showing the processing in the preferred embodiment. [0024] FIG. 4 depicts a typical perceptual pattern for a single electrode. [0025] FIG. 5 depicts a stimulation waveform train including interruption. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0026] 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. [0027] 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. [0028] 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. [0029] 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. [0030] 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 . [0031] 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 . [0032] 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 . [0033] 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. [0034] 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. [0035] 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. [0036] 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. [0037] 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. [0038] 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. [0039] 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 . [0040] 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. [0041] 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 The field of invention relates to golfing apparatus, and more particularly pertains to a new and improved golf ball retrieval apparatus wherein the same is arranged to project golf balls about a ground surface rearwardly onto receiving webs. 2. Description of the Prior Art The retrieval of golf balls typically found at golf courses, such as in driving ranges and the like, is a labor intensive, time consuming procedure typically associated in maintenance of a golf course. Prior art ball retrieval apparatus of various types have been utilized, but have heretofore not been specifically directed into the unique arrangement to retrieve golf balls relative to a golf green. For example, U.S. Pat. No. 4,077,533 to Meyer sets forth a tennis ball retrieving apparatus wherein tennis balls are directed rearwardly along a chute structure into a rearwardly positioned basket. U.S. Pat. No. 4,645,254 to Warden sets forth a portable golf ball retrieval tool wherein friction discs are arranged to engage golf balls therebetween. U.S. Pat. No. 3,995,759 to Hollrock, et al. sets forth a further example of a golf ball retrieval apparatus to engage golf balls between opposed disc-type structure that are deflected to secure a golf ball therebetween. As such, it may be appreciated that there continues to be a need for a new and improved golf ball retrieval apparatus as set forth by the instant invention which addresses both the problems of ease of use as well as effectiveness in construction and in this respect, the present invention substantially fulfills this need. SUMMARY OF THE INVENTION In view of the foregoing disadvantages inherent in the known types of golf ball retrieval apparatus now present in the prior art, the present invention provides a golf ball retrieval apparatus wherein the same is arranged to project golf balls rearwardly along a chute into receiving web structure positioned rearwardly of the chutes or ramp organization as utilized. As such, the general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new and improved golf ball retrieval apparatus which has all the advantages of the prior art golf ball retrieval apparatus and none of the disadvantages. To attain this, the present invention provides a rectilinear framework includes a plurality of rear wheels mounted to respective right and left axles, with the right axle including a rear axle pulley cooperative with a front pulley and drive belt to effect rotation of paddle wheels to traverse an underlying ground surface and project golf balls rearwardly along a chute structure onto associated fabric webs to contain the golf balls therewithin. My invention resides not in any one of these features per se, but rather in the particular combination of all of them herein disclosed and claimed and it is distinguished from the prior art in this particular combination of all of its structures for the functions specified. There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. Those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. 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 from a cursory inspection 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. It is therefore an object of the present invention to provide a new and improved golf ball retrieval apparatus which has all the advantages of the prior art golf ball retrieval apparatus and none of the disadvantages. It is another object of the present invention to provide a new and improved golf ball retrieval apparatus which may be easily and efficiently manufactured and marketed. It is a further object of the present invention to provide a new and improved golf ball retrieval apparatus which is of a durable and reliable construction. An even further object of the present invention is to provide a new and improved golf ball retrieval apparatus which is susceptible of a low cost of manufacture with regard to both materials and labor, and which accordingly is then susceptible of low prices of sale to the consuming public, thereby making such golf ball retrieval apparatus economically available to the buying public. Still yet another object of the present invention is to provide a new and improved golf ball retrieval apparatus which provides in the apparatuses and methods of the prior art some of the advantages thereof, while simultaneously overcoming some of the disadvantages normally associated therewith. These together with other objects of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: FIG. 1 is an isometric illustration of the instant invention. FIG. 2 is an orthographic top view of the instant invention. FIG. 3 is an orthographic side view of the instant invention. FIG. 4 is an orthographic frontal view of the instant invention. FIG. 5 is an isometric illustration of a modified aspect of the invention. FIG. 6 is an enlarged isometric illustration of section 6 as set forth in FIG. 5. FIG. 7 is an orthographic view, taken along the lines 7--7 of FIG. 6 in the direction indicated by the arrows. FIG. 8 is an isometric illustration of a modified framework structure utilized by the invention. FIG. 8a is an orthographic cross-sectional view of section 8a as set forth in FIG. 8. FIG. 9 is an orthographic top view of the framework structure as set forth in FIG. 8. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference now to the drawings, and in particular to FIGS. 1 to 9 thereof, a new and improved golf ball retrieval apparatus embodying the principles and concepts of the present invention and generally designated by the reference numeral 10 will be described. More specifically, the golf ball retrieval apparatus 10 of the instant invention essentially comprises a rectilinear framework 11, such as illustrated in FIG. 1, to include a right frame leg 12 spaced from and parallel a left frame leg 13 in a coextensive relationship. A forward frame leg 14 is spaced from and parallel a rear frame leg 19 that are in turn orthogonally oriented relative to the right and left frame legs 12 and 13. A mounting leg 15 extends orthogonally relative to the forward frame leg and is medially intersected relative thereto, and is formed witha forward terminal bifurcated leg end 16 to receive a latch pin 17 for securement of the organization relative to a desired tow vehicle such as atractor and the like (not shown). A central frame leg 18 arranged longitudinally aligned with the mounting leg 15 orthogonally bisects the forward and rear frame legs 14 and 19 respectively and is arranged parallel and medially of the right and left frame legs 12 and 13. A right axle 20 and a left axle 21 are arranged adjacent to and parallel the rear frame leg 19 and include respective right and left axle supports 20a and 21a rotatably mounting the right and left axles in a coaxially aligned relationship parallel to the rear frame leg 19. A right wheel 28 and a left wheel 29 are mounted respectively to the outer terminal ends of the right and left axles exteriorly of the right and left frame legs. Extending between respective right frame leg 12 and the central frame leg 18 is a right fabric first web 22 extending forwardly of the right axle 20, with a left fabric first web 23 extending forwardly of the left axle 21 between the central frame leg 18 and the left frame leg 13. A right fabric second web 24 extends upwardly relative to the right fabric first web 22, with a left fabric second web 25 extending upwardly relative to the left fabric first web 23. The right and left fabric first webs 22 and 23 define respective right and left pockets to receive golf balls projected thereto from a forwardly oriented set of respective right and left paddle blades 34 and 35, to be described in more detail below. The right guide plate 26 extends forwardly and downwardly relative to a forward edge of the right fabric first web 22, with a left guide plate 27 extending forwardly and downwardly relative to the left fabric first web 23, wherein the right and left guide plates 26 and 27 are coplanar relative to one another, and each include respective right and left guide plate chute side walls 26a and 27a to maintain guidance of golf balls ontothe chutes into the rearwardly oriented web pockets. The guide plates 26 and 27 extend downwardly positioned in a predetermined spaced relationshiprelative to the drive shaft axle 31 that is oriented in a parallel spaced relationship relative to the forward frame leg 14. The right and left paddle blades 34 and 35 are defined by a predetermined width substantiallyequal to the predetermined spacing defined between the guide plates 26 and 27 relative to the drive shaft axle 31. The drive shaft axle 31 includes adrive shaft axle pulley 32 coplanar with a right axle pulley 30 that is fixedly mounted relative to the right axle 20 to include a drive belt 33 to effect simultaneous rotation of the drive shaft axle 31 upon rotation of the right wheel 28. Right paddle blades 34 and left paddle blades 35 are mounted respectively between the central frame leg 18 and the respective right and left frame legs 12 and 13 in an equally spaced relationship about the drive shaft axle 31. The blades are arranged in a coplanar relationship relative to a drive shaft axle axis defined by the drive shaft axle 31. A respective right and left caster wheel 36 and 37 are mounted adjacent to and below the forward frame leg 14 to maintain the mounting leg 15 in a spaced relationship relative to an underlying ground surface for the organization when not in use to permit ease of lifting and maneuverabilityof the organization. Reference to FIGS. 5-7 illustrate the use of a support post 38 mounted orthogonally relative to the rectilinear framework 11, including a plurality of solar panels 39 in cooperation with solar collectors 40 to effect selective illumination of illumination bulbs 41 contained within a housing and operative through a flash unit 42 to activate flashing of the unit to provide enhanced visual orientation of the organization during use. The organization as set forth in FIGS. 8 and 9 further illustrate the use of containers 44 mounted upon a support plate 43 that is positioned between the right and left fabric first webs 22 and 23 and the rear frame leg 19. The containers 44 are arranged to provide for storage of golf balls contained within the pockets defined by the first right and left fabric webs 22 and 23 defined by the modified framework 11a. The blades 34 and 35, as illustrated in the modified organization in the FIGS. 8 and 9, include a series of threaded, spaced bores 46 mounted into each of the blades directed into the blades from the blades' outer edges 45. The blades outer edges 45 include the threaded spaced bores 46 to include threaded plugs 47 to be positioned therewithin to permit insertionof the spring fingers 48 within each plug. Each of the spring fingers includes a polymeric "U" shaped extension 49. The spring fingers 48 are themselves rigid, and wherein the polymeric "U" shaped extensions are of agenerally resilient construction and extend toward the forward frame leg 14to permit their reflection and enhance projection of golf balls as the organization is directed through turf and grass. Should the organization be used relative to an underlying rigid surface, such as concrete and the like, the plugs are removed from their associated bores relative to each of the blades to permit use of the blades alone in the retrieval of golf ball members. It is noted that standardized dimension of a golf ball is 1.75 inches and accordingly, the threaded spaced bores 46 are spaced apart a predetermineddistance that is less than 1.75 inches to insure engagement of a plurality of the spring fingers and the associated forwardly projecting "U" shaped extensions relative to each golf ball engaged by the fingers. As to the manner of usage and operation of the instant invention, the same should be apparent from the above disclosure, and accordingly no further discussion relative to the manner of usage and operation of the instant invention shall be provided. 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 ofoperation, assembly and use, are deemed readily apparent and obvious to oneskilled 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. 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 maybe resorted to, falling within the scope of the invention.

A rectilinear framework includes a plurality of rear wheels mounted to respective right and left axles, with the right axle including a rear axle pulley cooperative with a front pulley and drive belt to effect rotation of paddle wheels to traverse an underlying ground surface and project golf balls rearwardly along a chute structure onto associated fabric webs to contain the golf balls therewithin.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a national phase filing under 35 U.S.C. §371 of international application number PCT/US2005/029637, filed Aug. 18, 2005, which claims priority from provisional application No. 60/602,825, filed Aug. 19, 2004 and provisional application No. 60/694,067, filed Jun. 24, 2005. The entire content of each of these prior applications is incorporated herein by reference in its entirety. TECHNICAL FIELD The invention relates to protein chemistry, molecular biology, and neurobiology. BACKGROUND Neublastin, also known as Artemin and Enovin, is a 24-kDa homodimeric secreted protein that promotes the survival of neurons of the peripheral and central nervous system such as dopaminergic neurons (Baudet et al., 2000, Development, 127:4335; Rosenblad et al., 2000, Mol. Cell Neurosci., 15(2):199; GenBank AF120274). The gene encoding neublastin has been cloned and sequenced (Roseblad et al., 2000, Mol. Cell Neurosci., 15(2):199; Baloh et al., Neuron, 21:1291). Neublastin is a member of the glial cell line-derived neurotrophic factor (GDNF) ligand family. At the cellular level, GDNF members activate the receptor tyrosine kinase, RET. RET associates with a co-receptor, GDNF family receptor alpha (GFRalpha), a glycosylphosphatidyl inositol (GPI) linked membrane protein that provides ligand specificity for RET. Four GFRalphas are known (GFRalpha1-4). Neublastin binds to GFRalpha3 together with RET forming a ternary signaling complex (Baudet et al. 2000, Development, 127:4335; Baloh et al., 1998, Neuron, 21:1291), which is localized predominantly on nociceptive sensory neurons (Orozco et al., 2001, Eur. J. Neurosci., 13(11):2177). These neurons detect pain and injury. Thus, neublastin has clinical application in the general treatment of neuropathy and more specifically in the treatment of neuropathic pain. Neublastin and the other GDNF family members are members of the transforming growth factor beta (TGF beta) superfamily and thus, are characterized by the presence of seven conserved cysteine residues with similar spacing which form the structure of a cysteine knot (Saarma, 1999, Microsc. Res. Tech., 45:292). Each monomer contains two disulfide bonds that form a closed loop structure encircling the third disulfide to form a tight knot structure. The seventh cysteine contained within each monomer forms an intermolecular disulfide bond, covalently linking the monomers to form the final dimer product (Rattenholl et al 2000, J. Mol. Biol., 305:523). TGF beta family members are synthesized as pre pro proteins that eventually are secreted as a mature homodimer after cleavage of the signal peptide and pro-domain (see e.g. Rattenholl, et al., 2000, J. Mol. Biol., 305:523; Fairlie et al., 2001, J. Biol. Chem., 276(20): 16911). Both the signal peptide and pro-domain mediate proper secretion for TGF beta family members (Rattenholl et al., 2000, J. Mol. Biol., 305:523; Rattenholl et al., 2001, Eur. J. Biochem., 268:3296). SUMMARY The invention is based, at least in part, on the discovery that Neublastin binds to heparin sulfate and that particular amino acid residues in the Neublastin polypeptide contribute to this binding event. Substitution of selected amino acid residues was found to decrease heparin binding by variant Neublastin polypeptides and increase bioactivity and bioavailability of the variants. In one aspect, the invention features a polypeptide containing an amino acid sequence that is at least 80% identical to amino acids 15-113 of SEQ ID NO:1, wherein the amino acid sequence contains at least one amino acid substitution, relative to SEQ ID NO:1, selected from the group consisting of: (i) an amino acid other than arginine at the position corresponding to position 48 of SEQ ID NO:1 (e.g., the arginine is substituted with a non-conservative amino acid residue such as glutamic acid); (ii) an amino acid other than arginine at the position corresponding to position 49 of SEQ ID NO:1 (e.g., the arginine is substituted with a non-conservative amino acid residue such as glutamic acid); and (iii) an amino acid other than arginine at the position corresponding to position 51 of SEQ ID NO:1 (e.g., the arginine is substituted with a non-conservative amino acid residue such as glutamic acid). The polypeptide, when dimerized, binds to a complex containing GFRalpha3 and RET. In some embodiments, the amino acid sequence contains amino acids other than arginine at the positions corresponding to position 48 and position 49 of SEQ ID NO:1. For example, the arginine residue at position 48 and the arginine reside at position 49 of SEQ ID NO:1 can be substituted with non-conservative amino acid residues (e.g., glutamic acid). In some embodiments, the amino acid sequence is at least 90%, at least 95%, or at least 98% identical to amino acids 15-113 of SEQ ID NO:1. Also disclosed is a polypeptide containing amino acids 15-113 of SEQ ID NO:2, amino acids 15-113 of SEQ ID NO:3, amino acids 15-113 of SEQ ID NO:4, amino acids 15-113 of SEQ ID NO:5, amino acids 15-113 of SEQ ID NO:8, or amino acids 15-113 of SEQ ID NO:9. In some embodiments, the polypeptide contains amino acids 10-113 of SEQ ID NO:2, amino acids 10-113 of SEQ ID NO:3, amino acids 10-113 of SEQ ID NO:4, amino acids 10-113 of SEQ ID NO:5, amino acids 10-113 of SEQ ID NO:8, or amino acids 10-113 of SEQ ID NO:9. In some embodiments, the polypeptide contains the amino acid sequence of SEQ ID NO:2, the amino acid sequence of SEQ ID NO:3, the amino acid sequence of SEQ ID NO:4, the amino acid sequence of SEQ ID NO:5, the amino acid sequence of SEQ ID NO:8, or the amino acid sequence of SEQ ID NO:9. Also disclosed is a polypeptide containing an amino acid sequence at least 80% identical to amino acids 15-113 of SEQ ID NO:1, wherein the amino acid sequence comprises at least one amino acid substitution, relative to SEQ ID NO:1, selected from the group consisting of: (i) an amino acid other than serine at the position corresponding to position 20 of SEQ ID NO:1 (e.g., the serine is substituted with a non-conservative amino acid residue); (ii) an amino acid other than glutamine at the position corresponding to position 21 of SEQ ID NO:1 (e.g., the glutamine is substituted with a non-conservative amino acid residue); (iii) an amino acid other than histidine at the position corresponding to position 32 of SEQ ID NO:1 (e.g., the histidine is substituted with a non-conservative amino acid residue); (iv) an amino acid other than arginine at the position corresponding to position 33 of SEQ ID NO:1 (e.g., the arginine is substituted with a non-conservative amino acid residue); (v) an amino acid other than arginine at the position corresponding to position 39 of SEQ ID NO:1 (e.g., the arginine is substituted with a non-conservative amino acid residue); (vi) an amino acid other than serine at the position corresponding to position 46 of SEQ ID NO:1 (e.g., the serine is substituted with a non-conservative amino acid residue); (vii) an amino acid other than arginine at the position corresponding to position 68 of SEQ ID NO:1 (e.g., the arginine is substituted with a non-conservative amino acid residue); (viii) an amino acid other than glycine at the position corresponding to position 72 of SEQ ID NO:1 (e.g., the glycine is substituted with a non-conservative amino acid residue); (ix) an amino acid other than serine at the position corresponding to position 73 of SEQ ID NO:1 (e.g., the serine is substituted with a non-conservative amino acid residue); and (x) an amino acid other than valine at the position corresponding to position 94 of SEQ ID NO:1 (e.g., the valine is substituted with a non-conservative amino acid residue). The polypeptide, when dimerized, binds to a complex containing GFRalpha3 and RET. In some embodiments, the amino acid sequence is at least 90%, at least 95%, or at least 98% identical to amino acids 15-113 of SEQ ID NO:1. Also disclosed is a polypeptide containing an amino acid sequence at least 80% identical to SEQ ID NO:1, wherein the amino acid sequence comprises at least one amino acid substitution, relative to SEQ ID NO:1, selected from the group consisting of: (i) an amino acid other than arginine at the position corresponding to position 7 of SEQ ID NO:1 (e.g., the arginine is substituted with a non-conservative amino acid residue such as glutamic acid); (ii) an amino acid other than arginine at the position corresponding to position 9 of SEQ ID NO:1 (e.g., the arginine is substituted with a non-conservative amino acid residue such as glutamic acid); and (iii) an amino acid other than arginine at the position corresponding to position 14 of SEQ ID NO:1 (e.g., the arginine is substituted with a non-conservative amino acid residue such as glutamic acid). The polypeptide, when dimerized, binds to a complex containing GFRalpha3 and RET. In some embodiments, the amino acid sequence is at least 90%, at least 95%, or at least 98% identical to SEQ ID NO:1. The invention also features conjugates containing a polypeptide described herein conjugated to a non-naturally occurring polymer. An exemplary polymer is a water-soluble synthetic polymer such as a polyalkylene glycol (e.g., polyethylene glycol). The invention also features a fusion protein containing a polypeptide described herein and a heterologous amino acid sequence. The invention also features a dimer containing two of the polypeptides, conjugates, or fusion proteins described herein. The invention also features a pharmaceutical composition containing a polypeptide, dimer, conjugate, or fusion protein described herein and a pharmaceutically acceptable carrier or excipient. Also disclosed is a nucleic acid containing a sequence that encodes a polypeptide described herein, an expression vector containing the nucleic acid, and a cell containing the expression vector. Also disclosed is a method of making a polypeptide, the method including the following steps: (i) providing a cell containing an expression vector containing a nucleic acid encoding a polypeptide described herein, and (ii) culturing the cell under conditions that permit expression of the nucleic acid. The invention also features a method of treating or preventing a nervous system disorder in a mammal by administering to the mammal a therapeutically effective amount of a polypeptide, dimer, conjugate, fusion protein, or pharmaceutical composition described herein. The invention also features a method of treating neuropathic pain in a mammal by administering to the mammal a therapeutically effective amount of a polypeptide, dimer, conjugate, fusion protein, or pharmaceutical composition described herein. The invention also features a method of activating the RET receptor in a mammal by administering to the mammal an effective amount of a polypeptide, dimer, conjugate, fusion protein, or pharmaceutical composition described herein. An advantage of selected variant Neublastin polypeptides described herein is that they have decreased heparin binding ability as compared to wild type Neublastin. Decreased heparin binding results in a decreased clearance of the variant polypeptide in vivo. A variant Neublastin polypeptide having substitutions at amino acid positions 48 and 49 was unexpectedly found to have greatly deceased heparin binding ability and greatly increased potency and bioavailability as compared to single amino acid mutants and/or wild type Neublastin. For example, the double mutant was found to exhibit an approximately 185-fold increase in serum exposure as compared to wild type Neublastin. In addition, this double mutant was found to exhibit an over five fold increase in expression in vitro as compared to wild type Neublastin, thereby facilitating large scale production of the protein. The advantages and unexpected properties of the variant Neublastin polypeptides allow for treatment of subjects using lower doses of protein and/or allow for lengthened intervals between administrations (as compared to treatments with the wild type protein). 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 this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the exemplary methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present application, including definitions, will control. The materials, methods, and examples are illustrative only and not intended to be limiting. Other features and advantages of the invention will be apparent from the following detailed description, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an alignment of wild type human (SEQ ID NO:10), mouse (SEQ ID NO:11), and rat (SEQ ID NO:12) pre pro Neublastin polypeptides. The left and right vertical lines indicate, respectively, the start of the mature 113 amino and 104 amino acid forms. The RRXR heparin binding motif is boxed. FIG. 2A depicts a cationic elution profile of wild-type Neublastin (Peak D) and three single Arg-to-Glu substitution mutants (Peaks A, B, and C) (sloping line represents the theoretical sodium chloride concentration for any given volume eluted from the column). Data are a representation of the OD280 values of the eluted sample. FIG. 2B depicts a Heparin Sepharose elution profile of wild-type Neublastin (Peak H) and three single Arg-to-Glu substitution mutants (Peaks E, F, and G) (sloping line represents the theoretical sodium chloride concentration for any given volume eluted from the column). Data are a representation of the OD280 values of the eluted sample. FIGS. 3A-3B are photographs depicting SDS/PAGE of wild-type Neublastin following anionic chromatography in the presence (2A) or absence (2 B) of heparin. FIG. 4 is a graph depicting the results of a Neublastin CHO cell binding assay. Following SDS/PAGE and desitometry, OD values of Neublastin wild type and Arg48E mutant bands were plotted against the heparin concentration in each sample. FIG. 5 is a graph depicting the results of a heparin binding ELISA using wild type human NBN113, wild type human NBN104, Arg48E, Arg49E, Arg51E, and Arg48, 49E. FIG. 6 is a graph depicting the results of KIRA analysis of wild type rat NBN113, Arg51E, Arg48E, Arg49E, and rat NBN113. FIG. 7A is a graph depicting the results of KIRA analysis of wild type human Neublastin and Arg48,49E mutant human Neublastin (113 amino acid form). FIG. 7B is a graph depicting the results of KIRA analysis of wild type human Neublastin, Arg48,49E mutant human Neublastin (104 amino acid form), Arg48,51E human Neublastin (113 amino acid form), and Arg49,51E human Neublastin (113 amino acid form). FIG. 8 is a graph depicting the results of ternary complex analysis of wild type human Neublastin, Arg48E, Arg49E, Arg51E, Arg48,49E, and Arg48,49,51E Neublastin forms. FIG. 9 is a graph depicting the results of ternary complex analysis of wild type Neublastin, Arg48E, Arg49E, Arg51E, Arg48,49E, and Arg48,49,51E Neublastin forms. FIG. 10 is a graph depicting the results of pharmacokinetics analysis of wild type Neublastin and Arg48,49E following a single bolus 7 mg/kg subcutaneous injection (Neublastin plasma concentrations were determined using the Neublastin detection ELISA). FIG. 11 is a graph depicting the results of pharmacokinetics analysis of wild type Neublastin and Arg48,49E following a single bolus 1 mg/kg intravenous injection (Neublastin plasma concentrations were determined using the Neublastin detection ELISA). FIG. 12 is a graph depicting the results of pharmacokinetics analysis of 2×10K PEGylated Arg48,49E Neublastin following a single bolus subcutaneous 7 mg/kg (data presented are extrapolated down to 1 mg/kg) injection and 2×10K PEGylated Arg48,49E Neublastin administered intravenously at 1 mg/kg (Neublastin plasma concentrations were determined using the Neublastin detection ELISA). FIG. 13 is a graph depicting relative Neublastin expression levels in CHO cells transfected with plasmids encoding wild type Neublastin or Arg48,49E. FIG. 14 is a graph depicting relative Neublastin expression levels in the leading Arg48,49E double mutant transfected CHO cell lines and a leading wild type Neublastin transfected CHO cell line. DETAILED DESCRIPTION The present invention provides variant Neublastin polypeptides having substitutions at selected amino acid residues. As disclosed in the accompanying Examples, specific residues in the wild type Neublastin polypeptide have been found to be important for heparin binding. Because heparin binding is believed to contribute to clearance of Neublastin in vivo, substitutions at one or more of these specific residues are expected to decrease heparin binding and thereby increase serum exposure of the variant polypeptide. Variant Neublastin Polypeptides Mature wild type human Neublastin is 113 amino acids in length and has the following amino acid sequence: AGGPGSRARAAGARGCRLRSQLVPVRALGLGHRSDELVRFRFCSGSCRRARSPHDLSLASLLGAGALRPPPGSRPVSQPCCRPTRYEAVSFMDVNSTWRTVDRLSATACGCLG (SEQ ID NO:1). Disclosed herein are polypeptides that have substitutions at one or more selected amino acid residues of the Neublastin polypeptide. Mutations at one or more of these residues are expected to result in a variant Neublastin polypeptide having reduced or absent heparin binding ability as compared to wild type Neublastin. A variant Neublastin polypeptide contains an amino acid substitution, relative to SEQ ID NO:1, at (i) an arginine residue at one or more of positions 48, 49, or 51, and/or (ii) one or more of Ser 46, Ser 73, Gly 72, Arg 39, Gln 21, Ser 20, Arg 68, Arg 33, His 32, Val 94, Arg 7, Arg 9, or Arg 14. Unless otherwise stated, any reference herein to a Neublastin amino acid reside by position number refers to the numbering of residues relative to SEQ ID NO:1. A Neublastin amino acid residue designated for substitution (e.g., an arginine residue at position 48, 49, and/or 51) can be substituted with a non-conservative amino acid residue (e.g., glutamic acid) or a conservative or amino acid residue. As detailed in the accompanying Examples, substitution of Arg48, Arg 49, and/or Arg 51 with a non-conservative amino acid can result in a variant Neublastin polypeptide that has reduced heparin binding activity but retained (or even enhanced) Neublastin biological activity. Exemplary amino acids that can be substituted an amino acid residue identified herein (e.g., an arginine residue at position 48, 49, and/or 51) include glutamic acid, aspartic acid, and alanine. A biologically active variant Neublastin polypeptide, when dimerized, binds to a ternary complex containing GFRalpha3 and RET. Any method for detecting binding to this complex can be used to evaluate the biological activity a variant Neublastin polypeptide. Exemplary assays for detecting the ternary complex-binding ability of a variant Neublastin polypeptide are described in WO00/001815 and in Example 7. A variant Neublastin polypeptide can also be assessed to evaluate its ability to trigger the Neublastin signaling cascade. For example, the Kinase Receptor Activation (KIRA) assay described in Example 6 can be used to assess the ability of a variant Neublastin polypeptide to induce RET autophosphorylation (See also, Sadick et al., 1996, Anal. Biochem., 235(2):207). In addition to the specific amino acid substitutions identified herein, a variant Neublastin polypeptide can also contain one or more additions, substitutions, and/or deletions at other amino acid positions, as detailed in the following sections. A variant Neublastin polypeptide can, in addition to having one or more of the amino acid substitutions described herein, also vary in length. Although the mature human Neublastin polypeptide (SEQ ID NO:1) consists of the carboxy terminal 113 amino acids of pre pro Neublastin, not all of the 113 amino acids are required to achieve useful Neublastin biological activity. Amino terminal truncation is permissible. Thus, a variant Neublastin polypeptide can contain one or more of the amino acid substitutions described herein in the context of the carboxy terminal 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, or 113 amino acids of SEQ ID NO:1 (i.e., its length can be 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, or 113 amino acids). A variant Neublastin polypeptide can, in addition to having one or more of the amino acid substitutions described herein (and optionally having a truncation described herein), also vary in sequence. In particular, certain amino acid substitutions can be introduced into the Neublastin sequence without appreciable loss of a Neublastin biological activity. In exemplary embodiments, a polypeptide (i) contains one or more of the amino acid substitutions described herein, and (ii) is at least 70%, 80%, 85%, 90%, 95%, 98% or 99% identical to SEQ ID NO:1 (or 70%, 80%, 85%, 90%, 95%, 98% or 99% identical to amino acids 15-113 of SEQ ID NO:1). A variant Neublastin polypeptide differing in sequence from SEQ ID NO:1 (or differing in sequence from amino acids 15-113 of SEQ ID NO:1) may include one or more conservative amino acid substitutions, one or more non-conservative amino acid substitutions, and/or one or more deletions or insertions. FIG. 1 is an alignment of the wild type human, mouse, and rat pre pro Neublastin polypeptides. The vertical lines in FIG. 1 indicate the start of the mature 113 amino acid form (left vertical line) and 104 amino acid form (right vertical line) of Neublastin. The RRXR heparin binding motif is boxed. This alignment of naturally occurring, bioactive forms of Neublastin indicates specific exemplary residues (i.e., those that are not conserved among the human, mouse, and rat forms) that can be substituted without eliminating bioactivity. Percent identity between amino acid sequences can be determined using the BLAST 2.0 program. Sequence comparison can be performed using an ungapped alignment and using the default parameters (Blossom 62 matrix, gap existence cost of 11, per residue gap cost of 1, and a lambda ratio of 0.85). The mathematical algorithm used in BLAST programs is described in Altschul et al., 1997, Nucleic Acids Research 25:3389-3402. A conservative substitution is the substitution of one amino acid for another with similar characteristics. Conservative substitutions include substitutions within the following groups: valine, alanine and glycine; leucine, valine, and isoleucine; aspartic acid and glutamic acid; asparagine and glutamine; serine, cysteine, and threonine; lysine and arginine; and phenylalanine and tyrosine. The non-polar hydrophobic amino acids include alanine, leucine, isoleucine, valine, proline, phenylalanine, tryptophan and methionine. The polar neutral amino acids include glycine, serine, threonine, cysteine, tyrosine, asparagine and glutamine. The positively charged (basic) amino acids include arginine, lysine and histidine. The negatively charged (acidic) amino acids include aspartic acid and glutamic acid. Any substitution of one member of the above-mentioned polar, basic or acidic groups by another member of the same group can be deemed a conservative substitution. Non-conservative substitutions include those in which (i) a residue having an electropositive side chain (e.g., Arg, His or Lys) is substituted for, or by, an electronegative residue (e.g., Glu or Asp), (ii) a hydrophilic residue (e.g., Ser or Thr) is substituted for, or by, a hydrophobic residue (e.g., Ala, Leu, Ile, Phe or Val), (iii) a cysteine or proline is substituted for, or by, any other residue, or (iv) a residue having a bulky hydrophobic or aromatic side chain (e.g., Val, Ile, Phe or Trp) is substituted for, or by, one having a smaller side chain (e.g., Ala, Ser) or no side chain (e.g., Gly). Exemplary variant Neublastin polypeptides are disclosed in Table 1. Amino acid residues of the variant Neublastin polypeptides that are mutated as compared to the corresponding wild type position are bolded and underlined. In addition, the Neublastin polypeptide (113, 99, or 104 amino acids in length) used as the background for the substitution is depicted in Table 1. TABLE 1 Variant Neublastin Polypeptides Position Length of SEQ ID NO Substituted Polypeptide Amino Acid Sequence 2 Arg 48 113 AGGPGSRARAAGARGCRLRSQLVPVRA LGLGHRSDELVRFRFCSGSC E RARSPHD LSLASLLGAGALRPPPGSRPVSQPCCRPT RYEAVSFMDVNSTWRTVDRLSATACGC LG 3 Arg 49 113 AGGPGSRARAAGARGCRLRSQLVPVRA LGLGHRSDELVRFRFCSGSCR E ARSPHD LSLASLLGAGALRPPPGSRPVSQPCCRPT RYEAVSFMDVNSTWRTVDRLSATACGC LG 4 Arg 51 113 AGGPGSRARAAGARGCRLRSQLVPVRA LGLGHRSDELVRFRFCSGSCRRA E SPHD LSLASLLGAGALRPPPGSRPVSQPCCRPT RYEAVSFMDVNSTWRTVDRLSATACGC LG 5 Arg 48 and 113 AGGPGSRARAAGARGCRLRSQLVPVRA Arg 49 LGLGHRSDELVRFRFCSGSC EE ARSPHD LSLASLLGAGALRPPPGSRPVSQPCCRPT RYEAVSFMDVNSTWRTVDRLSATACGC LG 6 Arg 48 and 99 GCRLRSQLVPVRALGLGHRSDELVRFRF Arg 49 CSGSC EE ARSPHDLSLASLLGAGALRPPP GSRPVSQPCCRPTRYEAVSFMDVNSTW RTVDRLSATACGCLG 7 Arg 48 and 104 AAGARGCRLRSQLVPVRALGLGHRSDE Arg 49 LVRFRFCSGSC EE ARSPHDLSLASLLGA GALRPPPGSRPVSQPCCRPTRYEAVSFM DVNSTWRTVDRLSATACGCLG 8 Arg 49 and 113 AGGPGSRARAAGARGCRLRSQLVPVRA Arg 51 LGLGHRSDELVRFRFCSGSCR E A E SPHD LSLASLLGAGALRPPPGSRPVSQPCCRPT RYEAVSFMDVNSTWRTVDRLSATACGC LG 9 Arg 48 and 113 AGGPGSRARAAGARGCRLRSQLVPVRA Arg 51 LGLGHRSDELVRFRFCSGSC E RA E SPHD LSLASLLGAGALRPPPGSRPVSQPCCRPT RYEAVSFMDVNSTWRTVDRLSATACGC LG A variant Neublastin polypeptide can be optionally coupled to a polymer (e.g., a polyalkylene glycol moiety such as a polyethylene glycol moiety). In some embodiments, the polymer is coupled to the polypeptide at a site on the Neublastin polypeptide that is an N terminus. In some embodiments, the variant Neublastin polypeptide includes at least one amino acid substitution with respect to SEQ ID NO:1 (or with respect to amino acids 15-113 of SEQ ID NO:1), which provides an internal polymer conjugation site to which a polymer can be conjugated. In some embodiments, the polymer is coupled to the variant Neublastin polypeptide at a residue (numbered in accordance with the sequence of SEQ ID NO:1) selected from the group consisting of position 14, position 39, position 68, and position 95. Exemplary Neublastin variants that provide internal polymer conjugation sites are described in WO 02/060929 and WO 04/069176 (the contents of which are incorporated herein by reference). A polypeptide can optionally contain heterologous amino acid sequences in addition to a variant Neublastin polypeptide. “Heterologous,” as used when referring to an amino acid sequence, refers to a sequence that originates from a source foreign to the particular host cell, or, if from the same host cell, is modified from its original form. Exemplary heterologous sequences include a heterologous signal sequence (e.g., native rat albumin signal sequence, a modified rat signal sequence, or a human growth hormone signal sequence) or a sequence used for purification of a variant Neublastin polypeptide (e.g., a histidine tag). Neublastin polypeptides can be isolated using methods known in the art. Naturally occurring Neublastin polypeptides can be isolated from cells or tissue sources using standard protein purification techniques. Alternatively, mutated Neublastin polypeptides can be synthesized chemically using standard peptide synthesis techniques. The synthesis of short amino acid sequences is well established in the peptide art. See, e.g., Stewart, et al., Solid Phase Peptide Synthesis (2d ed., 1984). In some embodiments, variant Neublastin polypeptides are produced by recombinant DNA techniques. For example, a nucleic acid molecule encoding a variant Neublastin polypeptide can be inserted into a vector, e.g., an expression vector, and the nucleic acid can be introduced into a cell. Suitable cells include, e.g., mammalian cells (such as human cells or CHO cells), fungal cells, yeast cells, insect cells, and bacterial cells. When expressed in a recombinant cell, the cell is preferably cultured under conditions allowing for expression of a variant Neublastin polypeptide. The variant Neublastin polypeptide can be recovered from a cell suspension if desired. As used herein, “recovered” means that the mutated polypeptide is removed from those components of a cell or culture medium in which it is present prior to the recovery process. The recovery process may include one or more refolding or purification steps. Variant Neublastin polypeptides can be constructed using any of several methods known in the art. One such method is site-directed mutagenesis, in which a specific nucleotide (or, if desired a small number of specific nucleotides) is changed in order to change a single amino acid (or, if desired, a small number of predetermined amino acid residues) in the encoded variant Neublastin polypeptide. Many site-directed mutagenesis kits are commercially available. One such kit is the “Transformer Site Directed Mutagenesis Kit” sold by Clontech Laboratories (Palo Alto, Calif.). Pharmaceutical Compositions A variant Neublastin polypeptide can be incorporated into a pharmaceutical composition containing a therapeutically effective amount of the polypeptide and one or more adjuvants, excipients, carriers, and/or diluents. Acceptable diluents, carriers and excipients typically do not adversely affect a recipient's homeostasis (e.g., electrolyte balance). Acceptable carriers include biocompatible, inert or bioabsorbable salts, buffering agents, oligo- or polysaccharides, polymers, viscosity-improving agents, preservatives and the like. One exemplary carrier is physiologic saline (0.15 M NaCl, pH 7.0 to 7.4). Another exemplary carrier is 50 mM sodium phosphate, 100 mM sodium chloride. Further details on techniques for formulation and administration of pharmaceutical compositions can be found in, e.g., REMINGTON'S PHARMACEUTICAL SCIENCES (Maack Publishing Co., Easton, Pa.). Administration of a pharmaceutical composition containing a variant Neublastin polypeptide can be systemic or local. Pharmaceutical compositions can be formulated such that they are suitable for parenteral and/or non-parenteral administration. Specific administration modalities include subcutaneous, intravenous, intramuscular, intraperitoneal transdermal, intrathecal, oral, rectal, buccal, topical, nasal, ophthalmic, intra-articular, intra-arterial, sub-arachnoid, bronchial, lymphatic, vaginal, and intra-uterine administration. Formulations suitable for parenteral administration conveniently contain a sterile aqueous preparation of the variant Neublastin polypeptide, which preferably is isotonic with the blood of the recipient (e.g., physiological saline solution). Formulations may be presented in unit-dose or multi-dose form. An exemplary formulation contains a variant Neublastin polypeptide described herein and the following buffer components: sodium succinate (e.g., 10 mM); NaCl (e.g., 75 mM); and L-arginine (e.g., 100 mM). Formulations suitable for oral administration may be presented as discrete units such as capsules, cachets, tablets, or lozenges, each containing a predetermined amount of the variant Neublastin polypeptide; or a suspension in an aqueous liquor or a non-aqueous liquid, such as a syrup, an elixir, an emulsion, or a draught. Therapeutically effective amounts of a pharmaceutical composition may be administered to a subject in need thereof in a dosage regimen ascertainable by one of skill in the art. For example, a composition can be administered to the subject, e.g., systemically at a dosage from 0.01 μg/kg to 1000 μg/kg body weight of the subject, per dose. In another example, the dosage is from 1 μg/kg to 100 μg/kg body weight of the subject, per dose. In another example, the dosage is from 1 μg/kg to 30 μg/kg body weight of the subject, per dose, e.g., from 3 μg/kg to 10 μg/kg body weight of the subject, per dose. In order to optimize therapeutic efficacy, a variant Neublastin polypeptide is first administered at different dosing regimens. The unit dose and regimen depend on factors that include, e.g., the species of mammal, its immune status, the body weight of the mammal. Typically, protein levels in tissue are monitored using appropriate screening assays as part of a clinical testing procedure, e.g., to determine the efficacy of a given treatment regimen. The frequency of dosing for a variant Neublastin polypeptide is within the skills and clinical judgement of physicians. Typically, the administration regime is established by clinical trials which may establish optimal administration parameters. However, the practitioner may vary such administration regimes according to the subject's age, health, weight, sex and medical status. The frequency of dosing may also vary between acute and chronic treatments for neuropathy. In addition, the frequency of dosing may be varied depending on whether the treatment is prophylactic or therapeutic. Methods of Treatment Variant Neublastin polypeptides are useful for modulating metabolism, growth, differentiation, or survival of a nerve or neuronal cell. In particular, variant Neublastin polypeptides can be used to treat or alleviate a disorder or disease of a living animal, e.g., a human, which disorder or disease is responsive to the activity of a neurotrophic agent. The variant Neublastin polypeptides disclosed herein (and pharmaceutical compositions comprising same) can be used in methods for treating a disorder characterized by damage to sensory neurons or retinal ganglion cells, including neurons in the dorsal root ganglia or in any of the following tissues: the geniculate, petrosal and nodose ganglia; the vestibuloacoustic complex of the eighth cranial nerve; the ventrolateral pole of the maxillomandibular lobe of the trigeminal ganglion; and the mesencephalic trigeminal nucleus. In some embodiments, sensory and/or autonomic system neurons can be treated. In particular, nociceptive and mechanoreceptive neurons can be treated, more particularly A-delta fiber, C-fiber and A-beta fiber neurons. In addition, sympathetic and parasympathetic neurons of the autonomic system can be treated. In some embodiments, motor neuron diseases such as amyotrophic lateral sclerosis (“ALS”) and spinal muscular atrophy can be treated. In other embodiments, the variant Neublastin polypeptides can be used to enhance nerve recovery following traumatic injury. Alternatively, or in addition, a nerve guidance channel with a matrix containing polymer-conjugated Neublastin polypeptides, or fusion or conjugates of mutated Neublastin polypeptides can be used. Such nerve guidance channels are disclosed, e.g., U.S. Pat. No. 5,834,029. In some embodiments, the variant Neublastin polypeptides (and pharmaceutical compositions comprising same) are used in the treatment of various disorders in the eye, including photoreceptor loss in the retina in patients afflicted with macular degeneration, retinitis pigmentosa, glaucoma, and similar diseases. In some embodiments, the variant Neublastin polypeptides (and pharmaceutical compositions comprising same) are used for treating neuropathic pain, for treating tactile allodynia, for reducing loss of pain sensitivity associated with neuropathy, for treating viral infections and viral-associated neuropathies, for treating painful diabetic neuropathy, and for treating nervous system disorders. The methods are discussed in detail in the following subsections. 1. Treatment of Neuropathic Pain The variant Neublastin polypeptides disclosed herein (and pharmaceutical compositions comprising same) can be used in methods for treating neuropathic pain in a subject comprising administering to the subject an effective amount of a variant Neublastin polypeptide either alone, or by also administering to the subject an effective amount of an analgesia-inducing compound selected from the group consisting of opioids, anti-arrhythmics, topical analgesics, local anaesthetics, anticonvulsants, antidepressants, corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS). In one embodiment, the analgesia-inducing compound is an anticonvulsant. In another embodiment, the analgesia-inducing compound is gabapentin ((1-aminomethyl)cyclohexane acetic acid) or pregabalin (S-(+)-4-amino-3-(2-methylpropyl)butanoic acid). The variant Neublastin polypeptides disclosed herein (and pharmaceutical compositions comprising same) can be used in the treatment of pain associated with peripheral neuropathies. Among the peripheral neuropathies which can be treated are trauma-induced neuropathies, e.g., those caused by physical injury or disease state, physical damage to the brain, physical damage to the spinal cord, stroke associated with brain damage, and neurological disorders related to neurodegeneration. The variant Neublastin polypeptides disclosed herein (and pharmaceutical compositions comprising same) can be used in the treatment of a number of peripheral neuropathies, including: (a) trauma-induced neuropathies, (b) chemotherapy-induced neuropathies, (c) toxin-induced neuropathies (including but not limited to neuropathies induced by alcoholism, vitamin B6 intoxication, hexacarbon intoxication, amiodarone, chloramphenicol, disulfiram, isoniazide, gold, lithium, metronidazole, misonidazole, nitrofurantoin), (d) drug-induced neuropathies, including therapeutic drug-induced neuropathic pain (such as caused by anti-cancer agents, particularly anti-cancer agents selected from the group consisting of taxol, taxotere, cisplatin, nocodazole, vincristine, vindesine and vinblastine; and such as caused by anti-viral agents, particularly anti-viral agents selected from the group consisting of ddI, DDC, d4T, foscarnet, dapsone, metronidazole, and isoniazid), (e) vitamin-deficiency-induced neuropathies (including but not limited to vitamin B12 deficiency, vitamin B6 deficiency, and vitamin E deficiency), (f) idiopathic neuropathies, (g) diabetic neuropathies, (h) pathogen-induced nerve damage, (i) inflammation-induced nerve damage, (j) neurodegeneration, (k) hereditary neuropathy (including but not limited to Friedreich ataxia, familial amyloid polyneuropathy, Tangier disease, Fabry disease), (l) metabolic disorders (including but not limited to renal insufficiency and hypothyroidism), (m) infectious and viral neuropathies (including but not limited to neuropathic pain associated with leprosy, Lyme disease, neuropathic pain associated with infection by a virus, particularly a virus selected from the group consisting of a herpes virus (e.g. herpes zoster which may lead to post-herpetic neuralgia), a human immunodeficiency virus (HIV), and a papilloma virus), (n) auto-immune neuropathies (including but not limited to Guillain-Barre syndrome, chronic inflammatory de-myelinating polyneuropathy, monoclonal gammopathy of undetermined significance and polyneuropathy), (o) trigeminal neuralgia and entrapment syndromes (including but not limited to Carpel tunnel), and (p) other neuropathic pain syndromes including post-traumatic neuralgia, phantom limb pain, multiple sclerosis pain, complex regional pain syndromes (including but not limited to reflex sympathetic dystrophy, causalgia), neoplasia-associated pain, vasculitic/angiopathic neuropathy, and sciatica. Neuropathic pain may be manifested as allodynia, hyperalgesia, spontaneous pain or phantom pain. 2. Treatment of Tactile Allodynia The variant Neublastin polypeptides disclosed herein (and pharmaceutical compositions comprising same) can be used in the treatment of tactile allodynia in a subject. The term “tactile allodynia” typically refers to the condition in a subject where pain is evoked by stimulation of the skin (e.g. touch) that is normally innocuous. In some embodiments, tactile allodynia is treated by administering to the subject a pharmaceutically effective amount of a variant Neublastin polypeptide. In a related embodiment, tactile allodynia may be treated by administering to a subject an effective amount of a variant Neublastin polypeptide either alone, or by administering to the subject an effective amount of a variant Neublastin polypeptide with an effective amount of an analgesia-inducing compound selected from the group consisting of opioids, anti-arrhythmics, topical analgesics, local anaesthetics, anticonvulsants, antidepressants, corticosteroids and NSAIDS. In one embodiment, the analgesia-inducing compound is an anticonvulsant. In another preferred embodiment, the analgesia-inducing compound is gabapentin ((1-aminomethyl)cyclohexane acetic acid) or pregabalin (S-(+)-4-amino-3-(2-methylpropyl)butanoic acid). In some embodiments, a variant Neublastin polypeptide is administered in association with a therapeutic agent, including but not limited to an anti-cancer agent or an anti-viral agent. Anti-cancer agents include, but are not limited to, taxol, taxotere, cisplatin, nocodazole, vincristine, vindesine and vinblastine. Anti-viral agents include, but are not limited to, ddI, DDC, d4T, foscarnet, dapsone, metronidazole, and isoniazid. 3. Treatment for Reduction of Loss of Pain Sensitivity In another embodiment, variant Neublastin polypeptides disclosed herein (and pharmaceutical compositions comprising same) can be used in a method for reducing the loss of pain sensitivity in a subject afflicted with a neuropathy. In one embodiment, the neuropathy is diabetic neuropathy. In some embodiments, the loss of pain sensitivity is a loss in thermal pain sensitivity. This methods include both prophylactic and therapeutic treatment. In prophylactic treatment, a variant Neublastin polypeptide is administered to a subject at risk of developing loss of pain sensitivity (such a subject would be expected to be a subject with an early stage neuropathy). The treatment with a variant Neublastin polypeptide under such circumstances would serve to treat at-risk patients preventively. In therapeutic treatment, a variant Neublastin polypeptide is administered to a subject who has experienced loss of pain sensitivity as a result of affliction with a neuropathy (such a subject would be expected to be a subject with a late stage neuropathy). The treatment with a variant Neublastin polypeptide under such circumstances would serve to rescue appropriate pain sensitivity in the subject. 4. Treatment of Viral Infections and Viral-Associated Neuropathies Prophylactic treatment of infectious and viral neuropathies is contemplated. Prophylactic treatment is indicated after determination of viral infection and before onset of neuropathic pain. During treatment, a variant Neublastin polypeptide is administered to prevent appearance of neuropathic pain including but not limited to neuropathic pain associated with leprosy, Lyme disease, neuropathic pain associated with infection by a virus, particularly a virus selected from the group consisting of a herpes virus (and more particularly by a herpes zoster virus, which may lead to post-herpetic neuralgia), a human immunodeficiency virus (HIV), and a papilloma virus). In an alternative embodiment, a variant Neublastin polypeptide is administered to reduce the severity of neuropathic pain, should it appear. Symptoms of acute viral infection often include the appearance of a rash. Other symptoms include, for example, the development of persistent pain in the affected area of the body, which is a common complication of a herpes zoster infection (shingles). Post-herpetic neuralgia can last for a month or more, and may appear several months after any rash-like symptoms have disappeared. 5. Treatment of Painful Diabetic Neuropathy Prophylactic treatment of painful diabetic neuropathy is contemplated. Prophylactic treatment of diabetic neuropathies would commence after determination of the initial diagnosis of diabetes or diabetes-associated symptoms and before onset of neuropathic pain. Prophylactic treatment of painful diabetic neuropathy may also commence upon determining that a subject is at risk for developing diabetes or diabetes-associated symptoms. During treatment, a variant Neublastin polypeptide is administered to prevent appearance of neuropathic pain. In an alternative embodiment, a variant Neublastin polypeptide is administered to reduce the severity of neuropathic pain that has already appeared. 6. Treatment of Nervous System Disorders The variant Neublastin polypeptides disclosed herein (and pharmaceutical compositions comprising same) can be used in the treatment or prevention of a nervous system disorder in a subject (such as a human), by administering to a subject in need thereof a therapeutically effective amount of a variant Neublastin polypeptide, a composition containing a variant Neublastin polypeptide, or a complex that includes a stable, aqueous soluble conjugated variant Neublastin polypeptide coupled to a polyalkylene moiety such as, e.g., PEG. The nervous system disorder can be a peripheral nervous system disorder, such as a peripheral neuropathy or a neuropathic pain syndrome. Humans are preferred subjects for treatment. A variant Neublastin polypeptide is useful for treating a defect in a neuron, including without limitation lesioned neurons and traumatized neurons. Peripheral nerves that experience trauma include, but are not limited to, nerves of the medulla or of the spinal cord. Variant Neublastin polypeptides are useful in the treatment of neurodegenerative disease, e.g., cerebral ischemic neuronal damage; neuropathy, e.g., peripheral neuropathy, Alzheimer's disease, Huntington's disease, Parkinson's disease, amyotrophic lateral sclerosis (ALS). Such variant Neublastin polypeptides can be used in the treatment of impaired memory, e.g., memory impairment associated with dementia. The following are examples of the practice of the invention. They are not to be construed as limiting the scope of the invention in any way. EXAMPLES Example 1 Design and Synthesis of Variant Neublastin Polypeptides Human Neublastin was crystallized and its structure revealed a triad of sulfate ions interacting with the following four Neublastin residues in close proximity to each other: Arg14, Arg48, Arg49, and Arg51. Based upon the presence of this triad and their relative spacing to one another, it was postulated that this region of Neublastin could be a potential heparin sulfate-binding domain. Subsequently, a previously solved heparin sulfate structure was docked (in-silico) to Neublastin at the site of the sulfate triad. Heparin sulfate fit precisely in this position, suggesting that this region within Neublastin has potential for heparin sulfate binding. The Neublastin crystallization data also revealed that the following amino acid residues provide supplementary interactions with either the triad of sulfate ions or with one or more of three other sulfate ions that interact with Neublastin: Ser 46, Ser 73, Gly 72, Arg 39, Gln 21, Ser 20, Arg 68, Arg 33, His 32, and Val 94. In addition to the sulfate binding sites revealed by the crystal structure, Neublastin contains a heparin sulfate binding site consensus sequence (GPGSRAR) at residues 3-9 at its N-terminus. This region was unstructured in the crystal structure but may become ordered upon binding glycosaminoglycans. The region is likely to be close in space to the three sulfate cluster observed in the crystal structure (Arg14 contributes to the heparin-binding site that is mainly centered in the hinge region of the protein). To investigate the biological relevance of the potential heparin sulfate-binding domain, three individual single amino acid residue substitutions were made within the mature 113 amino acid human Neublastin (SEQ ID NO:1). The arginine residues at each of position 48 (variant named “Arg48E”; SEQ ID NO:2), position 49 (variant named “Arg49E”; SEQ ID NO:3), and position 51 (variant named “Arg51E”; SEQ ID NO:4) were replaced by glutamate (i.e., three different single amino acid variant constructs were prepared) with the intention of changing the residue charge from one that would attract sulfate to one that would repel, and to potentially stabilize surrounding arginine residues. Proteins were refolded and purified from E. coli inclusion bodies (see WO 04/069176). Each Neublastin variant was subjected to analysis to verify structural integrity and confirm the correct residue substitution. All three mutants were structurally comparable to the wild-type human Neublastin. Example 2 Cationic and Heparin Sepharose Chromatography The variant Neublastin polypeptides were subjected to further biochemical analysis to determine the effect each mutation had on heparin binding. Heparin Sepharose and cationic chromatography were both employed. Since wild-type human Neublastin is a basic protein with an apparent pI of 11.31, Neublastin binds efficiently to cationic-based resins. A single conversion of arginine to glutamate decreases the apparent pI to 10.88. However, this lower pI was not expected to dramatically alter cationic resin-binding nor was it expected to alter the elution profile of the mutants compared to that of the wild-type control. Each of the mutants (along with the wild-type Neublastin control) was subjected to cationic chromatography. The samples were loaded onto resin in buffer containing 5 mM phosphate pH 6.5 and 150 mM sodium chloride followed by elution with a linear salt gradient starting at 150 mM and ending with 1M sodium chloride. Wild-type Neublastin eluted at ˜800 mM sodium chloride ( FIG. 2A ; Peak D), whereas each of the three mutants eluted within a salt range of approximately 500 mM, thus reflecting their lower pI. Arg49E and Arg51E ( FIG. 2A ; Peaks B and C) eluted with slightly higher salt than was required to elute Arg48E ( FIG. 2A ; Peak A) (520 mM vs 490 mM, respectively). This difference suggested that Arg48 is more surface accessible and contributes more to cationic binding than that of the other two mutations. To determine whether the Arg-to-Glu substitutions had an effect on heparin binding, each of the three mutants (along with wild-type human Neublastin) was subjected to Heparin Sepharose chromatography ( FIG. 2B ). Binding and elution conditions were similar to those used for cationic chromatography. However, the observed elution profile was significantly different from the cationic resin elution profile. Wild-type Neublastin eluted at approximately 720 mM sodium chloride ( FIG. 2B ; Peak H) whereas Arg51E, Arg49E, and Arg48E eluted at 570 mM ( FIG. 2B ; Peak G), 510 mM ( FIG. 2B ; Peak F), and 450 mM ( FIG. 2B ; Peak E) sodium chloride, respectively. Arg48E appeared to have a particularly dramatic effect on heparin binding. Taken together, these chromatography profiles suggested that each mutation decreases Neublastin's apparent affinity for heparin. Example 3 Anionic Chromatography At standard pH conditions of 6.5 and a sodium chloride concentration of 150 mM, Neublastin does not bind to anionic resins. In contrast, heparin sulfate does bind to anionic resins under these same conditions. When Neublastin was pre-mixed in a 1:1 molar ratio with 16-kDa-heparin sulfate and applied to an anionic matrix using the above conditions, Neublastin bound and eluted with 600 mM sodium chloride ( FIG. 3B , lanes marked “FT”), suggesting that Neublastin was binding the anionic matrix through its interaction with heparin sulfate. In the absence of heparin, Neublastin did not bind to the anionic resin ( FIG. 3A , lanes marked “FT”) and no Neublastin eluted with 600 mM sodium chloride ( FIG. 3A , lanes marked “Elution”). These data provide further evidence of Neublastin's ability to bind to heparin. Example 4 Chinese Hamster Ovary Cell Binding Studies Neublastin has been shown previously to bind non-specifically to the surface of Chinese Hamster Ovary (CHO) cells. A Neublastin CHO cell-binding assay was established to determine whether this interaction is mediated, at least in part, through Neublastin's binding to cell surface heparin sulfate molecules. Wild-type human Neublastin (40 ug) or the Arg48E mutant was pre-mixed with CHO cells (10 6 cells) at a cell density which completely binds both Neublastin forms along with increasing amounts of 16 kDa heparin sulfate and incubated at 37° C. for 4 hours. Following incubation, the cells were pelleted by centrifugation and remaining non-bound Neublastin in the supernatant was subjected to SDS/PAGE analysis. After quantification of each protein band by densitometry, the resulting optical density value was plotted against the heparin concentration in each sample ( FIG. 4 ). At the two lower heparin concentrations, both the wild type and the mutant Neublastin forms had equal amounts of protein identified in the supernatant. However, as the heparin concentration increased to 0.5 ug/ml and higher, more wild-type Neublastin was identified in the supernatant than that of the Arg48E mutant. This observation suggested that heparin can compete with cell surface-bound heparin for wild-type Neublastin binding (i.e., binding of heparin to wild-type Neublastin results in its removal from the cell surface), whereas heparin cannot as readily compete off the Arg48E mutant. At the highest heparin concentration (50 ug/ml), the Arg48E mutant began to elute off the cell surface, suggesting an ionic interaction between heparin and the Arg48E mutant might be responsible for this observation. Example 5 Heparin Binding of Wild Type Neublastin and Variant Neublastin Polypeptides To further investigate the role of the identified arginine triad as a heparin-binding site of Neublastin, a heparin binding ELISA was established. In brief, an anti-Neublastin monoclonal antibody was coated onto a 96-well plate, followed by washing and the addition of one of the Neublastin forms. Biotinylated heparin was then added to the plate. Following an additional wash step, the Neublastin/Heparin complex was identified using a Strepavidin-HRP conjugate with a chemiluminescent substrate. This heparin-binding ELISA was used to compare wild type human Neublastin 113 amino acid (SEQ ID NO:1) and 104 amino acid (amino acids 10-113 of SEQ ID NO:1) forms to variant Neublastin polypeptides containing a single amino acid substitution (Arg48E, Arg49E, and Arg51E; SEQ ID NOS:2-4) as well as a double substitution (Arg48, 49E; SEQ ID NO:5). Both wild-type forms of Neublastin bound heparin with an EC50 of ˜1 ng/ml heparin ( FIG. 5 ). Arg49E and Arg51E bound less efficiently, with an apparent EC50 of ˜10 ng/ml, but maximum binding remained the same ( FIG. 5 ). Of the three single point mutations, Arg48E had the most dramatic effect on heparin binding, with an apparent EC50 of ˜100 ng/ml, but still achieved the same maximum heparin binding value when compared to the unmodified Neublastin forms ( FIG. 5 ). The Arg48E mutant was thus one hundred fold less efficient in binding heparin as compared to the unmodified Neublastin forms and ten fold less efficient as compared to the other single substitution mutants. When both Arg48 and Arg49 were substituted with glutamate, heparin binding was almost eliminated, resulting in a seven-fold decrease in maximum heparin binding, but the EC50 remained within range of the single point mutants. These results suggest that Arg48 plays an important role in heparin binding due to its central location in the putative heparin-binding site. Example 6 Kinase Receptor Activation Analysis of Wild-Type Neublastin and Heparin Binding Mutants To determine whether heparin-binding site mutations have an effect on Neublastin receptor signaling in a cell-based bioassay, mutant Neublastin forms along with the wild-type Neublastin were subjected to Kinase Receptor Activation (KIRA) analysis. Each of the single Arg-to-Glu substitution mutants appeared identical to the unmodified control with respect to KIRA activity, suggesting that these mutants are structurally similar to the wild-type and are capable of activating the Neublastin receptor and signaling cascade ( FIG. 6 ). Furthermore, these data suggest that heparin binding to Neublastin may not be required for receptor activation. When the Arg48,49E double mutant (SEQ ID NO:5; 113 amino acid form) was subjected to KIRA analysis, its apparent EC50 was shifted to the left by approximately one order of magnitude with an increase in its maximum receptor activation when compared with the wild-type human Neublastin control ( FIG. 7A ). Similarly, the Arg48,49E double mutant (SEQ ID NO:7; 104 amino acid form) also exhibited increased potency as compared to wild-type Neublastin ( FIG. 7B ). Each of the Arg48,51E and Arg49,51E double mutants (SEQ ID NO:9 and SEQ ID NO:8, respectively; 113 amino acid forms) appeared similar to the unmodified Neublastin control with respect to KIRA activity ( FIG. 7B ). Example 7 Ternary Complex Analysis Wild-type human Neublastin and each of the heparin mutants were subjected to ternary complex analysis using two slightly different protocols. The first protocol combined Neublastin's receptor components (GFRalpha3 and RET) along with Neublastin in a pool before addition to an ELISA plate coated with capture antibody ( FIG. 8 ). The second protocol added these components sequentially to an ELISA plate with GFRalpha3 added first, followed by Neublastin, and then RET ( FIG. 9 ). When the components were added together as a pool, maximum binding was achieved with both Arg48E and Arg48,49E, suggesting that these Neublastin forms have the highest affinity for their receptor. Wild-type Neublastin appeared to bind with a similar affinity to that of the Arg49E mutant, whereas the Arg51E and a triple mutant (Arg48, 49 and 51 all substituted to glutamate) demonstrated the weakest receptor binding. When the receptor components were added sequentially, Arg48E showed the best receptor binding. However under these conditions, the double mutant weakly bound to its receptor with an affinity that appeared similar to the Arg51E mutant. Arg49E and wild-type Neublastin had an affinity for the receptor that was midway between the observed maximum and minimum binding. The triple mutant did not bind under these conditions. Overall, these data suggest that Arg48 plays a pivotal role in affecting Neublastin's affinity for its receptor. Example 8 Near and Far UV CD Analysis To further investigate the effects of the double mutations on Neublastin's secondary and tertiary structure, the Arg48,49E double mutant was subjected to both Near and Far UV CD analysis. Although subtle differences were detected in the secondary and tertiary structures, the conformation of the double mutant was very close to that of the wild-type Neublastin. Example 9 Pharmacokinetic Analysis of the Neublastin Arg48, 49E Double Mutant Human Neublastin exhibits poor pharmacokinetics (PK) when administered to rats intravenously (IV) or subcutaneously (SC), with an overall bioavailability of less than 1%. Heparin-based clearance may be one of the reasons for this low bioavailability. To determine whether heparin-based clearance participates in human Neublastin's rapid clearance from the rat, the Arg48,49E double mutant (along with the wild-type control) was subjected to PK analysis. Both forms were administered separately in rats at 7 mg/kg SC. Serum samples were collected starting at 1 hour, completed at 96 hours, and analyzed for Neublastin ( FIG. 10 ). The observed area under the curve (AUC) for wild-type Neublastin was ˜109 whereas the observed AUC for the double mutant was 20,145. This represented a 185-fold increase in AUC for the double mutant (compared to wild-type Neublastin) and a significant increase in serum exposure. Both the wild type and double mutant Neublastin were also subjected to PK analysis following IV administration (1 mg/kg). The initial plasma concentration of the double mutant was approximately six-fold higher (diamonds) than that of the wild-type control (squares) at five minutes following injection but quickly approached wild type levels within one hour ( FIG. 11 ). These data suggest that the double mutation in Neublastin aids in increasing serum exposure but does not affect the overall clearance rate. Taken together with the SC observation, heparin-binding appears to be especially relevant following SC administration, perhaps resulting in a depot-like effect. Once Neublastin enters circulation, the rate at which the double mutant and wild type molecules are cleared is approximately the same. To address the rate at which Neublastin is cleared from circulation in the rat, both the wild type and double mutant forms of Neublastin were PEGylated with 10 kDa PEG using SPA-based coupling chemistry. Since Neublastin is a homo-dimer with no native lysine residues, the 10-kDa moieties specifically labeled the amino terminus of each monomer. 2×10K PEGylated human double mutant neublastin was purified to homogeneity, and subjected to structural and biological analysis prior to PK analysis. 2×10K PEG Arg48, 49E double mutant was injected either IV (1 mg/kg) or SC (7 mg/kg) into rats and serum collected at various time points for analysis. Following IV administration, 2×10K PEG double mutant achieved the theoretical Cmax of 10 ug/ml (diamonds) with typical alpha and beta phases ( FIG. 12 ). SC administration of the PEGylated double mutant demonstrated a Cmax of 40 ng/ml at 24 hours injection ( FIG. 12 ). Once the drug reached circulation, the apparent rate of clearance paralleled that of IV dose. Bioavailability of this construct was approximately 10% compared to less than 1% for the non-PEGylated or PEGylated wild type human Neublastin. Example 10 Expression of a Neublastin Heparin-Binding Mutant in Chinese Hamster Ovary Cells Plasmid constructs encoding wild type and mutant Neublastin were expressed in CHO cells and the amount of secreted soluble protein was measured by ELISA. The plasmid constructs used in these experiments encoded a fusion protein containing the human growth hormone signal peptide (SigPep) (with or without an intron included in the plasmid) fused to (i) the carboxy terminal 104 amino acids of wild type human Neublastin, or (ii) the Arg48,49E double mutant (104 amino acid form). The following are the amino acid sequences of the Neublastin fusion proteins used in these experiments. The Neublastin sequences are in upper case type. The human growth hormone signal peptide sequences are in lower case type. The junction of the signal peptide and Neublastin sequences is indicated with a carat (^). The amino acids at positions 48 and 49 are underlined. SigPep-NBN (wild type): matgsrtslllafgllclswlqegsa^AAAGARGCRLRSQLVPVRALGLGHRSDELVRFRFCSGSC RR ARSPHDLSLASLLGAGALRPPPGSRPVSQPCCRPTRYEAVSFMDVNSTWRTVDRLSATACGCLG (SEQ ID NO:13). SigPep-NBN (Arg48,49E): matgsrtslllafgllclswlqegsa^AAAGARGCRLRSQLVPVRALGLGHRSDELVRFRFCSGSC EE ARSPHDLSLASLLGAGALRPPPGSRPVSQPCCRPTRYEAVSFMDVNSTWRTVDRLSATACGCLG (SEQ ID NO:14). CHO cells were transfected with plasmids encoding each of the foregoing forms of Neublastin and cultured in 384-well plates. After several weeks, wells that contained growing cells were transferred to fresh 96-well culture plates. Conditioned medium was analyzed by ELISA to measure the titer of soluble Neublastin. The cumulative absorbance data for each plasmid tested (mean value with one standard deviation as error bars) was detected. Transfection of CHO cells with plasmids encoding the Arg48,49E double mutant resulted in a significantly increased number of cell lines exhibiting high expression levels of recombinant protein, as compared to cells transfected with plasmids encoding wild type Neublastin ( FIG. 13 ). The leading cell lines from each transfection were further expanded. Fixed numbers of cells were cultured for three days and total cell count, viability, and titer were determined. The titers of Neublastin expressed from the leading Arg48,49E double mutant cell lines were roughly five-fold greater than those of a leading wild type Neublastin cell line ( FIG. 14 ). Other Embodiments While the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims.

Compositions and methods for folding proteins belonging to the transforming growth factor beta superfamily are disclosed. The compositions and methods allow for the folding of such proteins when produced in an expression system that does not yield a properly folded, biologically active product.

BACKGROUND OF THE INVENTION The present invention relates to oral airways of the type adapted for use wherever and whenever it is necessary to prevent a patient's tongue from falling back into the throat and obstructing the flow of air to the lungs as, for example, when anesthetic is being or has been administered to the patient. Also, airways of this type are sometimes formed to provide a passage through which an aspirator or oxygen tube can be passed into the esophagus or trachea of the patient as required by the circumstances attending the use of the airway. Typical examples of prior art airways are disclosed by the patents listed below: ______________________________________Patent No. Inventor Issued______________________________________2,127,215 Gwathmey 8/16/382,599,521 Berman 6/3/523,306,298 Raimo 2/28/673,398,747 Raimo 8/27/683,756,244 Kinnear et al 9/4/733,908,665 Moses 9/30/753,926,196 Bornhorst et al 12/16/753,930,507 Berman 1/6/764,054,135 Berman 10/18/774,112,936 Blachly 9/12/784,196,724 Wirt et al 4/8/804,198,967 Dror 4/22/80______________________________________ All of the airways known to applicant, including those disclosed by the patents listed above, are adapted to be used by introducing the airway manually into the mouth of the patient and then holding it in some way so that it does not interfere with surgical operations or other treatment being performed on the patient. However, these airways have in common the disadvantage that they can be displaced by the tongue which results in the airway being obstructed by the tongue in certain situations. SUMMARY OF THE INVENTION The present invention provides an airway of the above mentioned character having an abutment portion at the forward end thereof that seats rearwardly against the patient's face adjacent to the mouth to limit inward movement of the airway during insertion thereof and provided also with a pivoted clamping member at the inner end thereof that can be manipulated manually from the forward or outer end of the airway and exteriorly of the patient's mouth and swung or rocked selectively forwardly toward the front of the patient's throat or rearwardly toward the back of the throat. When the airway is fully inserted, the clamping member projects into the throat angularly toward the back thereof at the base of the tongue. When the clamping member is swung forwardly in the manner described above, it presses against and clampingly engages the base of the tongue urging the latter forwardly and exerting a rearward force on the airway that pulls the abutment portion thereof firmly against the face. As a result, the patient's tongue is confined between the clamping member and the front portion of the curved section of the lower body member 12 to hold the tongue forwardly in the patient's mouth and to retain the airway in the clamped position in a manner that eliminates inadvertent displacement by the tongue and the necessity of holding the airway manually in place. If necessary or desirable, the clamping member may be provided with serrations or other means for preventing the clamping member from inadvertently sliding on and releasing the tongue while in the clamped position. Conversely, the clamping member can be swung toward the rear of the throat from the forward or outer end of the airway; and, as the clamping member swings away from the tongue it releases the latter sufficiently to permit ready removal of the airway from the patient's mouth. DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view of an airway embodying the present invention and showing the clamping member in the rearward or tongue-releasing position; FIG. 2 is a view similar to FIG. 1 but showing the airway fully inserted into the mouth of a patient and the clamping member in the forward or clamping position; FIG. 3 is an enlarged, fragmentary, side elevational view showing the forward portion of the airway with the parts thereof positioned as illustrated in FIG. 1; FIG. 4 is a view similar to FIG. 3 but showing parts of the airway positioned as illustrated in FIG. 2; FIG. 5 is an enlarged, transverse sectional view taken on the line 5--5 of FIG. 1; FIG. 6 is an enlarged, transverse sectional view taken on the line 6--6 of FIG. 2; and FIG. 7 is an enlarged, transverse sectional view taken on the line 7--7 of FIG. 3. DESCRIPTION OF THE PREFERRED EMBODIMENT As a special feature of this invention, the instant airway is uniquely formed so that it can be injection molded inexpensively in one piece of a suitable plastic resin material. Also, the airway is uniquely constructed so that, when it is fully inserted into the mouth of the patient, the clamping member at the inner end thereof can be manipulated manually entirely from the forward end of the airway and outside the patient's mouth to clamp and hold the tongue and the clamping member locked securely in the clamped position so that the airway alone will continue to hold the tongue until the clamping member is released. In this connection, the means for manipulating the clamping member also can be released manually entirely from the outer end of the airway and from a position outside the patient's mouth to swing the clamping member toward the rear of the throat and away from the patient's tongue and then locked in the released position so as not to interfere with removal of the airway. All of these operations can be performed easily and quickly from the forward end of the airway and without necessity of the person performing the operations having to put his hands or any portions thereof in the patient's mouth either to insert or to remove the airway or to hold the same in place during the time the airway remains in the mouth. More particularly, the airway of this invention comprises upper and lower body members 10 and 12 arranged in generally parallel relation, as perhaps best shown in FIGS. 1 and 2. In the particular form of the invention here shown by way of illustration, the body members 10 and 12 are generally T-shaped in transverse section, the upper body member 10 having a horizontal flange 14 provided at substantially the middle thereof with a depending web 16 and the lower body member 12 having a horizontal flange 18 provided with a medianly disposed upstanding web 20 that normally overlaps the web 16 along a substantial portion of its length. In the preferred form of the invention, the two webs 16 and 20 are offset in opposite directions from the center lines of their respective flanges 14 and 18, as shown in FIG. 5, so that the body members 10 and 12 are centered with respect to each other. Although the upper body member 10 is capable of being moved angularly with respect to the lower body member 12, as shown in FIG. 1, in the normal use and operation of the airway, the two body members normally are disposed in generally parallel relation each with respect to the other as is literally true, for example, when the clamping member previously referred to is disposed and locked in the clamped position, as shown in FIG. 2. Both of the body members 10 and 12 are of elongate configuration, and they are longitudinally curved so that, in the fully inserted position of the airway, they conform at least generally to the top surface of the patient's tongue. Since the upper body member 10 is superimposed on the lower body member 12, it does not physically contact the tongue; but, in use, the lower body member 12 overlays the tongue with the flange 18 thereof in direct contact with the top of the tongue. Also, as clearly shown in the drawing, the body members 10 and 12 are sufficiently long so that, when the airway is fully inserted, the inner ends of the body members are disposed at or slightly beyond the soft pallet 22 and the forward or outer ends thereof are disposed substantially at the tip 24 of the tongue 26 adjacent to the teeth 28 and 30. The clamping member 32 at the inner ends of the two body members 10 and 12 is hingedly connected to the latter by a pair of integral hinges 34 and 36, respectively. As clearly shown in the drawing, the clamping member 32 is of elongate configuration and extends from the body members 10 and 12 essentially as a continuation thereof so as to project into the throat and, in at least one position thereof, as hereinafter explained, to overlay the base of the tongue 26 and perhaps also at least partially to overlap at least the tip of the epiglottis 38, as shown in FIG. 2. The particular clamping member 32 here shown is formed with upper and lower longitudinal flanges 40 and 42 joined by a medianly disposed web 44; and it is longitudinally tapered toward the free end thereof so as to slip readily into the throat when the airway is inserted into the mouth of the patient. The adjacent ends of the two flanges 14 and 40 are tapered slightly and integrally joined by a flexible web of the plastic material from which the airway is made to form the hinge 34. Similarly, the adjacent ends of the flanges 18 and 42 are tapered and joined by a thin flexible web of plastic material to form the hinge 36. Thus, the two hinges 34 and 36 are spaced transversely of the airway so that when the lower body member 12 is moved inwardly longitudinally with respect to the upper body member 10, the lower hinge 36 is advanced to pivot or rock the clamping member 32 about the hinge 34, with the result that the clamping member is moved from the position shown in FIG. 2 to the position shown in FIG. 1. Conversely, if the lower body member 12 is moved outwardly longitudinally with respect to the upper body member 10, the lower hinge 36 is retracted to pivot the clamping member 32 counterclockwise about the hinge 34 from the position shown in FIG. 1 to the position shown in FIG. 2. At the forward outer ends of the body members 10 and 12, the web 16 of the upper body member 10 extends angularly forwardly and downwardly, as at 46, and across a forward extension 48 of the flange 18. The two extensions 46 and 48 cross almost at right angles with respect to each other, as shown in FIGS. 3 and 4; and the near portion of the flange 18, as viewed in FIGS. 3 and 4, is cut away as at 49 to accommodate the web extension 46. The extension 48 also is formed at the forward end of the cutout 49 with a guide block 50 that projects below the extension 48 and overlaps an elongate longitudinal shoulder 52 provided on a forwardly extending portion 54 of the web extension 46 at the lower end of the latter. In view of the foregoing, it will be readily apparent that the flange extension 48 passes behind the web extension 46 as viewed in FIG. 3 to limit movement of the flange extension 48 to the left, as viewed in FIG. 7; and the guide block 50 seats against the shoulder 52 to limit movement of the flange extension 48 to the right, as viewed in FIG. 7, so that the web extension 46 and the shoulder 52 mutually cooperate to prevent lateral separation of the body members at the forward ends thereof while at the same time permitting the forward ends of the body members, and consequently the body member 12, to move longitudinally with respect to the other body member 10. It is contemplated that the side of the web extension 46 engaged by the flange extension 48 and the shoulder 52 be spaced laterally sufficiently to permit free longitudinal movement of the flange extension 48 and consequently of the lower body member 12. At its outer end, the flange 14 is formed with a forwardly and upwardly curved extension 56 that provides a convenient hand-hold or handle by means of which the airway can be grasped and held manually when the airway is inserted into the mouth or removed therefrom and during longitudinal sliding movement of the lower body member 12 with respect to the upper body member 10. Manifestly, inward sliding movement of the lower body member 12 relative to the upper body member 10; viz., to the left as viewed in the drawings, swings the clamping member 32 clockwise on the hinge 34 and positions the clamping member as shown in FIG. 1 when the lower body member 12 is fully advanced. In this connection, it will be observed that the lower body member 12 can be advanced or moved inwardly relative to the upper body member 10 only until the guide block 50 engages the forward or outer edge of the web extension 46. On the other hand, when the lower body member 12 is moved forwardly or outwardly with respect to the upper body member 10 to pivot the clamping member 32 counterclockwise on the hinge 34, forward movement of the lower body member 12 is limited by engagement of the flange 18 with the web extension 46 at the inner end of the cutout 49. At the outward limit of its travel, the lower body member 12 positions the clamping member 32, as shown in FIG. 2, at the extreme limit of its counterclockwise respective movement about the hinge 34. In order to hold the lower body member 12 at the inner and outer limits of its horizontal sliding movement relative to the upper body member 10, the extension 46 of the web 16 is formed with a forwardly extending flange member 58 that is disposed substantially parallel to the member 54 and above the forward extension 48 so that the latter slides back and forth between the two members 54 and 58. At the forward end of the forwardly extending portion 54 is a substantially right angularly extending depending tab 60; and at the extreme forward or outer end of the forward extension 48 is a latch member 62 that is joined thereto by an integral hinge 64 which is formed similarly to the hinges 34 and 36 previously referred to. In the extreme rearward position of the lower body member 12, shown in FIG. 3, the hinge 64 is disposed substantially behind or rearwardly of the forward or outer end of the extension 54 which in turn is disposed substantially behind or rearwardly of the extreme forward end of the flange member 58. In the extreme outer position of the lower body member 12, shown in FIG. 4, the hinge 64 is disposed slightly beyond or forwardly of the outer end of the extension 54 and slightly rearwardly of or behind the forward end of the flange member 58. Also, in the extreme rearward position of the lower body member 12, a transverse rib 66 formed on the outer face of the latch member 62 substantially midway between the inner and outer ends thereof, engages behind a downwardly and rearwardly curved catch 68 formed on the end of the flange member 58; and in the extreme outer or forward position of the lower body member 12, a latching transverse rib 70 formed on the undersurface of the latch member 62 adjacent the outer end thereof engages behind a catch 72 formed on the outer face of the tab 60. In both positions of the lower body member 12, the latching ribs 66 and 70 engage behind respective catches 68 and 72 with a snap action. In practice, the lower body member 12 is advanced; viz., moved inwardly with respect to the upper body member 10 by pushing on the latch member 62 with the latter disposed substantially horizontally or in-line with the forward extension 48, as shown in FIGS. 1 and 3. As suggested, advancement of the lower body member 12 in this manner swings the clamping member 32 clockwise to the position shown in FIG. 1 which prepares the airway for insertion into the mouth of the patient. During inward movement of the lower body member 12, a transverse rib 74 on the underside of the flange member 58 rides on the top surface of the guide block 50 to hold the latter downwardly against the forwardly extending portion 54 to assure butting engagement between the guide block 50 and the shoulder 52. This butting engagement between the block 50 and the shoulder 52 at one side of the web extension 46 and the overlapping engagement of the web 20 on the other side of the web 16 in combination with the hinges 34 and 36 at the inner end of the airway holds the two body members 10 and 12 in proper sliding association with each other; viz., so that the lower body member 12 is free to slide relative to the upper body member 10. When the lower body member 12 approaches the normal limit of its inward travel and just before the guide block 50 engages the downward extension 46, the latching rib 66 moves into position with respect to the catch 68 such that the latch can be snapped behind the catch, as shown in FIGS. 1 and 3. If the airway is molded from plastic resin material, the latter is sufficiently flexible and resilient so that the latching rib can be readily snapped into position behind the catch; however, at the same time, the material is sufficiently stiff so that the catch holds the latching rib securely during normal handling and manipulation of the airway. Contrariwise, when it is desired to retract the lower body member 12 with respect to the upper body member 10; viz., to move it outwardly, the latching member 62 is first pushed downwardly about the hinge 64 to disengage the latching rib 66 from the catch 68 and then swung downwardly to engage the latching member with the outer end surface 76 of the forward extension 54. Thereafter, the surface 76 serves as a fulcrum about which the latch member 62 turns; and, as the downward swinging action of the latch member 62 progresses, it acts against the fulcrum 76 to retract the lower body member 12. As suggested, retractive or outward movement of the lower body member 12 swings the clamping member 32 counterclockwise on the two hinges 34 and 36 to the clamped position shown in FIG. 2. In the unclamped or extended position shown in FIG. 1, the clamping member 32 is disposed properly to enter the throat as the airway is inserted fully to a position where the tab 60 engages and lays against the lower lip of the patient; and, as the clamping member swings counterclockwise in the manner previously described, it moves toward the front of the throat and eventually assumes a downwardly and slightly forwardly inclined position, as shown in FIG. 2. In the latter position of the clamping member 32, it presses the tab 60 firmly against the patient's lip and securely holds the patient's tongue forward in the mouth. If necessary or desirable, the forward face of the clamping member 32 may be formed with transverse ribs or teeth 78 that embed in the base of the tongue and perhaps also in the tip portion of the epiglottis to prevent the clamping member 32 from slipping upwardly and inadvertently releasing the tongue. In any event, as the clamping member 32 approaches the limit of its counterclockwise travel, the latching rib 70 contacts the catch 72 just behind the lip of the latter and is readily snapped into position behind the catch by continued downward and inward pressure against the latch member 62. Thereafter, the airway will remain securely in the fully inserted position, as shown in the drawing, to hold the patient's tongue and to prevent it from falling back into the patient's throat until the latch member 62 is pulled outwardly to release the latching rib 70 from the catch 72. Continued upward pivotal movement of the released latch member 62 returns it to a straight or horizontal position in which the lower body member 12 can be pushed inwardly to return the clamping member 32 to the FIG. 1 position in the manner hereinabove described preparatory to removal of the airway from the patient's mouth. During the movements described above, the handle 56 and the flange members 54 and 58, including the tab 60 and the latch member 62, are accessible for manual manipulation of the airway as required to perform the insertion and removal of the airway and the clamping and unclamping motions of the member 32. Formed on and extending laterally from the web 16 of the upper body member 10 adjacent to the free edge of the web are a plurality of longitudinally spaced pins 80 that, in combination with the overhanging portion of the flange 14, define a way through which a tube can be inserted into the throat of the patient after the airway has been inserted and clamped in position. The tube, of course, is inserted from the outer end of the airway; and, after it passes over the top of the foremost pin 80, the overhanging portion of the flange 14 serves as a guide to direct the tube over the other two pins 80 and into the aligned channel defined by the flanges 40 and 42 of the clamping member 32. When the clamping member 32 is in the unclamped position shown in FIG. 1, the clamping member is positioned to direct the tube into the esophagus if that is required. Alternatively, the tube can be stopped at the entrance to the trachea if that is necessary, as in the case where the tube is used to supply oxygen to the lungs or to administer an anesthetic.

An airway having a pair of elongate generally parallel body members guided and restrained for limited longitudinal sliding motion of one member relative to the other, hingedly interconnected at the inner ends thereof to a tongue clamping member, and provided at the outer ends thereof with manual actuators at least one of which has a lateral extension that abuts against the face of a patient when the airway is inserted into the mouth, the body members being curved to conform at least generally to the tongue of the patient and the clamping member being adapted to extend into the throat of the patient when the airway is fully inserted, whereby manipulation of the body members in one direction acts through the hinges to rock the clamping member toward the front of the throat and into pressed engagement with the tongue to compress the same forwardly and whereby manipulation of the body members in the opposite direction rocks the clamping member toward the back of the throat to release the tongue and permit removal of the airway from the mouth.

BACKGROUND OF THE INVENTION [0001] This invention relates to the topical and/or intravitreal ophthalmic use of mdivi-1 and nutlin-3, individually or in combination, when indicated for treatment of glaucoma, ischemic optic neuropathies, hereditary optic neuropathies and retinal artery and vein occlusions. [0002] Nutlin-3 is disclosed in U.S. Pat. No. 6,617,346, 6,734,302, 6,916,833, 7,060,713, 7,425,638, 7,579,368, 7,625,895. The claims of the listed patents describe nutlin-3 inhibition of the interaction of MDM2 protein with a p53-like peptide and hence have anti proliferative activity. In this invention, nutlin-3 inhibit apoptosis by inhibiting Bax and Bak in the apoptosis pathway and produce neuroprotective effects rather than induce apoptosis as claimed in the previous patent disclosures. [0003] mdivi-1 is disclosed in U.S. Pat. Application No. 20050038051 and 20080287473. The claims of the listed patents describe mdivi-1 regulation of apoptosis via regulating mitochondrial fission or fusion. [0004] This patent claims nutlin-3 and mdivi-1 as an ophthalmic drug. In combination, these drugs block Bax/Bak and Drp1 interaction on the mitochondria surface as a key step in the apoptotic pathway of various ophthalmic diseases including glaucoma, ischemic optic neuropathy, hereditary optic neuropathy and retinal artery/vein occlusions. DESCRIPTION OF THE INVENTION [0005] Nutlin-3 is represented by the chemical formula described in U.S. Pat. No. 6,617,346, 6,734,302, 6,916,833, 7,060,713, 7,425,638, 7,579,368, 7,625,895. [0006] Mdivi-1 is represented by the chemical formula described in U.S. Pat. Application No. 20050038051 and 20080287473 [0007] Nutlin-3 and its active emantiomer nutlin-3a are available from Roche, Inc and Cayman Chemical, Inc. Mdivi-1 is available from various sources, including Enzo Life Science. [0008] The compositions of the present invention are administered either topically or intravitreally. The dosage is 0.001 to 1.0, e.g. mg/per eye BID to QID or as 1 time dose; wherein the cited mass figures represent the sum of the two components, mdivi-1 and nutlin-3. The compositions of the present invention can be administered as solutions in a suitable ophthalmic vehicle. [0009] The precise regimen is left to the discretion of the clinician, it is recommended that the solution be topically applied by placing one drop in each eye once to four times a day or as one time or weekly intravitreal injections. Other ingredients which may be desirable to use in the ophthalmic preparations of the present invention include preservatives, co-solvents and viscosity building agents. Antimicrobial Preservative [0010] Ophthalmic products are typically packaged in multidose form. Preservatives are thus required to prevent microbial contamination during use. Suitable preservatives include: benzalkonium chloride, thimerosal, chlorobutanol, methyl paraben, propyl paraben, phenylethyl alcohol, edetate disodium, sorbic acid, Onamer M, or other agents known to those skilled in the art. In the prior art ophthalmic products, typically such preservatives are employed at a level of from 0.004% to 0.02%. In the compositions of the present application the preservative, preferably benzalkonium chloride, may be employed at a level of from 0.001% to less than 0.01%, e.g. from 0.001% to 0.008%, preferably about 0.005% by weight. It has been found that a concentration of benzalkonium chloride of 0.005% is sufficient to preserve the compositions of the present invention from microbial attack. This concentration may be advantageously compared to the requirement of 0.01% benzalkonium chloride to preserve mdivi-1 and nutlin-3 in the individual, commercially-available ophthalmic products. It is noted that it is known that benzalkonium chloride at high concentrations is cytotoxic. Therefore, minimizing the patient's exposure to benzalkonium chloride, while providing the preservative effects afforded by benzalkonium chloride, is clearly desirable. Co-Solvents: [0011] The solubility of the components of the present compositions may be enhanced by a surfactant or other appropriate co-solvent in the composition. Such cosolvents include polysorbate 20, 60, and 80, Pluronic F68, F-84 and P-103, cyclodextrin, or other agents known to those skilled in the art. Typically such co-solvents are employed at a level of from 0.01% to 2% by weight. Viscosity Agents: [0012] Viscosity increased above that of simple aqueous solutions may be desirable to increase ocular absorption of the active compound, to decrease variability in dispensing the formulation, to decrease physical separation of components of a suspension or emulsion of the formulation and/or to otherwise improve the ophthalmic formulation. Such viscosity building agents include as examples polyvinyl alcohol, polyvinyl pyrrolidone, methyl cellulose, hydroxy propyl methylcellulose, hydroxyethyl cellulose, carboxymethyl cellulose, hydroxy propyl cellulose or other agents known to those skilled in the art. Such agents are typically employed at a level of from 0.01% to 2% by weight. [0013] The present invention further comprises an article of manufacture comprising packaging material and a pharmaceutical agent contained within said packaging material, wherein the pharmaceutical agent is therapeutically effective for neuroprotection and wherein the packaging material comprises a label which indicates the pharmaceutical agent can be used for lowering intraocular pressure and wherein said pharmaceutical agent comprises an effective amount of mdivi-1 and an effective amount of nutlin-3. [0014] The following example is a representative pharmaceutical composition of the invention for topical use when indicated for treating glaucoma, ischemic optic neuropathy, hereditary optic neuropathy and retinal artery or vein occlusion. EXAMPLE I [0015] The combination of active pharmaceutical ingredients is as follows: mdivi-1 0.10% (w/v) and nutlin-3 Maleate 0.25% (w/v) [0016] The formulation vehicle contains an isotonic phosphate buffer system at pH 6.9. The formulation preservative is benzalalkonium chloride (BAK) at a concentration of 0.005% (w/v) (50 ppm). [0017] The invention has been described herein by reference to certain preferred embodiments. However, as obvious variations thereon will become apparent to those skilled in the art, the invention is not to be considered as limited thereto.

Disclosed are pharmaceutical compositions comprising mdivi-1 and nutlin-3, individually and in combination, for topical or intravitreal ophthalmic delivery and a method of treatment comprising administering said composition when indicated for glaucoma, optic neuropathies including Leber Hereditary Optic Neuropathy, arteritic or non-arteritic Ischemic Optic Neuropathy, and retinal artery and vein occlusions.

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority from provisional application Ser. No. 60/283,124, “Automatic Flavor-Injected Blending Apparatus and Method,” filed Apr. 11, 2001. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to the dispensing and mixing of multi-flavored drinks and semisolid foods such as milkshakes, frozen custards, slushes, slurries, and the like, and more particularly to an efficient and cost effective method of preparing a flavored shake or slurry. 2. Description of Related Art Beverage dispensing systems are used to provide consumers with beverages that are typically a mixture of previously stored concentrate and water. Further, milk shake machines are available for use in fast-food-styled restaurants, but such machines are typically expensive. In addition, storage of product used is typically within the machine thus demanding expensive retail space for placement and convenient use. By way of example, U.S. Pat. No. 5,056,686 to Jarrett discloses a beverage dispensing system for providing different flavored drinks mixed from concentrate and water. Containers including the different flavors of concentrate are stored for pumping to a hand held, “bar-gun” styled, dispensing nozzle. Valves within the dispensing head control the concentrate discharge when a selected beverage is desired, and an appropriate amount of concentrate and water are discharged simultaneously to ensure that the end beverage contains the desired mixture. User operated vending machines, such as that described in U.S. Pat. No. 5,341,957 to Sizemore, discloses a cup-type vending system which includes a currency output device and automatically outputs a beverage into a cup in response to a payment and selection of a beverage. The vending machine includes a plurality of disposable containers of beverage syrup, such as “bag-in-box” packages, stored in an auxiliary cabinet. A dispensing system functions to draw syrup from the disposable containers and selectively dispense a predefined or selected amount of syrup into an awaiting cup. The system includes pumping stages wherein one stage draws a selected amount of syrup from a package through a feed conduit and discharges the selected amount through a nozzle into the cup. By way of further example, U.S. Pat. No. 3,295,997 to Tomlinson et al. discloses a milk shake machine which include a mixer for reducing pre-frozen flavored ingredients stored within a container to a flavored milk shake with the addition of a preselected amount of milk supplied from a milk storage tank carried by the machine. U.S. Pat. No. 5,323,691 to Reese et al. discloses a frozen drink mixer for preparing blended beverages, particularly frozen drinks, in which an ice dispenser, liquid mix dispenser, and blender are combined into a single unit. The apparatus automatically delivers an appropriate amount of ice and liquid to the blender unit and turns on the blender at an appropriate time to prepare the frozen drink of desired size. A drink mixing and dispensing machine described in U.S. Pat. No. 2,855,007 stores a mix within a tank carried by the machine and pumps the mix through a freezing chamber prior to dispensing into a cup which is held under a mixing blade. Syrup pumps are also carried within the cabinet of the machine for dispensing one or two syrups into the cup before repositioning the cup under the mixer for dispensing and mixing the syrup with the milk shape styled mix. In the known prior art, such systems are calibrated to deliver a predetermined amount of flavoring, which obviates the possibility of serving different-volume containers. While a variety of milk shake styled syrup dispensing and mixing devices and methods are known in the art, there remains a need for an economical method for efficiently and cost effectively providing a customer with a plurality of options for a milk shake flavored as desired by the customer, including varied sizes and flavors. Further, the currently known systems require manual holding and movement of the cup during the blending process, which in a fast-food-style environment is too time-intensive. SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide an automatic flavor-injected blending apparatus and a method of use. It is another object to provide such an apparatus and method for making a plurality of sized blended foodstuffs. It is an additional object to provide such an apparatus and method that decreases human interaction time. It is a further object to provide such an apparatus and method that includes an inventory function. It is also an object to provide such an apparatus and method that includes an ability to monitor a temperature of a material to be used in the blended foodstuff. It is yet an additional object to provide an apparatus and method for tracking consumption data on a foodstuff. It is yet another object to provide such an apparatus and method for relaying tracked consumption data to a remote site. These and other objects are achieved by the present invention, an automatic flavor-injected blending apparatus. The apparatus comprises a base, a processor, and user input means in signal communication with the processor. The input means has means for entering a flavor selection chosen from a plurality of flavor selections. The apparatus further comprises a blending spindle that is rotatably affixed at an upper end to the base. The spindle has a blending blade adjacent a lower end thereof. Means for rotating the spindle is under processor control. A container support, which is adapted to hold, for example, a cup, is movably affixed to the base. The container support has a support surface adapted to hold a container thereon. The container support is movable between a lower position for placing the container thereon and an upper position wherein the support surface is closer to the spindle's upper end. Means under processor control inject the selected flavor into the container. Software means are resident in the processor that is adapted to receive the flavor selection and actuate the injecting means. The software means is further adapted to actuate the spindle rotating means and lower the container support from the upper position to the lower position. The method of the present invention is for automatically preparing a flavor-blended comestible responsive to an order therefor. The method comprises the steps of This system achieves an automatic process and apparatus therefor for mixing a comestible product in a container such as a cup, for example. The comestible may comprise, but is not intended to be limited to, a milk shake, fruit shake, smoothie, or frozen dessert. Since the blending process is automated, the server can start the apparatus, step away and attend to other duties while the apparatus is functioning, and return at a later time after the timer has turned off the spindle rotator. Further, an improved quality and perception of improved quality are both achieved, since the blending occurs at the time of order, and the consumer is served a freshly prepared product. As an additional feature of the present invention, the software means is also adapted to track consumption data based upon operator input. An output in signal communication with the processor provides means for relaying consumption information tracked by the processor to a remote site. Such a feature is not intended to be limited to the beverage apparatus aspect of the present invention, and will be seen by one of skill in the art to provide benefit for inventorying and tracking consumption data from any point-of-sale outlet. The features that characterize the invention, both as to organization and method of operation, together with further objects and advantages thereof, will be better understood from the following description used in conjunction with the accompanying drawing. It is to be expressly understood that the drawing is for the purpose of illustration and description and is not intended as a definition of the limits of the invention. These and other objects attained, and advantages offered, by the present invention will become more fully apparent as the description that now follows is read in conjunction with the accompanying drawing. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front perspective view of the blending apparatus. FIG. 2 is a side perspective view of the blending apparatus. FIG. 3 is a top side view of the cup holder. FIG. 4 is a front view of the cup holder bracket. FIG. 5 is a front view of the selection touch screen. FIG. 6 is a schematic diagram of the system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A description of the preferred embodiments of the present invention will now be presented with reference to FIGS. 1-6 . Front and side views of the apparatus 10 of the present invention are shown in FIGS. 1 and 2 , and a schematic diagram in FIG. 7 . The functions of the apparatus 10 are under control of a processor 30 , which has resident thereon software 53 for performing the control calculations and functions (FIG. 10 ). A base of the apparatus 10 comprises a housing 11 that has a substantially horizontal bottom 12 positionable on a serving surface such as a counter. A substantially vertical back 13 extends upward from a back edge of the bottom 12 . A shelf 14 extending substantially horizontally forward of the back 13 and above the bottom 12 forms a space 50 enclosed on three sides. Depending from the underside of the shelf 14 at its upper end 151 is a rotatable spindle 15 that has a plurality of blending blades 16 adjacent a lower end 152 . The spindle 15 is rotatable by a motor 52 , the actuation of which is under processor 30 control, as will be discussed in the following. Through the shelf 14 extend a plurality of ports 17 for injecting flavoring therethrough from a plurality of reservoirs 33 . Each reservoir 33 holds a unitary flavoring in a flowable state. A pump 32 is in fluid communication with a line 321 leading from each reservoir 33 to an inlet 171 of a respective port 17 . Each port 17 further has an outlet 172 , the outlets 172 positioned adjacent and in surrounding relation to the spindle's top end 151 . Affixed to the back 13 within the space 50 is a cup holder bracket 18 (see FIGS. 3 and 4 ) having a holder stop 56 positioned within a groove 181 in the bracket 18 . The holder stop 56 comprises a switch in signal communication with the processor 30 . Slidably affixed to the bracket 18 is a cup holder 19 that comprises a traveling attachment portion 20 having a slider 201 that is insertable into the bracket 18 and is slidable relative thereto and a support surface 21 extending generally horizontally outward from the attachment portion 20 . The holder stop 56 serves to limit the upward motion of the cup holder 19 and thereby define the upper position of the cup holder 19 . The support surface 21 has a generally circular hole 22 therethrough that is dimensioned to hold a bottom portion of a cup 23 . A handle 24 depends downward from the front of the support surface 21 . In a preferred embodiment the cup 23 will contain a frozen neutral-flavored product, and a generally dome-shaped lid 25 is placed thereatop that has a hole 26 dimensioned to permit the spindle blades 16 therethrough and to permit an injection of flavoring through the ports 17 . An actuator 27 such as is known in the art is affixed at a bottom end 271 to the bottom 12 adjacent the back 13 . The actuator 27 has a movable arm 28 extending from the top 272 thereof that is attached to a protrusion 29 extending from the cup holder's attachment portion 20 . In this application the user places a cup 23 in the hole 26 when the cup holder 19 is in the lower position and lifts the handle 24 until the attachment portion 20 reaches the holder stop 56 , with the cup holder 19 in the upper position. When activated, the arm 28 moves up and down for a predetermined amount of time while the spindle 15 is rotating, thereby moving the cup holder bracket 18 and the cup 23 for a predetermined time to sufficiently blend the selected product. Preferably the arm 28 moves over a sufficient vertical range in order to translate the spindle blades 16 from adjacent the cup's bottom 231 to adjacent a fill level 232 of the cup 23 , in order to achieve a desired complete mixing of the flavoring into the neutral-flavored product. The software 53 thus is adapted to direct a repetitive vertical movement of the cup holder bracket 18 relative to the spindle 15 in a range of motion between a first blending position and a second blending position, wherein the upper position is contained within that range of motion. A substantially transparent shield 55 is affixed to the housing 11 depending from the shelf 14 . The shield 55 forms a three-sided protective guard around the spindle 15 in order to prevent splash and also to minimize user contact with the spindle 15 during operation. Housed atop the shelf 14 is the processor 30 that, with the resident software 53 , controls the functions and timing of the apparatus 10 . The processor 30 is in signal communication with a plurality of relays 31 that in turn control a plurality of pumps 32 . Each pump 32 is in fluid communication with a reservoir 33 of flavoring, such as a syrup. Fluid lines 321 lead from each reservoir 33 to the ports 17 to deliver the flavoring to the cup 23 . The software 53 is in communication with a timer 54 housed with the processor 30 and is adapted to receive a signal entered by the user, for example, for determining which reservoir 33 to tap, and for how long to run the pump 32 , comprising a first predetermined time. The type of flavoring is based upon the selected product flavor, and the amount of flavoring is based upon the selected product volume. The signal also determines blending duration, which is dependent, for example, upon such criteria as the product size and type selected and product viscosity (FIG. 6 ). The blending duration comprises a second predetermined time. An input signal is entered by the user via a touch screen 34 such as depicted in FIG. 9 , although this configuration and the selections thereon are not intended as limitations. The touch screen 34 is in signal communication with the processor 30 . The touch screen 34 is a preferred, although not exclusive, input device because it is readily adaptable and reprogrammable to different situations as desired. For example, as shown in FIG. 9 , three flavors 35 and three sizes 36 are available. In addition, prompts to the user are provided to permit different screens to be displayed on a menu 37 , select a flavor 38 , clean the apparatus 39 , cancel an order 40 , change language 41 , and turn the apparatus off 42 . These choices are exemplary and not intended to be limiting, and one of skill in the art will recognize that any configuration and arrangement of selections is possible. As the apparatus 10 is under processor 30 control, it will be seen that a virtually limitless array of options can be programmed, which is important in being adaptable to different settings, and, make allowances for viscosity of the product and a tested required blending time for certain flavorings that require a longer blending time than others. The processor 30 also controls the speed of the actuator's travel up and down, which is programmable for desired product. An additional feature of the invention comprises means for tracking a temperature of a freezer 44 in which the cup of neutral-flavored product is stored prior to blending. A sensor 45 in the freezer 44 has an output leading to an input to the processor 30 , where the software 53 is also adapted to monitor the temperature to assure that it stays within a predetermined acceptable range. If the temperature falls out of that range, an alarm is sent to the screen 34 for viewing by the user. The present apparatus 10 has in an exemplary embodiment been tested to require approximately 7 sec to set up and 3 sec to release the completed product, a total of 10 sec operator time, which makes possible the use of this apparatus 10 in settings wherein minimizing operator intervention time is a critical, such as fast food and other take-out-type restaurants. In an alternate embodiment, the desired product may require no flavoring to be added by the apparatus 10 . For example, in the type of product having a nonfluid additive such as crushed cookies or small candies, the operator would add the additive to the cup 23 prior to positioning the cover 25 and placing the cup 23 in the holder's hole 26 . Then the automatic blending process can ensue. Another aspect of the present invention, which may be considered distinct from the blending apparatus milieu, comprises means for tracking product consumed, with all the associated data such as flavors, sizes, alarm status, etc. The software 53 tracks these data and is adapted to output them to a remote site 43 , whether at the same location but a different computer or a distant central data processing center, such as a corporate headquarters. A modem 46 in electronic communication with the processor 30 provides an exemplary channel for outputting these data, which, as will be understood by one of skill in the art, is readily configurable to a desired functionality. In the foregoing description, certain terms have been used for brevity, clarity, and understanding, but no unnecessary limitations are to be implied therefrom beyond the requirements of the prior art, because such words are used for description purposes herein and are intended to be broadly construed. Moreover, the embodiments of the apparatus illustrated and described herein are by way of example, and the scope of the invention is not limited to the exact details of construction. Having now described the invention, the construction, the operation and use of preferred embodiment thereof, and the advantageous new and useful results obtained thereby, the new and useful constructions, and reasonable mechanical equivalents thereof obvious to those skilled in the art, are set forth in the appended claims. A timer that is under processor control times an activation of the rotating means based upon the product flavor and the product volume while the support is in the upper position.

An automatic flavor-injected blending apparatus includes a base, a processor, and a user input in signal communication with the processor. A blending spindle is rotatably affixed at an upper end to the base and is rotatable under processor control. A container support is movably affixed to the base and is movable between a lower position for placing a container thereon and an upper position closer to the spindle's upper end. A selected flavor is injectable into the container. Software is resident in the processor that is adapted to receive the flavor selection and actuate the injection. The software is further adapted to actuate the spindle rotation. Since the blending process is automated, the server can start the apparatus, step away and attend to other duties while the apparatus is functioning, and return at a later time after a timer has turned off the spindle rotator.

CROSS-REFERENCED APPLICATIONS [0001] This application relates to, and claims the benefit of the filing date of, co-pending U.S. Provisional Patent Application Ser. No. 60/762,675, (Docket No. ROSS 3388000), entitled EXPANDABLE HOUSING GENERATOR, filed Jan. 27, 2006, the entire contents of which are incorporated herein by reference for all purposes. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to portable oxygen generators and, more particularly, to a portable oxygen generator utilizing a catalytic reaction within an expandable housing. [0004] 2. Description of the Related Art [0005] In many applications of portable catalytic oxygen generators, the end use may be for increasing the level of emergency preparedness. These oxygen generators may be stored or carried (e.g., by a consumer, worker, or other professional) in the event that an emergency may occur in which a safe source of oxygen is instantly required. In essence, the oxygen generators are maintained on a standby basis, similar to a typical fire extinguisher. In addition, the oxygen is generated on an on-demand basis at the moment of the emergency (e.g., medical or otherwise). As a result, for most of the life of the device, the oxygen generator is in a “primed mode” or “standby mode.” The period of time during actual operation (i.e., meaning the catalytic generation of oxygen, when the chemicals are mixed and the reaction takes place) may be quite negligible in comparison. [0006] Furthermore, during the chemical reaction that produces the oxygen, there may be foam that develops on the inside of the reaction chamber. This foam may rise during the course of reaction. The so called “foam head” can typically occupy up to 3 times the volume of the base reactants. This foam may be inhibited or reduced by the use of foam breakers, screens, or surfactants. The chemical reactions, the use of foam breakers, the means to deliver the resulting oxygen, and the activation systems, among other information, may be more extensively described in following pending patent applications. These patent applications are all inventions of a sole inventor, Julian Ross, except in certain cases in which Charles Keyes, Jr. is listed as a co-inventor. The entire contents of the patent applications are incorporated herein by reference for all purposes as the “Ross Catalytic Oxygen Patent Applications”: 1. Ser. No. 10/718,131, entitled “Method & Apparatus for Generating Oxygen,” filed Nov. 20, 2003, (Docket No. ROSS 2864000); 2. Ser. No. 10/856,591, entitled “Apparatus and Delivery of Medically Pure Oxygen,” filed May 28, 2004, (Docket No. ROSS 2934000); 3. Ser. No. 11/045,805, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jan. 28, 2005, (Docket No. ROSS 3050000); 4. Ser. No. 11/158,993, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050001); 5. Ser. No. 11/159,016, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050002); 6. Ser. No. 11/158,377, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050003); 7. Ser. No. 11/158,362, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050004); 8. Ser. No. 11/158,618, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050005); 9. Ser. No. 11/158,989, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050006); 10. Ser. No. 11/158,696, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050007) 11. Ser. No. 11/158,648, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050008); 12. Ser. No. 11/159,079, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050009); 13. Ser. No. 11/158,763, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050010); 14. Ser. No. 11/158,865, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050011); 15. Ser. No. 11/158,958, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050012); 16. Ser. No. 11/158,867, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Jun. 22, 2005, (Docket No. ROSS 3050013); 17. Ser. No. 11/438,651, entitled “Method and Apparatus for Generating Oxygen,” filed May 22, 2006, (Docket No. ROSS 2864003); 18. Ser. No. 11/558,374, entitled “Method and Apparatus For Delivering Therapeutic Oxygen Treatments,” filed Nov. 9, 2006, (Docket No. ROSS 3353001); 19. Ser. No. 11/560,304, entitled “Method and Apparatus for Delivering Oxygenated Heated Vapor in Skin Care Applications,” filed Nov. 15, 2006, (Docket No. ROSS 3361002); 20. Ser. No. 11/567,196, entitled “Method and Apparatus for Controlled Production of a Gas,” filed Dec. 5, 2006, (Docket No. ROSS 3367001); 21. Ser. No. 60/699,094, entitled “Method and Apparatus for Generating Oxygen,” filed Jul. 14, 2005, (Docket No. ROSS 2864002); 22. Ser. No. 60/735,011, entitled “Oxygen Patch,” filed Nov. 15, 2005, (Docket No. ROSS 3353000); 23. Ser. No. 60/736,786, entitled “Method and Apparatus for Delivering Oxygenated Heated Vapor in Skin Care Applications,” filed Nov. 15, 2005, (Docket No. ROSS 3361000); 24. Ser. No. 60/742,436, entitled “Flexible Reaction Chamber with Frangible Seals and Activation Methods,” filed Dec. 5, 2005, (Docket No. ROSS 3367000); 25. Ser. No. 60/763,121, entitled “Method and Apparatus for Delivering Oxygenated Heated Vapor in Skin Care Applications,” filed Jan. 27, 2006, (Docket No. ROSS 3361001); 26. Ser. No. 11/614,244, entitled “METHOD AND APPARATUS FOR PROVIDING IMPROVED AVAILABILITY OF BREATHABLE AIR IN A CLOSED CIRCUIT,” filed Dec. 21, 2006, (Docket No. ROSS 3380003); 27. Ser. No. 11/623,721, entitled “METHOD AND SYSTEM FOR PORTABLE BREATHING DEVICES,” filed Jan. 16, 2007, (Docket No. ROSS 3380008); and 28. Ser. No. 11/623,727, entitled “METHOD AND APPARATUS FOR PORTABLE SELF CONTAINED RE-BREATHING DEVICES,” filed Jan. 16, 2007, (Docket No. ROSS 3380009). [0035] The use of foam breakers, screens, or surfactants, as described in the Ross Catalytic Oxygen Patent Applications may be effective solutions for inhibiting the growth of the foam generated during the gas producing reactions. However, in certain instances the increase in positive pressure resulting from the reaction may reduce the effectiveness of the particular solution used for foam breaking. Therefore, allowing a sufficient “head space” for the foam to develop may become a highly desirable alternative. This may be especially true in high flow applications where the pressure may build up to significant levels inside of the reaction chamber (i.e., potentially presenting a safety hazard). The creation of an area of “head space” may be a complete solution or a partial solution. In other words, the portable generator may be designed with head space in addition to a foam breaker solution that may involve a barrier foam breaker such as a screen, mesh, or a surfactant. Alternatively, the head space could obviate the need for any additional foam breaker solution. [0036] However, designing an area for additional head space into the volume of the reaction chamber(s) may equate to a larger overall form factor for the generator, which may be undesirable. It would be beneficial to provide the additional volume when it is required (e.g., during the chemical reaction), but to otherwise maintain the smallest possible form factor for the majority of the life of the device (e.g., such as during storage and transportation). SUMMARY OF THE INVENTION [0037] An expandable generator for catalytically producing a gas that comprises oxygen. The expandable generator may comprise a housing base and a housing top translatably coupled to the housing base. The housing base may contain a first chamber, a second chamber, and a third chamber. The first chamber, the second chamber, and the third chamber may be separated from one another by frangible seals. The first chamber, the second chamber, and the third chamber may respectively store a first component, a second component, and a third component of a chemical reaction to produce the gas. The expandable generator may further comprise one or more activation tabs configured to breach the one or more frangible seals when actuated, thereby commencing the chemical reaction. The housing top and at least one of a group consisting of the first chamber, the second chamber, and the third chamber, may be configured to extend along a vertical direction. BRIEF DESCRIPTION OF THE DRAWINGS [0038] For a more complete understanding of the present invention and the advantages thereof, reference is now made to the following Detailed Description taken in conjunction with the accompanying drawings, in which: [0039] FIG. 1A shows an embodiment of an oxygen generator according to the present invention in a “standby mode”; [0040] FIG. 1B shows the generator of FIG. 1A partially deployed; [0041] FIG. 1C shows the generator of FIG. 1A fully deployed; [0042] FIG. 2A shows an embodiment of an inner cartridge prior to activation; [0043] FIG. 2B shows the inner cartridge of FIG. 2A subsequent to activation and fully expanded; [0044] FIG. 3A shows cross-sectional side view of an embodiment of an outer housing and a single inner cartridge assembly in a stand by mode; [0045] FIG. 3B shows cross-sectional side view of an embodiment of an outer housing and double inner cartridge assembly in a stand by mode; [0046] FIG. 4A shows a cross-sectional side view of another embodiment of an outer housing and double inner cartridge assembly in a stand by mode; and [0047] FIG. 4B shows a cross-sectional side view of the outer housing and double inner cartridge assembly of FIG. 4A subsequent to activation and fully expanded. DETAILED DESCRIPTION [0048] 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 present invention may be practiced without such specific details. In other instances, well-known elements 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 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. [0049] The entire contents of Provisional Patent Application Ser. No. 60/762,675, (Docket No. ROSS 3388000), entitled “EXPANDABLE HOUSING GENERATOR”, filed Jan. 27, 2006, is incorporated herein by reference for all purposes. [0050] Turning now to the drawings, FIG. 1A shows an illustrative embodiment of the present invention. In this drawing, reference number 10 generally indicates an expandable oxygen generating device 10 . The expandable generator 10 may comprise an outer housing base 100 , an outer housing top 110 , and a primed volume 125 . The expandable generator 10 may be seen in FIG. 1A in a primed mode, in which the outer housing top 110 abuts a top edge of the outer housing base 100 . The primed volume 125 may be sufficient to accommodate the chemical reactants, actuation mechanisms (if any), and filtration apparatus (if any). The outer housing top 110 may be releasably coupled to the outer housing 100 through the use of tabs, clasps, belts, overlapping interconnecting structures, among others. The outer housing top 110 may be vertically movable with respect to the outer housing base 100 . In this illustrative embodiment, the outer housing top 110 and the outer housing base 100 may be made of a rigid plastic or thermoplastic, such as for example polycarbonate or acrylonitrile butadiene styrene (ABS), among others. [0051] Turning now to FIG. 1B , the expandable generator 10 is shown at a point in time after the commencement of the oxygen producing catalytic chemical reaction. The outer housing top 110 may be translatably coupled with the outer housing base 100 via a flexible member 120 . The outer housing top 110 may be effectively extended or raised relative to the outer housing base 100 . The outer housing base 100 may remain relatively static or stationary. FIG. 1B shows the expandable generator 10 partially deployed. The flexible member 120 may be configured in the form of an accordion, so as to extend and fold as the unit is activated or placed into storage. [0052] Turning now to FIG. 1C , the expandable generator 10 may be fully deployed. The outer housing top 110 may be at a maximum height relative to the outer housing base 100 . The flexible member 120 may be fully expanded. In addition to the primed volume 125 , the expandable generator 10 may now comprise a top head volume 135 . Any foam generation that may occur as the result of the oxygen generating reaction may move into the top head volume 135 . [0053] Turning now to FIG. 2A , the expandable generator 10 ( FIG. 1A ) may comprise an inner cartridge 200 . The inner cartridge 200 may contain the reaction and provide an activation mechanism. The inner cartridge 200 may comprise a first chamber 210 , a second chamber 220 , and a third chamber 230 . The inner cartridge 200 may also comprise a frangible seal 212 , a frangible seal 214 , activation tags 215 , and activation tags 225 . In addition, the inner cartridge 200 may comprise an outlet port 240 . The outlet port 240 may provide an exit for the generated oxygen or gas, as the case may be, to exit the inner cartridge 200 and be transported to a user via a delivery tube, for example. [0054] The first chamber 210 may be separated from the second chamber 220 by the frangible seal 212 . The second chamber 220 may be separated from the third chamber 230 by the frangible seal 214 . Each of the three chambers 210 , 220 , 230 , may separately contain a component required for the oxygen producing chemical reaction. By manipulating the activation tags 215 , 225 (e.g., by pulling away from each other), the frangible seals 212 , 214 may be breached, allowing the chemical reactants to combine and commence the chemical reaction. However, other methods may be used to breach the frangible seals 212 , 214 , such as applying pressure to one or more of the chambers 210 , 220 , 230 , for example. In certain embodiments, the inner cartridge 200 may be made of a flexible material including, but not limited to plastic, rubber, neoprene, among others, and may be configured to expand upon commencement of the reaction. [0055] Turning now to FIG. 2B , this drawing shows the inner cartridge 200 in a fully expanded state, after the commencement of the reaction. As seen in this figure, all three chambers 210 , 220 , 230 may have expanded beyond their storage or primed configuration. However, embodiments of the present invention may not be limited to this example. In certain embodiments, the three chambers 210 , 220 , 230 may only have one expanding chamber, or two or more expanding chambers. As shown in FIG. 2A , the third chamber 230 may be formed with a series of folds to allow for an increased level of expansion after commencement of the reaction. The outlet port 240 may be configured to be attached to the top of the inner cartridge 200 . In such a case, the outlet port 240 may rise as the inner cartridge 200 expands. Prior to the outlet port 240 may be a foam breaker and/or a foam filter (not shown). The foam breaker may comprise open celled foams, coarsely woven materials, or expanded extrusions, among others. The material for the foam breaker may comprise polypropylene, polyethylene, among other materials inert to the catalytic oxygen generating reaction specifics and not configured to absorb water (i.e., hydrophobic). Various types of materials used in the foam breaker may create an open cell structure that may facilitate the flow through of gas but effectively break down the bubbles of the foam, potentially suppressing the growth of a foam head within the inner cartridge 200 . The foam breaker may also act as a pre-filter, breaking down bubbles, speeding the release of oxygen, and facilitating the return of water to the catalytic reaction. Additionally, the foam breaker may create a tortuous path for the generated oxygen gas, allowing the condensing of water and a cooling of the oxygen gas. More details and alternative embodiments for cartridges and activation of cartridges may be found in the Ross Catalytic Oxygen Patent Applications, the entire contents of which are incorporated herein by reference for all purposes. [0056] Turning now to FIG. 3A , the expandable generator 10 may comprise the inner cartridge 200 . As shown in this figure, the expandable generator 10 may be in a primed or standby mode, prior to commencing of the chemical reaction. The outer housing top 110 may be adjacent to the outer housing base 100 . In addition, the outlet port 240 may extend through the outer housing top 110 . As shown in the previous figures, as the inner chamber 200 expands, the outer housing top 110 may extend along with the outlet port 240 . The outer housing base 100 may be adhered or attached to the first chamber 200 to prevent the inner cartridge 200 from moving within the outer housing base 100 or becoming separated from the outer housing base 100 . The inner cartridge 200 may be attached to the outer housing base 100 through the use of brackets (not shown) situated proximate to an interior surface of the outer housing base 100 . Otherwise, the inner cartridge 200 may lift up as the outer housing top 110 is moved in an upward direction relative to the outer housing base 100 after activation. [0057] Turning now to FIG. 3B , another illustrative embodiment of the present invention may comprise an expandable generator 30 containing two or more inner cartridges 200 (e.g., two are shown in the figure) in a larger outer housing base 300 and outer housing top 310 . The first chamber 210 of each of the inner cartridges 200 may be attached to outer housing base 300 to prevent their moving up relative to the outer housing base 300 after activation. The inner cartridges 200 may be directly attached to the outer housing base 300 via chemical adhesives, fasteners, among others, or indirectly attached to the outer housing base 300 via intermediary members such as brackets situated at an interior surface of the outer housing base 300 , for example. The inner cartridges 200 may be removably attached to the outer housing base 300 so as to facilitate repair or reuse of the outer housing base 300 and the outer housing top 310 after a single emergency use. The outer housing top 310 may be movably coupled with the outer housing base 300 via a flexible membrane (not shown in this view). [0058] The two inner cartridges 200 may be fluidly coupled with an outlet manifold 340 . The outlet manifold 340 may be directly attached to each of the inner cartridges 200 . Alternatively, the outlet manifold 340 may be attached to each of the outlet ports 240 ( FIG. 2A ). The outlet manifold 340 may be coupled with the outer housing top 310 and configured to rise along with the outer housing top 310 after activation of the chemical reaction. Although only two inner cartridges 200 may be shown, the outlet manifold 340 may be configured to couple three or more inner cartridges 200 together within an appropriately sized outer housing. [0059] Turning now to FIG. 4A , another embodiment of the present invention may comprise an expandable generator 40 . The expandable generator 40 may comprise an outer housing base 400 and an outer housing top 410 . Within the outer housing base 400 , and the outer housing top 410 , the expandable generator 40 may comprise two or more inner cartridges 200 , an outlet manifold 440 , expandable connections 450 A, 450 B, an outlet riser 460 , and a water trap 500 . The water trap 500 and/or the inner cartridges 200 may be secured to the outer housing base 400 via a bracket 510 . [0060] The outer housing base 400 may further comprise a base lip 402 extending outward from the top edge of the outer housing base 400 . The outer housing top 410 may further comprise a top lip 412 extending toward the interior of the outer housing top 410 from a lower edge of the outer housing top 410 . The base lip 402 and the top lip 412 may substantially overlap one another in a vertical direction when the outer housing top 410 is assembled to the outer housing base 400 . Additionally, an outer edge of the base lip 402 may slidingly abut an interior surface of the outer housing top 410 . An interior edge of the top lip 412 may slidingly abut an exterior surface of the outer housing base 400 . The outer housing top 410 may slidingly translate in a vertical direction relative to the outer housing base 400 after activation of the chemical reaction. Seals 405 A, 405 B, 405 C, and 405 D, may allow the outer housing top 410 to sealingly slide relative to the outer housing base 400 after activation. The slidable coupling between the outer housing top 410 and the outer housing base 400 may eliminate the need for a flexible member attached to both components (e.g., as with flexible member 120 in expandable generator 10 shown in FIGS. 1B and 1C ). As shown in FIG. 4A , the outer housing top 410 and the outer housing base 400 may be in a primed or standby mode. [0061] Two or more inner cartridges 200 may be contained within the outer housing base 400 and the outer housing top 410 . The inner cartridges 200 may be fluidly coupled to one another via the outlet manifold 440 . The outlet manifold 440 may be fluidly coupled via the expandable connection 450 A to an inlet of the water trap 500 . An outlet of the water trap 500 may be fluidly coupled via the expandable connection 450 B to the outlet riser 460 . The outlet riser 460 may be coupled to the outer housing top 410 , so as to rise along with the rising of the outer housing top 410 after commencement of the chemical reaction. [0062] The water trap 500 and/or the inner cartridges 200 may be secured to an interior surface of the outer housing base 400 through a bracket 510 . Alternatively, the water trap 500 and/or the inner cartridges 200 may be secured to an interior surface of the outer housing base 400 through the use of fasteners, welding (ultrasonic or otherwise), adhesive, straps, or interconnecting surfaces, among others. The securing of the water trap 500 and/or the inner cartridges 200 may inhibit or prevent the unintended movement of these components during shipping and storage and inhibit or prevent the rising up of these components along with the rising of the outer housing top 410 relative to the outer housing base 400 after activation of the chemical reaction. [0063] Turning now to FIG. 4B , the expandable generator 40 is shown in a fully expanded state after activation of the oxygen producing chemical reaction. The outer housing top 410 may have translated relative to the outer housing base 400 such that an additional head distance of D1 may be present. Within the outer housing base 400 and the outer housing top 410 , the inner cartridges 200 may also be at a fully expanded state. As the inner cartridges 200 expand, they may move the outlet manifold 440 with respect to water trap 500 . The expandable connection 450 A may expand to accommodate this difference in distance. The expandable connection 450 A may be in the form of a convoluted tube folded upon itself. Alternatively, the expandable connections 450 may comprise a resilient material able to stretch an appropriate distance without folds, or the expandable connection 450 may comprise an extra length of resilient tubing stored within the outer housing base 400 . The outlet riser 460 may comprise some extra tubing to allow the outer housing top 410 to be opened without disconnecting the outlet riser 460 . [0064] The expandable generator 40 may be used as follows. The expandable generator 40 may be retrieved from storage in a primed or standby mode may be retrieved from storage. The activation tabs 215 , 225 ( FIG. 2A ) may be pulled or actuated. The frangible seals 212 , 214 ( FIG. 2A ) may be breached, allowing the previously separated reactants in each of the three chambers 210 , 220 , and 230 , to flow together, commencing an oxygen producing catalytic reaction. The inner cartridges 200 may start to expand, slidably moving the outer housing top 410 away from the outer housing base 400 . As the inner cartridges 200 expand, the outlet manifold 440 moves away from the water trap 500 . A flexible connection 450 A may provide for the maintaining of the fluid connection between the outlets of the inner cartridges 200 and the inlet of the water trap 500 . As gas flows through the tubing, the gas may be bubbled through water contained within the water trap 500 . Bubbled gas may then exit from the water trap 500 . [0065] The bubbled gas may flow from the exit of the water trap 500 into an expandable connection 450 B. The expandable connection 450 B may allow the outlet riser 460 to remain coupled to the outer housing top 410 through the expansion. From the outlet riser 460 , the generated oxygen gas may be administrated to a user or victim of an emergency situation. ALTERNATIVE EMBODIMENTS [0066] The outer housing top may rise relative to the outer housing base due to a pressure build up within an activated inner cylinder. However, the outer housing top may be manually pulled away from the outer housing base. Additionally, or alternatively, a separate mechanism may exists for moving the outer housing top away from the outer housing base, such as a lever, linkage, pneumatic strut, among others. Also, the outer housing top may be held in place away from the outer housing base due to a support mechanism. [0067] Having thus described embodiments of the present invention by reference to certain exemplary 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 of an embodiment of the present invention 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 the illustrative embodiments. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the scope of the invention.

An expandable housing generator configured to occupy a small volume in a primed or standby mode, and a larger volume after the commencement of a chemical reaction to generate a gas comprising oxygen. The expandable housing generator may comprise a base housing, a top housing, a first chamber, a second chamber, and a third chamber. The three chambers may separately store components of a catalytic reaction generating the gas. The three chambers may be joined together upon actuation of an activating device. The top housing and at least one of the three chambers may extend along a vertical direction. The extension may accommodate a foam head produced during the reaction. Additionally, the extension may provide a small form factor and consequently better portability and manageability, while also providing sufficient volume to perform the chemical reactions safely and effectively.

TECHNICAL FIELD [0001] The present invention relates to the field of baby bottles and in particular to baby bottles including separable compartments for storage of a dry powder(powdered formula) and a liquid (water) prior to use and means releasing, combining and for mixing same. BACKGROUND OF THE INVENTION [0002] Powdered baby formula is mixed with water to produce a liquid formula milk replacement for consumption by infants. The dry powdered formula may be stored for long periods of time without refrigeration. However, once the powdered formula is mixed with water, the liquid formula must either be used or refrigerated within a short period of time. Otherwise the liquid formula spoils. [0003] Powdered baby formula and water are typically mixed by combining predetermined amounts of powdered formula and water in the bottle, attaching the nipple and lid, and shaking the baby bottle to thoroughly mix the powder with the water. This mixing process may be safely and accurately performed with the aid of suitable measuring devices and substantially sterile surroundings. In addition, the mixed liquid formula and bottle may be stored and refrigerated for later use. [0004] However, where refrigeration is unavailable, it is necessary to perform the mixing process just before use. If proper measuring devices and substantially sterile surroundings are unavailable, the process becomes problematic because contamination, spillage and the production of incorrectly mixed formula can occur. When traveling, it is inconvenient to carry formula and water separately and to measure out and mix the ingredients every time formula is needed for a baby. DESCRIPTION OF THE RELATED ART [0005] U.S. Pat. No. 5,275,298 by Holley, Jr. teaches a multi-component bottle with a mixing valve including a ball valve body which is rotated to align two sets of apertures to release the powdered formula into the lower water compartment for mixing. Holley stores the powdered formula within the hollow ball portion of the ball valve. Holley requires the alignment of two pairs of apertures and uses a complex ball valve with a cam arrangement for opening and closing the valve, unlike the present invention which only requires alignment of an aperture of a rotatable disk and a fixed disk. [0006] U.S. Pat. No. 5,794,802 by Caola teaches a multi-component bottle with a push rod under the nipple which is used to force open a valve member. Caola's valve doesn't involve the alignment of two apertures or the same type of sliding element for opening as is used in the present invention. [0007] U.S. Pat. No. 6,045,254 by Inbar et al teaches a movable plug in a necked down portion of the bottle to separate the powder from the water. Turning a top portion of the bottle raises the plug and allows the powder to fall into the liquid [0008] U.S. Pat. No. 5,419,445 by Kaesemeyer has a sealing member between upper and lower compartments which is dislodged by twisting a lid portion on the top of the bottle. The sealing member falls to the bottom of the container. A user can't easily see when the sealing member is dislodged. SUMMARY OF THE INVENTION [0009] The present invention provides a baby bottle including a nipple and separable compartments for holding powdered formula and water. By sliding or rotating a knob to a pre-selected mix position, apertures in the separable compartments are aligned thereby allowing mixture of the powdered formula from an upper compartment into a lower compartment containing the water. The bottle is shaken to thoroughly mix the formula and the water, after which, the bottle and formula mix are ready to use. [0010] More particularly, with the present invention, there is provided a combination baby bottle and powdered formula and water storage device comprising a lid with a nipple, a two part mixing valve and a water compartment. The lid is a cylindrically shaped lid including a top wall, a first sidewall, and a nipple. The first sidewall contains first female threads. The top wall has a circular aperture formed therein sized to receive the nipple and the bottom surface of the top wall abuts a top surface of the outer marginal portion of the nipple. The first part of the two part valve is a cylindrically shaped stationary valve member includes a second sidewall with first male threads at a top edge. The first male threads are capable of being threaded into the first female threads to connect the lid to the stationary valve member. The stationary valve member includes a first circular bottom wall having a first aperture formed therein. The first aperture is sized to fit within a one third circular sector of the first bottom wall and is located so as not to include the center point of the first bottom wall. The second sidewall extends below the first bottom wall and includes second female threads. The second sidewall has a slot formed therein, the slot is above and parallel to the second bottom wall and extends around one third of the circumference of the second sidewall. The second part of the two part valve is a cylindrically shaped movable valve member having a third sidewall and a second bottom wall. The third sidewall has a first circumferential groove formed within the outside surface thereof which is located near a top edge. The third sidewall has a second circumferential groove formed within the outside surface and is located near the bottom edge. The first and the second grooves each have an polymeric or elastomeric sealing means such as an O-ring, washer, or disc disposed therein. The movable valve member is capable of being inserted within the stationary valve member whereupon the first bottom wall abuts the second bottom wall and the O-rings form a leak-proof seal between the second sidewall and the third sidewall. The slot is therefore situated between the O-rings and is sealed from leaking. The third sidewall has a rectangular window formed therein and located between the first groove and the second groove. The window contains a vertical axle with a lever pivoting thereon. The back side of the window is sealed off with a box which is integral with the third sidewall. The lever is capable of being fully contained within the window and the box and is capable of being pivoted out through the slot to a position where a user can push the lever to spin the movable valve member within the stationary valve member. The second circular bottom wall has a second aperture which is sized to fit within a one third circular sector of the second bottom wall. The second aperture is the same size as the first aperture and is located so as not to include the center point of the second bottom wall. The first aperture and the second aperture are totally mis-aligned when the lever is at a first end of the slot, thus keeping the formula powder separate from the water. The first aperture and the second aperture are totally aligned when the lever is at a second end of the slot. The cylindrically shaped water compartment includes a bottom wall and a fourth sidewall with second male threads at a top edge which are capable of being threaded into the second female threads to connect the stationary valve member to the water compartment. [0011] It is an object of the present invention to provide a pair of apertures contained in a rotatable disk and a fixed disk alignable whereby visible movement and positioning of same is clearly visible upon movement of an adjustment means such as a tab or knob located on the outside of the container. [0012] It is an object of this invention to provide a baby bottle and storage device which separately stores dry formula and water for subsequent mixing and feeding. [0013] It is an object of this invention to provide a baby bottle and storage device which provides any easy to use formula and water mixing valve. [0014] It is an object of this invention to provide a baby bottle and storage device which provides a convenient and easily recognizable indication as to whether the mixing valve is open or closed. [0015] It is an object of this invention to provide a baby bottle and storage device which is easily disassembled for cleaning. [0016] Other objects, features, and advantages of the invention will be apparent with the following detailed description taken in conjunction with the accompanying drawings showing a preferred embodiment of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0017] A better understanding of the present invention will be had upon reference to the following description in conjunction with the accompanying drawings in which like numerals refer to like parts throughout the views wherein: [0018] FIG. 1 is a front perspective view of the baby bottle. [0019] FIG. 2 is a perspective view of a lid with a nipple installed. [0020] FIG. 3 is a perspective view of the movable portion of the mixing valve. [0021] FIG. 4 is a perspective view of the stationary portion of the mixing valve. [0022] FIG. 5 is a perspective view of the water compartment. [0023] FIG. 6 is a top view of the stationary portion of the mixing valve. [0024] FIG. 7 is a top view of the movable portion of the mixing valve. [0025] FIG. 8 is a perspective view of the stationary portion of the mixing valve showing the opening lever extended and ready for use. [0026] FIG. 9 is a close up view of the opening lever on the movable portion of the mixing valve shown in FIG. 3 . [0027] FIG. 10 is a top view of movable valve member 14 inside stationary valve member 24 with the apertures 36 and 37 mis-aligned. [0028] FIG. 11 is a top view of movable valve member 14 inside stationary valve member 24 with the apertures 36 and 37 almost completely aligned. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0029] FIG. 1 shows a baby bottle 8 including a lid 10 with a nipple 12 , a stationary mixing valve member 24 with a slot 26 and a mixing lever 15 , and a water compartment 35 . FIGS. 2-5 show the individual components. Lid 10 , stationary mixing valve member 24 and water compartment 35 are cylindrical in shape. [0030] FIG. 3 shows the movable mixing valve member 14 which is inserted into the top opening 21 of stationary mixing valve member 24 in preparation for use. Movable valve member 14 has an outer diameter which is slightly less than the inner diameter of opening 21 of stationary valve member 24 and includes sealing means comprising circumferential bands or most preferably O-rings 16 and 20 trapped within circular grooves surrounding the outside of the sidewall of movable valve member 14 . O-rings 16 and 20 provide a seal as movable valve member 14 is pressed down into stationary valve member 24 . As shown in FIG. 9 , lever 15 pivots on axle 17 in the side wall of movable mixing valve member 14 . Leak proof storage housing 13 is an integral part of the sidewall of movable valve member 14 and contains lever 15 and axle 17 so that powder stored within movable valve member 14 or liquid which is released into movable valve member 14 will not escape through window 19 in the outer sidewall of movable valve member 14 . Lever 15 must be able to rotate out of the way into the storage position as shown in FIG. 9 while inserting movable valve member 14 into stationary valve member 24 [0031] When inserting movable valve member 14 into stationary valve member 24 , bottom wall 11 of movable mixing valve member 14 is pressed down and seated against the bottom wall 23 of stationary valve member 24 . Bottom wall 23 has a crescent shaped aperture 36 . FIG. 8 shows bottom wall 23 and crescent aperture 36 in phantom lines. Bottom wall 11 of movable valve member 14 has a crescent shaped aperture 37 . Once movable valve member 14 is placed inside stationary valve member 24 , lever 15 may be swung out to a usable position as shown in FIG. 1 . [0032] Lower portion 25 of stationary valve member 24 extends below bottom wall 23 and contains internal female threads (not shown) which are threaded onto male threads 32 to connect stationary valve member 24 to water compartment member 35 . [0033] Lid 10 includes female threads (not shown) which are threaded onto male threads 22 of stationary mixing valve member 24 , shown in FIG. 4 . Lid 10 also includes a top wall 9 containing an aperture through which is inserted a nipple 12 . The outer marginal edge of nipple 12 is compressed securely between top wall 9 of lid 10 and the upper edge of stationary valve member 24 to form a leak proof fit. Water compartment member 35 includes sidewall 34 , male threads 32 and a bottom wall (not shown). It is understood that when the baby bottle is fully assembled, the threads connecting lid 10 , stationary valve member 24 and water compartment 35 forma water tight seal so that baby bottle 8 does not leak during use. [0034] To use the bottle, a user first puts lever 15 in the storage position as shown in FIG. 9 . Then the user puts inserts valve member 14 down into stationary valve member 24 so that bottom wall 11 of movable mixing valve member 14 is pressed down and seated against the bottom wall 23 of stationary valve member 24 . Once movable valve member 14 is placed inside stationary valve member 24 , lever 15 is swung out to a usable position as shown in FIG. 1 . (With lever 15 in this position, apertures 36 and 37 are totally mis-aligned so that the powdered formula is prevented from dropping into water compartment 35 .) Next the user puts a selected amount of water in water compartment 35 . Then the user threads stationary valve member 24 onto water compartment 35 tightly. Then a selected amount of powdered formula is put into the stationary valve member 24 . Finally, lid member 10 (including nipple 12 ) is threaded tightly onto male threads 22 of stationary valve member 24 . [0035] In the travel or storage mode, as shown in FIG. 10 , movable valve member 14 is positioned within stationary valve member 24 such that the apertures 36 and 37 are totally mis-aligned. FIG. 11 shows lever 15 and movable valve member 14 have been moved almost all the way to a position where apertures 36 and 37 are aligned and there is just a small part 38 of aperture 37 which is still covered. When a user wants to mix the water and powdered formula, lever 15 is moved all the way to the left end of slot 26 . This causes apertures 36 and 37 to become aligned and the formula will fall into the water. However, it can be seen that even if the apertures are only partially aligned, mixing of the water and powdered formula will still occur. Now the baby bottle is shaken and is ready to use. It is understood that apertures of other shapes such as round, square, triangular can be used instead of crescent and the selected shape is a matter of choice. In one preferred embodiment, the apertures in the valve members are sized to fit within a one third circular sector, that is, a circular sector of 120°, or less so that the movable valve must not be moved an excessive amount to align the apertures. Further, slot 26 would only extend one third of the way around the stationary valve member 24 . [0036] The foregoing detailed description is given primarily for clearness of understanding and no unnecessary limitations are to be understood therefrom, for modification will become obvious to those skilled in the art upon reading this disclosure and may be made upon departing from the spirit of the invention and scope of the appended claims. Accordingly, this invention is not intended to be limited by the specific exemplification presented herein above. Rather, what is intended to be covered is within the spirit and scope of the appended claims.

A baby bottle including a nipple and separable compartments for holding powdered formula and water. By sliding or rotating a knob to a pre-selected mix position, apertures in the separable compartments are aligned thereby allowing mixture of the powdered formula from an upper compartment into a lower compartment containing the water. The bottle is shaken to thoroughly mix the formula and the water, after which, the bottle and formula mix are ready to use.

BACKGROUND OF THE INVENTION The typical mattress has a tufted surface with shallow indentations. To provide greater comfort and support for the body, and to protect the mattress itself, a pad is often placed between the mattress and the sheets. Such pads are traditionally composed of down, especially in feather beds, which provide great cushioning, loft and insulation, but which are excessively warm for many sleepers, and are relatively difficult to clean. Other commonly used pads are composed of cotton wadding, quilted within fabric layers. This material is easily laundered, but provides little loft or cushioning. Sheepskin, which is also used, provides cushioning, loft and insulation like down, but is often an allergen and is difficult to clean. Desirable filling material for mattress padding should be lightweight, resilient and washable. It should be soft to provide comfort, but not so delicate that it compresses completely under the weight of the reclining body. It is also helpful if the pad retains its shape and position on the mattress to allow sleeping comfort in any position. Natural materials such as down, cotton wadding or batting, kapok and the like have been widely used in the past for mattress padding but are now being replaced by synthetic materials, such as spun polyester fiber, and Dacron. Flexible foam material, such as convoluted foam padding, in some forms referred to as "egg crate" material, has many advantages, but lacks luxuriousness and smoothness. The very popular polyester fiber filling is disadvantageous because it tends to flatten out after time in use. The use of polyurethane foam is advantageous in several respects. The contour of the foam can be shaped to conform to the body; the foam is generally nonallergenic; it is easily cleaned; and it is relatively durable. It has become recognized, however, that air circulation between the body and the foam product is necessary for the user's comfort. Various attempts have been made to enhance circulation, and one of the most common expedients is to form the surface of the foam abutting the body into corrugations or convolutions. These may take the form of repetitive series of peaks and valleys. However, when the head or body of a user rests on such a surface, it is in direct contact with a plurality of points which tend to bend or be crushed. The body is not contacted as desired by a smooth surface, but rather by separated pressure points which may improve air circulation but which may still give rise to discomfort. Also, of course, the feeling of cushioned resilience which is normally associated with such foam products is not had. OBJECTS AND SUMMARY OF THE INVENTION A major object of the present invention is a mattress pad which retains and enhances the comfort derived from the use of foam products without sacrificing air circulation. Another object of the invention is the provision of a smooth, relatively continuous surface in contact with the user rather than a surface of spaced points. A further object of the present invention is to improve the durability of mattress padding. A still further object of the present invention is to simplify the cleaning and maintenance of sanitation of mattress padding. GENERAL DESCRIPTION OF THE INVENTION These and other objects, features and advantages have been achieved by enclosing foam sheets in a "pocket" or pouch made up of two layers of material. Both layers may be made of quilted ticking, or one may be quilted and the other a planar sheet. Each quilted layer is made of two sheets, within which polyester fiber batting is quilted. The pattern of quilting may be either channel style or onion style, the former having longitudinal stitching and the latter being stitched in roughly circular patterns forming separated areas shaped roughly like onions. The polyester fiber batting is retained in position by the quilted stitching. The two layers are joined together at three peripheral edges, the fourth edges, preferably at an end and adjacent corners of the assembly, being jointed by a zipper closure. A sheet of foam which may be convoluted is inserted in the pouch formed by the joined layers. As noted, the one layer forming the top surface of the mattress pad may be quilted and the second or lower layer may be of simple sheet material. The resulting assembled mattress pad is placed on top of a mattress and secured thereto by four elastic corner bands. In either embodiment of the invention, the quilted top member presents a smooth, comfortable and immobile surface to the user. The foam pad is removable to permit easy and effective cleaning, as well as laundering of the enclosing pocket. These and other objects of the invention will become more apparent from a consideration of the accompanying drawing constituting a part of the specification in which like reference characters designate like parts, and in which: BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a view in perspective of a bed on which a mattress is mounted, the mattress pad of the invention being attached to the mattress; FIG. 2 is a fragmentary view in perspective with the outer members cut away to illustrate interior structure; FIG. 3 is an exploded view of the mattress pad indicating the method of insertion of a foam pad in the pouch; and FIG. 4 is a cross-section of the mattress pad taken along the lines 4--4 of FIG. 3. DESCRIPTION OF PREFERRED EMBODIMENT In FIG. 1, a bed 10 is shown having a mattress 12 to which there is attached a mattress pad 14. The mattress pad may be retained in place by any conventional device such as corner straps 18 and 20. Similar corner straps, preferably made of elastic material, are provided at each of the four corners of the mattress pad. The mattress pad is made up of two envelope layers which are described in greater detail hereinbelow. The layers are joined about their peripheral edges by permanent stitching, except for one edge and adjacent corners, as at 22 and 24, which are detachably connected by means of a zipper closure 26. The two layers with their zippered opening form a pocket or pouch in which a foam sheet is retained during use of the mattress pad. For purposes of cleaning the mattress pad, the foam sheet may be removed. FIGS. 2 and 3 indicate the manner in which assembly and disassembly of the mattress pad may be achieved. Also, detail on a preferred form of foam pad 28 is found in FIGS. 2 and 3. Although the pad may be a in simple planar form, the preferred embodiment is one in which the pad is convoluted. It will be noted that the convolution shown is one in which spaced truncated conical apertures are formed. This may be done utilizing a foam convolution cutting machine of the type made and sold commercially by Edge Sweets, Inc. of Grand Rapids, Mich. as Model No. M-60 RSS & C. It includes a heavy steel frame in which an electric motor may be mounted to drive two counter-rotating rollers. The rollers have shaped intermeshing radially extending hammers mounted on their peripheries, and are held in proximity to each other on the frame. The electric motor also drives a saw blade in a path which includes a straight run in a line parallel to the axes of the rollers. The saw blade is somewhat similar to a conventional band saw blade. Material to be processed, generally a block of polyurethane foam, is fed into the bite of the rollers, and the block is compressed to a fraction of its original thickness as it is formed about the opposing rotating hammers which deeply indent the block from both sides. As the block passes beyond the point of deep indentation but before it expands and recovers its original thickness, the saw blade severs the peaks of foam formed by and about the hammers. In the areas of greatest compression, the foam block peaks are forced so far into the openings opposite the hammers that the saw blade cuts entirely through the two blocks formed by the blade from the original single block. The foam blocks are allowed to expand to their original thickness as they emerge from the hammers. The severed peaks of course also expand with the remainder of the blocks. When the are removed, they leave deep conical openings through the blocks. U.S. Pat. No. 4,603,445 discloses apparatus and a method such as that described above, as well as a similar product obtained by practice of the method outlined. In FIG. 2, a practical embodiment of the invention is shown to include an open end 40 into which a convoluted polyurethane foam pad 28 has been inserted. The open end 40 is provided with a zipper closure 26 which may run the full width of the end 40 and extend around the corners for several inches down each side to facilitate insertion and removal of the convoluted pad 28. To attach the entire unit to the mattress, elastic bands of which the band 18 (FIG. 1) is typical run diagonally across the four corners of the total assembly. The top layer or envelope 32 includes an upper quilted sheet 33. In this instance, a so-called onion pattern of quilting is used, the stitching forming a pattern of onion-shaped portions. The top envelope is completed by a second quilted sheet 34 which forms its lower surface. The top quilted member and the bottom quilted member are edge-stitched about their peripheries after the envelope is filled with polyester fiber, which is held in position in the envelope by the quilting. The convoluted foam pad insert 28 is approximately 1" thick and has a pattern of vertical openings of roughly conical shape, the large end of which is approximately the size of a quarter and the smaller end of which is approximately the size of a dime. These openings serve as "air ports⃡ to enhance air circulation within the assembly. The bottom envelope member 36 is formed identically to the top envelope member 52. The quilting pattern need not be of the onion type but may be made up of longitudinal channels. In the sectional view of FIG. 4, a top layer of another preferred embodiment of the invention includes two sheets of fabric 52 and 54 which are quilted together to contain pockets of polyester batting 56. A similar bottom quilted layer made up of basic sheets 62 and 64 quilted to contain polyester batting 66 is stitched peripherally as described above to form a pouch which contains a convoluted polyurethane layer 68. It will be seen that typical openings 70, 72 and 74 are formed through the convoluted foam pad to provide desired air circulation. As noted, however, although a quilted upper layer is preferred, the lower layer need not be quilted but may consist of only the fabric sheet 64. Typical dimensions and configuration of the mattress pad utilized in the invention are as follows. The open end of the pouch preferably runs the full extent of the end and encompasses a length about the adjacent corners and a short distance down the sides. The elastic bands, best seen in FIG. 1, typically run diagonally across the four corners of the total assembly. The top layer member of the pouch is shown with a so-called onion pattern of quilting, the two quilted sheets being filled with polyester fiber prior to the quilting and edge stitching. The foam pad is approximately 1" thick. If convoluted, the foam pad has a pattern of conical openings, the large ends of which may be approximately 1" and the small ends about 5/8. Openings of those sizes have proven to provide suitable air circulation. In some situations where firmness is a greater consideration, the openings do not pass entirely through the foam pad, only alternating peaks and valleys being formed, and circulation is limited to a horizontal flow.

A mattress cover in which a convoluted sheet of foam is removably enclosed in a pocket or pouch composed of two layers, at least one of which is quilted to enclose quantities of fiber batting. A zippered closure joins the two layers and may be opened to remove the layer of foam and permit effective laundering of the outer layers.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a continuous flow rotary pump, preferably a continues axial flow rotary pump for impelling liquid through at least one stage, by transferring energy from rotating elements of the pump to a continuous fluid stream, and more preferably the invention relates to a continuous axial flow rotary pump for use in blood circulation assistance, either in intravascular or extravascular circuits, with maximized efficiency and with no, or at least extremely minimized, blood damage, blood clotting, as well as minimum pump dimensions. Although particular reference will be made in the present specification to a blood pump, it should be understood that the present pump is for use in any other field wherein any fluid must be transferred from one place to another one, either in a closed circulation loop or in any open circuit or path. 2. Description of the Prior Art It is well known to provide an axial-flow rotary pump comprising a generically cylindrical casing and/or stator with a rotor, or a plurality of rotors mounted inside the stator to drive a fluid through the pump. The driving of the liquid to transfer the same from an inlet of the pump to a pump outlet is based in the provision of energy to the liquid to increase the fluid pressure thereof. This energy, however, provides several undesired side effects. The elimination of these effects without impairing the pumping efficiency of the pump has been the aim of many developments in the field of pumps, particularly when handling of sensitive fluids, such as explosives, blood, etc., is involved. Contours, sizes, assemblies and relative positions of the different parts, as well as the stationary and movable surfaces of a pump are aspects and parameters that must be defined when designing the pump. The final objective of the design is to get a maximum efficiency of the pump with a minimum or no side effects resulting from the energy transferred to the fluid during the impelling thereof. Particularly in the case of a blood pump design, the aim is to reach to a pump having a maximum efficiency without side effects causing blood damage and/or blood clotting during operation. Another important objective is to have a pump having a minimum size. The side effects resulting from the energy transferred during rotation of the pump comprise the generation of secondary or side flows, vortex, cavitation and separation of the flow from the surfaces of the stationary and movable parts of the pump. The continuous fluid flow behavior through a rotary pump provided with blades is mathematically defined by the Euler equation. According to Euler, pressure energy imparted by the rotor is proportional to the increment of the tangential component of velocity. Analysis of the Euler equation is made through the so called velocity triangles shown in FIG. 1 for a conventional scheme. Vectors represent averaged velocities on a flow surface and the letter references used in FIG. 1 are: ω angular speed R radius u = ω.R rotation velocity C absolute velocity W relative velocity C u tangential component of absolute velocity index 1 is used for the pump inlet index 2 is used for the pump outlet The Euler equation applied to a conventional rotary pump is: ( R · C u ) 2 - ( R · C u ) 1 = g · H η · ω where ,   H Head G Acceleration     due     to     gravity η Efficiency if     C u1 = 0 , we     have C u2 = g · H R 2 · η · ω This is the reason why traditional pump designs include stator blades at the pump outlet, thus trying to reduce as much as possible the tangential component of the velocity and transform the kinetic energy into pressure energy. Although many efforts have been made to eliminate or at least reduce the above mentioned side effects, by reducing or eliminating the above tangential component, for example, no solutions have been found hereinbefore. When a small Reynold's number is involved, that is when one handles small pumps and/or viscous liquids, stator blades at the pump outlet can not effectively reduce the tangential component of the velocity and transform kinetic energy into pressure energy, no matter the shape or number of blades provided. Therefore, flow separation and side flows are formed at the stator blades which cause hemolysis and blood clotting. There are indeed several patents disclosing pumps with stator blades at the pump outlet with the purpose of eliminating, as much as possible, the tangential component of fluid speed exiting the impelling stage of the pump. U.S. Pat. No. 4,846,152, issued to Richard K. Wampler, discloses a miniature intravascular blood-pump formed as a single stage with a rotor and an elongated stator, the rotor having two rows of blades and the stator having a single row of blades, within a tubular housing. The blades of the stator are reversed-twisted and have an unusual length to straightens and slow the blood flow so as to prevent the deposit of blood particles. This stator, however, does not provide for the elimination of any tangential component of the flow speed at the exit of the pump. U.S. Pat. No. 4,908,012 to John C. Moise, discloses an implantable ventricular assistance pump having a tube in which a pump rotor and stator are coaxially contained, and purge fluid is introduced into stator blades of the pump to avoid creation of discontinuities in the blood path wall. The object of this cited patent is to reduce the size of the implant and minimize the risk of infection by reducing vibration, minimizing the percutaneous conduit, and directing most of the heat generated by the pump into the blood. The problem of the flow kinetic energy is not addressed and, in fact, the provision of the bladed stator does not reduce the tangential component of the flow speed. U.S. Pat. No. 5,209,650 to Guy B. Lemieux, discloses a pump integral with an electric motor and impeller assembly that rotates within a stator casing and is supported on hydrostatic radial and thrust bearings so as to avoid having to provide external seals or friction type bearings. Although rotors rotating in opposite directions are provided in this patent, it is clearly disclosed in its specification that the invention addresses the problems that occur with leaking mechanical seals and worn bearings. While Lemieux specifically includes stay vanes pitched to diffuse the liquid from the second stage integral rotor and impeller assembly, the problem of kinetic energy and tangential components of the blood flow is not considered, and it can not be overcome in any way by providing, as disclosed and illustrated in this patent, axial rotors separated by axial stators. U.S. Pat. No. 5,211,546 to Milton S. Issacson discloses an axial flow blood pump including stator blades and rotor, the object of which is to minimize the structure by which the rotor is suspended with respect to the stator to minimize the overall diameter of the motor and pump combination. No considerations are made relating to the tangential components of the blood flow and the side effects resulting thereof. U.S. Pat. No. 5,588,812 to Lynn P. Taylor discloses an implantable electric blood pump having a motor stator and a rotor, the stator including blades for slowing and de-spinning the blood flow. U.S. Pat. No. 5,678,306 to Richard J. Bozeman discloses a method for optimizing each of a plurality of blood pump configuration parameters in the known pump components and variations. While Bozeman includes a diffuser with five to eight fixed blades for deaccelerating and redirecting the outflow at blood flow path exit to boost pump performance, the problem of the tangential components of the speed is not solved. U.S. Pat. No. 5,707,218 issued to Timothy R. Maher discloses an axial-flow blood pump having a rotor suspended in ball-and-cup bearings which are blood-cooled but not actively blood-lubricated. While, Maher includes outlet stator blades for slowing and de-spinning the blood flow for discharge into the pump outlet, again, the problem of the tangential components in the blood flow is not addressed. Other rotary pumps are known from U.S. Pat. Nos. 4,779,614; 5,040,944; 5,112,292 and 5,692,882 but these documents have not addressed the problem of the tangential component of the flow velocity. Concluding, the problem of the flow separation and secondary flows have not been addressed and solved by any of the patents mentioned above. It would be therefore convenient to have a continuous axial-flow pump having a minimum quantity of components and capable of providing a continuous flow without side effects resulting from the kinetic energy of the circulating fluid and affecting the fluid integrity, particularly to avoid the blood damage and blood clotting by eliminating the flow separation and secondary flows. 3. Summary of the Invention It is therefore one object of the present invention to provide a continuous axial-flow pump for impelling a fluid under a continuous pattern without side effects to minimize and eliminate damage to fluid, the pump comprising two axial adjacent rotors rotating in opposite directions. It is still another object of the present invention to provide a continuous axial-flow pump having at least one stage, comprising an outer casing and rotor means mounted in the casing, the rotor means comprising at least two adjacent rotors rotating in opposite directions. It is a further object of the present invention to provide a rotary assembly for providing a continuous axial-flow, comprising at least two adjacent rotors rotating in opposite directions and capable of being mounted in a pump, preferably a blood pump. According to the invention, it has been found that with the substitution of the stator blades at the pump outlet of a conventional pump by a rotating impeller rotating in a direction opposite to the one of the conventional rotor, the pump is effective in eliminating the tangential component of the flow velocity and transforming the kinetic energy of the flow into pressure energy. For defined combinations of speeds and outputs, the flow at the pump outlet is axial without flow separation, and secondary flows disappear. The above and other objects, features and advantages of this invention will be better understood when taken in connection with the accompanying drawings and description. BRIEF DESCRIPTION OF THE DRAWINGS The present invention is illustrated by way of example in the following drawings wherein: FIG. 1 shows a diagram of velocity triangles according to the Euler equation for a conventional rotary pump; FIG. 2 shows an elevation view, partially in section, of a basic construction for a pump in accordance with the invention; FIG. 3 shows a perspective view of two adjacent impelling rotors according to the invention; FIG. 4 shows an elevation view, partially in section, of a basic construction for a pump in accordance with another embodiment of the invention; FIG. 5 shows an elevation view, partially in section, of a basic construction for a pump in accordance with even another embodiment of the invention; FIG. 6 shows an elevation view, partially in section, of a basic construction for a pump in accordance with a further embodiment of the invention; and FIG. 7 shows a diagram of velocity triangles according to the Euler equation for a rotary pump according to the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Now referring in detail to the drawings illustrating the pump of the invention it may be seen from FIG. 2 that the inventive rotary pump indicated by general numeral reference 1 is comprised of two adjacent impellers or rotary means, preferably a first rotor 2 having impeller means comprising twisted blades 3 , and a second rotor 4 provided with impeller means comprising twisted blades 5 . Blades 5 are twisted in opposite or reversed direction relative to blades 3 . Rotors 2 , 4 rotate, according to the concepts of the invention, in opposite directions, as shown by arrows A, B, around longitudinal axis X of the pump. According to the rotary directions indicated by arrows A, B, the left side of FIG. 2 corresponds to inlet 6 of the pump while the right side of the Figure corresponds to outlet 7 of the pump. Preferably, opposite outer ends 8 , 9 of rotors 2 , 4 are cone-shaped to accommodate the fluid flow. Inner facing ends 10 , 11 of rotors 2 , 4 are adjacent so that an outlet of rotor 2 , when rotor 2 is an inlet rotor, is adjacent to an inlet of rotor 4 when rotor 4 defines an outlet rotor. The “inlet” and “outlet” terms are used to qualify the rotor that is at the inlet side 6 or at the outlet side 7 of the pump. Obviously, the inlet and outlet of the pump will depend on the rotary directions of the rotors. Although the directions are indicated with arrows A, B these directions can be inverted if desired. Rotors 2 , 4 may be conveniently arranged within a casing, preferably a cylindrical, tubular casing and stator motor components 13 , 14 may be provided to drive the rotors. First rotor 2 rotates by the driving action of stator motor 13 and transfers energy to the fluid flow, preferably the blood flow, and increases the tangential component of velocity of the flow. Rotor 4 counter rotates under the action of stator motor component 14 and transfers pressure energy to the flow as well as eliminates the above cited tangential component at the outlet side of the pump for given combinations of heads and discharges or outputs. FIG. 3 shows rotors 2 , 4 in a perspective view wherein blades 3 , 4 are clearly depicted to see the location and development thereof around the corresponding rotor. Blades 3 , 4 are twisted around the rotors, more precisely, the blades extend hellicaly over the rotors with blades 3 defining a first-direction helix and blades 4 defining a second-direction helix opposite to the first-direction. FIG. 4 shows another embodiment of the invention wherein each rotor has an entire cone-shape and both rotors are faced and adjacent by their cone-bases. The numeral references used for identifying the equivalent components of the several embodiments comprise the same numeral reference used in FIGS. 2, 3 plus a dot (.) and the number of the corresponding Figure. Thus, the rotors in FIG. 4 are indicated with 2 . 4 , 4 . 4 . Casing 12 . 4 has a profile to accommodate rotors 2 . 4 , 4 . 4 inside and motor components 13 . 4 , 14 . 4 will be arranged correspondingly around casing 12 . 4 , as it clearly shown. FIG. 5 shows another embodiment of the invention wherein each stator motor component 13 . 5 , 14 . 5 is combined with a band 15 , 16 for hydrodynamic suspension of the components. Finally, FIG. 6 shows another embodiment of the invention wherein each outer end of the rotors comprises a ball-socket bearing 17 , 18 that is mounted on a corresponding support 19 , 20 which in turn is fixed to casing 12 . 6 . It is to be noted that although motor components 13 , 14 have been illustrated the rotors may be actuated through other means such as one or more rotary wires connected to the rotors. Referring to FIG. 7 the average velocity triangles of Euler equation for the present invention may be seen, where: ω 1 , η 1 , H 1 are angular speed, efficiency and head of the 1 st impeller, namely the first rotor; ω 2 , η 2 , H 2 are angular speed, efficiency and head of the 2 nd impeller, namely the second rotor; in double index the first one is the number of the impeller and the second means: 1 —inlet of impeller 2 —outlet of impeller. The Euler equation for the first impeller is ( R · C u ) 12 - ( R · C u ) 11 = g · H 1 η 1 · ω 1 If C u11 =0, then ( R · C u ) 12 = g · H 1 η 1 · ω 1     and C u12 = g · H 1 R 12  η 1 · ω 1 For the second impeller is ( R · C u ) 22 - ( R · C u ) 21 = g · H 2 η 2 · ω 2 since (R.C u ) 21 =(R.C u ) 12 Then ( R · C u ) 22 = g · H 2 η 2 · ω 2 + g · H 1 η 1 · ω 1 The total head is H=H 1 +H 2 Finally, If     g · H 2 η 2 · ω 2 = - g · H 1 η 1 · ω 1 , then, (R.C u ) 22 =0 and C u22 =0 Therefore, the flow at the pump outlet is totally axial. With (H 1 and H 2 ) and (η 1 and η 2 ) having the same sign, note that the equation g · H 2 η 2 · ω 2 = -    g · H 1 η 1 · ω 1 is feasible only if ω 1 and ω 2 have opposite signs. This is the reason why our proposed scheme includes two impellers rotating in opposite directions. Stator blades at the pump outlet are not necessary any more. There is an increase of hydraulic efficiency and there is a dramatic reduction of blood damage and blood clotting. The present invention provides a continuous flow rotary pump housing defining a blood flow path therethrough, and two impellers (rotors) with blades mounted within the pump housing. Rotors are adjacent and counter rotate to each other, While preferred embodiments of the present invention have been illustrated and described, it will be obvious to those skilled in the art that various changes and modifications may be made therein without departing from the scope of the invention as defined in the appended claims.

A continuous flow axial-flow pump for impelling a fluid under a continuous pattern without kinetic side effects to minimize and eliminate damage to fluid, the pump comprising two axial adjacent rotors rotating in opposite directions.

BACKGROUND OF THE INVENTION This invention relates to improvements in inflatable furniture. Beanbag chairs have been popular for many years as a low cost furnishing. However the plastic beans get squashed and a beanbag needs refilling with plastic beans every few months. Inflatable chairs have recently become more popular. Both of the above types of chairs are not capable of being easily rocked or reclined. In addition, there is increasing interest in healthy activities such as massage and stretching. Massage tables can be relatively expensive, take up significant indoor space, and are not usually convertible into a chair. Folding massage tables are heavy and not easy to fold, carry or travel with. BRIEF SUMMARY OF THE INVENTION These problems are overcome by the present invention, which provides a convertible inflatable furnishing which comprises an inflatable base, an inflatable backrest, a fixing means to fix the backrest to the base, and an air passage between the base and the backrest allowing a flow of air between the base and the backrest when loads on the base and backrest change. The preferred embodiment allows the backrest to be easily reclined by an occupant leaning back on it and reducing their weight on the base. The fixing means is sufficiently flexible to allow the backrest to recline increasingly with deflation of the backrest when the backrest is under an increasing load. Also the occupant can easily rock on the chair to an extent constrained by a connecting means provided to connect a region of the base upper skin to a region of the base lower skin with the connecting means being in tension when the base is substantially inflated. The preferred embodiment can easily be converted into an excellent massage support structure which is relatively inexpensive. A retaining means is provided which can be operated to retain the backrest inside the base in a substantially deflated state so that it does not obstruct the massage. The outer shape of the base has a horizontal breadth of between 700 mm and 1000 mm enabling the base, when rotated onto a rim side, to support the torso of a person at a height where massage and other body manipulation and stretching are facilitated. The preferred embodiment can be packed into its own backrest for portability. A fastening means is provided to retain the deflated base inside the deflated backrest. A purpose of the convertible furnishing described herein is to provide a comfortable, rockable, reclinable, light, aesthetic, affordable, and environmentally-friendly armchair. The provision of a strong fabric outer cover enables the use of an environmentally-friendly, lightweight bladder constructed from non-PVC plastic. A purpose of the convertible furnishing described herein is to provide a massage support structure. The curved structure stretches the torso enabling deep massage and simultaneously stretching muscles and connective tissue similarly to yogic practices. The convex lying surface allows nurturing postures similar to those experienced in infancy on the mother's body. The injectable inflated structure allows a greater degree of displacement or pulsation to be introduced into the massage than is possible on standard massage tables. In the prostrate position the head may hang with the chin resting gently. This allows the face to be easily included in the massage. The convertible furnishing described herein can be used for massage, stretching, relaxation, sitting, floatation, and children's and adult's recreation. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING FIG. 1 shows an elevation view of an embodiment of the convertible furnishing with a backrest erect. FIG. 2 shows an elevation view of an embodiment of the convertible furnishing placed on its rim side with the backrest unerect and enclosed in the base. FIG. 3 shows a combined elevation and cross-sectional view of an embodiment of the convertible furnishing with backrest erect and the internal spatial arrangement of the bladder indicated. FIG. 4 shows a combined elevation and cross-sectional view of an embodiment of the convertible furnishing with backrest reclined with the internal spatial arrangement of the bladder indicated. FIG. 5 shows a view of a bladder laid flat. FIG. 6 shows a view of an embodiment of the convertible furnishing in a deflated state packed into its own backrest. FIG. 7 shows an elevation view of an embodiment of the fixing means as a disconnected portion of the convertible furnishing. FIG. 8 shows a cross-sectional view of another embodiment of the convertible furnishing with the backrest erect. DETAILED DESCRIPTION OF THE INVENTION An embodiment of the convertible inflatable furnishing as shown in FIG. 1 for sitting and other uses comprises an inflatable base 1 including a base upper skin 17 which forms a layer of the upper side of the base 1 and a base lower skin 16 shown in FIG. 3 which forms a layer of the lower side of the base 1 , and a rim side 6 which links the edge of the upper side of the base to the edge of the lower side of the base, an inflatable backrest 2 providing back support for a person sitting on the base 1 , a fixing means 21 to fix the backrest to the base upper skin 17 , and an air passage 3 between the base 1 and the backrest 2 allowing a flow of air between the inside of the base 1 and the inside of the backrest 2 when loads on the base and backrest change, and a first part of retaining means 4 and a second part of retaining means 5 wherein the air in the backrest can be squeezed out of the backrest through the air passage 3 into the base 1 and a first part of retaining means 4 and a second part of retaining means 5 can be fastened together to retain the backrest 2 in a substantially unerect state shown in FIG. 2 enabling use of the base 1 for various purposes including body therapies in situations where a protruding backrest 2 is an obstruction. The base upper skin 17 and the base lower skin 16 are layers of the base 1 which participate in holding the tension created by pressure when a load is on the furnishing. The base upper skin 17 and the base lower skin 16 may be gas impermeable layers or other layers. The fixing means 21 (hatched in FIG. 1) consists of a flexible closed-loop strip forming a single hole with the internal surface of the flexible closed-loop strip not substantially adhered to itself at any place to form a hinge (shown In FIG. 7 ), an upper edge of the flexible closed-loop strip permanently connected to a lower end of the backrest 2 and a lower edge of the flexible closed-loop strip permanently connected to the base upper skin 17 . In the present embodiment the air passage 3 is provided by the entirely open hole through the fixing means 21 . The location of the reversible flow of air through the air passage 3 is indicated by the double-headed arrow that is intended to indicate a flow of air inside the convertible furnishing (shown more clearly in FIG. 7 ). In this embodiment shown in FIG. 1 a cover 9 is provided on which the first part of retaining means 5 and a flap 10 are mounted. The second part of retaining means 4 is mounted on the side of the flap 10 which is facing the cover 9 and is hidden from view by the flap 10 . Incidental creases in the cover 9 are shown with dotted lines in FIG. 1 and FIG. 2 . FIG. 2 shows the embodiment of the convertible furnishing tilted on the rim side 6 with the backrest 2 deflated and inserted into the base 1 and the first part of retaining means 4 shown in FIG. 1 and the second part of retaining means 5 shown in FIG. 1 fastened together to retain the backrest 2 in a substantially deflated state inside the base 1 and hidden from view. In this embodiment the first part of retaining means 4 is hook strip and the second part of retaining means 5 is loop strip and these strips can be fastened together by the well-known press-seal method (e.g. Velcro). In this case the backrest is retained substantially inside the base 1 . When this method of retaining the backrest is used it is preferable that the hook strip is mounted on the side of the flap 10 that is facing the cover 9 as indicated, but hidden from view, in FIG. 1 . Then when a load is applied to the furnishing with the press-seal engaged as shown in FIG. 2 the resulting force on the strips is substantially tangential to the surface of the strips and does not tend to separate the strips. FIG. 3 is a combined elevation and cross-sectional view showing the interior of the embodiment revealing that the base 1 and the backrest 2 share a single bladder 8 , the fabric cover 9 covers the entire bladder 8 , and the base lower skin 16 and the base upper skin 17 are parts of the cover 9 . The bladder 8 is of a size and shape that when inflated fills the cover 9 so that the shape of the cover 9 substantially determines the shape of the furnishing. As shown in FIG. 3 a zip 14 is provided on the base lower skin 16 for internal access and a nozzle 15 is fixed to the connecting means 11 provided near and accessible through the zip 14 for inflating and deflating the bladder 8 . In this embodiment the bladder 8 is substantially tubular with sealed ends, and the axis of the tubular bladder 8 is curved around the connecting means 11 and the bladder 8 is sufficiently long that a region of the bladder 8 in the vicinity of one sealed end of the bladder 8 abuts a region of the bladder 8 in the vicinity of the other sealed end of the bladder 8 . The tubular bladder 8 follows a curved path 18 around the axis defined by the connecting means 11 . The curved dashed line shown in FIGS. 3 and 4 indicates this curved path 18 . A first bladder end 13 is part of one end of the bladder 8 and protrudes upward into the backrest 2 according to the curved path 18 when the backrest 2 is erect. The first bladder end 13 may be shaped similarly to the backrest 2 but is preferably slightly larger than the backrest 2 so that the bladder 8 fully erects and fills the backrest 2 when the retaining means 4 is released and a load is applied to the base 1 . In this embodiment a connecting means 11 shown in cross-section in FIGS. 3 and 4 is provided to connect a region of the base upper skin 17 to a region of the base lower skin 16 with the connecting means 11 being in tension when the base 1 is substantially inflated. In this embodiment the said regions are near the center of the base upper skin 17 and the center of the base lower skin 16 . The connecting means 11 is an elasticized fabric formed into a cylindrical shape with the ends of the cylinder sewn with circular seams onto the base lower skin 16 and the base upper skin 17 . The length of the cylinder is sufficiently short to substantially constrain horizontal mobility of the base upper skin 17 relative to the base lower skin 16 when the base lower skin 16 is placed on a floor thereby providing a more stable, comfortable seat. The connecting means 11 is preferably of sufficient length to allow an occupant of the seat to make small rocking movements while sifting on the base upper skin 17 . The connecting means 11 preferably has such a length as to constrain horizontal mobility of the base upper skin within 20 cm of the equilibrium position when a horizontal component of force of 100N is applied to the base upper skin. The connecting means 11 is preferably an elastic material of sufficient tensile strength and elasticity to absorb pressure shocks resulting from sudden loads applied to the furnishing, such as 100 kg failing one meter onto the furnishing. It will be realized that the connecting means 11 according to the present invention is not restricted to the fabric construction described above, but may use cord, strap, fabric or film with any combination of materials of sufficient strength including inelastic materials. The fastening system for fastening the connecting means 11 to the base lower skin 16 and the base upper skin 17 is not restricted to sewing, but may use any fastening system with sufficient tensile strength and purchase, including bonding and bolting systems. In the embodiment shown in combined elevation and cross-section in FIG. 3 and FIG. 4 the air passage 3 is provided by providing the base 1 and the backrest 2 with a single shared bladder 8 allowing the air to flow back and forth between the backrest 2 and the base 1 through the region of the bladder 8 where the backrest 2 joins the base 1 . The location of the reversible flow of air through the air passage 3 is indicated by the double headed arrow (shown more clearly in FIG. 7 ). The embodiment shown in combined elevation and cross-section in FIG. 3 and FIG. 4 allows the backrest 2 to be easily reclined by an occupant leaning back on the backrest 2 and reducing their weight on the base 1 . The fixing means 21 (hatched in FIGS. 3 and 4) is sufficiently flexible to allow the backrest 2 to recline increasingly with deflation of the backrest 2 including when the backrest 2 is under an increasing load, and to allow the backrest 2 to erect increasingly with inflation of the backrest 2 including when the load on the backrest 2 is reducing. In this embodiment the fixing means 21 is a flexible region of the fabric cover 9 where the backrest 2 joins to the base 1 . The fabric provides flexibility by folding and bending and contracting at the rear side of the fixing means 21 and bending and stretching at the front side of the fixing means 21 as shown in FIG. 4 . In the embodiment shown in FIG. 4, the connecting means 11 includes an elastic material biasing the region of the base upper skin 17 towards the region of the base lower skin 16 . The elastic material in tension preferably provides a elastic modulus capable of supporting an increased load on the backrest 2 wherein the supporting force tending to maintain erection of the backrest 2 is increased when the base 1 volumetrically expands due to increased pressurization of the base 1 resulting from increased compression of the backrest 2 . In this manner the erection of the backrest 2 is assisted by the tension in the connecting means 11 and a person reclining on the convertible furnishing experiences increased back support at all angles of recline. It will be realized that the convertible furnishing according to this invention is not restricted to an embodiment having a fabric cover 9 , but may use an uncovered single bladder or plural bladders with no cover or partial covers. FIG. 5 shows an embodiment of the bladder 8 as a laid flat tube. A nozzle 15 for inflation and deflation of the bladder 8 is positioned near the first bladder end 13 . The nozzle 15 is preferably fixed to the cover 9 or to the connecting means 11 in the position shown in FIG. 3 to assist in locating the first bladder end 13 in the backrest 2 . It will be realized that the nozzle 15 may be fixed in other locations in the region of the backrest 2 in order to locate the first bladder end 13 relative to the backrest 2 . The preferred material of the bladder is a plastic film such as polyurethane, polyethylene or PVC. The film may be admixed, laminated, or metalized to reduce gas permeability. In the embodiment shown in FIG. 6 the base 1 when deflated and backrest 2 when deflated have relative volumes allowing the base 1 to be fully inserted into the backrest 2 and a first part of fastening means 19 and a second part of fastening means 20 are provided to retain the deflated base 1 inside the deflated backrest 2 . In this embodiment the first part of fastening means 19 is also the first part of retaining means 4 and the second part of fastening means 20 is also the second part of retaining means 5 . When the base 1 has been inserted into the backrest 2 , the flap 10 can be folded open so that the first part of fastening means 19 , which is hook strip, faces and can be press-seal fastened onto the second part of fastening means 20 , which is loop strip, to retain the base 1 inside the backrest 2 for the purposes of packing and portability. Other fasteners such as a zip or studs could provide this fastening. FIG. 7 shows an elevation view of an embodiment of the fixing means 21 as a disconnected portion of the convertible furnishing shown in FIG. 1 . The fixing means 21 consists of a flexible closed-loop strip forming a single hole with the internal surface of the flexible closed-loop strip not substantially adhered to itself at any place to form a hinge. The location of the reversible flow of air through the air passage 3 is indicated by the double headed arrow. The fixing means 21 may be the only connection between the base 1 and the backrest 2 . A cross-sectional view of another embodiment of the convertible furnishing with the backrest erect is shown in FIG. 8 and comprises a gas-permeable cover 51 fully enclosing a flexible bladder 52 , wherein the gas-permeable cover 51 is shaped to farm a seat with a base 53 and a backrest 54 and the flexible bladder 52 is not shaped similarly to the gas-permeable cover when it is inflated outside the gas-permeable cover. In one embodiment the flexible bladder 52 is shaped as a laid flat tube as shown in FIG. 5 as bladder 8 and described previously. In the embodiment shown in FIG. 8 a connecting means 57 is provided inside the gas-permeable cover 51 connecting a lower portion of the backrest front side 55 portion of the gas-permeable cover 51 to the base lower side 58 portion of the gas-permeable cover 51 arid preferably but not necessarily attaching to the base lower side 58 more forward than the attachment of the connecting means to the lower portion of the backrest front side 55 , and the flexible bladder 52 when inflated fills the whole gas-permeable cover 51 , preferably without laterally displacing the connecting means 57 . Lateral displacement of the connecting means 57 could cause unwanted lateral distortion of the gas-permeable cover 51 . In the embodiment shown in FIG. 8 the backrest front side 55 is shaped to provide a substantially smooth, unfolded, surface above the place of attachment of the connecting means 57 to the lower portion of the backrest front side 55 thereby facilitating an even and uninterrupted flow of tension up the backrest front side 55 . In the embodiment shown in FIG. 8, a region of the gas-permeable cover 51 is flexible and shaped as a loop 56 (shown hatched and assuming that the bladder 52 is transparent) encircling the backrest 54 and including a lower region of the backrest front side 55 and optionally including a rear region of the base 53 adjoining the backrest 54 . The loop 56 is a region of the gas-permeable cover 51 that can bend or fold to allow the backrest 54 to recline in the same manner as fixing means 21 previously described with reference to FIGS. 3 and 4. In the embodiment shown in FIG. 8 the flexible bladder 52 has a fully inflated volume outside the gas-permeable cover 51 at least twenty percent greater than its fully inflated volume inside the gas-permeable cover 51 with said volumes being measured at a pressure less than two kilopascals. In the embodiment in the erect state of the backrest 2 shown in FIG. 1 the outer shape of the base 1 has a horizontal width transverse to the usual direction of sitting of about 850 mm, but preferably at least 600 mm, to enable the base upper skin 17 to puff upward beside the outer sides of a sitter's thighs thereby providing armrests 7 . In the embodiment as shown in FIG. 1 the outer shape of the base 1 has a horizontal breadth of about 850 mm enabling the base 1 to be tilted onto a rim side 6 as shown in FIG. 2 to provide support for the torso of a person at a height where massage and other body manipulation and stretching is facilitated. These activities are facilitated when a horizontal breadth of the base 1 is in the range 700 mm to 1000 mm. A small cushion may be provided for the chin-tip of a person lying prostrate along the rim side 6 . In the embodiment shown in FIG. 1 about half the air can be released so that the furnishing can be used as a seat supporting the occupant at a height and in a posture similarly to a bean bag seat. It will be realized that the convertible furnishing according to this invention is not restricted to having a single backrest 2 positioned at or near one edge of the base upper skin 17 , but may have one or more backrests positioned at any location on the base upper skin 17 .

A convertible inflatable furnishing is disclosed. The furnishing can form a chair shape that can be converted into a supportive shape for massage and stretching by deflating and securing the backrest inside the furnishing. The chair is also capable of being rocked, reclined, and packed into itself.

FIELD OF INVENTION The present invention relates to a paste formulation, a tool, and a system for root canal treatment, and more particularly relates to the paste used for root canal filling, a paste injector, and a system used therewith. BACKGROUND ART In dental clinical treatments, root canal treatments are popularly operated. Among the root canal treatments, root canal filling is operated at the final stage of the root canal treatment, and then the root canal filling has large effects on prognosis of a damaged tooth. Since the length to an apical constriction varies from individual patients, a length of the root canal must be measured. A method for this measurement includes, conventionally to measure an actual length of the tooth by using a reamer, a file, or a scale as detection probes for an x-ray photograph. Recently, a method for measurement of the root canal length using an impedance is widely used, because there is a case that the x-ray exposure is not adequate for a pregnant woman and the impedance measurement is speedy and provides exact results. The root canal length measurement by impedance conventionally uses a root canal meter. A working length is then determined to be the reamer length inserted in the root canal minus 1 mm which is indicated by a predetermined impedance previously measured depending on the conditions of the instruments for measurement when a top of the reamer contacts the periodontal membrane. Alternatively, the working length is determined as the length that gives current or resistance being different by a certain value from the value which indicates contact to the periodontal membrane. A root canal filling material, or root canal filling agent such as a filler paste formulation conventionally used for the root canal filling includes a gutta percha point used together with various sealers, silver points and a filler in a paste formulation which may be formulated with a sustainable disinfectant or an accelerator for healing with osteoid scar. Especially, a method for filling the paste formulation in the root canal portion includes filling the paste formulation through the reverse-rotated reamer operated by hand, filling by using a filling device with a helical shape such as Rentulo plugger, or filling the paste through a paste injector. However, the methods using the reamer and Rentulo plugger have disadvantages, because these methods require an extra procedure for measuring the root canal length and the special device. FIG. 9 shows a conventional method for filling the paste formulation into the root canal by the injector. In the conventional root canal filling method using the injector, the injector 1 shown in FIG. 9 ( a ) filled with the paste formulation M is used. The injector 1 comprises a container portion 2 and an insert portion 3 which may be inserted into the container portion 2 . A tube for injection of the filler is disposed at a front end of the container portion 2 to form an injection portion 4 . In FIG. 9 ( a ), the tip of the paste injection tube is inserted into the root canal portion which has previously been spread widely. In the conventional root canal filling method, as shown in FIG. 9 ( b ), the paste formulation M is injected into the root canal while inserting the filler injection tube into the root canal and pressing the insert portion 3 in the direction of the arrow A. When the filling is completed, the filler injection tube is drawn out from the root canal and then the root canal filling operation is completed. When the root canal is filled by the injector, as described above, an advantage to complete the injection easily and quickly may be provided without the procedure to measure the root canal length previously. However, this method has some disadvantages, that is, filling of the paste to the apical constriction is unknown and the paste formulation may irritate root peripheral tissues when the paste formulation is injected beyond the apical constriction. When the filling is not enough, a dead space and/or residual pulps may be allowed to exist. Therefore, there are needs for the paste formulation, the paste injector, and the system for detecting the paste filling. SUMMARY OF THE INVENTION In the first aspect of the present invention, a paste formulation for dental use comprising electric conductive material may be provided. In the first aspect of the present invention, the paste formulation is provided, wherein the electric conductive material is powder. In the first aspect of the present invention, the paste formulation for dental use may be provided, wherein the electric conductive material is selected from the group consisting of metal powder, metal oxide powder, coated inorganic powder by metal and/or doped metal oxide, carbon powder, carbon whiskers, and whiskers integrated with metal. In the first aspect of the present invention, the paste formulation for dental use may be provided, wherein the paste formulation includes at least one compound selected from the group consisted of calcium hydroxide, hydroxy apatite, tricalcium phosphate. In the first aspect of the present invention, the paste formulation for dental use may be provided, wherein the paste formulation includes at least one compound selected from the group consisting of iodoform, barium sulfate, anhydrous zinc sulfate, aluminum sulfate, and zinc oxide. In the first aspect of the present invention, the paste formulation for dental use may be provided, wherein the paste formulation includes at least one vehicle selected from the group consisting of silicone oil, guaiacol formaldehyde mixture, propylene glycol, dry ethanol, caster oil, liquid paraffin. In the first aspect of the present invention, the paste formulation for dental use may be provided, wherein the paste formulation includes at least one compound selected from the group consisting of iodoform, barium sulfate, anhydrous zinc sulfate, aluminum sulfate, and at least one vehicle selected from the group consisting of silicone oil, guaiacol-formaldehyde mixture, propylene glycol, dry ethanol, caster oil, and fluid paraffin. In the first aspect of the present invention, the paste formulation for dental use may be provided, wherein the paste formulation includes an x-ray contrast agent. In the first aspect of the present invention, the paste formulation for dental use may be provided, wherein the electric conductive material is present between 5˜50 wt % based on a solid of the paste formulation. In the first aspect of the present invention, the paste formulation for dental use may be provided, wherein the paste formulation includes at least one compound selected from the group consisting of calcium hydroxide, hydroxy apatite, tricalcium phosphate not less than 30 wt % based on a solid of the paste. In the second aspect of the present invention, a paste injector may be provided. The paste injector comprises; a container portion within which electric conductive paste is held, an insert portion inserted into the container portion, an injection portion for injecting the electric conductive paste formulation into a constricted portion, and an electric conductive member for electrically connecting the electrically conductive paste formulation to an external electrode. In the second aspect of the present invention, the paste injector may be provided, wherein the electric conductive member comprises a terminal exposed at an end face of the insert portion inserted into the paste container portion and contacting the electric conductive paste formulation, a terminal disposed at the insert portion and exposed outside the insert portion, and a lead line connecting between the terminals. In the second aspect of the present invention, the paste injector may be provided, wherein the electric conductive member is inserted through the insert portion. In the second aspect of the present invention, the paste injector may be provided, wherein the electric conductive member comprises an end extending through an inner path of the injection portion, an end drawn out of the paste injector, and a lead line connecting between the ends. In the third aspect of the present invention, a system for detecting paste filling may be provided. The system comprises; a paste injector comprising an electric conductive paste formulation and an electric conductive member for electrically connecting the electric conductive paste to an external electrode, a current detector for detecting the current flowing through the electric conductive paste formulation injected into a constricted portion, and a current display device for indicating the current flowing through the electronic conductive paste. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 shows the paste injector according to the present invention; FIG. 2 shows details of the paste injector according to the present invention; FIG. 3 shows a second embodiment of the paste injector according to the present invention; FIG. 4 shows an arrangement of a conventional system for impedance measurement used for detecting the working length; FIG. 5 shows a method for the root canal length measurement using the reamer and the impedance; FIG. 6 shows an arrangement for filing electric conductive paste D into the root canal of the damaged tooth by the paste injector of a first embodiment according to the present invention; FIG. 7 shows an arrangement for filing electronic conductive paste D into the root canal of the damaged tooth by the paste injector of a second embodiment according to the present invention in the same arrangement shown in FIG. 6; FIG. 8 shows an electric circuit arrangement used for testing the paste according to the present invention; and FIG. 9 shows a conventional root canal filling method by a conventional injector. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS The present invention provides an electric conductive paste formulation for dental treatment, i.e., an electric conductive paste formulation, a paste injector, and a system for detecting paste filling. Hereafter, the electric conductive paste formulation, the paste injector, and the system for detecting paste filling will be described using the drawings attached when necessary. The electric conductive paste formulation according to the present invention may be formulated by mixing a suitable electric conductive material with conventional compositions for forming of calcium hydroxide paste, zinc eugenol paste, iodoform paste, paraform-formaline paste. These conventional paste compositions may include Triozinc pasta which is a mixture of paraform aldehyde, anhydrous zinc sulfate, aluminum sulfate, potassium sulfate, zinc oxide mixed with cresol, phenol, and creosote; Kri 1 which is a mixture of iodoform powder, parachlorophenol campher, menthol, lanolin, glycerin; Carbitar which is a mixture of iodoform powder, calcium hydroxide powder, sulfathiazole powder, guanofuracin with a vehicle such as T-caine and guanofuracin; Bitapex which is a mixture of calcium hydroxide powder and iodoform powder with silicone oil; FR which is a mixture of calcium hydroxide powder, zinc oxide powder, barium sulfate powder, and a vehicle such as guaiacol-formaldehyde mixture, propylene glycol, dry ethanol, caster oil, liquid paraffin; Sealapex which comprises a polymer resin and calcium hydroxide. Other paste formulation such as Endofil which uses a polymeric material as a base and the paste formulations which use hydroxy apatite or tricalcium phosphate may be useful, because such paste formulations exhibit affinity to live tissues and accelerate hard tissues formation. These paste formulations may provide advantages that the formulation may be absorbed by the tissues if the paste formulation runs out from the apical constriction. The above described calcium hydroxide, hydroxy apatite, tricalcium phosphate may be included in the electric conductive paste in an amount not less than 30 wt %, more preferably not less than 50 wt % based on the weight of solid contents in the electric conductive paste formulation. The electric conductive material suitably used in the present invention may include electric conductive powder so as to be mixed sufficiently with the above described paste formulations. Such electric conductive powder may have a particle size between 200 Ř100 μm, more preferably, between 0.01˜80 μm, most preferably between 10˜50 μm in order to achieve a good filing performance. Shapes of the electric conductive powder may be a spherical shape, a needle shape, and a scale shape. The powder may include metal powder such as, for example, gold powder, silver powder, copper powder, nickel powder, metal oxide powder such as, for example, ZnO, SnO 2 , I 2 O 3 , ITO, various doped metal oxides such as antimony doped SnO 2 , BaSO 4 coated with metal, SnO 2 , or other electric conductive materials, TiO 2 powder coated by Ag, TiO 2 powder coated with SnO 2 , electric conductive carbon black, powder having high aspect ratio such as, for example, potassium titanate whisker coated thereon by Ag or Pd, whisker coated thereon by SnO 2 , electric conductive carbon whiskers. Particularly, needle type powder may provide an improved volume resistivity of the electric conductive paste formulation with low contents. The above described electric conductive paste may have volume resistivity from 10 −2 Ωcm to 10 6 Ωcm, and it is preferred that the resistance of the electric conductive paste formulation when injected in the root canal portion may exhibit resistance in an order of the resistance through the periodontal membrane. As described below, if the volume resistivity is too high, the detection of the paste injection may not provide sufficiently exact results. The electric conductive powder maybe present in the electric conductive paste formulation so as to provide the required volume resistivity to the electric conductive paste formulation, and the powder may present from 5 wt %˜50 wt % based on the solid of the paste formulation, more preferably present from 10 wt %˜30 wt % based on the solid of the paste formulation. The vehicles may present in the electric conductive paste formulation from 10 wt %˜70 wt %, more preferably from 30 wt %˜60 wt %. Hereinbelow, an exemplary embodiment of the paste formulation including calcium hydroxide as its major component and electric conductive metal powder will be explained. First, calcium hydroxide is prepared. This calcium hydroxide may be used under the specification of Japanese Pharmacopoeia having the particle size from 10˜50 μm. In this electric conductive paste, iodoform may preferably be present, because an anti-bacterial activity may be extremely enhanced, and an x-ray imaging performance may be also improved. In addition, a vehicle described above such as silicone oil etc. may be added to calcium hydroxide. Addition of the silicone oil may provide an anti-corrosion property to the paste formulation as well as providing an adequate flow performance. Other additives to the calcium hydroxide may be selected from various types. For example, x-ray contrast agents including bismuth bicarbonate, bismuth sulfate, zirconium silicate may improve the x-ray imaging performance of the paste. A dispersion method for the powder may be selected from any well-known conventional dispersion methods. Especially, when the electric conductive powder having the particle size between 10 and 50 μm is used as described above, it is possible to apply various mixing and/or dispersion methods, because aggregation of the powder may not be so severe. In the preparation of the electric conductive paste formulation according to the present invention, the paste formulation may be prepared, for example, by providing a paste formulation which is premixed with calcium hydroxide, iodoform, and silicone oil, adding the electric conductive powder, mixing the resulting paste formulation again to formulate the electric conductive paste formulation, then filling the resulting electric conductive paste formulation into the injector in a form of a cylinder for use when necessary. However, it is possible to mix a non-conductive powder such as calcium hydroxide and the electric conductive powder together with the vehicle such as silicone oil at the same time so that as the paste formulation according to the present invention may be obtained. In the above described embodiment, the conductivity/resistivity described above may be obtained by adding electric conductive powder such as gold, silver, copper, and nickel having the particle size described above. Since the electric conductivity is provided with the paste formulation, and the paste formulation may be injected into the root canal by an injector implemented with an electric conductive member, the adequate injection of the paste formulation to the root canal may be proved by detecting the resistance. Further, since the electric conductive powder is added to the paste, and the thermal and electric conductivities of the paste are improved, good thermal and electric properties may be obtained. When carbon powder is used, it is expected to absorb formaldehyde included in form-cresol which is used to treat the root canal and is also included as the major component of form-cresol. Referring to figures, an embodiment of the paste injector, which is able to inject the electric conductive paste formulation into the root canal and simultaneously to measure the electric resistance, will be explained in detail. FIG. 1 shows an exploded view of a first embodiment of the paste injector 1 according to the present invention. The paste injector 1 comprises the container portion 2 for holding the fill electric conducting paste formulation, the insert portion 3 being inserted into the container portion 2 , the injection portion 4 formed as a tapered tube toward the tip and disposed at the front end of the container portion 2 , and the seal member 5 disposed at the end of the insert portion 3 which is inserted to the container portion 2 . The container portion 2 and the insert portion 3 may be made of glass, or synthetic resin such as polypropyrene, polycarbonate, polyvinyl chloride. However, when handling performance such as damage is considered, the portions 2 , 3 may preferably be made of a synthetic resin such as polypropyrene, polycarbonate, polyvinyl chloride. The container portion 2 has a hollow inside portion within which the electric conductive paste formulation is held. The container portion 2 comprises a projection 2 a at the end opposite to the injection portion 4 with which insertion of the insert portion 3 is made easy when fingers are rested thereon. Materials for forming the injection portion 4 may be selected from any suitable materials so that the shape of the tapered tube of the injection portion 4 is formed to be thin and flexible. The insert portion 3 is used to extrude the electric conductive paste formulation held in the container portion 2 . The seal member 5 disposed at the front end of the insert portion 3 improves the seal between the inner face of the container portion 2 and insert portion 3 . Installation of the seal member 5 onto the insert portion 3 may be achieved through various methods including engaging the seal member 5 in the shape of pipe onto a recess formed to the insert portion 3 , or molding the seal member 5 made of a synthetic resin integrally around the insert portion 3 . At the end of the insert portion 3 opposite to the end inserted into the container portion 2 there is included a projection 3 a extending beyond the diameter of the insert portion 3 so as to make the insert easy by exerting force by fingers when the electric conductive paste formulation is injected into the root canal. The projection 3 a may be formed separately from the container portion 3 and then may be adhered by some types of adhesives as well as being integrally formed with the container portion 3 . When the electronic conductive paste formulation is injected into the root canal, the above described paste injector 1 is held by one hand, and holding the projections 2 a , 3 a between the fingers to exert the force to extrude the electric conductive paste formulation into the root canal. As shown in FIG. 1, the first embodiment of the insert portion 3 of the paste injector 1 according to the present invention is implemented with the conductive member. The conductive member comprises the end 6 , the terminal 7 , the end 8 , the terminal 9 , and the lead line 10 extending between the end 6 and the end 8 . These components form the conductive member by the end 6 being connected to the terminal 7 formed on the side of the seal member 5 which contacts the electric conductive paste formulation. Another end 8 is connected to the terminal 9 extending outside the insert portion 3 from the position adjacent projection 3 a formed on the insert portion 3 . The lead line 10 extends through the insert portion 3 , thereby the electric conductive paste formulation is connected electrically outside the insert portion 3 . The lead line 10 and the terminals 7 , 9 may be formed by insert molding when the insert portion 3 is molded, or by inserting them after molding thereof. FIG. 2 shows an enlarged cross section of the terminal connecting portion of the terminal 9 of the first embodiment of the paste injector 1 according to the present invention. FIG. 2 ( a ) shows an enlarged cross section of the insert portion 3 comprising the terminal 9 . As shown in FIG. 2 ( a ), the terminal 9 extends outside the insert portion 3 from a position adjacent to the projection 3 a and electrode 106 is connected to the terminal 9 through the clip. FIG. 2 ( b ) shows that the terminal 9 is disposed in the projection 3 a , and protrudes outside the insert portion 3 from the lateral side of the projection 3 a . FIG. 2 ( c ) shows that the terminal 9 has the opening 11 facing outside the insert portion 3 into which a needle electrode may be inserted or screwed. FIG. 2 ( d ) shows that the terminal 9 is formed as a band which extends circumferentially and radially about the insert portion 3 at a position adjacent to the projection 3 a of the insert portion 3 . The arrangement of the terminal 9 illustrated in FIG. 2 may be selected depending on easiness of handling and operation for the root canal filling, and the constructions shown in FIG. 2 may be used in any combinations each other. FIG. 3 shows a second embodiment of the paste injector 1 according to the present invention. FIG. 3 ( a ) shows a partial cut away cross section of the paste injector 1 , and the paste injector 1 comprises the container portion 2 and the insert portion 3 which is inserted into the container portion 2 . The injection portion 4 is formed as a tapered tube and is disposed at the front end of the container portion 2 . In FIG. 3 ( a ), the container portion 2 is partly cut away to show the electric conductive paste formulation D. In the injection portion 4 of the paste injector 1 of the second embodiment according to the present invention, the lead line 10 extends outside the paste injector 1 at about the curved portion thereof so that the distance between a tip of the injection portion 4 and the end of the lead line 10 may be substantially decreased with respect to the first embodiment so as to reduce adverse effects of the resistance of the electric conductive paste formulation D on the resistance measurement. In FIG. 3 ( b ), an enlarged cross section of the curved portion of the injection portion 4 attached to the paste injector 1 is shown. The second embodiment of the paste injector 1 shown in FIG. 3 ( b ) has the lead line 10 extending through inside path 4 a adjacent to the tip from the lead line inlet position formed at the injection portion 4 as close as possible such that the end 6 may be located adjacent to the tip. from which the electric conductive paste D is injected. When such construction is adopted, the distance between the end 6 and another electrode 104 (not shown) through the electric conductive paste formulation D may be reduced, thereby reducing the effect on the resistance measurements due to the resistance of the electric conductive paste formulation D. When the lead line 10 is drawn out of the paste injector 1 of the second embodiment according to the present invention, the terminals 9 shown in FIG. 2 may be used. Alternatively, without providing the terminal 9 , the lead line 10 is stripped at the both ends to obtain sufficient conductivity such that one end is disposed in the inner path 4 a . Another end may be drawn outside the wall of he injection portion 4 c while maintaining seal performance with a heat-seal or the adhesive 4 b . It is of course possible to mold the lead line 10 integrally when the injection portion 4 is molded. The lead line 10 drawn out of the paste injector 1 may be extended to the projection 2 a formed on the container portion 2 along to the outer lateral side so as not to contact the stripped end to an oral cavity, and thereafter be connected to an electrode of the apparatus for measuring resistance. The lead line used may have any thickness. However, to obtain good handling performance while not degrading the injection through the injection portion 4 , the lead line 10 may preferably be sufficiently thin. The lead line 10 may have a cover, or may not have a cover. Now, a system for detecting the paste filling will be explained hereinbelow with referring to FIG. 4 -FIG. 7 . FIG. 4 shows a conventional arrangement of a system for measuring the root canal length by the resistance or the impedance. When the root canal length is conventionally measured by the resistance, the operation thereof comprises steps of; first spreading the root canal portion of the damaged tooth T, next cleaning the spread root canal 21 by hydrogen peroxide while retaining hydrogen peroxide within the root canal 21 , and then inserting the reamer 20 into the root canal 21 . The resistance measuring device 100 comprises the current detector 101 , the power supply 102 , the control device 103 including relay circuit, the electrode 104 connected to the damaged tooth through the lip, the current display device 105 including a current indication device and/or an alarm device, and the electrode 106 connected to the end of the reamer 20 . The resistance measuring device 100 actuates the current display device 105 through the control device 103 based on the current signal detected by the current detector 101 . The resistance measuring device 100 acknowledges to the operator that the resistances or the current values become predetermined values, or the top of the reamer reaches to the apical constriction P, or the top of the reamer reaches to the position having a predetermined distance, i.e., about 1 mm from the apical constriction P. Usually, when the reamer 20 , reaches the periodontal membrane, the electric circuit formed between the reamer 20 and the electrode 104 , which is connected to a tube contacting a lip and being extended from a dental pump, has a resistance about 6.5 kΩ including an internal resistance of the system for resistance measurement. FIG. 5 shows a schematic illustration of the resistances. In FIG. 5, the resistance of the reamer 20 is shown by the reference numeral R 1 . As shown in FIG. 5, the reamer 20 , the periodontal membrane, and the electrode 104 usually connected to the dental tube form an electric circuit including a resistance R 1 . Usually, the inside of the root canal in which the reamer 20 is inserted is cleaned and is almost dried under the measurement. Therefore, the current may not substantially flow in the circuit. However, the current begins to flow due to effects of exudate, and/or conductivity of hydrogen peroxide used in the cleaning process and remained therein as the top of the reamer 20 moves toward the periodontal membrane. When the reamer 20 reaches the periodontal membrane, the entire circuit resistance becomes the above explained resistance of about 6.5 kΩ. The present invention uses the electric conductive paste formulation D as a probe electrode rather than using the reamer 20 as the probe electrode for the measurement of the root canal length. FIG. 6 shows an arrangement when the electric conductive paste formulation is filled in the root canal 21 of the damaged tooth T using the paste injector 1 according to the first embodiment of the present invention. As shown in FIG. 6, the terminal 9 is connected to the electrode 106 of the resistance measurement device 100 , and the electrode 104 of the resistance measurement device 100 is connected to the dental tube. In the condition illustrated in FIG. 6, no current, or very low current flows through the current detecting device 101 , and then the resistance is held high. FIG. 7 shows the filling process of the electric conductive paste formulation D into root canal 21 using the same arrangement shown in FIG. 6 while the paste injector 1 according to the second embodiment of the present invention is used. As shown in FIG. 7, as the filling of the electric conductive paste formulation D proceeds and the electric conductive paste formulation D becomes closer to the apical constriction P, a week current starts to flow through the electric conductive paste formulation D. Finally the electric conductive paste D contacts the periodontal membrane, and then the resistance R 1 of the reamer 20 is replaced to the resistance R 2 . The resistance R 2 depends on the distance between the position where the lead line 10 contacts the electric conductive paste formulation D within the injection portion 4 and the periodontal membrane. Therefore, the detection of the filing of the electric conductive paste formulation D to the apical constriction P is determined by monitoring the resistance to be (6.5 kΩ−R 1 +R 2 ). Alternatively, the relation between the distance from the periodontal membrane to the electric conductive paste formulation D including conductive metals, or conductive metal oxides and the resistance is previously measured by x-ray photographs, and then the distance from the periodontal membrane may be estimated when the resistance reaches a certain resistance higher than (6.5 kΩ−R 1 +R 2 ). As described above, since the present invention uses the paste formulation filled in the root canal as the current probe, once the resistance reaches the above certain value, it is determined that the filling of the root canal by the paste formulation is completed. The construction described above allows the reduction of the complexity of root canal filing and/or injection operation that previously requires duplex steps; measuring the root canal length by the impedance, and next spreading the root canal portion and then inserting the gutta percha point to complete the filling of the root canal. In addition, the detection of whether or not the paste formulation is sufficiently filled within the root canal becomes easy, whereas such detection is regarded to be difficult in the conventional root canal filling/injection operation. Therefore, the present invention can provide a system for detecting paste filling which makes the measurement more speedy and easier, and that insures the filling of the paste formulation. The power supply 102 used may be selected from a direct current type or an alternating current type, and the value of R 2 and the internal resistance etc. may be selected as requested. The measurement etc. may be achieved through resistance measurement or impedance measurement depending on the kinds of the power supplies used. It may possible to alarm the operator to pay attention when the predetermined working length is obtained. Hereafter, the present invention will be explained in detail by examples, however, these examples are provided only for explanation of the present invention and do not intend to limit the scope of the present invention. EXAMPLES Example 1 To a solid component including 50 wt % of calcium hydroxyde, iodoform 20 wt %, 30 wt % of silicone oil was added and mixed to prepare a paste formulation. To this paste formulation, further 10 wt % of a silver powder based on the weight of the above solid component was added and mixed to form a paste formulation according to the present invention. The current of 5 mA was flowed in the resultant electric conductive paste formulation as measured by an ampere meter. Next, a lead line having 0.1 mm diameter was inserted into an injection portion of a commercially available paste injector so as to prepare the paste injector according to the present invention as shown in FIG. 3 . The electric conductive paste as prepared above was filled in the paste injector, and the paste discharge through the tip portion was confirmed. A circuit illustrated in FIG. 8 was constructed using a pulpless tooth and injecting the electronic conductive paste formulation into the root canal 21 using the paste injector in order to operate the root canal filling. The front end of the electrode 104 of the resistance measurement device 100 was located inside the root canal 21 slightly above the apical constriction P. As the injections of the electric conductive paste formulation was started and proceeded, the current detector 101 detected the current through the circuit shown in FIG. 8 . Thereafter, the injection portion of the paste injector was pulled out carefully from the pulpless tooth, and an x-ray photograph was taken to observe the filling condition of the electric conductive paste formulation. It was confirmed that the electric conductive paste formulation reached to the apical constriction P. That is, the detection of the circuit formation by the electric conductive paste formulation reached to the apical constriction P indicated the completion of the root canal filling. Example 2 40 wt % of hydroxy apatite, 10 wt % of barium sulfate, 50 wt % of silicone oil were mixed together to form the paste formulation. Au powder of 25 wt % was mixed to the above paste formulation. The current of 3 mA flowed in the resultant paste as measured by the ampere meter. The resultant electric conductive paste formulation was used in the same test as described in the Example 1. It was confirmed that the electric conductive paste was filled in the apical constriction P of the damaged tooth. INDUSTRIAL AVAILABILITY As described above, since the present invention uses the paste formulation filled in the root canal as the current probe, the completion of the paste formulation into the root canal is immediately detected when the resistance becomes the above described value. Therefore, conventional duplex procedures comprising measuring the root canal length by the impedance measurement, next spreading the root canal, and then inserting the gutta percha point so as to fill the root canal is not required. In addition, the detection whether or not the paste is entirely filled in the root canal becomes easy, which was difficult in the conventional root canal filling operation using paste. The present invention may provide the system for detecting of paste filling which is carried out more speedy and easier while insuring the sufficient filling of the paste. The present invention has been explained by non-limiting exemplary examples, however, it is appreciated by a person skilled in the art that many other variations, modifications, and omissions may be possible within the scope of the invention as described in the appended claims. True scope of the present invention will only be limited by the claims.

A paste formulation for dental use, a paste injector, and a system for detecting paste filling are disclosed. The paste formulation includes electric conductive material. The present invention also discloses the system for detecting paste filling comprising a paste injector containing electric conductive paste and an electric conductive member for electrically connecting the electric conductive paste to an external electrode, a current detector for detecting the current flowing through the electric conductive paste held in the container portion, and a current display device for indicating the current flowing through the electric conductive paste.

FIELD OF THE INVENTION The present invention relates generally to the art of food manufacturing, and more particularly relates to machines for manufacturing starch molded products also commonly known as mogul machines. BACKGROUND OF THE INVENTION Mogul machines have been used for many years in the manufacture of starch molded products such as pectin, gelantine, agar, agar-based jellies, gummies, liquorice, fondant, cream, marshmallow foam, and other similar materials. Many of these products are commonly referred to as candy. Mogul machines may also be used for depositing liqueur. The typical process for making these forms of candy or other starch molded products include dumping starch into trays, stamping cavities in the starch, pumping a liquefied candy mixture into the cavities, curing of the candy to allow it to sufficiently harden (e.g. drying), and then separating the candy from the starch. While the above process results in high volume production of candy, it has drawbacks. One problem that has existed for years since the existence of mogul machines is that a large amount of starch is lost when the cavities are stamped into the tray full of starch, particularly during subsequent movement of the tray and vibrations which can cause starch to spill over the top wall of the tray. This can translate into a loss thousands of dollars of year for candy manufacturers. BRIEF SUMMARY OF THE INVENTION It is therefore an objective of the present invention to reduce the starch loss in mogul machines due to the stamping of cavities into the starch. In that regard it is an further objective to reduce starch loss while maintaining speed and quality of starch molded products for economic feasibility. In accordance with these and other objectives, the present invention is directed toward a method of reducing starch loss by lowering the level of starch below the tray edge. According to the method, the tray is first filled with starch. The tray has a horizontally extending base and a vertically extending peripheral border wall containing starch in the tray. The border wall has a top edge. The starch is then leveled in the tray to a level below the top edge. Then, a plurality of cavities a formed into the starch which are then filled with liquefied starch molded mixture (e.g. liquefied candy). The liquefied starch molded mixture is then cured (e.g. dried) to form the starch molded products such as candy. The starch molded products are then separated from the starch. The present invention is also direct toward a mogul machine for manufacturing a plurality of starch molded products. The mogul machine uses a plurality of trays that hold starch. Each tray has a horizontally extending base and a vertically extending peripheral border wall containing starch in the tray. A conveyor mechanism conveys the trays with the top edge of the tray situated at a first vertical height. A starch depositor disposed along the conveyor mechanism deposits starch into the trays. A starch leveler (comprising at least one resilient member with a bottom leveling edge) levels the starch to a second vertical height below the first vertical height. The resilient member is sufficiently resilient to deflect past the top edge of the tray without damage to the tray or the resilient member. A recycling hopper is disposed underneath the starch leveler to catch starch removed by the starch leveler. After leveling of starch, the trays pass through a stamping station where a stamping plate stamps cavities into starch in the tray. The trays then pass through a pumping station that pumps liquefied starch molded product into cavities. The present invention also directed toward an apparatus for reducing starch loss in a mogul machine that can be used on an existing mogul machine as a retrofit or used in a new mogul machine. The apparatus comprises a pair of mounts for mounting to the mogul machine. The mounts are mounted to the mogul machine in spaced apart relation a distance greater than a width of the conveyor mechanism but less than an overall width of the mogul machine. A pair of support posts project vertically from the mounts such that the posts extend vertically above the conveyor mechanism when the mounts are mounted to the mogul machine. A cross support extends horizontally between the posts and is supported by the posts. An elongate blade is mounted to the cross support and extends vertically downwardly from the cross support. An elongate brush is also mounted to the cross support and extends vertically downwardly from the cross support in spaced relation to the elongate blade. Other objectives and advantages of the invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention. In the drawings: FIG. 1 is a side elevation view of a preferred embodiment of a mogul machine. FIG. 2 is a front elevation of a preferred embodiment of a starch leveler for use on a mogul machine such as that illustrated in FIG. 1 with part of the mogul machine frame and conveyor carrying a tray illustrated. FIG. 3 is a front view of the brush of the starch leveler illustrated in FIG. 2 . FIG. 4 is a front view of the resilient leveling blade of the starch leveler illustrated in FIG. 2 . FIG. 5 is a side elevation of the starch leveler illustrated in FIG. 2 . FIG. 6 is a cross section of the starch leveler of FIG. 2 illustrated in operation on an exemplary tray of starch. While the invention will be described in connection with certain preferred embodiments, there is no intent to limit it to those embodiments. On the contrary, the intent is to cover all alternatives, modifications and equivalents as included within the spirit and scope of the invention as defined by the appended claims. DETAILED DESCRIPTION OF THE INVENTION A preferred embodiment of the present invention has been depicted as starch leveler 20 as illustrated in FIGS. 2-3 incorporated into a mogul machine 22 as illustrated in FIG. 1 . Referring to FIG. 1, the mogul machine 22 includes multiple stations through which a plurality of trays 24 travel in order to make starch molded products such as candy. For purposes of reference, the disclosed mogul machine 20 includes generally the following stations/systems: a tray feeder 26 , a conveyor mechanism 28 , a starch and candy dumping mechanism 30 , a starch separation and reclamation system 32 , a starch depositor 34 , a starch leveler 20 , a candy cavity stamping station 38 , one or more candy pumping stations 40 , a tray stacker 41 and a bottom tray return conveyor 39 . Although one particular form of a mogul machine 22 is disclosed, other mogul machine configurations are known. As such, it will be appreciated that the invention is applicable across all mogul machines which can be used to stamp or print cavities into starch and fill the cavities with liquefied candy material. In operation, trays 24 containing cured (or dried) candy and starch from a previous run are stacked in a vertical stack 42 proximate the tray feeder 26 . The tray feeder 26 takes individual trays 24 and feeds them onto the conveyor mechanism 28 . The disclosed conveyor mechanism 28 is divided into two sections comprising an upstream intermittent belt conveyor 44 and a downstream controlled movement belt conveyor 46 (although belt conveyors are illustrated it will be appreciated that other conveyor mechanisms such as walkers common in other mogul machines may also be used). The cured candy and starch in each tray 24 is first dumped at the dumping station 30 where a rotating tumbler 48 may be used to separate starch from candy. Starch is separated and reclaimed in the starch separation and reclamation system 32 where starch is recovered in a collection hopper 52 . After the trays 24 are dumped, the now empty trays 24 are moved downstream to the starch depositor 34 . The starch depositor 34 deposits starch into the individual trays 24 . The depositor 34 also preferably measures the starch to get a rough level of starch in the tray close to the desired amount, typically just more than is necessary. The conveyor 44 then moves the trays 24 through a leveler 20 that levels the starch and then through a stamping station 38 that imprints a plurality of candy cavities into the starch. The stamping station 38 includes a vertically driven plate having a plurality of candy shaped molds projecting therefrom. The intermittent belt conveyor 44 then delivers the trays to the controlled motion belt conveyor 46 . The controlled motion belt conveyor 46 transfers trays through the one or more candy pumping stations 38 that fill the cavities will liquefied candy material. Thereafter, the conveyor 46 moves the trays now filled with starch and candy to the tray stacker 41 which stacks the trays in vertical stacks 54 for drying or curing the candy. In accordance with the invention, the starch leveler 20 levels and lowers the starch in the tray 24 to a level 56 below the top edge 58 of the tray 56 , as can be best seen in FIG. 6 (see also FIG. 2 ). By lowering the starch in the tray 24 to the lower level 58 , the starch which is displaced vertically upward due to cavity formation at the stamping station 38 stays in the tray 24 displacing upwardly roughly to the top edge 58 and is not pushed up on top of the top edge 58 or otherwise does not substantially protrude above the top edge 58 such that the starch in the tray is not prone to spilling over onto the floor in large quantities due to tray movement and vibrations further downstream for example at the pumping stations 40 . For purposes of reference, each tray 24 is generally rectangular including a border wall comprised of a leading wall 60 , and trailing wall 62 , and side walls 64 perpendicularly therebetween. The walls 60 , 62 , 64 project vertical upward from a horizontal support base 66 to form the top edge 58 . In the disclosed embodiment, the tops of all of the walls 60 , 62 , 64 lie in the same horizontal plane. To lower the starch level in the disclosed embodiment, the starch leveler 20 includes resilient material such that it can deflect past the leading and trailing walls 60 , 62 of the tray 24 . The starch leveler 20 includes two separate engaging devices including an elongate, resilient, plastic blade 68 and an elongate, resilient, plastic fiber brush 70 . The leveler 20 is mounted to the mogul machine frame 72 with a pair of mounts in the form of end flanges 74 , one on each side of the conveyor 28 or tray 24 . The end flanges 74 affix the starch leveler to the frame 72 in a stationary position. The end flanges 74 support a pair of support posts in the form of threaded rods 76 . The threaded rods 76 project vertically upward from the flanges 74 above the conveyor mechanism 28 to support a horizontally extending cross support 78 . The cross support 78 in turn is fastened to and supports both the blade 68 and the brush 70 . The blade 68 leads the brush 68 . The blade 68 has a length that is shorter than the length between sidewalls 64 such that blade 68 fits inside the tray 24 perpendicularly between sidewalls 64 and below the tray top edge 58 in order to effectively scrape starch to the level 56 below the tray top edge 58 . In operation, the blade 68 engages and deflects past the leading wall 60 of the tray in order to enter the tray 24 with its bottom edge 80 below the tray top edge 58 . The blade 68 also engages and deflects past the trailing wall 62 in order to exit the tray 24 (and thereafter enter the next tray). While in the tray, the blade 68 scrapes and removes most of the desired starch material thereby effectively leveling starch below the tray top edge 58 and thereby reducing starch loss. In the disclosed embodiment, the brush 70 performs a clean up operation to even better reduce starch loss. The brush 70 runs generally parallel to and behind the blade 68 to sweep up starch and smooth the starch further. In operation, the brush 70 engages and deflects past the leading wall 60 of the tray in order to enter the tray 24 with its bottom edge 82 below the tray top edge 58 . The brush 70 also engages and deflects past the trailing wall 62 in order to exit the tray 24 . In contrast to the blade 68 , however, the brush 70 is longer in length than distance between tray sidewalls 64 such that end portions 86 of the brush 70 engage and sweep starch from the tops of the sidewalls 64 that is left behind by the blade 68 . Starch removed by the blade 68 or brash 70 drops down via gravity into the underlying hopper 52 for collection and recycling. The bottom edges 80 , 82 of the blade 68 and brush 70 lie in parallel horizontal planes. The brush 70 is preferably just lower than the blade 68 by a couple of millimeters, typically anywhere from 0 to 3 millimeters. The exact spacing between the bottom edges 80 , 82 can be adjusted by an adjustment mechanism in the form of oval slots 88 in the brush 70 (or alternatively in the blade) which allow for vertical adjustment before the brush 70 is locked into position by fasteners to the cross support 78 . Different vertical spacings between the bottom edges 80 , 82 may be beneficial for different candy applications. The starch leveler 20 also includes a vertical actuator mechanism 89 in the disclosed form of a handle nut 90 and knurled nut 92 engaging the threaded rods 76 to support and position the cross support 78 vertically (and therefore the blade and brush vertically as well). The actuator mechanism 89 can be used to precisely set the heights of the blade 68 and brush 70 relative to the tray top edge 58 . The actually setting typically depends upon the depth of the candy to be imprinted into the starch as deeper imprints or more closely spaced imprints can displace greater amounts of starch. It has been found that setting the starch level 56 below the tray top edge 58 by an amount of between 2 and 6 millimeters has been most effective for most applications. The level 56 is set low enough so as to prevent starch from displacing over the tray during subsequent handling, but also high enough so that candy cavities properly form in the top of the starch at the stamping station 38 . When the machine 22 is changed from one candy pattern to a different candy pattern, the vertical actuator mechanism 89 may be used to optimize starch loss and the proper formation of candy cavities. Although a stationary starch leveler 20 has been disclosed wherein trays are conveyed past the blade and the brush, the invention also contemplates a driven starch leveler as an alternative to lower the starch level below the tray top edge. All of the references cited herein, including patents, patent applications, and publications, are hereby incorporated in their entireties by reference. The foregoing description of various embodiments 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 embodiments disclosed. Numerous modifications or variations are possible in light of the above teachings. The embodiments discussed were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.

A method and apparatus for reducing starch loss in mogul machines. Starch is lowered below the tray edge such that starch does not spill over the tray side walls when cavities are stamped into the starch for receiving liquefied candy material. The leveling device may include a brush and a resilient plastic blade. The leveling device recycles starch into a collection hopper.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a winged safety needle assembly and, more particularly, to a telescopic winged safety needle assembly having a winged cylindrical sheath for preventing sticking accidents from taking place when retracting the needle into the winged cylindrical sheath. Protection of the edge of the needle is achieved by unlocking and sliding the needle along the inner wall of the winged cylindrical sheath and a sleeve. [0003] 2. Discussion of the Related Art [0004] Needlestick injuries are intended to be avoided by proper disposal of needles. Used needles may be recapped with the same cover that originally covered the needles before use or by similar covers or tubes before the needle is discarded. This method requires movement of the hands toward the exposed needle and may promote needlestick injuries during the recapping. In addition, needles may also be disposed of by tossing them into nearby refuse containers. However, this creates danger to those who handle the refuse containers. [0005] Winged intravenous (IV) sets are well known in the art. A typical prior art IV butterfly needle used for the insertion into blood vessels and similar passageways in the body to permit the infusion or withdrawal of sterile fluids or blood is illustrated in FIG. 8 . The butterfly needle generally has a hollow needle or cannula 30 , a cylindrical hub 20 holding the needle 30 at one end and connected to an IV tube 52 at the opposite end, and a cylindrical housing 10 surrounding the needle with a wing-like extension 50 extending on each side thereof. [0006] The wings 50 are used to handle the assembly during insertion and withdrawal. For example, the wings of the needle assembly may be folded upwards around the hub to provide a gripping extension for the technician or nurse to use when attempting to insert the needle into the desired vein, artery or other passageway. The wings are also used to stabilize the device while in place by providing a broad surface area of contact with the patient which allows for taping of the device to the patient while discouraging movement, especially rotation, of the device. This assists the technician or nurse in affixing the needle to the patient during the infusion of fluids or medicants. [0007] A problem typical of butterfly needles as just described is that when the needle is withdrawn from the vein or artery, the sharpened end, now contaminated with blood or other body fluid, remains exposed. The exposed needle can be a source of great danger to the operator or to anyone who might be pricked or scratched. Needle injuries may result in the transmission of diseases such as hepatitis, HIV, or cause other types of infection. A common solution available to the operator was to simply drop the needle and its holder into a trash receptacle. However, a danger to clean up and medical waste disposal personnel continues if the used needles are not rendered harmless in some way. Another solution is to attempt to recap the needle with a safety cover immediately after use. This, however, may in itself cause injury if the operator should accidentally stick themselves during the recapping process. In addition, caps or covers may come loose and expose the used needle. [0008] Therefore, in order to prevent such sticking accidents various proposals have been made. One such proposal is a winged needle assembly disclosed in U.S. Pat. No. 5,505,711 (hereinafter referred to as the '711 patent). The '711 patent describes an indwelling injector needle assembly having wings including a cannula or needle body, a hub supporting a proximal end of the needle body, a tube in fluid communication with the needle body, a cylindrical holder having a distal end from which the wings protrude, and a latching mechanism. The hub can slide along an inner periphery of the holder between a first position near the distal end of the holder and a second position near a proximal end of the holder. The latching mechanism is formed in and disposed between the hub and the holder so that the hub is inhibited from moving from the first position toward the second position, and vice versa. The needle edge can be retracted within the holder while its wings remain fixed to a patient's skin. [0009] However, the winged needle assembly disclosed in '711 patent has several disadvantages. Use of a safety needle assembly with a longer overall length (e.g., 55 mm) results in unnecessary damage to a vessel in which the needle has been inserted. This is due to the fact that any accidental movement of an exposed hub, holder, or sheath is likely to result in unnecessary damage to a vessel from the needle. In addition, the use of a longer overall length safety needle assembly requires a larger radius loop of a profusion tube connected to the safety needle assembly which is ultimately secured (taped) to the patient, i.e., a longer assembly requires a larger loop of tubing to prevent kinking of the tube. A smaller loop of tubing helps prevent accidental movement of the assembly. The '711 Patent also discloses a non-rotating needle. Therefore the needle cannot be rotated when needed after cannulation in order to maximize blood or fluid flow to or from the vessel. [0010] Therefore, what is needed is a telescopic winged safety needle device that provides a maximum overall length for ease of handling during insertion of the needle into a vessel, and a minimum overall length while being secured to a patient to prevent damage to the vessel. In addition, a minimized overall length of a device while being secured to a patient allows a loop of tubing to be kept to a minimum radius and secured to the patient without introducing a kink in the tube. Also, a winged safety needle device is needed that allows for rotation of the needle after cannulation in order to maximize blood or fluid flow to or from the vessel. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 illustrates an exploded view of the Telescopic Safety AVF needle according to an embodiment of the present invention; [0012] FIG. 2 illustrates a locked insertion position of the Telescopic Safety AVF needle according to an embodiment of the present invention; [0013] FIG. 3 illustrates an initial retrieved position of the Telescopic Safety AVF needle according to an embodiment of the present invention; [0014] FIG. 4 illustrates a final locked position of the Telescopic Safety AVF needle according to an embodiment of the present invention; [0015] FIG. 5 illustrates a cannulation procedure of the Telescopic Safety AVF needle according to an embodiment of the present invention; [0016] FIG. 6 a illustrates a cross-section view of a sleeve according to an embodiment of the present invention; [0017] FIG. 6 b illustrates three cross-section views of a hub moving relative to a sleeve according to an embodiment of the present invention; [0018] FIG. 6 c illustrates a cross-section view of a sleeve and a hub in a locked position according to an embodiment of the present invention; [0019] FIG. 7 a illustrates a first view showing an orientation of a cannula bevel according to an embodiment of the present invention; [0020] FIG. 7 b illustrates a second view showing an orientation of a cannula bevel according to an embodiment of the present invention; and [0021] FIG. 8 illustrates a prior art intravenous butterfly needle. DETAILED DESCRIPTION [0022] The Telescopic Safety Arteriovenous Fistula (AVF) needle assembly 100 as shown in FIG. 1 , is a telescopic retractable winged safety needle device having a needle holder 110 (hereinafter referred to as a “hub”), a needle or cannula 120 , a winged sheath 130 , and a sleeve 140 . Referring to FIGS. 1, 2 , 3 , and 4 , the hub 110 may be tubular in shape and may be made of a polycarbonate or other polymeric material. The hub 110 secures a proximal end of the needle or cannula 120 at the distal end. The needle or cannula 120 is hollow, has a beveled edge 121 at the distal end, and may be made of stainless steel. The base 122 or proximal portion of the hollow needle 120 is fixed to and supported by the hub 110 . A tube, for example a polyvinyl chloride (PVC) tube 150 , is slid over the proximal end of the hub 110 , providing a fluid tight seal. The hub 110 has a stopper 115 at the proximal end for tube 150 bonding. The winged sheath 130 and sleeve 140 are axially slideable on the hub 110 to form a telescopic union of the three pieces. [0023] The hub 110 also has two large diameter portions, a first annular ring 111 and a second annular 112 , a second groove 114 near the distal end, and a first groove 113 at the proximal end. [0024] The winged sheath 130 is a cylindrical structure with a hollow interior. The winged sheath 130 may be made of a polyethylene material. The winged sheath 130 , which is axially slideable on the hub 110 , has a constant inner diameter (defining the hollow interior). At the distal end of the sheath, a pair of wings 131 are positioned for use in grasping the device when squeezed together for cannulation into the patient's skin (see FIG. 5 ) and for adhering the device to a patient's skin during infusion, haemodialysis, apheresis, and blood collection when laying flat. The wings may be adhered to a patient using, for example, medical tape. The flexible wings 131 are integrally formed with the body of the supporting cylinder of the winged sheath 130 on both sides thereof, and the shape of the wings 131 is not particularly limited. The wings 131 are preferably provided on the cylinder body to form one plane as shown in FIG. 1 - FIG. 5 . [0025] Referring to FIG. 1 and FIG. 2 , the sheath 130 has two rear lugs 132 , 133 located on each of the top and bottom of the exterior surface at the proximal end. A notch 134 is formed between the rear lugs 132 , 133 . Also at the proximal end of the sheath 130 , distal of the rear lugs 132 , 133 there is an opening 138 for receiving a protrusion 147 of a locking tab 145 attached to the sleeve 140 that can be selectively placed in a locked or unlocked position. The locking tab 145 has a hinge 146 attached to the side of the sleeve 140 so that when in an unlocked position, it stays attached thereto. The locking tab 145 utilizes the protrusion 147 that fits into an opening 148 in the sleeve 140 and in the opening 138 in the sheath 130 when the locking tab 145 is in the locked position. The protrusion 147 extends into the first groove 113 of the hub 110 to prevent movement of the sleeve 140 and sheath 130 with respect to the hub 110 . [0026] In the insertion position (see FIG. 2 ), the needle 120 is exposed through the distal end of the sheath 130 and is held in this position when the protrusion 147 of the locking tab 145 engages the first groove 113 in the hub 110 through the opening 148 in the sleeve 140 and the opening 138 in the sheath 130 . In the insertion position the telescopic relationship of the sheath 130 , sleeve 140 , and hub 110 is such that the overall length of the Telescopic Safety AVF device 100 is minimized (e.g., 38 mm overall length). This minimized length prevents unnecessary damage to the vessel in which the needle 120 has been inserted. This is due to the fact that any accidental movement of the exposed hub 110 , sleeve 140 , and sheath 130 is likely to be reduced because of the overall reduced length of such an assembly relative to a longer length prior art safety needle device (e.g., 55 mm). In addition, the use of a minimized length also allows a minimized radius loop of the PVC tube 150 which is ultimately secured (taped) to the patient, i.e., a longer device requires a larger loop of tubing to prevent kinking of the tube. A smaller loop of tubing helps prevent accidental movement of the device. Therefore, a loop of PVC tube 150 may be kept to a minimum radius and secured to the patient without introducing a kink in the tube. [0027] Referring to FIG. 3 , when the needle 120 is to be withdrawn from the patient, any tape securing the wings 131 to the patient is removed. The technician then places his/her index finger against a notch 139 to hold the sheath 130 against the patient. The locking tab 145 of the sleeve 140 is disengaged and the hub 110 with the attached needle 120 are pulled in a proximal direction relative to the sheath 130 and sleeve 140 (which are no longer locked together) until the second large diameter portion (second annular ring) 112 of the hub 110 is pulled to the proximal end of the sleeve 140 and abuts against three inner ribs 151 located 120 degrees apart around the inner proximal surface of the sleeve 140 . [0028] Referring to FIG. 6 a and FIG. 6 b, as the first groove 113 moves in a proximal direction toward the rear lug 144 , the hub 110 surface on either side of the first groove 113 is supported by the three inner ribs 151 . This allows the hub 110 to pass smoothly through the proximal portion of the sleeve 140 . As the first groove 113 passes through the proximal end of the sleeve and under the rear lug 144 , the 3 inner ribs 151 prevent the first groove 113 from engaging the rear lug 144 . [0029] As the hub 110 continues to be drawn in the proximal direction, the sleeve 140 is now also drawn in the proximal direction due to the abutment of the second annular ring 112 with the three inner ribs 151 . It should be noted that the second annular ring 112 , which is aligned next to but proximal of the first annular ring 111 on the hub 110 , includes a sloped surface that tapers in the proximal direction. [0030] The hub 110 is drawn in the proximal direction until the sheath 130 is engaged in a final locking position in which the sheath 130 becomes unreleasably locked to the sleeve 140 . The two rear lugs 132 , 133 located on each of top and bottom of the exterior surface of the sheath 130 at the proximal end unreleasably lock with a corresponding pair of distal inner circumferential rings, interior first annular ring 142 and interior second annular ring 143 , that protrude from the inner distal surface of the sleeve 140 . The most proximal top and bottom lugs 133 seat in a corresponding top and bottom pair of openings 149 in the sleeve 140 . [0031] Next, referring to FIG. 4 and FIG. 6 c, the hub 110 continues to be drawn in the proximal direction relative to the sheath 130 (locked to the sleeve 140 ) until the hub 110 unreleasably locks to the sleeve 140 . A sharp angle shaped rear lug 144 of the sleeve 140 allows the second annular ring 112 to pass out of the sleeve 140 before the rear lug 144 seats in the second groove 114 of the hub 110 . The sloped surface of the second annular ring 112 (that tapers in the proximal direction) in conjunction with the sharp angle shaped rear lug 144 of the sleeve 140 facilitates the passage of the second annular ring 112 out of the sleeve 140 . The sharp angle shape of the rear lug 144 is such that the second annular ring 112 cannot re-enter the sleeve 140 past the rear lug 144 . In fact, if the hub 110 is pushed in the distal direction relative to the sleeve 140 , the contact between the second annular ring 112 (the distal perpendicular side of the second annular ring 112 ) and the sharp angle shaped rear lug 144 of the sleeve 140 will tend to cause the angle shaped rear lug 144 to curve inward, i.e., bend from being pushed by the second annular ring 112 . Therefore, the rear lug 144 will grip onto the second groove 114 to further prevent the hub 110 and cannula 120 from moving distally out of the sleeve 140 . [0032] The needle 120 has now been withdrawn from the patient. Also note that the locking tab 135 is used only for maintaining the locked relationship between the sheath 130 and hub 110 in the insertion position and not in the protection position. [0033] Referring to FIG. 7 a and FIG. 7 b, the Telescopic Safety AVF needle assembly 100 also includes a rotational feature that allows the hub 110 with attached needle or cannula 120 to rotate 360 degrees within the winged sheath 130 . This feature allows the cannula bevel 121 orientation within the fistula or graft to be adjusted and ascertained. A black dot mark on the distal exterior surface of the hub 110 is visible when facing up (see FIG. 7 a ) and indicates the cannula bevel 121 is facing up within the fistula or graft. Alternatively, a red dot mark on the distal exterior surface of the hub 110 is visible when facing up (see FIG. 7 b ) and indicates the cannula bevel 121 is facing down within the fistula or graft. Therefore, the handling of the Telescopic Safety AVF needle assembly 100 of the present invention is simplified, since after inserting the needle 120 with the beveled surface 121 facing up into a blood vessel (the black dot on the distal exterior surface of the hub 110 is visible when facing up as shown in FIG. 7 a ), the beveled edge 121 is then made to face down by simply rotating the hub 110 until the red dot on the distal exterior surface of the hub 110 is visible when facing up and the needle 120 is then retained in that state (see FIG. 7 b ). The ability to adjust the orientation (0-360 degrees) of the cannula bevel 121 within a vessel allows a technician to adjust for maximum fluid flow. [0034] In contrast, some prior art winged retention needles have the disadvantage that the operation thereof is troublesome, since a hollow needle is directly fixed to a winged portion with the edge surface faced up and accordingly the edge surface must be faced down by a half rotation of the entire winged needle assembly after insertion into blood vessels. [0035] While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention. The presently disclosed 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 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 telescopic intravenous infusion set and/or blood collection assembly is provided with a safety feature for covering the used needle. The safety feature is a telescopic device including a shield with handling wings, which when placed in cooperating relationship, allows accommodation of a conventional unmodified blood collection needle affixed to a hub, and a sleeve with a locking cap. After use, the hub with the needle are pulled rearwardly into positive locking position which prevent the hub and needle from moving out of the shield thereafter. The telescopic nature of the device then allows the locked needle/hub to move rearward in relation to the shield until the shield is unreleasably locked to the sleeve. The shield provides for passage of the needle and hub from a releasable locked use position to a shielded and unreleasable locked protected position.

FIELD OF THE INVENTION The present invention relates to an improved delivery system for the administration of large-molecule pharmaceuticals, e.g. peptidic drugs, vaccines and hormones. In particular it relates to pharmaceuticals which may be administered by means of an aerosol into the mouth, for buccal or pulmonary application. BACKGROUND OF THE INVENTION Sub-optimal disease management for respiratory illnesses, e.g. asthma, cystic fibrosis, and chronic obstructive pulmonary disease (COPD) collectively represents about billion dollar worldwide market for biotechnology-derived proteins. The pulmonary delivered protein, represent an enormous market opportunity for pulmonary drug delivery. The delivery of drugs via inhalation for local delivery to the upper lung (most commonly in the form of metered-dose inhalers) and for systemic delivery (into the bloodstream) via the deep lung defines the scope of pulmonary drug delivery, is the subject of intense research. For more than a decade, companies have searched extensively to find a drug delivery technology which is patient-friendly, non-invasive, and an economically viable alternative to injecting the large macromolecule proteins. Some of the earliest efforts involved transdermal delivery via electroporations but this has mostly been abandoned as large molecules simply can't pass through the skin. Oral delivery, which would clearly be the preferable dosage form, has had some success, but a major obstacle is the degradation and denaturization of proteins in the gastrointestinal tract. Drug delivery through the lung appears optimal for two major reasons, i.e. the enormous surface area available for delivery, and permeability to large molecules. The lung has about a half billion alveoli. The alveoli in an average adult lung have a surface area the size of a tennis court, far exceeding the surface area of most other delivery routes, e.g. GI tract, by several orders of magnitude. The alveoli allow oxygen and other molecules to readily pass into the circulatory system. Conventional metered dose inhalers, primarily used for asthma, deliver drugs into the upper branches of the lung. In terms of permeability, the buccal cavity and lung are ideal absorption areas for both small and large molecules. Large proteins, including antibodies, are readily absorbed through the alveoli either directly into the circulatory system or, more frequently, via the lymphatic system, which subsequently releases the drug into the bloodstream. The ability to deliver large molecule drugs orally (buccally) and/or into the deep lung will represent one of the most significant technical breakthroughs in drug delivery. New products that address these drug delivery needs are sought, which simultaneously provide patients with a convenient user friendly mechanism and physicians with a tool to improve therapy, compliance, and to prevent or reduce expensive hospital stays. The absorption of proteins and peptides is believed to be enhanced by the diffusion of large molecules entrapped in droplet form through the aqueous pores and the cell structure perturbation of the tight paracellular junctions. In order to further improve the penetration and absorption of formulation it has now been found that such formulations can be mixed with a propellant (preferably a non-CFC) and delivered, e.g. applied to the buccal mucosa, through metered dose inhalers (MDIs) or similar. The present invention uses novel formulations that are intended to improve the quality (in terms of absorption), stability, and performance of MDI-delivered pharmaceuticals. A novel method is used to solubilize drugs in a propellant. The formulation ingredients are selected specifically to give enhancement in the penetration through the pores and facilitate the absorption of the drugs to reach therapeutic levels in the plasma. With previous formulations, in order to administer the pharmaceutical agent, it is necessary to shake the vial in order to temporarily intimately mix the two phases, so that a mixture of pharmaceutical formulation and propellant are expelled from the vial upon opening a dosing valve. The propellant and pharmaceutical phases quickly separate after shaking. Separation of the phases may lead to situations wherein the person administering the drug does not shake the vial sufficiently, forgets to shake the vial or waits too long before opening the dosing valve. Such situations lead to a lack of uniformity in the amount of pharmaceutical being administered from one opening of the valve to the next, i.e. from “shot” to “shot”. This is particularly problematic where the amount of pharmaceutical agent to be administered is critical, e.g. with insulin and some pain killing drugs and narcotics. It is desirable, therefore, for the formulation and propellant to be evenly mixed, e.g. as a solution, stable suspension or the like. The present invention is directed to providing a stable mixture of propellant and pharmaceutical agent. The terms “comprising” and “comprises” when used in this specification are taken to specify the presence of the stated features, integers, steps or components but do not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof. The term “solubilized” is used in this specification to refer to a stable intimate mixture of ingredients. It has not been determined whether the mixture is a solution, suspension or other form of intimate mixture. Such a solubilized mixture is stable for substantial periods of time, e.g. months, without separation. SUMMARY OF THE INVENTION Accordingly the present invention provides a pressurized container containing a stable solubilized mixture of propellant which is liquid under pressure and an intermediate formulation which comprises a pharmaceutical agent, water, first ingredient, second ingredient and at least one third ingredient, wherein the first ingredient is selected from glycerin and polyglycerin and mixtures thereof in an amount of from 1-50 wt./wt. % of the intermediate formulation, the second ingredient is selected from phenol, methyl phenol and mixtures thereof in an amount of from 1-20 wt./wt. % of the intermediate formulation, each third ingredient is selected from the group consisting of alkali metal C8 to C22 alkyl sulphate, polidocanol C6 to C40 alkyl ethers, trihydroxy oxo-cholanyl glycines and pharmaceutically acceptable salts thereof, polyoxyethylene ethers, alkyl-aryl polyether alcohols, hyaluronic acid and pharmaceutically suitable salts thereof, monoolein, triolein, lysine, polylysine, oleic acid, linoleic acid, linolenic acid, monooleates and laurates, glycolic acid, lactic acid, chamomile extract, cucumber extract, borage oil and evening of primrose oil and mixtures thereof, in an amount of from 1-50 wt./wt % of the intermediate formulation, and wherein the total concentration of first, second and third ingredients is less than 90 wt./wt % of the intermediate formulation. In one embodiment, the alkali metal C8 to C22 alkyl sulphate is in a concentration of from 2 to 20 wt./wt. % of the intermediate formulation, especially 5 to 15 wt./wt. %. In a further embodiment, the methyl phenol is m-cresol. In another embodiment, the alkali metal C8 to C22 alkyl sulphate is sodium lauryl sulphate. In a further embodiment the polidocanol alkyl ether is a polidocanol 10 or 20 lauryl ether. In another embodiment, the polyoxyethylene ether is polyoxyethylene sorbitan ether, and particularly polyoxyethylene sorbitan 80 lauryl ether. In yet another embodiment, the third ingredient is present in a concentration of from about 1 to about 25 wt./wt. %. In yet another embodiment, the propellant is selected from the group consisting of tetrafluoroethane, tetrafluoropropane, dimethylfluoropropane, heptafluoropropane, dimethyl ether, n-butane and isobutane. In a further embodiment, the weight ratio of intermediate formulation to propellant is from 5:95 to 25:75. In one embodiment, the pharmaceutical agent, water, first, second and third ingredients and propellant have been solubilized by a process comprising the steps of: a) dissolving the pharmaceutical agent in water and adjusting the pH to a level suitable for pharmaceutical use; b) mixing with the first ingredient in an amount of from 1-50 wt./wt. % of the intermediate formulation; c) then mixing with the second ingredient in an amount of from 1-20 wt./wt. % of the intermediate formulation; d) subsequently adding and mixing at least one third ingredient to form the intermediate formulation; e) charging the intermediate formulation to a pressurizable container and subsequently charging the container with the propellant. The invention also provides a process for making a stable aerosol pharmaceutical composition in which a propellant and an intermediate formulation, which comprises a pharmaceutical agent, water and first, second and third ingredients, has been solubilized by a process comprising the steps of: a) dissolving the pharmaceutical agent in water and adjusting the pH to a level suitable for pharmaceutical use; b) mixing with a first ingredient selected from glycerin, polyglycerin and mixtures thereof in an amount of from 1-50 wt./wt. % of the intermediate formulation; c) then mixing with a second ingredient selected from phenol, methyl phenol and mixtures thereof in an amount of from 1-20 wt./wt. % of the intermediate formulation; d) subsequently adding and mixing at least one third ingredient to form the intermediate formulation, said third ingredient being selected from the group consisting of alkali metal C8 to C22 alkyl sulphate, polidocanol C6 to C40 alkyl ethers, trihydroxy oxocholanyl glycines and pharmaceutically acceptable salts thereof, polyoxyethylene ethers, alkyl-aryl polyether alcohols, hyaluronic acid and pharmaceutically suitable salts thereof, monoolein, triolein, lysine, polylysine, oleic acid, linoleic acid, linolenic acid, monooleates and laurates, glycolic acid, lactic acid, chamomile extract, cucumber extract, borage oil and evening of primrose oil and mixtures thereof, each of said third ingredients being present in an amount of from 1-50 wt./wt % of the intermediate formulation, and wherein the total concentration of first, second and third ingredients are less than 90 wt./wt % of the intermediate formulation; e) charging the intermediate formulation to a pressurizable container and subsequently charging the container with the propellant. In one embodiment, the alkali metal C8 to C22 alkyl sulphate is in a concentration of from 2 to 25 wt./wt. % of the intermediate formulation. In a further embodiment, the methyl phenol is m-cresol. In another embodiment, the alkali metal C8 to C22 alkyl sulphate is sodium lauryl sulphate. In a further embodiment the polidocanol alkyl ether is a polidocanol 10 or 20 lauryl ether. In another embodiment, the polyoxyethylene ether is polyoxyethylene sorbitan ether, particularly polyoxyethylene sorbitan 80 lauryl ether. In yet another embodiment, the third ingredient is present in a concentration of from about 1 to about 25 wt./wt. %. In another embodiment, in step a) the pH is adjusted to between 6.0 and 9.0, and preferably between 7.0. and 8.0. In yet another embodiment, the propellant is selected from the group consisting of tetrafluoroethane, tetrafluoropropane, dimethylfluoropropane, heptafluoropropane, dimethyl ether, n-butane and isobutane. In a further embodiment, the weight ratio of intermediate formulation to propellant is from 5:95 to 25:75. In yet another embodiment, step d) is accomplished with a high speed mixer or sonicator. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS The present invention provides an improved, stable formulation. The formulation allows delivery of macromolecular (high molecular weight) pharmaceutical agents, particularly through the membranes in the mouth or lungs. The pharmaceutical agents cover a wide spectrum of agents, including proteins, peptides, hormones, vaccines and drugs. The molecular weights of the macromolecular pharmaceutical agents are preferably above 1000, especially between 1000 and 2 000 000. The proteinic pharmaceutical agent may be selected from a wide variety of macromolecular agents, depending on the disorder being treated, generally with molecular weights greater than about 1000 and especially between about 1000 and 2 000 000. Preferred pharmaceutical agents are selected from the group consisting of insulin, heparin, low molecular weight heparin, hirulog, hirugen, huridine, interferons, interleukins, cytokins, mono and polyclonal antibodies, immunoglobins, chemotherapeutic agents, vaccines, glycoproteins, bacterial toxoids, hormones, calcitonins, insulin like growth factors (IGF), glucagon like peptides (GLP-1), large molecule antibiotics, protein based thrombolytic compounds, platelet inhibitors, DNA, RNA, gene therapeutics and antisense oligonucleotides and many injectable opiods, narcotics, hypnotics, steroids and pain killers (non-steroidal anti-inflammatory drugs). For insulin-containing and some other compositions, the composition may also contains at least one inorganic salt which helps to open channels in the membranes of the mouth or lungs, and may provide additional stimulation to release insulin. Non-limiting examples of inorganic salts are sodium, potassium, calcium and zinc salts, especially sodium chloride, potassium chloride, calcium chloride, zinc chloride and sodium bicarbonate. It will be recognized by those skilled in the art that for many pharmaceutical compositions it is usual to add at least one antioxidant to prevent degradation and oxidation of the pharmaceutically active ingredients. It will also be understood by those skilled in the art that colorants, flavouring agents and non-therapeutic amounts of other compounds may be included in the formulation. Typical flavouring agents are menthol, sorbitol and fruit flavours. The antioxidant may be selected from the group consisting of tocopherol, deteroxime mesylate, methyl paraben, ethyl paraben and ascorbic acid and mixtures thereof. A preferred antioxidant is tocopherol. In a preferred embodiment at least one protease inhibitor is added to the formulation to inhibit degradation of the pharmaceutical agent by the action of proteolytic enzymes. Of the known protease inhibitors, most are effective at concentrations of from 1 to 3 wt./wt. % of the formulation. Non-limiting examples of effective protease inhibitors are bacitracin, soyabean trypsin, aprotinin and bacitracin derivatives, e.g. bacitracin methylene disalicylate. Bacitracin is the most effective of those named when used in concentrations of from 1.5 to 2 wt./wt. %. Soyabean trypsin and aprotinin two may be used in concentrations of about 1 to 2 wt./wt. % of the formulation. The amount of the first ingredient is present in a concentration of from 1 to 50 wt/wt % of the intermediate formulation. The amount of the second ingredient is present in a concentration of from 1 to 20 wt/wt % of the intermediate formulation and the third ingredient is present in a concentration of from 1 to 50 wt/wt % of the intermediate formulation, and total concentration of such ingredients is less than 90 wt./wt % of the formulation. It is believed that the phenolic compounds act mainly as preservatives and complexing agents to stabilize drugs, e.g. insulin. Besides their function as a stabilizer and preservative, they may also act as antiseptic agents and furthermore may help in absorption. The methyl phenol may be o-cresol, m-cresol or p-cresol, but m-cresol is preferred. The order of addition of the ingredients in the formulation are important in order to obtain a stable mixture. First, the pharmaceutical agent is dissolved in water. Preferably, the pH is adjusted to between about 6.0 and 9.0, and even more preferably to between about 7.0 and 8.0. Secondly, the aqueous pharmaceutical agent mixture is mixed first with glycerin, polyglycerin or mixtures thereof (the first ingredient), and then with phenol, methyl phenol or mixtures thereof (the second ingredient). Subsequently the third ingredient is added and mixed to form the intermediate formulation. The third ingredient is at least one of the following compounds: alkali metal C8 to C22 alkyl sulphate, polidocanol C6 to C40 alkyl ethers, trihydroxy oxocholanyl glycines and pharmaceutically acceptable salts thereof, polyoxyethylene ethers, alkyl-aryl polyether alcohols, hyaluronic acid and pharmaceutically suitable salts thereof, monoolein, triolein, lysine, polylysine, oleic acid, linoleic acid, linolenic acid, monooleates and laurates, glycolic acid, lactic acid, chamomile extract, cucumber extract, borage oil and evening of primrose oil. The ingredients are mixed together with a mixer. When the third ingredient is added, a high speed mixer or sonicator is preferred. The resulting mixture is referred to herein as the intermediate formulation. Each of the non-pharmaceutical substances referred to in the previous paragraph may be added in concentrations previously indicated, provided that the total amount of such substances does not exceed 90 wt./wt. % of the intermediate formulation. After formation of the intermediate formulation, the formulation is charged to a pressurizable container. Preferably the container is a vial suitable for use with a metered dose inhaler or applicator. Then the vial is charged with propellant. As the propellant is introduced into the vial, there is great turbulence in the vial and the propellant and pharmaceutical formulation become intimately mixed and do not separate on standing. It is believed that the propellant and pharmaceutical mixture so formed would be stable for several months. As a result, it is not necessary to shake the vial before use, although, through habit with other formulations, many users may shake the vial. The advantage of the solubilized formulation will be immediately apparent to those skilled in the art. For example, the relative homogeneity of the mixture provides good accuracy of pharmaceutical dispensing from “shot” to “shot” and from the first shot to the last from the container. As is known, in order to deliver the pharmaceutical agent to the lung, it is necessary for the user to breathe deeply when the aerosol spray from the pressurized container is released. Without breathing in, the pharmaceutical agent is delivered to the buccal cavity. The method chosen will depend on a number of factors, including the type of pharmaceutical agent, the concentration in the aerosol, the desired rate of absorption required and the like. A particular advantage with the use of metered dose applicators or inhalers is that the formulation can be delivered in a relatively precise dose, e.g. titratable to injection within 1 unit of insulin dose. The droplet size of the formulation preferably falls between 1-5 μm in order for droplets to penetrate buccal mucosa or to reach to the deep lung surface. Thus, the present invention is suitable for delivery of proteinic drugs such as insulin for the treatment of diabetes. The pressurized inhalers also offer a wide dosing range and consistent dosing efficiency. With such a delivery, greater than about 95% of the dose may reach the target area. The smaller particle size (1-5 μm) obtained using pressurized inhalers also enhances dosing due to broader coverage within the lung cavity. In this situation, increased coverage can help more absorption of a drug like insulin. Furthermore, because these devices are self-contained, potential contamination is avoided. The amount of physiologically peptide or protein in the compositions of this invention is typically a quantity that provides an effective amount of the drug to produce the physiological activity (therapeutic plasma level) for which peptide or protein is being administered. In consideration of the fact that the bioavailability of any active substance can never be 100%, that is to say the administered dose of the active drug is not completely absorbed, it is preferable to incorporate slightly larger amount than the desired dosage. Where the dosage form is a spray (aerosol) or the like which is repeatedly dispensed from the same container, it is preferably so arranged that the unit dose will be slightly greater than the desired dose. It should be understood that dosage will vary with species of warm blood animals such as man, domestic animals, and their body weights. The utilization of atomizer or aerosol spray devices (metered dose inhalers or nebulizers) is important to provide particle sizes for effective absorption from the nasal or lung cavity so the drug may successfully absorbed or reach to the specific site. It is believed that a variety of proteins retain their biological activity even after prolonged exposure to propellants commonly used in metered dose inhalers. The advantages of the present invention are illustrated by the following non-limiting examples in which insulin is the pharmaceutical agent. EXAMPLE 1 Method of Insulin Solution Preparation: (U200, 400, 600, 800 and 1000 per mL) Appropriate quantities of insulin powder (in order to make 200 units, 400 units or 600 units 800 units or 1000 units per mL, depending on the activity (27.5-28.3 units/mg) were weighed accurately on an analytical balance. The powders were transferred to glass beakers equipped with stirrer. Distilled water was added to the beakers and the solution was stirred at low speed. To each beaker was added 5M HCl (pH 2) solution dropwise until the insulin powder therein was solubilized completely. These solutions were then neutralized with 5M NaOH dropwise to pH 7-8. The solution was stirred continuously at low speed. The solution was stirred further for 30 minutes and stored at 10° C. or at room temperature. This gave solutions containing insulin with 200U, 400U, 600U, 800U and 1000U/mL. Glycerin was added to each of these solutions, with stirring, in an amount of 20 wt./wt. % glycerin in the intermediate formulation. After this, phenol was added, with stirring, in an amount of 10 wt./wt. % phenol in the intermediate formulation. Then 15 wt./wt % sodium lauryl sulphate, 10 wt./wt. % trihydroxy oxo cholanyl glycine and 20 wt./wt. % polidocanol 20 lauryl ether was added and mixed with a high speed stirrer. One millilitre portions of the solutions of insulin (U200, U400, U600, U800 or U1000/mL) were pipetted into special glass vials coated on the outside with a plastic coating, for protection in the event of mechanical failure of the glass. The vials were then charged with a non-CFC tetrafluoroethane (134a) propellant with the aid of a Pamasol 2008 (trade mark) semi-automatic gas filling equipment. The amount of 134a propellant in each vial was adjusted to 9 mL shot size in order to deliver amounts of insulin equivalent to 2, 4, 6, 8 or 10 units/actuation when actuated through the valve of the vial. For example, the shot size of 2 units per actuation refers to the U200 insulin solution in a vial. The valves were specially designed to deliver exactly 100 μL spray per actuation. Aerodynamic Particle Size The aerodynamic particle sizes of formulations sprayed from the vials were then determined by 8-stage USP Anderson Multistage Cascade Impactor-Mark-II (trade mark). The Multistage Cascade Impactor was cleaned with methanol and air-dried at 30° C. Glass fibre filters were placed on the collection plates. Seals were aligned properly and the actuator was attached to a mouthpiece and assembled onto the USP induction port and jet stages. A vacuum pump was connected and air flow rate is set to 28.3 litres/min. Each vial was actuated twice to waste. The shots were then delivered by discharging the actuator into the mouthpiece and repeated for 25 times. The deposited insulin was collected by rinsing the mouthpiece with 0.6 mg/mL EDTA in 10 mL water at pH 8.7. The filters were carefully removed and placed in scintillation vials and the vials sonicated for 15 minutes. The quantity of the insulin was then analysed using RP-HPLC. The results are shown in Tables I, II and III for U400, U600 and U800 solutions. TABLE I (U400, 4 units/actuation) Stage vol. units/ Particle size # mL mg units actuation Actuation μm 0 10 1 10 2 10 3 10 0.77 20.1 5 4.0 4.0 4 10 0.78 20.1 5 4.0 3.8 5 10 0.81 20.0 5 4.0 3.0 6 10 0.80 20.3 5 4.0 2.1 7 10 0.80 20.1 5 4.0 1.0 8 10 0.79 20.1 5 4.0 0.7 TABLE II (U600, 6 units/actuation) Stage vol. units/ Particle size # mL mg units actuation Actuation μm 0 10 n/d 1 10 n/d 2 10 n/d 3 10 0.77 30.1 5 6.0 4.0 4 10 0.78 30.1 5 6.0 3.8 5 10 0.81 30.0 5 6.0 3.0 6 10 0.80 30.3 5 6.0 2.1 7 10 0.80 30.1 5 6.0 1.0 8 10 0.79 30.1 5 6.0 0.7 TABLE III (U800, 8 units/actuation) Stage vol. units/ Particle size # mL mg units actuation Actuation μm 0 10 n/d 1 10 n/d 2 10 n/d 3 10 0.77 40.1 5 8.0 3.8 4 10 0.78 40.1 5 8.0 3.3 5 10 0.81 40.0 5 8.0 3.0 6 10 0.80 40.3 5 8.0 2.0 7 10 0.80 40.1 5 8.0 1.0 8 10 0.79 40.1 5 8.0 0.6 Conclusion: The particle sizes were determined to be around 3 μm and stages 0-2 showed no insulin deposition indicating that most particles were smaller than 6 μm. Thus, this analysis suggests a strong likelihood of deep lung deposition, as the droplet sizes were generally smaller than 4 μm. Shot Size Accuracy The shot size accuracy was determined by firing shots in specially designed glass thiel tubes and weighing the tubes before and after the sample collection. Each vial had a capacity of 100 shots. The number of units per actuation are shown in Table IV. TABLE IV (U400) Shot weight (g) Shot Number 4 units/act. 6 units/act 8 units/act 10 0.076 0.090 0.179 15 0.073 0.093 0.180 20 0.076 0.096 — 25 0.074 0.094 — 30 0.070 0.090 0.178 40 — — 0.176 70 — — 0.177 Conclusion: The analysis indicates the uniformity of the shot size delivered through the valves. Insulin Dose The volume of insulin dose delivered, in terms of units/actuation was then determined by HPLC analysis. The vials were actuated twice to waste. Shots were delivered by discharging the actuator into the mouthpiece and repeated for 25 times. The deposited insulin was collected by rinsing the mouthpiece with 0.6 mg/mL EDTA in 10 mL water at pH 8.7, carefully remove the filters and place them in scintillation vials and sonicate the vials for 15 minutes. The quantity of the insulin was then analysed using RP-HPLC. The results for 6 and 8 units/actuation formulations are shown in Tables V and VI. Each vial had a capacity of 100 shots. Shot numbers 5-10 were at the beginning of the vial's discharge, 45-50 were in the middle and 85-90 were at the end. TABLE V (6 units/actuation) Dose delivered Dose delivered Shot Nos. μg units  5-10 118 6.2 45-50 110 6.0 85-90 105 5.8 TABLE VI (8 units/actuation) Dose delivered Dose delivered Shot Nos. μg units  5-10 173.3 8.1 45-50 171.1 7.9 85-90 172.7 8.0 Conclusion: The analysis indicates the uniformity of the dose delivered per actuation through the valves. Clinical Results 15 healthy volunteers were given the following doses of insulin for three days. Day-1: 5 puffs of 4 units each (total 20 units) Day-2: 5 puffs of 6 units each (total 30 units) Day-1: 5 puffs of 8 units each (total 40 units) Plasma insulin levels, in pmol/L, were measured every 15 minutes for first 90 minutes and then every 30 minutes for 2 hours. The results are shown in Table VII. TABLE VII Day-1 Day-2 Day-3 Time 20 units 30 units 40 units 0 35 38 42 15 56 62 72 30 89 97 112 45 119 138 178 60 160 178 202 75 160 175 190 90 142 157 173 120 78 112 141 150 62 87 92 180 37 49 67 These data shows significant absorption of insulin through buccal mucosa, oropharynx, and lungs regions. EXAMPLE 2 As a comparison, i.e. outside the scope of the invention, tests were conducted with an insulin formulation which did not have any of the solubilizing ingredients. Appropriate quantities of insulin powder (in order to make 200 units, 400 units or 600 units 800 units or 1000 units per mL, depending on the activity (27.5-28.3 units/mg) was weighed accurately on an analytical balance. The powders were transferred to glass beakers equipped with stirrers. Distilled water was added and the solution was stirred at low speed. To this was added 5M HCl (pH 2) solution dropwise till insulin powder was solubilized completely. This solution was then neutralized with 5M NaOH dropwise to pH 7-8. The solution was stirred continuously at low speed. The solution was stirred further for 30 minutes and stored at 10° C. This gave solutions containing insulin (200U, 400U, 600U, 800U or 1000U/mL). Shot Size Shot size accuracy was determined by firing shots in thiel tubes and weighing the tubes before and after the sample collection. Each vial had a capacity of 100 shots. The average shot weights for 5 sequential shots were determined, as shown in Tables VIII, IX and X. TABLE VIII (400U/mL) Shot # # of Shots Shot Weight (g) 10-15 5 0.065 20-25 5 0.087 30-35 5 0.077 40-45 5 0.063 70-75 5 0.051 TABLE IX (600U/mL) Shot # # of Shots Shot Weight (g) 10-15 5 0.077 20-25 5 0.064 30-35 5 0.091 40-45 5 0.051 70-75 5 0.083 Table X is on the next page TABLE X (800U/mL) Shot # # of Shots Shot Weight (g) 10-15 5 0.049 20-25 5 0.071 30-35 5 0.065 40-45 5 0.088 70-75 5 0.102 Highly irregular shot weight distribution was observed due to the insolubility of insulin in the propellant and the inability to facilitate formation of small droplets Aerodynamic Particle Size The aerodynamic particle sizes of formulations sprayed from the vials were determined by 8-stage USP Anderson Multistage Cascade Impactor-Mark-II (trade mark) by the same procedure outlined in Example 1. The results are shown in Tables XI and XII. TABLE XI (U600, 6 units/actuation) Stage vol. units/ Particle size # mL mg units actuation Actuation μm 0 10 0.91 56.5 5 11.3 >9 1 10 0.60 46.7 5 9.3 >7 2 10 0.42 33.3 5 6.7 >5 3 10 not detected TABLE XII (U800, 8 units/actuation) Stage vol. units/ Particle size # mL mg units actuation Actuation μm 0 10 0.97 77.7 5 15.5 >9 1 10 0.88 66.9 5 13.4 >7 2 10 0.42 55.6 5 11.1 >5 3 10 not detected This demonstrates highly irregular droplet sizes and number of units delivered through the aerosol valves. EXAMPLE 3 Another experiment was conducted to provide data for comparative purposes. This example does not fall within the scope of the present invention. Powdered insulin was placed in a glass beaker equipped with a stirrer. Distilled water was added and the solution was stirred at low speed. To this solution was added 5M HCl (pH 2) solution dropwise until the insulin was solubilized completely. This solution was then neutralized with 5M NaOH solution dropwise until the pH was between 7 and 8. Seven mg phenol and 7 mg m-cresol were added to the solution and mixed thoroughly. The solution was diluted with distilled water until there were 200 units insulin per milliliter of solution. One milliliter portions were then transferred to glass vials, which were then charged with 10.8 g HFA 134a propellant using a Pamasol (trade mark) 2008 semi-automatic gas filling apparatus. The propellant and insulin solution remained as separate phases. EXAMPLE 4 A further comparative experiment was conducted. Powdered insulin was placed in a glass beaker equipped with a stirrer. Distilled water was added and the solution was stirred at low speed. To this solution was added 5M HCl (pH 2) solution dropwise until the insulin was solubilized completely. This solution was then neutralized, while stirring slowly, with 5M NaOH solution dropwise until the pH was between 7 and 8. To this solution was added 7 mg sodium lauryl sulphate, 7 mg polyoxyethylene ether (10 lauryl) and 7 mg trihydroxy oxo cholanyl glycine and dissolved completely. Seven mg lecithin, solubilized in a water alcohol solution (7 mg/mL) was then added while stirring at high speed, i.e. 2000 rpm. The solution was stirred for 30 minutes and then stored at 10° C. The resulting mixed micellar solution had about 200 units insulin. To this mixture 5 mg phenol, 5 mg m-cresol and 10 mg glycerin were added. The solution was pipetted ( 1 mL/vial) into 10 mL capacity glass vials. The vials were then charged with HFA 134a propellant with a Pamasol 2008 automatic gas filling apparatus. The amount of propellant was adjusted to 9 mL shot size in order to deliver 2 units insulin per actuation of the aerosol vial. The valves of the vials were designed to deliver 100 μL spray per actuation, containing 2 units insulin. The aqueous pharmaceutical composition and the propellant remained as separate phases. Prior to discharging shots of the formulation, shaking of the vial was necessary in order to entrain the pharmaceutical in the propellant phase. After discharging a shot, the propellant separated from the aqueous pharmaceutical composition within about 20 seconds. The aerodynamic particle size was determined by an 8-stage USP Anderson (trade mark) Cascade Impactor Mark II. The impactor was cleaned with methanol and air dried at 30° C. Glass fibre filters were placed on the collection plates. The actuator was attached to the mouthpiece of the impactor and assembled onto the USP induction port and jet stages. A vacuum pump was connected and the air flow rate set to 28.3 liters per minute. The vial was primed by shaking for 10 seconds and actuating twice to waste. The shot was delivered by discharging the actuator into the mouthpiece and repeating 25 times. The deposited insulin was collected by rinsing the mouthpiece with 0.6 mL EDTA in 10 mL water at pH 8.7. The filters were removed and placed in scintillation vials and sonicated for 15 minutes. The quantity of insulin was then analysed using RP-HPLC. The results are shown in Table XIII (2 units per actuation) and XIV (4 units per actuation). TABLE XIII Stage No. 0 1 2 3 Volume (mL) 10 10 10 10 Mass (mg) 0.79 0.81 0.78 * Units 10.4 10.0 10.0 Actuation 5 5 5 Units per 2.0 2.0 2.1 actuation Particle size (μm) 8.8 5.8 5.7 * not determined/detected TABLE XIV Stage No. 0 1 2 3 Volume (mL) 10 10 10 10 Mass (mg) 0.79 0.81 0.78 ** Units 20.7 21.0 20.1 Actuation 5 5 5 Units per 4.15 4.18 4.01 actuation Particle size (μm) 9 5.8 4.7 ** not determined Based on these tests, the particle size was determined to be about 7 μm, and stages 3-8 showed no insulin deposition, indicating that most particles were larger than about 6 μm. This suggests that there would be no deep lung deposition formulation and that most of the formulation would be deposited in the buccal cavity.

A pharmaceutical composition solubilized in a propellant that can be administered buccally or to the lungs using a metered dose dispenser is provided. The composition comprises a pharmaceutical agent; glycerin and/or polyglycerin; phenol and/or methyl phenol; and at least one absorption enhancing compound. A pressurized container with the composition and a methods of making the composition are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] 1. Provisional application No. 61/294,850, Jan. 14, 2010 STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable. REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISC APPENDIX [0003] Not applicable. BACKGROUND OF THE INVENTION References Cited [0000] 1. U.S. Pat. No. 5,636,824, “Music Stand” (Americole Biasini, 1997) 2. U.S. Pat. No. 5,037,057, “Collapsible Music Stand” (Kim N. Andrews, 1991) 3. U.S. Pat. No. 4,355,779, “Collapsible Stand For Sheet Music And The Like” (Simca Heled, 1979) 4. U.S. Pat. No. 4,561,339, “Music Stand For Guitar Player” (Gary L. Jensen, 1984) 5. U.S. Pat. No. 5,356,109, “Music Support Apparatus and Method” (Americole Biasini, 1994) 6. U.S. Pat. No. 5,114,111, “Music Stand” (Kim N. Andrews, 1992) 7. U.S. Pat. No. 4,312,490, “Music Stand Extender” (Americole Biasini, 1982) 8. U.S. Pat. No. 4,372,518, “Music Stand Extender” (Americole Biasini, 1983) 9. U.S. Pat. No. 5,692,719, “Sheet Music Stand” (Charles G. Shepherd, 1997) [0013] The present invention relates to a page support apparatus such as those that support sheet music for a musician, and more specifically to an apparatus that can attach to standard music stands, replacing and extending the usable area of such stands with a significantly wider area. [0014] Various types of stands for securing and displaying printed sheet music are well known, and are described in prior art, such as Biasini 1997, Andrews 1991, Heled 1979 and Jensen, 1984. In keeping with generally accepted terminology, this document will refer to such devices as “music stands”. The purpose of a music stand is to secure printed music and related instructions in a position such that one or more musicians or vocalists can read the music and/or instructions while performing. Various designs for music stands have been developed in prior art for servicing both general and specialized needs. [0015] A limitation of the most common music stands is their inability to display more than two or three sheets of music side by side. This can create challenges in situations where turning pages is difficult, or where multiple musicians or vocalists need to share a music stand. Different classes of remedies to these challenges exist in prior art, including mechanical extensions to existing music stands (e.g., Biasini 1994), as well as self-contained stands with the extension features included (e.g., Andrews 1992). The present invention is a mechanical extension to an existing music stand. Due to difficulties in deployment, the music stand extensions in most common use are typically attached semi-permanently to host music stands, even though it is possible to remove them. This usage pattern is inconsistent with the needs of musicians who might need to use a music stand extension in more than one context. A wider, more portable, easily deployable and affordable device that can travel with the musician is needed, but is currently lacking in the marketplace. [0016] Prior art exists both in the area of mechanical extensions to existing music stands, as well as self-contained music stands. Biasini, 1994, Biasini, 1982, and Biasini, 1983 describe different approaches to extending an existing music stand. Biasini, 1982 describes a set of retractable structures that attaches to the left and right sides of a music stand. Devices based on this design are available in the marketplace, particularly for non-collapsible music stands. Biasini, 1983 describes a similar solution for a common type of collapsible music stand. Because such devices involve two distinct components, each attaching separately to the music stand at multiple points in perpendicular planes, they are more difficult to transport and attach than the present invention. Such devices also impose manufacturing limitations in terms of materials, tolerances and compatibility with a range of host stands. Finally, the usable width offered by these devices is less than what many practical situations require. [0017] Biasini, 1994 describes a more elaborate, collapsible structure. This device addresses some of the transportability and ease of deployment issues of Biasini 1982, since it is a collapsible device embodied in a single, integrated unit. However, it is a more complex design due to its explicit accommodation for a collapsible ledge section, as well as a dual-purpose slot area that both secures the device in use and stores music when not in use. This complexity would increase the cost of manufacturing the device, and the dual-purpose design of the slot area restricts the usability of the device to a certain class of music stands with little or no physical border around the perimeter of the display plane of the music stand. Music stand designs with such a perimeter border are now common in the marketplace. [0018] Other prior art, such as Andrews, 1991 and Shepherd, 1997, embody complete music stand designs, with extensibility and/or collapsibility features included. These solutions are a separate category, both in principle and in practice, as they require the user to abandon existing investments in simpler, cheaper music stand equipment in exchange for more complex and expensive equipment. The present invention pertains specifically to a device that adapts to a broad class of existing music stands, thus allowing the user to preserve previous investments in equipment. [0019] A need exists for an inexpensive and easy to use music stand extension device that can handle a larger set of detached, individual pages of music, either for an individual musician for whom turning pages is a challenge, or in cases where two or more musicians or vocalists need to share a music stand. A common example is guitarists who perform in contemporary church settings. Typical situations often require playing five or more different songs in sequence, with no delay between songs. In this and other situations, it is desirable to display all of the sheets of music side by side, because guitar players have difficulty turning pages quickly. Similarly, larger vocal groups often need to share a limited number of music stands. In these situations, a music stand extension of sufficient width can allow one stand to serve the needs of two or three vocalists. [0020] Set-up time and complexity are critical concerns in many situations. Church musicians often need to set up and break down equipment in as little as ten or fifteen minutes, to accommodate the time constraints of multiple church services. Electric guitarists in particular often need to connect and configure a range of electronic equipment, such as amplifiers, effects devices, tuners and associated wiring. Similar time constraints exist for guitar players and other musicians in a variety of performance situations. Consequently, any music stand extension device targeted to these types of situations must not add significant time or complexity to set-up processes that already present difficult challenges. BRIEF SUMMARY OF THE INVENTION [0021] The disclosed invention is a collapsible device that is easily mounted to a conventional music stand to provide for viewing of up to six sheets of paper side by side. The device consists principally of four generally rectangular panel sections of similar design, connected via pivotal connections on two perpendicular axes. When fully deployed, the four sections form a single, generally rectangular surface that covers and extends the display panel of the music stand. In the deployed position, the upper two sections hang from the top horizontal edge of the music stand via lips on each section. The two lower sections are attached via pivotal connections to the upper sections directly above them, respectively, and to each other via a central, vertical pivotal connection. The two top sections are not directly attached to each other. Lip features are also included on the bottom of each lower section for securing individual sheets of music. [0022] The pivotal connections employed by the device permit it to be folded on two perpendicular axes for compact storage and transport. This is accomplished by first disengaging the upper sections from the top of the music stand with a lifting motion, then folding the upper sections forward and down until they rest parallel to the lower sections, and then folding the entire device in half laterally. Thus, in the fully collapsed state, the four main sections stack against each other, resulting in a roughly 70% reduction in device size in the collapsed state vs. the fully deployed state. The lips of the device do not interfere with each other in the collapsed state due to a difference in size between the upper and lower panel sections. [0023] The disclosed invention offers significant advantages over prior art in solving specific challenges that musicians commonly face. These challenges include usable size, portability and transportability, ease of deployment, and adaptability to wide variety of music stands. It also has advantages in manufacturing and choice of materials, making the device cost-effective and adaptable to a wide variety of situations and user preferences. [0024] When expanded, the device can display up to six unbound sheets of music side by side without significant overlap, which is an improvement over other designs. In the collapsed state, it is small enough to fit into carry bags that musicians typically use to carry equipment. For situations where a carry bag is not otherwise used, an alternate embodiment allows for a built-in carry handle with no adverse impact on the utility or portability of the device. The weight of the device will vary depending on material type and thickness, but will typically be about 2 pounds in the preferred embodiment. This is reasonable compared to the equipment that musicians typically need to transport. Thus, the present invention allows the musician to treat the extension device as part of his or her personal gear, rather than having to allocate it to a specific music stand at a fixed location. [0025] The disclosed invention is simple to deploy. It attaches to the host music stand via a lip along a single line, without fasteners, using only gravity and friction. The attachment point need not be snug, thus allowing for high tolerances in the lip geometry. This reduces the complexity of fitting the device to the stand, relative to other solutions that require a snug fit along perpendicular axes. In addition, the hinge geometry allows the device to unfold itself, via gravity, if the user holds it in the correct position when deploying. The device naturally falls into the expanded, planar geometry, and the user simply hangs it on the top edge of the music stand. [0026] The disclosed invention is adaptable to any music stand that has a continuous horizontal top edge. These types of music stands tend to be sturdy and stable, and, consequently, are a popular choice in high-use situations such as churches and concert halls. Because the display panel of this type of music stand is thin and flat, and therefore prone to bending and warping, manufacturers typically crimp the material in different ways to control this. Those stands that have crimped or bent edges (or other bracing on the perimeter), as opposed to crimping within the plane of the device, present difficulties for extension devices that depend on a snug fit along flat, thin edges. To address this, the disclosed invention allows for a wide or variable lip size that can accommodate most music stands in this category, regardless of the location of crimping or bracing. [0027] The disclosed invention allows for flexibility in manufacturing techniques and choice of materials. The rectangular sections that comprise the bulk of the device share a similar design, and thus can be fabricated using similar methods and a limited number of molds, jigs, forms, etc. The device can be constructed from a wide variety of materials, including, but not limited to, various sheet metals and thermoplastics, each servicing different preferences and cost structures. If the device is constructed of sheet metal, the lip features can be easily fabricated by bending the material using standard brake equipment. For devices that use such an integrated upper lip, the angle and radius of the lip can be designed to accommodate music stands with edges of varying thickness. In contrast, bending does not work well with thermoplastics, due to the well-documented tendency of thinner sheets to warp when heated and bent along long axes. However, the lip features for devices made of thermoplastics can be easily fabricated separately in a number of ways. For example, rectangular lip sections can be chemically welded together from strips of varying width. Alternatively, strips can be attached with screws and spacers, allowing for variable-width lip geometries. Lips can also be fabricated separately as extrusions, and chemically welded to the edge of the panel sections. Thermoplastics such as acrylic and polycarbonate offer other advantages, such as the ease by which hinges and other parts can be chemically welded into position, as well as transparency and tinting options that some users might find desirable for cosmetic reasons. [0028] The preferred fabrication technique will depend on material and quantity, due to varying fixed cost structures involved with different techniques. For example, in larger quantities, the main panel sections of thermoplastic devices can be injection molded or extruded (allowing for an integrated lip without heat bending, if desired). In smaller quantities, thermoplastic devices can be assembled by hand with appropriate jigs, using stock parts and chemical welds. For devices constructed of sheet metal, different standard manufacturing techniques are available, including sheet metal brakes for bending, riveting the hinges, stamping of logos, etc. Thus, cost effective, well-established manufacturing options are available across a wide range of materials and quantities. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING [0029] FIG. 1 is a perspective view of the front of the device when fully unfolded. [0030] FIG. 2 is a perspective view of the rear of the device when fully unfolded. [0031] FIG. 3 is a perspective close-up view from the top of the device when fully unfolded. [0032] FIG. 4 is a side view of the device when fully unfolded. [0033] FIG. 5 is a perspective view of the front of the device when fully unfolded, to illustrate an alternate embodiment. [0034] FIG. 6 is a perspective view of the rear of the device when fully unfolded, to illustrate an alternate embodiment. [0035] FIG. 7 is a side view of the device when fully unfolded, to illustrate an alternate embodiment. [0036] FIG. 8 is a perspective view of the front of the device when mounted on a music stand. [0037] FIG. 9 is a perspective view of the rear of the device when mounted on a music stand. [0038] FIG. 10 is a perspective view of the front of the device in partially collapsed position, with the top sections folded downward. [0039] FIG. 11 is a side view of the device in partially collapsed position, with the top sections folded downward. [0040] FIG. 12 is a perspective view of the rear of the device when the top sections are folded downward. [0041] FIG. 13 is a perspective view of the device in fully collapsed position. [0042] FIG. 14 is a perspective view of the front of the device when fully unfolded. It is the same as FIG. 1 , and is provided without numbering as a “Front Page View”, as needed. DETAILED DESCRIPTION OF THE INVENTION [0043] Referring to FIG. 1 , the present invention consists of a set of four thin rectangular sections 1 , 2 , 3 , and 4 , each section similar to the others, except that the two upper sections 1 and 2 are nominally one inch smaller than the two lower sections 3 and 4 in the preferred embodiment, as measured in the vertical (smaller) dimension of each rectangle. In the preferred embodiment, each rectangular section 1 , 2 , 3 and 4 is about 24 inches in width, with the upper sections 1 and 2 about 5.5 inches in height and the lower sections 3 and 4 about 6.5 inches in height. In the preferred embodiment, rectangular sections 1 , 2 , 3 and 4 have rounded corners as a safety feature. In the preferred embodiment, the fully assembled and expanded device is approximately 48 inches in length and 12.5 inches in height. [0044] The present invention can be fabricated from either sheet metal or a thermoplastic material such as acrylic, polycarbonate or acrylonitrile butadiene styrene (ABS). The nature of the invention and the function of the device do not change with the material, but material thicknesses and fabrication options differ with the chosen material. The preferred embodiment is a thermoplastic device, due to the availability of fabrication options with lower fixed costs, as well as weight and cosmetic advantages. However, sheet metal devices offer other advantages and are a viable alternate embodiment. [0045] Continuing to refer to FIG. 1 , the top edge of section 1 and the top edge of section 2 include lips 7 that face toward the rear of the device when deployed. Lips 7 engage the device on the top edge of the music stand. The bottom edge of section 3 and the bottom edge of section 4 include lips 8 that face toward the front of the device when deployed. Lips 8 support the sheets of music. [0046] Referring to FIG. 2 and FIG. 3 , in the preferred thermoplastic embodiment, lips 7 are separate rectangular members that attach to the device with standard binder posts 9 , or other functionally equivalent screw and spacer mechanism. In this configuration, the posts engage the top edge of the music stand to support the device, and the rectangular members prevent the device from slipping off the edge of the music stand. This allows lips 7 to have a variable depth to accommodate different types of music stands, by using screws and spacers 9 of different lengths. [0047] Referring again to FIG. 1 , lips 8 must be continuous members because of their role in supporting sheets of music along the length of the device. Lips 8 may be either permanently attached to the device or removably fastened to accommodate variable depth. Lips 8 may be constructed of long strips of material, with a wider strip on the outer edge to form an L shape, creating a channel in which sheets of music may rest. If such strips are removably fastened with screws, the depth of lips 8 may be varied by adding additional or wider strips of material. For thermoplastic devices, fixed depth lips may be fabricated by chemically welding the strips to together, and to sections 3 and 4 . An extrusion of appropriate cross-section could also be used instead of fabricating the lips 8 from strips of material. Other embodiments of lips 7 and lips 8 are possible within the scope of the present invention. [0048] Referring to FIG. 2 , the two sections 3 , 4 comprising the lower half of the device are connected via pivotal connection 10 along short sides of each section 3 , 4 . The upper sections 1 , 2 are not directly connected to each other. Care must be observed in selecting and fastening pivotal connection 10 . Torsionally-induced stresses in this connection, with the device in the collapsed state, can be significant. Therefore, in the preferred embodiment, the pivotal connection 10 is a rigid, sturdy, piano-type hinge or equivalent, extending for most of the height of sections 3 , 4 , or about 6 inches. [0049] Referring again to FIG. 1 , pivotal connections 5 connect the upper section 1 to lower section 4 , and pivotal connections 6 connect the upper section 2 to lower section 3 . The specific number and mechanisms for the pivotal connections can vary within the scope of the present invention, and will depend on the materials used. For thermoplastic devices, segments of standard, off-the-shelf thermoplastic piano hinge can be chemically welded to the front faces of sections 1 , 2 , 3 , and 4 . The preferred embodiment uses four hinges, each roughly three inches in length. Two hinges pivotally connect section 1 to section 4 , and two hinges pivotally connect section 2 to section 3 . Other approaches to the pivotal connections are possible with thermoplastic devices without changing the basic function of the device. For example, continuous “living hinges” are commercially available for hinging thermoplastic sheet, and are easily cut to size and attached to the edges of sheets 1 , 2 , 3 and 4 . For sheet metal devices, standard metal hinges of varying types can be screwed or riveted to the front faces of sections 1 , 2 , 3 , and 4 , using the hinge geometry shown in FIG. 1 . [0050] Referring to FIG. 4 , the thickness 11 of the sections will range from 1/16 inch to ⅛ inch in preferred embodiments. The preferred thickness depends on the material used. The preferred thickness for thermoplastic devices is ⅛ inch, for strength and durability reasons, although thinner thermoplastic material can be used to create lighter weight devices. The preferred thickness for sheet metal devices is 1/16 inch, due to weight considerations, and also to allow for easier construction of the lip features via bending in a sheet metal brake. [0051] FIG. 5 and FIG. 6 depict an alternate embodiment of the device with integrated lip features. In this embodiment, the lips 7 and lips 8 are formed directly in sheets 1 , 2 , 3 and 4 either by bending the material, or through extrusion or injection molding. In this alternate embodiment, lips 7 extend the full length of sections 1 and 2 , since they are formed directly from sections 1 and 2 . This embodiment is most appropriate for devices constructed of sheet metal, where sheet metal brakes are well-suited to bending the material for this application. For thermoplastic devices, similar geometry may be attained through extrusion or injection molding rather than bending, due to warping issues when heating and bending thin thermoplastic sheet along long axes. In this alternate embodiment, the angle of the lip features can vary within the scope of the present invention. The optimal angle depends on preferred tradeoffs between maximum stability and minimum collapsed size of the device vs. the usability of the device with a wider variety of music stands. Maximum stability in use, and minimum size in the collapsed state, are achieved if lips 7 and lips 8 are bent or formed to 180°, so that the plane of the lip is parallel to the plane of the main sections of the device, as shown in FIG. 5 and FIG. 6 . However, such a device is limited to music stands with a thin upper edge, due to the narrow space between the planes of the sections 1 , 2 , 3 and 4 and the planes of the associated lips 7 and lips 8 . Referring to FIG. 7 , if the angle 12 of lip 7 and angle 13 of lip 8 is decreased by about 45°, the lips 7 will adequately engage music stands with wider top edges, and inserting pages into lips 8 will be easier. However, the device and supported sheets will be slightly less stable in this configuration. If the angle of lips 8 is decreased by about 90°, so that lips 8 are perpendicular to the main sections, the device could be adapted to display thicker, bound volumes rather than individual sheets of music. However, this embodiment of the device is of lesser interest in practical applications because the ledge of the host music stand remains available to support a bound volume, regardless of the configuration of lips 8 on the extension device. [0052] Referring to FIG. 8 and FIG. 9 , the device is deployed by hanging the fully expanded unit on the upper edge of the music stand 14 via the lips 7 on the upper sections 1 and 2 . The lower sections 3 and 4 hang downward, with lips 8 near the ledge 15 of the music stand. Sheets of music may be placed in the lips 8 of the device, along the length of the device, so that the lips 8 support the sheets. Thus, five to six sheets of paper, each 8½ inches wide, can be viewed simultaneously on the device. Six sheets can be displayed within the available 48 inch display area either by overlapping the side margin areas of the sheets, or by allowing the left and right sheets to overhang the left and right sides of the device, respectively, by about 1.5 inches. [0053] The device is collapsed for storage and transport by lifting the lips 7 off the top of the music stand, then briefly resting the lips 8 on the ledge of the stand. Referring to FIG. 10 and FIG. 11 , the upper sections 1 , 2 fold down 180° so that the planes of the upper sections 1 , 2 and planes of the lower sections 3 , 4 rest against each other. The lips 7 of the upper sections do not intersect the lips 8 of the lower sections due to the difference in size between upper sections 1 , 2 and lower sections 3 , 4 . Referring to FIG. 12 and FIG. 13 , the entire device can then be folded in half along the hinge 10 that connects the lower sections 3 and 4 . In the preferred embodiment, the collapsed sized of the device will be approximately 24 inches by 6.5 inches. [0054] Referring to FIG. 13 , in an alternate embodiment, handle 16 is formed when individual holes in sections 1 , 2 , 3 , 4 line up when the device is fully collapsed. In the preferred embodiment, these holes are elliptical for ease of manufacture, but a variety of other shapes would be acceptable to form different types of handles. However, if holes are not provided in sections 1 , 2 , 3 , 4 , the basic function of the device is unaffected.

A collapsible device that can be quickly and easily mounted to certain types of music stands to allow viewing of up to six sheets of paper side by side. The device consists principally of four panel sections, two of which, in the expanded position, hang from the top horizontal edge of the music stand via lips provided for this purpose. Two lower panels, each attached via hinge to the upper panel directly above it, also include lip features at the bottom of the device for holding the sheets of paper. In the expanded position, the four panels cover and extend the viewable plane of the stand. The device can be folded on two perpendicular axes for compact storage and transport. Usable width combined with ease of transport and deployment differentiate the device from prior art, allowing the device to be treated as part of a musician's personal gear.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to rackets for tennis, badminton or other similar games, particularly to rackets having weights provided on a portion of the frame thereof. 2. Description of the Related Art Rackets provided with weights are publicly disclosed in Japanese unexamined Utility Model Publication No. 54-41364. This type of racket has a frame made from foam synthetic resin, and has weights made from aluminum, titanium or other similar material. These weights are fixed onto the lateral sides of a head-frame so as to oppose each other across the sweet spot of the racket. The frame and the weights are both covered with fiber-reinforced material. With this structure, the mass of the frame can be concentrated at the sweet spot, which results in mitigation of shock transmitted to the handle upon striking a ball, and offers a pleasant feeling upon striking of a ball. Generally, the weight of such a part is limited to be less than a few grams. Thus, if metal having a large weight per unit area is to be used as the weight, as is the case with conventional rackets, the position to which the weight is fixed had to be limited to a small area. Therefore, even though the shock being transmitted to the handle can be mitigated, these weights could not contribute much to stabilizing the face of the head-frame and reducing the amount of bending deformation. Further, in conventional cases, the weights had to be covered with cylindrically-knitted fiber reinforced material upon fixing, in order to realize firm attachment. This covering procedure was extremely laborious. It is also possible to flatten the conventional metal weights into thin strips and fix them to the frame. In this case, however, the repetitive bending of the frame caused by the shock imparted upon each ball-strike impairs the bond between the metal weight and the frame, owing to the large difference in ratio of extension of the metal and the fiber reinforced resin-made frame. Thus, it is not possible to integrally maintain the weight and the frame as one body. SUMMARY OF THE INVENTION In order to solve the above-mentioned and other problems, it is an object of this invention to provide a racket which is capable of mitigating the shock transmitted to the handle, improving the stability of the face of the head-frame, and enhancing the ability to damp the vibration imparted to the head-frame upon striking, by fixing weights onto the lateral sides of the frame in a manner so as to extend over a rather wide area thereof. Another object of this invention is to provide a racket in which the weights can be easily attached to the surface of the fiber reinforced resin-made frame, and in which the bond between the weights and the frame is not impaired by the repetitive bending of the frame. A racket according to one aspect of the present invention has meshed pieces integrally attached to the surface of lateral sides of a racket frame so that the meshed pieces are opposed to each other across the sweet spot of the racket. The meshed piece is made from titanium and has a predetermined shape. Although the specific gravity of titanium is 4.53, which is considerably larger than that of aluminum, which is 2.7, since the titanium weights are formed to have a mesh structure, they can be attached along a rather wide area of the lateral sides of the frame (in the longitudinal direction,) in a manner so that the sweet spot of the racket is interposed therebetween. In other words, the area per unit weight to which the meshed piece is attached can be enlarged. Thus, not only is it possible to provide the conventional shock-mitigating characteristics, the toughness of titanium also makes it possible to reduce the amount of bending of the head-frame, improve the stability of the face of the frame, and enhance the ability in damping the vibration imparted to the head-frame upon impact. In addition to the fact that titanium has an extremely large extension ratio (23%) compared to other titanium alloys, the mesh structure further enhances the extension characteristic of this titanium-made member. Therefore, the meshed piece can be bent and deformed with the frame even if it is attached along a rather wide area of the frame in the longitudinal direction. Further, upon bonding the meshed piece to the frame with the resin used for molding, the resin can penetrate through the multitude of small openings of the meshed piece. Therefore, the weight can be easily and securely attached to the frame. Preferably, the meshed piece is wrapped around the whole periphery of the frame. With this structure, the toughness of the whole section of the head-frame can be increased, and the vibration-damping characteristic can be further improved. The racket frame is preferably of the type used for tennis, and each of the meshed pieces attached thereto weighs from 0.7 to 2.0 grams. Further, the racket frame is preferably of the type used for badminton, and each of the meshed pieces attached thereto weighs from 0.2 to 0.5 grams. As many different embodiments of this invention may be made without departing from the spirit and scope thereof, it is to be understood that the invention is not limited to the specific embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1A-1B shows a tennis racket according to an embodiment of the present invention, wherein FIG. 1A is a front view thereof, and FIG. 1B is a side view thereof; FIG. 2 is an enlarged plan view of a meshed piece according to an embodiment of the present invention; FIGS. 3A-3C show vibration-damping characteristics upon impartment of vibration to the frame when shock is applied to the gut-strung face of the racket, wherein FIG. 3A shows the characteristics of a racket with no weights, FIG. 3B shows the characteristics of a racket having a pair of lead plummets (1 gram each) attached to the lateral sides of its frame, and FIG. 3C shows the characteristics of a racket according to an embodiment of the present invention; and FIG. 4 is an enlarged plan view of a meshed piece preferably applied to a badminton racket. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS A preferred embodiment of the present invention will be described hereinafter with reference to the accompanying drawings. FIG. 1A is a front view of a racket frame according to one aspect of the present invention, and FIG. 1B is a side view thereof. The racket frame shown in FIGS. 1A and 1B comprises a head-frame 1 having an oval-like front view, a connecting shaft 2 which is branched to form a triangular shape, and a handle 3 . The head-frame 1 and the shaft 2 are integrally formed from fiber reinforced resin into a hollow structure. The handle 3 is integrally attached to the rectilinearly-extending bottom end of the shaft 2 . The head-frame 1 is formed to have an oval-like longitudinal section, and there is a recess 4 provided around the outer periphery thereof. This recess 4 is capable of receiving a strip band which covers eyelets for inserting gut strings. In FIGS. 1A and 1B, the gut strings are not shown for simplicity of the drawings. In this embodiment, a pair of titanium-made meshed pieces 5 are integrally wrapped on the lateral sides of the head-frame 1 so that the sweet spot located in the central portion of the racket face is interposed therebetween. The dimension of the meshed piece 5 is as shown in FIG. 2, i.e., the width a is 70 mm, length b is 60 mm, and length c is 82 mm. As can be seen from the same Figure, the upper end of the mesh piece 5 is projectingly curved outwards while the lower end thereof is curved inwards in the same shape. The meshed piece 5 weighs 1 g (gram), and is made from titanium standardized by Japanese Industrial Standard (JIS) Class 2, having a specific gravity of 4.53, hardness of 200 (Hv), tensile strength of 69.6 kgf/mm 2 , and extension ratio of 23%. The openings of the meshed piece 5 have a diamond-like shape, and each side thereof is about 0.8 mm. The multitude of openings can be formed by piercing or by etching into a thin titanium sheet, or by subjecting the thus pierced titanium sheet to rolling. The meshed piece 5 is integrally fixed to the head-frame 1 according to the following procedure. Before molding the fiber reinforced resin-made frame, the meshed piece 5 is wrapped around the head-frame 1 so that the sweet spot, which is located in the central portion of the head-frame, is interposed therebetween. Here, the protruding upper end of the meshed piece 5 faces upwards, and the center of the protrusion is placed at the inner side of the head-frame 1 . The head-frame 1 is then hot molded in a metal die, and the meshed pieces 5 are integrated therewith. Finally, the surface of the frame 1 is covered with a coating. A test was carried out in order to compare the bending characteristics of a racket frame according to one embodiment of this invention having meshed pieces attached to the head-frame, and the same racket frame without any meshed pieces, the results of which are listed in TABLE 1 below. TABLE 1 Bending upon holding Bending upon Frame deformation both ends holding one end 80 kgf 40 kgf Specifi- Weight 60 kgf 80 kgf 100 kgf 15 kgf longitudinal lateral cation g mm mm mm mm mm mm No meshed 236 14.9 20.1 25.0 33.6 9.6 7.2 pieces Present 238 13.7 18.3 22.9 32.4 8.5 7.0 invention The column labeled “Bending upon holding both ends” in TABLE 1 shows the amount of bending at the central portion of the racket when a bending test is carried out by holding both the upper and lower ends of the racket and applying a load to the central portion thereof, i.e., to the bottom end of the head-frame. The “Bending upon holding one end” column lists the amount of bending at the to tip of the head-frame when a bending test is carried out by holding the handle of the racket and applying a load to the tip portion of the head-frame. The column labeled “longitudinal” beneath “Frame deformation” shows the amount of lateral deformation when the top and bottom portions of the head-frame are longitudinally compressed. The “lateral” column lists the amount of longitudinal deformation when the right and left sides of the head-frame are laterally compressed. From TABLE 1, it can be readily appreciated that according to the racket of the present invention in which a pair of meshed pieces are fixed to the lateral sides of a head-frame, both the amount of bending and the amount of lateral/longitudinal deformation are remarkably reduced in comparison with the racket without weights. This result signifies that the stiffness of the head-frame has increased. Particularly, it can be appreciated that the stability of the face of the head-frame has remarkably improved, from the fact that the longitudinal stiffness increased by about 13%, and the lateral stiffness increased by about 2%. Next, a vibration-damping test was conducted by using a tennis racket having a weight of 236 g, the center of gravity located 376 mm away from the end of the handle, and a face pressure of 57 lb after stringing the gut strings. The handle of the racket was held so that the racket face was kept horizontal. A steel ball having a weight of 68 g was dropped from a height of 1 m onto the gut-strung face, and the vibration-damping effect (i.e., degree of damping of vibration being applied to the handle) was measured by an accelerometer pickup (CF-350 PORTABLE DUAL CHANNEL FFT ANALYZER) placed on the handle at a position 12 cm away from the handle end. FIG. 3A is a diagram showing a vibration-damping characteristic of a racket having no weights attached to its head-frame; FIG. 3B is a diagram showing a vibration-damping characteristic of a racket having a pair of lead plummets (1 g each) mounted on the lateral sides of its head-frame; and FIG. 3C is a diagram showing a vibration-damping characteristic of a racket according to one aspect of the present invention having a pair of meshed pieces (1 g each) attached to the lateral sides of its head-frame, as shown in FIG. 1 . The rackets used in FIGS. 3B and 3C weigh 238 g and the center of gravity thereof is located 378 mm away from the end of the handle, since a pair of lead plummets and a pair of meshed pieces are attached to the head-frames of the respective rackets. From FIGS. 3A and 3B, it is apparent that a better damping effect can be obtained from the racket provided with lead weights than from the racket without weights. Further, from comparing FIGS. 3B and 3C, it can be appreciated that the racket of the present invention provided with the meshed pieces has a superior damping effect against vibration caused by initial shock impartment, not to mention the subsequent, excellent damping effect. Although the above description is of a preferred embodiment of the present invention applied to a tennis racket, this invention is also applicable to badminton rackets or rackets used in other sports. In applying the present invention to a badminton racket, the dimensions of titanium meshed pieces 5 a are much smaller than the ones used for a tennis racket, as is shown in FIG. 4, since the badminton rackets are lighter in weight. Here, the width a′ is 30 mm, length b′ is 42 mm, and length c′ is 50 mm. Other features are to be the same as those of the meshed pieces for tennis rackets. Various modifications can be made without departing from the scope of the present invention. For example, instead of winding the meshed pieces around the whole periphery of the head-frame as in the above embodiment, it is possible to form the meshed pieces into strips and attach a pair of these strips on the inner surface of each of the lateral sides of the head-frame, (i.e., four strips in total,) so that each pair of strips sandwiches the gut-strung face from both the upper and lower sides. In other embodiments, a pair of strips can be attached to the outer surface of each lateral sides of the head-frame (a total of four strips), or, to both the inner and outer surfaces of the lateral sides of the head-frame (a total of eight strips). In the above-described embodiment, the length of one side of each opening of the meshed pieces is 0.8 mm; but in other embodiments, this length can be in the range of 2.0 mm or less. However, the length of the opening should not exceed 2.0 mm, because the surface area of the meshed piece having the same weight as that of the above embodiment will become too large, and cause difficulty in maintaining the predetermined shape of the meshed piece upon wrapping and attachment. Although the weight of each meshed piece is described to be 1 g in the above embodiment, it is preferable to vary the weight thereof according to the weight of the racket. The weight of the meshed piece can be in the range of 0.7 to 2.0 g for commonly used, fiber reinforced resin-made tennis rackets. The weight of the meshed piece can be in the range of 0.2 to 0.5 g for badminton rackets, since these rackets are much lighter than tennis rackets.

A racket which is capable of mitigating the shock transmitted to the handle, improving the stability of the face of the head-frame, and enhancing the ability to damp the vibration imparted to the frame upon impact is disclosed. The racket has two meshed pieces ( 5 ) integrally attached to the surface of each of the lateral sides of a head-frame ( 1 ) so that the meshed pieces ( 5 ) are opposed to each other across the sweet spot of the racket. The meshed piece ( 5 ) is made from titanium and has a predetermined shape.

BACKGROUND [0001] Bedridden and incontinent patients typically require continuous care to dispose of human waste products. Typically, bedridden patients may relieve themselves into a separate receptacle that is then replaced by a caretaker. As the patient has to adjust their position to use the receptacle, such a method of relief may be cause discomfort to the patient for physical reasons as well as for reasons of embarrassment. [0002] Patients unable to move, as well as incontinent patients, are typically incapable of using a separate receptacle for relief. In such cases, human waste products are typically collected on an absorbent pad or similar device that may be fastened to the patient's bed or to the patient themselves. However, such devices are incapable of preventing human waste products from contacting the skin of the patient due to compression of the absorbent pad by the patient's weight. Consequently, the patient may develop pressure ulcers from continued contact with the waste products. Additionally, the necessity of having a caretaker change an unclean absorbent pad may cause further embarrassment for the patient. [0003] Other alternatives for waste collection for bedridden and incontinent patient include waste collection receptacles that may be inserted into a cavity defined in a mattress while the patient is relieving themselves. However this alternative does not prevent the human waste products from contacting the patient's skin due to compression of the mattress and may be difficult to remove while the patient remains on the bed. A similar alternative involves adding a mattress overlay device to address the problem of mattress compression; however for reasons of patient comfort and other factors the device needs to be installed when the patient is ready to relieve themselves and removed immediately following relief, making such a device unsuitable for incontinent patients. Another alternative involves inflating a mattress and inserting a waste collection receptacle into a cavity defined in the mattress when the mattress is inflated; however, this device must similarly be inserted when the patient is ready for relief and removed immediately thereafter, thereby making continuous collection of human waste products impossible. SUMMARY [0004] According to at least one embodiment, an apparatus for continuous collection of human waste products is disclosed. The apparatus may allow for continuous collection of human waste products while maintaining the patient in a comfortable position. The apparatus may further facilitate preventing human waste products from contacting the skin of the patient, thereby substantially reducing the occurrence of pressure ulcers. Additionally, the apparatus may reduce the need for the use of Foley catheters for incontinence management, thereby reducing the occurrence of urinary tract infections related to such use. The apparatus for continuous collection of human waste products may also allow for an easy and efficient process of waste product disposal, thereby reducing the physical and emotional discomfort of the patient. [0005] The apparatus for continuous collection of human waste products may include a bed frame, a lower plate having a container coupled thereto, an upper plate having an aperture defined therein, a mattress having an aperture defined therein, a mattress cover having an aperture defined therein and an absorbent pad having a bag coupled thereto. The absorbent pad may be placed on top of the mattress or the mattress cover with the bag of the absorbent pad being received through the apertures of the mattress cover, mattress, and upper plate and within the container of the lower plate. [0006] According to another embodiment, a method for incontinence management is disclosed. The method for incontinence management may include placing an absorbent pad having a bag coupled thereto into an aperture in a mattress, positioning the patient comfortably over the aperture, separating the waste products from the patient's skin by collecting the waste products in the bag, and replacing the absorbent pad while reducing the physical and emotional discomfort of the patient. BRIEF DESCRIPTION OF THE DRAWINGS [0007] FIG. 1 is an isometric view of an exemplary embodiment of an apparatus for continuous collection of human waste products. [0008] FIG. 2 is an isometric view of an exemplary embodiment of an absorbent pad having a bag coupled thereto. [0009] FIG. 3 is an exploded isometric view of an exemplary embodiment of an apparatus for continuous collection of human waste products. DETAILED DESCRIPTION [0010] Aspects of the invention are disclosed in the following description and related drawings directed to specific embodiments of the invention. Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. Further, to facilitate an understanding of the description discussion of several terms used herein follows. [0011] As used herein, the word “exemplary” means “serving as an example, instance or illustration.” The embodiments described herein are not limiting, but rather are exemplary only. It should be understood that the described embodiment are not necessarily to be construed as preferred or advantageous over other embodiments. Moreover, the terms “embodiments of the invention”, “embodiments” or “invention” do not require that all embodiments of the invention include the discussed feature, advantage or mode of operation. [0012] Referring to FIGS. 1-3 , an exemplary embodiment of an apparatus for continuous collection of human waste products 100 may include a bed frame 102 , lower plate 108 , upper plate 114 , mattress 120 , at least one mattress cover 124 , and absorbent pad 130 . [0013] Bed frame 102 may be made of metal, such as, for example, welded steel, or any other suitable construction known to one having ordinary skill in the art. In one embodiment, bed frame 102 may be sized to accommodate a mattress having a length of about 80 inches and a width of about 38 inches, such as, for example, a long size twin mattress. Bed frame 102 may include a pair of lower transverse rails 104 and a pair of lower longitudinal rails 106 . Bed frame 102 may also include a plurality of upper transverse rails 105 and a pair of upper longitudinal rails 106 . In one embodiment, bed frame 102 may incorporate a support platform (not shown) such as, for example the support platform disclosed in U.S. Pat. No. 7,237,289, or any other support platform known to one having ordinary skill in the art. In one embodiment, the structure of bed frame 102 , lower longitudinal rails 106 , or a support platform included with bed frame 102 may allow for the elevation of the head portion of mattress 120 relative to the foot portion of mattress 120 . In one embodiment, the head portion of mattress 120 may be elevated about 30 degrees relative to the horizontal plane. In one embodiment, bed frame 102 may be a semi-electric bed similar to Invacare Product No. 5310IVC or the like. [0014] Absorbent pad 130 may be constructed of materials that facilitate the absorption of human waste products into the interior of the pad while resisting the passage of absorbed products to the outside of the pad. Absorbent pad 130 may be sized such that the length of absorbent pad 130 substantially corresponds to the width of mattress 120 . In one embodiment, absorbent pad 130 may have a length of about 28 inches. Absorbent pad 130 may have a horizontal portion 132 and an aperture 136 defined substantially in the center thereof. Aperture 136 may have a substantially rectangular shape, with the longitudinal axis of aperture 136 being positioned transversely to the longitudinal axis of absorbent pad 130 . Absorbent pad 130 may also include bag 138 . Bag 138 may be constructed of polyethylene or any other material that facilitates isolation of human waste products that is known to a person having ordinary skill in the art. Bag 138 may be coupled to absorbent pad 130 such that the upper edges of bag 138 are coterminous with the edges of aperture 136 , thereby defining a cavity 137 such that the inner surface of cavity 137 is contiguous with the upper surface of absorbent pad 130 . Human waste products may therefore be collected within cavity 137 of bag 138 , thereby facilitating keeping away human waste products from contact with the skin of the patient. In one embodiment, cavity 137 may have a width of about 5 inches, a length of about 10 inches, and a depth of about 8 inches. [0015] Apparatus for continuous collection of human waste products 100 may include at least one mattress cover 124 . At least one mattress cover 124 may include an impermeable layer that facilitates protecting the top of mattress 120 from moisture and contamination. In one embodiment, mattress cover 124 may be an Advanced Performance Non-Vinyl Mattress Protector manufactured by Tempur-Pedic International, Inc. In another embodiment, mattress cover 124 may be constructed of a vinyl or similar material. A mattress cover 124 may also be a bed sheet constructed of a fabric material or any other material known to one having ordinary skill in the art. [0016] In one embodiment, mattress cover 124 may be sized to substantially cover the top of a mattress having a length of about 80 inches and a width of about 38 inches, such as, for example, a long size twin mattress. Mattress cover 124 may also include an aperture 126 defined substantially near the midpoint of the transverse axis of mattress cover 124 , wherein the longitudinal axis of aperture 126 may be substantially parallel to the longitudinal axis of mattress cover 124 . Aperture 126 may have dimensions that facilitate receiving bag 138 within aperture 126 . In one embodiment, aperture 126 may have a width of about 5 inches and a length of about 10 inches. [0017] Apparatus for continuous collection of human waste products 100 may also include mattress 120 . Mattress 120 may include an aperture 122 defined substantially near the midpoint of the transverse axis of mattress 120 , wherein the longitudinal axis of aperture 122 may be substantially parallel to the longitudinal axis of mattress 120 . Aperture 122 may have dimensions that facilitate receiving bag 138 within aperture 122 . Aperture 122 may also have dimensions that facilitate increasing patient comfort while the patient is lying on mattress 120 . In one embodiment, aperture 122 may have a width of about 5 inches and a length of about 10 inches. [0018] Mattress 120 may facilitate maintaining the patient's body in a comfortable position. Mattress 120 may also facilitate maintaining the patient's rectum and urethra above aperture 122 , thereby facilitating the collection of human waste products within cavity 137 of absorbent pad 130 . In one embodiment, mattress 120 may include a layer that may be constructed from a polyurethane foam with low rebound properties, such that the mattress may mold to the body of the patient, thereby further facilitating the maintenance of the patient's anus and urethra above aperture 122 . For example, in one embodiment, mattress 120 may be a mattress manufactured by Tempur-Pedic International, Inc. In another embodiment, mattress 120 may be constructed of any material known to one having ordinary skill in the art that facilitates maintaining the patient in the position described herein. [0019] While bed frame 102 may include a plurality of upper transverse rails 105 that facilitate providing support to mattress 120 , the presence of bag 138 may interfere with the placement of upper transverse rails 105 proximate to the central portion of bed frame 102 . To facilitate providing support to the central portion of mattress 107 , upper plate 114 may engage upper longitudinal rails 107 or any analogous of bed frame 102 . Upper plate 114 may include an aperture 116 defined substantially therein, such that when upper plate 116 is coupled to bed frame 102 , aperture 116 may receive bag 138 within aperture 116 . Aperture 116 may have dimensions that facilitate receiving bag 138 within aperture 116 . In one embodiment, aperture 116 may have a width of about 5 inches and a length of about 10 inches. [0020] Lower plate 108 may engage the lower longitudinal rails 106 or any analogous structure of bed frame 102 . Lower plate 108 may include container 112 coupled thereto, container 112 defining a cavity 110 that is sized to receive bag 138 of absorbent pad 130 therein. Container 112 may facilitate supporting bag 138 when apparatus 100 is in use. Consequently, when bag 138 contains human waste, container 112 may provide support to bag 138 and its contents, thereby reducing tension on bag 138 and reducing the likelihood of absorbent pad 130 shifting in position. [0021] In operation, the caretaker may place absorbent pad 130 on the top surface of mattress 120 or mattress cover 124 and insert bag 138 into cavity 110 of lower support plate 108 . The patient may then lie on apparatus 100 such that the patient's anus and urethra are comfortably positioned substantially over the center of aperture 136 of absorbent pad 130 . The caretaker may desire to raise the head portion of mattress 120 to provide comfort to the patient and to increase the effectiveness of apparatus 100 in collecting human waste products from the patient. For example, raising the head portion of mattress 120 to 20 degrees above the horizontal may further increase the effectiveness of collecting urine waste from female patients, while raising the head portion of mattress 120 to 30 degrees above the horizontal may further increase the effectiveness of collecting urine waste for male patients. The apparatus thus allows for continuous collection of human waste products while the patient is lying on mattress 120 . [0022] To replace absorbent pad 130 , the caretaker may roll the patient onto their side such that they are located on one side of mattress 120 . The caretaker may then gather and compact half of horizontal portion 132 such that cavity 110 of bottom plate 112 is accessible. The caretaker may then place a replacement absorbent pad onto mattress 120 , roll out half of horizontal portion 132 of the replacement pad, and insert bag 138 of the replacement pad into cavity 110 . The patient may then be rolled onto their other side such that they are located on the opposite side of mattress 120 . The caretaker may then withdraw the used absorbent pad and roll out the remaining half of horizontal portion 132 of the replacement pad. The patient may then be placed such that the patient's anus and urethra are comfortably positioned substantially over the center of aperture 136 of replacement absorbent pad 130 , allowing for further continuous collection of human waste products from the patient. [0023] The foregoing description and accompanying figures illustrate the principles, preferred embodiments and modes of operation of the invention. However, the invention should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art. [0024] Therefore, the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the invention as defined by the following claims.

According to at least one embodiment, an apparatus for continuous collection of human waste products is disclosed. The apparatus may include a bed frame, a lower plate having a container coupled thereto, an upper plate having an aperture defined therein, a mattress having an aperture defined therein, a mattress cover having an aperture defined therein and an absorbent pad having a bag coupled thereto. The apparatus may allow for continuous collection of human waste products while maintaining the patient in a comfortable position. The apparatus may further facilitate preventing human waste products from contacting the skin of the patient, thereby substantially reducing the occurrence of pressure ulcers. Additionally, the apparatus may reduce the need for the use of Foley catheters for incontinence management, thereby reducing the occurrence of urinary tract infections related to such use.

BACKGROUND [0001] 1. Technical Field [0002] The present invention relates to food ingredient comprising functional peptide extracted from coffee bean and having anti-tumor characteristic. [0003] 2. Related Art [0004] As a technique for extracting effective ingredient contained in vegetable or the like, it is described in JP-A-H09-67259. This extracting technique is about extracting effective ingredients of small quantity from vegetable, animal, mineral, etc. The inventor established a technique for extracting effective ingredient of small quantity from coffee bean, soybean, etc. [0005] Extract ingredient by the technique is obtainable in water solution state, however quantity of effective ingredient in water solution is very small, so it is difficult to ascertain the sort of ingredient, and inconvenient to handle, so usage of it has been restrained. [0006] So, the inventor devised solidifying technique for extract obtained by said extracting technique and described it in JP-A-2003-117303. By this solidifying technique, ascertainment and classification of extract became easy, so the inventor found out novel functional peptide that is included in coffee-bean extract and has anti-cancer and anti-tumor characteristic, and described the novel invention in JP-A-2005-516790. SUMMARY [0007] However, extract efficiency of the conventional technique is not so high. That is, so much material and long time is required for extracting. And, quantity of novel ingredient of peptide obtainable by the extracting is very small, so it is difficult to use the ingredient as it is for material of medicine or food. So, it is inevitable to disperse the ingredient uniformly in harmless extender. And, for example, solubility of vegetable peptide is generally much influenced by pH or concentration of salt (ion intensity), particularly in acidic zone, solubility of it deteriorates and it deposits or coheres, so ingestion by oral administration of it mixed with food is not always easy, so it is required to disperse the peptide uniformly in harmless means or dispersing means. [0008] An advantage of some aspect of the invention provides A food ingredient manufactured by process comprising: A: Step for powdering fresh milk by freeze drying; B: Step for dissolving powered milk obtained by the step A in water solution of coffer-bean-extract peptide; C: Step for powdering the solution obtained by the step B by freeze drying, wherein the coffee-bean-extract peptide is manufactured by process comprising: (a) Step for generating atomized-water particles by atomizer including heater for heating reserved water to a desired temperature and atomizing means for water, (b) Step for extracting peptide ingredient onto surface of coffee-been-crushed particle by decompressing and vibrating the atomized-water particle with material layer of the coffee-bean-crushed particles filled in extracting device, (c) Step for capturing peptide ingredient extracted on surface of the crushed particle into the atomized-water particle by passing of the atomized-water particle with air flow through the material layer that is vibrated in decompressed state, (d) Step for liquefying the atomized-water particle capturing the peptide ingredient by condensing device, (e) Step for collecting by dropping liquefied peptide-ingredient-containing water into reservoir, (f) Step for recycling atomized-water particle that is not liquefied by the condensing device to the atomizer, and (g) Step for solidifying peptide-ingredient-containing water by contacting the peptide-ingredient-containing water with absorbent and drying the absorbent. [0019] And, according to an aspect of the present invention, it is preferable that means for vibrating the material layer of the coffee-bean-crushed particle is magnetic vibrator or ultrasonic vibrator. [0020] Moreover, it is preferable that material of the absorbent can include glass fiber, and the drying can be freeze drying. [0021] Moreover, it is preferable that the coffee-bean-extract peptide can have amino acid sequence of tyrosine-glycine-serine-arginine-serine. [0022] According to another aspect of the present invention provides a food ingredient comprising peptide having tyrosine-glycine-serine-arginine-serine and manufactured by process comprising: (a) Step for heating water to desired temperature; (b) Step for atomizing the heated water; (c) Step for contacting coffee-bean-crushed particles with heated atomized-water particle with vibrating under decompressed state; (d) Step for condensing the atomized-water particle; (e) Step for collecting cooled condensate obtained by the step (d); (f) Step for mixing the cooled condensate with milk; and (g) Step for powdering mixture of the cooled condensate and the milk by drying. [0030] And, it is preferable that the drying in step (g) can be freeze drying. [0031] Moreover, it is preferable that the milk in step (f) can be obtained by drying fresh milk. [0032] By uniformly dispersing efficiently-extracted-coffee-bean peptide in milk, even small quantity of peptide can be efficiently usable. And, in the milk, the peptide exists to be uniformly dispersed between caseins, colloid particles of fat globule, so it is easily digestible and absorbable, and permeability to cell is increased. BRIEF DESCRIPTION OF THE DRAWINGS [0033] FIG. 1 is block diagram of manufacturing apparatus and manufacturing method. [0034] FIG. 2 is external perspective view of manufacturing apparatus. [0035] FIG. 3 is a perspective view showing interior of the cooling chamber comprised in the apparatus. [0036] FIG. 4 is a external perspective view of the external cylinder included in the extracting device. [0037] FIG. 5 is a external perspective view of the internal cylinder included in the extracting device. [0038] FIG. 6 is a table showing the result of test 1 . [0039] FIG. 7 is a table showing the result of test 2 . [0040] FIG. 8 is a table showing the result of test 3 . DESCRIPTION OF EXEMPLARY EMBODIMENTS [0041] According to an aspect of the invention, the food ingredient is manufactured by mixing milk and coffee-bean-extract peptide, and the method of mixing is preferably as follows. A: Step for powdering fresh milk by freeze drying, B: Step for dissolving powered milk obtained by the step A in water solution of coffer-bean-extract peptide, C: Step for powdering the solution obtained by the step B by freeze drying. [0045] As water solution of coffee-bean-extract peptide, coffee-bean-extract peptide refined by process as follows and dissolved in water is used. (a) Step for generating atomized-water particle by atomizer including heater for heating reserved water to a desired temperature and atomizing means for water, (b) Step for extracting peptide ingredient onto surface of coffee-been-crushed particle by decompressing and vibrating the atomized-water particle with material layer of the coffee-bean-crushed particles filled in extracting device, (c) Step for capturing peptide ingredient extracted on surface of the crushed particle into the atomized-water particle by passing the atomized-water particle with air flow through the material layer that is vibrated in decompressed state, (d) Step for liquefying the atomized-water particle capturing the peptide ingredient by condensing device, (e) Step for collecting by dropping liquefied peptide-ingredient-containing water into reservoir, (f) Step for recycling atomized-water particle that is not liquefied by the condensing device to the atomizer, and (g) Step for solidifying peptide-ingredient-containing water by contacting the peptide-ingredient-containing water with absorbent and drying the absorbent. [0053] And, according to another aspect of the invention, water solution of coffee-bean-extract peptide refined by process as follows also can be used. (a) Step for generating atomized-water particle by atomizer including heater for heating reserved water to a desired temperature and atomizing means for water, (b) Step for extracting peptide ingredient onto surface of coffee-been-crushed particle by decompressing and vibrating the atomized-water particle with material layer of the coffee-bean-crushed particles filled in extracting device, (c) Step for capturing peptide ingredient extracted on surface of the crushed particle into the atomized-water particle by passing the atomized-water particle with air flow through the material layer that is vibrated in decompressed state, (d) Step for liquefying the atomized-water particle capturing the peptide ingredient by condensing device, (e) Step for collecting by dropping liquefied peptide-ingredient-containing water into reservoir, and (f) Step for recycling atomized-water particle that is not liquefied by the condensing device to the atomizer. [0060] And, in the above description, temperature of water in the atomizer is approximately 80° C. and less, and it is preferable to set the temperature of material layer and atomized-water particle in extracting device to be approximately 60° C.-70° C. [0061] Material layer of the coffee-bean-crushed particles is decompressed and vibrated. Materials are repetitively vibrated by the vibration, so the atomized-water particles uniformly contact with all surface of the material, and the surface can efficiently capture the extracted ingredient. As a means for vibrating, magnetic vibrating means, ultrasonic vibrating means, or other known vibrating means can be used. [0062] Hereinafter, preferred embodiment of apparatus for manufacturing peptide extracted from coffee bean (containing water) will be described in detail with reference to the accompanying drawings. [0063] FIG. 1 is a block diagram showing constitutions of a first embodiment of the manufacturing device, and in the FIG. 1 , reference numeral symbol 1 is an atomizer, reference numeral symbol 2 is an extracting device for extracting effective ingredient from raw material of crushed coffee bean with vibration by atomized-water particle sent from the atomizer 1 , reference numeral symbol 3 is a condensing device for liquefying the atomized-water particle holding the effective ingredient of the raw material transferred from the extracting device 2 , reference numeral symbol 4 is a reservoir tank for receiving water liquefied at the condensing device 3 and containing the effective ingredient of the raw material from the condensing device 3 , reference numeral symbol 5 is a blower provided between the reservoir tank 4 and the atomizer 1 . And, reference numeral symbol 6 is a second reservoir tank connected to the reservoir tank 4 , and reference numeral symbol 7 is a cooling means for cooling the condensing device, reservoir tank 4 , and the second reservoir tank 6 . As shown in the figure, each device such as the atomizer 1 , the extracting device 2 is respectively connected by connecting pipe, so that a circulating path is formed around the atomizer 1 , and it is made such that the atomized-water particle circulates together with air flow by operation of the blower in this circulation path. [0064] FIG. 2 is a external perspective view of the manufacturing apparatus comprising above described constitutions. In the FIG. 2 , reference numeral symbol 1 is an atomizer structured with a water tank that is made of stainless steel and has width and length of 35 cm and depth of 60 cm, and the water tank is made such that approximately 30-40 liters of water is always reserved in this water tank during operation. Reference numeral symbol 1 a is a ultrasonic-wave-generating device, and eight vibrators included in the device la are provided at bottom portion of the water tank 1 , and each vibrator has an ability to atomize water of about 0.5 liter of per one hour. Reference numeral symbol 1 b is a heater for maintaining the water temperature to a desired temperature. [0065] And, reference numeral symbol 2 is hereinafter described extracting device, and it is provided at a side wall of the cooling chamber 7 of cooling means, and connected with the atomizer 1 through a flexible plastic pipe P of 28 mm in diameter and about 1.3 m in length. Further, reference symbol d is a discharged-water tank receiving water discharged from the extracting device 1 . And, reference symbol P 2 is a metal pipe of 40 mm in diameter for connecting the extracting device 2 and a hereinafter described condensing device 3 . [0066] FIG. 3( a ) is a fragmentary perspective view showing an interior of the cooling chamber 7 , and in the FIG. 3( a ), reference numeral symbol 3 is a condensing device made of a plurality (six in this embodiment) of condensing cylinders 3 a , and connected with the extracting device 2 provided at outside of the cooling chamber 7 through the pipe P 2 as described above. In this embodiment, each condensing cylinder 3 a is constituted by metal pipe of 85 mm in diameter and about 550 mm in length, and a cooling plate 3 b is provided at interior of each condensing cylinder 3 a as shown in FIG. 3( b ). Top end of each condensing cylinder 3 a is connected to the connecting pipe P 2 through a branch pipe, and bottom end them are connected to a connecting pipe P 3 through a branch pipe. [0067] Reference numeral symbol 4 is a reservoir tank connected with the condensing device 3 through a connecting pipe P 3 of 40 mm in diameter, and the reservoir tank is provided for receiving water liquefied from the atomized-water particle by the condensing device 3 . Upper portion of this reservoir tank 4 and the blower 5 provided at outside of the cooling chamber are connected through a connecting pipe P 4 of 40 mm in diameter. Further, reference numeral symbol 6 is a second reservoir tank, and it is connected with the reservoir tank 4 through a drain pipe 6 a. The cooling device of the cooling chamber 7 is provided at top ceiling portion, however a window type air conditioner may be fixed at side wall portion for increasing cooling capacity. [0068] FIG. 4 is a external perspective view of external cylinder that is a constituting element of the extracting device 2 , and the external cylinder includes a first external cylinder 2 a and a second external cylinder 2 b , and both external cylinders are made to be supported by clamping device C 1 such that they freely joint, release, and open. And, they are formed to be cylindrical shape of 200 mm in diameter and about 150 mm in depth, and they are made of stainless steel. Further, a temperature sensor for detecting temperature during extracting operation is installed at the second external cylinder 2 b provided at lower side. FIG. 5 is a explanatory view of internal cylinder that is constituting element of the extracting device 2 , and FIG. 5(A) is a perspective view of the internal cylinder 2 c. The internal cylinder 2 c has shape and size capable of fitting to the external cylinder, and a net portion for holding the raw material crushed to small pieces is provided at bottom portion, and vibrating base as a vibrating means is provided at side portion. FIG. 5( b ) shows a guide plate for being inserted into the internal cylinder 2 c, and as shown in FIG. 5( c ), it is made to partition the crushed pieces S of coffer bean in an interior of the internal cylinder 2 c. Existence of this guide plate 2 d bring an effect to make passage of the pulverized minute particles to be easy and smooth as will be described hereinafter. And, this guide plate 2 d may be formed in spiral shape. As described above, the extracting device 2 is constituted with a pair of external cylinder and the internal cylinder for being inserted to that. [0069] Operation of manufacturing apparatus and manufacturing process for coffee-bean-extract peptide (containing-peptide water) will be described based on the above described constitution. In the embodiment, raw coffee bean is used as raw material. First, coffee beans crushed to a magnitude of particulate are filled in the internal cylinder 2 c shown in FIG. 5( a ). The weight of coffee beans filled in the internal cylinder is about 1800 g. With the coffee beans filling, guide plate 2 d shown in FIG. 5( b ) is installed in the internal cylinder 2 c. Further, after filling, if a net is provided on the coffee beans, the coffee beans may be stably maintained in the internal cylinder. [0070] Next, the internal cylinder 2 c is inserted into the external cylinder 2 shown in FIG. 4 . On the other hand, water of about 30-50 liters is reserved in the atomizer 1 shown in FIG. 2 . And, it is constituted such that aforementioned amount of water is always automatically maintained in the atomizer 1 . When preparation of water into the atomizer 1 and raw material of coffee beans into the extracting device 2 is finished, temperature of water in the water tank 1 is set by the heater 1 b of the atomizer 1 . When coffee beans are used as raw material, the set temperature of 85° C. seems to be most preferable by experience. The temperature of 85° C. is most suitable for maintaining temperature in the extracting device 2 to be 60-70° C., as will be described hereinafter. [0071] When the temperature of water in the water tank 1 reaches the set temperature of 85° C., switches of the ultrasonic wave generating device la and the blower are turned on. By operation of the blower 5 , air flow circulates the circulation path formed by the atomizer 1 , the extracting device 2 , the condensing device 3 , the reservoir tank 4 , the blower 5 , and the connecting pipes connecting these respective devices. By this configuration, the atomized-water particle generated by the atomizer 1 passes through the aforementioned plastic pipe P 1 together with the air flow and reaches the extracting device 2 . Further, the temperature of the atomized-water particle in the extracting device 2 is preferable to be in the range of 60-70° C., as described above. For this reason, the temperature in the extracting device is always detected by the temperature sensor provided to the extracting device 2 , and the water temperature in the atomizer 1 is adjusted in response to the detected result by the sensor in order to obtain preferable temperature. [0072] As described above, the air flow circulates through each device by operation of the blower 5 , however crushed coffee beans as raw material are filled in the extracting device, so air flow passing through the pipe P 1 suffers resistance, and the flow weakens. On the other hand, at downstream side of the connecting pipe P 2 , nothing disturbs the air flow. So, space in the extracting device 2 becomes decompressed state. [0073] When the space in the extracting device 2 become decompressed state, known ingredient and unknown ingredient contained within the coffee beans are extracted out to the surface of crushed pieces of coffee beans that are raw material. The above described various ingredients extracted to surface of the crushed coffee beans are captured by the atomized-water particles that pass through. And, the crushed coffee beans are vibrated by the vibrating means 21 , atomized-water particles uniformly contact with all surfaces of the crushed coffee beans and capture ingredients. And, as described above, since the temperature in the extracting device, more particularly in the internal cylinder 2 c is maintained to be approximately 65° C., ingredient contained in the coffee beans are extracted into the atomized-water particle without being destroyed by heat. [0074] The atomized-water particles containing the effective ingredient of coffee beans reach the respective condensing cylinder 3 a of the condensing device 3 through the connecting pipe P 2 together with the air flow. Since the condensing cylinder 3 a and the cooling plate 3 b therein are present in the cooling chamber 7 for cooling, the atomized-water particles passing through therein are liquefied and changed to water containing effective ingredient of coffee bean. This water containing ingredient of coffee bean is dropped into the reservoir tank 4 , and finally collected to the second reservoir tank 6 through the drain pipe 6 a. The coffee-bean-ingredient-containing water collected to the second reservoir tank 6 is filtered by a filter for eliminating miscellaneous impurities, and then extract-ingredient-containing water as final product in which effective ingredients of coffee bean are contained as major ingredient is made. [0075] In the meanwhile, the atomized-water particles which were not liquefied at the condensing device 3 are sucked to the blower 5 through the connecting pipe 4 together with the air flow and return to the atomizer 1 , and thereafter are sent to the extracting device 2 again through the plastic pipe P 1 . [0076] As described above, the atomized-water particles circulate the circulating path so that the effective ingredient of the coffee bean as a raw material is captured by the atomized-water particles, and thereby the extract-ingredient-containing water containing effective ingredient of the coffee bean is obtained by liquefying the atomized-water particles, here the single operation period of the manufacturing apparatus is one hour. That is, in the above described embodiment, extract-ingredient-containing water of about 3˜4 liters can be finally manufactured by executing one hour extraction with about 180 g of crushed coffee bean pieces. [0077] However, although very small-sized particulates of coffee bean are used in the above described embodiment, concentration of the effective ingredient contained in the final product can be adjusted by changing the size of the crushed pieces of the coffee bean. That is, as the crushed piece of the coffee bean is made to be finer, product of higher concentration can be obtained. However, in that case, the manufacturing quantity per hour is decreased. On the contrary, when the crushed piece is made to be bigger, the manufacturing quantity per hour is increased, and the concentration of ingredient becomes lower. [0078] In the above described embodiment, although the guide plate 2 d is used in the internal cylinder 2 c of the extracting device 2 , when this guide plate is used, yield quantity of extract-ingredient-containing water per hour increases about 20% compared to a case of no use, but concentration is decreased. And, by vibrating raw material of coffee bean, efficient extract is possible, so same quantity of extract-ingredient-containing water can be obtained from a quarter quantity of raw material. [0079] However, in the embodiment related to the above described manufacturing apparatus, as shown in FIGS. 1 , 2 , and 3 , although non-liquefied atomized-water particles are returned to the atomizer 1 through the connecting pipe P 4 and the blower 5 , since this atomized-water particles are cooled at the cooling chamber 7 , so temperature of the atomized-water particles goes down to about 15° C. And, when this cooled atomized-water particles are mixed with newly atomized-water particles generated at the water tank 1 in this state and sent to the plastic pipe P 1 , temperature of the newly atomized-water particle goes down and condenses to water droplet, so transfer of the atomized-water particle in the pipe P 1 may be disturbed. To solve this problem, it is preferable to heat some part of the connecting pipe P 4 provided at outside of the cooling chamber, or to rotate the atomized-water particle sent from the blower 5 to the atomizer 1 with rectifying plate of spiral shape, and then temperature of the atomized-water particle is raised during the rotation, and after that, the atomized-water particle is preferably sent to the plastic pipe P 1 . [0080] Meanwhile, water comprising peptide extracted from coffee bean by above described manufacturing apparatus is mixed with fresh milk to obtain novel food ingredient. That is, coffee-bean-extract peptide uniformly spread and stably exists in milk ingredient, so the coffee-bean-extract peptide exists even in very small quantity of milk, moreover the peptide is mixed with milk, so the food ingredient has high compatibility with peptide transporter in viscera and arrives at desired viscera in state of easily absorbable and easily permeates into cells. [0081] However, this liquefied food ingredient is inconvenient to preserve and handle, so powder or solid type is preferable as a final product. [0082] In the embodiment, fresh milk is powdered by known freeze drying, and the powdered milk is dissolved in water solution of coffee-bean-extract peptide obtainable by above described embodiment, moreover the mixture of powdered milk and the water solution of peptide is powdered by freeze drying, and food ingredient of powder type is made. And, known nonfat dry milk can be used instead of the powdered milk. [0083] In the above described embodiment, although water solution of coffee-bean-extract peptide obtained by extracting of coffee bean is used, mixture of solidified coffee-bean-extract peptide and water also can be used. [0084] That is, by contacting coffee-bean-extract-peptide-containing water obtained by above described manufacturing apparatus with absorbent, thereafter by drying the absorbent, the coffee-bean-extract peptide is solidified. [0085] First embodiment of procedure for solidification is as follows. First of all, as for the absorbent, non-nutritional material is used. Suitable materials for the absorbent is hydrophilic membrane filters such as polyvinylidene fluoride membrane of the Durapore filter commercially available from Milipore Corporation. And, membrane made of glass fiber, cotton, nylon, cellulose, or paper material that is used for tea bag is also desirable. The shape of the membrane is not particularly limited, and can be sheet shape, disc shape, etc. [0086] The absorbent contacts with the extract (coffee-bean-extract peptide) obtained by above manufacturing apparatus. It is preferable that the entire surface of the absorbent is wetted by the liquid final product containing the extract. When membrane is used as absorbent, to completely wet the membrane with the final product (extract), for example, driving force of vacuum pump or the like can be used to push or pull the extract through the filter. Optionally, the absorbent can be heated before or during wetting to expand pores and enhance the wetting. Alternatively or in addition to the heating, the final product (extract) may be heated. If the absorbent is sufficiently wetted by the final product (extract), the extract more preferably adheres to the absorbent than in dried condition. Drying can be done by freeze drying, heat drying, air flow drying, however freeze drying is preferable. Dried extract can be preserved for a long time without deterioration. And, the dried extract can be dissolved in water or other solvent to obtain liquid containing effective ingredient. Pressure can be applied to facilitate the dissolution, if desired. [0087] The inventor find out that coffee-bean-extract peptide obtained by above described embodiment is pentapeptide that has amino acid sequence of: tyrosine-glycine-serine-arginine-serine, and the coffee-bean-extract peptide has anti-cancer, anti-inflammation, anti-tumor characteristic. [0088] Composition containing effective amount of the coffee-been-extracted peptide are useful as drug or food ingredient for human or animal, for example, useful in treatment and/or prevention of various diseases and conditions including anticancer and anti-inflammatory condition. Various diseases against which the peptide is effective include cancers of various types. Various types of inflammation against which the peptide is effective include encephalitis, cerebral meningitis, marginal blepharitis, conjunctivitis, keratitis, iritis, retinitis, stomatitis, cheilitis, glossitis, tonsillitis, internal otitis, external otitis, glossitis, tonsillitis, internal otitis, external otitis, otitis media, gastritis, duodenitis, pneumonia, pleurisy, bronchitis, rhinitis, colitis, inflammation of the small intestine, nephritis, pyelitis, pancreatitis, cholecystitis, hepatitis, thyroiditis, prostatitis, cystitis, myotis, periostitis, osteomyelitis, orchitis, endometritis, vaginitis, ovaritis, dermatitis, arthritis, periproctitis, lymphadenitis, diabetes (inflammation of the pancreatic islets), common cold (tonsillitis, bronchitis, rhinitis, mucositis), urticaria, various kinds of eczema (dermatitis), nephrosis (nephritis), alveolar pyorrhea (parodontitis, aplicalis, endodontitis), asthma (bronchitis), neuralgia (neuritis), infectious diseases (inflammation induced by bacteria and virus), allergy (inflammation induced by antigen-antibody reaction), leprosy (viral dermatitis, and myotis), cancer (inflammation and fibroid induration are also causes), ulcer (progression of inflammation), fibroid induration (progression of inflammation and ulcer), reduced energy (adenitis), keratosis, collagen diseases, hysteria, neurosis, liver cirrhosis, hypertension, thrombosis, angina, rheumatism, gout, stiffness, Alzheimer, Lyme disease, mad cow disease, and inflammation due to parasites. [0089] The coffee-bean-extract peptide having above described amino acid sequence is isolated and classified as follows. [0090] Coffee bean as a raw material is used in above described extraction method. With the obtained extract, glass fiber membrane of 96.4 g is wetted. The membrane is extracted three times with ethyl acetate of 300 ml. The ethyl acetate is almost dried under vacuum by rotary evaporator. Temperature of solvent layer does not exceed 40° C. Residue is liquid (20.6 ml) with light brown color. [0091] Then, the extract is extracted with ethyl ether of 150 ml. Layer of the ethyl ether is dried with anhydrous sodium sulfate. The sodium sulfate is removed and the ethyl ether layer is dried in rotary evaporator under vacuum. White compound of short-needle shape is obtained. This compound is dissolved in ethanol and re-crystallized by evaporation of the ethanol. The compound is chemically analyzed, and we obtain following parameters: [0000] Absorption Spectrum: 348 mu Thin layer chromatography 3.8 Silica gel by Merk Corp.: Micro Kjeldahl: 12.4% Melting Point: 172° C. Amino acid sequence: Tyrosine-Glycine-Serine- Arginine-Serine Test 1 Protocol Design: [0092] Adjuvant-induced arthritis model has been developed by using rats to allow screening of compound that may be useful in treatment of rheumatoid arthritis of human. Adjuvant-induced arthritis responds to both of steroids and non-steroid. Degree of inflammation is estimated by measuring differences in weight and/or volume of foot. Test Organism: [0093] Rats with weight of 150-200 g have been purchased from Animal Technologies Ltd., Kent, Wash. They are male Sprague-Dawley rats. The rats have been kept in stainless steel cages individually with free water and food (Harlan Teklan Rodent Diet). Light and darkness cycle has been maintained to be 12 hours of light and 12 hours of darkness. Temperature has been maintained to be 22° C.±3° C. with relative humidity of from 40% to 70%. Dose Administration: [0094] Test material is dissolved or suspended in deionized water at doses of 10 mcg/kg or 1 mcg/kg to body weight. The test compound and hydrocortisone are administered by gavage. Experimental Design: [0095] Male Sprague-Dawley rats (150-200 g) are sensitized by injecting Fruend complete adjuvant (0.5% suspension of killed mycobacterium tuberculosis (H37RA, Difco in mineral oil)). Aliquot of 0.1 ml is intradermally administered at plantar portion of right rear leg of each rat. [0096] The test materials are orally administered (by gavage) to 5 rats in each treatment group once per single day during 10 days. Administration of the test materials initiates from sensitization day. [0097] The left rear paw was investigated just before sensitization and again on tenth day. Plantar-edema-inhibitory rate and body-weight-increase rate are determined by comparing with non-sensitized rat groups. [0098] Weights of the paws are averaged. Anti-inflammatory activity is determined by comparing weights of paws and calculated as follows: [0000] % Anti-inflammatory response=[(Mean paw weight of controll group)−(Mean paw weight of test group)]/(Mean paw weight of test group) [0099] Hydrocortisone is used as a positive control. The hydrocortisone is a general anti-inflammatory administered to rheumatoid arthritis patients at a dose of 10 mg/kg to body weight. Peptide is administered by 10 mcg/kg or 1 mcg/kg to body weight. [0100] As shown in table 1 and 2 of FIG. 6 , the result indicates that the peptide of 10 mcg/kg to body weight inhibits the induced inflammation 100%. At level of 1 mcg/kg to body weight, the peptide inhibits 85.3%. [0101] Accordingly, the peptide is powerful inflammation inhibitor without inducing weight loss. [0000] Test 2 (a) Test Organism Species: Mouse Strain: Swiss-Webster Supplier: Animal Technologies Ltd., Kent, WA Sex: Female Weight: 26~30 Number Used: 60 (b) Husbandry [0102] Research Facility: USDA Registration No. 91-R-043. NIH Public Health Assurance No.A3932-01 [0103] Animal Rooms: Light cycle—12 hours light, 12 hours darkness. Temperature/Relative humidity: every attempt is made to maintain temperature of 22° C.±3° C. and relative humidity of from 40% to 70%. [0104] Housing: Five mice per single group are kept in standard cage, according to the “Guide for the Care and Use of Laboratory Animals” of the Institute of Laboratory Resources, National Research Council. [0105] Sanitation: Waste materials are removed twice a week. Cages and feeders are sanitized by every two weeks. [0106] Food: Marlan Teklad Rodent Diet #8604 properly. [0107] Food Analysis: There are no contaminants that are reasonably expected to be present in the diet material and known to be capable of interfering with the purpose or conduct of the investigation. [0108] Water: Deionized water available for living thing and not containing pyrogen. [0109] Water analysis: The system is periodically maintained by Continental Water System Company by every six months (change carbon tanks, D.I. beds and in-line filters). Replacement of the UF membranes is by every two years, the UV lamp by every year. [0110] Test Article: Isolates form coffee bean. [0111] Dose Administration: Water solution of the isolate is administered by gavage for continuous eleven days. [0112] Administration Volume of Test Article: 0.2 ml by gavage. [0113] Treatment Time: For eleven days. Sacrifice on 12 th day. (c) Assay Method [0114] The tumor stock is Sarcoma 180 that originates in the laboratory of American Type Culture Collection. This stock culture has been passed at weekly intervals as ascites in non-treated Swiss-Webster mice. [0115] The studies are all conducted with Swiss-Webster mice obtained from Animal Technologics Ltd., Kent, Wash. To prepare the inoculum, ascites fluid of 7 th ˜12 th day mouse is aspirated by sterile technique. Viability of tumor cells is checked by trypan-blue staining technique. After number of cells is confirmed, the tumor cells are diluted with normal saline or phosphate buffered saline to obtain final concentration of from 1×10 6 to 2×10 6 cells per mm 3 . Then the tumor suspension is injected into mice. The final dilution is plated on trypticase-soy agar to find out whether there is contamination or not. [0116] One tenth (0.1 ml) of the suspension is inoculated into left rear leg muscle (hamstring muscle mass) of each mouse. The inoculated mice are placed into one large cage and then are randomly segregated into groups of five mice. The mice are housed in shoebox cage with wood shavings therein in condition of free access to water and laboratory chow. The mice are weighed on inoculation day, on 7 th day, on 12 th day, and at the time of sacrifice. Treatment for the mouse begins the day of transplantation. At the end of observation, the mice are sacrificed with ether anesthesia. Skin on the left rear leg is removed to expose the tumor, and then the leg and tumor are picked out to the hip joint. Remnant skin is removed and the legs with tumors are weighed individually. Ten normal legs (right legs) are prepared in a similar manner and weighed. Mean value of the normal legs is subtracted from the weight of the leg with tumor to obtain estimated value of actual tumor weight. [0000] % Inhibition=[(Mean Tumor Weight (Test Group))/(Mean Tumor Weight (Control Group))]×100 [0117] Result: Shown in Table 3, 4 of FIG. 7 . [0118] As shown in table 3 and 4, the result indicates that the peptide of 10 mcg/kg to body weight proves 100% inhibits. Increase of weight by administration of peptide proves nontoxic like the control. [0000] Test 3 (a) Test Organism Species: Mice Strain: Swiss-Webster Supplier: Harlan Laboratories, Inc., Gilroy, CA. Sex: male Weight: 17~20 Number Used: 10 (b) Husbandry [0119] Research Facility: USDA Registration No. 91-R-043. NIH Public Health Assurance No.A3932-01 [0120] Animal Rooms: Light cycle—12 hours light, 12 hours darkness. Temperature/Relative humidity: every attempt is made to maintain temperature of 22° C.±3° C. and relative humidity of from 40% to 70%. [0121] Housing: Five mice per single group are kept in standard cage, according to the “Guide for the Care and Use of Laboratory Animals” of the Institute of Laboratory Resources, National Research Council. [0122] Sanitation: Waste materials are removed twice a week. Cages and feeders are sanitized by every two weeks. [0123] Food: Harlan Teklad Rodent Diet # 8604 properly and other acceptable Lab chow. [0124] Food Analysis: There are no contaminants that are reasonably expected to be present in the diet material and known to be capable of interfering with the purpose or conduct of the investigation. [0125] Water: Deionized water available for living thing and not containing pyrogen [0126] Water analysis: The system is periodically maintained by Continental Water System Company by every six months (change carbon tanks, D.I. beds and in-line filters). Replacement of the UF membranes is by every two years, the UV lamp by every year. [0127] Test Article: Mixture of coffee-bean-isolated peptide (YGSRS, amino acid sequence: tyrosine-glycine-serine-arginine-serine) and nonfat dry milk (the peptide is diluted in solution including nonfat dry milk of 1 g and distilled water of 10 ml). [0128] Dose Administration: 1 ml/day/mouse (two times with 0.5 ml in a day), for continuous fourteen days right after transplantation of tumor by gavage. (c) Experimental Design [0129] Goroup 1 . five mice are treated with tumor in distilled water two times in a day. [0130] Goroup 2 . five mice are treated with tumor and mixture of coffee-bean-isolated peptide (YGSRS, amino acid sequence: tyrosine-glycine-serine-arginine-serine) and nonfat dry milk two times in a day. [0131] The test article of 1 mm is treated per a day. Dose of 0.5 ml is administered in the morning and 0.5 ml in the afternoon at approximately same time of each day. Treatment continues for fourteen days starting from right after transplantation of tumor. [0132] At the end of 14 th day of gavage, the mice are sacrificed and the tumors are weighed. (d) Assay Method [0133] Sarcoma 180 tumor is used to furnish tumor cells with livability of 2×10 2 /0.1 ml that is made up from transplant-source mouse, and the tumor cells are injected into left rear leg muscle (hamstring muscle mass) of mouse. [0134] At the termination of the experiment, the mouse is weighed and the left rear leg is amputated at thigh. And, skin is removed to expose the tumor portion. Net tumor weight is determined by subtracting the mean value obtained from ten normal legs. (e) Result [0135] The result is as shown in table 5 of FIG. 8 . As for table 5, tumor inhibition percent is calculated compared to the water control values. All administration is oral by gavage. (f) Conclusion [0136] The mixture of coffee-bean-isolated peptide and nonfat dry milk actively functions to inhibit the sarcoma 180 tumor in condition of every single day administration with 10 mcg/kilo to body weight for fourteen days. [0137] What is claimed is: [0138] 1. A food ingredient manufactured by process comprising: [0139] A: Step for powdering fresh milk by freeze drying; [0140] B: Step for dissolving powered milk obtained by the step A in water solution of coffer-bean-extract peptide; [0141] C: Step for powdering the solution obtained by the step B by freeze drying, wherein the coffee-bean-extract peptide is manufactured by process comprising: [0142] (a) Step for generating atomized-water particles by

With efficient extracting of peptide from coffee bean, and by providing food ingredient in which small quantity of peptide is uniformly dispersed by harmless means or dispersing means, the peptide is easily orally ingested. That is, so much material and long time is required for extracting. And, quantity of novel ingredient of peptide obtainable by the extracting is very small, so it is difficult to use the ingredient as it is for material of medicine or food. So, it is inevitable to disperse uniformly in harmless extender. And, for example, solubility of vegetable peptide is generally much influenced by pH or concentration of salt (ion intensity), so particularly in acidic zone, solubility of it deteriorates and it deposits or coheres, ingestion by oral administration of it mixed with food is not always easy, so it is required to disperse the peptide uniformly in harmless means or dispersing means.

RELATED APPLICATIONS This application claims priority as a national stage of PCT application No: PCT/IL2011/000625 filed on Aug. 2, 2011 and published as WO 2012/020399. The PCT application claims priority as a continuation in part of U.S. application Ser. No. 12/852,525 filed on Aug. 9, 2010 the disclosure of which is incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to attaching RE tags in general and to attaching RF tags to a sponge and gauze item in particular. 2. Discussion of the Related Art There are many environments in which multiple tools and disposables are used, including for example operation rooms, hangars, garages, or the like. An operation room is a facility in which intrusive operations are performed on patients. Typically, multiple people participate in an operation, using multiple tools, such as scalpels, forceps, and others, varying according to the surgery being performed. Intensive efforts are invested in keeping track of all tools and disposables, in order to make sure no tool unintentionally remains inside the patient's body. Therefore, careful counting is performed before, during and after the operation. Counting the tools is a tedious job and requires intensive resources, including mental resources, personnel time and down-time of the operating room. Counting the tools towards the end of an operation also increases the time the patient's body is open with the associated risks, in addition, counting is not always error-free, and in too many cases tools end up being left within the patient's body, causing severe damages and even death. One of the elements counted in an operation room is sponge items, such as gauze and laparotomy sponges. It is also desired to count the sponge items after an operation to verify that none is left in the patient's tissues. Counting the sponge items can be performed by detecting X-ray detectable wires attached to the sponge items using an X-ray machine, Such machine generates radiation and cannot distinguish one sponge item from several items. As a result, after removing a sponge item from the patient's tissue, one still cannot verify that the patient's tissue is free from sponge items unless rescanning the patient again with X-ray machine. To solve the above problem, RE tags may be attached to sponge items by sewing. The sewing may be performed manually, which is not cost-effective and time consuming. Manual sewing reduces the throughput of the attaching process and increases the costs of the machine that outputs the sponges from raw sheet of the sponge material. It is challenging to mechanize the sewing process, as there are many sizes and models of sponge items, on which the RE tags are to be attached. For example, a different machine is required for sewing an RE tag to a 30 cm long sponge than for a 45 cm long sponge. There is thus a need in the art for a biocompatible and sterilization-resistant identification tag to be attached to a sponge, and a automated cost effective method for attaching the tag to the sponge. SUMMARY OF THE PRESENT INVENTION The subject matter discloses a method of attaching a tag to a sponge item, the method comprising obtaining a tag, obtaining a sponge item and attaching the tag to the disposable item using an adhesive material. The adhesive material is cured by ultraviolet radiation. The method further comprises applying the ultraviolet radiation on the tag attached on the disposable item. In some cases, the tag is an RE tag. In some cases, the adhesive material is attached to the tag before the tag is attached to the disposable item. In some cases, the adhesive material is attached to the disposable item before the tag is attached to the disposable item. In some cases, the method further comprises a step of folding the disposable item. In some cases, the adhesive material is attached to more than one layer of the folded disposable item. In some cases, the ultraviolet radiation cures the adhesive material in more than one layer of the folded disposable item. In some cases, the step of attaching is performed before folding the disposable item. In some cases, the method further comprises a step of maneuvering the tag from tag storage to a working plate on which the disposable item is mounted. Optionally, the adhesive material is DYMAX Ultra Light-Weld 204-CTH-F. The subject matter also discloses a system for attaching a tag to a sponge item, the system comprising a maneuvering mechanism for maneuvering the tag towards the sponge item and an adhesive material storage unit for providing adhesive material attaching the tag and the sponge item. The system also comprises an ultraviolet radiation module for radiating ultraviolet radiation on the tag attached to the sponge item; wherein the ultraviolet radiation cures the adhesive material. In some cases, the maneuvering mechanism maneuvers the tag to the adhesive material storage unit before mounting the tag on the sponge item. BRIEF DESCRIPTION Exemplary non-limited embodiments of the disclosed subject matter will be described, with reference to the following description of the embodiments, in conjunction with the figures. The figures are generally not shown to scale and any sizes are only meant to be exemplary and not necessarily limiting. Corresponding or like elements are optionally designated by the same numerals or letters. FIG. 1 shows a schematic illustration of an operation room, in which an identification and tracking system and method are required, according to exemplary embodiments of the subject matter; FIG. 2 shows a top view of a production line environment for attaching a tag to a disposable item, according to exemplary embodiments of the subject matter; FIG. 3 shows a method for attaching a tag to a disposable item, according to exemplary embodiments of the subject matter. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS One technical challenge disclosed in the subject matter is to attach a tag to a sponge item while maintaining sterilization requirements, such as used in medical environments and hospitals. One technical solution of the disclosed subject matter is a system and a method for attaching a tag to a sponge item. The tag can be an RF tag. The method comprises receiving a sponge item from a storage and mounting the sponge item on a working plate. The method further comprises receiving a tag to be soaked in a UV adhesive material and placed on the sponge item and placing the tag on the sponge item. The method also comprises a step of drying an adhesive material, attaching the tag to the disposable item. The drying is performed using Ultraviolet light emitted from a UV emitter. FIG. 1 shows a schematic illustration of an operation room, in which an identification and tracking system and method are required. A typical operation room comprises an operation bed 104 on which a patient 110 being operated on lies. A surgeon 108 stands by patient 110 and operates on him, A circulating nurse who does not touch the sponges but only opens their wraps may place the sponges on instrument table 112 . Surgeon 108 receives the sponges as required from a scrub nurse who takes the sponges from an instrument table 112 . Surgeon 108 or another team member can place the sponges on a moveable tray 116 placed above or near the patient 110 , often called a Mayo. Each operation room typically has one or more instrument tables and one or more Mayos, depending on factors such as the complexity of the surgery, number of surgeons and other team members, personal preferences or others. The team members retrieve clean sponges from one or more clean sponge bins or dispenser 120 , and throw the used ones into one or more waste buckets 124 . Thus, at the end of the surgery, all sponges that were in the operation room prior to the surgery, should be on instrument table 112 , on Mayo 116 , in clean sponge bin 120 or in waste bucket 124 (collectively referred to as the “utilities”). The operation room is also equipped with a wand 128 , which is also an antenna, and which is used for identifying and tracking items within the body of patient 110 , by waving the wand near patient 110 . FIG. 2 shows a top view of a production line environment 200 for attaching a tag to a disposable item, according to exemplary embodiments of the subject matter. The environment 200 comprises a tag storage 220 for storing one or more tags to be attached to disposable items. The environment 200 further comprises a disposable item storage 210 for storing disposable items. The disposable items may also be provided directly from a manufacturing machine or a production line of disposable items, which may be regarded as equivalent to the disposable item storage 210 . The disposable item may be of one or more types, such as sponges, or cotton wool items. The disposable item may be a gauze pad, a laparotomy sponge and the like. The disposable item storage 210 may comprise two or more storage units for storing two or more types of disposable items. The tag storage 220 may store the tags arranged in a tag stack. The tag storage 220 may comprise a mechanism for outputting one or more tags every predefined period, for example for 2 disposable items every 10 seconds. The environment 200 may further comprise a working plate 230 on which the tag is attached to the disposable item. The working plate 230 may be a conveyor belt. The working plate 230 may be positioned between the disposable item storage 210 and an endpoint 250 to which the disposable items with an attached tag are provided. Optionally, disposable items are released from disposable item storage 210 and conveyed along working plate 230 to endpoint 250 . The environment 200 may further comprise a maneuvering mechanism 225 for maneuvering tags from the tag storage 220 to meet disposable items such as 212 , 213 , and 214 as they are being conveyed along working plate 230 . Optionally, tag storage 220 has a tag release interface 232 that provides tags from tag storage 220 to maneuvering mechanism 225 . Optionally, the maneuvering mechanism 225 moves tags from tag release interface 232 , wherein the maneuver mechanism 225 obtains a tag, to a disposable item interface 237 , wherein the maneuvering mechanism 225 delivers the tags to be mounted on the disposable item. The maneuvering mechanism 225 may contain one or more gripping arms (not shown) to receive the tag from the tag storage 220 . The tag is attached to the disposable item using an adhesive material that is UV curable. The adhesive material may be provided on the tag before or after the tag is obtained from the maneuvering mechanism 225 . The adhesive material can be provided on the disposable item before attachment to the tag. The UV curable adhesive material may be DYMAX Ultra Light-Weld 204-CTH-F. In an exemplary embodiment of the disclosed subject matter, the maneuvering mechanism 225 grips a tag, maneuvers the tag to a dispensing area of an adhesive material storage and places the tag containing the adhesive material on the disposable item. In some cases, the adhesive material is obtained only on one side of the tag, the side attached to the disposable item. The disposable items such as 212 , 213 , and 214 may be positioned on the working plate 230 when the tags are mounted thereon. The disposable items may be folded in order to reduce the volume or surface area they consume. Attaching the tags may be done before folding or after. The environment 200 further comprises an ultraviolet (UV) emitting device 240 . The UV emitting device 240 emits UV radiation 241 on the tag attached to the disposable item as it passes by. The UV radiation 241 cures the adhesive material. The adhesive material is adapted to be cured by the UV radiation 241 . The UV radiation 241 may be applied on a predefined area on the working plate 230 or applied generally to the direction of the tag attached to the disposable item. FIG. 3 shows a method for attaching a tag to a disposable item, according to exemplary embodiments of the subject matter. In step 320 , a disposable item is obtained. The disposable item may be obtained from a disposable item storage or from a user. As explained above the disposable item may be a sponge, cotton wool, and the like. In step 310 , a tag is obtained. The tag may contain a transmitting device, sending a signal to a computerized or electronic entity. Such computerized or electronic entity receives signals from one or more items in the environment and provides indications to the user. The tag may contain an RF transmitter or another transmitter that transmits wireless signals to the computerized or electronic entity. In step 325 , the tag is maneuvered from a tag storage to the disposable item. The maneuvering may be performed using a maneuvering mechanism 225 . The tag can be held in one or more gripping arms while being maneuvered towards the disposable item. The maneuver can be made to a predefined area in the working plate 230 as shown in FIG. 2 . In step 330 , the tag is attached to the disposable item. The attachment may be performed on a predefined area of the disposable item. In some cases, the maneuvering mechanism 225 comprises a control unit for determining the location in which the tag is released from the maneuvering mechanism 225 . In step 322 , adhesive material is provided to attach the tag to the disposable item. The adhesive material is curable using ultraviolet radiation. The adhesive material may be, for example, DYMAX Ultra Light-Weld 204-CTH-F. The adhesive material may be provided on the tag. Alternatively, the adhesive material may be provided on the disposable item. In step 340 , the disposable item is folded. The folding may be performed before or after the tag is attached to the disposable item. The folding may be performed by a mechanical or electronic mechanism or by a person. The adhesive material may be in contact with more than one layer of the folded disposable item. In step 345 , ultraviolet radiation is applied on the disposable item attached to the tag. Such ultraviolet radiation may be in an amount of about 50 mW/cm 2 or in a range of 50 mW/cm 2 -10 W/cm 2 . The ultraviolet radiation may be applied for a duration in a range of 0.5 to 2 seconds in order to cure the adhesive material on the disposable item. In other cases, the amount of ultraviolet radiation depends on the type of the adhesive material. The radiated ultraviolet radiation cures the adhesive material. In step 350 , one or more disposable items are packed into a package for delivery to a hospital or another entity using the disposable items. In step 355 , the number of tags in each package are counted to verify the number of disposable items in each package. While the disclosure has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings without departing from the essential scope thereof. Therefore, it is intended that the disclosed subject matter not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but only by the claims that follow.

The subject matter discloses a method of attaching a tag to a disposable item such as a sponge, the method comprising obtaining a tag and a disposable item; attaching the tag to the disposable item using an adhesive material. The adhesive material is cured by ultraviolet radiation. The method also comprises applying the ultraviolet radiation on the tag attached on the disposable item. The tag may be an RE tag.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims priority to U.S. Provisional Patent Application Ser. No. 61/499,950 entitled VENTILATION MASK WITH INTEGRATED PILOTED EXHALATION VALVE filed Jun. 22, 2011, and U.S. Provisional Patent Application Ser. No. 61/512,750 entitled VENTILATION MASK WITH INTEGRATED PILOTED EXHALATION VALVE AND METHOD OF VENTILATING A PATIENT USING THE SAME filed Jul. 28, 2011, the disclosures of which are incorporated herein by reference. STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT [0002] Not Applicable BACKGROUND OF THE INVENTION [0003] 1. Field of the Invention [0004] The present invention relates to systems and methods for controlling delivery of a pressurized flow of breathable gas to a patient and, more particularly, to a ventilation mask such as a full face mask, nasal mask, nasal prongs mask or nasal pillows mask for use in critical care ventilation, respiratory insufficiency or OSA (obstructive sleep apnea) with CPAP (Continuous Positive Airway Pressure) therapy and incorporating a piloted exhalation valve inside the mask. [0005] 2. Description of the Related Art [0006] As is known in the medical arts, mechanical ventilators comprise medical devices that either perform or supplement breathing for patients. Early ventilators, such as the “iron lung”, created negative pressure around the patient's chest to cause a flow of ambient air through the patient's nose and/or mouth into their lungs. However, the vast majority of contemporary ventilators instead use positive pressure to deliver gas to the patient's lungs via a patient circuit between the ventilator and the patient. The patient circuit typically consists of one or two large bore tubes (e.g., from 22 mm ID for adults to 8 mm ID for pediatric) that interface to the ventilator on one end, and a patient mask on the other end. Most often, the patient mask is not provided as part of the ventilator system, and a wide variety of patient masks can be used with any ventilator. The interfaces between the ventilator, patient circuit and patient masks are standardized as generic conical connectors, the size and shape of which are specified by regulatory bodies (e.g., ISO 5356-1 or similar standards). [0007] Current ventilators are designed to support either “vented” or “leak” circuits, or “non-vented” or “non-leak” circuits. In vented circuits, the mask or patient interface is provided with an intentional leak, usually in the form of a plurality of vent openings. Ventilators using this configuration are most typically used for less acute clinical requirements, such as the treatment of obstructive sleep apnea or respiratory insufficiency. In non-vented circuits, the patient interface is usually not provided with vent openings. Non-vented circuits can have single limb or dual limb patient circuits, and an exhalation valve. Ventilators using non-vented patient circuits are most typically used for critical care applications. [0008] Vented patient circuits are used only to carry gas flow from the ventilator to the patient and patient mask, and require a patient mask with vent openings. When utilizing vented circuits, the patient inspires fresh gas from the patient circuit, and expires CO2-enriched gas, which is purged from the system through the vent openings in the mask. This constant purging of flow through vent openings in the mask when using single-limb circuits provides several disadvantages: 1) it requires the ventilator to provide significantly more flow than the patient requires, adding cost/complexity to the ventilator and requiring larger tubing; 2) the constant flow through the vent openings creates and conducts noise, which has proven to be a significant detriment to patients with sleep apnea that are trying to sleep while wearing the mask; 3) the additional flow coming into proximity of the patient's nose and then exiting the system often causes dryness in the patient, which often drives the need for adding humidification to the system; and 4) patient-expired CO2 flows partially out of the vent holes in the mask and partially into the patient circuit tubing, requiring a minimum flow through the tubing at all times in order to flush the CO2 and minimize the re-breathing of exhaled CO2. To address the problem of undesirable flow of patient-expired CO2 back into the patient circuit tubing, currently known CPAP systems typically have a minimum-required pressure of 4 cmH2O whenever the patient is wearing the mask, which often produces significant discomfort, claustrophobia and/or feeling of suffocation to early CPAP users and leads to a high (approximately 50%) non-compliance rate with CPAP therapy. [0009] When utilizing non-vented dual limb circuits, the patient inspires fresh gas from one limb (the “inspiratory limb”) of the patient circuit and expires CO2-enriched gas from the second limb (the “expiratory limb”) of the patient circuit. Both limbs of the dual limb patient circuit are connected together in a “Y” proximal to the patient to allow a single conical connection to the patient mask. When utilizing non-vented single limb circuits, an expiratory valve is placed along the circuit, usually proximal to the patient. During the inhalation phase, the exhalation valve is closed to the ambient and the patient inspires fresh gas from the single limb of the patient circuit. During the exhalation phase, the patient expires CO2-enriched gas from the exhalation valve that is open to ambient. The single limb and exhalation valve are usually connected to each other and to the patient mask with conical connections. [0010] In the patient circuits described above, the ventilator pressurizes the gas to be delivered to the patient inside the ventilator to the intended patient pressure, and then delivers that pressure to the patient through the patient circuit. Very small pressure drops develop through the patient circuit, typically around 1 cmH2O, due to gas flow though the small amount of resistance created by the tubing. Some ventilators compensate for this small pressure drop either by mathematical algorithms, or by sensing the tubing pressure more proximal to the patient. [0011] Ventilators that utilize a dual limb patient circuit typically include an exhalation valve at the end of the expiratory limb proximal to the ventilator, while ventilators that utilize a single limb, non-vented patient circuit typically include an exhalation valve at the end of the single limb proximal to the patient as indicated above. Exhalation valves can have fixed or adjustable PEEP (positive expiratory end pressure), typically in single limb configurations, or can be controlled by the ventilator. The ventilator controls the exhalation valve, closes it during inspiration, and opens it during exhalation. Less sophisticated ventilators have binary control of the exhalation valve, in that they can control it to be either open or closed. More sophisticated ventilators are able to control the exhalation valve in an analog fashion, allowing them to control the pressure within the patient circuit by incrementally opening or closing the valve. Valves that support this incremental control are referred to as active exhalation valves. In existing ventilation systems, active exhalation valves are most typically implemented physically within the ventilator, and the remaining few ventilation systems with active exhalation valves locate the active exhalation valve within the patient circuit proximal to the patient. Active exhalation valves inside ventilators are typically actuated via an electromagnetic coil in the valve, whereas active exhalation valves in the patient circuit are typically pneumatically piloted from the ventilator through a separate pressure source such a secondary blower, or through a proportional valve modulating the pressure delivered by the main pressure source. BRIEF SUMMARY OF THE INVENTION [0012] In accordance with the present invention, there is provided a mask (e.g., a nasal pillows mask) for achieving positive pressure mechanical ventilation (inclusive of CPAP, ventilatory support, critical care ventilation, emergency applications), and a method for a operating a ventilation system including such mask. The mask preferably includes a pressure sensing modality proximal to the patient connection. Such pressure sensing modality may be a pneumatic port with tubing that allows transmission of the patient pressure back to the ventilator for measurement, or may include a transducer within the mask. The pressure sensing port is used in the system to allow pressure sensing for achieving and/or monitoring the therapeutic pressures. Alternately or additionally, the mask may include a flow sensing modality located therewithin for achieving and/or monitoring the therapeutic flows. [0013] The mask of the present invention also includes a piloted exhalation valve that is used to achieve the target pressures/flows to the patient. In the preferred embodiment, the pilot for the valve is pneumatic and driven from the gas supply tubing from the ventilator. The pilot can also be a preset pressure derived in the mask, a separate pneumatic line from the ventilator, or an electro-mechanical control. In accordance with the present invention, the valve is preferably implemented with a diaphragm. [0014] One of the primary benefits attendant to including the valve inside the mask is that it provides a path for patient-expired CO2 to exit the system without the need for a dual-limb patient circuit, and without the disadvantages associated with a single-limb patient circuit, such as high functional dead space. For instance, in applications treating patients with sleep apnea, having the valve inside the mask allows patients to wear the mask while the treatment pressure is turned off without risk of re-breathing excessive CO2. [0015] Another benefit for having the valve inside the mask is that it allows for a significant reduction in the required flow generated by the ventilator for ventilating the patient since a continuous vented flow for CO2 washout is not required. Lower flow in turn allows for the tubing size to be significantly smaller (e.g., 2-9 mm ID) compared to conventional ventilators (22 mm ID for adults; 8 mm ID for pediatric). However, this configuration requires higher pressures than the patient's therapeutic pressure to be delivered by the ventilator. In this regard, pressure from the ventilator is significantly higher than the patient's therapeutic pressure, though the total pneumatic power delivered is still smaller than that delivered by a low pressure, high flow ventilator used in conjunction with a vented patient circuit and interface. One obvious benefit of smaller tubing is that it provides less bulk for patient and/or caregivers to manage. For today's smallest ventilators, the bulk of the tubing is as significant as the bulk of the ventilator. Another benefit of the smaller tubing is that is allows for more convenient ways of affixing the mask to the patient. For instance, the tubing can go around the patient's ears to hold the mask to the face, instead of requiring straps (typically called “headgear”) to affix the mask to the face. Along these lines, the discomfort, complication, and non-discrete look of the headgear is another significant factor leading to the high non-compliance rate for CPAP therapy. Another benefit to the smaller tubing is that the mask can become smaller because it does not need to interface with the large tubing. Indeed, large masks are another significant factor leading to the high non-compliance rate for CPAP therapy since, in addition to being non-discrete, they often cause claustrophobia. Yet another benefit is that smaller tubing more conveniently routed substantially reduces what is typically referred to as “tube drag” which is the force that the tube applies to the mask, displacing it from the patient's face. This force has to be counterbalanced by headgear tension, and the mask movements must be mitigated with cushion designs that have great compliance. The reduction in tube drag in accordance with the present invention allows for minimal headgear design (virtually none), reduced headgear tension for better patient comfort, and reduced cushion compliance that results in a smaller, more discrete cushion. [0016] The mask of the present invention may further include a heat and moisture exchanger (HME) which is integrated therein. The HME can fully or at least partially replace a humidifier (cold or heated pass-over; active or passive) which may otherwise be included in the ventilation system employing the use of the mask. The HME is positioned within the mask so as to be able to intercept the flow delivered from a flow generator to the patient in order to humidify it, and further to intercept the exhaled flow of the patient in order to capture humidity and heat for the next breath. The HME can also be used as a structural member of the mask, adding q cushioning effect and simplifying the design of the cushion thereof. [0017] The present invention is best understood by reference to the following detailed description when read in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0018] These, as well as other features of the present invention, will become more apparent upon reference to the drawings wherein: [0019] FIG. 1 is top perspective view of a nasal pillows mask constructed in accordance with the present invention and including an integrated diaphragm-based piloted exhalation valve; [0020] FIG. 2 is an exploded view of the nasal pillows mask shown in FIG. 1 ; [0021] FIG. 3 is a partial cross-sectional view of the nasal pillows mask shown in FIG. 1 taken along lines 3 - 3 thereof, and depicting the valve pilot lumen extending through the cushion of the mask; [0022] FIG. 4 is a partial cross-sectional view of the nasal pillows mask shown in FIG. 1 taken along lines 4 - 4 thereof, and depicting the pressure sensing lumen extending through the cushion of the mask; [0023] FIG. 5 is a cross-sectional view of the nasal pillows mask shown in FIG. 1 taken along lines 5 - 5 thereof; [0024] FIG. 6 is a top perspective view of cushion of the nasal pillows mask shown in FIG. 1 ; [0025] FIG. 7 is a top perspective view of exhalation valve of the nasal pillows mask shown in FIG. 1 ; [0026] FIG. 8 is a bottom perspective view of exhalation valve shown in FIG. 7 ; [0027] FIG. 9 is a cross-sectional view of exhalation valve shown in FIGS. 7 and 8 ; [0028] FIG. 10 is a cross-sectional view similar to FIG. 5 , but depicting a variant of the nasal pillows mask wherein an HME is integrated into the cushion thereof; [0029] FIGS. 11A , 11 B and 11 C are a series of graphs which provide visual representations corresponding to exemplary performance characteristics of the exhalation valve subassembly of the nasal pillows mask of the present invention; [0030] FIG. 12 is a schematic representation of an exemplary ventilation system wherein a tri-lumen tube is used to facilitate the operative interface between the nasal pillows mask and a flow generating device; [0031] FIG. 13 is a schematic representation of an exemplary ventilation system wherein a bi-lumen tube is used to facilitate the operative interface between the nasal pillows mask and a flow generating device; and [0032] FIG. 14 is a side-elevational view of the nasal pillows mask of the present invention depicting an exemplary manner of facilitating the cooperative engagement thereof to a patient through the use of a headgear assembly. [0033] Common reference numerals are used throughout the drawings and detailed description to indicate like elements. DETAILED DESCRIPTION OF THE INVENTION [0034] Referring now to the drawings wherein the showings are for purposes of illustrating various embodiments of the present invention only, and not for purposes of limiting the same, FIGS. 1-4 depict a ventilation mask 10 (e.g., a nasal pillows mask) constructed in accordance with the present invention. Though the mask 10 is depicted as a nasal pillows mask, those skilled in the art will recognize that other ventilation masks are contemplated herein, such as nasal prongs masks, nasal masks, fill face masks and oronasal masks. As such, for purposes of this application, the term mask and/or ventilation mask is intended to encompass all such mask structures. The mask 10 includes an integrated, diaphragm-implemented, piloted exhalation valve 12 , the structural and functional attributes of which will be described in more detail below. [0035] As shown in FIGS. 1-5 , the mask 10 comprises a housing or cushion 14 . The cushion 14 , which is preferably fabricated from a silicone elastomer having a Shore A hardness in the range of from about 20 to 60 and preferably about 40, is formed as a single, unitary component, and is shown individually in FIG. 6 . The cushion 14 includes a main body portion 16 which defines a first outer end surface 18 and an opposed second outer end surface 20 . The main body portion 16 further defines an interior fluid chamber 22 which is of a prescribed volume. In addition to the main body portion 16 , the cushion 14 includes an identically configured pair of hollow pillow portions 24 which protrude from the main body portion 16 in a common direction and in a prescribed spatial relationship relative to each other. More particularly, in the cushion 14 , the spacing between the pillow portions 24 is selected to facilitate the general alignment thereof with the nostrils of an adult patient when the mask 10 is worn by such patient. As seen in FIGS. 3 and 4 , each of the pillow portions 24 fluidly communicates with the fluid chamber 22 . [0036] As shown in FIG. 2 , the main body portion 16 of the cushion 14 includes an enlarged, circularly configured valve opening 26 which is in direct fluid communication with the fluid chamber 22 . The valve opening 26 is positioned in generally opposed relation to the pillow portions 24 of the cushion 14 , and is circumscribed by an annular valve seat 27 also defined by the main body portion 16 . As also shown in FIG. 2 , the main body portion 16 further defines opposed first and second inner end surfaces 28 , 30 which protrude outwardly from the periphery of the valve opening 26 , and are diametrically opposed relative thereto so as to be spaced by an interval of approximately 180°. The valve opening 26 , valve seat 27 , and first and second inner end surfaces 28 , 30 are adapted to accommodate the exhalation valve 12 of the mask 10 in a manner which will be described in more detail below. [0037] As shown FIGS. 3-6 , the main body portion 16 of the cushion 14 further defines first and second gas delivery lumens 32 , 34 which extend from respective ones of the first and second outer end surfaces 18 , 20 into fluid communication with the fluid chamber 22 . Additionally, a pressure sensing lumen 36 defined by the main body portion extends from the first outer end surface 18 into fluid communication with the fluid chamber 22 . The main body portion 16 further defines a valve pilot lumen 38 which extends between the second outer end surface 20 and the second inner end surface 30 . The use of the first and second gas delivery lumens 32 , 34 , the pressure sensing lumen 36 , and the valve pilot lumen 38 will also be discussed in more detail below. Those of ordinary skill in the art will recognize that the gas delivery lumens 32 , 34 , may be substituted with a single gas delivery lumen and/or positioned within the cushion 14 in orientations other than those depicted in FIG. 6 . For example, the gas delivery lumen(s) of the cushion 14 may be positioned frontally, pointing upwardly, pointing downwardly, etc. rather than extending laterally as shown in FIG. 6 . [0038] Referring now to FIGS. 2-5 and 7 - 9 , the exhalation valve 12 of the mask 10 is made of three (3) parts or components, and more particularly a seat member 40 , a cap member 42 , and a diaphragm 44 which is operatively captured between the seat and cap members 40 , 42 . The seat and cap members 40 , 42 are each preferably fabricated from a plastic material, with the diaphragm 44 preferably being fabricated from an elastomer having a Shore A hardness in the range of from about 20-40. [0039] As is most easily seen in FIGS. 2 , 7 and 9 , the seat member 40 includes a tubular, generally cylindrical wall portion 46 which defines a distal, annular outer rim 48 and an opposed annular inner seating surface 49 . As shown in FIG. 9 , the diameter of the outer rim 48 exceeds that of the seating surface 49 . Along these lines, the inner surface of the wall portion 46 is not of a uniform inner diameter, but rather is segregated into first and second inner surface sections which are of differing inner diameters, and separated by an annular shoulder 51 . In addition to the wall portion 46 , the seat member 40 includes an annular flange portion 50 which protrudes radially from that end of the wall portion 46 opposite the outer rim 48 . As shown in FIGS. 2 and 7 , the flange portion 50 includes a plurality of exhaust vents 52 which are located about the periphery thereof in a prescribed arrangement and spacing relative to each other. Additionally, as is apparent from FIG. 9 , the seat member 40 is formed such that each of the exhaust vents 52 normally fluidly communicates with the bore or fluid conduit defined by the wall portion 46 . [0040] The cap member 42 of the exhaust valve 12 comprises a circularly configured base portion 54 which defines an inner surface 56 and an opposed outer surface 58 . In addition to the base portion 54 , the cap member 42 includes an annular flange portion 60 which circumvents and protrudes generally perpendicularly relative to the inner surface 56 of the base portion 60 . The flange portion 60 defines a distal annular shoulder 62 . As shown in FIG. 9 , the shoulder 62 and inner surface 56 extend along respective ones of a spaced, generally parallel pair of planes. Further, as shown in FIG. 8 , formed in the outer surface 58 of the base portion 54 is an elongate groove 64 which extends diametrically across the outer surface 58 . The use of the groove 64 will be described in more detail below. The seat and cap members 40 , 42 , when attached to each other in the fully assembled exhalation valve 12 , collectively define an interior valve chamber 59 of the exhalation valve 12 . More particularly, such valve chamber 59 is generally located between the inner surface 56 defined by the base portion 54 of the cap member 42 and the seating surface 49 defined by the wall portion 46 of the seat member 40 . [0041] The diaphragm 44 of the exhalation valve 12 , which resides within the valve chamber 59 , has a circularly configured, central body portion 66 , and a peripheral flange portion 68 which is integrally connected to and circumvents the body portion 66 . The body portion 66 includes an annular lip 72 which circumvents and protrudes upwardly from one side or face thereof. The flange portion 68 includes an arcuately contoured primary region and a distal region which protrudes radially from the primary region. As such, the primary region of the flange portion 68 extends between the distal region thereof and the body portion 66 , and defines a continuous, generally concave channel 70 . [0042] In the exhalation valve 12 , the flange portion 68 of the diaphragm 44 is operatively captured between the flange portions 50 , 60 of the seat and cap members 40 , 42 . More particularly, the annular distal region of the flange portion 68 is compressed (and thus captured) between the shoulder 62 defined by the flange portion 60 of the cap member 42 , and a complimentary annular shoulder 53 which is defined by the flange portion 50 of the seat member 40 proximate the exhaust vents 52 . The orientation of the diaphragm 44 within the valve chamber 59 when captured between the seat and cap members 40 , 42 is such that the channel 70 defined by the arcuately contoured primary region of the flange portion 68 is directed toward or faces the seating surface 49 defined by the wall portion 46 of the seat member 40 . [0043] The diaphragm 44 (and hence the exhalation valve 12 ) is selectively moveable between an open position (shown in FIGS. 3-5 and 9 ) and a closed position. When in its normal, open position, the diaphragm 44 is in a relaxed, unbiased state. Importantly, in either of its open or closed positions, the diaphragm 44 is not normally seated directly against the inner surface 56 defined by the base portion 54 of the cap member 42 . Rather, a gap is normally maintained between the body portion 66 of the diaphragm 44 and the inner surface 56 of the base portion 54 . The width of such gap when the diaphragm 44 is in its open position is generally equal to the fixed distance separating the inner surface 56 of the base portion 54 from the shoulder 62 of the flange portion 60 . Further, when the diaphragm 44 is in its open position, the body portion 66 , and in particular the lip 72 protruding therefrom, is itself disposed in spaced relation to the seating surface 49 defined by the wall portion 46 of the seat member 40 . As such, when the diaphragm 44 is in its open position, fluid is able to freely pass through the fluid conduit defined by the wall portion 46 , between the seating surface 49 and diaphragm 44 , and through the exhaust vents 52 to ambient air. As shown in FIGS. 3 , 8 and 9 , the flange portion 60 of the cap member 42 is further provided with a pilot port 74 which extends therethrough and, in the fully assembled exhalation valve 12 , fluidly communicates with that portion of the valve chamber 59 disposed between the body portion 66 of the diaphragm 44 and the inner surface 56 of the base portion 54 . The use of the pilot port 74 will also be described in more detail below. [0044] As will be discussed in more detail below, in the exhalation valve 12 , the diaphragm 44 is resiliently deformable from its open position (to which it may be normally biased) to its closed position. An important feature of the present invention is that the diaphragm 44 is normally biased to its open position which provides a failsafe to allow a patient to inhale ambient air through the exhalation valve 12 and exhale ambient air therethrough (via the exhaust vents 52 ) during any ventilator malfunction or when the mask is worn without the therapy being delivered by the ventilator. When the diaphragm 44 is moved or actuated to its closed position, the lip 72 of the body portion 66 is firmly seated against the seating surface 49 defined by the wall portion 46 of the seat member 40 . The seating of the lip 72 against the seating surface 49 effectively blocks fluid communication between the fluid conduit defined by the wall portion 46 and the valve chamber 59 (and hence the exhaust vents 52 which fluidly communicate with the valve chamber 59 ). [0045] In the mask 10 , the cooperative engagement between the exhalation valve 12 and the cushion 14 is facilitated by the advancement of the wall portion 46 of the seat member 40 into the valve opening 26 defined by the cushion 14 . As best seen in FIG. 5 , such advancement is limited by the ultimate abutment or engagement of a beveled seating surface 76 defined by the flange portion 50 of the seat member 40 against the complimentary valve seat 27 of the cushion 14 circumventing the valve opening 26 . Upon the engagement of the seating surface 76 to the valve seat 27 , the fluid chamber 22 of the cushion 14 fluidly communicates with the fluid conduit defined by the wall portion 46 of the seat member 40 . As will be recognized, if the diaphragm 44 resides in its normal, open position, the fluid chamber 22 is further placed into fluid communication with the valve chamber 59 via the fluid conduit defined by the wall portion 46 , neither end of which is blocked or obstructed by virtue of the gap defined between the lip 72 of the diaphragm 44 and the seating surface 49 of the wall portion 46 . [0046] When the exhalation valve 12 is operatively coupled to the cushion 14 , in addition to the valve seat 27 being seated against the seating surface 76 , the first and second inner end surfaces 28 , 30 of the cushion 14 are seated against respective, diametrically opposed sections of the flange portion 68 defined by the cap member 42 . As best seen in FIGS. 3 and 4 , the orientation of the exhalation valve 12 relative to the cushion 14 is such that the end of the valve pilot lumen 38 extending to the second inner end surface 30 is aligned and fluidly communicates with the pilot port 74 within the flange portion 60 . As such, in the mask 10 , the valve pilot lumen 38 is in continuous, fluid communication with that portion of the valve chamber 59 defined between the inner surface 56 of the base portion 54 and the body portion 66 of the diaphragm 44 . [0047] To assist in maintaining the cooperative engagement between the exhalation valve 12 and the cushion 14 , the mask 10 is further preferably provided with an elongate frame member 78 . The frame member 78 has a generally V-shaped configuration, with a central portion thereof being accommodated by and secured within the complimentary groove 64 formed in the outer surface 58 defined by the base portion 54 of the cap member 42 . As shown in FIGS. 3 and 4 , the opposed end portions of the frame members 78 are cooperatively engaged to respective ones of the first and second outer end surfaces 18 , 20 of the cushion 14 . More particularly, as shown in FIG. 2 , the frame member 78 includes an identically configured pair of first and second connectors 80 , 82 which extend from respective ones of the opposed end portions thereof. An inner portion of the first connector 80 is advanced into and frictionally retained within the first gas delivery lumen 32 of the cushion 14 . Similarly, an inner portion of the second connector 82 is advanced into and frictionally retained within the second gas delivery lumen 34 of the cushion 14 . In addition to the inner portions advanced into respective ones of the first and second gas delivery lumens 32 , 34 , the first and second connectors 80 , 82 of the frame member 78 each further include an outer portion which, as will be described in more detail below, is adapted to be advanced into and frictionally retained within a corresponding lumen of a respective one of a pair of bi-lumen tubes fluidly coupled to the mask 10 . [0048] As shown in FIGS. 3 and 4 , the frame member 78 further includes a tubular, cylindrically configured pressure port 84 which is disposed adjacent the first connector 80 . The pressure port 84 is aligned and fluidly communicates with the pressure sensing lumen 36 of the cushion 14 . Similarly, the frame member 78 is also provided with a tubular, cylindrically configured pilot port 86 which is disposed adjacent the second connector 82 . The pilot port 86 is aligned and fluidly communicates with the valve pilot lumen 38 of the cushion 14 . As will also be discussed in more detail below, the pressure and pilot ports 84 , 86 of the frame member 78 are adapted to be advanced into and frictionally maintained within corresponding lumens of respective ones of the aforementioned pair of bi-lumen tubes which are fluidly connected to the mask 10 within a ventilation system incorporating the same. The receipt of the frame member 78 within the groove 64 of the cap member 42 ensures that the cushion 14 , the exhalation valve 12 and the frame member 78 are properly aligned, and prevents relative movement therebetween. Though not shown, it is contemplated that in one potential variation of the mask 10 , the cushion 14 may be formed so as not to include the valve pilot lumen 38 . Rather, a suitable valve pilot lumen would be formed directly within the frame member 78 so as to extend therein between the pilot port 86 thereof and the pilot port 74 of the exhalation valve 12 . [0049] In the mask 10 , the exhalation valve 12 is piloted, with the movement of the diaphragm 44 to the closed position described above being facilitated by the introduction of positive fluid pressure into the valve chamber 59 . More particularly, it is contemplated that during the inspiratory phase of the breathing cycle of a patient wearing the mask 10 , the valve pilot lumen 38 will be pressurized by a pilot line fluidly coupled to the pilot port 86 , with pilot pressure being introduced into that portion of the valve chamber 59 normally defined between the body portion 66 of the diaphragm 44 and the inner surface 56 defined by the base portion 54 of the cap member 42 via the pilot port 74 extending through the flange portion 60 of the cap member 42 . The fluid pressure level introduced into the aforementioned region of the valve chamber 59 via the pilot port 74 will be sufficient to facilitate the movement of the diaphragm 44 to its closed position described above. [0050] Conversely, during the expiratory phase of the breathing cycle of the patient wearing the mask 10 , it is contemplated that the discontinuation or modulation of the fluid pressure through the valve pilot lumen 38 and hence into the aforementioned region of the valve chamber 59 via the pilot port 74 , coupled with the resiliency of the diaphragm 44 and/or positive pressure applied to the body portion 66 thereof, will facilitate the movement of the diaphragm 44 back to the open position or to a partially open position. In this regard, positive pressure as may be used to facilitate the movement of the diaphragm 44 to its open position may be provided by air which is exhaled from the patient during the expiratory phase of the breathing circuit and is applied to the body portion 66 via the pillows portions 24 of the cushion 14 , the fluid chamber 22 , and the fluid conduit defined by the wall portion of the seat member 40 . As will be recognized, the movement of the diaphragm 44 to the open position allows the air exhaled from the patient to be vented to ambient air after entering the valve chamber 59 via the exhaust vents 52 within the flange portion 50 of the seat member 40 which, as indicated above, fluidly communicate with the valve chamber 59 . [0051] As will be recognized, based on the application of pilot pressure thereto, the diaphragm 44 travels from a fully open position through a partially open position to a fully closed position. In this regard, the diaphragm 44 will be partially open or partially closed during exhalation to maintain desired ventilation therapy. Further, when pilot pressure is discontinued to the diaphragm 44 , it moves to an open position wherein the patient can inhale and exhale through the mask 10 with minimal restriction and with minimal carbon dioxide retention therein. This is an important feature of the present invention which allows a patient to wear the mask 10 without ventilation therapy being applied to the mask 10 , the aforementioned structural and functional features of the mask 10 making it more comfortable to wear, and further allowing it to be worn without carbon dioxide buildup. This feature is highly advantageous for the treatment of obstructive sleep apnea wherein patients complain of discomfort with ventilation therapy due to mask and pressure discomfort. When it is detected that a patient requires sleep apnea therapy, the ventilation therapy can be started (i.e., in an obstructive sleep apnea situation). [0052] To succinctly summarize the foregoing description of the structural and functional features of the mask 10 , during patient inhalation, the valve pilot lumen 38 is pressurized, which causes the diaphragm 44 to close against the seating surface 49 , thus effectively isolating the fluid chamber 22 of the mask 10 from the outside ambient air. The entire flow delivered from a flow generator fluidly coupled to the mask 10 is inhaled by the patient, assuming that unintentional leaks at the interface between the cushion 14 and the patient are discarded. This functionality differs from what typically occurs in a conventional CPAP mask, where venting to ambient air is constantly open, and an intentional leak flow is continuously expelled to ambient air. During patient exhalation, the pilot pressure introduced into the valve pilot lumen 38 is controlled so that the exhaled flow from the patient can be exhausted to ambient air through the exhalation valve 12 in the aforementioned manner. In this regard, the pilot pressure is “servoed” so that the position of the diaphragm 44 relative to the seating surface 49 is modulated, hence modulating the resistance of the exhalation valve 12 to the exhaled flow and effectively ensuring that the pressure in the fluid chamber 22 of the mask 10 is maintained at a prescribed therapeutic level throughout the entire length of the exhalation phase. When the valve pilot lumen 38 is not pressurized, the exhalation valve 12 is in a normally open state, with the diaphragm 44 being spaced from the seating surface 49 in the aforementioned manner, thus allowing the patient to spontaneously breathe in and out with minimal pressure drop (also referred to as back-pressure) in the order of less than about 2 cm H2O at 601/min. As a result, the patient can comfortably breathe while wearing the mask 10 and while therapy is not being administered to the patient. [0053] Referring now to FIGS. 11A , 11 B and 11 C, during use of the mask 10 by a patient, the functionality of the exhalation valve 12 can be characterized with three parameters. These are Pt which is the treatment pressure (i.e., the pressure in the mask 10 used to treat the patient; Pp which is the pilot pressure (i.e., the pressure used to pilot the diaphragm 44 in the exhalation valve 12 ); and Qv which is vented flow (i.e., flow that is exhausted from inside the exhalation valve 12 to ambient. These three particular parameters are labeled as Pt, Pp and Qv in FIG. 9 . When the patient is ventilated, Pt is greater than zero, with the functionality of the exhalation valve 12 being described by the family of curves in the first and second quadrants of FIG. 11A . In this regard, as apparent from FIG. 11A , for any given Pt, it is evident that by increasing the pilot pressure Pp, the exhalation valve 12 will close and the vented flow will decrease. A decrease in the pilot pressure Pp will facilitate the opening of the valve 12 , thereby increasing vented flow. The vented flow will increase until the diaphragm 44 touches or contacts the inner surface 56 of the base portion 54 of the cap member 42 , and is thus not able to open further. Conversely, when the patient is not ventilated, the inspiratory phase can be described by the third and fourth quadrants. More particularly, Qv is negative and air enters the mask 10 through the valve 12 , with the pressure Pt in the mask 10 being less than or equal to zero. Pilot pressure Pp less than zero is not a configuration normally used during ventilation of the patient, but is depicted for a complete description of the functionality of the valve 12 . The family of curves shown in FIG. 11A can be described by a parametric equation. Further, the slope and asymptotes of the curves shown in FIG. 11A can be modified by, for example and not by way of limitation, changing the material used to fabricate the diaphragm 44 , changing the thickness of the diaphragm 44 , changing the area ratio between the pilot side and patient side of the diaphragm 44 , changing the clearance between the diaphragm 44 and the seating surface 49 , and/or changing the geometry of the exhaust vents 52 . [0054] An alternative representation of the functional characteristics of the valve 12 can be described by graphs in which ΔP=Pt−Pp is shown. For example, the graph of FIG. 11B shows that for any given Pt, the vented flow can be modulated by changing ΔP. In this regard, ΔP can be interpreted as the physical position of the diaphragm 44 . Since the diaphragm 44 acts like a spring, the equation describing the relative position d of the diaphragm 44 from the seating surface 49 of the seat member 40 is k·d+Pt·At=Pp·Ap, where At is the area of the diaphragm 44 exposed to treatment pressure Pt and Ap is the area of the diaphragm 44 exposed to the pilot pressure Pp. A similar, alternative representation is provided in the graph of FIG. 11C which shows Pt on the x-axis and ΔP as the parameter. In this regard, for any given ΔP, the position d of the diaphragm 44 is determined, with the valve 12 thus being considered as a fixed opening valve. In this scenario Pt can be considered the driving pressure pushing air out of the valve 12 , with FIG. 11C further illustrating the highly non-linear behavior of the valve 12 . [0055] FIG. 12 provides a schematic representation of an exemplary ventilation system 88 wherein a tri-lumen tube 90 is used to facilitate the fluid communication between the mask 10 and a blower or flow generator 92 of the system 88 . As represented in FIG. 12 , one end of the tri-lumen tube 90 is fluidly connected to the flow generator 92 , with the opposite end thereof being fluidly connected to a Y-connector 94 . The three lumens defined by the tri-lumen tube 90 include a gas delivery lumen, a pressure sensing lumen, and a valve pilot lumen. The gas delivery lumen is provided with an inner diameter or ID in the range of from about 2 mm to 15 mm, and preferably about 4 mm to 10 mm. The pressure sensing and valve pilot lumens of the tri-lumen tube 90 are each preferably provided with an ID in the range of from about 0.5 mm to 2 mm. The outer diameter or OD of the tri-lumen tube 90 is preferably less than 17 mm, with the length thereof in the system 88 being about 2 m. The Y-connector 94 effectively bifurcates the tri-lumen tube 90 into the first and second bi-lumen tubes 96 , 98 , each of which has a length of about 6 inches. The first bi-lumen tube 96 includes a gas delivery lumen having an ID in the same ranges described above in relation to the gas delivery lumen of the tri-lumen tube 90 . The gas delivery lumen of the first bi-lumen tube 96 is fluidly coupled to the outer portion of the first connector 80 of the frame member 78 . The remaining lumen of the first bi-lumen tube 96 is a pressure sensing lumen which has an ID in the same range described above in relation to the pressure sensing lumen of the tri-lumen tube 90 , and is fluidly coupled to the pressure port 84 of the frame member 78 . Similarly, the second bi-lumen tube 98 includes a gas delivery lumen having an ID in the same ranges described above in relation to the gas delivery lumen of the tri-lumen tube 90 . The gas delivery lumen of the second bi-lumen tube 98 is fluidly coupled to the outer portion of the second connector 82 of the frame member 78 . The remaining lumen of the second bi-lumen tube 98 is a valve pilot lumen which has an ID in the same range described above in relation to the valve pilot lumen of the tri-lumen tube 90 , and is fluidly coupled to the pilot port 86 of the frame member 78 . [0056] In the system 88 shown in FIG. 12 , the pilot pressure is generated at the flow generator 92 . In the prior art, a secondary blower or proportional valve that modulates the pressure from a main blower is used to generate a pressure to drive an expiratory valve. However, in the system 88 shown in FIG. 12 , the outlet pressure of the flow generator 92 is used, with the flow generator 92 further being controlled during patient exhalation in order to have the correct pilot pressure for the exhalation valve 12 . This allows the system 88 to be inexpensive, not needing additional expensive components such as proportional valves or secondary blowers. [0057] FIG. 13 provides a schematic representation of another exemplary ventilation system 100 wherein a bi-lumen tube 102 is used to facilitate the fluid communication between the mask 10 and the blower or flow generator 92 of the system 100 . As represented in FIG. 13 , one end of the bi-lumen tube 102 is fluidly connected to the flow generator 92 , with the opposite end thereof being fluidly connected to the Y-connector 94 . The two lumens defined by the bi-lumen tube 102 include a gas delivery lumen and a pressure sensing lumen. The gas delivery lumen is provided with an inner diameter or ID in the range of from about 2 mm to 10 mm, and preferably about 4 mm to 7 mm. The pressure sensing lumen of the bi-lumen tube 102 is preferably provided with an ID in the range of from about 0.5 mm to 2 mm. The outer diameter or OD of the bi-lumen tube 90 is preferably less than 11 mm, with the length thereof being about 2 m. The Y-connector 94 effectively bifurcates the bi-lumen tube 102 into the first and second bi-lumen tubes 96 , 98 , each of which has a length of about 6 inches. The first bi-lumen tube 96 includes a gas delivery lumen having an ID in the same ranges described above in relation to the gas delivery lumen of the bi-lumen tube 102 . The gas delivery lumen of the first bi-lumen tube 96 is fluidly coupled to the outer portion of the first connector 80 of the frame member 78 . The remaining lumen of the first bi-lumen tube 96 is a pressure sensing lumen which has an ID in the same range described above in relation to the pressure sensing lumen of the bi-lumen tube 102 , and is fluidly coupled to the pressure port 84 of the frame member 78 . Similarly, the second bi-lumen tube 98 includes a gas delivery lumen having an ID in the same ranges described above in relation to the gas delivery lumen of the bi-lumen tube 102 . The gas delivery lumen of the second bi-lumen tube 98 is fluidly coupled to the outer portion of the second connector 82 of the frame member 78 . The remaining lumen of the second bi-lumen tube 98 is a valve pilot lumen which has an ID in the same range described above in relation to the pressure sensing lumen of the bi-lumen tube 102 , and is fluidly coupled to the pilot port 86 of the frame member 78 . [0058] In the system 100 shown in FIG. 13 , the valve pilot lumen 38 is connected to the gas delivery air path at the Y-connector 94 . More particularly, the gas delivery lumen of the bi-lumen tube 102 is transitioned at the Y-connector 94 to the valve pilot lumen of the second bi-lumen tube 98 . As such, the pilot pressure will be proportional to the outlet pressure of the flow generator 92 minus the pressure drop along the bi-lumen tube 102 , which is proportional to delivered flow. This solution is useful when small diameter tubes are used in the system 100 , since such small diameter tubes require higher outlet pressure from the flow generator 92 for the same flow. In this regard, since the pressure at the outlet of the flow generator 92 would be excessive for piloting the exhalation valve 12 , a lower pressure along the circuit within the system 100 is used. In the system 100 , though it is easier to tap in at the Y-connector 94 , anywhere along the tube network is acceptable, depending on the pressure level of the flow generator 92 which is the pressure required by the patient circuit in order to deliver the therapeutic pressure and flow at the patient. [0059] In each of the systems 88 , 100 , it is contemplated that the control of the flow generator 92 , and hence the control of therapeutic pressure delivered to the patient wearing the mask 10 , may be governed by the data gathered from dual pressure sensors which take measurements at the mask 10 and the output of the flow generator 92 . As will be recognized, pressure sensing at the mask 10 is facilitated by the pressure sensing lumen 36 which, as indicated above, is formed within the cushion 14 and fluidly communicates with the fluid chamber 22 thereof. As also previously explained, one of the lumens of the first bi-lumen tube 96 in each of the systems 88 , 100 is coupled to the pressure port 84 (and hence the pressure sensing lumen 36 ). As a result, the first bi-lumen tube 96 , Y-connector 94 and one of the tri-lumen or bi-lumen tubes 90 , 102 collectively define a continuous pressure sensing fluid path between the mask 10 and a suitable pressure sensing modality located remotely therefrom. A more detailed discussion regarding the use of the dual pressure sensors to govern the delivery of therapeutic pressure to the patient is found in Applicant's co-pending U.S. application Ser. No. 13/411,257 entitled Dual Pressure Sensor Continuous Positive Airway Pressure (CPAP) Therapy filed Mar. 2, 2012, the entire disclosure of which is incorporated herein by reference. [0060] Referring now to FIG. 10 , there is shown a mask 10 a which comprises a variant of the mask 10 . The sole distinction between the masks 10 , 10 a lies in the mask 10 a including a heat and moisture exchanger or HME 104 which is positioned within the fluid chamber 22 of the cushion 14 . The HME 104 is operative to partially or completely replace a humidifier (cold or heated pass-over; active or passive) which would otherwise be fluidly coupled to the mask 10 a . This is possible because the average flow through the system envisioned to be used in conjunction with the mask 10 a is about half of a prior art CPAP mask, due to the absence of any intentional leak in such system. [0061] The HME 104 as a result of its positioning within the fluid chamber 22 , is able to intercept the flow delivered from the flow generator to the patient in order to humidify it, and is further able to capture humidity and heat from exhaled flow for the next breath. The pressure drop created by the HME 104 during exhalation (back-pressure) must be limited, in the order of less than 5 cmH2O at 601/min, and preferably lower than 2 cmH2O at 601/min. These parameters allow for a low back-pressure when the patient is wearing the mask 10 a and no therapy is delivered to the patient. [0062] It is contemplated that the HME 104 can be permanently assembled to the cushion 14 , or may alternatively be removable therefrom and thus washable and/or disposable. In this regard, the HME 104 , if removable from within the cushion 14 , could be replaced on a prescribed replacement cycle. Additionally, it is contemplated that the HME 104 can be used as an elastic member that adds elasticity to the cushion 14 . In this regard, part of the elasticity of the cushion 14 may be attributable to its silicone construction, and further be partly attributable to the compression and deflection of the HME 104 inside the cushion 14 . [0063] The integration of the exhalation valve 12 into the cushion 14 and in accordance with the present invention allows lower average flow compared to prior art CPAP masks. As indicated above, normal masks have a set of apertures called “vents” that create a continuous intentional leak during therapy. This intentional leak or vented flow is used to flush out the exhaled carbon dioxide that in conventional CPAP machines, with a standard ISO taper tube connecting the mask to the flow generator or blower, fills the tubing up almost completely with carbon dioxide during exhalation. The carbon dioxide accumulated in the tubing, if not flushed out through the vent flow, would be inhaled by the patient in the next breath, progressively increasing the carbon dioxide content in the inhaled gas at every breath. The structural/functional features of the exhalation valve 12 , in conjunction with the use of small inner diameter, high pneumatic resistance tubes in the system in which the mask 10 , 10 a is used, ensures that all the exhaled gas goes to ambient. As a result, a vent flow is not needed for flushing any trapped carbon dioxide out of the system. Further, during inspiration the exhalation valve 12 can close, and the flow generator of the system needs to deliver only the patient flow, without the additional overhead of the intentional leak flow. In turn, the need for lower flow rates allows for the use of smaller tubes that have higher pneumatic resistance, without the need for the use of extremely powerful flow generators. The pneumatic power through the system can be kept comparable to those of traditional CPAP machines, though the pressure delivered by the flow generator will be higher and the flow lower. [0064] The reduced average flow through the system in which the mask 10 , 10 a is used means that less humidity will be removed from the system, as well as the patient. Conventional CPAP systems have to reintegrate the humidity vented by the intentional leak using a humidifier, with heated humidifiers being the industry standard. Active humidification introduces additional problems such as rain-out in the system tubing, which in turn requires heated tubes, and thus introducing more complexity and cost into the system. The envisioned system of the prent invention, as not having any intentional leak flow, does not need to introduce additional humidity into the system. As indicated above, the HME 104 can be introduced into the cushion 14 of the mask 10 a so that exhaled humidity can be trapped and used to humidify the air for the following breath. [0065] In addition, a big portion of the noise of conventional CPAP systems is noise conducted from the flow generator through the tubing up to the mask and then radiated in the ambient through the vent openings. As previously explained, the system described above is closed to the ambient during inhalation which is the noisiest part of the therapy. The exhaled flow is also lower than the prior art so it can be diffused more efficiently, thus effectively decreasing the average exit speed and minimizing impingement noise of the exhaled flow on bed sheets, pillows, etc. [0066] As also explained above, a patient can breathe spontaneously when the mask is worn and not connected to the flow generator tubing, or when therapy is not administered. In this regard, there will be little back pressure and virtually no carbon dioxide re-breathing, due to the presence of the exhalation valve 12 that is normally open and the inner diameters of the tubes integrated into the system. This enables a zero pressure start wherein the patient falls asleep wearing the mask 10 , 10 a wherein the flow generator does not deliver any therapy. Prior art systems can only ramp from about 4 mH2O up to therapy pressure. A zero pressure start is more comfortable to patients that do not tolerate pressure. [0067] As seen in FIG. 14 , due to the reduced diameter of the various tubes (i.e., the tri-lumen tube 90 and bi-lumen tubes 96 , 98 , 102 ) integrated into the system 88 , 100 , such tubes can be routed around the patient's ears similar to conventional O2 cannulas. More particularly, the tubing can go around the patient's ears to hold the mask 10 , 10 a to the patient's face. This removes the “tube drag” problem described above since the tubes will not pull the mask 10 , 10 a away from the face of the patient when he or she moves. As previously explained, “tube drag” typically decreases mask stability on the patient and increases unintentional leak that annoys the patient. In the prior art, head gear tension is used to counter balance the tube drag, which leads to comfort issues. The tube routing of the present invention allows for lower head gear tension and a more comfortable therapy, especially for compliant patients that wear the mask 10 approximately eight hours every night. The reduction in tube drag in accordance with the present invention also allows for minimal headgear design (virtually none), reduced headgear tension for better patient comfort as indicated above, and reduced cushion compliance that results in a smaller, more discrete cushion 14 . The tube dangling in front of the patient, also commonly referred to as the “elephant trunk” by patients, is a substantial psychological barrier to getting used to therapy. The tube routing shown in FIG. 14 , in addition to making the mask 10 , 10 a more stable upon the patient, avoids this barrier as well. Another benefit to the smaller tubing is that the mask 10 , 10 a can become smaller because it does not need to interface with large tubing. Indeed, large masks are another significant factor leading to the high non-compliance rate for CPAP therapy since, in addition to being non-discrete, they often cause claustrophobia. [0068] This disclosure provides exemplary embodiments of the present invention. The scope of the present invention is not limited by these exemplary embodiments. Numerous variations, whether explicitly provided for by the specification or implied by the specification, such as variations in structure, dimension, type of material and manufacturing process may be implemented by one of skill in the art in view of this disclosure.

In accordance with the present invention, there is provided a mask for achieving positive pressure mechanical ventilation (inclusive of CPAP, ventilator support, critical care ventilation, emergency applications), and a method for a operating a ventilation system including such mask. The mask of the present invention includes a piloted exhalation valve that is used to achieve the target pressures/flows to the patient. The pilot for the valve may be pneumatic and driven from the gas supply tubing from the ventilator. The pilot may also be a preset pressure derived in the mask, a separate pneumatic line from the ventilator, or an electro-mechanical control. The mask of the present invention may further include a heat and moisture exchanger (HME) which is integrated therein.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application is a continuation application of PCT/JP2015/058040 filed on Mar. 18, 2015 and claims benefit of Japanese Application No. 2014-191727 filed in Japan on Sep. 19, 2014, the entire contents of which are incorporated herein by this reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a medical observation system, and particularly relates to a medical observation system used to specify a position of a predetermined object existing inside a living body. [0004] 2. Description of the Related Art [0005] As a treatment method for removing a stone inside a kidney, for example, treatment methods such as ESWL (extracorporeal shock wave lithotrity), TUL (transurethral ureterolithotomy) and f-TUL (flexible transurethral ureterolithotomy) are conventionally known. [0006] In addition, for example, Japanese Patent Application Laid-Open Publication No. 2013-527782 discloses, as a treatment method for accelerating removal of a stone inside the kidney, a method of specifying a position of the stone using a known imaging modality such as fluoroscopy and applying extrusion ultrasound having a pressure amplitude of a predetermined range to the stone. SUMMARY OF THE INVENTION [0007] A medical observation system of one aspect of the present invention includes: a position information storage portion configured to perform processing for storing first position information which is information indicating an initial position of an object for executing treatment in a three-dimensional image generated based on a plurality of tomographic images of a subject; a movement detection portion configured to detect movement of the object for executing the treatment; a position information acquisition portion configured to perform processing for acquiring second position information which is information indicating a present position of the object for executing the treatment in the three-dimensional image when the movement of the object for executing the treatment is detected by the movement detection portion; and a display image generation portion configured to update a position of the object for executing the treatment in the three-dimensional image from the first position information to the second position information in a case that the second position information is acquired by the position information acquisition portion, and generate an image superimposed on the three-dimensional image or on a pseudo fluoroscopic image generated based on the plurality of tomographic images. BRIEF DESCRIPTION OF THE DRAWINGS [0008] FIG. 1 is a diagram illustrating a configuration of a main portion of a medical observation system relating to an embodiment; [0009] FIG. 2 is a diagram for describing one example of a configuration of an image processing device relating to the embodiment; [0010] FIG. 3 is a diagram illustrating one example of distal end position data stored in a distal end position storage portion; [0011] FIG. 4 is a schematic diagram for describing one example of three-dimensional model data of a predetermined luminal organ; [0012] FIG. 5 is a schematic diagram for describing an example different from FIG. 4 , of the three-dimensional model data of the predetermined luminal organ; [0013] FIG. 6 is a diagram for describing one example of an image displayed at a display device; [0014] FIG. 7 is a diagram illustrating one example of stone position data stored in a stone position storage portion; [0015] FIG. 8 is a flowchart for describing one example of processing performed in a medical observation system relating to the embodiment; [0016] FIG. 9 is a diagram for describing another example of the image displayed at the display device; [0017] FIG. 10 is a diagram for describing another example of the image displayed at the display device; [0018] FIG. 11 is a diagram for describing another example of the image displayed at the display device; and [0019] FIG. 12 is a diagram for describing another example of the image displayed at the display device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0020] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. [0021] FIG. 1 to FIG. 12 relate to the embodiment of the present invention. FIG. 1 is a diagram illustrating a configuration of a main portion of a medical observation system relating to the embodiment. [0022] As illustrated in FIG. 1 , a medical observation system 1 is configured including an endoscope 2 , an endoscope image generation device 3 , a position detection device 4 , an X-ray C-arm device 5 , a server 6 , an image processing device 7 , a display device 8 , and an input device 9 . [0023] The endoscope 2 is configured including an elongated insertion portion 11 insertable into a subject and formed with flexibility, an operation portion 12 connected to a proximal end portion of the insertion portion 11 , and a cable 13 extended from a side face of the operation portion 12 . [0024] The endoscope 2 is configured to be connected through the cable 13 to the endoscope image generation device 3 , and be connected through a cable 14 to the position detection device 4 . [0025] On a distal end portion 11 A of the insertion portion 11 , an image pickup portion 10 for picking up an image of an object inside the subject is provided. [0026] The image pickup portion 10 is, for example, configured to pick up the image of the object by an image pickup device such as a CCD, and generate image pickup signals according to the object, the image of which is picked up. Then, the image pickup signals generated in the image pickup portion 10 are outputted through the operation portion 12 and the cable 13 to the endoscope image generation device 3 . [0027] At a part from the distal end portion 11 A to a proximal end portion of the insertion portion 11 , a plurality of magnetic sensors 51 that detect a magnetic field originated from the position detection device 4 and generate electric signals according to the detected magnetic field are disposed at every predetermined interval. Then, the electric signals generated in the plurality of magnetic sensors 51 are outputted through the operation portion 12 the cable 14 to the position detection device 4 . [0028] The endoscope image generation device 3 is configured to be connected to the endoscope 2 through the cable 13 . In addition, the endoscope image generation device 3 is configured to generate endoscope image data by executing a predetermined image processing to the image pickup signals outputted from the endoscope 2 through the cable 13 , and output the generated endoscope image data to the image processing device 7 . [0029] The position detection device 4 is configured to be connected to the endoscope 2 through the cable 14 . In addition, the position detection device 4 is configured to extract the electric signals generated in the magnetic sensor 51 positioned on a most distal end side of the insertion portion 11 from the electric signals inputted through the cable 14 , perform an arithmetic operation for detecting a position in real space and a direction of the distal end portion 11 A of the insertion portion 11 based on the extracted electric signals at every predetermined time interval, generate distal end position data and distal end direction data indicating arithmetic results obtained by the arithmetic operation, and successively output the generated distal end position data and distal end direction data to the image processing device 7 . [0030] The position detection device 4 is configured to perform an arithmetic operation for detecting an insertion shape of the insertion portion 11 based on the electric signals inputted through the cable 14 , generate insertion shape data indicating the arithmetic result obtained by the arithmetic operation, and output the generated insertion shape data to the image processing device 7 . [0031] The position detection device 4 is configured to perform an arithmetic operation for detecting a position of an X-ray C-arm (described later) in the X-ray C-arm device 5 or the like based on the electric signals inputted through a cable 15 , generate X-ray image pickup position data indicating the arithmetic result obtained by the arithmetic operation, and output the generated X-ray image pickup position data to the image processing device 7 . [0032] The X-ray C-arm device 5 is configured including an X-ray generation portion configured to generate X-rays to be transmitted through the subject, and the X-ray C-arm provided with an X-ray detection portion for detecting the X-rays originated from the X-ray generation portion in a roughly opposite position. In addition, the X-ray C-arm device 5 is configured to acquire intraoperative X-ray image data from multiple directions by rotating the X-ray C-ram to an arbitrary angle, and output the acquired intraoperative X-ray image data to the image processing device 7 . [0033] The X-ray C-arm of the X-ray C-arm device 5 is provided with a magnetic sensor (not shown in the figure) that detects the magnetic field originated from the position detection device 4 and generates the electric signals according to the detected magnetic field. Then, the electric signals generated in the magnetic sensor are outputted through the cable 15 to the position detection device 4 . [0034] In the server 6 , for example, pieces of preoperative multi-slice image data 16 a - 16 n acquired by picking up the image of the subject by CT or MRI or the like are stored. The pieces of preoperative multi-slice image data 16 a - 16 n are outputted to the image processing device 7 through a network line of a local area network or the like, for example. [0035] Note that, in the present embodiment, without being limited to the configuration that the pieces of preoperative multi-slice image data 16 a - 16 n are outputted from the server 6 to the image processing device 7 , for example, the pieces of preoperative multi-slice image data 16 a - 16 n stored beforehand in a portable storage medium such as a CD-ROM may be read by the image processing device 7 . [0036] The display device 8 is provided with a liquid crystal display or the like, for example, and is configured to display the image outputted from the image processing device 7 . [0037] The input device 9 is provided with a touch panel or a keyboard or the like, for example, and is configured to be able to input information according to an operation of a user such as an operator to the image processing device 7 . Note that, according to the present embodiment, for example, in a scope switch (not shown in the figure) of the operation portion 12 of the endoscope 2 or the like, the information similar to the input device 9 may be inputted. [0038] Next, a detailed configuration or the like of the image processing device 7 will be described. [0039] As illustrated in FIG. 2 , the image processing device 7 is configured including a storage portion 21 , a distal end position storage portion 22 , an arithmetic portion 23 , a distal end coordinate transformation portion 24 , an image processing portion 25 , and a stone position storage portion 26 . FIG. 2 is a diagram for describing one example of the configuration of the image processing device relating to the embodiment. [0040] The storage portion 21 is provided with a storage device such as a hard disk drive, and is configured to store the preoperative multi-slice image data 16 a - 16 n outputted from the server 6 . [0041] The distal end position storage portion 22 is configured to store the insertion shape data outputted from the position detection device 4 . [0042] The distal end position storage portion 22 is configured to impart a time stamp TSP to the distal end position data and the distal end direction data outputted from the position detection device 4 and store the data. Then, according to such a configuration of the distal end position storage portion 22 , for example, as illustrated in FIG. 3 , storage is performed in a state that a time stamp TSP 1 is imparted to an X coordinate value A 1 , a Y coordinate value B 1 and a Z coordinate value C 1 of the distal end position data outputted from the position detection device 4 . Note that, for simplification, the distal end direction data is omitted and FIG. 3 is illustrated. FIG. 3 is a diagram illustrating one example of the distal end position data stored in the distal end position storage portion. [0043] The arithmetic portion 23 is configured to calculate a transformation equation for transforming a coordinate value indicating a position in real space to a coordinate value indicating a position in three-dimensional data by comparing a coordinate value of the distal end position data stored in the distal end position storage portion 22 with a coordinate value (described later) of core line data outputted from the image processing portion 25 , when it is detected that input of information for executing positioning is performed in the input device 9 . [0044] The distal end coordinate transformation portion 24 is configured to transform the distal end position data and the distal end direction data stored in the distal end position storage portion 22 to the coordinate value indicating the position in the three-dimensional data, based on the transformation equation calculated in the arithmetic portion 23 . In addition, the distal end coordinate transformation portion 24 is configured to store the distal end position data and the distal end direction data after transformation, the distal end position data and direction data before the transformation, and the time stamp TSP together in the distal end position storage portion 22 . Then, according to such processing of the distal end coordinate transformation portion 24 , for example, as illustrated in FIG. 3 , the X coordinate value A 1 , the Y coordinate value B 1 and the Z coordinate value C 1 in real space that are the distal end position data before the transformation, an X coordinate value D 1 , a Y coordinate value E 1 and a Z coordinate value F 1 in the three-dimensional data that are the distal end position data after the transformation, and the time stamp TSP 1 are stored together in the distal end position storage portion 22 . In addition, according to the processing of the distal end coordinate transformation portion 24 as described above, the distal end position data in the three-dimensional data is time-sequentially stored in the distal end position storage portion 22 . [0045] That is, according to the processing of the arithmetic portion 23 and the distal end coordinate transformation portion 24 as described above, a coordinate position in three-dimensional model data of a predetermined luminal organ and a coordinate position of a distal end of the insertion portion 11 acquired in the position detection device 4 can be matched. [0046] The image processing portion 25 is configured to generate the three-dimensional model data of the subject using the preoperative multi-slice image data 16 a - 16 n stored in the storage portion 21 , and extract three-dimensional model data 31 (see FIG. 4 ) of the predetermined luminal organ including a ureter 40 , a kidney pelvis 41 , calyces 42 - 49 , and a stone ST. In addition, the image processing portion 25 is configured to extract the coordinate value of the core line data of a lumen in the three-dimensional model data 31 , and output the extracted coordinate value of the core line data to the arithmetic portion 23 . In addition, the image processing portion 25 is configured to generate three-dimensional model data 32 (see FIG. 5 ) for which the three-dimensional model data 31 extracted as described above is rotated by an arbitrary angle in order to observe the predetermined luminal organ from two directions. FIG. 4 is a schematic diagram for describing one example of the three-dimensional model data of the predetermined luminal organ. FIG. 5 is a schematic diagram for describing an example different from FIG. 4 , of the three-dimensional model data of the predetermined luminal organ. [0047] Note that the image processing portion 25 of the present embodiment may extract the three-dimensional model data including not only the ureter 40 , the kidney pelvis 41 and the calyces 42 - 49 but also a bladder and a urethra for example, from the three-dimensional model data of the subject. In addition, the image processing portion 25 of the present embodiment is not limited to the portion that extracts the three-dimensional model data of the predetermined luminal organ from the three-dimensional model data of the subject, and may be the portion that reads the three-dimensional model data of the predetermined luminal organ stored beforehand in the server 6 or the storage portion 21 , for example. [0048] On the other hand, the image processing portion 25 is configured including a pseudo X-ray image generation portion 25 a , a movement detection portion 25 b , a stone position acquisition portion 25 c , and a display image generation portion 25 d. [0049] The pseudo X-ray image generation portion 25 a is configured to generate pseudo X-ray image data based on the preoperative multi-slice image data 16 a - 16 n stored in the storage portion 21 . [0050] The movement detection portion 25 b is configured to calculate a difference value by executing matching processing to the endoscope image data at an initial position of the stone ST and the endoscope image data at a present position of the stone ST, and acquire the calculated difference value as a movement amount of the stone ST. Or, the movement detection portion 25 b is configured to calculate a difference value by executing matching processing to the pseudo X-ray image data including the stone ST generated by the pseudo X-ray image generation portion 25 a and the X-ray image data obtained by picking up the image of the stone ST existing inside the subject by the X-ray C-arm device 5 , and acquire the calculated difference value as a movement amount of the stone ST. [0051] Note that the endoscope image data at the initial position of the stone ST is assumed to be outputted from the endoscope image generation device 3 as moving image data or still image data obtained by picking up the image of the stone ST before treatment to the stone ST existing inside the subject is performed for example, and stored in a memory or the like not shown in the figure of the image processing portion 25 . In addition, the endoscope image data at the present position of the stone ST is assumed to be outputted from the endoscope image generation device 3 as the moving image data or the still image data obtained by picking up the image of the stone ST in the middle of the treatment performed to the stone ST existing inside the subject for example, and stored in the memory or the like not shown in the figure of the image processing portion 25 . [0052] The movement detection portion 25 b is configured to detect whether or not the stone ST has moved, based on a comparison result for which the movement amount of the stone ST acquired as described above and a predetermined threshold TH are compared or based on a judgement result for which whether or not the information is inputted according to the operation of a switch SW 1 (not shown in the figure) of the input device 9 is determined. Note that the switch SW 1 is configured, for example, as a switch capable of inputting, to the image processing portion 25 , the information for notifying that the stone ST has moved in the case that it is clear that the stone ST is moved according to an intention of a user such as the case that the stone ST is moved to a position suitable for the treatment. [0053] The stone position acquisition portion 25 c is configured to acquire the coordinate value indicating the initial position of the stone ST in the three-dimensional model data of the subject, based on the three-dimensional model data of the subject generated using the preoperative multi-slice image data 16 a - 16 n. [0054] The stone position acquisition portion 25 c is configured to acquire the coordinate value indicating the present position of the stone ST in the three-dimensional data by projecting the movement amount acquired by the movement detection portion 25 b on the pseudo X-ray image data generated by the pseudo X-ray image generation portion 25 a based on the transformation equation calculated by the arithmetic portion 23 and the X-ray image pickup position data outputted from the position detection device 4 when the movement of the stone ST is detected by the movement detection portion 25 b. [0055] Or, the stone position acquisition portion 25 c is configured to read an X coordinate value Dn, a Y coordinate value En and a Z coordinate value Fn (see FIG. 3 ) of the latest distal end position data to which a time stamp TSPn is imparted from the distal end position storage portion 22 , when the movement of the stone ST is detected by the movement detection portion 25 b , and acquire the read X coordinate value Dn, Y coordinate value En and Z coordinate value Fn as the coordinate value indicating the present position of the stone ST in the three-dimensional data. [0056] The stone position acquisition portion 25 c is configured to successively output the coordinate value indicating the initial position of the stone ST in the three-dimensional data and the coordinate value indicating the present position of the stone ST in the three-dimensional data to the stone position storage portion 26 as stone position data. [0057] The display image generation portion 25 d is configured to generate one or more markers M indicating the position of the stone ST in the three-dimensional data based on the stone position data stored in the stone position storage portion 26 , and combine the generated markers M with the three-dimensional model data 31 and 32 . [0058] The display image generation portion 25 d is configured to generate a display image by combining the three-dimensional model data 31 and 32 including the markers M, the endoscope image 34 generated by executing predetermined image processing to the endoscope image data outputted from the endoscope image generation device 3 , and one piece of preoperative multi-slice image data 16 i selected by the user from the preoperative multi-slice image data 16 a - 16 n stored in the storage portion 21 , and output the generated display image to the display device 8 . Then, by such processing of the display image generation portion 25 d , for example, the image as illustrated in FIG. 6 is displayed at the display device 8 . FIG. 6 is a diagram for describing one example of the image displayed at the display device. [0059] The display image generation portion 25 d is configured to change a display aspect of a marker indicating the position of the stone ST in the three-dimensional data, based on the stone position data stored in the stone position storage portion 26 when it is detected that the information is inputted according to the operation of a switch SW 2 (not shown in the figure) of the input device 9 . Note that the switch SW 2 is configured as a switch capable of inputting information for selecting one or more markers displayed in the three-dimensional model data 31 and 32 and inputting information for changing the display aspect of the selected one or more markers to a desired display aspect to the image processing portion 25 , for example. [0060] The stone position storage portion 26 is configured to impart a time stamp TSQ to the stone position data successively outputted from the image processing portion 25 and store the data. Then, according to such a configuration of the stone position storage portion 26 , for example, as illustrated in FIG. 7 , the storage is performed in the state that a time stamp TSQ 1 is imparted to an X coordinate value G 1 , a Y coordinate value H 1 and a Z coordinate value I 1 indicating the initial position of the stone ST. In addition, according to the configuration of the stone position storage portion 26 as described above, for example, as illustrated in FIG. 7 , the storage is performed in the state that a time stamp TSQm is imparted to an X coordinate value Gm, a Y coordinate value Hm and a Z coordinate value Im indicating latest position of the stone ST. That is, according to the configuration of the stone position storage portion 26 as described above, the stone position data successively outputted from the image processing portion 25 is time-sequentially stored. FIG. 7 is a diagram illustrating one example of the stone position data stored in the stone position storage portion. [0061] Subsequently, an action of the present embodiment will be described. FIG. 8 is a flowchart for describing one example of processing performed in the medical observation system relating to the embodiment. [0062] The image processing portion 25 generates the three-dimensional model data of the subject using the preoperative multi-slice image data 16 a - 16 n stored in the storage portion 21 , and extracts the three-dimensional model data 31 of the predetermined luminal organ including the ureter 40 , the kidney pelvis 41 , the calyces 42 - 49 and the stone ST from the generated three-dimensional model data of the subject. In addition, the image processing portion 25 generates the three-dimensional model data 32 for which the three-dimensional model data 31 extracted as described above is rotated by the arbitrary angle. [0063] The stone position acquisition portion 25 c acquires the coordinate value indicating the initial position of the stone ST in the three-dimensional model data of the subject, based on the three-dimensional model data of the subject generated using the preoperative multi-slice image data 16 a - 16 n , and outputs the acquired coordinate value to the stone position storage portion 26 as the stone position data. [0064] The display image generation portion 25 d performs processing as described below as the processing for generating the image indicating the initial position of the stone (step S 1 in FIG. 8 ). [0065] The display image generation portion 25 d generates a marker M 1 indicating the initial position of the stone ST in the three-dimensional data based on the stone position data stored in the stone position storage portion 26 , and combines the generated marker M 1 with the three-dimensional model data 31 and 32 . In addition, the display image generation portion 25 d generates the display image by combining the three-dimensional model data 31 and 32 including the marker M 1 , the endoscope image 34 and the preoperative multi-slice image data 16 i , and outputs the generated display image to the display device 8 . [0066] Then, by the processing as described above being performed in the display image generation portion 25 d , for example, the image as illustrated in FIG. 9 is displayed at the display device 8 . FIG. 9 is a diagram for describing another example of the image displayed at the display device. Note that, in FIG. 9 , details of the endoscope image 34 displayed at the display device 8 before the insertion portion 11 is inserted to an inside of the subject are omitted for the simplification. [0067] The user inserts the insertion portion 11 to the inside of the subject while confirming the position of the marker M 1 in the image displayed at the display device 8 and thus arranges the distal end portion 11 A of the insertion portion 11 near the stone ST of the calyx 49 . Then, according to such an insertion operation by the user, for example, as illustrated in FIG. 10 , the endoscope image 34 including the stone ST positioned inside the calyx 49 is displayed at the display device 8 . FIG. 10 is a diagram for describing another example of the image displayed at the display device. [0068] Thereafter, the user starts the treatment to the stone ST positioned inside the calyx 49 while confirming the endoscope image 34 displayed at the display device 8 . [0069] The movement detection portion 25 b performs one piece of processing from individual pieces of processing described below as the processing for detecting the movement of the stone ST (step S 2 in FIG. 8 ). [0070] The movement detection portion 25 b calculates the difference value by executing the matching processing to the endoscope image data at the initial position of the stone ST and the endoscope image data at the present position of the stone ST, and acquires the calculated difference value as a movement amount DA of the stone ST. Then, the movement detection portion 25 b compares the movement amount DA with a predetermined threshold TH 1 , and detects the movement of the stone ST in the case of obtaining the comparison result that the movement amount DA is equal to or larger than the predetermined threshold TH 1 . [0071] The movement detection portion 25 b calculates the difference value by executing the matching processing to the pseudo X-ray image data including the stone ST generated by the pseudo X-ray image generation portion 25 a and the X-ray image data obtained by picking up the image of the stone ST existing inside the subject by the X-ray C-arm device 5 , and acquires the calculated difference value as a movement amount DB of the stone ST. Then, the movement detection portion 25 b compares the movement amount DB with a predetermined threshold TH 2 , and detects the movement of the stone ST in the case of obtaining the comparison result that the movement amount DB is equal to or larger than the predetermined threshold TH 2 . [0072] The movement detection portion 25 b determines whether or not the information is inputted according to the operation of the switch SW 1 of the input device 9 , and detects that the stone ST has moved in the case of obtaining the judgement result that the information is inputted according to the operation of the switch SW 1 . [0073] The stone position acquisition portion 25 c performs one piece of processing from individual pieces of processing described below as the processing for acquiring the present position of the stone ST when the movement of the stone ST is detected by the movement detection portion 25 b (step S 3 in FIG. 8 ). [0074] The stone position acquisition portion 25 c acquires the coordinate value indicating the present position of the stone ST in the three-dimensional data by projecting the movement amount DA or DB acquired by the movement detection portion 25 b on the pseudo X-ray image data generated by the pseudo X-ray image generation portion 25 a , based on the transformation equation calculated by the arithmetic portion 23 and the X-ray image pickup position data outputted from the position detection device 4 , when the movement of the stone ST is detected by the movement detection portion 25 b . Then, the stone position acquisition portion 25 c outputs the coordinate value indicating the present position of the stone ST in the three-dimensional data to the stone position storage portion 26 as the stone position data. [0075] The stone position acquisition portion 25 c reads the X coordinate value Dn, the Y coordinate value En and the Z coordinate value Fn of the latest distal end position data to which the time stamp TSPn is imparted from the distal end position storage portion 22 , when the movement of the stone ST is detected by the movement detection portion 25 b , and acquires the read X coordinate value Dn, Y coordinate value En and Z coordinate value Fn as the coordinate value indicating the present position of the stone ST in the three-dimensional data. Then, the stone position acquisition portion 25 c outputs the coordinate value indicating the present position of the stone ST in the three-dimensional data to the stone position storage portion 26 as the stone position data. [0076] The display image generation portion 25 d including a function as a position information presentation portion performs processing as described below as the processing for generating the image indicating the present position of the stone (step S 4 in FIG. 8 ). [0077] The display image generation portion 25 d generates a marker Mn indicating the present position of the stone ST in the three-dimensional data based on the latest stone position data stored in the stone position storage portion 26 , combines the generated marker Mn with the three-dimensional model data 31 and 32 , and eliminates the marker generated before the generated marker Mn from the three-dimensional model data 31 and 32 . In addition, the display image generation portion 25 d generates the display image by combining the three-dimensional model data 31 and 32 including the marker Mn, the endoscope image 34 , and the preoperative multi-slice image data 16 i , and outputs the generated display image to the display device 8 . [0078] Then, by the processing as described above being performed in the display image generation portion 25 d , for example, the image as illustrated in FIG. 11 is displayed at the display device 8 . FIG. 11 is a diagram for describing another example of the image displayed at the display device. [0079] That is, according to the present embodiment, by repeatedly performing the processing of steps S 2 -S 4 in FIG. 8 , the marker indicating the present position of the stone ST can be displayed roughly in real time in the three-dimensional model data of the predetermined luminal organ. As a result, according to the present embodiment, burdens of an operator who performs the treatment relating to removal of the stone can be reduced. [0080] Note that the display image generation portion 25 d of the present embodiment is not limited to the portion that generates the display image by combining the marker indicating the position of the stone ST with the three-dimensional model data 31 of the predetermined luminal organ, and may be the portion that generates the display image by combining the marker with the three-dimensional model data of the subject before the three-dimensional model data 31 of the predetermined luminal organ is extracted, or may be the portion that generates the display image by combining the marker with the pseudo X-ray image data generated by the pseudo X-ray image generation portion 25 a , for example. [0081] In addition, the display image generation portion 25 d of the present embodiment is not limited to the portion that performs the processing described above in step S 4 in FIG. 8 , and may perform processing of coloring the plurality of markers including at least the marker Mn in mutually different colors and combining the plurality of colored markers with the three-dimensional model data 31 and 32 when the input of the information according to the operation of the switch SW 2 of the input device 9 is detected, for example. [0082] In addition, the display image generation portion 25 d of the present embodiment may be the portion that generates the display image which displays the marker indicating the position of the stone ST and a comment imparted to the marker according to the operation of the input device 9 together, for example. [0083] In addition, the display image generation portion 25 d of the present embodiment is not limited to the portion that performs the processing described above in step S 4 in FIG. 8 , and may generate the marker Mn indicating the present position of the stone ST in the three-dimensional data and a line segment LS indicating a moving track of the stone ST in the three-dimensional data from the marker M 1 to the marker Mn respectively and combine the generated marker Mn and the line segment LS with the three-dimensional model data 31 and 32 when the input of the information according to the switch SW 2 of the input device 9 is detected, for example. In addition, in such a case, the moving track of the stone ST maybe created by using the stone position data stored in the stone position storage portion 26 , or the moving track of the stone ST may be created by using the information stored time-sequentially in the distal end position storage portion 22 (see FIG. 3 ). Furthermore, in the above-described case, the moving track of the stone ST may be created (inputted) manually according to the operation of the input device 9 , or the like, by the user such as the operator. Then, in the case that the processing as described above is performed in the display image generation portion 25 d , for example, the image as illustrated in FIG. 12 is displayed at the display device 8 . FIG. 12 is a diagram for describing another example of the image displayed at the display device. [0084] Note that the present invention is not limited to the embodiment described above, and it is needless to say that various changes and applications are possible without changing a subject matter of the present invention.

A medical observation system includes: a position information storage portion configured to perform processing for storing first position information indicating an initial position of an object for executing treatment in a three-dimensional image generated using a plurality of tomographic images of a subject; a movement detection portion configured to detect movement of the object; a position information acquisition portion configured to acquire second position information indicating a present position of the object in the three-dimensional image when the movement of the object is detected; and a display image generation portion configured to update a position of the object in the three-dimensional image from the first position information to the second position information in a case that the second position information is acquired, and generate an image superimposed on the three-dimensional image or on a pseudo fluoroscopic image generated based on the plurality of tomographic images.

RELATED APPLICATION [0001] This application is a divisional of and claims priority to U.S. Utility patent application Ser. No. 11/022,392, entitled “MODULAR DISPLAY APPARATUS,” filed on Dec. 22, 2004. The contents of that application are incorporated expressly by reference herein, as if fully set forth and full Paris Convention Priority is hereby expressly claimed. BACKGROUND [0002] The present invention relates generally to a modular display apparatus and more particularly to a modular display apparatus having a number of improved static display features, as well as interactive instructional capabilities. In an illustrative embodiment, these features are directed to the selection and application of wood treatment products. [0003] In the past, wood treatment products such as paints, stains, water proofers, etc., have customarily been made available for purchase at various hardware, paint supply, and home supply stores. Selection of an appropriate product by the consumer has entailed reading product labels and brochures, examining various samples, and chatting with store personnel in a decentralized and often ad hoc or haphazard manner. Learning how to properly apply such products typically involves discussion with store personnel, reading often terse product labeling and trial and error. SUMMARY [0004] The following is a summary of various aspects and advantages realizable according to various embodiments of a modular display apparatus according to the present invention. It is provided as an introduction to assist those skilled in the art to more rapidly assimilate the detailed discussion of the invention that ensues and does not and is not intended in any way to limit the scope of the claims that are appended hereto. [0005] With this in mind, according to one aspect of the invention, there is provided a modular display comprising a number of interchangeable modules installable adjacent one another on a shelf. The modules may be designed to conveniently present samples and brochure information. According to another inventive aspect, one of the modules may comprise an interactive video unit providing instruction as to product selection and/or application. One or more of the modules may further provide concavely curved receptacles or grooves for receiving a flat display panel and imparting a concave contour thereto. Such a panel may carry sample chips, attached, for example, by a two piece chip holder which facilitates removal or changing out of sample chips. [0006] According to another aspect, a mechanism is provided for removably retaining the modules in place on the shelf. One embodiment of such a mechanism comprises a panel slideable into and out of position between the shelf and the modules. A front molding piece is attached to the front panel and comes into abutment with the modules to retain them in place. [0007] A specially designed lighting fixture may further be provided to uniformly and attractively illuminate the display. The modular structure may further be provided with a sprinkler irrigation feature comprising a water flow-through system for channeling and distributing water discharged by fire sprinkler systems. [0008] Various of the inventive aspects just discussed may be combined to provide a product selection center where a customer may conveniently and centrally access information concerning the selection and application of wood treatment products. DRAWINGS [0009] FIG. 1 is a perspective view of an illustrative embodiment of a display apparatus according to the invention; [0010] FIG. 2 is a perspective view illustrating a plurality of display modules employed in the display apparatus of FIG. 1 ; [0011] FIG. 3 is a perspective view of a first of the display modules of FIG. 2 ; [0012] FIG. 4 is a front view of the display module of FIG. 3 ; [0013] FIG. 5 is a side view of the display module of FIG. 3 ; [0014] FIG. 6 is a side view of a cabinet component in which display modules employed in the apparatus of FIG. 1 may be installed; [0015] FIG. 7 is a top view of the cabinet of FIG. 6 ; [0016] FIG. 8 is a perspective view of a second display module for use in the display apparatus of FIG. 1 ; [0017] FIG. 9 is a side view, of the second display module of FIG. 8 ; [0018] FIG. 10 is a perspective view of a third display module; [0019] FIG. 11 is a side view of the display module of FIG. 10 ; [0020] FIG. 12 is a perspective view of a fourth display module; [0021] FIG. 13 is a side view of the display module of FIG. 12 ; [0022] FIG. 14 is a perspective view of a fifth display module; [0023] FIG. 15 is a side view of the display module of FIG. 14 ; [0024] FIG. 16 , is a front view of a display panel insertable into the fourth display module of FIG. 12 ; [0025] FIG. 17 is a front view of the display panel of FIG. 16 with a plurality of sample chip display units mounted thereon; [0026] FIG. 18 is a perspective view of a recessed lighting fixture of the display apparatus of FIG. 1 ; [0027] FIG. 19 is a sectional view of the apparatus taken at 19 - 19 of FIG. 23 ; [0028] FIG. 20 is an end view of a lamp fixture utilized in the apparatus of FIG. 18 ; [0029] FIG. 21 is a top view of the lighting fixture of FIG. 18 ; [0030] FIG. 22 is a side view of the fixture of FIG. 18 ; [0031] FIG. 23 is a sectional view of the fixture of FIG. 18 taken at 23 - 23 ; [0032] FIG. 23 a is a top view of a diffuser component employed in connection with the light fixture of FIG. 18 ; [0033] FIG. 23 b is an enlarged view of a fragment of the diffuser of FIG. 23 a; [0034] FIG. 24 is a perspective view of components of the display apparatus of FIG. 1 illustrating a water flow through feature; [0035] FIG. 25 is a rear perspective view of the apparatus of FIG. 24 ; [0036] FIG. 26 is a perspective view of an interactive video module of the apparatus of FIG. 1 ; [0037] FIG. 27 is a perspective view of a portion of the interactive video apparatus of FIG. 26 further illustrating a removable paint chip display panel; [0038] FIG. 28 is a perspective view illustrating an apparatus for securing the display modules of the display apparatus of FIG. 1 in position; [0039] FIG. 29 is an enlarged perspective view of a portion of the apparatus of FIG. 28 ; [0040] FIG. 30 is a perspective of a portion of the apparatus of FIG. 28 illustrating the installed position; [0041] FIG. 31 is a fragmentary view further illustrating an alternate method and an apparatus for securing display modules of the display apparatus in position; [0042] FIG. 32 is a fragmentary view of a portion of the display panel of the display 11 of FIG. 1 illustrating a particular embodiment of a wood chip mounting mechanism; [0043] FIG. 33 is a perspective view of a chip clip mounting mechanism in disassembled relation; [0044] FIG. 34 is a perspective view of a removable chip holder component of the chip mounting; and [0045] FIG. 35 through 37 are sectional views illustrating the sequential assembly and installation of a chip mounting mechanism. DETAILED DESCRIPTION [0046] A display apparatus 11 according to an illustrative embodiment is shown FIG. 1 . The apparatus 11 includes a cabinet 13 which mounts 5 display modules, 17 , 19 , 21 , 23 , 25 . In the illustrated embodiment, the modules 17 , 19 , 21 , 23 , 25 separately mount into the cabinet 11 and therefore are subject to being reordered in any desired sequence. [0047] The first and fifth display modules 17 , 25 comprise brochure display modules. The first display module 17 presents brochures of a first size, while the fifth display module displays brochures of a second size. The size, of course, could be the same or different, as desired. [0048] The second and fourth display modules 19 , 23 , mount respective concave display panels 27 , 28 . The first display panel of 27 may provide a display of a plurality of wood chips to each of which has been applied a different water proofing coating. The second display panel 28 may present a display of a plurality of wood chips each stained with a different wood stain, which may be, for example, either a solid and/or semi-transparent stain. [0049] The third display module 21 includes an interactive instructive video display 29 , which may comprise a DVD/DVI ( 143 , FIG. 26 ) player. The module 21 further mounts a display panel 31 . The display panel 31 preferably mounts a plurality of adjacently disposed wood chips. Each of the chips comprises a different species of wood to which the same wood stain product has been applied. In this manner, a potential customer may appreciate the difference in overall appearance contributed by the underlying wood species. [0050] A recessed fluorescent lighting fixture 27 is disposed above the display modules 17 , 19 , 21 , 23 , 25 . As will be explained in more detail below, the recessed lighting fixture 27 is specially designed to provide optimum and uniform illumination of the samples displayed by the display panels 27 , 28 . [0051] FIG. 2 illustrates the display apparatus 11 and the modules 17 , 19 , 21 , 23 , 25 with various graphic display components removed. Each of these components 11 , 17 , 19 , 21 , 23 , 25 of FIG. 2 will be now described in more detail. [0052] FIGS. 3 thru 5 illustrate the construction of the large brochure module 25 . This module 25 includes first and second side panels, 33 , each of which has a bottom edge 39 and back edge 38 , which meet at right angles to one another. The front edge of each panel 33 is defined by a first vertical linear section 30 , which meets with a convexly curved section 36 , which then leads to a second vertical depending section 32 . The vertical section 32 forms into a surface whose top edge 132 is disposed at a slightly acute angle to the horizontal. Thus, a vertical leg 34 and a horizontal foot 37 are defined on each of the side panels 33 . The side panels 33 are linked to one another by a back panel 35 , a floor or base panel 47 , and an upper horizontal panel 44 . The module 25 further includes a central panel 45 having a convex outer edge 46 , which lies in parallel with the respective convex edges 36 of the side panels 33 . A hole 26 is formed in the floor panel 47 through which a fastening device such as a screw may be inserted to fasten or attach the module 25 to an underlying shelf or other structure. [0053] Respective deck panels 41 , 42 are disposed between the first side panel 33 and the central panel 45 and between the central panel 45 and the second side panel 33 , respectively. Clear vertical face panels 46 , 48 are further mounted in slots in the respective side and central panels 33 , 45 . The face panels 46 , 48 may comprise, for example, plexi-glass preferably anchored in place by a suitable adhesive. The panels 33 , 35 , 47 , 45 of the module 25 are preferably made of suitable wood or wood substitute materials fastened together according to conventional means well-known to those skilled in the woodworking arts. [0054] FIGS. 6 and 7 further illustrate the cabinet 13 , which mounts the five modules 17 , 19 , 21 , 23 , 25 . As shown, the cabinet 13 preferably includes identical rectangular vertically disposed end panels 51 , 53 , between which are mounted a horizontal rectangular base “shelf” 56 and a vertical rectangular back panel 55 . The back panel 55 is inset from the back edge 58 of the base 56 . Holes 57 are bored through base portion or shelf 56 behind the back panel 55 to facilitate water flow according to a fire prevention irrigation feature described in more detail hereafter. [0055] FIGS. 8 and 9 further illustrate the third display module 21 , which mounts the video monitor 29 ( FIG. 1 ). The module 21 includes first and second rectangular vertical side panels 61 , 63 spaced apart by a width appropriate to mount the video monitor 29 . The side panels 61 , 63 further include horizontally extending display card mounting portions 67 , 69 in which are formed suitably curved grooves 75 for receiving a display card as described in further, detail hereafter. The module 21 further preferably includes a horizontally disposed rib 73 , which provides a support structure to horizontally stabilize the module 21 . Again, the module 21 may be fabricated of suitable wood or wood substitutes according to techniques well-known to those in the woodworking arts. [0056] FIGS. 10 and 11 illustrate the fourth display module 23 in more detail. The fourth module 23 includes a rectangular base member 73 , a vertical rectangular back panel 71 and respective vertical side panels 75 , 77 . The side panels 75 , 77 each have a horizontal bottom edge 76 and a vertical back edge 78 . Each of the display panels 75 , 77 further has a concave outer edge 80 , 82 and an interior concave groove, e.g., 84 , for receiving the display panel 28 . The respective interior grooves, e.g., 84 , are mirror images of and lie parallel to one another. [0057] The fourth display module 23 further includes first and second interior support panels 79 , 81 , each of which has a respective horizontal bottom edge, vertical back edge, and a concave surface 68 , 69 . The concave surfaces 68 , 69 are parallel to one another and disposed in line with the grooves 84 so as to provide support to the display panel 28 , after it has been inserted into the grooves 84 , as described in more detail below. Finally, the bottom panel 73 of the module 23 includes a number of water drainage holes 86 . These holes cooperate with the fire sprinkler water distribution system to be described in further detail below. [0058] FIGS. 12 and 13 illustrate the second display card holding module 19 in more detail. The module 19 includes first and second vertically disposed side panels 91 , 93 , each of which has a vertical back edge 94 and a horizontal bottom edge. 95 . Each of the side panels 91 , 93 further includes a concave outer edge 97 , 99 . Each interior side surface of each of the side panels 91 , 93 includes a concave groove, e.g., 101 . The grooves 101 are again mirror images of and disposed parallel to one another. The second display module 19 further includes a vertical, rectangular back panel 90 and a horizontal rectangular base panel 92 . Again, suitable drainage holes 106 are created in the bottom panel 92 . [0059] FIGS. 14 and 15 illustrate the first display module 17 in more detail. The first display module 17 includes first and second side panels 101 , 103 contoured similarly to those of the display module 25 of FIGS. 3-5 . Like module 25 , the module 17 includes a horizontal rectangular base panel 105 and vertical rectangular back panel 107 . The module 17 further includes a plurality of rectangular horizontal deck members 109 , 111 , 113 , disposed in step-like fashion with respect to one another. The module 17 further includes a number of vertical transparent face plates 115 , 117 , 119 , 120 , which may be, for example, disposed in suitable grooves in the side panels 101 , 103 and retained in place by a suitable adhesive. A hole 29 is formed in the base panel 105 through which a fastening device such as a screw may be inserted to attach the module 17 to an underlying shelf or other structure. [0060] FIGS. 16 and 17 show an illustrative embodiment for a display panel 28 ( FIG. 1 ) for insertion into the fourth display module 23 . The panel 28 shown in FIG. 15 may comprise, for example, a rectangular panel of 0.125 millimeter thick expanded PVC. Illustrative dimensions of such a panel are 825.5 millimeters (32.5 inches) in width (w) and 590.55 millimeters (23.250 inches) in height (h). As further illustrated, suitable holes 113 , which may be for example 166 in number, are punched or otherwise created in the panel 28 in order to attach sample mounting chips such as are illustrated in FIG. 34 . FIG. 17 illustrates the graphic layout of sample chips 115 on the panel 28 . During installation, the flat panel 15 is inserted into the curved slots in the module and thereby is effectively turned into a curved panel, which is more suitable to a typical consumer's line of sight and results in improved, light distribution and space conservation. [0061] FIGS. 18 thru 23 illustrate the recessed lighting fixture or “light box” 27 of FIG. 1 in more detail. The fixture 27 includes a number of pairs of fluorescent lamp fixtures 123 disposed within a housing 124 . Each lamp fixture 123 preferably includes a biaxial lamp unit, preferably a Philips PL-L55W, 55 watt, 5500 K, 92 CRI unit. A CRI of 90 or above is preferred. The housing 124 comprises a perforated horizontal mounting (ceiling) panel 121 , first and second rectangular vertical end members 125 , 126 and a rear edge member 127 . FIG. 19 illustrates a centered header attachment support 134 , and a rectangular reinforcement member 136 , which member 136 preferably extends the entire length of the light box 127 . The header support 134 and reinforcement member 136 serve to prevent sagging of the middle of the structure. The member 136 may, for example, be a metal tube or formed from a portion of a metal sheet used to fabricate panel 121 . [0062] Each fixture of the pair of lighting fixtures 123 is mounted parallel to an adjacent fixture 123 and at a slight acute angle to the horizontal edge 130 of the mounting panel 121 . The acute angle may be for example eight (8) degrees. The light fixtures 123 are so arrayed as to create a uniform lighting effect on the concave display panels. As may be seen in FIG. 22 , the pairs of parallel light tubes of the fixtures 123 lie horizontally and provide a substantially linear line of light-radiating, surface. [0063] FIG. 20 shows a detail of a lamp fixture 123 and its associated reflector 131 . A single side reflector 131 is positioned behind each lamp fixture 123 . The reflector 131 is especially designed with angled side sections 131 , 135 in order to appropriately direct the light. Angled section 133 may be ½″ in length and formed at an angle of 130 degrees with respect to horizontal portion 126 , which maybe 2.5 inches in width. Angled portion 135 may also be ½″ in length and formed at an angle of 160 degrees to angled portion 135 . The reflecting surface may be 95% reflective, 92% specular. The single side reflector 131 further directs light downwardly, preventing glare in the customer's eyes. [0064] FIG. 23 illustrates a decorative front face plate 129 which closes the front of the fixture 27 and is seen by one viewing the display 11 . A diffuser grill 201 ( FIG. 1 ) is mounted at the bottom of the lamp fixture 27 and is further illustrated in FIGS. 23A and 23B . The diffuser may be a rectangular plastic grill (“egg crate” diffuser) comprising square openings each of which may be ½ inch on a side. [0065] The lamp mounting arrangement shown in FIG. 18 positions a light producing lamp portion adjacent a “tombstone” lamp mounting receptacle. The light box 27 is relatively shallow in depth and the staggered arrangement of light fixtures 123 together with the diffuser 201 substantially eliminates dark spots and provides a uniform, customer-attracting and aesthetically pleasing light distribution. [0066] FIGS. 24 and 25 illustrate an advantageous irrigation feature, which cooperates with sprinkler systems positioned above the display 11 to distribute the flow of fire retarding water throughout the unit and to goods, e.g., 202 ( FIG. 1 ), stored beneath the display 11 . As may be seen, the perforations, e.g., 122 , in the light fixture housing 121 cooperate with holes, e.g., 86 , 186 , in underlying module members to permit water flow down and throughout the display 11 and its modular components 17 , 19 , 21 , 23 , 25 . Holes 186 and 86 overlie matching holes, e.g., 57 in the cabinet 13 . [0067] FIGS. 26 and 27 illustrate further details of the interactive video module 21 . The module 21 encloses a video display monitor 29 which has a display viewing screen 145 and user manipulated buttons 141 . The buttons 141 permit a user to step through a menu of audio/video displays describing, for example, various tasks required in applying and selecting stains, waterproofing, and other products. [0068] FIG. 26 shows a cover plate 147 in a removed position, revealing a DVD/DVI player 143 . The DVD or DVI player 143 may be an adaptation of a commercially available unit providing a track selection feature cooperating with the buttons 141 . FIG. 27 further illustrates a display panel 151 partially inserted into the concave grooves 75 of the module 21 . The display panel 151 may carry, for example, four rows of wood chips, e.g., 152 , 151 selectively stained. Each of the chips 154 may comprise a different species of wood each stained with the same stain, thereby illustrating to the consumer the different effects which the underlying wood can have on the finished appearance of the stained wood. [0069] FIGS. 28 thru 31 illustrate an apparatus and method for securing the modules 17 , 19 , 21 , 23 into the surrounding cabinet 13 . In particular, a flat horizontal panel 166 , preferably sheet metal, is provided with suitable parallel slots 163 and with a front molding piece 167 providing a vertically extending surface 170 for abutting respective noses 171 of the modules 17 , 19 , 21 , 23 , 25 . A stud 165 is positioned in each slot 163 and serves to position and guide the panel 166 . The panel 166 is slideable in and out between the shelf 56 and the base panels 47 , 71 , 92 , 73 , 105 of the respective modules 17 , 19 , 21 , 23 , 25 , guided by the studs 165 . [0070] Considering FIGS. 29 and 30 , in the order to secure the modules 17 , 19 , 21 , 23 in place, the front molding piece 167 is pushed in towards the respective noses 171 of the modules 17 , 19 , 21 , 23 , 25 until the position shown in FIG. 30 is reached, at which point, screws or other devices are inserted through the holes 26 , 29 in the base of each of modules 17 , 25 , then through the sheet metal panel 166 , and finally into the shelf 56 , thereby securely fixing the molding piece 167 and hence the modules 17 , 19 , 21 , 23 , 25 in position. Other means of securing the modules in place can of course be used. In one alternate embodiment, for example, a piano hinge could be used to mount a suitable front molding piece 167 . It will also be noted further that the placement of the fastening devices through holes 26 , 29 in the respective brochure modules 17 , 25 renders them inconspicuous, for example, as compared to side insertion through panel 13 . FIG. 31 illustrates an alternate approach wherein a screw or other fastening device is inserted through a display panel, then through a module base and a sheet metal panel, and into the shelf 56 . The approach using holes 26 , 29 is preferred over this approach because it is less conspicuous. [0071] FIGS. 32 through 37 illustrate a chip mounting mechanism 215 . As illustrated in FIG. 33 , the chip mounting mechanism includes a removable chip holder 217 , which mounts into a carrier 225 . Both the chip holder 217 and the carrier 225 may be fabricated, for example, of a suitable molded plastic. [0072] The chip holder 217 includes a base portion 232 on which is formed first and second horizontal tabs 229 , 221 and an acutely angled tab 230 . The chip holder 217 further includes vertically depending edge portions 235 , 237 and respective lips 239 , 240 ( FIG. 35 ). Each lip 239 , 240 has a cammed surface 350 to facilitate installation as further described below. [0073] As illustrated in FIG. 34 , the tabs 229 , 231 , 230 facilitate removable mounting of respective wood chips 219 , 221 , each of which has a groove 227 formed therein for slideably receiving the respective tabs 229 , 231 . The opposite ends of the respective chips 219 , 221 slide snuggly underneath the acutely angled tab 230 . [0074] The carrier member 225 includes a flat rectangular bottom 253 and a generally rectangular rim 251 formed about the periphery of the bottom 253 . First and second slots 241 , 243 are formed in the carrier member 225 for receiving the respective tabs 239 , 240 ( FIG. 35 ) of the chip holder 217 . The vertically depending edge portions 235 , 237 of the chip holder 217 are sized such that they snuggly fit within the rectangular rim 251 of the carrier member 225 . On the underside of the bottom 253 of the carrier member 225 are formed respective expandable plugs 250 , which insert into respective adjacent mounting holes e.g., 261 , 263 formed in the display panel 28 . [0075] FIGS. 35 through 37 illustrate the manner of insertion of the removable chip holder 217 into the carrier member 225 . As shown, the first lip 239 is engaged with the first slot 241 , and then the chip holder 217 is pressed downward such that the second lip 240 snaps into the slot 243 with the assistance of the cammed surface 350 , thereby snuggly joining the chip holder 217 and carrier member 225 together. Suitable wood chips, e.g., 229 may then be slideably inserted into the chip carrier 217 . Thereafter, the assembled unit may be mounted on the display panel 28 by inserting the prongs 250 through the respective mounting holes, e.g., 261 , resulting in the mounted position shown in FIG. 37 . The construction illustrated in FIGS. 32-37 permits sample chips to be removed by the retailer (but not the customer) for purposes of changing out or updating different chips, as desired. [0076] Those skilled in the art will appreciate that various adaptations and modifications of the just-described preferred embodiment can be configured without departing from the scope and spirit of the invention. Therefore, it is to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described herein.

A plurality of separate display modules are interchangeably installed on a shelf of a cooperating cabinet structure and arranged to provide convexly curved display panels mounting selected arrangements of illuminated sample chips, an interactive video display, and brochure receptacles. The structure is provided with an integral sprinkler water distribution system and may include a two-part sample chip mounting mechanism which facilitates changing out of sample chips.

BACKGROUND OF THE INVENTION The present invention relates to supports, and more particularly, to a support having a rod bearing dividers for separating loop forming objects being stored from one another. Looped objects such as necklaces, bracelets, and the like, must from time to time be retrieved from storage for use. In the case of jewelry, it is desirable to observe and select from stored articles of jewelry. Also, small articles such as necklaces and bracelets are difficult to grasp if bunched together, as may occur in storage. Apparatuses intended to address the above concerns would find utility. SUMMARY OF THE INVENTION The present disclosure addresses the above stated needs by providing a support adapted for separating looped objects such as necklaces and bracelets, permitting observation of the looped objects while the looped objects are stored, and separating the looped objects to permit ready grasp and removal of one of the looped objects from storage. The present invention relates to a storage and display rack for necklaces, comprising a bar including a cylindrical central section having a diameter, a first series of circumferential grooves on one side of the cylindrical central section, and a second series of circumferential grooves on an opposed side of the cylindrical central section. A holder includes a mounting base including a flat base surface, and a grip configured to partially encircle the bar. The grip is ultimately connected to the flat base surface and includes an elastic member having a circular inner wall having an extent between one hundred eighty and two hundred seventy degrees of a circle defined by the circular inner wall. The circular inner wall has an opening to the interior of the circular inner wall, the opening having an extent between ninety and one hundred eighty degrees of a circle defined by the circular inner wall, an inner surface slightly smaller in diameter than the diameter of the cylindrical central section of the bar, and an axis located centrally within the inner surface. The axis is parallel to the inner surface and also parallel to the flat base surface. Therefore, the grip can be elastically spread open to receive and release the central section of the bar, and elastically closes over and retains the bar after insertion of the bar in the grip. In an exemplary realization of the disclosure, there is disclosed a storage and display rack for necklaces, comprising a bar including a proximal end, a distal end, and a series of circumferential grooves between the proximal end and the distal end; a pivot support at the proximal end of the bar, the pivot support including an engagement element engaging the proximal end of the bar and enabling the bar to pivot thereabout; and a holder at the distal end of the bar. The bar and the holder generally have the characteristics of the bar and holder of the previously described realization. The pivot support enables the bar to be lifted or rotated out of its former position received in the holder. This enables one or more necklaces to be retrieved from the bar. The bar may then be returned to its prior position received by the holder. Various advantages of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiment, when read in light of the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a storage and display rack for necklaces, according to one realization of the disclosure. FIG. 2 is a perspective detail view of a holder shown at the upper center of FIG. 1 . FIG. 3 is a fragmentary end detail view of the holder of FIG. 2 , the holder shown engaging a bar seen at the top of FIG. 1 . FIG. 4 is a fragmentary side detail view of an alternative to the holder of FIG. 2 . FIG. 5 is a perspective view of a storage and display rack according to at least one other aspect of the disclosure. FIG. 6 is a perspective view of a storage and display rack according to at least one further aspect of the disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT To these and other ends, and referring to FIG. 1 , in one exemplary realization, there is disclosed a storage and display rack 100 for necklaces 10 , comprising a bar 102 including a cylindrical central section 104 having a diameter, a first series of circumferential grooves 106 on one side of the cylindrical central section 104 , and a second series of circumferential grooves 108 on an opposed side of the cylindrical central section 104 . Referring also to FIGS. 2 and 3 , a holder 110 includes a mounting base 112 including a flat base surface 114 , and a grip 116 configured to partially encircle the bar 102 . The grip 116 is ultimately connected to the flat base surface 114 and includes an elastic member 118 having a circular inner wall 120 having an extent between about one hundred eighty-one and about two hundred seventy degrees of a circle defined by the circular inner wall 120 . The circular inner wall 120 has an opening 122 to the interior of the circular inner wall 120 , the opening 122 having an extent between about ninety and about one hundred eighty degrees of a circle defined by the circular inner wall 120 , the inner surface 124 slightly smaller in diameter than the diameter of the cylindrical central section 104 of the bar 102 , and an axis 126 located centrally within the inner surface 124 . The axis 126 is parallel to the inner surface 124 and also parallel to the flat base surface 114 . Therefore, the grip 116 can be elastically spread open to receive and release the central section 104 of the bar 102 , and elastically closes over and retains the bar 102 after insertion of the bar 102 in the grip 116 . Orientation of the axis 126 enables the grip 116 to hold the bar 102 parallel to a flat environmental surface, such as a building wall or partition (not shown) on which the holder 110 is mounted. Spacing of the circumferential grooves 106 , 108 , or of the high portions of the bar 102 , may be consistent, or alternatively, may be variable. Some circumferential grooves 106 , 108 may be larger than others in depth or length or both, for example, to accommodate necklaces of different dimensions. The grip 116 is ultimately connected to the flat base surface 114 in that there may be one or more intervening elements, such as straight sections 128 . The circular inner wall 120 does not form a complete circle. Rather, there is left open a portion enabling the bar 102 to be inserted into a receptacle provided by the grip 116 . The circular inner wall 120 occupies just over half of the complete circle (e.g., about one hundred eighty-one to about two hundred seventy degrees of the complete circle), so that the bar 102 will be constrained against inadvertent dislodging from the grip 116 . The complete circle alluded to above may be seen in FIG. 3 as the circumference 130 of the central section 104 of the bar 102 . Therefore, it will be appreciated that “circular” as employed herein is intended as a descriptor indicating that the configuration of the inner surface 124 of the opening 122 corresponds to the circular outer surface of the central section 104 or of the bar 102 , and is not to be construed as denoting full circular extent. The magnitude of the theoretical full circle accounted for by the holder 110 is sufficient to retain the bar 102 within the grip 116 under ordinary conditions. Because the grip 116 is slightly elastic, it will deform to pass the bar 102 when the bar 120 is installed in and removed from the grip 116 . The holder 110 may be made from steel sheet metal having slight spring characteristics, and may be a standard or off-the-shelf commercial product, such as a curtain rod holder. An exemplary rod holder is depicted in FIG. 2 . Reference to the inner surface 124 as being slightly smaller in diameter than the diameter of the cylindrical central section 104 of the bar 102 refers to deformation of the holder 110 when inserting or withdrawing the bar 102 . Deformation occurs as the grip 116 spreads to accommodate the relatively greater diameter of the bar 102 . This deformation disappears after full seating of the bar 102 within the grip 116 , or after removal of the bar 116 from the grip 116 . The slightly smaller diameter of the inner surface 124 prevails with the grip 116 in the undeformed state, in the absence of forces either spreading or compressing the circular inner wall 120 . Optionally, and as illustrated in FIG. 1 , a diameter of the cylindrical central section 104 is equal to the diameter of the bar 102 between any two ones of first and second series of the circumferential grooves 106 , 108 . Optionally, and also illustrated in FIG. 1 , the storage and display rack 100 may include a fastener 132 coupling the bar 102 to the holder 110 . The fastener 132 may be a pin, rivet, screw, or other fastener passing through the holder 110 and being anchored within the bar 102 . The fastener 132 assures sturdiness of a connection between the bar 102 and the holder 110 . Optionally, it would be possible to support the bar 102 at both ends (this option is not shown), using two holders 110 , rather than supporting the bar 102 at its center, as shown in FIG. 1 . Referring now to FIG. 4 , the storage and display rack 100 may include a plurality of O-rings 134 on the bar 102 . Each one of the circumferential grooves 106 (or circumferential grooves 108 ) is defined between two adjacent ones of the plurality of O-rings 134 . It would be possible to include some circumferential grooves 106 and/or 108 formed integrally within the bar 102 , by cutting with a lathe for example, and some circumferential grooves 106 and/or 108 entirely or partially formed by the O-rings 134 . An advantage of the O-rings 134 is that the O-rings 134 are movable along the bar 102 , to vary width of the grooves 106 , 108 . Also, thicker 0 -rings 134 may be utilized to increase depth of resultant the grooves 106 , 108 . The O-rings 134 may be of a variety of colors, for ornamentation or for coding of necklaces for different uses, for example. Turning now to FIG. 5 , there is shown a storage and display rack 200 which includes a plurality of bars 202 . The bars 202 may be similar in construction to the bars 102 of FIGS. 1-4 . The bars 202 project from a wall mounting plate 204 . The bars 202 may be secured to the wall mounting plate 204 by fasteners such as screws (not shown) passing through wall mounting plate 204 . Alternatively, ends (concealed from view in FIG. 5 ) of the bars 202 may enter and at least partially occupy holes (not shown) in the wall mounting plate 204 . Arrangement of the bars 202 may be varied from the triangular pattern illustrated in FIG. 5 . For example, the bars 202 could be linearly arrayed in a vertical column, a horizontal row, or a diagonal row. Plural rows or columns of bars 202 may be provided. Where plural rows or columns are used, rows and columns may be staggered or offset from one another (options of arrangements of bars 202 are not shown). The bars 202 may be of different lengths, diameters, and groove dimensions and spacing. The plurality of bars 202 of the storage and display rack 200 accommodates a correspondingly greater number of necklaces 10 ( FIG. 1 ) than could be provided by storage and display rack 100 having only one bar 102 . Referring to FIG. 6 , a storage and display rack 300 includes the bar 302 adapted to pivot (as indicated by arrow 301 ). The bar 302 may generally have the characteristics of the bar 102 of FIGS. 1-4 , with the exception that at the right end 303 , as depicted in FIG. 6 , a pivot mount 305 is provided. Also, the holder 310 has the characteristics of the holder 110 of FIGS. 1-4 . The storage and display rack 300 for necklaces comprises a pivot support 305 including an engagement element engaging the proximal end of the bar 302 and enabling the bar 302 to pivot thereabout. The holder 310 is at a distal end 307 of the bar 310 . The pivot support 305 may include an axle 309 and a wall mounting plate 311 supporting the axle 309 . The pivot support 305 enables the bar 302 to be lifted or rotated out of its former position received in the holder 310 , rotation indicated by arrow 301 . This enables one or more necklaces 10 ( FIG. 1 ) to be retrieved from the bar 302 . The bar 302 may then be returned to its prior position received within the holder 310 . The bars 102 , 202 , 302 may be made from wood, plastics, metals, and of other materials, and in combinations thereof. Each one of the first and second series of circumferential grooves 106 , 108 (and corresponding circumferential grooves of bars 202 and 302 ) may be formed using a lathe (not shown). Of course, other materials and fabrication techniques may be used for the bars 102 , 202 , 302 , such as injection molding from a synthetic plastic material. The bars 102 , 202 , 302 may be coated (e.g., painted or lined with a rubber-like material for friction enhancement), anodized, or otherwise have a surface treatment, for ornamentation or to alter friction characteristics. The bars 102 , 202 , and 302 , the holders 110 , 310 , and the wall mounting plate 204 may be provided in a variety of structures and shapes. Different examples of the apparatuses disclosed herein include a variety of components, features, and functionalities. It should be understood that the various examples of the apparatuses disclosed herein may include any of the components, features, and functionalities of any of the other examples of the apparatuses disclosed herein in any feasible combination. All such possibilities are intended to be within the spirit and scope of the present disclosure. Many modifications of examples set forth herein will come to mind to one skilled in the art to which the present disclosure pertains, the one skilled in the art having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the present disclosure is not to be limited to the specific examples presented and that modifications and other examples are intended to be included within the scope of the appended claims. Moreover, although the foregoing description and the associated drawings describe examples of the present disclosure in the context of certain illustrative combinations of elements and/or functions, it should be appreciated that different combinations of elements and/or functions may be provided by alternative implementations without departing from the scope of the appended claims.

A rack supports and displays loop-like articles, such as necklaces. The rack includes a bar having a series of circumferential grooves and a holder for supporting the bar from a vertical surface. In one implementation, the holder is at the center of the bar, and is rigidly connected to the bar. In another implementation, the holder is at one end of the bar, with a pivot support at the other end of the bar. The bar is permanently and pivotally fixed to the pivot support, and releasably received in the holder. In the latter implementation, the bar can be lifted or pivoted out of engagement with the holder so that a necklace can be removed from the bar.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of U.S. Provisional Application No. 60/668,818, filed Apr. 6, 2005. U.S. Provisional Application No. 60/668,818 is hereby incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to a device for regenerating bone in a patient, particularly for use in a distraction osteogenesis method. Specifically, the present invention relates to an improved device that facilitates angled and vertical bone regeneration in the oral cavity, allowing for bone growth in a direction that is not necessarily vertical to the device. BACKGROUND OF THE INVENTION [0003] During the 1950's, Professor Gavril Ilizaroz revealed that controlled, mechanically applied tension stress on fractured bone produces successful regeneration of bone and soft tissue, a technique known today as distraction osteogenesis. Initially used for the treatment of fractures and non-unions, his methods have proven successful for limb lengthening and bone transportation. [0004] Today, distraction osteogenesis is used to lengthen long bones, correct bone deformities, correct maxillofacial abnormalities, and treat periodontal bone deficiency. Generally, distraction osteogenesis involves making small bone cuts at precise positions and applying forces across these cuts using a distraction device to induce and direct normal bone formation. [0005] More specifically, a typical procedure for distraction osteogenesis involves the following four sequentially performed stages: osteotomy, latency, distraction, and consolidation. The first stage, osteotomy, involves cutting a section of a bone requiring treatment into two pieces, known as a controlled fracture, thus initiating the fracture's natural healing process. Fracture healing is a process whereby fibrous deformable tissue forms and is gradually replaced by non-deformable tissue (i.e., ossification). [0006] The second stage, latency, is a “rest” period (e.g., approximately 5-7 days), during which healing of the fracture proceeds until a blood clot is formed. Upon formation of the blood clot, the distraction stage begins. Distraction is a process wherein bony fragments or joint surfaces of a limb are separated or otherwise spread by extension. During distraction, a “gap” is created at the site of the osteotomy. Following formation of the appropriately sized gap, a consolidation stage, or period of healing, occurs. [0007] During the distraction stage, conventional devices are employed to control and direct the bone distraction. However, conventional distraction devices for intra-oral distraction facilitate bone regeneration in only a vertical direction. Because bone geometries vary from patient to patient and include overlaps and non-vertical angles, vertical regeneration alone does not provide the necessary treatment option for many patients. [0008] Accordingly, there is a need for a distraction device that allows for improved regeneration of bone, particularly in the oral cavity. SUMMARY OF THE INVENTION [0009] The present invention relates to a distraction device and a method for facilitating angled and vertical bone regeneration in the oral cavity. The device is particularly suited for use by oral surgeons, periodontists, plastic surgeons, and maxilla specialists in the treatment of traumatic injury, cancer, tumor ablation, or growth disharmony, such as those affecting the temporo-mandibular joint (TMJ). The distraction device facilitates the displacement of a healthy portion of bone to a deficient area to allow for bone regeneration and soft tissue growth. Advantageously, the distraction device allows for both vertical and angular bone regeneration by facilitating both vertical and angular distraction. [0010] The distraction device according to an embodiment of the present invention may be used to regenerate bone tissue in deficient areas of a patient's upper and/or lower jaw bones (i.e., the maxilla and/or mandible bones) to allow for subsequent dental implantation. According to an aspect of the present invention, the distraction device includes multi-tooth capabilities based on a patient's needs. One having ordinary skill in the art will appreciate that the distraction device may be used for vertical and angular bone regeneration in other areas of the body and is not limited to intra-oral use. [0011] According to an embodiment of the present invention, the distraction device includes a threaded rod with a connecting wedge housing at one end, a threaded nut for engaging with the threaded rod, two lower transport plates for positioning on either side of a lower portion of the threaded rod, an upper transport plate for securing an upper portion of the threaded rod, and one or more connecting wedges adapted to fit in the distraction device. [0012] Each connecting wedge includes a main body and a connecting-wedge extension extending from each side of the main body. The main body of the connecting wedge is offset relative to the connecting-wedge extensions at an angle, referred to as an “offset angle.” The term “wedge” is intended to include, but is not limited to, any structure, device, piece, component, etc. having any suitable shape or size such that it is adapted to provide an offset angle as described herein. As such, the term “wedge” may not be limited to any conventional definition, particular shape, and/or geometric configuration. [0013] In operation, the two lower transport plates are fixed to a healthy portion of bone or tissue adjacent an area of bone deficiency according to a technique known in the art. An upper transport plate is secured to the site of an osteotomy with a securing mechanism, such as for example standard bone screws. The upper transport plate includes a sleeve through which the threaded rod is passed, thereby releasably coupling the upper transport plate and the threaded rod. The threaded nut is engaged on the threaded rod and may be moved to shift the upper transport plate and adjust a vertical component of the distraction (i.e., the vertical distraction). [0014] The main body of the connecting wedge is fitted within the connecting wedge housing of the threaded rod. With the main body securely attached to the threaded rod, the connecting wedge extensions are engaged within the lower transport plates, and the threaded rod is stabilized by the lower transport plates. Further, when the threaded rod, the connecting wedge, and the lower transport plates are assembled, the threaded rod extends at an angle that is offset relative to the lower transport plates. That is, the threaded rod and the lower transport plates form an angular relationship that is not necessarily parallel or perpendicular. The angular arrangement of the threaded rod relative to the lower transport plates allows for angular distraction and angular bone regeneration. [0015] In another embodiment of the present invention, the distraction device includes a threaded rod engaged within a correspondingly threaded hub. The distraction device also includes a shaft that passes horizontally through the hub, wherein each end of the shaft extending out of the sides of the hub are secured by a lower transport plate. The threaded rod, the hub, and the shaft combine to form a setscrew. When rotated in a clockwise direction, the threaded rod moves in a downward direction within the hub and into contact with the shaft. When sufficient contact between the threaded rod and the shaft is established, the threaded rod and the hub are prevented from rotating about the shaft, and the distraction device is in a locked position. [0016] Correspondingly, when the threaded rod is turned in a counter-clockwise direction, the threaded rod moves in an upward direction and out of contact with the shaft, placing the distraction device in an unlocked position. In the unlocked position, the threaded rod and hub are free to rotate about the shaft and may be positioned at an angle relative to the lower transport plates. When the desired angle of the threaded rod (i.e., the desired angle of bone regeneration) has been assigned, the angle may be set by turning the threaded rod in the clockwise direction to place the distraction device in the locked position. Advantageously, the distraction device allows for the angle of regeneration to be adjusted at any time during the distraction procedure. BRIEF DESCRIPTION OF THE DRAWINGS [0017] The present invention will be more readily understood from the detailed description of the preferred embodiment(s) presented below considered in conjunction with the attached drawings, of which: [0018] FIG. 1 is an isometric view of a distraction device, according to an embodiment of the present invention; [0019] FIG. 2 is a rear view of a distraction device, according to an embodiment of the present invention; [0020] FIG. 3 is a side view of a distraction device, according to an embodiment of the present invention; [0021] FIG. 4 is an isometric view of a connecting wedge, according to an embodiment of the present invention; [0022] FIG. 5 is a side view of a connecting wedge, according to an embodiment of the present invention; [0023] FIG. 6 is an exploded view of a distraction device, according to an embodiment of the present invention; [0024] FIG. 7 depicts an exemplary connecting wedge having an offset angle of 0° and a distraction device including the exemplary connecting wedge, according to an embodiment of the present invention; [0025] FIG. 8 depicts an exemplary connecting wedge having an offset angle of 10° and a distraction device including the exemplary connecting wedge, according to an embodiment of the present invention; [0026] FIG. 9 is an isometric illustration of a distraction device, according to an embodiment of the present invention; [0027] FIG. 10 depicts an exemplary hub, according to an embodiment of the present invention; and [0028] FIG. 11 depicts an exemplary shaft, according to an embodiment of the present invention. [0029] It is to be understood that the attached drawings are for the purpose of illustrating concepts of the present invention and may not be to scale. DETAILED DESCRIPTION OF THE INVENTION [0030] The present invention relates to a distraction device for facilitating both vertical and angular bone regeneration, particularly in the oral cavity. [0031] FIGS. 1 , 2 , 3 , and 6 depict an exemplary distraction device 100 according to an embodiment of the present invention. The distraction device 100 includes a threaded rod 1 , a threaded nut 4 disposed on the threaded rod 1 , an upper transport plate 2 , one or more lower transport plates 3 A, 3 B, and a connecting wedge 5 . At one end of the threaded rod 1 is a connecting wedge housing 11 that includes an opening 12 shaped and sized to fit the connecting wedge 5 , as described in detail below. In a preferred embodiment, the threaded rod 1 is composed of M0.5×3 standard isometric threads. [0032] According to an embodiment of the present invention, the one or more lower transport plates 3 A, 3 B are adapted to be secured or attached to a healthy portion of a patient's bone and/or tissue surrounding the area of bone deficiency, referred to as a target area. For example, if the mandible is the target area, the one or more lower transport plates 3 A, 3 B are fixed below the target bone. In another example, if the maxilla is the target area, the one or more lower transport plates are fixed above the target area. One having ordinary skill in the art will appreciate that the lower transport plates 3 A, 3 B may be secured proximal to the target area by any suitable fastening mechanism or method, including, but not limited to, a screw assembly. [0033] According to a preferred embodiment, two lower transport plates 3 A, 3 B are employed. Although the distraction device 100 is described as preferably including two lower transport plates 3 A, 3 B, one having ordinary skill in the art will appreciate that any number of lower transport plates may be employed, with an important consideration being that the lower portion of the distraction device 100 is adequately secured in place. [0034] The lower transport plates 3 A, 3 B each include one or more holes 7 , as shown in FIG. 2 . Each hole 7 is adapted to accept a screw or similar securing mechanism for affixing the lower transport plates 3 A, 3 B to the area adjacent the target area. Preferably, the lower transport plates 3 A, 3 B are arranged relatively coplanar to each other. [0035] The upper transport plate 2 is fixed at or near a target area (e.g., the site of an osteotomy) by one or more bone screws passing through one or more holes 6 of the upper transport plate 2 , as shown in FIG. 2 . The upper transport plate 2 includes a sleeve 15 with an opening sized and shaped to surround the threaded rod 1 . As shown in FIGS. 1 , 2 , and 6 , the threaded rod 1 is releasably coupled to the upper transport plate 2 , by passing the threaded rod 1 through the sleeve 15 of the upper transport plate 2 , such that the threaded rod 1 acts as a transport vector for the bone distraction. One having ordinary skill in the art will appreciate that the threaded rod 1 and the upper transport plate 2 may be releasably coupled to one another according to any suitable means or mechanism. One having ordinary skill in the art will appreciate that the upper transport plate 2 and the lower transport plates 3 A, 3 B may be manufactured using any known method, such as, for example, a machining method, a die casting method, or a Computer Numerical Control (CNC) method. [0036] Disposed on the threaded rod 1 is the threaded nut 4 . The threaded nut 4 is threadably engaged on the threaded rod 1 such that the threaded nut 4 is able to move axially along the threaded rod 1 upon the application of a force. To adjust an amount of vertical distraction provided by the distraction device 100 , a user turns the threaded nut 4 thus causing the threaded nut 4 to move into contact with the upper transport plate 2 and shift the upper transport plate 2 in the desired direction by the desired amount. Because the interior surface of the sleeve 15 is not threaded, the osteotomy moves longitudinally, in parallel with the threaded rod 1 . [0037] In a preferred embodiment, the threaded nut 4 may be turned using a suitable tool, such as for example a small hexagonal wrench. In an exemplary configuration, the threaded rod 1 includes threads having a pitch of approximately 0.5 mm. According to this exemplary arrangement, the user may turn the threaded nut 4 one complete turn twice a day in order to shift the upper transport plate 2 a total distance of approximately 1 mm a day. Although the threaded nut 4 and the threaded rod 1 are described as engaged by a threaded connection, alternative arrangements for disposing the threaded nut 4 on the threaded rod 1 are contemplated, such that the threaded nut 4 is movable along the threaded rod 1 . [0038] FIGS. 4 and 5 depict an exemplary connecting wedge 5 according to an embodiment of the present invention. The connecting wedge 5 attaches the lower transport plates 3 A, 3 B to the threaded rod 1 , and also provides a mechanism for setting the angle of the threaded rod 1 relative to the lower transport plates 3 A, 3 B. According to an embodiment of the present invention, the connecting wedge 5 includes a main body 9 and two connecting wedge extensions 10 A, 10 B extending from opposing sides of the main body 9 . Preferably, both the main body 9 and the connecting wedge extensions 10 A, 10 B have a rectangular shape, as shown in FIG. 4 . One having ordinary skill in the art will appreciate that the main body 9 and the connecting wedge extensions 10 A, 10 B may be integrally formed as a single piece. [0039] The main body 9 of the connecting wedge 5 is offset relative to the connecting wedge extensions 10 A, 10 B at a particular angle, referred to as an “offset angle,” graphically represented by the symbol “θ” in FIG. 8 . One having ordinary skill in the art will appreciate that the connecting wedge 5 may be configured to have any desired offset angle. One having ordinary skill in the art will appreciate that each connecting wedge 5 may be configured such that the relative arrangement of the main body 9 and the connecting wedge extensions 10 A, 10 B is adjustable (i.e., the position of the main body 9 and/or the connecting wedge extensions 10 A, 10 B may be made changed to set a new offset angle.) For example, the connecting wedge extensions 10 A, 10 B may be adapted to rotate relative to the main body 9 , to adjust the offset angle provided by the connecting wedge 5 . [0040] An exemplary connecting wedge 5 having an offset angle of 10° (i.e., the main body 9 is offset relative to the connecting wedge extensions 10 A, 10 B at an angle of 10°) is shown in FIG. 8 . [0041] One having ordinary skill in the art will appreciate that the distraction device 100 according to an embodiment of the present invention may be adapted to fit any one of a collection of interchangeable connecting wedges 5 , each having a particular offset angle. Further, it is to be appreciated that the main body 9 may be any shape or size, with an important consideration being that the main body 9 fits securely within the opening 12 of the connecting wedge housing 11 and is adapted for arrangement relative to the connecting wedge extensions 10 A, 10 B to produce an offset angle. [0042] Each lower transport plate 3 A, 3 B includes an opening 8 A, 8 B that extends perpendicularly to the surface of the target area, as shown in FIGS. 3 and 6 . The opening 8 A, 8 B are adapted to accept and secure the connecting wedge extension 10 A, 10 B. The openings 8 A, 8 B of the lower transport plates 3 A, 3 B have the same shape as the connecting wedge extensions 10 A, 10 B. Preferably, the openings 8 A, 8 B and the connecting wedge extensions 10 A, 10 B are square-shaped. [0043] The distraction device 100 is assembled by fitting the main body 9 into the opening 12 of the connecting wedge housing 11 and engaging the connecting wedge extensions 10 A, 10 B within the openings 8 A, 8 B of the lower transport plates 3 A, 3 B, respectively, thus holding the threaded rod 1 and the lower transport plates 3 A, 3 B together. Further, an upper portion of the threaded rod 1 is secured by the upper transport plate 2 , as described above. Advantageously, the distraction device 100 is stabilized by the lower transport plates 3 A, 3 B and the surrounding soft tissue of the region adjacent the target area, thus preventing any separation of the components of the distraction device 100 while in situ. [0044] The offset angle of the connecting wedge 5 dictates the angle at which the threaded rod 1 extends relative to the lower transport housings 3 A, 3 B, and thus provides the angle of bone regeneration provided by the distraction device 100 . FIG. 7 depicts an exemplary connecting wedge 5 with an offset angle θ of approximately 0° (i.e., the main body 9 is not offset relative to the connecting wedge extensions 10 A, 10 B). Accordingly, when the connecting wedge 5 depicted in FIG. 7 is loaded into the distraction device 100 , there is an approximately 0° offset angle between the lower transport plates 3 A, 3 B and the threaded rod 1 . Thus, the distraction device 100 according to this exemplary arrangement provides an approximately 0° angle of angular bone regeneration. [0045] FIG. 8 depicts an exemplary connecting wedge 5 with an offset angle θ of 10°. Accordingly, when the connecting wedge 5 shown in FIG. 8 is loaded into the distraction device 100 , the threaded rod 1 extends at a 10° angle relative to the lower transport plates 3 A, 3 B. Thus, the distraction device 100 according to this exemplary arrangement facilitates bone regeneration at a 10° angle. [0046] Advantageously, each connecting wedge 5 may be configured at a different offset angle, to allow a user to select from a wide range of angles for angular bone regeneration, depending on the individual patient's needs. The distraction device 100 may be fitted with any one of a collection of connecting wedges 5 depending on the angle of angular bone regeneration desired. [0047] One having ordinary skill in the art will appreciate that the distraction device 100 may be composed of any suitable material, such as for example titanium or surgical-grade stainless steel. Preferably, the distraction device 100 may be fabricated using known CNC technology. [0048] FIG. 9 illustrates a distraction device 100 according to another embodiment of the present invention. As shown in FIG. 9 , the distraction device 100 includes an upper transport plate 2 adapted to be secured the site of an osteotomy. As described above, the upper transport plate 2 includes a sleeve 15 with an opening sized and shaped to surround the threaded rod 1 . [0049] According to this embodiment of the present invention, the distraction device 100 includes a threaded nut 4 engaged on a threaded rod 1 , as described in detail above. As described above, the threaded nut 4 may be turned to shift the upper transport plate 2 to allow for vertical adjustment of the distraction device 100 . As such, the threaded rod 1 acts as a transport vector for bone distraction. As described above, two lower transport plates 3 A, 3 B are secured to a healthy portion of the patient's bone or tissue proximal to the target area. The lower transport plates 3 A, 3 B each include a sleeve adapted to accept and secure the ends of a shaft 50 . [0050] The distraction device 100 includes a hub 30 positioned between the lower transport plates 3 A, 3 B. The hub 30 includes an opening in its top and a threaded interior surface for insertion and engagement of the threaded rod 1 , as shown in FIG. 10 . The hub 30 also includes an opening on each side that aligns with the openings of the lower transport plates 3 A, 3 B to allow for insertion of the shaft 50 , shown in FIG. 11 . When assembled, the center portion of the shaft 50 is arranged within the hub 30 and the ends of the shaft 50 are held on either side by the lower transport plates 3 A, 3 B, such that the threaded rod 1 and the shaft 50 are substantially perpendicular to each other, as shown in FIG. 9 . The threaded rod 1 , the hub 30 , and the shaft 50 combine to form a setscrew for adjustment of the angle of the threaded rod 1 relative to the lower transport plates 3 A, 3 B, which in turn dictates the distraction angle. [0051] A knob 20 , or other equivalent structure, is positioned at an end of the threaded rod 1 and is used to adjust the position of the threaded rod 1 . In operation, the knob 20 may be turned in a clockwise direction to cause the threaded rod 1 to move downwardly into the hub 30 until the threaded rod 1 makes contact with the shaft 50 . When the threaded rod 1 is moved into sufficient contact with the shaft 50 , the hub 30 and threaded rod 1 are prevented from rotating about the shaft 50 , thus placing the distraction device 100 in a locked position at the desired distraction angle. [0052] Turning the knob 20 of the threaded rod 1 in a counter-clockwise direction moves the threaded rod 1 out of contact with the shaft 50 , thus placing the device 100 in an unlocked position. In the unlocked position, the threaded rod 1 and hub 30 may be rotated about the shaft 50 to a desired distraction angle. As described above, while maintaining the desired angle, the user may turn the knob 20 in a clockwise direction causing the threaded rod 1 to rotate into contact with the shaft 50 , thus setting the distraction device 100 in a locked position at the desired distraction angle. Advantageously, this embodiment of the present invention allows for in situ adjustment of the angle of regeneration provided by the distraction device 100 . The distraction device 100 according to this embodiment of the present invention allows for the angle of regeneration to be adjusted at any time during the distraction procedure. [0053] Although the present invention has been described in considerable detail with reference to certain preferred embodiments and version, other versions and embodiments are possible. Therefore, the scope of the present invention is not limited to the description of the versions and embodiments expressly disclosed herein. The references and disclosure provided in the ‘Background of the Invention’ section are not admitted to be prior art with respect to the disclosure provided in the present application.

A distraction device that allows for an improved use of the existing process of distraction osteogenesis. The distraction device facilitates the displacement of a healthy portion of bone to a deficient area to enable bone and soft tissue growth in a fracture gap and allows for both vertical and angular bone regeneration.

BACKGROUND OF THE INVENTION The present invention relates to therapies for the prevention and treatment of postpartum depression, as well as other psychological disturbances that develop after childbirth. It has long been recognized that psychological disturbances are very common in the postpartum period, usually beginning within 6 weeks after delivery. The psychological conditions can range from "maternity blues," which are usually mild, to a more severe depression, which is known to occur in fully 10% of postpartum women. Depression can have psychological effects that last for several months and occasionally even longer. A related concern is the impaired cognitive abilities and delayed social development that can be seen in the children of women who have experienced postpartum depression. At least a part of the explanation for postpartum depression is the changing hormone milieu in the woman's body following childbirth. Estrogen hormone achieves and maintains a high level during pregnancy and then drops precipitously within 48 hours after delivery to nearly the follicular level, which is the lowest level in a normally menstruating woman. This causes an acute estrogen withdrawal state, which could have effects on psychological and mental functioning. In this regard postpartum depression has been treated successfully with estrogen. In other reports estrogen has been administered immediately after childbirth to prevent recurrence of depression and other psychological disorders in women who are at risk of developing these problems in the postpartum period. Various antidepressant drugs, such as lithium, tricyclic compounds and serotonin-specific reuptake inhibitors (SSRI), have been used in postpartum depression with varying degrees of success. There is, however, concern about their side effects and their safety in breastfeeding women. Treatment with large doses of estrogen is also a concern in breastfeeding women. Safer, effective therapies for treating and preventing postpartum depression continue to be sought. SUMMARY OF THE INVENTION The invention features a method of treating or preventing postpartum depression in a woman who has recently given birth to a baby; the method involves administering to the woman, within six weeks (and preferably, within 24, or even 12, hours) a composition containing one or more purified isoflavonoids selected from the group consisting of genistein, daidzein, biochanin A, formononetin, O-desmethylangolensin, glycitin, and equol. Preferably, the composition is administered orally, providing a dosage of at least 20 mg of total isoflavonoid per serving. The orally-administerable composition can be a non-naturally occurring dietary product such as a convectionary bar, cereal, biscuit, or beverage. Alternatively, the composition can take the form of a medicament such as a pill, capsule, tablet, powder, or syrup, in which the total isoflavonoid is present in at least an amount of 20 mg per unit dose. Preferably, the dietary product or medicament is orally consumed by the patient once, twice, or three times per day, to provide a daily oral isoflavonoid dose of between 20 and 300 mg. Preferably, the oral ingestion of the composition is sufficient to produce a transient concentration in the bloodstream of the woman of at least 50 nm of total isoflavonoid per liter of blood. By "purified" isoflavonoid is meant an isoflavonoid in more concentrated form than occurs in plants. The isoflavonoids can also be administered in the form of a topical medicament applied directly to the skin; the medicament is composed of a dermatologically acceptable base substance admixed with the isoflavonoids; preferably, the topically applied composition contains between 1 and 40 mg isoflavonoid per gram of base. In one embodiment, the medicament forms part of a transdermnal delivery system or patch, which is applied to the skin once, twice, or three times per day. Other features and advantages of the invention will be apparent from the following Detailed Description thereof, and from the claims. DETAILED DESCRIPTION Isoflavonoids are naturally occurring substances, found primarily in soy beans. These compounds can also be found in high concentrations in red clover and in lower amounts in many other types of plants. An isoflavonoid-containing fraction useful in the invention can be extracted from a soy or plant product. It is preferred that the isoflavonoids be extracted and concentrated from soy bean or soy powder, but other plants such as clover can be used. Isoflavonoids are also available commercially in substantially pure form. The concentrated isoflavonoid is preferably included in a food carrier to form a dietary product. Any type of palatable carrier may be used, but as the isoflavonoid concentrate has a strong flavor, it is preferred that the carrier include suitable flavorings to impart a different, more palatable flavor. The dietary product may be any type of food product, e.g., a confectionary bar, biscuit, cereal, or beverage. It is preferred that the dietary product contain at least 20 mg/serving total isoflavonoids. The isoflavonoid concentrate included in the dietary product preferably includes a blend of isoflavonoids with genistein, daidzein, biochanin A, formononetin, O-desmethylangolensin, glycitin, and equol; these may be administered alone or in combination. Preferably, a dietary product containing the preferred dosage of isoflavonoids is consumed at least once per day, more preferably 2, or 3 times per day for more severe symptoms, to provide a daily oral isoflavonoid dose of 20-300 mg, more preferably 30-75 mg. The isoflavonoid also can be administered, preferably in similar dosages, in medicament form, e.g., mixed with a pharmaceutically acceptable carrier to form a pill, tablet, capsule or powder, or a liquid or syrup formulation. A topical medicament form can also be included in a transdermal delivery system or patch such as those that are well-known for the delivery of sustained doses of nicotine or estrogen. When isoflavonoids are fed to healthy American adults, the absorption into the bloodstream is 10 to 20% of the amount consumed. This produces blood levels of isoflavonoids 200 to 2000 times higher than the levels of the most active natural estrogen in women, estradiol. It is known that the estrogenic activity of isoflavonoids is about 1000 to 10,000 lower than that of estrogen contained in estrogen replacement therapy. These determinations indicate that consumption of isoflavonoids in dosages of 20 to 50 mg per day provides blood levels with estrogenic activity in the range of that found with estrogen replacement therapy. Isoflavonoids have similar chemical properties to estrogens, specifically they are poorly soluble in water but are readily soluble in alcohol or organic solvents. For topical application in a transdermal delivery system or patch, isoflavonoid is mixed in a conventional dermatologically acceptable base with ingredients such as alcohol, mineral oil, glyceryl monostearate, an ether complex of fatty acids, acetyl alcohol, lanolin, propylene glycol, stearyl alcohol, or sodium lauryl sulfate. The dose of isoflavonoid in the topical form is 1 to 40 mg per gram of the base. Other embodiments are within the claims.

A method of treating or preventing postpartum depression by administration of a composition containing one or more purified, naturally-occurring isoflavonoids.

REFERENCE TO RELATED APPLICATION This application claims priority from U.S. Provisional Patent Application No. 60/886,626, filed 25 Jan. 2007 and entitled “LEG EXERCISER”. TECHNICAL FIELD This invention relates to exercise machines. Certain embodiments relate to leg exercise machines capable of being attached to or integrated with standard office chairs which can be used for exercising the legs while seated and without interfering with or impeding the performance of office duties. BACKGROUND Office work is routinely sedentary. Sedentary work brings with it an increased risk of poor health. Consequently, many office workers seek ways to integrate exercise into their workday. There exist a number of prior art devices for exercising in chairs, including the following: U.S. Pat. No. 5,044,633 to Rice; U.S. Pat. No. 5,599,260 to Rovinsky et al.; U.S. Pat. No. 6,099,445 to Rovinsky et al.; U.S. Patent Application Publication No. 2004/0053756 to Tremayne; U.S. Patent Application Publication No. 2004/0142797 to Andre; and, U.S. Pat. No. 6,979,284 to Curtis. The inventor has identified a need for improved exercise devices which may be attached to or incorporated into chairs. SUMMARY The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above-described problems have been reduced or eliminated, while other embodiments are directed to other improvements. One aspect of the invention provides an exercise device comprising a chair attachment assembly adapted for attachment to a chair at a location under a seat of the chair and configured to extend outwardly therefrom. A pair of leg supports are pivotally coupled at first ends thereof to a pivot point on the chair attachment assembly. Each leg support is independently moveable between a contracted position and an extended position. A leg holder is coupled to each leg support near a second end thereof. A resistance element is pivotally coupled between each leg support and the chair attachment assembly. Each resistance element is configured to provide resistance against both outward movement of the associated leg support from the contracted position to the extended position and inward movement of the associated leg support from the extended position to the contracted position. In one embodiment of the present invention, two adjustable resistance mechanisms, one for each leg, enable each leg to be exercised independently of the other. Additionally, so that the muscles on the top of the leg can be exercised independently from the muscles at the back of the leg, different resistance settings, requiring a different applied force, can be used for stretching the leg outward as opposed to retracting the leg to its original position. In one embodiment the present invention comprises an exercise device which may be attached to a standard office chair (or built into an existing chair, sofa, bench, etc). The present invention has a chair attachment assembly with a pair of leg supports pivotally attached thereto. Each leg support is independently movable between an extended and a contracted position, and has a leg or ankle holder attached to its outer end. A resistance mechanism, which may comprise a hydraulic cylinder, is coupled to each leg support and resists motion of the associated leg support. The resistance mechanism optionally has an adjustment mechanism to regulate the amount of force required to move the attached leg support. In embodiments wherein the resistance mechanism is a hydraulic cylinder, the adjustment mechanism may comprise an adjustable valve, for example. Further aspects of the invention and details of specific embodiments are set out below. BRIEF DESCRIPTION OF DRAWINGS In drawings which illustrate non-limiting embodiments of the invention: FIG. 1 is a schematic representation of a leg exerciser attached to an office chair according to one embodiment of the invention with both leg supports in a contracted position; FIG. 2 shows the leg exerciser of FIG. 1 with the right leg support in an extended position FIG. 3 is a front view of the leg exerciser of FIG. 1 ; FIG. 4 is a top view of the leg exerciser of FIG. 1 ; FIG. 5 is a schematic representation of a leg exerciser attached to an office chair according to another embodiment of the invention; FIG. 6 is a schematic representation of a leg exerciser attached to a chair according to another embodiment of the invention; and, FIG. 7 shows the attachment assembly of the FIG. 6 embodiment in isolation. DESCRIPTION Throughout the following description specific details are set forth in order to provide a more thorough understanding to persons skilled in the art. However, well known elements may not have been shown or described in detail to avoid unnecessarily obscuring the disclosure. Accordingly, the description and drawings are to be regarded in an illustrative, rather than a restrictive, sense. Referring to FIGS. 1-4 , one embodiment of the present invention provides a leg exerciser 10 which may be attached to a chair 20 having a central post 22 such as, for example, an office chair. Leg exerciser 10 comprises a chair attachment assembly comprising a main supporting element 30 coupled to a bracket 100 at an inward end thereof. The terms “inward” and “outward” are used herein refer to the directions toward and away from central post 22 of chair 20 , respectively. In the illustrated embodiment, bracket 100 comprises a generally cylindrical bracket adapted for mounting leg exerciser 10 to a central post 22 of chair 20 , but it is to be understood that bracket 100 may be differently configured for mounting leg exerciser 10 to different types of chairs. Bracket 100 is coupled to supporting element 30 by a tab 102 extending outwardly from bracket 100 in the illustrated embodiment. Tab 102 may have apertures therethrough for receiving bolts (not specifically enumerated), which also are received through slots 104 defined in supporting element 30 . Slots 104 allow a user to adjust the position of supporting element 30 inwardly and outwardly with respect to chair 20 by loosening the bolts, sliding supporting element to the desired position, and then tightening the bolts. In other embodiments, bracket 100 could be integrally formed with supporting element 30 , or could be coupled to supporting element 30 by other mechanisms. A pair of leg supports 80 L and 80 R are pivotally attached to supporting element 30 at a pivot point 40 near an outward end of supporting element 30 . Left leg support 80 L is not visible in FIG. 1 , since left leg support 80 L is hidden behind right leg support 80 R. Left leg support 80 L is visible in FIG. 2 , which shows right leg support 80 R in an extended position. In the illustrated embodiment, leg supports 80 L and 80 R are coupled to supporting element 30 by means of a pin 42 (see FIG. 3 ) inserted through apertures in leg supports 80 L and 80 R and supporting element 30 , and spacers 44 (see FIG. 3 ) are provided to maintain a desired separation between leg supports 80 L and 80 R and supporting element 30 . Pivot point 40 is preferably located at a height approximately equal to a height of the seat of chair 20 . In the illustrated embodiment, a user may adjust the position of supporting element 30 inwardly or outwardly, as discussed above, such that pivot point 40 is positioned approximately on a line passing through the user's knee joints. In embodiments wherein the position of supporting element 30 with respect to chair 20 is not adjustable, supporting element 30 may be provided with a plurality of apertures (not shown) in different locations for receiving pin 42 (see FIG. 3 ), to allow the user to position pivot point 40 close to a line passing through the user's knee joints. Each of leg supports 80 L and 80 R has a leg holder coupled thereto. In the illustrated embodiment, the leg holders comprise left and right leg grippers 90 L and 90 R which are respectively attached to leg supports 80 L and 80 R near the ends thereof opposite pivot point 40 (i.e., near the lower ends of leg supports 80 L and 80 R). Leg grippers 90 L and 90 R are shaped to receive a user's leg or ankle to facilitate pushing and pulling the leg supports 80 L and 80 R. As shown in FIG. 4 , leg grippers 90 L and 90 R define leg receiving recesses 92 L and 92 R, respectively. Leg grippers 90 L and 90 R may be positioned such that the distance between leg receiving recesses 92 L and 92 R is suitable for receiving lower portions of a user's legs. Leg grippers 90 L and 90 R may be padded for the comfort of the user. Alternatively, the leg holders could comprise straps or the like for wrapping around the user's legs or ankles. Footrests 95 L and 95 R may be respectively attached to the lower ends of leg supports 80 L and 80 R. In some embodiments, footrests 95 L and 95 R may be removable from leg supports 80 L and 80 R, or may be foldably coupled to leg supports 80 L and 80 R so that a user may fold footrests 95 L and 95 R up and out of the way when they are not desired. In some embodiments, footrests 95 L and 95 R may have a construction similar to footrests of a motorcycle. Left and right resistance elements 60 L and 60 R are pivotally coupled between supporting element 30 and leg supports 80 L and 80 R, respectively. The inward ends of resistance elements 60 L and 60 R are pivotally attached to supporting element 30 at attachment points 70 L and 70 R, respectively. The outward ends of resistance elements 60 L and 60 R are pivotally attached to leg supports 80 L and 80 R at attachment points 50 L and 50 R, respectively. Attachment points 50 L and 50 R may be located between pivot point 40 and leg grippers 90 L and 90 L, respectively. In some embodiments, attachment points 50 L and 50 R may be located closer to pivot point 40 than to leg grippers 90 L and 90 L. Resistance elements 60 L and 60 R provide resistance against both outward and inward movement of leg supports 80 L and 80 R. Resistance elements 60 L and 60 R may include adjustment mechanisms for individually varying the amount of force required to move leg supports 80 L and 80 R. The adjustment mechanisms may also permit different amounts of force to be required for outward movement of leg supports 80 L and 80 R than for inward movement of leg supports 80 L and 80 R. Resistance elements 60 L and 60 R may comprise, for example, hydraulic or pneumatic cylinders, and the adjustment mechanisms may comprise adjustable valves. In operation, when a user is seated in chair 20 , the right leg is slipped into right leg gripper 90 R and the left leg in slipped into left leg gripper 90 L with both leg supports 80 L and 80 R in the contracted position shown in FIG. 1 . To begin exercising, the user extends their right leg, for example. In so doing, the leg pushes against leg gripper 90 R and moves leg support 80 R in a direction rotationally away from the seated user to an extended position, as shown in FIG. 2 . After the right leg is fully extended, the exerciser begins to push the left leg against gripper 90 L while contracting the right leg against gripper 90 R. This cycle may be repeated for as long as the exerciser desires. Alternatively, leg exerciser 10 could be used by extending and contracting both legs at the same time. FIG. 5 shows a leg exerciser 10 ′ according to another embodiment of the invention. Leg exerciser 10 ′ is the same as leg exerciser 10 of FIGS. 1-4 , except that leg exerciser 10 ′ comprises a calf exerciser mechanism 110 attached to right leg support 80 R. Another calf exerciser mechanism 110 may be attached to left leg support 80 L but has been omitted from FIG. 5 to avoid cluttering the drawing. Calf exerciser mechanism 110 comprises a resistance element 120 pivotally attached to right leg support 80 R at attachment point 130 . Resistance element 120 may comprise, for example, an adjustable hydraulic or pneumatic cylinder similar to resistance elements 60 L and 60 R. A foot gripper 140 is attached to the end of resistance element 120 opposite attachment point 130 . In operation, a user seated in chair 20 places their foot in foot gripper 140 . The user may then exercise their calf muscles by raising and lowering their toes, such that their foot pulls and pushes on foot gripper 140 , which in turn contracts and extends resistance element 120 . FIG. 6 shows a leg exerciser 150 according to another embodiment of the invention. Leg exerciser 150 is adapted for use with a chair 200 having a seat 210 coupled to a frame 220 . In the FIG. 6 embodiment, the chair attachment assembly comprises an attachment plate 160 coupled to a supporting element 170 . FIG. 7 shows attachment plate 160 and supporting element 170 in isolation. Attachment plate 160 is configured to be attached between seat 210 and frame 220 of chair 200 . The remaining components of leg exerciser 150 are equivalent to those of leg exerciser 10 described above with reference to FIGS. 1-4 (and are identified with the same reference characters), and are not described again to avoid repetition. While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.

An exercise device comprising a chair attachment assembly adapted for attachment to a chair at a location under a seat of the chair and configured to extend outwardly therefrom. A pair of leg supports are pivotally coupled at first ends thereof to a pivot point on the chair attachment assembly. Each leg support is independently moveable between a contracted position and an extended position. A leg holder is coupled to each leg support near a second end thereof. A resistance element is pivotally coupled between each leg support and the chair attachment assembly. Each resistance element is configured to provide resistance against both outward movement of the associated leg support from the contracted position to the extended position and inward movement of the associated leg support from the extended position to the contracted position.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This Application is a divisional of and claims the benefit under 35 U.S.C. §120 of U.S. patent application Ser. No. 12/903,921 entitled “Swab for Collecting Biological Specimens,” which is a continuation of U.S. Pat. No. 8,114,027, entitled “Swab for Collecting Biological Specimens,” filed Jul. 28, 2005, that claims priority under 35 U.S.C. §365 of PCT/EP2004/003392 filed Mar. 31, 2004, and that claims priority under 35 U.S.C. §119 of Italian Application No. MI2003A000643 filed Apr. 1, 2003. Applicant incorporates by reference herein the disclosures of these four applications and patent. FIELD OF THE INVENTION [0002] The present invention relates to a swab for collecting biological specimens. BACKGROUND OF THE INVENTION [0003] In the field of clinical and diagnostic analyses, swabs for collecting biological specimens of organic material are known, consisting essentially of a cylindrical rod around one end of which, known as the tip, is wrapped a wad of fibre such as rayon or a natural fibre such as cotton, with hydrophilic properties to allow rapid absorption of the quantity of specimen to be collected and tested. Stable adherence of the fibre wrapped around the tip of the rod is generally achieved by gluing. [0004] Usually, especially if the specimen is to be examined by culturing the microorganisms gathered with the collection, a swab is immersed in a test-tube containing culture medium immediately after collection for appropriate conservation of the specimen during storage and/or transport thereof to the analytical laboratory. [0005] An example of this type of device is given in patent EP0643131 by the same Applicant and refers to a swab for collecting and in vitro transporting specimens, of the type comprising a test-tube with culture medium in gel form and a rod carrying at one end a stopper for sealing the test-tube and at the opposite end means for collecting said specimen, for example a wad of fibre wrapped around the tip of the rod, to be dipped into the culture medium. [0006] The tip of the cylindrical rod, generally manufactured from essentially rigid material such as plastic, for example by extrusion, commonly presents a truncating cut which would make it difficult to insert the swab rod into the cavities (oral, nasal, ocular or rectal, urethral, vaginal etc.) of the patient from whom the specimen is taken, if the tip is not adequately protected. Therefore, the wad of hydrophilic fibre wrapped around said truncated end must not only contain sufficient material to allow absorption of the specimen in the desired quantity, in general 100 microlitres, but must also have a sufficiently thick and rounded shape to sheathe the edge of the truncated end so that it cannot cause damage or irritation to the patient during specimen collection. For this reason the fibre wad is wrapped around the tip of the rod in a rounded shape, typically developing into an ogive or similar shape so that it gradually becomes thicker towards the end of the rod thus reaching maximum thickness and therefore maximum protective effect, precisely around the truncated end. A wad of such a shape, while protecting the patient from any risk of contact with said truncated end of the rod, results in a number of drawbacks. The main one is that the thickness of the wad, because of the hydrophilic nature of the fibre, leads to penetration of collected liquid specimen into the mass of said wad. As, for practical reasons, the sample is released from the swab at the moment of analysis by simply gripping the rod of the swab and delicately sliding its tip and hence the fibre impregnated with liquid, along for example a petri dish with culture medium, in practice by spreading the specimen onto this latter (swabbing), even if this operation is repeated and is careful, it does not enable the entire volume e.g. the 100 ml of absorbed specimen to be released, because that part of it which has penetrated into the interior of the wad in the direction of its tip cannot be pressed out towards the surface and hence released by the swab during this operation [0007] Due to this defect, on average only about 40% of the liquid specimen collected can in practice be recovered for analysis. Such loss of specimen translates inevitably into reduced sensitivity of analysis and increased false negatives. In this respect, referring to the aforementioned average specimen loss after swabbing the swab, by testing only the 40 microlitres released for swabbing out of the 100 microlitres of specimen initially collected, it becomes difficult to establish whether a negative test effectively refers to the absence of the microorganism sought or rather to its non- or insufficient transfer from swab to test plate. [0008] A further problem derived from the bulky fibre wad of a swab of the known art is particularly evident for example in the case of urethral or ocular use of said swab. In these and other particular applications it would actually be even more desirable to be able to minimize swab thickness and hence patient discomfort during collection. SUMMARY OF THE INVENTION [0009] As a solution to these problems, and also to achieve other advantages which will be apparent from the description, the present invention proposes a swab for collecting biological specimens of the type consisting of a rod terminating with a tip covered in fibre with hydrophilic properties to allow absorption of said specimens, characterised In that said fibre covers said tip In the form of a layer applied by means of flocking [0010] With the aim of better understanding the characteristics and advantages of the invention, a non-limiting example of a practical embodiment thereof is described hereinafter, with reference to the figures of the accompanying drawings. Said example refers to the case of a swab suitable for both the collection and storage of a biological specimen, and therefore also includes a test-tube containing a culture medium suitable for the collected microorganisms into which the swab is to be immersed after collection, such as for example the type described in the aforementioned patent EP0643131 by the same Applicant. BRIEF DESCRIPTION OF THE FIGURES [0011] FIG. 1 shows an exploded view of the two components of a device in accordance with the example, that is the swab and test-tube, whereby the test-tube is partially sectioned longitudinally. [0012] FIG. 2 shows an enlarged detail of the swab of FIG. 1 in section. DETAILED DESCRIPTION OF THE INVENTION [0013] With reference to said figures, a device of the invention in accordance with the illustrated example comprises an essentially cylindrical test-tube 10 containing a culture medium in gel form 11 , presenting a free surface level 12 inside the test-tube. [0014] The upper open end of the test-tube presents a collar 13 for receiving a closure means. [0015] The device is completed by a swab 20 consisting of a rod 14 carrying at one end a stopper 15 which has to act as the closure means of the test-tube and is hence shaped so that it can engage, for example by snap-engaging, with the collar 13 of the test-tube. [0016] At the opposite end, the rod 14 terminates with a tip 16 carrying a suitable means, for example a layer of fibre 17 , for collecting the specimen to be analysed. In the illustrated example, said tip 16 of the rod is shaped in a rounded geometry, similar to an ogive, and said fibre 17 being disposed as a layer of uniform thickness. [0017] In general terms, in accordance with the fundamental characteristic of the invention, said fibre with hydrophilic properties is deposited by means of flocking The flocking technique is preferably of the type conducted in an electrostatic field which deposits the fibres in an ordered manner, perpendicular to the surface of the tip of the swab rod, which has been previously coated with adhesive for example by immersion or spraying. [0018] The fibre which is to form the flocked layer is subjected to an electrostatic field, and is hence deposited in an oriented manner and anchored to the surface of the tip, being retained by the adhesive. [0019] The adhesive is preferably water-based: once dried it enables the fibre to be anchored in a stable manner to the swab and to resist abrasion. [0020] The flocked swab is then dried by exposing it to a source of heat or radio-frequency. [0021] The tip of the swab stem is covered with a layer of fiber, preferably of uniform thickness, and from 0.6 to 3 mm thick. The fiber count, i.e. the weight in grams per 10,000 linear meters of a single fiber, is preferably between, 1.7 and 3.3 Dtex. In particular, a fiber of 0.6 mm length and 1.7 Dtex can be applied by flocking to obtain a fine nap, and a fiber up to 3 mm in length and 3.3 Dtex can be applied to obtain a long nap, obtaining, for values intermediate between the aforedefined, corresponding intermediate characteristics of thickness and fineness of the flocked layer. [0022] Within the wide choice of such values, the expedient to be respected according to the objects of the invention is to maintain an ordered arrangement of the fibres, substantially parallel to each other and normal to the surface of the rod, avoiding any overlapping of fibres which can occur if the nap is too long. Indeed, in this manner the capillary represented by each fibre, by virtue of which it can carry out its task of absorbing and releasing essentially the same quantity of specimen, remains unimpaired and functional. [0023] The amount of fibre to be deposited for forming the flocked layer in accordance with the invention is determined on the basis of the type of fibre and the pre-chosen layer characteristics of thickness and fineness, in such a manner as to enable 100 microlitres of specimen to be absorbed. [0024] In accordance with the objects of the invention, the fibre is chosen from a wide range of materials provided they are hydrophilic by capillarity, such as for example, synthetic or artificial materials e.g. rayon, polyester, polyamide, carbon fibre or alginate, natural materials e.g. cotton and silk, or mixtures thereof. EXAMPLES [0025] Some preparative examples are now given of a swab according to the invention. Such examples are not intended in any way to limit the scope of the invention. Example 1 [0026] A swab is prepared using a plastic rod, suitable for human clinical collection, of diameter 2.5 mm which decreases to 1 mm over a length of about 6 cm. [0027] The tip of the part with the smallest diameter is dipped in or sprayed with an adhesive, then the rod is placed vertically in a flocking apparatus in electrostatic field to deposit a polyamide flock. [0028] The polyamide flock of 0.7 mm length and 1.7 Dtex allows 0.5 μl per mm 2 to be absorbed, therefore by flocking the 10 mm long tip of said rod the absorbing capacity obtained is 40 μl. Example 2 [0029] Proceeding as per example 1, a rod with a spatulate end is used, suited for example to collecting organic specimens from the oral cavity of a patient. Polyester fibre of 1 mm length and 1.7 Dtex count are used for the flocking Example 3 [0030] Proceeding as per examples 1 and 2, polyester fibre of 2 mm length and 2.5 Dtex count is used. [0031] Continuing in general terms, it is calculated that a swab of the invention is capable of releasing about 90% of the absorbed specimen by swabbing, in this manner considerably increasing the sensitivity of the analysis compared with swabs of the known art, in particular by almost completely eliminating the risk of false negatives resulting from the incomplete release of the collected specimen from swab to test plate. [0032] In addition, the fact of being able to form, according to the invention, a fibre layer of any thickness, even very small, around the tip of the rod rather than a mass to cover it, as in the known art, means that the required rounded shape of the swab, i.e. free of edges, no longer has to depend on the mass of fibre itself but on the tip of the rod, which can therefore be preferably shaped into a round form, as indeed occurs in the aforedescribed example and shown in the accompanying drawings. Particularly in specific cases where swabs of the greatest possible thinness are required, for example urethral or ocular, this represents a further definite advantage over known swabs. Indeed a swab can be provided with a rounded tip by virtue of its shaping, around which a thin layer of fibre is deposited by flocking to allow on the one hand collection of a sufficient quantity of specimen for analysis, and on the other to minimize the total bulk of the part of the swab which is to penetrate the urethra, in consequence so reducing the discomfort of the patient undergoing the collection procedure. [0033] The shape given to the tip of the swab nevertheless varies greatly according to the type of collection it is intended for, and can even be truncated or have edges when the type of collection (for example oral) allows it. [0034] According to the invention, the type of adhesive, type of fibre and fibre characteristics, such as length and count, are in any case chosen from a wide range of options in order to obtain an ideal specific marker for identifying the microbiological specimen, whether by a direct diagnostic technique, by immuno-test, or by molecular biology techniques such as PCR, or with other known culturing, enrichment or selection techniques. [0035] The specimen to be collected with a swab of the invention generally consists of bacteria or viruses or DNA or RNA or a mixture thereof.

A swab for collecting biological specimens is of the type consisting of a rod terminating in a tip covered with fibers with hydrophilic properties to allow absorption of said specimens, wherein said fibers cover said tip in the form of a layer deposited by flocking