Abstract:
A Support Apparatus for Urinary Implant Cuff Valve. The device should be worn directly against the skin, underneath the underclothing. It has a pair of juxtaposed sling staps that pass beneath the wearer&#39;s genitals when the device is worn. These sling straps relieve pressure from the cuff valve when the wearer repositions from sitting to standing, and vice versa. A pair of side pads interconnect the sling straps with leg straps that are worn to encircle the upper thigh area of the wearer. An alternate version has an additional adjustable waist band that supports the legs straps by a plurality of vertical support straps.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    This invention relates generally to therapeutic support garments and, more specifically, to a Support Apparatus for Urinary Implant Cuff Valve. 
         [0003]    2. Description of Related Art 
         [0004]    An artificial urinary sphincter (also known as “spinster” or AUS) involves a simple surgical procedure to help relieve lingering incontinence in men following prostate cancer treatment. The procedure can be done on an outpatient basis or with an overnight hospital stay.  FIG. 1  depicts the essential elements of a prior art AUS 
         [0005]    The urinary control system implant  10  comprises a cuff valve  12  encircling the urethra  14 . The cuff valve  12  is made of a silicone rubber material. The surgical process consists of a doctor placing a small balloon  22  in the lower abdomen and a actuator pump  20  in the scrotum, in addition to the cuff valve  12 . When the cuff  12  accumulates fluid, it will impose compressive force onto the urethra  14  so that urine will not be released. Patients simply squeeze the pump  20  a few times when they want to urinate. Once the pump  20  is activated the fluid flows from the cuff valve  12  to the balloon  22  via return tubing  24 . The cuff valve  12  is designed to remain open for three to five minutes so that all of the urine can drain from the bladder  16 . Once urination is completed, all fluid will flow back into the cuff valve  12 , and will thereby block of the urethra  14  once again. 1    1  http://www.prostate-cancer.com/coping-with-prostate-cancer/incontinence-urinary-sphincters.html 
         [0006]    While the AUS can be extremely liberating when successful at controlling urine flow, it can also become very problematic when it allows unwanted leakage. It has been noticed that one common instigator for leakage is when the patient stands up after having been seated for more than a few minutes. It is believed that this type of leakage is caused because remaining seated for prolonged periods can inadvertantly cause the fluid to be squeezed out of the pump  20  or cuff valve  12 , and into the pressure regulating ballon  22 . While seated, enough pressure is exerted on the urethra  14  to prevent leakage. However, when the patient stands up this pressure on the cuff valve  12  from being seated is removed, and urine can be allowed to leak by until the actuating fluid returns to the cuff valve  12  from the balloon  22 . 
         [0007]    The only known solutions to the AUS leakage problem are to add some sort of cushion or support device to the patient&#39;s chair, such as an inflatable ring. Carrying this sort of cushion is very inconvenient and may not be compatible with certain types of chairs or seats. What is needed is a device that is always on the patient&#39;s person to prevent inadvertant cuff leakage no matter where the patient wishes to sit down. 
       SUMMARY OF THE INVENTION 
       [0008]    In light of the aforementioned problems associated with the prior devices, it is an object of the present invention to provide a Support Apparatus for Urinary Implant Cuff Valve. The device should be worn directly against the skin, underneath the underclothing. It should have a pair of juxtaposed sling staps that pass beneath the wearer&#39;s genitals when the device is worn. These sling straps should relieve pressure from the cuff valve when the wearer repositions from sitting to standing, and vice versa. A pair of side pads should interconnect the sling straps with leg straps that are worn to encircle the upper thigh area of the wearer. An alternate version should be provided that has an additional adjustable waist band that supports the legs straps by a plurality of vertical support straps. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The objects and features of the present invention, which are believed to be novel, are set forth with particularity in the appended claims. The present invention, both as to its organization and manner of operation, together with further objects and advantages, may best be understood by reference to the following description, taken in connection with the accompanying drawings, of which: 
           [0010]      FIG. 1  is a cutaway side view of an in-situ artificial urinary control system implant; 
           [0011]      FIG. 2  is a front perspective view of a preferred embodiment of the cuff valve support apparatus of the present invention; 
           [0012]      FIGS. 3A-3C  are top, front and partial side views, respectively, of the apparatus of  FIG. 2 ; 
           [0013]      FIG. 4  is a perspective view of the apparatus of  FIGS. 2 and 3  when donned by a user; and 
           [0014]      FIG. 5  is a perspective view of an alternate design of the apparatus of  FIGS. 2-4  when donned by a user. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0015]    The following description is provided to enable any person skilled in the art to make and use the invention and sets forth the best modes contemplated by the inventor of carrying out his invention. Various modifications, however, will remain readily apparent to those skilled in the art, since the generic principles of the present invention have been defined herein specifically to provide a Support Apparatus for Urinary Implant Cuff Valve. 
         [0016]    The present invention can best be understood by initial consideration of FIG.  2 . 2    FIG. 2  is a front perspective view of a preferred embodiment of the cuff valve support apparatus  28  of the present invention. As is depicted below in  FIG. 4 , the apparatus  28  is designed to be worn by the user in the upper thigh area of both legs. A pair of leg straps  30 A,  30 B encircle the user&#39;s upper thighs. The straps  30 A,  30 B could be made from elasticised material (or have a cloth-covered elastic core), or could be adjustible in diameter and be provided with buckles, hook-and-loop fasteners, or other fastening means to adjust their diameter to provide a snug fit.  2  As used throughout this disclosure, element numbers enclosed in square brackets [ ] indicates that the referenced element is not shown in the instant drawing figure, but rather is displayed elsewhere in another drawing figure. 
         [0017]    First and second side pads  36 A,  36 B are attached to the facing sides of the two straps  30 A,  30 B. They are located as such so that they will provide cushioning to the user&#39;s upper thigh and genitals area when the apparatus  28  is being worn. A support sling  32  of one or more straps interconnects the two pads  36 A,  36 B. In the depicted version, there is an upper sling strap  34 A and a lower sling strap  34 B. These straps  34 A,  34 B are preferably made from elastic material so that they will provide strength, yet flexibility in their support. 
         [0018]    As should be apparent, when the apparatus  28  is worn by the user in its proper location at the upper thighs, the support sling  32  will pass directly beneath the user&#39;s genitals. The upper support strap  34 A is positioned to gently support the genitals, particularly when the user sits down. The lower strap  34 B is positioned lower down, so as to guard the genital area from anything pressing against the genitals (and particularly against the cuff valve [ 12 ] or actuator pump [ 20 ]). 
         [0019]    While it is not specifically known whether the common problem of cuff [ 12 ] leakage after being seated is caused by compression of the cuff [ 12 ], or by overpressure in one of the tubes [ 18 ] or [ 24 ], extensive testing has determined that the dual-level support sling  32  shown here has effectively eliminated this phenomena. It is believed that the upper sling strap  34 A raises and supports the urethra [ 14 ] and potentially the cuff valve [ 12 ] so that pressure from the seating surface does not cause the cuff valve [ 12 ] to partially release its compression against the urethra [ 14 ]. As an added safety factor, the lower sling strap  34 B prevents the user&#39;s clothing or other external elements from pressing against the components of the urinary control system implant [ 10 ].  FIGS. 3A-3C  provide additional detail. 
         [0020]      FIGS. 3A-3C  are top, front and partial side views, respectively, of the apparatus  28  of  FIG. 2 . Here, we see that the lower sling strap  34 B is marginally wider than the upper sling strap  34 A. There is no specific ratio that has proven to be the most desireable between the widths, however, a narrower upper sling strap  34 A tends to create less discomfort to the user, while the wider lower sling strap  34 B provides an additional barrier without creating additional user discomfort. 
         [0021]      FIG. 3C  shows that the pads  36 A,  36 B are generally “T”-shaped in the instant design. The center portion  35  is larger and extends downwardly from the leg strap  30 A by at least one inch (or more) to provide additional comfort for the user, as well as to create a mounting location for the lower sling strap  34 B. The two end portions  37 A,  37 B extend toward the front and back of the leg strap  30 A (when being worn), and are much narrower—essentially only covering the strap  30 A in the genital area of the wearer. 
         [0022]    The entire apparatus  28  is made from durable, washable materials. It is typically worn directly against the skin (i.e. underneath the undergarments), if desired.  FIG. 4  depicts the device  28  as if worn beneath the undergarments. 
         [0023]      FIG. 4  is a perspective view of the apparatus  28  of  FIGS. 2 and 3  when donned by a user. As discussed above, the thigh straps  30 A,  30 B are worn at the upper thighs  40 A,  40 B so that the upper sling strap  34 A is gently supporting the user&#39;s genitals. The lower sling strap  34 B is then in spaced relation with the upper sling strap  34 A. As can be seen, the first and second side pads  36 A,  36 B reside between the legs  40 A,  40 B and the genitals in order to stabilize them and to add comfort. 
         [0024]    In the event that the wearer desires to have additional vertical support for the device to prevent slippage, an alternate version has been provided, and is depicted in  FIG. 5 .  FIG. 5  is a perspective view of an alternate design  28 A of the apparatus of  FIGS. 2-4  when donned by a user. Here, a waist band  50  has been incorporated into the device  28 A. The waist band  50  is preferably made from stronger, more durable, elastic material than is the rest of the device  28 A. This is feasible since the waist band  50  is located around the user&#39;s torso or hips, rather than between (or around) the legs. The waist  50  terminates in first and second ends  52 A,  52 B. The waist band  50  has fastener pads  54  at the ends  52 A,  52 B so that the diameter can be adjusted and then fixed, so that the band  50  will fit properly. Two or more vertical support straps  56  interconnect the waist band  50  and the leg straps  30 A,  30 B (more straps  56  could be at the back-side of the device  28 A—not depicted here). 
         [0025]    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.