Patent Publication Number: US-2007117880-A1

Title: Fluid impervious gel barrier

Description:
This application is a Continuation-In-Part of U.S. Ser. No. 10/868,289, filed Jun. 14, 2004, now U.S. Pat. No. 7,166,092, issued Jan. 23, 2007, which is a Continuation-In-Part of U.S. Ser. No. 10/705,187, filed Nov. 10, 2003. 
    
    
     BACKGROUND OF THE INVENTION  
      1. Field of the Invention  
      The present invention is directed to a gel composition for use in applying devices to the human body and particularly male incontinent devices and, more specifically, a device which both fits over and around the penis. The gel composition also has use in retaining other devices on the body including female incontinence devices, ostomy devices, and wound care products.  
      2. Background  
      Urinary Incontinence (UI) is a problem estimated to afflict about 4 million men in the United States. Another 9 million US females also suffer from incontinence. The annual cost of providing care for persons with UI is estimated to be in excess of $16 billion. The market for adult absorbent devices or diapers alone is in excess of $2 billion and continues to grow. The worldwide ostomy market is in excess of $1.5 billion. The wound care market is very diverse and enormous in size.  
      A shift to a healthier, more active and older population and a society which is increasingly mobile is resulting in an increasing number of persons suffering from incontinence, and a demand from that population for more effective and reliable solutions for UI. UI can affect persons of all ages, and may be the result of physical disability or a psychological condition. There are several different types of incontinence. Acute (or Transient) Incontinence is caused by generally treatable medical problems. Medical conditions such as dehydration, delirium, urinary retention, fecal impaction/constipation, and urinary tract infection can cause an onset of UI. Additionally, certain medications can cause or contribute to an incontinence problem, such as anticholinergic agents, antihistamines, antidepressants (TCA), phenothiazines, disopyramides, opiates, antispasmodics, Parkinson drugs, alpha-adrenergic agents (high blood pressure drugs), sympathomimetics (decongestants), and sympatholytics (e.g., prazosin, terazosin, and doxazosin).  
      Chronic UI is conventionally classified into four groups: Stress, Urge, Overflow, and Functional incontinence. They may occur alone or in combination, the latter being more common as the patient ages. Chronic UI is persistent and more difficult problem to treat  
      Stress incontinence is the involuntary leakage of small amounts of urine resulting from an increased pressure in the abdomen. Events which may result in such involuntary leakage include sneezing, coughing, laughing, bending, lifting, etc. While primarily a female problem, men also suffer from stress incontinence. Stress incontinence in men is typically the result of a weakened urethral sphincter that surrounds the prostate, frequently as a result of prostate surgery.  
      Urge incontinence, characterized by insufficient ability to prevent voiding once the urge to void arises, is most common in middle aged and older people. Detrunorm hyperreflexia or instability which is associated with disorders of the lower urinary tract or neurologic system is a common cause. However, urge incontinence can also be the result of urologic carcinoma, diverticula, or other physical abnormalities.  
      Overflow incontinence, which accounts for 10-15% of urinary incontinence, is usually the result of an obstruction. (e.g., enlarged prostate, urethral stricture) of the bladder outlet or an atonic bladder as the result of neurologic injury (e.g., spinal chord trauma, stroke), diabetic neuropathic bladder, or drug-induced atonia. The obstruction leads to bladder overfilling, resulting in a compulsive detrusor contraction. In this form of UI chronic “dribbling” is common. Drug induced atonia can be caused by anti-cholinergics, narcotics, anti-depressants, and smooth muscle relaxants.  
      Functional incontinence accounts for 25% of all incontinence. It occurs primarily when a person is confined and sedentary, such as in a nursing home or during a long period of convalescence. Functional incontinence is sometimes diagnosed as a result of the individual simply being unable to communicate his or her needs, or through other sensory impairments that make the individual unaware of his or her need to void. This condition can further result from decreased mental function, decreased functional status, and/or a simple unwillingness to physically go to the toilet.  
      Incontinence is also frequent among persons rehabilitating from stroke, head injury, multiple sclerosis, amputations, and spinal cord injury.  
      Nocturnal enuresis afflicts approximately 15-20% of school age children between the ages of 4 and 16. Most often, the reason a child or adult will have the problem of nocturnal enuresis is because they simply cannot wake up. Treatment of enuresis typically requires training the person to recognize the need to urinate during sleep, or to train the person to sleep correctly. Moisture sensing alarms have been successfully employed, but if soiled bedding is to be avoided, diapers, absorbent padding or other collection devices are required.  
      UI, or even the fear of an incontinent incidence, can lead to discomfort and embarrassment, and eventually to social withdrawal and isolation. Normal activities, social interaction, and sexual activity are often curtailed or avoided as a result. UI is the predominant reason aging parents are put into nursing homes.  
      Incontinence is typically treated by catheterization, use of absorbent products, and for males, devices attached to the exterior surface of the penis to collect urine discharge. Catheterization, whether intermittent or permanent, is an unacceptable approach in many instances and is the least preferred type of bladder management. The procedure is very inconvenient and many patients are psychologically averse to self-catheterization, or physically unable to perform the manipulations required. A major deficiency of either permanent or intermittent catheterization is that the urine of virtually every patient becomes contaminated by bacteria. Catheter-associated bacteria represent the most common infection acquired in acute care and long-term care facilities. Complications ranging from bladder spasms and catheter leakage to death caused by septicemia are also well known limitations. Bacterial entry into the bladder occurs either from extra luminal migration along the outside of the catheter, contamination on insertion of the catheter, or contamination of the drainage bag, leading to bacterial growth and subsequent migration into the bladder.  
      Diapers and other absorbent constructions are the most popular remedy because they are easily obtained, and can address acute UI symptoms quickly. However, while affording reasonably effective control of urine leakage and providing mobility to the patient, absorbents also have very serious drawbacks. A major deficiency is that urine is not removed from the genital region. The absorbents merely collect and disperse the urine and maintain a moist environment with the urine typically remaining in contact with skin surfaces, causing irritation and discomfort. While improved constructions with different absorbent layers attempt to direct the urine to a region away from the skin and minimize contact, the resulting benefit is less then desired.  
      Absorbent devices also require a large area of absorbent material surrounded by water proof external barriers, usually in the form of pants or diapers. Such an arrangement when dry is uncomfortable to the wearer. When wet the discomfort level increases greatly and the wearer must deal with the distinctive, embarrassing odor of urine. Once removed, whether soiled or not, the disposable-type diaper usually must be disposed of, creating the need to always carry a supply of such absorbent devices.  
      In men, an alternative to the indwelling catheter or absorbent device is an external collecting device that is fitted over the male genitalia, like a condom. This may include an absorbent material or can be connected by a tube to a drainage bag that is typically held onto the thigh by leg straps. In a non-ambulatory situation, bedside drainage bags can be used. Many such “external catheter” devices are described in the prior art. Alternatively, rather then being attached to an external bag, the sheath may have an enlarged integral, drainable lower portion for collecting the urine. Typically such devices include some means to keep the urine in the collection portion separated from the penile tissue. The condom or sheath portion is usually fabricated from a latex, silicone or similar flexible, non-porous film material. These devices, are normally provided in a rolled-up or folded state and are unrolled or everted onto the penis and then sealingly engaged in some manner to the penis. Alternatively the sheath may be formed by rolling a sheet material around the penis and then sealing the opening along the length and to the penis such as is shown in U.S. Pat. No. 6,113,582 to Dwork, one of the inventors of the present device. Sealing the condom-like sheath to the penis may be accomplished by a two-faced adhesive strip within the upper end of the sheath that is applied to the penis The sheath may additionally be held to the penis by an external band which surrounds the sheath and is secured using a VELCRO® hook and loop fasteners. An attaching ring may also be mounted on an undergarment to securing the top of the sheath. As a further alternative a strap structure may be applied around the user&#39;s waist. Other structural features which may be included are accordion like pleats to allow the sheath to expand should the wearer experience an erection or to accommodate a different size flaccid penis. However, all of these techniques or devices have a tendency to leak if a long term, fluid resistant, flexible barrier is not provided between the penis and the sheath.  
      These devices have numerous disadvantages in their use. They may be to complex to apply and they must be properly sized for the device to function properly without leaking, falling off or restricting normal blood flow to the penis. The application of the condom member requires some degree of dexterity to position and unroll the condom onto the penis, which is frequently flaccid. The flaccid state of the penis renders the seal created by the condom often ineffective, and frequently inadequate. Frequently, the issue of device sizing creates difficulties, because of variability between individuals or daily size variations in a single individual.  
      A further serious disadvantage with this type of device is that a blockage in the drainage tube or in the connection between the tube and the sheath will cause a back-up of urine in the condom causing the sheath to leak, break, or slip from the penis. Such events can be extremely messy and embarrassing as urine is inadvertently discharged from the sheath wetting the user&#39;s clothing and creating an aroma problem. Still further, constant contact between the external penile surface and urine can result in severe irritation of the external tissue as well as provide an entry path for bacterial infection of the urinary tract.  
      Other devices comprise loose-fitting sleeves for the penis, such as the McGuire style male urinal. The urinal, which is in effect a bag into which the penis extends, is used in conjunction with a valve tube leading to a leg bag. In theory, the urinal drains into the leg bag. These devices also have problems with poor sealing and spillage of urine and a flaccid penis may withdraw from the upper opening of the device. Still further, because the device relies on gravity to feed urine from the urinal to the leg bag, the urine will not drain properly when an individual is in a sitting or prone position.  
     SUMMARY OF THE INVENTION  
      A unique gel seal assembly with means to ensure that it is applied in a gap free manner and thus provide a continuous seal preventing fluid leakage is provided.  
      In one application, a fluid impervious wrap or pocket is provided which allows the formation of a fluid tight, flexible and expandable sheath around the penis of a user. The sheath that is formed has an open proximal end position including an open longitudinal flap portion above the top of the penile sheath, and a distal end for drainage or attachment of a collection device, such as an external urine bag or a leg mounted collection bag. The sheath structure, once placed over the head of the penis, is manually sized to circumferentially envelop and effect a fluid-tight seal about at least a portion of the length of the penis proximal to the glans of a user with the flap portion overlapping and releasably attached to the remainder of the outer surface of the device, providing a first fluid-tight seal to the penile sheath. Use of low tension elastic materials of construction for at least some of the components of the device allows for expansion of the assembled sheath without leakage or disruption of the seals within the assembled sheath or to the penis. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      The foregoing and other features and advantages of the present invention when used as part of a male incontinence device will be more fully understood from the following detailed description of an illustrative embodiment, taken in conjunction with the accompanying drawings in which:  
       FIG. 1  is an isometric view of a first embodiment of a device incorporating features of the invention as it is ready to be secured to the penis of a user of the device, partially cutaway to show hidden features.  
       FIG. 2  is a plane view of a first stage in the fabrication of the device of  FIG. 1  wherein a preferred shape is cut from a single sheet of elastomeric or polymeric material.  
       FIG. 3  is a plane view of an alternate configuration of  FIG. 2  wherein additional material has been provided in order to reinforce portions of the device.  
       FIG. 4  is a plane view of  FIG. 3  wherein the additional reinforcing material has been folded over and heat sealed to the main body to reinforce the body of the device of  FIG. 1  in the regions indicated creating a form congruent to the form of  FIG. 2 .  
       FIG. 5  is a plane view of a second stage in the fabrication of the sheath device of  FIG. 1  wherein functional components are positioned on the cut form shown in  FIG. 2  or  FIG. 3 .  
       FIG. 6  is an isomeric view of a male coupling device for attachment to the device of  FIG. 2  or  FIG. 3 .  
       FIG. 7  is an isometric view of a gel strip assembly for attachment to the device of  FIG. 2  or  FIG. 3  having a portion of one element cut away to expose the layer below.  
       FIG. 8  is an enlarged, partial sectional view taken along line  8 - 8  of  FIG. 7 .  
       FIG. 9  is an isometric view of the gel strip assembly of  FIG. 7  depicting the removal of a strip of a protective release liner from its bottom surface to expose an adhesive coating for bonding to the cut sheet of  FIG. 2  or  FIG. 3 .  
       FIG. 10  is a plane view of a third stage in the fabrication of the device of  FIG. 1  partially cutaway to show hidden features.  
       FIG. 11  is an isometric view of an elastomeric adhesive backed tape strip prior to its application to the sheath of  FIG. 10 .  
       FIG. 12  is an isometric view of the elastomeric adhesive backed tape strip of  FIG. 11  with a portion of the adhesive exposed prior to application to the sheath of  FIG. 10 .  
       FIG. 13  is an isometric view of the tape strip identified in  FIG. 12  following removal of one segment of release liner and application of the tape strip to the sheath of  FIG. 10 .  
       FIG. 14  is a view from the patient&#39;s perspective wherein the device of  FIG. 1  is being applied to the user&#39;s penis.  
       FIG. 15  is a view from the patient&#39;s perspective wherein the patient is pressing the device of  FIG. 1  against the underside of his penis and grasping the release liners of the gel strip assembly in preparation for their removal.  
       FIG. 16  is a view from the patient&#39;s perspective wherein the patient is grasping and removing the release liners of the gel strip assembly from the gel strip assembly.  
       FIG. 17  is a view from the patient&#39;s perspective wherein the patient is pressing the exposed and opposing surfaces of the gel strip together to form a fluid tight seal around the user&#39;s penis.  
       FIG. 18  is a view from the patient&#39;s perspective wherein the patient is removing the second release liner from the tape strip of  FIG. 13  and exposing the remaining adhesive backing on the tape.  
       FIG. 19  is a view from the patient&#39;s perspective wherein the patient is stretching and wrapping the adhesive backed tape around the circumference of the device shown in  FIG. 1  to secure the device to the penis of the patient.  
       FIG. 20  is a view from the patient&#39;s perspective after securing the adhesive backed tape around the circumference of the device of  FIG. 1 .  
       FIG. 21  is a side view of the device of  FIG. 1  secured to the penis of the patient.  
       FIG. 22  is an isometric view of a female coupler which sealably mates with the male coupling device of  FIG. 6 .  
       FIG. 23  is an isometric view of an optional locking ring for securing the mating of the female coupler of  FIG. 22  to the male coupling device of  FIG. 6 .  
       FIG. 24  is an isometric cross-sectional view of the locking ring of  FIG. 23  taken along line  24 - 24  of  FIG. 23 .  
       FIG. 25  is an isometric view of the locking ring of  FIG. 23  positioned in its unlocked position on the female coupler of  FIG. 22 , further showing a length of tubing attached to the female coupling and a partial view of distal portion of the device of  FIG. 1 .  
       FIG. 26  is an isometric view of the locking ring of  FIG. 23  positioned in its locked position on the female coupler of  FIG. 22  after the female coupler has been mated to the male coupling device of  FIG. 6 .  
       FIG. 27  is an isometric expanded view of a preferred method of connection of the device of  FIG. 1  to a collection bag utilizing two male couplers, and two female couplers of  FIGS. 6 and 22  respectively.  
       FIG. 28  is an isometric view of a sealing plug for use with the female coupler of  FIG. 22 .  
       FIG. 29  is a cross sectional view of the sealing plug taken along the line  29 - 29  of  FIG. 28 .  
       FIG. 30  is an isometric view of a sealing cap for use with the male coupler of  FIG. 6 .  
       FIG. 31  is a cross sectional view of the sealing cap taken along the line  31 - 31  of  FIG. 30 .  
       FIG. 32  shows the assembly of  FIG. 27  with the female coupler of the collection bag sealed with the sealing plug of  FIG. 28  and the male coupler of the sheath sealed with the sealing cap of  FIG. 30 .  
       FIG. 33  is an isometric view of an alternative male coupler having an external profile identical to that of the male coupler of  FIG. 6 .  
       FIG. 34  is a cross sectional view of the alternate male coupler taken along line  34 - 34  of  FIG. 33  showing an internal annular boss.  
       FIG. 35  is an isometric view of a check valve for use within the interior of the male coupler of  FIG. 33 .  
       FIG. 36  is a cross sectional view of the check valve taken along line  36 - 36  of  FIG. 35  shown in position on the internal annular boss of the interior fluid channel of the male coupler of  FIG. 34 .  
       FIG. 37  is an isometric view of a faceplate retention ring and straps utilized to further secure the device of  FIG. 1  to the body of an ambulatory patient.  
       FIG. 38  is an isometric view of the device of  FIG. 1  attached to the face plate of  FIG. 37  and connected to a collection bag.  
       FIG. 39  is an isometric view of the device of  FIG. 1  made from the reinforced sheath construction depicted in  FIG. 4  attached directly to the face plate of  FIG. 37  without the use of straps.  
       FIG. 40  is an isometric view from the user&#39;s perspective of an alternate embodiment of the Male Urinary Incontinence Sheath being pulled onto the penis of the user.  
       FIG. 41  is an isometric view of an alternate embodiment of an adhesive gel strip to be placed on the penis of the user prior to the application of the alternative embodiment of Male Urinary Incontinence Sheath of  FIG. 40  to the penis of the user.  
       FIG. 42  is an isometric view from the user&#39;s perspective of an elastomeric adhesive backed tape strip being applied to the outer surface of the alternate embodiment of the sheath.  
       FIG. 43  is an isometric view from the user&#39;s perspective of the release liner being removed from the elastomeric adhesive backed tape strip following its application to the outer surface of the alternate embodiment of the sheath.  
       FIG. 44  is an isometric view from the user&#39;s perspective of the elastomeric adhesive backed tape strip being stretched and applied to the outer surface of the alternate embodiment of the sheath.  
       FIG. 45  is an isometric view from the user&#39;s perspective of the alternate embodiment of the sheath securely attached to the penis of the user.  
       FIG. 46  is a partially cutaway view of a gel strip with imbedded matrix in an unstretched configuration.  
       FIG. 47  shows the gel strip of  FIG. 46  in a stretched condition. 
    
    
     DETAILED DESCRIPTION  
      The securement means for a male external condom catheter or other sleeve-like medical device described herein is a polymeric gel strip  500  comprising a highly viscous, conformable, extrudable, hydrophobic, fully cross-linked silicone adhesive gel material  502 , which is impervious to urine or other bodily fluids for the functional life of the medical device. While the gel strip is impervious to body fluids for in excess of 24 hours, the device is typically replaced at 24 hour intervals.  
      In an embodiment for placement of a urinary sheath, the polymeric gel strip  500  is first adhered to the circumference of the shaft of the circumcised or uncircumcised penis of an individual, proximal to the glans of the penis and then adhesively attached to a circumferential portion of the inner surface of a male external condom sheath adjacent the first end (proximal) opening of the sheath following placement of a sheath on the penis. The sheath can be rolled or wrapped, or layered about the circumference of the penis or applied in any suitable manner over the prior applied gel strip.  
      The gel strip  500  is comprised of a highly viscous, conformable fully cross-linked silicone gel material  502  having a thickness of between 0.005 and 0.25 inches, a width of between 0.05 and 2.00 inches, and a length suitable to encircle the penile diameters, approximately at least 40 mm in length.  
      The cross-linked silicone material comprising the gel strip is completely impervious to body fluids, even after prolonged contact. The gel strip  500  has a tacky, conformable, extrudable skin contact surface which provides adhesion to the irregular skin surface of the penis, and which by virtue of its extrudable properties, fills in minute gaps and voids between the surface of the penis and the inner surface of the sheath. The extrudable property of the gel strip allows it to be wrapped around itself and form a tangential overlap that allows a condom sheath to be seated or applied in a conformal manner without a gap. This extrudable character is unlike open or closed cell foams having a thin, 0.001 to 0.003 inch monolayer of pressure sensitive adhesive, which merely lay on top of the wrinkled skin surface.  
      The viscous gel strip  500  provides excellent resistance to sliding over the skin of the penis as well as resistance to sliding of the sheath in relation to the gel strip. Conversely, the gel strip is readily removable from the skin when the sheath is removed on a daily basis for hygienic purposes without leaving residual gel material on the surface of the penis. The silicone gel strip is formed from a safe, Class VI material for specially selected long-term, non-reactive, non irritating skin contact.  
      The gel material is stretchable and contractible after application of the sheath to the penis to an extent substantially similar to changes in circumference or length of the penis after application without compromising adhesion to the sheath or penile skin surface or allowing urine leakage. The stretchable nature of the gel material enables it to be wrapped around the penis under tension and to exert a circumferential, inwardly directed force to assure intimate contact with the skin of the penis. The material is stretchable and contractible after application of the sheath to the penis to an extent substantially similar to changes in circumference or length of the penis after application without constriction of the urethra or compromising adhesion to the sheath or penile skin surface or allowing urine leakage  
      In a preferred embodiment to prevent the gel strip  500  from tearing when stretched during application by patients, a reinforcing matrix  504  as shown in  FIGS. 46 and 47  may be added to the gel.  
      A relatively thin, non-reactive scrim matrix  504  on the order of 0.002 to 0.0075 inches thick, the scrim having an interlocking structure which allows deformation upon stretching and contraction of the gel strip, best shown in  FIG. 47 , is imbedded in the gel material  502  during production of the gel strip  500 . When tension (stretching) is released, the gel strip  500  with imbedded matrix returns to its original rest condition ( FIG. 46 ).  
      For ease in application, the gel strip skin contact surface has a removable barrier material covering the contact surface. The barrier is removable prior to placement of the gel strip on the penis. The gel strip has a sheath contact surface covered by at least one barrier material which is removable prior to contact with the sheath.  
      A first embodiment of an easily applied sheath type device  1  for use on incontinent males is shown in  FIG. 1 . The substantially cylindrical sheath body  2  is formed from a liquid (urine) impervious polymeric material. A method of manufacturing the sheath is described below with reference to  FIGS. 2-13 . The cylindrical section of sheath body  2  has a funnel shaped distal portion  3 . A male coupling device  4  is secured in the distal end  5  of the funnel portion  3  in a liquid tight manner such as by heat sealing to the polymeric material. A lower heat sealed edge  6  merges with the distal end  5  of the funnel shaped portion  3 . An upper heat sealed side edge  7  of the funnel shaped portion  3  of sheath device  1  extends from the heat sealed distal end  5  and merges with the upper, longitudinal heat sealed edge  8  of the cylindrical sheath body  2 . The heat sealed portions identified above enable the flat sheet of material from which the incontinent device is formed to be a fluid-tight device with a proximal opening  9  for receiving the penis of a user and a distal opening  10  from which urine can be directed for storage or disposal.  
      The proximal end of the cylindrical sheath body  2  has a right hand flap  11  and a left hand flap  12  which extend vertically (as shown in  FIG. 1 ) from an upper, unsealed area at the open end of the cylindrical sheath body  2 . The distal, vertical edges of the two flaps are sealed together forming a heat sealed area  13  which is contiguous with the heat sealed edge  8 . Heat sealing the various edges and areas of the flat sheet of material of sheath  1  as described above, result in the construction of a generally cylindrical sheath for enclosing the penis of a user to direct urine away from the body and into a collection device or other disposal means. The upper edges  14 ,  15  of the right and left hand flaps  11 ,  12  respectively are open (not sealed), allowing the right and left flaps  11 ,  12  to be used for grasping the sheath body  2  for placement on the penis and to provide a larger opening into which the penis can be readily placed.  
      Integral with the edge  16  of the proximal opening  9  of the cylindrical sheath body  2  are two spaced apart tabs. The right side tab  17  and the left side tab  18  are formed with slots  19 ,  20  respectively to receive adjustable straps (omitted here for clarity) which attach to connectors on a retention plate mounted on a waist-encircling belt as depicted in  FIGS. 37-38 .  
      Located and adhesively affixed on the interior surface of the sheath body  2  (by removing a release liner and exposing an adhesive surface) and extending generally circumferentially and aligned with the proximal opening  9  of the cylindrical sheath body  2 , is a gel strip assembly  21  comprising a compliant, viscous and stretchable polymeric gel strip  22 , two folded strips of a release liner film, right half  23  and left half  24 , releasably adhered to the inner surface of the gel strip  22  and a double-backed adhesive strip  25  with two different adhesives for permanently bonding the gel strip to the inner surface of sheath body  2 . The gel strip assembly  21  is further described below and illustrated in  FIGS. 7-9 .  
      The two folded strips of release liner film  23 ,  24  which cover the surface of the gel strip  22  are provided to facilitate the insertion of the user&#39;s penis into the interior of the sheath body  2  by preventing the viscous gel from prematurely contacting and adhering to the shaft of the penis during its insertion into the sheath. Such unwanted adherence would make insertion of the penis into the sheath more difficult and possibly affect the integrity of the seal around the circumference of the penis provided by the gel strip. The two folded release liner film strips  23 ,  24  each have a patient side surface which contacts the penis of the user and a gel strip side in contact with the gel strip. The folded ends of each strip are positioned adjacent to each other at the center of the bottom of the proximal cylindrical opening of sheath body  2 . The two release liner film strips  23 ,  24  are folded so that the gel strip sides are shorter in length than the patient contacting sides. The gel strip  22  halves are each coextensive with a half of the gel strip surface. The gel strip sides have perforations  71  to reduce the contact area to facilitate removal of the strips and to allow a predetermined area of the viscous gel strip to adhere to the undersides of the patient sides to prevent separation of the layers of release film which could otherwise interfere with insertion of the penis into the sheath.  
      The gel strip  22 , in addition to extending around the inner circumference of the sheath body  2 , has a right hand segment  26  and a left hand segment  27  which extend vertically and are bonded to right and left hand flaps  11 ,  12  respectively. These vertical segments terminate approximately 0.150 inches from the upper flap edges  14  and  15 .  
      The longer, patient sides, right hand liner film side tab  28 , and left hand liner film side tab  29 , of the release liner film strips  23 ,  24 , extend vertically beyond the two gel strip segments  26 ,  27  and beyond upper edges  14 ,  15  of the right and left hand sheath flaps  11 ,  12 . The right and left hand sides  28 ,  29  of the patient side release liners  23 ,  24  are heat sealed together to provide a heat sealed tab  30 , approximately 0.250 inches wide. The heat sealed tab  30  allows the user to grasp and remove the two release liners simultaneously as is described below.  
      Affixed to the outer surface of the adjacent proximal opening  9  of the sheath body  2  is an elastomeric, adhesive-backed tape strip assembly  31  of sufficient length to wrap completely around the circumference of the cylindrical body of the sheath. In the embodiment depicted in  FIG. 1 , the tape strip assembly  31  is shown adhered to the left side of the sheath body  2 . It can alternatively be placed on the right side of the sheath body  2  without affecting its function. The adhesive-backed tape strip  31  is aligned with the edge of the proximal opening  9  and has a lower segment  32  approximately 1.0 inches long adhesively affixed to the outer surface of the sheath  2 . The longer, upper segment of tape strip assembly  31  is covered by a removable release liner  33  on the reverse side having a portion thereof folded back on itself creating a release liner tab  34 . The release liner is removed to expose the adhesive when it is desirable to wrap the tape around the circumference of the sheath to secure it to the penis of the patient. The adhesive is exposed by pulling on the release liner tab  34  which extends vertically upwards or outward past the upper edge  15  of left hand flap  12 . The tape strip is described in greater detail in  FIGS. 11-13  and  18 - 20 . The tape strip assembly  31  is preferably wider than flaps  11  and  12  by approximately 0.25 inches so that after the adhesive is exposed, a liquid-tight barrier can be created distally to the gel strip following folding over of the flaps and stretching and wrapping the tape around the outer circumference of the sheath body  2 .  
      Referring to  FIGS. 2-13 , the fabrication of a first embodiment of the invention is described. The starting material for fabrication of the sheath  1  is a flat film of a liquid impervious, flexible polymeric material, preferably soft-to-the-touch and non-allergenic. It is also preferred that the material is a thermoplastic so that it can be heat sealed. However, thermoset polymers can also be used and sealing accomplished by using room temperature or hot melt adhesives, RF sealing or other common attachment techniques. In the assembly procedure described below, heat sealing is referred to. However, any suitable sealing techniques can be used. Suitable materials include, but are not limited to silicone, polyvinylchloride, polyethylene, latex and synthetic rubber. A preferred material is a medical grade, designed for skin contact, 5 to 8 mil thick polyurethane film provided in sheets with a useable area of at least about 7 inches by 8 inches or roll stock from which similar sized sections can be separated.  
      A first piece of the sheath body  2 , such as shown in  FIG. 2 , is cut from the film by any technique known to the art such as die cutting, using a punch, laser cutting, etc. The first piece of the sheath body  2  after cutting has a number of landmarks useful in describing its construction into the sheath  1  of the present invention. In the preferred embodiment, the sheath body  2  is symmetrical about the longitudinal centerline  35  having a right side section  36  and a left side section  37 . The distal edges  38 ,  39 ,  40 ,  41 ,  42 ,  43  and the side edges  44 ,  45 ,  46 ,  47 , constitute mating elements which are aligned and heat sealed to form the sheath  1 . The upper edges  14 ,  15  of the right hand flap  11  and the left hand flap  12  respectively, are left unsealed except for a short section of the adjacent edges  44 ,  47  as is shown in greater detail in  FIG. 10 . The right side and left side tabs  17 ,  18  are left unsealed as are the three collinear proximal edges  60 ,  61 ,  62 . The right hand section  36  and left hand section  37  are not symmetric about their respective centerlines  48 ,  49 . Slots  19  and  20  are cut at the same time as is the sheath body  2 .  
       FIG. 3  depicts an alternate construction, first piece  50  of the sheath body  2  described with reference to  FIG. 2 . It is cut from the same film material by any technique described above. It incorporates additional material which, when folded and heat sealed as described below, serves to reinforce areas of the sheath. This first piece  50  is symmetrical about the longitudinal centerline  53  and has a distal section  51  which is intended to be folded over the centerline  55  onto the distal portion of the body section  255 . The first piece  50  also includes proximal tab sections  52  which are folded over the tab centerline  54  onto the proximal portion of body section  255 . As can be seen in  FIG. 4 , the folded over tab sections,  52  and distal section  51  are heat sealed to body section  255  and reinforce it in the overlapped areas. Once the folded over sections are heat sealed to body section  255 , the alternate construction has the same shape as the first piece  2  shown in  FIG. 2 .  
       FIG. 4  depicts the second step of construction using the alternate first piece  50  wherein the folded over reinforcing sections of die cut film body have been heat sealed to the body section  255  forming a reinforced die cut film body  56 . The folded over distal section  51  is heat sealed along its peripheral edge areas  57  and transverse areas  58 . Tab sections  52  are heat sealed forming sealed areas  59 , leaving the proximal portions  259  unsealed to form a loop in the tabs so that a sheath fabricated from this alternate construction  50  may be attached directly to a user worn faceplate retention ring as depicted in  FIG. 39 . Subsequent to this second stage of construction, the first piece of the alternate construction  50  is identical in its planer form to the first piece shown in  FIG. 2  and differs only in that it has reinforced areas and loops in the tabs. The reinforced die cut film body  56  is intended for use in the event polymeric material is not available in a thickness sufficient to provide the physical properties for the sheath  1  to perform its intended functions or it is desirous to provide a sheath for patients having short penises.  
      Because of the congruence between the first piece  2  and the reinforced die cut film body  56 , the remaining Figures and descriptions will only reference a sheath made from a first piece  2 . It should be noted however, that the alternate reinforced die cut film body  56  as described with reference to  FIG. 4 , can be used interchangeably with the sheath first piece  2  without departing from the spirit or intent of the present invention.  
       FIG. 5  depicts a second stage of construction starting with the first piece of the sheath body  2  wherein a gel strip assembly  21  is mated (having had a release liner removed to expose an adhesive surface) to the interior surface of sheath body  2 . The gel strip assembly  21  is centered on the body centerline  35  and coincident with the three proximal edges  60 ,  61 ,  62  of the sheath body  2  and adhesively bonded to sheath body  2  by the application of a uniform pressure applied to the entire surface of the two folded strips of a release liner film, right half  23  and left half  24 , for a predetermined period of time. The adhesive is especially chosen to insure a permanent bond of the gel strip subassembly  21  to the polymeric material of sheath body  2 . A more detailed description of the gel strip subassembly  21  is provided below with reference to  FIGS. 7-9 . A male coupling device  4  (more completely described below and shown in  FIG. 6 ) is positioned on the centerline  48  of the interior of right side segment  36  of sheath body  2  so that the distal edge  63  of a heat sealing ring  67  is coincident with a distal edge  39  of the right side section  36 . Male coupling device  4  is maintained in this location during assembly by appropriate jigs and fixtures, well known in the industry and not described herein, in preparation for the next step in the assembly of sheath  1  as is explained with reference to  FIG. 10 .  
       FIG. 6  is an isometric view of male coupling device  4 . It is molded from a suitable polymeric material having dimensional stability, resistance to the effects of exposure to urine and a melt index allowing it to be heat sealed to the thin polymeric material from which sheath body  2  is fabricated. The male coupling device  4  has a fluid entrance  211  and a fluid outlet  210 . The coupling distal portion  65  has a smooth tapered surface which sealably mates with a female coupler  91  described with reference to  FIG. 22 . Proximal to the tapered coupling distal portion  65  is a rounded positioning boss  64  which, in conjunction with a mating feature  95  on the female coupler  91  of  FIG. 22 , helps to position the male coupling device  4  in a fluid tight relationship with the female coupler  91 . At the proximal end of the male coupler are two closely spaced distal sealing rings  66  and a more distal sealing ring  67  having distal edge  63 . The male coupling device  4  is heat sealed to sheath body  2  as more fully described with reference to  FIG. 10 .  
       FIG. 7  is an isometric view of a pre-application gel strip assembly  68 . It differs from gel strip assembly  21  only in that gel strip assembly  21  has a release liner covering an adhesive surface which is removed to affix the gel strip  21  assembly to the sheath body  2 , as is shown more fully in  FIGS. 8-9 . The gel strip assembly  68  consists of four components. The first two are lengths of polymeric release liners which have been folded over onto themselves comprising a patient contacting right release liner piece  23  and a shorter, right gel contact segment  69  and a patient contacting left release liner piece  24  and a shorter, left gel contact segment  70 . Both the right and left gel contact segments  69 ,  70  are folded under the patient side segments and are perforated with a plurality of holes  71 ,  72  respectively. The area of the holes has been selected to permit the desired amount of surface area of the viscous gel to exude through the holes during application of the release liners. Although circular perforations are shown, openings having alternate geometry are acceptable providing the exposed area is equivalent. The release liners folded edges  73  and  74  are coincident and aligned with the centerline  75  of gel strip assembly  68 . The third component is a viscous polymeric gel  22 , preferably a conformable, soft, flexible, extensible, biologically inert, gel material possessing long term physical and chemical stability, with a thickness in the range of 0.05-0.10 inches. The polymeric gel  22  should not absorb, swell, erode or be permeable to urine. The polymeric gel  22  is intended to seal to the penile shaft and stretch with the penile tissue as the penis changes in diameter without loosing adhesion or its integrity, without allowing leakage. Accordingly, it has a relatively high modulus of elongation and high shear strength. While the polymeric gel  22  must adhere to penile tissue it should not adhere so aggressively that it cannot be readily removed or, when purposely removed, leave a residue (or an unacceptable or not easily removed residue) on the tissue. A specially formulated, 2-component silicone mixture which can be fully cured in a short period of time is preferred as the material of choice for the polymeric gel  22 . The fourth component is a double backed adhesive strip  25 . One release liner (not shown) is removed prior to the adhesive strip being mated to the polymeric gel strip  22  in the process of forming and curing the gel strip  22  from its component parts in a production process not described herein. The widths of the left and right side release liner segments  23 ,  24 , the polymeric gel  22  and the double backed adhesive strip  25  are equal.  
      The plurality of perforations  71 ,  72  in the gel contact segments  69 ,  70  allow portions of the viscous gel strip  22  to be extruded through the thin film of the contact segments  69  and  70  so that the gel releasably bonds to the undersides of the longer segments  23  and  24  thus effectively releasably bonding the layers of the folded release liners together. This bonding prevents unwanted, premature separation of the layers of release film which could otherwise interfere with insertion of the penis into the sheath. Portions of the longer right and left side release liners  23 ,  24 , identified as release liner segments  28  and  29  respectively, extend beyond the edges of gel strip  22  and the right and left gel contact segments  69  and  70 . These segments are further described with reference to  FIG. 10 .  
       FIG. 8  is an enlarged, cross-sectional view taken along line  8 - 8  of  FIG. 7 . The right side release liner  23  and left side liner  24  are positioned with their folded edges  73  and  74  coincident with the centerline  75  of the polymeric gel strip assembly  68 . Bonded to the underside and coextensive with polymeric gel strip  22  during its production, as noted above, is a double-backed adhesive strip  25 . The double-backed adhesive strip consists of four components. The first component is a first adhesive layer  76  coextensive with the gel strip. The adhesive  76  has been chosen especially to form a permanent bond with the polymeric gel  22 . The second is a thin (0.01 inches or less) polymeric carrier film  77  onto which the adhesive  76  has been applied. The third is a second adhesive layer  78 , coextensive with the carrier film  77 , particularly suited to establish a permanent bond with the polymeric film material of the sheath body  2  so as to effect permanent attachment of the polymeric gel  22  to sheath body  2 . The fourth is a release liner  79 , which completely covers the second adhesive layer  78  until the gel strip assembly  21  is ready to be affixed to sheath body  2 , following removal of the release liner  79 .  
      The double-backed adhesive strip  25  is a necessary component of the sheath  1  of the invention, carefully chosen to mate the polymeric gel  22  to the polymeric film of sheath body  2  as the properties of the polymeric film and the polymeric gel  22  are such, that while each has the unique characteristics that make them desirable for their independent functions, these same properties prohibit them from permanently bonding to each other to provide a reliable barrier preventing fluid leakage from the interior of the sheath  1 .  
       FIG. 9  is an isometric view of the pre-application gel strip assembly  68  from which the release liner  79  is being peeled away to create gel strip assembly  21 . Release liner  79  is removed just prior to the mating of gel strip assembly  21  to sheath body  2  as illustrated in  FIGS. 1 and 5  where the assembled component is identified as gel strip  21  following removal of the release liner and placement onto the sheath body  2 .  
       FIG. 10  is a plan view of the third stage of construction of the sheath body  2 , wherein the right side  36  and the left side  37  of the sheath body  2  (Reference  FIG. 2 ) have been folded flat about the centerline  35  so that all perimeter edges are aligned and, with the exception of the tabs  17 ,  18  and specified edges  14 ,  15 ,  60 ,  62 ,  61  of sheath body  2 , the edges are heat sealed to a minimum width of 0.10 inches so that the heat sealed areas  5 ,  6 ,  7 ,  8 ,  13  form a fluid tight continuous seal around the perimeter of sheath body  2 . The male coupling  4  is heat sealed about its circumference at the distal end of the funnel area  3 , proximal to edges  39 ,  44  thereof. Polymeric gel strip assembly  21  is also folded over in the interior of sheath body  2  and bonded to it by the adhesive  86  which is coextensive with the underside of polymeric gel  22 . Gel strip assembly  21  is coincident with the inner edge  80  of the heat sealed area  13 . The top edge  81  of the polymeric gel  22  is located at a distance of about 0.15 inches from edges  14 ,  15  of tabs  11 ,  12 . The outermost ends of the release liner segments  28 ,  29  are joined together to form a tab  30 , at their ends, preferably by means of heat sealing, during this assembly step. Joining the ends together insures that as the release liners are removed, as will be subsequently described, they will be removed from the right side and the left sides of the polymeric gel strip simultaneously starting at the centerline  35  where the adjacent folded edges are positioned at the lowermost point of the penis of the user. Removing the release liners in this manner insures a continuous, gap free, and fluid tight releasable bond between the polymeric gel  22  and the circumference of the penis.  FIGS. 15 and 16  further illustrate the removal of the release liners from the gel strip. To aid in placement of the sheath the internal diameter of the sheath is made larger than the diameters of the 90 th  percentile patient and of sufficient length to fit over the head of the penis of this same population group.  
       FIG. 11  is an isometric view of an elastic adhesive tape assembly  83 . It is fabricated from a thin, polymeric, base material  85  preferably having an elastic modulus in excess of 100% so that it may be stretched to provide tension throughout its period of use. It is coated with a high tack adhesive formulated to securely adhere to the tape base material  85  and to the polymeric film from which sheath body  2  is fabricated. The specially selected adhesive has properties which include the ability to maintain a secure bond while under tension as a result of the tape strip being stretched around the sheath to compress and secure the sheath to the penis of the user and also be easily strippable by the user when the sheath  1  is to be removed after use. The adhesive tape assembly  83  is provided with two release liner segments, a short segment  84  and a longer segment  33 , which includes the tab segment  34  (shown in  FIG. 12 ) that remains in place until the tape is to be affixed to the surface of sheath. In the assembly depicted in  FIG. 11 , release liner segment  84  covers approximately one inch of adhesive and extends over the longer release liner segment for approximately 1.75 inches making the segment easy to remove in preparation for attaching the tape assembly to the sheath as shown in  FIG. 1  and  13  wherein it is identified as tape strip assembly  31  as explained in reference to  FIG. 12 .  
       FIG. 12  depicts a tape strip assembly  31  which differs from the tape strip assembly  83  in that the release liner segment  84  has been removed to expose approximately 1.0 inch of the adhesive  86  which covers the elastomeric base material  85 . Removal of the release liner segment  84  exposes the previously covered tab  34  of the release liner  33 . The tape release liner segment  34  is shown in an elevated position for clarity. It would normally be approximately parallel to the surface of the tape assembly. Tab  34  is subsequently grasped by the user and peeled from the adhesive coated tape strip  85  as the user prepares to secure the sheath to his penis as is described and illustrated in  FIGS. 18, 19  and  20 .  
      Reference to  FIG. 13  illustrates the fourth and final step of assembly for a sheath  1  incorporating features of the invention. The tape strip assembly  31  is applied to the outer surface of the sheath body  2  following the removal of the release liner segment  84 . The tape strip assembly  31  is placed so that it is coincident with edge  62  and affixed to sheath  2  so that the upper edge of the adhesive exposed on the inner surface of the lower tape segment  32  by the removal of release liner segment  84  is approximately collinear with the outer edge of the heat sealed edge area  8 . It should be noted that the folded edge of tab  34  is in practice, also collinear with the outer edge of heat sealed edge area  8 , however it is shown above the flap ends  11 ,  12  for clarity. It should also be noted that tape strip  31  is wider than the flaps  11 ,  12  of the sheath body  2 . This is to insure that as the adhesive coated base tape material  85  is wrapped around the sheath body  2  to create a snug fit around the penis of the user, as shown in FIGS.  18  to  21 , a smooth, sealed edge is provided so that the sheath will not be snagged on the users clothing and the additional seal provided by the overlap, further insures the fluid tight seal in this area.  
      Reference to  FIG. 14  illustrates, as viewed from the perspective of the user, the method whereby the user of the sheath device  1  inserts his downwardly extending penis  89  into the proximal opening  9  of sheath body  2 . To facilitate insertion, a right handed user would typically grasp the right sheath tab  17  with his right hand  87  and left sheath tab  18  with his left hand  88  and pull the sheath body  2  over the shaft of his penis towards his body so that, as a minimum, his penis is inserted into the sheath body  2  a sufficient distance to insure that the glans  90  of his penis is distal to the patient right and left release liners  23 ,  24  respectively which cover the polymeric gel  22 . In the event the sheath  1  was being placed on the patient by a caregiver instead of by the user himself, the position of the hands would be reversed as the caregiver would typically be facing the patient.  
       FIG. 15  depicts a right handed user removing the right and left side release liners  23 ,  24  covering the polymeric gel strip  22  after positioning his penis  89  in sheath body  2 . The user first pushes the sheath upwards so it is pressed to the underside of the penile shaft. He then grasps the heat sealed tab  30  joining the two upper patient side folded release liner film segments  28 ,  29  together and pulls them vertically in a direction away from the longitudinal axis of the sheath body  2  to expose the polymeric gel strip  22  after the liners are completely removed from sheath body  2 . As tab  30  is pulled, both patient side release liner segments  23  and  24  are simultaneously pulled up in relation to the polymeric gel strip  22 . As the release liner tab  30  is pulled away from the longitudinal axis of sheath body  2 , the right and left gel side release liners  69 ,  70  are peeled away from the surface of the polymeric gel strip  22  as the patient side liners transition into gel side liners at the folded edges  73  and  74  as shown in  FIG. 8 . The gel strip side release liners are effect “rolled” up over the surface as pulling on tab  30  continues until the release liners are clear of the sheath body  2 . As the release liners are removed, they exert an upwards reactive force on sheath  2  surrounding the penis due to the resistance (peel strength) of gel adhesive forces opposing the peeling of the strips away from the surface of the gel. This upward pull on the sheath insures that the gel strip is releasably mated with the user&#39;s penis in a controlled manner as contact and adhesion of the gel strip to the penis is initiated at the lowermost portion on the circumference of the penis.  
      As can be seen in  FIGS. 16 , while holding onto his penis with his left hand (not shown) the continued pulling upward on patient side release liner segments  28 ,  29  results in completely peeling the gel strip side release liners  69 ,  70  from the surfaces of the upper right hand and left hand segments  26  and  27  respectively of polymeric gel strip  22  so it is completely exposed to and adhered to the circumference of the penis in both a clockwise and counter clockwise direction at essentially the same rate and in a continuous manner to preclude gaps in which no gel contacts the external surface of the penis.  
      Following removal of the two release liners covering the inner surface of the polymeric gel strip  22 , as described with reference to  FIG. 16 , the user gently presses on the outer surface of the sheath, starting at the underside and continuing around the entire circumference of the sheath to further insure gel strip contact and a fluid tight seal with the skin of the penis  89 . Following this, the user squeezes the right flap and left flap  11 ,  12  of the sheath body  2  together as depicted in  FIG. 17 . As the sheath flaps  11 ,  12  are squeezed together, so are the vertical ends of the upper right hand segment  26  and left hand segment  27  of polymeric gel strip  22  extending upwards from the portion of gel strip  22  surrounding the penile shaft. Pressing the gel strip end segments together creates a fluid-tight seal between them extending down to and around the circumference of the penis. The interior of sheath  1  is now completely sealed around the penis. Fluid outlet  10  of male coupling  4 , as intended, provides the only outlet from the sheath of the present invention through which urine can flow.  
      Referring to  FIG. 18 , viewed once again from the perspective of the user, the removable release liner  33  of the adhesive backed tape strip assembly  31  is shown being removed by the right hand  87  pulling on release liner tab  34  in preparation to securing the sheath body  2  to the penis  89  of the user while the gel strip segments  26  and  27  affixed to sheath tabs  11  and  12  remain sealed together.  
      Once the final tape release liner  33  has been removed from the tape strip assembly  31 , the adhesive backed elastomeric tape strip  85  is stretched over the sheath flaps  11 ,  12 , folding them together and down onto the outer surface of the sheath body  2  as shown in  FIG. 19 . The elastomeric tape is adhesively bonded to the outer surface of the sheath  2  by stretching the tape strip, folding any excess sheath material around the outer surface of the sheath and pressing the adhesive onto the outer surface of the sheath to create a snug fit on the penis. As noted above with reference to  FIG. 1 , the elastomeric tape is wider than the sheath tabs  17 ,  18  so that after the tape is wrapped around the sheath body  2 , as illustrated in  FIG. 20 , a smooth exterior surface is obtained.  
       FIG. 21  is a lateral view of the user&#39;s penis  89  positioned properly within the sheath  1  so that the glans  90  is distal to the polymeric gel strip  22  (not shown as it is hidden below tape) with elastomeric tape strip  85  wrapped around the circumference of sheath body  2 . Aligned with male coupling  4 , is female coupler  91  connected to a length of fluid transport tubing  92 . The female coupling and tubing will subsequently be described in greater detail.  
      Depicted in  FIG. 22  is a female coupler  91  intended to be used in cooperation with male coupling  4  to allow for easily transferring a patient or user&#39;s urine from the sheath device  1  to a receptacle for temporary storage prior to disposing of the urine. The female coupler  91  is molded from a suitable polymeric material having dimensional stability and resistance to the effects of prolonged exposure to urine. Preferably it is molded from the same material as the male coupling  4  so that their coefficients of thermal expansion are matched to help insure a fluid tight fit when mated to each other. The female coupler  91  is designed to easily and securely sealably mate in a releasable manner with male coupling  4 . To facilitate mating and sealing, the female coupler entrance  98  is provided with a plurality of outwardly tapered tangs  93  with a lead-in angle  94  of between 30 and 45 degrees. Distal to the opening  98  is a mating feature having an internally concave positioning boss  95  which encourages a corresponding convex positioning boss  64  on the male coupler  4  to seat within it. The bosses  64 ,  95  have a geometrical relationship such that the male boss  64  must be inserted to a sufficient depth within the coupler to affect a fluid tight seal between the external tapered portion  65  of male coupler  4  and the matching internal taper of the distal portion  100  of the female coupler  91  before the convex and concave bosses align. The proximal ends of tangs  93  form a circular opening that is smaller in diameter than the positioning boss of the male connector and require a force to connect the two components and also to disconnect them. The tangs act as cantilever beams in that they are flexed open as the positioning boss of male couple  4  is pressed into position. The design of the tangs is such that it is easier to affect a connection between the components than is to separate them. The axial force to separate the connectors is about two pounds. As a result of this design, the user is assured of a secure connect until he intends to disconnect the components. This design is superior to the current methods of connecting male condoms or sheaths which utilize barbed fittings, procured by the users as accessories, to connect to transfer or storage means. Fluid exits the female coupler through distal opening  99 . The distal end of the female coupler has a taper  97  on it to facilitate attachment to a transfer or storage device. A plurality of sealing rings  96  help to maintain a secure connection to a tube  92  as shown in  FIG. 21  or a storage or urine collection device described herein below.  
      As described in regard to  FIG. 22 , female coupler  91  is releasably mated with male coupler  4  and requires an axial force to affect separation. For an active user however, a more secure connection might be required. To insure a more secure mating of the male and female couplers a locking collar  101  shown in  FIGS. 23 and 24  is provided. The collar  101  has a plurality of indicator bosses  102  on the entrance face which provide a reference direction as an aid to affixing the locking collar to the female coupler  91  as is further explained with reference to  FIG. 25 . The locking collar has a snap ring boss  103  at its entrance face, an internal locator boss annulus  104  and a stop ring boss  106  at its end face. As an aid to positioning the collar between a first non-locking position and a second locking position when on the female coupler  91 , the locking collar  101  is provided with a gripping annulus  105  on its exterior circumference.  FIG. 24  is a cross-sectional view of the locking collar taken along line  24 - 24 .  
       FIGS. 25 and 26  show locking collar  101  in the unlocked and locked positions respectively in relation to the female coupler  91 . Female coupler  91  is aligned with and partially mated with the tapered surface  65  of the male connector  4  which is sealed into the distal end of sheath device  1 . A length of fluid tubing  92  is shown connected to the distal end of the female coupler  91 . In the unlocked position depicted in  FIG. 25 , the snap ring boss  103  is located distal to the positioning boss  95  of the female coupler  91 . In order to affect a seal and to complete mating of the male and female couplers  4 ,  91  the female coupler  91  is slid axially over the male coupler  4  until the positioning bosses  64 ,  95  are coincident. The coupler tangs  93  are free to flex to allow them to bend outwards over the boss  64  of the male coupler  4  as the female coupler  91  is mated with the male coupler  64 . The gripping annulus  105  then enables the user to securely grip the locking collar  101  and slide it axially over the positioning boss  95  of the female coupler once the female coupler has been completely engaged with the male coupler  4 , placing it in the locked position depicted in  FIG. 26 . The snap ring boss  103  is now positioned proximal of the outer diameter of the positioning boss  95  of the female coupler  91 . When in the locked position, the locking collar  101  prevents the tangs  93  from flexing and this in turn prevents relative movement between the male and female connectors  64 ,  91 . In order to disconnect the couplers, the locking collar  101  must be moved to its unlocked position by sliding it axially in a distal direction.  
      One of the objects of this invention is to make the connection and disconnection of the sheath of device  1  to a urine storage or collection device easier and more convenient for the user or his care giver. At present, the standard of care in the field of incontinence care is the use of barbed connectors. While the connection of barbed components can be accomplished without a great deal of difficulty, the disconnection of these same components is very difficult due to the barbs and the necessary tight compressive fit of the components. Following the securing of the sheath  1  to the penis of the user, connection of the male connector  4  to a female connector  91  and connection of tubing  92  to a collection bag  107  can take place as shown in  FIG. 27 . The male coupler  4  and the female coupler  91  have been uniquely designed to connect and disconnect with ease and to securely and releasably mate with each other. They have also been designed to securely and permanently mate with other components required for proper incontinence care.  
       FIG. 27  depicts a typical assembly of the components allowing the transport of urine from the user into a storage bag. Male coupler  4  is permanently heat sealed into device  1  and may be releasably connected to female coupling  91  permanently connected to tubing  92 . Inserted in the distal end of tubing  92  is a second male coupler  4  which is aligned for mating with a second female coupling  91  which may be permanently sealed into the inlet of a collection bag  107 .  
      When it becomes necessary to dispose of the contents of storage bag  107  such as depicted in  FIG. 27 , it is desirable to insure that the collected urine is sealed within the bag. To accomplish this goal, a female coupler plug  108  is provided. The coupler plug  108  has a closed end  109  and a plug positioning boss  110  which mates with the positioning boss  95  of the female coupler  91  as shown in  FIG. 32 . The plug  108  is also provided with a recessed entrance flange  111  shaped to receive the thumb or finger of the user or caregiver as the plug is pressed into the female coupler to seal the collection bag.  FIG. 29 , is a section view of plug  108  taken along line  29 - 29  of  FIG. 28  depicting more clearly, the closed end  109  of the plug.  
      It may also be necessary to cap the male coupler  4  at the distal end of the sheath device  1  when disposing of the urine in the storage bag  107 . To accomplish this goal, a male coupler cap  112  is provided and is depicted in  FIG. 30 . The coupler cap has a closed end  114  and a cap positioning boss  115  which mates with the positioning boss  64  of the male coupler  4  as is shown in  FIG. 32 . The cap is pressed onto the male coupler  4  flexing the tangs  113  and reaches its sealing position when positioning boss  115  is coincident with positioning boss  64  of the male coupler  4 . As an alternative, if the tubing is not disconnected from the sheath device  1 , the sealing cap  114  can be mated to the male coupler  4  at the distal end of tubing  92 .  
       FIG. 31  is a section view of cap  112  taken along line  31 - 31  of  FIG. 30  depicting more clearly, the closed end  114  and the positioning boss  115 .  
       FIG. 32  illustrates the male coupler seal cap  112  in position on the male coupler  4  sealed into the sheath device  1  and the female plug  108  in position and sealing the female coupler  91  of storage bag  107 .  
       FIG. 33  shows an alternative male coupler  116 , similar to male coupler  4 , except that it is provided with an internal boss  117  located near the proximal end of the coupler  116 , best shown in  FIG. 34  which is a cross sectional view of the alternative male coupler taken along line  34 - 34  of  FIG. 33 . The internal boss  117  is provided to serve as a retaining and locating feature for an internal, streamlined, compact one-way flow valve  118  more fully described in  FIGS. 35 and 36 .  
       FIG. 35  is an isometric view of a unique, streamlined, compact, injection molded one-way flow valve  118 . The material of choice is polypropylene characterized by a high flow-melt index. The valve&#39;s cross-sectional area has a rapid transition from the relatively thick section in proximity to the locking grove  119  located distally to the tapered inlet  121  of the valve. The thick cross-section of the valve in the region surrounding the locking grove  119  tapers to the thin outlet leaflets  122  of the distal end. These leaflets  122  are essentially rectangular in cross-section and are very thin, on the order of 0.002 to 0.005 in thickness, and are separated from each other by a leaflet wide opening  123  measuring 0.005 inches or less in height. The leaflets  122  are relatively unwetable by the urine which passes through them, entering the valve at opening  120  and exiting distally through the leaflets. Small droplets of urine however, will form on their surfaces aiding in the function of the valve as explained in reference to  FIG. 36   
      Operation of the valve  118  is further explained with reference to  FIG. 36  which shows the valve body (cross-section, taken along line  36 - 36  of  FIG. 35 ) fixed in place with locking groove  119  seated on the internal boss  117  of alternative male coupler  116 . The tapered inlet allows for smooth flow of urine into the valve opening  120  and prevents the build up of fluid on the face of the valve body. Urine then flows through the leaflet opening  123  and passes through the tube  92  and into storage bag  107  referenced previously. As the leaflets are relatively unwetable, only small droplets of urine will adhere to their surfaces but due to their very thin cross-section, the surface tension of the urine will tend to make the leaflets releasably adhere to each other and in effect, close the valve. If there is a retrograde flow of urine, it will flow against the exterior surfaces of the already closed valve leaflets and further increases of fluid pressure will only serve to keep the leaflets closed and thereby prevent back flow or leakage of the urine.  
      Reference to  FIG. 37  illustrates accessories provided with the sheath device  1  to secure it to body of its user by means of straps  125 ,  126 ,  127  (not shown) and  128 , which in the preferred embodiment, are made from soft washable cotton material and provide an appropriate closure and adjustment means well known in the medical appliance and clothing industry. Although the polymeric gel strip  22  surrounding the penis of the user in cooperation with the elastomeric adhesive tape  85  wrapped under tension around the exterior of the sheath device  1  provides almost four pounds force of axial resistance to the sheath being pulled off, use of the straps  125 ,  126 ,  127 ,  128  provides even a greater sense of security to the user. In  FIG. 37 , the penis  89  of the user is seen protruding through a retention ring  124  which is similar in many respects to the retention ring disclosed in U.S. Pat. No. 6,248,096b1. It has however, an important unique and distinguishing feature in that it is provided with a set of right and left cantilever arms  134 ,  135 . These arms are provided with a bulbous tip  137  which in their unflexed or closed position abut the edge  138  of retention ring  124 . Left and right waist straps  125 ,  126  and leg straps  127 ,  128  are similar to and serve the same function as those described in U.S. Pat. No. 6,248,096 B1. Two unique Velcro securing straps,  129  and  130  have been provided to easily secure the sheath of device  1  to the retention ring cantilever arms  134  and  135 . They are identical in design and construction and can be used interchangeably on either the right or left sides. Each strap has a composite tip  136  on it with the inner surface  131  of the tip faced with a Velcro “hook” fastener which can be secured to the surface of the body of the strap  132  which is faced with a Velcro “loop” fastener. The use of these fasteners to releasably secure straps is well known. However the straps of the invention are unique as they are provided with a plurality of preformed attachment openings or loops  133  spaced along the length of the strap. A patient having a relatively long penis would attach the most proximal or end attachment loop over the arms  134  and  135 , passing them over the bulbous tip  137 . A patient having a shorter penile length would attach the straps using more distally positioned attachment loops. Additional adjustment is made possible by the ability to adhere the hooks  131  at any point on the strap surface  132 . Once positioned over the cantilever arms, the straps are prevented from accidentally being dislodged as the cantilever arms  134 ,  135  are pressed against the edges  138  of the retention ring. The Velcro strap tips  136  are designed to readily pass through the slots  19  and  20  on right tab  17  and left tab  18  respectively, of sheath body  2 , first identified in  FIG. 1 .  
       FIG. 38  depicts the sheath device  1  with the user&#39;s penis  89  secured within. The Velcro securing strap  129  is shown with tip  136  folded over so that hook fasteners on the tip  136  are attached to the loop fasteners on the surface of strap body  132 . Straps  125 ,  126 ,  127 ,  128  are secured to the retention ring  124  and to the patents body as described in U.S. Pat. No. 6,248,096 B1. The male coupler  4  of the sheath device  1  is connected to a female coupler  91  which in turn is connected to the tubing  92  and the collection bag  107 .  
       FIG. 39  depicts a second embodiment of sheath device  1  constructed using the alternate first piece  50  as described with reference to  FIG. 4  with the user&#39;s penis  89  secured within. The Velcro securing straps  129  and  130  are not required to secure this embodiment to the retention ring  124  instead, the tabs  19  and  20  are secured to the retention ring  124  by passing the loops  259  formed in the tabs when the reinforced segments  52  are heat sealed to the sheath body  259  (reference  FIG. 4 ) over the cantilever arms  134 ,  135  of the retention ring  124 . Alternatively but not shown, the cantilever arms  134 ,  135  could be passed through the slots  19  and  20  respectively, to secure the sheath to the retention ring. The male coupler  4  of the sheath device  1  is connected to a female coupler  91  which in turn is connected to the tubing  92  and the collection bag  107  in the same way as described with reference to  FIG. 38 .  
       FIGS. 40-45  depict an alternate configuration and method of use or application of the Male Urinary Incontinence Sheath on the penis of a user. In this alternative embodiment, the gel strip assembly  21  of the first sheath embodiment shown in  FIG. 1 , has been modified. It is not initially adhered to the inner surface of the sheath but is provided as a separate item to be affixed to the penis of the user prior to applying a sheath which does not have pre-attached gel strip. The alternate version of the gel strip assembly  200  shown in  FIG. 41  is comprised of polymeric gel strip  22 , with its properties unchanged from those of the first embodiment, an upper right-side release liner segment  201 , an upper left-side release liner segment  202  and a lower release liner  203 . Referring to  FIG. 40 , the user first removes the lower release liner  203  and places one end of the exposed gel strip  22  on the surface of the penis at a location proximal to the glans of the penis. For the circumcised male, after removing the lower release liner  203  the user can remove either the left or right side upper release liner. The user then presses the exposed gel strip  22  onto the penis and wraps the exposed gel strip  22  around the penis while stretching it to insure intimate contact with the skin of the penile shaft. When the shaft is almost completely wrapped, one or the other, or both of the release liner segments  201  and  202  are removed and the remaining length of gel strip  22  is lightly stretched over the prior applied gel strip already on the penis and pressed onto the skin to insure intimate contact with the entire circumference of the penile shaft. The viscous easily deformable gel strip  22  is thus extruded into the folds and irregularities of the skin of the penis to provide a seal to prevent leakage of urine after the Male Urinary Incontinence Sheath  2  is applied.  
      The use of a separate adhesive gel strip exhibits numerous advantages over the current methods and adhesives utilized in commercially available latex or silicone condom catheters. The principal advantage is it provides a superior non-irritating, bio-compatible, stable fluid barrier as a result of its formulation. While the gel strip  22  is preferably about 0.07 inches thick it may be thicker or thinner depending on the particular applications. It incorporates a silicone material with high viscosity, high friction, extrudability for excellent void filling and is easy to remove following use. This gel fluid barrier and seal is almost an order of magnitude thicker than the adhesive films now in use which measure only a few thousandths of an inch. These thin adhesives cannot adequately provide a reliable seal against the leakage of urine as they cannot bridge the surface irregularities or skin folds and channels found on the surface of the penile shaft. This defect of the prior used thin films exists regardless of whether they are applied directly to a condom sheath or a compressible foam strip or tape. Another advantage in using this modified embodiment is noted when the user has relatively long pubic hair. The application of the adhesive gel strip  22  can be more closely controlled to insure that no hair is entrapped in the gel which can result in pulling of the hair and the attendant discomfort. Another advantage is observed when used on an uncircumcised male. Application of the adhesive gel strip to the skin behind the glans, when the loose foreskin of the penis has been pulled distally over the glans, will help to insure that the sheath is positioned correctly and will not be dislodged if the foreskin had been retracted or pushed back while the sheath is being positioned.  
      After securing the gel strip  22  to the penis, the user, as depicted in  FIG. 40  grasps the vertical right and left side tabs  17 ,  18  in his right and left hands  87 ,  88 , respectively and pulls the sheath body  2  towards the user&#39;s body so that penis  89  enters the proximal opening  9  of the sheath below the right and left hand flaps  11 ,  12 . After the sheath has been positioned so that the proximal edge of the sheath is aligned with the proximal edge of the gel strip  22 , the elastomeric adhesive-backed tape strip assembly  85  is affixed to the outer surface of the sheath body coincident with the width of the gel strip  22 . As shown in  FIG. 42 , after the dependent lower portion of the tape strip  32  is affixed to the sheath body  2 , the user pinches the flaps  11 ,  12  together and then removes the release liner  33  by pulling up on tab  34  as depicted in  FIG. 43  to expose the adhesive on the undersurface of the tape strip  85 . Following removal of the release liner to expose the adhesive, the elastomeric tape strip  85  is gently stretched and wrapped around the circumference of the sheath body  2  covering the penis  89  as depicted in  FIG. 44 . Once the tape is completely wrapped and secured to itself around the sheath, as shown in  FIG. 45 , the Male Urinary Incontinence Sheath is ready to be attached to the fluid collection tubing and leg or bed urine collection reservoirs as described with regard to the first embodiment.  
      Based on the teachings herein one skilled in the art will recognize that the Male Urinary Incontinence Sheath can take many forms without departing from the spirit of the invention. While the application of the sheath has been primarily described as pulling the sheath over the tip of the penis, it is contemplated that a tubular sheath, such as a condom drainage device can be rolled over the tip of the penis as well. Additionally, while the sheath has been described as being fabricated from a clear polymeric material, alternate materials can be utilized including latex or silicone. Additionally, the invention also applies to dip molded or injection molded sheaths as well as those fabricated by thermal sealing, application of adhesives and otherwise generally well known manufacturing methods.  
      Using the device and accessories disclosed in this invention, an incontinent user can be assured of a leak proof system to manage his incontinence with ease, convenience, and at a reasonable cost while avoiding many of the problems associated with latex condoms, indwelling catheters or diapers.  
      In summary, some of the unique aspects of devices incorporating features of the invention include:  
      A closed cell foam having a viscous coating on at least one surface, a gel, or any other type viscous, easily releasable, sealing strip fabricated of a material which leaves no or minimal residue when removed, said material conforming and accommodating to the adjustable sizing of the device, to prevent leakage. This wrap around, folding over configuration, ensures a proper fit around the penis, allowing for infinite sizing capabilities within a given minimal and maximum range of the device. This viscous, gelatinous material is adhered to the inner surface of the sheath of the invention. The material may be silicone, gels, or foams which create a seal between the interior surface of the sheath and the skin of the penis.  
      The various alternative materials of construction may be layered together in different configurations, which may include the laying of the foam, or like material directly on the viscous gelatinous material, or actually combining the two materials together.  
      The outer tape strip is easily deformable, stretchable foam, polymeric or elastomeric material which compensates for the differences in penile diameters which may occur throughout the period of wear by an individual and is suitable for use by a wide range of users who may have different penile diameters.  
      The current art incorporates adhesives that are of essentially zero thickness and have little or no capability to fill in the voids or spaces between the sheath and the surface of the penis and does not provide a comprehensive seal nor use any viscous gels, foams, or the like to create a seal. The new device described herein utilizes viscous, deformable gels or the like to create a seal. The unique gel or like materials creates a seal by conforming to the variations of skin texture of the penis and will fill in the wrinkles or folds of the loose skin whether flaccid or firm. The gel, although viscous, easily peels off the skin, leaving no residue and no skin irritation as do current adhesives.  
      The adhesive properties of the viscous gel strip include high shear strength along the axis of the penis to prevent the sheath or pouch from being easily separated or pulled off or falling off. Previous art discloses glues and adhesives which easily dislodge from the skin of the penis allowing prior art devices to easily fall or slip off. A further defect of prior devices, eliminated by the current design, is that liquid is allowed to get between the skin of the penis and the prior art sheath, further accelerating leakage and the sheath separating from the penile shaft.  
      The viscous gel strip adhesive has a very low tensile or peeling strength which facilitates easy removal by the user. This provides a quick and painless removal as well as leaving no residual adhesives, glues or the like on the skin of the penis.  
      The combination of the viscous gel material or the like, with the “compressible medium” is unique in that, depending on the various conditions or configurations of the penis, it provides adjustability, conformity and leak-proof sealing properties.  
      Based on the description herein, one skilled in the art will recognize that the gel strip can be used to attach various devices to the human body and is not limited to use in applying urinary sheaths. For example, the gel strip, or devices of different lateral dimensions such as patches, rings or discs, can be used for attachment of ostomy devices, female incontinence devices, retention of I.V. needles or other skin piercing devices, eye patches, and in various wound treatment procedures.