Male urinary incontinence sheath system including conformable silicone gel and elastic securement tape

A male urinary incontinence device comprises a cylindrical sheath with an open first end to receive the penis and a tubular connector at a second end for discharge of collected urine. A viscous gel strip is applied to the penis of a user and then to the upper inner circumference of the sheath as the sheath is applied to the penis. An elastic strap is applied to the upper outer circumference of the sheath, the gel strip and strap acting cooperatively to retain the sheath on the penis and to render the sheath leak proof in use. The sheath also includes a connector assembly for attachment of tubing and a urine collection vessel.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is directed to a device and related accessories for use by incontinent males and, more specifically, a device which both fits over and around the penis.

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. 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'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.

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'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

The male incontinence devices described herein, which incorporate features of the invention, provide a means of handling male urinary incontinence that overcomes the problems of the prior devices. The invention permits an individual or a care giver to easily place the device onto any sized male member, within a specified range, without the need for the application of any force to stretch or deform the device while applying it, even if the penis is flaccid and withdrawn, and provides a positive seal while generally isolating the external penile tissue and surrounding skin from prolonged contact with urine. The devices also provide compensation for changes in penile length and diameter over time by providing flexibly compliant portions engaging the penile shaft.

According to the invention, 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.

The invention also incorporates a method of forming and assembling devices incorporating features of the invention.

Still further, the invention includes a unique new coupling device for attaching a drainage tube or other collection devices to the male incontinence device. However, the utility of the connection device is not limited to use with the male incontinence device herein described. It may be used for the attachment of any number of tubular devices, indwelling catheters or other collection means to create a readily connected and disconnected, leak free liquid flow path between devices. The coupling device may be provided with an internally mounted one-way check valve. The coupling device may also be provided with a collar which may in a first position, permit connection and disconnection, and in a second position prevent connection or disconnection.

Still further, the invention includes 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.

Still further, the invention includes multi-loop strap means which allow for ready attachment and adjustment for penile length of the sheath of the invention to a plate secured to the patient by means of an adjustable waist belt.

DETAILED DESCRIPTION

A first embodiment of an easily applied sheath type device1for use on incontinent males is shown inFIG. 1. The substantially cylindrical sheath body2is formed from a liquid (urine) impervious polymeric material. A method of manufacturing the sheath is described below with reference toFIGS. 2–13. The cylindrical section of sheath body2has a funnel shaped distal portion3. A male coupling device4is secured in the distal end5of the funnel portion3in a liquid tight manner such as by heat sealing to the polymeric material. A lower heat sealed edge6merges with the distal end5of the funnel shaped portion3. An upper heat sealed side edge7of the funnel shaped portion3of sheath device1extends from the heat sealed distal end5and merges with the upper, longitudinal heat sealed edge8of the cylindrical sheath body2. 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 (also refered to as a first end opening)9for receiving the penis of a user and a distal opening10from which urine can be directed for storage or disposal.

The proximal end of the cylindrical sheath body2has a right hand flap11and a left hand flap12which extend vertically (as shown inFIG. 1) from an upper, unsealed area at the open end of the cylindrical sheath body2. The distal, vertical edges of the two flaps are sealed together forming a heat sealed area13which is contiguous with the heat sealed edge8. Heat sealing the various edges and areas of the flat sheet of material of sheath1as 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 edges14,15of the right and left hand flaps11,12respectively are open (not sealed), allowing the right and left flaps11,12to be used for grasping the sheath body2for placement on the penis and to provide a larger opening into which the penis can be readily placed.

Integral with the edge16of the proximal opening9of the cylindrical sheath body2are two spaced apart tabs. The right side tab17and the left side tab18are formed with slots19,20respectively to receive adjustable straps (omitted here for clarity) which attach to connectors on a retention plate mounted on a waist-encircling belt as depicted inFIGS. 37–38.

Located and adhesively affixed on the interior surface of the sheath body2(by removing a release liner and exposing an adhesive surface) and extending generally circumferentially and aligned with the proximal opening9of the cylindrical sheath body2, is a gel strip assembly21comprising a compliant, viscous and stretchable polymeric gel strip22, two folded strips of a release liner film, right half23and left half24, releasably adhered to the inner surface of the gel strip22and a double-backed adhesive strip25with two different adhesives for permanently bonding the gel strip to the inner surface of sheath body2. The gel strip assembly21is further described below and illustrated inFIGS. 7–9.

The two folded strips of release liner film23,24which cover the surface of the gel strip22are provided to facilitate the insertion of the user's penis into the interior of the sheath body2by 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 strips23,24each 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 body2. The two release liner film strips23,24are folded so that the gel strip sides are shorter in length than the patient contacting sides. The gel strip22halves are each coextensive with a half of the gel strip surface. The gel strip sides have perforations71to 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 strip22, in addition to extending around the inner circumference of the sheath body2, has a right hand segment26and a left hand segment27which extend vertically and are bonded to right and left hand flaps11,12respectively. These vertical segments terminate approximately 0.150 inches from the upper flap edges14and15.

The longer, patient sides, right hand liner film side tab28, and left hand liner film side tab29, of the release liner film strips23,24, extend vertically beyond the two gel strip segments26,27and beyond upper edges14,15of the right and left hand sheath flaps11,12. The right and left hand sides28,29of the patient side release liners23,24are heat sealed together to provide a heat sealed tab30, approximately 0.250 inches wide. The heat sealed tab30allows the user to grasp and remove the two release liners simultaneously as is described below.

Affixed to the outer surface of the adjacent proximal opening9of the sheath body2is an elastomeric, adhesive-backed tape strip assembly31of sufficient length to wrap completely around the circumference of the cylindrical body of the sheath. In the embodiment depicted inFIG. 1, the tape strip assembly31is shown adhered to the left side of the sheath body2. It can alternatively be placed on the right side of the sheath body2without affecting its function. The adhesive-backed tape strip31is aligned with the edge of the proximal opening9and has a lower segment32approximately 1.0 inches long adhesively affixed to the outer surface of the sheath2. The longer, upper segment of tape strip assembly31is covered by a removable release liner33on the reverse side having a portion thereof folded back on itself creating a release liner tab34. 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 tab34which extends vertically upwards or outward past the upper edge15of left hand flap12. The tape strip is described in greater detail inFIGS. 11–13and18–20. The tape strip assembly31is preferably wider than flaps11and12by 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 body2.

Referring toFIGS. 2–13, the fabrication of a first embodiment of the invention is described. The starting material for fabrication of the sheath1is 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 body2, such as shown inFIG. 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 body2after cutting has a number of landmarks useful in describing its construction into the sheath1of the present invention. In the preferred embodiment, the sheath body2is symmetrical about the longitudinal centerline35having a right side section36and a left side section37. The distal edges38,39,40,41,42,43and the side edges44,45,46,47, constitute mating elements which are aligned and heat sealed to form the sheath1. The upper edges14,15of the right hand flap11and the left hand flap12respectively, are left unsealed except for a short section of the adjacent edges44,47as is shown in greater detail inFIG. 10. The right side and left side tabs17,18are left unsealed as are the three collinear proximal edges60,61,62. The right hand section36and left hand section37are not symmetric about their respective centerlines48,49. Slots19and20are cut at the same time as is the sheath body2.

FIG. 3depicts an alternate construction, first piece50of the sheath body2described with reference toFIG. 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 piece50is symmetrical about the longitudinal centerline53and has a distal section51which is intended to be folded over the centerline55onto the distal portion of the body section255. The first piece50also includes proximal tab sections52which are folded over the tab centerline54onto the proximal portion of body section255. As can be seen inFIG. 4, the folded over tab sections,52and distal section51are heat sealed to body section255and reinforce it in the overlapped areas. Once the folded over sections are heat sealed to body section255, the alternate construction has the same shape as the first piece2shown inFIG. 2.

FIG. 4depicts the second step of construction using the alternate first piece50wherein the folded over reinforcing sections of die cut film body have been heat sealed to the body section255forming a reinforced die cut film body56. The folded over distal section51is heat sealed along its peripheral edge areas57and transverse areas58. Tab sections52are heat sealed forming sealed areas59, leaving the proximal portions259unsealed to form a loop in the tabs so that a sheath fabricated from this alternate construction50may be attached directly to a user worn faceplate retention ring as depicted inFIG. 39. Subsequent to this second stage of construction, the first piece of the alternate construction50is identical in its planer form to the first piece shown inFIG. 2and differs only in that it has reinforced areas and loops in the tabs. The reinforced die cut film body56is intended for use in the event polymeric material is not available in a thickness sufficient to provide the physical properties for the sheath1to perform its intended functions or it is desirous to provide a sheath for patients having short penises.

Because of the congruence between the first piece2and the reinforced die cut film body56, the remaining Figures and descriptions will only reference a sheath made from a first piece2. It should be noted however, that the alternate reinforced die cut film body56as described with reference toFIG. 4, can be used interchangeably with the sheath first piece2without departing from the spirit or intent of the present invention.

FIG. 5depicts a second stage of construction starting with the first piece of the sheath body2wherein a gel strip assembly21is mated (having had a release liner removed to expose an adhesive surface) to the interior surface of sheath body2. The gel strip assembly21is centered on the body centerline35and coincident with the three proximal edges60,61,62of the sheath body2and adhesively bonded to sheath body2by the application of a uniform pressure applied to the entire surface of the two folded strips of a release liner film, right half23and left half24, for a predetermined period of time. The adhesive is especially chosen to insure a permanent bond of the gel strip subassembly21to the polymeric material of sheath body2. A more detailed description of the gel strip subassembly21is provided below with reference toFIGS. 7–9. A male coupling device4(more completely described below and shown inFIG. 6) is positioned on the centerline48of the interior of right side segment36of sheath body2so that the distal edge63of a heat sealing ring67is coincident with a distal edge39of the right side section36. Male coupling device4is 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 sheath1as is explained with reference toFIG. 10.

FIG. 6is an isometric view of male coupling device4. 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 body2is fabricated. The male coupling device4has a fluid entrance211and a fluid outlet210. The coupling distal portion65has a smooth tapered surface which sealably mates with a female coupler91described with reference toFIG. 22. Proximal to the tapered coupling distal portion65is a rounded positioning boss64which, in conjunction with a mating feature95on the female coupler91ofFIG. 22, helps to position the male coupling device4in a fluid tight relationship with the female coupler91. At the proximal end of the male coupler are two closely spaced distal sealing rings66and a more distal sealing ring67having distal edge63. The male coupling device4is heat sealed to sheath body2as more fully described with reference toFIG. 10.

FIG. 7is an isometric view of a pre-application gel strip assembly68. It differs from gel strip assembly21only in that gel strip assembly21has a release liner covering an adhesive surface which is removed to affix the gel strip21assembly to the sheath body2, as is shown more fully inFIGS. 8–9. The gel strip assembly68consists 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 piece23and a shorter, right gel contact segment69and a patient contacting left release liner piece24and a shorter, left gel contact segment70. Both the right and left gel contact segments69,70are folded under the patient side segments and are perforated with a plurality of holes71,72respectively. 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 edges73and74are coincident and aligned with the centerline75of gel strip assembly68. The third component is a viscous polymeric gel22, 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 gel22should not absorb, swell, erode or be permeable to urine. The polymeric gel22is 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 gel22must 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 gel22. The fourth component is a double backed adhesive strip25. One release liner (not shown) is removed prior to the adhesive strip being mated to the polymeric gel strip22in the process of forming and curing the gel strip22from its component parts in a production process not described herein. The widths of the left and right side release liner segments23,24, the polymeric gel22and the double backed adhesive strip25are equal.

The plurality of perforations71,72in the gel contact segments69,70allow portions of the viscous gel strip22to be extruded through the thin film of the contact segments69and70so that the gel releasably bonds to the undersides of the longer segments23and24thus 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 liners23,24, identified as release liner segments28and29respectively, extend beyond the edges of gel strip22and the right and left gel contact segments69and70. These segments are further described with reference toFIG. 10.

FIG. 8is an enlarged, cross-sectional view taken along line8—8ofFIG. 7. The right side release liner23and left side liner24are positioned with their folded edges73and74coincident with the centerline75of the polymeric gel strip assembly68. Bonded to the underside and coextensive with polymeric gel strip22during its production, as noted above, is a double-backed adhesive strip25. The double-backed adhesive strip consists of four components. The first component is a first adhesive layer76coextensive with the gel strip. The adhesive76has been chosen especially to form a permanent bond with the polymeric gel22. The second is a thin (0.01 inches or less) polymeric carrier film77onto which the adhesive76has been applied. The third is a second adhesive layer78, coextensive with the carrier film77, particularly suited to establish a permanent bond with the polymeric film material of the sheath body2so as to effect permanent attachment of the polymeric gel22to sheath body2. The fourth is a release liner79, which completely covers the second adhesive layer78until the gel strip assembly21is ready to be affixed to sheath body2, following removal of the release liner79.

The double-backed adhesive strip25is a necessary component of the sheath1of the invention, carefully chosen to mate the polymeric gel22to the polymeric film of sheath body2as the properties of the polymeric film and the polymeric gel22are 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 sheath1.

FIG. 9is an isometric view of the pre-application gel strip assembly68from which the release liner79is being peeled away to create gel strip assembly21. Release liner79is removed just prior to the mating of gel strip assembly21to sheath body2as illustrated inFIGS. 1 and 5where the assembled component is identified as gel strip21following removal of the release liner and placement onto the sheath body2.

FIG. 10is a plan view of the third stage of construction of the sheath body2, wherein the right side36and the left side37of the sheath body2(ReferenceFIG. 2) have been folded flat about the centerline35so that all perimeter edges are aligned and, with the exception of the tabs17,18and specified edges14,15,60,62,61of sheath body2, the edges are heat sealed to a minimum width of 0.10 inches so that the heat sealed areas5,6,7,8,13form a fluid tight continuous seal around the perimeter of sheath body2. The male coupling4is heat sealed about its circumference at the distal end of the funnel area3, proximal to edges39,44thereof. Polymeric gel strip assembly21is also folded over in the interior of sheath body2and bonded to it by the adhesive86which is coextensive with the underside of polymeric gel22. Gel strip assembly21is coincident with the inner edge80of the heat sealed area13. The top edge81of the polymeric gel22is located at a distance of about 0.15 inches from edges14,15of tabs11,12. The outermost ends of the release liner segments28,29are joined together to form a tab30, 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 centerline35where 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 gel22and the circumference of the penis.FIGS. 15 and 16further 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 90thpercentile patient and of sufficient length to fit over the head of the penis of this same population group.

FIG. 11is an isometric view of an elastic adhesive tape assembly83. It is fabricated from a thin, polymeric, base material85preferably 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 material85and to the polymeric film from which sheath body2is 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 sheath1is to be removed after use. The adhesive tape assembly83is provided with two release liner segments, a short segment84and a longer segment33, which includes the tab segment34(shown inFIG. 12) that remains in place until the tape is to be affixed to the surface of sheath. In the assembly depicted inFIG. 11, release liner segment84covers 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 inFIG. 1 and 13wherein it is identified as tape strip assembly31as explained in reference toFIG. 12.

FIG. 12depicts a tape strip assembly31which differs from the tape strip assembly83in that the release liner segment84has been removed to expose approximately 1.0 inch of the adhesive86which covers the elastomeric base material85. Removal of the release liner segment84exposes the previously covered tab34of the release liner33. The tape release liner segment34is shown in an elevated position for clarity. It would normally be approximately parallel to the surface of the tape assembly. Tab34is subsequently grasped by the user and peeled from the adhesive coated tape strip85as the user prepares to secure the sheath to his penis as is described and illustrated inFIGS. 18,19and20.

Reference toFIG. 13illustrates the fourth and final step of assembly for a sheath1incorporating features of the invention. The tape strip assembly31is applied to the outer surface of the sheath body2following the removal of the release liner segment84. The tape strip assembly31is placed so that it is coincident with edge62and affixed to sheath2so that the upper edge of the adhesive exposed on the inner surface of the lower tape segment32by the removal of release liner segment84is approximately collinear with the outer edge of the heat sealed edge area8. It should be noted that the folded edge of tab34is in practice, also collinear with the outer edge of heat sealed edge area8, however it is shown above the flap ends11,12for clarity. It should be also be noted that tape strip31is wider than the flaps11,12of the sheath body2. This is to insure that as the adhesive coated base tape material85is wrapped around the sheath body2to create a snug fit around the penis of the user, as shown inFIGS. 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 toFIG. 14illustrates, as viewed from the perspective of the user, the method whereby the user of the sheath device1inserts his downwardly extending penis89into the proximal opening9of sheath body2. To facilitate insertion, a right handed user would typically grasp the right sheath tab17with his right hand87and left sheath tab18with his left hand88and pull the sheath body2over the shaft of his penis towards his body so that, as a minimum, his penis is inserted into the sheath body2a sufficient distance to insure that the glans90of his penis is distal to the patient right and left release liners23,24respectively which cover the polymeric gel22. In the event the sheath1was 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. 15depicts a right handed user removing the right and left side release liners23,24covering the polymeric gel strip22after positioning his penis89in sheath body2. The user first pushes the sheath upwards so it is pressed to the underside of the penile shaft. He then grasps the heat sealed tab30joining the two upper patient side folded release liner film segments28,29together and pulls them vertically in a direction away from the longitudinal axis of the sheath body2to expose the polymeric gel strip22after the liners are completely removed from sheath body2. As tab30is pulled, both patient side release liner segments23and24are simultaneously pulled up in relation to the polymeric gel strip22. As the release liner tab30is pulled away from the longitudinal axis of sheath body2, the right and left gel side release liners69,70are peeled away from the surface of the polymeric gel strip22as the patient side liners transition into gel side liners at the folded edges73and74as shown inFIG. 8. The gel strip side release liners are effect “rolled” up over the surface as pulling on tab30continues until the release liners are clear of the sheath body2. As the release liners are removed, they exert an upwards reactive force on sheath2surrounding 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'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 inFIGS. 16, while holding onto his penis with his left hand (not shown) the continued pulling upward on patient side release liner segments28,29results in completely peeling the gel strip side release liners69,70from the surfaces of the upper right hand and left hand segments26and27respectively of polymeric gel strip22so 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 strip22, as described with reference toFIG. 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 penis89. Following this, the user squeezes the right flap and left flap11,12of the sheath body2together as depicted inFIG. 17. As the sheath flaps11,12are squeezed together, so are the vertical ends of the upper right hand segment26and left hand segment27of polymeric gel strip22extending upwards from the portion of gel strip22surrounding 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 sheath1is now completely sealed around the penis. Fluid outlet10of male coupling4, as intended, provides the only outlet from the sheath of the present invention through which urine can flow.

Referring toFIG. 18, viewed once again from the perspective of the user, the removable release liner33of the adhesive backed tape strip assembly31is shown being removed by the right hand87pulling on release liner tab34in preparation to securing the sheath body2to the penis89of the user while the gel strip segments26and27affixed to sheath tabs11and12remain sealed together.

Once the final tape release liner33has been removed from the tape strip assembly31, the adhesive backed elastomeric tape strip85is stretched over the sheath flaps11,12, folding them together and down onto the outer surface of the sheath body2as shown inFIG. 19. The elastomeric tape is adhesively bonded to the outer surface of the sheath2by 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 toFIG. 1, the elastomeric tape is wider than the sheath tabs17,18so that after the tape is wrapped around the sheath body2, as illustrated inFIG. 20, a smooth exterior surface is obtained.

FIG. 21is a lateral view of the user's penis89positioned properly within the sheath1so that the glans90is distal to the polymeric gel strip22(not shown as it is hidden below tape) with elastomeric tape strip85wrapped around the circumference of sheath body2. Aligned with male coupling4, is female coupler91connected to a length of fluid transport tubing92. The female coupling and tubing will subsequently be described in greater detail.

Depicted inFIG. 22is a female coupler91intended to be used in cooperation with male coupling4to allow for easily transferring a patient or user's urine from the sheath device1to a receptacle for temporary storage prior to disposing of the urine. The female coupler91is 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 coupling4so that their coefficients of thermal expansion are matched to help insure a fluid tight fit when mated to each other. The female coupler91is designed to easily and securely sealably mate in a releasable manner with male coupling4. To facilitate mating and sealing, the female coupler entrance98is provided with a plurality of outwardly tapered tangs93with a lead-in angle94of between 30 and 45 degrees. Distal to the opening98is a mating feature having an internally concave positioning boss95which encourages a corresponding convex positioning boss64on the male coupler4to seat within it. The bosses64,95have a geometrical relationship such that the male boss64must be inserted to a sufficient depth within the coupler to affect a fluid tight seal between the external tapered portion65of male coupler4and the matching internal taper of the distal portion100of the female coupler91before the convex and concave bosses align. The proximal ends of tangs93form 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 couple4is 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 opening99. The distal end of the female coupler has a taper97on it to facilitate attachment to a transfer or storage device. A plurality of sealing rings96help to maintain a secure connection to a tube92as shown inFIG. 21or a storage or urine collection device described herein below.

As described in regard toFIG. 22, female coupler91is releasably mated with male coupler4and 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 collar101shown inFIGS. 23 and 24is provided. The collar101has a plurality of indicator bosses102on the entrance face which provide a reference direction as an aid to affixing the locking collar to the female coupler91as is further explained with reference toFIG. 25. The locking collar has a snap ring boss103at its entrance face, an internal locator boss annulus104and a stop ring boss106at 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 coupler91, the locking collar101is provided with a gripping annulus105on its exterior circumference.FIG. 24is a cross-sectional view of the locking collar taken along line24—24.

FIGS. 25 and 26show locking collar101in the unlocked and locked positions respectively in relation to the female coupler91. Female coupler91is aligned with and partially mated with the tapered surface65of the male connector4which is sealed into the distal end of sheath device1. A length of fluid tubing92is shown connected to the distal end of the female coupler91. In the unlocked position depicted inFIG. 25, the snap ring boss103is located distal to the positioning boss95of the female coupler91. In order to affect a seal and to complete mating of the male and female couplers4,91the female coupler91is slid axially over the male coupler4until the positioning bosses64,95are coincident. The coupler tangs93are free to flex to allow them to bend outwards over the boss64of the male coupler4as the female coupler91is mated with the male coupler64. The gripping annulus105then enables the user to securely grip the locking collar101and slide it axially over the positioning boss95of the female coupler once the female coupler has been completely engaged with the male coupler4, placing it in the locked position depicted inFIG. 26. The snap ring boss103is now positioned proximal of the outer diameter of the positioning boss95of the female coupler91. When in the locked position, the locking collar101prevents the tangs93from flexing and this in turn prevents relative movement between the male and female connectors64,91. In order to disconnect the couplers, the locking collar101must 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 device1to 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 sheath1to the penis of the user, connection of the male connector4to a female connector91and connection of tubing92to a collection bag107can take place as shown inFIG. 27. The male coupler4and the female coupler91have 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. 27depicts a typical assembly of the components allowing the transport of urine from the user into a storage bag. Male coupler4is permanently heat sealed into device1and may be releasably connected to female coupling91permanently connected to tubing92. Inserted in the distal end of tubing92is a second male coupler4which is aligned for mating with a second female coupling91which may be permanently sealed into the inlet of a collection bag107.

When it becomes necessary to dispose of the contents of storage bag107such as depicted inFIG. 27, it is desirable to insure that the collected urine is sealed within the bag. To accomplish this goal, a female coupler plug108is provided. The coupler plug108has a closed end109and a plug positioning boss110which mates with the positioning boss95of the female coupler91as shown inFIG. 32. The plug108is also provided with a recessed entrance flange111shaped 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 plug108taken along line29—29ofFIG. 28depicting more clearly, the closed end109of the plug.

It may also be necessary to cap the male coupler4at the distal end of the sheath device1when disposing of the urine in the storage bag107. To accomplish this goal, a male coupler cap112is provided and is depicted inFIG. 30. The coupler cap has a closed end114and a cap positioning boss115which mates with the positioning boss64of the male coupler4as is shown inFIG. 32. The cap is pressed onto the male coupler4flexing the tangs113and reaches its sealing position when positioning boss115is coincident with positioning boss64of the male coupler4. As an alternative, if the tubing is not disconnected from the sheath device1, the sealing cap114can be mated to the male coupler4at the distal end of tubing92.

FIG. 31is a section view of cap112taken along line31—31ofFIG. 30depicting more clearly, the closed end114and the positioning boss115.

FIG. 32illustrates the male coupler seal cap112in position on the male coupler4sealed into the sheath device1and the female plug108in position and sealing the female coupler91of storage bag107.

FIG. 33shows an alternative male coupler116, similar to male coupler4, except that it is provided with an internal boss117located near the proximal end of the coupler116, best shown inFIG. 34which is a cross sectional view of the alternative male coupler taken along line34—34ofFIG. 33. The internal boss117is provided to serve as a retaining and locating feature for an internal, streamlined, compact one-way flow valve118more fully described inFIGS. 35 and 36.

FIG. 35is an isometric view of a unique, streamlined, compact, injection molded one-way flow valve118. The material of choice is polypropylene characterized by a high flow-melt index. The valve's cross-sectional area has a rapid transition from the relatively thick section in proximity to the locking grove119located distally to the tapered inlet121of the valve. The thick cross-section of the valve in the region surrounding the locking grove119tapers to the thin outlet leaflets122of the distal end. These leaflets122are 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 opening123measuring 0.005 inches or less in height. The leaflets122are relatively unwetable by the urine which passes through them, entering the valve at opening120and 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 toFIG. 36

Operation of the valve118is further explained with reference toFIG. 36which shows the valve body (cross-section, taken along line36—36ofFIG. 35) fixed in place with locking groove119seated on the internal boss117of alternative male coupler116. The tapered inlet allows for smooth flow of urine into the valve opening120and prevents the build up of fluid on the face of the valve body. Urine then flows through the leaflet opening123and passes through the tube92and into storage bag107referenced 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 toFIG. 37illustrates accessories provided with the sheath device1to secure it to body of its user by means of straps125,126,127(not shown) and128, 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 strip22surrounding the penis of the user in cooperation with the elastomeric adhesive tape85wrapped under tension around the exterior of the sheath device1provides almost four pounds force of axial resistance to the sheath being pulled off, use of the straps125,126,127,128provides even a greater sense of security to the user. InFIG. 37, the penis89of the user is seenn protruding through a retention ring124which 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 arms134,135. These arms are provided with a bulbous tip137which in their unflexed or closed position abut the edge138of retention ring124. Left and right waist straps125,126and leg straps127,128are similar to and serve the same function as those described in U.S. Pat. No. 6, 248,096B1. Two unique VELCRO® securing straps,129and130have been provided to easily secure the sheath of device1to the retention ring cantilever arms134and135. They are identical in design and construction and can be used interchangeably on either the right or left sides. Each strap has a composite tip136on it with the inner surface131of the tip faced with a VELCRO® “hook” fastener which can be secured to the surface of the body of the strap132which is faced with a VELCRO® “loop” fastener. The use of these fasteners to releasably secure straps as well known. However the straps of the invention are unique as they are provided with a plurality of preformed attachment openings or ioops133spaced along the length of the strap. A patient having a relatively long penis would attach the most proximal or end attachment loop over the arms134and135, passing them over the bulbous tip137. 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 hooks131at any point on the strap surface132. Once positioned over the cantilever arms, the straps are prevented from accidentally being dislodged as the cantilever arms134,135are pressed against the edges138of the retention ring. The VELCRO® strap tips136are designed to readily pass through the slots19and20on right tab17and left tab18respectively, of sheath body2, first identified inFIG. 1.

FIG. 38depicts the sheath device1with the user's penis89secured within. The VELCRO® securing strap129is shown with tip136folded over so that hook fasteners on the tip136are attached to the loop fasteners on the surface of strap body132. Straps125,126,127,128are secured to the retention ring124and to the patents body as described in U. S. Pat. No. 6,248,096B1. The male coupler4of the sheath device1is connected to a female coupler91which in turn is connected to the tubing92and the collection bag107.

FIG. 39depicts a second embodiment of sheath device1constructed using the alternate first piece50as described with reference toFIG. 4with the user's penis89secured within. The VELCRO® securing straps129and130are not required to secure this embodiment to the retention ring124instead, the tabs19and20are secured to the retention ring124by passing the loops259formed in the tabs when the reinforced segments52are heat sealed to the sheath body259(referenceFIG. 4) over the cantilever arms134,135of the retention ring124. Alternatively but not shown, the cantilever arms134,135could be passed through the slots19and20respectively, to secure the sheath to the retention ring. The male coupler4of the sheath device1is connected to a female coupler91which in turn is connected to the tubing92and the collection bag107in the same way as described with reference toFIG. 38.

FIGS. 40–45depict 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 assembly21of the first sheath embodiment shown inFIG. 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 assembly200shown inFIG. 41is comprised of polymeric gel strip22, with its properties unchanged from those of the first embodiment, an upper right-side release liner segment201, an upper left-side release liner segment202and a lower release liner203. Referring toFIG. 40, the user first removes the lower release liner203and places one end of the exposed gel strip22on the surface of the penis at a location proximal to the glans of the penis. For the circumcised male, after removing the lower release liner203the user can remove either the left or right side upper release liner. The user then presses the exposed gel strip22onto the penis and wraps the exposed gel strip22around 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 segments201and202are removed and the remaining length of gel strip22is 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 strip22is 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 Sheath2is 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. Additionally, the gel strip22is about 0.07 inches thick and incorporates high viscosity, high friction, extrudability, for excellent void filling, and easy removal 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 (i.e.. at least about 0.02 inches thick). 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 strip22can 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 strip22to the penis, the user, as depicted inFIG. 40grasps the vertical right and left side tabs17,18in his right and left hands87,88, respectively and pulls the sheath body2towards the user's body so that penis89enters the proximal opening9of the sheath below the right and left hand flaps11,12. After the sheath has been positioned so that the proximal edge of the sheath is aligned with the proximal edge of the gel strip22, the elastomeric adhesive-backed tape strip assembly85is affixed to the outer surface of the sheath body coincident with the width of the gel strip22. As shown inFIG. 42, after the dependent lower portion of the tape strip32is affixed to the sheath body2, the user pinches the flaps11,12together and then removes the release liner33by pulling up on tab34as depicted inFIG. 43to expose the adhesive on the undersurface of the tape strip85. Following removal of the release liner to expose the adhesive, the elastomeric tape strip85is gently stretched and wrapped around the circumference of the sheath body2covering the penis89as depicted inFIG. 44. Once the tape is completely wrapped and secured to itself around the sheath, as shown inFIG. 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 new viscous gel, water resistant foams or the like, allow for a water tight seal under all conditions of change in the penis size during the course of daily activities, which include, sleep, walking, sitting, spontaneous erection of a flaccid penis, lifting and stretching, etc.

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.

The ability to apply the device without having to roll it on, slip over, or stretch and pull it up onto the penis is new and unique to this art. The device described and shown allows the penis to be laid in an open cylindrical sheath or pouch before the device is sealed around the penis, a technique which is a new and unique approach to apply a urinary incontinence sheath. The inclusion of foam or gel material for sizing adjustment, or a viscous gel or materials of the like for creating a seal against the penis, whether used separately and alone, or in combination is unique and new.

The ability to insert the head of the penis into a collection device without the shaft of the penis being encased, during insertion, by the sheath material allows for an easier approach for application, as well as accommodating a flaccid organ. The sheath material is then caused to surround the penis by folding, closing the sheath around the penis followed by a final seal or wrap, both of which are not shown in prior art devices.

Two folded release liners are positioned on the viscous gel seal to facilitate simultaneous removal after the penis is position in the sheath, ensuring that the gel is uniformly adhered circumferentially to the penis, starting at the bottom surface thereof. The tack or resistance of the release liners to removal from the gel insures that by removal of the release liners the gel is pressed against the penis.

Perforations on the inner gel side folded elements of the release liner allows viscous gel to extrude therethrough to adhere to the patient side film layer, thus maintaining the inner patient side layer in a coincident relationship with the gel side layer.

A water-tight sheath formed from a heat sealed, preformed pouch formed in combination with a pre-assembled tape or flexible adhesive back tape assembly placed onto the preformed pouch, the tape being applied over a portion of the heat sealed pouch and adhered to the heat sealed portion of the pouch and the collinear edges of the open cylinder. When applied to the penis the combination forms an expandable, water tight sheath in a tubular configuration.

The device incorporates a new and unique quick disconnect assembly. The configuration of the male and female connectors provides for easy attachment to extension tubings, or to leg bags, or bedside drain bags, etc. This connector arrangement is not limited to the disclosed device but may be incorporated in various different fluid flow systems in which a liquid-tight quick and clean disconnect and reconnect is desired including, including but not limited to other urine collection assemblies and devices such as catheters, thereby reducing the risk of urinary tract infections (UTI), urine drainage devices, various body fluid collection or delivery bags, containers, or the like,. This connector can be used with many configurations of tubing which require connection and disconnection on a routine basic. This includes intravenous lines, medication lines and catheter lines to include urostomy. Further, the locking collar prevents the male and female halves of the connector set from accidentally disconnecting

The use of a strap attached between the sheath, pouch, or the like, and the face plate provides added security of attachment of the sheath, pouch, or the like, minimizing the likelihood of the device falling off or disengaging from the penis.

The inclusion of an anti-reflux valve into the device or as an attachment to the end of the device prevents the back flow of fluid.

The use of a leg strap which is attached to the face plate for securing the device to the body, with the leg strap wrapped around the thigh of the user, i.e., not passing between the legs and going up through the crotch and attached to the waist band, is new and unique arrangement.

The doubled-over, heat sealed end of the sheath device has stiffness built in to provide an easier entry of the head of the penis to the device, as well as providing additional support for the head of the penis and the penile shaft. This also provides greater comfort to the user.

The doubled-over, heat sealed tabs of the sheath device form loops which permit the device to be attached directly to the cantilever arms of the face plate without the need for additional straps

The face plate has recesses for belts and straps so they do not contact and cause irritation to the skin of the user when it is in contact with the skin. The faceplate also has cantilever arms for easy attachment of the waistband and to facilitate a stable placement of the bands.

One skilled in the art will recognize that, based on the above descriptions various modifications in the sheath construction and its method of fabrication may be adapted. For example, an option is to not fully heat seal the device so that it has the form of a trough or base assembly for application. A trough would have the device completely open Unsealed along a longitudinal edge. For application of the device the penis would be laid on the open device with the glans inserted into the distal end. The device would then be folded over the penis and sealed along the open edge using various folding and adhesive techniques to form a cylindrical sheath followed by sealing of the device around the penile organ as previously herein described. Once the device encases the penis, in any of the above mentioned configurations, the adjustability for firming or tightening the device for a water tight and comfortable seal can be accomplished by rolling, folding, turning, or any method of decreasing the looseness of the device around the penile shaft in order to create a waterproof seal, and then sealing the flap or fold or the like to the outer material of the device. Alternatively the device can be secured to the penis not only by having the gel, foam, or the like, but additionally by securing the device circumferentially by wrapping and elastic band that adheres to it by various methods, which may include VELCRO® fasteners, tacky adhesives, clips, or any method of securing the wrap to it.

As a further alternative, the nozzle may be offset downward from the central axis of the sheath. This offset of the nozzle to the lower end at the distal end of the device will assure that when urine is expelled or released it will flow out at the lowest end of the device. By positioning the nozzle opening lower than the middle of the distal end of the device there is less chance of urine pooling in any open space in the distal end off the sheath which is not filled by the penile gland. Also the internal configuration of the sheath which contacts the penile glans or the end of the penis may be modified by providing the material of construction with ripples, forming a wavy appearance, or grooves, or the like to direct the urine flow to the offset nozzle opening. This configuration would offset the outlet tube from the orifice opening of the penis so as not to occlude it and to prevent urine from flowing out of the penis. It is also possible to construct the sheath of a non-wetable but porous material, with minimal elasticity that would allow for air exchange, yet not allow fluid to pass through the pores of the material. This approach would decrease the potential for irritation or excoriation of the skin of the penis.