Male urinary incontinence sheath having gel adhesive and elastic securement tape Number:7,160,277 from the United States Patent and Trademark Office (PTO) owispatent

Title: Male urinary incontinence sheath having gel adhesive and elastic securement tape

Abstract: 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, the sheath having a longitudinal opening along at least one side to allow ready placement of the penis therein. A viscous gel strip is applied to the upper inner circumference of the sheath and 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. Placement of the device may also include a mounting ring and a strap assembly.

Patent Number: 7,160,277 Issued on 01/09/2007 to Elson,   et al.

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Inventors:	Elson; Edward E. (Anaheim, CA), Dwork; Paul (Camarillo, CA), Dwork; Joshua (Camarillo, CA)
Assignee:	Leading Edge Innovations, Inc. (Camarillo, CA)
Appl. No.:	11/342,062
Filed:	January 27, 2006

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Current U.S. Class:	604/352 ; 604/349
Current International Class:	A61F 5/443 (20060101); A61F 5/453 (20060101)
Field of Search:	604/346-356,307 128/760 606/201

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References Cited [Referenced By]

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U.S. Patent Documents

	3788324		January 1974		Lim
	3835857		September 1974		Rogers et al.
	3863638		February 1975		Rogers, III et al.
	4187851		February 1980		Hauser
	4378018		March 1983		Alexander et al.
	4475909		October 1984		Eisenberg
	4534767		August 1985		Habib
	4540409		September 1985		Nystrom et al.
	4576599		March 1986		Lipner
	4588397		May 1986		Giacalone
	4626250		December 1986		Schneider
	4650817		March 1987		Allen, Jr. et al.
	4759753		July 1988		Schneider et al.
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	5065459		November 1991		Tjahaja et al.
	5336211		August 1994		Metz
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	5618277		April 1997		Goulter
	5643235		July 1997		Figuerido
	5716350		February 1998		Ryan
	5752944		May 1998		Dann et al.
	5797890		August 1998		Goulter et al.
	6007524		December 1999		Schneider
	6010489		January 2000		Blackburn
	6039750		March 2000		Kubalak et al.
	6068618		May 2000		Anderson
	6113582		September 2000		Dwork
	6200195		March 2001		Furuno et al.
	6248096		June 2001		Dwork et al.
	6479726		November 2002		Cole

Foreign Patent Documents

	2126483		Mar., 1984		GB
	08-010279		Jan., 1996		JP

Primary Examiner: Zalukaeva; Tatyana
Assistant Examiner: Hill; Laura C.
Attorney, Agent or Firm: Koppel, Patrick & Heybl Ram; Michael J.

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Parent Case Text

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This is a Divisional of U.S. patent application Ser. No. 10/868,289, filed Jun. 14, 2004, which is a Continuation-in-Part of U.S. patent application Ser. No. 10/705,187, filed Nov. 10, 2003, now abandoned.

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Claims

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We claim:

1. A device for attachment to the penis of an individual for receiving urine and delivering the urine to a collection chamber, the device comprising a sheath non-permeable to urine, the sheath being cylindrically shaped when fully applied to the penis, the cylindrical sheath having an inner surface and an outer surface and a first end and a second end at opposite ends of the cylindrical sheath and having: an opening in the first end of the cylindrical sheath sized to receive at least a portion of the length of a penis, the second end of the cylindrical sheath, spaced longitudinally along a central axis of the cylindrical sheath from said first end, including a hollow connector sealed therein, the hollow connector configured to mate with a second hollow connector attached to the collection chamber, the distance between the first end and the second end being sufficient to enclose at least the glans of the penis and carry a first securement means on the inner surface and a second securement means on the outer surface at the first end, the first and second securement means encircling the penis above the glans, the first securement means comprising a compliant, viscous, stretchable and conformable polymeric gel strip and the second securement means comprising an elastic securement tape, the sheath having an upper portion with a longitudinal opening extending from the opening in the first end at least partially along the length of the sheath toward the second end, the polymeric gel strip adhesively attached to an upper circumferential portion of the inner surface of the sheath adjacent the opening in the first end of the sheath, the gel strip comprising a compliant, viscous stretchable and conformable polymeric gel material impervious to urine, resistant to swelling, absorption, erosion, permeation when exposed to urine and inherently adherent to skin surfaces, the gel strip having, on a sheath contacting surface, a double sided adhesive strip comprising a first adhesive which bonds to the gelatinous polymeric material and a second adhesive which bonds to the inner surface of the sheath, the double sided adhesive strip function to permanently secure the gelatinous polymeric material to the sheath; having a skin contact surface which provides adhesion to the skin surface of the penis but is readily removable there from without leaving residual gel material on the surface of the penis, the gel material being stretchable and contractible after application 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, said gel strip skin contact surface having a removable barrier material covering said contact surface, the barrier removable during placement of the sheath on the penis, the elastic securement tape having a first end attached to an upper circumferential portion of the outer surface of the sheath adjacent the first end opening of the sheath, the tape oriented to be wrapped circumferentially around the sheath, said securement tape having attachment means extending along the length of an inner surface thereof so that upon wrapping said tape around the upper circumferential surface of the sheath the tape becomes adhered to the sheath, secures the sheath to the penis placed therein and closes the opening extending longitudinally from the first open end at least a portion of the distance between the first end and the second end in a leak proof manner.

2. The device of claim 1 further including slotted tabs extending from an upper edge of the sheath, each of said slotted tabs configured to receive one or more adjustable straps there through, the adjustable straps also passing through slots in a ring encircling the base of the penis.

3. The device of claim 2 wherein the ring is retained on the individual by multiple belts encircling the waist and thighs of the individual.

4. The device of claim 1 wherein the hollow connector comprises a tubular male coupling of a predetermined outer diameter an intermediate portion of the outer surface of the coupling having a raised boss encircling the connector, the tubular mail coupling being sized to be received within the second hollow connector attached to the urine collector.

5. The device of claim 4 wherein the second hollow connector is a tubular female coupler having two or more longitudinal slots along a portion of a first end thereof forming outwardly tapering tangs there between and an intermediately positioned, internally concave positioning boss, the inner diameter of the tubular female coupler and internally concave positioning boss sized to mate with the male coupling in a leak-proof manner, the second end of the female coupler being attached to the urine collection chamber.

6. The device of claim 5 wherein the urine collection means comprises tubing attached to a urine collection container, the tubing also being attached to a second end of the female coupler.

7. The device of claim 5 further including an encircling, sliding locking collar sized for locking placement over the boss on the male coupler and the female coupling after engagement thereof.

8. The device of claim 1 further including a one way flow valve positioned at or below the second end of the sheath, the one way valve configured to allow urine to flow from the sheath to the collection chamber but to prevent urine from flowing from the collection chamber into the sheath.

9. The device of claim 8 wherein the one way valve includes first and second flat leaflet portions, said leaflet portions positioned at their lower end in contact each other for urine to flow between the leaflets and through said lower end.

10. The device of claim 8 wherein the one way flow valve is positioned within a lumen of the hollow connector.

11. The device of claim 1 wherein the gelatinous polymeric material comprises a 2-component silicone material.

12. The device of claim 1 wherein the polymeric gel material has a modulus of elongation and a shear strength such that the gel material will elongate an amount equal to expansion of the penis during normal usage without the gel material separating, the adhesion to the skin is not compromised and leakage is prevented.

13. The device of claim 1 wherein the removable barrier material covering the gel strip skin contact surface has perforations therein which allow penetration of the gel material there through prior to removal of the barrier material for application to a skin surface.

14. The device of claim 1 wherein the elastic securement tape comprises an elastic, polymeric base material having an adhesive on a sheath contacting surface for attaching the securement tape to the outer surface of the sheath.

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Description

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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.

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. 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.RTM. hook and loop fasteners. An attaching ring may also be mounted on an undergarment to secure 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 too 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.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the present invention will be more fully understood from the following detailed description of an illustrative embodiment, taken in conjunction with the accompanying drawing 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's perspective wherein the device of FIG. 1 is being applied to the user's penis.

FIG. 15 is a view from the patient'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'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'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's penis.

FIG. 18 is a view from the patient'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'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'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.

DETAILED DESCRIPTION

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 first end opening 9, also referred to as a proximal opening, for receiving the penis of a user and a distal or second end 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 (a removable barrier material), 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'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.sup.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. Th