WO2008063623A2

WO2008063623A2 - External urinary incontinence device and adhesive composition for attaching same

Info

Publication number: WO2008063623A2
Application number: PCT/US2007/024213
Authority: WO
Inventors: Jarl Jensen; Richard Bradley
Original assignee: Euromed Inc.
Priority date: 2006-11-20
Filing date: 2007-11-19
Publication date: 2008-05-29
Also published as: WO2008063623A9; WO2008063623A3

Abstract

A disposable unisex external urinary incontinence device (100) with the ability to be worn for an extended period of time is provided. The unisex external urinary incontinence device (100) is composed of a collection receptacle (110), a drainage tube (120), and an extended-wear hydrocolloid adhesive (130). The extended-wear hydrocolloid adhesive (130) is comprised of a hydrocolloid, an acrylic polymer, a tackifier resin, and optionally, either one or more of an extender, such as mineral oil, a copolymer such as ethylene vinyl acetate, or a styrene-isoprene- styrene block copolymer. The adhesive may also contain an antimicrobial additive or other components deemed necessary to manage a patient's well- weing or other specific condition, such as an antimicrobial agent or odor eliminator.

Description

EXTERNAL URINARY INCONTINENCE DEVICE AND ADHESIVE COMPOSITION FOR ATTACHING SAME

RELATED APPLICATIONS

[001 ] This application claims priority of Provisional U.S. Patent Application Ser. No. 60/860,448 filed November 20, 2006, titled "External Urinary Incontinence Device and Adhesive Composition for Attaching Same," which is incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

[002] The present invention relates to a disposable unisex external urinary incontinence device (100), a method of making the device, and an extended-wear hydrocolloid adhesive (130) for attaching the device to the body. The device may be one- piece where the collection component (the collection receptacle (1 10) and drainage tube (120)) is permanently attached to the extended-wear adhesive such that the device and the extended-wear adhesive are removed together and discarded. The device may also be a two- piece design where the adhesive body is removable attached to the collection component. The extended-wear adhesive may be attached through a mating flange system or fixation system.

[003] The disposable unisex external urinary incontinence device (100) of the present invention reduces or eliminates urinary tract infection associated with conventional urinary catheters and other incontinence devices and skin irritation normally associated with pressure sensitive adhesives and is a reliable external device for the management of female urinary incontinence and problem male urinary incontinence which_, may be the result of a retracted penis condition due to obesity or other problems. More specifically, the invention relates to a disposable unisex external urinary incontinence device (100) that is composed of a collection receptacle (1 10), a drainage tube (120), and an extended-wear hydrocolloid adhesive (130). The collection receptacle (1 10), which may be made of a vacuum formed film, may be circular, oval, pear, or any other shape that fits securely over the genitals of both males and females. The drainage tube (120) is attached to the outer surface (1 12) of the collection receptacle (1 10) by various means, including welding by heat, radio frequency, or ultrasonic bonding, or adhesive bonding. The extended-wear hydrocolloid adhesive (130) is comprised of a hydrocolloid, an acrylic polymer, a tackifier resin, and optionally, either one or more of an extender such as mineral oil, ethylene vinyl acetate, or styrene-isoprene-styrene (SIS) block copolymer. It may also comprise an antimicrobial additive or other components, such as an odor eliminator, deemed necessary to manage a patient's well-being or other specific condition. The extended-wear hydrocolloid adhesive (130) is attached to the inner surface (1 14) of the collection receptacle (1 10) and forms the interface between the device and the user's skin.

BACKGROUND AND SUMMARY OF THE INVENTION [004] People experience many forms of incontinence. In stress incontinence, urine leaks due to pressure on the lower stomach muscles. In urge incontinence, people experience a sudden urge to urinate. Others experience overflow incontinence, which is a constant release of urine because the bladder continually overflows. Still others have normal bladder control but are unable to reach the toilet in time because of physical limitations (functional incontinence). There are still others that experience total incontinence, typically as a result of a birth defect or injury.

[005] The incontinence may be short-term as a result of bladder infections, constipation, or the side-effects of medication or surgical procedure. It may be long-term as a result of childbirth, surgical procedures, or injury. Or, it may be chronic as a result of a birth defect or a progressive illness, such as Alzheimer's.

[006] Currently, urinary incontinence is treated with urinary catheters, condom catheters, incontinence pads and diapers. There are several problems associated with the current treatments, including infections, leakage, discomfort in wear, and in the case of most catheters, medical intervention for placement or removal.

[007] For males and females, the urinary catheter is inserted through the urethra into the bladder. The incidence of urinary tract infections with catheters, particularly indwelling invasive urinary catheters, is well described in current medical literature. A. Bartlett. Infection risk of urinary catheters. Nurs Stand. 2006 Apr 19-25; 20 (32):55.

[008] For males, the conventional treatment is a condom catheter, which is essentially a sheath connected to a tube. This sheath is usually attached to the penis by a circumferential adhesive band. Often the attachment is inadequate and the condom catheter falls off or leaks. In other cases, the circumferential adhesive band results in irritation or even strangulation of the penis. Additionally, in obese men where their large physical size causes what is known as a retracted penis, the condom catheter is ineffective due to the inability to place the device on, and reliably keep it on the retracted penis.

[009] Incontinence pads or diapers, whether used on male or female patients, also contribute to the onset and severity of infections because the excreted urine and/or feces contained in these devices are excellent media for bacterial growth. Such bacteria can enter the urethra when left unchanged for extended periods of time as can occur in long term care facilities where personnel are often unable to change patients' diapers as frequently as recommended by good medical practice. Additionally, incontinence pads and diapers are prone to leakage, which leads to embarrassment for the wearer. [0010] Given the difficulties with infections, particularly with internal devices, in both males and females, the inability to use condom catheters in some males, and the leakage of diapers and incontinence pads, it is recognized that there is a need for an effective unisex external urinary incontinence device that lessens infection and eliminates leakage. There is also a need for a unisex external urinary incontinence device that is more user-friendly and can be managed by the patient or caregiver without the intervention of a medical practitioner. Furthermore, there is a need for an external urinary incontinence device that is more comfortable to wear and provides psychological and realistic assurance that it is capable of properly performing over an extended period of time. The present invention may be used to treat any of the forms of incontinence for any period of time; however, it is more appropriate for those with chronic incontinence.

[001 1] Others in the field have attempted to solve the difficulties associated with current urinary incontinence devices. Specifically, Lauclar, a Spanish company, has produced a urinary incontinence device. The Lauclar incontinence device, Viluc , is made of a molded silicone that encapsulates the genitals. The device is attached using a medical grade acrylic adhesive manufactured by companies such as 3M in St. Paul, MN or Avery Dennison in Belgium. However, Viluc^® presents with several of the problems associated with other urinary incontinence devices. Specifically, the device is uncomfortable to wear and expensive because of the design material (medical grade silicone). It also leaks when the patient is in the prone position. And, the acrylic adhesive used for the device disintegrates in the presence of urine requiring that the device be changed every 2 to 6 hours on average. The use of an acrylic adhesive also causes problems when the user bathes or showers as this class of adhesive generally is not hydrophilic and loses bond strength to the skin when it becomes wet. [0012] It is therefore an object of the present invention to reduce or eliminate infection associated with the use of conventional urinary catheters, incontinence pads and diapers and condom catheters. It is also an object of the present invention to provide a more comfortable external device thus increasing patient compliance, comfort and quality of life. Another object of the invention is to provide a unisex external urinary incontinence device that can be worn up to 24 hours without premature leakage from the device. In satisfying these objectives, the present invention provides a disposable external urinary incontinence device (100) for females and males that is comprised of a collection receptacle (1 10), a drainage tube (120), and an extended-wear hydrocolloid adhesive (130).

[0013] The collection receptacle (1 10) is a film, such as, but not limited to, polyurethane, polyolefins, or a specialty barrier film, which can be vacuum formed. The collection receptacle (1 10) has an outer surface (1 12) and an inner surface (1 14). The collection receptacle (1 10) may be circular, oval, pear, or any shape that fits securely over the genitals. The inner surface (1 14) is placed over the genitals and adhered to the body using an extended-wear hydrocolloid adhesive (130), which is attached to the outer perimeter (1 16) of the collection receptacle (1 10). It holds the device in place on the body in a secure manner and provides a barrier to external contaminants and a moisture seal that prevents leakage of the collected urine. This collection receptacle (1 10) is much more comfortable than Viluc^® and other medical devices made of the standard medical grade silicone because it is smaller and more flexible. The vacuum formed collection receptacle (1 10) is also less expensive than medical devices made from standard medical grade materials such as the silicone used in the commercial Viluc® device.

[0014] The drainage tube (120) of the unisex external urinary incontinence device (100) is comprised of either polyurethane, polyolefin, or a polyvinyl chloride (PVC) and has a proximal end (122) and a distal end (124). The proximal end (122) of the drainage tube (120) is attached to the outer surface (1 12) of the collection receptacle (1 10). The proximal end (122) of the drainage tube (120) may be attached to the collection receptacle (1 10) through various means, including welding by heat, radiofrequency, ultrasonic bonding, or adhesive bonding. This allows for extended wear of the external urinary incontinence device (100) and removal of liquid from the body surface, thus eliminating maceration. The distal end (124) of the drainage tube (120) may be attached to a urinary collection device (140), such as a leg bag or night drainage bag or bottle, allowing constant removal of urine from the skin.

[0015] The extended-wear hydrocolloid adhesive (130) of the unisex external urinary incontinence device (100) is comprised of a hydrocolloid, an acrylic polymer, a tackifier resin, and optionally, either one or more of mineral oil, ethylene viηyl acetate, styrene- isoprene-styrene copolymer, an antimicrobial additive, or other components, such as an odor additive to manage urine odor, deemed necessary to manage a patient's well-being or other specific condition.

[0016] The hydrocolloid may be any naturally occurring hydrocolloid, a naturally modified derived absorbent substance such as carboxymethylcellulose, or synthetic absorbent materials, and animal derived absorbent substances. The hydrocolloid may be water absorbable or water swellable, or a combination of one or more types. The tackifier resin may be synthetic or natural, including rosin resins, hydrocarbon resins, and terpene rosins. Synthetic esters of rosin resins, and hydrocarbon resins are preferred for medical products over terpene resins and other tackifiers of natural origin because they are less likely to cause irritation and sensitization reactions and provide a better balance of adhesion and tack properties. Of the rosin esters, hydrogenated rosins esters are preferred because they impart less color to the hydrocolloid adhesive and are generally more heat stable. Addition of an extender, such as mineral oil to the hydrocolloid adhesive increases flexibility and lowers modulus (stiffness); while addition of the ethylene vinyl acetate or a styrene-isoprene-styrene copolymer reduces cold flow of the hydrocolloid adhesive. The reduction of cold flow is beneficial in minimizing sticking to bed clothes and bed linen and avoiding residual adhesive around the dressing during wear.

[0017] This extended-wear hydrocolloid adhesive (130) is an improvement over the "standard" medical grade acrylic pressure sensitive adhesive. The "standard" medical grade acrylic pressure sensitive adhesive disintegrates when exposed to urine, and typically lasts for 2 to 6 hours. The extended-wear hydrocolloid adhesive (130) lasts for about 24 hours, three times as long as the "standard" medical grade acrylic pressure sensitive adhesive and in some patients may remain up to 48 hours. This is significant, especially for female users; it eliminates the number of times the device must be removed due to leakage or disintegrates from movement and urine. The long lasting property is also less damaging to the body and more comfortable for a patient, who has to change the device less often. It allows the device to maintain contact when the patient is in the prone position, which has been a problem for previously designed external female devices and for male external incontinence devices when worn by males with a retracted penis condition. With reduced cold flow, the device also reduces or eliminates the "ring" left by adhesives with higher cold flow values.

[0018] THE DRAWINGS

[0019] The present invention is shown in the accompanying drawings, in which —

[0020] FIG. 1 is a full frontal view of the unisex disposable external urinary incontinence device (100) showing the drainage tube (120) and urine collection device (140); [0021] FIG. 2 is a full back view of the unisex disposable external urinary incontinence device (100) with the hydrocolloid adhesive (130);

[0022] FlG. 3 is an exploded view of the two piece unisex disposable external urinary incontinence device (100) and the extended-wear hydrocolloid adhesive (130) fitting on the inner surface (1 14) as a picture frame (1 16) with the drainage tube (120);

DETAILED DESCRIPTION OF THE INVENTION

[0023] The disposable external urinary incontinence device (100) for females and males is comprised of a collection receptacle (1 10), a drainage tube (120), and an extended- wear hydrocolloid adhesive (130). The collection receptacle (1 10) js a film having an inner surface (1 14) and an outer surface (1 12). The film is any that can be vacuum formed, such as polyurethane, polyolefins, or specialty barrier films (e.g., multi-layer blown films which contain a center core of polyvinylidene fluoride as an example). Preferably, the film is a flexible conformable film. The collection receptacle (1 10) may be circular, oval, pear, or any shape that fits securely over the genitals. The extended-wear hydrocolloid adhesive (130) is placed on the inner surface (1 14) of the collection receptacle (1 10). Preferably, the extended- wear hydrocolloid adhesive (130) forms a picture frame along the outside border (1 16) of the inner surface (1 14) of the collection receptacle (1 10); provided, however, any configuration that allows the external urinary incontinence device (100) to be secμred to the patient to prevent leakage of urine is also acceptable. The inner surface (1 14) of the collection receptacle (1 10) is placed over the genitals and adhered to the body using the extended-wear hydrocolloid adhesive (130).

[0024] The drainage tube (120) of the unisex external urinary incontinence device (100) is made of any medical grade material for medical tubing such as polyurethane, polyolefin, silicone, or a polyvinyl chloride (PVC) and has a proximal end (122) and a distal end (124). The proximal end (122) of the drainage tube (120) is attached to the outer surface (1 12) of the collection receptacle (1 10) at a tube opening (1 18). The proximal end (122) of the drainage tube (120) is attached to the collection receptacle (1 10) through various means, including welding by heat, radiofrequency or ultrasonic bonding, or adhesive bonding. This allows for extended wear of the external urinary incontinence device (100) and removal of liquid from the body surface. The distal end (124) of the drainage tube (120) may be attached to a urinary collection device (140), such as a leg bag, allowing constant removal of urine from the skin.

[0025] The extended-wear hydrocolloid adhesive (130) is comprised of any hydrocolloid, a polyacrylic polymer, and a tackifier resin. The hydrocolloid adhesive may further comprise one or more of an extender, such as mineral oil, an ethylene vinyl acetate copolymer, or a styrene-isoprene-styrene copolymer. Optionally, the hydrocolloid may further comprise antimicrobial additives or other components, such as an odor eliminator, deemed necessary to manage a patient's well-being or other specific condition.

[0026] The hydrocolloid may be any naturally occurring hydrocolloid, such as pectin, guar gum, karaya gum, locust bean gum, carageenan, tragacanth gum, alginates, xanthum gum, a naturally derived modified absorbent substance such as carboxymethylcellulose, or synthetic materials such as polyvinyl alcohol, polyoxyalkylene polyols, polyvinyl pyrollidone, and animal derived substances such as gelatin. Ionic hydrocolloids such as hyaluronic acid, chitosan salts or DEAE Dextran may also be used. The hydrocolloid may be water absorbable or water swellable, and combinations of one type or more types may be used in any ratio. Preferably, the hydrocolloid is sodium carboxymethylcellulose.

[0027] The tackifier resin may be synthetic or natural, including rosin resins, hydrocarbon resins, and terpene rosins. Rosin resins are preferred for medical products over terpene resins and other natural product resins because they are less likely to cause irritation and reactions and provide a better balance of adhesion and tack properties, respectively.

[0028] The rosin ester resins, which impart excellent aggressive adhesion to almost all polymer types, may be selected from the group consisting of rosin acids, rosin esters, hydrogenated rosin resins, dimerized rosin resins, or modified rosin resins. Rosin acids, which are generated from the pine tree, may be selected from the group consisting of gum rosin, wood rosin and tall oil rosin. Rosin esters result from the esterification of the rosin acid using alcohol. Hydrogenated rosin resins result from the hydrogenation of the rosin acid and impart an improved thermal stability and lighter color due to the resulting resin. Dimerized rosin resins are produced from dimerized rosin acids, a process which increases the molecular weight, softening point and thermal stability of the rosin acids. Modified rosin resin refers to any modification of a rosin resin that is not esterification, hydrogenation, or dimerization.

[0029] Of the rosin resins, rosin esters or hydrogenated rosin resins are preferred. Rosin esters may be selected from the group consisting of methyl, triethylene glycol, glycerol, and pentaerythritol esters. Hydrogenated rosins esters are the most preferred for the extended-wear hydrocolloid adhesive (130) because they impart less color to the hydrocolloid adhesive and are generally more heat stable. A hydrogenated rosin ester may be selected from the group consisting of diethylene glycol ester of hydrogenated rosjn, hydrogenated glycerol ester of rosin, and pentaerythritol ester of hydrogenated rosin. Preferably, the hydrogenated rosin ester is hydrogenated glycerol ester of rosin, such as Foral^® 85, which may be replaced or blended with any effective tackifier resin such as hydrocarbons, cyclic hydrocarbons, and α and β pinenes. The hydrogenated rosin resin will have a softening point of 85 ⁰C to 105 ⁰C. For example, the hydrogenated glycerol ester of rosin may be Foral^® 85. The pentaerythritol ester of rosin will have a softening point of 75 ⁰C to 140 ⁰C. For example, the pentaerythritol ester of rosin may be Foral^® 105. Most preferably, the tackifier resin is Foral^® 85.

[0030] The acrylic polymer may be any acrylic polymer. Preferably, the acrylic polymer has a softening point of 85⁰C to 150 ⁰C. Most preferably, the acrylic polymer has a softening point range of 100 ⁰C to 125 ⁰C. Ideally, the acrylic polymer is Acrynax^® 1 1891.

[0031] The properties of the hydrocolloid adhesive may be further improved by optionally adding one or more of an extender, such as mineral oil, an ethylene vinyl acetate copolymer, or a styrene-isoprene-styrene copolymer. The addition of mineral oil to the hydrocolloid adhesive increases flexibility and lowers modulus (stiffness); while the addition of ethylene vinyl acetate and the styrene-isoprene-styrene copolymer reduces cold flow of the hydrocolloid adhesive. The ethylene vinyl acetate copolymer may have 6-32% vinyl acetate. Preferably, the ethylene vinyl acetate copolymer contains 28% vinyl acetate. For example, Elvax^® 260 may be used. The styrene-isoprene-styrene copolymer may be any styrene- isoprene-styrene copolymer. Preferably it is a styrene-isoprene-styrene block copolymer. Most preferably, it is a linear styrene-isoprene-styrene block copolymer, such as Vector® or Kraton^®.

[0032] Additionally, antimicrobial additives, such as silver containing molecules (e.g., silver zeolite, silver chloride, silver sulfadiazine, silver glass, and silver nitrate, and other medicaments, can be added to the formula to increase the devices ability to manage microbial infection.

[0033] In one embodiment, the extended-wear hydrocolloid adhesive (130) is comprised of 20-60% (by weight) hydrocolloid, 10-50% (by weight) tackifier resin, and 18- 40% (by weight) acrylic polymer. In a preferred embodiment, the extended-wear hydrocolloid adhesive (130) is comprised of 30 weight % acrylic polymer (such as Acrynax^®), 30 weight % hydrogenated glycerol ester of rosin (such as Foral^® 85) and 40 weight % hydrocolloid (such as sodium carboxymethylcellulose).

[0034] The properties of the hydrocolloid adhesive may be further improved by adding one or more extenders such as, mineral oil, vitamin E oil, an essential oil, or aromatic oil, an ethylene vinyl acetate copolymer, or a styrene-isoprene-styrene copolymer. The weight percent of these components can be 0-15%. In one embodiment, the extended-wear hydrocolloid adhesive (130) is comprised of 20-60% (by weight) hydrocolloid, 10-50% (by weight) tackifier resin, 20-40% (by weight) acrylic polymer, and 0-2% (by weight) of either or both of mineral oil or an ethylene vinyl acetate copolymer. Preferably, the extended-wear hydrocolloid adhesive (130) is comprised of 28 weight % acrylic polymer, 28% weight hydrogenated glycerol ester of rosin, 40 weight % hydrocolloid, 2 weight % of mineral and 2 weight % of ethylene vinyl acetate. Most preferably, the adhesive is comprised of 28 weight % Acrynax^® 1 1891 , 28 weight % Foral^® 85, 40 weight % sodium carboxymethylcellulose, and 2 weight % of mineral and 2 weight % of Elvax^® 260. In another embodiment, the extended-wear hydrocolloid adhesive (130) is comprised of 29-36 % (by weight) hydrocolloid, 20-30% (by weight) tackifier resin, 18-20% (by weight) acrylic polymer, 5- 15% (by weight) of mineral oil, and 10-13 % (by weight) of styrene-isoprene-styrene copolymer. Most preferably, in this embodiment, the extended-wear hydrocolloid adhesive (130) is comprised of 36 % (by weight) hydrocolloid, 30 % (by weight) tackifier resin, 18 % (by weight) acrylic polymer, 5 % (by weight) of mineral oil, and 1 1 % (by weight) of styrene- isoprene-styrene copolymer. More specifically, in this embodiment, the extended-wear hydrocolloid adhesive (130) is comprised of 36 % (by weight) sodium carboxymethylcellulose, 30 % (by weight) Acrynax ^® 1 1891, 18 % (by weight) Foral ^® 85, 5 % (by weight) of mineral oil, and 1 1 % (by weight) of Kraton ^® Dl (61. [0035] Alternatively, antimicrobial additives, such as silver containing molecules and antimicrobial medicaments, can be added to the formula for the extended-wear hydrocolloid adhesive (130) to increase the devices ability to manage microbial infection. The silver containing molecules include but are not limited to silver zeolite, silver chloride, silver sulfadiazine, silver glass and silver nitrate. Other additives such as those used to control odor, as for example, zinc ricinoleate, may be incorporated to increase the quality of life of the user.

[0036] The hydrocolloid adhesive may either be easily removed from the skin and disposed in the case of a one-piece device, or remain on the skin when the collection component (the collection receptacle (1 10) and drainage tube (120)) of the device is removed as may be the case in a two-piece device construction. A new collection component of the device may then be adhered or mechanically locked to the adhesive component. The extended-wear hydrocolloid adhesive (130) may stay in place for at least 24 hours. The extended-wear hydrocolloid adhesive (130) has better balance of physical properties for tack than other hydrocolloid adhesives. Specifically, the cold flow of the extended wear adhesive of the present invention is much improved. It reduces or eliminates the "ring" left by adhesives with higher cold flow values.

[0037] The external urinary incontinence device (100) is manufactured by vacuum forming a flexible film (e.g., polyurethane) to form the collection receptacle (1 10). The proximal end (122) of the drainage tube (120) is bonded to the film. The extended-wear hydrocolloid adhesive (130) is applied to the inner surface (1 14) of the collection receptacle (1 10). The adhesive preferably forms a "picture frame" along the oμtside border (1 16) of the device although any configuration that allows the device to be secured to the patient to prevent leaking of urine or other fluid is also acceptable. [0038] The term "adhesive" as used herein means a substance, inorganic or organic, natural or synthetic, that is capable of attachment to the intended application site of the skin and the device.

[0039] Objects and advantages of this invention will now be illustrated by the following examples, but the particular materials and amounts thereof recited in these examples as well as other conditions and details, should not be construed to unduly limit this invention.

EXAMPLES

[0040] Example 1 : Compositions of Hydrocolloid Adhesive

[0041 ] Three formulations of the hydrocolloid adhesive of the present invention were created:

[0042] Formulation 1 (H 121) comprised of 30% of Acrynax^® 1 1891 , 30% Foral^® 85, and 40% sodium carboxymethylcellulose;

[0043] Formulation 2 (H071 ) comprised of 28% of Acrynax^® 1 1891, 28% Foral^® 85, and 40% sodium carboxymethylcellulose, 2% of mineral oil and 2% of Elvax^® 260; and

[0044] Formulation 3 (H025M4) comprised of 36 % (by weight) sodium carboxymethylcellulose, 30 % (by weight) Acrynax ^® 1 1891 , 18 % (by weight) Foral ^® 85, 5 % (by weight) of mineral oil, and 1 1 % (by weight) of Kraton ^® Dl 161.

[0045] Example 2: Physical Properties of Extended-wear hvdrocolloid adhesive (Adhesive)

[0046] The physical properties of the hydrocolloid adhesive of the present invention were evaluated as follows and are presented in Table 1 :

[0047] Percentage Water absorption After 24 hours [0048] Water absorption determines the amounts of fluid uptake into a known surface of hydrocolloid adhesive. Water absorption of the hydrocolloid adhesive was measured by cutting a sample that was a 1" circular disk. All paper was moved from the sample and the sample was applied to the double-stick tape so that the adhesive side was exposed. Any excessive PET was removed from around the sample. The sample was weighed and recorded (WO). One sample with the adhesive side up was placed in each well of a tray. Approximately 50 ml of saline solution was poured into each well of the tray and the sample submerged into under the solution. Each sample was removed from submersion after 24 hours using silicone tipped forceps. Excess fluid was removed from the sample by gently tapping the sample against the cup. The final weight (W24) of the sample was recorded. The absorption was calculated using the formula:

[0049] Water Absorption (g/10 cm^Λ2) = (W24 - WO) * 10 / 5.065 [0050] [Area = 3.14 * (2.54/2)^Λ2 cm2 = 5.065]

[0051] The water absorption for Formulations 1, 2, and 3 were 557.82, 463.96, and 287.3 %, respectively.

[0052] Modulus

[0053] Modulus measures strength and stiffness of a material at a given strain. It is defined as the ratio, for small strains, of the rate of change of stress with strain. The modulus of the hydrocolloid adhesive of the present invention was measured by cutting a 1" wide strip hydrocolloid sample. The sample was marked with a 25 mm wide strip through the middle. One side of sample was taped to the clamp and the other side to the steel plate. The tensile tester (Chatillon® Tensile Tester) was set a speed of 300 mm/min. The T-peak reading was recorded after 1-2 minutes. The modulus of Formulations 1 , 2, and 3 were 14.682, 1 1.806, and 4.89 (N/in²), respectively. [0054] Probe Tack

[0055] Probe tack measures the adhesive properties of a film for very short contact times. The probe tack of the hydrocolloid adhesive was measured by cutting 1.25 ± 0.05 mm thick (with two sides of silicon paper) 0.5 inch diameter circles of the pressed dough of the hydrocolloid adhesive. The samples were placed on the top metal sample plate of the Probe Tack Tester covering the holes on the side of the plate without overlapping the samples. The top metal plate was positioned on top of the bottom metal plate. The tester measures the force it takes to pull the probe from the sample surface. The probe tack of Formulations 1 , 2, and 3 was found to be 855.82, 737.01, and 239.8 N, respectively.

[0056] Cold Flow

[0057] Cold Flow measures the flow of the hydrocolloid adhesive under a specified pressure after a specified time. Cold flow of the hydrocolloid adhesive of the present invention was measured by cutting 1 " disks of the sample. The disks were stacked (adhere each disk to the next) until the height reached as close to 0.25 inches as possible. The height was measured using a calibrated caliper, and then recorded. The sample was placed under a cold flow gauge and a weight placed on top. The initial micrometer reading was recorded, then readings were recorded every 30 minutes for 150 minutes or at the end of 150 minutes. The cold flow of Formulations 1 , 2, and 3 was found to be was 0.012, 0.010, and 0.04, respectively.

[0058] Peel Adhesion of Hydrocolloid on Stainless Steel

[0059] Peel adhesion of a hydrocolloid adhesive from stainless steel is the average force to remove a hydrocolloid adhesive, laminated under specified conditions on a stainless steel (SS) panel, from the SS panel at constant speed and at an angel of 90°. The peel adhesion of the hydrocolloid adhesive of the present invention was measured by cutting a hydrocolloid sample 25 mm wide and 100 mm long. The sample and test panel were conditioned at room temperature for approximately 8 hours. 20-30 mm of the hydrocolloid adhesive was separated at one end to later be affixed to the upper clamps. The entire specimen was then removed from its liner and placed above the test panel. The sample was allowed to fall gently onto the panel, then using only the weight of the roller, the adhesive was applied to the panel while minimizing the occurrence of air pockets under the sample and allowing only the weight of the roller to press the sample to the panel. 15 mm of the sample was applied to the upper clamp of the tensile tester (Chatillon® Tensile Tester) and the SS panel on the lower clamp of the tester. The peel adhesion was measure at a speed of 5.0 ± 0.2 mm/s while maintaining the angle between the peel direction and the SS panel at 90°. The peel adhesion from stainless steel for the hydrocolloid adhesive Formulations 1 , 2, and 3 was 16.705, 19.476, and 6.93 (N), respectively.

Table 1

[0060] Example 3: Evaluation of Effectiveness of Hydrocolloid Adhesive [0061 ] The effectiveness of the extended-wear hydrocolloid adhesive (130) of the present invention was evaluated on the Viluc female incontinence device (manufactured by

Lauclar, Spain).

[0062] The hydrocolloid adhesive and Viluc device were pjaced on patients with incontinence of urine for three days in succession with alterations every 24 hours by the collector. The patients were female and older than 18 years with an average age of 74 years. They had an average indicator from Katz to H and an average indicator from Barthel at 20 points. The patients had the risk of the appearance of ulcers by pressure at 13 points on the modified NORTON value scale.

[0063] In all patient cases, at the time of the removal of the device, residue was observed on the patient's skin. At the time of removal, the adhesive acquired a blended texture and left residue on the patient's skin. No leaks were observed between the device and the collector, or the skin and the adhesive. When attempting to remove the device the collection device separates from the hydrocolloid adhesive, leaving the adhesive sticking to the perineum.

Claims

WE CLAIM:

1. A disposable external urinary incontinence device (100) comprising a collection receptacle (1 10), a drainage tube (120), and an extended-wear hydrocolloid adhesive (130).

2. The disposable external urinary incontinence device of claim 1 wherein said device is a one-piece device.

3. The disposable external urinary incontinence device of claim 1 wherein said device is a two-piece device.

4. The disposable external urinary incontinence device of claim 1 wherein the collection receptacle (1 10) has an outer surface (1 12) and inner surface (1 14) wherein the drainage tube (120) having a proximal end (122) and a distal end (124) is attached at the proximal end (122) to the outer surface (1 12) and the extended-wear hydrocolloid adhesive (130) is attached to the inner surface (1 14).

5. The disposable external urinary incontinence device of claim 4 wherein the collection receptacle (1 10) having an outer surface (1 12) and inner surface (1 14) has an outer border (1 16) around the inner surface (1 14) where the extended-wear hydrocolloid adhesive (130) is applied.

6. The disposable external urinary incontinence device of claim 1 wherein the collection receptacle is a vacuum formable film.

7. The disposable external urinary incontinence device of claim 1 wherein the collection receptacle is a flexible conformable film.

8. The disposable external urinary incontinence device of claim 1 wherein the extended wear hydrocolloid adhesive stays on at least twice as long as a standard acrylic adhesive.

9. An extended-wear hydrocolloid adhesive comprising of 20-60% (by weight) hydrocolloid, 10-50% (by weight) tackifier resin, 18-40% (by weight) acrylic polymer, and optionally, 0.5 - 15% (by weight) of one or more of an extender.

10. The extended-wear hydrocolloid adhesive of claim 9, wherein the extender is selected from the group consisting of mineral oil, vitamin E oil, an essential oil, an aromatic oil, an ethylene vinyl acetate copolymer, and a styrene-isoprene-styrene copolymer.

1 1. The extended-wear hydrocolloid adhesive of claim 9 comprising 40 weight % of a hydrocolloid, 30 weight % hydrogenated glycerol ester of rosin, and 30 weight % of an acrylic polymer.

12. The extended-wear hydrocolloid adhesive of claim 9 comprising 40 weight % hydrocolloid, 28% weight hydrogenated glycerol ester of rosin, 28 weight % of an acrylic polymer, 2 weight % of mineral and 2 weight % of ethylene vinyl acetate.

13. The extended-wear hydrocolloid adhesive of claim 9 comprising of 29-36 % (by weight) hydrocolloid, 20-30% (by weight) tackifier resin, 18-20% (by weight) acrylic polymer, 5- 15% (by weight) of mineral oil, and 10-13 % (by weight) of styrene-isoprene-styrene copolymer.

14. The extended-wear hydrocolloid adhesive of claim 9 comprising 36 % (by weight) hydrocolloid, 30 % (by weight) tackifier resin, 18 % (by weight) acrylic polymer, 5 % (by weight) of mineral oil, and 1 1 % (by weight) of styrene-isoprene-styrene copolymer.

15. The extended wear hydrocolloid adhesive of claim 9 further comprising an antimicrobial additive or an odor control additive.

16. The extended wear hydrocolloid adhesive of claim 9 wherein the hydrocolloid is selected from the group consisting of pectin, guar gum, karaya gum, locust bean gum, carageenan, tragacanth gum, alginates, xanthum gum, carboxymethylcellulose, polyvinyl alcohol, polyoxyalkylene polyols, polyvinyl pyrollidone, gelatin, hyaluronic acid, chitosan salts, DEAE Dextran, and a combination thereof.

17. The extended wear hydrocolloid adhesive of claim 9 wherein the tackifier resin is selected from the group consisting of rosin resins, hydrocarbon resins, and terpene resins.

18. The extended wear hydrocolloid adhesive of claim 9 wherein the acrylic polymer has a softening point in the range of 85°C and 150⁰C.

19. The extended wear hydrocolloid adhesive of claim 9 wherein the ethylene vinyl acetate copolymer contains 6-32% vinyl acetate.

20. The extended wear hydrocolloid adhesive of claim 9 wherein the ethylene vinyl acetate copolymer contains 6-32% vinyl acetate.