WO2008106556A2

WO2008106556A2 - External male catheter with adhesive article for attachment

Info

Publication number: WO2008106556A2
Application number: PCT/US2008/055191
Authority: WO
Inventors: Robert Jensen
Original assignee: Jentec Inc.
Priority date: 2007-02-28
Filing date: 2008-02-27
Publication date: 2008-09-04
Also published as: WO2008106556A3

Abstract

A sheath for an external male catheter having an adhesive article (240) comprised of a pressure non-silicone sensitive adhesive (245) and either a silicone adhesive (247) or an integrated foam strip (243) wherein the design of the adhesive article (240) helps to prevent wrinkling, and thus leakage, and promotes comfort is disclosed.

Description

EXTERNAL MALE CATHETER WITH ADHESIVE ARTICLE FOR ATTACHMENT

BACKGROUND OF THE INVENTION

[001] The invention relates to the sheath 210 for an external catheter 200 for male urinary incontinence. Typically, an external urinary catheter comprises a thin, elastomeric fluid-impermeable sheath that is open at one end and merges at the other end into a narrow drainage tube that is attached to a collection bag, which may be attached to the leg of the wearer of the bag. The sheath, which is applied to the user's penis, is essentially a condom. To work properly, the sheath must be securely fastened to the penis using an adhesive.

[002] Typically, an adhesive is applied to the inner surface of the sheath to allow the catheter to be securely fastened. The sheath is rolled-up in a number of successive windings such that the adhesive on its inner surface is entirely enclosed in the windings so that the adhesive does not adhere to its outer surface. To apply the sheath, it is unrolled slightly until the layer of adhesive on the inner surface is exposed. The sheath is positioned on the penis and the layer of adhesive is brought into contact with the skin and the unwinding is completed.

[003] Silicone is typically used to make the sheaths because of low skin irritation, limited creep, shape retention, and nonstick properties. The adhesive is typically a pressure sensitive adhesive, which easily releases from the sheath when in the rolled-up state. This release effect of the pressure sensitive adhesive from the sheath presents a difficulty in sheath design. To have an effective sheath, the adhesive must attach strongly to the inner surface of the sheath but not to the outer surface. Additionally, the adhesive must attach securely and, preferably, comfortably to the wearer.

[004] Various mechanisms have been used to securely attach adhesive to the inner surface of the sheath. US Patent 5,176,666 describes how to adhere a pressure sensitive adhesive to a dipped silicone sheath. This is accomplished by overcoating a non-cured silicone sheath on a mandrel where adhesive has already been applied. The silicone on the mandrel with adhesive is then cured, which creates a physical binding between the silicone and the adhesive. US Patent 5,779,964 applies a pressure sensitive adhesive to the outside of the sheath, which is transferred to the inside after application of a surface preparation and rolling of the sheath to effect the transfer. WO2006027349 discloses a method for attaching an adhesive to the inside of a cured silicone sheath using an oxidative treatment.

[005] Silicone adhesives have also been used; however, these readily attach to the silicone sheath on both the inner and outer surface upon rolling. A special release layer must be applied to the outer surface of the sheath to prevent the silicone adhesive from adhering to it once in the rolled-up position. U.S. Patent 5,376,085 discloses a method of making a male external catheter with a strip of adhesive where the adhesive is attached to a mandrel and then overcoated with the silicone rubber, which is subsequently vulcanized. The sheaths of catheters made from these methods wrinkle and leak. They can also be uncomfortable for the patient. Thus, there remains a need for an adhesive that securely bonds to the inner surface of the sheath and readily releases from the outer surface of the sheath, which is wrinkle resistant and leak free sheath that is securely and preferably, comfortably, attached to the user.

[006] An object of the present invention is to provide such a sheath using an adhesive article to affect attachment. The present invention provides an external catheter with a wrinkle resistant sheath that reduces the possibility of leakage using an adhesive article comprised of either a silicone adhesive and pressure sensitive non- silicone adhesive or a foam strip and pressure- sensitive non-silicone adhesive or combination thereof.

SUMMARY OF THE INVENTION

[007] The objects of the present invention are obtained by adding an adhesive article 240 to a sheath 210. In one embodiment, the adhesive articles 240 is comprised of a foam strip 243 that is attached to a strip of pressure sensitive non-silicone adhesive 247. The foam strip 243 of the adhesive article 240 may be attached to the inner surface 230 of the sheath 210 during the curing of the sheath material, which is typically an elastomer such as silicone. In another embodiment, the adhesive article 240 is comprised of a silicone adhesive strip 245 that is attached to a strip of pressure sensitive non-silicone adhesive 247. The silicone adhesive strip 245 may be attached to the inner surface 230 of the sheath 210 by rolling the sheath 210 onto the silicone adhesive strip 245 side of adhesive article 240. When the adhesive article is comprised of the silicone adhesive strip 245 that is attached to a strip of pressure sensitive non-silicone adhesive 247, it may be applied directly to the user prior to attachment to the sheath 210. This two-piece system was not previously available for silicone male external catheters. In yet another embodiment, the adhesive article 240 may be comprised of one or more layers of a foam strip 243, a silicone adhesive 245, and a non- silicone adhesive 247.

[008] The sheath 210 may be made by injecting the elastomer into a form or dipping a form into an elastomeric material. The sheath 210 may then be rolled onto the adhesive article 240 or may be bonded when it is injected into a form in which the adhesive article 240 has been placed. When the adhesive article 240 is comprised of the foam strip 243 and pressure sensitive non-silicone adhesive 247, the elastomer (e.g., silicone) seeps into the foam which traps the elastomer in its "open cells" or bonds to the silicone adhesive. Upon curing of the elastomer, it becomes integrated into the open cells of the foam to form a strong mechanical interlock between the elastomer and foam or securely adhered to the silicone adhesive 247. A pressure sensitive non-silicone adhesive 247 is then attached to the foam strip 243 during a separate manufacturing process using coating, lamination or other common methods, which are known to those skilled in the art. The adhesive can also be added in an integral manufacturing step where the adhesive, foam and catheter material is added in succession or simultaneously to accomplish the desired product. [009] The sheath 210, which may be made from any thin, flexible, elastomeric, moisture-impermeable material, such as latex rubber or silicone rubber, is a tube-like shape with a constricted downstream end portion adapted to receive the collection tube 250 that transfers the urine into a collection bag 260. The addition of a collection tube 250 to the sheath 210 and, optionally, a collection bag 260, completes the catheter. Without the addition of the collection tube 250, and, optionally, a collection bag 260, the sheath 210 is essentially a condom.

[0010] Other features, advantages, and objects of the invention will become apparent from the specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Fig. 1 is a perspective view of the male external catheter with the adhesive article 240;

[0012] Fig. 2 is a perspective view of the male external catheter with the adhesive article 240 in the rolled up state;

[0013] Fig. 3 is a perspective view of the male external catheter with the adhesive article 240 in the partially unrolled condition;

[0014] Fig. 4A is an expanded view of a cross-section of the adhesive article 240 with the foam strip 243 and pressure sensitive non-silicone adhesive 247; and

[0015] Fig. 4B is an expanded view of a cross-section of the adhesive article 240 with the silicone adhesive 245 and pressure sensitive non-silicone adhesive 247.

[0016] Fig. 4C is an expanded view of a cross-section of the adhesive article 240 with a layer of silicone adhesive 245, foam strip 243, and pressure sensitive non-silicone adhesive 247.

DETAILED DESCRIPTION OF THE PRESENT INVENTION [0017] The objects of the present invention are obtained by adding an adhesive article 240 to a sheath 210. The adhesive article 240 may be comprised of one or more layers of a foam strip 243 or a silicone adhesive 245 that is attached to a pressure sensitive non-silicone adhesive 247. The adhesive article 240 is attached to the inner surface 230 of a sheath 210. The pressure sensitive non-silicone adhesive 247 will always be the exposed surface of the adhesive article and attach to the wearer.

[0018] The sheath 210 may be made from any thin, flexible, elastomeric, moisture- impermeable material, such as latex rubber or silicone rubber. The sheath 210 is a tube-like shape with a constricted downstream end portion adapted to receive the collection tubing 250 which transfers the urine into an optional collection bag 260. The sheath 210 may be made by injecting the elastomer into a form or dipping a form into the elastomer. The sheath 210 may also be purchased from commercial manufacturers, such as Colorplast or Rochester.

[0019] The foam strip 243 may be made from any cell foam that can be used for medical purposes. The foam may be open cell or closed cell. It may also be hydrophilic or hydrophobic. Preferably, the foam is open cell, absorbent, soft, exceptionally hydrophilic, and readily expandable as it absorbs aqueous fluids. One such foam is disclosed in U.S. Pat. No. 3,903,232. The foam is prepared with polyoxyethylene, polyisocyanates, water and certain surfactants and has an exceptionally fine, uniform, soft, hydrophilic cell structure. It is low density, open cell or semi-open cell in structure, and has an extreme affinity for aqueous fluids. Use of an absorbent foam aids in the reduction of leakage. The foam strip 243 may be any size that accomplishes the goal of the invention. The foam strip 243 is from 0.5 mm to 2.0 mm in thickness. The width is dependent upon the length of the sheath. It may be as wide as necessary to accomplish the object of the invention. For example, in those patients with an inverted penis, the foam strip 243 may be up to 90% of the length of the sheath 210. It may be as thin as desired, provided it is able to securely fasten the adhesive article 240 to the sheath 210. When used as a two-piece system or to attach a condom, the user's preference will determine the size. One skilled in the art will recognize that it will be substantially the same size as the silicone adhesive 245 or pressure sensitive non-silicone adhesive 247 adhered to it.

[0020] The silicone adhesive 245 may be any that can be used in medical applications, such as BIO-SPA® 7-4560 sold by Dow Corning. The silicone adhesive 245 is from 0.01 mm to 0.5 mm in thickness. The width is dependent upon the length of the sheath. It may be as wide as necessary to accomplish the object of the invention. For example, in those patients with an inverted penis, the silicone adhesive 245 may be up to 90% of the length of the sheath 210. It may be as thin as desired, provided it is able to securely fasten the adhesive article 240 to the sheath 210. When used as a two-piece system or to attach a condom, the user's preference will determine the size. One skilled in the art will recognize that it will be substantially the same size as the foam strip 243 or pressure sensitive non- silicone adhesive 247 adhered to it.

[0021] The pressure sensitive non-silicone adhesive 247 may be any adhesive that is currently used to attach medical devices, e.g., wounds dressings and ostomy appliances, to the skin. It may be an acrylic adhesive or a hydrocolloid adhesive. Preferably, it is a hydrocolloid adhesive, which absorbs liquid, prevents leakage, and maintains a moist environment around the adhered skin. For example, the hydrocolloid adhesive may be the HO14 formulation currently manufactured by Euromed, Inc. It may also be the extended- wear hydrocolloid adhesive composition disclosed and claimed in PCT/US07/24213 filed on November 19, 2007, which is incorporated herein by reference. The pressure sensitive non- silicone adhesive 247 is from 0.25 mm to 0.5 mm in thickness. The width is dependent upon the length of the sheath. It may be as wide as necessary to accomplish the object of the invention. For example, in those patients with an inverted penis, the pressure sensitive non- silicone adhesive 247 may be up to 90% of the length of the sheath 210. It may be as thin as desired, provided it is able to securely fasten the adhesive article 240 to the sheath 210. When used as a two-piece system or to attach a condom, the user' s preference will determine the size. One skilled in the art will recognize that it will be substantially the same size as the silicone adhesive 245 or foams strip 243 to which it is adhered.

[0022] In one embodiment, as shown in Fig. 4A, the adhesive articles 240 is comprised of a foam strip 243 that is attached to a strip of pressure sensitive non-silicone adhesive 247. The foam strip 243 of the adhesive article 240 may be attached to the inner surface 230 of the sheath 210 during the curing of the sheath material, which is typically an elastomer such as silicone. To create the catheter 200, initially, attach the adhesive article comprising the foam strip 243 and the pressure sensitive non-silicone adhesive 247 to the sheath 210. The attachment may be accomplished by injecting the elastomer into a form or dipping a form into the elastomer on which the foam strip 243 has been placed. The elastomer seeps into the foam which traps it in its "open cells." Another method of attachment utilizes the silicones ability to crosslink with the foam material and the sheath simultaneously thereby creating the bond necessary to attach the foam and adhesive to the catheter. Upon curing of the elastomer, the elastomer becomes integrated into the open cells of the foam to form a strong mechanical interlock between the elastomer and foam. Another method of attachment utilizes the silicones ability to crosslink with the foam material and the sheath simultaneously thereby creating the bond necessary to attach the foam and adhesive to the catheter. A pressure sensitive non-silicone adhesive 247 is then attached to the foam strip 243. The pressure sensitive non-silicone adhesive 247 may be attached during a separate manufacturing process using coating, lamination or other common methods, which are known to those skilled in the art. The pressure sensitive non-silicone adhesive 247 can also be added in an integral manufacturing step where the pressure sensitive non-silicone adhesive 247, foam strip 243 and sheath material is added in succession or simultaneously to accomplish the desired product. The silicone can be "painted" onto the outer surface of the foam strip 243 and the strip attached to a ready made sheath 210.

[0023] In another embodiment, as shown in Fig. 4B, the adhesive article 240 is comprised of a silicone adhesive strip 245 that is attached to a strip of pressure sensitive non- silicone adhesive 247. The adhesive article 240 can be assembled on a mandrel where the pressure sensitive non- silicone adhesive 247 is applied followed by the silicone adhesive 245. The silicone adhesive strip 245 may be attached to the inner surface 230 of the sheath 210 by rolling the sheath 210 onto the mandrel containing the adhesive article where the silicone adhesive strip 245 of adhesive article 240 is exposed. Alternatively, the adhesive article 240 can be assembled during a separate manufacturing process using coating, lamination or other common methods, which are known to those skilled in the art, to attach the silicone adhesive 245 and pressure sensitive non- silicone adhesive 247 together. The silicone adhesive 245 and pressure sensitive non- silicone adhesive 247 readily attach to one another when placed together under a reasonable pressure. This two-piece system was not previously available for silicone male external catheters. The two-piece approach also reduces the complexity of the manufacturing process. In this embodiment, the adhesive article 240 may be applied directly to the user prior to attachment to the sheath 210. For example, it may be applied directly to the penis and the catheter applied. Similarly, it may be applied to the user for u se with a condom (a sheath 210 without the optional collection bag 260). Likewise, it may be applied to a female patient who uses an incontinence device applied to a female similar to that described in PCT/US07/24213 filed on November 19, 2007, which is incorporated herein by reference.

[0024] In yet another embodiment, the adhesive article 240 may be comprised of one or more layers of a foam strip 243, a silicone adhesive 245, and a pressure sensitive non- silicone adhesive 247. For example, as shown in Fig. 4C, it may be comprised of a foam strip 243 attached to the inner surface 230 of the sheath, followed by a layer of silicone adhesive 245 and then a pressure sensitive non-silicone adhesive 247. One skilled in the art will understand that as many layers as desired may be utilized provided that the adhesive article 240 is securely fastened to the sheath 210 and the final layer is a pressure sensitive non- silicone adhesive 247 for attachment to the skin.

[0025] The addition of a collection tube 250 to the sheath 210 and, optionally, a collection bag 260, completes the catheter.

[0026] While embodiments of the invention have been disclosed in considerable detail for purposes of illustration, it will be understood by those skilled in the art that many of these details may be varied without departing from the spirit and scope of the invention.

Claims

WE CLAIM:

1. An adhesive article 240 comprising one or more layers of a foam strip 243 or a silicone adhesive 245 attached to a pressure sensitive non- silicone adhesive 247.

2. The adhesive article 240 of claim 1 comprising a foam strip 243 and a pressure sensitive non- silicone adhesive 247.

3. The adhesive article 240 of claim 1 comprising a silicone adhesive 245 and a pressure sensitive non- silicone adhesive 247.

4. A male external catheter comprising a sheath 210 having an inner surface 230 comprising an adhesive article 240, a collection tube 250 and, optionally, a collection bag 260.

5. The male external catheter of claim 4, wherein the adhesive article 240 comprises a foam strip 243 attached to the inner surface 230 of the sheath 210 and a pressure sensitive non-silicone adhesive 247 attached to the exposed surface of the foam strip 243.

6. The male external catheter of claim 4, wherein the adhesive article 240 comprises a silicone adhesive 245 attached to the inner surface 230 of the sheath 210 and a pressure sensitive non-silicone adhesive 247 attached to the exposed surface of the silicone adhesive 245.

7. The male external catheter of claim 4, wherein the sheath 210 is made from any thin, flexible, elastomeric, moisture-impermeable material, such as latex rubber or silicone rubber.

8. The male external catheter of claim 5, wherein the foam strip 243 is made from any open cell foam that can be used for medical purposes.

9. The male external catheter of claim 5, wherein the pressure sensitive non- silicone adhesive 247 is any used to attach medical devices to the skin.

10. The male external catheter of claim 6, wherein the pressure sensitive pressure sensitive non-silicone adhesive 247 is any used to attach medical devices to the skin.

11. The male external catheter of claim 9, wherein the pressure sensitive non- silicone adhesive 247 is an acrylic or hydrocolloid adhesive.

12. The male external catheter of claim 10, wherein the pressure sensitive non- silicone adhesive 247 is an acrylic or hydrocolloid adhesive.

13. The male external catheter of claim 11, wherein pressure sensitive a non- silicone adhesive 247 is a hydrocolloid adhesive.

14. The male external catheter of claim 12, wherein the pressure sensitive non- silicone adhesive 247 is a hydrocolloid adhesive.

15. A method of making a male external catheter comprising: a) Applying the adhesive article 240 to a mandrel; and b) Unrolling a silicone sheath 210 onto the mandrel over the adhesive article 240; and c) Attaching a collection tube 250 to the sheath 210, and, optionally, a collection bag 260.

16. A method of making the male external catheter of claim 15 comprising: a) Applying the pressure sensitive non-silicone adhesive 247 to the mandrel; b) Applying the silicone adhesive 245 to the pressure sensitive non- silicone adhesive 247 to the mandrel; and c) Unrolling a silicone sheath 210 onto the mandrel over the silicone adhesive 247; and d) Attaching a collection tube 250 to the sheath 210, and, optionally, a collection bag 260.

17. A method of making the male external catheter of claim 15 comprising: a) Applying a foam strip 243 to a form used to make a sheath 210; b) Applying an elastomer to the form; c) Allowing the elastomer to seep into the foam such that the elastomer gets trapped in the "open cells" of the foam; d) Curing or cross-linking the elastomer so that it becomes integrated into the open cells of the foam; and e) Attaching a pressure- sensitive non- silicone adhesive 247 to the foam strip 243.

18. The method of claim 17, where the elastomer is applied to the form using injection or dipping.

19. The method of claim 17, where the pressure-sensitive non-silicone adhesive 247 is applied to the foam strip 243 during a separate manufacturing process using coating, lamination or other common methods.

20. The method of claim 17, where the pressure-sensitive non-silicone adhesive 247 is applied to the foam strip 243 in an integral manufacturing step.