WO2008106556A2 - Cathéter externe pour homme avec article adhésif pour fixation - Google Patents

Cathéter externe pour homme avec article adhésif pour fixation Download PDF

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Publication number
WO2008106556A2
WO2008106556A2 PCT/US2008/055191 US2008055191W WO2008106556A2 WO 2008106556 A2 WO2008106556 A2 WO 2008106556A2 US 2008055191 W US2008055191 W US 2008055191W WO 2008106556 A2 WO2008106556 A2 WO 2008106556A2
Authority
WO
WIPO (PCT)
Prior art keywords
adhesive
silicone adhesive
sheath
silicone
pressure sensitive
Prior art date
Application number
PCT/US2008/055191
Other languages
English (en)
Other versions
WO2008106556A3 (fr
Inventor
Robert Jensen
Original Assignee
Jentec Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jentec Inc. filed Critical Jentec Inc.
Publication of WO2008106556A2 publication Critical patent/WO2008106556A2/fr
Publication of WO2008106556A3 publication Critical patent/WO2008106556A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the objects of the present invention are obtained by adding an adhesive article 240 to a sheath 210.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 1 is a perspective view of the male external catheter with the adhesive article 240;
  • FIG. 2 is a perspective view of the male external catheter with the adhesive article 240 in the rolled up state
  • FIG. 3 is a perspective view of the male external catheter with the adhesive article 240 in the partially unrolled condition
  • 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;
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Reproductive Health (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne une gaine pour un cathéter externe pour homme ayant un article adhésif (240) comprenant un adhésif sensible à la pression non en silicone (245) et soit un adhésif en silicone (247) soit une bande de mousse intégrée (243), la conception de l'article adhésif (240) permettant d'empêcher les plis, et ainsi les fuites, et favorisant le confort.
PCT/US2008/055191 2007-02-28 2008-02-27 Cathéter externe pour homme avec article adhésif pour fixation WO2008106556A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US90394807P 2007-02-28 2007-02-28
US90394707P 2007-02-28 2007-02-28
US60/903,948 2007-02-28
US60/903,947 2007-02-28

Publications (2)

Publication Number Publication Date
WO2008106556A2 true WO2008106556A2 (fr) 2008-09-04
WO2008106556A3 WO2008106556A3 (fr) 2009-09-17

Family

ID=39618771

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/055191 WO2008106556A2 (fr) 2007-02-28 2008-02-27 Cathéter externe pour homme avec article adhésif pour fixation

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WO (1) WO2008106556A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111110430A (zh) * 2019-12-31 2020-05-08 帝斯博（常州）医疗用品股份有限公司 自粘型男用导尿套及其制作方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4769099A (en) * 1987-07-06 1988-09-06 Hollister Incorporated Method of making an adhesive lined elastic sheath
US5078707A (en) * 1991-02-08 1992-01-07 Sierra Laboratories, Inc. External urine collection device
WO1992008426A1 (fr) * 1990-11-09 1992-05-29 Rochester Medical Corporation Catheter externe pour l'urine comprenant un systeme de fixation incorpore
US5830932A (en) * 1991-08-20 1998-11-03 Bioderm, Inc. External incontinence device and vapor-absorptive adhesive compositions
EP2008624A1 (fr) * 2007-06-26 2008-12-31 MBH International A/S Laminé adhésif, cathéter urinaire externe male comportant le laminé adhésif, et procédé d'application du laminé adhésif

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4769099A (en) * 1987-07-06 1988-09-06 Hollister Incorporated Method of making an adhesive lined elastic sheath
WO1992008426A1 (fr) * 1990-11-09 1992-05-29 Rochester Medical Corporation Catheter externe pour l'urine comprenant un systeme de fixation incorpore
US5078707A (en) * 1991-02-08 1992-01-07 Sierra Laboratories, Inc. External urine collection device
US5830932A (en) * 1991-08-20 1998-11-03 Bioderm, Inc. External incontinence device and vapor-absorptive adhesive compositions
EP2008624A1 (fr) * 2007-06-26 2008-12-31 MBH International A/S Laminé adhésif, cathéter urinaire externe male comportant le laminé adhésif, et procédé d'application du laminé adhésif

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111110430A (zh) * 2019-12-31 2020-05-08 帝斯博（常州）医疗用品股份有限公司 自粘型男用导尿套及其制作方法

Also Published As

Publication number Publication date
WO2008106556A3 (fr) 2009-09-17

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