GB2283916A - Adhesive flange for stomal appliance - Google Patents

Adhesive flange for stomal appliance Download PDF

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Publication number
GB2283916A
GB2283916A GB9321934A GB9321934A GB2283916A GB 2283916 A GB2283916 A GB 2283916A GB 9321934 A GB9321934 A GB 9321934A GB 9321934 A GB9321934 A GB 9321934A GB 2283916 A GB2283916 A GB 2283916A
Authority
GB
United Kingdom
Prior art keywords
adhesive
hydrogel
adhesive flange
radially
hydrogel layer
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
GB9321934A
Other versions
GB2283916B (en
GB9321934D0 (en
Inventor
Christopher John Raper
Gillian Rose Little
Rory James Maxwell Smith
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Welland Medical Ltd
Original Assignee
Welland Medical Ltd
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 Welland Medical Ltd filed Critical Welland Medical Ltd
Priority to GB9321934A priority Critical patent/GB2283916B/en
Publication of GB9321934D0 publication Critical patent/GB9321934D0/en
Publication of GB2283916A publication Critical patent/GB2283916A/en
Application granted granted Critical
Publication of GB2283916B publication Critical patent/GB2283916B/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A61L24/0031—Hydrogels or hydrocolloids
    • 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
    • A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/06—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/14—Adhesives for ostomy devices

Abstract

An adhesive flange for a stomal appliance such as an ostomy bag comprising an adhesive hydrogel layer 1 arranged to surround a stomal opening and having a radially inner edge and radially outer edge, the hydrogel layer 1 being bonded to a backing layer 3 formed of a water-vapour permeable material, wherein the backing layer 3 extends radially beyond the said inner edge and outer edge of the hydrogel layer and is arranged in use to form a seal (4) against the skin of a patient radially inwardly and radially outwardly of the hydrogel layer 1. <IMAGE>

Description

ADHESIVE FLANGE The invention relates to an adhesive flange suitable for securing a stomal appliance such as an ostomy bag to the skin of a patient about a stomal opening.
Currently, stomal appliances such as ostomy bags are fixed to the skin of a patient about the stomal opening by means of adhesives such as hydrocolloid adhesives, typically based on mixtures of polyisobutylene, gelatin, pectin and carboxymethyl cellulose. However, a problem with hydrocolloid adhesives is that they tend to leave deposits when removed, and are somewhat less flexible than is ideally desirable. Also, they have a tendency to become dry and brittle at their edges.
There is a need for a new form of adhesive flange which is more flexible than those currently available, and which is more "skin friendly". It is an object of the present invention to provide such an adhesive flange.
Accordingly, in a first aspect, the invention provides an adhesive flange for a stomal appliance such as an ostomy bag, the adhesive flange comprising an adhesive hydrogel layer arranged to surround a stomal opening and having a radially inner edge and a radially outer edge, the hydrogel layer being bonded to a backing layer formed of a watervapour permeable material, wherein the backing layer extends radially beyond the said inner edge and outer edge of the hydrogel layer and is arranged in use to form a seal against the skin of a patient radially inwardly and radially outwardly of the hydrogel layer.
In use, the hydrogel adhesive is affixed to the body of the patient, and the backing layer faces outwardly from the body. The backing layer typically is secured to an ostomy appliance such as an ostomy bag by, for example, adhesive bonding or welding.
The hydrogel adhesive can be an adhesive waterswellable polymer. Typically the hydrogel adhesive is formed of polymeric materials which are cross-linked, either physically or chemically. Examples of cross-linked polymers are cross-linked polyacrylamide gels; polymers containing cross-linked polymer chains derived from styrene, isoprene, cyclopentadiene and dioctyl adipate monomers; and polyhydroxy ethyl methacrylic acids.
Alternatively gel-forming natural and modified polysaccharides can be used.
The hydrogel layer may be of any shape suitable for use in a stomal appliance context. For example, it may be in the form of a circular annulus, or it may be oval in shape. The hydrogel layer may be of generally uniform thickness, but it may also vary in thickness across its width. Thus, for example, it may decrease in thickness in a radially outward direction.
The hydrogel layer may be reinforced by having incorporated into the matrix thereof a reinforcing fabric, for example a woven, knitted or non-woven fabric. A preferred reinforcing medium is activated carbon cloth, which may be in woven, non-woven or knitted form. The activated carbon cloth serves the purpose of adsorbing odours penetrating laterally through the flange.
In another aspect of the invention, there is provided an adhesive article, e.g. an adhesive patch, comprising an adhesive hydrogel reinforced by means of activated carbon cloth. The reinforcement may be in the form of a single layer or multiple layers within the matrix formed by the hydrogel.
Examples of carbon cloth are carbon cloths such as those supplied by Charcoal Cloth (International) Ltd of Houghton le Spring, Sunderland, UK) a particular example being the heavy weave carbon cloth designated FM 5/250. In the adhesive flange of the present invention, the backing layer may be provided with an adhesive to enable it to be adhered to the skin to form the seal radially inwardly and radially outwardly of the hydrogel layer. The adhesive may extend around only the periphery of the backing layer, or a layer of adhesive may be interposed between the hydrogel layer and the backing layer to bond the hydrogel layer thereto. The adhesive will be a hypoallergenic adhesive which does not cause undue skin irritation.
In a further aspect, the invention provides an ostomy device, such as an ostomy bag, wherein said ostomy device includes an adhesive flange as hereinbefore defined.
The invention will now be illustrated by reference to the particular embodiments shown in the accompanying drawings, of which: Figure 1 is a view from one side of an adhesive flange according to one embodiment of the invention; Figure 2 is a sectional elevation along line I-I of Figure 1; and Figure 3 is a sectional elevation along line I-I of an alternative embodiment of the invention.
Referring now to the Figures it can be seen that an adhesive flange according to the invention can comprise a hydrogel disc 1, for example formed of cross-linked polyhydroxy ethyl methacrylic acid. The hydrogel disc is provided with a generally central aperture 2 through which the stoma S of the patient may protrude. Overlying the hydrocolloid gel disc 1 is a backing layer 3 formed of a polyurethane foam material, for example a polyurethane foam material manufactured by 3M Ltd of Loughborough, UK.
Extending around the periphery of the backing layer 3 is a layer of adhesive 4, for example formed from an emulsion acrylic adhesive. As can be seen from the Figures, the backing layer 3 is provided with portions 5 and 6 which extend beyond radially outer and radially inner edges 7 and 8 respectively of the hydrogel layer.
The surface 9 of the backing layer typically is bonded to an ostomy appliance such as an ostomy bag, for example by means of adhesive or by welding. For the purposes of clarity, the ostomy bag is not illustrated.
In use, the adhesive flange with ostomy appliance attached is affixed to the skin of the patient about the stomal opening S, the hydrocolloid adhesive 1 serving to adhere the flange to the skin of the patient. Portions 5 and 6 of the backing layer 3 form a seal against the skin by virtue of the adhesive layers 4. The seal between the backing layer and the skin serves to prevent waste materials from the stomal opening coming into contact with the hydrocolloid adhesive.
An alternative embodiment is illustrated in Figure 3, wherein the hydrocolloid layer 11 is shown having a thickness which varies across its width and decreases in thickness away from the generally central aperture 12.
An advantage of adhesive flanges of the present invention is that they are generally kinder to the skin of the patient than is the case with hydrocolloid adhesives, and moreover tend to be more flexible than known types of flange.
The invention has been illustrated by reference to particular embodiments, but it will be readily appreciated that numerous modifications and alterations may be made to the exemplified embodiments without departing from the principles underlying the invention. For example, the hydrocolloid layers shown in Figures 1, 2 and 3 can be reinforced by an activated carbon fabric, the carbon fabric serving to adsorb odours permeating transversely through the flange. Also, although the flange has been shown as being of circular form, it may be of any other suitable shape, provided that it is suitable for fitting about the stomal opening of the patient to enable the connection thereto of an ostomy appliance. All such modifications and alterations are intended to be embraced by this application.

Claims (11)

1. An adhesive flange for a stomal appliance such as an ostomy bag, the adhesive flange comprising an adhesive hydrogel layer arranged to surround a stomal opening and having a radially inner edge and a radially outer edge, the hydrogel layer being bonded to a backing layer formed of a water-vapour permeable material, wherein the backing layer extends radially beyond the said inner edge and outer edge of the hydrogel layer and is arranged in use to form a seal against the skin of a patient radially inwardly and radially outwardly of the hydrogel layer.
2. An adhesive flange according to Claim 1 where the hydrogel adhesive is an adhesive water-swellable polymer.
3. An adhesive flange according to Claim 2 wherein the hydrogel adhesive is formed of polymeric materials which are cross-linked, either physically or chemically.
4. An adhesive flange according to Claim 3 wherein the cross-linked polymer is a cross-linked polyacrylamide gel, a polymer containing cross-linked polymer chains derived from styrene, isoprene, cyclopentadiene and dioctyl adipate monomers; and polyhydroxy ethyl methacrylic acids.
5. An adhesive flange according to Claim 2 wherein the adhesive water-swellable polymer is a gel-forming natural or modified polysacharide.
6. An adhesive flange according to any one of the preceding Claims wherein the hydrogel layer is reinforced by having incorporated into the matrix thereof a reinforcing fabric.
7. An adhesive flange according to Claim 6 wherein the reinforcing fabric is a woven, knitted or non-woven fabric.
8. An adhesive flange according to Claim 6 or Claim 7 wherein the reinforcing fabric is activated carbon cloth.
9. An adhesive article comprising an adhesive hydrogel as defined in any one of the preceding Claims reinforced by means of activated carbon cloth.
10. An ostomy device, such as a ostomy bag, wherein said ostomy device includes an adhesive flange as defined in any one of Claims 1 to 8.
11. An adhesive flange substantially as described herein with reference to the accompanying drawings.
GB9321934A 1993-10-25 1993-10-25 Adhesive flange Expired - Fee Related GB2283916B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB9321934A GB2283916B (en) 1993-10-25 1993-10-25 Adhesive flange

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB9321934A GB2283916B (en) 1993-10-25 1993-10-25 Adhesive flange

Publications (3)

Publication Number Publication Date
GB9321934D0 GB9321934D0 (en) 1993-12-15
GB2283916A true GB2283916A (en) 1995-05-24
GB2283916B GB2283916B (en) 1997-06-18

Family

ID=10744056

Family Applications (1)

Application Number Title Priority Date Filing Date
GB9321934A Expired - Fee Related GB2283916B (en) 1993-10-25 1993-10-25 Adhesive flange

Country Status (1)

Country Link
GB (1) GB2283916B (en)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0806210A2 (en) * 1996-04-30 1997-11-12 Hollister Incorporated Adhesive wafer with embossed skin-contacting surface
US5730736A (en) * 1996-04-30 1998-03-24 Dansac A/S Ostomy appliance and contoured adhesive wafer therefor
WO2000030576A1 (en) * 1998-11-19 2000-06-02 Coloplast A/S An ostomy appliance
EP1044667A1 (en) * 1999-04-12 2000-10-18 The Procter & Gamble Company Container for the collection of bodily waste.
AU750942B2 (en) * 1998-06-26 2002-08-01 Procter & Gamble Company, The Faecal collector having breathable skin attachment means
GB2418861A (en) * 2004-10-07 2006-04-12 Welland Medical Ltd Adhesive flange for an ostomy bag
WO2007121744A1 (en) * 2006-04-25 2007-11-01 Coloplast A/S An adhesive wafer
WO2010121623A1 (en) * 2009-04-21 2010-10-28 Coloplast A/S Adhesive wafer for use in a collecting device
US9999535B2 (en) 2010-12-17 2018-06-19 Coloplast A/S Ostomy wafer
US11077224B2 (en) 2015-02-02 2021-08-03 Coloplast A/S Ostomy device
US11160681B2 (en) 2015-04-10 2021-11-02 Coloplast A/S Ostomy device

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0072607A2 (en) * 1981-04-20 1983-02-23 Pfizer Inc. Adhesive pad for ostomy use
EP0426422A2 (en) * 1989-11-01 1991-05-08 Ndm Acquisition Corp. Hydrogel wound dressing product
GB2277031A (en) * 1993-03-30 1994-10-19 Welland Medical Ltd Drainable collection bag

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0072607A2 (en) * 1981-04-20 1983-02-23 Pfizer Inc. Adhesive pad for ostomy use
EP0426422A2 (en) * 1989-11-01 1991-05-08 Ndm Acquisition Corp. Hydrogel wound dressing product
GB2277031A (en) * 1993-03-30 1994-10-19 Welland Medical Ltd Drainable collection bag

Cited By (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0806210A2 (en) * 1996-04-30 1997-11-12 Hollister Incorporated Adhesive wafer with embossed skin-contacting surface
US5730736A (en) * 1996-04-30 1998-03-24 Dansac A/S Ostomy appliance and contoured adhesive wafer therefor
US5811116A (en) * 1996-04-30 1998-09-22 Hollister Incorporated Adhesive wafer with embossed skin-contacting surface
US5834009A (en) * 1996-04-30 1998-11-10 Hollister Incorporated Contoured adhesive wafer for ostomy appliance
EP0806210A3 (en) * 1996-04-30 2000-03-22 Hollister Incorporated Adhesive wafer with embossed skin-contacting surface
EP0832626A3 (en) * 1996-09-26 1999-08-18 Hollister Incorporated Ostomy appliance and contoured adhesive wafer therefor
AU750942B2 (en) * 1998-06-26 2002-08-01 Procter & Gamble Company, The Faecal collector having breathable skin attachment means
US6626878B1 (en) 1998-11-19 2003-09-30 Coloplast A/S Ostomy appliance with perforated flange
AU770808B2 (en) * 1998-11-19 2004-03-04 Coloplast A/S An ostomy appliance
EP1466573A3 (en) * 1998-11-19 2004-12-08 Coloplast A/S An ostomy appliance
WO2000030576A1 (en) * 1998-11-19 2000-06-02 Coloplast A/S An ostomy appliance
EP1044667A1 (en) * 1999-04-12 2000-10-18 The Procter & Gamble Company Container for the collection of bodily waste.
WO2000061051A1 (en) * 1999-04-12 2000-10-19 The Procter & Gamble Company Container for the collection of bodily waste
GB2418861B (en) * 2004-10-07 2009-10-28 Welland Medical Ltd Ostomy bags
GB2418861A (en) * 2004-10-07 2006-04-12 Welland Medical Ltd Adhesive flange for an ostomy bag
WO2007121744A1 (en) * 2006-04-25 2007-11-01 Coloplast A/S An adhesive wafer
US8319003B2 (en) 2006-04-25 2012-11-27 Coloplast A/S Adhesive wafer
US20090312685A1 (en) * 2006-04-25 2009-12-17 Hans Olsen Adhesive Wafer
CN101431969B (en) * 2006-04-25 2011-06-15 科洛普拉斯特公司 An adhesive wafer
RU2525703C2 (en) * 2009-04-21 2014-08-20 Колопласт А/С Adhesive plate for use in receiving unit
CN102413797A (en) * 2009-04-21 2012-04-11 科洛普拉斯特公司 Adhesive wafer for use in a collecting device
US8679082B2 (en) 2009-04-21 2014-03-25 Coloplast A/S Adhesive wafer for use in a collecting device
WO2010121623A1 (en) * 2009-04-21 2010-10-28 Coloplast A/S Adhesive wafer for use in a collecting device
CN102413797B (en) * 2009-04-21 2015-01-14 科洛普拉斯特公司 Adhesive wafer for use in a collecting device
US9999535B2 (en) 2010-12-17 2018-06-19 Coloplast A/S Ostomy wafer
US11077224B2 (en) 2015-02-02 2021-08-03 Coloplast A/S Ostomy device
US11771798B2 (en) 2015-02-02 2023-10-03 Coloplast A/S Ostomy device with a switchable adhesive layer located between a backing layer and an absorbent adhesive layer
US11160681B2 (en) 2015-04-10 2021-11-02 Coloplast A/S Ostomy device
US11819444B2 (en) 2015-04-10 2023-11-21 Coloplast A/S Ostomy device with a switchable adhesive composition adapted to be switched by moisture activation of a switch initiator

Also Published As

Publication number Publication date
GB2283916B (en) 1997-06-18
GB9321934D0 (en) 1993-12-15

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PCNP Patent ceased through non-payment of renewal fee

Effective date: 20121025