GB2418861A

GB2418861A - Adhesive flange for an ostomy bag

Info

Publication number: GB2418861A
Application number: GB0422338A
Authority: GB
Inventors: Rory James Maxwell Smith; Richard Finn; Martina Reider
Original assignee: Welland Medical Ltd
Current assignee: Welland Medical Ltd
Priority date: 2004-10-07
Filing date: 2004-10-07
Publication date: 2006-04-12
Anticipated expiration: 2024-10-07
Also published as: WO2006038025A1; GB0422338D0; GB2418861B

Abstract

The invention provides an adhesive flange for securing an ostomy bag to the body of a patient about a stomal opening; the adhesive flange comprising a support member 2 having secured to one side thereof (the bag-side) an ostomy bag 6 or means for connection to an ostomy bag, and having on the other side thereof (the body-side) a layer of a bioadhesive (e.g. a hydrocolloid adhesive) 4 for securing the support member to the body of the patient; the support member and adhesive layer having an aperture 8 for locating about the stomal opening and through which stomal waste can pass; characterized in that the aperture is lined with a water repellent material 10 that prevents or inhibits lateral migration of water into the bioadhesive layer 4.

Description

OSTOMY BAGS

This invention relates to improved ostomy bags and in particular to improved methods for securing an ostomy bag to the body of a patient.

Backaround of the Invention

According to UK Department of Health Statistics, about 80,000 people in the UK have stomas of various types. The operation that creates a stoma, known as an ostomy, involves the division of the bowel and the joining of the ends to the body surface either as loop or end stoma. Common bowel conditions that may require stoma formation include carcinomas, Crohn's disease and trauma of various types.

As is well known, there are several different types of ostomy operation: Colostomy: creating an opening for the large intestine or colon on the wall of the abdomen.

Ileostomy: creating an opening for the small bowel on the wall of the abdomen.

15. Urostomy: creating an opening Or the urinary duct on the wall of the abdomen. .

:.: .. Numerous appliances for collecting bodily discharges from patients with stomas ë . have been developed and are in widespread use. Such appliances typically comprise a bag or pouch for receiving liquid, solid or semi- solid waste from the stoma, together with a means for securing the bag to the body of the patient about ë.e the stomal opening. One commonly used method of securing the ostomy bag to the body of the patient is to use an adhesive flange or plate that is f xed around the stoma in order to attach the appliance securely to the skin.

Many ostomy bags in current use make use of hydrocolloid adhesives. One form of hydrocolloid adhesive comprises powdered gelatin, pectin and cellulose in a polyisobutylene (PIB) matrix. The powdered gelatine, pectin and cellulose absorb moisture and gel within the matrix. An adhesive flange of this type can be formed by mixing together PIB and powder components for a period of about 45 minutes at to 75 C and then extruding the mixture for further processing.

Hydrocolloid adhesives have proved to be very effective for use with colostomy patients. The hydrocolloid forms a good bond to the skin for the period over which the colostomy bag is in place, and is very skinfriendly, causing negligible adverse skin reactions.

in the case of colostomy bags, where the waste received from the stoma is of a more solid nature, the moisture absorbed by the hydrocolloid will be mainly water lost through the skin by transpiration. I Iowever, in the case of ileostomy and urostomy bags, additional factors have to be considered. Since the output from the stoma is more liquid, and the edge of the hydrocolloid is exposed around the stoma, the fluid from the stoma and in the bag will be absorbed laterally by the hydrocolloid causing the hydrocolloid to swell progressively until a point is reached where the hydrocolloid begins to dissolve and break down. As the hydrocolloid dissolves, so the adhesion between the adhesive pad and skin of the patient progressively diminishes until there is no longer sufficient adhesion to adhere the medical device to the patient.

Some hydrocolloid adhesives ("integrated hydrocolloid") contain a crosslinked matrix which swells rather than dissolves but a problem here is that once the liquid Abbe 20 absorbent capacity of the matrix is exceeded, the adhesion to the patient fails . shortly thereafter. .e

: The loss of integrity of the adhesive flange not only allows dissolved hydrocolloid to leak into the stomal wound but also allows urine and mucus to leak under the e flange causing maceration of the skin and soiling of the patient's clothing. a

One solution to this problem is to increase the absorbent capacity of the adhesive flange by increasing the thickness of the hydrocolloid layer. For example, whereas a colostomy pouch might be provided with a 0.6 mm thick layer of hydrocolloid, an ileostomy pouch may require a 0.9 mm thick layer of hydrocolloid and a urostomy pouch a 1.8 mm thick layer of hydrocolloid.

Although effective in many respects, increasing the thickness is a rather crude approach to the problem and is not a very cost effective solution, since larger amounts of material are required. Furthermore, some patients have difficulty with cutting the thicker flanges to fit their stomas, and the thicker flanges can be less

comfortable to wear.

Thus, there remains a need for an adhesive flange which has good bioadhesive properties, is skin-friendly, and which retains its integrity in the presence of liquid exudates from a stoma.

Summary of the Invention

In a first aspect, the present invention provides an adhesive flange for securing an ostomy bag to the body of a patient about a stomal opening; the adhesive flange comprising a support member having secured to one side thereof an ostomy bag or means for connection to an ostomy bag, and having on the other side thereof a layer of a bioadhesive (e.g. a hydrocolloid adhesive) for securing the support member to the body of the patient; the support member and adhesive layer having an aperture for locating about the stomal opening and through which stomal waste can pass; characterized in that the aperture is lined with a water repellent material that prevents or inhibits lateral migration of water into the layer. it, . .

2, The present invention also provides an adhesive flange for securing an ostomy bag 20 to the body of a patient about a stomal opening; the adhesive flange comprising a support member having secured to one side thereof an ostomy bag or means for connection to an ostomy bag, and having on the other side thereof a layer of a bioadhesive (e.g. a hydrocolloid adhesive) for securing the support member to the .' body of the patient; the support member and adhesive layer having an aperture for locating about the stomal opening and through which stomal waste can pass; characterized in that the aperture is lined with a moisture barrier to shield the bioadhesive layer from liquid stomal waste.

The bioadhesive is typically one which is degraded by water, for example a hydrocolloid adhesive, e.g. a hydrocolloid adhesive of the type described herein.

The water repellent material is typically a polymer such as a silicone or a polyurethane. The silicone may be one which has adhesive (e.g. lightly adhesive) properties thereby providing a more effective seal around the stoma.

The water repellent material acts as a moisture barrier to prevent or inhibit moisture from migrating from the stoma into the hydrocolloid adhesive. The water repellent material can be presented in the form of a moulded insert that is seated in the aperture in the bioadhesive (e.g. hydrocolloid) layer. The moulded insert typically has a portion (e.g. a portion having a radially outwardly facing surface) for lining the aperture (e.g. a radially inwardly facing surface thereof) and a flange portion that overlies a portion of the body-side surface of the hydrocolloid layer. The insert may also have a flange portion that overlies a portion of the bag-side surface of the hydrocolloid adhesive or the support member.

The insert can be provided separately for use with ostomy bag adhesive flanges, or it can be incorporated into the adhesive flange during manufacture.

The insert can be die cut to a particular size so as to fit a particular size of stoma, and an adhesive Bange may be provided with several inserts of differing sizes so that a patient can select an insert of the appropriate size. Where necessary, the patient can cut the aperture in the adhesive flange to the required size and then fit ha the appropriately sized insert. a.e

In an alternative, the insert can be formed from a material that is deformable (e.g. Abbe plastic) but has negligible elastic memory so that its shape can be adjusted in sit,' to : fit about the stoma of the patient without the need for cutting. 1

a. The insert may be substantially planar in the region in which it comes into contact : "' with the skin of the patient, or it can have a convex formation extending in the direction of the patient's body for applying pressure to the region around the stoma.

This may be beneficial in achieving a better seal between the patient's skin and the ostomy bag flange, particularly when the stoma is retracted or the peristomal area is uneven.

The support member typically takes the fonm of a moulding or film layer to which the hydrocolloid adhesive is applied. The support member may have an ostomy bag secured (for example by adhesive or by welding (e.g. r. f. welding) to one side thereof: Alternatively, the support member may be provided with means for attachment of an ostomy bag, for example when the ostomy bag flange is of the "two-piece" variety comprising separable "body-side" and "bag-side" flange members, the adhesive flange of the invention constituting or forming part of the "body-side" flange member. Such attachment means can be mechanical, for example an anray of ridges and/or grooves on the "bag-side" surface of the support member that interlock with grooves and/or ridges on a "bag- side" flange" to which the bag is attached. Alternatively, or additionally, the attachment means can be adhesive.

In a further aspect, the invention provides an ostomy bag comprising an adhesive flange as defined herein.

Brief Descrintion of the Drawings Figure 1 is a perspective view of an adhesive flange according to one embodiment of the invention.

Figure 2 is a sectional view along line I-I in Figure 1 but additionally showing part of an ostomy bag attached thereto.

Figures 3a, 3b, 3b-1 and 3b-2 show a separate moisture barrier insert, its insertion into a hydrocolloid flange and the resulting composite structure. e. e

. ..

Figure 4 is a cross sectional elevation of an insert according to another embodiment e..

of the invention.

en.

Detailed Description of the Invention .

The invention will now be illustrated in greater detail by reference to the specific embodiments illustrated in the drawings.

As shown in Figures I and 2, an ostomy bag flange according to the invention comprises a support member 2 to which is bonded a layer 4 of a hydrocolloid adhesive. Usually, the hydrocolloid layer will be provided with a protective release layer (not shown) to prevent damage and soiling of the adhesive prior to use. The support member in this embodiment is a layer of thermoplastic film such as polyethylene film. Secured to one side of the support member 2, for example by welding, is one wall of an ostomy bag 6. The ostomy bag may be of conventional form and can be formed of a polymeric film of a type well known for the construction of ostomy bags.

The support member 2 and hydrocolloid layer 4 have a central aperture 8 through which waste from the stoma of a patient can pass. In order to protect the hydrocolloid from the degradative effects of liquid from the stoma' the flange is provided with an insert 10 moulded from a silicone material. The insert 10 has a main portion 12 that lines the inner surface of the aperture 8, and a flange portion 14 that overlies part of the body-side surface of the hydrocolloid layer. The insert acts as a moisture barrier that prevents liquid from the stoma from coming into contact with the hydrocolloid adhesive.

The moisture barrier can be formed and supplied integrally with the adhesive flange or it can be formed separately. Where it is formed separately, it can be inserted into an adhesive flange as part of the manufacturing process or it can be presented separately for insertion by a patient or medically qualified person at the point of . use. ë ..

. Figure 3a shows a separately formed insert 30, which in this embodiment, is formed from a slightly adhesive grade of silicone rubber. The adhesiveness of the silicone ë..

rubber helps to provide a better seal against the peristomal region surrounding the . patient's stoma. As with the embodiment of Figures 1 and 2, the insert has a central A aperture 32 through which the stomal waste can pass, and a radially outwardly facing surface 34 for sealing against and protecting the inner surface of a hydrocolloid adhesive flange. Flange 36 in use overlies part of the body-side surface of the adhesive flange thereby providing further protection against liquid from the stoma.

Figure 3b-2 illustrates the insertion of the moisture barrier insert 30 into the hydrocolloid flange 38.

Figure 3b- 1 illustrates a moisture barrier insert generally similar to that of Figure 3b-2, in that it has a radially outwardly facing surface 44 for engaging and sealing against the inner edge 52 of an aperture in the hydrocolloid flange 50, and a flange 42 which overlies part of the body-side surface of the adhesive flange. However, it differs from the insert of Figure 3b-2 in that it also has a smaller flange 46 which overlies part of the opposite side (bag-side) of the hydrocolloid flange. The flanges 42 and 46 define a groove in which the edge of the hydrocolloid can be seated, the two [ranges providing even more protection against the degradative effects of liquid form the stoma.

Figure 3c illustrates the adhesive flange and insert in an assembled state.

Figure 4 shows a section through an adhesive flange according to another embodiment of the invention. In this embodiment, the insert has a cylindrical portion 62 having a radially outwardly facing surface 64 which engages the inner surface 68 of an aperture in hydrocolloid adhesive flange 66. Flange 70 on the insert 60 in use overlies a portion of the body-side surface of the hydrocolloid flange. However, the insert 60 differs from the inserts of Figures 1, 2, 3a, 3b-1 and 3b-2 in that it has a convex formation 72 extending away from the cylindrical portion 62. The convex formation 72 has a central aperture 74 surrounded by a rim 76. In use, the convex formation 72 applies gentle pressure against the peristomal . . region thereby providing a better seal between the adhesive flange and the patient's : 25 skin and hence further reducing the likelihood of leakage of liquid into the region between the hydrocolloid and the skin. .

: Id: In each of the foregoing embodiments, the insert can be constructed from a water repellent material, such as an appropriate grade of silicone, which has negligible elasticity but is deformable. This permits accommodation of stomas of varying sizes within the internal diameter of the insert by stretching the insert, rather than by cutting the insert to the required shape, an action which can be inconvenient and difficult for patients of impaired manual dexterity.

Equivalents It will readily be apparent that numerous modifications and alterations may be made to the specific embodiments of the invention described above without departing from the principles underlying the invention. All such modifications and alterations are intended to be embraced by this application. . ... I.. I. ë.e .e . . e

Claims

1. An adhesive flange for securing an ostomy bag to the body of a patient about a stomal opening; the adhesive flange comprising a support member having secured to one side thereof (the bag-side) an ostomy bag or means for connection to an ostomy bag, and having on the other side thereof (the body side) a layer of a bioadhesive (e.g. a hydrocolloid adhesive) for securing the support member to the body of the patient; the support member and adhesive layer having an aperture for locating about the stomal opening and through which stomal waste can pass; characterized in that the aperture is lined with a water repellent material that prevents or inhibits lateral migration of water into the bioadhesive layer.

2. An adhesive flange according to claim 1 wherein the water repellent material takes the form of a moulded insert.

3. An adhesive flange according to claim I or claim 2 wherein the water repellent ] 5 material is formed integrally with the adhesive flange.

4. An adhesive flange according to claim 2 wherein the moulded insert is presented separately from the adhesive flange.

5. An adhesive flange according to any one of claims 2 to 4 wherein the insert has a radially outwardly facing surface for engaging and sealing against a radially inwardly facing surface of the aperture in the bioadhesive layer. ë

6. An adhesive flange according to any one of claims 2 to 5 wherein the insert has a flange for overlying a portion of the body-side surface of the bioadhesive . layer.

7. An adhesive flange according to any one of claims 2 to 6 wherein the insert has * 25 a flange for overlying a portion of the bag-side surface of the bioadhesive layer.

8. An adhesive flange according to any one of claims 2 to 7 wherein the insert has a substantially planar surface on the body-side thereof.

9. An adhesive flange according to any one of claims 2 to 7 wherein the insert has a convex formation on the body-side thereof.

10. An adhesive flange according to any one of the preceding claims wherein the water repellent material is a polymer such as a silicone or polyurethane.

1 1. An adhesive flange according to claim 10 wherein the water repellent material is a silicone polymer such as a silicone rubber.

12. An adhesive flange according to claim 10 or claim I 1 wherein the polymer has adhesive properties.

13. An adhesive flange according to any one of claims 10 to 12 wherein the polymer is deformable.

14. An adhesive flange according to claim 13 wherein the polymer has negligible elasticity.

15. An adhesive flange substantially as described herein with reference to the accompanying drawings.

16. An ostomy bag comprising an adhesive flange as defined in any one of the preceding claims.

17. An ostomy bag according to claim 16 which is an ileostomy or urostomy bag.

.

18. An ostomy bag according to claim 17 which is drainable. . a..

19. A moulded insert for an adhesive flange as defined in any one of the preceding . 20 claims. ..

20. A kit comprising an adhesive flange and one or more inserts as defined in claim 2 and any claim dependent thereon. .. e....