Reformable convex adapter for ostomy appliance and method of use

• US 6,569,134 B1
• Filed: 06/14/2000
• Issued: 05/27/2003
• Est. Priority Date: 06/14/2000
• Status: Expired due to Term

• Current Assignee: Hollister Incorporated
• Original Assignee: Hollister Incorporated
• Inventors: Metz, Michael A., Botten, Ronald S., Leise, Walter F. Jr.
• Primary Examiner(s): Lo, Weilun
• Assistant Examiner(s): TRUONG, LINH T
• Application Number:
  US09/593,549
• Time in Patent Office: 1,077 Days
• Field of Search: 604/277, 604/332-342
• US Class Current: 604/332
• CPC Class Codes: A61F 2005/4483 Convex pressure ring
• CPC Class Codes: A61F 5/448 Means for attaching bag to seal ring

Abstract

A convex adapter for ostomy appliances, including an adapter ring formed entirely of soft, moisture-absorbent, hydrocolloid-containing adhesive material that retains its integrity on hydration and is shape-recoverable, and a thin stretchable cover film (preferably transparent or translucent) removably covering and extending over and beyond the ring'"'"'s convex bodyside surface. A flexible but substantially non-stretchable release sheet is removably attached to the opposite pouchside surface of the ring and may be peeled away from the ring during an initial step in the use of the product. With the release sheet so removed, a user may grasp adapter ring and its cover film and reform the ring so that its opening is sized and shaped to match a patient'"'"'s stoma, after which the reformed adapter ring is adhered to the adhesive faceplate of an ostomy appliance, the cover film is removed, and the combination faceplate/adapter is adhesively secured to a patient'"'"'s peristomal skin surfaces.

Claims

1. A convex adapter for use with an adhesive faceplate of an ostomy appliance, comprising an adapter ring formed entirely of soft shape-recoverable skin barrier material having a convex body surface, a generally planar opposing surface, and a centrally-located stoma-receiving opening therethrough;

a removable release sheet covering said opposing surface; and

a stretchable and removable cover film covering said convex surface;

said barrier material consisting essentially of a continuous phase of an elastomeric adhesive and a discontinuous phase of moisture-absorbing and swellable hydrocolloid particles dispersed therein;

said removable cover film being sufficiently transparent for revealing said adapter ring therethrough and having a marginal portion extending outwardly beyond the periphery of said adapter ring.

2. The convex adapter of claim 1 in which said removable release sheet has a marginal portion extending outwardly beyond the periphery of said adapter ring.

3. The convex adapter of claim 2 in which said removable cover film and said removable release sheet are of substantially the same size.

4. The convex adapter of claim 1 in which said removable cover film has an outline larger than that of an adhesive faceplate to which said ring is adapted to be secured.

5. The convex adapter of claims 1, 2 or 3 in which said barrier material consists essentially of a continuous phase of an elastomeric adhesive having a styrene-olefin-styrene copolymer as an ingredient thereof.

6. The convex adapter of claim 5 in which said barrier material is a homogenous blend of a styrene-olefin-styrene copolymer and polyisobutylene for providing said adapter ring with shape recoverability, non-flowability, and retention of integrity on hydration.

7. The convex adapter of claims 1, 2 or 3 in which said cover film extends into said centrally-located stoma-receiving opening of said adapter ring;

said stoma-receiving opening having a generally cylindrical surface covered by said cover film.

8. The convex adapter of claim 7 in which said cover film bridges said stoma-receiving opening along the plane of said opposing surface of said adapter ring.

9. The convex adapter of claims 1, 2 or 3 in which said skin barrier material of said adapter ring adheres more strongly to said removable cover film than to said release sheet.

10. A method for providing an adhesive faceplate of an ostomy appliance with a convex adapter having an opening reformable to match the shape of a patient'"'"'s stoma, comprising the steps of providing an adapter ring composed of soft, shape-recoverable adhesive skin barrier material having a convex surface covered by a stretchable and removable cover film;

said cover film being generally transparent and having an outer portion extending substantially beyond the periphery of said adapter ring;

gripping portions of said cover film and adapter ring and urging the same in different directions with sufficient force to alter the shape of said opening of said adapter ring so that it matches the outline of a patient'"'"'s stoma;

securing said adapter ring to the bodyside surface of an adhesive faceplate of an ostomy appliance while the opening of said ring is so altered in shape; and

then removing said cover film from said adapter ring and said faceplate.

11. The method of claim 10 in which said cover film is larger than said adhesive faceplate and includes a marginal portion extending beyond said faceplate when said adapter ring is secured thereto;

said removing step comprising gripping a portion of said cover film extending beyond said faceplate and peeling said cover film away from said adapter ring and faceplate.

12. The method of claims 10 or 11 in which said adapter ring includes a stoma-receiving opening having a generally cylindrical surface and said cover film extends into said opening and covers said surface;

said step or urging said cover film and adapter ring in different directions comprises contacting opposing portions of said film-covered cylindrical surface of said ring and urging the same outwardly in opposite directions.