SEAL FOR CONTROLLED EVACUATION OSTOMY APPLIANCE

• US 20070191794A1
• Filed: 01/03/2007
• Published: 08/16/2007
• Est. Priority Date: 01/06/2006
• Status: Active Grant

• Current Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Cline, John, Gregory, Christopher, Scarfe, Julian, Cucknell, Alan, Cauwood, Pete, Davies, Geraint
• Granted Patent: US 8,070,737 B2
• Time in Patent Office: Days
• US Class Current: 604/335
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence

Abstract

A controlled evacuation ostomy appliance comprises a membrane that is urged into sealing engagement with a stoma, by the generation of radial tension in the membrane. A tensioning device applies tension, with respect to the stoma, at one or more positions that are (i) outboard of the periphery of the projecting portion of the stoma, and/or (ii) between the level of the peristomal skin and the level of the most projecting part of the stoma. Tension limiting means are disclosed. The membrane may be gas-permeable to allow flatus to be vented.

Claims

1. A controlled evacuation ostomy appliance comprising:

a. a frame having a stomal aperture;

b. a membrane located inside said frame, in the region of said stomal aperture, and configured for contacting a stoma of a wearer to obstruct the discharge of at least solid body waste therefrom; and

c. a tensioning device for generating tension in the membrane, at least in use when the appliance is fitted to a stoma, the tension being in a direction to urge the membrane towards the stomal aperture.

2. The controlled evacuation ostomy appliance according to claim 1, wherein the tensioning device is configured to apply said tension from one or more positions that are adjacent to the stomal aperture.

3. The controlled evacuation ostomy appliance according to claim 1, wherein the tensioning device is configured to apply said tension from one or more positions that are, in use, outboard of a stoma when the appliance is fitted to the stoma.

4. The controlled evacuation ostomy appliance according to claim 1, wherein the tensioning device is configured to apply said tension from one or more positions that are, in use, between the level of the wearer'"'"'s skin, and the level of the most projecting portion of the stoma.

5. The controlled evacuation ostomy appliance according to claim 1, wherein the tensioning device is adjustable for adjusting the magnitude of the tension in the membrane.

6. The controlled evacuation ostomy appliance according to claim 1, wherein the membrane is not under substantial tension prior to fitting to a stoma, the membrane being configured such that entry of the stoma into the stomal aperture presses against the membrane in such a manner that the tensioning device and stoma together tension the membrane.

7. The controlled evacuation ostomy appliance according to claim 1, wherein the tensioning device has a closed-loop shape.

8. The controlled evacuation ostomy appliance according to claim 1, wherein the tensioning device has a shape selected from:

circular; and

non-circular.

9. The controlled evacuation ostomy appliance according to claim 1, further comprising a deodorizing filter on the opposite side of the membrane to the stomal aperture.

10. The controlled evacuation ostomy appliance according to claim 1, wherein at least a portion of the membrane is gas-permeable to allow flatus to pass from the stoma through the membrane.

11. The controlled evacuation ostomy appliance according to claim 10, wherein the permeable portion of the membrane comprises a phase separator allowing gas to pass therethrough while obstructing the passage of solid and/or liquid body waste.

12. The controlled evacuation ostomy appliance according to claim 11, wherein the phase separator comprises one or more selected from:

an activated charcoal filter;

open cell foam;

an expanded PTFE block; and

a composite membrane comprising multiple layers defining a tortuous gas flow path therethrough.

13. The controlled evacuation ostomy appliance according to claim 1, wherein the tensioning device is configured to leave a clearance between the membrane and the wearer'"'"'s peristomal skin.

14. The controlled evacuation ostomy appliance according to claim 1, wherein the membrane comprises a tension limiter.

15. The controlled evacuation ostomy appliance according to claim 14, wherein the tension limiter comprises a frangible support for holding the membrane in an artificially contracted state, such that upon the tension reaching a breaking threshold, the frangible connection breaks to release the artificially contracted state of the membrane.

16. The controlled evacuation ostomy appliance according to claim 14, wherein the tension limiter comprises a constant force spring member.

17. The controlled evacuation ostomy appliance according to claim 1, further comprising a shape defining member for pressing against the membrane on the opposite side to the stoma, for defining a shape that is not possible by applying tension alone.

18. The controlled evacuation ostomy appliance according to claim 17, wherein the shape defining member comprises a projection for defining a central bulge in the membrane for at least partly entering the mouth of the stoma.

19. The controlled evacuation ostomy appliance according to claim 18, further comprising a support for the shape defining member.

20. The controlled evacuation ostomy appliance according to claim 19, wherein the support comprises a second tensioned membrane.

21. The controlled evacuation ostomy appliance according to claim 1, further comprising a releasable coupling for enabling the tensioning device to be detachable.

22. A controlled evacuation ostomy appliance, comprising a membrane for forming a seal against a wearer'"'"'s stoma, and wherein, in use, the membrane is tensioned in a concave configuration with respect to the stoma.

23. The controlled evacuation ostomy appliance according to claim 22, wherein tension is applied to the membrane at at least one position that is laterally outside the projecting portion of the stoma.

24. The controlled evacuation ostomy appliance according to claim 22, wherein tension is applied to the membrane at at least one position that is between the level of the peristomal skin of the wearer and the level of the most projecting part of the stoma.

25. A controlled evacuation ostomy appliance comprising a tensioning device for urging a membrane into sealing engagement with a stoma, in use, by creating radial tension in the membrane.