Ostomy containment device

• US 8,998,862 B2
• Filed: 07/14/2010
• Issued: 04/07/2015
• Est. Priority Date: 07/14/2009
• Status: Active Grant

• Current Assignee: B Braun Medical SAS (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Medical SAS (B. Braun Holding GmbH & Co. KG)
• Inventors: Hanuka, David, Or, Meir
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): SASS, SARA A
• Application Number:
  US13/384,343
• Publication Number:
  US 20120136324A1
• Time in Patent Office: 1,728 Days
• US Class Current: 604/318
• CPC Class Codes: A61F 2005/4455 Implantable
• CPC Class Codes: A61F 5/4405 Valves or valve arrangements specially adapted therefor A61F5/441 takes precedence; Fluid inlets or outlets A61F5/4407 takes precedence
• CPC Class Codes: A61F 5/441 having venting or deodorant means, e.g. filters ; having antiseptic means, e.g. bacterial barriers
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence

Abstract

An artificial Ostomy containment device comprising an implantable intra-abdominal sleeve adapted to interfere with movement of a closure assembly positioned within the sleeve; and a closure assembly comprising a hollow stomal insert sized and shaped to conduct waste content from an intestinal portion in an abdominal cavity through said insert and out of a stoma, and a fixation element coupled to said stomal insert sized and positioned to interfere with said intra-abdominal sleeve.

Claims

1. An artificial ostomy containment device comprising:

a closure assembly adapted to conduct waste content from an intestinal portion in an abdominal cavity and out of a stoma;

a fixation element sized and positioned to interfere with movement of said closure assembly;

a stomal cover sized and shaped to cover the stoma from outside the abdominal cavity; and

a pressure indicator which acts as a pressure sensing mechanism, the pressure indicator having a portion externally positioned on the device outside the abdominal cavity, the portion being configured to bulge from an equilibrium state as a buildup of axial pressure conveyed from within the abdominal cavity to said pressure indicator occurs, and according to said conveyed pressure.

2. The containment device according to claim 1 wherein the fixation element is an inflatable balloon.

3. The containment device according to claim 1 wherein the closure assembly comprises an inflation valve for introducing the expansion fluid into a lumen.

4. The containment device according to claim 1 wherein the fixation element is a pre-shaped elastically deformable element configured to be inserted into said intestinal portion.

5. The containment device according to claim 1 wherein said stomal cover includes a flatus release mechanism for controlling a pressure buildup in said closure assembly.

6. The containment device according to claim 1 comprising a safety mechanism for releasing bowel waste content when a colonic pressure reaches a predetermined value.

7. The containment device according to claim 1 wherein the closure assembly comprises a material of durometer ranging from 20-80 Shore A for allowing peristaltic propelling of the waste content.

8. The containment device according to claim 1 wherein the fixation element comprises a non-collapsible balloon.

9. The containment device according to claim 1 wherein a shape of said stomal cover is invertible to allow access to the stoma.

10. The containment device according to claim 1 comprising a disposable bag assembly for collecting waste content from the device, said assembly comprising:

a bag housing attachable to a proximal end of said closure assembly; and

a waste content collection bag folded in said bag housing.

11. The containment device according to claim 10 wherein the bag housing is replaceable.

12. The containment device according to claim 10 wherein the bag housing is permanently affixed to the closure assembly.

13. The containment device according to claim 1 wherein said pressure sensing mechanism is configured to sense a pressure from said waste content.

14. The containment device of claim 5 wherein said flatus release mechanism is controllable by a user of the device.

15. The containment device of claim 5 wherein said flatus release mechanism includes a sealable opening in said stomal cover configured for allowing passage of flatus.

16. The containment device of claim 1 comprising a waste blocking mechanism for preventing waste content from flowing out of the device when a waste content collection bag is unattached to the device.

17. The containment device of claim 16 wherein said waste blocking mechanism includes a one-way valve.

18. The containment device of claim 1 wherein said fixation element is coupled to a stomal insert in said closure assembly.

19. The containment device of claim 1 wherein said stomal cover is coupled to a stomal insert in said closure assembly.

20. The containment device according to claim 1, wherein said closure assembly further comprises a stomal insert passing into the stoma.

21. The containment device according to claim 20, wherein the stomal insert comprises a lumen for conveying an expansion fluid to an inflatable balloon.

22. The containment device according to claim 20, comprising an inflatable balloon inside the stomal insert for blocking a flow of the waste content.

23. The containment device according to claim 20, wherein the fixation element comprises a broadening of the stomal insert.

24. The containment device according to claim 1, wherein said stomal cover blocks said conducting of waste content, and comprises an external surface adapted to change shape due to pressure from within the abdominal cavity.

25. The containment device according to claim 24, wherein said change of shape communicates to a user an indication of said pressure.

26. The containment device according to claim 24, wherein said change of shape comprises protruding.

27. The containment device according to claim 24, wherein said change of shape comprises holding a protruding conformation.