OSTOMY PORT

• US 20130060212A1
• Filed: 11/01/2012
• Published: 03/07/2013
• Est. Priority Date: 07/14/2009
• Status: Active Grant

• Current Assignee: B Braun Medical SAS (B. Braun Holding GmbH & Co. KG)
• Original Assignee: Stimatix GI Ltd (B. Braun Holding GmbH & Co. KG)
• Inventors: HANUKA, David, Or, Meir
• Granted Patent: US 8,845,607 B2
• Time in Patent Office: Days
• US Class Current: 604/333
• CPC Class Codes: A61F 2005/4402 disposable
• CPC Class Codes: A61F 2005/4455 Implantable
• CPC Class Codes: A61F 5/44 Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aidsabsorbent pads, e.g. sanitary towels, A61F13/15; drainage appliances for wounds A61M27/00; emptying devices for urine bags B65B69/0016; Colostomy devices adhesives for colostomy devices A61L24/00; materials for colostomy devices A61L28/00
• CPC Class Codes: A61F 5/4404 Details or parts
• 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 5/4407 Closure means other than valves
• 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 5/442 having irrigation ports or means irrigators A61M3/02
• CPC Class Codes: A61F 5/443 having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums adhesives or sealing pads therefor A61L24/00
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61F 5/449 Body securing means, e.g. belts, garments

Abstract

A stomal insert for conducting waste content from an intestinal portion in an abdominal cavity through a stoma in an abdominal wall comprising; a cover for covering the stoma; a fixation element for anchoring the stomal insert to a visceral side of the abdominal wall; and a pliable, axially elastic tube interconnecting said cover and said fixation element and sized to apply a tensile force to said cover and to said fixation element.

Claims

1. An ostomy port for conducting waste content from an intestinal portion in an abdominal cavity through a stoma in an abdominal wall comprising;

a cover for covering the stoma;

a fixation element for anchoring the port to a visceral side of the abdominal wall;

a pliable, axially elastic tube interconnecting said cover and said fixation element and sized to apply a tensile force to said cover and to said fixation element; and

a cap for sealing an opening to said port;

wherein said cap includes a shell for accommodating a waste content collection bag.

2. The ostomy port according to claim 1 wherein at least one of said cover, fixation element, elastic tube, and cap is adapted to deform for regulating pressure applied by said fixation element on said abdominal wall due to said tensile force.

3. The ostomy port according to claim 2 characterized by the pressure applied by said fixation element due to said tensile force decreasing to less than 10 mmHg when colonic pressure is equal to or greater than approximately 10 mmHg.

4. The ostomy port according to claim 1 wherein said waste content collection bag is deployable from said shell upon sensing of an intra-colonic pressure of approximately 100 mmHg or greater.

5. The ostomy port according to claim 1 wherein said waste collection bag is deployed through a removable cover.

6. The ostomy port according to claim 1 wherein said elastic tube includes a material of durometer ranging from 5 to 50 shore A.

7. The ostomy port according to claim 1 wherein said elastic tube comprises a material of durometer ranging from 20-30 shore A.

8. The ostomy port according to claim 1 wherein a portion of said elastic tube is adapted to allow relative motion between said cover and said fixation element.

9. The ostomy port according to claim 1 where said elastic tube is collapsible.

10. The ostomy port according to claim 1 wherein said fixation element includes a material of a durometer ranging from 5 to 50 Shore A.

11. The ostomy port according to claim 1 wherein said fixation element is a balloon and wherein said balloon includes a seamless exterior surface.

12. The ostomy port according to claim 1 wherein said fixation element deforms in an axial direction when pressed against the abdominal wall.

13. The ostomy port according to claim 12 wherein pressure applied by said fixation element on the abdominal wall ranges from 1 to 200 mmHg.

14. The ostomy port according to claim 1 wherein said cover includes an elastic material of a durometer ranging from 5 to 50 Shore A.

15. The ostomy port according to claim 1 wherein said cover is adapted to elastically press against the abdominal wall.

16. The ostomy port according to claim 1 wherein said cover is deformable by 5 mm in an axial direction.

17. The ostomy port according to claim 1 wherein said cover is substantially mushroom-shaped.

18. The ostomy port according to claim 1 wherein said cover includes a shape which is adjustable to variations in abdominal wall thickness.

19. The ostomy port according to claim 1 wherein said elastic tube includes an attachment mechanism for attaching said waste content collection bag.

20. The ostomy port according to claim 19 wherein said attachment mechanism include a snap-and-fit arrangement for securing said waste content collection bag to said elastic tube.

21. The ostomy port according to claim 1 wherein said elastic tube is pliable enough to collapse.

22. The ostomy port according to claim 2 wherein said deformation is an elastic deformation.

23. The ostomy port according to claim 1, further comprising a gas filtering mechanism.

24. The ostomy port according to claim 1, further comprising an active gas filtering mechanism for filtering gases.

25. The active gas filtering mechanism according to claim 24 wherein the active gas filtering mechanism includes a valve.

26. The ostomy port according to claim 1 wherein said elastic tube, said cover, and said fixation element are integrally formed in said ostomy port.

27. The ostomy port according to claim 26 further comprising an integral waste collection bag.

32. The ostomy port according to claim 2 wherein said waste content collection bag is deployable from said shell upon sensing of an intra-colonic pressure of approximately 100 mmHg or greater.

33. The ostomy port according to claim 3 wherein said waste content collection bag is deployable from said shell upon sensing of an intra-colonic pressure of approximately 100 mmHg or greater.

34. The ostomy port according to claim 2 wherein a portion of said elastic tube is adapted to allow relative motion between said cover and said fixation element.

35. The ostomy port according to claim 4 wherein a portion of said elastic tube is adapted to allow relative motion between said cover and said fixation element.

36. The ostomy port according to claim 3 where said elastic tube is collapsible.

37. The ostomy port according to claim 4 where said elastic tube is collapsible.

38. The ostomy port according to claim 3 wherein said fixation element deforms in an axial direction when pressed against the abdominal wall.

39. The ostomy port according to claim 4 wherein said fixation element deforms in an axial direction when pressed against the abdominal wall.

40. The ostomy port according to claim 4 wherein said elastic tube includes an attachment mechanism for attaching said waste content collection bag.

41. The ostomy port according to claim 8 wherein said elastic tube includes an attachment mechanism for attaching said waste content collection bag.

28. A method for preventing leakage from a stoma comprising:

inserting in a stoma an insertable portion of an ostomy port comprising a cover, a fixation element, and an axially elastic tube interconnecting said cover and said fixation element, said elastic tube being sized for pressing said cover and said fixation element to an abdominal wall; and

sealing an opening into said port with a cap.

29. The method according to claim 28 including administering through an inflation port an expansion fluid for inflating said fixation element.

30. The method for preventing leakage from a stoma on an abdominal wall comprising:

applying tension to a cover and a fixation element on opposing sides of the stoma with a collapsible pliable tube;

wherein at least one of the cover, fixation element, and pliable tube is adapted to elastically deform for regulating a pressure applied by the fixation element on the abdominal wall due to a variation in a tensile force applied by the tube to the cover and to the fixation element; and

characterized by a decrease in said pressure to substantially zero when colonic pressure is equal to or greater than approximately 10 mmHg.

31. The ostomy port cap comprising a deformable cover for providing a visual indication of an intra-colonic pressure of approximately 100 mmHg or greater.