Ostomy port

• US 8,845,607 B2
• Filed: 11/01/2012
• Issued: 09/30/2014
• 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
• Primary Examiner(s): Su, Susan
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US13/666,178
• Publication Number:
  US 20130060212A1
• Time in Patent Office: 698 Days
• Field of Search: 604/333
• 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 stomal tissue external to an abdominal wall, said cover extending around a proximal opening of said ostomy port and being connected to a pliable, axially elastic tube in communication with said proximal opening;

said tube being of a length to extend longitudinally from a proximal side connected with said cover pass along a length of intestine extending distally from said stoma and cross said abdominal wall such that said tube reaches a visceral side of said abdominal wall;

said tube interconnecting said cover with a fixation element for anchoring the port to said visceral side of the abdominal wall, said anchoring of the port comprising the fixation element having an expanded cross-section, upon said anchoring, too large to pass proximally through said length of intestine;

said length of said tube being sized and configured such that, when said cover and said fixation element are interconnected across said abdominal wall, a tensile force acts through said tube along said longitudinal extent upon said cover and upon said fixation element, whereby said fixation element is drawn toward an interior side of said abdominal wall to seal against leakage around said fixation element at the tissue interface to which said fixation element is drawn, and whereby said cover is drawn against the exterior of said abdominal wall;

said tube being sufficiently pliable for being radially and reversibly collapsible upon constriction within said length of intestine, and said tube being axially elastic such that it extends upon relative movement of said cover and said fixation element, due to displacement by changes in tissue position while inserted across said abdominal wall;

said extending provided while remaining below a predetermined maximum level of said tensile force; and

a cap for sealing said proximal opening;

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.

28. The ostomy port according to claim 1 wherein said cap comprises a deformable cover for providing a visual indication of an intra-colonic pressure of approximately 100 mmHg or greater.

29. 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.

30. 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.

31. 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.

32. 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.

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

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

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

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

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

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

39. 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 along the axial length of said tube;

during said inserting, collapsing said fixation element and a portion of said axially elastic tube to pass through a narrow region of intestine distally beyond the opening of said stoma;

allowing said fixation element and a length of said portion of said axially elastic tube to expand upon passing distally beyond said narrow of intestine;

said elastic tube being sized for pulling said cover and said fixation element to press on opposing sides of an abdominal wall forming a seal thereto; and

sealing an opening into said port with a cap.

40. The method according to claim 39 including administering through an inflation port an expansion fluid for inflating said fixation element.

41. A method for preventing leakage from a stoma on an abdominal wall comprising:

applying tension to form a seal against said leakage comprising a cover and a fixation element pulled to press on opposing sides of an abdominal wall via the stoma and through the body of 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;

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