Disposable ostomy assemblies

• US 8,858,519 B2
• Filed: 11/19/2012
• Issued: 10/14/2014
• 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:
  US13/680,161
• Publication Number:
  US 20130079736A1
• Time in Patent Office: 694 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

Disposable elements for use in ostomy. In one embodiment a cap with an integral bag is provided. In another embodiment a sealable bag is provided with means for sealing. In another embodiment, the ostomy port itself is disposable.

Claims

1. A cap for sealing a proximal opening in an ostomy port, including:

a collapsable ostomy bag;

a thin, flexible cover, positionable to cover said ostomy bag in a collapsed configuration within said cap when said cap is attached to said ostomy port;

wherein said cover comprises a sensing mechanism configured for sensing and indicating a positive pressure from within the abdominal cavity in a range below 150 mmIIg while said cap closes said opening;

wherein

said indicating comprises deforming while said cover remains attached to said ostomy port; and

wherein

said cap is attachable to and detachable from said proximal opening along a peripheral distal edge of said ostomy port.

2. A cap according to claim 1, wherein said bag is housed in a body of said cap.

3. A cap according to claim 1, wherein said cap is wider at a proximal side thereof than at a distal side thereof.

4. A cap according to claim 1, wherein said cap is configured to extend less than 1 cm proximally from said port.

5. A cap according to claim 1, wherein said cap is configured to fit into said port.

6. A cap according to claim 1, wherein said cap is configured to interlock with an interlocking mechanism of said port.

7. A cap according to claim 1, wherein said bag is configured to deploy when a pressure in said port is above a preselected threshold.

8. A cap according to claim 1, wherein said bag includes a pullable element for manual deployment.

9. A cap according to claim 1, wherein said cap includes a pressure indicator.

10. A cap according to claim 1, wherein said cap includes a sensing circuitry.

11. A cap according to claim 1, wherein said cap includes a foil seal.

12. A cap according to claim 1, wherein said cap includes a separately openable and closable cap-covering.

13. A cap according to claim 1, wherein said cap includes a separately openable cap-covering.

14. A cap according to claim 12, wherein said cap has a sleeve shaped body and wherein said cap-covering is configured to fit on two opposite sides of said body.

15. A cap according to claim 1, wherein said cover comprises an elastomeric material.

16. A cap according to claim 1, wherein said bag is elastic.

17. A cap according to claim 1, wherein said bag is integrally formed with said cap.

18. A cap according to claim 1, wherein said bag is permanently attached to said cap.

19. A cap according to claim 1, wherein said cap includes a closure for sealing said bag after filling thereof.

20. A cap according to claim 1, wherein said cap includes an adhesive attachment element for attaching said bag after deployment directly to a body of a patient.

21. A cap according to claim 1, wherein said bag has a volume when collapsed of less than 10 cc and when full of at least 300 cc.

22. A cap according to claim 1, wherein said sensing mechanism is configured to communicate to a user a need for evacuation by sensing an increase in intestinal pressure.

23. A cap according to claim 1, wherein said sensing mechanism includes at least one distensible element configured to distend in response to pressure in said cap.

24. A cap according to claim 23, wherein said distensible element is a cover.

25. A cap according to claim 24, wherein said bag is configured to serve as said cover.

26. A cap according to claim 23, wherein said distensible element is configured to protrude outwards in response to a pressure of predetermined value.

27. A cap according to claim 26, wherein said predetermined value is 50 mmHg or higher.

28. A cap according to claim 23, wherein said distensible element is configured to protrude outwards a distance selected from 2-30 mm.

29. A cap according to claim 26, wherein said distensible element is configured to protrude outwards a distance selected from 2-3 mm, 5-7 mm, 10-13 mm, 18-22 and 25-30 mm.

30. A cap according to claim 23, wherein said distensible element is concave shaped.

31. A cap according to claim 23, wherein said distensible element is fabricated from an elastomer.

32. A cap according to claim 31, wherein said distensible element is fabricated from silicone rubber.

33. A cap according to claim 23, wherein said distensible element is of a durometer selected from the range of from 5-100 Shore A.

34. A cap according to claim 33, wherein said distensible element is of a durometer selected from 5-7 Shore A, 10-20 shore A, 25-30 Shore A, 40-45 shore A, 50-60 shore A, 70-80 shore A, and 85-100 shore A.

35. A cap according to claim 23, wherein said distensible element has a thickness in the range of from 0.1-2 mm.

36. A cap according to claim 35, wherein said distensible element has a thickness selected from 0.1-0.3 mm, 0.4-0.6 mm and 0.75-1.25 mm.

37. A cap according to claim 1, wherein said sensing mechanism includes logic implemented in said cap for sensing an increase in pressure.

38. A cap according to claim 1, wherein said sensing mechanism includes components configured for mechanically sensing an increase in pressure.

39. A cap according to claim 1, wherein said sensing mechanism is configured to generate a warning for notifying a user of an increase in pressure.

40. A cap according to claim 39, wherein said warning is at least one of a visual warning, an audible warning, and a sensible warning.

41. A cap according to claim 39, wherein said warning includes at least one of a mechanically activated protruding element configured to be seen by the user, an electrical indication configured to be perceived by the user, and an electromechanical indication configured to be perceived by the user.

42. A cap according to claim 39, wherein said warning includes at least one of a light, a vibration, a sound, and a wireless signal.

43. A cap according to claim 39, wherein said warning includes at least one of Instant messaging, SMS, and Bluetooth signal.

44. A cap according to claim 1, wherein the pressure is due to intestinal pressure.

45. A cap according to claim 1, further including a deployment prevention element.

46. A cap according to claim 1, wherein said bag is housed in a proximal portion of said cap.

47. A cap according to claim 1, wherein said positive pressure is in a range below 100 mmHg.

48. A cap according to claim 1, wherein said positive pressure is in a range above 50 mmHg.

50. A cap according to claim 1, wherein said indicating is by deforming of said sensing mechanism by a distance within the range of 2-30 mm.

51. A cap according to claim 1, wherein said closing of said opening by said cap is such as to withstand pressure from within the abdominal cavity at least up to 150 mmIIg.

52. A cap according to claim 1, wherein said positive pressure is exerted upon said sensing mechanism by one or more of flatus and waste content.

53. A cap according to claim 1, wherein said closing of said opening comprises continuing to maintain said collapsed ostomy bag in the cap.

54. A cap according to claim 1, wherein said cover is comprised of a rubber material.

55. A cap according to claim 1, wherein said ostomy bag in a collapsed configuration within said cap comprises said ostomy bag being contained within said cover.

49. A method for sensing and relieving pressure in an ostomy port, comprising:

sealing an opening into the port with a cap comprising a thin, flexible cover; and

deforming said cover by a distance of between 2-30 mm in response to pressure in the cap, said cap remaining in place upon said deformation; and

relieving said pressure by detaching said cover from along a peripheral distal edge of said ostomy port.

56. The method according to claim 49, wherein said deforming comprises distending.

57. A method according to claim 56, wherein said cover comprises an elastomer.

58. A method according to claim 56, wherein said cover is configured to protrude outwards in response to a pressure of predetermined value.

59. The method according to claim 56, wherein said pressure in the cap is exerted from within the abdominal cavity.

60. The method according to claim 56, wherein said pressure in the cap is positive pressure under 150 mmHg.

61. The method according to claim 56, wherein said pressure in the cap is positive pressure under 100 mmIIg.

62. The method according to claim 56, wherein said deformation occurs while said cap continues to seal said opening of said port.