Disposable ostomy assemblies

• US 8,821,464 B2
• Filed: 11/01/2012
• Issued: 09/02/2014
• 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:
  US13/666,513
• Publication Number:
  US 20130060213A1
• Time in Patent Office: 670 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, comprising:

a housing attachable over said proximal opening, said proximal opening being on the side of said port away from the abdominal cavity when worn;

an ostomy bag having a distinct collapsed waste continence mode and deployed waste collection mode;

said ostomy bag being attached to said housing in said collapsed waste continence mode; and

a deployment prevention element attached extending along a periphery of said cap, such that it is configured to prevent deployment of said bag into said waste collection mode due to the pressure of ostomy waste content;

wherein

said ostomy bag being in said collapsed waste continence mode comprises being located and held in restraint proximal to the proximal opening of the port, on the side of the port away from the abdominal cavity when worn.

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

3. The cap according to claim 2, wherein said cap is configured to fit into said port.

4. The cap according to claim 2, wherein said bag is configured to deploy when pressure in said port is above a threshold.

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

6. The cap according to claim 1, wherein said cap is configured to fit into said port.

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

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

9. The cap according to claim 8, wherein said cap is wider at a proximal side thereof than at a distal side thereof.

10. The cap according to claim 8, wherein said cap is configured to fit into said port.

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

12. The cap according to claim 11, wherein said cap is wider at a proximal side thereof than at a distal side thereof.

13. The cap according to claim 11, wherein said cap is configured to fit into said port.

14. The cap according to claim 11, wherein said bag is configured to deploy when pressure in said port is above a threshold.

15. The cap according to claim 1, wherein said cap includes a pressure indicator.

16. The cap according to claim 15, herein said cap is wider at a proximal side thereof than at a distal side thereof.

17. The cap according to claim 15, wherein said cap is configured to fit into said port.

18. The cap according to claim 15, wherein said bag is configured to deploy when pressure in said port is above a threshold.

19. The cap according to claim 1, wherein said cap includes a sensing circuitry.

20. The cap according to claim 1, wherein said cap includes a foil seal.

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

22. The cap according to claim 21, wherein said cap has a sleeve shaped body and wherein said cap-covering is configured to fit on two opposite sides of said body.

23. The cap according to claim 1, wherein said cap includes a separately openable cap-covering.

24. The cap according to claim 1, comprising a removable cap covering formed of an elastomeric material and which is removable to allow deployment of said bag.

25. The cap according to claim 1, wherein said bag is an elastic bag.

26. The cap according to claim 1, wherein said bag is integrally formed with said cap.

27. The cap according to claim 1, wherein said bag is permanently attached to said cap.

28. The cap according to claim 1, wherein said cap includes a closure for sealing said bag.

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

30. The 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.

31. The cap according to claim 1, further comprising at least one distensible element, which distends in response to a pressure in said cap.

32. The cap according to claim 1, further comprising a safety mechanism configured for relieving buildup pressure in said cap.

33. The cap according to claim 32, wherein the buildup pressure includes intestinal pressure.

34. The cap according to claim 1, further including a gas filtering mechanism.

35. The cap according to claim 1, wherein said ostomy bag is coupled with a closure element for sealing thereof.

36. The cap according to claim 35, wherein said bag has a rim for mounting on an ostomy port and wherein said closure element comprises a cap that fits on said rim.

37. The cap according to claim 36, wherein said cap is configured to fit on either side of said rim.

38. The cap according to claim 35, wherein said closure element comprises a tie.

39. The disposable cap according to claim 1, wherein said cap includes a coupler adapted to couple to said ostomy port.

40. The disposable cap according to claim 1, wherein said cap includes a cover.

41. The cap according to claim 1, wherein said held position at least partially proximal to the proximal side of the port comprises the entire distal-to-proximal depth of a portion of the bag being proximal to the proximal side of the port.

42. The cap according to claim 1, wherein locations proximal to the proximal side of the port are defined as being proximal to the nearest portion of the port body.

43. The cap according to claim 42, wherein locations proximal to the proximal side of the port are defined by being proximal to all portions of the port body.

44. The cap according to claim 1, wherein said housing comprises:

an opening on a distal side thereof, configured for receiving waste;

wherein

said ostomy bag is attached proximal to said distal-side opening in the housing; and

said ostomy bag comprises an opening for receiving waste at least as large as said distal-side opening in the housing.

45. The cap according to claim 1, wherein said ostomy bag comprises an opening for receiving waste larger than said distal-side opening in the housing.

46. The cap according to claim 1, wherein said ostomy bag is fully deployable to a flat configuration lying proximal to a housing of said ostomy cap, and extending radially beyond the entire circumference thereof, upon removal of said deployment element.

47. The cap according to claim 1, wherein said being attached extending along a periphery of said cap comprises being attached extending along all of said periphery.

48. The cap according to claim 1, wherein said being attached extending along a periphery of said cap comprises being attached extending along all of said periphery.

49. A method of using an ostomy cap including a deployment prevention element, comprising:

a) covering an ostomy by attaching said ostomy cap to an ostomy port to position a waste collection bag in a waste continence mode proximal to a proximal side of said port, on a side of said port away from said ostomy;

b) applying pressure by ostomy waste content to said ostomy cap while said waste collection bag is restrained in said waste continence mode by a deployment prevention element attached extending along a periphery of said cap;

c) determining that said waste needs to be evacuated from said ostomy;

d) releasing restraint of said bag, said releasing comprising detaching said deployment prevention element from said periphery;

e) deploying said hag to a waste collection mode, without opening the ostomy to the outside of the bag;

f) allowing waste to enter the bag;

g) removing the bag with waste inside; and

h) sealing the ostomy.

50. The method according to claim 49, wherein said removing said deployment prevention element comprises opening a cover of the cap.

51. The method according to claim 49, further comprising sealing the bag with waste inside.

52. The method according to claim 51, wherein said sealing the bag comprises sealing with a cover of the cap.

53. The method according to claim 51, wherein said sealing the bag comprises sealing by narrowing a portion of the bag.

54. The method according to claim 51, wherein said sealing the ostomy comprises sealing with one or both of a collapsed bag and a cap.

55. The method according to claim 51, wherein said sealing the ostomy comprises sealing without a bag.

56. The method according to claim 49, wherein:

a housing of said ostomy cap comprises an opening on a distal side thereof;

configured for receiving waste; and

said waste collection bag comprises an opening for receiving waste at least as large as and attached proximal to said distal-side opening in the housing.

57. The method according to claim 49, wherein said waste collection bag comprises an opening for receiving waste larger that said distal-side opening in the housing.