DISPOSABLE OSTOMY ASSEMBLIES

• US 20130079737A1
• Filed: 11/19/2012
• Published: 03/28/2013
• 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 8,821,465 B2
• Time in Patent Office: Days
• US Class Current: 604/318
• 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 collapsed ostomy bag;

wherein said cap includes a safety mechanism configured for relieving a pressure therein.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

17. A cap according to claim 16, wherein said cap has a sleeve-shaped body and wherein said cap-covering is configured to fit on two opposite sides of said body.

18. A cap according to claim 1, comprising a removable cap-covering formed of an elastomeric material.

19. A cap according to claim 1 comprising a cap-covering, wherein said cap-covering is removable to allow deployment of said bag.

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

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

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

23. 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.

24. 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.

25. A cap according to claim 1, wherein said safety mechanism is configured to eject a section of said cap when a pressure inside said cap reaches a predetermined value.

26. A cap according to claim 16, wherein said safety mechanism is configured to eject said cap-covering when a pressure inside said cap reaches a predetermined value.

27. A cap according to claim 1, wherein said safety mechanism includes a pressure-sensitive mechanism.

28. A cap according to claim 26, wherein said safety mechanism includes at least one of logic circuitry and mechanical logic configured for determining when to release said cap-covering.

29. A cap according to claim 1, wherein said safety mechanism includes electro-mechanical components.

30. A cap according to claim 1, wherein said safety mechanism is configured for pushing said bag out of said cap.

31. A cap according to claim 1, wherein said safety mechanism is configured for being actuated by a pressure ranging between 50 mmHg and 200 mmHg

32. A cap according to claim 31, wherein said safety mechanism is configured for being actuated by a pressure of one of 65 mmHg, 75 mmHg, 80 mm Hg, 90 mmHg, 95 mmHg, 100 mmHg, 150 mmHg, and 200 mmHg

33. A cap according to claim 1, wherein said safety mechanism is configured for being actuated when a pressure inside said cap exceeds a predetermined value for a predetermined period of time.

34. A cap according to claim 33, wherein said predetermined pressure is one of 60 mmHg, 100 mmHg, and 150 mmHg

35. A cap according to claim 33, wherein said predetermined period of time is greater than one of 5 seconds, 10 Seconds, 15 seconds, 30 seconds, 60 seconds, and 90 seconds.

36. A cap according to claim 1, further comprising a pressure sensor and a control unit, said control unit configured to receive pressure signals from said pressure sensor, said control unit being programmed with a logic algorithm for performing predetermined actions upon fulfilling predetermined conditions.

37. A cap according to claim 36, wherein said predetermined actions include at least one of deploying said collapsed ostomy bag;

releasing gas from said cap;

generating an indication for notifying a user of an increase in pressure, and generating an indication for notifying a user of a need to release gas.

38. A cap according to claim 1, wherein said safety mechanism is configured for releasing gas from a gas release mechanism.

39. A cap according to claim 1, wherein said safety mechanism includes an indication mechanism.

40. A cap according to claim 39, wherein said indication mechanism includes at least one of a visual indication, an audible indication, a mechanically activated protruding element configured to be seen by a user, an electrical indication configured to be perceived by a user, an electromechanical indication configured to be perceived by a user, a light, a vibration, a sound, a wireless signal, an instant message, an SMS transmission, and a Bluetooth signal.

41. A cap according to claim 36, wherein said action is configured to be ceased one of manually by a user and automatically by said control unit when the pressure decreases below a predetermined value.

42. A disposable cap according to claim 41, wherein said predetermined value is 30 mmHg

43. A cap according to claim 36, wherein said logic algorithm is reprogrammable.

44. A cap according to claim 1, wherein said cap includes a gas filter.

45. A cap according to claim 1, wherein said safety mechanism is configured to allow at least a portion of said bag to unfurl by pushing of waste content discharging from a stoma.

46. A cap according to claim 45, wherein said safety mechanism is configured to allow a portion of said bag to unfurl and to allow a user to unfurl a furled portion of said bag.

47. A cap according to claim 46, wherein said bag includes one of a strap and a cord at one of a proximal and a distal end of said bag, said one of a strap and a cord configured to be pulled on by the user for unfurling said bag.

48. A method for relieving a pressure in an ostomy, comprising:

sealing the ostomy with a cap, wherein the cap includes a collapsed ostomy bag; and

providing a safety mechanism in the cap for relieving a pressure in the cap.

49. A method according to claim 48, wherein said bag is configured to deploy when a pressure in said cap is above a preselected threshold.

50. A method according to claim 48, wherein said cap includes a separately openable cap-covering.

51. A method according to claim 48, wherein said cap includes a cap-covering, wherein said cap-covering is removable to allow deployment of said bag.

52. A method according to claim 51, wherein said safety mechanism is configured to eject said cap-covering when a pressure inside said cap reaches a predetermined value.

53. A method according to claim 48, wherein said safety mechanism is configured for pushing said bag out of said cap.

54. A method according to claim 48, wherein said safety mechanism includes an indication mechanism.