IP Library Granted Patent US 8,821,465
Granted Patent B2
US 8,821,465 · App. 13/680,169 · Granted Sep 2, 2014

Disposable ostomy assemblies

Inventors: David Hanuka (Ramat-Yishai, IL); Meir Or (Kfar Eshchar, IL)
Assignee: Stimatix GI Ltd.
A61F5/44A61F5/4407A61F5/442
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Quick Facts
Patent No.
US 8,821,465
App. No.
13/680,169
Granted
Sep 2, 2014
Kind
B2
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 (72)

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

a collapsed ostomy bag held within said cap;

wherein said cap includes an automatic safety mechanism comprising a cover positioned over said collapsed ostomy bag by attachment to a proximal end of said cap, the cover in said attached position blocking bag expansion beyond a proximal end of said cap;

said safety mechanism being configured for automatic release of said cover from said expansion-blocking position to a release configuration upon a predetermined pressure being exerted from within said cap;

wherein said release of said cover to said release configuration comprises at least partial detachment of said cover from said cap, permitting deployment of said bag to expand beyond said cap end, such that said pressure is relieved; and

said safety mechanism also being manually actuatable for manual release of said cover from said expansion-blocking position to said release configuration, permitting said deployment of said bag.

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 hag 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 mmHg, 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;

providing an automatic safety mechanism in the cap for automatically relieving a pressure in the cap above a predetermined pressure threshold by a change in safety mechanism position relative to said cap, said change permitting deployment of said bag;

waiting for buildup of pressure within said cap; and

manually actuating said change in safety mechanism position relative said cap to permit manual deployment of said bag.

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.

55. A cap according to claim 1 , wherein said safety mechanism comprises a removable cover.

56. A cap according to claim 55 , wherein said cover is ejectable by pressure from said bag pushing on said cover.

57. A cap according to claim 55 , wherein said cover is releasable by a pressure sensing mechanism in said cap.

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

a collapsed ostomy bag held within a housing of said cap, said bag being held to receive a pressure from within said proximal opening;

wherein said cap includes an automatic safety mechanism comprising a cover positioned over said collapsed ostomy bag by attachment to a proximal end of said cap housing, the cover in said attached position blocking bag expansion beyond a proximal end of said cap;

said safety mechanism being configured for automatic release of said cover from said expansion-blocking position to a release configuration upon a predetermined pressure being exerted upon said cover by pressure from said bag, due to said pressure received from within said proximal opening;

wherein said release of said cover to said release configuration comprises at least partial detachment of said cover from said cap housing, permitting deployment of said bag to expand beyond said cap end, such that said pressure received from within said proximal opening is relieved; and

said safety mechanism also being manually actuatable for manual release of said cover from said expansion-blocking position to said release configuration, permitting said deployment of said bag.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 12, 2014
From: STIMATIX GI LTD
To: B. BRAUN MEDICAL SAS
Reel/Frame 034156/0410 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 27, 2012
From: HANUKA, DAVID; OR, MEIR
To: STIMATIX GI LTD.
Reel/Frame 029353/0806 →
Continuity (8)
Division 13666513 · Nov 1, 2012
Continuation PCTIB2011051938 · May 2, 2011
Continuation In Part PCTIL2010000565 · Jul 14, 2010
Provisional Application 61330359 · May 2, 2010
Provisional Application 61431084 · Jan 10, 2011
Provisional Application 61225546 · Jul 14, 2009
Provisional Application 61330359 · May 2, 2010
Related Publication 20130079737A1 · Mar 28, 2013