Stoma plug

• US 7,258,661 B2
• Filed: 09/13/2004
• Issued: 08/21/2007
• Est. Priority Date: 09/13/2004
• Status: Active Grant

• Current Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Cline, John, Gregory, Christopher C., Scarfe, Julian, Cucknell, Alan, Cauwood, Pete, Davies, Geraint
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): Lustusky; Sara
• Application Number:
  US10/939,846
• Publication Number:
  US 20060058576A1
• Time in Patent Office: 1,072 Days
• Field of Search: 600 29- 32, 604332-343, 128/DIG.25, 128897-898, 128/887
• US Class Current: 600/32
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence

Abstract

An ostomy plug is described comprising first and second chambers having adjacent ends coupled to, and in fluid communication with, each other. The first chamber may be for insertion into a stoma. The second chamber may contain fluid for inflating the first chamber when the second chamber is squeezed or otherwise compressed. The plug may have a figure-of-eight configuration. The plug may be configured to permit venting of flatus while obstructing escape of other body waste from the stoma. The plug may incorporate an insertion aid for aiding insertion into a stoma. The plug may also incorporate a device for regulating the inflation pressure of the fluid to avoid undesirably high inflation pressures in the stoma.

Claims

1. An ostomy plug comprising:

a. a first chamber for insertion into a stoma;

b. a second chamber in fluid communication with the first chamber to enable fluid from the second chamber to inflate the first chamber;

c. a flatus vent channel incorporated as an internal passage within at least one of the first or second chambers for venting flatus, wherein the first chamber is configured, when inflated, to (i) obstruct escape of solid and/or liquid body waste from the stoma; and

(ii} permit venting of flatus from the stoma at an interface between the first chamber and a wall of the stoma.

2. The ostomy plug according to claim 1, wherein the plug further comprises a third chamber disposed around at least a part of the first chamber, and wherein a flatus vent is arranged at an interface between the first and third chambers.

3. The ostomy plug according to claim 1, wherein a flatus vent is defined by a surface texture of the first chamber.

4. The ostomy plug of claim 1, wherein adjacent ends of the first and second chambers are coupled to each other at a junction region.

5. The ostomy plug according to claim 4, wherein the second chamber is detachable from the first chamber after inflation of the first chamber.

6. The ostomy plug according to claim 4, wherein a fluid communication path extends between a first region of the first chamber at or near to the junction region to a second region of the second chamber at or near the junction region.

7. The ostomy plug according to claim 4, wherein the first and second chambers together have a figure-of-eight configuration.

8. The ostomy plug according to claim 4, wherein at least one of the first and second chambers has a convex shape.

9. The ostomy plug according to claim 4, wherein the inflation pressure in the first chamber is controlled by the amount of fluid transferred from the second chamber to the first chamber.

10. The ostomy plug according to claim 4, wherein said valve means includes a pressure relief valve located in or connected to the second chamber.

11. The ostomy plug according to claim 4, further comprising a cover for covering the second chamber, the cover being attachable directly or indirectly to the peristomal skin.

12. The ostomy plug according to claim 11, wherein the cover is a rigid component.

13. The ostomy plug according to claim 11, wherein the cover is a non-rigid elastomeric component.

14. The ostomy plug according to claim 11, wherein the cover is made of flexible film.

15. The ostomy plug according to claim 11, wherein the inflation pressure in the first chamber is controlled by a compression force exerted on the second chamber by the cover.

16. The ostomy plug according to claim 4, further comprising a collar at the junction region, the collar being more rigid than the first and second chambers.

17. The ostomy plug according to claim 4, further comprising an insertion member at the junction region, the insertion member being more rigid than the first and second chambers.

18. The ostomy plug according to claim 17, wherein the insertion member comprises a tube.

19. The ostomy plug according to claim 17, wherein the insertion member is sized and tapered at its proximal end to connect with the stoma opening.

20. The ostomy plug according to claim 17, wherein the first chamber is inverted and stored at least partly within the insertion member prior to inflation of the first chamber.

21. The ostomy plug according to claim 17, wherein the first chamber is inverted and stored at least partly within the second chamber prior to inflation of the first chamber.

22. An ostomy plug comprising:

a. a first chamber for insertion into a stoma;

b. a second chamber in fluid communication with the first chamber to enable fluid from the second chamber to inflate the first chamber;

said first and second chambers having adjacent ends coupled to each other at a junction region;

c. a flatus vent channel incorporated as an internal passage within at least one of the first or second chambers for venting flatus, wherein the first chamber is configured, when inflated, to (i) obstruct escape of solid and/or liquid body waste from the stoma; and

(ii} permit venting of flatus from the stoma; and

d. valve means for controlling pressure in the first chamber, said valve means preventing fluid communication between the first and second chambers when the pressure in the first chamber reaches a specific value.

23. An ostomy plug comprising:

a. a first chamber for insertion into a stoma;

b. a second chamber in fluid communication with the first chamber to enable fluid from the second chamber to inflate the first chamber;

said first and second chambers having adjacent ends coupled to each other at a junction region;

c. a flatus vent channel incorporated as an internal passage within at least one of the first or second chambers for venting flatus, wherein the first chamber is configured, when inflated, to (i) obstruct escape of solid and/or liquid body waste from the stoma; and

(ii} permit venting of flatus from the stoma; and

d. rupturable means for controlling the inflation pressure in the first chamber, said rupturable means being located in said second chamber and capable of rupturing the second chamber when the pressure in the second chamber reaches a specified value.

24. An ostomy plug comprising:

a first chamber for insertion into a stoma;

a second chamber in fluid communication with the first chamber to enable fluid from the second chamber to inflate the first chamber;

a third chamber for insertion into the stoma; and

a fourth chamber in fluid communication with the third chamber to enable fluid from the fourth chamber to inflate the third chamber.

25. The ostomy plug according to claim 24, wherein the third chamber is disposed around at least a part of the first chamber.

26. The ostomy plug according to claim 24, wherein the fourth chamber is disposed around at least a part of the second chamber.

27. The ostomy plug according claim 24, wherein the second and fourth chambers are manipulable substantially at the same time to inflate the first and third chambers together.

28. The ostomy plug according to claim 24, wherein the third chamber is inflateable to a different pressure from the first chamber.

29. The ostomy plug according to claim 24, wherein the third chamber has a different surface characteristic from an exposed portion of the first chamber.

30. The ostomy plug according to claim 24, further comprising a flatus vent passage defined at an interface between the first and third chambers.

31. An ostomy plug comprising a first chamber for insertion into a stoma, and a second chamber in fluid communication with the first chamber to enable fluid from the second chamber to inflate the first chamber, wherein the first chamber comprises a non-smooth surface portion for engaging a wall of the stoma.

32. The ostomy plug according to claim 31, wherein the first chamber has a surface portion embossed with a pattern of ridges and valleys.

33. The ostomy plug according to claim 31, wherein the first chamber has a surface portion carrying a plurality of ribs or flap projections.

34. The ostomy plug according to claim 31, wherein the non-smooth surface portion is configured to enhance frictional engagement between the first chamber and a wall of the stoma.

35. The ostomy plug according to claim 31, wherein the non-smooth surface portion is configured to enhance a seal between the first chamber and a wall of the stoma.

36. The ostomy plug according to claim 31, wherein the non-smooth surface portion is configured to enhance venting of flatus around the first chamber.

37. The ostomy plug according to claim 31, wherein the non-smooth surface portion has a microstructure.

38. The ostomy plug of claim 31, wherein at least a portion of the plug carries a surface coating selected from one or more of the group consisting of:

a lubricant;

a hydrophobic material;

a hydrophilic material; and

an adhesive.

39. The ostomy plug according to claim 38, wherein said portion of the plug is at least a portion of the first chamber.

40. The ostomy plug of claim 31 further comprising a frangible region for enabling at least a major part of the second chamber to be permanently detached from the first chamber after the first chamber has been inflated.

41. The ostomy plug according to claim 31, further comprising a valve between the first and second chambers, the valve being configured to admit fluid from the second chamber into the first chamber, and to obstruct fluid flow out of the first chamber.

42. The ostomy plug of claim 31 further comprising:

an insertion aid member, the insertion aid member being more rigid than the first and second chambers, wherein in a non-deployed condition of the plug, the first chamber is substantially deflated and does not protrude substantially from the insertion aid member.

43. The ostomy plug of claim 42, wherein the insertion aid member is disposed at a junction region between the first and second chambers.

44. The ostomy plug of claim 42, wherein the insertion aid member includes a portion that is selected from the group consisting of:

a tube;

a sleeve; and

a collar.

45. The ostomy plug of claim 42, wherein the insertion aid member has an opening that is inwardly tapered for guiding the first chamber into the stoma during inflation of the first chamber.

46. The ostomy plug of claim 42, wherein, in said non-deployed condition, the first chamber is stowed at least partly in the insertion aid member.

47. The ostomy plug of claim 42, wherein, in said non-deployed condition, the first chamber is stowed at least partly in the second chamber.

48. The ostomy plug of claim 42, wherein the insertion aid member is dimensioned to be presented to a stoma without entry of the insertion aid member into the stoma.

49. The ostomy plug of claim 31 further comprising

a fluid control valve.

50. The ostomy plug according to claim 49, wherein the fluid control valve is disposed in the fluid communication path between the first and second chambers.

51. The ostomy plug according to claim 50, wherein the fluid control valve is configured as an inflation retention device for retaining inflation pressure in the first chamber once the first chamber has been inflated.

52. The ostomy plug according to claim 51, wherein the fluid Control valve is configured to admit fluid flow from the second chamber to the first chamber, and to obstruct fluid flow from the first chamber to the second chamber.

53. The ostomy plug according to claim 50, wherein the fluid control valve is responsive to fluid pressure.

54. The ostomy plug according to claim 49, wherein the fluid control valve is configured as an inflation pressure regulator for regulating the inflation pressure of the first chamber.

55. The ostomy plug according to claim 54, wherein the fluid control valve is configured to shut the fluid communication path between the first and second chambers when the pressure in the first chamber exceeds a shut-off threshold.

56. The ostomy plug according to claim 54, wherein the fluid control valve is configured to shut the fluid communication path between the first and second chambers when the pressure in the second chamber exceeds a shut-off threshold.

57. The ostomy plug according to claim 54, wherein the fluid control valve comprises a pressure relief valve for venting fluid when the internal pressure exceeds a pressure relief threshold.

58. The ostomy plug according to claim 57, wherein the pressure relief valve is configured to vent fluid from the second chamber.

59. The ostomy plug of claim 31 further comprising

an inflation regulation device for regulating the fluid pressure to which the first chamber is inflated in use.

60. The ostomy plug according to claim 59, wherein the inflation regulation device comprises a member for pressing against the second chamber for generating a predetermined pressure therein.

61. The ostomy plug according to claim 59, wherein the inflation regulation device comprises a cover for the plug.

62. The ostomy plug according to claim 59, wherein the inflation regulation device comprises a fluid control Valve.

63. The ostomy plug according to claim 62, wherein the fluid control valve is responsive to fluid pressure.

64. The ostomy plug according to claim 62, wherein the fluid control valve is configured to shut the fluid communication path between the first and second chambers when the fluid pressure exceeds a predetermined threshold.

65. The ostomy plug according to claim 62, wherein the fluid control valve is configured as a pressure relief valve for venting fluid when the fluid pressure exceeds a pressure relief threshold.

66. The ostomy plug according to claim 59, wherein the inflation regulation device comprises a rupturable portion for venting pressure from the second chamber when the fluid pressure in the second chamber exceeds a rupture threshold.