Ostomy appliance

• US 20040193122A1
• Filed: 03/26/2003
• Published: 09/30/2004
• Est. Priority Date: 03/27/2002
• Status: Active Grant

• Current Assignee: Convatec Technologies, Inc. (ConvaTec Group Plc)
• Original Assignee: Convatec Technologies, Inc. (ConvaTec Group Plc)
• Inventors: Ansell, Iain, Stacey, Gary, Johnson, Paul A., Cline, John B., DeMary, Tinh Nguyen, Lovatt, Andrew M., Davies, Philip A.
• Granted Patent: US 7,347,844 B2
• Time in Patent Office: Days
• US Class Current: 604/332
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61F 5/448 Means for attaching bag to seal ring

Abstract

An ostomy appliance is described in the form of a controlled discharge device for controlling discharge from the stoma and/or an ostomy pouch for collecting discharged waste. The appliance may include one or more of: an elastomeric stoma seal for providing a seal around or directly against the stoma; a stoma occluder for occluding the stoma without passing internally into the stoma; a peristomal foam wall; a confinement seal for confining at least solid excreta to a confinement region adjacent to the stoma; a stowable collector bag; and interchangeable controlled discharge devices and ostomy pouches. The foam wall may provide a barrier to stool, but allow escape of flatus. The foam wall and/or the stoma occluder and/or the confinement seal may apply a force in a direction to increase the sealing force on the stoma seal.

Claims

1. An ostomy appliance comprising:

an adhesive member for removably adhering the ostomy appliance to an ostomate'"'"'s skin, the adhesive member comprising a stomal aperture; and

an elastomeric sealing member for sealing an inner periphery of the adhesive member around the stomal aperture to protect the adhesive member from contact by stomal discharge.

2. An ostomy appliance according to claim 1, wherein the sealing member at least partly overlaps an edge of the adhesive member, to define an overlapped seal.

3. An ostomy appliance according to claim 1, wherein the sealing member projects inwardly of the inner periphery of the adhesive member.

4. An ostomy appliance according to claim 3, wherein the sealing member comprises a tissue contacting portion for contacting a portion of the ostomate'"'"'s tissue.

5. An ostomy appliance according to claim 4, wherein the tissue contacting portion comprises a peristomal skin contacting portion.

6. An ostomy appliance according to claim 5, wherein the sealing member is configured not to contact the stoma.

7. An ostomy appliance according to claim 4, wherein the tissue contacting portion comprises a stoma contacting portion.

8. An ostomy appliance according to claim 1, further comprising a pressure applying member for applying pressure directly or indirectly to a surface of the sealing member facing away from the skin, in use, to urge the sealing member in a direction towards the skin.

9. An ostomy appliance according to claim 8, wherein the pressure applying member is configured to apply pressure directly or indirectly to the adhesive member.

10. An ostomy appliance according to claim 8, wherein the pressure applying member is configured to apply pressure directly or indirectly to a region of the sealing member projecting radially inward of the inner periphery of the adhesive member.

11. An ostomy appliance according to claim 8, wherein the pressure applying member comprises a resiliently compressible member.

12. An ostomy appliance according to claim 11, wherein the pressure applying member comprises resiliently compressible foam.

13. An ostomy appliance according to claim 8, wherein the pressure applying member comprises an inflatable or inflated member.

14. An ostomy appliance according to claim 1, wherein the ostomy appliance comprises a controlled discharge device.

15. An ostomy appliance according to claim 1, wherein the ostomy appliance comprises a collection pouch.

36. An ostomy appliance according to claim 1, further comprising a shape defining member for directly or indirectly applying pressure through at least a peristomal region of the sealing member to the ostomate'"'"'s peristomal skin.

44. An ostomy appliance according to claim 1, wherein the sealing member comprises a synthetic material.

45. An ostomy appliance according to claim 1, wherein the sealing member comprises foam.

16. An ostomy appliance for controlling discharge from a stoma, the appliance being non-entrant into the stoma and comprising an adhesive member for removably adhering the appliance to an ostomate'"'"'s skin, a confinement member supported by the adhesive member for confining at least solid waste excreted from the stoma to a confinement region adjacent to the stoma, the confinement member being configured, in use, to apply pressure directly or indirectly to peristomal tissue without applying pressure to the stoma.

17. An ostomy appliance according to claim 16, wherein the confinement member comprises an inflated or inflatable member.

18. An ostomy appliance according to claim 16, wherein the confinement member comprises a resiliently compressible member.

19. An ostomy appliance according to claim 18, wherein the confinement member comprises foam.

20. An ostomy appliance according to claim 16, wherein the confinement member is releasably separable from the adhesive member.

21. An ostomy appliance according to claim 16, further comprising an elastomeric sealing member for sealing around a stomal aperture of the adhesive member.

22. An ostomy appliance for controlling discharge from a stoma, the appliance comprising a portless sealed inflated member containing inflation fluid, the inflated member being configured to apply a sealing pressure directly or indirectly to the ostomate'"'"'s tissue for forming a seal there against.

23. An ostomy appliance according to claim 22, wherein the inflated member is configured for applying pressure to the stoma.

24. An ostomy appliance according to claim 22, wherein the inflated member is configured for applying pressure to peristomal skin.

25. An ostomy appliance according to claim 22, wherein the inflated member is configured for applying pressure to peristomal skin without applying pressure to the stoma.

26. An ostomy appliance for controlling discharge from a stoma, the appliance comprising:

a non-entrant stoma occluder for occluding a stoma externally; and

an elastomeric sealing member for forming a seal around the stoma.

27. An ostomy appliance according to claim 26, wherein the elastomeric sealing member comprises a stoma contacting surface for contacting the stoma to seal against the stoma.

28. An ostomy appliance according to claim 26, wherein the non-entrant stoma occluder comprises a stoma occluding surface configured, in use, to apply a force directly or indirectly to the elastomeric sealing member, to urge the sealing member towards to from the seal.

29. An ostomy appliance according to claim 28, wherein the elastomeric sealing member is configured to be at least partly sandwiched between the stoma and the stoma occluding surface as a gasket.

30. An ostomy appliance according to claim 26, wherein the elastomeric sealing member partly overlaps the stoma to apply an at least partly axial sealing force against the stoma.

46. An ostomy pouch according to claim 26, wherein the stoma occluder comprises an inflatable member.

31. An ostomy appliance comprising:

an adhesive member for removably adhering the ostomy appliance to an ostomate'"'"'s skin, the adhesive member comprising a stomal aperture; and

a substantially non-moldable elastomeric sealing member located at the stomal aperture for contacting the stoma to seal an inner periphery of the stomal aperture of the adhesive member, the elastomeric sealing member having a stoma engaging surface and being configured to at least partly overlap the stoma to apply an at least partly axial sealing force against the stoma.

32. An ostomy appliance according to claim 31, wherein the stoma engaging surface of the elastomeric sealing member is configured, at least in use, to have or adopt a generally closed-loop concave configuration, to at least partly cup the stoma.

33. An ostomy appliance comprising:

an adhesive member for removably adhering the ostomy appliance to an ostomate'"'"'s skin, the adhesive member comprising a stomal aperture; and

a substantially non-moldable elastomeric sealing member located at the stomal aperture for contacting the stoma to seal an inner periphery of the stomal aperture of the adhesive member, the sealing member comprising a stoma engaging surface configured, at least in use, to have or adopt a generally closed-loop concave configuration, to at least partly cup the stoma.

34. An ostomy appliance according to claim 33, wherein the stoma engaging surface of the sealing member is tapered or flared to define said concave configuration.

35. An ostomy appliance according to any of claims 33, wherein the stoma engaging surface of the sealing member is generally frusto-conical.

37. An ostomy appliance comprising:

an adhesive member for removably adhering the ostomy appliance to an ostomate'"'"'s skin, the adhesive member comprising a stomal aperture;

a substantially non-moldable elastomeric sealing member located at the stomal aperture for sealing an inner periphery of the stomal aperture of the adhesive member; and

a shape defining member for directly or indirectly applying pressure through at least a peristomal region of the sealing member to the ostomate'"'"'s skin.

38. An ostomy appliance according to claim 37, wherein the elastomeric sealing member comprises a stoma engaging surface for contacting the stoma.

39. An ostomy appliance according to claim 37, wherein the shape defining member is configured not to apply pressure directly to the stoma engaging surface of the elastomeric sealing member.

40. An ostomy appliance according to claim 37, wherein the shape defining member is configured to apply pressure to the stoma engaging surface of the elastomeric sealing member.

41. An ostomy appliance according to claim 37, wherein the shape defining member comprises a resilient member.

42. An ostomy appliance according to claim 37, wherein the shape defining member is configured to define a generally convex shape in a peristomal region.

43. An ostomy appliance according to claim 37, wherein the shape defining member is integrally formed with the elastomeric sealing member.

47. An elastomeric sealing member for sealing an inner periphery of a stomal aperture of an ostomy appliance, the clastomeric sealing member having a closed loop configuration, and comprising an outer peripheral mounting portion, and an inner peripheral stoma engaging surface, the stoma engaging surface having a generally closed-loop concave configuration, for at least partly cup the stoma in use.

48. An ostomy appliance for controlling discharge from a stoma, the appliance being non-entrant into the stoma and comprising a wall of closed loop configuration arranged at least peristomally to define a confinement region for confining any solid waste excreted from the stoma, the wall comprising open cell foam for permitting flatus to vent therethrough.

49. An ostomy appliance according to claim 48, wherein the appliance further comprises a first member attachable directly or indirectly to an ostomate'"'"'s skin and having a stomal aperture, and a cover releasably securable directly or indirectly to the first member.

50. An ostomy appliance according to claim 49, wherein the wall comprises resiliently compressible foam that, when the cover is secured to the first member, is compressed to seal said confinement region between the first member and the cover.

51. An ostomy appliance for controlling discharge from a stoma, the appliance being non-entrant into the stoma and comprising a first member attachable directly or indirectly to an ostomate'"'"'s skin and having a stomal aperture, a cover releasably securable directly or indirectly to the first member, and a wall of closed loop configuration arranged at least peristomally to define a peristomal confinement region for confining solid waste excreted from the stoma, the wall comprising a resiliently compressible foam that, when the cover is secured to the first member, is compressed to seal said confinement region between the first member and the cover.

52. An ostomy appliance according to claim 51, wherein the appliance further comprises a sealing member for sealing an inner periphery of a stomal aperture of the first member, and wherein the wall comprises resiliently compressible foam that, when the cover is secured to the first member, is compressed to apply at least a peristomal force to the sealing member.

53. An ostomy appliance for controlling discharge from a stoma, the appliance being non-entrant into the stoma and comprising a first member attachable directly or indirectly to an ostomate'"'"'s skin and having a stomal aperture, a cover releasably securable directly or indirectly to the first member, a sealing member for sealing an inner periphery of the stomal aperture of the first member, and a wall of closed loop configuration arranged at least peristomally to define a peristomal confinement region for confining any solid waste excreted from the stoma, the wall being resiliently compressible such that, when the cover is secured to the first member, the wall is compressed to apply at least a peristomal force directly or indirectly to the sealing member.

54. An ostomy appliance according to claim 53, wherein the wall comprises resiliently compressible foam.

55. An ostomy appliance according to claim 53, wherein the wall comprises an inflated or inflatable member.

56. An ostomy appliance according to claim 53, wherein the sealing member is elastomeric.

57. An ostomy appliance according to claim 53, wherein the sealing member comprises a stoma engaging surface for contacting the stoma to seal against the stoma.

58. An ostomy appliance according to claim 57, wherein the sealing member overlaps the stoma to apply an at least partly axial force thereto.

59. An ostomy appliance according to claim 57, wherein the stoma engaging surface of the sealing member has a generally closed loop concave configuration, for at least partly cupping the stoma.

60. An ostomy appliance according to claim 53, wherein the sealing member comprises foam.

61. An ostomy appliance according to claim 53, wherein the sealing member is carried by the wall.

62. An ostomy appliance according to claim 53, wherein the sealing member is carried by the first member.

63. An ostomy appliance according to claim 53, wherein the wall comprises a region of open-cell foam, and a region of closed-cell foam.

64. An ostomy appliance according to claim 53, wherein the wall comprises a relatively compressible region, and a relatively stiff region of greater stiffness than the relatively compressible region.

65. An ostomy appliance according to claim 53, wherein the wall is secured to one of the first member and the cover.

66. An ostomy appliance according to claim 53, wherein the wall has a generally annular shape.

67. An ostomy appliance according to claim 53, wherein when the cover is secured to the first member, the appliance is operative to substantially confine any solid matter excreted from the stoma to within said confinement region, and when the cover is separated from the first member, the appliance is operative to permit discharge of solid matter outside said confinement region.

68. An ostomy appliance according to claim 67, further comprising a non-entrant stoma occluder having a stoma occluding surface for occluding the stoma without entering the stoma, the wall encircling the stoma occluding surface.

69. An ostomy appliance according to claim 68, wherein the non-entrant stoma occluder comprises an inflatable member.

70. An ostomy appliance according to claim 68, wherein the non-entrant stoma occluder comprises foam.

71. An ostomy appliance for controlling and collecting stomal discharge, the appliance comprising:

a first member attachable directly or indirectly to an ostomate and having a stomal aperture;

a second cover member releasably secured or releasably securable to the first member; and

a collapsible collector connected between the first and second members, the collector being collapsible to a stowed condition to allow the first and second members to be secured together, and the collector being distendible by separation of the first and second members,

wherein when the second member is secured to the first member, the appliance is operative to substantially block or confine the discharge of solid waste from the stoma, and when the second member is released from the first member, the appliance permits the discharge of waste into the distended collector.

72. An ostomy appliance according to claim 71, wherein the collector comprises a collapsible bag.

73. An ostomy appliance according to claim 71, further comprising an adhesive faceplate for adhesive attachment to the ostomate'"'"'s skin, the first member being releasably securable to the adhesive faceplate.

74. An ostomy appliance according to claim 71, further comprising a confinement member for substantially confining solid waste to a predetermined confinement region when the second member is secured to the first member.

75. An ostomy pouch according to claim 74, wherein the confinement member comprises a non-entrant stoma occluder for occluding the stoma without entering the stoma.

76. An ostomy pouch according to claim 74, wherein the confinement member comprises a wall of closed loop shape and arranged peristomally.

77. An ostomy pouch according to claim 74, wherein the confinement member permits the passage of flatus.

78. An ostomy pouch according to claim 71, further comprising a peristomal sealing member for sealing a region around the stoma.

79. An ostomy system for managing a stoma, the system comprising:

an adhesive faceplate adherable to an ostomate'"'"'s skin, the adhesive faceplate comprising a stomal aperture;

a controlled discharge device releasably securable to the faceplate to provide a controlled discharge function for controlling at least partly the discharge of body waste through the stoma; and

a collection pouch releasably securable to the faceplate in place of the controlled discharge device, the collection pouch providing substantially unobstructed discharge of body waste from the stoma;

whereby the controlled discharge device and the collection pouch may be interchanged and secured to the body using said faceplate.

80. An ostomy system according to claim 79, wherein the controlled discharge device comprises a non-entrant stoma occluder for occluding the stoma without entering into the stoma.

81. An ostomy system according to claim 79, wherein the faceplate comprises an elastomeric seal for sealing against the stoma.

82. An ostomy system according to claim 81, wherein the controlled discharge device is configured to apply additional sealing force directly or indirectly to the sealing member when the controlled discharge device is secured to the faceplate.

83. An ostomy system according to claim 79, wherein the controlled discharge device comprises a compressible foam member.

84. An ostomy system according to any of claim 79, wherein the controlled discharge device comprises a second collection pouch.

85. An ostomy appliance for controlling discharge from a stoma, the appliance comprising an inflatable or inflated device disposed outside the stoma for applying pressure generally in a direction towards a body surface for forming a seal, and a volume adjustment device for mechanically adjusting the volume of the inflatable or inflated device without changing the quantity of inflation fluid therein.

86. An ostomy appliance according to claim 85, wherein the volume adjustment device is operative to adjust a pressure of inflation fluid within the inflatable or inflated device.