Ostomy appliance

• US 20040006320A1
• Filed: 07/03/2002
• Published: 01/08/2004
• Est. Priority Date: 07/03/2002
• Status: Active Grant

• Current Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Buglino, Donald Edward, Jones, James Donald
• Granted Patent: US 6,840,924 B2
• Time in Patent Office: Days
• US Class Current: 604/344
• CPC Class Codes: A61F 2005/4483 Convex pressure ring
• 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 5/448 Means for attaching bag to seal ring

Abstract

An ostomy body fitment for attaching an ostomy pouch to a person'"'"'s body comprises a shapeable adhesive pad, and a shape defining member. In a first annular fixed shape zone, the shapeable pad is supported and shaped by the shape defining member. In a second central reshapeable zone, a portion of the adhesive pad is unsupported by the shape defining member, and can be molded to fit an individual'"'"'s stoma. A flexible flange for removable adhesive attachment to an ostomy pouch has an attachment zone outside the periphery of the shape defining member, to reduce direct application of external forces.

Claims

1. An ostomy body fitment for attaching an ostomy appliance to a person'"'"'s body, the body fitment comprising:

a pliable adhesive pad having a first adhesive surface for contacting the person'"'"'s skin and a second adhesive surface opposite the first adhesive surface; and

a backing overlying and contacting a portion of the second adhesive surface;

wherein the adhesive pad and the backing define;

a first zone in which the second adhesive surface of the adhesive pad is substantially exposed at least in use, to enable the pad to be reshaped manually by folding or rolling back a portion of the adhesive pad in the first zone into adhesive contact with a portion of the exposed second adhesive surface; and

a second zone in which the second adhesive surface of the adhesive pad is contacted by the backing to substantially cover the second adhesive surface in the second zone;

wherein the portions of adhesive in the first and second zones are integral with each other, and the adhesive is not transferable from the second zone to the first zone.

2. An ostomy body fitment according to claim 1, wherein the pad has a stomal aperture in the first zone.

3. An ostomy body fitment according to claim 2, wherein the exposed second adhesive surface in the first zone permits the aperture to be enlarged by rolling or folding back a rim portion of the adhesive pad surrounding the aperture, into adhesive contact with a portion of the exposed second adhesive surface of the adhesive pad.

4. An ostomy body fitment according to claim 2, wherein the first zone has a width of at least 3 mm from an edge of the second zone to a rim of the aperture.

5. An ostomy body fitment according to claim 4, wherein the width from said edge of the second zone to the rim of the aperture is at least 5 mm.

6. An ostomy body fitment according to claim 1, wherein the backing is flexible.

7. An ostomy body fitment according to claim 1, wherein the backing is a sheet.

8. An ostomy body fitment according to claim 1, wherein the backing is of plastics.

9. An ostomy body fitment according to claim 1, wherein the backing is of fabric.

10. An ostomy body fitment according to claim 1, wherein the backing is resilient.

11. An ostomy body fitment according to claim 1, wherein the backing comprises a member that is more rigid than the adhesive.

12. An ostomy body fitment according to claim 1, wherein the member is a shape defining member for imparting a predetermined shape to the adhesive pad in the second zone.

13. An ostomy body fitment according to claim 1, wherein the adhesive pad comprises a laminate of a first adhesive layer providing said first adhesive surface, a second adhesive layer providing said second adhesive surface, and a flexible sheet between said first and second layers.

14. An ostomy body fitment according to claim 1, wherein said adhesive pad has a substantially uniform thickness in said first and second zones.

15. An ostomy body fitment according to claim 1, wherein a thickness of the adhesive pad is substantially the same in the first zone as in the second zone.

16. An ostomy body fitment according to claim 1, wherein said adhesive pad has a substantially uniform consistency in the first and second zones.

17. An ostomy body fitment according to claim 1, wherein a consistency of the adhesive pad is substantially the same in the first zone as in the and second zone.

18. An ostomy body fitment for attaching an ostomy appliance to a person'"'"'s body, the body fitment comprising:

a pliable adhesive pad comprising at least a first adhesive layer, the first adhesive layer including a first adhesive surface at a surface of the pad for contacting the person'"'"'s skin, and the pad further comprising a second adhesive surface opposite the first adhesive surface; and

a backing overlying and contacting a portion of the second adhesive surface;

wherein the adhesive pad and the backing define;

a first zone in which the second adhesive surface of the adhesive pad is substantially exposed at least in use, to enable the pad to be reshaped manually by folding or rolling back a portion of the adhesive pad in the first zone into adhesive contact with a portion of the exposed second adhesive surface; and

a second zone in which the second adhesive surface of the adhesive pad is contacted by the backing to substantially cover the second adhesive surface in the second zone;

wherein the portions of adhesive in the first and second zones are integral with each other, and the first adhesive surface of the first adhesive layer extends across both said first and second zones at said surface of the pad.

19. An ostomy body fitment for attaching an ostomy pouch to a person'"'"'s body, the body fitment comprising an adhesive pad having a stomal aperture therein, at least a region of the pad immediately adjacent to the aperture being shapeable to permit the aperture to be enlarged by manually reshaping said region to fit an individual'"'"'s stoma,

wherein at least said shapeable region of the pad immediately adjacent to the aperture comprises a laminate of a first adhesive layer, a second adhesive layer, and a flexible sheet between said first and second adhesive layers.

20. An ostomy body fitment according to claim 19, wherein the first adhesive layer provides a first adhesive surface for contacting the person'"'"'s body, the second adhesive layer provides a second adhesive surface on an opposite face of the pad to the first adhesive surface, and at least a portion of the second adhesive surface is exposed at least in use.

21. An ostomy body fitment according to claim 20, wherein the wherein the exposed second adhesive surface permits the stomal aperture to be enlarged by rolling or folding back a rim portion of the adhesive pad surrounding the aperture, into adhesive contact with a portion of the exposed second adhesive surface of the adhesive pad.

22. An ostomy body fitment according to claim 19, wherein the first adhesive layer, the second adhesive layer and the flexible sheet are substantially coextensive.

23. An ostomy body fitment according to claim 19, wherein the flexible sheet is resilient.

24. An ostomy body fitment according to claim 19, wherein the flexible sheet provides the shapeable region of the adhesive pad with a degree of memory to cause the shapeable region to at least partly tighten around a stoma after the shapeable region has been manually shaped to enlargen the stomal aperture.

25. An ostomy body fitment according to claim 19, wherein the pad comprises a first shapeable zone surrounding the aperture, and a second zone having a more constrained shape surrounding the first zone.

26. An ostomy body fitment according to claim 25, wherein said adhesive pad has a substantially uniform thickness in said first and second zones.

27. An ostomy body fitment according to claim 25, wherein a thickness of the adhesive pad is substantially the same in the first zone as in the second zone.

28. An ostomy body fitment according to claim 25, wherein said adhesive pad has a substantially uniform consistency in the first and second zones.

29. An ostomy body fitment according to claim 25, wherein a consistency of the adhesive pad is substantially the same in the first zone as in the and second zone.

30. An ostomy body fitment for attaching an ostomy appliance to a person'"'"'s body, the body fitment comprising:

a pliable adhesive pad; and

a shape defining member on one side of the adhesive pad and having a first aperture over which the adhesive pad at least partly extends;

wherein the pad and the shape defining member together define;

a first shapeable zone in which the adhesive pad is unsupported by the shape defining member, and is pliably shapeable to enable a portion of the pad to be shaped manually to fit an individual'"'"'s stoma; and

a second fixed-shape zone in which the adhesive pad is supported by, and has a shape defined by, the shape defining member;

wherein the portions of the pad in the first and second zones are integral with each other, and the pad has substantially the same thickness in both the first and second zones.

31. An ostomy body fitment according to claim 30, wherein the adhesive pad comprises a laminate of a first adhesive layer, a second adhesive layer, and a flexible sheet between the first and second adhesive layers.

32. An ostomy body fitment according to claim 30, wherein the adhesive pad has a first adhesive surface for securing to an individual'"'"'s skin, and a second adhesive surface opposite to the first adhesive surface, wherein the second adhesive surface is substantially exposed in the first zone at least in use to enable the aperture to be enlarged by rolling or folding back a rim portion of the skin adhesive surrounding the aperture into adhesive contact with a portion of the exposed second adhesive surface.

33. An ostomy body fitment for attaching an ostomy appliance to a person'"'"'s body, the body fitment comprising:

a pliable adhesive pad; and

a shape defining member on one side of the adhesive pad, the shape defining member having a contour to impart a shape to the pad to cause the pad to bulge away from said one side on which the shape defining member is located, the shape defining member comprising a first aperture over which the adhesive pad at least partly extends;

wherein the pad and the shape defining member together define;

a first re-shapeable zone in which the adhesive pad is unsupported by the shape defining member, and is pliably reshapeable to enable a portion of the pad to be reshaped manually to fit an individual'"'"'s stoma; and

a second fixed-shape zone in which the adhesive pad is supported by, and has a shape defined by, the shape defining member;

wherein the portions of the pad in the first and second zones are integral with each other.

34. An ostomy body fitment according to claim 33, wherein the first re-shapeable zone is located at the first aperture of the shape defining member, and the second fixed-shape zone surrounds the first zone.

35. An ostomy body fitment according to claim 33, wherein the adhesive pad has a substantially uniform thickness in the first and second zones.

36. An ostomy body fitment according to claim 33, wherein the adhesive pad has substantially the same thickness in the first and second zones.

37. An ostomy body fitment according to claim 33, wherein the pad has a substantially uniform consistency in the first and second zones.

38. An ostomy body fitment according to claim 33, wherein the pad has a second aperture, the second aperture being smaller than, and surrounded by, the first aperture.

39. An ostomy body fitment according to claim 38, wherein a linear dimension of the second aperture is not more than two thirds of a corresponding linear dimension of the first aperture.

40. An ostomy body fitment according to claim 39, wherein said linear dimension of the second aperture is not more than a half of said linear dimension of the first aperture.

41. An ostomy body fitment according to claim 38, wherein a width of the first zone from an edge of the first aperture to a closest edge of the second aperture is at least 3 mm.

42. An ostomy body fitment according to claim 41, wherein said width from the first zone from said edge of the first aperture to said closest edge of the second aperture is at least 5 mm.

43. An ostomy body fitment according to claim 33, wherein said adhesive pad comprises a laminate of a first adhesive layer, a second adhesive layer, and a flexible sheet between the first and second adhesive layers.

44. An ostomy body fitment according to claim 33, further comprising a coupling portion for enabling the body fitment to be releasably coupled to said ostomy appliance.

45. An ostomy body fitment according to claim 33, wherein said body fitment is permanently attached to an ostomy pouch.

46. A one-piece ostomy appliance comprising:

a pouch having a front and a rear; and

an adhesive pad permanently secured directly or indirectly to the rear of the pouch for adhesively attaching the pouch to a person'"'"'s body, the adhesive pad comprising at least a first adhesive layer, the first adhesive layer having;

(i) a stomal aperture therethrough;

(ii) a first shapeable zone around the stomal aperture, in which the adhesive pad is pliably shapeable to enable the aperture to be enlarged by manually shaping the adhesive pad in the first zone; and

(iii) a second zone around the first zone in which the adhesive pad has a more constrained shape than in the first zone;

wherein the first adhesive layer of the pad further includes a first adhesive surface extending across the first and second zones at a surface of the pad for contacting the person'"'"'s skin.

47. An ostomy appliance according to claim 46, wherein the adhesive pad has a generally planar configuration.

48. A one-piece ostomy appliance according to claim 46, wherein:

the body fitment further comprises a shape defining member on an interior side of the adhesive pad, the shape defining member being contoured to impart a shape to the adhesive pad to cause the adhesive pad to bulge away from the side of the shape defining member, the shape defining member having an aperture therein larger than said stomal aperture; and

wherein

the adhesive pad and the body fitment together define;

a first re-shapeable zone around the stomal aperture in which the adhesive pad is unsupported by the shape defining member and is reshapeable to enable said enlargement of the stomal aperture; and

a second fixed-shape zone in which the adhesive pad is supported by, and has a shape defined by, the shape defining member;

wherein the portions of the adhesive pad in the first and second zones are integral with each other.

49. A one-piece ostomy appliance according to claim 46, wherein the adhesive pad comprises a laminate of said first adhesive layer, a second adhesive layer, and a flexible sheet between the first and second adhesive layers.

50. A one-piece ostomy appliance according to claim 49, wherein the first adhesive layer, the second adhesive layer and the flexible sheet are substantially coextensive.

51. A one-piece ostomy appliance according to claim 46, wherein the adhesive pad has a second adhesive surface opposite the first adhesive surface, and wherein:

the second adhesive surface is substantially exposed in the first zone at least in use to enable the aperture to be enlarged by rolling or folding back a rim portion of the adhesive surrounding the aperture into adhesive contact with a portion of the exposed second adhesive surface; and

the second adhesive surface is substantially non-exposed in the second zone;

wherein the portions of the skin adhesive in the first and second zones are integral with each other, and the skin adhesive is not transferable from the second zone to the first zone.

52. A body fitment for removable attachment to an ostomy pouch, the body fitment comprising:

an adhesive pad comprising at least a first adhesive layer, the first adhesive layer including a first zone in which the layer is pliably shapeable to fit around an individuals stoma, and a second zone having a more constrained shape than the first zone, the first adhesive layer further including a first adhesive surface extending across the first and second zones at a surface of the pad for contacting a person'"'"'s skin; and

a flange for permitting adhesive attachment of a said ostomy pouch to the flange, the flange being substantially flexible and being permanently secured directly or indirectly to the pad at a location inboard of an outer periphery of the flange, at least a peripheral portion of the flange being unattached to permit the flange to flex relative to the shape defining member.

53. A body fitment according to claim 52, wherein the flange is attached directly or indirectly to the adhesive pad at a location outside the first zone.

54. A body fitment according to claim 52, wherein the flange is attached directly or indirectly to the adhesive pad at a location near the boundary between the first and seconds.

55. A body fitment according to claim 52, wherein the flange is resiliently flexible out of a normal plane.

56. A body fitment according to claim 52, wherein the adhesive has substantially the same thickness in the first and second zones.

57. A body fitment according to claim 52, wherein the adhesive has substantially the same consistency in the first and second zones.

58. A body fitment according to claim 52, wherein the pad has a first adhesive surface or contacting a wearer'"'"'s skin, and a second adhesive surface opposite to the first adhesive surface, the second adhesive surface being substantially exposed in the first zone, at least in use of the body fitment, and the second surface being substantially non-exposed in the second zone.

59. A body fitment according to claim 52, wherein, in at least one of the zones, the adhesive pad comprises a laminate of a first adhesive layer, a second adhesive layer, and a flexible sheet between the first and second layers.

60. A body fitment for removable attachment to an ostomy pouch, the body fitment comprising:

an integral, pliable adhesive pad;

a shape defining member on one side of the adhesive pad for imparting a predetermined shape to a first portion of the integral adhesive pad, leaving a second portion of the integral adhesive pad unsupported and shapeable to permit said second portion to be manually shaped to fit an individual'"'"'s stoma,

and a flange for permitting adhesive attachment of a said ostomy pouch to the flange, the flange being substantially flexible and being secured directly or indirectly to the shape defining member at a location inboard of an outer periphery of the flange, at least a peripheral portion of the flange being unattached to permit the flange to flex relative to the shape defining member.

61. A body fitment according to claim 60, wherein the flange includes a landing zone to which a said pouch is adhesively attachable, the landing zone being of closed loop shape and having an inner periphery which is transversely outward of an inner periphery of the shape defining member.

62. A body fitment according to claim 60, wherein the flange is resiliently flexible out of its normal plane.

63. A body fitment according to claim 60, wherein the shape defining member is contoured to cause the first portion of the adhesive to bulge away from said one side on which the shape defining member is located.

64. An assembly comprising a first fitment for adhesive attachment to a person'"'"'s body, and a second fitment for removably attaching an ostomy appliance to the first fitment, wherein:

the first fitment comprises;

an integral, pliable adhesive pad;

a shape defining member on one side of the adhesive for imparting a predetermined shape to a first portion of the integral adhesive pad, leaving a second portion of the integral adhesive pad unsupported and reshapeable to permit said second portion to be manually reshaped to fit an individual'"'"'s stoma,

a first apertured flange secured directly or indirectly to the shape defining member at a location inboard of an outer periphery of the flange, the flange being substantially flexible, and at least a peripheral portion of the flange being unattached to permit the flange to flex relative to the shape defining member; and

the second fitment comprises;

a second apertured flange carrying an adhesive for removably attaching the second flange to the first flange.