Peelable and flushable ostomy pouch and method of use

• US 20050113770A1
• Filed: 10/20/2004
• Published: 05/26/2005
• Est. Priority Date: 10/21/2003
• Status: Active Grant

• Current Assignee: Hollister Incorporated
• Original Assignee: Hollister Incorporated
• Inventors: Pedersen, Ole, Giori, Claudio, Forbjerg-larsen, Jorgen
• Granted Patent: US 7,517,339 B2
• Time in Patent Office: Days
• US Class Current: 604/332
• CPC Class Codes: A61F 2005/4402 disposable
• CPC Class Codes: A61F 5/448 Means for attaching bag to seal ring
• CPC Class Codes: B32B 1/00 Layered products having a non-planar shape
• CPC Class Codes: B32B 2307/7163 Biodegradable
• CPC Class Codes: B32B 2307/7242 Non-permeable
• CPC Class Codes: B32B 2307/7265 Non-permeable
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 27/10 of paper or cardboard
• CPC Class Codes: B32B 27/36 comprising polyesters
• CPC Class Codes: B32B 3/02 characterised by features of form at particular places, e.g. in edge regions non-uniform thickness B32B3/263
• CPC Class Codes: B32B 9/04 comprising such particular substance as the main or only constituent of a layer, which is next to another layer of the same or of a different material next to a glass layer B32B17/06; layered products with at least two ceramic layers composed mainly of ceramic B32B18/00

Abstract

An ostomy appliance having a face plate assembly and inner and outer pouches joined thereto, has its outer pouch provided with one or more peripherally-extending sealing seams that allow the walls of the outer pouch to be separated by peeling forces applied in directions transverse to such seam or seams. In preferred embodiments, the sealing seam, also peelably join the peripheral edges of the outer pouch to those of the inner pouch. A method of disposing of the pouch assembly of such an ostomy appliance is also disclosed.

Claims

1. An ostomy appliance for receiving discharge from a human stoma and comprising:

attachment means for attaching the appliance to the peristomal skin surface of a user of the appliance, and

an ostomy pouch assembly comprising;

an inner pouch attached to said attachment means and having a first aperture for receiving the stoma of said user,

said inner pouch being defined by a flexible body side or proximal inner pouch wall and a flexible distal inner pouch wall, and one or more peripherally extending inner pouch sealing seams,

an outer pouch enclosing said inner pouch, attached to said attachment means and having a second aperture for receiving said stoma and being aligned with said first aperture,

said outer pouch being defined by a flexible body side or proximal outer pouch wall and a flexible distal outer pouch wall, and one or more peripherally extending outer pouch sealing seams,

said one or more outer pouch sealing seams being manually peelable such that the attachment forces provided by said one or more peelable outer pouch sealing seams may be manually eliminated by manually pulling said distal outer pouch wall in a direction transverse to said one or more peelable outer pouch sealing seams.

2. An ostomy appliance according to claim 1, wherein said one or more outer pouch sealing seams peelably attach said distal outer pouch wall to said distal inner pouch wall and said proximal outer pouch wall to said proximal inner pouch wall.

3. An ostomy appliance according to claim 1, wherein said one or more outer pouch sealing seams peelably attach said distal outer pouch wall directly to said proximal outer pouch wall.

4. An ostomy appliance according to claims 1, 2 or 3, wherein said inner pouch is attached to said attachment means by a peelable interior sealing seam extending around said stoma receiving aperture in said inner pouch.

5. An ostomy appliance according to claim 4, wherein the material of said inner pouch walls is biodegradable.

6. An ostomy appliance according claims 1, 2 or 3, wherein said inner pouch walls are made of a plastic film laminated to a web of tissue paper, said web facing outwards relative to the interior of said inner pouch.

7. An ostomy appliance according to claim 6, wherein said tissue paper and said plastic film are biodegradable.

8. An ostomy appliance according to claim 1, wherein said inner pouch walls are impermeable to liquid and gas and permeable to odours, and said outer pouch walls are impermeable to liquid, gas and odours.

9. An ostomy appliance according to claim 1, wherein said one or more outer pouch peeling seams comprises a peeling action initiation zone, where said one or more outer pouch sealing seams comprises a peak-like extent tapering in the direction opposite a predetermined peeling direction

10. An ostomy appliance according to claim 1, wherein said one or more outer pouch peeling seams comprises a peeling action ending zone, where said one or more outer pouch sealing seams comprises a peak-like extent tapering in a predetermined peeling direction.

11. An ostomy appliance according to claim 4, wherein said interior inner pouch sealing seam comprises a peeling action initiation zone, where interior inner pouch sealing seam comprises a peak-like extent tapering in the direction opposite a predetermined peeling direction.

12. An ostomy appliance according to claim 4, wherein said interior inner pouch sealing seam comprises a peeling action ending zone, where interior inner pouch sealing seam comprises a peak-like extent tapering in a predetermined peeling direction.

13. An ostomy appliance according to claim 1, wherein said proximal outer pouch wall is attached to said attachment means by a heat sealed sealing seam.

14. An ostomy appliance according to claim 1, wherein said proximal outer pouch wall is attached to said attachment means by a peelable sealing seam.

15. An ostomy appliance according to claim 1, wherein said attachment means comprise a face plate assembly comprising a wafer of skin friendly adhesive material having a third aperture for receiving said stoma aligned with said first and second apertures, and a first coupling ring surrounding said third aperture and attached to said wafer and in engagement with a second coupling ring surrounding said first and second apertures and attached to said proximal outer pouch wall and/or to said proximal inner pouch wall.

16. An ostomy appliance according to claim 15, wherein said proximal outer pouch wall is attached to said second coupling ring by means of a heat sealed sealing seam.

17. An ostomy appliance according to claim 15 or 16, wherein said proximal inner pouch wall is attached to said second coupling ring by means of said peelable interior sealing seam.

18. An ostomy appliance according to claim 15 or 16, wherein said proximal inner pouch wall is attached to said proximal outer pouch wall in a region surrounding said first and second apertures by means of said peelable interior sealing seam.

19. An ostomy appliance according to claim 1, wherein said attachment means comprise a face plate assembly comprising a wafer of skin friendly adhesive material having a third aperture for receiving said stoma aligned with said first and second apertures, and a first coupling means surrounding said third aperture and attached to said wafer and in releasably adhesive engagement with a second coupling means surrounding said first and second apertures and attached to said proximal outer pouch wall and/or to said proximal inner pouch wall.

20. An ostomy appliance according to claim 19, wherein said proximal outer pouch wall is attached to said second coupling means by means of a heat sealed sealing seam.

21. An ostomy appliance according to claim 19 or 20, wherein said proximal inner pouch wall is attached to said second coupling means by means of said peelable interior sealing seam.

22. An ostomy appliance according to claim 19 or 20, wherein said proximal inner pouch wall is attached to said proximal outer pouch wall in a region surrounding said first and second apertures by means of said peelable interior sealing seam.

23. An ostomy appliance according to claim 1, wherein said attachment means comprise a face plate assembly comprising a wafer of skin friendly adhesive material having a fourth aperture for receiving said stoma aligned with said first and second apertures, and a carrier sheet attached to the distal surface of said wafer and attached to said proximal outer pouch wall and to said proximal inner pouch wall.

24. An ostomy appliance according to claim 23, wherein said proximal outer pouch wall is attached to said carrier sheet by means of a heat sealed sealing seam.

25. An ostomy appliance according to claim 23 or 24, wherein said proximal inner pouch wall is attached to said carrier sheet by means of said interior peelable sealing seam.

26. An ostomy appliance according to claim 23 or 24, wherein said proximal inner pouch wall is attached to said proximal outer pouch wall in a region surrounding said first and second apertures by means of said peelable interior sealing seam.

27. An ostomy appliance according claim 4, wherein said peelable interior sealing seam is constituted by a sheet of film or textile with a fifth stoma receiving aperture and having adhesive on both opposed surfaces.

28. An ostomy appliance according to claims 15, wherein an annular insert having a sixth aperture for receiving said stoma is provided within said second coupling ring for preventing said stomal discharge from soiling said second coupling ring.

29. An ostomy appliance according to claim 1, wherein said attachment forces provided by said one or more peelable outer pouch sealing seams are such that the pulling force required for manually eliminating said attachment forces is between approx. 0.5 Newton and approx. 6 Newton, preferably between approx. 0.7 Newton and approx. 5.5 Newton, even more preferably between approx. 0.8 Newton and approx. 5.0 Newton, even more preferably between approx. 0.9 Newton and approx. 4.5 Newton and most preferably between approx. 1.0 Newton and approx. 4.0 Newton

30. An ostomy appliance according to claim 29, wherein said outer pouch peelable sealing seams are between 4 and 6 mm wide, preferably approximately 5 mm wide.

31. An ostomy appliance according to claim 1, wherein at least a portion the outer peripheral edges of said outer pouch walls and inner pouch walls has been formed by cutting through said walls in the areas of said outer pouch peelable seams.

32. An ostomy appliance according to claim 1, wherein a portion of said outer pouch walls and inner pouch walls extend beyond said outer pouch peelable seams to form inner pouch wall and outer pouch wall gripping tabs for peeling said walls apart.

33. An ostomy appliance according to claim 6, wherein said outer pouch peelable seam is made by applying heat and/or RF to the outer surface of one or both of said outer pouch walls.

34. An ostomy pouch according to claim 33, wherein an area of each of said inner pouch wall gripping tabs extending into the area covered by the adjacent outer pouch peelable seam has been subjected to application of heat and/or RF prior to the formation of said outer pouch peelable seams.

35. An ostomy appliance according to claim 6, wherein a significant portion of the fibres of said paper have a generally uniform orientation and said orientation is transversal to a line extending from the top to the bottom of said outer and inner pouches when a user to which said pouches have been applied around a stoma is standing erect, said orientation preferably being generally orthogonal to said line.

36. A method of disposing of an ostomy pouch assembly of an ostomy appliance according to claims 1, 2 or 3 after use thereof, said method comprising the steps of:

gripping an edge portion of said distal outer pouch wall,

pulling said edge portion of said distal outer pouch wall away from the body of the user such that the attachment of said distal outer pouch wall by the respective one of said one or more peelable outer pouch sealing seams to the rest of said appliance is disrupted,

gripping mutually superimposed edge portions of said distal and proximal inner pouch wall,

pulling said superimposed edge portions away from the body of the user such that the attachment of said inner pouch by the respective peelable sealing seams to the rest of said appliance is eliminated, and

disposing of the inner pouch with contents in a toilet bowl.

37. A method according to claim 36, wherein the pulling force exerted for pulling said edge portion of said distal outer pouch wall away from the body of the user and the pulling force exerted for pulling said superimposed edge portions away from the body of the user is between approx. 0.5 Newton and approx. 6 Newton, preferably between approx. 0.7 Newton and approx. 5.5 Newton, even more preferably between approx. 0.8 Newton and approx. 5.0 Newton, even more preferably between approx. 0.9 Newton and approx. 4.5 Newton and most preferably between approx. 1.0 Newton and approx. 4.0 Newton.