Peelable and flushable ostomy pouch and method of use

• US 7,517,339 B2
• Filed: 10/20/2004
• Issued: 04/14/2009
• Est. Priority Date: 10/21/2003
• Status: Active Grant

• Current Assignee: Hollister Incorporated
• Original Assignee: Hollister Incorporated
• Inventors: Forbjerg-Iarsen, Jørgen, Pedersen, Ole, Giori, Claudio
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Craig; Paula L
• Application Number:
  US10/969,523
• Publication Number:
  US 20050113770A1
• Time in Patent Office: 1,637 Days
• Field of Search: 604/344, 604/345, 604/327, 604/332
• US Class Current: 604/345
• 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 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,

said one or more outer pouch sealing seams peelably attaching said distal outer pouch wall to said distal inner pouch wall and said proximal outer pouch wall to said proximal inner pouch wall.

2. An ostomy appliance according to claim 1, 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.

3. An ostomy appliance according to claim 2, wherein the material of said inner pouch walls is biodegradable.

4. An ostomy appliance according to claim 2, wherein said interior inner pouch sealing seam comprises a peeling action initiation zone, where the interior inner pouch sealing seam comprises a peak-like extent tapering in the direction opposite a predetermined peeling direction.

5. An ostomy appliance according to claim 1, 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.

6. An ostomy appliance according to claim 5, wherein said tissue paper and said plastic film are biodegradable.

7. An ostomy appliance according to claim 5, wherein said outer pouch peelable seam is made by applying heat and/or RE to the outer surface of one or both of said outer pouch walls.

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

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 1, wherein said proximal outer pouch wall is attached to said attachment means by a heat sealed sealing seam.

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

13. An ostomy appliance according to claim 1, wherein said attachment means comprises 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.

14. An ostomy appliance according to claim 13, wherein said proximal outer pouch wall is attached to said second coupling ring by means of a heat sealed sealing seam.

15. An ostomy appliance according to claim 13 or 14, wherein said proximal inner pouch wall is attached to said second coupling ring by means of said peelable interior sealing seam.

16. An ostomy appliance according to claim 13 or 14, 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.

17. An ostomy appliance according to claim 1, wherein said attachment means comprises 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.

18. An ostomy appliance according to claim 17, wherein said proximal outer pouch wall is attached to said second coupling means by means of a heat sealed sealing seam.

19. An ostomy appliance according to claim 17 or 18, wherein said proximal inner pouch wall is attached to said second coupling means by means of said peelable interior sealing seam.

20. An ostomy appliance according to claim 17 or 18, 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.

21. An ostomy appliance according to claim 1, wherein said attachment means comprises 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.

22. An ostomy appliance according to claim 21, wherein said proximal outer pouch wall is attached to said carrier sheet by means of a heat sealed sealing seam.

23. An ostomy appliance according to claim 21 or 22, wherein said proximal inner pouch wall is attached to said carrier sheet by means of said interior peelable sealing seam.

24. An ostomy appliance according to claim 21 or 22, 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.

25. 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 overcoming said attachment forces is between approximately 0.5 Newton and approximately 6 Newton.

26. An ostomy appliance according to claim 25, wherein said outer pouch peelable sealing seams are between 4 and 6 mm wide.

27. An ostomy appliance according to claim 25 wherein said pulling force is between approximately 1.0 Newton and approximately 4.0 Newton.

28. An ostomy appliance according to claim 26 wherein said outer pouch sealing seams are approximately 5 mm wide.

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

30. 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 overcome by manually pulling said distal outer pouch wall in a direction transverse to said one or more peelable outer pouch sealing seams,

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, and

wherein said interior inner pouch sealing seam comprises a peeling action ending zone, where the interior inner pouch sealing seam comprises a peak-like extent tapering in a predetermined peeling direction.

31. 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 overcome by manually pulling said distal outer pouch wall in a direction transverse to said one or more peelable outer pouch sealing seams,

said inner pouch being attached to said attachment means by a peelable interior sealing seam extending around said stoma receiving aperture in said inner pouch,

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.

32. 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 overcome by manually pulling said distal outer pouch wall in a direction transverse to said one or more peelable outer pouch sealing seams,

wherein said attachment means comprises 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,

a first coupling ring surrounding said third aperture and attached to said wafer and in releasable adhesive 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,

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.

33. 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 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, a portion of said outer pouch walls and inner pouch walls extending beyond said outer pouch peelable seams to form inner pouch wall and outer pouch wall gripping tabs for peeling said walls apart.

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 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 overcome by manually pulling said distal outer pouch wall in a direction transverse to said one or more peelable outer pouch sealing seams,

said inner pouch walls being made of a plastic film laminated to a web of tissue paper, said web facing outwards relative to the interior of said inner pouch,

wherein a significant portion of the fibers of said tissue 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 said pouches have been applied around a stoma is standing erect, said orientation being generally orthogonal to said line.