COMPACT OSTOMY APPLIANCE

• US 20160113810A1
• Filed: 05/08/2014
• Published: 04/28/2016
• Est. Priority Date: 05/10/2012
• Status: Active Grant

• Current Assignee: B Braun Medical SAS (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: HANUKA, David, OR, Meir, SOMMER, Refael, SHAVIT, Tamir
• Granted Patent: US 10,524,953 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2005/4402 disposable
• CPC Class Codes: A61F 2005/4415 venting by manual operation
• CPC Class Codes: A61F 5/4401 with absorbent pads diapers A61F13/49
• CPC Class Codes: A61F 5/4404 Details or parts
• CPC Class Codes: A61F 5/4405 Valves or valve arrangements specially adapted therefor A61F5/441 takes precedence; Fluid inlets or outlets A61F5/4407 takes precedence
• CPC Class Codes: A61F 5/4407 Closure means other than valves
• CPC Class Codes: A61F 5/441 having venting or deodorant means, e.g. filters ; having antiseptic means, e.g. bacterial barriers
• CPC Class Codes: A61F 5/442 having irrigation ports or means irrigators A61M3/02
• 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
• CPC Class Codes: B31B 50/26 Folding sheets, blanks or webs

Abstract

Ostomy appliance components providing low profile containment of waste from a surgical stoma. Waste collection pouch configuration, positioning, and positioning structure relate to potential advantages in manufacturing and operation of components.

Claims

1. An ostomy appliance to provide continence to a stoma, comprising:

a collapsed waste collection pouch for receiving stomal waste, and having a membranous body;

said membranous body having an aperture attached to a proximal end of said ostomy appliance and sized to receive waste therefrom;

a closure region of said membranous body comprising membrane surface extending substantially parallel and proximal to said aperture;

wherein

the limits of said closure region are defined by folds; and

said folds restrict waste reaching said aperture from moving past said closure region into the remainder of the pouch body, when attached as a collapsed pouch to said ostomy appliance.

2. The ostomy appliance of claim 1, wherein the body of said waste collection pouch comprises a folded configuration having a polygonal cross-section perpendicular to a distal-proximal axis, the area of said cross-section being less than 25% of the enclosed area of the unfolded pouch.

3. The ostomy appliance of any one of claims 1-2, wherein at least one region of said pouch outside said closure region extends substantially parallel to said aperture and across at least 80% of said closure region.

4. The ostomy appliance of any one of claims 1-3, wherein a plurality of separate regions of said pouch, each separated from said closure region by at least one of said folds, are folded to overlap one another.

5. The ostomy appliance of any one of claims 2-4, wherein said pouch comprises at least two plies of a membranous material, secured to one another at the edges to create a sealed receptacle for receiving waste.

6. The ostomy appliance of any one of claims 2-5, wherein said folded configuration comprises a predetermined number of layered panels of pouch material lying substantially perpendicular to a proximal-distal axis.

7. The ostomy appliance of any one of claims 2-6, wherein said closure region membrane surface comprises a substantially flat wall proximal to said proximal end.

8. The ostomy appliance of any one of claims 2-7, wherein said polygonal cross-section is fitted to the shape of a recess in a component of said ostomy appliance.

9. The ostomy appliance of claim 8, wherein said recess is fitted to the depth of said collapsed waste collection pouch, such that the collapsed pouch is held with layers compressed against one another.

10. The ostomy appliance of claim 8, comprising a pouch restraint, wherein said pouch restraint comprises said recess.

11. The ostomy appliance of claim 8, comprising an ostomy component housing extending distally from said pouch, wherein said ostomy component housing comprises said recess.

12. The ostomy appliance of claim 1, wherein said folds comprise bends in opposite enclosing surfaces of said membranous body, such that said enclosing surfaces are pressed into continuous contact with one another along the extent of said folds.

13. The ostomy appliance of claim 12, wherein said membranous body is held into a compact configuration such that said folds are pressed together, such that there is insufficient volume beyond them for said waste to move into.

14. The ostomy appliance of claim 2, wherein said polygonal cross-section comprises a shape formed by folds comprising a plurality of substantially parallel crease lines.

15. The ostomy appliance of claim 14, wherein said plurality comprises at least three crease lines.

16. The ostomy appliance of any one of claim 14 or 15, wherein said polygonal cross-section comprises a shape formed by folds comprising at least one crease line at a substantially right angle to said substantially parallel crease lines.

17. The ostomy appliance of claim 2, wherein said polygonal cross-section comprises a shape formed by folds comprising at least two crease lines substantially at relative angles characteristic of at least one of the group of right quadrilateral, regular pentagon, and regular hexagon.

18. The ostomy appliance of claim 17, wherein said at least two crease lines comprise intersections in the body of said waste collection pouch.

19. The ostomy appliance of claim 7, wherein said substantially flat wall proximal to said proximal end comprises a smooth region which occupies a predetermined distance from a distal floor of said ostomy appliance.

20. The ostomy appliance of claim 19, wherein said predetermined distance comprises a stomal height, adjusted by a predetermined tolerance spacing.

21. The ostomy appliance of claim 20, wherein said predetermined tolerance is greater than 0 mm, and less than 5 mm.

22. The ostomy appliance of claim 20, wherein said predetermined tolerance is greater than 0 mm, and less than 2 mm.

23. The ostomy appliance of claim 1, wherein said pouch is restrained from deployment by the folded structure of said pouch body interfering with its own opening.

24. The ostomy appliance of claim 23, wherein said interfering comprises a first fold being restrained from opening before a second fold opens.

25. The ostomy appliance of claim 23, wherein said interfering comprises distributing forces acting to deploy the pouch body such that non-zero magnitude opening forces at a fold are insufficient to overcome forces that act to close the fold.

26. The ostomy appliance of claim 1, wherein said collapsed waste collection pouch is folded to present a proximal surface comprising the face of a single folded panel.

27. The ostomy appliance of claim 1, wherein said collapsed waste collection pouch is folded to present a proximal surface comprising a region which is adapted to be manipulated to deploy the pouch for filling with waste.

28. The ostomy appliance of claim 27, wherein pulling on a proximal portion of said folded pouch in a single direction deploys the pouch for filling with waste.

29. The ostomy appliance of claim 2, wherein said folded configuration comprises at least one fold following a crease-line which runs substantially at an angle between parallel to and perpendicular to an axis of the bag which follows the direction along which the bag hangs when deployed.

30. The ostomy appliance of claim 1, wherein the proximal end of said ostomy appliance to which said pouch is attached comprises an ostomy appliance cap.

31. A folded pouch for use with an ostomy appliance to provide continence to a stoma, comprising:

a membranous body having an aperture;

configured to fit against a proximal end of said ostomy appliance and sized to receive waste therefrom;

a frame configured to attach to said ostomy appliance and fit said aperture thereto;

a closure region of said membranous body comprising membrane surface extending substantially parallel and proximal to said aperture;

wherein

folding of said pouch restricts waste reaching said aperture from moving past said closure region into the remainder of the pouch body, when attached as a collapsed pouch to said ostomy appliance.

32. The folded pouch of claim 31, wherein said folding comprises folds at an angle deviating from substantially parallel and substantially perpendicular to a direction of force applied when said pouch is manipulated to be deployed for filling with waste.

33. A packaged set of ostomy appliance components for providing continence to a stoma, comprising:

at least a predetermined number of collapsed waste collection pouches, each having a body; and

at least one pouch restraint;

wherein

a proximal surface region of said body is disposed to press against said pouch restraint upon receiving pressure from a distal side;

said pouch restraint being configured to release said pouch on average at a target level of said pressure; and

the standard deviation of the actual release pressure among all pouches provided in the packaged set is no more than 20% of said target level.

34. The packaged set of ostomy appliance components of claim 33, wherein said standard deviation is no more than 10% of said target level.

35. The packaged set of ostomy appliance components of claim 33, wherein said predetermined number of collapsed waste collection pouches is ten or more.

36. A method of deploying a pouch from an ostomy appliance, comprising:

setting a pouch restraint to release a pouch for deployment at a predetermined release pressure; and

automatically releasing said restraint at an actual intra-abdominal release pressure based on said predetermined release pressure;

wherein

for an unbiased sampling of at least ten such actual intra-abdominal release pressures, the standard deviation of said unbiased sampling is no more than 20% of said predetermined release pressure.

37. A method of manufacturing a waste collection pouch for use with an ostomy appliance, comprising:

receiving a folding pattern for said waste collection pouch comprising crease lines and directions of folding therearound; and

folding the pouch according to said folding pattern.

38. The method of claim 37, wherein said folding comprises setting a jig for setting the location of said crease lines on said pouch.

39. The method of claim 37, comprising setting a pouch restraint to prevent deployment of said pouch below a predetermined release pressure.

40. The method of claim 37, wherein said folding pattern comprises at least four parallel creases.

41. An ostomy cap for sealing a surgical stoma comprising:

a folded ostomy pouch; and

a pressure-releasing pouch restraint positioned to prevent the pouch from deploying from its collapsed state below a selected threshold of pressure received from within the abdominal cavity;

wherein

the folding pattern of the collapsed pouch is adjustable to one of a plurality of predetermined folding patterns; and

said selected threshold of pressure is changeable, according to said folding pattern.

42. The ostomy cap of claim 41, wherein:

the relative orientation of said folded ostomy pouch and said pressure-releasing pouch restraint is selectable from among a plurality of relative orientations, and

said selected threshold of pressure is changeable, according to said relative orientation.

43. An ostomy appliance for sealing a surgical stoma comprising:

a collapsed pouch; and

a pressure-releasing pouch restraint mechanism, including a region of reversible attachment to said ostomy appliance along an extent of an attachment interface, wherein

said region of reversible attachment is positioned to receive pressure from said pouch due to pressure exerted from within the abdominal cavity;

said region of reversible attachment is configured to progressively detach along said extent over a range of said abdominal cavity pressures, as said abdominal cavity pressure increases.

44. The ostomy appliance of claim 43, wherein the difference in pressure between the lower and upper pressures of said range is at least 10 mmHg.

45. An ostomy cap for sealing a surgical stoma comprising:

an ostomy waste collection pouch,

collapsed by crimped folding into a package comprising substantially parallel layers of sub-panels, and

having a waste inlet into a first sub-panel; and

a filter element,

sealed across a break in the material of a second sub-panel of said pouch separated from said first sub-panel by a crimped fold,

such that it is configured to receive flatus reaching it from said waste inlet pouch, and vent said flatus to the pouch exterior.

46. The ostomy cap of claim 45, wherein said first and said second sub-panels are separated by a crease located, when said ostomy cap is worn, above said waste inlet, and above said filter element.

47. The ostomy cap of any one of claims 45-46, wherein the side of said second sub-panel to which said filter element is attached is overlaid on the outside of the pouch by a substantially parallel surface pressed thereagainst.

48. The ostomy cap of any one of claims 45-47, wherein said crimped fold comprises a region which resists the flow of fluid into said second sub-panel.

49. The ostomy cap of any one of claims 45-48, configured such that said filter element operates to allow the passage of gas at or above a predetermined pressure level.

50. The ostomy cap of claim 49, wherein said predetermined pressure level is between 1 mmHg and 10 mmHg.