OSTOMY APPLIANCE

• US 20130304008A1
• Filed: 05/09/2013
• Published: 11/14/2013
• Est. Priority Date: 05/10/2012
• Status: Active Grant

• Current Assignee: B Braun Medical SAS (B. Braun Holding GmbH & Co. KG)
• Original Assignee: Stimatix GI Ltd (B. Braun Holding GmbH & Co. KG)
• Inventors: HANUKA, David, OR, Meir, ZISO, Hadas
• Granted Patent: US 9,345,612 B2
• Time in Patent Office: Days
• US Class Current: 604/334
• 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 for cleaning and related maintenance of a surgical stoma. Components take the form of attachments, inserted elements, and/or separate parts in contact with ostomy ports, wafers, and/or other connecting components.

Claims

1. A flushing device for distributing fluid within an ostomy appliance worn over a surgical stoma, comprising:

an annular body, sized and shaped to fittingly insert into the opening of the ostomy appliance;

an attachment element for attaching the body to its inserted position; and

a fluid delivery lumen passing into the annulus of the body having;

an inlet sized and positioned to attach to a fluid source, and

at least one outlet sized and positioned to deliver fluid to one or more predetermined locations.

2. The flushing device according to claim 1, wherein the attachment to the ostomy appliance is sealed to prevent outflow of delivered fluid, except through the proximal end of the annular body.

3. The flushing device according to claim 2, wherein the fitting insertion of the annular body of the device to the ostomy appliance is reversible.

4. The flushing device according to claim 2, comprising a waste collection pouch in sealed fluid communication with the proximal end of the annular body.

5. The flushing device according to claim 4, wherein the pouch is collapsed.

6. The flushing device according to claim 2, wherein the proximal end of the annular body is closed.

7. The flushing device according to claim 2 wherein the at least one outlet of the delivery lumen terminates external to the stoma when the annular body of the device is inserted into the ostomy appliance.

8. The flushing device according to claim 2 wherein fluid delivery to the one or more predetermined locations of the stoma comprises washing at least a portion of the stoma.

9. The flushing device according to claim 2 wherein fluid delivery to the one or more predetermined locations comprises washing at least a portion of the ostomy appliance.

10. The flushing device according to claim 2 wherein fluid delivery to the one or more predetermined locations comprises softening fecal material accumulated in the ostomy appliance.

11. The flushing device according to claim 2 wherein the at least one outlet of the delivery lumen terminates internal to the stoma when the annular body of the device is inserted into the ostomy appliance.

12. The flushing device according to claim 2 wherein fluid delivery to the one or more predetermined locations of the stoma comprises injecting fluid into the space behind the stomal aperture.

13. The flushing device according to claim 2 wherein the delivery lumen comprises a removable tubule at its distal end.

14. The flushing device according to claim 1 wherein the fitting insertion of the annular body of the device to the ostomy appliance is sufficiently secure that irrigation does not dislodge it.

15. The flushing device according to claim 1 wherein the fitting insertion of the annular body of the device to the ostomy appliance is sufficiently secure that it does not dislodge during ambulatory movement.

16. The flushing device according to claim 1 wherein said attachment element is configured such that the annular body is interchangeable with an ostomy cap.

17. A flushing element for distributing fluid within an ostomy appliance worn over a surgical stoma, comprising:

a body, sized and shaped to fittingly occupy a cavity of the ostomy device; and

at least one flushing channel comprising a void in the body, having;

an inlet, positioned so that when the body is fitted to the cavity, the inlet receives and transmits pressurized fluid delivered from a fluid delivery port inside the cavity; and

at least one outlet sized and positioned to deliver fluid received by the inlet to one or more predetermined locations.

18. The flushing element according to claim 17, wherein the fluid delivery port receives fluid from a lumen passing in through a wall of the ostomy appliance.

19. The flushing element according to claim 17, wherein the flushing element body fits within the ostomy appliance such that it acts as a seal resisting leakage from the stomal aperture to the exterior of the ostomy appliance.

20. The flushing element according to claim 17, wherein the flushing element body fits within the ostomy appliance such that it acts as a seal resisting leakage from the stomal aperture to a region of the skin.

21. The flushing element according to claim 17, wherein the flushing element body fits within the ostomy appliance such that it acts as a spacer occupying at least a portion of the space between the stoma and the ostomy appliance.

22. The flushing element according to claim 20, wherein the material of the flushing element body comprises an elastomer.

23. The flushing element according to claim 17, wherein the flushing channel comprises an internal lumen of the flushing element body.

24. The flushing element according to claim 17, wherein the flushing channel comprises a depression in the surface of the flushing element body.

25. The flushing element according to claim 17, wherein the at least one outlet connects to the interior of the cavity through at least one one-way valve.

26. The flushing element according to claim 17, wherein the at least one outlet connects to the interior of the cavity through at least one slit.

27. The flushing element according to claim 17, wherein the flushing element body comprises an annulus.

28. The flushing element according to claim 17, wherein the flushing channel comprises a manifold.

29. The flushing element according to claim 17, wherein the at least one outlet comprises a plurality of outlets.

30. The flushing element according to claim 29, wherein at least two of the plurality of outlets are radially separated by at least one third of the circumference of the stoma.

31. An insert for an ostomy appliance used with a surgical stoma comprising a pad of absorbent material fitted to be held at a predefined location within the ostomy appliance such that discharge material exiting the stoma contacts it.

32. The insert of claim 31, wherein the insert, held at the predefined location, does not contact tissue of the stoma.

33. The insert of claim 31, wherein the insert is located at a distal side of an ostomy cap.

34. The insert of claim 33, wherein the ostomy cap is provided to the user with the insert contained therein.

35. The insert of claim 31, wherein the predefined location is circumferential to the stoma.

36. The insert of claim 35, wherein the shape of the pad is annular.

37. A restraint for a collapsed waste collection pouch of an ostomy appliance comprising:

a body,

held to the ostomy appliance by surface bonding;

positioned to restrain the collapsed pouch from expanding under pressure from within the ostomy appliance to the volume which the unrestrained pouch is rated to contain; and

having the strength of the surface bonding set so that it breaks when pressed by a pressure from within the ostomy appliance which exceeds a predetermined threshold.

38. The restraint according to claim 37, wherein the body ceases to restrain the pouch upon the breaking of the surface bonding.

39. The restraint according to claim 37, wherein the restraint is a sealing cover for the ostomy appliance which resists the escape of stomal gases as long as the surface bonding is intact.

40. The restraint according to claim 39, wherein:

regions of surface bonding break at one of at least different two pressure thresholds;

one threshold being predetermined for each region;

breaking at the lower threshold comprising a loss of resistance to the escape of stomal gasses; and

breaking at the higher threshold comprising loss of restraint on the expansion of the pouch.

41. The restraint according to claim 37, wherein the surface bond is by welding.

42. The restraint according to claim 37, wherein the surface bond is by adhesion.

43. A restraint for a collapsed waste collection pouch of an ostomy appliance, comprising:

a body;

upon the body, one element of

at least one pair comprising a receiving aperture and an inserting projection,

the projection sized to insert into the aperture and form a fitting attachment,

the other element of the at least one pair being upon the ostomy appliance;

such that

the attached body is positioned to restrain the collapsed pouch from expanding under pressure from within the ostomy appliance to the volume which the unrestrained pouch is rated to contain; and

the strength of the fitting attachment is set so that it breaks when pressed by a pressure from within the ostomy appliance which exceeds a predetermined threshold.

44. The restraint according to claim 43, wherein the restraint is fixedly attached to the ostomy appliance through a flexible member.

45. The restraint according to claim 44, wherein the flexible member is a hinge.

46. The restraint according to claim 43, wherein the elements of the at least one pair are disposed on facing surfaces of the body and the ostomy appliance.

47. The restraint according to claim 46, wherein at least one element of the at least one pair comprising a receiving aperture and inserting projection is of variable size, at least across a profile, such that the relative size of receiving aperture and projection at the place of attachment is selected by the relative positioning of the pair elements.

48. The restraint according to claim 47, wherein the attachment-breaking pressure is different depending on the relative attached positioning of the at least one pair comprising a receiving aperture and inserting projection.

49. The restraint according to claim 43, wherein:

at least two regions of fitting attachment have attachment broken, each above a different pressure threshold;

one threshold being higher than the other;

attachment loss at the lower threshold comprising a loss of resistance to the escape of stomal gasses from the ostomy appliance; and

attachment loss at the higher threshold comprising loss of restraint on the expansion of the pouch.