Temporary ostomy appliance

• US 8,858,520 B2
• Filed: 04/21/2009
• Issued: 10/14/2014
• Est. Priority Date: 04/22/2008
• Status: Active Grant

• Current Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Original Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Inventors: Gregory, Christopher
• Primary Examiner(s): Su, Susan
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US12/988,826
• Publication Number:
  US 20110040231A1
• Time in Patent Office: 2,002 Days
• Field of Search: 604/346
• US Class Current: 604/346
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence

Abstract

A temporary ostomy appliance is disclosed, including a catheter for extending through the abdominal wall into the intestine. The catheter may be a transcecal catheter for extending through the cecal valve into the ileum. A portion of a catheter that extends through the cecal valve is made collapsible when the catheter is empty. The collapsed portion expands to permit passage of effluent. A balloon carried on the catheter is preformed with a shape and size in order to permit inflation without elastic stretching of the balloon wall material. A filament is provided for permitting a portion of the catheter to be fastened to internal body tissue by surgical sutures or staples. In order to release the fastening without further surgery, the filament is withdrawn by pulling on a proximal portion outside the body.

Claims

1. A temporary ostomy appliance comprising:

a catheter for extending through the abdominal wall into the large intestine, the catheter including an inlet aperture for drainage of effluent from the large intestine;

an inflatable balloon disposed on the catheter for blocking the passage of effluent in the large intestine, and diverting effluent through the inlet aperture for drainage via the catheter; and

a fender disposed on the catheter and separate from the inflatable balloon for separating the outside surface of the intestinal wall from direct contact with the inner abdominal wall at the site where the catheter enters the intestine.

2. The temporary ostomy appliance of claim 1 wherein the catheter is transcecal extending

through the abdominal wall into the large intestine and through the cecal valve into the ileum, the catheter including a first tubular portion intended to be received in the ileum, and a second tubular portion intended to be received at the cecal valve, the first and second tubular portions defining a drainage channel therein, and the second tubular portion being more easily collapsible, to collapse the drainage channel, than the first tubular portion.

3. The temporary ostomy appliance of claim 2, wherein the second tubular portion has a thinner wall thickness than the first tubular portion.

4. The temporary ostomy appliance of claim 2, wherein the second tubular portion is made of a more compliant material with a lower Youngs Modulus or durometer than the first tubular portion.

5. The temporary ostomy appliance of claim 2, wherein the second tubular portion is collapsible to less than about 1 cm in external diameter when the catheter is empty, without compression of the catheter wall material.

6. The temporary ostomy appliance of claim 2, wherein the second tubular portion is expandable to greater than about 1 cm in external diameter when passing effluent, without stretching of the catheter wall material.

7. The temporary ostomy appliance of claim 2, wherein the first and second tubular portions are made of material selected from:

silicone; and

/or polyurethane, and/or another polymer material.

8. The temporary ostomy appliance of claim 2, further comprising a third tubular portion intended to be received in the large intestine, the second tubular portion being more easily collapsible, to collapse the drainage channel, than the third tubular portion.

9. The temporary ostomy appliance of claim 1 wherein the inflatable balloon is made of flexible material defining a hollow bladder of predetermined size that is not substantially smaller than the size of the balloon when inflated in use against the intestinal tissue.

10. The temporary ostomy appliance of claim 9, wherein the balloon is inflatable to said predetermined size without elastic stretching of the balloon wall material.

11. The temporary ostomy appliance of claim 9, wherein said predetermined size is significantly greater than the size of the balloon when inflated in use in the intestine.

12. The temporary ostomy appliance of claim 9, wherein the balloon comprises material of a thickness of about 100 microns or less.

13. The temporary ostomy appliance of claim 1 wherein the catheter includes a first portion accessible in use from outside the abdominal wall and a second portion that is received in use inside the body;

and

a filament that extends between first and second eyes at the second catheter portion, to define a bridge feature that is fastenable to internal body tissue during surgery by a surgical suture or a surgical staple, the filament extending to the first portion of the catheter;

wherein in use, the filament is withdrawable from the eyes by pulling on a portion of the filament at the first portion.

14. The temporary ostomy appliance of claim 13, wherein the eyes comprise lugs that space the filament proud of the surface of the catheter.

15. The temporary ostomy appliance of claim 14, wherein the filament extends from the eyes to the first portion, via an internal passage in the catheter.

16. The temporary ostomy appliance of claim 15, wherein the filament passes to the exterior of the catheter near or at the first portion.

17. The temporary ostomy appliance of claim 1 wherein the catheter is transcecal extending through the abdominal wall into the large intestine, and through the cecal valve into the ileum, the catheter comprising:

a first lumen for drainage of material from the ileum through the catheter; and

a second lumen for communicating with an interior of the large intestine and/or the ileum, for permitting admission of fluid or separate instrumentation thereto.

18. The temporary ostomy appliance of claim 1 wherein the catheter is transcecal extending through the abdominal wall into the large intestine, and through the cecal valve into the ileum, and includes at least one sensor for measuring a parameter of the catheter or catheter contents in use.

19. The temporary ostomy appliance of claim 18, wherein the sensor is configured to generate an electronic output signal.

20. The temporary ostomy appliance of claim 18, wherein the sensor is selected from a group consisting of a strain sensor;

a temperature sensor;

a flow sensor;

a weight sensor;

a pressure sensor.

21. The temporary ostomy appliance of claim 18 wherein:

the catheter further comprises at least one longitudinally extending stiffening element for resisting kinking of the catheter.

22. The temporary ostomy appliance of claim 1 wherein the catheter is transcecal for extending from a proximal portion through the abdominal wall into the large intestine, through the cecal valve and into the ileum, the catheter include a lumen for communicating with an interior space of the large intestine and/or ileum, and the catheter further comprising a closable access port at the proximal portion for permitting insertion of additional catheters into the lumen.

23. The temporary ostomy appliance of claim 1, further comprising a transcecal extension that extends from the large intestine, through the cecal valve into the ileum.

24. The temporary ostomy appliance of claim 23, wherein the transcecal extension further comprises an inflatable balloon at a distal portion for locating the distal portion in the ileum.

25. The temporary ostomy appliance of claim 23, wherein the inlet aperture is configured to be at least 10 cm from the cecal valve, in use.

26. The temporary ostomy appliance of claim 1, wherein the fender is selectively expandable and/or collapsible.

27. The temporary ostomy appliance of claim 1, wherein the fender comprises an inflatable fender balloon.

28. The temporary ostomy appliance of claim 1, wherein the inflatable balloon and the fender are configured to sandwich the intestinal wall between the inflatable balloon and the fender at the site where the catheter enters the intestine.

29. The temporary ostomy appliance of claim 1, wherein the catheter is a transcecal catheter for extending into the large intestine, and through the cecal valve into the ileum.