INFLATABLE STOMAL IMPLANT

• US 20110015475A1
• Filed: 07/14/2010
• Published: 01/20/2011
• Est. Priority Date: 07/14/2009
• 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, GREENBERG, Ron, GREENBERG, Shay
• Granted Patent: US 8,900,116 B2
• Time in Patent Office: Days
• US Class Current: 600/32
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2005/4455 Implantable
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence

Abstract

A stomal implant comprising a longitudinal portion configured to envelop at least a section of the bowel or ileal conduit, said longitudinal portion comprising: a proximal end for positioning at a stomal opening; a distal end for positioning within an abdomen; and a reversibly pressure-exerting device providing an ascending pressure gradient from the distal end to the proximal end, such that pressure exerted at the proximal end provides complete closure of the bowel or urethra.

Claims

1. A stomal implant comprising a longitudinal portion configured to envelop at least a section of a bowel or ileal conduit, said longitudinal portion comprising:

a proximal end for positioning at a stomal opening;

a distal end for positioning within an abdomen;

at least one pressure-exerting device; and

a removable closure for insertion within said proximal end;

wherein upon insertion of said removable closure within said proximal end and activation of said pressure-exerting device, a pressure gradient is provided over a section of the bowel or ileal conduit, said pressure gradient providing closure of said bowel or ileal conduit.

2. The stomal implant of claim 1, wherein said at least one pressure-exerting device comprises a first inflatable device positioned around at least a portion of the circumference of said proximal end.

3. The stomal implant of claim 2, wherein said first inflatable device comprises an inflatable ring.

4. The stomal implant of claim 3, wherein said inflatable ring extends 360°

around said circumference of said longitudinal sleeve.

5. The stomal implant of claim 2 comprising a second inflatable device positioned around at least a portion of the circumference of said distal end, wherein a pressure exerted on said longitudinal sleeve upon inflation of said first inflatable device is greater than a pressure exerted on said longitudinal portion upon inflation of said second inflatable device, thereby providing a decreasing pressure gradient along said longitudinal sleeve from said proximal end to said distal end.

6. The stomal implant of claim 5, wherein said second inflatable device comprises a second inflatable ring.

7. The stomal implant of claim 6, wherein said second inflatable ring extends 270°

around said circumference of said longitudinal portion.

8. The stomal implant of claim 5, wherein said longitudinal portion further comprises at least a third inflatable device positioned around at least a portion of the circumference of said longitudinal portion, between said first inflatable device and said second inflatable device, wherein a pressure exerted on said longitudinal portion upon inflation of said third inflatable device is greater than a pressure exerted on said longitudinal portion upon inflation of said second inflatable device, and greater than a pressure exerted on said longitudinal portion upon inflation of said second inflatable device.

9. The stomal implant of claim 8, wherein said third inflatable device comprises a third inflatable ring.

10. The stomal implant of claim 1 wherein said inflatable device is inflated by insertion of a fluid.

11. The stomal implant of claim 10, wherein said fluid, prior to inflation of said inflatable device, is contained within a reservoir.

12. The stomal implant of claim 11, wherein said reservoir is located intra-abdominally or retroperitoneally.

13. The stomal implant of claim 11, wherein said reservoir is positioned on said longitudinal portion.

14. The stomal implant of claim 11, wherein said reservoir comprises a plurality of separate compartments, wherein each of said compartments serves as a reservoir for a single inflatable device.

15. The stomal implant of claim 11, further comprising an activator valve in communication with said reservoir, wherein activation of said activator valve forces said fluid from said reservoir into at least one of said rings.

16. The stomal implant of claim 11, wherein said fluid is selected from the group consisting of a liquid, a gel, a colloid, a suspension, an emulsion, a gas, and a supercritical fluid.

17. The stomal implant of claim 16, wherein said liquid comprises saline.

18. The stomal implant of claim 15, wherein said activator valve is positioned subcutaneously.

19. The stomal implant of claim 11, further comprising a port, in fluid communication with said reservoir, wherein said port provides control of flow of said fluid from said reservoir to said at least one ring.

20. The stomal implant of claim 1, wherein said implant is attached to the intra abdominal wall by at least one selected from the group consisting of a suture, a clip or a staple, or combinations thereof.

21. The stomal implant of claim 1, wherein the implant is constructed from silicon or polyurethane.

22. The stomal implant of claim 1, wherein said removable closure comprises a base located at a proximal end and a protruding section.

23. The stomal implant of claim 22, wherein said base comprises a flattened section having a circumference greater than that of said inflatable first ring in an inflated state.

24. The stomal implant of claim 23, wherein said flattened section is configured to adhere to the skin of the outer abdominal wall.

25. The stomal implant of claim 22, wherein said protruding section comprise a stem and a bulbous distal end, said bulbous end being sealingly retained within said proximal end of said longitudinal sleeve upon inflation of said first ring.

26. The stomal implant of claim 22, wherein said removable closure comprises a reversibly inflatable balloon at a distal end.

27. The stomal implant of claim 1, further comprising a protective layer for positioning around said proximal end for prevention of peristomal hernia.

28. The stomal implant of claim 1, wherein said pressure-exerting device comprises a reversibly inflatable balloon fixedly attached to a distal end of said removable closure.

29. The stomal implant of claim 1, wherein said removable closure further comprises at least one of a unidirectional gas valve, an inflation port, a deflation port and a pressure overload cutoff valve.

30. The stomal implant of claim 29, wherein said unidirectional gas valve is manually controllable by a user.

31. A method for providing fecal continence, the method comprising providing a stomal implant comprising a longitudinal portion configured to envelop at least a section of a bowel or ileal conduit, said longitudinal portion comprising a proximal end for positioning at a stomal opening, a distal end for positioning within an abdomen, at least one pressure-exerting device;

and a removable closure for insertion within said proximal end;

inserting said stomal implant within said stomal opening;

inserting said removable closure within said proximal end; and

activating said pressure-exerting device, such that a pressure gradient is provided which retains said removable closure within said proximal end and provides closure of said bowel or ileal conduit.