Inflatable stomal implant

• US 8,900,116 B2
• Filed: 07/14/2010
• Issued: 12/02/2014
• 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, Shay, Greenberg, Ron
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): WILSON, KAYLEE R
• Application Number:
  US12/835,838
• Publication Number:
  US 20110015475A1
• Time in Patent Office: 1,602 Days
• Field of Search: 600/29, 600/30, 600/32, 600/37, 604/332, 606/151, 623 2364- 2368
• 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 including;

a proximal end for positioning at a stomal opening, and

a distal end for positioning within an abdomen;

a removable closure including a base located at a proximal end outside of said abdomen and a protruding section for insertion within said stomal opening; and

a plurality of pressure-exerting devices, comprising a first pressure-exerting device fixedly attached to a distal end of said removable closure, and a second pressure-exerting device integral with said longitudinal portion;

wherein upon insertion of said first pressure-exerting device attached to said removable closure within said proximal end of said longitudinal portion and activation of said first and second pressure-exerting devices, a pressure gradient is provided by pressing of said section of bowel or ileal conduit between said removable closure and said longitudinal portion along said 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 plurality of pressure-exerting devices comprises at least one inflatable device, said at least one inflatable device being inflated by insertion of a fluid.

3. The stomal implant of claim 2, wherein said fluid, prior to inflation of said at least one inflatable device of said second pressure-exerting device, is contained within a reservoir.

4. The stomal implant of claim 3, wherein said reservoir is located on an outer surface of said longitudinal portion.

5. The stomal implant of claim 3, wherein said at least one inflatable device of said second pressure-exerting device comprises a plurality of inflatable devices, and wherein said reservoir comprises a plurality of separate compartments, wherein each of said compartments serves as a reservoir for a corresponding subset of the plurality of inflatable devices, said subset being mutually distinct among said compartments.

6. The stomal implant of claim 3, further comprising an activator valve in communication with said reservoir, wherein activation of said activator valve forces said fluid from said reservoir into said at least one inflatable device of said second pressure-exerting device.

7. The stomal implant of claim 6, wherein said activator valve is positioned subcutaneously.

8. The stomal implant of claim 3, 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.

9. The stomal implant of claim 8, wherein said liquid comprises saline.

10. The stomal implant of claim 3, 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 inflatable device of said second pressure-exerting device.

11. The stomal implant of claim 1, wherein said longitudinal portion is adapted to be 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.

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

13. The stomal implant of claim 1, wherein said removable closure comprises a reversibly inflatable balloon the distal end of said removable closure.

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

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

16. 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.

17. The stomal implant of claim 16, comprising said unidirectional gas valve, and wherein said unidirectional gas valve is disposed and configured to be manually controllable by a user while said removable closure is inserted.

18. The stomal implant of claim 17, comprising said pressure overload cutoff valve, and wherein said pressure overload cutoff valve is configured to release gas automatically above a predetermined safety limit threshold of pressure exerted from within said section of bowel or ileal conduit, said predetermined safety limit being at least 60 mmHg.

19. The stomal implant of claim 1, wherein said provided pressure gradient does not exceed 30-60 mmHg.

20. A method for providing fecal continence, the method comprising:

providing an implanted 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 positioned at a stomal opening,

a distal end positioned within an abdomen, and

a first pressure-exerting device; and

said stomal implant further comprising;

a removable closure for insertion within said stomal opening, and

a second pressure-exerting device fixedly attached to a distal end of said removable closure;

inserting said second pressure-exerting device attached to said removable closure within said proximal end of said longitudinal portion; and

activating said first and second pressure-exerting devices, such that a pressure gradient is provided by pressing of said section of bowel or ileal conduit between said removable closure and said longitudinal portion which retains said removable closure within said proximal end and provides closure of said bowel or ileal conduit.

21. The method of claim 20, wherein said removable closure comprises a pressure overload cutoff valve, and said pressure overload cutoff valve releases gas automatically above a predetermined safety limit threshold of pressure exerted from within said section of bowel or ileal conduit, said predetermined safety limit being at least 60 mmHg.