INFLATABLE DEVICE FOR ENTERIC FISTULA TREATEMENT

• US 20100249828A1
• Filed: 09/28/2009
• Published: 09/30/2010
• Est. Priority Date: 09/04/2008
• Status: Active Grant

• Current Assignee: Curaseal Inc
• Original Assignee: Curaseal Inc
• Inventors: Kim, Eliot, Bansner, Leif Erik, Maier, Nathan Christopher, MAVANI, Akshay, Carrison, Harold Francis, Fong, Kenton, Pinto, Moshe, Hu, Dean
• Granted Patent: US 8,221,451 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/00902 transparent or translucent

Abstract

Disclosed herein is an implantable fistula closure device. The device may include an expandable longitudinally segmented body including a proximal end and a distal end. The segmented body may further include a plurality of porous bodies and a connecting member operably joining together the plurality of porous bodies. The plurality of porous bodies includes a first porous body with a proximal end and a distal end and a second porous body with a proximal end and a distal end, and the connecting member operably connects the proximal end of the first porous body with the distal end of the second porous body.

Claims

1. A method of treating a fistula, comprising:

inserting an expandable occluder attached to at least one tether in its collapsed state through a tissue tract toward a body lumen using a tubular member, wherein the disc occluder is non-resorbable;

tensioning at least one tether to conform the expandable occluder against a surface of the body lumen;

separating the tubular member from the expandable occluder;

removing the tubular member from the tissue tract;

implanting a plurality of bioresorbable expansion members within the tissue tract, wherein at least one of the bioresorbable expansion members is coupled to at least one tether; and

restraining at least one tether in a tensioned state by fixing at least one tether to a proximal anchor located against a tissue surface different from the surface of the body lumen.

2. The method of claim 1, wherein the plurality of bioresorbable expansion members are interconnected.

3. A fistula treatment kit, comprising:

at least one tube containing at least four interconnected elongate bioresorbable expansion members;

a push member configured to push the expansion members out of the tube; and

an expandable occluding member comprising a substantially non-elastic polymer material.

4. The fistula treatment kit of claim 3, further comprising at least two tubes, each containing at least four interconnected expansion members.

15. The method of claim 3, wherein inserting the occluding member occurs before filling the tissue tract with the bioresorbable material.

5. A method of treating a tissue tract, comprising:

inserting an occluding member into a tissue tract toward an anatomical body space;

occluding the tissue tract by applying the occluding member against a surface of the body space; and

filling the tissue tract with a first bioresorbable material without pre-coupling the first bioresorbable material to the inserted occluding member.

6. The method of claim 5, further comprising restraining the occluding member against the surface of the body space by fixing the occluding member against a surface transverse to the tissue tract.

7. The method of claim 5, further comprising positioning a filling device between the occluding member and a wall of the tissue tract.

8. The method of claim 7, wherein the first bioresorbable material comprises a plurality of interconnected bioresorbable structures.

9. The method of claim 8, further comprising pushing at least two bioresorbable structures out of the filling device.

10. The method of claim 5, further comprising expanding the occluding member.

11. The method of claim 10, wherein expanding the occluding member comprises decreasing a first dimension of the occluding member while increasing a second dimension of the occluding member that is transversely oriented to the first dimension.

12. The method of claim 11, wherein the first dimension is a longitudinal length of the occluding member.

13. The method of claim 5, wherein expanding the occluding member comprises expanding the occluding member along a second dimension to a size of at least four times or greater than a size of the occluding member along a first dimension, wherein the second dimension is transversely oriented to the first dimension.

14. The method of claim 13, wherein the occluding member is expanded along the second dimension to a size of at least 2 cm or greater.

16. The method of claim 5, further comprising evacuating the tissue tract.

17. The method of claim 16, further comprising sealing the evacuated tissue tract to resist gaseous inflow.

18. The method of claim 16, further comprising reducing the pressure of the tissue tract by about 100 mm Hg to about 325 mm Hg from the ambient pressure.

19. The method of claim 5, wherein the body space is a portion of a gastrointestinal lumen.

20. The method of claim 19, wherein the portion of the gastrointestinal lumen is located distal to the ligament of Trietz and proximal to the rectum.

21. The method of claim 6, wherein the transverse surface is a skin surface.

22. The method of claim 5, further comprising directly visualizing the insertion of the occluding member using a fiberscope.

23. The method of claim 5, wherein inserting the occluding member into the tissue tract is performed using a flexible catheter.

24. The method of claim 5, wherein occluding the tissue tract comprises tensioning a tether of the occluding member.

25. The method of claim 5, further comprising debriding the tissue tract before filling the tissue tract with a first bioresorbable material.

26. A tissue tract treatment system, comprising:

an expandable distal anchor comprising an anchor attachment site and having a delivery configuration with a first cross-sectional area and a deployment configuration with a second cross-sectional area greater than the first cross-sectional area;

an anchor tether;

a first delivery tube configured to deliverably retain the expandable distal anchor and the anchor tether; and

a plurality of expandable fill structures located in a second delivery tube.

27. The system of claim 26, wherein the expandable fill structures comprise elongate polymeric members.

28. The system of claim 26, wherein the elongate polymeric members are compressed elongate polymeric members.

29. The system of claim 26, wherein the plurality of expandable fill structures are interconnected.