Body lumen closure

• US 20030191479A1
• Filed: 04/03/2002
• Published: 10/09/2003
• Est. Priority Date: 04/03/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Thornton, Sally C.
• Granted Patent: US 7,007,698 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Method and apparatus implementing and using techniques for body lumen closure, including use of an implantable medical closure device. The device includes a flexible strand defining an arcuate form. The strand is deformable upon implantation from a large cross-section condition to a small cross-section condition and has at least two anchoring portions disposed along the strand. The anchoring portions are configured to penetrate a wall of a body lumen such that when the strand is deformed to the small cross-section condition, the wall of the body lumen is disposed inwardly.

Claims

1. An implantable medical closure device, comprising a flexible strand defining an arcuate form, the strand being deformable upon implantation from a large cross-section condition to a small cross-section condition and having at least two anchoring portions disposed along the strand, the anchoring portions configured to penetrate a wall of a body lumen such that when the strand is deformed to the small cross-section condition, the wall of the body lumen is disposed inwardly.

2. The device of claim 1, wherein the strand is deformable from a second small cross-section condition to the large cross-section condition.

3. The device of claim 1, wherein the strand includes free ends.

4. The device of claim 3, wherein the anchoring portions comprise the free ends of the strand.

5. The device of claim 1, wherein the strand defines an arc.

6. The device of claim 1, wherein the strand defines a helix.

7. The device of claim 1, wherein the strand includes linear leg portions.

8. The device of claim 1, wherein the strand is a filament-form.

9. The device of claim 1, wherein the strand is a band.

10. The device of claim 1, wherein the strand is corrugated.

11. The device of claim 1, wherein the strand deforms from the large cross-section condition to the small cross-section condition by elastic recovery forces.

12. The device of claim 1, wherein the strand deforms from the large cross-section condition to the small cross-section condition by thermal shape-memory effect.

13. The device of claim 1, wherein the anchoring portions include a loop.

14. The device of claim 1, wherein the anchoring portions include a barb.

15. The device of claim 13, wherein the strand includes free ends and the anchoring portions include the free ends of the strand.

16. The device of claim 15, wherein the strand is made of metal.

17. The device of claim 16, wherein the metal is nitinol.

18. The device of claims 14, wherein the strand includes free ends and the anchoring portions include the free ends of the strand.

19. The device of claim 18, wherein the strand is made of metal.

20. The device of claim 19, wherein the metal is nitinol.

21. A catheter system, comprising:

a catheter for delivery into a lumen, the catheter including an expander that can be operated between a small cross-section and a large cross-section, and

a closure device positioned about the expander, the closure device comprising a strand defining an arcuate form and including at least two anchoring portions configured to penetrate a wall of a body lumen, the closure device being deformable by the expander from a first small cross-section condition to a larger cross-section condition to dispose the closure device into engagement with the lumen wall, and the closure device being further deformable to a second small cross-section condition, so that the wall of the body lumen is disposed inwardly.

22. The catheter system of claim 21, wherein the expander comprises an inflatable balloon.

23. The catheter system of claim 21, wherein the expander comprises a mechanical expander.

24. The catheter system of claim 23, wherein the mechanical expander includes:

a two-part axial member having a first inner part connected to a first coiled spring and a second outer part connected to a second coiled spring;

wherein;

the closure device is mounted on the first and second coiled springs;

the first inner part of the axial member is rotatable to expand the first coiled spring and the second outer part of the axial member is rotatable to expand the second coiled spring; and

expansion of the first and second coiled springs expands the closure device.

25. The catheter system of claim 24, wherein each coiled spring includes a distal end configured to fit within a groove formed on either end of the closure device.

26. The catheter system of claim 21, wherein the expander comprises a leveraging device.

27. The catheter system of claim 26, wherein the leveraging device comprises:

a two-part axial member including a first outer part and a second inner part;

a splayed cuff connected to the distal end of the first outer part of the two-part axial member; and

at least two flexible legs connected to the distal end of the second inner part of the two-part axial member and flared outwardly to contact the distal end of the splayed cuff;

wherein;

the closure device is positioned about the flexible legs;

the second inner part of the two-part axial member is moveable in a first direction such that the flexible legs are pressed against the splayed cuff causing the flexible legs and the splayed cuff to expand radially; and

expansion of the flexible legs expands the closure device from the first small cross-section condition to the larger cross-section condition.

28. The catheter system of claim 27, wherein the second inner part of the two-part axial member is moveable in a second direction such that the flexible legs move away from the splayed cuff causing the flexible legs and the splayed cuff to retract.

29. A method of treating a body lumen, comprising:

delivering a closure device into a lumen, the closure device comprising a strand;

positioning the strand about a body lumen such that a portion of the strand penetrates the wall of the body lumen; and

deforming the strand to the smaller cross-section condition such that the wall of the body lumen is disposed inwardly.

30. The method of claim 29, wherein the strand is positioned about the body lumen such that an end of the strand extends through the wall of the body lumen.

31. The method of claim 30, further comprising:

disposing the strand on a catheter; and

delivering the catheter into the body lumen.

32. The method of claim 31, further comprising:

providing the strand on a catheter including an expansion member.

33. The method of claim 29, further comprising:

positioning the strand about a valve structure.