Self-tensioning vascular occlusion device and method for its use

• US 20050277980A1
• Filed: 05/27/2004
• Published: 12/15/2005
• Est. Priority Date: 05/27/2004
• Status: Active Grant

• Current Assignee: Cardiva Medical, Inc. (Haemonetics Corporation)
• Original Assignee: Cardiva Medical, Inc. (Haemonetics Corporation)
• Inventors: Yassinzadeh, Zia
• Granted Patent: US 7,572,274 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

Abstract

The present invention advantageously provides self-tensioning occlusion devices, systems, and methods for percutaneous access and closure of vascular puncture sites. One device comprises a catheter body having a proximal end and a distal end, an occlusion member, and a tensioning member. The occlusion member, such an expansible member, is disposed on a distal end of the body. The tensioning member, such as a spring or coil, is slidably disposed over the body and proximal the expansion member. Generally, during application, the tensioning member will be positionable against subcutaneous tissue so as to lodge and anchor the expansible member against the puncture site. In particular, the expansible member allows for sealing of the puncture site while the tensioning member applies and maintains tension to the expansible occluder so that it is seated against the puncture site at a vascular surface.

Claims

1. A method for hemostasis of a puncture site in a blood vessel at an end of a tissue tract, the method comprising:

providing a catheter having a proximal end, a distal end, an expansible member at the distal end thereof, and a tensioning member proximal the expansible member;

inserting the catheter through the tissue tract so that the expansible member is positioned within the blood vessel;

deploying the expansible member in the blood vessel; and

deploying the tensioning member within the tissue tract to hold the expansible member against the puncture site.

2. A method as in claim 1, further comprising anchoring the expansible member against the puncture site.

3. A method as in claim 2, wherein the anchoring is carried out by an external clip seated against a skin surface.

4. A method as in claim 1, wherein the tension applied to the expansible member is in a range from 0.5 ounce to 30 ounces.

5. A method as in claim 1, further comprising increasing tension on the expansible member.

6. A method as in claim 5, further comprising pulling a tubular member coupled to the tensioning member in a proximal direction.

7. A method as in claim 5, further comprising coupling an external clip to the proximal end of the catheter.

8. A method as in claim 1, further comprising applying a predetermined amount of tension to the expansible member.

9. A method as in claim 1, wherein deploying the expansible member comprises pushing or pulling a handle assembly coupled to the expansible member.

10. A method as in claim 9, further comprising locking the handle assembly so that the expansible member remains in a deployed configuration.

11. A method as in claim 9, further comprising interlocking the handle assembly with a tubular member coupled to the tensioning member.

12. A method as in claim 1, further comprising deploying the expansible member to an expanded configuration within the blood vessel having a diameter in a range from about 3 mm to about 10 mm.

13. A method as in claim 1, wherein deploying the tensioning member comprises removing an elongated tubular member disposed over the tensioning member in a proximal direction.

14. A method as in claim 13, wherein a diameter of the tensioning member in a relaxed state is greater than an inner diameter of the elongated tubular member.

15. A method as in claim 1, wherein the expansible member and tensioning member are deployed sequentially.

16. A method as in claim 1, wherein the expansible member and tensioning member are deployed simultaneously.

17. A kit comprising:

a self-tensioning vascular occlusion device; and

instructions to use the device for hemostasis of a puncture site in a blood vessel according to claim 1.

18. A device for hemostasis of a puncture site in a body lumen or tract, the device comprising:

a catheter body having a proximal end and a distal end;

an expansible member disposed on the distal end of the body; and

a tensioning member slidably disposed over the body and proximal the expansible member.

19. A device as in claim 18, wherein the tensioning member is positionable against subcutaneous tissue so as to lodge and anchor the expansible member against the puncture site.

20. A device as in claim 18, wherein the tensioning member comprises a spring or coil of wire.

21. A device as in claim 20, wherein the wire has a diameter in a range from about 0.02 mm to about 1 mm.

22. A device as in claim 20, wherein the spring or coil comprises 1 to 30 loops.

23. A device as in claim 20, wherein the spring or coil diameter is in a range from about 1 mm to about 10 mm.

24. A device as in claim 18, wherein the tensioning member comprises stainless steel, shape memory alloy, or superelastic metal.

25. A device as in claim 18, wherein the expansible member comprises a braided filament, mesh layer, spring, coil, slotted tube, coiled string, or balloon.

26. A device as in claim 25, wherein the expansible member comprises a braided filament having small pores.

27. A device of claim 26, wherein the braided filament is coated with a hydrophobic coating.

28. A device as in claim 25, wherein the expansible member comprises coiled string having a disc or dome shape in an expanded configuration.

29. A device as in claim 25, further comprising a deformable membrane at least partially disposed over the expansible member.

30. A device as in claim 29, further comprising a membrane tip.

31. A device as in claim 18, further comprising a tip deflector coupleable to the catheter and distal the expansible member.

32. A device as in claim 18, further comprising a tubular member slidably disposed over the body and coupleable to a proximal end of the tensioning member.

33. A device as in claim 18, further comprising expansible member deployment means coupleable to the proximal end of the body.

34. A device as in claim 32 or 33, further comprising a locking mechanism on the deployment means or tubular member.

35. A system for hemostasis of a puncture site in a body lumen or tract, the system comprising:

a catheter having a body, an occlusion member at a distal end thereof, and a coil or spring slidably disposed over the body and proximal the occlusion member; and

a catheter loading element.

36. The system of claim 35, further comprising a sheath disposed at least partially over the catheter loading element.

37. The system of claim 36, wherein a diameter of the coil or spring in a relaxed state is at least greater than an inner diameter of the loader.

38. The system of claim 37, wherein a difference between the coil diameter and a diameter of the loader or the sheath determines an amount of applied tension on the expansible member.

39. The system of claim 35, further comprising an external clip coupleable to the catheter body.