Apparatus and Method for Closing an Opening in a Blood Vessel Using Memory Metal and Collagen

• US 20080312683A1
• Filed: 02/05/2008
• Published: 12/18/2008
• Est. Priority Date: 02/05/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Jenson, Mark L., Drasler, William J., Eidenschink, Tracee, Thielen, Joseph M., Sadasiva, Anu
• Granted Patent: US 9,427,217 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, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

An apparatus and method for closing an arteriotomy site are disclosed. The apparatus and method employ the use of a delivery sheath within which is provided an anchoring device formed of memory metal. The delivery sheath can be inserted through a tissue tract extending from an epidermal layer to the blood vessel wall, whereupon the anchoring device can be extended from the delivery sheath into the blood vessel itself The memory metal, once freed from the delivery sheath, obtains a non-linear or coiled configuration which can then be pulled back against the inner surface of the blood vessel to form a backstop. A biodegradable plug is then introduced into the tissue tract until it engages the backstop formed by the anchoring device thereby ensuring proper positioning of the biodegradable plug. The anchoring device can then be retracted through the biodegradable plug leaving the arteriotomy site substantially closed with hemostasis being formed therearound The various biodegradable plugs disclosed provide for improved retention of the biodegradable plug and proper positioning of the plug within the tissue tract.

Claims

1. An apparatus for closing an opening in a blood vessel, comprising:

an anchoring device having a linear insertion configuration and non-linear deployed configuration; and

a biodegradable plug adapted to be inserted through a tissue tract against the anchoring device when the anchoring device is in the deployed configuration.

2. The apparatus of claim 1, wherein the anchoring device is a material having shape memory.

3. The apparatus of claim 2, wherein the anchoring device is made of a nickel-titanium alloy

4. The apparatus of claim 2, wherein the anchoring device is made of a cobalt-chromium-nickel alloy.

5. The apparatus of claim 1, wherein the anchoring device forms at least one loop when deployed

6. The apparatus of claim 1, wherein the anchoring device forms a continuous loop when deployed.

7. The apparatus of claim 1, wherein the anchoring device forms an oval when deployed.

8. The apparatus of claim 1, further including a delivery sheath, the anchoring device being fully received within the delivery sheath when in the insertion configuration and being partially extended from the delivery sheath when in the deployed configuration.

9. The apparatus of claim 1, wherein the anchoring device is removable after the biodegradable plug is deployed.

10. The apparatus of claim 1, further including a tamp rod adapted to compact the biodegradable plug against the anchoring device.

11. The apparatus of claim 1, wherein the biodegradable plug is substantially cylindrical in shape, with a relatively rigid upper portion and a relatively malleable lower portion.

12. The apparatus of claim 1, wherein the biodegradable plug is substantially cylindrical with a plurality of exterior barbs.

13. The apparatus of claim 1, wherein the biodegradable plug further includes at least one thread wrapped therearound, the thread compressing the size of the collagen plug when pulled taut, the collagen plug expanding when the thread is released.

14. The apparatus of claim 13, wherein the thread is wound around an exterior surface of the plug and thereby adds frictional interference with the tissue tract when deployed.

15. The apparatus of claim 1, wherein the biodegradable plug is made of collagen.

16. The apparatus of claim 1, wherein the biodegradable plug is made of polyactic acid.

17. The apparatus of claim 1, wherein the biodegradable plug is made of poly(actic-co-glycolic) acid.

18. The apparatus of claim 1, wherein the biodegradable plug is made of polyethylene glycol.

19. The apparatus of claim 1, wherein the biodegradable plug has different properties in a distal end than a proximal end

20. The apparatus of claim 1, wherein the biodegradable plug includes a plurality of slits.

27. The apparatus of claim 19, wherein the memory metal is a nickel-titanium alloy.

28. The apparatus of claim 19, wherein the memory metal is a cobalt-chromium-nickel alloy.

21. A method of closing an opening in a blood vessel, comprising:

inserting a delivery sheath into a tissue tract extending from an epidermal layer of a patient to an arteriotomy site in a blood vessel;

extending an anchoring device from the delivery sheath and into the blood vessel, the anchoring device being formed of a shape memory alloy, the anchoring device being held in a linear configuration when within the delivery sheath and assuming a non-linear configuration when extended from the delivery sheath;

retracting the delivery sheath and anchoring device a distance sufficient to engage the anchoring device with an inner surface of the blood vessel proximate the arteriotomy site;

pushing a biodegradable plug down the tissue tract until the plug engages the anchoring device; and

retracting the anchoring device from the blood vessel, through the biodegradable plug and out of the tissue tract.

22. The method of claim 21, wherein extending the anchoring device causes a distal end of the anchoring device to coil.

23. The method of claim 21, wherein extending the anchoring device causes a distal end of the anchoring device to from a cloverleaf.

24. The method of claim 21, further including driving a ram rod down the tissue tract to compress the biodegradable plug against the anchoring device.

25. The method of claim 21, wherein the biodegradable plug has at least one thread wrapped therearound, and the method further includes releasing tension in the thread once the biodegradable plug is in engagement with the anchoring device, the biodegradable plug thereby expanding against interior surfaces of the tissue tract.

26. An apparatus for closing an opening in blood vessel comprising:

a delivery sheath having a distal end and a proximal end, the delivery sheath being insertable into a tissue tract extending from an epidermal layer to an arteriotomy site; and

a length of memory metal positioned within the delivery sheath, the memory metal being substantially linear in shape when within the delivery sheath and being substantially non-linear when extended from the delivery sheath.

29. The apparatus of claim 26, further including a sealing plug adapted to be pushed down the tissue tract and into engagement with the memory metal when in the substantially non-linear configuration.

30. The apparatus of claim 29, wherein the sealing plug is made of collagen

31. The apparatus of claim 30, wherein the collagen plug includes a plurality of external barbs.

32. The apparatus of claim 30, wherein the collagen plug includes a relatively hard upper portion, and a relatively soft lower portion.

33. The apparatus of claim 30, wherein the collagen plug further includes at least one thread wrapped therearound, the thread compressing the size of the collagen plug when pulled taut, the collagen plug expanding when the thread is released.

34. The apparatus of claim 33, when the thread is wrapped around an exterior surface of the collagen plug.

35. An apparatus for closing an opening in a blood vessel, comprising:

a collagen plug; and

a thread wrapped around the collagen plug, the collagen plug being compressed into a first, relatively small dimension when the thread is pulled tight, the collagen plug expanding into a second relatively large dimension when the thread is loose.

36. An apparatus for closing an opening in a blood vessel comprising a biodegradable plug having a relatively dense, hard upper portion and a relatively malleable, soft lower portion.