Clot capture coil

• US 20020016609A1
• Filed: 06/25/2001
• Published: 02/07/2002
• Est. Priority Date: 02/02/1996
• Status: Active Grant

• Current Assignee: Gobin Y. Pierre, Jeffrey P. Wensel
• Original Assignee: Gobin Y. Pierre, Jeffrey P. Wensel
• Inventors: Wensel, Jeffrey P., Gobin, Y. Pierre
• Granted Patent: US 6,436,112 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A clot and foreign body removal device is described which comprises a catheter with at least one lumen. Located within the catheter is a clot capture coil that is connected to an insertion mandrel. In one embodiment, the clot capture coil is made out of a solid elastic or superelastic material which has shape memory, preferably nitinol. The elasticity or superelasticity of the coil allows it to be deformed within the catheter and to then reform its original coil configuration when the coil is moved outside of the catheter lumen. In another embodiment the coil is a biphasic coil which changes shape upon heating or passing an electric current. Once the coil configuration has been established, the coil can be used to ensnare and corkscrew a clot in a vessel. A clot is extracted from the vessel by moving the clot capture coil and catheter proximally until the clot can be removed or released into a different vessel that does not perfuse a critical organ. Foreign bodies are similarly captured by deploying the coil distal to the foreign body and moving the clot capture coil proximally until the foreign body is trapped within the coil. By removing the device from the body, the foreign material is also removed.

Claims

1. A clot capture coil device comprising:

(a) a catheter having proximal and distal ends and a lumen extending therethrough;

(b) an insertion mandrel having proximal and distal ends, wherein the distal end of the mandrel is slidable within the lumen of the catheter;

(c) a coil formed of a continuous piece of solid shape memory material, said coil having proximal and distal ends, expanded and compressed forms, and a varying diameter along its length when in expanded form, wherein one end of the coil is connected to the mandrel near the mandrel'"'"'s distal end and the other end of the coil is freely moveable, the coil being slidably contained within the lumen of the catheter when in compressed form;

whereby distal movement of the mandrel relative to the catheter results in distal movement of the coil relative to the catheter, releases the coil from the lumen and allows the coil to expand into its expanded form, and whereby proximal movement of the mandrel relative to the catheter results in proximal movement of the coil relative to the catheter, and forces the coil into its compressed form within the lumen of the catheter.

2. A clot capture coil device of claim 1 wherein the coil is elastic.

3. A clot capture coil device of claim 1 wherein the coil is superelastic.

4. A clot capture coil device of claim 1 wherein the coil comprises a solid nitinol wire.

5. A clot capture coil device of claim 1 wherein the proximal end of the coil is connected near the distal end of the insertion mandrel.

6. A clot capture coil device of claim 1 wherein the distal end of the coil is connected near the distal end of the insertion mandrel.

7. A clot capture coil device of claim 1 wherein the diameter of the coil ranges from about 1 mm to about 30 mm.

8. A clot capture coil device of claim 1 wherein the length of the coil ranges from about 3 mm to about 100 mm.

9. A clot capture coil device of claim 8 wherein the length of the coil ranges from about 3 mm to about 20 mm.

10. A clot capture coil device of claim 6 wherein the coil is inserted within the lumen of the catheter and the coil section is deformed to form a substantially straight line and extends distally from the distal end of the insertion mandrel.

11. A clot capture coil device of claim 1 wherein the coil is barrel shaped.

12. A clot capture coil device of claim 1 wherein the coil is conically shaped.

13. A clot capture coil device of claim 1 wherein the coil is cup shaped.

14. A clot capture coil device of claim 1 wherein the coil is cylindrically shaped.

15. A clot capture coil device of claim 1 wherein the coil is a random tangle.

16. A clot capture coil device of claim 1 wherein at least a part of the coil comprises a radiopaque material.

17. A clot capture coil device of claim 16 wherein the radiopaque material is platinum or gold.

18. A clot capture coil device of claim 16 wherein at least a part of the coil is made of a radiopaque material.

19. A clot capture coil device of claim 16 wherein at least a part of the coil is covered with a radiopaque material.

20. A clot capture coil device of claim 19 wherein a radiopaque microcoil surrounds the distal tip of the coil.

21. A clot capture coil device of claim 20 wherein the radiopaque microcoil is made of platinum or gold.

26. A clot capture coil device of claim 1 wherein at least a part of the coil comprises a radiopaque material.

22. A clot capture coil device comprising:

(a) a catheter having proximal and distal ends and a lumen extending therethrough;

(b) an insertion mandrel having proximal and distal ends, wherein the distal end of the mandrel is slidable within the lumen of the catheter;

(c) a coil formed of a continuous piece of solid shape memory material, said coil having proximal and distal ends, expanded and compressed forms, and a varying diameter along its length when in expanded form, wherein at least one end of the coil is connected to the mandrel, said coil being slidably contained within the lumen of the catheter when in compressed form;

whereby distal movement of the mandrel relative to the catheter results in distal movement of the coil relative to the catheter, releases the coil from the lumen and allows the coil to expand into its expanded form, and whereby proximal movement of the mandrel relative to the catheter results in proximal movement of the coil relative to the catheter, and forces the coil into its compressed form within the lumen of the catheter.

23. A clot capture coil device of claim 22 wherein the coil is elastic.

24. A clot capture coil device of claim 22 wherein the coil is superelastic.

25. A clot capture coil device of claim 22 wherein the coil comprises a solid nitinol wire.

27. A clot capture coil device of claim 26 wherein the radiopaque material is platinum or gold.

28. A clot capture coil device of claim 26 wherein at least a part of the coil is made of a radiopaque material.

29. A clot capture coil device of claim 26 wherein at least a part of the coil is covered with a radiopaque material.

30. A clot capture coil device of claim 29 wherein a radiopaque microcoil surrounds the distal tip of the coil.

31. A clot capture coil device of claim 30 wherein the radiopaque microcoil is made of platinum or gold.

32. A clot capture coil device of claim 22, wherein the coil is shaped to form a double helix.

33. A clot capture coil device of claim 22, wherein both ends of the coil are connected to the mandrel.

34. A clot capture coil device of claim 22, wherein the catheter comprises two lumens and two corresponding insertion mandrels, wherein the distal end of each mandrel is slidable within its corresponding lumen of the catheter, and wherein each end of the coil is connected to a different mandrel.

35. A clot capture coil device comprising:

(a) a catheter having proximal and distal ends and a lumen extending therethrough;

(b) an insertion mandrel having proximal and distal ends, wherein the distal end of the mandrel is slidable within the lumen of the catheter;

(c) a coil formed of a continuous piece of biphasic material, said coil having proximal and distal ends, expanded and compressed forms, and a varying diameter along its length when in expanded form, wherein one end of the coil is connected to the mandrel near the mandrel'"'"'s distal end and the other end of the coil is freely moveable, the coil being slidably contained within the lumen of the catheter when in compressed form;

whereby distal movement of the mandrel relative to the catheter results in distal movement of the coil relative to the catheter, releases the coil from the lumen and allows the coil to expand into its expanded form, and whereby proximal movement of the mandrel relative to the catheter results in proximal movement of the coil relative to the catheter, and forces the coil into its compressed form within the lumen of the catheter.

36. A method of filtering thrombic material in a vessel, comprising the steps of:

(a) inserting a catheter having a least one lumen into the vessel;

(b) inserting into the lumen a coil formed of a continuous piece of solid, superelastic, shape memory material having a varying diameter along its length, the coil being connected at one of its ends to an insertion mandrel, whereby the coil deforms to an essentially straight configuration;

(c) advancing the coil to the distal end of the catheter by translating the insertion mandrel distally;

(d) advancing the coil distally out of the catheter to allow the superelastic shape memory coil to reform its natural coil configuration;

(e) allowing blood to flow through the coil to thereby trap thrombic material contained in the blood within the coil; and

(f) moving the thrombic material out of the vessel by moving the coil out of the vessel.