Clot retrieval system

• US 9,155,552 B2
• Filed: 12/02/2014
• Issued: 10/13/2015
• Est. Priority Date: 01/03/2014
• Status: Active Grant

• Current Assignee: Legacy Ventures, LLC
• Original Assignee: Legacy Ventures, LLC
• Inventors: Ulm, Arthur John III
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/558,712
• Publication Number:
  US 20150190156A1
• Time in Patent Office: 315 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

The invention relates to systems for removing obstructions and other objects within a blood vessel or other interior lumen of an animal. The system may be deployed in the lumen from a catheter and includes a pull wire having a proximal end and a distal end, and a distal body having a proximal hub, a basket, and a distal hub. In some embodiments, the distal body includes a plurality of proximal strips that form a closeable claw that is used to capture the obstruction. In other embodiments, the basket includes an enlarged opening that allows the object to enter the basket. Optionally, the basket includes x-ray markers adjacent to the enlarged openings to allow the operator to locate the openings, as well as twisting strips that connect the basket to the proximal hub. The present invention also relates to methods of making and using such systems.

Claims

1. A system for removing objects within an interior lumen of an animal, the system comprising:

a pull wire having a proximal end, a distal end and a pull wire longitudinal axis extending from the proximal end to the distal end;

a coaxial sheath having a hollow interior, an open proximal end leading to the interior, and an open distal end leading to the interior, the coaxial sheath enveloping the pull wire, the coaxial sheath slideable along at least a segment of the pull wire;

a distal basket comprising an interior, a proximal end, a distal end, a distal basket length extending from the distal basket proximal end to the distal basket distal end, a distal basket height perpendicular to the distal basket length, a plurality of proximal cells defined by a plurality of proximal cell memory metal strips, each proximal cell comprising a proximal crown located at a proximal end of the proximal cell and pointing generally in the proximal direction and a distal crown located at a distal end of the proximal cell and pointing generally in the distal direction, and a plurality of distal cells distal to the proximal cells;

a plurality of proximal strips, each proximal strip having a proximal end extending from the coaxial sheath, a distal end attached to a proximal crown of a proximal cell and a length extending from the proximal end to the distal end; and

a catheter having a hollow interior, a proximal end leading to the interior and a distal end leading to the interior, the catheter comprised of a biocompatible material, the distal basket comprised of a memory metal and having;

a relaxed state in which the open distal end of the coaxial sheath is located at a first position along the pull wire, the first position located a first distance proximal to the proximal crowns, and in which the distal basket, as measured at the proximal end of the distal basket, has a first height,

a proximal collapsed state in which the open distal end of the coaxial sheath is located at a second position along the pull wire, the second position located a second distance proximal to the proximal crowns, and in which the distal basket, as measured at the proximal end of the distal basket, has a second height, the second distance greater than the first distance, the second heights less than the first height, and

a distal collapsed state in which the open distal end of the coaxial sheath is located at a third position along the pull wire, the third position distal to the proximal crowns and located in the distal basket interior, and in which the distal basket, as measured at the proximal end of the distal basket, has a third height, the third height less than the first height,

wherein the catheter is configured to envelope the distal basket when the distal basket is in the proximal collapsed state;

wherein the distal basket is configured to move from the relaxed state to the proximal collapsed state by moving the open distal end of the coaxial sheath proximally to the second position while keeping the distal basket at a fixed location along the pull wire; and

wherein the distal basket is configured to move from the relaxed state to the distal collapsed state by moving the open distal end of the coaxial sheath distally to the third position while keeping the distal basket at a fixed location along the pull wire;

further wherein the distal end of the distal basket is fixed relative to the pull wire; and

further wherein, in the distal collapsed state, the proximal end of the distal basket is substantially closed.

2. The system of claim 1, wherein the coaxial sheath is flexible.

3. The system of claim 1, wherein each proximal crown comprises an eyelet and further wherein each proximal strip passes through an eyelet.

4. The system of claim 3, wherein the distal end of each proximal strip comprises a loop attaching the proximal strip to an eyelet.

5. The system of claim 1, wherein each proximal crown has an interior surface facing the distal basket interior and an exterior surface opposite the interior surface and further wherein each proximal strip contacts an exterior surface of a proximal crown in the proximal collapsed state and in the distal collapsed state.

6. The system of claim 1, wherein the pull wire extends through the distal basket interior and further wherein the proximal crowns are configured to move towards each other and towards the pull wire when the distal basket moves from the relaxed state to the distal collapsed state and when the distal basket moves from the relaxed state to the proximal collapsed state.

7. The system of claim 1, wherein the proximal crowns are configured to remain a fixed distance from the distal end of the distal basket when the distal basket moves from the relaxed state to the distal collapsed state.

8. The system of claim 1, wherein the coaxial sheath is a braided catheter comprised of a plurality of braids, each braid comprising a proximal segment and a distal segment, and further wherein the proximal segments of the braids are wound together to form the braided catheter and further wherein the distal segments of the braids are unwounded and the distal segment of each braid forms a proximal strip.

9. The system of claim 1 wherein at least one proximal crown further comprises an x-ray marker.

10. The system of claim 1, wherein the proximal ends of the proximal strips are integral with the coaxial sheath.

11. The system of claim 1, wherein the proximal ends of the proximal strips are attached to the coaxial sheath.

12. The system of claim 1, wherein the system comprises between two and four proximal strips and the proximal strips are spaced substantially evenly apart.

13. The system of claim 1, wherein the proximal strips have a length of from about 5 millimeters to about 40 millimeters in the relaxed state.

14. The system of claim 1, wherein the pull wire extends through the distal basket interior from the distal basket proximal end to the distal basket distal end.

15. The system of claim 1, wherein the coaxial sheath interior has a size and shape, and further wherein the size and shape of the coaxial sheath interior are configured to prevent a segment of the pull wire located in the distal basket interior and distal relative to the open distal end of the coaxial sheath from moving through the coaxial sheath interior.

16. The system of claim 1, wherein the distal end of the distal basket comprises a distal tube having an open proximal end and an open distal end, the distal tube comprised of a memory metal.

17. The system of claim 16, wherein the distal basket and the distal tube were prepared from the same memory metal tube.

18. The system of claim 16, wherein the distal tube is attached to the pull wire such that the distal tube is not slideable along the pull wire.

19. The system of claim 1, wherein all proximal crowns of the proximal cells are attached to a proximal strip.

20. The system of claim 1, wherein the second and third positions along the pull wire each comprise an x-ray marker.

21. The system of claim 1, wherein the proximal strips and the distal basket have a different material composition.

22. The system of claim 1, wherein the proximal strips are comprised of a polymer.

23. The system of claim 22, wherein the polymer is selected from the group consisting of fluorinated ethylene propylene, polytetrafluoroethylene, and tetrafluoroethtylene.

24. The system of claim 1 wherein the proximal strips are comprised of a material selected from the group consisting of plastic, rubber, nylon, suture material, and braided catheter material.

25. The system of claim 1 wherein, in the distal collapsed state, the proximal crowns contact the pull wire.

26. A method of removing a clot from a blood vessel of an animal, the blood vessel having an interior wall forming the blood vessel, the method comprising the steps of:

a) providing the system of claim 1, wherein the coaxial sheath is located in the catheter interior and the distal basket is located in the catheter interior in a collapsed state;

b) positioning the catheter in the blood vessel;

c) deploying the distal basket from the distal end of the catheter so that the proximal crowns of the proximal cells are distal to the clot;

d) allowing the distal basket to move to the relaxed state;

e) moving the coaxial sheath to a fourth position along the pull wire, the fourth position located distal to the proximal crowns but proximal to the third position;

f) capturing the clot in the distal basket interior;

g) moving the coaxial sheath further distally into the distal basket interior so that the distal basket height, as measured at the proximal end of the distal basket, decreases and the proximal crowns move toward each other and the pull wire; and

h) moving the clot and the distal basket proximally out of the blood vessel.

27. A method of removing a clot from a blood vessel of an animal, the blood vessel having an interior wall forming the blood vessel, the method comprising the steps of:

a) providing the system of claim 1, wherein the coaxial sheath is located in the catheter interior and the distal basket is located in the catheter interior in a collapsed state;

b) positioning the catheter in the blood vessel;

c) deploying the distal basket from the distal end of the catheter so that the proximal crowns of the proximal cells are distal to the clot;

d) allowing the distal basket to move to the relaxed state;

e) moving the distal basket proximally towards the clot to capture the clot in the distal basket interior; and

f) moving the distal and captured clot proximally out of the blood vessel.

28. The method of claim 27 further comprising, after step d), moving the coaxial sheath distally into the distal basket interior so that the distal basket height, as measured at the proximal end of the distal basket, decreases and the proximal crowns move toward each other and the pull wire.