Clot retrieval system

• US 9,173,668 B2
• Filed: 12/02/2014
• Issued: 11/03/2015
• 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:
  US14/558,705
• Publication Number:
  US 20150190155A1
• Time in Patent Office: 336 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 from an interior lumen of an animal, the system comprising:

a pull wire having a proximal end and a distal end;

a distal body attached to the pull wire, the distal body comprising an interior, a proximal end, a distal end, a distal body length extending from the proximal end to the distal end, a proximal junction forming the proximal end of the distal body, a plurality of proximal strips, a basket comprised of a plurality of cells formed by a plurality of basket strips, and a distal junction comprising a proximal end, the proximal end of the distal junction forming a distal end of the basket, the basket comprising a basket interior, each proximal strip having a distal end attached to a cell and a proximal end, the proximal ends of the proximal strips converging at the proximal junction, the distal body having a relaxed state wherein the distal body has a first height and a first width, and a collapsed state wherein the distal body has a second height and a second width, the second height less than the first height, the second width less than the first width; and

a catheter having an interior, a proximal end leading to the interior and a distal end leading to the interior, the catheter comprised of a biocompatible material and configured to envelope the distal body when the distal body is in the collapsed state,

wherein, in the relaxed state, the basket comprises a first pair of distal crowns not attached to another cell of the basket and pointing generally in the distal direction, the distal crowns in the first pair of distal crowns located approximately the same distance from the proximal junction and between 150 degrees and 180 degrees relative to each other, and further wherein the basket further comprises a second pair of distal crowns not attached to another cell of the basket and pointing generally in the distal direction, the second pair of distal crowns located distally relative to the first pair of distal crowns, each of the distal crowns in the second pair of distal crowns located between 60 degrees and 90 degrees relative to a distal crown in the first pair of distal crowns, the distal crowns in the second pair of distal crowns located approximately the same distance from the proximal junction and further wherein each of the distal crowns in the first and second pair of distal crowns comprises an x-ray marker, the x-ray maker more visible under x-ray as compared to the basket strips when the distal body is located in a cranial blood vessel inside the body of a human and the x-ray is taken from outside the human'"'"'s body and further wherein each distal crown in the first and second pair of distal crowns forms part of a cell,

and further wherein at least some of the basket strips are located at the distal end of the basket, wherein each of the basket strips located at the distal end of the basket have a distal end, wherein each of the distal ends of the basket strips located at the distal end of the basket converge at the distal junction and further wherein the distal body, in the relaxed state, comprises a tapered region in which the distal body height and width decrease as the basket strips located at the distal end of the basket approach the distal junction.

2. The system of claim 1, wherein, the x-ray markers are comprised of a material different than the material forming the basket strips.

3. The system of claim 1, wherein, in the relaxed state, the basket interior is substantially hollow.

4. The system of claim 1, wherein, in the relaxed state, the distal body does not have another x-ray marker that is located approximately the same distance from the proximal junction as the first pair of x-ray markers and the distal body does not have another x-ray marker that is located approximately the same distance from the proximal junction as the second pair of x-ray markers.

5. The system of claim 1, wherein each distal crown in the first and second pair of distal crowns forms part of an enlarged cell and further wherein the surface area of the enlarged cells in the relaxed state is greater than the surface area of the other cells of the basket and further wherein the enlarged cells are configured to allow a thrombus to pass therethrough and into the basket interior.

6. The system of claim 1 wherein, in the relaxed state, the distal body does not have another free distal-pointing crown that is located approximately the same distance from the proximal junction as the first pair of distal crowns and the distal body does not have another free distal-pointing crown that is located approximately the same distance from the proximal junction as the second pair of distal crowns.

7. The system of claim 1 wherein the basket strips are comprised of a memory metal.

8. The system of claim 1, wherein each of the distal crowns in the first pair of distal crowns are configured to contact each other when an exterior, external compressive force is exerted on a distal crown of the first pair of distal crowns when the distal body is in the relaxed state.

9. The system of claim 1 wherein the proximal junction is located approximately in the center of the first height and first width in the relaxed state.

10. The system of claim 1, wherein the proximal end of a first proximal strip is located at least about 65 degrees relative to the distal end of the first proximal strip, wherein the proximal end of a second proximal strip is located at least about 65 degrees relative to the distal end of the second proximal strip, and further wherein the first and second proximal strips intersect adjacent and distal to the proximal junction.

11. The system of claim 1, wherein each distal crown forms part of a cell that further comprises a proximal crown pointing generally in the proximal direction and connected to a memory metal strip.

12. The system of claim 1, wherein the proximal junction is in the form of a proximal tube, wherein the basket, the proximal tube and the proximal strips are comprised of a memory metal, wherein the proximal tube comprises a proximal end and a distal end, and further wherein the proximal strips are integral with the distal end of the proximal tube.

22. A method of removing a blood clot from a blood vessel of an animal the method comprising the steps of:

a) providing the system of claim 1;

b) positioning the system in the blood vessel;

c) deploying the distal body from the distal end of the catheter;

d) allowing the height and width of the distal body to increase;

e) irradiating the distal body with x-rays;

f) moving the blood clot into the basket interior; and

g) moving the distal body proximally out of the blood vessel.

23. The method of claim 22 further comprising irradiating the distal body with x-rays at at least two different angles.

24. The method of claim 22, wherein the second pair of distal crowns are distal to the blood clot when the distal body is deployed from the distal end of the catheter.

25. The method of claim 22, wherein, in the relaxed state, the distal body does not have another x-ray marker that is located approximately the same distance from the proximal junction as the first pair of x-ray markers and the distal body does not have another x-ray marker that is located approximately the same distance from the proximal junction as the second pair of x-ray markers.

26. The method of claim 25, wherein, in the relaxed state, each distal crown in the first and second pair of distal crowns forms part of an enlarged cell and further wherein the surface area of the enlarged cells in the relaxed state is greater than the surface area of the other cells of the basket.

27. The method of claim 22 further comprising applying contrast dye proximally and distally to the blood clot.

28. The method of claim 22 further comprising the steps of providing a suction catheter having a proximal end and a distal end, and attaching the distal end of the suction catheter to the blood clot by applying suction to the suction catheter.

29. The method of claim 28 further comprising aspirating by hand a pre-determined volume of fluid from the suction catheter using a syringe and then locking the syringe at the pre-determined volume.

30. The method of claim 28 further comprising the step of delivering the suction catheter adjacent to the blood clot by advancing the suction catheter over the pull wire.

13. A system for removing objects from an interior lumen of an animal, the system comprising:

a pull wire having a proximal end and a distal end;

a distal body attached to the pull wire, the distal body comprising an interior, a proximal end, a distal end, a distal body length extending from the proximal end to the distal end, a proximal junction forming the proximal end of the distal body, a plurality of proximal strips, a basket comprised of a plurality of cells formed by a plurality of basket strips, a distal junction comprising a proximal end, the proximal end of the distal junction forming a distal end of the basket, the basket comprising a basket interior, each proximal strip having a distal end attached to a cell and a proximal end, the proximal ends of the proximal strips converging at the proximal junction, the distal body having a relaxed state wherein the distal body has a first height and a first width, and a collapsed state wherein the distal body has a second height and a second width, the second height less than the first height, the second width less than the first width; and

a catheter having an interior, a proximal end leading to the interior and a distal end leading to the interior, the catheter comprised of a biocompatible material and configured to envelope the distal body when the distal body is in the collapsed state, wherein, in the relaxed state, the basket comprises a first pair of distal crowns not attached to another cell of the basket and pointing generally in the distal direction, the distal crowns in the first pair of distal crowns located approximately the same distance from the proximal junction and between 150 degrees and 180 degrees relative to each other, and further wherein the basket further comprises a second pair of distal crowns not attached to another cell of the basket and pointing generally in the distal direction, the second pair of distal crowns located distally relative to the first pair of distal crowns, each of the distal crowns in the second pair of distal crowns located between 60 degrees and 90 degrees relative to a distal crown in the first pair of distal crowns, the distal crowns in the second pair of distal crowns located approximately the same distance from the proximal junction, wherein each distal crown in the first and second pair of distal crowns forms part of a cell that further comprises a proximal crown pointing generally in the proximal direction and connected to a memory metal strip,

wherein each of the distal crowns in the first pair and second pair of distal crowns curve radially inward toward the basket interior in the relaxed state, wherein the distal crowns in the first pair of distal crowns are configured to contact each other when an exterior, external compressive force is exerted on a distal crown in the first pair of distal crowns when the distal body is in the relaxed state, and further wherein the distal crowns in the second pair of distal crowns are configured to contact each other when an exterior, external compressive force is exerted on a distal crown in the second pair of distal crowns when the distal body is in the relaxed state,

and further wherein at least some of the basket strips are located at the distal end of the basket, wherein each of the basket strips located at the distal end of the basket have a distal end, wherein each of the distal ends of the basket strips located at the distal end of the basket converge at the distal junction and further wherein the distal body, in the relaxed state, comprises a tapered region in which the distal body height and width decrease as the basket strips located at the distal end of the basket approach the distal junction.

14. The system of claim 13, wherein, in the relaxed state, the distal body does not have another free distal-pointing crown that is located approximately the same distance from the proximal junction as the first pair of distal crowns and the distal body does not have another free distal-pointing crown that is located approximately the same distance from the proximal junction as the second pair of distal crowns.

15. The system of claim 13 wherein, in the relaxed state, the basket interior is substantially hollow.

16. The system of claim 13, wherein the proximal end of a first proximal strip is located at least about 65 degrees relative to the distal end of the first proximal strip, wherein the proximal end of a second proximal strip is located at least about 65 degrees relative to the distal end of the second proximal strip, and further wherein the first and second proximal strips intersect adjacent and distal to the proximal junction.

17. The system of claim 13 wherein each distal crown in the first and second pair of distal crowns forms part of an enlarged cell and further wherein the surface area of each enlarged cell in the relaxed state is at least twice as large as the surface area of the other cells of the basket and further wherein the enlarged cells are configured to allow a thrombus to pass therethrough and into the basket interior.

18. The system of claim 13 wherein the pull wire is attached to the proximal junction.

19. The system of claim 13, wherein the proximal junction is in the form of a proximal tube, wherein the basket, the proximal tube and the proximal strips are comprised of a memory metal, wherein the proximal tube comprises a proximal end and a distal end, and further wherein the proximal strips are integral with the distal end of the proximal tube.

20. The system of claim 13, wherein the distal body further comprises a lead wire extending distally from the distal junction, the lead wire having a length of from about 3 mm to about 10 mm.

21. The system of claim 13, wherein the proximal junction is in the form of a proximal tube, wherein the distal junction is in the form of a distal tube, wherein the distal tube, the proximal tube, and the basket are comprised of a nitinol having the same material composition and further wherein the proximal and the distal tubes are generally cylindrical in shape and each has an outer diameter and an inner diameter, the inner diameter forming apertures of the proximal and distal tubes and further wherein the outer diameters of the proximal and distal tubes are substantially the same size and further wherein the inner diameters of the proximal and distal tubes are substantially the same size.