Clot Retrieval System

• US 20150190155A1
• Filed: 12/02/2014
• Published: 07/09/2015
• Est. Priority Date: 01/03/2014
• Status: Active Grant

• Current Assignee: Legacy Ventures, LLC
• Original Assignee: Legacy Ventures, LLC
• Inventors: Ulm, Arthur John III
• Granted Patent: US 9,173,668 B2
• Time in Patent Office: 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 tube forming the proximal end of the distal body, a distal tube forming the distal end of the distal body, a basket located between the proximal tube and the distal tube and comprised of a plurality of cells, a plurality of proximal strips, each proximal strip having a proximal end attached to the proximal tube, and a distal end attached to a cell, the distal body having a relaxed state wherein the distal body has a first height and width, and a collapsed state wherein the distal body has a second height and 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, at least two cells of the basket comprise a proximal crown pointing generally in the proximal direction and a distal crown pointing generally in the distal direction, the distal crowns of the at least two cells not attached to another cell of the basket, and further wherein at least one of the distal crowns comprises an x-ray marker configured to be detected by an x-ray radiation of 0.01 mrem 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.

2. The system of claim 1, wherein, in the relaxed state, at least two of the distal crowns are located approximately 180 degrees relative to each other and approximately the same distance from the proximal tube, and each of the at least two distal crowns comprise an x-ray marker configured to be detected by an x-ray radiation of 0.01 mrem 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.

3. The system of claim 1, 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 first pair of distal crowns located approximately the same distance from the proximal tube and approximately 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, and approximately 90 degrees relative to, the first pair of distal crowns, and further wherein each of the distal crowns comprise an x-ray marker configured to be detected by an x-ray radiation of 0.01 mrem 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.

4. The system of claim 3, wherein, in the relaxed state, the second pair of distal crowns form a cell adjacent to a cell formed by the first pair of distal crowns.

5. The system of claim 3, 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.

6. The system of claim 5 wherein, in the relaxed state, the surface area of each enlarged cell is at least twice as large as the surface area of the other cells of the basket when the distal body.

7. The system of claim 5 wherein, in the relaxed state, the surface area of each enlarged cell is approximately the same.

8. The system of claim 1, wherein the proximal tube and the distal tube each comprise an x-ray marker configured to be detected by an x-ray radiation of 0.01 mrem 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.

9. The system of claim 8 wherein the proximal tube and distal tube each comprise an interior, and further wherein the x-ray marker of the proximal tube is attached to the interior of the proximal tube and the x-ray marker of the distal tube is attached to the interior of the distal tube.

10. The system of claim 1, wherein, in the relaxed state, the distal crowns of the at least two cells curve towards the interior of the distal basket.

11. The system of claim 1, wherein the proximal end of a proximal strip is located at least about 65 degrees relative to the distal end of the same proximal strip.

12. The system of claim 1, wherein the proximal end of a proximal strip is located approximately 180 degrees relative to the distal end of the same proximal strip.

13. The system of claim 1, wherein the proximal crowns of the at least two cells are each attached to another cell of the basket.

14. The system of claim 1, wherein the basket comprises a plurality of cells proximal to the at least two cells.

15. The system of claim 1, wherein the distal crowns of the at least two cells are located at least 5 mm from the proximal tube.

16. The system of claim 1, wherein the distal crowns of the at least two cells are located at least 5 mm from the distal tube.

17. The system of claim 1, wherein, in the relaxed state, the distal crowns of the at least two cells form flex points of the basket.

18. The system of claim 1 wherein the pull wire is attached to the proximal tube.

19. The system of claim 1, 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 1, wherein the distal body further comprises a lead wire extending distally from the distal tube, the lead wire having a length of from about 3 mm to about 10 mm.

21. The system of claim 1, 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.

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 lumen;

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 clot into the distal 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 at least one x-ray marker attached to the distal crowns is distal to the 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 basket comprises a first pair of distal crowns not attached to another cell of the basket and pointing generally in the distal direction, the first pair of distal crowns located approximately the same distance from the proximal tube and approximately 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, and approximately 90 degrees relative to, the first pair of distal crowns, and further wherein each of the distal crowns comprise an x-ray marker configured to be detected by an x-ray radiation of 0.01 mrem 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.

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 when the distal body is in the relaxed state.

27. The method of claim 22 further comprising applying contrast dye proximally and distally to the 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 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 clot by advancing the catheter over the pull wire.