Clot retrieval system

• US 9,808,271 B2
• Filed: 06/21/2017
• Issued: 11/07/2017
• Est. Priority Date: 01/03/2014
• Status: Active Grant

• Current Assignee: Legacy Ventures, LLC
• Original Assignee: Legacy Ventures, LLC
• Inventors: Ulm, III, Arthur John
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US15/629,703
• Publication Number:
  US 20170290600A1
• Time in Patent Office: 139 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• 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 2017/00526 Methods of manufacturing
• 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 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• 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

Catheter-delivered endovascular medical devices are described. The devices may include a pull wire attached to a distal body. The distal body may be formed of a distal body outer body comprising a basket comprised of a plurality of cells defined by a plurality of basket strips and a distal body inner body located in the interior of the distal body outer body and comprising a plurality of distal braided mesh openings formed by a plurality of woven linear strands. The distal braided mesh openings may be smaller than the cells when the device is in the relaxed state. Methods of using and making the devices are also described.

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 and comprising a distal body proximal end comprising a distal body proximal junction, a distal body distal end comprising a distal body distal junction, a distal body length extending from the distal body proximal end to the distal body distal end, a distal body longitudinal axis extending from the distal body proximal junction to the distal body distal junction, and a distal body height and width perpendicular to the distal body length, the distal body comprising;

a distal body outer body extending from the distal body proximal end to the distal body distal end, the distal body outer body comprising the distal body proximal junction and the distal body distal junction, the distal body outer body comprising a distal body outer body perimeter separating a distal body outer body interior from a distal body outer body exterior, the distal body outer body comprising a basket comprised of a plurality of cells spaced about the distal body outer body perimeter and formed by a plurality of basket memory metal strips, wherein at least some of the basket memory metal strips are located at a distal end of the basket, wherein each of the basket memory metal strips located at the distal end of the basket have a distal end, and wherein each of the distal ends of the basket memory metal strips located at the distal end of the basket converge at, and are attached to, the distal body distal junction;

a distal body inner body comprised of a plurality of braided mesh openings formed by a plurality of woven linear strands, the distal body inner body having a distal body inner body perimeter, each woven linear strand rotating about the distal body inner body perimeter relative to the distal body longitudinal axis a plurality of times in a helical fashion, the distal body inner body comprising a distal body inner body proximal end and a distal body inner body distal end,

wherein the distal body has 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,

wherein the system further comprises 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 the woven linear strands comprise a proximal end and a distal end, and at least some of the distal ends of the woven linear strands are attached to the distal body distal junction,

wherein, in the relaxed state, the median surface area of the cells is larger than the median surface area of the braided mesh openings,

wherein, the distal body inner body and the distal body outer body each have a length generally parallel to the distal body length, the distal body inner body and distal body outer body lengths configured to elongate upon moving from the relaxed state to the collapsed state,

wherein, upon moving from the relaxed state to the collapsed state, the length of the distal body inner body is configured to elongate a greater percentage than the length of the distal body outer body,

wherein, upon moving from the relaxed state to the collapsed state, the distal body inner body is configured to elongate proximally within the distal body outer body interior toward the distal body proximal junction,

wherein, in the relaxed state, the distal body inner body proximal end is located a first distance distal from the distal body proximal junction,

wherein, in the collapsed state, the distal body inner body proximal end is located a second distance distal from the distal body proximal junction, the second distance less than the first distance,

wherein, in the collapsed state and in the relaxed state, the distal body inner body is located in the distal body outer body interior,

wherein the woven linear strands rotate about the distal body inner body perimeter relative to the distal body longitudinal axis a fewer number of times per unit of length in the collapsed state as compared to the relaxed state, and

further wherein the distal body inner body comprises an active agent when the distal body inner body is in the catheter interior.

2. The system of claim 1 wherein the active agent is selected from the group consisting of a reolytic agent, a neuroprotective agent and combinations thereof.

3. The system of claim 1 wherein the active agent is located in the distal body inner body interior when the distal body inner body is located in the catheter interior.

4. The system of claim 3 wherein the active agent is too large to pass through the braided mesh openings when the distal body inner body is located in the catheter interior.

5. The system of claim 1 wherein the woven linear strands are coated with the active agent when the distal body inner body is located in the catheter interior.

6. The system of claim 5 wherein the basket memory metal strips are not coated with the active agent when the distal body inner body is located in the catheter interior.

7. The system of claim 1 wherein the proximal ends of at least some of the woven linear strands converge at and are attached to a distal body inner body proximal junction, the distal body inner proximal junction located distal relative to the distal body proximal junction.

8. The system of claim 7 wherein the distal body inner body proximal junction forms the proximal end of the distal body inner body.

9. The system of claim 7 wherein the distal body outer body further comprises a plurality of proximal strips, each proximal strip having a distal end attached to a proximal crown of a cell and a proximal end, the proximal ends of the proximal strips converging at the distal body proximal junction.

10. The system of claim 9, wherein the proximal ends of each of the woven linear strands converge at and are attached to the distal body inner body proximal junction and further wherein the distal ends of each of the woven linear strands converge at and are attached to the distal body distal junction.

11. The system of claim 7, wherein the distal body inner body comprises a distal body inner body height and a distal body inner body width, wherein the distal body inner body in the relaxed state comprises a distal body inner body distal tapered region in which the distal body inner body height and the distal body inner body width decrease as the woven linear strand distal ends approach the distal body distal junction, wherein the distal body outer body comprises a distal body outer body height and a distal body outer body width, and further wherein the distal body outer body comprises a tapered region in which the distal body outer body height and the distal body outer body width decrease as the distal ends of the basket memory metal strips located at the distal end of the basket approach the distal body distal junction, wherein the distal body inner body in the relaxed state comprises a distal body inner body proximal tapered region in which the distal body inner body height and the distal body inner body width decrease as the proximal ends of the woven linear strands approach the distal body inner body proximal junction.

12. The system of claim 7 wherein the system further comprises a tether connecting the distal body proximal junction to the distal body inner body proximal junction.

13. The system of claim 12 wherein the tether is a segment of the pull wire.

14. The system of claim 12 wherein the tether is comprised of a conductive material.

15. The system of claim 12 wherein the distal body inner body proximal end is substantially closed.

16. The system of claim 12 wherein the tether comprises a proximal end attached to the distal body proximal junction and a distal end attached to the distal body inner body proximal junction.

17. The system of claim 12, wherein the tether is located approximately in the center of the distal body height and the distal body width when the distal body is in the relaxed state and the tether is generally parallel to the distal body longitudinal axis when the distal body is in the relaxed state.

18. The system of claim 1 wherein, the basket memory metal strips are located on the distal body outer body perimeter and comprise an interior surface facing the distal body outer body interior and an exterior surface opposite the interior surface, and further wherein in the relaxed state, at least some of the woven linear strands contact the interior surface of at least some of the basket memory metal strips.

19. The system of claim 1 wherein the distal body distal junction is the sole connection point of the distal body inner body to the distal body outer body.

20. The system of claim 1, wherein in the relaxed state, the distal body inner body is more flexible than the distal body outer body and wherein, in the relaxed state, the median radial force of the distal body inner body is substantially less than the median radial force of the distal body outer body.

21. The system of claim 1, wherein, in the relaxed state, the distal body inner body impedes blood flow to a greater extent than the distal body outer body when the distal body outer body and the distal body inner body are placed in a blood vessel.

22. The system of claim 1, wherein, prior to removal of an obstruction, the distal body inner body is configured to automatically reduce blood flow when the distal body inner body is placed in a blood vessel.

23. The system of claim 1, wherein, in the relaxed state, the distal body outer body 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 distal body proximal junction and located 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 distal body proximal junction, each of the distal crowns forming a portion of a cell,

wherein each distal crown in the first and second pair of distal crowns forms part of a different enlarged cell, each enlarged cell having a center,

wherein the centers of the enlarged cells of the first pair of distal crowns are between 150 degrees and 180 degrees relative to each other and between 60 degrees and 90 degrees relative to the centers of the enlarged cells of the second pair of distal crowns,

wherein the enlarged cells are configured to allow a thrombus to pass therethrough and into the basket interior.

24. The system of claim 23 wherein, in the relaxed state, the distal body inner body is located distally relative to the first and second pair of distal crowns.

25. The system of claim 1 wherein the distal body inner body is radiopaque.

26. The system of claim 1, wherein, in the relaxed state, the distal body inner body length is no more than about 33% of the distal body outer body length.

27. The system of claim 1 wherein the system further comprises a lead wire extending distally from the distal body distal junction.

28. 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) moving the blood clot into the interior of the distal body outer body;

f) before, after or simultaneous with step e) delivering the active agent from the distal body inner body into the blood vessel; and

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

29. The method of claim 28 wherein the proximal ends of at least some of the woven linear strands converge at and are attached to a distal body inner body proximal junction, the distal body inner proximal junction located distal relative to the distal body proximal junction, and further wherein the system further comprises a tether connecting the distal body proximal junction to the distal body inner body proximal junction.

30. The method of claim 29 wherein the method further comprises propagating an electrical charge from the pull wire, through the tether, and to the distal body inner body to deliver the active agent from the distal body inner body into the blood vessel.