Intravascular thromboembolectomy device comprising a plurality of clot engaging elements and method using the same

• US 10,271,863 B2
• Filed: 03/04/2015
• Issued: 04/30/2019
• Est. Priority Date: 03/04/2014
• Status: Active Grant

• Current Assignee: Scientia Vascular, LLC
• Original Assignee: Thrombx Medical, Inc.
• Inventors: Marks, Michael P., Que, Like
• Primary Examiner(s): Rosen, Eric J
• Assistant Examiner(s): Igboko, Chima U
• Application Number:
  US14/638,994
• Publication Number:
  US 20150250497A1
• Time in Patent Office: 1,518 Days
• 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 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end

Abstract

A device and a method for increasing or restoring a flow in a body lumen are provided. The device and the method may treat conditions like a stroke by removing a clot from a blood vessel and/or reopen the vessel. The device may have a plurality of engaging elements, wires that can link at least two engaging elements, a central wire, and proximal control element. The positions of the engaging elements and the distance there between can be adjusted to ensure the engagement of the clot or occlusion.

Claims

1. A device for use in a body lumen comprising:

a central wire comprising a proximal end and a distal end thereof;

a plurality of engaging elements comprising a distal engaging element, a proximal engaging element, and one or more middle engaging elements, each of the plurality of the engaging elements being associated with the central wire;

wherein each of the plurality of engaging elements comprises a distal end and a proximal end thereof;

wherein the distal engaging element is most distally located among the plurality of the engaging elements and is fixed to a distal tip of the central wire;

wherein the proximal engaging element is most proximally located among the plurality of the engaging elements and can freely slide on the central wire; and

wherein the one or more middle engaging elements is located between the distal and proximal engaging elements and can freely slide on the central wire, each of the one or more middle engaging elements having an open distal end;

a flexible connection wire that associates with the proximal engaging element and at least one more engaging element of the plurality of engaging elements, said flexible connection wire configured to set the associated engaging elements apart at a pre-set distance; and

a proximal end control element that is located proximal to the proximal engaging element, wherein the proximal end of the proximal engaging element is fixed at the proximal end control element;

wherein the device has an open state including spaces between each adjacent engaging element that are open the pre-set distance and a closed state including spaces between each adjacent engaging element shortened from the pre-set distance to a second distance; and

wherein pulling the control element proximally while holding the central wire causes the distance between the capture elements to increase until the connection wire is under tension, thereby setting the associated engaging elements apart at the pre-set distance.

2. The device according to claim 1, wherein the proximal end control element comprises a tubing compartment comprising a distal end and a proximal end thereof, and the proximal end of the proximal engaging element is fixed at about the distal end of the tubing compartment.

3. The device according to claim 2, wherein the central wire can freely slide inside the tubing compartment.

4. The device according to claim 1, wherein the proximal end control element comprises a control wire comprising a distal end and a proximal end thereof, and the proximal end of the proximal engaging element is fixed at about the distal end of the control wire.

5. The device according to claim 1, wherein the proximal end control element comprises a wire comprising a distal end and a proximal end thereof, a distal segment of the wire is flexible serving as a connection wire, and all of the engaging elements are fixed to the connection wire.

6. The device according to claim 1, wherein at least one of the plurality of engaging elements comprises a plurality of wires or struts.

7. The device according to claim 1, wherein at least one of the plurality of engaging elements is self-expandable.

8. The device according to claim 1, wherein an overall shape of the engaging elements is conical, spherical, tubular, ellipsoid, or any combination thereof.

9. The device according to claim 1, wherein the pre-set distance between the associated engaging elements is an equal distance.

10. The device according to claim 1, wherein the flexible connection wire is flexible or floppy to allow the pre-set distance between the free-sliding engaging elements to be shortened when it is desired to bring the engaging elements closer together.

11. The device according to claim 1, wherein one or more of the engaging elements are linked with a spacing wire which is stiffer than the connection wire to maintain spaces between each adjacent engaging element the distance at the open state.

12. The device according to claim 1, wherein the proximal end of the central wire is operably linked to a handle to allow controlling the distal engaging element upon pushing or pulling the central wire.

13. The device according to claim 1, wherein the pre-set distance between the engaging elements may be adjusted 0 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, and 50 mm, or any range therebetween.

14. The device according to claim 1, wherein the closed state is configured to hold, cinch, or grab an occlusion or clot.

15. The device according to claim 1, wherein the distal engaging element has a closed distal end.

16. A method of removing at least part of an occlusion from a first location in a body lumen comprising:

introducing the device according to claim 1 into the body lumen;

locating the device at about the first location;

engaging at least part of the occlusion with at least one of the plurality of the engaging elements; and

removing the engaged occlusion from the first location.

17. The method according to claim 16, wherein said engaging comprises:

adjusting the position of one or more of the plurality of the engaging elements by;

holding the proximal end control element while pulling the central wire to engage the occlusion between at least two engaging elements, and/or

holding the central wire while pushing the proximal end control element to engage the occlusion between at least two of the engaging elements.