THROMBOEMBOLIC PROTECTION DEVICE

• US 20160128822A1
• Filed: 11/06/2014
• Published: 05/12/2016
• Est. Priority Date: 11/06/2014
• Status: Active Grant

• Current Assignee: Furqan Tejani
• Original Assignee: Furqan Tejani
• Inventors: Tejani, Furqan
• Granted Patent: US 9,987,117 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

Disclosed herein are systems and methods for protecting a subject from embolisms during TAVR percutaneous valve procedures. Various embodiments include an intravascular embolism protection device that includes an elongated, compliant wire frame made from a material having a shape-memory function, and a mesh sleeve coupled to the compliant wire frame, the mesh material having a pore size selected to allow blood to pass therethrough while retaining potential emboli. In some embodiments, the embolism protection device has a collapsed state wherein device fits within the lumen of a deployment/retrieval catheter and an expanded state wherein the embolism protection device expands to span the width of the aorta and the distance between the aortic valve and the puncture site in the femoral artery.

Claims

1. An intravascular embolism protection device comprising:

an elongated, compliant wire frame comprising a material having a shape-memory function;

an elongated mesh sleeve having an outer surface and an inner lumen, the elongated, compliant, wire frame being disposed within the inner lumen, the mesh sleeve having a pore size selected to allow blood to pass therethrough while restricting the passage of potential emboli;

wherein the embolism protection device has a collapsed state wherein the embolism protection device fits within the lumen of a catheter, and an expanded state wherein the embolism protection device forms a hollow tube that is sized to span the width of an aorta and extend from an aortic valve to a puncture site in a femoral artery.

2. The intravascular embolism protection device of claim 1, wherein the elongated, compliant frame has a length dimension of about 300-500 mm.

3. The intravascular embolism protection device of claim 1, wherein the embolism protection device has a width dimension in the expanded state of about 10-40 mm.

4. The intravascular embolism protection device of claim 1, wherein the mesh material has a pore size of about 80-100 mm.

5. The intravascular embolism protection device of claim 1, wherein the mesh material has a pore size of about 100 mm.

6. The intravascular embolism protection device of claim 1, wherein the embolism protection device is sized to cover the ostia of at least four arterial branches arising from the aorta.

7. The intravascular embolism protection device of claim 1, wherein the elongated, compliant, wire frame comprises a proximal end and a distal end, and wherein the distal end is flared radially outward.

8. A kit for preventing embolisms during a TAVR procedure, the kit comprising:

a first catheter having a proximal end and a distal end and being sized to span a distance between an aortic valve and a puncture site in a femoral artery;

an intravascular embolism protection device comprising;

an elongated, compliant wire frame comprising a material having a shape-memory function; and

an elongated mesh sleeve having an outer surface and an inner lumen, the elongated, compliant, wire frame being disposed within the inner lumen, the mesh sleeve having a pore size selected to allow blood to pass therethrough while restricting the passage of potential emboli;

wherein the embolism protection device comprises a proximal end and a distal end, and has a collapsed state wherein the embolism protection device fits within the lumen of the first catheter, and an expanded state wherein the embolism protection device forms a hollow tube that is sized to span the width of an aorta and extend from an the aortic valve to the puncture site in a femoral artery.

9. The kit of claim 8, wherein the first catheter and the embolism protection device are both sized to extend out of the puncture site in the femoral artery.

10. The kit of claim 8, wherein the first catheter is a deployment catheter, and wherein the proximal end is flared radially outward.

11. The kit of claim 10, wherein the kit further comprises a seciond catheter having a proximal end and a distal end and being sized to span a distance between an aortic valve and a puncture site in a femoral artery, wherein the second catheter is a retrieval catheter.

12. The kit of claim 11, wherein the retrieval catheter has a distal end that is flared radially outward.

13. The kit of claim 8, wherein the first catheter is a deployment/retrieval catheter, and wherein one of the first and second ends is flared radially outward.

14. The kit of claim 8, wherein the first catheter is a deployment/retrieval catheter, and wherein both the proximal and distal ends are flared radially outward.

15. A method of protecting a subject from embolism during a percutaneous valve procedure, comprising:

advancing a guidewire through the vasculature of the subject through a puncture site in a femoral artery, through an iliac artery, and at least partially through an aorta;

advancing a catheter along the guidewire to a position adjacent an aortic valve, the catheter having a proximal end and a distal end;

advancing an embolism protection device within the catheter to the distal end, wherein the embolism protection device comprises;

an elongated, compliant wire frame comprising a material having a shape-memory function; and

an elongated mesh sleeve having an outer surface and an inner lumen,

the elongated, compliant, wire frame being disposed within the inner lumen, the mesh sleeve having a pore size selected to allow blood to pass therethrough while restricting the passage of potential emboli; and

withdrawing the catheter through the puncture site in the femoral artery, thereby allowing the embolism protection device to self-expand to form a hollow tube spanning a width of the aorta and extending from the aortic valve to the puncture site in the femoral artery;

performing the percutaneous valve procedure;

advancing the catheter to collapse the embolism protection device; and

removing the embolism protection device, catheter, and guidewire from the vasculature of the subject.

16. The method of claim 15, wherein the catheter has one or more outwardly flared ends.

17. The method of claim 15, wherein the steps of (1) advancing the catheter along the guidewire to a position adjacent an aortic valve;

and (2) advancing the embolism protection device within the catheter to a position adjacent the aortic valve;

occur simultaneously.

18. The method of claim 15, wherein the steps of (1) advancing the catheter along the guidewire to a position adjacent an aortic valve;

and (2) advancing the embolism protection device within the catheter to a position adjacent the aortic valve;

occur sequentially.

19. The method of claim 15, wherein the catheter and the embolism protection device are sized to extend from the aortic valve to the puncture site in the femoral artery.

20. The method of claim 15, wherein the catheter and the embolism protection device are sized to extend from the aortic valve and out of the puncture site in the femoral artery.