Embolic Protection Device and Method of Use

• US 20100211095A1
• Filed: 09/11/2007
• Published: 08/19/2010
• Est. Priority Date: 09/11/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Carpenter, Judith T.
• Granted Patent: US 9,480,548 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2230/0021 square
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

There is disclosed a porous emboli deflector for preventing cerebral emboli while maintaining cerebral blood flow during an endovascular or open surgical procedure. The device prevents the entrance of emboli of a size able to cause stroke (greater than 100 microns in the preferred embodiment) from entering either the right or left carotid arteries by deflecting emboli downstream in the blood flow. The device can be placed prior to any manipulation of the heart or aorta allowing maximal protection of the brain during the index procedure. The device has a low profile within the aorta which allows sheaths, catheters, or wires used in the index procedure to pass. Also disclosed are methods for insertion and removal of the device.

Claims

1. A embolus deflector for protecting against cerebral embolization comprising a blood flow permeable covering extending over either (a) the ostia of the right common carotid and left common carotid arteries, or (b) the ostia of the brachiocephalic and the left common carotid arteries.

2. The deflector of claim 1 wherein the deflector is capable of being inserted and placed through a catheter in an artery of the arm of a patient.

3. The deflector of claim 2 wherein the artery is the brachial artery of a patient.

4. The deflector of claim 1 wherein the deflector is capable of being inserted and placed through a catheter in the femoral artery of a patient.

5. The deflector of claim 1 wherein the deflector is capable of being inserted and placed directly into the aorta of a patient during an open surgical procedure.

6. The deflector of claim 1 wherein prior to withdrawal, the deflector may be inverted, trapping debris.

7. The deflector of claim 1 wherein prior to withdrawal, the deflector may be closed, trapping debris.

8. The deflector of claim 1 wherein the periphery is adapted to seal against the walls of the aortic arch.

9. The deflector of claim 6 wherein the periphery is supported by a flexible member.

10. The deflector of claim 8 wherein the periphery is supported by a member constructed from one or more materials selected from the group comprising:

nitinol, Elgiloy, stainless steel, plastic, PTFE, ePTFE, polyester, nylon, silicone, and titanium.

11. The deflector of claim 8 wherein the shape of the periphery is selected from the group comprising:

round, oval, square, rectangular, elliptical, and edge-scalloped and irregular.

12. The deflector of claim 11 wherein the profile of the deflector in side view is selected from the group comprising:

flat, rounded, peaked, onion shaped, tent shaped, parachute shaped, conic, cylindrical, plateau, disc shaped (flat, concave, convex, or concave-convex, and spherical.)

13. The deflector of claim 11 wherein a supporting member protrudes from the top surface and extends to the opposite wall of the aortic lumen when the deflector is in place.

14. The deflector of claim 1 further comprising a locking means.

15. The deflector of claim 14 wherein the locking means is selected from the group comprising:

a clamp, a twist screw without ratchet, a twist screw with ratchet, a balloon, and a stent-like sleeve.

16. A method of employing an emboli deflector to cover either (a) the ostia of the right common carotid and left common carotid arteries, or (b) the ostia of the brachiocephalic and the left common carotid arteries comprising the steps of:

a. Accessing the circulation through percutaneous insertion of a catheter into an artery;

b. Guiding a wire through the artery into the aortic arch;

c. Placing a collapsed deflector in a sheath over the wire, and guiding the deflector into the aortic arch;

d. Withdrawing the sheath from the deflector, exposing the deflector to aortic blood flow, and expanding the deflector; and

e. Positioning the deflector to cover either (a) the ostia of the right common carotid and left common carotid arteries, or (b) the ostia of the brachiocephalic and the left common carotid arteries.

17. The method of claim 16 further comprising the steps of:

f. Performing a surgical procedure;

g. Inverting the deflector into a sheath or closing it in a manner to trap any debris or clot remaining on the device surface; and

h. Withdrawing the inverted or closed deflector from the patient.

18. The method of claim 16 wherein step (a) comprises accessing the circulation through percutaneous insertion of a catheter into an artery of the arm;

and step (b) comprises guiding a wire through the artery into the aortic arch via the innominate artery;

19. The method of claim 18 further comprising the steps of:

f. Performing a surgical procedure;

g. Inverting the deflector into a sheath or closing it in a manner to trap any debris or clot remaining on the device surface; and

h. Withdrawing the inverted or closed deflector from the patient.