Embolic protection device and method of use

• US 9,480,548 B2
• Filed: 03/11/2009
• Issued: 11/01/2016
• 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.
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US12/440,839
• Publication Number:
  US 20100211095A1
• Time in Patent Office: 2,792 Days
• Field of Search: 606/200, 606/194, 606113-114, 606127-128, 623/1.15, 623/2.11
• US Class Current: 1/1
• 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. An embolus deflector for protecting against cerebral embolization, the embolus deflector being deployable from a first ostium of the aortic arch selected from the group consisting of an ostium of a right common carotid artery, an ostium of a left common carotid artery, and an ostium of a brachiocephalic artery, the embolus deflector comprising a blood-flow-permeable covering configured to simultaneously extend over the first ostium and a second one of the group of ostiums, wherein the embolus deflector comprises:

a hollow sheath;

a generally elongated shaft, the shaft having a distal end and a proximal end and being arranged to pass through and be displaced linearly within the hollow sheath;

an expandable shield extending from the shaft distal end, the expandable shield having an open configuration and a closed configuration, the expandable shield comprising a first petal and a second petal, the expandable shield comprising;

a Nitinol expandable support frame extending from the shaft distal end, wherein the support frame comprises a first petal frame and a second petal frame, wherein the first petal frame defines a perimeter of the first petal and is dimensioned, when the expandable shield is in the open configuration, to define a first petal area of sufficient size to extend across and cover the first ostium, and wherein the second petal frame defines a perimeter of the second petal and is dimensioned, when the expandable shield is in the open configuration, to define a second petal area of sufficient size to extend across and cover the second ostium, the first and second petal frames extending in opposite longitudinal directions from laterally outward ends of a pair of proximal struts of the support frame that attach to the shaft distal end, the proximal struts diverging in lateral directions from each other so that the first and second petal frames define an oval periphery of the support frame consisting of just the first and second petals;

porous material extending across the first petal area and across the second petal area, wherein the porous material comprises a membrane having pores with individual diameters of 100 micron or less; and

a loop of bio-compatible plastic monofilament suture secured to the expandable support frame, ends of the loop of suture secured to the distal end of the elongated shaft, and the loop of suture operable to collapse the expandable shield for retrieval when the shaft is retracted within the sheath;

wherein the expandable shield in the closed configuration is sized and configured to be advanced through the sheath, and the expandable shield is sized and configured to be converted from the closed configuration to the open configuration within the aortic arch, wherein in the closed configuration the first and second petals are held against each other in general longitudinal alignment with the shaft, and in the open configuration the first and second petals extend substantially radially away from each other and substantially radially away from the distal end of the shaft and define the oval periphery, wherein in the open configuration the expandable shield is sized and configured to be positioned within the aortic arch and against the aortic wall such that the expanded first petal extends over the first ostium while the expanded second petal simultaneously extends over the second ostium, wherein the expandable shield presents a low profile against the aortic wall and within a lumen of the aortic arch to thereby cause minimal resistance to blood flow in the aortic arch by permitting blood to flow through the aortic arch past the expandable shield and also to allow sheaths, catheters, or wires to pass through the aortic arch and past the expandable shield without passing therethrough.

2. The deflector of claim 1 wherein the expandable shield 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, the first ostium is the ostium of the brachiocephalic artery, and the second ostium is the ostium of the left common carotid artery.

4. The deflector of claim 1 wherein the expandable shield 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 expandable shield 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 expandable shield may be inverted, trapping debris.

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

8. The deflector of claim 1 further including a radiopaque marker attached to outer ends of each of the first and second petals of the support frame.

9. The deflector of claim 1 wherein the porous material consists of a polyurethane membrane with laser-drilled pores.

10. The device of claim 1, wherein the first and second petals when expanded together form a substantially oval shape with a long dimension of about 60 mm.

11. The device of claim 1, wherein the nitinol support frame comprises different thicknesses along the perimeter of the first petal frame to provide varying stiffness therearound.

12. A method of employing an emboli deflector to cover an ostium of a brachiocephalic artery and an ostium of a left common carotid artery, the method comprising the steps of:

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

b. Advancing a deflection device through the artery into an aortic arch through the ostium of the brachiocephalic (innominate) artery, the deflection device having a hollow sheath within which slides a deflector in a collapsed configuration coupled to a distal end of a shaft, the hollow sheath including a proximal end defining a hemostasis valve through which the shaft passes, the shaft further having a torquer locked thereon that permits gripping and manipulation of the shaft during use;

c. Using the torquer and shaft, advancing the shaft and deflector in its collapsed configuration through the sheath, wherein the deflector comprises a Nitinol expandable support frame with only first and second petals extending in opposite longitudinal directions from laterally outward ends of a pair of proximal struts of the support frame that attach to the shaft distal end, the deflector comprising the collapsed configuration and an expanded configuration, wherein the petals, when expanded, are positioned in adjacent fashion, radially extending from opposite sides of the shaft to form the expanded deflector;

d. Advancing the deflector from within the sheath in the aortic arch so as to permit expansion of the deflector within the aortic arch, wherein expansion of the deflector involves the two petals expanding to radially extend away from each other to form an oval-shaped continuous porous surface that has a longitudinal dimension greater than a lateral dimension;

e. Positioning the deflector by manipulating the petals using the torquer to simultaneously cover the ostium of the brachiocephalic artery and the ostium of the left common carotid artery with the substantially continuous porous surface;

f. Sealing an edge of the deflector to a wall of the aortic arch with the porous surface against the wall of the aortic arch; and

g. Retracting the shaft to pull a loop of bio-compatible plastic monofilament suture secured to the shaft and to the deflector to collapse the deflector for retrieval within the sheath.

13. The method of claim 12 further comprising the steps of:

h. Performing a cardiac or vascular interventional medical procedure;

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

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

14. The method of claim 12, wherein positioning the deflector to simultaneously cover the ostium of the brachiocephalic artery and the ostium of the left common carotid artery comprises simultaneously leaving the ostium of a left subclavian artery uncovered.

15. The method of claim 12, wherein positioning the deflector comprises retracting the deflector toward the ostium of the brachiocephalic artery.

16. The method of claim 12, wherein the plurality of petals comprises a first petal and a second petal, wherein the first petal is sized and configured to cover the ostium of the brachiocephalic artery, and the second petal is sized and configured to cover the ostium of the left common carotid artery.