Embolic deflection device

• US 9,339,367 B2
• Filed: 01/11/2010
• Issued: 05/17/2016
• 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., Carpenter, Jeffrey P., Rezac, David A., Cerier, Jeffrey C., Fortier, Richard C., Robinson, Timothy W.
• Primary Examiner(s): Rodjom, Katherine
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US12/685,591
• Publication Number:
  US 20100179585A1
• Time in Patent Office: 2,318 Days
• Field of Search: 606/200, 606/194, 606/1.15, 606/2.11, 606113-114, 606127-128, 623/1.15, 623/2.11
• US Class Current: 1/1
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• 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
• CPC Class Codes: A61F 2230/0095 Saddle-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 (such as greater than 100 microns) from entering either the right or left common carotid arteries, and/or the right or left vertebral arteries by deflecting emboli downstream of these vessels. 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 deflector 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 deflector.

Claims

1. A temporary emboli diversion device for use during an endovascular procedure to prevent emboli from entering a carotid artery from the aortic arch, comprising:

an elongated introducer sheath comprising a proximal end, a distal end, and a lumen extending therethrough, the introducer sheath being dimensioned for accessing the aortic arch through a connecting artery;

an elongate, flexible shaft, having a proximal end and a distal end, the flexible shaft dimensioned to extend from the proximal end to the distal end of the introducer sheath, and through the lumen thereof;

an embolic deflector connected to the distal end of the flexible shaft configured to be transformed from a first, reduced size configuration constrained during delivery within the introducer sheath lumen to a second, unconstrained expanded configuration when the flexible shaft is advanced relative to the introducer sheath, the embolic deflector comprising a flexible frame of nitinol and consisting of, in its unconstrained expanded configuration;

first and second struts extending from a common junction connected to the distal end of the flexible shaft, each of the first and second struts extending distally from the junction and curving away so as to diverge from the other strut and define a mid-plane of the deflector;

first and second lobes each formed of a thin curved nitinol member having opposite medial ends each of which is connected to one of the first and second struts on the mid-plane and extend in opposite lateral directions from the mid-plane so as to form a complete loop with lateral ends farthest away from the mid-plane, wherein each of the divergent first and second struts further laterally diverge in opposite lateral directions and are contiguous with the loops defined by the first and second lobes, wherein the deflector is concave in a proximal direction and convex in a distal direction, the combination of the first and second lobes defining a periphery of an oval shape having a minor axis on the midplane and a major axis perpendicular thereto; and

a single membrane secured around the first and second lobes and having a shape that generally matches the oval shape of the combination of the first and second lobes and extends on both sides of the mid-plane, the membrane having a pore size configured to permit passage of blood but deflect emboli greater than a selected size, wherein

the oval shape of the embolic deflector is adapted to be deployed from the connecting artery into the aortic arch into its second, unconstrained expanded configuration having a sufficient length along the major axis and width along the minor axis to cover and prevent emboli from entering the ostia of both the connecting artery and a carotid artery while at the same time the reduced width relative to the length permits the embolic deflector to be oriented along one side wall of the aortic arch.

2. The device of claim 1, further including discrete radiopaque markers positioned at each of the lateral ends of the first and second lobes.

3. The device of claim 2, wherein the discrete radiopaque markers are positioned offset from the major axis to avoid interfering with folding of the flexible frame when converted between the second expanded configuration to the first reduced size configuration.

4. The device of claim 1, further including two sutures heat formed into loops attached to the flexible shaft and each extending along the minor axis adjacent different ones of the first and second struts so that the respective loops terminate beyond the point at which the lobes laterally diverge from the struts, the sutures facilitating collapse of the flexible frame into the introducer sheath lumen.

5. The device of claim 1, wherein the first and second lobes are identically shaped such that the mid-plane defines a plane of symmetry of the flexible frame.

6. The device of claim 1, wherein the membrane has a pore size with an average diameter of no greater than about 100 micrometers.

7. The device of claim 1, further including means for preventing axial movement of the flexible shaft within the introducer sheath so as to maintain the embolic deflector in a desired position in the body.

8. The device of claim 1, wherein if the connecting artery is the brachiocephalic artery, the embolic deflector has a sufficient length to cover and prevent emboli from entering the ostia of the brachiocephalic artery, the left common carotid artery, and the left subclavian artery.

9. The device of claim 1, wherein the lateral ends of the first and second lobes have a radius of curvature that is approximately one half the width of the oval shape of the embolic deflector along the minor axis.

10. The device of claim 1, wherein the distal end of the flexible shaft has a shape that positively engages a complementary portion of the junction of the first and second struts.

11. The device of claim 10, further including a hypotube provided around the engaged flexible shaft distal end and junction.

12. The device of claim 11, further including a radiopaque marker carried on the hypotube.

13. A temporary emboli diversion device for use during an endovascular procedure to prevent emboli from entering a carotid artery from the aortic arch, comprising:

an elongated introducer sheath comprising a proximal end, a distal end, and a lumen extending therethrough, the introducer sheath being dimensioned for accessing the aortic arch through a connecting artery;

an elongate, flexible shaft, having a proximal end and a distal end, the flexible shaft dimensioned to extend from the proximal end to the distal end of the introducer sheath, and through the lumen thereof;

an embolic deflector connected to the distal end of the flexible shaft configured to be transformed from a first, reduced size configuration constrained during delivery within the introducer sheath lumen to a second, unconstrained expanded configuration when the flexible shaft is advanced relative to the introducer sheath, the embolic deflector comprising a flexible frame of nitinol and consisting of, in its unconstrained expanded configuration;

first and second struts extending distally from a common junction connected to the distal end of the flexible shaft, each of the first and second struts extending distally from the junction;

first and second lobes each formed of a thin curved nitinol member having opposite medial ends each of which are connected to one of the first and second struts so as to form a complete loop with lateral ends farthest away from each other, the combination of the first and second lobes defining a periphery of an elongated atraumatic shape having a minor axis and a larger major axis perpendicular thereto, and the periphery is concave in a proximal direction with a first curvature along the major axis and a second smaller curvature along the minor axis; and

a single membrane secured around the first and second lobes and having a peripheral shape that generally matches the atraumatic shape of the combination of the first and second lobes, the membrane having a pore size configured to permit passage of blood but deflect emboli greater than a selected size, wherein

the atraumatic shape of the embolic deflector is adapted to be deployed from the connecting artery into the aortic arch into its second, unconstrained expanded configuration having a sufficient length along the major axis and width along the minor axis to cover and prevent emboli from entering the ostia of both the connecting artery and a carotid artery, and the flexible frame being capable of flattening when pulled proximally against the aortic arch wall and forming a seal therewith around the atraumatic shape.

14. The device of claim 13, further including discrete radiopaque markers positioned at each of the lateral ends of the first and second lobes.

15. The device of claim 14, wherein the discrete radiopaque markers are positioned offset from the major axis to avoid interfering with folding of the flexible frame when converted between the second expanded configuration to the first reduced size configuration.

16. The device of claim 13, wherein each of the first and second struts extend distally from the junction and curve away so as to diverge from the other strut parallel to the minor axis of the deflector, and each of the divergent first and second struts further laterally diverge in opposite lateral directions and continue as the loops defined by the first and second lobes, and further including two sutures heat formed into loops attached to the flexible shaft and each extending along the minor axis adjacent different ones of the first and second struts so that the respective loops terminate beyond the point at which the lobes laterally diverge from the struts, the sutures facilitating collapse of the flexible frame into the introducer sheath lumen.

17. The device of claim 13, wherein the first and second lobes are identically shaped.

18. The device of claim 13, wherein the membrane has a pore size with an average diameter of no greater than about 100 micrometers.

19. The device of claim 13, further including means for preventing axial movement of the flexible shaft within the introducer sheath so as to maintain the embolic deflector in a desired position in the body.

20. The device of claim 13, wherein if the connecting artery is the brachiocephalic artery, the embolic deflector has a sufficient length to cover and prevent emboli from entering the ostia of the brachiocephalic artery, the left common carotid artery, and the left subclavian artery.

21. The device of claim 13, wherein the lateral ends of the first and second lobes have a radius of curvature that is approximately one half the width of the oval shape of the embolic deflector along the minor axis.

22. The device of claim 13, wherein the distal end of the flexible shaft has a shape that positively engages a complementary portion of the junction of the first and second struts.

23. The device of claim 22, further including a hypotube provided around the engaged flexible shaft distal end and junction.

24. The device of claim 23, further including a radiopaque marker carried on the hypotube.