Embolic deflection device

• US 10,426,591 B2
• Filed: 05/12/2016
• Issued: 10/01/2019
• 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): Stransky, Katrina M
• Assistant Examiner(s): Bachman, Lindsey
• Application Number:
  US15/153,552
• Publication Number:
  US 20160317277A1
• Time in Patent Office: 1,237 Days
• 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 method of reducing the risk of emboli entering the cerebral circulation as a consequence of an index procedure in the heart or the aorta, comprising the steps of:

placing a wire through a first side branch vessel and into the aortic arch;

advancing an elongated introducer sheath over the wire and along the first side branch vessel until a distal end of the sheath is positioned in the aortic arch, wherein the elongated introducer sheath houses an expandable emboli deflection device attached to a distal end of an elongate shaft, the emboli deflection device having an elongated periphery in plan view when expanded, the periphery defined by a Nitinol skeleton in a modified rectangle with straight longitudinal sides terminating in opposite rounded ends, the periphery having a concave depth profile with a concave side facing toward the shaft, the emboli deflection device having a porous material stretched over the skeleton, the material having pores to allow the flow of blood but deflect or trap emboli;

retracting the sheath to expose and permit the emboli deflection device to expand;

manipulating the emboli deflection device such that the concave side covers the ostia of each of the first side branch vessel and a second side branch vessel, wherein manipulating the deflection device comprises pulling the shaft to create a seal between the periphery of the emboli deflection device and a wall of the aortic arch around the ostia of the first and second side branch vessels;

wherein the emboli deflection device permits blood flow from the main vessel into each of the first and second side branch vessels, but deflects emboli from entering the first and second side branch vessels;

performing an index procedure in the heart selected from the group consisting of a balloon aortic or mitral valvuloplasty, a mitral or aortic valve replacement, and a coronary angioplasty; and

retracting the emboli deflection device into the sheath and withdrawing the sheath from the body.

2. The method of claim 1 wherein the first side branch vessel is the brachiocephalic artery.

3. The method of claim 2, wherein the second side branch vessel is the left common carotid artery.

4. The method of claim 1, wherein the index procedure is a transcatheter aortic valve implantation.

5. The method of claim 1, wherein the step of retracting is done by inverting the emboli deflection device so that the concave side faces away from the ostia of each of the first and second side branch vessels and then pulling the emboli deflection device into the elongate sheath.

6. The method of claim 1, wherein the skeleton comprises first and second longitudinally extending lobes extending in opposite directions along a long axis of the elongated periphery.

7. The method of claim 1, wherein when expanded the skeleton comprises first and second longitudinally extending lobes extending in opposite directions along a long axis of the elongated periphery.

8. The method of claim 7, wherein the skeleton comprises first and second diverging struts extending from a common junction connected to the distal end of the flexible shaft.

9. The method of claim 8, wherein the first and second longitudinally extending lobes each has opposite medial ends which are each connected to one of the first and second struts.

10. The method of claim 9, wherein each of the first and second struts extend distally from the common junction and diverge from the other strut to define a mid-plane of the skeleton with the first and second longitudinally extending lobes being symmetric.

11. The method of claim 10, wherein each of the first and second longitudinally extending lobes each formed of a thin curved nitinol member, and the first and second struts further laterally diverge in opposite lateral directions and are contiguous with the thin curved nitinol members of the first and second longitudinally extending lobes.

12. The method of claim 10, wherein the elongated periphery has a minor axis on the midplane and a major axis perpendicular thereto.

13. The method of claim 12, further including two sutures heat formed into loops attached to the shaft and each extending along the minor axis adjacent different ones of the first and second longitudinally extending struts so that the respective loops terminate beyond a point at which the lobes longitudinally diverge from the struts, the sutures facilitating collapse of the flexible frame into the introducer sheath lumen.

14. The method of claim 7, further including discrete radiopaque markers positioned at rounded ends of the first and second longitudinally extending lobes, wherein the step of manipulating includes viewing a position of the radiopaque markers.

15. The method of claim 14, wherein the elongated periphery has a minor axis on the midplane and a major axis perpendicular thereto, and the discrete radiopaque markers are positioned offset from the major axis to avoid interfering with retracting the emboli deflection device into the elongate shaft.

16. The method of claim 1, further including means for preventing axial movement of the shaft within the sheath so as to maintain the emboli deflection device in a desired position in the body.

17. The method of claim 1, wherein the first side branch vessel is the brachiocephalic artery and the second side branch vessel is the left common carotid artery, and the emboli deflection device 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.