Methods of embolic deflection

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.

What is claimed is: 
     
         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 into a first side branch vessel of the aorta selected from the group consisting of the brachiocephalic artery, the left common carotid artery, and the left subclavian artery;   advancing the wire from the first side branch vessel into the aorta;   advancing first and second expandable emboli deflection devices over the wire, the emboli deflection devices carried by an elongate shaft;   guiding the distal end of the elongate shaft into position adjacent the first side branch vessel;   manipulating the emboli deflection devices such that they expand and the first and second expandable emboli deflection devices span across the first side branch vessel and a second side branch vessel, respectively, wherein manipulating the deflection device comprises creating a seal between the emboli deflection device and surrounding tissue;   wherein the emboli deflection devices permit blood flow from the main vessel into each of the first and second side branch vessels, but deflect emboli from passing through the first and second side branch vessels;   performing an index procedure in the heart or the aorta; and   retracting the emboli deflection devices into the elongate shaft and withdrawing the shaft from the body.   
     
     
         2 . The method of  claim 1  wherein the first 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 index procedure is a balloon aortic or mitral valvuloplasty. 
     
     
         6 . The method of  claim 1 , wherein the index procedure is a mitral or aortic valve replacement. 
     
     
         7 . The method of  claim 1 , wherein the index procedure is a coronary angioplasty. 
     
     
         8 . The method of  claim 1 , wherein each emboli deflection device expands with a concave surface facing the ostia of each of the respective first and second side branch vessels after the manipulating step. 
     
     
         9 . The method of  claim 8 , wherein the step of retracting is done by inverting the emboli deflection devices so that the concave surfaces face away from the ostia of each of the first and second side branch vessels and then pulling the emboli deflection devices into the elongate shaft. 
     
     
         10 . The method of  claim 1 , wherein the emboli deflection devices comprise first and second laterally extending lobes. 
     
     
         11 . The method of  claim 10 , wherein the emboli deflection devices comprise a Nitinol frame supporting a porous membrane. 
     
     
         12 . The method of  claim 1 , wherein the emboli deflection devices each comprise a Nitinol frame supporting a porous membrane. 
     
     
         13 . The method of  claim 12 , wherein when expanded the emboli deflection devices comprise first and second laterally extending lobes. 
     
     
         14 . The method of  claim 13 , wherein the emboli deflection devices comprise first and second diverging struts extending from a common junction connected to the distal end of the flexible shaft. 
     
     
         15 . The method of  claim 14 , wherein each of the first and second laterally extending lobes has opposite medial ends which are each connected to one of the first and second struts. 
     
     
         16 . The method of  claim 15 , 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 deflector with the first and second laterally extending lobes being symmetric. 
     
     
         17 . The method of  claim 16 , wherein each of the first and second laterally 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 laterally extending lobes. 
     
     
         18 . The method of  claim 16 , wherein the first and second laterally extending lobes define an oval periphery having a minor axis on the midplane and a major axis perpendicular thereto.