Embolic deflection device
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.
1. A device adapted to be installed in an aortic arch of a human and reduce the risk of emboli entering the cerebral circulation as a consequence of an index procedure in the heart or the aorta, comprising:
a wire sized to extend from outside the body through a first side branch vessel and into the aortic arch;
an elongated introducer sheath sized to extend from outside the body over the wire and along the first side branch vessel until a distal end of the sheath is positioned in the aortic arch;
an expandable emboli deflection device attached to a distal end of an elongate shaft and housed within the elongated introducer sheath, the emboli deflection device when expanded having a periphery in plan view defined by a nickel-titanium alloy skeleton, 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, and wherein the skeleton is sized large enough to cover the ostia of each of the first side branch vessel and a second side branch vessel, the emboli deflection device further including drawstrings attached to the skeleton that enable inversion of the emboli deflection device.
2. The device of claim 1 , wherein the skeleton comprises first and second longitudinally extending lobes extending in opposite directions along a long axis of the periphery.
3. The device of claim 2 , wherein the emboli deflection device comprises first and second diverging struts extending from a common junction connected to the distal end of the elongate shaft.
4. The device of claim 3 , wherein each of the first and second longitudinally extending lobes has opposite medial ends which are each connected to one of the first and second diverging struts.
5. The device of claim 4 , wherein each of the first and second diverging struts extend distally from the common junction and diverge from the other strut to define a mid-plane of the emboli deflection device with the first and second longitudinally extending lobes being symmetric.
6. The device of claim 5 , wherein each of the first and second longitudinally extending lobes each formed of a thin curved nickel-titanium alloy member, and the first and second diverging 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.
7. The device of claim 5 , wherein the first and second longitudinally extending lobes define an oval periphery having a minor axis on the midplane and a major axis perpendicular thereto.
8. The device of claim 2 , further including discrete radiopaque markers positioned at rounded ends of the first and second longitudinally extending lobes.
9. The device of claim 8 , 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 elongated introducer sheath.