Temporary Embolic Protection Device And Medical Procedure For Delivery Thereof

Abstract

An embolic protection device and medical procedure for positioning the device in the aortic arch is disclosed. The device and method effectively prevent material from entering with blood flow into side branch vessels of the aortic arch. The device is a collapsible embolic protection device devised for temporary transvascular delivery to an aortic arch of a patient, wherein the device has a protection unit that comprises a selectively permeable unit adapted to prevent embolic material from passage with a blood flow into a plurality of aortic side branch vessels at the aortic arch. The protection unit is permanently attached to a transvascular delivery unit at a connection point provided at the selectively permeable unit, and a first support member for the protection unit that is at least partly arranged at a periphery of the selectively permeable unit. In an expanded state of the device, the connection point is enclosed by the first support member or arranged at said support member.

1 . A collapsible embolic protection device for transvascular delivery to an aortic arch, said protection device comprising:
 a delivery unit and   a protection unit comprising a selectively permeable material, a support frame provided in form of a wire, and a connection point configured for attachment to said delivery unit;   wherein:   said protection unit has a collapsed delivery state and an expanded state;   a perimeter of said support frame, in the expanded state of said protection unit, is shaped to releasably engage with vessel tissue of the aortic arch, such that said selectively permeable material covers a plurality of side branch vessel ostia;   said selectively permeable material is attached to or is integral with said support frame such that said support member surrounds an entire perimeter of said selectively permeable material and expands said selectively permeable material along a length and a width into a non-tubular shape, said selectively permeable material allows blood to pass into said plurality of side branch vessels but prevents embolic material in the blood from entering said plurality of side branch vessels during a medical procedure.   
     
     
         2 . A device according to  claim 1 , wherein the protection unit includes a stem connected to said support frame and extends towards said connection point for connecting said device to said delivery unit; and;
 said stem is connected directly to said support frame at a proximal end of the perimeter of said support frame; and wherein said connection point is configured to be connected to said delivery unit after the collapsible embolic protection device has been arranged in said aortic arch and during said medical procedure.   
     
     
         3 . The device according to  claim 2 , wherein said stem is isolated from said selectively permeable material. 
     
     
         4 . The device according to  claim 1 , wherein the delivery unit is permanently attached to said connection point. 
     
     
         5 . The device according to  claim 1 , wherein said connection point is at a proximal portion of said perimeter of said support member. 
     
     
         6 . The device according to  claim 1 , wherein said connection point is a single connection point on said support frame. 
     
     
         7 . The device according to  claim 1 , wherein said wire is forming a loop. 
     
     
         8 . The device according to  claim 1 , wherein said connection point is arranged directly on said periphery of said support frame. 
     
     
         9 . The device according to  claim 1 , wherein said delivery unit is arranged at an angle with the support member in a longitudinal direction of the embolic protection device such that a force may be applied through said delivery unit onto the embolic protection device toward a wall of the aortic arch. 
     
     
         10 . The device according to  claim 1 , wherein said connection point is an integral of said support member. 
     
     
         11 . The device according to  claim 1 , wherein said protection unit is sized and shaped to extend across an apex of the aortic arch. 
     
     
         12 . The device according to  claim 1 , wherein said wire, which forms said perimeter of said support frame, comprises two branches of said wire that are joined at said connection point. 
     
     
         13 . The device according to  claim 1 , wherein said selectively permeable material is a rigid, non-elastic material which is non-conformable to ostia of aortic side branch vessels. 
     
     
         14 . The device according to  claim 1 , wherein said selectively permeable material comprises a mesh of strands. 
     
     
         15 . The device according to  claim 14 , wherein said strands are made of a metallic material. 
     
     
         16 . The device according to  claim 14 , wherein said permeable material has been molded in a heat setting process to set a desired shape. 
     
     
         17 . The device according to  claim 1 , wherein said wire is shaped into a tongue at a distal end. 
     
     
         18 . The device according to  claim 17 , wherein said tongue has a width smaller than the rest of the support frame. 
     
     
         19 . The device according to  claim 17 , wherein said tongue has an angle deviating longitudinally from a plane of said protection unit.