Embolic protection device and method
A catheter device is disclosed comprising; an elongate sheath ( 503 ) with a lumen and a distal end for positioning at a heart valve ( 6 ), an embolic protection device ( 200 ) for temporarily positioning in the aortic arch for deflection of embolic debris from the ascending aorta to the descending aorta, said embolic protection device is connectable to a transluminal delivery unit ( 130 ) extending proximally from a connection point ( 131 ), and having: a frame with a periphery, a blood permeable unit within said periphery for preventing embolic particles from passing therethrough with a blood flow downstream an aortic valve into side vessels of said aortic arch to the brain of a patient, and at least one tissue apposition sustaining unit ( 300, 350 ) extending from said catheter, into said aortic arch, and being attached to said embolic protection device at a sustaining point ( 502 ), for application of a stabilization force offset to said connection point at said embolic protection device, such as at said periphery, and for providing said stabilization force towards an inner wall of said aortic arch, away from said heart, and in a direction perpendicular to a longitudinal extension of said periphery, when said catheter device is positioned in said aortic arch, such that tissue apposition of said periphery to an inner wall of said aortic arch is supported by said force for improving stability and peripheral sealing. In addition related methods are disclosed.
1 . An embolic protection device for positioning in an aortic arch, said device having a periphery for apposition with an inner wall of said aortic arch to cover ostia of side vessels at least including the carotid arteries for preventing embolic particles from passing therethrough into side vessels to the brain of a patient;
a blood permeable unit within said periphery for preventing embolic particles from passing therethrough with a blood flow downstream an aortic valve into said side vessels of said aortic arch to the brain of the patient, and said blood permeable unit having a surface which is convexly shaped towards said ostia from said periphery when arranged in the aortic arch;
a transvascular delivery unit coupled to the periphery;
an elongate sheath adjacent to the embolic protection device, the sheath having a lumen and a distal end for positioning at a heart valve proximate to the aortic arch; and
a pigtail catheter having a length wherein, when a distal most end of the pigtail catheter is adjacent to said heart valve, a portion of the pigtail catheter is positioned along the aortic arch proximate to the elongate sheath and the blood permeable unit when the blood permeable unit is positioned along an inner wall of said aortic arch.
2 . The device of claim 1 , wherein the embolic protection device is configured to be collapsed along a longitudinal axis when in a stowed configuration before delivery.
3 . The device of claim 1 , wherein the periphery is coupled to the transvascular delivery unit at a connection point.
4 . The device of claim 1 , further comprising: a pushing unit arranged underneath said blood permeable unit configured to apply a pushing force against said periphery and/or blood permeable unit.
5 . The device of claim 1 , wherein said blood permeable unit is a mesh.
6 . The device of claim 1 , wherein said periphery is formed by a frame connected to said transvascular delivery unit.
7 . The device of claim 1 , wherein said transvascular delivery unit is pre-shaped with a bend.
8 . The device of claim 1 , wherein said device is adapted for use during a therapeutic cardiovascular procedure, such as a TAVI procedure.
9 . The device of claim 1 , wherein said blood permeable unit includes or is made of a porous material.
10 . The device of claim 1 , wherein said periphery is bent transverse to an extension of said aortic arch when positioned therein.
11 . The device of claim 1 , wherein said device including a flange unit extending radially outward from the periphery of the device.
12 . The device of claim 1 , wherein said device including one or more tetherline(s) that is provided to control a sealing degree of the periphery by direction of apposition towards aortic tissue/cerebral arteries.
13 . The device of claim 1 , wherein said embolic protection device, when positioned in said aortic arch, is curved along said aortic arch.