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. A catheter device comprising:
an elongate sheath with a lumen and a distal end for positioning at a heart valve,
an embolic protection device for temporarily positioning across an apex of 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 extending proximally from a connection point, and having:
a frame with a periphery,
a blood permeable unit within said periphery and configured for allowing blood flow to permeate therethrough while preventing embolic particles from passing therethrough 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 comprising an elongated pusher body extending from said catheter, configured to be positioned into said aortic arch, and being attached to said embolic protection device at a sustaining point located at a distal region of said embolic protection device, said pusher body configured for application of a stabilization force offset to said connection point at said embolic protection device and said pusher body configured to provide said stabilization force by pushing said embolic protection device towards side vessels of an inner wall of said aortic arch and at the same time raising a portion of said blood permeable unit out of a plane of said embolic protection device to form a dome shape, 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 stabilization force for improving stability and peripheral sealing;
wherein said elongated pusher body is positioned in a first position when said embolic protection device is in an expanded configuration; said first position comprising said elongated pusher body extending distally out of said sheath, beneath a lateral plane of said embolic protection device opposite of said side vessels of said aortic arch, in a longitudinal direction between a proximal and a distal end of said embolic protection device relative to the elongated sheath, centrally of the blood permeable unit, and within the periphery; said elongated pusher body forcing said embolic protection unit in said direction perpendicular to a longitudinal extension of said periphery.
2. The catheter device of claim 1 , wherein said blood permeable unit has at least one guiding unit comprising an eyelet and said pusher body passes through the eyelet.
3. The catheter device of claim 1 , wherein said embolic protection device further comprises a radiopaque fiducial marker positioned at an attachment point of said tether pusher body to said distal region of said embolic protection device.
4. The catheter device of claim 1 , said frame including at least one rib, wherein said elongated pusher body is distally attached at said rib.
5. The catheter device of claim 4 , wherein said at least one rib connects between opposite joints.
6. The catheter device of claim 1 , wherein said blood permeable unit is a flexible flat membrane with defined porosity or holes, and the elongated pusher body is distally attached to said membrane.
7. The catheter device of claim 1 , wherein the catheter device further comprises a spring or a shape memory element configured to said elongated pusher body.