Device and method for delivery of medical devices to a cardiac valve
A catheter device for transvascular delivery of a medical device to a cardiac valve region of a patient comprises an elongate sheath with a first lumen, a distal end for positioning at a heart valve, a second lumen that extends parallel to or in the sheath, and an expandable embolic protection filter. The filter is arranged to extend from an orifice of the second lumen and, in the expanded, covers ostia of the side branch vessels in the aortic arch.
1 . A method for transvascularly delivering a medical device to a cardiac valve of a patient, comprising
introducing a first lumen comprising a proximal end and a distal end;
passing a guidewire along the first lumen from the proximal end of the first lumen to the distal end of the first lumen;
introducing a second lumen that extends parallel to the first lumen from the proximal end of the first lumen to the distal end of the first lumen, wherein the second lumen comprises an orifice at a distal end of the second lumen, a delivery unit, and a connection point;
positioning the orifice proximally with respect to the distal end of the first lumen;
advancing an expandable embolic protection filter in an unexpanded delivery shape along the second lumen;
extending the expandable embolic protection filter from the orifice at the distal end of the second lumen;
fully expanding the expandable embolic protection filter, via the delivery unit and the connection point, to a non-tubular shape;
arranging the expandable embolic protection filter so that a distal end of the expandable embolic protection filter is in a direction of an ascending aorta;
covering at least one ostia of side branch vessels in an aortic arch when extending the expandable embolic protection filter from the orifice at the distal end of the second lumen;
arranging the distal end of the first lumen distally of the distal end of the expandable embolic protection filter when the expandable embolic protection filter is fully expanded into the non-tubular shape; and
delivering the medical device through the first lumen while the expandable embolic protection filter is fully expanded into the non-tubular shape, wherein the medical device is a cardiac valve repair or replacement device.
2 . The method of claim 1 , wherein the expandable embolic protection filter stabilizes the distal end of the first lumen when the expandable embolic protection filter extends from the orifice of the second lumen and fully expands into the non-tubular shape, wherein the expandable embolic protection filter appositions against a surrounding vessel wall when fully expanded.
3 . The method of claim 1 , further comprising positioning the first lumen at a desired position in relation to the distal end of the first lumen via the use of a plurality of radially expandable units, wherein the plurality of radially expandable units expands to an expanded state.
4 . The method of claim 3 , wherein delivering the medical device through the first lumen further comprises delivering the medical device while the plurality of radially expandable units is in the expanded state.
5 . The method of claim 1 , wherein the expandable embolic protection filter anchors the first lumen when fully expanded into the non-tubular shape.
6 . The method of claim 1 , wherein the delivery unit provides an anchoring function to the first lumen.
7 . The method of claim 1 , further comprising arranging the connection point off-center at the expandable embolic protection filter such that the delivery unit is connectable off-center to the expandable embolic protection filter.
8 . The method of claim 1 , wherein the non-tubular shape is substantially planar.
9 . The method of claim 1 , further comprising covering all ostia of side branch vessels in the aortic arch when extending the expandable embolic protection filter from the orifice at the distal end of the second lumen and fully expanding the expandable embolic protection filter.
10 . The method of claim 1 , further comprising configuring the distal end of the expandable embolic protection filter to apposition against an inner wall of an ascending aortic arch portion of the aortic arch.