Systems and methods for predictable commissural alignment of a replacement heart valve
A replacement heart valve prosthesis is loaded onto a balloon mounted onto a balloon shaft of a catheter system. The balloon shaft is rotatably engaged with an actuator on the handle of the catheter system. Rotation of the actuator by a first amount in a first direction permits rotation of the heart valve prosthesis by a known amount during the procedure so that alignment of the commissures of the replacement valve with the commissures of the existing valve can be predictably achieved.
1 . A transcatheter prosthetic heart valve delivery system comprising:
a balloon shaft;
a balloon mounted onto the balloon shaft, the balloon having a delivery diameter, the balloon in fluid communication with a fluid source for expansion of the balloon from the delivery diameter to a deployed diameter; and
a handle comprising an actuator engaged with the balloon shaft,
wherein rotation of the actuator by an actuator rotation amount in a first direction predictably rotates the balloon in the first direction by a balloon rotation amount that is proportional to the actuator rotation amount.
2 . The transcatheter prosthetic heart valve delivery system of claim 1 , wherein a ratio of the actuator rotation amount to the balloon rotation amount is 1:1.
3 . The transcatheter prosthetic heart valve delivery system of claim 1 , further comprising a valve prosthesis loaded onto the balloon wherein the valve prosthesis comprises a valve construct attached to a frame.
4 . The transcatheter prosthetic heart valve delivery system of claim 3 , wherein the valve construct comprises a sutureless single-piece three-dimensional structure with three leaflets molded into the sutureless single-piece three-dimensional structure.
5 . The transcatheter prosthetic heart valve delivery system of claim 3 , wherein the frame includes at least one radiopaque marker.
6 . The transcatheter prosthetic heart valve delivery system of claim 5 , wherein the at least one radiopaque marker is positioned on a commissural post of the frame.
7 . The transcatheter prosthetic heart valve delivery system of claim 6 , wherein the at least one radiopaque marker is positioned onto at least one of a node or a strut adjacent to the commissural post.
8 . The transcatheter prosthetic heart valve delivery system of claim 1 , wherein the handle further comprises at least one actuator stop.
9 . The transcatheter prosthetic heart valve delivery system of claim 1 , wherein the handle further comprises a locking member, wherein when the locking member is engaged with the actuator, the balloon shaft cannot rotate.
10 . The transcatheter prosthetic heart valve delivery system of claim 1 , wherein the actuator is rotatable in the first direction and in a second direction opposite the first direction.
11 . A prosthetic heart valve transcatheter delivery system comprising:
an inner shaft;
a balloon coupled to a distal end portion of the inner shaft;
an outer shaft; and
a lock having a locked position and an unlocked position,
wherein rotation of the inner shaft by a shaft rotation amount in a first direction predictably rotates the balloon in the first direction by a balloon rotation amount that is proportional to the shaft rotation amount, and
wherein, when the lock is in the locked position, axial movement of the inner shaft and balloon relative to the outer shaft is prevented.
12 . The prosthetic heart valve transcatheter delivery system of claim 11 , further comprising a handle with a locking switch that engages the lock into the locked position.
13 . The prosthetic heart valve transcatheter delivery system of claim 12 , wherein the locking switch disengages the lock from the locked position into the unlocked position.
14 . The prosthetic heart valve transcatheter delivery system of claim 11 , wherein in the locked position, the inner shaft can be rotated in the first direction.
15 . The prosthetic heart valve transcatheter delivery system of claim 14 , wherein in the locked position, the inner shaft can be rotated in a second direction.
16 . The prosthetic heart valve transcatheter delivery system of claim 11 , wherein in the unlocked position, the inner shaft can move in an axial direction relative to the outer shaft and the inner shaft can be rotated in at least the first direction.
17 . The prosthetic heart valve transcatheter delivery system of claim 11 , wherein the inner shaft is a braided shaft.
18 . The prosthetic heart valve transcatheter delivery system of claim 11 , further comprising a valve prosthesis comprising at least one alignment marker.
19 . The prosthetic heart valve transcatheter delivery system of claim 18 , wherein the valve prosthesis comprises at least three alignment markers.
20 . The prosthetic heart valve transcatheter delivery system of claim 18 , wherein the at least one alignment marker comprises two overlapping serpentine struts forming a numeral 8 shape defining two openings containing radiopaque markers.