CPC A61F 2/2433 (2013.01) [A61F 2/2436 (2013.01); A61M 25/0136 (2013.01); A61M 25/0662 (2013.01); A61F 2/9517 (2020.05); A61F 2/958 (2013.01); A61M 25/0045 (2013.01); A61M 25/005 (2013.01); A61M 25/0147 (2013.01); A61M 39/0613 (2013.01)] | 29 Claims |
1. An assembly comprising:
a prosthetic heart valve comprising a stent portion and a valve structure supported within the stent portion; and
a delivery apparatus comprising:
a handle;
a first shaft having a first proximal end portion and a first distal end portion;
a second shaft extending coaxially through the first shaft and having a second proximal end portion and a second distal end portion, the first and second proximal end portions extending distally from the handle;
one or more radiopaque markers on the second distal end portion of the second shaft for positioning of the prosthetic heart valve in a radially compressed state within a native aortic annulus;
a balloon mounted on the second distal end portion of the second shaft, wherein the assembly has a delivery configuration for advancing the prosthetic valve through vasculature of a patient in which the prosthetic heart valve is mounted around the balloon in the radially compressed state, wherein the balloon is inflatable to transition the prosthetic heart valve from the radially compressed state to a radially expanded state; and
an end piece disposed at the first distal end portion of the first shaft and covering a proximal portion of the balloon, wherein the end piece comprises a flared portion having a distal end face that is a terminal distal end of the end piece, the distal end face having a greater diameter than a diameter of the first distal end portion of the first shaft, and wherein, in the delivery configuration of the assembly, the distal end face of the end piece is proximal relative to a proximal end of the radially compressed prosthetic heart valve;
wherein the handle comprises a lock transitionable between an engaged position and a disengaged position;
wherein the delivery apparatus is configured such that, when the lock is in the engaged position, axial movement of the second shaft relative to the first shaft is prevented for advancing the first and second distal end portions through a patient's vasculature and positioning the one or more radiopaque markers relative to the native aortic annulus; and
wherein the delivery apparatus is configured such that, when the lock is in the disengaged position, axial movement of the second shaft relative to the first shaft is enabled for retracting the first shaft relative to the second shaft so as to retract the end piece relative to the balloon so that the end piece no longer covers the balloon.
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