HYDRAULIC DELIVERY SYSTEMS FOR PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED METHODS
Systems, apparatuses, and methods for treating native heart valves are disclosed herein. A system for delivering a prosthetic device into a heart of a patient includes an elongated catheter body and a delivery capsule. The delivery capsule can be hydraulically driven to deploy at least a portion of a prosthetic heart valve device. The delivery capsule can release the prosthetic heart valve device at a desired treatment site in a patient.
1 . A delivery system comprising:
a catheter body having a distal portion and a proximal portion;
a delivery capsule coupled to the distal portion of the catheter body, the delivery capsule configured to house a prosthetic heart valve therein; and
a positioner having a delivery state configured for delivery and a tissue-contacting state for engaging tissue of a heart, wherein in the tissue-contacting state the positioner is configured to position the delivery capsule relative to the heart.
2 . The delivery system of claim 1 , wherein the positioner comprises a mechanical positioner assembly.
3 . The delivery system of claim 2 , wherein the mechanical positioner assembly comprises a plurality of deployable members, wherein in the delivery state the deployable members are substantially parallel to a central longitudinal axis of the delivery capsule, and wherein in the tissue-contacting state the deployable members extend radially outward from the delivery capsule.
4 . The delivery system of claim 3 , wherein the deployable members are flexible elongated arms or tines.
5 . The delivery system of claim 3 , wherein the deployable members are pivotably coupled to the delivery capsule.
6 . The delivery system of claim 3 , wherein the deployable members are self-deployable to the tissue-contacting state.
7 . The delivery system of claim 3 , wherein the deployable members comprise radiopaque material or comprise one or more radiopaque markers.
8 . The delivery system of claim 3 , wherein a transverse dimension of the mechanical positioner assembly in the tissue-contacting state is such that the deployable members do not pass through a native heart valve of the heart.
9 . The delivery system of claim 8 , wherein the native heart valve is a native mitral valve, and wherein the deployable members are sized to contact opposing sides of a left atrial wall of the heart in the tissue-contacting state.
10 . A method comprising:
delivering a delivery catheter to a native heart valve of a heart, the delivery catheter including a catheter body, a delivery capsule coupled to a distal portion of the catheter body, a positioner in a delivery state, and a prosthetic heart valve disposed within the delivery capsule in a low-profile delivery configuration;
deploying the positioner to a tissue-contacting state in which the positioner contacts tissue of the heart;
deploying the prosthetic heart valve from the delivery capsule;
after deploying the prosthetic heart valve, returning the positioner to the delivery state; and
removing the delivery catheter.
11 . The method of claim 10 , wherein the positioner comprises a plurality of elongate arms, wherein in the delivery state the elongate arms are substantially parallel to a central longitudinal axis of the delivery capsule, and wherein deploying the elongate arms comprises pivoting the elongate arms such that the elongate arms extend radially outward from the delivery capsule.
12 . The method of claim 11 , wherein delivering the delivery catheter comprises delivering the delivery catheter through a guide catheter that holds the elongate arms in the delivery state, and wherein deploying the elongate arms comprises removing the elongate arms from the guide catheter.
13 . The method of claim 12 , wherein the elongate arms self-deploy to the tissue-contacting state when removed from the guide catheter.
14 . The method of claim 11 , wherein the delivery catheter includes a proximal sheath and a distal sheath, wherein the elongate arms are coupled to the proximal sheath, and wherein deploying the prosthetic heart valve comprises distally advancing the distal sheath.
15 . The method of claim 10 , wherein the positioner comprises a plurality of elongate arms, wherein deploying the elongate arms comprises moving the elongate arms distally out of openings in the delivery capsule.
16 . The method of claim 15 , wherein the delivery catheter includes a proximal sheath and a distal sheath, wherein the openings are disposed in the proximal sheath, and wherein deploying the prosthetic heart valve comprises distally advancing the distal sheath.
17 . The method of claim 11 , wherein the native heart valve is a mitral valve, and wherein delivering the delivery catheter to the mitral valve comprises delivering the delivery catheter from the left atrium and into the mitral valve.
18 . The method of claim 11 , wherein the native heart valve is a mitral valve, and wherein delivering the delivery catheter to the mitral valve comprises delivering the delivery catheter transapically.
19 . The method of claim 18 , wherein in the delivery state outer surfaces of the elongate arms are flush with an exterior surface of the capsule, and wherein deploying the elongate arms comprises rotating the elongate arms radially outwardly.
20 . The method of claim 19 , wherein in the delivery state the elongate arms are disposed within recesses or slots in the capsule.