Delivery systems with tethers for prosthetic heart valve devices and associated methods

Abstract

Delivery systems with tethers for prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, an elongated catheter body, a capsule carried by the elongated catheter body and carrying a prosthetic heart valve device, and a cinching member slidably disposed within the capsule. The delivery system can further include a plurality of tether elements coupled to the prosthetic device and extending through the cinching member and the catheter body. Retraction of the tether elements can urge at least a portion of the prosthetic device into a distal end portion of the cinching member to resheathe at least a portion of the prosthetic device and allow repositioning of the prosthetic device relative to the native valve after a portion of the prosthetic device has contacted tissue of a native valve.

I/We claim: 
     
         1 . A delivery system for delivering a prosthetic heart valve device to a target site within the heart of a human patient, the delivery system comprising:
 a capsule configured to be moved between a containment configuration for holding the prosthetic heart valve device and a deployment configuration for at least partially deploying the prosthetic heart valve device;   a cinching member including a distal end portion disposed at a distal region of the delivery system; and   a tether element having a first end and a second end and extending from the first end, through the cinching member, through an engagement feature, and proximally back to the second end;   wherein proximal retraction of the second end of the tether element is configured to urge at least a portion of the prosthetic heart valve device toward the distal end portion of the cinching member to resheathe at least a portion of the prosthetic heart valve device after a portion of the prosthetic heart valve device has been deployed at the target site;   wherein the tether element is releasable from prosthetic heart valve device by threading the first end of the tether element through the engagement feature to disengage the prosthetic heart valve device from the tether element.   
     
     
         2 . The delivery system of  claim 1 , further comprising a handle assembly at a proximal portion of the elongated catheter body, the handle assembly having an actuator, wherein the second end of the tether is coupled to the actuator and the actuator is configured to proximally retract the tether element. 
     
     
         3 . The delivery system of  claim 1 , wherein the tether element comprises a plurality of tether elements. 
     
     
         4 . The delivery system of  claim 1  wherein the cinching member is axially movable relative to the capsule. 
     
     
         5 . The delivery system of  claim 1 , further comprising the prosthetic heart valve device, wherein the prosthetic heart valve device includes a plurality of arms permanently attached to an end portion of the prosthetic heart valve device, and wherein the plurality of arms are attached to the engagement feature. 
     
     
         6 . The delivery system of  claim 5  wherein the engagement feature is a loop through which the tether element is threaded. 
     
     
         7 . The delivery system of  claim 5  wherein the plurality of arms comprises wires or cables. 
     
     
         8 . The delivery system of  claim 5 , further comprising a handle assembly at a proximal portion of the elongated catheter body, the handle assembly having an actuator, wherein the second end of the tether element is coupled to the actuator and the actuator is configured to proximally retract the tether element. 
     
     
         9 . The delivery system of  claim 5  wherein the end portion of the prosthetic heart valve device is at the outflow region of the prosthetic heart valve device. 
     
     
         10 . The delivery system of  claim 5  wherein the cinching member is axially movable relative to the capsule. 
     
     
         11 . A method for delivering a prosthetic heart valve device to a native valve of a heart of a human patient, the method comprising:
 positioning a delivery capsule of an elongated catheter body within the heart, the delivery capsule carrying the prosthetic heart valve device, the prosthetic heart valve device including a plurality of arms extending from an end portion thereof, the plurality of arms being attached to an engagement feature;   deploying the prosthetic heart valve device from the delivery capsule to allow the prosthetic heart valve device to radially expand against tissue of the native valve;   retracting, via a handle assembly at a proximal portion of the elongated catheter body, a second end of a tether element, the tether element having a fixed first end at the proximal end of the elongated catheter, the tether element being threaded through a cinching member having a distal end portion disposed at a distal region of the elongated catheter body, through the engagement feature of the prosthetic heart valve device, and extending proximally back to the second end of the tether element, wherein retracting the second end of the tether element resheathes at least a portion of the prosthetic heart valve device; and   repositioning of the prosthetic heart valve device relative to the native valve while the prosthetic heart valve is at least partially sheathed.   
     
     
         12 . The method of  claim 11  wherein retracting the second end of the tether element contracts an outflow portion of the prosthetic heart valve device to a first diameter less than an inner diameter of the delivery capsule. 
     
     
         13 . The method of  claim 11  wherein retracting the second end of the tether element moves at least an outflow portion of the prosthetic heart valve device into the cinching member. 
     
     
         14 . The method of  claim 11  wherein deploying the prosthetic heart valve device comprises fully expanding the prosthetic heart valve device before retracting the tether element to at least partially resheathe the prosthetic heart valve device. 
     
     
         15 . The method of  claim 11  wherein the engagement feature comprises a loop. 
     
     
         16 . The method of  claim 11  wherein the end portion of the prosthetic heart valve device is an outflow portion of the prosthetic heart valve device. 
     
     
         17 . The method of  claim 11 , further comprising releasing the tether element from the prosthetic heart valve device after fully deploying the prosthetic heart valve device. 
     
     
         18 . The method of  claim 17  wherein releasing the tether element comprises severing the fixed first end and threading the tether element through the engagement feature to disengage the tether element from the prosthetic heart valve device. 
     
     
         19 . The method of  claim 11 , wherein the native valve is a native mitral valve.