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

Patent metadata

Field	Value
Publication number	US-11389295-B2
Application number	US-201916584461-A
Country	US
Kind code	B2
Filing date	Sep 26, 2019
Priority date	Apr 18, 2017
Publication date	Jul 19, 2022
Grant date	Jul 19, 2022

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.

First claim

I claim:

1. A method comprising:
positioning a delivery capsule of an elongated catheter body within a heart, the delivery capsule carrying a prosthetic heart valve device;
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 mitral valve;
extending a distal portion of a cinching member beyond a distal end of the delivery capsule;
extending a distal platform slidably disposed within the cinching member beyond a distal end of the cinching member;
retracting, via a handle assembly at a proximal portion of the elongated catheter body, a plurality of tether elements coupled to the prosthetic heart valve device, wherein the tether elements extend through the cinching member, and wherein retracting the tether elements at least partially contracts the prosthetic heart valve device to resheathe at least a portion of the prosthetic heart valve device; and
repositioning the prosthetic heart valve device relative to the native mitral valve while the prosthetic heart valve device is at least partially sheathed.

2. The method of claim 1 , wherein retracting the plurality of tether elements contracts a ventricular portion of the prosthetic heart valve device to a diameter less than an inner diameter of the delivery capsule.

3. The method of claim 1 , wherein retracting the plurality of tether elements moves at least a ventricular portion of the prosthetic heart valve device into the distal portion of the cinching member.

4. The method of claim 1 , wherein deploying the prosthetic heart valve device comprises fully expanding the prosthetic heart valve device before retracting the tether elements to at least partially resheathe the prosthetic heart valve device.

5. The method of claim 1 , wherein:
deploying the prosthetic heart valve device from the delivery capsule comprises distally sliding the distal platform in the delivery capsule; and
retracting the plurality of tether elements allows a ventricular end portion of the prosthetic heart valve device to wrap at least partially around the distal platform.

6. The method of claim 5 , wherein the plurality of tether elements extend through eyelets on the platform and are removably coupled to corresponding engagement features of the prosthetic heart valve.

7. The delivery system of claim 5 , wherein the platform and the cinching member are fixed relative to the handle assembly at the proximal portion of the elongated catheter body.

8. The method of claim 1 , further comprising:
fully deploying the prosthetic heart valve device after repositioning the prosthetic heart valve device; and
releasing the tether elements from the prosthetic heart valve device after fully deploying the prosthetic heart valve device.

9. The method of claim 1 , wherein retracting the plurality of tether elements comprises rotating an actuator at the handle assembly.

10. The method of claim 1 , further comprising manipulating an actuator of the handle assembly to pull and relax the plurality of tether elements.

11. The method of claim 1 , wherein a tethering assembly is fixedly attached to the prosthetic heart valve device, wherein the tethering assembly comprises a plurality of arm members extending from a ventricular end portion of the prosthetic heart valve device and an engagement feature coupled to the arm members, and wherein the engagement feature is releasably attached to the tether element.

12. The method of claim 1 , wherein the plurality of tether elements are configured to be removably coupled to hook elements on a ventricular end of the prosthetic heart valve device.

13. The method of claim 1 , wherein each tether element of the plurality of tether elements is configured to extend through a first loop and a second loop on a ventricular end of the prosthetic heart valve device, and wherein the first and second loops are spaced circumferentially apart from each other on the ventricular end of the prosthetic heart valve device.

14. The method of claim 1 , wherein each tether element has a first end and a second end, wherein the first end is fixed and the second end is coupled to the actuator.

15. The method of claim 1 , wherein a push rod extends through the elongated catheter body, and wherein the push rod comprises a distal end portion coupled to the cinching member.

16. The method of claim 15 , wherein the distal end portion of the push rod comprises a plurality of loops, and wherein the plurality of tether elements extend through the loops and through the push rod.

Assignees

• Twelve Inc

Inventors

• Mclean Matthew

Classifications

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2250/0069

  Sealing means · CPC title

• A61F2002/9534

  for repositioning of stents · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title