Hydraulic systems for delivering prosthetic heart valve devices and associated methods

Patent metadata

Field	Value
Publication number	US-2018296325-A1
Application number	US-201715490008-A
Country	US
Kind code	A1
Filing date	Apr 18, 2017
Priority date	Apr 18, 2017
Publication date	Oct 18, 2018
Grant date	—

Abstract

Systems for delivering 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 delivery capsule carried by the elongated catheter body, and two fluid chambers within the delivery capsule. The delivery capsule can be hydraulically driven 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. For example, the delivery capsule can be urged towards the deployment configuration when fluid is removed from the first chamber and fluid is delivered into the second chamber, whereas the delivery capsule can be urged towards the containment configuration to resheathe the prosthetic heart valve device when fluid is removed from the second chamber and delivered into the first chamber.

First claim

I/We claim:

1 . A system for delivering a prosthetic heart valve device into a heart of a patient, the system comprising:
an elongated catheter body; and a delivery capsule carried by the elongated catheter body and configured to be hydraulically driven 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, wherein the delivery capsule includes a housing and a platform, and wherein
the housing and the platform define, at least in part, a first chamber and a second chamber,
at least a portion of the delivery capsule is urged towards the deployment configuration when fluid is at least partially drained from the first chamber while fluid is delivered into the second chamber, and
at least a portion of the delivery capsule is urged towards the containment configuration to resheathe at least a portion of the prosthetic heart valve device when fluid is at least partially drained from the second chamber and delivered into the first chamber.

2 . The system of claim 1 , further comprising a manifold at a proximal end region of the elongated catheter body and configured to receive the fluid for delivery to the first and/or second chambers, wherein the manifold comprises a first fluid lumen and first valve in fluid communication with the first chamber, and a second fluid lumen and a second valve in fluid communication with the second chamber.

3 . The system of claim 2 wherein the first and second valves are three-way valves.

4 . The system of claim 2 wherein the manifold is configured to be external to the patient during a implantation procedure.

5 . The system of claim 2 wherein the first fluid lumen is fluidly isolated from the second fluid lumen.

6 . The system of claim 1 wherein the delivery capsule is configured to axially restrain the prosthetic heart valve device while a first portion of the prosthetic heart valve device is deployed from the delivery capsule and to release an axially restrained portion of the prosthetic heart valve device while the first portion of the prosthetic heart valve device contacts tissue of a native valve of the heart of the patient.

7 . The system of claim 1 wherein the delivery capsule is configured to substantially prevent translation of the prosthetic heart valve device relative to the elongated catheter body while the prosthetic heart valve device moves between the containment configuration and the deployment configuration.

8 . The system of claim 1 , further comprising a biasing device positioned along the catheter body and configured to urge the delivery capsule towards the containment configuration.

9 . The system of claim 8 wherein the biasing device comprises a spring positioned to be compressed as the delivery capsule moves towards the deployment configuration to deploy the prosthetic heart valve device when fluid is transferred to the first chamber.

10 . The system of claim 1 , further comprising an engagement shaft extending through at least a portion of the elongated catheter body, wherein a distal end region of the engagement shaft is releasably coupled to the prosthetic heart valve device via one or more attachment elements, and wherein the one or attachment elements comprise pockets configured to mate with corresponding attachment features of the prosthetic heart valve device.

11 . The system of claim 10 wherein the attachment features comprise eyelet shaped projections configured to releasably engage corresponding pockets at the distal end region of the engagement shaft.

12 . The system of claim 10 wherein the attachment features comprise T-shaped projections configured to releasably mate with corresponding T-shaped pockets at the distal end region of the engagement shaft.

13 . A system for delivering a prosthetic heart valve device for implantation at a native heart valve of a patient, the system comprising:
an elongated catheter body; a delivery capsule coupled to the elongated catheter body and configured to contain the prosthetic heart valve device, wherein
the delivery capsule is configured to be hydraulically driven between a containment configuration for holding the prosthetic heart valve device and a deployment configuration for deploying at least a portion of the prosthetic heart valve device,
the delivery capsule includes a housing and a platform that define, at least in part, a deployment chamber; and
an expandable member coupled to the elongated catheter body and distal to the delivery capsule, wherein the expandable member is configured to urge the delivery capsule towards the containment configuration and resheathe at least a portion of the prosthetic heart valve device when fluid is at least partially drained from the deployment chamber while fluid is delivered to the expandable member.

14 . The system of claim 13 wherein the delivery capsule is configured to substantially prevent translation of the prosthetic heart valve device relative to the elongated catheter body while the prosthetic heart valve device is at least partially resheathed.

15 . The system of claim 13 wherein the delivery capsule further comprises a containment chamber configured to contain the prosthetic heart valve device, and wherein the containment chamber is fluidically sealed from the deployment chamber via the platform.

16 . The system of claim 13 wherein the expandable member is a balloon.

17 . A method for delivering a prosthetic heart valve device to a native mitral 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; delivering fluid to a first chamber within the delivery capsule to move the prosthetic heart valve device from a containment configuration within the delivery capsule to a deployment configuration, wherein the first chamber is proximal to the prosthetic heart valve device; while fluid is delivered to the first chamber, draining fluid from a second chamber within the delivery capsule, wherein the second chamber is proximal to the prosthetic heart valve device; and allowing the prosthetic heart valve device to radially expand to engage tissue of the native mitral valve when the delivery capsule moves from the containment configuration towards the deployment configuration.

18 . The method of claim 17 , further comprising:
urging the delivery capsule toward the containment configuration to resheathe the prosthetic heart valve device after allowing the prosthetic heart valve device to at least partially radially expand, wherein urging the delivery capsule toward the containment configuration comprises
draining fluid from the first chamber; and
while draining fluid from the first chamber, delivering fluid to the second chamber.

19 . The method of claim 17 wherein:
delivering fluid to the first chamber comprises delivering fluid from a manifold at a proximal portion of the elongated catheter body via a first fluid lumen; and
draining fluid from the second chamber comprises removing fluid via a second fluid lumen to the manifold.

20 . The method of claim 17 wherein delivering fluid to the first chamber and draining fluid from the second chamber at least substantially prevents translation of the prosethetic heart valve device relative to the elongated catheter body while the prosthetic heart valve device moves from the containment configur

Assignees

• Twelve Inc

Inventors

• Mclean Matthew

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2002/9665

  with additional retaining means · CPC title

• A61F2002/9534

  for repositioning of stents · CPC title

• A61F2/243 Primary

  Deployment by mechanical expansion · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title