Hydraulic systems for delivering prosthetic heart valve devices and associated methods

• US 10,575,950 B2
• Filed: 04/18/2017
• Issued: 03/03/2020
• Est. Priority Date: 04/18/2017
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: McLean, Matthew
• Primary Examiner(s): Schwiker, Katherine H
• Application Number:
  US15/490,008
• Publication Number:
  US 20180296325A1
• Time in Patent Office: 1,050 Days
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means

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.

Claims

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, wherein the housing and the platform define boundaries of a first chamber and a second chamber; and

a manifold at a proximal end region of the elongated catheter body and configured to receive fluid for delivery to at least one of the first 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,

wherein at least a portion of the delivery capsule is urged proximally towards the deployment configuration when fluid is at least partially drained from the first chamber while fluid is delivered into the second chamber, and

wherein at least a portion of the delivery capsule is urged distally 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 wherein the first and second valves are three-way valves.

3. The system of claim 1 wherein the manifold is configured to be external to the patient during an implantation procedure.

4. The system of claim 1 wherein the first fluid lumen is fluidly isolated from the second fluid lumen.

5. 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.

6. 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 delivery capsule transitions between the containment configuration and the deployment configuration.

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

8. The system of claim 7 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.

9. 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 more attachment elements comprise pockets configured to mate with corresponding attachment features of the prosthetic heart valve device.

10. The system of claim 9 wherein the attachment features comprise eyelet shaped projections configured to releasably engage corresponding pockets at the distal end region of the engagement shaft.

11. The system of claim 9 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.