IP Library › Granted Patent US 12,201,523
Granted Patent B2
US 12,201,523 · App. 18/351,728 · Granted Jan 21, 2025

Hydraulic systems for delivering prosthetic heart valve devices and associated methods

Inventor: Matthew McLean (San Francisco, CA)
Assignee: Twelve, Inc.
A61F2/243A61F2/2433A61F2/2436A61F2/9517A61F2002/9534A61F2002/9665
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Quick Facts
Patent No.
US 12,201,523
App. No.
18/351,728
Granted
Jan 21, 2025
Kind
B2
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 (28)

1. A system for delivering a prosthetic heart valve device into a heart of a patient, the system comprising:

an elongated catheter body;

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;

a first chamber at least partially defined by a first surface of a platform and a housing of the capsule;

a second chamber at least partially defined by the housing of the capsule and a second surface of the platform opposite the first surface, the first chamber and the second chamber configured to receive and drain fluid; 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 in the containment configuration the first chamber is at least partially filled with fluid and the second chamber is at least partially drained of fluid, and wherein in the deployment configuration the second chamber is at least partially filled with fluid and the first chamber is at least partially drained of fluid.

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 , further comprising a biasing device positioned along the elongated catheter body and configured to urge the delivery capsule towards the containment configuration.

7. The system of claim 6 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.

8. The system of claim 1 wherein the delivery capsule is configured to move distally towards the deployment configuration.

9. The system of claim 1 wherein the delivery capsule is configured to move proximally towards the deployment configuration.

10. The system of claim 1 , further comprising:

an engagement device coupled to a portion of the prosthetic heart valve device, wherein in the deployment configuration the portion of the prosthetic heart valve device is disposed within the capsule such that the prosthetic heart valve device is partially deployed, wherein in a fully deployed configuration, the engagement device is advanced such that the portion of the prosthetic heart valve device is not disposed within the capsule.

11. The system of claim 10 , wherein the engagement device includes shaped recesses configured to receive shaped attachment features of the prosthetic heart valve device.

12. 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; and

delivering fluid from a first fluid lumen of a manifold to a first chamber at least partially defined by a first surface of a platform and a housing of the capsule and simultaneously draining fluid from a second chamber at least partially defined by the housing of the capsule and a second surface of the platform opposite the first surface into a second fluid lumen of the manifold to move the delivery capsule from a containment configuration with the prosthetic heart valve device disposed within the delivery capsule towards a deployment configuration with the prosthetic heart valve device at least partially released from the delivery capsule.

13. The method of claim 12 , further comprising: delivering fluid from the second fluid lumen of the manifold to the second chamber and draining fluid from the first chamber into the first fluid lumen of the manifold to move the delivery capsule from the deployment configuration towards the containment configuration to resheathe at least a portion of the prosthetic heart valve device within the delivery capsule.

14. The method of claim 12 wherein moving the delivery capsule towards the deployment configuration comprises moving the delivery capsule distally.

15. The method of claim 12 wherein moving the delivery capsule towards the deployment configuration comprises moving the delivery capsule proximally.

16. The method of claim 12 , further comprising:

with the capsule in the deployment configuration and the prosthetic heart valve device partially expanded, advancing an engagement device coupled to the prosthetic heart valve device to fully deploy the prosthetic heart valve device.

17. The method of claim 16 , wherein with the capsule in the deployment configuration, the engagement device and a portion of the prosthetic heart valve device coupled to the engagement device are disposed within the capsule, and wherein advancing the engagement device releases the portion of the prosthetic heart valve device from the capsule to fully deploy the prosthetic heart valve device.

18. The method of claim 16 , wherein the engagement device is coupled to a shaft, wherein advancing the engagement device comprises advancing the shaft.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2023
From: MCLEAN, MATTHEW
To: TWELVE, INC.
Reel/Frame 064243/0549 →
Continuity (3)
Continuation 16752137 · Jan 24, 2020
Division 15490008 · Apr 18, 2017
Related Publication 20230346553A1 · Nov 2, 2023
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