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

• US 10,433,961 B2
• Filed: 04/18/2017
• Issued: 10/08/2019
• 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): Ulsh, George J
• Application Number:
  US15/490,024
• Publication Number:
  US 20180296339A1
• Time in Patent Office: 903 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0069 Sealing means

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.

Claims

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

an elongated catheter body;

a capsule carried by the elongated catheter body and configured to be moved between (a) a containment configuration for holding the prosthetic heart valve device and (b) a deployment configuration for at least partially deploying the prosthetic heart valve device;

a cinching member slidably disposed within at least a portion of a distal region of the capsule;

a plurality of tether elements extending through the cinching member and the catheter body to a proximal end thereof, wherein the tether elements are configured to be releasably coupled to the prosthetic heart valve; and

a distal platform movably positioned in the capsule, wherein the distal platform is configured to allow the prosthetic heart valve device to at least partially expand out of the capsule, and wherein at least a portion of the distal platform is slidably disposed within the cinching member,

wherein proximal retraction of the tether elements is configured to urge at least a portion of the prosthetic heart valve device toward a distal end portion of the cinching member to resheathe at least the portion of the prosthetic heart valve device and allow repositioning of the prosthetic heart valve device relative to a native valve after a part of the prosthetic heart valve device has contacted tissue of the native valve of the heart of the patient.

2. The delivery system of claim 1, wherein the tether elements are configured to be releasably attached to a ventricular end of the prosthetic heart valve device.

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

4. The delivery system of claim 1, wherein each tether element 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.

5. 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 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, and

wherein the actuator is configured to proximally retract and distally advance the tether elements.

6. The delivery system of claim 1, further comprising a push rod extending through the catheter body and having a distal end portion coupled to the cinching member.

7. The delivery system of claim 6 wherein the distal end portion of the push rod comprises a plurality of loops, and wherein the tether elements extend through the loops and through the push rod.

8. The delivery system of claim 1, wherein the tether elements extend through eyelets on the distal platform and are removably coupled to corresponding engagement features of the prosthetic heart valve.

9. The delivery system of claim 1, wherein the distal platform and the cinching member are fixed relative to a handle assembly at a proximal portion of the catheter body.

10. The delivery system of claim 1 wherein the cinching member is axially movable relative to the capsule.

11. The delivery system of claim 1 wherein the cinching member is independently movable with respect to the elongated catheter body and the capsule.

12. The delivery system of claim 1 wherein the capsule has a first diameter and the cinching member has a second diameter less than the first diameter.

13. 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 configured to pull and relax the tether elements.

14. The delivery system of claim 13 wherein the actuator comprises a rotational actuator mechanism at the handle assembly.

15. The delivery system of claim 1 wherein the plurality of tether elements comprises three tether elements.

16. The delivery system of claim 1 wherein proximal retraction of the tether elements is configured to urge at least a portion of the prosthetic heart valve device into the distal end portion of the cinching member to resheathe at least a portion of the prosthetic heart valve device.

17. A delivery system, comprising:

an elongated catheter body having a distal portion and a proximal portion;

a handle assembly at the proximal portion of the elongated catheter body;

a delivery capsule coupled to the elongated catheter body and configured to be moved between a delivery arrangement for holding a prosthetic heart valve device and a deployment arrangement for at least partially deploying the prosthetic heart valve device into a heart of a human patient, wherein the delivery capsule has a first diameter;

a cinching member slidably disposed within at least a portion of a distal region of the catheter body and the delivery capsule, wherein the cinching member has a second diameter less than the first diameter and is axially movable with respect to the catheter body and the delivery capsule; and

a plurality of tether elements configured to be releasably coupled to the prosthetic heart valve, wherein the tether elements extend from the prosthetic heart valve device through the cinching member and the catheter body to the handle assembly; and

a distal platform movably positioned in the delivery capsule, wherein the distal platform is configured to allow the prosthetic heart valve device to at least partially expand out of the capsule, and wherein at least a portion of the distal platform is slidably disposed within the cinching member,

wherein retraction of the tether elements toward the handle assembly is configured to cause a ventricular end of the prosthetic heart valve device to move from an at least partially deployed arrangement to a contracted arrangement having a third diameter less than the first diameter.

18. The delivery system of claim 17, wherein the tether elements are configured to loop around engagement features at the ventricular end of the prosthetic heart valve device.

19. The delivery system of claim 17, wherein each tether element is configured to extend from the distal end portion of the cinching member and through at least a first engagement feature and a second engagement feature on the ventricular end of the prosthetic heart valve device, and wherein the first and second engagement features are spaced circumferentially apart from each other on the ventricular end of the prosthetic heart valve device.

20. The delivery system of claim 17 wherein the handle assembly includes an actuator operably coupled to the tethers, wherein the actuator is configured to proximally retract and distally advance the tether elements.

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

an elongated catheter body;

a capsule carried by the elongated catheter body and configured to be moved between (a) a containment configuration for holding the prosthetic heart valve device and (b) a deployment configuration for at least partially deploying the prosthetic heart valve device;

a cinching member slidably disposed within at least a portion of a distal region of the capsule;

at least one tether element extending through the cinching member and the catheter body to a proximal end thereof, wherein the tether element is configured to be releasably coupled to the prosthetic heart valve;

a tethering assembly 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, wherein the engagement feature is releasably attached to the tether element; and

a distal platform movably positioned in the capsule, wherein the distal platform is configured to allow the prosthetic heart valve device to at least partially expand out of the capsule, and wherein at least a portion of the distal platform is slidably disposed within the cinching member,

wherein proximal retraction of the at least one tether element is configured to urge at least a portion of the prosthetic heart valve device into a distal end portion of the cinching member to resheathe at least the portion of the prosthetic heart valve device and allow repositioning of the prosthetic heart valve device relative to a native valve after a part of the prosthetic heart valve device has contacted tissue of the native valve of the heart of the patient.