Actively controllable stent, stent graft, heart valve and method of controlling same

Patent metadata

Field	Value
Publication number	US-10980650-B2
Application number	US-201916359548-A
Country	US
Kind code	B2
Filing date	Mar 20, 2019
Priority date	Oct 21, 2011
Publication date	Apr 20, 2021
Grant date	Apr 20, 2021

Abstract

A delivery apparatus can include a handle portion and at least one rotatable drive shaft. The handle portion has an actuation mechanism. The actuation mechanism includes a motor and one or more actuators. The rotatable drive shaft has a proximal end portion and a distal end portion. The proximal end portion is coupled to the motor, and the distal end portion is configured to be releasably coupled to a prosthetic heart valve. The actuation mechanism is configured to control and monitor expansion of the prosthetic heart valve. The handle is configured for actuating the actuation mechanism, tracking a response of native tissue when the prosthetic heart valve is in contact with the native tissue, and stopping expansion of the prosthetic heart valve once a rate of change of expansion of the prosthetic heart valve declines below a threshold.

First claim

What is claimed is:

1. A delivery apparatus, comprising:
a handle portion comprising an actuation mechanism, wherein the actuation mechanism includes a motor and one or more actuators; and
at least one rotatable drive shaft having a proximal end portion and a distal end portion, wherein the proximal end portion is coupled to the motor, and the distal end portion is configured to be releasably coupled to a prosthetic heart valve,
wherein the actuation mechanism is configured to control and monitor expansion of the prosthetic heart valve, and
wherein the handle portion is configured for actuating the actuation mechanism, tracking a response of native tissue when the prosthetic heart valve is in contact with the native tissue, and stopping expansion of the prosthetic heart valve once a rate of change of expansion of the prosthetic heart valve declines below a threshold.

2. The delivery apparatus of claim 1 , wherein the handle portion is configured for expanding the prosthetic heart valve synchronized with contractions of a native heart to coincide with any particular portion of a sinus rhythm.

3. The delivery apparatus of claim 1 , wherein the handle portion is configured for controlling and monitoring expansion of the prosthetic heart valve by limiting current to the motor.

4. The delivery apparatus of claim 1 , wherein the actuation mechanism is configured to expand the prosthetic heart valve from a fully contracted diameter to a pre-defined diameter and to stop expansion at the pre-defined diameter based on a first actuation by a user.

5. The delivery apparatus of claim 4 , wherein the pre-defined diameter of the prosthetic heart valve is less than a fully expanded diameter of the prosthetic heart valve.

6. The delivery apparatus of claim 5 , wherein the actuation mechanism is configured to expand the prosthetic heart valve from the pre-defined diameter to the fully expanded diameter in increments of less than or equal to 1 mm.

7. The delivery apparatus of claim 5 , wherein the actuation mechanism is configured to contract the prosthetic heart valve from the pre-defined diameter, the fully expanded diameter, or an intermediate diameter between the pre-defined diameter and the fully expanded diameter in decrements of less than or equal to 1 mm.

8. The delivery apparatus of claim 1 , wherein the actuation mechanism further comprises a torque limiting member configured to limit an electrical current of the motor.

9. The delivery apparatus of claim 1 , wherein the actuation mechanism further comprises a clutch mechanism configured to limit torque transmitted to the rotatable drive shaft from the motor.

10. The delivery apparatus of claim 1 , wherein the actuation mechanism further comprises a gear assembly coupled to the motor and the rotatable drive shaft and configured to transfer rotational movement of the motor to the rotatable drive shaft.

11. The delivery apparatus of claim 1 , wherein the handle portion further comprises a display configured to display a diameter of the prosthetic heart valve.

12. The delivery apparatus of claim 11 , wherein the display is configured to display a radial force imparted to native heart valve tissue by the prosthetic heart valve.

13. The delivery apparatus of claim 11 , wherein the displayed diameter of the prosthetic heart valve is a real-time diameter of the prosthetic heart valve.

14. The delivery apparatus of claim 11 , wherein the display is configured to display the diameter of the prosthetic heart valve as a circle that has a diameter that is the same as the diameter of the prosthetic heart valve.

15. The delivery apparatus of claim 1 , wherein the handle portion further comprises electronic control circuitry configured for actuating the actuation mechanism, tracking the response of the native tissue when the prosthetic heart valve is in contact with the native tissue, and stopping expansion of the prosthetic heart valve once the rate of change of expansion of the prosthetic heart valve declines below the threshold.

16. A method for implanting a prosthetic heart valve, comprising:
advancing a prosthetic heart valve into a patient's vasculature with a delivery apparatus;
positioning the prosthetic heart valve at an implantation location;
expanding the prosthetic heart valve from a contracted state to an expanded state with the delivery apparatus;
tracking a response of native tissue at the implantation location when the prosthetic heart valve is in contact with the native tissue; and
stopping expansion of the prosthetic heart valve once a rate of change of expansion of the prosthetic heart valve declines below a threshold.

17. The method of claim 16 , further comprising tracking a radial force imparted to the native tissue by the prosthetic heart valve on a display during the act of expanding the prosthetic heart valve and during the act of tracking a response of the native tissue.

18. The method of claim 16 , further comprising tracking a diameter of the prosthetic heart valve on a display of the delivery apparatus.

19. A method for implanting a prosthetic heart valve, comprising:
advancing a prosthetic heart valve in a contracted state into a patient's vasculature with a delivery apparatus;
positioning the prosthetic heart valve in a native heart valve;
setting a first radial force with the delivery apparatus, the first radial force limiting a radial force the delivery apparatus and the prosthetic heart valve apply to native tissue adjacent to the prosthetic heart valve;
expanding the prosthetic heart valve from the contracted state with the delivery apparatus;
monitoring a response of the native tissue adjacent to the prosthetic heart valve when the prosthetic heart valve is expanding from the contracted state;
stopping expansion of the prosthetic heart valve at a first expanded state once a rate of change of expansion of the prosthetic heart valve declines below a threshold;
determining whether paravalvular leak exists around the prosthetic heart valve;
setting a second radial force with the delivery apparatus, the second radial force being greater than the first radial force and limiting a radial force the delivery apparatus and the prosthetic heart valve apply to the native tissue adjacent to the prosthetic heart valve;
expanding the prosthetic heart valve from the first expanded state with the delivery apparatus;
monitoring a response of native tissue adjacent to the prosthetic heart valve when the prosthetic heart valve is expanding from the first expanded state; and
stopping expansion of the prosthetic heart valve at a second expanded state once a rate of change of expansion of the prosthetic heart valve declines below the threshold.

20. The method of claim 19 , further comprising displaying the first radial force and the second radial force on a display of the delivery apparatus.

Assignees

• Edwards Lifesciences Cardiaq Llc

Inventors

• Cartledge Richard George
• Smith Kevin W
• Bales Jr Thomas O
• Deville Derek Dee
• Kline Korey
• Mendez Max Pierre
• Palmer Matthew A
• Kirk Michael Walter
• Rivera Carlos
• Petersen Eric
• Mcbrayer M Sean

Classifications

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2250/0065

  telescopic · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2250/0007

  for adjusting length · CPC title

• A61F2002/825

  having longitudinal struts · CPC title