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

Patent metadata

Field	Value
Publication number	US-10874508-B2
Application number	US-201715822985-A
Country	US
Kind code	B2
Filing date	Nov 27, 2017
Priority date	Oct 21, 2011
Publication date	Dec 29, 2020
Grant date	Dec 29, 2020

Abstract

An assembly includes a prosthetic heart valve and a delivery apparatus. The prosthetic heart valve has a plurality of pivotably connected struts and one or more adjustable elements rotatably coupled to the struts. Rotating the adjustable elements in a first direction relative to the struts radially expands the prosthetic heart valve. Rotating the adjustable elements in a second direction relative to the struts radially contracts the prosthetic heart valve. The delivery apparatus includes one or more motors, one or more drive wires coupled to the motors, and a memory. The drive wires are coupled to the adjustable elements of the prosthetic heart valve. The motors are configured to rotate the drive wires and the adjustable elements to expand and contract the prosthetic heart valve. The memory is configured for storing one or more characteristics of the motors, the drive wires, or the prosthetic heart valve.

First claim

The invention claimed is:

1. An assembly, comprising:
a prosthetic heart valve having a plurality of pivotably connected struts and one or more drive screws rotatably coupled to the struts, wherein rotating the one or more drive screws in a first direction relative to the struts radially expands the prosthetic heart valve, and wherein rotating the one or more drive screws in a second direction relative to the struts radially contracts the prosthetic heart valve; and
a delivery apparatus including one or more motors, one or more drive wires coupled to the one or more motors, and a memory, wherein the one or more drive wires are coupled to the one or more drive screws of the prosthetic heart valve, wherein the one or more motors are configured to rotate the one or more drive wires and the one or more drive screws to expand and contract the prosthetic heart valve, wherein the memory is configured for storing one or more characteristics of the one or more motors, the one or more drive wires, or the prosthetic heart valve, wherein the one or more characteristics stored in the memory of the delivery apparatus include first characteristics corresponding to expanding the prosthetic heart valve outside a patient's body, and wherein the delivery apparatus is further configured to display second characteristics corresponding to expanding the prosthetic heart valve inside the patient's body and to compare the second characteristics to the first characteristics.

2. The assembly of claim 1 , wherein the one or more characteristics include a current drawn by the one or more motors.

3. The assembly of claim 1 , wherein the one or more characteristics are functions of time.

4. The assembly of claim 1 , wherein the one or more characteristics include a diameter of the prosthetic heart valve.

5. The assembly of claim 1 , wherein the one or more characteristics include a torque of the prosthetic heart valve.

6. The assembly of claim 1 , wherein the one or more characteristics include a force.

7. The assembly of claim 1 , wherein the first and second characteristics include an outward radial force imposed by the prosthetic heart valve.

8. The assembly of claim 7 , wherein the outward radial force includes a first outward radial force corresponding to the first characteristics and a second outward radial force corresponding to the second characteristics, wherein the delivery apparatus is configured to determine a deviation of the second outward radial force from the first outward radial force and to display a diameter of the patient's native annulus based on the determined deviation.

9. The assembly of claim 1 , wherein the second characteristics include an expansion velocity of the prosthetic heart valve.

10. The assembly of claim 1 , wherein the second characteristics include a diameter of the prosthetic heart valve, an outward radial force imposed by the prosthetic heart valve, and an expansion velocity of the prosthetic heart valve.

11. The assembly of claim 1 , wherein the first characteristics include average values measured by one or more other delivery apparatuses during expansion of other prosthetic heart valves.

12. The assembly of claim 11 , wherein the second characteristics are measured dynamically during expansion of the prosthetic heart valve inside the patient's body.

13. The assembly of claim 1 , wherein the delivery apparatus includes a handle, and the memory is disposed in the handle.

14. The assembly of claim 13 , wherein the handle includes one or more actuators configured for actuating the one or more motors.

15. An assembly, comprising:
a prosthetic heart valve comprising a radially expandable and compressible annular frame that is expandable from a radially compressed state to a radially expanded state; and
a delivery apparatus including one or more actuators operatively coupled to the frame and configured to expand the frame from the radially compressed state to the radially expanded state,
wherein the delivery apparatus is configured such that, as the prosthetic valve is radially expanded within a native annulus of a patient's heart, the delivery apparatus measures a characteristic of the one or more actuators corresponding to force being applied to the prosthetic valve and compares the measured characteristic to a predetermined characteristic curve corresponding to force required to expand the prosthetic valve from a first diameter to a second diameter in an unloaded state outside of the patient's body, and the delivery apparatus provides feedback to a user when the measured characteristic deviates from the predetermined characteristic curve to indicate that the prosthetic valve is in contact with the native annulus.

16. The assembly of claim 15 , wherein the measured characteristic of the one or more actuators is current drawn by the one or more actuators.

17. The assembly of claim 15 , wherein the measured characteristic of the one or more actuators is torque of the one or more actuators.

18. The assembly of claim 15 , wherein the delivery apparatus comprises a memory for storing the predetermined characteristic curve.

19. The assembly of claim 15 , wherein the delivery apparatus is configured to stop expansion of the frame when the measured characteristic deviates from the predetermined characteristic curve.

20. The assembly of claim 15 , further comprising a visual display for displaying the measured characteristic.

21. The assembly of claim 15 , wherein the one or more actuators comprise one or more drive wires that are configured to rotate respective one or more drive screws on the frame of the prosthetic heart valve.

22. The assembly of claim 15 , wherein the delivery apparatus comprises a visual display and the feedback comprises a visual indication on the visual display when the prosthetic valve contacts the native annulus.

23. The assembly of claim 22 , wherein the delivery apparatus displays the diameter of the prosthetic valve on the visual display as it is being expanded.

24. The assembly of claim 15 , wherein the delivery apparatus dynamically measures the characteristic of the one or more actuators corresponding to the force being applied to the prosthetic valve.

Assignees

• Edwards Lifesciences Cardiaq Llc

Inventors

• Cartledge Richard
• 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 Sean

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2250/006

  modular · CPC title

• A61F2250/001

  for adjusting a diameter · CPC title

• A61F2002/9534

  for repositioning of stents · CPC title