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

• US 10,238,514 B2
• Filed: 10/25/2017
• Issued: 03/26/2019
• Est. Priority Date: 10/21/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• 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
• Primary Examiner(s): Yabut, Diane
• Application Number:
  US15/793,867
• Publication Number:
  US 20180104077A1
• Time in Patent Office: 517 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• CPC Class Codes: A61F 2250/0008 : for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0065 : telescopic

Abstract

A delivery apparatus comprises a handle portion and at least one rotatable drive shaft. The handle portion has an actuation mechanism and a display. 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, and the display is configured to display a diameter of the prosthetic heart valve.

Claims

1. A delivery apparatus, comprising:

a handle portion having an actuation mechanism and a display, 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 display is configured to display a 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.

2. The delivery apparatus of claim 1, wherein the display is configured to display a radial force imparted to native heart valve tissue by the prosthetic heart valve.

3. The delivery apparatus of claim 1, wherein the display is a digital display.

4. The delivery apparatus of claim 1, wherein the displayed diameter of the prosthetic heart valve is a real-time diameter of the prosthetic heart valve.

5. 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.

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

7. The delivery apparatus of claim 6, wherein the pre-defined diameter is less than 20 mm, and the fully expanded diameter is greater than or equal to 23 mm.

8. 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.

9. 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.

10. 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.

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

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

13. 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; and

displaying a diameter of the prosthetic heart valve on a display during the act of expanding;

displaying a radial force imparted to native heart valve tissue by the prosthetic heart valve on the display during the act of expanding; and

providing a warning when the radial force is less than a force necessary to prevent embolization of the prosthetic heart valve.

14. The method of claim 13, wherein the display is located on a handle of the delivery apparatus.

15. The method of claim 13, wherein the display is disposed on a display device separate from a handle of the delivery apparatus.

16. The method of claim 15, wherein the display device is coupled to the delivery apparatus with a cord.

17. The method of claim 15, wherein the display device wirelessly communicates with the delivery apparatus.

18. The method of claim 13, wherein the displayed diameter of the prosthetic heart valve is a real-time diameter of the prosthetic heart valve.

19. The method of claim 13, further comprising contracting the prosthetic heart valve with the delivery apparatus.

20. The method of claim 13, wherein the act of expanding the prosthetic heart valve comprises:

expanding the prosthetic heart valve from a first diameter to a second diameter with the delivery apparatus;

stopping expansion of the prosthetic heart valve at the second diameter with the delivery apparatus;

expanding the prosthetic heart valve from the second diameter to a third diameter with the delivery apparatus; and

stopping expansion of the prosthetic heart valve at the third diameter with the delivery apparatus.

21. The method of claim 20, wherein act of displaying the diameter of the prosthetic heart valve includes displaying the first diameter, the second diameter, and the third diameter.

22. The method of claim 13, wherein the act of expanding comprises synchronizing expansion of the prosthetic heart valve with the native heart'"'"'s contractions.

23. A delivery apparatus, comprising:

a handle portion having 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 includes electronic control circuitry configured to expand the prosthetic heart valve from a fully contracted diameter to a pre-defined diameter and to automatically stop expansion at the pre-defined diameter based on a first actuation by a user.

24. The delivery apparatus of claim 23, wherein the pre-defined diameter is more than 1 mm larger than the fully contracted diameter, wherein the first actuation is a first press of a first actuator of the one or more actuators, and wherein the electronic control circuitry of the actuation mechanism is configured such that each additional press of the first actuator results in the prosthetic heart valve expanding from the pre-defined diameter to the fully expanded diameter in increments of less than or equal to 1 mm.

25. The delivery apparatus of claim 23, wherein the handle portion further comprises a display, wherein the display is configured to display a diameter of the prosthetic heart valve during an implantation procedure and to display a radial force imparted to native heart valve tissue by the prosthetic heart valve.