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

Patent metadata

Field	Value
Publication number	US-9827093-B2
Application number	US-201414278594-A
Country	US
Kind code	B2
Filing date	May 15, 2014
Priority date	Oct 21, 2011
Publication date	Nov 28, 2017
Grant date	Nov 28, 2017

Abstract

A method for implanting a stent includes contracting a self-expanding/forcibly-expanding stent of a shape-memory material set to a given shape to a reduced implantation size with a delivery system having drive wires. The stent has a selectively adjustable assembly with adjustable elements operatively connected to the drive wires such that, when the adjustable elements are adjusted by the drive wires, a configuration change in at least a portion of the self-expanding stent occurs. The contracted stent is inserted into a native annulus in which the stent is to be implanted. The drive wires are rotated with the delivery system to forcibly expand the stent into the native annulus. While rotating the drive wires, a torque applied to the drive wires is determined with the delivery system. Rotation of the drive wires is stopped based upon a value of the determined torque.

First claim

What is claimed is:

1. A method for implanting a stent, which comprises:
contracting a stent to a reduced implantation size with a delivery system having drive wires, the stent having a selectively adjustable assembly with adjustable elements operatively connected to the drive wires such that, when the adjustable elements are adjusted by the drive wires, a configuration change in at least a portion of the stent occurs;
inserting the contracted stent into a native annulus in which the stent is to be implanted;
rotating the drive wires with the delivery system to forcibly expand the stent;
while rotating the drive wires, determining with the delivery system a torque applied to the drive wires;
stopping rotation of the drive wires based upon a value of the determined torque when the stent contacts the native annulus and has a first diameter; and
after the stent contacts the native annulus, repeatedly rotating and stopping rotation of the drive wires to incrementally expand the stent from the first diameter to a second, final diameter.

2. The method according to claim 1 , which further comprises providing a user with a dynamic value of the torque and permitting the user to change the expansion and contraction of the stent.

3. The method according to claim 2 , which further comprises disconnecting the stent from the delivery system to implant the stent in the native annulus.

4. The method according to claim 1 , which further comprises disconnecting the stent from the delivery system to implant the stent in the native annulus.

5. The method according to claim 1 , wherein the delivery system has at least one drive wire motor connected to the drive wires for rotating the drive wires and wherein the act of stopping includes:
measuring a current required to drive the at least one drive wire motor; and
stopping the at least one drive wire motor and thereby the rotation of the drive wires based upon a value of the current.

6. The method according to claim 5 , which further comprises:
calculating an outward radial force imposed by the expanding stent lattice on the native annulus with the value of the current; and
stopping the at least one drive wire motor and thereby the rotation of the drive wires based upon a value of the calculated outward radial force.

7. The method according to claim 1 , wherein the delivery system has at least one drive wire motor connected to the drive wires for rotating the drive wires and wherein the act of stopping includes:
determining an outward radial force imposed by the expanding stent lattice based upon a current required to drive the at least one drive wire motor; and
stopping the at least one drive wire motor and thereby the rotation of the drive wires based upon a value of the calculated outward radial force.

8. The method according to claim 1 , wherein stopping the rotation of the drive wires as the stent incrementally expands from the first diameter to the second diameter allows the stent to contract to a plurality of intermediate diameters between the first diameter and the second diameter due to force of the native annulus pressing against the stent.

9. The method according to claim 1 , wherein repeatedly rotating and stopping rotation of the drive wires includes:
rotating the drive wires such that the stent expands from the first diameter to a third diameter which is less than the second diameter; and
stopping rotation of the drive wires after the stent has the third diameter, whereupon the stent contracts from the third diameter to a fourth diameter which is less than the second diameter and the third diameter and greater than the first diameter due to force of the native annulus pressing against the stent.

10. The method according to claim 9 , wherein repeatedly rotating and stopping rotation of the drive wires includes:
rotating the drive wires such that the stent expands from the fourth diameter to a fifth diameter which is less than the second diameter and greater than the third diameter; and
stopping rotation of the drive wires after the stent has the fifth diameter, whereupon the stent contracts from the fifth diameter to a sixth diameter which is less than the second diameter and the fifth diameter and greater than the fourth diameter due to force of the native annulus pressing against the stent.

11. A method for implanting a stent, which comprises:
contracting a stent to a reduced implantation size with a delivery system having drive wires, the stent having a selectively adjustable assembly with adjustable elements operatively connected to the drive wires such that, when the adjustable elements are adjusted by the drive wires, a configuration change in at least a portion of the stent occurs;
inserting the contracted stent into a native annulus in which the stent is to be implanted;
rotating the drive wires with the delivery system to forcibly expand the stent;
while rotating the drive wires, determining with the delivery system a torque applied to the drive wires;
stopping rotation of the drive wires based upon a first value of the determined torque when the stent contacts the native annulus; and
repeatedly rotating and stopping rotation of the drive wires based upon a second of value of the determined torque greater than the first value to incrementally expand the stent after the stent initially contacts the native annulus.

12. The method according to claim 11 , which further comprises providing a user with a dynamic value of the torque and permitting the user to change the expansion and contraction of the stent.

13. The method according to claim 12 , which further comprises disconnecting the stent from the delivery system to implant the stent in the native annulus.

14. The method according to claim 11 , which further comprises disconnecting the stent from the delivery system to implant the stent in the native annulus.

15. The method according to claim 11 , wherein the delivery system has at least one drive wire motor connected to the drive wires for rotating the drive wires and wherein the act of stopping includes:
measuring a current required to drive the at least one drive wire motor; and
stopping the at least one drive wire motor and thereby the rotation of the drive wires based upon a value of the current.

16. The method according to claim 15 , which further comprises:
calculating an outward radial force imposed by the expanding stent lattice on the native annulus with the value of the current; and
stopping the at least one drive wire motor and thereby the rotation of the drive wires based upon a value of the calculated outward radial force.

17. The method according to claim 11 , wherein the delivery system has at least one drive wire motor connected to the drive wires for rotating the drive wires, and wherein the act of stopping includes:
determining an outward radial force imposed by the expanding stent lattice based upon a current required to drive the at least one drive wire motor; and
stopping the at least one drive wire motor and thereby the rotation of the drive wires based upon a value of the calculated outward radial force.

18. A method for implanting a stent, which comprises:
contracting a stent to a reduced implantation size with a delivery system having drive wires, the stent having a selectively adjustable assembly with adjustable elements operatively connected to the drive wires such that, when the adjustable elements are adjusted by the drive wires, a configuration change in at least a portion of the stent occurs;
inserting the contracted stent into a native an

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

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2250/0007

  for adjusting length · CPC title

• A61F2/95

  Instruments specially adapted for placement or removal of stents or stent-grafts · CPC title

• A61F2/844

  folded prior to deployment · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title