Actively Controllable Stent, Stent Graft, Heart Valve and Method of Controlling Same

• US 20140296962A1
• Filed: 05/15/2014
• Published: 10/02/2014
• Est. Priority Date: 10/21/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Syntheon Cardiology, LLC
• Inventors: Cartledge, Richard, Smith, Kevin W., Bales, Thomas O. Jr., Deville, Derek Dee, Kline, Korey, Mendez, Max Pierre, Palmer, Matthew A., Kirk, Michael Walter, Rivera, Carlos, Petersen, Eric, McBrayer, Sean
• Granted Patent: US 9,827,093 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• 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 2002/9665 with additional retaining means
• 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 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• 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
• CPC Class Codes: A61F 2250/0069 : Sealing means

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.

Claims

1. A method for implanting a stent, which comprises:

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 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 self-expanding 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 into the native annulus;

while rotating the drive wires, determining with the delivery system a torque applied to the drive wires; and

stopping rotation of the drive wires based upon a value of the determined torque.

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 which further comprises carrying out the stopping step by:

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 which further comprises carrying out the stopping step by:

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 a value of the calculated outward radial force.

8. 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 into the native annulus;

while rotating the drive wires, determining with the delivery system a torque applied to the drive wires; and

stopping rotation of the drive wires based upon a value of the determined torque.

9. The method according to claim 8, 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.

10. The method according to claim 9, which further comprises disconnecting the stent from the delivery system to implant the stent in the native annulus.

11. The method according to claim 8, which further comprises disconnecting the stent from the delivery system to implant the stent in the native annulus.

12. The method according to claim 8, wherein the delivery system has at least one drive wire motor connected to the drive wires for rotating the drive wires and which further comprises carrying out the stopping step by:

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.

13. The method according to claim 12, 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.

14. The method according to claim 8, wherein the delivery system has at least one drive wire motor connected to the drive wires for rotating the drive wires and which further comprises carrying out the stopping step by:

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 a value of the calculated outward radial force.

15. 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;

moving the drive wires with the delivery system to forcibly expand the stent into the native annulus;

while moving the drive wires, determining with the delivery system a torque applied to the drive wires; and

stopping movement of the drive wires based upon a value of the determined torque.

16. The method according to claim 15, wherein the moving step comprises rotating the drive wires to forcibly expand the stent into the native annulus.

17. The method according to claim 15, 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.

18. The method according to claim 17, which further comprises disconnecting the stent from the delivery system to implant the stent in the native annulus.

19. The method according to claim 15, which further comprises disconnecting the stent from the delivery system to implant the stent in the native annulus.

20. The method according to claim 15, wherein the delivery system has at least one drive wire motor connected to the drive wires for rotating the drive wires and which further comprises carrying out the stopping step by:

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.

21. The method according to claim 20, 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.

22. The method according to claim 15, wherein the delivery system has at least one drive wire motor connected to the drive wires for rotating the drive wires and which further comprises carrying out the stopping step by:

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 a value of the calculated outward radial force.