Device, system and method to affect the mitral valve annulus of a heart

• US 7,351,259 B2
• Filed: 05/10/2004
• Issued: 04/01/2008
• Est. Priority Date: 06/05/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Green, Erik G., Swinford, Gary, Wilkins, Jay N., Clem, William E., Williamson, Cory, Albini, Martin B.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/843,223
• Publication Number:
  US 20050004667A1
• Time in Patent Office: 1,422 Days
• Field of Search: 623 236- 237
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A device for modifying the shape of a mitral valve annulus. In one embodiment, the device includes a connector disposed between first and second anchors, the first and second anchors each adapted to be deployed in a coronary sinus adjacent the mitral valve annulus to anchor the device in the coronary sinus; and an actuation element adapted to receive a proximally or distally directed actuation force from an actuator and to transmit the actuation force to the first and second anchors simultaneously. The invention also includes a system for modifying the shape of a mitral valve annulus, including a percutaneous deployment apparatus, including an actuator; and a percutaneous mitral valve annuloplasty device with a connector disposed between first and second anchors, the first and second anchors each adapted to be deployed in a coronary sinus adjacent the mitral valve annulus to anchor the device in the coronary sinus; and an actuation element adapted to receive a distally proximally directed actuation force from the actuator and to transmit the actuation force to the first and second anchors simultaneously. The invention also includes a method of using such devices and systems.

Claims

1. A device for modifying the shape of a mitral valve annulus comprising:

a connector disposed between first and second anchors, the first and second anchors each adapted to be deployed in a coronary sinus adjacent the mitral valve annulus to anchor the device in the coronary sinus; and

an actuation element adapted to receive a distally or proximally directed actuation force from an actuator and to transmit the actuation force to expand the first and second anchors simultaneously.

2. The device of claim 1 wherein the first anchor is further adapted to change shape in response to the actuation force.

3. The device of claim 1 wherein the first and second anchors are each adapted to change shape in response to the actuation force.

4. The device of claim 1 further comprising a lock adapted to lock the first and second anchors in a deployed configuration.

5. The device of claim 4 wherein the lock is further adapted to unlock in response to an unlocking force.

6. The device of claim 4 wherein the lock comprises first and second lock elements, the first anchor and the first lock element being formed from a single wire.

7. The device of claim 4 wherein the actuation element is integral with the lock.

8. The device of claim 1 wherein the first anchor is formed from wire.

9. The device of claim 8 wherein the first anchor is formed in a substantially figure eight configuration.

10. The device of claim 1 wherein the actuation element is a first actuation element, the actuation force is a first actuation force, the device further comprising a second actuation element adapted to receive a second actuation force from an actuator and to transmit the second actuation force to the first and second anchors simultaneously.

11. The device of claim 10 wherein the first actuation force is a proximally directed force and the second actuation force is a distally directed force, the first and second actuation elements being adapted to move toward each other in response to the first and second actuation forces.

12. The device of claim 11 wherein the first and second actuation elements comprise a lock adapted to lock the first and second anchors in a deployed configuration.

13. The device of claim 11 further comprising an extension extending between the first anchor and the second anchor, the connector being further adapted to move with respect to the extension in response to the first and second actuation forces.

14. The device of claim 13 wherein the extension and the connector each communicate with the first anchor to change the first anchor'"'"'s shape in response to relative movement between the extension and the connector.

15. The device of claim 14 wherein the first anchor is integral with the extension.

16. The device of claim 15 wherein the first anchor is integral with the connector.

17. The device of claim 13 further comprising a lock adapted to lock the first and second anchors in a deployed configuration, wherein the first and second anchors, the lock, the connector and the extension are all formed from a single wire.

18. A system for modifying the shape of a mitral valve annulus comprising:

a percutaneous deployment apparatus comprising an actuator; and

a percutaneous mitral valve annuloplasty device comprising a connector disposed between first and second anchors, the first and second anchors each adapted to be deployed in a coronary sinus adjacent the mitral valve annulus to anchor the device in the coronary sinus; and

an actuation element adapted to receive a distally or proximally directed actuation force from the actuator and to transmit the actuation force to the first and second anchors simultaneously.

19. The device of claim 18 wherein the first anchor is adapted to change shape in response to the actuation force.

20. The device of claim 18 wherein the first and second anchors are each adapted to change shape in response to the actuation force.

21. The device of claim 18 wherein the percutaneous mitral valve annuloplasty device further comprises a lock adapted to lock the first and second anchors in a deployed configuration.

22. The device of claim 21 wherein the lock is further adapted to unlock in response to an unlocking force.

23. The device of claim 22 wherein the deployment apparatus further comprises an unlocking actuator adapted to deliver an unlocking force to the lock.

24. The device of claim 23 wherein the unlocking actuator comprises a tether adapted to deliver a proximally directed unlocking force on the lock.

25. The system of claim 18 wherein the actuator is a first actuator and the actuation element of the percutaneous mitral valve annuloplasty device is a first actuation element, the deployment apparatus further comprising a second actuator and the percutaneous mitral valve annuloplasty device further comprising a second actuation element adapted to receive an actuation force from the second actuator and to transmit the second actuation force to the first and second anchors simultaneously.

26. The system of claim 25 wherein the first actuator is adapted to deliver a proximally directed actuation force and the first actuation element of the mitral valve annuloplasty device is adapted to receive the proximally directed actuation force.

27. The device of claim 26 wherein the first actuator is a tether.

28. The device of claim 26 wherein the second actuator is adapted to deliver a distally directed actuation force and the second actuation element of the mitral valve annuloplasty device is adapted to receive the distally directed actuation force, the first and second actuation elements being adapted to move toward each other in response to the first and second actuation forces.

29. The device of claim 28 wherein the second actuator is a catheter.

30. The device of claim 28 wherein the first and second actuation elements of the mitral valve annuloplasty device comprise a lock adapted to lock the first and second anchors in a deployed configuration.

31. The device of claim 28 further comprising an extension extending between the first anchor and the second anchor, the connector being further adapted to move with respect to the extension in response to the first and second actuation forces.

32. The device of claim 31 wherein the extension and the connector each communicate with the first anchor to change the first anchor'"'"'s shape in response to relative movement between the extension and the connector.