Reduced length tissue shaping device

• US 20050137685A1
• Filed: 12/19/2003
• Published: 06/23/2005
• Est. Priority Date: 12/19/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Nieminen, Gregory, Aronson, Nathan, Beget, Garrett, Gordon, Lucas, Reuter, David
• Granted Patent: US 7,837,728 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape

Abstract

One aspect of the invention is a method of treating mitral valve regurgitation in a patient. The method includes the steps of delivering a tissue shaping device to the patient'"'"'s coronary sinus in an unexpanded configuration within a catheter having an outer diameter no more than nine or ten french, with the tissue shaping device including a connector disposed between a distal expandable anchor comprising flexible wire and a proximal expandable anchor comprising flexible wire, the device having a length of 60 mm or less; and deploying the device to reduce mitral valve regurgitation, such as by anchoring the distal expandable anchor by placing the distal expandable anchor flexible wire in contact with a wall of the coronary sinus, e.g., by permitting the distal expandable anchor to self-expand or by applying an actuating force to the distal expandable anchor and possibly locking the distal expandable anchor after performing the applying step. The invention also includes a device for performing the method.

Claims

1. A method of treating mitral valve regurgitation in a patient, the method comprising:

delivering a tissue shaping device to the patient'"'"'s coronary sinus in an unexpanded configuration within a catheter having an outer diameter no more than ten french, the tissue shaping device comprising a connector disposed between a distal expandable anchor comprising flexible wire and a proximal expandable anchor comprising flexible wire, the device having a length of 60 mm or less; and

deploying the device to reduce mitral valve regurgitation.

2. The method of claim 1 wherein the delivering step comprises delivering the tissue shaping device to the patient'"'"'s coronary sinus in an unexpanded configuration within a catheter having an outer diameter no more than nine french.

3. The method of claim 1 wherein the deploying step comprises anchoring the distal expandable anchor by placing the distal expandable anchor flexible wire in contact with a wall of the coronary sinus.

4. The method of claim 1 wherein the deploying step comprises permitting the distal expandable anchor to self-expand.

5. The method of claim 1 wherein the deploying step comprises applying an actuating force to the distal expandable anchor.

6. The method of claim 5 wherein the deploying step further comprises locking the distal expandable anchor after performing the applying step.

7. The method of claim 1 wherein the deploying step comprises anchoring the distal expandable anchor with an anchoring force of at least one pound.

8. The method of claim 6 wherein the deploying step comprises anchoring the distal expandable anchor with an anchoring force of at least two pounds.

9. The method of claim 1 wherein the deploying step further comprises applying a proximally directed force on the distal expandable anchor through the connector.

10. The method of claim 9 wherein the step of applying a proximally directed force comprises applying a proximally directed force on the distal anchor from outside the patient.

11. The method of claim 9 wherein the applying step comprises moving the proximal anchor proximally with respect to the coronary sinus.

12. The method of claim 9 wherein the deploying step further comprises anchoring the proximal anchor.

13. The method of claim 12 wherein the step of anchoring the proximal anchor is performed after the step of applying a proximally directed force on the distal expandable anchor.

14. The method of claim 9 wherein the applying step comprises moving the proximal anchor proximally with respect to the coronary sinus after the step of anchoring the distal expandable anchor.

15. The method of claim 14 wherein the step of anchoring the proximal anchor is performed after the moving step.

16. The method of claim 9 wherein the step of anchoring the proximal anchor comprises expanding the proximal anchor.

17. The method of claim 16 wherein the anchoring step comprises permitting the proximal expandable anchor to self-expand.

18. The method of claim 16 wherein the anchoring step comprises applying an actuating force to the proximal expandable anchor.

19. The method of claim 18 wherein the deploying step further comprises locking the proximal expandable anchor after performing the applying step.

20. The method of claim 1 wherein the delivering step comprises delivering the tissue shaping device to the coronary sinus in an unexpanded configuration in which none of the distal expandable anchor flexible wire extends proximally along the connector within the catheter.

21. The method of claim 1 wherein the delivering step comprises delivering the tissue shaping device to the coronary sinus in an unexpanded configuration in which at least a portion of the distal expandable anchor flexible wire extends proximally along the connector within the catheter.

22. The method of claim 1 wherein the distal expandable anchor further comprises a distal expandable anchor flexible wire connection substantially limiting proximal and distal movement of the connection with respect to the distal expandable anchor, the delivering step comprising delivering the tissue shaping device to the coronary sinus in an unexpanded configuration in which at least a portion of the distal expandable anchor flexible wire extends from the connection proximally along the connector within the catheter.

23. The method of claim 1 wherein the distal expandable anchor further comprises a distally and proximally movable distal expandable anchor flexible wire connection, the delivering step comprising delivering the tissue shaping device to the coronary sinus in an unexpanded configuration in which at least a portion of the distal expandable anchor flexible wire extends proximally along the connector within the catheter.

24. The method of claim 23 wherein the deploying step comprises moving the connection distally to actuate the distal expandable anchor.

25. The method of claim 24 wherein the deploying step further comprises locking the distal expandable anchor after performing the moving step.

26. The method of claim 1 wherein the distal expandable anchor further comprises a distally and proximally movable distal expandable anchor flexible wire connection, the delivering step comprising delivering the tissue shaping device to the coronary sinus in an unexpanded configuration in which at least a portion of the distal expandable anchor flexible wire extends distally along the connector within the catheter.

27. The method of claim 26 wherein the deploying step comprises moving the connection distally to actuate the distal expandable anchor.

28. The method of claim 27 wherein the deploying step further comprises locking the distal expandable anchor after performing the moving step.

29. A tissue shaping device adapted to be delivered to a coronary sinus in an unexpanded configuration within a catheter having an outer diameter of no more than ten french and further adapted to be deployed in the coronary sinus to reduce mitral valve regurgitation, the device comprising a connector disposed between a distal expandable anchor comprising a flexible wire and a proximal expandable anchor comprising a flexible wire, the device having a length of 60 mm or less.

30. The tissue shaping device of claim 29 wherein the tissue shaping device is adapted to be delivered to a coronary sinus in an unexpanded configuration within a catheter having an outer diameter of no more than nine french.

31. The device of claim 29 wherein the distal expandable anchor is adapted to conform to a range of coronary sinus diameters by expanding to contact a wall portion of the coronary sinus to provide an anchoring force sufficient to anchor the device within the coronary sinus.

32. The device of claim 31 wherein the anchoring force is at least one pound.

33. The device of claim 32 wherein the anchoring force is at least two pounds.

34. The device of claim 29 wherein the device has an expanded configuration, the distal expandable anchor comprising at least one bending point and first and second arms extending from the bending point, the first and second arms being adapted to deform about the bending point when the device moves from the expanded configuration to the unexpanded configuration.

35. The device of claim 34 wherein the bending point is a first bending point, the distal expandable anchor comprising a second bending point and third and fourth arms extending from the second bending point, the third and fourth arms being adapted to deform about the second bending point when the device moves from the expanded configuration to the unexpanded configuration.

36. The device of claim 35 wherein the first and second bending points are disposed at a tallest point of the distal expandable anchor when the distal expandable anchor is in the expanded configuration.

37. The device of claim 34 wherein the first and second arms extend generally proximally when the tissue shaping device is in the unexpanded configuration.

38. The device of claim 34 wherein the first and second arms extend generally distally when the tissue shaping device is in the unexpanded configuration.

39. The device of claim 34 wherein the distal expandable anchor flexible wire has a preformed shape.

40. The device of claim 34 wherein the bending point comprises a section of the flexible wire having an increased radius of curvature compared to adjacent wire sections.

41. The device of claim 34 wherein the bending point comprises a loop formed in the flexible wire.

42. The device of claim 34 wherein the distal expandable anchor has a distal side and a proximal side, the bending point being disposed on the distal side.

43. The device of claim 34 wherein the distal expandable anchor has a distal side and a proximal side, the bending point being disposed on the proximal side.

44. The device of claim 29 further comprising a distal expandable anchor flexible wire connection substantially limiting proximal and distal movement of the connection with respect to the distal expandable anchor.

45. The device of claim 29 further comprising a distally and proximally movable connection between the distal expandable anchor and the connector.

46. The device of claim 29 wherein the distal expandable anchor comprises a self-expanding anchor.

47. The device of claim 29 wherein the distal expandable anchor comprises an actuatable anchor.

48. The device of claim 47 wherein the actuatable anchor further comprises an actuator and a lock adapted to lock the actuator in a deployed position.

49. The device of claim 29 wherein the device has an expanded configuration, the device being further adapted to be recaptured from the expanded configuration within the coronary sinus to the unexpanded configuration within a catheter within the coronary sinus.

50. The device of claim 49 wherein the device is further adapted to be redeployed in the coronary sinus after being recaptured.

51. The device of claim 29 wherein the proximal anchor is adapted to conform to a range of coronary sinus diameters by expanding to contact a wall portion of the coronary sinus with an anchoring force sufficient to anchor the device within the coronary sinus.

52. The device of claim 29 wherein the device has an expanded configuration, the proximal anchor comprising at least one bending point and first and second arms extending from the bending point, the first and second arms being adapted to deform about the bending point when the device moves from the expanded configuration to the unexpanded configuration.

53. The device of claim 29 wherein the proximal anchor comprises a self-expanding anchor.

54. The device of claim 29 wherein the proximal anchor comprises an actuatable anchor.

55. The device of claim 54 wherein the actuatable anchor further comprises an actuator and a lock adapted to lock the actuator in a deployed position.