Transluminal mitral annuloplasty

• US 6,810,882 B2
• Filed: 07/19/2001
• Issued: 11/02/2004
• Est. Priority Date: 01/30/2001
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: EV3 Santa Rosa, Inc.
• Inventors: van der Burg, Erik, Lesh, Michael D., Langberg, Jonathan J.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/909,101
• Publication Number:
  US 20020103532A1
• Time in Patent Office: 1,202 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.15, 623/1.24, 623/1.26, 623/2.1, 623/2.11, 623/2.37, 623/900, 623/904, 606/139, 606/108, 600/37, 128/898
• US Class Current: 128/898
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A mitral annuloplasty and left ventricle restriction device is designed to be transvenously advanced and deployed within the coronary sinus and in some embodiments other coronary veins. The device places tension on adjacent structures, reducing the diameter and/or limiting expansion of the mitral annulus and/or limiting diastolic expansion of the left ventricle. These effects may be beneficial for patients with dilated cardiomyopathy.

Claims

1. A method of performing transluminal mitral annuloplasty, comprising the steps of:

providing a catheter, having a prosthesis thereon, the catheter having a rotatable member extending axially therethrough and releasably engaged with a rotatable component of the prosthesis;

inserting the catheter into the venous system;

transluminally advancing the prosthesis into the coronary sinus;

rotating a component of the prosthesis to cause the prosthesis to exert a compressive force on adjacent atrial musculature;

releasing the rotatable member from the prosthesis; and

removing the rotatable member from the patient.

2. The method of claim 1, further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.

3. The method of claim 2, wherein the accessing step is accomplished by accessing one of the veins selected from the group consisting of internal jugular, subclavian and femoral veins.

4. The method of claim 1, further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the inserting step.

5. The method of claim 1, further comprising the step of measuring hemodynamic function following the rotating step.

6. The method of claim 5, further comprising the steps of determining an ongoing drug therapy taking into account the post implantation hemodynamic function.

7. The method of claim 1, wherein the rotating a component step causes the prosthesis to bend into an arcuate configuration.

8. The method of claim 7, further comprising the step of locking the prosthesis in the arcuate configuration.

9. The method of claim 8, wherein the locking step comprises engaging a first threaded surface with a second threaded surface.

10. The method of claim 8, wherein the locking step comprises providing an interference fit.

11. The method of claim 8, wherein the locking step comprises providing an adhesive bond.

12. The method of claim 8, wherein the locking step comprises providing a knot.

13. The method of claim 8, wherein the locking step comprises providing a compression fit.

14. The method of claim 1, further comprising the step of deploying the prosthesis in the coronary sinus.

15. The method of claim 14, further comprising the step of removing the catheter from the venous system.

16. The method of claim 1, additionally comprising the step of monitoring hemodynamic function to assess mitral valve regurgitation.

17. The method of claim 16, wherein the monitoring step comprises monitoring hemodynamic function prior to the rotating step.

18. The method of claim 16, wherein the monitoring step comprises monitoring hemodynamic function during the rotating step.

19. The method of claim 16, wherein the monitoring step comprises monitoring hemodynamic function following the rotating step.

20. The method of claim 16, wherein the rotating step results in axially moving a forming element with respect to the prosthesis, to bend the prosthesis.

21. The method of claim 16, wherein the transluminally advancing step is accomplished using a catheter.

22. The method of claim 16, further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the inserting step.

23. The method of claim 16, wherein the step of monitoring hemodynamic function is accomplished using transesophageal echo cardiography.

24. The method of claim 16, wherein the step of monitoring hemodynamic function is accomplished using surface echo cardiographic imaging.

25. The method of claim 16, wherein the step of monitoring hemodynamic function is accomplished using intracardiac echo cardiographic imaging.

26. The method of claim 16, wherein the step of monitoring hemodynamic function is accomplished using fluoroscopy with radiocontrast media.

27. The method of claim 16, wherein the step of monitoring hemodynamic function is accomplished using left atrial or pulmonary capillary wedge pressure measurements.

28. The method of claim 16, further comprising the step of tightening the prosthesis to reduce regurgitation.

29. The method of claim 28, wherein the tightening step is performed to achieve at least a one grade reduction in regurgitation.

30. A method of performing transluminal mitral annuloplasty, comprising the steps of:

providing a catheter, having a rotatable core extending therethrough and a prosthesis removably engaged with the core;

inserting the catheter into the venous system;

transluminally advancing the prosthesis into the coronary sinus;

rotating the core to rotate a first component of the prosthesis with respect to a second component of the prosthesis; and

releasing the prosthesis from the catheter, such that the rotatable core is disengaged from the prosthesis and the prosthesis exerts a force on the wall of the coronary sinus.

31. The method of claim 30, further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.

32. The method of claim 31, wherein the accessing step is accomplished by accessing one of the veins selected from the group consisting of internal jugular, subclavian and femoral veins.

33. The method of claim 30, further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the inserting step.

34. The method of claim 30, further comprising the step of measuring hemodynamic function following the rotating step.

35. The method of claim 34, further comprising the step of determining an ongoing drug therapy taking into account post implantation hemodynamic function.

36. The method of claim 30, further comprising the step of changing the shape of the prosthesis from an implantation configuration to a remodeling configuration in response to the rotating step.

37. The method of claim 36, wherein the prosthesis is reversibly movable between an implantation configuration for transluminal implantation and a remodeling configuration for exerting a force against a vessel wall.

38. The method of claim 36, wherein the prosthesis defines an arc when in the remodeling configuration.

39. The method of claim 36, wherein the changing the shape step comprises forming an arc which is concave in the direction of the mitral valve.

40. The method of claim 38, wherein a best fit constant radius curve corresponding to the arc has a radius within the range of from about 10 mm to about 20 mm.

41. The method of claim 30, further comprising the step of retaining the body in a remodeling configuration following the rotating step.

42. The method of claim 41, wherein the retaining step comprises engaging a lock on the prosthesis.

43. The method of claim 42, wherein the lock comprises an interference fit.

44. The method of claim 42, wherein the lock comprises a ratchet.

45. The method of claim 42 wherein the lock comprises an engagement surface, which is movable between a first, disengaged configuration and a second, engaged configuration.

46. The method of claim 42, wherein the lock is biased in a locked direction.

47. The method of claim 42, wherein the lock is biased in an unlocked direction.

48. The method of claim 30, further comprising a coating on the prosthesis.

49. The method of claim 30, further comprising the step of deploying an anchor for retaining the prosthesis at a deployment site within a vessel.

50. The method of claim 49, wherein the anchor comprises a distal extension of the implant.

51. The method of claim 49, wherein the anchor comprises a friction enhancing surface structure for engaging the wall of the vessel.

52. The method of claim 49, wherein the deploying an anchor step comprises deploying at least one barb for piercing the wall of the vessel.

53. The method of claim 30, wherein the prosthesis has an axial length of no more than about 10 cm.

54. The method of claim 30, wherein the cross sectional area through the implant is no more than about 10 mm².

55. The method of claim 30, additionally comprising the step of monitoring hemodynamic function to assess mitral valve regurgitation.

56. The method of claim 55, wherein the monitoring step comprises monitoring hemodynamic function prior to the rotating step.

57. The method of claim 55, wherein the monitoring step comprises monitoring hemodynamic function during the rotating step.

58. The method of claim 55, wherein the monitoring step comprises monitoring hemodynamic function following the rotating step.

59. The method of claim 55, wherein the step of monitoring hemodynamic function is accomplished using transesophageal echo cardiography.

60. The method of claim 55, wherein the step of monitoring hemodynamic function is accomplished using surface echo cardiographic imaging.

61. The method of claim 55, wherein the step of monitoring hemodynamic function is accomplished using intracardiac echo cardiographic imaging.

62. The method of claim 55, wherein the step of monitoring hemodynamic function is accomplished using fluoroscopy with radiocontrast media.

63. The method of claim 55, wherein the step of monitoring hemodynamic function is accomplished using left atrial or pulmonary capillary wedge pressure measurements.

64. The method of claim 55, further comprising the step of determining an ongoing drug therapy taking into account post implantation hemodynamic function.

65. The method of claim 30, further comprising the step of locking the prosthesis to retain a compressive force on the annulus following the manipulating step.