Mitral valve regurgitation treatment device and method

• US 20050027351A1
• Filed: 12/19/2003
• Published: 02/03/2005
• Est. Priority Date: 05/14/2001
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Nieminen, Gregory, Mathis, Mark L., Aronson, Nathan, Beget, Garrett, Gordon, Lucas, Reuter, David, Alferness, Clif
• Application Number:
  US10/742,747
• Publication Number:
  US 20050027351A1
• 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
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A method of treating regurgitation of a mitral valve in a patient'"'"'s heart. The method includes the steps of: delivering a tissue shaping device to the coronary sinus; and deploying the tissue shaping device to reduce mitral valve regurgitation, the deploying step comprising applying a force through the coronary sinus wall toward the mitral valve solely proximal to a crossover point where a coronary artery passes between a coronary sinus and the mitral valve. The invention is also a set of devices for use in treating mitral valve regurgitation. The set includes a plurality of tissue shaping devices having different lengths, each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french.

Claims

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

delivering a tissue shaping device to the coronary sinus; and

deploying the tissue shaping device to reduce mitral valve regurgitation, the deploying step comprising applying a force through the coronary sinus wall toward the mitral valve solely proximal to a crossover point where a coronary artery passes between a coronary sinus and the mitral valve.

2. The method of claim 1 further comprising determining the crossover point.

3. The method of claim 1 wherein the delivering step comprises delivering the tissue shaping device to the coronary sinus in a catheter having an outer diameter no more than ten french.

4. The method of claim 3 wherein the delivering step comprises delivering the tissue shaping device to the coronary sinus in a catheter having an outer diameter no more than nine french.

5. The method of claim 1 wherein the deploying step comprises placing a distal end of the tissue shaping device proximal to the crossover point.

6. The method of claim 1 wherein the deploying step comprises placing a distal end of the tissue shaping device distal to the crossover point.

7. The method of claim 1 wherein the tissue shaping device comprises a distal anchor, the deploying step comprising anchoring the distal anchor proximal to the crossover point.

8. The method of claim 7 wherein the anchoring step comprises expanding the distal anchor.

9. The method of claim 8 wherein the anchoring step comprises permitting the distal anchor to self-expand.

10. The method of claim 8 wherein the anchoring step comprises applying an actuation force to the distal anchor.

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

12. The method of claim 11 wherein the anchoring step comprises anchoring the distal anchor with an anchoring force of at least two pounds.

13. The method of claim 7 wherein the deploying step further comprises applying a proximally directed force on the distal anchor.

14. The method of claim 13 wherein the step of applying a proximally directed force comprises applying a proximally directed force on the distal anchor from outside the patient.

15. The method of claim 13 wherein the tissue shaping device further comprises a proximal anchor and a connector disposed between the distal anchor and the proximal anchor, the deploying step further comprising anchoring the proximal anchor.

16. The method of claim 15 wherein the step of anchoring the proximal anchor comprises anchoring the proximal anchor in the coronary sinus.

17. The method of claim 15 wherein the step of anchoring the proximal anchor comprises anchoring the proximal anchor at least partially outside the coronary sinus.

18. The method of claim 15 wherein the step of anchoring the proximal anchor is performed after the step of applying a proximally directed force on the distal anchor.

19. The method of claim 15 wherein the applying step comprises moving the proximal anchor proximally after the step of anchoring the distal anchor.

20. The method of claim 19 wherein the step of anchoring the proximal anchor is performed after the moving step.

21. The method of claim 15 wherein the step of anchoring the proximal anchor comprises expanding the proximal anchor.

22. The method of claim 21 wherein the anchoring step comprises permitting the proximal anchor to self-expand.

23. The method of claim 21 wherein the anchoring step comprises applying an actuating force to the proximal anchor.

24. The method of claim 1 wherein the tissue shaping device comprises a distal anchor, the deploying step further comprising deploying the distal anchor from a distal end of a catheter.

25. The method of claim 24 further comprising recapturing the distal anchor into a catheter.

26. The method of claim 25 further comprising anchoring the distal anchor after recapturing the distal anchor.

27. The method of claim 1 wherein the tissue shaping device comprises a proximal anchor, the deploying step further comprising deploying the proximal anchor from a distal end of a catheter.

28. The method of claim 27 further comprising recapturing the proximal anchor into a catheter.

29. The method of claim 28 further comprising anchoring the proximal anchor after recapturing the proximal anchor.

30. The method of claim 1 wherein the delivering step comprises delivering the tissue shaping device to the coronary sinus in a catheter, the deploying step further comprising deploying the tissue shaping device from a distal end of the catheter, the method further comprising recapturing the tissue shaping device into a catheter.

31. The method of claim 1 further comprising selecting the tissue shaping device from a set of tissue shaping devices comprising tissue shaping devices of a plurality of lengths prior to the delivering step.

32. The method of claim 1 wherein the tissue shaping device comprises an anchor, the method further comprising selecting the tissue shaping device from a set of tissue shaping devices comprising tissue shaping devices of a plurality of anchor sizes prior to the delivering step.

33. A set of devices for use in treating mitral valve regurgitation, the set comprising:

a plurality of tissue shaping devices having different lengths, each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french.

34. The set of claim 33 further comprising a catheter having an outer diameter no greater than nine french.

35. The set of claim 33 wherein the tissue shaping devices each comprise an anchor having an unexpanded configuration and an expanded configuration, each tissue shaping device being further configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french when its distal anchor is in its unexpanded configuration.

36. The set of claim 33 wherein the tissue shaping devices in the set each comprise:

a proximal anchor having an unexpanded configuration and an expanded configuration;

a distal anchor having an unexpanded configuration and an expanded configuration; and

a connector disposed between the proximal anchor and the distal anchor,

each tissue shaping device being further configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french when its proximal anchor and distal anchor are in their unexpanded configurations.

37. The set of claim 36 wherein at least one tissue shaping device in the set has a length 60 mm or less and at least one tissue shaping device in the set has a length more than 60 mm.

38. The set of claim 36 wherein the distal anchor of each tissue shaping device in the set has a diameter in its expanded configuration equal to or greater than a coronary sinus diameter at a distal anchor location.

39. The set of claim 38 wherein the diameters of the distal anchors of the tissue shaping devices in the set in their expanded configurations range from about 7 mm. to about 16 mm.

40. The set of claim 36 wherein the proximal anchor of each tissue shaping device in the set has a diameter in its expanded configuration equal to or greater than a coronary sinus diameter at a proximal anchor location.

41. The set of claim 40 wherein the diameters of the proximal anchors of the tissue shaping devices in the set in their expanded configurations range from about 9 mm. to about 20 mm.

42. The set of claim 36 wherein the distal anchor of each tissue shaping device in the set comprises a self-expanding anchor.

43. The set of claim 36 wherein the proximal anchor of each tissue shaping device in the set comprises a self-expanding anchor.

44. The set of claim 36 wherein the distal anchor of each tissue shaping device in the set comprises an actuatable anchor.

45. The set of claim 36 wherein the proximal anchor of each tissue shaping device in the set comprises an actuatable anchor.

46. The set of claim 36 wherein the distal anchor of at least one tissue shaping device in the set comprises a self-expanding anchor and the distal anchor of at least one tissue shaping device in the set comprises an actuatable anchor.

47. The set of claim 36 wherein the proximal anchor of at least one tissue shaping device in the set comprises a self-expanding anchor and the proximal anchor of at least one tissue shaping device in the set comprises an actuatable anchor.

48. The set of claim 33 wherein each of the tissue shaping devices is configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than nine french.

49. A set of devices for use in treating mitral valve regurgitation, the set comprising:

a plurality of tissue shaping devices each comprising an anchor having an unexpanded configuration and an expanded configuration, the anchors having different diameters when in their expanded configurations, each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french.

50. The set of claim 49 wherein the anchor of each device is a distal anchor, the devices each further comprising a proximal anchor having an unexpanded configuration and an expanded configuration, the proximal anchors having different diameters when in their expanded configurations.

51. The set of claim 50 wherein the diameters of the distal anchors of the tissue shaping devices in the set in their expanded configurations range from about 7 mm. to about 16 mm.

52. The set of claim 50 wherein the diameters of the proximal anchors of the tissue shaping devices in the set in their expanded configurations range from about 9 mm. to about 20 mm.

53. The set of claim 52 wherein the distal anchor of each tissue shaping device in the set comprises a self-expanding anchor.

54. The set of claim 52 wherein the proximal anchor of each tissue shaping device in the set comprises a self-expanding anchor.

55. The set of claim 52 wherein the distal anchor of each tissue shaping device in the set comprises an actuatable anchor.

56. The set of claim 52 wherein the proximal anchor of each tissue shaping device in the set comprises an actuatable anchor.

57. The set of claim 52 wherein the distal anchor of at least one tissue shaping device in the set comprises a self-expanding anchor and the distal anchor of at least one tissue shaping device in the set comprises an actuatable anchor.

58. The set of claim 52 wherein the proximal anchor of at least one tissue shaping device in the set comprises a self-expanding anchor and the proximal anchor of at least one tissue shaping device in the set comprises an actuatable anchor.

59. The set of claim 49 further comprising a catheter having an outer diameter no greater than ten french.

60. The set of claim 49 wherein each of the tissue shaping devices is configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than nine french.