Method and apparatus for improving mitral valve function

• US 20040073302A1
• Filed: 05/27/2003
• Published: 04/15/2004
• Est. Priority Date: 02/05/2002
• Status: Active Grant

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Viacor, Inc.
• Inventors: Cohn, William E., Liddicoat, John R., Taylor, Daniel C., Rourke, Jonathan
• Granted Patent: US 7,125,420 B2
• Time in Patent Office: Days
• 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 method and apparatus for reducing mitral regurgitation. The apparatus is inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

Claims

1. A method for reducing mitral regurgitation comprising:

inserting apparatus into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation;

the apparatus comprising an elongated body having a degree of curvature, in an unstressed state, which is less than the degree of curvature of the coronary sinus prior to insertion of the elongated body into the coronary sinus, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

2. A method according to claim 1 wherein said elongated body is substantially straight in an unstressed condition.

3. A method according to claim 1 wherein said elongated body is at least partially curved in an unstressed condition.

4. A method according to claim 1 wherein said elongated body is substantially straight after insertion into the coronary sinus.

5. A method according to claim 1 wherein said elongated body is substantially curved after insertion into the coronary sinus.

6. A method according to claim 1 wherein said elongated body comprises first and second end portions connected together by an intermediate portion, and wherein said first and second end portions are substantially curved after the elongated body is inserted into the coronary sinus, and further wherein said intermediate portion is substantially straight after the elongated body is inserted into the coronary sinus.

7. A method according to claim 1 wherein said elongated body comprises first and second end portions connected together by an intermediate portion, wherein said intermediate portion comprises first and second regions connected together by a central region, wherein said central region and said first and second end portions are substantially curved after said elongated body is inserted into the coronary sinus, and further wherein said first and second regions are substantially straight after the elongated body is inserted into the coronary sinus.

8. A method according to claim 7 wherein said central region, said first and second end portions and said first and second regions have a length such that said elongated body applies an anteriorly-directed force to the walls of the coronary sinus substantially adjacent to the posterior leaflet of the valve, and applies a posteriorly-directed force to the walls of the coronary sinus substantially adjacent to the commissures of the valve.

9. A method according to claim 1 wherein said elongated body is formed at least in part out of a resilient material.

10. A method according to claim 9 wherein said elongated body effects valve remodeling on a continuous basis over a prolonged period of time.

11. A method according to claim 10 wherein said elongated body is formed at least in part out of a superelastic material.

12. A method according to claim 1 wherein said apparatus comprises a stabilizing scaffold engaging to said elongated body.

13. A method according to claim 12 wherein said stabilizing scaffold is inserted into the coronary sinus before said elongated body is inserted into said coronary sinus.

14. A method according to claim 12 wherein said stabilizing scaffold is inserted into the coronary sinus at the same time that said elongated body is inserted into said coronary sinus.

15. A method according to claim 12 wherein said elongated body is separable from said stabilizing scaffold.

16. A method according to claim 12 wherein said elongated body is selectively connectable to said stabilizing scaffold.

17. A method according to claim 12 wherein said stabilizing scaffold is formed integral with said elongated body.

18. A method according to claim 12 wherein said stabilizing scaffold comprises a cylindrical frame having openings therein.

19. A method according to claim 18 wherein said stabilizing scaffold comprises a guide connected to said cylindrical frame for receiving said elongated body therein.

20. A method according to claim 18 wherein said stabilizing scaffold comprises a plurality of ribs.

21. A method according to claim 18 wherein said ribs are connected to said elongated body.

22. A method according to claim 18 wherein said ribs are connected to a spine.

23. A method according to claim 22 wherein said spine includes a lumen sized to receive the elongated body therein.

24. A method for reducing mitral regurgitation comprising:

inserting apparatus into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to move at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve anteriorly, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation;

the apparatus comprising an elongated body having a straighter configuration, in an unstressed condition, than the coronary sinus prior to insertion of the elongated body into the coronary sinus, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

25. A method according to claim 24 wherein said apparatus comprises a stabilizing scaffold connected to said elongated body.

26. A method for reducing mitral regurgitation comprising:

inserting apparatus into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to reduce the degree of natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation;

the apparatus comprising an elongated body having a relatively straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

27. A method according to claim 26 wherein said apparatus comprises a stabilizing scaffold connected to said elongated body.

28. A method for reducing mitral regurgitation comprising:

inserting apparatus into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to increase the natural radius of curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation;

the apparatus comprising an elongated body having a relatively straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

29. A method according to claim 28 wherein said apparatus comprises a stabilizing scaffold connected to said elongated body.

30. A method for reducing mitral regurgitation comprising:

inserting apparatus into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus having a distal end, a proximal end and an intermediate portion, the apparatus being configured so that when the apparatus is positioned in the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, the distal and proximal ends will apply a posteriorly-directed force to the walls of the coronary sinus and the intermediate portion will apply an anteriorly-directed force to the walls of the coronary sinus, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation;

the apparatus comprising an elongated body having a relatively straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

31. A method according to claim 30 wherein said apparatus comprises a stabilizing scaffold connected to said elongated body.

32. A method for reducing mitral regurgitation comprising:

inserting a substantially straight elongated body into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the length of the substantially straight elongated body being sized relative to the natural curvature of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve so that when the substantially straight elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a substantially straight configuration adjacent to the posterior leaflet of the mitral valve, whereby to increase the radius of curvature of the mitral annulus and thereby improve leaflet coaptation;

the substantially straight elongated body comprising a bar having a substantially straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

33. A method according to claim 32 wherein said substantially straight elongated body is substantially straight prior to insertion into the patient and substantially curved after insertion into the patient.

34. A method according to claim 32 wherein said apparatus comprises a stabilizing scaffold connected to said bar.

35. A method for reducing mitral regurgitation comprising:

inserting a substantially rigid elongated body into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the substantially rigid elongated body being configured relative to the natural curvature of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve so that when the substantially rigid elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a different configuration adjacent to the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation;

the substantially rigid elongated body comprising a bar having a relatively straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

36. A method according to claim 35 wherein said substantially rigid elongated body is more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, but still flexible.

37. A method according to claim 35 wherein said apparatus comprises a stabilizing scaffold connected to said bar.

38. A method for reducing mitral regurgitation comprising:

inserting a substantially straight, substantially rigid elongated body into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the length of the substantially straight, substantially rigid elongated body being sized relative to the natural curvature of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve so that when the substantially straight, substantially rigid elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a substantially straight configuration adjacent to the posterior leaflet of the mitral valve, whereby to increase the radius of curvature of the mitral annulus and thereby improve leaflet coaptation;

the substantially straight, substantially rigid elongated body comprising a bar having a substantially straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

39. A method according to claim 38 wherein said substantially straight elongated body is substantially straight prior to insertion into the patient and substantially curved after insertion into the patient.

40. A method according to claim 38 wherein said substantially rigid elongated body is more rigid than the anatomical tissue disposed between the apparatus and the mitral vale, but still flexible.

41. A method according to claim 38 wherein said apparatus comprises a stabilizing scaffold connected to said bar.

42. A method according to claim 38 wherein the straight, substantially rigid elongated body is inserted into the coronary sinus percutaneously.

43. A method according to claim 42 wherein the straight, substantially rigid elongated body is inserted into the coronary sinus by introducing the straight, substantially rigid elongated body into the patient'"'"'s jugular vein, passing it down the superior vena cava, passing it through the right atrium and then passing it into the coronary sinus.

44. A method according to claim 42 wherein the straight, substantially rigid elongated body is inserted into the coronary sinus by introducing the straight, substantially rigid elongated body into the patient'"'"'s left subclavian vein, passing it down the superior vena cava, passing it through the right atrium and then passing it into the coronary sinus.

45. A method according to claim 38 wherein the straight, substantially rigid elongated body is inserted into the coronary sinus through an incision in the patient'"'"'s heart.

46. A method according to claim 38 wherein the straight, substantially rigid elongated body is guided into position by passing it through a pre-positioned delivery catheter.

47. A method according to claim 46 wherein the straight, substantially rigid elongated body is guided into position by inserting a guidewire into the coronary sinus, passing the delivery catheter over the guidewire and into the coronary sinus, removing the guidewire, and then passing the straight, substantially rigid elongated body down the delivery catheter.

48. A method according to claim 38 wherein the straight, substantially rigid elongated body is guided into position by passing it over a pre-positioned guidewire.

49. A method according to claim 48 wherein the straight, substantially rigid elongated body is guided into position by inserting a guidewire into the coronary sinus and then passing the straight, substantially rigid elongated body down the guidewire.

50. A method according to claim 38 further comprising the subsequent step of removing the straight, substantially rigid elongated body from the coronary sinus.

51. A method according to claim 38 wherein the straight, substantially rigid elongated body is inserted under visualization.

52. A method according to claim 51 wherein visualization is achieved by using a procedure chosen from the group consisting of fluoroscopy, echocardiography, intravascular ultrasound, angioscopy and real-time magnetic resonance imaging.

53. A method according to claim 38 including the additional step of assessing the efficacy of the procedure.

54. A method according to claim 38 wherein said straight, substantially rigid elongated body is guided into position without the use of a guide catheter and a guidewire.

55. Apparatus for reducing mitral regurgitation comprising:

a body having a distal end, a proximal end and an intermediate portion, the body being configured so that when the body is positioned in the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, the distal and proximal ends will apply a posteriorly-directed force to the walls of the coronary sinus, and the intermediate portion will apply an anteriorly-directed force to the walls of the coronary sinus, whereby to move the posterior annulus of the mitral valve anteriorly and thereby improve leaflet coaptation;

the body comprising a bar having a relatively straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

56. Apparatus according to claim 55 further comprising a stabilizing scaffold connected to said bar.

57. Apparatus for reducing mitral regurgitation comprising:

a substantially straight elongated body adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the length of the substantially straight elongated body being sized relative to the natural curvature of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve so that when the substantially straight elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a substantially straight configuration adjacent to the posterior leaflet of the mitral valve, whereby to increase the radius of curvature of the mitral annulus, moving it anteriorly, and thereby improve leaflet coaptation;

the body comprising a bar having a substantially straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

58. A method according to claim 57 wherein said substantially straight elongated body is substantially straight prior to insertion into the patient and substantially curved after insertion into the patient due to passive elastic interaction with the anatomy.

59. Apparatus according to claim 57 wherein said apparatus comprises a stabilizing scaffold connected to said bar.

60. Apparatus for reducing mitral regurgitation comprising:

a substantially rigid elongated body adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the substantially rigid elongated body being configured relative to the natural curvature of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve so that when the substantially rigid elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a different configuration adjacent to the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation;

the body comprising a bar having a substantially straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

61. A method according to claim 60 wherein said substantially rigid elongated body is more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, but still flexible.

62. Apparatus according to claim 60 wherein said apparatus comprises a stabilizing scaffold connected to said bar.

63. Apparatus for reducing mitral regurgitation comprising:

a substantially straight, substantially rigid elongated body adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the length of the substantially straight, substantially rigid elongated body being sized relative to the natural curvature of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve so that when the substantially straight, substantially rigid elongated body is positioned in the coronary sinus, it will cause at least a portion of the coronary sinus to assume a substantially straight configuration adjacent to the posterior leaflet of the mitral valve, whereby to increase the radius of curvature of the mitral annulus, moving it anteriorly, and thereby improve leaflet coaptation;

the body comprising a bar having a substantially straight configuration in an unstressed condition, and the apparatus being more rigid than the anatomical tissue disposed between the apparatus and the mitral valve, whereby disposition of the apparatus in the coronary sinus will move the posterior annulus anteriorly and improve leaflet coaptation.

64. A method according to claim 63 wherein said substantially straight elongated body is substantially straight prior to insertion into the patient and substantially curved after insertion into the patient.

65. A method according to claim 63 wherein said substantially rigid elongated body is more rigid than the anatomical tissue disposed between the apparatus and the mitral vale, but still flexible.

66. Apparatus according to claim 63 wherein said apparatus comprises a stabilizing scaffold connected to said bar.

67. Apparatus according to claim 63 further comprising a delivery catheter adapted to be positioned within the coronary sinus of the patient, said flexible deliver catheter being formed out of a flexible material so that it will substantially assume the configuration of the coronary sinus, said delivery catheter being adapted to receive said straight, substantially rigid elongated body therein.

68. Apparatus according to claim 67 wherein said straight, substantially rigid elongated body is mounted to a rod, wherein said rod is formed out of a flexible material so that said rod will assume the configuration of the coronary sinus, and further wherein said rod is sized to fit within said delivery catheter.

69. Apparatus according to claim 63 further comprising a removable guidewire for positioning said delivery catheter in the coronary sinus.

70. Apparatus according to claim 63 further comprising a guidewire adapted to be positioned within the coronary sinus, said guidewire being formed out of a flexible material so that it will substantially assume the configuration of the coronary sinus, and further wherein the straight, substantially rigid elongated body is cannulated for riding along said guidewire.

71. Apparatus according to claim 63 wherein at least one of the distal and proximal ends of said straight, substantially rigid elongated body includes a flexible portion for relieving the stress imposed on the coronary sinus when said straight, substantially rigid elongated body is disposed within the coronary sinus.

72. Apparatus according to claim 63 wherein at least one of the distal and proximal ends of said straight, substantially rigid elongated body is tapered for relieving the stress imposed on the coronary sinus when said straight, substantially rigid elongated body is disposed within the coronary sinus.

73. Apparatus according to claim 63 wherein said straight, substantially rigid elongated body has a length no longer than the segment of the coronary sinus located between the coronary ostium and the AIV.

74. Apparatus according to claim 67 wherein said apparatus further comprises a support catheter for preventing said delivery catheter from diverting into the inferior vena cava when said straight, substantially rigid elongated body is passed through said delivery catheter.

75. A method for reducing mitral regurgitation comprising:

inserting apparatus into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to invert the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, wherein said apparatus comprises a bar and a stabilizing scaffold connected to said bar.

76. Apparatus for reducing mitral regurgitation comprising:

an elongated body adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to invert the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, wherein said apparatus comprises a bar and a stabilizing scaffold connected to said bar.