Method and apparatus for improving mitral valve function

• US 6,656,221 B2
• Filed: 02/05/2002
• Issued: 12/02/2003
• Est. Priority Date: 02/05/2001
• Status: Expired due to Term

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Viacor, Inc.
• Inventors: Cohn, William E., Liddicoat, John R., Davenport, Todd F., Streeter, Richard B., Taylor, Daniel C., Woolfson, Steven B., Kordis, Thomas F.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): SWEET, THOMAS
• Application Number:
  US10/068,264
• Publication Number:
  US 20020183835A1
• Time in Patent Office: 665 Days
• Field of Search: 623/2.11, 623/2.36
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape

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 an elongated substantially straight 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, and being so configured that the distal and proximal ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, 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.

2. A method for reducing mitral regurgitation comprising:

inserting an elongated substantially straight 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, and being so configured that the distal and proximal ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, 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.

3. A method for reducing mitral regurgitation comprising:

inserting an elongated substantially straight 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, and being so configured that the distal and proximal ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, 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.

4. A method for reducing mitral regurgitation comprising:

inserting an elongated substantially straight 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, and being so configured that the distal and proximal ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the intermediate portion app lies an anteriorly-directed force to the anterior wall of the coronary sinus, 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.

5. A method for reducing mitral regurgitation comprising:

inserting an elongated substantially straight 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 apply a posteriorly-directed force to the posterior wall of the coronary sinus and the intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation.

6. A method according to the claim 5 wherein the apparatus is fixed on a push rod and the step of inserting the apparatus into the coronary sinus comprises advancing the push rod into the coronary sinus until the apparatus is positioned in the coronary sinus in the vicinity of the posterior leaflet of the mitral valve.

7. A method according to claim 6 wherein a delivery catheter is advanced into the coronary sinus until a distal portion thereof is in the vicinity of the posterior leaflet, and the push rod is subsequently advanced through the delivery catheter.

8. A method according to claim 7 wherein a guidewire is advanced into the coronary sinus until a distal portion thereof is in the vicinity of the posterior leaflet, thereafter the delivery catheter is advanced into the coronary sinus, the guidewire is withdrawn from the patient, and thereafter the push rod is advanced through the delivery catheter.

9. A method according to claim 7 wherein the apparatus is guided into position by the delivery catheter, and prior to advancing the delivery catheter a support catheter is pre-positioned such that the delivery catheter is advanced through the support catheter.

10. A method according to claim 6 wherein the push rod is advanced by manipulation of a handle fixed on the push rod proximate a proximal end of the push rod.

11. A method according to claim 5 wherein the step of inserting the apparatus into the coronary sinus comprises advancing a guidewire into the coronary sinus and to the vicinity of the posterior leaflet of the mitral valve, providing the apparatus having an axial central lumen extending therethrough, mounting the apparatus on the guidewire for sliding movement thereon, mounting a push cannula on the guidewire so as to slide along the guidewire, and pushing the push cannula to thereby push the apparatus into the vicinity of the posterior leaflet.

12. A method according to claim 11 and comprising the further steps of withdrawing the push cannula, and withdrawing the guidewire.

13. A method for reducing mitral regurgitation comprising:

inserting a substantially straight elongated body having a distal end, a proximal end, and an intermediate portion 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, the body ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the body intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, to 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.

16. A method according to claim 13 wherein the elongated body is inserted into the coronary sinus.

17. A method according to claim 16 wherein the elongated body is inserted into the coronary sinus by introducing the elongated body into the patient'"'"'s jugular vein, passing the down the superior vena cava, passing the body through the right atrium and then passing 14 the body into the coronary sinus.

18. A method according to claim 16 wherein the elongated body is inserted into the coronary sinus by introducing the elongated body into the patient'"'"'s left subclavian vein, passing the body down the superior vena cava, passing the body through the right atrium and then passing the body into the coronary sinus.

14. A method for reducing mitral regurgitation comprising:

inserting a substantially rigid and substantially straight elongated body having a distal end, a proximal end, and an intermediate portion into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the 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 elongated body is positioned in the coronary sinus, the body ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the body intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, to 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.

15. A method for reducing mitral regurgitation comprising:

inserting a substantially straight, substantially rigid elongated body having a distal end, a proximal end, and an intermediate portion into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the length of the 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 elongated body is positioned in the coronary sinus, the body ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the body intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, to 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.

19. A method according to claim 15 wherein the elongated body is inserted into the coronary sinus through an incision in the patient'"'"'s heart.

20. A method according to claim 15 wherein the elongated body is guided into position by passing the body through a pre-positioned delivery catheter.

21. A method according to claim 20 wherein the 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 elongated body down the delivery catheter.

22. A method according to claim 15 wherein the elongated body is guided into position by passing the body over a pre-positioned guidewire.

23. A method according to claim 22 wherein the elongated body is guided into position by inserting a guidewire into the coronary sinus and then passing the elongated body down the guidewire.

24. A method according to claim 15 further comprising the subsequent step of removing the elongated body from the coronary sinus.

25. A method according to claim 15 wherein the elongated body is inserted under visualization.

26. A method according to claim 15 wherein the visualization is achieved by using a procedure chosen from the group consisting of fluoroscopy, echocardiography, intravascular ultrasound, angioscopy and real-time magnetic resonance imaging.

27. A method according to claim 15 including the additional step of assessing the efficacy of the procedure.

28. A method according to claim 15 wherein said substantially straight, substantially rigid elongated body is guided into position without the use of a guide catheter and a guidewire.

29. Apparatus for reducing mitral regurgitation comprising:

an elongated substantially straight 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 apply a posteriorly-directed force to the posterior wall of the coronary sinus, and the intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, whereby to move the posterior annulus of the mitral valve anteriorly and thereby improve leaflet coaptation.

30. Apparatus according to claim 29 wherein said body configuration is a selected one of (i) wavy, (ii) spiraled, (iii) curved in part, (iv) curved entirely, (v) curved inverted to the natural curvature of the coronary sinus, and (vi) “

w”

shaped.

31. Apparatus according to claim 29 wherein said body intermediate portion is substantially rigid and wherein said body ends are flexible.

32. Apparatus according to claim 29 wherein said body is provided with a central lumen extending therethrough, and said apparatus further comprises:

a guidewire dimensioned for slidable disposition in the body central lumen; and

a cannula for sliding disposition on said guidewire;

whereby said body and said cannula are mountable on said guidewire and movement of said cannula on said guidewire in a distal direction pushes said body distally along said guidewire.

33. Apparatus for reducing mitral regurgitation comprising:

a substantially straight elongated body having a distal end, a proximal end and an intermediate portion, and 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, the body ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the body intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, to 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.

34. Apparatus for reducing mitral regurgitation comprising:

a substantially rigid and substantially straight elongated body having a distal end, a proximal end, and an intermediate portion, and 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 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 elongated body is positioned in the coronary sinus, the body applies a posteriorly-directed force to the posterior wall of the coronary sinus and applies an anteriorly-directed force to the anterior wall of the coronary sinus, to 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.

35. Apparatus for reducing mitral regurgitation comprising:

a substantially straight, substantially rigid elongated body having a distal end, a proximal end, and an intermediate portion, and 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 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 elongated body is positioned in the coronary sinus, the body ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the body intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, to 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.

36. Apparatus according to claim 35 further comprising a delivery catheter adapted to be positioned within the coronary sinus of the patient, said delivery 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 elongated body therein.

37. Apparatus according to claim 36 wherein said 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.

38. Apparatus according to claim 37 wherein said rod is provided with a handle portion proximate a proximal end of said rod, said handle portion facilitating manipulation of said rod to locate said body in the vicinity of the posterior leaflet.

39. Apparatus according to claim 36 further comprising a removable guidewire for positioning said delivery catheter in the coronary sinus.

40. Apparatus according to claim 39 wherein said guidewire is provided with a spring tip at a distal end thereof.

41. Apparatus according to claim 35 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 elongated body is cannulated for riding along said guidewire.

42. Apparatus according to claim 35 wherein at least one of the distal and proximal ends of said elongated body includes a flexible portion for relieving stress imposed on the coronary sinus when said elongated body is disposed within the coronary sinus.

43. Apparatus according to claim 35 wherein at least one of the distal and proximal ends of said elongated body is tapered for relieving stress imposed on the coronary sinus when said elongated body is disposed within the coronary sinus.

44. Apparatus according to claim 35 wherein said elongated body has a length no longer than a segment of the coronary sinus located between the coronary ostium and the AIV.

45. Apparatus according to claim 36 wherein said apparatus further comprises a support catheter for preventing said delivery catheter from diverting into the inferior vena cava when said elongated body is passed through said delivery catheter.

46. A method for reducing mitral regurgitation comprising:

inserting an elongated substantially straight apparatus having a distal end, a proximal end and an intermediate portion into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being so configured that the apparatus ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the apparatus intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, 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.

47. Apparatus for reducing mitral regurgitation comprising:

an elongated substantially straight body having a distal end, a proximal end and an intermediate portion, and adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the body being so configured that the body ends apply a posteriorly-directed force to the posterior wall of the coronary sinus and the body intermediate portion applies an anteriorly-directed force to the anterior wall of the coronary sinus, 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.