Method and apparatus for improving mitral valve function

• US 20020183838A1
• Filed: 03/29/2002
• Published: 12/05/2002
• Est. Priority Date: 03/29/2001
• Status: Active Grant

• Current Assignee: Guided Delivery Systems, Inc.
• Original Assignee: Viacor, Inc.
• Inventors: Daveport, Todd F., Cohn, William E., Liddicoat, John R., Streeter, Richard B., Taylor, Daniel C., Woolfson, Steven B.
• Granted Patent: US 7,186,264 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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
• CPC Class Codes: Y10S 623/903 Blood vessel
• 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 move at least a portion of the coronary sinus anteriorly, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, the apparatus comprising a plurality of elements separated from one another during insertion into the coronary sinus and thereafter united in situ so as to form the apparatus.

2. A method according to claim 1 wherein each of the elements is substantially rigid.

3. A method according to claim 1 wherein each of the elements has a length such that it is, by itself, insufficient to significantly move the coronary sinus.

4. A method according to claim 1 wherein the elements are adapted to be secured to one another in situ.

5. A method according to claim 4 wherein the elements are secured to one another by at least one screw connection.

6. A method according to claim 1 wherein the distalmost of the elements is fixed to an elongated flexible body.

7. A method according to claim 6 wherein the distalmost of the elements is delivered to the coronary sinus by advancing the flexible body into the coronary sinus.

8. A method according to claim 7 wherein the remainder of the elements are delivered to the coronary sinus by passing them over the flexible body.

9. A method according to claim 1 wherein all of the elements are delivered to the coronary sinus by passing them over a flexible body.

10. A method according to claim 1 wherein the apparatus is substantially straight along its length.

11. A method according to claim 1 wherein the apparatus is substantially curved along its length.

12. A method according to claim 1 wherein the apparatus is both substantially straight and curved along its length.

13. A method according to claim 1 wherein the elements are inserted into the coronary sinus percutaneously.

14. A method according to claim 13 wherein the elements are inserted into the coronary sinus by introducing the elements into the patient'"'"'s jugular vein, passing them down the superior vena cava, passing them through the right atrium and then passing them into the coronary sinus.

15. A method according to claim 15 wherein the elements are inserted into the coronary sinus by introducing them into the patient'"'"'s left subclavian vein, passing them down the superior vena cava, passing them through the right atrium and then passing them into the coronary sinus.

16. A method according to claim 1 wherein the elements are inserted into the coronary sinus through an incision in the patient'"'"'s heart.

17. A method according to claim 1 wherein the elements are guided into position by passing them through a pre-positioned delivery catheter.

18. A method according to claim 13 wherein the elements are 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 elements down the delivery catheter.

19. A method according to claim 1 wherein the elements are guided into position by passing them over a pre-positioned guidewire.

20. A method according to claim 19 wherein the elements are guided into position by inserting a guidewire into the coronary sinus and then passing the elements down the guidewire.

21. A method according to claim 1 further comprising the subsequent step of removing the apparatus from the coronary sinus.

22. A method according to claim 1 wherein the elements are inserted under visualization.

23. A method according to claim 22 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.

24. A method according to claim 1 including the additional step of assessing the efficacy of the procedure.

26. A method according to claim 25 wherein the inflatable structure comprises a balloon.

27. A method according to claim 26 wherein the balloon is adapted to be inflated in situ.

28. A method according to claim 27 wherein the balloon is adapted to move the coronary sinus anteriorly when the balloon is inflated.

29. A method according to claim 25 wherein the inflatable structure comprises an expandable piston.

25. 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 anteriorly, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, the apparatus comprising a inflatable structure.

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 being adapted to move at least a portion of the coronary sinus anteriorly, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, the apparatus being adapted to be introduced into the coronary sinus through the use of an electrical lead.

31. A method according to claim 30 wherein the apparatus is connected to the electrical lead and is positioned in the coronary sinus as the electrical lead is disposed in the body.

32. A method according to claim 30 wherein the apparatus is delivered to the coronary sinus by sliding the apparatus down the electrical lead.

33. 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 anteriorly, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, the apparatus being adapted to permit blood flow through the coronary sinus even when the apparatus is disposed in the coronary sinus.

34. A method of claim 33 wherein the apparatus has a diameter less than diameter of the coronary sinus.

35. A method according to claim 33 wherein the apparatus comprises at least one surface groove facilitating blood flow past the apparatus.

37. Apparatus according to claim 36 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 plurality of elements.

38. Apparatus according to claim 33 wherein at least one of said elements 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.

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 33 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 all of the elements are cannulated for riding along said guidewire.

36. Apparatus for reducing mitral regurgitation comprising:

a plurality of elements adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve while separated from one another and to be thereafter united in situ so as to form an elongated body, 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 it will cause at least a portion of the coronary sinus to move at least a portion of the coronary sinus anteriorly, whereby to reduce mitral regurgitation.

41. Apparatus for reducing mitral regurgitation comprising:

an inflatable structure 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 inflatable structure being sized, when inflated, relative to the natural curvature of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve so that 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 reduce mitral regurgitation.

42. Apparatus for reducing mitral regurgitation comprising:

a structure 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 structure being sized relative to the natural curvature of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve so that 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 reduce mitral regurgitation, the apparatus being adapted to be introduced into the coronary sinus through the use of an electrical lead.

43. Apparatus for reducing mitral regurgitation comprising:

a structure 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 structure being sized relative to the natural curvature of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve so that 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 reduce mitral regurgitation, the apparatus being adapted to permit blood flow through the coronary sinus even when the apparatus is disposed in the coronary sinus.

44. 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 anteriorly, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, the apparatus comprising a plurality of elements movable relative to one another during insertion into the coronary sinus so that the apparatus may assume the curvature of the coronary sinus, and thereafter lockable in a straighter configuration relative to one another so that the apparatus may move at least a portion of the coronary sinus anteriorly.

45. 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 anteriorly, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, the apparatus being substantially flexible during insertion into the coronary sinus so that it may initially assume the curvature of the coronary sinus and being thereafter activatable so as to assume a straighter configuration, whereby it may move at least a portion of the coronary sinus anteriorly.

46. 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 anteriorly, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, the apparatus being sufficiently small during insertion to allow insertion into the coronary sinus without substantially affecting leaflet coaptation and being thereafter expandable so as to improve leaflet coaptation.

47. 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 anteriorly, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation, the apparatus having a flexible configuration at a first temperature and a more rigid configuration at a second temperature, the apparatus being inserted into the coronary sinus at the first temperature and thereafter transitioning to said second temperature.

48. A method for treating cardiac dysfunction 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 anteriorly, whereby to alter the shape of other cardiac tissues, the apparatus being substantially flexible during insertion into the coronary sinus so that it may initially assume the curvature of the coronary sinus and being thereafter activatable so as to assume a straighter configuration, whereby to alter the shape of other cardiac tissues and thereby treat cardiac dysfunction.

49. Apparatus for reducing mitral regurgitation comprising:

a plurality of elements adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve while movable relative to one another so that the apparatus may assume the curvature of the coronary sinus, and to be thereafter locked in a straighter configuration relative to one another so that it may move at least a portion of the coronary sinus anteriorly.

50. Apparatus for treating cardiac dysfunction comprising:

a plurality of elements adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve while movable relative to one another so that the apparatus may assume the curvature of the coronary sinus, and to be thereafter locked in a straighter configuration relative to one another so that it may move at least a portion of the coronary sinus anteriorly whereby to alter the shape of other cardiac tissues and thereby treat cardiac dysfunction.

51. Apparatus for treating cardiac dysfunction comprising:

a device adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve while movable so as to assume the curvature of the coronary sinus, and to be thereafter locked in a straighter configuration so that it may move at least a portion of the coronary sinus anteriorly whereby to alter the shape of other cardiac tissues and thereby treat cardiac dysfunction.