Percutaneous mitral annuloplasty with hemodynamic monitoring

• US 6,709,456 B2
• Filed: 10/01/2001
• Issued: 03/23/2004
• Est. Priority Date: 01/31/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: EV3 Santa Rosa, Inc. (Medtronic Plc)
• Inventors: Lesh, Michael D., Langberg, Jonathan J.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/968,272
• Publication Number:
  US 20020016628A1
• Time in Patent Office: 904 Days
• Field of Search: 623/1.1, 623/1-1-, 623/2.1, 623/2.11, 623/2-6-, 623/902, 623/11.11, 623/66.1, 606/191-192, 606/194-195, 606/198, 606/153, 606/151, 606/155, 600/16, 600/37, 128/898
• US Class Current: 623/2.37
• 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: A61N 2001/0585 Coronary sinus electrodes

Abstract

A minimally invasive method of performing mitral annuloplasty is disclosed. An implantable device is positioned within the coronary sinus and tightened around the mitral annulus. Mitral valve regurgitation is monitored before, during, and/or after the tightening step. An on-going drug therapy may be determined, taking into account post-implantation hemodynamic function.

Claims

1. A method of treating a patient, comprising the steps of:

transluminally advancing a prosthesis into the coronary sinus;

manipulating the prosthesis to exert a compressive force on the mitral valve annulus;

locking the prosthesis to retain a compressive force on the annulus following the manipulating step; and

monitoring hemodynamic function to assess mitral valve regurgitation.

2. A method as in claim 1, wherein the monitoring step comprises monitoring hemodynamic function prior to the manipulation step.

3. A method as in claim 1, wherein the monitoring step comprises monitoring hemodynamic function during the manipulation step.

4. A method as in claim 1, wherein the monitoring step comprises monitoring hemodynamic function following the manipulation step.

5. A method as in claim 1, further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.

6. A method as in claim 5, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian or femoral veins.

7. A method as in claim 1, wherein the manipulating step comprises axially moving a forming element with respect to the prosthesis, to bend the prosthesis.

8. A method as in claim 1, wherein the transluminally advancing step is accomplished using a catheter.

9. A method as in claim 1, wherein the locking step comprises moving an engagement surface from a disengaged configuration to an engaged configuration.

10. A method as in claim 1, wherein the locking step comprises providing an interference fit.

11. A method as in claim 1, wherein the locking step comprises providing an adhesive bond.

12. A method as in claim 1, wherein the locking step comprises providing a knot.

13. A method as in claim 1, wherein the locking step comprises providing a compression fit.

14. A method as in claim 1, further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the transluminally advancing step.

15. A method as in claim 1, wherein the step of monitoring hemodynamic function is accomplished using transesophageal echo cardiography.

16. A method as in claim 1, wherein the step of monitoring hemodynamic function is accomplished using surface echo cardiographic imaging.

17. A method as in claim 1, wherein the step of monitoring hemodynamic function is accomplished using intracardiac echo cardiographic imaging.

18. A method as in claim 1, wherein the step of monitoring hemodynamic function is accomplished using fluoroscopy with radiocontrast media.

19. A method as in claim 1, wherein the step of monitoring hemodynamic function is accomplished using left atrial or pulmonary capillary wedge pressure measurements.

20. A method as in claim 1, further comprising the step of determining an ongoing drug therapy taking into account post implantation hemodynamic function.

21. A method of remodeling a mitral valve annulus to reduce mitral valve regurgitation, comprising the steps of:

providing a prosthesis which is adjustable between a first configuration for transluminal deployment within the coronary sinus and a second configuration for exerting a compressive force against the mitral valve annulus from within the coronary sinus;

transluminally advancing the prosthesis to a position at least partially within the coronary sinus;

tightening the prosthesis to reduce mitral valve regurgitation;

locking the prosthesis to retain a compressive force on the annulus following the tightening step; and

monitoring the degree of regurgitation.

22. A method as in claim 21, wherein the monitoring step comprises monitoring the degree of regurgitation prior to the tightening step.

23. A method as in claim 21, wherein the monitoring step comprises monitoring the degree of regurgitation during the tightening step.

24. A method as in claim 21, wherein the monitoring step comprises monitoring the degree of regurgitation following the tightening step.

25. A method of remodeling a mitral valve annulus as in claim 21, wherein sufficient tightening is accomplished to achieve at least a one grade reduction in regurgitation.

26. A method as in claim 21, further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.

27. A method as in claim 26, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian or femoral veins.

28. A method as in claim 21, wherein the tightening step comprises axially moving a forming element with respect to the prosthesis, to bend the prosthesis.

29. A method as in claim 21, wherein the locking step comprises moving an engagement surface from a disengaged configuration to an engaged configuration.

30. A method as in claim 21, wherein the locking step comprises providing an interference fit.

31. A method as in claim 21, wherein the locking step comprises providing an adhesive bond.

32. A method as in claim 21, wherein the locking step comprises providing a knot.

33. A method as in claim 21, wherein the locking step comprises providing a compression fit.

34. A method as in claim 21, further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the transluminally advancing step.

35. A method as in claim 21, wherein the monitoring step is accomplished using transesophageal echo cardiography.

36. A method as in claim 21, wherein the monitoring step is accomplished using surface echo cardiographic imaging.

37. A method as in claim 21, wherein the monitoring step is accomplished using intracardiac echo cardiographic imaging.

38. A method as in claim 21, wherein the monitoring step is accomplished using fluoroscopy with radiocontrast media.

39. A method as in claim 21, wherein the monitoring step is accomplished using left atrial or pulmonary capillary wedge pressure measurements.

40. A method as in claim 21, further comprising the step of determining an ongoing drug therapy taking into account post implantation hemodynamic function.

41. A method as in claim 40, comprising measuring residual regurgitation following implantation and formulating an ongoing drug therapy taking into account the residual regurgitation.