Percutaneous mitral annuloplasty with hemodynamic monitoring

• US 7,935,146 B2
• Filed: 03/23/2004
• Issued: 05/03/2011
• Est. Priority Date: 01/31/2000
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Lesh, Michael D., Langberg, Jonathan J.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US10/806,906
• Publication Number:
  US 20040176840A1
• Time in Patent Office: 2,597 Days
• Field of Search: 623 237- 238, 623/1.15, 623/1.11, 623/1.16, 623/1.18, 128/898, 606/194
• 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 in a first configuration into a coronary sinus;

manipulating the prosthesis to a second configuration different from the first configuration to exert a compressive force on the mitral valve annulus;

monitoring hemodynamic function while the prosthesis is in the second configuration;

assessing mitral valve regurgitation in response to the monitoring step; and

adjusting the prosthesis to a third configuration different from the second configuration in response to the assessing step.

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

3. The method as in claim 2, further comprising the step of accessing one of the internal jugular, subclavian or femoral veins.

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

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

6. The method as in claim 1, further comprising the step of locking the prosthesis to retain a compressive force on the annulus following the adjusting step.

7. The method as in claim 6, wherein the locking step comprises moving an engagement surface from a disengaged configuration to an engaged configuration.

8. The method as in claim 6, wherein the locking step comprises providing an interference fit.

9. The method as in claim 6, wherein the locking step comprises providing an adhesive bond.

10. The method as in claim 6, wherein the locking step comprises providing a knot.

11. The method as in claim 6, wherein the locking step comprises providing a compression fit.

12. The 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 advancing step.

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

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

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

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

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

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

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

advancing an adjustable prosthesis in a first configuration into a coronary sinus;

manipulating the prosthesis from the first configuration toward a second configuration for exerting a compressive force against the mitral valve annulus to reduce mitral valve regurgitation;

monitoring the degree of regurgitation while manipulating the prosthesis from the first configuration toward the second configuration;

assessing the degree of regurgitation in response to the monitoring step; and

fixing the prosthesis in the second configuration in response to the assessing step.

20. The method of remodeling a mitral valve annulus as in claim 19, wherein sufficient manipulating is performed to achieve at least a one grade reduction in regurgitation.

21. The method as in claim 19, further comprising the step of percutaneously accessing the venous system prior to the advancing step.

22. The method as in claim 21, further comprising the step of accessing one of the internal jugular, subclavian or femoral veins.

23. The method as in claim 19, wherein the manipulating step comprises axially moving a forming element with respect to the prosthesis, to bend the prosthesis.

24. The method as in claim 19, further comprising the step of locking the prosthesis to retain a compressive force on the annulus following the manipulating step.

25. The method as in claim 24, wherein the locking step comprises moving an engagement surface from a disengaged configuration to an engaged configuration.

26. The method as in claim 24, wherein the locking step comprises providing an interference fit.

27. The method as in claim 24, wherein the locking step comprises providing an adhesive bond.

28. The method as in claim 24, wherein the locking step comprises providing a knot.

29. The method as in claim 24, wherein the locking step comprises providing a compression fit.

30. The method as in claim 19, further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the advancing step.

31. The method as in claim 19, wherein the monitoring step is accomplished using transesophageal echo cardiography.

32. The method as in claim 19, wherein the monitoring step is accomplished using surface echo cardiographic imaging.

33. The method as in claim 19, wherein the monitoring step is accomplished using intracardiac echo cardiographic imaging.

34. The method as in claim 19, wherein the monitoring step is accomplished using fluoroscopy with radiocontrast media.

35. The method as in claim 19, wherein the monitoring step is accomplished using left atrial or pulmonary capillary wedge pressure measurements.

36. The method as in claim 19, further comprising the step of determining an ongoing drug therapy taking into account post implantation hemodynamic function.

37. The method as in claim 36, comprising measuring residual regurgitation following implantation and formulating an ongoing drug therapy taking into account the residual regurgitation.