Transluminal mitral annuloplasty with active anchoring

• US 7,296,577 B2
• Filed: 08/05/2003
• Issued: 11/20/2007
• 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: Taylor, David, Birdsall, Matthew, Lashinski, Randall, Lau, Jan
• Primary Examiner(s): Isabella; David J.
• Application Number:
  US10/634,643
• Publication Number:
  US 20040138744A1
• Time in Patent Office: 1,568 Days
• Field of Search: 623/2.36, 623/2.37, 623/1.1, 623/1.11, 623/1.13, 623/1.16, 623/2.1, 623/2.11, 623/1.2, 623/11.11, 623/66.1, 623/902, 623/900, 623/912, 606/108, 606/151, 606/198, 606191-195, 600/481, 600/483, 600/485, 600/37, 604/509, 604/510, 604/528, 604/544, 128/898
• US Class Current: 128/898
• 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

Abstract

A medical apparatus and method for remodeling a mitral valve annulus adjacent to the coronary sinus includes an elongate body having a proximal end and a distal end. The elongate body is movable from a first, flexible configuration for transluminal delivery to at least a portion of the coronary sinus to a second configuration for remodeling the mitral valve annulus.

Claims

1. A method of performing transluminal mitral annuloplasty, comprising the steps of:

providing a catheter, having a prosthesis thereon;

inserting the catheter into the venous system;

transluminally advancing the prosthesis into the coronary sinus such that a distal end portion of the prosthesis is in contact with an inner wall of the coronary sinus;

actuating a pull wire on the catheter to actively advance at least one tissue anchor on the distal end portion from a retracted position to an extended position; and

manipulating a component of the prosthesis to cause the prosthesis to exert force on the mitral valve annulus.

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

3. A method as in claim 2, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian and femoral veins.

4. 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 inserting step.

5. A method as in claim 1, further comprising the step of measuring hemodynamic function following the manipulating a component of the prosthesis step.

6. A method as in claim 5, further comprising the step of determining an ongoing drug therapy taking into account the post implantation hemodynamic function.

7. A method as in claim 1, wherein the advancing at least one tissue anchor step comprises advancing the anchor from an axial orientation to an inclined orientation.

8. A method as in claim 7, wherein the tissue anchor has a proximal end for piercing tissue and a distal point of attachment to the prosthesis, and the advancing at least one tissue anchor step comprises rotating the anchor about the point of attachment.

9. A method as in claim 1, comprising advancing at least two tissue anchors to an extended position.

10. A method as in claim 8, comprising advancing at least two tissue anchors to an extended position.

11. A method as in claim 1, wherein the manipulating a component of the prosthesis step causes the prosthesis to transform into a curved configuration having a first side facing towards the mitral valve annulus and a second side facing away from the mitral valve annulus.

12. A method as in claim 11, wherein the tissue anchor is configured to be advanced in the direction of the mitral valve annulus.

13. 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.

14. A method as in claim 1, further comprising the step of locking the prosthesis to retain a force on the annulus following the manipulating step.

15. A method as in claim 14, wherein the locking step comprises moving an engagement surface from a disengaged configuration to an engaged configuration.

16. A method as in claim 14, wherein the locking step comprises providing an interference fit.

17. A method as in claim 14, wherein the locking step is accomplished with a threaded engagement.

18. A method as in claim 5, wherein the step of monitoring hemodynamic function is accomplished using transesophageal echo cardiography.

19. A method as in claim 5, wherein the step of monitoring hemodynamic function is accomplished using surface echo cardiographic imaging.

20. A method as in claim 5, wherein the step of monitoring hemodynamic function is accomplished using intracardiac echo cardiographic imaging.

21. A method as in claim 5, wherein the step of monitoring hemodynamic function is accomplished using fluoroscopy with radiocontrast media.

22. A method as in claim 5, wherein the step of monitoring hemodynamic function is accomplished using left atrial or pulmonary capillary wedge pressure measurements.