Method and apparatus for improving mitral valve function

• US 7,186,264 B2
• Filed: 03/29/2002
• Issued: 03/06/2007
• Est. Priority Date: 03/29/2001
• Status: Expired due to Fees

• Current Assignee: Guided Delivery Systems, Inc.
• Original Assignee: Viacor, Inc.
• Inventors: Cohn, William E., Liddicoat, John R., Davenport, Todd F., Streeter, Richard B., Taylor, Daniel C., Woolfson, Steven B.
• Primary Examiner(s): Pellegrino; Brian E.
• Application Number:
  US10/112,354
• Publication Number:
  US 20020183838A1
• Time in Patent Office: 1,803 Days
• Field of Search: 623/1.1, 623/1.16, 623/2.11, 623/2.37, 623/903, 623/904
• 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: 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 forming a straightening device having a first end and a second end, the straightening device defining a longitudinal axis between the first end and the second end, and the straightening device defining a first side and a second side on opposing sides of the longitudinal axis, the first side defining a series of gaps between the plurality of elements, the straightening device having an insertion configuration comprising orienting the gaps away from the mitral valve so as to allow the straightening device to curve as required to follow a natural curvature of the coronary sinus, the first end configured to allow rotation of the straightening device, the first end having a given length configured to extend outside of the coronary sinus with the second end and the plurality of elements forming the straightening device disposed within the coronary sinus, the straightening device having a straightened configuration wherein the gaps are oriented toward the mitral valve so as to force the straightening device to straighten within the coronary sinus, and wherein the straightening device is configured to rotate within the coronary sinus between the insertion configuration and the straightened configuration, the plurality of elements being separated apart from one another during insertion into the coronary sinus and thereafter closed together in situ so as to form the apparatus;

wherein each of the elements has a length such that it is, by itself, insufficient to significantly move the coronary sinus.

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

3. A method according to claim 2 wherein the distalmost of the elements is delivered to the coronary sinus by advancing the flexible body into the coronary sinus.

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

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

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

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

8. A method according to claim 7 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.

9. A method according to claim 1 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.

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

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

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

13. A method according to claim 12 wherein the elements are guided into position by inserting the guidewire into the coronary sinus and then passing the elements down the guidewire.

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

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

16. A method according to claim 15 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.

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

18. 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 forming a straightening device having a first end and a second end, the straightening device defining a longitudinal axis between the first end and the second end, and the straightening device defining a first side and a second side on opposing sides of the longitudinal axis, the first side defining a series of gaps between the plurality of elements, the straightening device having an insertion configuration comprising orienting the gaps away from the mitral valve so as to allow the straightening device to curve as required to follow a natural curvature of the coronary sinus, the first end configured to allow rotation of the straightening device, the first end having a given length configured to extend outside of the coronary sinus with the second end and the plurality of elements forming the straightening device disposed within the coronary sinus, the straightening device having a straightened configuration wherein the gaps are oriented toward the mitral valve so as to force the straightening device to straighten within the coronary sinus, and wherein the straightening device is configured to rotate within the coronary sinus between the insertion configuration and the straightened configuration, the plurality of elements being separated apart from one another during insertion into the coronary sinus and thereafter closed together in situ so as to form the apparatus;

wherein the elements are inserted into the coronary sinus percutaneously; and

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 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 forming a straightening device having a first end and a second end, the straightening device defining a longitudinal axis between the first end and the second end, and the straightening device defining a first side and a second side on opposing sides of the longitudinal axis, the first side defining a series of gaps between the plurality of elements, the straightening device having an insertion configuration wherein the gaps are orientated away from the mitral valve so as to the allow the straightening device to curve as required to follow a natural curvature of the coronary sinus, the straightening device having a straightened configuration wherein the gaps are oriented toward the mitral valve so as to force the straightening device to straighten within the coronary sinus, and the straightening device is configured to rotate within the coronary sinus between the insertion configuration and the straightened configuration, the plurality of elements being separated apart from one another during insertion into the coronary sinus and thereafter closed together in situ so as to form the straightened configuration;

wherein the elements are guided into position by passing them over a pre-positioned guidewire; and

wherein the elements are guided into position by inserting the guidewire into the coronary sinus and then passing the elements down the guidewire.