Methods and devices for reducing paravalvular leakage

• US 10,390,953 B2
• Filed: 03/08/2017
• Issued: 08/27/2019
• Est. Priority Date: 03/08/2017
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Wypych, Rick
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US15/453,734
• Publication Number:
  US 20180256330A1
• Time in Patent Office: 902 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

Methods and devices for reducing paravalvular leakage associated with a replacement mitral valve. The methods can include monitoring for paravalvular leakage between a replacement mitral valve and tissue proximate the mitral valve annulus; if a sufficient amount of paravalvular leakage is observed, deploying a tissue reshaping device at least partially within a coronary sinus; remodeling coronary sinus tissue with the tissue reshaping device to remodel at least one of mitral valve annulus tissue, at least one mitral valve leaflet, and left atrium tissue in an attempt to reduce the paravalvular leakage; and monitoring for a reduction in paravalvular leakage after the remodeling step.

Claims

1. A method of reducing paravalvular leakage associated with a replacement mitral valve, comprising:

monitoring for paravalvular leakage between a replacement mitral valve and tissue proximate the mitral valve annulus;

if paravalvular leakage is observed, deploying a tissue reshaping device solely within a coronary sinus;

intravascularly remodeling coronary sinus tissue with the tissue reshaping device deployed solely within the coronary sinus to cause the remodeling of at least one of mitral valve annulus tissue, at least one mitral valve leaflet, and left atrium tissue in an attempt to reduce the paravalvular leakage; and

monitoring for a reduction in paravalvular leakage after the remodeling step.

2. The method of claim 1, wherein, after monitoring for a reduction in paravalvular leakage after the remodeling step, if the monitored paravalvular leakage has been reduced, maintaining the remodeling of the coronary sinus with the tissue reshaping device and maintaining the remodeling of the at least one of the mitral valve annulus tissue, mitral valve leaflets, and left atrium tissue to maintain the reduced paravalvular leakage.

3. The method of claim 2, wherein the maintaining step comprises releasing the tissue reshaping device from a delivery device to implant the tissue reshaping device.

4. The method of claim 2, further comprising releasing the replacement mitral valve from a delivery device.

5. The method of claim 1, further comprising, if the monitored paravalvular leakage has been reduced, releasing the tissue reshaping device from a delivery device.

6. The method of claim 1, further comprising, if the monitored paravalvular leakage has been reduced, releasing the replacement mitral valve from a delivery device.

7. The method of claim 6, further comprising monitoring paravalvular leakage after releasing the replacement mitral valve from the delivery device to determine if paravalvular leakage increased as a result of releasing the replacement mitral valve from the delivery device, and if so, repeating the remodeling and second monitoring steps.

8. The method of claim 1, further comprising, after monitoring for paravalvular leakage after the remodeling step, if the paravalvular leakage has not been reduced, further remodeling coronary sinus tissue with the tissue reshaping device to further remodel at least one of mitral valve annulus tissue, mitral valve leaflets, and left atrium tissue in an attempt to reduce paravalvular leakage, and further monitoring paravalvular leakage.

9. The method of claim 8, further comprising, if paravalvular leakage has not been reduced, repeating the further remodeling and further monitoring steps until the paravalvular leakage has been reduced.

10. The method of claim 8, wherein if the paravalvular leakage has been reduced, releasing the tissue reshaping device from a delivery device to thereby implant the tissue reshaping device and maintain the reduced paravalvular leakage.

11. The method of claim 8, wherein if the paravalvular leakage has been reduced, releasing the mitral valve replacement from a delivery device.

12. The method of claim 1, wherein remodeling coronary sinus tissue with the tissue reshaping device comprises plicating coronary sinus tissue with the tissue reshaping device.

13. The method of claim 12, wherein deploying a tissue reshaping device comprises anchoring a first anchor of the tissue reshaping device within the coronary sinus, and wherein plicating coronary sinus tissue comprises proximally pulling on the tissue reshaping device after the first anchor is anchored within the coronary sinus.

14. The method of claim 13, further comprising anchoring a second anchor of the tissue reshaping device against tissue when the monitored paravalvular leakage has been reduced.

15. The method of claim 13, wherein deploying a tissue reshaping device comprises anchoring first and second anchors, and wherein plicating coronary sinus tissue comprises proximally pulling on a portion of the tissue reshaping device after the first and second anchors are anchored.

16. The method of claim 1, wherein remodeling coronary sinus tissue with the tissue reshaping device comprises reducing the curvature of at least a portion of the coronary sinus.

17. The method of claim 1, wherein remodeling coronary sinus tissue with the tissue reshaping device comprises increasing the curvature of at least a portion of the coronary sinus.

18. The method of claim 1, wherein remodeling coronary sinus tissue with the tissue reshaping device is at least partially caused by pulling on the tissue reshaping device.

19. The method of claim 1, wherein remodeling coronary sinus tissue with the tissue reshaping device is at least partially caused by straightening at least a portion of the tissue reshaping device.

20. The method of claim 1, wherein remodeling coronary sinus tissue with the tissue reshaping device is at least partially caused by increasing the curvature of at least a portion of the tissue reshaping device.

21. The method of claim 1, further comprising, prior to the first monitoring step, expanding the replacement mitral valve into contact with at least one of left atrial tissue, mitral valve annulus tissue, native mitral valve leaflet tissue, and left ventricular tissue.

22. The method of claim 21, wherein the expanded replacement mitral valve remains secured to a delivery device when the remodeling step is initiated.

23. The method of claim 1, wherein, if paravalvular leakage is observed after the first monitoring step, the method further comprises delivering the tissue reshaping device to the coronary sinus.

24. The method of claim 1, wherein monitoring for paravalvular leakage between the replacement mitral valve and tissue proximate the mitral valve annulus comprising monitoring blood flow between the replacement mitral valve and tissue using an imaging modality.