Method to reduce mitral regurgitation by cinching the commissure of the mitral valve

• US 8,382,829 B1
• Filed: 03/09/2009
• Issued: 02/26/2013
• Est. Priority Date: 03/10/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Inventors: Call, Aaron M., Lane, Joseph P.
• Primary Examiner(s): Matthews, William H.
• Application Number:
  US12/400,350
• Time in Patent Office: 1,450 Days
• Field of Search: 623/2.11, 623 236- 237, 600/16, 606138-140, 606142-158
• US Class Current: 623/2.37
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0466 Suture bridges
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

Methods of repairing the mitral valve and reducing mitral regurgitation. One method includes securing a first tissue anchor to a position on a posterior portion of the annular tissue of the mitral valve and a second tissue anchor to a position on an anterior portion of the annular tissue of the mitral valve. At least one tensile member spans between the first and second tissue anchors and across the orifice of the mitral valve. When tension is applied to the at least one tensile member, the posterior portion of the annular tissue is pulled toward the anterior portion.

Claims

1. A method of repairing a mitral heart valve, the mitral heart valve having posterior and anterior leaflets forming an orifice therebetween, an annulus surrounding the posterior and anterior leaflets, and posterior and anterior commissures where the posterior and anterior leaflets join the annulus, the method comprising:

(a) providing at least first and second tissue anchors, wherein each of the first and second tissue anchors includes a plurality of discrete, flat, flexible anchor elements coupled by at least one tensile member;

(b) securing the first tissue anchor to a position on a posterior portion of the annulus between the posterior and anterior commissures by advancing at least two of the plurality of discrete, flat, flexible anchor elements through to one side of the annulus with at least one of the discrete, flat, flexible anchor elements disposed on the other side of the annulus;

(c) securing the second tissue anchor to a position on an anterior portion of the annulus between the posterior and anterior commissures by advancing at least two of the plurality of discrete, flat, flexible anchor elements through to one side of the annulus with at least one of the discrete, flat, flexible anchor elements disposed on the other side of the annulus;

(d) drawing the at least two of the plurality of discrete, flat, flexible anchor elements of each of the first and second anchors along their respective tensile members and into contact with each other;

(e) spanning at least one of the tensile members between the first and second tissue anchors and across the orifice of the mitral valve; and

(f) applying tension to the at least one tensile member, thereby pulling the posterior portion of the annulus toward the anterior portion of the annulus.

2. The method according to claim 1, wherein the at least one tensile member is a suture.

3. The method according to claim 1 further comprising:

maintaining the tension applied to the at least one tensile member with a suture locker.

4. The method according to claim 3 further comprising:

percutaneously directing the suture locker to the at least one tensile member with at least one catheter.

5. The method according to claim 1 further comprising:

percutaneously directing the first tissue anchor to the position on the posterior portion of the annulus with at least one catheter; and

percutaneously directing the second tissue anchor to the position on the anterior portion of the annulus with the at least one catheter.

6. The method according to claim 1, wherein the posterior leaflet includes P1, P2, and P3 regions and the anterior leaflet includes A1, A2, and A3 regions, the position on the posterior portion of the annulus being near the P1 region and the position on the anterior portion of the annulus being near the A1 region.

7. The method according to claim 1, wherein the posterior leaflet includes P1, P2, and P3 regions and the anterior leaflet includes A1, A2, and A3 regions, the position on the posterior portion of the annulus being near the P3 region and the position on the anterior portion of the annulus being near the A3 region.

8. The method according to claim 1, further comprising:

(g) securing a third tissue anchor to a second position on the posterior portion of the annulus between the posterior and anterior commissures;

(h) securing a fourth tissue anchor to a second position on the anterior portion of the annulus between the posterior and anterior commissures;

(i) spanning at least one tensile member between the third and fourth tissue anchors and across the orifice of the mitral valve; and

(j) applying tension to the at least one tensile member to further pull the posterior portion of the annulus toward the anterior portion of the annulus.

9. The method according to claim 8, wherein the posterior leaflet includes P1, P2, and P3 regions and the anterior leaflet includes A1, A2, and A3 regions, the first position on the posterior portion of the annulus being near the P1 region, the second position on the posterior portion of the annulus being near the P3 region, the first position on the anterior portion of the annulus being near the A1 region, and the second position on the anterior portion of the annulus being near the A3 region.

10. A method of repairing a mitral heart valve, the mitral heart valve having posterior and anterior leaflets forming an orifice therebetween, an annulus surrounding the posterior and anterior leaflets, and posterior and anterior commissures where the posterior and anterior leaflets join the annulus, the method comprising:

(a) directing a first guide-wire into the right atrium, across an intra-atrial septum, into the left atrium, and to a position on a posterior portion of the annulus between the posterior and anterior commissures;

(b) advancing a first tissue anchor along the first guide-wire to the position on the posterior portion of the annulus, the first tissue anchor including a plurality of discrete, flat, flexible anchor elements coupled by at least one tensile member;

(c) securing the first tissue anchor to the position on the posterior portion of the annulus by advancing at least two of the plurality of discrete, flat, flexible anchor elements through to one side of the annulus with at least one of the discrete, flat, flexible anchor elements disposed on the other side of the annulus;

(d) directing a second guide-wire into the right atrium, across the intra-atrial septum, into the left atrium, and to a position on an anterior portion of the annulus between the posterior and anterior commissures;

(e) advancing a second tissue anchor along the second guidewire to the position on the anterior portion of the annulus, the first tissue anchor including a plurality of discrete, flat, flexible anchor elements coupled by at least one tensile member;

(f) securing the second tissue anchor to the position on the anterior portion of the annulus by advancing at least two of the plurality of discrete, flat, flexible anchor elements through to one side of the annulus with at least one of the discrete flat flexible anchor elements disposed on the other side of the annulus;

(g) drawing the at least two of the plurality of discrete, flat, flexible anchor elements of each of the first and second anchors along their respective tensile members and into contact with each other;

(h) spanning at least one of the tensile members between the first and second tissue anchors and across the orifice of the mitral valve; and

(i) applying tension to the at least one tensile member, thereby pulling the posterior portion of the annulus toward the anterior portion of the annulus.

11. The method according to claim 10, wherein the steps (a)-(i) are performed percutaneously with at least one catheter.

12. The method according to claim 11, wherein the at least one catheter is percutaneously directed into the right atrium through the inferior or superior vena cava.

13. The method according to claim 10 further comprising:

maintaining the tension applied to the at least one tensile member with a suture locker.

14. The method according to claim 10, wherein the posterior leaflet includes P1, P2, and P3 regions and the anterior leaflet includes A1, A2, and A3 regions, the position on the posterior portion of the annulus being near the P1 region and the position on the anterior portion of the annulus being near the A1 region.

15. The method according to claim 10, wherein the posterior leaflet includes P1, P2, and P3 regions and the anterior leaflet includes A1, A2, and A3 regions, the position on the posterior portion of the annulus being near the P3 region and the position on the anterior portion of the annulus being near the A3 region.

16. The method according to claim 10, further comprising:

(j) directing a third guide-wire into the right atrium, across the intra-atrial septum, into the left atrium, and to a second position on the posterior portion of the annulus between the posterior and anterior commissures;

(k) advancing a third tissue anchor to the second position on the posterior portion of the annulus;

(l) securing the third tissue anchor to the second position on the posterior portion of the annulus;

(m) directing a fourth guide-wire into the right atrium, across the intra-atrial septum, into the left atrium, and to a second position on the anterior portion of the annulus between the posterior and anterior commissures;

(n) advancing a fourth tissue anchor to the second position on the anterior portion of the annulus;

(o) securing the fourth tissue anchor to the second position on the anterior portion of the annulus;

(p) spanning at least one tensile member between the third and fourth tissue anchors and across the orifice of the mitral valve; and

(q) applying tension to the at least one tensile member to further pull the posterior portion of the annulus toward the anterior portion of the annulus.

17. The method according to claim 16, wherein the posterior leaflet includes P1, P2, and P3 regions and the anterior leaflet includes A1, A2, and A3 regions, the first position on the posterior portion of the annulus being near the P1 region, the second position on the posterior portion of the annulus being near the P3 region, the first position on the anterior portion of the annulus being near the A1 region, and the second position on the anterior portion of the annulus being near the A3 region.