IP Library Granted Patent US 8,382,829
Granted Patent B1
US 8,382,829 · App. 12/400,350 · Granted Feb 26, 2013

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

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Quick Facts
Patent No.
US 8,382,829
App. No.
12/400,350
Granted
Feb 26, 2013
Kind
B1
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 (49)

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 P 1 , P 2 , and P 3 regions and the anterior leaflet includes A 1 , A 2 , and A 3 regions, the position on the posterior portion of the annulus being near the P 1 region and the position on the anterior portion of the annulus being near the A 1 region.

7. The method according to claim 1 , wherein the posterior leaflet includes P 1 , P 2 , and P 3 regions and the anterior leaflet includes A 1 , A 2 , and A 3 regions, the position on the posterior portion of the annulus being near the P 3 region and the position on the anterior portion of the annulus being near the A 3 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 P 1 , P 2 , and P 3 regions and the anterior leaflet includes A 1 , A 2 , and A 3 regions, the first position on the posterior portion of the annulus being near the P 1 region, the second position on the posterior portion of the annulus being near the P 3 region, the first position on the anterior portion of the annulus being near the A 1 region, and the second position on the anterior portion of the annulus being near the A 3 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 P 1 , P 2 , and P 3 regions and the anterior leaflet includes A 1 , A 2 , and A 3 regions, the position on the posterior portion of the annulus being near the P 1 region and the position on the anterior portion of the annulus being near the A 1 region.

15. The method according to claim 10 , wherein the posterior leaflet includes P 1 , P 2 , and P 3 regions and the anterior leaflet includes A 1 , A 2 , and A 3 regions, the position on the posterior portion of the annulus being near the P 3 region and the position on the anterior portion of the annulus being near the A 3 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 P 1 , P 2 , and P 3 regions and the anterior leaflet includes A 1 , A 2 , and A 3 regions, the first position on the posterior portion of the annulus being near the P 1 region, the second position on the posterior portion of the annulus being near the P 3 region, the first position on the anterior portion of the annulus being near the A 1 region, and the second position on the anterior portion of the annulus being near the A 3 region.

Assignments (8)
RELEASE OF SECURITY INTEREST Recorded May 31, 2019
From: SOLAR CAPITAL LTD
To: MITRALIGN, INC.
Reel/Frame 049329/0183 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 19, 2019
From: MITRALIGN, INC.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 048941/0323 →
ASSIGNMENT OF INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded May 24, 2016
From: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS RETIRING AGENT
To: SOLAR CAPITAL LTD., AS SUCCESSOR AGENT
Reel/Frame 038806/0390 →
ASSIGNMENT OF INTELLECTUAL PROPERTY SECURITY INTEREST Recorded Nov 18, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, RETIRING AGENT
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC, SUCCESSOR AGENT
Reel/Frame 037146/0250 →
SECURITY INTEREST Recorded Jan 5, 2015
From: MITRALIGN, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 034635/0173 →
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2012
From: GENERAL ELECTRIC CAPITAL CORPORATION
To: MITRALIGN INC.
Reel/Frame 028992/0635 →
SECURITY AGREEMENT Recorded Jul 27, 2011
From: MITRALIGN, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 026661/0810 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 1, 2009
From: CALL, AARON M.; LANE, JOSEPH P.
To: MITRALIGN, INC.
Reel/Frame 022761/0247 →