Cardiac tissue cinching

• US 9,801,720 B2
• Filed: 06/14/2015
• Issued: 10/31/2017
• Est. Priority Date: 06/19/2014
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Gilmore, Michael, Denti, Paolo, Guidotti, Andrea, Latib, Mohamed Azeem, Lynn, Kevin, Mullins, John, Maisano, Francesco, Zarbatany, David
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): Wei, Charles
• Application Number:
  US15/123,157
• Publication Number:
  US 20170086975A1
• Time in Patent Office: 870 Days
• Field of Search: 606132, 606232
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

A method is provided including making an opening (300) through an atrial septum (302) at a septal site (304) at least 5 mm from a fossa ovalis (330). A first tissue anchor (204) is endovascularly advanced to a left-atrial site (306) on an annulus of a mitral valve (310) or a wall of a left atrium (308) above the annulus. The first tissue anchor (204) is implanted at the left-atrial site (306). A second tissue anchor (24) is endovascularly advanced to a right-atrial site (320) on an annulus of a tricuspid valve (207) or a wall of a right atrium (200) above the annulus. The second tissue (24) anchor is implanted at the right-atrial site (320). The left-atrial site (306) and the right-atrial site (320) are approximated by tensioning a tether (22) that passes through the opening (300) of the atrial septum (302) and connects the first and the second tissue anchors (204, 24). Other embodiments are also described.

Claims

1. A method comprising:

making an opening through an atrial septum at a septal site at least 5 mm from a fossa ovalis;

endovascularly advancing a first tissue anchor to a left-atrial site selected from the group of sites consisting of;

a mitral annular site on an annulus of a mitral valve, and a wall of a left atrium of a heart above the mitral annular site;

implanting the first tissue anchor at the left-atrial site;

endovascularly advancing a second tissue anchor to a right-atrial site selected from the group of sites consisting of;

a tricuspid annular site on an annulus of a tricuspid valve, and a wall of a right atrium of the heart above the tricuspid annular site;

implanting the second tissue anchor at the right-atrial site; and

reducing the size of the tricuspid valve orifice and the size of the mitral valve orifice by approximating the left-atrial site and the right-atrial site by tensioning a tether that passes through the opening of the atrial septum and connects the first and the second tissue anchors.

2. The method according to claim 1, wherein endovascularly advancing the first and the second tissue anchors comprises percutaneously advancing the first and the second tissue anchors to the left- and right-atrial sites, respectively.

3. The method according to claim 1, wherein the mitral annular site circumferentially corresponds to a posterior leaflet of the mitral valve.

4. The method according to claim 3, wherein the mitral annular site circumferentially corresponds to an annular site of the mitral valve, which is characterized by at least one of the following:

the annular site is within 1 cm of a lateral scallop (P1) of the posterior leaflet, and the annular site is within 1 cm of a middle scallop (P2) of the posterior leaflet.

5. The method according to claim 1, wherein the tricuspid annular site circumferentially corresponds to an annular site of the tricuspid valve that is (a) at or clockwise to a point on the tricuspid annulus 2 cm counterclockwise to an anteroposterior commissure (APC) of the tricuspid valve, and (b) at or counterclockwise to a posteroseptal commissure of the tricuspid valve, as viewed from the right atrium.

6. The method according to claim 1,

wherein the mitral annular site circumferentially corresponds to a posterior leaflet of the mitral valve, and

wherein the tricuspid annular site circumferentially corresponds to an annular site of the tricuspid valve that is (a) at or clockwise to a point on the tricuspid annulus 2 cm counterclockwise to an anteroposterior commissure (APC) of the tricuspid valve, and (b) at or counterclockwise to a posteroseptal commissure of the tricuspid valve, as viewed from the right atrium.

7. The method according to claim 1, wherein the septal site is at least 10 mm from the fossa ovalis.

8. The method according to claim 1, wherein the septal site is anterior to the fossa ovalis.

9. The method according to claim 1, wherein the septal site is apical to the fossa ovalis.

10. The method according to claim 1, wherein the septal site is between 3 and 20 mm superior and anterior to a coronary sinus orifice and between 3 and 10 mm posterior to an aorta.

11. The method according to claim 1, wherein implanting the first and the second tissue anchors and tensioning the tether comprises implanting the first and the second tissue anchors and tensioning the tether such that an angle formed in the tether at the opening of the atrial septum is at least 120 degrees.

12. The method according to claim 11, wherein, if the tensioned tether were to be projected onto a coronal plane of the heart, the angle as projected would be at least 120 degrees.

13. The method according to claim 11, wherein, if the tensioned tether were to be projected onto a transverse plane of the heart, the angle as projected would be at least 120 degrees.

14. The method according to claim 1, wherein implanting the first and the second tissue anchors and tensioning the tether comprises implanting the first and the second tissue anchors and tensioning the tether such that (a) a portion of the tensioned tether in the left atrium between the opening of the atrial septum and the first tissue anchor and (b) a plane defined by the annulus of the mitral valve, form an angle of less than 30 degrees.

15. The method according to claim 1, wherein implanting the first and the second tissue anchors and tensioning the tether comprises implanting the first and the second tissue anchors and tensioning the tether such that (a) a portion of the tensioned tether in the right atrium between the opening of the atrial septum and the second tissue anchor and (b) a plane defined by the annulus of the tricuspid valve, form an angle of less than 30 degrees.

16. The method according to claim 1, further comprising placing, in the opening of the atrial septum, an annular reinforcement element that is shaped so as to define an opening therethrough, and wherein the tether passes through the opening of the reinforcement element.

17. The method according to claim 1, wherein endovascularly advancing the second tissue anchor comprises endovascularly advancing the second tissue anchor after implanting the first tissue anchor.

18. The method according to claim 1, wherein endovascularly advancing the first tissue anchor comprises endovascularly advancing the first tissue anchor after implanting the second tissue anchor.

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

placing a locking mechanism in the opening of the atrial septum; and

transitioning the locking mechanism from an unlocked state to a locked state, wherein the locking mechanism, in the locked state, inhibits sliding of the tether through the locking mechanism, thereby fixing respective distances between the opening of the atrial septum and the first and the second tissue anchors.

20. The method according to claim 19, wherein transitioning the locking mechanism comprises transitioning the locking mechanism from the unlocked state to the locked state after tensioning the tether.