Percutaneous transvalvular intraannular band for mitral valve repair

• US 10,238,488 B2
• Filed: 10/17/2016
• Issued: 03/26/2019
• Est. Priority Date: 04/16/2008
• Status: Active Grant

• Current Assignee: Heart Rhythm Technologies, Inc.
• Original Assignee: Heart Rhythm Technologies, Inc.
• Inventors: Subramanian, Valavanur A., Afzal, Thomas, Hulme, Gary, Christian, Jeffrey, Reo, Michael L.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Shipmon, Tiffany
• Application Number:
  US15/295,204
• Publication Number:
  US 20170100245A1
• Time in Patent Office: 890 Days
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2/2457 Chordae tendineae prostheses

Abstract

Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band has a first end, a first anchoring portion located proximate the first end, a second end, a second anchoring portion located proximate the second end, and a central portion. The central portion is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets. The band may be implanted via translumenal access or via thoracotomy.

Claims

1. A transvalvular intraannular delivery system, comprising:

a percutaneous delivery catheter;

a movable outer sheath; and

a transvalvular intraannular implant comprising an elongate body having a longitudinal axis from a first end to a second end, wherein the transvalvular intraannular implant is configured to be transformable from a first radially reduced configuration to a second radially enlarged configuration, wherein the transvalvular intraannular implant is configured to be housed within the percutaneous delivery catheter in the first radially reduced configuration, wherein the transvalvular intraannular implant is configured to be transformed to the second radially enlarged configuration within a valve annulus and positioned such that the transvalvular intraannular implant is oriented in the valve annulus such that the longitudinal axis of the transvalvular intraannular implant is oriented substantially transversely to a coaptive edge of a heart valve positioned within the valve annulus, wherein transvalvular intraannular implant comprises a narrowed central portion to reduce resistance to blood flow.

2. The system of claim 1, further comprising a control wire operably attached to the transvalvular intraannular implant for positioning the transvalvular intraannular implant within the valve annulus.

3. The system of claim 1, further comprising at least one tissue anchor for attaching the transvalvular intraannular implant to tissue of the valve annulus.

4. The system of claim 1, further comprising a self-expandable support structure operably connected to the transvalvular intraannular implant, for securing the transvalvular intraannular implant to tissue of the valve annulus.

5. The system of claim 1, wherein the narrowed central portion is narrower than first and second shoulder portions to reduce resistance to blood flow, and wherein the first and second shoulder portions are narrower than first and second anchoring portions to reduce resistance to blood flow.

6. The system of claim 1, wherein the transvalvular intraannular implant comprises first and second anchoring portions, first and second shoulder portions, and the narrowed central portion, the first anchoring portion located proximate the first end, the second anchoring portion located proximate the second end, the first shoulder portion located between the first anchoring portion and the narrowed central portion, the second shoulder portion located between the second anchoring portion and the narrowed central portion.

7. The system of claim 1, wherein the transvalvular intraannular implant does not comprise an annuloplasty ring.

8. The system of claim 1, wherein the narrowed central portion extends out of a reference plane including a portion of the first and second ends, and such that the narrowed central portion extends transversely across a coaptive edge formed by two or three valve leaflets when the transvalvular intraannular implant is positioned.

9. The system of claim 1, wherein the narrowed central portion comprises at least one strut extending between the first and second ends.

10. The implant of claim 1, wherein the valve annulus is a mitral valve annulus.

11. The implant of claim 1, wherein the valve annulus is an aortic valve annulus.

12. The implant of claim 1, wherein the valve annulus is a tricuspid valve annulus.

13. The implant of claim 1, wherein the valve annulus is a pulmonary valve annulus.

14. The system of claim 1, wherein the transvalvular intraannular implant is configured to treat mitral valve prolapse.

15. The system of claim 1, wherein the transvalvular intraannular implant is configured to treat tricuspid valve prolapse.

16. A transvalvular intraannular delivery system, comprising:

a percutaneous delivery catheter;

an outer sheath; and

a transvalvular intraannular implant comprising an elongate body having a first end, a second end, and a convex shaped central portion, wherein the elongate body does not form a ring, wherein the convex shaped central portion is displaced out of a reference plane containing the first and second ends, and wherein the reference plane is configured to coincide with an intraannular plane of the valve annulus when the transvalvular intraannular implant is implanted;

wherein a portion of the transvalvular intraannular implant is configured to be positioned within the intraannular plane of the valve annulus such that the transvalvular intraannular implant extends transversely across a coaptive edge formed by the closure of two or three leaflets during systole, and such that the convex shaped central portion is convex relative to the reference plane to elevate the position of the coaptive edge during valve closure.

17. The system of claim 16, wherein the transvalvular intraannular implant is configured to treat mitral valve prolapse.

18. The system of claim 16, wherein the transvalvular intraannular implant is configured to treat tricuspid valve prolapse.

19. A transvalvular intraannular delivery system, comprising:

a percutaneous delivery catheter;

a movable outer sheath; and

a transvalvular intraannular implant comprising an elongate body having a longitudinal axis from a first distinct end to a second distinct end, and a narrowed central portion therebetween, wherein the transvalvular intraannular implant is configured to be transformable from a first radially reduced configuration to a second radially enlarged configuration, wherein the transvalvular intraannular implant is configured to be housed within the percutaneous delivery catheter in the first radially reduced configuration, wherein the transvalvular intraannular implant is configured to be positioned within a valve annulus in the second radially enlarged configuration such that the longitudinal axis of the transvalvular intraannular implant is oriented substantially transversely to a coaptive edge of a heart valve positioned within the valve annulus, wherein securing the transvalvular intraannular implant does not affect the size and shape of the valve annulus.

20. The system of claim 19, wherein the transvalvular intraannular implant does not comprise an annuloplasty ring.