Percutaneous transvalvular intraannular band for mitral valve repair

• US 9,468,526 B2
• Filed: 02/20/2015
• Issued: 10/18/2016
• Est. Priority Date: 04/16/2008
• Status: Active Grant

• Current Assignee: Heart Rhythm Technologies, Inc. (Boston Scientific Corporation)
• Original Assignee: Heart Rhythm Technologies, Inc. (Boston Scientific Corporation)
• 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:
  US14/628,114
• Publication Number:
  US 20150223935A1
• Time in Patent Office: 606 Days
• Field of Search: 623 236- 238
• US Class Current: 1/1
• 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. An intraannular heart valve implant comprising:

a body having first and second ends, first and second anchoring portions, first and second shoulder portions, and a convex shaped 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 proximate the first anchoring portion and the central portion, the second shoulder portion located proximate the second anchoring portion and the central portion,

wherein the central portion comprises a narrowed portion narrower than part of the first and second shoulder portions to reduce resistance to blood flow, and wherein the first and second shoulder portions each comprise a narrowed portion narrower than the first and second anchoring portions to reduce resistance to blood flow,

wherein a portion of the body is dimensioned for attachment within an intraannular plane of a heart valve annulus,

wherein part of the implant is configured to be positioned within the intraannular plane of the heart valve annulus such that the convex shaped central portion extends out of a reference plane including a portion of the first and second ends, and such that the convex shaped central portion extends transversely across a coaptive edge formed by two or three valve leaflets, and

wherein the implant does not comprise an annuloplasty ring.

2. The implant of claim 1, wherein the first and second shoulder portions taper from a first width to a second width, the second width less than the first width, wherein the first width comprises a width of the first or second anchoring portion and the second width comprises a width of the central portion.

3. The implant of claim 2, wherein the first and second shoulder portions comprise a convex shape, wherein the first shoulder portion extends away from the reference plane, and wherein the second shoulder portion extends away from the reference plane.

4. The implant of claim 1, wherein the convex shaped central portion is formed with a frame, the frame comprising at least one strut extending between the first and second ends.

5. The implant of claim 1, wherein the heart valve annulus is a mitral valve annulus or an aortic valve annulus.

6. The implant of claim 1, wherein the first and second anchoring portions are configured to be attached to tissue proximate the valve annulus within the intraannular plane.

7. The implant of claim 1, wherein the implant is further configured to be positioned within the intraannular plane of the heart valve annulus such that the convex shaped central portion is convex in the direction of the outflow side of the intraannular plane to support the two or three valve leaflets and elevate the position of the coaptive edge in the direction of outflow during valve closure.

8. The implant of claim 7, wherein the convex shaped central portion is configured to elevate the position of the coaptive edge by at least about 4 mm or in the range of about 6 mm to about 12 mm.

9. An intraannular heart valve implant comprising:

an intraannular band dimensioned for attachment within an intraannular plane of a mitral valve annulus, wherein the band comprises a body comprising a first end, a second end, and a convex shaped central portion;

wherein a portion of the intraannular band is configured to be positioned within the intraannular plane of the mitral valve annulus such that the convex shaped central portion extends transversely across a coaptive edge formed by the mitral valve leaflets, and such that the convex shaped central portion is convex in the direction of the ventricular side of the intraannular plane to support the leaflets and elevate the position of the coaptive edge in the direction of the ventricle during mitral valve closure, and

wherein the band does not comprise an annuloplasty ring.

10. The implant of claim 9, wherein the convex shaped central portion comprises a narrowed portion configured to reduce resistance to blood flow.

11. The implant of claim 10, wherein the body further comprises first and second anchoring portions, the first anchoring portion located proximate the first end, the second anchoring portion located proximate the second end, wherein the first and second anchoring portions are configured to be attached to tissue proximate the mitral valve annulus within the intraannular plane.

12. The implant of claim 11, wherein the body further comprises first and second shoulder portions, the first shoulder portion located between the first anchoring portion and the central portion, the second shoulder portion located between the second anchoring portion and the central portion, wherein part of the central portion is narrower than the first and second shoulder portions to reduce resistance to blood flow, and wherein part of the first and second shoulder portions are narrower than the first and second anchoring portions to reduce resistance to blood flow.

13. The implant of claim 11, wherein the body further comprises first and second shoulder portions, the first shoulder portion located proximate the first anchoring portion and the central portion, the second shoulder portion located proximate the second anchoring portion and the central portion, wherein the first and second shoulder portions taper from a first width to a second width, the second width less than the first width.

14. The implant of claim 13, wherein the first width comprises a width of the first or second anchoring portion and the second width comprises a width of the central portion.

15. The implant of claim 9, wherein the convex shaped central portion is configured to elevate the position of the coaptive edge by at least about 4 mm or in the range of about 6 mm to about 12 mm.

16. The implant of claim 9, wherein the implant is configured to be transformable from a first radially reduced configuration to a second radially enlarged configuration, and wherein the implant is configured to be housed within a percutaneous delivery catheter in its first radially reduced configuration, the percutaneous delivery catheter comprising an elongate body and a movable outer sheath.

17. An intraannular heart valve implant comprising:

an intraannular band comprising a body having 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 convex shaped central portion, wherein the central portion is displaced out of a reference plane containing the first and second ends, and wherein said reference plane is configured to coincide with an intraannular plane of the mitral valve when the band is implanted;

wherein a portion of the intraannular band is configured to be positioned within the intraannular plane of the mitral valve annulus such that the intraannular band extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets during systole, and such that the central portion is convex in the direction of the left ventricle relative to the reference plane to elevate the position of the coaptive edge in the direction of the ventricle during valve closure, and

wherein attaching the first and second anchoring portions does not affect the size and shape of the mitral annulus.

18. The implant of claim 17, wherein the body further comprises first and second shoulder portions, the first shoulder portion located between the first anchoring portion and the central portion, the second shoulder portion located between the second anchoring portion and the central portion, wherein the first and second shoulder portions taper from a first width to a second width to reduce resistance to blood flow, the second width less than the first width, wherein the first width comprises a width of the first or second anchoring portion and the second width comprises a width of the central portion, and wherein part of the central portion is narrower than the first and second shoulder portions to reduce resistance to blood flow.

19. The implant of claim 17, wherein the convex shaped central portion is formed with a frame, the frame comprising at least one strut extending between the first and second ends.

20. The implant of claim 17, wherein the convex shaped central portion is configured to elevate the position of the coaptive edge by at least about 4 mm or in the range of about 6 mm to about 12 mm.