Transvalvular intraanular band for ischemic and dilated cardiomyopathy

• US 9,615,925 B2
• Filed: 02/13/2015
• Issued: 04/11/2017
• 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 P
• Application Number:
  US14/622,611
• Publication Number:
  US 20150257884A1
• Time in Patent Office: 788 Days
• Field of Search: 623 236- 239
• 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
• 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

Abstract

Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets, to inhibit prolapse into the left atrium. At least one marginal chordae is severed, to permit leaflet closure against the band.

Claims

1. A method of treating ischemic or dilated cardiomyopathy, comprising the steps of:

providing an intraannular band dimensioned for attachment within an intraannular plane of a mitral valve annulus of a mitral valve, wherein the band comprises a body having a first end, a second end, and a convex shaped central portion, wherein the band does not comprise an annuloplasty ring; and

attaching the band within the intraannular plane of the annulus such that the convex shaped central portion extends transversely across a coaptive edge formed by mitral valve leaflets of the mitral valve, 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.

2. A method as in claim 1, wherein the elevate the position step comprises elevating the position of the coaptive edge by at least about 4 mm.

3. A method as in claim 1, wherein the elevate the position step comprises elevating the position of the coaptive edge in the range of from about 6 mm to about 12 mm.

4. A method as in claim 1, wherein the convex shaped central portion comprises a narrowed portion configured to reduce resistance to blood flow.

5. A method as in claim 4, 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.

6. A method as in claim 5, 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.

7. The implant of claim 5, 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.

8. A method as in claim 7, 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.

9. A method of treating a mitral valve, the method comprising:

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

attaching the first anchoring portion to a first portion of tissue proximate the mitral annulus within the intraannular plane; and

attaching the second anchoring portion to a second portion of tissue proximate the mitral annulus within the intraannular plane such that the intraannular band extends transversely across a coaptive edge formed by the closure of mitral valve leaflets of the mitral valve 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,

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

10. A method as in claim 9, 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.

11. A method as in claim 10, 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.

12. A method as in claim 9, wherein the elevate the position step comprises elevating the position of the coaptive edge by at least about 4 mm.

13. A method of treating ischemic or dilated cardiomyopathy, comprising the steps of:

providing an intraannular band dimensioned for attachment within an intraannular plane of a heart valve annulus of a heart valve, wherein the band comprises a body having a first end, a second end, and a convex shaped central portion, wherein the band does not comprise an annuloplasty ring; and

attaching the band within the intraannular plane of the annulus such that the convex shaped central portion extends out of a reference plane including a portion of the first and second ends, such that the convex shaped central portion extends transversely across a coaptive edge formed by two or three valve leaflets of the heart valve, and 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.

14. A method as in claim 13, wherein the first and second anchoring portions comprise an arcuate shape, wherein the arcuate shape is configured to extend around a portion of a circumference proximate the valve annulus.

15. A method as in claim 13, wherein the body further comprises first and second anchoring portions and first and second shoulder portions, 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 part of the first and second anchoring portions to reduce resistance to blood flow.

16. A method as in claim 13, 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.

17. A method as in claim 13, 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.

18. A method as in claim 13, wherein the heart valve annulus is a mitral valve annulus or an aortic valve annulus.

19. A method as in claim 13, wherein the elevate the position step comprises elevating the position of the coaptive edge by at least about 4 mm.

20. A method as in claim 13, wherein the elevate the position step comprises elevating the position of the coaptive edge in the range of from about 6 mm to about 12 mm.