Transvalvular intraannular band for mitral valve repair

• US 10,456,259 B2
• Filed: 10/13/2016
• Issued: 10/29/2019
• 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): Woznicki, Jacqueline
• Application Number:
  US15/293,111
• Publication Number:
  US 20170105839A1
• Time in Patent Office: 1,111 Days
• 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 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

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 band, the transvalvular band comprising:

an elongate 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 central portion connected to the first end and the second end, wherein the central portion comprises a convex arcuate shape and comprises a plurality of crossing struts encapsulated by a material such that the plurality of crossing struts are fixed relative to each other, the crossing struts intersecting at an intersection zone, the central portion configured to be displaced transversely from an intraannular plane when the band is attached to an annulus;

wherein the first end and the second end are configured to be attached to the annulus within the intraannular plane and the central portion is configured to be convex in a direction of outflow to support valve leaflets at a point displaced toward a ventricle from the intraannular plane, wherein the first end and the second end reside on a septal-lateral axis transverse to coaptive edges of the valve leaflets when the band is attached to the annulus, and wherein the band does not comprise an annuloplasty ring.

2. The transvalvular intraannular band of claim 1, wherein the band is configured to withstand a tension force of at least about 0.80 N when implanted in the valve annulus.

3. The transvalvular intraannular band of claim 1, wherein the band is configured to withstand a compressive force of at least about 0.60 N when implanted in the valve annulus.

4. The transvalvular intraannular band of claim 1, wherein the band is configured to withstand a leaflet load of at least about 1.3 N when implanted in the valve annulus.

5. The transvalvular intraannular band of claim 1, wherein the material comprises silicone.

6. The transvalvular intraannular band of claim 1, wherein the first anchoring portion and the second anchoring portion comprise a fabric material.

7. The transvalvular intraannular band of claim 6, wherein the fabric material comprises PET.

8. The transvalvular intraannular band of claim 1, wherein a width of the central portion at the intersecting zone is between about 20% and about 50% of the width of the central portion directly adjacent to the first anchoring portion.

9. The transvalvular intraannular band of claim 1, wherein a thickness of the first anchoring portion is between about 25% and about 75% greater than a thickness of the central portion.

10. The transvalvular intraannular band of claim 1, wherein each crossing strut comprises a lateral curved transition zone having a first curvature and a medial curved transition zone having a second curvature different from the first curvature.

11. The transvalvular intraannular band of claim 1, wherein the intersection zone comprises a vertex of the central portion.

12. The transvalvular intraannular band of claim 1, wherein the width of each strut is between about 1 mm and about 2 mm.

13. The transvalvular intraannular band of claim 1, wherein the struts comprise Nitinol.

14. The transvalvular intraannular band of claim 1, wherein the plurality of struts form an X shape.

15. The transvalvular intraannular band of claim 1, wherein the plurality of struts comprise a shape memory metal.

16. The transvalvular intraannular band of claim 15, wherein the material comprises silicone.

17. The transvalvular intraannular band of claim 1, wherein the central portion narrows toward the intersection zone.

18. The transvalvular intraannular band of claim 1, wherein the central portion forms an X that gradually narrows toward the intersection zone.

19. The transvalvular intraannular band of claim 1, wherein the plurality of struts comprises two struts.

20. The transvalvular intraannular band of claim 1, wherein each strut comprises a lateral curved transition zone which has a first curvature, and medial curved transition zone which has a second curvature different from the first curvature, the lateral curved transition zone and the medial curved transition zone extending from one of the first or second anchoring portions to the intersection zone.

21. The transvalvular intraannular band of claim 1, wherein the material follows the shape of the plurality of crossing struts.