Device, system, and method for transcatheter treatment of valve regurgitation
The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation enhancement element for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, catheter and driver; and a method for transcatheter implantation of a coaptation element across a heart valve.
1. A coaptation implant system comprising:
a coaptation implant comprising:
a coaptation surface and a leaflet surface;
a superior edge, lateral edges, and an inferior edge, wherein a distance between the lateral edges generally decreases toward the inferior edge;
a hub; and
at least one strut, wherein a strut of the at least one strut extends from the hub toward the inferior edge; and
a helical anchor configured to be rotated relative to the hub to engage tissue, wherein the coaptation implant is configured to be suspended across a valve plane of a valve from an atrium proximally and toward a ventricle distally, wherein the coaptation implant is configured to be suspended such that the coaptation surface coapts with a first leaflet and the leaflet surface overlies a second leaflet.
2. The coaptation implant system of claim 1 , wherein the coaptation implant is configured to attach superiorly to a posterior aspect of an annulus.
3. The coaptation implant system of claim 1 , wherein the hub is cylindrical.
4. The coaptation implant system of claim 1 , wherein the hub is spaced inward from the superior edge.
5. The coaptation implant system of claim 1 , wherein more than one anchor is configured to attach the coaptation implant to tissue.
6. The coaptation implant system of claim 1 , wherein during diastole, the coaptation implant is configured to stay in substantially the same position while movement of the first leaflet opens the valve.
7. The coaptation implant system of claim 1 , wherein during systole, a surface of the coaptation implant is configured to stretch away from the helical anchor while the helical anchor remains unmoved.
8. A coaptation implant system comprising:
a coaptation implant comprising:
a coaptation surface and a leaflet surface;
a superior edge, lateral edges, and an inferior edge, wherein a distance between the lateral edges generally decreases toward the inferior edge;
a hub configured to be located near a mitral valve annulus; and
a strut extending from the hub toward the inferior edge; and
a helical anchor configured to be rotated relative to the hub; and
a driver configured to rotate the helical anchor, wherein the driver is configured to engage to the helical anchor extra-corporeally, the helical anchor is configured to engage to the hub extra-corporeally, wherein the driver is configured to be withdrawn into a catheter for delivery with the coaptation implant collapsed for delivery.
9. The coaptation implant system of claim 8 , further comprising a secondary driver for engaging a secondary anchor.
10. The coaptation implant system of claim 9 , wherein the driver and the secondary driver are configured to be separately manipulated.
11. The coaptation implant system of claim 8 , wherein the coaptation implant is configured to cover a posterior leaflet so the coaptation implant coapts with an anterior leaflet during systole and maintains a valve seal.
12. The coaptation implant system of claim 8 , wherein the hub is configured to extend toward the left atrium when the coaptation implant is positioned on the mitral valve annulus.
13. A coaptation implant system comprising:
a coaptation implant comprising:
a coaptation surface and a leaflet surface;
a superior edge, lateral edges, and an inferior edge, wherein a distance between the lateral edges generally decreases toward the inferior edge;
a central hub;
a first anchoring location laterally spaced from the central hub; and
a strut extending from the hub toward the inferior edge;
a central anchor configured to be rotated relative to the central hub to engage an annulus of a heart valve; and
a first anchor configured to be rotated relative to the first anchoring location to engage a first lateral commissure of the heart valve.
14. The coaptation implant system of claim 13 , further comprising a second anchoring location laterally spaced from the central hub and a second anchor configured to be rotated relative to the second anchoring location to engage a second lateral commissure of the heart valve.
15. The coaptation implant system of claim 14 , wherein the first anchoring location and the second anchoring location define a diameter which corresponds to the distance between the first and second lateral commissures, wherein the distance is between 35 mm and 45 mm.
16. The coaptation implant system of claim 13 , wherein the first anchor and the second anchor are configured to maintain the shape and position of the coaptation implant once deployed.
17. The coaptation implant system of claim 13 , wherein the coaptation implant is configured to cover a posterior leaflet.
18. The coaptation implant system of claim 13 , wherein the central anchor comprises a helical anchor.