Coaptation enhancement implant, system, and method
Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle. An outer surface of the valve body may accommodate tissue ingrowth or endothelialization, while a fluid-absorbing matrix can swell after introduction into the heart. The valve body shape may be selected after an anchor has been deployed, and catheter-based deployment systems may have a desirable low profile.
1. A coaptation assist system for treating mal-coaptation of a heart valve in a heart of a patient, the heart valve having a valve annulus and first and second leaflets, the coaptation assist system comprising:
a coaptation assist body having a first coaptation surface and a second, opposed surface extending between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body introducible into the heart and deployable from a first configuration to a second configuration, wherein in the second configuration the first coaptation surface is in position to coapt with the first leaflet of the heart valve, wherein the first coaptation surface comprises a concave surface configured to coapt with the first leaflet,
wherein the coaptation assist body comprises a hub positioned on the first coapation surface; and
an anchor configured to rotate at least partially within the hub of the coaptation assist body to drive the anchor into tissue of the heart.
2. The system of claim 1 , wherein the coaptation assist body further comprises struts.
3. The system of claim 1 , further comprising a secondary anchor configured to rotate relative to the coaptation assist body.
4. The system of claim 1 , further comprising a tether.
5. The system of claim 1 , further comprising a suture to change the shape of the coaptation assist body.
6. The system of claim 1 , wherein the coaptation assist body comprises one or more layers.
7. The system of claim 1 , wherein the coaptation assist body comprises a layer of ePTFE.
8. The system of claim 1 , wherein the coaptation assist body comprises a Nitinol support.
9. The system of claim 1 , wherein the coaptation assist body tapers between the first lateral edge and the second lateral edge.
10. The system of claim 1 , wherein the coaptation assist body comprises a reinforcement layer.
11. The system of claim 1 , wherein the coaptation assist body comprises a layer to decrease a modulus of elasticity.
12. The system of claim 1 , wherein the coaptation assist body comprises a layer to alter characteristics along a selected portion of the coaptation assist body.
13. A coaptation assist system for treating mal-coaptation of a heart valve in a heart of a patient, the heart valve having a valve annulus and first and second leaflets, the coaptation assist system comprising:
a coaptation assist body having a first coaptation surface and a second, opposed surface extending between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body introducible into the heart and deployable from a first configuration to a second configuration, wherein in the second configuration the first coaptation surface is in position to coapt with the first leaflet of the heart valve, the coaptation assist body comprising a hub, wherein the first coaptation surface is configured to curve laterally across a valve opening,
wherein the hub comprises an outer collar extending from the first coaptation surface; and
a helical anchor extending axially through the hub, wherein the helical anchor is configured to be rotated relative to the outer collar and the first coaptation surface so as to screw the helical body into tissue of the heart.
14. The system of claim 13 , further comprising a secondary anchor.
15. The system of claim 13 , wherein the coaptation assist body comprises more than one layers of material which alter the mechanical characteristics of the coaptation assist body.
16. The system of claim 13 , wherein the coaptation assist body tapers axially inwardly downstream of the first coaptation surface.
17. A coaptation assist system for treating mal-coaptation of a heart valve in a heart of a patient, the heart valve having a valve annulus and first and second leaflets, the coaptation assist system comprising:
a coaptation assist body having a first coaptation surface and a second, opposed surface extending between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body introducible into the heart and deployable from a first configuration to a second configuration, wherein in the second configuration the first coaptation surface is in position to coapt with the first leaflet of the heart valve, wherein the first coaptation surface comprises a curved cross-sectional shape,
wherein the coaptation assist body comprises a tubular hub engaged with the first coaptation surface;
a helical anchor configured to be movable relative to the tubular hub to engage a tip of the anchor with tissue of the heart; and
a torque shaft configured to be removably connected to the helical anchor to rotate the helical anchor relative to the tubular hub, wherein the torque shaft comprises a forked end.
18. The system of claim 17 , further comprising a secondary anchor.
19. The system of claim 17 , wherein the coaptation assist body comprises two or more layers.
20. The system of claim 17 , wherein the first and second lateral edges taper radially inwardly.