Leaflet extension for cardiac valve leaflet
Leaflet extension devices for cardiac valve leaflets and methods of treating cardiac valve leaflets. Several embodiments are devices for resolving regurgitation in a cardiac valve comprising an expandable member and a cover. The expandable member has a stabilizing portion, a fixation member in opposition to the stabilizing portion, and a coaptation portion between the stabilizing portion and the expandable member. The stabilizing portion and the fixation member clamps the first native leaflet between the stabilizing portion and the fixation member. The coaptation portion projects from the stabilizing portion and the fixation member inwardly with respect to a first native leaflet of a cardiac valve such that the coaptation portion functionally extends the first native leaflet. The cover is attached to at least the coaptation portion of the expandable member.
1 . A device for resolving regurgitation in a cardiac valve, comprising:
an expandable member having a stabilizing portion, a fixation member in opposition to the stabilizing portion, and a coaptation portion between the stabilizing portion and the fixation member, wherein the stabilizing portion and the coaptation portion comprise a plurality of interconnected struts and together define a hollow volume, wherein the stabilizing portion and the fixation member are configured to clamp a first native leaflet of the cardiac valve between the stabilizing portion and the fixation member, and wherein the coaptation portion is configured to project from the stabilizing portion and the fixation member inwardly with respect to the first native leaflet such that the coaptation portion is positioned to at least partially coapt with a second native leaflet of the cardiac valve; and
a cover attached to at least the coaptation portion of the expandable member.
2 . The device of claim 1 wherein at least one of the stabilizing portion and the fixation member are formed of a super-elastic material configured to resume a native shape in the absence of a countervailing force, and wherein the stabilizing portion and the fixation member are configured to clamp the first native leaflet solely by a compressive force exerted between the stabilizing portion and the fixation member.
3 . The device of claim 1 , wherein the stabilizing portion comprises at least two primary struts, and each of the at least two primary struts has a first end and a second end, the first ends being commonly joined, and the second ends being splayed apart.
4 . The device of claim 3 , wherein the coaptation portion is configured to project inwardly with respect to a native annulus of the cardiac valve beyond a free end of the first native leaflet, and the first end of the stabilizing portion is configured to extend beyond a fixed end of the first native leaflet and superiorly along an atrial wall of the cardiac valve.
5 . The device of claim 1 , wherein the stabilizing portion and the fixation member clamp the first native leaflet without piercing into the first native leaflet such that the device can be repositioned and/or removed.
6 . The device of claim 1 , wherein the stabilizing portion comprises a lattice of the plurality of interconnected struts and openings interposed between adjacent ones of the plurality of interconnected struts.
7 . The device of claim 1 , wherein the fixation member comprises at least one primary strut, and the at least one primary strut is attached to the stabilizing portion.
8 . The device of claim 1 , wherein the fixation member comprises at least two primary struts spaced apart from one another.
9 . The device of claim 8 , wherein each of the at least two primary struts has a first end and a second end, the first ends are commonly joined, and the second ends are splayed apart.
10 . The device of claim 1 , wherein the fixation member comprises a plurality of primary struts and cross-struts between the plurality of primary struts and connected to the plurality of primary struts.
11 . The device of claim 1 , wherein at least one of the fixation member and the stabilizing portion further comprises frictional engagement elements.
12 . The device of claim 1 , wherein the cover encloses the hollow volume.
13 . The device of claim 12 , wherein the coaptation portion projects inwardly with respect to a native annulus beyond a free end of the first native leaflet and a first end of the stabilizing portion extends superiorly beyond a fixed end of the first native leaflet and along an atrial wall of the cardiac valve.
14 . The device of claim 1 wherein the coaptation portion is integrally formed with at least one of the stabilizing portion and the fixation member.
15 . The device of claim 1 , wherein the coaptation portion is orthogonal to each of the stabilizing portion and the fixation member, and the coaptation portion has a concave surface configured to face the first native leaflet and a convex surface configured to face the second native leaflet.
16 . The device of claim 1 , further comprising an atrial stabilizer attached to a first end of the stabilizing portion, the atrial stabilizer having a polygonal shape and includes a frictional engagement element and/or a second cover.
17 . The device of claim 1 , further comprising an atrial stabilizer attached to a first end of the stabilizing portion, the atrial stabilizer having a polygonal shape.
18 . The device of claim 1 , wherein the fixation member includes at least one strut integrally formed with the coaptation portion.
19 . The device of claim 1 , wherein the plurality of interconnected struts define a frame at the coaptation portion.
20 . The device of claim 1 wherein the coaptation portion is configured to project from the stabilizing portion and the fixation member inwardly with respect to the first native leaflet such that the coaptation portion is positioned to at least partially coapt with a plurality of leaflets of the cardiac valve including the second native leaflet.
21 . A valve repair device, comprising:
an expandable member (i) comprising a frame having a plurality of interconnected struts and (ii) enclosing a hollow volume, wherein the expandable member has a first portion configured to coapt with a first native leaflet of a cardiac valve and a second portion configured to abut an atrial side of at least a portion of a second native leaflet of the cardiac valve; and
a clip extending from the first portion of the expandable member, wherein the clip is configured to abut a ventricular side of at least the portion of the second native leaflet of the cardiac valve to clamp the portion of the second native leaflet between the second portion of the expandable member and the clip to secure the expandable member to the second native leaflet.
22 . The valve repair device of claim 21 wherein the portion of the second native leaflet is a central portion of the second native leaflet.
23 . The valve repair device of claim 21 wherein the cardiac valve is a mitral valve, wherein the second native leaflet is a posterior leaflet of the mitral valve, and wherein the portion of the posterior leaflet is at least portion of a central scallop P 2 of the posterior leaflet, wherein the first native leaflet is an anterior leaflet of the mitral valve, and wherein the expandable member is sized to permit at least one lateral scallop of the posterior leaflet to coapt with the anterior leaflet.
24 . The valve repair device of claim 21 , further comprising a cover over the frame along at least the first portion of the expandable member, wherein the cover is configured to provide an atraumatic coaptation surface for the first native leaflet along the first portion of the expandable member.
25 . The valve repair device of claim 21 , further comprising a cover over at least a portion of the clip.
26 . The valve repair device of claim 21 , further comprising a plurality of frictional elements extending from the second portion of the expandable member, wherein the plurality of frictional elements are sized to penetrate into the atrial side of the second native leaflet without piercing completely through the second native leaflet.
27 . The valve repair device of claim 21 , further comprising a plurality of frictional elements extending from the clip, wherein the plurality of frictional elements are sized to penetrate into the ventricular side of the second native leaflet without piercing completely through the second native leaflet.
28 . The valve repair device of claim 21 wherein the clip is separate from the expandable member and coupled to the expandable member.
29 . The valve repair device of claim 21 wherein the clip is integrally formed with the expandable member.
30 . The valve repair device of claim 21 wherein the clip is biased toward the second portion of the expandable member.
31 . The valve repair device of claim 21 wherein the plurality of interconnected struts include a plurality of primary struts and plurality of cross struts, wherein individual ones of the plurality of cross struts extend between and connect a pair of the plurality of primary struts.
32 . A valve repair device, comprising:
an expandable member (i) comprising a frame having a plurality of interconnected struts and (ii) enclosing a hollow volume, wherein the expandable member has a coaptation portion configured to coapt with a first native leaflet of a cardiac valve and a stabilizing portion configured to abut an atrial side of at least a portion of a second native leaflet of the cardiac valve; and
a fixation member extending from the coaptation portion of the expandable member, wherein the fixation member is configured to abut a ventricular side of at least the portion of the second native leaflet of the cardiac valve to clamp the portion of the second native leaflet between the stabilizing portion of the expandable member and the fixation member to secure the expandable member to the second native leaflet.
33 . The valve repair device of claim 32 wherein the plurality of interconnected struts include a plurality of primary struts and plurality of cross struts, wherein individual ones of the plurality of cross struts extend between and connect a pair of the plurality of primary struts.