PROSTHETIC HEART VALVE FOR TRANSFEMORAL DELIVERY
Apparatus is provided that includes a valve prosthesis for attachment to a native valve complex of a subject. The prosthesis includes a support frame, which is shaped so as to define a plurality of axial support arches, which extend in a radially outward direction, and are configured to apply, regardless of a rotational orientation of the support frame with respect to the native valve complex, an upstream axial force to a downstream side of one or more native structures selected from the group consisting of: native leaflet tips of the native valve complex, and native valve commissures. The support frame is also shaped so as to define an upstream skirt, which is configured to apply a downstream axial force on an upstream side of the native valve complex. The prosthesis further includes a prosthetic heart valve, coupled to a portion of the support frame. Other embodiments are also described.
1 . Apparatus comprising a valve prosthesis for attachment to a native valve complex of a subject, the prosthesis comprising:
a support frame, which is shaped so as to define:
a plurality of axial support arches, which extend in a radially outward direction, and are configured to apply, regardless of a rotational orientation of the support frame with respect to the native valve complex, an upstream axial force to a downstream side of one or more native structures selected from the group consisting of: native leaflet tips of the native valve complex, and native valve commissures, and
an upstream skirt, which is configured to apply a downstream axial force on an upstream side of the native valve complex; and
a prosthetic heart valve, coupled to a portion of the support frame.
2 . The apparatus according to claim 1 , wherein the axial support arches extend in an upstream and radially outward direction.
3 . The apparatus according to claim 1 , wherein the axial support arches extend radially outward in a direction orthogonal to a central longitudinal axis of the prosthesis.
4 . The apparatus according to claim 1 , wherein the axial support arches protrude radially outward over the native leaflet tips.
5 . The apparatus according to claim 1 , wherein the axial support arches are sized so as to not extend to floors of aortic sinuses of the native valve complex.
6 . The apparatus according to claim 1 , wherein the support frame is configured to assume a radially collapsed position for delivery to the native valve complex, and a radially expanded position upon implantation at the native valve complex.
7 . The apparatus according to claim 1 , wherein the support frame is shaped so as to define a multiple of three of the axial support arches.
8 . The apparatus according to claim 1 , wherein a longitudinal distance from an upstream-most portion of each of the axial support arches to a downstream-most portion of the axial support arch is no more than 15 mm.
9 . The apparatus according to claim 1 , wherein the support frame is shaped so as to define a plurality of commissural posts, and wherein at least one end of each of the axial support arches is coupled to one of the commissural posts.
10 . The apparatus according to claim 1 , wherein the axial support arches extend in the upstream and radially outward direction at an angle of between 110 and 30 degrees with respect to a central longitudinal axis of the prosthesis.
11 . The apparatus according to claim 1 , wherein the valve prosthesis is configured to not radially squeeze native leaflets of the native valve complex between any elements of the valve prosthesis.
12 . The apparatus according to claim 1 , wherein the valve prosthesis is configured such that the upstream and downstream axial forces together anchor the valve prosthesis to the native valve complex.
13 . The apparatus according to claim 1 ,
wherein the prosthetic valve is coupled to a downstream section of the support frame,
wherein the support frame is shaped so as to define a throat section longitudinally between the upstream skirt and the downstream section,
wherein a cross-sectional area of the valve prosthesis gradually decreases from the upstream skirt to the throat section, and gradually increases from the throat section to the downstream section, and
wherein a cross-sectional area of the throat section is less than a cross-sectional area of an aortic annulus of the native valve complex.
14 . A method comprising:
providing a valve prosthesis, which includes (a) a support frame, which is shaped so as to define (i) a plurality of axial support arches, which extend in a radially outward direction, and (ii) an upstream skirt, and (b) a prosthetic heart valve, coupled to a portion of the support frame; and
positioning the valve prosthesis at a native valve complex of a subject, such that:
the axial support arches apply, regardless of a rotational orientation of the support frame with respect to the native valve complex, an upstream axial force to a downstream side of one or more native structures selected from the group consisting of: native leaflet tips of the native valve complex, and native valve commissures, and
the upstream skirt applies a downstream axial force on an upstream side of the native valve complex.
15 . The method according to claim 14 , wherein providing the valve prosthesis comprises providing the valve prosthesis such that the axial support arches extend in an upstream and radially outward direction.
16 . The method according to claim 14 , wherein providing the valve prosthesis comprises providing the valve prosthesis such that the axial support arches extend radially outward in a direction orthogonal to a central longitudinal axis of the prosthesis.
17 . The method according to claim 14 , wherein positioning the valve prosthesis does not comprise rotationally aligning the valve prosthesis with respect to the native valve complex.
18 . The method according to claim 14 , wherein positioning the valve prosthesis comprises positioning the valve prosthesis such that the axial support arches protrude radially outward over the native leaflet tips.
19 . The method according to claim 14 , wherein positioning the valve prosthesis comprises positioning the valve prosthesis such that the axial support arches do not extend to floors of aortic sinuses of the native valve complex.
20 . The method according to claim 14 , wherein positioning the valve prosthesis comprises:
radially collapsing the support frame prior to delivery of the valve prosthesis to the native valve complex;
transluminally delivering the valve prosthesis to a vicinity of the native valve complex while the support frame is radially collapsed; and
radially expanding the support frame at the native valve complex.
21 . The method according to claim 14 , wherein positioning the valve prosthesis comprises positioning the valve prosthesis such that the upstream and downstream axial forces together anchor the valve prosthesis to the native valve complex.