Geometric prosthetic heart valves
Described embodiments are directed toward prosthetic heart valve leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic heart valve comprises a leaflet frame having a generally tubular shape with attached film. The leaflet frame defines a plurality of leaflet windows. The film defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment zone on the leaflet frame has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat.
1. A method of deploying a prosthetic valve, the method comprising:
delivering the prosthetic valve to an implant site, the prosthetic valve including,
a leaflet frame having a generally tubular shape, the leaflet frame including frame elements defining an inner surface and an outer surface and a cover material coupled to at least one of the inner surface and the outer surface of the frame elements, the frame elements and cover material defining a plurality of leaflet attachment zones, each of the plurality of leaflet attachment zones having a pair of diverging, sides and a flat base, and
a plurality of leaflets extending from the leaflet frame and the cover material at the plurality of leaflet attachment zones, each leaflet having two leaflet sides, a leaflet base, and a leaflet free edge opposite the leaflet base;
transitioning the prosthetic valve from a collapsed configuration to an expanded configuration, such that the prosthetic valve is exposed to blood flow, each leaflet base of each leaflet being flat and each leaflet base being defined along a fold line; and
exposing the prosthetic valve to fluid flow in the body such that,
under influence of downstream fluid pressure each leaflet bends at the fold line and the free edges of the plurality of plurality of leaflets come together to coapt which results in closing the prosthetic valve, and
under influence of upstream fluid pressure each leaflet bends at the fold line and the free edges of the plurality of leaflets move apart which results in opening of the prosthetic valve.
2. The method of claim 1 , wherein each of the plurality of leaflets is coupled to the leaflet frame such that the fold line of each leaflet of the prosthetic valve being delivered to the implant site is spaced apart from the leaflet frame of the prosthetic valve.
3. The method of claim 1 , wherein each leaflet of the prosthetic valve being delivered to the implant site defines a planar central region when the free edges of the plurality of plurality of leaflets come together to coapt to result in closing the prosthetic valve.
4. The method of claim 1 , wherein each leaflet of the prosthetic valve being delivered to the implant site is coupled to the leaflet frame with the two leaflet sides being coupled to the pair of diverging, sides of one of the plurality of attachment zones and the leaflet base being coupled to the base of one of the attachment zones.
5. The method of claim 1 , wherein the implant site to which the prosthetic valve is being delivered is in a heart.
6. The method of claim 1 , wherein the prosthetic valve being delivered to the implant site further includes an outer frame having a generally tubular shape, the leaflet frame being nested within and coupled with the outer frame by the cover and the outer frame engaging the implant site when the prosthetic valve is transitioned from the collapsed configuration to the expanded configuration.
7. The method of claim 6 , wherein the outer frame of the prosthetic valve being delivered to the implant site is elastically deformable and flexes under load.
8. The method of claim 6 , wherein the leaflet frame of the prosthetic valve being delivered to the implant site is plastically deformable to be expanded by a balloon and the outer frame is elastically deformable so as to be self-expanding, and further wherein transitioning the prosthetic valve from the collapsed configuration to the expanded configuration includes plastically deforming the leaflet frame and allowing the outer frame to self-expand.
9. The method of claim 1 , wherein each leaflet of the prosthetic valve being delivered to the implant site defines a central region that is planar and two side regions on either side of the central region that are both also planar when the plurality of leaflets come together to coapt to result in closing the prosthetic valve.
10. The method of claim 1 , wherein the fold line of each leaflet is not in contact with the leaflet frame of the prosthetic valve.
11. A method of deploying a prosthetic valve, the method comprising:
delivering the prosthetic valve to an implant site, the prosthetic valve including,
a leaflet frame including frame elements and cover material defining a plurality of leaflet attachment zones each having a pair of diverging, sides and a flat base, the cover material being coupled to at least one of an inner surface and an outer surface of the frame elements of the leaflet frame,
a plurality of leaflets extending from the leaflet frame at the plurality of leaflet attachment zones, each leaflet having two leaflet sides, a leaflet base, and a leaflet free edge opposite the leaflet base; and
an outer frame having a generally tubular shape, the leaflet frame being nested within the outer frame and coupled to the leaflet frame via the cover material extending from the leaflet frame to the outer frame,
transitioning the prosthetic valve from a collapsed configuration to an expanded configuration, such that the prosthetic valve is exposed to blood flow, each leaflet base being flat and each leaflet base being defined along a fold line and the outer frame engaging the implant site when the prosthetic valve is transitioned from the collapsed configuration to the expanded configuration; and
exposing the prosthetic valve to fluid flow in the body such that,
under influence of downstream fluid pressure each leaflet bends at the fold line and the free edges of the plurality of plurality of leaflets come together to coapt which results in closing the prosthetic valve, and
under influence of upstream fluid pressure each leaflet bends at the fold line and the free edges of the plurality of leaflets move apart which results in opening of the prosthetic valve.
12. The method of claim 11 , wherein the outer frame of the prosthetic valve being delivered to the implant site is elastically deformable and flexes under load.
13. The method of claim 11 , wherein the leaflet frame of the prosthetic valve being delivered to the implant site is plastically deformable to be expanded by a balloon and the outer frame is elastically deformable so as to be self-expanding, and further wherein transitioning the prosthetic valve from the collapsed configuration to the expanded configuration includes plastically deforming the leaflet frame and allowing the outer frame to self-expand.