Geometrically-accommodating heart valve replacement device
A replacement heart valve device is disclosed. In some embodiments, the device includes a frame coupled to one or more leaflets that are moveable between open and closed configurations. In some embodiments, the frame comprises at least two frame sections that join at a pair of commissural posts. In some embodiments, the device may be geometrically accommodating to adapt to different vasculature shapes and sizes and/or to be able to change size while implanted within a growing patient.
1 . A valve replacement device, comprising:
a valve frame comprising first and second U-shaped frame sections connected at one end by a pair of commissures, the valve frame defining an opening for the passage of fluid, the first and second frame sections each having first and second arms, the valve frame being expandable to permit an increase in a diameter of the opening over a diameter size range of the opening;
a valve leaflet coupled to the valve frame, the valve leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the valve leaflet at least partially covers the opening, wherein the valve leaflet is configured to be moveable between the open and closed configurations over the diameter size range of the opening; and
a sleeve coupled to the valve frame, the sleeve having a first expandable direction orientated to permit the increase in the diameter of the opening of the valve frame,
wherein the sleeve further comprises a film, wherein the film is configured to minimize native tissue ingrowth into the sleeve.
2 . The valve replacement device of claim 1 , wherein the film is on an exterior of the sleeve.
3 . The valve replacement device of claim 1 , wherein the film has a tighter microstructure than the rest of the sleeve.
4 . The valve replacement device of claim 1 , wherein the sleeve comprises a first sleeve portion and a second sleeve portion coupled to the valve frame.
5 . The valve replacement device of claim 4 ,
wherein the first and second sleeve portions are constructed from sections of tube graft, the sections of tube graft having a longitudinal direction, and
wherein the first expandable direction of the sleeve is the longitudinal direction of the sections of tube graft.
6 . The valve replacement device of claim 1 , wherein a proximal end of the sleeve is configured for suture fixation to native structures.
7 . The valve replacement device of claim 1 , wherein the valve frame is expandable to permit an increase in the diameter of the opening past a functional range of the valve leaflet in order to configure the valve replacement device as a pre-stent for a transcatheter valve-in-valve replacement procedure.
8 . The valve replacement device of claim 1 , wherein the valve frame is expandable to permit the increase in the diameter of the opening to be greater than 22 mm.
9 . The valve replacement device of claim 1 , wherein the valve leaflet is configured to maintain a constant surface area with expansion of the valve frame.
10 . The valve replacement device of claim 1 ,
wherein the valve frame has a plurality of holes through the valve frame,
wherein the valve leaflet comprises a first leaflet and a second leaflet,
wherein the first leaflet has an outer edge, and is coupled to the valve frame using at least some of the plurality of holes through the valve frame, and the second leaflet has an outer edge, and is coupled to the valve frame using at least some of the plurality of holes through the valve frame,
wherein the first and second leaflets have a plurality of leaflet attachment points for coupling the first and second leaflets to the valve frame, and
wherein the plurality of leaflet attachment points are located a non-uniform distance from the outer edges of the first and second leaflets.
11 . The valve replacement device of claim 10 ,
wherein the plurality of holes are through the first and second U-shaped frame sections and through the pair of commissures,
wherein the first leaflet is coupled to the holes in the first U-shaped frame section and the pair of commissures, and
wherein the second leaflet is coupled to the holes in the second U-shaped frame section and the pair of commissures.
12 . The valve replacement device of claim 11 ,
further comprising a first reinforcement feature that connects the pairs of commissures,
further comprising a second reinforcement feature that connects the first and second U-shaped frame sections, and
wherein the first reinforcement feature is of a different shape than the second reinforcement feature.
13 . The valve replacement device of claim 1 , wherein the valve frame includes a plurality of holes through the valve frame, wherein the valve leaflet is coupled to the valve frame using at least some of the plurality of holes through the valve frame, and wherein the sleeve is coupled to the valve frame using at least some of the plurality of holes through the valve frame.
14 . The valve replacement device of claim 1 , wherein the sleeve is formed from ePTFE.