Three-dimensional thin-film leaflet valve device
Examples of the disclosure are directed toward a valve device comprising an opening and a leaflet and methods of operating and manufacturing the valve device. In some embodiments, the leaflet is a three-dimensional thin-film leaflet, and the leaflet comprises a dome portion. In a first configuration, the leaflet of the valve device may occlude the opening of the device. In a second configuration, the leaflet may not occlude the opening, and blood may flow across the opening of the device. The valve device may be collapsible for transportation in a catheter.
1 . A valve device, comprising:
an opening,
a leaflet comprising:
a downstream surface to trap blood pumped by a heart muscle, and
an upstream surface to selectively occlude the opening when the leaflet's downstream surfaces trap blood pumped by the heart muscle, wherein the upstream surface comprises a dome portion,
wherein:
the leaflet is a three-dimensional thin-film leaflet,
a shape of the leaflet includes a plurality of profiles,
each profile includes dimensions of an interfacing surface height, an outer cylindrical surface height, and a profile slope angle, and
the profile slope angle is associated with geometries of the dome portion, and
a frame defining the opening and comprising anchoring prongs, wherein:
the leaflet is attached to the frame, and
when the frame is in a partially deployed configuration, the anchoring prongs are at an angle between 15 and 60 degrees relative to an axis from the downstream surface to the upstream surface.
2 . The device of claim 1 , wherein the interfacing surface height is 2-10 mm, the outer cylindrical surface height is 3-25 mm, and the profile slope angle is −45 to 45 degrees.
3 . The device of claim 1 , further comprising a second leaflet, wherein the leaflets' upstream surfaces collectively occlude the opening when the leaflets are in a first configuration, and the upstream surfaces do not collectively occlude the opening when the leaflets are in a second configuration.
4 . The device of claim 3 , wherein each leaflet comprises an interfacing surface that, while the leaflets occlude the opening, contacts an adjacent leaflet's interfacing surface.
5 . The device of claim 1 , wherein the leaflet has a thickness of 5-25 μm.
6 . The device of claim 1 , wherein the device comprises a collapsed configuration such that the device in the collapsed configuration is deliverable in a catheter having a cross sectional diameter of 5-15 mm.
7 . The device of claim 1 , wherein the leaflet comprises:
a first configuration in response to a force from the downstream side to the upstream side, and
a second configuration in response to a force from the upstream side to the downstream side.
8 . The device of claim 7 , wherein the force from the downstream side to the upstream side includes a force generated by an increase of the blood being trapped.
9 . The device of claim 7 , wherein the leaflet collapses in response to the force from the upstream side to the downstream side.
10 . The device of claim 1 , wherein the leaflet returns toward an inflated shape in response to an increase of the blood being trapped.
11 . The device of claim 1 , wherein:
the anchoring prongs maintain the device at a native valve location, and
the anchoring prongs are in a pinching position upon contact with an underside of native leaflets.
12 . The device of claim 1 , further comprising a cord connecting the anchoring prongs, the cord configured to tighten and pull the anchoring prongs toward the frame as the frame expands from a collapsed configuration such that the anchoring prongs are in a pinching position upon contact with an underside of native leaflets.
13 . A method of operating an artificial valve comprising:
deploying the artificial valve;
in response to blood pumped by a heart muscle in a direction from a downstream surface to an upstream surface of a thin-film leaflet of the artificial valve:
selectively occluding an opening of the artificial valve with the upstream surface, wherein the upstream surface comprises a dome portion, and
trapping the blood pumped by the heart muscle with the downstream surface; and
in response to blood flow in a direction from the upstream surface to the downstream surface:
deforming, with a force of the blood flow, the leaflet, and
allowing the blood flow across the opening,
wherein:
the leaflet is a three-dimensional thin-film leaflet,
a shape of the leaflet includes a plurality of profiles,
each profile includes dimensions of an interfacing surface height, an outer cylindrical surface height, and a profile slope angle, and
the profile slope angle is associated with geometries of the dome portion, and
deploying the artificial valve comprises configuring a frame of the artificial valve to a partially deployed configuration, wherein when the frame is in the partially deployed configuration, anchoring prongs of the frame are at an angle between 15 and 60 degrees relative to an axis from the downstream surface to the upstream surface.
14 . The method of claim 13 , wherein deploying the artificial valve further comprises tightening a cord of the artificial valve connecting the anchoring prongs to pull the anchoring prongs toward the frame as the frame expands from a collapsed configuration such that the anchoring prongs are in a pinching position upon contact with an underside of native leaflets.
15 . A method of manufacturing a valve device comprising:
fabricating a three-dimensional thin-film leaflet via vacuum deposition, PVD, CVD, or any combination thereof, wherein the thin-film leaflet comprises:
a downstream surface, and
an upstream surface, wherein the upstream surface comprises a dome portion, wherein:
a shape of the leaflet includes a plurality of profiles,
each profile includes dimensions of an interfacing surface height,
an outer cylindrical surface height, and a profile slope angle, and
the profile slope angle is associated with geometries of the dome portion;
providing a plurality of cells;
forming a frame by coupling the plurality of cells, wherein the frame defines an opening of the valve device; and
attaching the leaflet to the frame.
16 . The method of claim 15 , further comprising shaping the leaflet via the vacuum deposition, the PVD, the CVD, or any combination thereof.
17 . The method of claim 15 , wherein one of more the cells comprise anchoring prongs, the method further comprising providing a cord connecting the anchoring prongs.