Polymeric mitral heart valve

A polymeric mitral heart valve, comprising leaflets, a stent frame, and an annulus;

• the stent frame has a hollow cylindrical structure, and the stent frame comprises a first end and a second end;
• the first end is arranged with three circumferentially spaced strut peaks, with strut valleys formed correspondingly;
• the leaflets are arranged at the center of the first end, the number of the leaflets is identical to the number of the strut peaks, and the three leaflets are circumferentially arranged to sequentially connect two adjacent strut peaks;
• wherein the annulus is arranged on the outer periphery of the second end of the stent frame, and the annulus forms two protruding sections axially toward the first end at positions circumferentially corresponding to two of the strut peaks and a planar section at the remaining one strut peak;
• the valve further comprises an insert having a hollow cylindrical structure matching the stent frame, and the insert is adapted to be axially inserted into the stent frame;
• the leaflets, the stent frame, and the annulus are formed by one-shot injection molding, and the insert is embedded in the stent frame during injection molding to be formed integrally with the stent frame;
• each leaflet comprises a free edge and an attachment edge connected to the stent frame;
• in a natural state, gaps are reserved between the free edges of adjacent leaflets, a concave structure is formed between the midpoint of each free edge and the endpoints of the attachment edge, and the leaflets are semi-open;
• the free edge of a single leaflet is located in a coordinate plane, where the X-axis of the coordinate system is defined by the line connecting the midpoint of the free edge and one endpoint of the attachment edge, and the Y-axis is perpendicular to the connecting line and passes through the midpoint of the free edge;
• the parametric curve Y of the free edge from the midpoint to one endpoint of the attachment edge is represented by the following formula:
• Y
• =
• {
• H
• 1
• ⁢
• sin
• ⁡
• (
• X
• L
• 1
• ⁢
• π
• )
• 0
• ≤
• X
• ≤
• L
• 1
• H
• 2
• ⁢
• sin
• ⁡
• (
• X
• L
• 1
• +
• L
• 2
• ⁢
• 3
• ⁢
• π
• )
• L
• 1
• <
• X
• <
• L
• 2
• H
• 3
• ⁢
• sin
• ⁡
• (
• X
• L
• 2
• +
• L
• 3
• ⁢
• π
• )
• L
• 2
• ≤
• X
• ≤
• L
• 3
• wherein L1 and L2 are adjustable parameters and satisfy L3/10≤L1≤L3/5 and 2L3/3≤L2≤3L3/4, respectively;
• L3 is a linear distance between the midpoint of the free edge and one endpoint of the attachment edge;
• H1, H2, and H3 are adjustable parameters and satisfy 0.05 mm≤H1≤0.20 mm, 0.20 mm≤H2≤1.0 mm, and 0 mm≤H3≤0.25 mm, respectively.