摘要Despite continuous efforts to improve the robustness of cardiac valve implants,neither bioprosthetic nor mechanical valves fulfill both hemodynamic and durability requirements.This study discussed novel flexible leaflet designs,focusing on poly-meric materials with proven hemocompatibility,such as polyether ether ketone,of much higher stiffness than native tissue,aiming at optimal valve implants.A biomimetic valve with a single-curvature belly-curve(B-C)was used as a reference for new design variants with a double-curvature B-C with varying radii.Soft(13.2 MPa)and stiff(2.4 GPa)leaflet materials and different thicknesses were studied using lean simulations and in vitro experiments under physiologic hemodynamic con-ditions.The performance was assessed using opening pressure(OP)and orifice area(OA).The latter was determined by a newly developed automatized image processing tool.Experimental trends are in agreement with simulations and demonstrated that a buckling-inspired double-curvature leaflet design significantly enhances the trileaflet valve opening behavior,which is particularly advantageous for stiffer leaflet materials.Compared to the reference,the best-performing variant showed an OP improvement of 47%and 44%based on simulations and experiments,respectively.In contrast,the achieved mean pressure differential was directly comparable to state-of-the-art bioprosthetic valves.The OA was slightly reduced for new variants but still in the satisfying range.
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