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Bio-Design and Manufacturing  2025 Vol.8 No.5 P.835-846

http://doi.org/10.1631/bdm.2500046


Designsimulationmanufacturingassessment framework for geometric optimization of polymeric heart valves toward enhanced durability


Author(s):  Tianle Xu (???), Zihan Zhu (???), Yunhan Cai (???), Shunping Chen (???), Jia Guo (??) & Shengzhang Wang (???)

Affiliation(s):  nstitute of Biomechanics, Department of Aeronautics and Astronautics, Fudan University, Shanghai 200433, China; more

Corresponding email(s):   guojia@fudan.edu.cn, szwang@fudan.edu.cn

Key Words:  Polymeric heart valve Durability Optimization Finite element method (FEM) Dip-molding


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Tianle Xu (???), Zihan Zhu (???), Yunhan Cai (???), Shunping Chen (???), Jia Guo (??) & Shengzhang Wang (???) . Designsimulationmanufacturingassessment framework for geometric optimization of polymeric heart valves toward enhanced durability[J]. Journal of Zhejiang University Science D, 2025, 8(5): 835-846.

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Abstract: 
Owing to their excellent biocompatibility and potential for durability enhancement, polymeric heart valves (PHVs) are emerging as a promising alternative to traditional prostheses. Unlike conventional materials, PHVs can be manufactured un? der precise design criteria, enabling targeted performance improvements. This study introduces a geometric optimization strategy for enhancing the durability of PHVs. The finite element method (FEM) is combined with a dip-molding technique to develop a novel polymeric aortic valve with improved mechanical properties. The tri-leaflet geometry is parameterized us? ing B-spline curves, and the maximum stress in the valve is reduced from 2.4802 to 1.7773 MPa using a multiobjective opti? mization algorithm NSGA-II (non-dominated sorting genetic algorithm II). Pre-optimized and optimized valve prototypes were fabricated via dip-molding and evaluated during pulsatile-flow tests and accelerated wear tests. The optimized design meets the ISO 5840 standards, with an effective orifice area of 2.019 cm2 , a regurgitant fraction of 5.693%, and a transvalvu? lar pressure gradient of 7.576 mmHg. Moreover, the optimized valve maintained its structural integrity and functionality over 14 million cycles of the accelerated wear test, whereas the unoptimized valve failed after two million cycles. These find? ings confirm that the FEM-based geometric optimization method enhances both the mechanical performance and durability of PHVs

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