Structural validation of novel bileaflet mechanical heart valve hinge mechanism.

The structural performance of hinges in mechanical heart valves (MHVs) is essential for durability and reliability. This study evaluates the iValve, a novel bileaflet MHV, using advanced finite element method (FEM) simulations to assess its hinge design under physiological and supra-physiological conditions. The hinge design aims to minimize stress concentrations, reduce wear, and enhance durability compared to conventional valves. A detailed 3D FEM model, incorporating precise hinge geometry, was developed to analyze stress distribution, deformation, and potential failure zones. While our study uses a quasi-static finite element approach, and thus does not capture full dynamic or fluid-structure interactions, it evaluates peak physiological loading conditions representative of the cardiac cycle. The results show a lower and more uniform stress distribution in the iValve compared to conventional bileaflet MHVs, suggesting reduced stress concentrations and potentially improved fatigue life. The model was validated against experimental data from in vitro flow simulators, ensuring accurate representation of the hemodynamic forces during the cardiac cycle. Results show that the iValve's hinge design achieves superior stress distribution with significantly lower peak von Mises stresses than traditional designs. Optimized materials and geometric features reduce the risk of fatigue and wear, while high-cycle fatigue simulations confirmed minimal deformation, demonstrating suitability for extended use. This study highlights the role of FEM in advancing MHV design by balancing mechanical performance with physiological compatibility. The iValve addresses hinge failure and thrombus risks, offering a durable, anticoagulation-free solution.