A New Holistic Approach for Prosthesis Polymeric Aortic Valve Design

Aortic valve insufficiency is a life-threatening condition. The primary treatment approach is the replacement of the native valve with prosthetic valves in severe cases. However, current prostheses often lead to complications such as durability issues, the need for lifelong anticoagulation medicine usage, and tissue rejection. As a result, multiple surgical interventions are frequently required for prosthesis replacement. This study highlights the importance of a comprehensive prosthetic design process by encompassing patient-specific design, careful material selection, and advanced three-dimensional fabrication, which is essential for addressing these challenges. To enhance the mechanical durability of polymeric heart valve prostheses, we introduce a framework that combines fluid-structure interaction (FSI) simulations to obtain hemodynamic properties prior to advanced structural analyses. While our methodology is based on determining hemodynamic loads with FSI simulations and transferring them to an additional finite element model (FEM) that captures the detailed mechanical properties of valve tissue, the results presented in this study are obtained using more traditional loading conditions in FEM to ensure the validity and comparability of our findings. These results serve as a foundation for future studies incorporating full FSI-driven structural simulations. These analyses lead to the creation of a geometrically optimized design, fabricated with a digital light processing-based (DLP) method. Subsequently, mechanical testing was conducted to evaluate the effects of this manufacturing technique on material behavior, producing more realistic material model coefficients for use in numerical simulations. Consequently, different ratios of material rigidity in fiber-reinforced models are investigated with FEM analysis. An important novelty of this approach is to be able to detect stress accumulations by taking hemodynamic indices into account to optimize the stress distribution in the valve to enhance its durability utilizing mechanical test data. Additionally, different computational frameworks are combined with the experimental tests to develop a comprehensive design approach. This multidisciplinary framework offers a more reliable and long-lasting solution for aortic valve prostheses.