A combined approach of numerical simulation and additive manifacturing technique for in-silico and in-vitro testing of a 3d printing-based aortic polymeric heart valve

Heart valve diseases are among the leading causes of cardiac failure around the globe. Current advances in imaging technology, in numerical simulation and in additive manufacturing are opening new frontiers in the field of development of new personalised prosthetic devices. The 3D printing technique could allow the realisation of personalised models for each patient undergoing valve replacement surgery. A CAD model of an aortic valve prosthesis was designed on the basis of elliptic-hyperboloid formulation. The resulting CAD model was used both to perform numerical in-silico simulation and to design a modular mould for AV fabrication. Simulations were performed through a novel hybrid approach based on RBF mesh morphing technique and CFD simulations. The polymeric aortic valve was manufactured by 3D printed process and spray deposition technique. To assess the in-vitro valve properties, the prototype was inserted in a custom mock circulatory loop to reproduce the aortic flow conditions. The manufacturing process of both the mould and the valve was successful and the in-vitro testing showed an effective orifice area (2.5 mm2) and regurgitation fraction (5%) in accordance with the ISO-5840-2. The novel simulation strategies have revealed to be a promising approach to test both structural and functional device performances