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While the current generation of devices for minimally invasive treatment of severe symptomatic aortic valve stenosis is based on xenogenic leaflet-material, artificial polymeric leaflet-structures represent a promising approach for future improvement of heart valve performance. For enhanced long-term success of polymeric leafletstructures, limitations regarding calcification and durability have to be addressed. The objective of the presented study was the development of a constitutive law representing the material properties of artificial polymeric leaflet-structures of transcatheter heart valve prostheses in numerical simulation to assess the in silico leaflet-performance. Mechanical characterization of cast films and nonwoven specimens of a polycarbonate based silicone elastomer were conducted by means of uniaxial tension and planar shear testing, respectively. For validation purposes, experimental data were compared with the results of finite-element analysis (FEA) using different hyperelastic models. Strain energy function for third-order ogden hyperelastic model achieved the best fit of the non-linear stress-strain behavior of the isotropic polymeric material with the experimental data. It was chosen for further FEA of valve leaflet-performance under physiological pressurization to analyze the suitability of various manufacturing processes for polymeric leafletstructures. Therefore a specific leaflet-design with a wall thickness of 400 μm was used. As a result of FEA, time dependent leaflet-deformation, leaflet coaptation surface area (CSA) and leaflet opening area (LOA) of cast and nonwoven leaflet-structures were calculated. While LOA was comparable for cast and nonwoven leaflet-structures, obtained leaflet-dynamics in a cardiac cycle under physiological pressurization demonstrated crucial influence of the manufacturing process. For nonwoven leafletstructures, an enhanced CSA could be demonstrated in comparison to cast structures. FEA using a validated hyperelastic constitutive law represents a useful tool for in silico performance evaluation of polymeric leaflet-structures under physiological loading and proves the suitability of the polymeric artificial leaflet-material for percutaneous heart valve prostheses.

Development of a constitutive law for numerical simulation of artificial leaflet-structures for transcatheter heart valve prostheses