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For the treatment of severe symptomatic aortic valve stenosis, minimally invasive heart valve prostheses are increasingly used, especially for elderly patients. The current generation of devices is based on  xenogenic  leaflet material, involving limitations with regard to calcification and durability. Artificial polymeric leaflet-structures re-present a promising approach for improvement of valve performance. Within the current work, finite-element ana-lysis (FEA) design studies of polymeric leaflet structures were conducted. Design of an unpressurized and axially-symmetric trileaflet heart valve was developed based on nine parameters. Physiological pressurization in FEA was specified, based on  in vitro  hydrodynamic testing of a commercially available heart valve prosthesis. Hyper-elastic constitutive law for polymeric leaflet material was implemented based on experimental stress strain curves resulting from uniaxial tensile and planar shear testing. As a result of FEA, time dependent leaflet deformation of the leaflet structure was calculated. Obtained leaflet dynamics were comparable to  in vitro  performance of the analyzed prosthesis. As a major design parameter, the lunula angle has demonstrated crucial influence on the performance of the polymeric leaflet structures. FEA represented a useful tool for design of improved polymeric leaflet structures for minimally invasive implantable heart valve prostheses.

Assessment of heart valve performance by finite-element design studies of polymeric leaflet-structures