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Numerical simulation of the functionality of a stent structure for venous valve prostheses

Abstract Chronic venous insufficiency (CVI) is a common disease characterized by impaired venous drainage leading to congestion in the lower limbs. Currently, there are no artificial or biological venous valve prostheses commercially available. Previous minimally invasive design concepts failed to achieve sufficient long term results in animal or in vitro studies. The aim was to implement structural numerical simulation of clinically relevant loading cases for minimally invasive implantable venous valve prostheses. A bicuspid valve design was chosen as it showed superior results compared to tricuspid valves in previous studies. The selfexpanding support structure was developed by using diamond-shaped elements. Using finite-element analysis (FEA), various loading cases, including expansion and crimping of the stent structure and the release into a venous vessel, were simulated. A hyperelastic constitutive law for the vascular model was generated from uniaxial tensile test data of unfixated human vein walls. This study also compared numerical and experimental results regarding compliance and tensile tests to validate the vein material model. The calculated performance concerning expansion and crimping, as well as the release of the stent into a venous vessel, demonstrated the suitability of the stent design for minimally invasive application.