Fatigue life assessment of cardiovascular balloon-expandable stents: a two-scale plasticity-damage model approach.

Cardiovascular disease has become a major global health care problem in the present decade. To tackle this problem, the use of cardiovascular stents has been considered a promising and effective approach. Numerical simulations to evaluate the in vivo behavior of stents are becoming more and more important to assess potential failures. As the material failure of a stent device has been often associated with fatigue issues, as a result of the high number of cyclic loads these devices are subjected to in vivo, numerical approaches for fatigue life assessment of stents has gained special interest in the engineering community. Numerical fatigue predictions can be used to modify the design and prevent failure, without making and testing numerous physical devices, thus preventing from undesired fatigue failures. This work presents a fatigue life numerical method for the analysis of cardiovascular balloon-expandable stainless steel stents. The method is based on a two-scale continuum damage mechanics model in which both plasticity and damage mechanisms are assumed to take place at a scale smaller than the scale of the representative volume element. The fatigue failure criterion is based on the Soderberg relation. The method is applied to the fatigue life assessment of both PalmazShatz and Cypher stent designs. Validation of the method is performed through comparison of the obtained numerical results with some experimental results available for the PalmazShatz stent design. The present study gives also possible directions for future research developments in the framework of the numerical fatigue life assessment of real balloon-expandable stents.