InSilc Computational Tool for In Silico Optimization of Drug-Eluting Bioresorbable Vascular Scaffolds

Abstract

Stents made by different manufacturers must meet the requirements of standard in vitro mechanical tests performed under different physiological conditions in order to be validated. In addition to in vitro research, there is a need for in silico numerical simulations that can help during the stent prototyping phase. In silico simulations have the ability to give the same stent responses as well as the potential to reduce costs and time needed to carry out experimental tests. The goal of this paper is to show the achievements of the computational platform created as a result of the EU-funded project InSilc, used for numerical testing of most standard tests for validation of preproduction bioresorbable vascular scaffolds (BVSs). Within the platform, an ad hoc simulation protocol has been developed based on the finite element (FE) analysis program PAK and user interface software CAD Field and Solid. Two different designs of two different stents have been numerically simulated using this integrated tool, and the results have been demonstrated. The following standard tests have been performed: longitudinal tensile strength, local compression, kinking, and flex 1-3. Strut thickness and additional pocket holes (slots) in two different scaffolds have been used as representative parameters for comparing the mechanical characteristics of the stents (AB-BVS vs. AB-BVS-thinner and PLLA-prot vs. PLLA-plot-slot). The AB-BVS-thinner prototype shows better overall stress distribution than the AB-BVS, while the PLLA-prot shows better overall stress distribution in comparison to the PLLA-plot-slot. In all cases, the values of the maximum effective stresses are below 220 MPa—the value obtained by in vitro experiment. Despite the presented results, additional considerations should be included before the proposed software can be used as a validation tool for stent prototyping.