Investigating the Equivalent Plastic Strain in a Variable Ring Length and Strut Width Thin-Strut Bioresorbable Scaffold

Purpose

The ArterioSorb™ bioresorbable scaffold (BRS) developed by Arterius Ltd is about to enter first in man clinical trials. Previous generations of BRS have been vulnerable to brittle fracture, when expanded via balloon inflation in-vivo, which can be extremely detrimental to patient outcome. Therefore, this study explores the effect of variable ring length and strut width (as facilitated by the ArterioSorb™ design) on fracture resistance via analysis of the distribution of equivalent plastic strain in the scaffold struts post expansion. Scaffold performance is also assessed with respect to side branch access, radial strength, final deployed diameter and percentage recoil.

Methods

Finite element analysis was conducted of the crimping, expansion and radial crushing of five scaffold designs comprising different variations in ring length and strut width. The Abaqus/Explicit (DS SIMULIA) solution method was used for all simulations. Direct comparison between in-silico predictions and in-vitro measurements of the performance of the open cell variant of the ArterioSorb™ were made. Paths across the width of the crown apex and around the scaffold rings were defined along which the plastic strain distribution was analysed.

Results

The in-silico results demonstrated good predictions of final shape for the baseline scaffold design. Percentage recoil and radial strength were predicted to be, respectively, 2.8 and 1.7 times higher than the experimentally measured values, predominantly due to the limitations of the anisotropic elasto-plastic material property model used for the scaffold. Average maximum values of equivalent plastic strain were up to 2.4 times higher in the wide strut designs relative to the narrow strut scaffolds. As well as the concomitant risk of strut fracture, the wide strut designs also exhibited twisting and splaying behaviour at the crowns located on the scaffold end rings. Not only are these phenomena detrimental to the radial strength and risk of strut fracture but they also increase the likelihood of damage to the vessel wall. However, the baseline scaffold design was observed to tolerate significant over expansion without inducing excessive plastic strains, a result which is particularly encouraging, due to post-dilatation being commonplace in clinical practice.

Conclusion

Therefore, the narrow strut designs investigated herein, are likely to offer optimal performance and potentially better patient outcomes. Further work should address the material modelling of next generation polymeric BRS to more accurately capture their mechanical behaviour. Observation of the in-vitro testing indicates that the ArterioSorb™ BRS can tolerate greater levels of over expansion than anticipated.