Comprehensive computational analysis of the crimping procedure of PLLA BVS: effects of material viscous-plastic and temperature dependent behavior.

Recently, researchers focused their attention on the use of polymeric bioresorbable vascular scaffolds (BVSs) as alternative to permanent metallic drug-eluting stents (DESs) for the treatment of atherosclerotic coronary arteries. Due to the different mechanical properties, polymeric stents, if compared to DESs, are characterized by larger strut size and specific design. It implies that during the crimping phase, BVSs undergo higher deformation and the packing of the struts, making this process potentially critical for the onset of damage. In this work, a computational study on the crimping procedure of a PLLA stent, inspired by the Absorb GT1 (Abbott Vascular) design, is performed, with the aim of evaluating how different strategies (loading steps, velocities and temperatures) can influence the results in terms of damage risk and final crimped diameter. For these simulations, an elastic-viscous-plastic model was adopted, based on experimental results, obtained from tensile testing of PLLA specimens loaded according to ad hoc experimental protocols. Furthermore, the results of these simulations were compared with those obtained by neglecting strain rate and temperature dependence in the material model (as often done in the literature), showing how this lead to significant differences in the prediction of the crimped diameter and internal stress state.

Validation of the computational model of a coronary stent: a fundamental step towards in silico trials.

The proof of the reliability of a numerical model is becoming of paramount importance in the era of in silico clinical trials. When dealing with a coronary stenting procedure, the virtual scenario should be able to replicate the real device, passing through the different stages of the procedure, which has to maintain the atherosclerotic vessel opened. Nevertheless, most of the published studies adopted commercially resembling geometries and generic material parameters, without a specific validation of the employed numerical models. In this work, a workflow for the generation and validation of the computational model of a coronary stent was proposed. Possible sources of variability in the results, such as the inter-batches variability in the material properties and the choice of proper simulation strategies, were accounted for and discussed. Then, a group of in vitro tests, representative of the device intended use was used as a comparator to validate the model. The free expansion simulation, which is the most used simulation in the literature, was shown to be only partially useful for stent model validation purposes. On the other hand, the choice of proper additional experiments, as the suggested uniaxial tensile tests on the stent and deployment tests into a deformable tube, could provide further suitable information to prove the efficacy of the numerical approach.

From the real device to the digital twin: A coupled experimental-numerical strategy to investigate a novel bioresorbable vascular scaffold.

The purpose of this work is to propose a workflow that couples experimental and computational activities aimed at developing a credible digital twin of a commercial coronary bioresorbable vascular scaffold when direct access to data about material mechanical properties is not possible. Such a situation is be faced when the manufacturer is not involved in the study, thus directly investigating the actual device is the only source of information available. The object of the work is the Fantom® Encore polymeric stent (REVA Medical) made of Tyrocore™. Four devices were purchased and used in mechanical tests that are easily reproducible in any mechanical laboratory, i.e. free expansion and uniaxial tension testing, the latter performed with protocols that emphasized the rate-dependent properties of the polymer. Given the complexity of the mechanical behaviour observed experimentally, it was chosen to use the Parallel Rehological Framework material model, already used in the literature to describe the behaviour of other polymers, such as PLLA. Calibration of the material model was based on simulations that replicate the tensile test performed on the device. Given the high number of material parameters, a plan of simulations was done to find the most suitable set, varying each parameter value in a feasible range and considering a single repetitive unit of the stent, neglecting residual stresses generated by crimping and expansion. This strategy resulted in a significant reduction of computational cost. The performance of the set of parameters thus identified was finally evaluated considering the whole delivery system, by comparing the experimental results with the data collected simulating free expansion and uniaxial tension testing. Moreover, radial force testing was numerically performed and compared with literature data. The obtained results demonstrated the effectiveness of the digital twin development pipeline, a path applicable to any commercial device whose geometric structure is based on repetitive units.