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Experimental and mathematical characterization of coronary polyamide-12 balloon catheter membranes
(2020)
The experimental quantification and modeling of the multiaxial mechanical response of polymer membranes of coronary balloon catheters have not yet been carried out. Due to the lack of insights, it is not shown whether isotropic material models can describe the material response of balloon catheter membranes expanded with nominal or higher, supra-nominal pressures. Therefore, for the first time, specimens of commercial polyamide-12 balloon catheters membranes were investigated during uniaxial and biaxial loading scenarios. Furthermore, the influence of kinematic effects on the material response was observed by comparing results from quasi-static and dynamic biaxial extension tests. Novel clamping techniques are described, which allow to test even tiny specimens taken from the balloon membranes. The results of this study reveal the semi-compliant, nonlinear, and viscoelastic character of polyamide-12 balloon catheter membranes. Above nominal pressure, the membranes show a pronounced anisotropic mechanical behavior with a stiffer response in the circumferential direction. The anisotropic feature intensifies with an increasing strain-rate. A modified polynomial model was applied to represent the realistic mechanical response of the balloon catheter membranes during dynamic biaxial extension tests. This study also includes a compact set of constitutive model parameters for the use of the proposed model in future finite element analyses to perform more accurate simulations of expanding balloon catheters.
In-stent restenosis remains a major problem of arteriosclerosis treatment by stenting. Expansion-optimized stents could reduce this problem. With numerical simulations, stent designs/ expansion behaviours can be effectively analyzed. For reasons of efficiency, simplified models of balloon-expandable stents are often used, but their accuracy must be challenged due to insufficient experimental validation. In this work, a realistic stent life-cycle simulation has been performed including balloon folding, stent crimping and free expansion of the balloon-stent-system. The successful simulation and validation of two stent designs with homogenous and heterogeneous stent stiffness and an asymmetrically positioned stent on the balloon catheter confirm the universal applicability of the simulation approach. Dogboning ratio, as well as the final dimensions of the folded balloon, the crimped and expanded stent, correspond well to the experimental dimensions with only slight deviations. In contrast to the detailed stent life-cycle simulation, a displacement-controlled simulation can not predict the transient stent expansion, but is suitable to reproduce the final expanded stent shape and the associated stress states. The detailed stent life-cycle simulation is thus essential for stent expansion analysis/optimization, whereas for reasons of computational efficiency, the displacement-controlled approach can be considered in the context of pure stress analysis.