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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.
Vascular damage develops with diverging severity during and after percutaneous coronary intervention with stent placement and is the prevailing stimulus for in-stent restenosis. Previous work has failed to link mechanical data obtained in a realistic in vivo or in vitro environment with data collected during imaging processes. We investigated whether specimens of porcine right coronary arteries soften when indented with a stent strut shaped structure, and if the softening results from damage mechanisms inside the fibrillar collagen structure. To simulate the multiaxial loading scenario of a stented coronary artery, we developed the testing device ‘LAESIO’ that can measure differences in the stress-stretch behavior of the arterial wall before and after the indentation of a strut-like stamp. The testing protocol was optimized according to preliminary experiments, more specifically equilibrium and relaxation tests. After chemical fixation of the specimens and subsequent tissue clearing, we performed three-dimensional surface and second-harmonic generation scans on the deformed specimens. We analyzed and correlated the mechanical response with structural parameters of high-affected tissue located next to the stamp indentation and low-affected tissue beyond the injured area. The results reveal that damage mechanisms, like tissue compression as well as softening, fiber dispersion, and the lesion extent, are direction-dependent, and the severity of them is linked to the strut orientation, indentation pressure, and position. The findings highlight the need for further investigations by applying the proposed methods to human coronary arteries. Additional data and insights might help to incorporate the observed damage mechanisms into material models for finite element analyses to perform more accurate simulations of stent-implantations.