Experimental and Mathematical Characterization of Coronary Polyamide 12 Balloon Catheter Membranes

The experimental quantification and modeling of the multiaxial mechanical response of polymer membranes of coronary balloon catheters have not yet been carried out.<br>Due to the lack of knowledge of such a study, it is not known whether isotropic material models can describe the material response of balloon catheter membranes expanded with the nominal or an even higher pressure. Therefore, for the first time, specimens of commercial polyamide 12 balloon catheters membranes were observed by performing uniaxial and biaxial extension tests. The quasi-static and dynamic testing scenarios include rupture, relaxation, and equibixial testing procedures. Novel clamping techniques are described, which allow even to test 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.<br>This data set contains experimental data collected in biaxial tensile tests presented in Figs 6, 7, 8, 9, 10, 13, 14, and the Cauchy stress-stretch relation until failure of the median and all single samples as depicted in Fig 12 in the respective publication.<br>See the attached readme file for a description of the data.<br>

目前尚未开展冠状动脉球囊导管（coronary balloon catheters）聚合物膜多轴力学响应的实验量化与建模研究。由于此类研究的知识储备空白，目前尚无法确定各向同性材料模型能否描述以标称压力或更高压力扩张的球囊导管膜的力学响应。因此，本研究首次针对商用聚酰胺12（polyamide 12）球囊导管膜试样开展单轴与双轴拉伸试验（uniaxial and biaxial extension tests）。本次测试涵盖准静态与动态两种测试场景，包含断裂、松弛及等双轴测试（equibiaxial testing）流程。本文还提出了新型夹持技术，可实现取自球囊膜的微小试样的力学测试。本研究结果揭示了聚酰胺12球囊导管膜的半柔顺、非线性与粘弹性特性。当压力超过标称值时，膜材料表现出显著的各向异性力学行为，周向刚度更高。各向异性特征随应变速率（strain-rate）的提升而进一步加剧。本研究采用修正多项式模型，以表征动态双轴拉伸试验中球囊导管膜的真实力学响应。本研究还提供了一套精简的本构模型参数集，供未来有限元分析（finite element analyses）中使用所提模型，以实现更精准的球囊导管扩张仿真。本数据集包含双轴拉伸试验的实验数据，对应公开文献中的图6、7、8、9、10、13、14，以及中位样本与全部单一样本失效前的柯西应力-拉伸比关系（Cauchy stress-stretch relation），详见对应公开文献中的图12。有关本数据集的详细说明，请参阅附带的readme文件。