冠脉支架设计的材料适应性研究
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南京大学现代工程与应用科学学院

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Study on Material Adaptability of Coronary Stent Design
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    摘要:

    【目的】基于一种确定的冠脉支架设计分析不同材料的适应性,建立支架设计-材料选择的评价方法。【方法】针对可能应用的五种支架材料,利用有限元数值模拟方法分析支架在血管中的扩张性能,考察支架设计和材料的安全性及可用性。针对不可降解材料重点考察支架在长期植入后的耐疲劳性能;对可降解材料分析其降解过程中的支撑力变化,明确支架所能提供的支撑力的规律。【结果】针对文中确定的冠脉支架设计,模拟显示316L不锈钢和L605钴铬合金支架的径向回弹率分别是25%和19%,轴向短缩率分别为0.22%和0.28%,最大等效应力分别为551.2 MPa和829.1 MPa,疲劳动态安全系数分别为1.33和1.67,针对可降解材料——AZ31镁合金、铁(Iron)和左旋聚乳酸(PLLA),基于该设计的支架的模拟破坏时间分别为30小时、6个月和9个月。【结论】基于本文的支架设计,L605钴铬合金具有最佳的扩张性能和耐疲劳性能,可以满足临床需求。相较于AZ31的快速降解破坏,铁支架和PLLA支架的力学性能接近但仍需结构优化后才能满足临床需求。有限元数值模拟,尤其是扩张性能分析和耐疲劳性能分析可以有效地模拟支架力学行为并为支架制造材料选择和设计优化提供依据。

    Abstract:

    [Objective] To analyze the adaptability of different materials based on a defined coronary stent design and to establish an evaluation method for stent design-material selection. [Methods] Using finite element numerical simulation methods (FEA), the expansion performance of the stent in the blood vessel were analyzed, and the safety and usability of the stent design and materials were investigated for five potential applicable materials. For the permanent materials, the focus was on the fatigue resistance performance after long-term implantation; while for the degradable materials, the changes of support force during degradation were analyzed to clarify the rules of the support force provided by the stent. [Results] For the specific coronary stent design, the results given by the FEA showed that for 316L stainless steel and L605 cobalt-chromium alloy stents, the radial resilience were 25% and 19%, the axial shortening were 0.22% and 0.28%, the maximum equivalent forces were 551.2 MPa and 829.1 MPa, and the fatigue dynamic safety factors were 1.33 and 1.67, respectively. The simulated damage times of the stents based on this design were 30 hours, 6 months and 9 months for the degradable materials such as AZ31 magnesium alloy, iron and poly(L-lactic acid) (PLLA), respectively. [Conclusion] Based on the stent design in this paper, the L605 cobalt-chromium alloy exhibited the best expansion performance and fatigue resistance to match the clinical requirements. Compared with the rapid degradation damage of AZ31, the mechanical properties of iron stent and PLLA stent are close but still need structural optimization. While FEA, especially the expansion performance analysis and fatigue resistance analysis, can be effectively used to simulate the mechanical behavior of the stent and provide basis for the selections of stent materials and the design optimizations.

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  • 收稿日期:2023-04-12
  • 最后修改日期:2023-05-22
  • 录用日期:2023-05-23
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