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不同支架设计在机械性能方面的可靠性和性能比较研究:缩短、回缩、径向力和柔韧性。

A comparative reliability and performance study of different stent designs in terms of mechanical properties: foreshortening, recoil, radial force, and flexibility.

机构信息

Graduate Program in Biomedical Engineering, Yonsei University.

出版信息

Artif Organs. 2013 Apr;37(4):368-79. doi: 10.1111/aor.12001. Epub 2013 Mar 5.

Abstract

This study seeks to improve the mechanical performance of stents by conducting reliability performance testing and finite element method (FEM)-based simulations for coronary stents. Three commercially available stent designs and our own new design were tested to measure the factors affecting performance, specifically foreshortening, recoil, radial force, and flexibility. The stents used in the present experiments were 3 mm in working diameter and 18 mm of working length. The results of the experiments indicate that the foreshortening of stents A, B, C, and our new design, D, was equivalent to 2.25, 0.67, 0.46, and 0.41%, respectively. The recoil of stents A, B, C, and D was 6.00, 4.35, 3.50, and 4.36%, respectively. Parallel plate radial force measurements were A, 3.72 ± 0.28 N; B, 3.81 ± 0.32 N; C, 4.35 ± 0.18 N; and D, 4.02 ± 0.24 N. Radial forces determined by applying uniform pressure in the circumferential direction were A, 28.749 ± 0.81 N; B, 32.231 ± 1.80 N; C, 34.522 ± 3.06 N; and D, 42.183 ± 2.84 N. The maximum force of crimped stent at 2.2-mm deflection was 1.01 ± 0.08 N, 0.82 ± 0.08 N, 0.92 ± 0.12 N, and 0.68 ± 0.07 N for each of stents A, B, C and D. The results of this study enabled us to identify several factors to enhance the performance of stents. In comparing these stents, we found that our design, stent D, which was designed by a collaborative team from seven universities, performed better than the commercial stents across all parameter of foreshortening, recoil, radial force, and flexibility.

摘要

这项研究旨在通过对冠状动脉支架进行可靠性性能测试和有限元方法(FEM)模拟来提高支架的机械性能。对三种市售的支架设计和我们自己的新设计进行了测试,以测量影响性能的因素,特别是缩短、回缩、径向力和柔韧性。本实验中使用的支架工作直径为 3mm,工作长度为 18mm。实验结果表明,支架 A、B、C 和我们的新设计 D 的缩短率分别为 2.25%、0.67%、0.46%和 0.41%。支架 A、B、C 和 D 的回缩率分别为 6.00%、4.35%、3.50%和 4.36%。平行板径向力测量结果为 A 支架为 3.72±0.28N;B 支架为 3.81±0.32N;C 支架为 4.35±0.18N;D 支架为 4.02±0.24N。通过在圆周方向施加均匀压力确定的径向力为 A 支架为 28.749±0.81N;B 支架为 32.231±1.80N;C 支架为 34.522±3.06N;D 支架为 42.183±2.84N。在 2.2mm 挠度下卷曲支架的最大力为 1.01±0.08N、0.82±0.08N、0.92±0.12N 和 0.68±0.07N,分别为支架 A、B、C 和 D。本研究的结果使我们能够确定一些增强支架性能的因素。在比较这些支架时,我们发现我们的设计,即由七所大学的合作团队设计的支架 D,在缩短率、回缩率、径向力和柔韧性等所有参数方面都优于商业支架。

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