The mechanical properties of nitinol iliac vein stent (NIVS) have been studied by many scholars at home and abroad, but the study on the mechanical properties of iliac vein stent under different release scales has not been reported yet. Based on the finite element analysis method, the mechanical properties of three self-developed NIVS were studied to reveal the influence of stent diameters (12, 14, 16 mm) and different release scales (80%, 90%) on its strength, fatigue life and vein wall biomechanical properties. With an increases in the release scales, the equivalent elastic strain, fatigue strength safety factors, and vessel wall equivalent stress exhibited a downward trend, while the most stressed cross-section coincided with the arc of stent-connecting rods. Through 30, 60 and 90 days' animal test, a narrowed vascular model was established in the iliac veins of 12 pigs, and the developed iliac vein stents were implanted to comprehensively evaluate the safety and effectiveness of the stent, and at the same time the mechanical properties of stents were verified to provide important reference for the type inspection and clinical trials of follow-up products.
国内外学者对镍钛合金血管支架的力学性能进行了多方面的研究，关于不同释放尺度下的髂静脉支架力学性能的研究尚未见报道。利用有限元法，对自主研发的三款镍钛合金髂静脉支架力学性能进行研究，揭示支架直径（12、14、16 mm）与不同释放尺度（80%、90%）对其强度、疲劳寿命和静脉壁生物力学性能影响的规律。研究结果显示，不同直径的支架随着释放尺度的增加，支架弹性应变、血管壁等效应力和疲劳强度的安全系数均有减小的趋势，危险截面发生在支架连接杆圆弧处。通过 30 天、60 天和 90 天的动物实验，对 12 头猪的髂静脉建立狭窄的血管模型，植入研发的髂静脉支架，综合评价支架的安全性和有效性，同时验证了三款支架的力学性能，为后续产品的型式检验及临床试验提供了重要的参考依据。.
Keywords: animal test; fatigue strength; finite element analysis; iliac vein stent; mechanical properties.