ABSTRACT
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.