In order to evaluate the safety performance of self-expandable NiTi alloy stents systematically, the dynamic safety factor drawn up by International Organization for Standardization, was used to quantitatively reflect the safety performance of stents. Based on the constitutive model of super-elastic memory alloy material in Abaqus and uniaxial tensile test data of NiTi alloy tube, finite element method and experiments on accelerated fatigue life were carried out to simulate the self-expansion process and the shape change process under the action of high and low blood pressure for three L-type stents of Φ8×30 mm, Φ10×30 mm, Φ12×30 mm. By analyzing the changes of stress and strain of self-expanding NiTi alloy stent, the maximum stress and strain, stress concentration position, fatigue strength and possible failure modes were studied, thus the dynamic safety factor of stent was calculated. The results showed that the maximum stress and plastic strain of the stent increased with the increase of grip pressure, but the maximum stress and strain distribution area of the stent had no significant change, which were all concentrated in the inner arc between the support and the connector. The dynamic safety factors of the three stents were 1.31, 1.23 and 1.14, respectively, which indicates that the three stents have better safety and reliability, and can meet the fatigue life requirements of more than 10 years, and safety performance of the three stents decreases with the increase of stent’s original diameter.
The dynamic analysis of the implantation process of a new vena cava filter was carried out by finite element analysis method to reveal the influence of the angle, length, width and thickness of the filter rod on its mechanical properties and the inner wall of the blood vessel. The results showed that the high-stress and high-strain areas of the filter were mainly concentrated in the connection between the filter rod and the filter wire. With the increase of the angle of the filter rod, the maximum equivalent stress and the maximum elastic strain on the filter wall decreased, while the maximum equivalent stress on the vascular wall increased. With the increase of the length of the filter rod, the maximum equivalent stress and strain peak of the filter wall increased, but the maximum equivalent stress of the vessel wall decreased. With the increase of the width and thickness of the filter rod, the maximum equivalent stress of the filter wall, the maximum elastic strain and the maximum equivalent stress of the vessel wall all showed an upward trend. The static safety factor of all filter models was greater than 1, and the structure after implantation was safe and reliable. The results of this study are expected to provide a theoretical basis for the structural optimization and deformation mechanism of the new type vena cava filter.
Lower extremity movement is a complex and large range of limb movement. Arterial stents implanted in lower extremity are prone to complex mechanical deformation, so the stent is required to have high comprehensive mechanical properties. In order to evaluate the mechanical property of different stents, in this paper, finite element method was used to simulate and compare the mechanical properties of six nitinol stents (Absolute Pro, Complete SE, Lifestent, Protégé EverFlex, Pulsar-35 and New) under different deformation modes, such as radial compression, axial compression/tension, bending and torsion, and the radial support performance of the stents was verified by experiments. The results showed that the comprehensive performance of New stent was better than other stents. Among which the radial support performance was higher than Absolute Pro and Pulsar-35 stent, the axial support performance was better than Complete SE, Lifestent and Protégé EverFlex stent, the flexibility was superior to Protégé Everflex stent, and the torsion performance was better than Complete SE, Lifestent and Protégé Everflex stent. The TTR2 type radial support force tester was used to test the radial support performance of 6 types, and the finite element analysis results were verified. The mechanical properties of the stent are closely related to the structural size. The result provides a reference for choosing a suitable stent according to the needs of the diseased location in clinical applications.
To explore the influence of bionic texture coronary stents on hemodynamics, a type of bioabsorbable polylactic acid coronary stents was designed, for which a finite element analysis method was used to carry out simulation analysis on blood flow field after the implantation of bionic texture stents with three different shapes (rectangle, triangle and trapezoid), thus revealing the influence of groove shape and size on hemodynamics, and identifying the optimal solution of bionic texture groove. The results showed that the influence of bionic texture grooves of different shapes and sizes on the lower wall shear stress region had a certain regularity. Specifically, the improvement effect of grooves above 0.06 mm on blood flow characteristics was poor, and the effect of grooves below 0.06 mm was good. Furthermore, the smaller the size is, the better the improvement effect is, and the 0.02 mm triangular groove had the best improvement effect. Based on the results of this study, it is expected that bionic texture stents have provided a new method for reducing in-stent restenosis.
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.
Vena cava filter is a filter device designed to prevent pulmonary embolism caused by thrombus detached from lower limbs and pelvis. A new retrievable vena cava filter was designed in this study. To evaluate hemodynamic performance and thrombus capture efficiency after transplanting vena cava filter, numerical simulation of computational fluid dynamics was used to simulate hemodynamics and compare it with the commercialized Denali and Aegisy filters, and in vitro experimental test was performed to compare the thrombus capture effect. In this paper, the two-phase flow model of computational fluid dynamics software was used to analyze the outlet blood flow velocity, inlet-outlet pressure difference, wall shear stress on the wall of the filter, the area ratio of the high and low wall shear stress area and thrombus capture efficiency when the thrombus diameter was 5 mm, 10 mm, 15 mm and thrombus content was 10%, 20%, 30%, respectively. Meanwhile, the thrombus capture effects of the above three filters were also compared and evaluated by in vitro experimental data. The results showed that the Denali filter has minimal interference to blood flow after implantation, but has the worst capture effect on 5 mm small diameter thrombus; the Aegisy filter has the best effect on the trapping of thrombus with different diameters and concentrations, but the low wall shear stress area ratio is the largest; the new filter designed in this study has a good filtering and capture efficiency on small-diameter thrombus, and the area ratio of low wall shear stress which is prone to thrombosis is small. The low wall shear stress area of the Denali and Aegisy filters is relatively large, and the risk of thrombosis is high. Based on the above results, it is expected that the new vena cava filter designed in this paper can provide a reference for the design and clinical selection of new filters.