Abstract： The first generation scaffolds of bare metal stents （BMS） and the second generation of drug eluting stents （DES） have been widely used in the treatment of coronary heart diseases. However, long term incidences of major adverse cardiovascular events and revascularization treatments are still high because of in-stent re-stenosis and thrombosis. These may be caused by chronic inflammations and vascular wall damages due to persistent metal stents stimulation. What’s more, the eluting drugs within metal stents could also disturb normal growth of vascular endothelial cell, intima, tunica media, smooth muscle and epimysium. Therefore, in order to meet these demands several fully biodegradable scaffolds and drug carried stents have been manufactured using polymers polyester, polycarbonate and polyphosphate, etc. Among them, the security and histo-and hemo-compatibilities of coronary scaffolds made from poly-lactic acid （PLA）, poly-glycolic acid（PGA）, chitosan as coating, poly-caprolactone （PCL） and other copolymer like poly-lactic-co-glycolic acid （PLGA） have been testified to be sound. Nevertheless, there exist several different shortages for these stents such as tensile strength deficiency and slow degradation. PLA is hard and brittle with slow degradation, while PGA is soft with insufficient support force and fast degradation. Whether stents degrade too fast or too slow, they could not supply sufficient strength and effective support after implantation, and also they may cause target vascular injuries and elastic shrink inducing restenosis and thrombosis in long terms. Using optimized molar ratio component of PLA and PGA with chitosan coating, we can get sound composite materials with better biocompatibility, moderate degradation （approximately 3 - 6 months of completedegradation）, adequate mechanical strength, lower inflammatory response and good range of extension, and establish an experiment ground for fully biodegradable vascular scaffolds fabrication.
This paper adopted UG8.0 to bulid the stent and blood vessel models. The models were then imported into the finite element analysis software ANSYS. The simulation results of ANSYS software showed that after endothelial stent implantation, the velocity of the blood was slow and the fluctuation of velocity was small, which meant the flow was relatively stable. When blood flowed through the endothelial stent, the pressure gradually became smaller, and the range of the pressure was not wide. The endothelial shear stress basically unchanged. In general, it can be concluded that the endothelial stents have little impact on the flow of blood and can fully realize its function.
The interventional therapy of vascular stent implantation is a popular treatment method for cardiovascular stenosis and blockage. However, traditional stent manufacturing methods such as laser cutting are complex and cannot easily manufacture complex structures such as bifurcated stents, while three-dimensional (3D) printing technology provides a new method for manufacturing stents with complex structure and personalized designs. In this paper, a cardiovascular stent was designed, and printed using selective laser melting technology and 316L stainless steel powder of 0?10 μm size. Electrolytic polishing was performed to improve the surface quality of the printed vascular stent, and the expansion behavior of the polished stent was assessed by balloon inflation. The results showed that the newly designed cardiovascular stent could be manufactured by 3D printing technology. Electrolytic polishing removed the attached powder and reduced the surface roughness Ra from 1.36 μm to 0.82 μm. The axial shortening rate of the polished bracket was 4.23% when the outside diameter was expanded from 2.42 mm to 3.63 mm under the pressure of the balloon, and the radial rebound rate was 2.48% after unloading. The radial force of polished stent was 8.32 N. The 3D printed vascular stent can remove the surface powder through electrolytic polishing to improve the surface quality, and show good dilatation performance and radial support performance, which provides a reference for the practical application of 3D printed vascular stent.
The current finite element analysis of vascular stent expansion does not take into account the effect of the stent release pose on the expansion results. In this study, stent and vessel model were established by Pro/E. Five kinds of finite element assembly models were constructed by ABAQUS, including 0 degree without eccentricity model, 3 degree without eccentricity model, 5 degree without eccentricity model, 0 degree axial eccentricity model and 0 degree radial eccentricity model. These models were divided into two groups of experiments for numerical simulation with respect to angle and eccentricity. The mechanical parameters such as foreshortening rate, radial recoil rate and dog boning rate were calculated. The influence of angle and eccentricity on the numerical simulation was obtained by comparative analysis. Calculation results showed that the residual stenosis rates were 38.3%, 38.4%, 38.4%, 35.7% and 38.2% respectively for the 5 models. The results indicate that the pose has less effect on the numerical simulation results so that it can be neglected when the accuracy of the result is not highly required, and the basic model as 0 degree without eccentricity model is feasible for numerical simulation.
In vitro experimental test for mechanical properties of a vascular stent is a main method to evaluate its effectiveness and safety, which is of great significance to the clinical applications. In this study, a comparative study of planar, V-groove and radial compression methods for the radial support property test were performed, and the effects of compression rate and circumferential position on the test results were conducted. Based on the three-point bending method, the influences of compression rate and circumferential position on flexibility were also explored. And then a best test proposal was selected to evaluate the radial support property and flexibility of the three self-designed stents and the comparative biodegradable vascular stent (BVS) (BVS1.1, Abbott Vascular, USA) with different outside diameters of 1.4 mm, 1.7 mm and 2.4 mm. The results show that the developing trends of the compression load with the compression displacement measured by the three radial support property test methods are the same, but normalized radial force values are quite different. The planar compression method is more suitable for comparing the radial support properties of stents with different diameters and structures. Compression rate has no obvious effect on the testing results of both the radial support property and flexibility. Compression circumferential position has a great impact on testing radial support property with the planar or V-groove compression methods and testing flexibility with three-point bending method. The radial support properties of all the three self-designed stents are improved at a certain degree compared to that of the BVS stent. The study has better guide significance and reference value for testing mechanical properties of vascular stents.
New biodegradable intravascular stent can reduce risk of foreign bodies retained, thus, it is widely concerned and some of the products have been introduced into the clinic. However, the characteristic of biodegradable may lead to more safety concerns associated with thrombosis. To ensure the safety, the thrombus formation experiment in vivo needs to be carefully designed and evaluated based on GB/T 16886.4 standard, but current standard do not provide explicit testing and evaluating methods. Establishing animal model with experimental pigs, the study compares biodegradable coronary stents and metal stents by simulating clinical implantation in vivo on the thrombus formation in the implanting process, and after the short-term and long-term implantation. The evaluation methods include gross observation, digital subtraction angiography intraoperative analysis, optical coherence tomography analysis, scanning electron microscopy and so on. The results show that combining these methods could comprehensively evaluate the whole process of the thrombus formation from the beginning of implantation to the end of preclinical animal experiments, so that, it may better predict the clinical thrombosis risk, and the selection of the control was very important. The study tries to use the comparison examples of thrombosis on the new medical instrument to provide the clue for thrombosis evaluation in vivo on similar instruments and show the methodology on the preclinical evaluation.
Objective To prepare a spider silk protein bilayer small diameter vascular scaffold using electrospinning, and to observe the blood compatibility in vitro. Methods The Arg-Gly-Asp-recombinant spider silk protein (pNSR16), polycaprolactone (PCL), gelatin (Gt), and heparin (Hep) were blended. Spider silk protein bilayer small diameter vascular scaffold (experimental group) was prepared by electrospinning, with pNSR16 ∶ PCL ∶ Hep (5 ∶ 85 ∶ 10, W/W) hybrid electrospun solution as inner spinning solution and pNSR16 ∶ PCL ∶ Gt (5 ∶ 85 ∶ 10, W/W) hybrid electrospun solution as outer spinning solution, but pNSR16 ∶ PCL (5 ∶ 85, W/W) hybrid electrospun solution was used as inner spinning solution in control group. The scaffold structure of experimental group was observed under scanning electron microscope (SEM); and the hemolysis rate, recalcification clotting time, dynamic clotting time, platelet adhesion, and platelet activation in vitro were compared between 2 groups. Results SEM results showed that bilayer fibers of scaffold were quite different in experimental group; the diameter distribution of inner layer fibers was relatively uniform with small pores, however diameter difference of the outer layer fiber was relatively big with big pores. The contact angle, hemolysis rate, recalcification clotting time, and P-selectin expression of scaffold were (35 ± 3) ° , 1.2% ± 0.1%, (340 ± 11) s, and 0.412 ± 0.027 respectively in experimental group, and were (70 ± 4) ° , 1.9% ± 0.1%, (260 ± 16) s, and 0.678 ± 0.031 respectively in control group; significant difference were found in indexes between 2 groups (P lt; 0.05). With the extension of time, the curve of coagulation time in experimental group sloped downward slowly and had a long time; the blood clotting index values before 30 minutes were significantly higher than those in control group (P lt; 0.05). Platelet adhesion test showed that the scaffold surface almost had no platelet adhesion in experimental group. Conclusion The spider silk protein bilayer small diameter vascular scaffold could be prepared through electrospinning, and it has good blood compatibility in vitro.
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.
Cardiovascular disease is one of the most common causes of death. Coronary artery stent implantation has been the most important method to cure coronary disease and inhibit angiostegnosis. However, restenosis and thrombus at the site of implanting cardiovascular devices remains a significant problem in the practice of interventional cardiology. Recently, lots of studies have revealed that endothelial impairment is considered as one of the most important mechanisms contributing to restenosis. As a result, the method of accelerating endothelial regeneration at the injury site could prevent restenosis and thrombus. Considering the surface modification of cardiovascular stent implantation, this paper summarizes the progress on this direction, especially for the prevention of cardiovascular restenosis. Furthermore, this paper also proposes the methods and the future developing prospects for accelerating in vivo re-endothelialization at the site of intravascular stent with different biological molecules.