Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model

BACKGROUND@#Biodegradable poly (l-lactic acid) (PLLA), a bio safe polymer with a large elastic modulus, is widely used in biodegradable medical devices. However, because of its poor mechanical properties, a PLLA strut must be made twice as thick as a metal strut for adequate blood vessel support. Therefore, the mechanical properties of a drug-eluting metal-based stents (MBS) and a bioresorbable vascular scaffolds (BVS) were evaluated and their safety and efficacy were examined via a long-term rabbit iliac artery model. @*METHODS@#The surface morphologies of the MBSs and BVSs were investigated via optical and scanning electron microscopy. An everolimus-eluting (EE) BVS or an EE-MBS was implanted into rabbit iliac arteries at a 1.1:1 stent-toartery ratio. Twelve months afterward, stented iliac arteries from each group were analyzed via X-ray angiography, optical coherence tomography (OCT), and histopathologic evaluation. @*RESULTS@#Surface morphology analysis of the EE coating on the MBS confirmed that it was uniform and very thin (4.7 lm). Comparison of the mechanical properties of the EE-MBS and EE-BVS showed that the latter outperformed the former in all aspects (radial force (2.75 vs. 0.162 N/mm), foreshortening (0.24% vs. 1.9%), flexibility (0.52 vs. 0.19 N), and recoil (3.2% vs. 6.3%). At all time points, the percent area restenosis was increased in the EE-BVS group compared to the EE-MBS group. The OCT and histopathological analyses indicate no significant changes in strut thickness. @*CONCLUSION@#BVSs with thinner struts and shorter resorption times should be developed. A comparable long-term safety/efficacy evaluation after complete absorption of BVSs should be conducted.

Deduction and Verification of Optimal Factors for Stent Structure and Mechanical Reaction Using Finite Element Analysis / 의학물리

Recently, along with technology development of endoscopic equipment, a stent has been developed for the convenience of operation, shortening of recovery times, and reduction of patient's pain. To this end, optimal factors are simulated for the stent structure and mechanical reaction and verified using finite element analysis. In order to compare to present commercialized product such as Zilver (Cook, Bloomington, Indiana, USA) and S.M.A.R.T (Cordis, Bridgewater Towsnhip, New Jersey, USA), mechanical impact factors were determined through Taguchi factor analysis, and flexibility and expandability of all the products including ours were tested using finite element analysis. Also, important factors were sought that fulfill the optimal condition using central composition method of response surface analysis, and optimal design were carried out based on the important factors. From the centra composition method of Response surface analysis, it is found that importat factors for flexibility is stent thickness (T) and unit area (W) and those for expandability is stent thickness (T). In results, important factors for optimum condition are 0.17 mm for stent thickness (T) and 0.09 mm2 for unit area (W). Determined and verified by finite element analysis in out research institute, a stent was manufactured and tested with the results of better flexibility and expandability in optimal condition compared to other products. Recently, As Finite element analysis stent mechanical property assessment for research much proceed. But time and reduce expenses research rarely stent of optimum coditions. In this research, Important factor as mechanical impact factor stent Taguchi factor analysis arrangement to find flexibility with expansibility as Finite element analysis. Also, Using to Center composition method of Response surface method appropriate optimized condition searching for important factor, these considering had design optimized. Production stent time and reduce expenses was able to do the more coincide with optimum conditions. These kind of things as application plan industry of stent development period of time and reduce expenses etc. be of help to many economic development.

A Study on Fatigue Characteristic of Stent Using Finite Element Analysis / 의학물리

Stents are frequently used throughout the human body. They keep pathways open in vascular or nonvascular duct for a long time. Therefore its stability is very important factor. In recent years, aconsiderable amount of research has been carried out in order to estimate mechanical properties of the stent such as expansion pressure behavior, radial recoil and longitudinal recoil using FEM (Finite element analyses). However, published works on simulation of stent fatigue behavior using FEM are relatively rare. In this paper, a nonlinear finite-element method was employed to analyses the compression of a stent using external pressure and fatigue behavior. Finite element analyses for the stent system were performed using NASTRAN FX. In conclusion this paper shows how the stent is behaved in the body, and its fatigue behavior.

The Verification of Computer Simulation of Nitinol Wire Stent Using Finite Element Analysis / 의학물리

Recently, the mathematical analysis of stent simulation has been improved, with the help of development of various tool which measure mechanical property and location of stent in artery. The most crucial part of the stent modeling is how to design ideal stent and to evaluate the interaction between stent and artery. While there has been great deal of researches on the evaluation of the expansion, stress distribution, deformation of the stent in terms of the various parameters, few verification through computer simulation has been performed about deformation and stress distribution of the stent. In this study, we have produced the corresponding results between experimental test using Universal Testing Machine and computer simulation for the ideal model of stent. Also, we have analyzed and compared stress distribution of stent in the cases of that with membrane and that without membrane. The results of this study would provide minimum change of plan and good quality for ideal stent replacing damaged artery through the analysis using computer simulation in the early stage of stent design.

The Verification of Computer Simulation of Nitinol Wire Stent Using Finite Element Analysis / 의학물리

Recently, the mathematical analysis of stent simulation has been improved, with the help of development of various tool which measure mechanical property and location of stent in artery. The most crucial part of the stent modeling is how to design ideal stent and to evaluate the interaction between stent and artery. While there has been great deal of researches on the evaluation of the expansion, stress distribution, deformation of the stent in terms of the various parameters, few verification through computer simulation has been performed about deformation and stress distribution of the stent. In this study, we have produced the corresponding results between experimental test using Universal Testing Machine and computer simulation for the ideal model of stent. Also, we have analyzed and compared stress distribution of stent in the cases of that with membrane and that without membrane. The results of this study would provide minimum change of plan and good quality for ideal stent replacing damaged artery through the analysis using computer simulation in the early stage of stent design.