血管支架论文：血管支架物理力学性能实验研究.doc

血管支架论文：血管支架物理力学性能实验研究【中文摘要】近年来随着血管支架用量的逐年增加,人们越来越关注其在使用过程中的安全性和有效性问题,物理力学性能是保证使用有效性以及决定临床使用效果的关键因素。但目前物理力学性能指标的检测以各个厂家的自定标准为主,实验方法的差异造成了产品间对比的困难性,因此在统一实验方法的基础上对支架的性能进行研究具有重要的理论价值。本文以血管支架的物理力学性能为研究对象,在相同实验条件下对血管支架进行实验研究和性能比对研究：通过对血管支架的物理力学性能指标进行综合分析,选择支架的径向力学性能和耐疲劳性能进行研究,分析得出关键性的影响因素,为后续实验研究建立理论基础。平行选择了相同适应症、相同公称内径的球囊扩张式支架,以及不同用途的自膨式支架作为研究对象,进行了径向力学性能的实验研究,研究结果表明：统一的实验方法有利于血管支架间性能的比较,但对血管支架优劣的比较,则应考虑各个因素的综合影响；实际血管支架间的个体差异性和复杂性,决定了对支架成品进行实验研究的必要性并应建立相应的评价体系。对血管支架耐疲劳性能实验的关键参数进行了测试分析,并对疲劳实验后血管支架的径向力学性能进行实验研究,简化了疲劳实验过程中参数测试的步骤,结论表明疲劳实验显著降低了血管支架的径向力学性能,提出应建立疲劳实验后的评价体系。本课题的研究将相同产品、相同实验条件的观念引入目前的检测理念,弥补了目前实际产品检测数据的空白,并首次在相同冠脉支架间进行了横向对比,提出了血管支架评价方法的解决方案,为建立血管支架产品检测评价体系奠定了基础。【英文摘要】Due to the increasing of the use of vascular stent, more and more people make more attention to its safety and effection, the physical and mechanics performance of the stent is the critical factors to decide the clinical effection, but the requirment of the physical and mechanics performance is mainly focus on the standard which is compiled by manufacture themselves, its difficult to compare the products performance without the unified inspection method, so there will have the important theorys value to make the research to study the vascular stent performance on the basis of unified testing method.The study choose the physical and mechanics performance of vascular stent as object of study to build the experiment reasearch and performance comparison based on the same testing conditions.First I analysis the main physical and mechanics performance of vascular stent, choose the performance of radial force and fatigue resistence as the crucial target to research, have the factor which influent them, and build the theory basis to the following study. Then I choose the balloon expandable stent with the same nominal diameter and same indication, the self-expandable stent with different application to do the radial force performance study, the result indicate that the same testing method is benefit to compare the performance of vascular stent, but when you want to know which stent product is best, you must consider all the factors that influence the stents function. Due to the individual different and complexity, its necessary to do the experiment on the stent product and build an evaluation system used to compare the stent. I make a experiment study to the crucial data of the fatigue resistence performance, simplifing the steps of data testing, and study the stents radial force performance after the fatigue testing, the result indicate that the fatigue testing reduce the radial force performance of the stent, it need to build the evaluation system after the fatigue testing.The study bring the idea of same product and same condition to the inspection theory, remedy a blank of real product inspection data, compare the stent performance for the first time, give the solution idea to evaluate the stent, make a theory basis to build the stent inspection and evaluation system.【关键词】血管支架 物理力学性能 检测评价体系【英文关键词】vascular stent physical and mechanics performance inspection and evalution system【目录】血管支架物理力学性能实验研究目录5-7CONTENTS7-9摘要9-10ABSTRACT10第1章 绪论11-191.1 血管支架概述12-161.1.1 血管支架材料12-141.1.2 血管支架分类14-161.2 国内外研究现状161.3 血管支架物理力学性能实验研究的必要性16-171.4 本文研究内容17-19第2章 血管支架径向力学和耐疲劳性影响因素分析19-252.1 影响血管支架植入状态的关键指标19-212.2 血管支架径向力学性能和耐疲劳性能的测试要求21-222.2.1 径向力学性能的测试要求21-222.2.2 耐疲劳性能的测试要求222.3 血管支架径向力学性能和耐疲劳性能影响指标的分析22-232.4 本章小结23-25第3章 血管支架径向力学性能实验研究25-473.1 血管支架径向力学性能测试方法25-283.1.1 实验样品选择方法25-263.1.2 实验方法的选择26-283.1.2.1 常用径向力学性能的实验方法26-283.1.2.2 实验方法选择283.2 球囊扩张式支架抗挤压性能实验研究28-393.2.1 实验样品28-313.2.2 相同充盈直径下球囊扩张式支架抗挤压性能的实验31-363.2.2.1 实验设计313.2.2.2 实验结果与分析31-343.2.2.3 实验研究结论34-363.2.3 不同充盈直径下球囊扩张式支架抗挤压性能的实验36-393.2.3.1 实验设计363.2.3.2 实验结果与分析36-373.2.3.3 实验方法研究结论37-393.3 自膨式支架抗压缩性能的实验研究39-453.3.1 实验样品39-413.3.2 实验研究41-443.3.3 实验方法研究结论44-453.4 本章小结45-47第4章 血管支架耐疲劳性能实验方法研究47-614.1 血管支架疲劳机理及测试方法47-484.2 血管支架疲劳性能测试实验48-574.2.1 样品选择48-494.2.2 实验原理49-504.2.3 实验设备50-524.2.4 实验关键指标的研究52-554.2.5 实验关