本文以一种有源植入式医疗器械的玻璃封接馈通作为研究对象，分析了馈通在人体内温度应力作用下的失效机理，建立馈通的失效寿命分布模型，提出了恒定应力加速寿命试验方案，并通过试验，得到了馈通的失效寿命分布数据。从而得到了馈通可靠性方面的相关信息，为进一步改善馈通生产工艺，提高馈通可靠性奠定了基础。首先，本文介绍了国内外关于植入式医疗器械封装，以及可靠性研究的发展历史和现状，对植入式医疗器械封装的重要性，可靠性试验的方法及其发展趋势，进行了回顾及评述。其次，阐述了玻璃-金属封接机理，分析了影响封接可靠性的因素，提出了封接材料、封接工艺上的要求。第三，根据玻璃-金属封接的失效机理，确立了馈通的失效寿命分布，并在此基础上通过高应力加速寿命试验确定相关参数，提出了恒定应力加速寿命试验方案。第四，通过最小二乘法、最佳线性无偏法等不同方法对加速寿命试验数据进行处理，得到了人体环境下馈通的失效寿命分布，预测馈通的使用寿命及可靠性变化，发现目前馈通尚无法满足植入式医疗领域的使用需求，仍需进一步改进。第五，对试验结果进行进一步处理，提高了馈通失效寿命分布的准确性，在此基础上计算馈通失效的激活能。同时设计进行了两项对照试验——低温加速寿命试验和环境应力寿命试验，通过对照试验进一步提升加速寿命试验结果的可靠性，并为进一步工作奠定了基础。最后，对全文工作进行总结，提出了植入式医疗器械可靠性试验的进一步研究内容，并指出了本课题接下来的研究方向。
Brain pacemaker is a kind of high-end active implantable medical devices, its implant life is about 5 to 10 years by working in harsh environment of body fluid. As the core device of brain pacemaker hermetic package, feedthroughs are very important to the reliability of brain pacemakers.In this dissertation, a kind of glass sealing feedthrough which is using on domestic brain pacemakers was taken as the object. The possible failure mode has been analyzed, and a study of its effective working life and reliability has been done by accelerated life test and control experiment. Firstly, this dissertation stated and reviewed the develop history and current situation of implantable medical device package and reliability engineering.Secondly, described the glass-to-metal sealing mechanism, analyzed the influence factors of sealing reliability. According to this, the failure distribution model of feedthroughs has been established, and accelerated life test plan has been put forward.Thirdly, according to the existing processing technology and equipment, completed the accelerated life test in half a year. By calculating the test data, estimated the life distribution of the feedthroughs in body fluid.Fourthly, a kind of temperature and humidity measuring device for the wireless remote measurement of human body has been designed and completed to measure the humidity in the device during more than a year and a half. As a control experiment, this helps to improve the accuracy of the results of the experiment.Finally, gave a conclusion to research content of the entire dissertation.
