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清华大学学报(自然科学版)  2023, Vol. 63 Issue (5): 792-801    DOI: 10.16511/j.cnki.qhdxxb.2022.21.028
  医疗设备 本期目录 | 过刊浏览 | 高级检索 |
有源植入式医疗器械可靠性研究的特点和进展
王伟明1,2, 李冰2, 李路明1,2
1. 清华大学 航天航空学院, 北京 100084;
2. 清华大学 神经调控技术国家工程研究中心, 北京 100084
Characteristics and progress of research on the reliability of active implantable medical devices
WANG Weiming1,2, LI Bing2, LI Luming1,2
1. School of Aerospace Engineering, Tsinghua University, Beijing 100084, China;
2. National Engineering Research Center for Neuromodulation Technology, Tsinghua University, Beijing 100084, China
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摘要 有源植入式医疗器械是中国医疗器械产业实现转型升级和高质量发展目标的关键领域。该文概述了高风险有源植入式医疗器械的可靠性特点。从系统级、部件级到元器件级3个层面,系统阐述了有源植入式医疗器械领域的可靠性研究进展。在系统级,主要关注有源植入式医疗器械寿命的影响因素、关键部件之间的连接和医生手术过程的再操作等。在部件级,电路板的可靠性保障与传统高可靠性保障方法相比发生了显著变化,简化元件级试验并增加用户板级试验内容,结合实际工况设计相关试验条件和判据,成为了商用器件用于高可靠领域的可靠性保障的发展方向。电极与组织之间相互作用的长期可靠性是有源植入式医疗器械可靠性研究的重点内容。在元器件级,以电容为例对关键部件用于有源植入式医疗器械领域的可靠性问题进行了结合应用场景的分析。此外,微小型植入式医疗器械因植入简单,能够降低和导线密切相关的电磁兼容、核磁等风险,同时能够避免因导线变形、断裂等引发的可靠性问题,成为有源植入式医疗器械的重要发展方向,其可靠性先行的特征尤为明显。以设计应用方作为研究主体,侧重结合实际应用情况进行可靠性保障,是有源植入式医疗器械等高可靠性领域可靠性研究当前阶段的突出特点和发展趋势。
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关键词 医疗器械有源植入可靠性植入电极界面植入脑机接口    
Abstract:[Significance] Active implantable medical devices (AIMDs) are key areas for transformation, upgradation, and high-quality development in China's medical device industry.[Progress] The reliability characteristics of AIMD are summarized in this paper. The progress of research on the reliability of AIMDs is systematically described at the system, module, and component levels. At the system level, it is critical to study the primary factors affecting the life of AIMDs, including their structure, material, various stress environment profiles, working conditions, failure mode, failure mechanism, connection, and reoperation. Among them, the connection between the key modules and the content related to the doctor's multiple operations are critical components, thus requiring increased attention. At the module level, the reliability of key modules, primarily including the feed-through, implanted batteries, wires, implanted electrodes, and PCBA, has significantly impacted the reliability of the entire system and may even directly determine the reliability specifications of AIMDs. The reliability assurance of the circuit board has changed significantly with time compared with the traditional high-reliability assurance method. Directions for future development of the reliability assurance of commercial devices include simplifying component-level tests, adding user board-level test content, and designing relevant test conditions and criteria according to actual working conditions. The long-term reliability of the interaction between electrodes and tissues is a key issue in the reliability of AIMDs. Thus, establishing an accurate electrode structure model of the interaction between electrodes and tissues is a research focus. At the component level, the reliability of the key components used in AIMDs is analyzed along with the application scenarios considering capacitors as an example because they are the main cause of dysfunction in pacemakers and defibrillators. To date, no reliability specifications or methods exist for the components of AIMDs to the best of our knowledge. In the development and industrialization of domestic nerve stimulator products, the capacitors screened by reliability screening and the identification method developed by the National Engineering Research Center for Nerve Regulation have been applied to domestic nerve stimulator products, and no capacitor-induced failure has occurred thus far. To a certain extent, research on the reliability of AIMDs is also related to the development and application of new technologies and processes, such as micro-miniaturization-related technology application in the field of active implant medicines. Micro-implantable medical devices can reduce the risks of electromagnetic compatibility and magnetic resonance imaging closely related to lead and can avoid the reliability problems caused by lead deformation and fracture and its simple implantation.[Conclusions and Prospects] Micro-implantable medical devices have become an important development direction of AIMDs, exhibiting clear reliability. Despite the different methods, research in the field of high reliability, such as that of AIMDs, exhibits a prominent feature and development trend of considering design and application as the research subject and focusing on the guarantee of reliability based on the actual application. This multi-field and all-around exploration attempt will gradually form a series of specifications or unified standards after a certain stage of closed-loop verification by practical applications.
Key wordsmedical devices    active implantation    reliability    implanted electrode interface    implanted brain-computer interface
收稿日期: 2022-04-25      出版日期: 2023-04-23
基金资助:国家自然科学基金面上项目(62071274)
作者简介: 王伟明(1975—),女,高级工程师。E-mail:wangweiming@tsinghua.edu.cn
引用本文:   
王伟明, 李冰, 李路明. 有源植入式医疗器械可靠性研究的特点和进展[J]. 清华大学学报(自然科学版), 2023, 63(5): 792-801.
WANG Weiming, LI Bing, LI Luming. Characteristics and progress of research on the reliability of active implantable medical devices. Journal of Tsinghua University(Science and Technology), 2023, 63(5): 792-801.
链接本文:  
http://jst.tsinghuajournals.com/CN/10.16511/j.cnki.qhdxxb.2022.21.028  或          http://jst.tsinghuajournals.com/CN/Y2023/V63/I5/792
  
  
  
  
  
  
  
  
  
  
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