| MEDICAL EQUIPMENT |
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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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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.
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| Keywords
medical devices
active implantation
reliability
implanted electrode interface
implanted brain-computer interface
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Issue Date: 23 April 2023
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2023,
Vol. 63
