植入式脑机接口设备的磁共振兼容安全性讨论
Discussion on Magnetic Resonance Compatibility of Implantable Brain-Computer Interface Devices
靳凯翔 1刘勋 2胡晟 2李永华 3吴悦彤 4黎家兴 5莫承怀5
作者信息
- 1. 复旦大学信息科学与工程学院生物医学工程系,上海市,200483;上海市医疗器械检验研究院,上海市,201318
- 2. 上海市医疗器械检验研究院,上海市,201318;国家药品监督管理局医用电气设备重点实验室,上海市,201318;国家药品监督管理局呼吸麻醉设备重点实验室,上海市,201318
- 3. 上海市医疗器械检验研究院,上海市,201318;国家药品监督管理局医用电气设备重点实验室,上海市,201318
- 4. 上海市医疗器械检验研究院,上海市,201318
- 5. 上海交通大学生物医学工程学院,上海市,200030
- 折叠
摘要
脑机接口(brain-computer interface,BCI)设备是神经刺激和记录的重要工具,在神经疾病的诊断和治疗以及脑机接口系统的神经活动传递方面具有潜在的广泛应用前景.同时,磁共振成像(magnetic resonance imaging,MRI)是记录全脑信号的有效且无创的技术之一,可以提供大脑结构的细节和激活模式图.结合BCI设备,特别是植入式BCI的神经刺激/记录与MRI的无创检测功能,被认为对解析脑功能具有重要意义.然而,这种结合对植入式BCI接口器件的组成材料和结构提出了特殊要求.该文首先对植入式BCI设备与MRI在交互使用时可能引发的安全隐患进行了归纳和梳理;然后,从安全隐患产生的源头,特别是植入体内的关键组件如金属电极及导线等,分析问题并整理总结了当前研究中的应对策略;最后,简要讨论了国内外磁共振安全性监管法规,并提出了改善相关产品磁共振兼容安全性的发展方向.
Abstract
Brain-computer interface(BCI)devices are crucial tools for neural stimulation and recording,offering broad prospects in the diagnosis and treatment of neurological disorders.Furthermore,magnetic resonance imaging(MRI)is an effective and non-invasive technique for capturing whole-brain signals,providing detailed information on brain structures and activation patterns.Integrating the neural stimulation/recording capabilities of BCI devices with the non-invasive detection function of MRI is considered highly significant for brain function analysis.However,this combination imposes specific requirements on the magnetic and electronic performance of neural interface devices.The interaction between BCI devices and MRI is initially explored.Subsequently,potential safety risks arising from their combination are summarized and organized.Starting from the source of these hazards,such as the metallic electrodes and wires of BCI devices,the issues are analyzed,and current research countermeasures are summarized.In conclusion,the regulatory oversight of BCI's magnetic resonance safety is briefly discussed,and suggestions for enhancing the magnetic resonance compatibility of related BCI devices are proposed.
关键词
植入式脑机接口/磁共振兼容性/材料与结构/监管法规Key words
implantable brain computer interface/magnetic resonance compatibility/materials and structure/supervision laws and regulations引用本文复制引用
出版年
2024
NETL
NSTL
万方数据