植入式神经信号再生与阻断微电子接口器件关键技术研究

This project is related to more than 20 million patients with limb paralysis caused by stroke, brain trauma, spinal cord injury, multiple sclerosis, neurofibromatosis, sequela of poliomyelitis, et al. and several million patients with neural dysfunction caused by cerebral palsy, Parkinson's disease, epilepsia, et al..The aims include: To explore and find the information relationship among the electrical activities in the brain, the spinal cord, the peripheral nerves, the muscles and the limb functions, in order to lay the scientific foundation for the study on the regulation and control of different neural functions; To research and develop different electrodes of neural interface to apply to neural signal detection and functional electrical stimulation; To develop following the key techniques to the IC design, including amplification of weak neural signal, pattern recognition of multi-channel neural signals, low power circuits, and in-body energy supply; For nerve injury and signal deficiency, the implanted micro-electronic interface device of neural channel bridging and signal regeneration will be developed in order to make the motor function of paralyzed limbs to rehabilitate or rebuild, while for neural signal abnormity the implanted micro-electronic interface device of signal blocking will be developed according to the antimissile principle, in order to resolve the problem of the muscle twitch and limb spasm; To solve the problem of bio-compatibility of the electrodes and microelectronic modules; and to carried out animal experiments and clinical scientific experiments..The efforts will be made to get instrument certification and to apply to the clinic application.

面向我国两千多万因中风、脑外伤、脊髓损伤、多发性硬化症、神经纤维瘤病、脊髓灰质炎后遗症等其伤病引起的肢体瘫痪患者和数千万脑瘫、帕金森氏病、癫痫等动作神经功能异常患者，探索发现脑电、脊髓神经电、外周神经电、肌电与肌肉动作相关信号之间的信息关联，为研究动作神经功能调控芯片系统奠定科学理论基础；研发神经接口的各类电极，应用于各种神经信号的探测与功能电刺激；研发弱信号放大、多信道信号模式识别与分离、低功耗、体内供电等芯片设计关键技术；针对神经损伤和信号缺失，研究神经信道桥接与信号再生的植入式微电子接口器件，帮助肢体瘫痪患者实现运动功能恢复或重建；针对神经信号异常，研究基于反导原理的植入式神经信号阻断微电子接口器件，解决患者肌肉抽搐和肢体痉挛等病症。解决电极与系统模块的生物相容性问题；对研发的可植入微电子系统进行动物实验、临床科学实验，争取通过临床认证实验，应用于肢瘫和神经功能异常病患的治疗。

研究团队开展了四方面的工作：1）设计并制作了基于反导原理的神经信号阻断系统，其中包括探测电路、信号处理电路和阻断信号发生电路。利用这些电路在蟾蜍、牛蛙和大鼠身上进行了相关的基于反导原理神经信号阻断实验，验证了反导原理的可行性，研究了相关的阻断信号参数和电极参数对阻断效果的影响；接下来建立了痉挛大鼠模型，并在动物模型上验证了基于反导原理神经信号阻断技术对痉挛抑制的可行性。除此之外，还在病人身上探测了痉挛相关的病态神经肌肉电信号。2）利用椎管内微刺激测定了大鼠腰骶段脊髓的运动功能分布，测定了脊髓损伤前后的屈髋运动和伸髋运动核心区域，应用OpenMV CAM、Processing、MATLAB、Origin8.0等建模工具和分析软件，搭建了一套实用的步态运动捕捉与分析系统，实现了对下肢运动运动学参数的采集、计算、仿真和分析。并对脊髓损伤的大鼠进行慢性运动功能重建实验，开展了基于脊髓功能电刺激重建大鼠后肢运动功能的训练，绘制瘫痪了后肢各关节间角度曲线回旋图。3）基于微电子神经桥思想，针对大鼠脊髓损伤模型的脊髓信号探测和刺激展开了研究，提出了一种高密度柔性电极并确定了脊髓刺激位点，提出了一套针对不同损伤模型动物模型确定刺激位点的方法。研制了脊髓刺激器和脊髓信号无线传输平台，并设计了微电子神经桥原型系统。4）设计了相应的电极和肌电信号探测系统，并进行了瘫痪病人的临床科学实验，验证了同侧增强型肌电桥和穿戴式肌电桥在瘫痪病人肢体动作重建方面的作用。