国产脑深部电刺激系统动物试验研究

Experimental study on the first domestic Chinese implantable DBS device

目的验证清华大学航天航空学院自主研发的国产化脑深部电刺激（DBS）系统的各项性能，为临床应用提供实验依据。方法选取6只雄性恒河猴，年龄8～12岁，体质量10～15kg，制成偏侧恒河猴帕金森病模型，对其实施国产DBS植入相关手术，对该系统的整体陛能进行了验证。结果从2008年1月至2009年12月进行了近24个月的动物实验验证的结果显示：整套系统组织相容性良好。术中电极入脑组铡顷畅，路径无偏移，电极无回缩现象。电极与延长导线连接时，对位良好，无变形，目视标志点清晰。延伸导线和脉冲发生器连接时，延伸导线插入脉冲发生器操作方便，手术操作性良好。通过对恒河猴术后近3—18个月的长期监测与观察，系统运转正常，刺激电极电阻恒定，恒河猴对刺激反应情况稳定，效果明显，系统稳定性和功能性良好。结论清华大学研发的国产DBS系统的生物安全性、组织相容性、系统稳定性以及刺激作用有效性均已符合国家相关规定，能够满足临床推广应用的要求。

Objective To evaluate the properties of domestic deep brain stimulation （DBS） system developed by Aerospace school of Tsinghua University, which could provide experimental basis for its clinical application. Methods Six male rhesus monkeys, aged 8 to 12 years old, weighing 10 to 15 kg were choosen to be made unilateral rhesus monkey model of Parkinson＇s disease, and then DBS - related surgeries were performed for more than 20 times, therefore the overall system properties were testified. Results According to the results generated from the animal verification experimental, which lasted for nearly 24 months （from January 2008 to December 2009） ,the histocompatibility of entire system is very well. The lead could get into brain tissue smoothly without deviation during the operation, and the lead was not retracted. Leads connected well with extension in good alignment, with no distortion and clear visual landmarks. It is easy to operate when extension was connected to pulse generator. The DBS - implanted rhesus monkeys were evaluated for about 3 - 18 months after surgery, which showed that the system worked well, resistance of stimulating electrode was stable, and rhesus monkeys respond very well to stimulation constantly. The beneficial effect is obvious, the stability and functionality were very well too. Conclusion The domestic deep brain stimulation system developed by Tsinghua University possess good biological safety, biocompatibility, system stability and the surgical stimulus effectiveness are in line with national regulations,to meet the requirements of clinical applications.