节点文献
国产脑起搏器的研制与临床试验进展
Development of Chinese deep brain stimulator and the progress in clinical trial
【Author】 Li Luming1,Hao Hongwei1,Zhang Jianguo2,Ma Yu2(1 School of Aerospace,Tsinghua University,Beijing 100084 2 Beijing Tiantan Hospital affiliated to Capital Medical University,Beijing 100050)
【机构】 清华大学航天航空学院; 首都医科大学附属北京天坛医院;
【摘要】 脑起搏器是治疗帕金森病的首选外科治疗方法,自上世纪90年代以后发展迅速,而我国的患者受限于高昂的费用难以应用。为此,清华大学的研究团队在过去的7年中致力于脑起搏器的国产化,在攻克了电子、软件、材料、制造、可靠性等一系列技术难题后,研制完成国产的脑起搏器,包括植入体内的脉冲发生器、延长导线和电极,以及用于遥测、程控的体外程控仪。在完成注册检验和动物试验后,目前正在进行临床试验研究,已经在北京天坛医院完成10例手术,均取得了满意的治疗效果,无不良事件发生,初步验证了国产脑起搏器的安全性和有效性。
【Abstract】 Deep brain stimulator is the preferred therapy for Parkinson’s disease,developing rapidly since 1990s,but rarely used by Chinese patients due to very high price.In last 7 years,a team in Tsinghua University has been working to develop DBS device,a series of technical problems in electronics,software,material,manufacture and reliability were solved,and the Chinese deep brain stimulator was developed successfully,including implantable pulse generator,extension and lead,and controller for outside telemetry and programming.After registration inspection and animal studies,the clinical trial is being in process.Up to now,10 implantation surgeries have been finished,the satisfied effects have been achieved for all the patients,and no adverse events have been observed,showing the safety and effectiveness of Chinese deep brain stimulator.
【Key words】 Chinese deep brain stimulator Parkinson’s disease clinical trial;
- 【会议录名称】 中国生物医学工程学会成立30周年纪念大会暨2010中国生物医学工程学会学术大会壁报展示论文
- 【会议名称】中国生物医学工程学会成立30周年纪念大会暨2010中国生物医学工程学会学术大会
- 【会议时间】2010-12-02
- 【会议地点】中国北京
- 【分类号】R318.6
- 【主办单位】中国生物医学工程学会