一种评价医疗器械脑植入后局部组织反应的新方法初探  

A preliminary new method study for evaluating local effects of medical device after brain implantation

作　　者：孙立魁[1] 车国喜 刘佳[1] 朱福余 刘成虎[1] SUN Li-kui;CHE Guo-xi;LIU Jia;ZHU Fu-yu;LIU Cheng-hu(National Medical Products Administration Jinan Quality Supervision and Inspection Center for Medical Devices,Key Lab of Biological Evaluation of Medical Devices of Shandong Province,Jinan Shandong 250101,China)

机构地区：[1]国家食品药品监督管理局济南医疗器械质量监督检验中心,山东省医疗器械生物学评价重点实验室,山东济南250101

出　　处：《毒理学杂志》2020年第3期232-236,共5页Journal of Toxicology

摘　　要：目的建立一种评价医疗器械脑植入后局部组织反应的新方法,弥补评价方法缺失的不足。方法将脑植入医疗器械(颅脑引流导管)与阴性对照样品分别植入到24只家兔脑组织内,每个周期试验样品设4只家兔(2雌2雄),阴性对照样品设4只家兔(2雌2雄)。观察周期为1、4和12周,通过神经行为学和组织病理学等方面评价受试物对脑组织产生刺激及毒性反应的潜在可能性。结果未发现与植入物相关的异常临床体征或中枢神经系统状况,引流导管和阴性对照周围均可见轻度星形胶质细胞增生和小神经胶质细胞激活,未见神经元坏死、矿化、室管膜层改变,可见疏松囊腔形成。结论脑植入评价方法的建立,可有效评价神经/脑组织接触类医疗器械植入后局部组织反应,填补了评价神经/脑组织接触类医疗器械植入后局部组织反应的空白。Objective A new method for evaluating the local effects of medical devices after brain implantation was established to make up for the lack of evaluation method. Methods The brain implanted medical device(cranial drainage catheter) and negative control samples were implanted into the brain tissues of 24 rabbits respectively. The test samples of each cycle were 4 rabbits(2 females and 2 male), and the negative contrel samples were four rabbits(two females and two males). The observation period is one week, four weeks, and 12 weeks, and the potential stimulation and toxicity of the test articles to brain tissue were evaluated through neurobehavior and histopathology. Results No abnormal clinical signs or central nervous system conditions related to implants were found. Mild astrocyte and microglial activation were seen around the drainage catheter and negative control, and there were no neuronal necrosis, mineralization, and ventricular tube. The change of the membrane layer showed the formation of loose cysts. Conclusion The brain implantation evaluation method can effectively evaluate the local effects of neuro/brain tissue contact medical devices after implantation, filling in the blanks for evaluating the local effects of neuro/brain tissue contact medical devices after implantation.

关 键 词：医疗器械 生物学评价 脑植入 

分 类 号：R994.6[医药卫生—毒理学]