人工颈椎间盘假体体外功能试验方法及评价策略  

Functional Testing and Evaluation Tactics of Artificial Cervical Disc Prosthesis In Vitro

作　　者：张家振 翟豹 闵玥 刘斌[1] ZHANG Jiazhen;ZHAI Bao;MIN Yue;LIU Bin(Center for Medical Device Evaluation,China Food and Drug Administration,Beijing 100081,China)

机构地区：[1]国家食品药品监督管理总局医疗器械技术审评中心,北京市100081

出　　处：《组织工程与重建外科杂志》2018年第2期61-66,共6页Journal of Tissue Engineering and Reconstructive Surgery

基　　金：国家重点研发计划(2017YFB1104105)

摘　　要：人工颈椎间盘置换术保留了相邻椎体节段的运动功能,减少了相邻节段的应力水平,有利于防止术后邻近节段发生退变。目前,国内应用的人工颈椎间盘假体主要是进口产品,国产同类产品大多处于研发生产过程中。本文通过介绍人工颈椎间盘假体的体外功能评价方法,包括假体沉陷、蠕变、推出、半脱位试验,以及动静态压缩、剪切试验和磨损试验等,结合人体颈椎的生物力学数据,以评价产品临床使用的安全性和有效性;基于FDA关于人工颈椎间盘假体的公开数据,对5种不同设计的人工颈椎间盘假体体外功能性试验结果进行分析比较,探讨人工椎间盘假体体外评价试验的可接受依据,为国产同类产品的研发提供参考。Artificial cervical disc replacement which retains the movement of adjacent vertebral segments,reduce the stress level of adjacent segments,is conducive to preventing the degeneration of adjacent segments.At present,the domestic application of artificial cervical disc prosthesis is mainly imported products,most of domestic similar products are in the process of R&D and production.The in vitro evaluation methods of prosthetic cervical intervertebral disc prosthesis in vitro was presented,including subsidence,creep,expulsion,subluxation testing,dynamic and static compression,shear testing,wear testing.Combined with the biomechanical data of human cervical spine,the clinical safety and effectiveness of the product was evaluated.Based on the open data of the FDA on artificial cervical disc prosthesis,the results of in vitro functional tests of 5 different designs of artificial cervical disc prosthesis were analyzed and compared.The acceptable criterion for the in vitro evaluation test of artificial disc prosthesis was discussed,which can provide a reference for the R&D of domestic products.

关 键 词：人工颈椎间盘假体 体外评价 生物力学 磨损试验 

分 类 号：R318.1[医药卫生—生物医学工程]