踝关节假体磨损测试及仿真研究进展  

Research progress of in vitro wear test and computational wear simulation of ankle joint prosthesis

作　　者：杨抒 张延伟 高进涛 徐良 潘莹 季芳 梁雨烟 陈瑱贤 YANG Shu;ZHANG Yanwei;GAO Jintao;XU Liang;PAN Ying;JI Fang;LIANG Yuyan;CHEN Zhenxian(GBA Center for Medical Device Evaluation and Inspection,NMPA,Shenzhen 518000,China;State Key Laboratory For Manufacturing Systems Engineering,School of Mechanical Engineering,Xi’an Jiaotong University,Xi’an 710054,China;Key Laboratory of Road Construction&Equipment of MOE,School of Mechanical Engineering,Chang'an University,Xi’an 710064,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评检查大湾区分中心,广东省深圳市518000 [2]西安交通大学机械工程学院机械制造系统工程国家重点实验室,陕西省西安市710054 [3]长安大学工程机械学院道路施工技术与装备教育部重点试验室,陕西省西安市710064

出　　处：《组织工程与重建外科》2024年第5期584-594,共11页Journal of Tissue Engineering and Reconstructive Surgery

摘　　要：假体磨损造成的无菌性松动是人工踝关节失效的主要原因,而人工踝关节磨损的模拟机测试和数值仿真是临床前评估假体磨损性能的重要方法。本文对国内外踝关节假体磨损研究中采用的力学和运动学曲线进行了对比,并对相关研究结果进行总结、归纳和分析。结果表明:①早期研究没有ISO测试标准,造成各研究的加载条件主要在轴向载荷和前后位移上存在差异,因此很难通过横向对比得到踝关节假体的磨损规律。②国外研究了踝关节假体的设计、材料、测试条件及润滑介质等因素对磨损测试结果的影响,然而国内暂未检索到相关文献发表。③人工踝关节磨损的数值仿真结果与体外测试结果相近,这表明经验证的磨损模型能够用于预测踝关节假体的磨损性能。Aseptic loosening caused by wear and wear particles is the main cause for the failure of artificial ankle joints.The in vitro tests and computational simulation are important methods for pre-clinical evaluation of prosthetic wear performance.In this paper,the kinematic and dynamic curves used in wear studies of ankle prosthesis were compared.Afterwards,the results of the wear studies were summarized and analyzed.The results showed that:①Due to the lack of ISO testing standard in the early stage,there are differences in the loading conditions of various studies,mainly reflected in axial load and anteroposterior displacement.Therefore,it is difficult to obtain the wear mechanism of ankle prostheses through the horizontal comparison.②Foreign researchers have studied the effects of factors such as the implant design,materials,testing conditions,and lubricating media of artificial ankle joint prostheses on wear test results,but relevant literature has not been published in China.③The numerical simulation wear results of artificial ankle joint are similar to its in vitro test results,indicating that the validated simulation model can be used to predict the wear performance of ankle joint prostheses.

关 键 词：人工踝关节 磨损 磨损加载条件 磨损测试 数值仿真 

分 类 号：R318.07[医药卫生—生物医学工程]