镍钛形状记忆合金骨板形状恢复能力测试方法的研究  

Study on the test method of shape recovery ability of nickel-titanium shape memory alloy bone plate

作　　者：闫鹏伟 宋可婧 陈大雷 宋丽霞 樊立阳 郑亚亚 高海艳 唐琰 方延学 缪祥文 汤京龙[2] YAN Pengwei;SONG Kejing;CHEN Dalei;SONG Lixia;FAN Liyang;ZHENG Yaya;GAO Haiyan;TANG Yan;FANG Yanxue;MIAO Xiangwen;TANG Jinglong(Lanzhou Seemine SMA Co.,Ltd.,Lanzhou 730000;National Institutes for Food and Drug Control,Beijing 100050;Gansu Medical Equipment Inspection and Testing Institute,Lanzhou 730000;Gansu Provincial Drug Administration Review and Inspection Center,Lanzhou 730000)

机构地区：[1]兰州西脉记忆合金股份有限公司,兰州730000 [2]中国食品药品检定研究院,北京100050 [3]甘肃省医疗器械检验检测所,兰州730000 [4]甘肃省药品监督管理局审核查验中心,兰州730000

出　　处：《北京生物医学工程》2021年第4期418-424,共7页Beijing Biomedical Engineering

基　　金：国家重点研发计划(2018YFC1106700)资助。

摘　　要：目的建立镍钛形状记忆合金骨板形状恢复能力测试方法。方法首先确定镍钛形状记忆合金骨板形状恢复能力标准评价体系需要测试相变温度、形状恢复力、形状恢复率,然后分别建立骨板相变温度、形状恢复力、形状恢复率的标准测试方法。因各企业生产的镍钛形状记忆合金骨板形状结构不同,为保证测试方法的统一性,测试采用标准试样代替,试样使用原材料与被替代产品的原材料为同一批次,机械加工处理工艺保持一致。结果根据已上市产品技术文件,镍钛形状记忆合金骨板相变温度Af点为37℃,产品形状恢复率应大于95%。按照本文提供的相变温度、形状恢复力、形状恢复率测试方法,试样测试时恢复至原始形状相对应的温度为37℃,即镍钛形状记忆合金骨板的Af点为37℃;依据镍钛形状记忆合金骨板临床使用时的温度,将试样测试温度设置为37℃,试样在31℃~37℃温度区间恢复力数据曲线一直上升,到达峰值后趋于稳定状态,通过数据分析,峰值的恢复力数据即镍钛形状记忆合金骨板工作时的形状恢复力,试样形状恢复力测试结果平均值为64.18 N;两种试样测试形状恢复率,并计算分析数据,所有试样形状恢复率均大于95%,与厂家提供的技术文件相符合。结论结果说明提供的镍钛形状记忆合金骨板形状恢复能力(相变温度、形状恢复力、形状恢复率)的测试标准方法,可为企业的质量监管提供依据,为监管部门提供监管指南,按照测试方法通过测试评价后可保证产品临床使用的安全性。Objective To establish a test method for shape recovery capability of nickel-titanium shape memory alloy bone plate.Methods Firstly,we determine the standard evaluation system for the shape recovery ability of nickel-titanium shape memory alloy bone plates,in which the phase transition temperature,shape recovery force,and shape recovery rate need to be tested.And then we establish standard test methods for bone plate phase transition temperature,shape restoring force,and shape restoring rate.Due to the different shape and structure of the nickel-titanium shape memory alloy bone plates produced by various enterprises and to ensure the uniformity of the test method,this test uses a standard sample instead of the raw material of the product.For the same batch,the machining process remains the same.Results According to the technical documents of marketed products,the phase transition temperature A f of nickel-titanium shape memory alloy bone plate is 37℃,and the product shape recovery rate should be greater than 95%.According to the test method of phase transition temperature,shape restoring force and shape restoring rate provided in this paper,the temperature corresponding to the sample returning to the original shape during the test is 37℃,that is,the A f point of the nickel-titanium shape memory alloy bone plate is 37℃.According to the temperature of nickel-titanium shape memory alloy bone plate in clinical use,the test temperature of the sample is set to 37℃.In the temperature range of 31℃to 37℃,the restoring force data curve of the sample increases continuously,and tends to a stable state after reaching the peak value.According to the data analysis,the peak value of the restoring force data is the shape restoring force of Ni-Ti shape memory alloy bone plate when it is working,and the average value of the test results of the sample shape restoring force is 64.18N.The shape recovery rates of the two samples are tested,and the calculation and analysis data show that the shape recovery rate of all sample

关 键 词：镍钛形状记忆合金 骨板 形状恢复能力测试方法 相变温度 形状恢复力 形状恢复率 

分 类 号：R318.08[医药卫生—生物医学工程] TG139[医药卫生—基础医学]