北京生物医学工程

镍钛形状记忆合金骨板形状恢复能力测试方法的研究

Research on evaluating shape recoverability of nickel-titanium shape memory alloy bone plates

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

单位：兰州西脉记忆合金股份有限公司(兰州 730000), 中国食品药品检定研究院(北京 100050), 甘肃省医疗器械检验检测所(兰州 730000), 甘肃省药品监督管理局审核查验中心(兰州 730000)。通信作者：宋丽霞，助理工程师，E-mail：1102168142@qq.com；汤京龙，正高级工程师，E-mail：wys-xbs@nifdc.org.cn <p> </p>

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；TG139+.6；TH781

出版年·卷·期（页码）：2021·40·4（413-417）

摘要：

目的以完善镍钛形状记忆合金骨板形状恢复能力标准评价体系为目的，建立镍钛形状记忆合金骨板形状恢复能力测试方法。方法首先查询国内外相关测试方法和镍钛形状记忆合金骨板临床使用方法，在此基础上，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，测试结果会有差异性，为保证测试方法的统一性，本次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。结果根据兰州西脉记忆合金股份有限公司等企业提交至国家药品监督管理局医疗器械技术审评中心的镍钛形状记忆合金骨板技术文件，镍钛形状记忆合金骨板相变温度为34℃±3℃（Af点为37℃），按照本文提供的相变温度测试方法测试试样时试样恢复至原始形状相对应的温度为37℃，即为镍钛形状记忆合金骨板的Af点为37℃。按照本文提供的镍钛形状记忆合金骨板形状恢复力测试方法测试，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，到达峰值后会趋于稳定状态，对数据分析后此时的峰值的恢复力数据就是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。形状恢复率测试时，2种试样按照本文方法测试后，所有试样形状率均大于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 improve the standard evaluation system of shape recovery capability of nickel-Titanium shape memory alloy (NiTi) bone plate and establish a test method for shape recovery capability of nickel-titanium shape memory alloy bone plate. Methods Firstly, on the basis of inquiring about domestic and foreign related test methods and clinical use methods of nickel-titanium shape memory alloy bone plates, to determine the standard evaluation system for the shape recovery ability of nickel-titanium shape memory alloy bone plates, the phase transition temperature, shape recovery force, and shape recovery rate need to be tested. ,And then 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, the test results will be different. To ensure the uniformity of the test method, this test uses a standard sample instead of the raw material of the product to be replaced. For the same batch, the machining process remains the same. Results According to the technical documents of nickel-titanium shape memory alloy bone plate submitted by Lanzhou Seemine SMA Co.,Ltd,. and other enterprises to the Center for Medical Devices Evaluation.NMPA , the phase transition temperature of the nickel-titanium shape memory alloy bone plate was 34℃±3℃. When the sample is tested according to the phase transition temperature test method provided in this article, the temperature at which the sample returns to the fully austenite state is 37 ℃, that is, the Af point of the Nitinol shape memory alloy bone plate is 37 ℃. According to the nickel-titanium shape memory alloy bone plate shape resilience test method provided in this article, according to the temperature of the nickel-titanium shape memory alloy bone plate in clinical use, the sample test temperature is set to 37 ℃, and the sample recovery force data curve keeps rising After reaching the peak, it will tend to a stable state. The restoring force data of the peak at this time after data analysis is the shape restoring force of the nickel-titanium shape memory alloy bone plate at work. The average value of the sample shape restoring force test result is 64.18 N. In the shape recovery rate test, after the two samples are tested according to the method in this article, the shape rate of all samples is greater than 95%, which is consistent with the technical documents provided by the manufacturer. Conclusions The results show that the provided standard method for testing the shape recovery ability (phase transition temperature, shape recovery force, and shape recovery rate) of the nickel-titanium shape memory alloy bone plate can provide a basis for the quality supervision of enterprises and provide supervision guidelines for the regulatory authorities. After the test method passes the test evaluation, the safety of the product in clinical use can be guaranteed

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