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鎳鈦形狀記憶合金骨板形狀恢復(fù)能力測(cè)試方法的研究
Research on evaluating shape recoverability of nickel-titanium shape memory alloy bone plates |
| 作者： 閆鵬偉 宋可婧 陳大雷 宋麗霞 樊立陽 鄭亞亞 高海艷 唐琰 方延學(xué) 繆祥文 湯京龍 |
| 單位：蘭州西脈記憶合金股份有限公司(蘭州 730000), 中國(guó)食品藥品檢定研究院(北京 100050), 甘肅省醫(yī)療器械檢驗(yàn)檢測(cè)所(蘭州 730000), 甘肅省藥品監(jiān)督管理局審核查驗(yàn)中心(蘭州 730000)。通信作者：宋麗霞，助理工程師，E-mail：[email protected]；湯京龍，正高級(jí)工程師，E-mail：[email protected] <p> </p> |
| 關(guān)鍵詞： 鎳鈦形狀記憶合金；骨板；形狀恢復(fù)能力測(cè)試方法；相變溫度；形狀恢復(fù)力；形狀恢復(fù)率 |
| 分類號(hào)： R318.08；TG139+.6；TH781 |
| 出版年·卷·期（頁碼）：2021·40·4（413-417） |
| 摘要： |
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目的 以完善鎳鈦形狀記憶合金骨板形狀恢復(fù)能力標(biāo)準(zhǔn)評(píng)價(jià)體系為目的，建立鎳鈦形狀記憶合金骨板形狀恢復(fù)能力測(cè)試方法。方法 首先查詢國(guó)內(nèi)外相關(guān)測(cè)試方法和鎳鈦形狀記憶合金骨板臨床使用方法，在此基礎(chǔ)上，確定鎳鈦形狀記憶合金骨板形狀恢復(fù)能力標(biāo)準(zhǔn)評(píng)價(jià)體系需要測(cè)試相變溫度、形狀恢復(fù)力、形狀恢復(fù)率，然后分別建立骨板相變溫度、形狀恢復(fù)力、形狀恢復(fù)率的標(biāo)準(zhǔn)測(cè)試方法。因各企業(yè)生產(chǎn)的鎳鈦形狀記憶合金骨板形狀結(jié)構(gòu)不同，測(cè)試結(jié)果會(huì)有差異性，為保證測(cè)試方法的統(tǒng)一性，本次測(cè)試采用標(biāo)準(zhǔn)試樣代替，試樣使用原材料與被替代產(chǎn)品的原材料為同一批次，機(jī)械加工處理工藝保持一致。結(jié)果 根據(jù)蘭州西脈記憶合金股份有限公司等企業(yè)提交至國(guó)家藥品監(jiān)督管理局醫(yī)療器械技術(shù)審評(píng)中心的鎳鈦形狀記憶合金骨板技術(shù)文件，鎳鈦形狀記憶合金骨板相變溫度為34℃±3℃（Af點(diǎn)為37℃），按照本文提供的相變溫度測(cè)試方法測(cè)試試樣時(shí)試樣恢復(fù)至原始形狀相對(duì)應(yīng)的溫度為37℃，即為鎳鈦形狀記憶合金骨板的Af點(diǎn)為37℃。按照本文提供的鎳鈦形狀記憶合金骨板形狀恢復(fù)力測(cè)試方法測(cè)試，依據(jù)鎳鈦形狀記憶合金骨板臨床使用時(shí)的溫度，將試樣測(cè)試溫度設(shè)置為37℃，試樣在31℃～37℃溫度區(qū)間恢復(fù)力數(shù)據(jù)曲線一直上升，到達(dá)峰值后會(huì)趨于穩(wěn)定狀態(tài)，對(duì)數(shù)據(jù)分析后此時(shí)的峰值的恢復(fù)力數(shù)據(jù)就是鎳鈦形狀記憶合金骨板工作時(shí)的形狀恢復(fù)力，試樣形狀恢復(fù)力測(cè)試結(jié)果平均值為64.18 N。形狀恢復(fù)率測(cè)試時(shí)，2種試樣按照本文方法測(cè)試后，所有試樣形狀率均大于95%，與廠家提供的技術(shù)文件相符合。結(jié)論 結(jié)果說明提供的鎳鈦形狀記憶合金骨板形狀恢復(fù)能力（相變溫度、形狀恢復(fù)力、形狀恢復(fù)率）的測(cè)試標(biāo)準(zhǔn)方法，可為企業(yè)的質(zhì)量監(jiān)管提供依據(jù)，為監(jiān)管部門提供監(jiān)管指南，按照測(cè)試方法通過測(cè)試評(píng)價(jià)后可保證產(chǎn)品臨床使用的安全性。 |
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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 |
| 參考文獻(xiàn)： |
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[1]? 鄭玉峰，趙連城.生物醫(yī)用鎳鈦合金[M]. 北京：科學(xué)出版社，2004. [2] 張玉紅，嚴(yán)彪.形狀記憶合金的發(fā)展[J]. 上海有色金屬，2012, 33(4): 192-195. Zhang YH，Yan B. The development of shape memory alloys[J]. Shanghai Nonferrous Metals, 2012, 33(4)：192-195. [3] 蔡偉，孟祥龍，趙新青，等. TiNi基高溫形狀記憶合金的馬氏體相變與形狀記憶效應(yīng)[J].中國(guó)材料進(jìn)展，2012，31(12)：40-47. Cai W，Meng XL，Zhao XQ，et al. Martensitic transformation and shape memory effect of Ti-Ni based high temperature shape memory alloys[J].Materials China，2012，31(12)：40-47. [4] 王野平，趙立群，顧云峰，等. 醫(yī)用形狀記憶合金 (SMA)[J] .中國(guó)醫(yī)療器械雜志，1999，23（3）：155-159. Wang YP, Zhao LQ, Gu YF, et al. Medical shape memory alloy[J]. Chinese Journal of Medical Instrumentation，1999，23(3)：155-159. [5] 何惠明，郭天文.鎳鈦形狀記憶合金在口腔醫(yī)學(xué)的應(yīng)用研究[J].國(guó)外醫(yī)學(xué)口腔醫(yī)學(xué)分冊(cè)，1994, 21(4)：222-225. [6] 尹玉霞，王魯寧，郝樹斌，等.醫(yī)用鎳鈦記憶合金在微創(chuàng)介入領(lǐng)域的應(yīng)用[J].中國(guó)醫(yī)療設(shè)備, 2019, 34(6) :153-156. Yin YX，Wang LN，Hao SB，et al. Biomedical application of Ni-Ti alloy in minimally invasive intervention[J].China Medical Devices, 2019, 34(6): 153-156. [7] 徐震壯，吳小波，胡斌. 胸腔鏡輔助鎳鈦記憶合金肋骨接骨板內(nèi)固定術(shù)治療多發(fā)肋骨骨折臨床療效研究[J].創(chuàng)傷外科雜志，2018，20(11): 848-851. Xu ZZ，Wu XB，Hu B. Clinical effect of thoracoscopy assisted internal fixation of NiTi memory alloy rib bone plate in the treatment of multiple rib fractures[J]. Journal of Traumatic Surgery, 2018, 20(11): 848-851. [8] Dai KR, Hou XK, Sun YH, et al. Treatment of intra-articular fractures with shape memory compression staples[J]. Injury, 1993, 24(10): 651-655. [9] 張春才，王家林，肖劍，等.鎳鈦-聚髕器治療髕骨骨折及其生物力學(xué)特性[J].骨與關(guān)節(jié)損傷雜志，1996，11(2): 78-81. Zhang CC, Wang JL, Xiao J, et al. The research of NiTi-paterllar concentrator(NT-PC) and biomemory mechanical characteristics for treatment of every types of patellar fracture[J]. The Journal of Bone and Joint Injury, 1996,11(2): 78-81. [10] 袁志山，吳艷華，楊華，等.鎳鈦形狀記憶合金標(biāo)準(zhǔn)發(fā)展現(xiàn)狀[J].金屬功能材料，2014，21（5）：42-45. Yuan ZS，Wu YH，Yang H，et al. Development of nickel-titanium shape memory alloy standard[J].Metallic Functional Materials，2014，21（5）：42-45. [11] US-ASTM. ASTM F2082M-16 Standard test method for determination of transformation temperature of nickel-titanium shape memory alloys by bend and free recovery[S].West Conshohocken, PA,?USA: ASTM International，2016. [12] 中華人民共和國(guó)工業(yè)和信息化部．YS/T 970—2014 鎳鈦形狀記憶合金相變溫度測(cè)定方法[S]．北京：中國(guó)標(biāo)準(zhǔn)出版社，2014. [13] US-ASTM. ASTM F2516-18 Standard test method for tension testing of nickel-titanium superelastic materials[S]. West Conshohocken, PA,?USA: ASTM International，2018. [14] 湯京龍，馬立翠，溫莉茵，等.我國(guó)醫(yī)用鎳鈦形狀記憶合金標(biāo)準(zhǔn)現(xiàn)狀分析[J].中國(guó)藥事，2019，33(6)：649-654. Tang JL，Ma LC，Wen LY，et al. Analysis of current status of standards of medical nickel-titanium shape memory alloy in China[J]. Chinese Pharmaceutical Affairs，2019，33(6)：649-654. [15] 何軍林，韓欣欣. 人體溫度為何是37℃[J].建筑工人，2010,31(5): 56. [16] 國(guó)家藥品監(jiān)督管理局. YY/T 0641—2008熱分析法測(cè)量NiTi合金相變溫度的標(biāo)準(zhǔn)方法[S]．北京：中國(guó)標(biāo)準(zhǔn)出版社，2008． [17]National Medical Products Administration. YY/T 0641—2008 Standard test method for transformation temperature of nikel-titanium alloys by thermal analysis[S]．Beijing: Standards Press of China, 2008. |
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