不同标记线制备方法对脊柱连接棒疲劳性能的影响
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1.武汉迈瑞科技有限公司;2.天津市医疗器械质量监督检验中心

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Effects of different preparation methods of marker lines on fatigue properties of spinal connection rods
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    摘要:

    目的:研究不同标记线制备工艺对脊柱后路内固定系统连接棒疲劳性能和系统压缩疲劳性能的影响。方法:根据YY/T 0119.4-2014标准对脊柱连接棒进行四点弯曲疲劳测试。在一定应力作用下,依据YY/T 0857-2011对激光标记线连接棒和双色彩氧标记线连接棒进行系统压缩疲劳试验。结果:在715MPa的应力下,自制激光标记线连接棒(R1)和竞品厂家激光标记线连接棒(R2)疲劳寿命较无标记线连接棒(R0)分别下降至其5%和2%;与未标记连接棒相比,激光标记连接棒疲劳强度由742MPa下降至342MPa,降低了54%。双色彩氧连接棒的疲劳寿命和疲劳强度与无标记线连接棒相当。双色彩氧连接棒系统压缩疲劳强度较激光标记连接棒提高约20%。结论:激光制备标记线显著降低了脊柱连接棒的疲劳性能和系统的压缩疲劳强度,改进的双色彩氧工艺制备标记线对连接棒的疲劳性能无影响,能有效降低临床断裂风险,为连接棒的性能改善和工艺开发提供参考。

    Abstract:

    Objective: To study the effects of different marking line preparation techniques on fatigue properties of connection rod and compression fatigue properties of posterior spine internal fixation system. Methods: According to YY/T 0119.3-2014 standard, four-point flexural fatigue test was performed on the spinal connection rod. According to YY/T 0857-2011 under certain stress, systematic compression fatigue tests were carried out on laser marker line connection rod and two-color oxygen marker line connection rod. Results: Under the stress of 715MPa, the fatigue life of the self-made laser marking line connection rod (R1) and the competitive laser marking line connection rod (R2) decreased to 5% and 2%, respectively, compared with the unmarked connection rod (R0), and the fatigue strength of the laser labeled connection rod decreased by 54% from 742MPa to 342MPa compare with unmarked connection rod. The fatigue life and strength of the dual-color anodized marking line connection rod are similar to that of the unmarked connection rod. The compression fatigue strength of the dual-color anodized marking line connection rod system is 20% higher than that of the laser mark connection rod. Conclusion: Laser preparation of marker line significantly reduces the fatigue performance of the spinal rod and the compressive fatigue strength of the system. The improved dual-color anodized marking line technology has no effect on the fatigue performance,and could effectively reduce the risk of clinical fracture, providing a reference for the performance improvement and process development of the spinal bar.

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  • 收稿日期:2023-02-15
  • 最后修改日期:2023-04-08
  • 录用日期:2023-04-11
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