不可吸收带线锚钉典型功能失效及力学性能研究

      Study of Typical Functional Failure and Mechanical Properties of Non-absorbable Suture Anchor

      • 摘要: 目的 针对不可吸收带线锚钉在临床使用中的典型功能失效模式,研究与失效相关的力学性能,为企业设计研发及验证提供参考。方法 通过检索相关不良事件数据库,汇总不可吸收带线锚钉典型功能失效模式,通过研究与功能失效相关的力学性能,进一步分析功能失效的影响因素,并检索公开的相关测试数据进行验证,同时为研究者提供参考。结果 不可吸收带线锚钉典型功能失效模式包括锚钉失效、缝线失效、固定松动、插入器失效,与旋入式锚钉的旋入扭矩和断裂扭矩、敲入式锚钉的插入力、缝线断裂强力、系统疲劳前后拔出力及疲劳后缝线伸长量等力学性能相关。结论 企业在产品设计研发时应注重从材料、结构设计、缝线编织工艺等方面提高产品力学性能水平,以保证产品安全有效。

         

        Abstract: Objective To study the mechanical properties related to the typical functional failure modes of non-absorbable suture anchor in clinical use, and to support product design, development and verification. Methods By retrieving the database of relevant adverse events, the typical functional failure modes of non-absorbable suture anchor were summarized, and the influencing factors of functional failure were further analyzed by studying the mechanical properties related to functional failure. The publicly available test data was retrieved for verification and provided reference for the researchers. Results The typical functional failure modes of non-absorbable suture anchor include anchor failure, suture failure, fix loosening, inserter failure, which are related to the mechanical properties of products, such as screw-in torque and break torque of screw-in anchors, insertion force of knock-in anchors, suture strength, pull-out force before and after system fatigue test and elongation of sutures after fatigue test. Conclusion Enterprises should pay attention to improving the mechanical performance level of products through material, structural design and the suture weaving process to ensure the safety and effectiveness of products.

         

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