微创漏斗胸矫形钢板的技术改进

Minimally invasive pectus excavatum correction plate technology to improve

目的探讨微创漏斗胸矫形术的矫形器(包括内置钢板及固定片)研究及临床应用。方法通过查阅大量文献,参考国内外同类器材专利钢板的应用材料,结合最新医用钛合金研究进展,寻求到β型Ti-35Nb-5Ta-7Zr钛合金加工成矫形器。在AG-550电子万能试验机上与另外4种最具代表性的医用生物材料,测试了力学性能,并结合它们的物理化学特性进行了比较。最后结合国家药品临床试验基地试验结果和本院临床应用观察其有效性及人体安全性,做出临床评价。结果经临床试验本微创漏斗胸内置矫形器不论生物力学性能,生物相容性还是人体安全性及临床疗效均符合临床运用。结论由β型Ti-3Zr-Mo-15Nb钛合金钢板为原料制造的本内置矫形器,具有良好的耐蚀性能、机械性能和生物相容性并且质量轻,能够减轻手术后患者的不适感,疗效显著,适用于临床。

Objective Minimally invasive pectus excavatum correction of orthopedic surgery（including built-in plate and fixed sheet） research and clinical application.Methods Through consulting a large numbers of related literatures,referring to domestic and international patents of steel material and the latest research progress of medical titanium alloy,β-type Ti-35Nb-5Ta-7Zr was researched and processed into titanium alloy orthoses.The mechanical properties of the orthoses were tested in the model AG-550 electronic universal testing machine,and compared with the other four most representative biological materials combining with their physical and chemical characteristics.Finally,the clinical evaluation was made based on national drug clinical trial result and clinical observation of the effectiveness and security in humans.Results The biomechanical properties,biocompatibility and biological security are all in line with clinical application.Conclusion The orthopaedic orthoses made by Ti-by beta type 3Zr-Mo-15Nb titanium alloy were suitable for clinical application due to excellent corrosion resistance,biocompatibility and mechanical properties.Moreover,they can alleviate discomfort after surgery patients due to lightweight.