作　　者： ; ;

机构地区： 广东省医疗器械质量监督检验所

出　　处： 《中国医学工程》 2018年第10期26-29,共4页

摘　　要： 目的研究一种新型3D打印钛合金骨修复体植入兔骨组织后的生物相容性,为进一步评价其安全有效性及临床应用提供动物试验依据。方法依据GB/T16886.6-2015《医疗器械生物学评价第6部分:植入后局部反应试验》,采用15只家兔,每只家兔通过手术操作,将2个样品植入其左侧胫骨,将2个对照品植入其右侧胫骨;分别在植入后4周、12周、26周各安乐死5只动物,取植入物及周围组织进行肉眼观察及组织学评价。结果应用半定量评价系统对植入物周围骨组织进行评价,4周、12周、26周骨组织的刺激指数均小于2.9,判为无刺激反应。结论该新型3D打印钛合金骨修复体具有良好的骨组织生物相容性,在骨修复领域具有很好的临床应用前景。 【Objective】Through study the bone tissue biocompatibility of a new type tissue prosthesis made by 3D printing technology after implanted into rabbit bone tissue to provided animal experimental basis for further evaluation of its safety and effectiveness and clinical application.【Methods】According to the requirements in GB/T16886.6-2015 Biological Evaluation of Medical Devices-Part 6： Tests for local effects after implantation, 15 New Zealand rabbits were used, 2 samples were implanted to the left legs and 2 negative controls were implanted to the right legs. The animals were euthanatized respectively at 4, 12, 26 weeks after implantation. Tissues were excised and the implant sites were examined macroscopically.【Results】After 4, 12, 26 weeks implantation, the average irritant scores were less than 2.9.【Conclusion】The new type tissue prosthesis which made by 3D printing technology has good bone tissue biocompatibility, and it has a good prospect of clinical application in the field of bone repair.

关 键 词： 打印 修复体 生物相容性

领　　域： []