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.
引文
[1]孙皎.颅颌面植入材料[J].口腔材料器械杂志,2008,17(1):36-49.
[2]Liu CK,Jing CX,Tan XY,et al.Using three-dimensional porous internal titanium scaffold or allogenic bone scaffold for tissueengineering condyle as a novel reconstruction of mandibular condylar defects[J].Journal of Medical Hypotheses and Ideas,2014,8(2):69-73.
[3]郑扬,李危石,刘忠军.骨组织3D打印:骨再生的未来[J].北京大学学报(医学版),2015,47(2):203-206.
[4]Fanzio PM,Chang KP,Chen HH,et al.Plate exposure after anterolateral thigh free-flap reconstruction in head and neck cancer patients with composite mandibular defects[J].Annals of Surgical Oncology,2015,22(9):3055-3060.
[5]Mehdizadeh H,Sumo S,Bayrak ES,et al.Three-dimensional modeling of angiogenesis in porous biomaterial scaffolds[J].Biomaterials,2013,34(12):2875-2887.
[6]赵冰净,胡敏.用于3D打印的医用金属研究现状[J].口腔颌面修复学杂志,2015,16(1):53-56.
[7]田冶,曾庆慧,胡相华,等.3D打印技术及在组织工程领域的研究进展[J].中国医疗器械信息,2015(8):7-12.
[8]Arabnejad S,Burnett JR,Pura JA,et al.High-strength porous biomaterials for bone replacement:a strategy to assess the interplay between cell morphology,mechanical properties,bone ingrowth and manufacturing constraints[J].Acta Biomaterialia,2016,30:345-356.
[9]奚廷斐.医疗器械生物学评价[M].北京:中国质检出版社,2012:203.
[10]郝和平,奚廷斐,卜长生.医疗器械监督管理和评价[M].北京:中国医药科技出版社,2000:177.
[11]俞耀庭,张兴栋.生物医用材料[M].天津:天津大学出版社,2000:18-19.