中国医疗器械杂志2024,Vol.48Issue(3) :257-263.DOI:10.12455/j.issn.1671-7104.230611

3D打印Ti-6Al-4V骨盆假体的表征和生物相容性研究

Research on Characterization and Biocompatibility of 3D Printed Ti-6Al-4V Pelvic Prosthesis

蔡雨辰 郭佳乐 付步芳
中国医疗器械杂志2024,Vol.48Issue(3) :257-263.DOI:10.12455/j.issn.1671-7104.230611

3D打印Ti-6Al-4V骨盆假体的表征和生物相容性研究

Research on Characterization and Biocompatibility of 3D Printed Ti-6Al-4V Pelvic Prosthesis

蔡雨辰 1郭佳乐 2付步芳3
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作者信息

  • 1. 中国食品药品检定研究院,北京市,102629;沈阳药科大学,沈阳市,110016
  • 2. 中国食品药品检定研究院,北京市,102629;北京航空航天大学材料科学与工程学院,北京市,100191
  • 3. 中国食品药品检定研究院,北京市,102629
  • 折叠

摘要

骨折或骨组织病变引起的骨缺损的治疗一直是骨科领域的难题,植入高性能钛合金假体是治疗骨缺损的有效方法,3D打印技术可以制造多孔结构的低模量钛合金植入物,为上述问题提供较好的解决方案,这种技术设计便捷,在制作骨科植入物方面具有巨大优势.该文采用3D打印技术中的电子束熔融制造了2种Ti-6Al-4V假体样品,包括实体结构骨盆假体和多孔结构骨盆假体.假体力学性能的研究得出棒状拉伸试样的屈服强度和抗拉强度分别为894 MPa 和956 MPa,而多孔骨盆假体的压缩模量和抗压强度分别为55 GPa 和65.2 MPa.L929细胞毒性试验和MC3T3-E1细胞黏附试验的结果表明假体样品具有良好的生物相容性.采用新西兰大白兔制备股骨髁空腔缺损模型,并植入2种骨盆假体.植入4周后的显微CT扫描结果显示,骨钻引起的骨缺损已经愈合,骨盆假体的多孔结构在孔内形成了一种新的骨小梁结构.总之,3D打印的Ti-6Al-4V骨盆假体具有良好的力学性能,生物相容性和促进新骨生长能力.

Abstract

The treatment of bone defects caused by fractures or bone tissue lesions has always been a difficult problem in the field of orthopedics.Implantation of high-performance titanium alloy prosthesis is an effective method to treat bone defects.3D printing technology can produce low-modulus titanium alloy implants with porous structures,providing a better solution to the above problems.This technology is convenient to design and has a huge advantage in making orthopedic implants.The article used electron beam melting in 3D printing technology to create two samples of Ti-6Al-4V prosthesis,including solid structural pelvic prosthesis and porous structural pelvic prosthesis.The mechanical properties of the prosthesis showed that the yield and tensile strengths of the rod tensile specimen were 894 MPa and 956 MPa,respectively,and the compressive modulus and compressive strength of the porous pelvic prosthesis were 55 GPa and 65.2 MPa,respectively.The results of the L929 cytotoxicity assay and the MC3T3-E1 cell adhesion assay demonstrated good biocompatibility of the prosthetic samples.New Zealand white rabbits were used to prepare the femoral joint cavity defect models and two pelvic prostheses were implanted.A microscopic CT scan 4 weeks after implantation showed that the bone defect caused by the drill had healed and that the porous structure of the pelvic prosthesis formed a new trabecular structure within the hole.In conclusion,the 3D printed Ti-6Al-4V pelvic prosthesis has excellent mechanical properties,biocompatibility,and the ability to promote new bone growth.

关键词

3D打印/骨科/钛合金/医疗器械/生物学相容性

Key words

3D printing/orthopedic/titanium alloy/medical device/biocompatibility

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基金项目

国家重点研发计划(2018YFC1106700)

出版年

2024
中国医疗器械杂志
上海市医疗器械检测所

中国医疗器械杂志

CSTPCD
影响因子:0.503
ISSN:1671-7104
参考文献量7
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