摘要
3D打印技术近年来在骨科植入医疗器械领域发展迅速,由于其能够根据患者需求个性化地定制植入物形状,并且精确控制植入物的复杂微观结构,从而实现植入物外形和力学性能与人体自身骨的双重适配。生物医用钛及钛合金作为目前骨科植入物的主要原材料,具有优越的生物相容性,与3D打印技术结合,成为各国科学家以及医疗器械厂家研发的热点,促进3D打印钛金属骨科植入物的商业化。针对3D打印钛金属骨科植入物的特点、钛金属粉末要求、已上市产品情况、临床研究、存在的问题以及标准和审评规范等的现状与发展进行论述和展望。
3 D printing technology has developed rapidly in the field of orthopedic implanted medical devices in recent years.It can customize the shape of the implant according to patient needs and precisely control the complex microstructure,thus achieving the double adaptation of the shape and mechanics between the implants and the human bone.Biomedical titanium and its alloys as the main raw materials of the orthopedic implants,have excellent biocompatibility.Recently the combination of 3 D printing became the hot spot in the orthopedic implant research area.This review summarized the state of the art and trends of 3 D printed Ti-based orthopedic implants.
作者
甄珍
王健
奚廷斐
刘斌
Zhen Zhen;Wang Jian;Xi Tingfei;Liu Bin(Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China;Institute for Medical Devices Control,National Institute for Food and Drug Control,Beijing 102629,China;Academy for Advanced Interdisciplinary Studies,Peking University,Beijing 100871,China)
出处
《中国生物医学工程学报》
CAS
CSCD
北大核心
2019年第2期240-251,共12页
Chinese Journal of Biomedical Engineering
基金
国家十三五重点研发计划(2018YFC1106700)
关键词
3D打印
钛金属
骨科植入物
标准
审评规范
3D printing
titanium
orthopedic implants
standards
registration guidance
