增材制造个性化植入物技术发展与挑战  

Development and Challenges of Additive Manufactured Customized Implant

作　　者：孙畅宁 孟子捷 王玲[1,2,3,4] 贺健康[1,2,3,4] 连芩[1,2,3,4] 高琳[1,2,3,4] 李骁 毛茅[1,2,3,4] 朱卉 李涤尘[1,2,3,4] SUN Changning;MENG Zijie;WANG Ling;HE Jiankang;LIAN Qin;GAO Lin;LI Xiao;MAO Mao;ZHU Hui;LI Dichen(National Medical Products Administration(NMPA)Key Laboratory for Research and Evaluation of Additive Manufacturing Medical Devices,Xi'an Jiaotong University,Xi’an,7100542;National Innovation Platform(Center)for Industry-Education Integration of Medical Technology,Xi’an Jiaotong University,Xi’an,7100493;State Key Laboratory for Manufacturing System Engineering,Xi’an Jiaotong University,Xi’an,7100544;School of Mechanical Engineering,Xi’an Jiaotong University,Xi’an,7100495;Frontier Institute of Science and Technology,Xi’an Jiaotong University,Xi’an,710054)

机构地区：[1]西安交通大学国家药品监督管理局医用增材制造器械研究与评价重点实验室,西安市710054 [2]西安交通大学国家医学攻关产教融合创新平台(中心),西安市710049 [3]西安交通大学精密微纳制造技术全国重点实验室,西安市710054 [4]西安交通大学机械工程学院,西安市710049 [5]西安交通大学前沿科学技术研究院,西安市710054

出　　处：《中国医疗器械杂志》2024年第3期237-244,共8页Chinese Journal of Medical Instrumentation

基　　金：国家自然科学基金项目(12202347,51835010);陕西省创新团队(2023-CX-TD-17);陕西省秦创原“科学家+工程师”队伍建设项目(2022KXJ-102,2022KXJ-106);中央高校基本科研业务费。

摘　　要：增材制造(3D打印)技术与未来医疗行业精准化和定制化的发展方向相契合,是我国高端医疗器械领域创新发展的重要机遇。目前3D打印医疗器械的研究和产业化主要分为不可降解植入物和可降解植入物,逐渐形成了金属3D打印骨植入物、聚醚醚酮骨植入物和可降解植入物等主要临床应用和产业发展领域。该文列举近年来上述领域的研究成果,论述个性化植入物的增材制造技术和应用,从技术、应用和监管角度分析不同植入物面临的挑战,并对未来发展提出展望和建议。Additive manufacturing(3D printing)technology aligns with the direction of precision and customization in future medicine,presenting a significant opportunity for innovative development in high-end medical devices.Currently,research and industrialization of 3D printed medical devices mainly focus on nondegradable implants and degradable implants.Primary areas including metallic orthopaedic implants,polyether-ether-ketone(PEEK)bone implants,and biodegradable implants have been developed for clinical and industrial application.Recent research achievements in these areas are reviewed,with a discussion on the additive manufacturing technologies and applications for customized implants.Challenges faced by different types of implants are analyzed from technological,application,and regulatory perspectives.Furthermore,prospects and suggestions for future development are outlined.

关 键 词：增材制造 骨植入物 多孔结构 聚醚醚酮 可降解植入物 

分 类 号：R318.08[医药卫生—生物医学工程]