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, 710054.
National Innovation Platform (Center) for Industry-Education Integration of Medical Technology, Xi'an Jiaotong University, Xi'an, 710049.
Zhongguo Yi Liao Qi Xie Za Zhi. 2024 May 30;48(3):237-244. doi: 10.12455/j.issn.1671-7104.230681.
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.
增材制造（3D打印）技术符合未来医学精准化和定制化的发展方向，为高端医疗器械的创新发展提供了重大机遇。目前，3D打印医疗器械的研究与产业化主要集中在不可降解植入物和可降解植入物上。包括金属骨科植入物、聚醚醚酮（PEEK）骨植入物和生物可降解植入物在内的主要领域已得到开发，用于临床和工业应用。本文综述了这些领域的最新研究成果，并讨论了定制植入物的增材制造技术及应用。从技术、应用和监管角度分析了不同类型植入物面临的挑战。此外，还概述了未来发展的前景和建议。
