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为复杂骨缺损提供新治疗方案
Xin Lang Cai Jing· 2026-01-15 00:53
Core Insights - The emergence of 3D printed bio-adaptive artificial bone represents a significant innovation in the field of orthopedic, dental, and neurosurgery, addressing challenges such as limited sources of autologous bone and the risk of rejection associated with allogeneic and xenogeneic bone [1][4] Group 1: Bio-adaptive Concept - The traditional focus on biocompatibility in implantable medical devices is evolving towards a bio-adaptive approach, which emphasizes the active role of materials in adapting to the unique physiological microenvironment of the implantation site [2][3] - The bio-adaptive concept, proposed by academician Wang Yingjun in 2011, aims to not only ensure safety and compatibility but also to actively promote effective tissue repair and restoration of physiological functions [2][3] Group 2: 3D Printing Technology - Advances in 3D printing technology enable the precise manufacturing of bio-adaptive artificial bones, allowing for tailored designs that match the patient's anatomical needs, thus eliminating the need for secondary adjustments [4][5] - 3D printed bio-adaptive artificial bones can dynamically match the degradation rate of the implant with the regeneration rate of new bone tissue, ensuring a safe and effective bone regeneration process [5] Group 3: Clinical Applications and Innovations - A comprehensive technology system has been established, integrating 3D printed bio-adaptive artificial bones with medical imaging and computer-aided design, facilitating clinical applications across various complex cases, including trauma and bone tumors [6] - The world's first limb-salvaging treatment for an ultra-large bone defect of 230mm was successfully completed using this technology, demonstrating its significant clinical potential [6] Group 4: Regulatory Science - Regulatory science in medical devices aims to develop new tools and standards to assess the safety and effectiveness of medical devices throughout their lifecycle, supporting regulatory decisions and promoting industry innovation [7] - The rapid development of 3D printed bio-adaptive artificial bones has been positively influenced by the regulatory science research advocated by the National Medical Products Administration since 2019 [7]