患者特异性3D打印模具系统用于上半规管第三窗修复：设计、制造及首次人体可行性研究

文献信息

中文摘要

上半规管裂开（SSCD）是内耳骨迷路的一种病理性缺损，因异常流体力学而产生听觉和前庭症状。传统手术方法，包括半规管填塞和表面重建，常导致前庭功能部分或完全丧失。本研究报道了一种患者特异性、3D打印硅胶模具系统的设计、制造及首次临床验证，用于上半规管的解剖学重建。利用高分辨率计算机断层扫描（CT）、三维重建和计算机辅助设计（CAD），制造了与上半规管形态相符的可灭菌模具。该模具能够对聚甲基丙烯酸甲酯（PMMA）骨水泥进行离体浇铸和塑形，以精确的解剖对齐封闭病理性第三窗缺损。使用3D打印颞骨模型进行的验证证实了完美的贴合和密封精度。随后该系统成功应用于一例临床病例，实现了症状完全缓解并保留了前庭功能。这项转化研究表明，增材制造可有效应用于耳科手术中的患者特异性缺损修复，标志着向精准内耳重建迈出了重要一步。关键词：3D打印；生物制造；患者特异性植入物；硅胶模具；上半规管裂开；骨水泥；转化手术。

英文摘要

Superior semicircular canal dehiscence (SSCD) is a pathological defect in the bony labyrinth of the inner ear that produces auditory and vestibular symptoms due to abnormal fluid mechanics. Conventional surgical methods, including canal plugging and resurfacing, often result in partial or total loss of vestibular function. This study reports the design, fabrication, and first clinical validation of a patient-specific, 3D-printed silicone mold system for the anatomical restoration of the superior semicircular canal. Using high-resolution computed tomography (CT), three-dimensional reconstruction, and computer-aided design (CAD), a sterilizable mold conforming to the superior semicircular canal was fabricated. The mold enables ex-vivo casting and shaping of polymethyl methacrylate (PMMA) bone cement to close the pathological third-window defect with precise anatomical alignment. Validation using a 3D-printed temporal bone model confirmed perfect fit and sealing accuracy. The system was then successfully applied in a clinical case, achieving full symptom resolution and preservation of vestibular function. This translational study demonstrates that additive manufacturing can be effectively applied to otologic surgery for patient-specific defect repair, marking a major step toward precision inner-ear reconstruction.
Keywords
3D printing; Biofabrication; Patient-Specific Implant; Silicone Mold; Superior Semicircular Canal Dehiscence; Bone Cement; Translational Surgery.