Abstract Craniomaxillofacial reconstruction implants, which are extensively used in head and neck surgery, are conventionally made in standardized forms. During surgery, the implant must be bended manually to match the anatomy of the individual bones. The bending process is time-consuming, especially for inexperienced surgeons. Moreover, repetitive bending may induce undesirable internal stress concentration, resulting in fatigue under masticatory loading in vivo and causing various complications such as implant fracture, screw loosening, and bone resorption. There have been reports on the use of patient-specific 3D printed implants for craniomaxillofacial reconstruction, although few reports have considered implant quality. In this paper, we present a systematic approach for making 3D printed patient-specific surgical implants for craniomaxillofacial reconstruction. The approach consists of three parts: First, an easy-to-use design module is developed using Solidworks® software, which helps surgeons to design the implants and the axillary fixtures for surgery. Design engineers can then carry out the detailed design and use finite-element simulation (FEM) to optimize the design. Second, the fabrication process is carried out in three steps: ① testing the quality of the powder; ② setting up the appropriate process parameters and running the 3D printing process; and ③ conducting post-processing treatments (i.e., heat and surface treatments) to ensure the quality and performance of the implant. Third, the operation begins after the final checking of the implant and sterilization. After the surgery, postoperative rehabilitation follow-up can be carried out using our patient tracking software. Following this systematic approach, we have successfully conducted a total of 41 surgical cases. 3D printed patient-specific implants have a number of advantages; in particular, their use reduces surgery time and shortens patient recovery time. Moreover, the presented approach helps to ensure implant quality.

中文翻译：

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制作用于颅颌面重建的 3D 打印患者特定植入物的系统方法

摘要 颅颌面重建植入物广泛用于头颈部手术，通常以标准化形式制造。在手术过程中，必须手动弯曲植入物以匹配各个骨骼的解剖结构。弯曲过程非常耗时，尤其是对于没有经验的外科医生而言。此外，重复弯曲可能会导致不良的内应力集中，导致体内咀嚼负荷下的疲劳，并导致各种并发症，如植入物断裂、螺钉松动和骨吸收。尽管很少有报告考虑到植入物的质量，但已有关于使用患者特定的 3D 打印植入物进行颅颌面重建的报道。在本文中，我们提出了一种系统的方法来制作用于颅颌面重建的 3D 打印的患者特异性手术植入物。该方法由三部分组成：首先，使用 Solidworks® 软件开发了一个易于使用的设计模块，该模块可帮助外科医生设计用于手术的植入物和腋窝固定装置。然后，设计工程师可以进行详细设计并使用有限元仿真 (FEM) 来优化设计。二、制作过程分三步进行：①检测粉体质量；②设置合适的工艺参数并运行3D打印工艺；③ 进行后加工处理（即热处理和表面处理），以保证种植体的质量和性能。第三，在对植入物进行最终检查和消毒后开始手术。手术后，可以使用我们的患者跟踪软件进行术后康复随访。按照这种系统的方法，我们已经成功地进行了总共 41 例手术病例。3D 打印的患者专用植入物具有许多优点；特别是，它们的使用减少了手术时间并缩短了患者康复时间。此外，所提出的方法有助于确保植入质量。