颅颌面(CMF)手术领域具有丰富的病理多样性,并且在其治疗的年龄范围内广泛。此外,CMF骨架是感觉器官和硬软组织的复杂汇合处,具有可在毫米内变化的承重要求。计算机辅助设计(CAD)和增材制造(AM)创造了非凡的机会来修复由于上述情况而存在的无限组的颅颌面缺陷。3D打印支架有可能作为“黄金标准”自体移植的可比替代方案。体外和体内研究继续研究最佳的3D打印支架设计和组成,以促进适合每个CMF缺损的独特生物和机械环境的骨再生。此外,3D打印的固定装置可作为现成可用的患者专用替代品,有机会减少手术时间并优化配合。已经发现类似的益处适用于3D打印解剖模型和用于术前或术中使用的手术引导件。这些设备的创建和实施需要广泛的临床前和临床研究,新颖的制造能力,以及严格的监管。研究人员,制造商,CMF外科医生,和美国食品和药物管理局(FDA)正在共同努力,以进一步在各自领域内开发这种技术,都有一个共同的目标来提供安全,有效,成本效益高,以及针对患者的CMF护理。这份手稿回顾了FDA的监管状况,3D打印技术,生物材料,和适用于颅颌面骨骼3D打印设备的灭菌程序。它还试图讨论最近的临床应用,经济可行性,以及这项新技术的未来方向。通过回顾3D打印在CMF手术中的现状,我们希望对其影响有更好的了解,进而发现进一步发展针对患者的外科护理的机会。
The field of craniomaxillofacial (CMF) surgery is rich in pathological diversity and broad in the ages that it treats. Moreover, the CMF skeleton is a complex confluence of sensory organs and hard and soft tissue with load-bearing demands that can change within millimeters. Computer-aided design (CAD) and additive manufacturing (AM) create extraordinary opportunities to repair the infinite array of craniomaxillofacial defects that exist because of the aforementioned circumstances. 3D printed scaffolds have the potential to serve as a comparable if not superior alternative to the \"gold standard\" autologous graft. In vitro and in vivo studies continue to investigate the optimal 3D printed scaffold design and composition to foster bone regeneration that is suited to the unique biological and mechanical environment of each CMF defect. Furthermore, 3D printed fixation devices serve as a patient-specific alternative to those that are available off-the-shelf with an opportunity to reduce operative time and optimize fit. Similar benefits have been found to apply to 3D printed anatomical models and surgical guides for preoperative or intraoperative use. Creation and implementation of these devices requires extensive preclinical and clinical research, novel manufacturing capabilities, and strict regulatory oversight. Researchers, manufacturers, CMF surgeons, and the United States Food and Drug Administration (FDA) are working in tandem to further the development of such technology within their respective domains, all with a mutual goal to deliver safe, effective, cost-efficient, and patient-specific CMF care. This manuscript reviews FDA regulatory status, 3D printing techniques, biomaterials, and sterilization procedures suitable for 3D printed devices of the craniomaxillofacial skeleton. It also seeks to discuss recent clinical applications, economic feasibility, and future directions of this novel technology. By reviewing the current state of 3D printing in CMF surgery, we hope to gain a better understanding of its impact and in turn identify opportunities to further the development of patient-specific surgical care.