Bockstedte Marit, Quante Mirja, Poets Christian F, Aretxabaleta Maite
Department of Orthodontics, University Hospital Tübingen, Osianderstr. 2-8, 72076, Tübingen, Germany; Center for Cleft Lip, Palate and Craniofacial Malformations, University Hospital Tübingen, Osianderstr. 2-8, 72076, Tübingen, Germany.
Department of Neonatology, University Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany; Center for Cleft Lip, Palate and Craniofacial Malformations, University Hospital Tübingen, Osianderstr. 2-8, 72076, Tübingen, Germany.
Sleep Med. 2025 Sep;133:106608. doi: 10.1016/j.sleep.2025.106608. Epub 2025 May 27.
Non-Invasive Ventilation (NIV) effectiveness relies on proper mask fit, which is often difficult to achieve in patients with craniofacial anomalies. Advances in Computer-Aided Design and Manufacturing (CAD/CAM) enable rapid in-house production of customized NIV masks. Despite its potential, these remain limited by manufacturing constraints. This pilot study aimed to develop a workflow for in-house production of personalized masks and evaluate its effectiveness in an exemplary patient.
A 4.5-year-old girl with achondroplasia was referred because of a poor fit of commercially available NIV masks. A facial scan allowed the design of a personalized nasal mask using Fusion 360 software in a semi-automated workflow. The customized interface was fabricated using additive manufacturing with medically-approved soft material. Sleep studies assessed the effectiveness of commercial versus customized masks.
Compared to the conventional mask, the Obstructive Apnoea-Hypopnea Index (OAHI) was reduced from 22.1/h to 0.1/h. Caregiver reported a reduction in pressure marks and fewer night-time alarms. The initial version of the personalized mask caused minor forehead pressure marks, which were effectively addressed in the second iteration. Initial setup costs were <$5400 (€6500), with material costs per mask of <$15 (€16).
This study demonstrates a fully digital CAD/CAM workflow for the in-house production of customized NIV masks. The approach offers a feasible solution for patients with craniofacial anomalies, enhancing NIV efficacy, comfort, and accessibility to personalized respiratory interfaces.
无创通气（NIV）的有效性依赖于面罩的合适佩戴，而这在患有颅面畸形的患者中往往难以实现。计算机辅助设计与制造（CAD/CAM）技术的进步使得能够在医院内部快速生产定制的NIV面罩。尽管有其潜力，但这些仍受到制造限制。这项前瞻性研究旨在开发一种在医院内部生产个性化面罩的工作流程，并在一个典型患者中评估其有效性。
一名4.5岁患有软骨发育不全的女孩因市售NIV面罩佩戴不合适而前来就诊。通过面部扫描，使用Fusion 360软件以半自动工作流程设计个性化鼻面罩。定制接口采用经医学批准的软材料通过增材制造工艺制造。睡眠研究评估了商用面罩与定制面罩的有效性。
与传统面罩相比，阻塞性呼吸暂停低通气指数（OAHI）从22.1次/小时降至0.1次/小时。护理人员报告压力痕迹减少，夜间警报减少。个性化面罩的初始版本导致轻微的前额压力痕迹，在第二次迭代中得到有效解决。初始设置成本<5400美元（6500欧元），每个面罩的材料成本<15美元（16欧元）。
本研究展示了一种用于医院内部生产定制NIV面罩的全数字化CAD/CAM工作流程。该方法为颅面畸形患者提供了一种可行的解决方案，提高了NIV的疗效、舒适度以及获得个性化呼吸接口的便利性。
