Design and Fabrication of Custom-Fit BiPAP and CPAP Masks Using Three-Dimensional Imaging and Three-Dimensional Printing Techniques

Noninvasive ventilator support such as bi-level positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP) is often used for patients with obstructive sleep apnea or neuromuscular disorders, such as amyotrophic lateral sclerosis (ALS), where respiratory muscles are weakened. Current commercially available masks for BiPAP and CPAP are often cited as being ill-fitting and leaky, leading to poor quality of sleep or reduced usage of therapy. This project seeks to minimize leaks and maximize comfort by developing custom-fit masks. Patient faces are imaged using an in-house camera system to obtain a three-dimensional (3D) facial contour. Custom interfaces are generated based on this contour using interactive computer software. Using 3D printing to enable rapid tooling, these interfaces are produced in a skin-safe silicone and attached to an off-the-shelf (OTS) mask to create a custom mask. The methodology has been initially tested on five healthy subjects who underwent a two-night sleep study, one night with an OTS mask and one night with a custom-fit mask, to evaluate the leakage and comfort of the custom-fit mask compared to the OTS version. Subjects filled out a questionnaire asking them about mask comfort, leakage, and quality of sleep along with open-ended questions. While the custom-fit mask did not reduce the average measured leakage for subjects, subjects reported experiencing less leakage. Overall, results suggest that the custom-fit masks are more comfortable and tolerable than the provided OTS option. Subject feedback will be implemented into future masks that will be used in a clinical study.