Custom-Fit Three-Dimensional-Printed BiPAP Mask to Improve Compliance in Patients Requiring Long-Term Noninvasive Ventilatory Support

Abstract

Noninvasive ventilator support using bi-level positive airway pressure/continuous positive airway pressure (BiPAP/CPAP) is commonly utilized for chronic medical conditions like sleep apnea and neuromuscular disorders like amyotrophic lateral sclerosis (ALS) that lead to weakness of respiratory muscles. Generic masks come in standard sizes and are often perceived by patients as being uncomfortable, ill-fitting, and leaky. A significant number of patients are unable to tolerate the masks and eventually stop using their devices. The goal of this project is to develop custom-fit masks to increase comfort, decrease air leakage, and thereby improve patient compliance. A single-patient case study of a patient with variant ALS was performed to evaluate the custom-fit masks. His high nose bridge and overbite of lower jaw caused poor fit with generic masks, and he was noncompliant with his machine. Using desktop Stereolithography three-dimensional (3D) printing and magnetic resonance imaging (MRI) data, a generic mask was extended with a rigid interface such that it was complementary to the patient's unique facial contours. Patient or clinicians interactively select a desired mask shape using a newly developed computer program. Subsequently, a compliant silicone layer was applied to the rigid interface. Ten different custom-fit mask designs were made using computer-aided design software. Patient evaluated the comfort, extent of leakage, and satisfaction of each mask via a questionnaire. All custom-fit masks were rated higher than the standard mask except for two. Our results suggest that modifying generic masks with a 3D-printed custom-fit interface is a promising strategy to improve compliance with BiPAP/CPAP machines.

Non-invasive Ventilation for Pediatric Hypoxic Acute Respiratory Failure Using a Simple Anesthetic Mask With 3D Printed Adaptor: A Case Report

“…Among several other groups ( 7 , 8 ), we are currently developing a research platform to personalize NIV masks using ultrarapid 3D scanning and printing techniques, which may in the future be exploited also in the acute phase of critical illness in the PICU. Wu et al have reported the development of custom-fitted masks for long-term NIV in adult patients with sleep apnoea or neuromuscular disease using stereolithography 3D printing and magnetic resonance imaging (MRI) data ( 7 ). In addition, Willox et al workers have tested the feasibility of different designs of 3D printed, customized masks in adult volunteers, to inform future development and implementation in pediatric patients ( 8 ).…”

“…The need for personalized NIV masks is currently widely recognized, although potential strategies have mostly focused on long-term use in adults or children in home settings (7)(8)(9)(10)(11). Commercially available non-vented pediatric NIV masks are limited in their range of dimensions.…”

Establishing a point-of-care additive manufacturing workflow for clinical use

“…With continued frustration, patients elect to discontinue their use, and ultimately, the intended treatment cannot be delivered. One study examined the effects of custom fitting BiPAP/CPAP for one patient; the participant described improvement in the majority of the custom-made masks, and most notably noted the comfortability of the fits [ 130 ]. These findings, though only in a single patient study, are promising and pave the way for future use in creating comfortable, appropriate masks that are easy for patients to use consistently.…”

Interfaces, Circuits and Humidifiers

“…These interfaces are described as more comfortable, leading to less skin lesions and having the potential to increase ventilation efficacy ( 22 – 24 ). The growing availability of 3D medical printing leads to the development of 3D-printed custom masks for adults and children ( 25 , 26 ).…”