Feasibility of three-dimensional facial imaging and printing for producing customised nasal masks for continuous positive airway pressure

Kelvin Duong, Joel Glover, Alexander C Perry, Deborah Olmstead, Mark Ungrin, Pina Colarusso, Joanna E MacLean, Andrew R Martin, Kelvin Duong, Joel Glover, Alexander C Perry, Deborah Olmstead, Mark Ungrin, Pina Colarusso, Joanna E MacLean, Andrew R Martin

Abstract

Rationale: Delivery of continuous positive airway pressure (CPAP) is the standard treatment for obstructive sleep apnoea in children and adults. Treatment adherence is a major challenge, as many patients find the CPAP mask uncomfortable. The study aim was to demonstrate the feasibility of delivered CPAP through customised nasal masks by assessing mask leak and comfort of customised masks compared to commercially available CPAP masks.

Methods: Six healthy adult volunteers participated in a crossover study including commercial masks in three different sizes (petite, small/medium and large) from the same supplier and a customised mask fabricated for each subject using three-dimensional facial scanning and modern additive manufacturing processes. Mask leak and comfort were assessed with varying CPAP levels and mask tightness. Leak was measured in real time using an inline low-resistance Pitot tube flow sensor, and each mask was ranked for comfort by the subjects.

Results: Mask leak rates varied directly with CPAP level and inversely with mask tightness. When ranked for comfort, three subjects favoured the customised mask, while three favoured a commercial mask. The petite mask yielded the highest mask leaks and was ranked least comfortable by all subjects. Relative mask leaks and comfort rankings for the other commercial and customised masks varied between individuals. Mask leak was comparable when comparing the customised masks with the highest ranked commercial masks.

Conclusion: Customised masks successfully delivered target CPAP settings in all six subjects, demonstrating the feasibility of this approach.

Conflict of interest statement

Conflict of interest: K. Duong has nothing to disclose. Conflict of interest: J. Glover has nothing to disclose. Conflict of interest: A.C. Perry has nothing to disclose. Conflict of interest: D. Olmstead has nothing to disclose. Conflict of interest: M. Ungrin has nothing to disclose. Conflict of interest: P. Colarusso is cofounder of Luxidea, Inc. Luxidea has no financial or related interest in the work described here. Conflict of interest: J.E. MacLean reports grants from Alberta Economic Development and Trade during the conduct of the study. Conflict of interest: A.R. Martin reports grants from Alberta Economic Development and Trade during the conduct of the study.

Copyright ©ERS 2021.

Figures

FIGURE 1
FIGURE 1
Schematic of experimental apparatus. CPAP: continuous positive airway pressure.
FIGURE 2
FIGURE 2
Final customised mask. a) Portion of mask labelled “coupler” (front) interfaces with the headgear and hosing that conducts positive pressure from the continuous positive airway pressure (CPAP) machine. The “cushion” (back) contacts the subject's face. b) Demonstration of the coupler attached to the headgear and hosing of the Wisp CPAP system. c) Customised mask worn in situ.
FIGURE 3
FIGURE 3
a) Top-down view of all six customised cushions; b) front view of all six customised cushions.
FIGURE 4
FIGURE 4
a) Assembled mould box components with one component removed for visualisation. Outer mould shown in magenta, inner mould shown in black. b) Demonstration of custom cushion created after injection of cavity with silicone (white).
FIGURE 5
FIGURE 5
Mask air leak for each subject's preferred commercial continuous positive airway pressure mask and their customised counterparts at an appropriate fit (350 g). SLPM: standard litres per minute.

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Source: PubMed

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