The objective of this study was to present a methodology and manufacturing workflow for non-invasive ventilation interfaces (NIV) for neonates and small infants. It aimed to procure a fast and feasible solution for personalized NIV produced in-house with the aim of improving fit and comfort for the patient. Three-dimensional scans were obtained by means of an intraoral (Trios 3) and a facial scanner (3dMd Flex System). Fusion 360 3D-modelling software was employed to automatize the design of the masks and their respective casting molds. These molds were additively manufactured by stereolithography (SLA) and fused filament fabrication (FFF) technologies. Silicone was poured into the molds to produce the medical device. In this way, patient individualized oronasal and nasal masks were produced. An automated design workflow and use of additive manufacturing enabled a fast and feasible procedure. Despite the cost for individualization likely being higher than for standard masks, a user-friendly workflow for in-house manufacturing of these medical appliances proved to have potential for improving NIV in neonates and infants, as well as increasing comfort.
Keywords: craniofacial malformations; customized medical device; design and manufacturing workflow; facial scanning; intraoral scanning; rapid tooling; ventilation mask.