ABSTRACT
The ongoing COVID-19 pandemic has revealed alarming shortages of personal protective equipment for frontline healthcare professionals and the general public. Therefore, a 3D-printable mask frame was developed, and its air seal performance was evaluated and compared. Personalized masks (PM) based on individual face scans (n = 8) and a statistically shaped mask (SSM) based on a standardized facial soft tissue shape computed from 190 face scans were designed. Subsequently, the masks were additively manufactured, and in a second step, the PM and SSM were compared to surgical masks (SM) and FFP2 masks (FFP2) in terms of air seal performance. 3D-printed face models allowed for air leakage evaluation by measuring the pressure inside the mask in sealed and unsealed conditions during a breathing simulation. The PM demonstrated the lowest leak flow (p < 0.01) of inspired or expired unfiltered air of approximately 10.4 ± 16.4%, whereas the SM showed the highest (p < 0.01) leakage with 84.9 ± 7.7%. The FFP2 and SSM had similar values of 34.9 ± 18.5% leakage (p > 0.68). The developed framework allows for the time- and resource-efficient, on-demand, and in-house production of masks. For the best seal performance, an individually personalized mask design might be recommended.
Subject(s)
COVID-19 , Masks , Personal Protective Equipment , Biometry , Equipment Design , Health Personnel , Humans , Printing, Three-Dimensional , Public HealthABSTRACT
A polyolefin with certified biocompatibility according to USP class VI was used by our group as feedstock for filament-based 3D printing to meet the highest medical standards in order to print personal protective equipment for our university hospital during the ongoing pandemic. Besides the chemical resistance and durability, as well as the ability to withstand steam sterilization, this polypropylene (PP) copolymer is characterized by its high purity, as achieved by highly efficient and selective catalytic polymerization. As the PP copolymer is suited to be printed with all common printers in fused filament fabrication (FFF), it offers an eco-friendly cost-benefit ratio, even for large-scale production. In addition, a digital workflow was established focusing on common desktop FFF printers in the medical sector. It comprises the simulation-based optimization of personalized print objects, considering the inherent material properties such as warping tendency, through to validation of the process chain by 3D scanning, sterilization, and biocompatibility analysis of the printed part. This combination of digital data processing and 3D printing with a sustainable and medically certified material showed great promise in establishing decentralized additive manufacturing in everyday hospital life to meet peaks in demand, supply bottlenecks, and enhanced personalized patient treatment.