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Custom-made 3D Printed Mask for Neonates with Non-invasive Ventilation
characteristics are quite inevitable, especially in younger The research team made up of two physicians and
patients or in patients with peculiar facial features [3,8] . A poor six nurses who are part of the Skin Adverse Events’
fit of the mask may have relevant clinical consequences such Working Group of our hospital. The project was also
as air leaks, making it difficult to achieve proper ventilation, a collaboration with an engineer from the Biomedical
and oxygenation . The great diversity of human faces’ Engineering Department of the Hospital Clínic who is
[9]
geometries, especially in newborns during the 1 days of used to work on 3D printing models in resin for orthopedic
st
life or in growing infants, may represent a limitation for and reconstructive surgery, and a collaboration with
standardized masks . An individualized mask was recently Avinent Implant System S.L.U. (Santpedor, Spain) and
[5]
designed for the application of nocturnal continuous positive Elkem Silicones France SAS companies.
airway pressure (CPAP) in a pediatric patient with Treacher- The followings steps were proposed to obtain the
Collins syndrome and obstructive sleep apnea . With the tailor-made mask:
[3]
use of this individualized mask, Morrison et al. described an (i) Image capture. Scan of the facial surface of the
air leakage reduction of 74% and a greater adherence of the manikin was made using the 3D Peel 2 CAD scanner
patient to therapy compared to the standard mask. with LED light. The scanner has a mesh resolution
In addition, skin in-contact with the mask can suffer of 0.25 mm and a scan area of 380 mm × 380 mm.
pressure ulcers, especially if the mask does not fit properly. This step necessitates the use of a device that does
Mask-related pressure ulcers cause pain, discomfort and loss not need contact with the manikin, can be used inside
of function, resulting in extended hospital stays and increased the incubator and does not use harmful radiations.
costs , and are recognized as preventable adverse events (ii) Image processing. Once the points’ cloud of the
[4]
in healthcare [10,11] . Despite the application of best practices scanned surface was obtained, we converted it into
to prevent medical device-related pressure ulcers, the Skin a.STL file (standard data transmission format that
Adverse Events’ Working Group of the Hospital Clínic transformed the scanned volumetric surface to a solid
reported an incidence of 30.7% of pressure ulcers related reconstruction using triangle-faces modeling). Next,
to the use of NIV masks in very preterm infants during the we redesigned the standard mask model by adapting
1 week of life (65% of these patients will suffer from a the part that is in contact with the manikin so that it
st
recurrence) . Other complications related to these ulcers matches the exact physiognomy of the scanned face.
[12]
can range from local/systemic infections to long-term scars. (iii) 3D mask printing. The mask was printed using the
More effective strategies to prevent pressure Liquid Deposition Modeling technique, which consists
ulcers related to the use of medical devices are urgently of deposition by extrusion of liquid silicone at room
needed . There is no report regarding individualized temperature with a curing process. The printed mask
[4]
neonatal masks for NIV. We believe that 3D printing can had a resolution of 200 µm thick layer and was extruded
make an important contribution to a more personalized through a nozzle orifice with diameter of 234 µm. Avinent
neonatal care in the near future. Implant System S.L.U. (Santpedor, Spain) Company is
Before a planned test with premature patients, the owner of the bioprinter. The chosen material for this
we checked with the present work the feasibility of the purpose was from the AMSil™ Silicone Elastomers
process of creating and printing a 3D customized mask series. Elkem Silicones France SAS Company is the
for NIV for a manikin. Our primary objective is to design manufacturer of the silicone. In addition to the already
an individualized prototype of a biocompatible silicone known properties, other properties of silicone include
nasal mask for NIV for the Premature Anne manikin from resistance to oxidation processes, thermal stability, and
Laerdel using a 3D printer. The secondary objectives are: resistance to compression and friction; these properties
®
(i) To assist the manikin achieve adequate thoracic justify the wide application of silicone in the health
excursion using the customized mask; sector. Moreover, the printable silicone is hypoallergenic
(ii) To compare the reduction in air leakage between the when it is in contact with the skin.
customized mask and standardized mask suitable for
the aforementioned manikin; and
We compared air leaks detected by the ventilator
(iii) To compare the pressure distribution at the skin contact between the customized mask and the standard mask that
areas between the customized mask and standardized corresponds to the size of the manikin according to our
mask suitable for the aforementioned manikin.
interface selection protocol for non-invasive neonatal
ventilation. The standard mask used was the CareFusion
®
2. Methods Infant Flow LP Nasal CPAP System. The manikin was
modified to minimize leakage through the mouth.
This experimental observational study was carried out The edges of both masks were marked with ink on
in the Neonatology Department of the Hospital Clínic the face of the manikin to qualitatively compare their
Barcelona in 2020 and 2021. support areas.

26 International Journal of Bioprinting (2022)–Volume 8, Issue 2