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Custom-made 3D Printed Mask for Neonates with Non-invasive Ventilation
A B Unfortunately, the use of these interfaces has raised other
problems such as air leaks and pressure ulcers . It is
[14]
possible to optimize the fit of these interfaces by adapting
them to the specific characteristics of each patient [6,15] .
Given the vulnerability of the target population
(very premature infants), the development conditions
of the mask are very demanding. For this reason, we
proposed a preliminary study in which we worked with a
manikin (subject of the present publication).
Requested requirements for the first step of the
described process, that is, facial image capture, were
accomplished. We worked without touching the manikin
(scanning the face instead of using a mold), keeping it
inside the incubator (avoiding extra mobilizations), and
without using harmful radiation or long light exposures
Figure 4. (A) Support areas of the personalized nasal mask. (B) (maximum 2 min). It is known that long or intense light
Support areas of the standard nasal mask to two manikin’s face exposures are detrimental to the neurodevelopment of
[16]
prints. Material used for customized mask was AMSil™ Silbione™ premature patients . AsorCAD Creafom gamma Academia
24501-50 TRS A-B from Elkem Silicones France SAS. Material 3D scanner has given us these advantages as well as an
used for standardized mask was Medical Grade Liquid Silicone adequate image resolution for the size of the manikin’s face.
Rubber from CareFusion and for printed faces was Agilus30Clear This step lasted less than 10 min, similar to that described
®
from Stratasys TM (PolyJet technology). by Willox et al. in their customized masks’ tests on adult
®
patients . This form of facial image capture has a limitation
[8]
4. Discussion that it can be affected by the patient’s gestures, so a neutral
[8]
This is a pilot study that demonstrated that a customized posture of the face should be acquired .
NIV mask for a manikin (a manikin that emulates the size The 3D printing of the mask has been made with
of an extremely premature patient) can be 3D printed a biocompatible and hypoallergenic silicone thanks
using a 3D scanner imaging system. The customized to the participation of the companies Avinent Implant
nasal mask was designed to mimic existing nasal masks System S.L.U. (Santpedor, Spain) and Elkem Silicones
but has a tailor-made shape to fit the manikin’s face. The France SAS. 3D printing with silicone is a strong point
evaluation of the process of designing a mask from scan of our project, because despite its universal use in
data, the organization of its manufacture and the printing healthcare, the application of this material in 3D printing
of the prototype described in this study are valuable is quite novel. Its most notable characteristics are low
experiences for future reference. allergenicity, durability, non-deformability and stability
To the best of our knowledge, although this is not the at high temperatures (in case of sterilization procedures).
first study that demonstrated effectiveness of 3D scanning The transparency of the mask is a point to improve.
and printing technology in healthcare [6,8] , this is the first A breakthrough in the field of 3D printing materials is
article reporting the manufacture of a 3D individualized expected in the near future.
mask for neonatal population and the application of The personalized mask perfectly fits the facial
silicone certified for medical use. features of the manikin compared to standardized masks.
The use of NIV changed the way neonatologists We believe that this perfect fit reduces air leaks and
treated patients with respiratory failure, thereby avoids an excessively firm fixation as indicated in our
minimizing the risks and complications associated with results. If the mask is too tightly fitted, the pressure on
endotracheal intubation and invasive ventilation. There the skin leads to the appearance of skin lesions. Through
are between 350,000 and 400,000 births each year in the qualitative tests with ink, we observed that the
Spain; about 7 – 13% are preterm births . The majority support area of the personalized mask on the face was
[13]
of very preterm infants (born before week 32 of gestation) homogeneous and the pressure was better distributed, but
need NIV, especially during the first few days or weeks even so, there is no guarantee that the personalized mask
of life. Around 100 very preterm infants are born in will not cause pressure injuries in patients. This is an issue
our hospital each year; more than 70% of them will to be explored in further studies. The standardized mask
require NIV for a mean period of 8 days. NIV needs an discontinuously rested on manikin’s face; high pressure
interface that links the ventilator with the patient. There points on the nasal bridge and the upper lip were detected.
are different types of interfaces, for example, prongs or These areas are susceptible to frequent occurrence of
nasal masks (the current project is based on nasal masks). pressure ulcers .
[12]
28 International Journal of Bioprinting (2022)–Volume 8, Issue 2