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Designing for the extremes: development of a 3D printed individualized mask for neonatal non-invasive ventilation

Problem

Neonates in intensive care units often need a ventilatory mask. Today’s neonatal masks are designed based on generic facial models and often don’t fit well.  A poor fit may have consequences ranging from air leaks to skin damage,  pressure ulcers and head deformities due to the force done by the strips used to seal the masks.

 

Solution

A 3D printed, customizable, ventilatory mask for premature babies. 

 

The face of the newborn is scanned from outside the incubator in 40 seconds. The mask is then 3Dprinted using a biocompatible and hypoallergenic silicone. 

 

Results

14% air leaks reduction when testing the prototype with a manikin. An optimal distribution of the pressure around the contact mask area was also obtained, consequently reducing pain points.

 

Encountered challenges

Material: it was difficult to find an hypoallergenic silicon material that could be used for 3D printing and that would get fixed to the patient’s face but could also be removed easily. On top of this, the material had to resist a sterilization process and be flexible enough so not to be harmful to the delicate skin of newborns.

 

Image acquisition: images were taken from outside the incubator with the glass acting as a reflexing barrier which led to less quality images. Also, when scanning, in order to avoid flash light exposure to the babies’ eyes, we had to cover them with protector glasses.

 

Delivery time: the image acquisition and printing process needs to be done quickly enough to be ready before ulcers appear (maximum of 2 days). 

 

Face changes over time: the face of the baby  changes significantly every week, so the process of scanning and printing needs to be repeated every week.

Current and Next steps

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Award competition: this project has been awarded with 25 000 € as part of the innovation price received by Hospital Clínic of Barcelona at the end of 2021

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Publication: the project has been published in the International Journal of Bioprinting on February 2022

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Currently: we are currently starting the 1st phase of the clinical trial that consist on testing the prototype with real users and confirm the reduction of facial ulcers

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Duration of the project: started in 2020 and still running

Collaborators: Neonatologists Dr. Óscar Garcia-Algar and  Dra Cristina Borrás 

Industrial partners: Avinent Implant System S.L.U and Elkem Silicones France SAS

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