This collaborative project between UPPS, Amsterdam UMC and nSize is aimed to revolutionise paediatric intensive care by developing personalised non-invasive ventilation (NIV) masks for children, leveraging 3D scanning and printing technology. In light of the detrimental side-effects associated with conventional invasive ventilation methods—such as infections and long-term lung damage—there has been a significant shift towards NIV, particularly for the over fifty per cent of children in intensive care who require ventilation due to severe respiratory distress. However, the effectiveness of NIV is highly depended upon the mask's fit, with a notable scarcity of suitably sized masks for young children. The project was spurred by Jip Spijker's graduate work, which produced design options for tailored masks that enhance ventilation efficacy. Focusing on creating a modular mask that can be custom-fitted for individual paediatric patients through 3D printing, the project aimed to improve treatment outcomes on paediatric IC units. The primary objective was to devise a process for the rapid production of ideal custom-fit masks for children aged 0-7 years, intended initially for hospital use within a 24-hour timeframe.
In paediatric intensive care, over half of the patients require ventilation, often through invasive methods that can lead to significant adverse effects. The current one-size-fits-all approach with NIV masks fails to provide an optimal fit, especially for young children, compromising the effectiveness of the treatment. The project seeks to address the lack of suitable NIV masks by developing personalised solutions that can be rapidly produced and custom-fitted for individual paediatric patients.
In the design phase, the project used parametric modelling techniques to adapt and refine the basic design of the mouth-nose mask, originally taken from another project. Coen and Renée from Amsterdam UMC were important in this process, ensuring the technical details such as dimensions and shapes were meticulously defined. This approach allowed for the creation of a model that could be easily adjusted based on specific requirements, avoiding the need to start the design process again for each mask. The custom-fit cushion part of the mask, designed to comfortably fit individual facial contours, was a key focus of this phase.
The design process was highly collaborative, involving multiple stakeholders to ensure the final product met user needs. The soft, flexible cushion, essential for creating an airtight seal while being gentle on children's skin, was developed with input from healthcare professionals and engineers. This co-creation approach ensured the mask was not only functional but also comfortable for the young patients, embodying the principles of user-centred design.
The project carefully selected materials and production techniques to meet the unique requirements of the mouth-nose mask. The frame and frame ring required a sturdy yet transparent material to allow visibility of the child's face, while the cushion needed to be soft and flexible to ensure comfort and an effective seal. The chosen materials, MED610 for the frame and MED625FLEX for the cushion, were biocompatible, ensuring safety for extended skin contact. Additive Manufacturing was identified as the ideal production technique due to its ability to produce a large quantity of unique items, addressing the challenge of customisation inherent in UPPS.
The manufacturing process was streamlined to meet the project's ambitious goal of producing personalised masks within a 24-hour timeframe. The use of multi-material printers enabled the simultaneous printing of both the rigid and flexible components of the mask in one seamless process. This efficiency was crucial in ensuring the rapid turnaround from 3D scan to final product, essential for the fast-paced medical environment.
The evaluation stage was critical in assessing the effectiveness and comfort of the prototype masks. This was achieved through testing on two specially developed test heads, equipped with pressure sensors to measure the mask's fit and comfort. These tests, conducted in a simulated use environment using a ventilator, provided valuable feedback on the mask's performance. The differing ages of the test heads, representing a 1-year-old and a 4-year-old child, allowed for the assessment of different mask sizes, further informing the design and production process.
The project showcased the potential of parametric modelling and additive manufacturing in creating personalised medical devices, specifically mouth-nose masks for paediatric patients. The collaborative design process, involving input from both medical professionals and engineers, ensured the masks met both medical and comfort criteria. The selection of biocompatible materials and the use of multi-material printers facilitated the efficient production of these personalised masks, capable of being produced within a 24-hour period. The thorough evaluation using test heads provided essential feedback, highlighting the project's success in combining comfort, functionality, and rapid production to meet the urgent needs of paediatric respiratory care. This approach not only demonstrates the feasibility of personalised medical devices but also paves the way for broader applications in personalised healthcare solutions.
