Enhancing facemask effectiveness during the COVID-19 pandemic through the development of personalised additively manufactured PPE

Lead Research Organisation: King's College London
Department Name: Dental Institute

Abstract

This project brings together digitial facial profiling with advanced additive manufacturing of medical grade silicones to improve the effectiveness of facemasks for key workers during the COVID-19 crisis. Customisation of FFP3 standard facemasks, whether generic or those being developed through alternative manufacturing routes to address the global supply shortage, is urgently required to (i) provide an effective seal protecting workers against viral transmission and (ii) enhance wearability to prevent skin trauma that is associated with prolonged use.

In this project we will firstly assess the suitability of using smart phone based 3D imaging technologies to capture facial form and compare this data with clinically used photogrammetry. Simultaneously we will develop and assess a range of custom silicone interface prototypes that can be applied to existing FFP3 masks and newly developed designs. To achieve this we will use our existing expertise of 3D printing silicone to systematically optimise compositions tailored for this application exploring rheological and deposition variables. Our aim is to rapidly progress to mask 'fit' checking according to standard clinical procedures, evaluating for superiority in seal, comfort and reduced fitting time. Efficacy of viral disinfection of the additively manufactured silicone interfaces will also be assessed to facilitate translation. End-users will take an active part in the project, which itself will be supported by institutional research and development / commercialisation teams to maximise the chance of scale-up at the earliest timepoint.

Publications

10 25 50
 
Description This project aimed to establish the feasibility of a design and manufacturing pathway for custom-fitting respirator 'face-masks' as a response to the failings of existing designs for many front-line workers. Here we demonstrated and validated the feasibility of using accessible technology (smart-phone cameras) to capture facial profiles; developed algorithms to assess whether an individual was likely to have good fit to a series of standard designs; and identified materials and designs to be able to manufacture custom-fit devices through additive processes. We have filed patent claims on a number of design / process features; identified a scale-up partner who have leveraged further support (http://www.mymaskfit.co.uk/) with free licensing through the pandemic period and have submitted findings for publication.
Exploitation Route We have aimed from the outset of this award to make our findings as rapidly accessible to others during the covid-19 pandemic.
To this end we have engaged with multiple other groups working to similar goals form the outset of the project including: Imperial College London https://www.imperial.ac.uk/news/199913/high-impact-covid-19-projects-strengthened-community-jameel/ and University of Cambridge https://www.matchconsortium.org/

Findings from our original research led to patent claims filing: PB158065GB, PB158105GB with immediate offer of no cost licensing (during the pandemic) to a start-up http://www.mymaskfit.co.uk/ who have subsequently leveraged further funds from Innovate UK (with Swansea University) and MadeSmarter (NPL) to explore scale-up.

Throughout the project we have had active discussion with policy makers, NHS procurement and with groups working on additive manufacture of PPE. Importantly a strong interaction with the National Physical Laboratory has led to ongoing work on how we develop appropriate pre-deployment testing for full customized medical devices and we are continuing to support their digital test bed project.
Sectors Healthcare,Manufacturing, including Industrial Biotechology

URL https://redirect.vuelio.co.uk/broadcast?data=MjF4NFN6Q004R2F0akQxVjMyMmFOQ0dtQ3g2cmdwYUdCYTFwb2ZodDNnaXdWUEhrYVlVNlh1dHhJd3U0Q1JERUhnMjA4MDAyMzNPdHp5TVZtRlVHUFpQcEVad1dObHRqdjBTdlRkaW1WWldDVTJIZTExUWM5VjlUaFJocDZuanlpS0I1SlRLU0FNdXEzTCtZbUF5RnJKUGhKVXRvb0puUTZUNXp4WTVoRjRoUThQbC93U20rZUk4eGFLQnJxY3NUVlVRMFEwRmRkQWhXc1dYS1NuczJiZFM1SWl1b2pscUVIamF3UC9Rd3FSTDlncVg5b0lOQS9LbGZvSWVTZndxRmJjZzIvaU8yemRJaW5BckpIOVVSZHR4c3BTQjNOdkRyTGFTcjdMOGducHdVYVRkVlU0eVRnZjFpaUhpUTFadlVDRzd4dWFxZHgzeUlveU9MM2wwbz
 
Description The primary non-academic benefit has been transfer of of knowhow to mymaskfit http://www.mymaskfit.co.uk/ a SME set-up to explore scale-up of customized respirators for all. The company has subsequently leveraged funds to develop from our initial work to a product for widespread deployment. Secondary benefits include raising greater awareness about the design and materials considerations for respirator devices with feedback to policy makers including public health England. The project has been widely publicized with >20 pick-ups from print, electronic and TV media to date.
First Year Of Impact 2020
Impact Types Economic,Policy & public services

 
Description Addressing testing standards for respirator PPE 
Organisation National Physical Laboratory
Country United Kingdom 
Sector Academic/University 
PI Contribution New collaboration initiated in ~August 2020 - working with NPL to address the testing requirements needed for 'fit-testing' of fully customized respirators. Manufacture of a high fidelity test rig - a anthropometric average head with skin mimic and differential facial compliance to NPL. Regular feedback meetings and contribution to an NPL (recipient) MadeSmarter Digital Testbed award (ongoing)
Collaborator Contribution Provision of test data for filtration and seal efficacy of respirator prototypes
Impact Ongoing
Start Year 2020
 
Title PATIENT INTERFACE 
Description A respiatory mask includes a frame and a cushion module. The frame can include a front wall having a vent and/or a gas inlet opening and a collar extending away from the front wall. The collar surrounds the vent and/or the gas inlet opening. The cushion module comprises a cushion and a housing, which is made of a material more rigid than the cushion. The housing defines a connection opening. A friction coupling selectively couples the cushion module to the frame and comprises an elastomeric friction member coupled to a portion of the housing that defines the connection opening. In some arrangements, an outer surface of the friction member is exposed when the cushion module is coupled to the frame. In some arrangements, the housing extends through the peripheral surface. 
IP Reference US2021001072 
Protection Patent application published
Year Protection Granted 2021
Licensed Commercial In Confidence
Impact The license has been offered free of charge during the pandemic to a company who will scale up the invention.
 
Title Patient interface 
Description A respiratory mask includes a frame and a cushion module. The frame can include a front wall having a vent and/or a gas inlet opening and a collar extending away from the front wall. The collar surrounds the vent and/or the gas inlet opening. The cushion module comprises a cushion and a housing, which is made of a material more rigid than the cushion. The housing defines a connection opening. A friction coupling selectively couples the cushion module to the frame and comprises an elastomeric friction member coupled to a portion of the housing that defines the connection opening. In some arrangements, an outer surface of the friction member is exposed when the cushion module is coupled to the frame. In some arrangements, the housing extends through the peripheral surface. 
IP Reference AU2019231515 
Protection Patent application published
Year Protection Granted 2020
Licensed Commercial In Confidence
Impact The invention has been licensed free of cost during the covid-19 pandemic to a scale-up partner