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PNEUMACRIT: Preterm Neonate / neonatal Embedded Universal Microelectronic wearable Acquisition For Cardio Respiratory Intensive Therapy

Lead Research Organisation: Middlesex University
Department Name: Faculty of Science & Technology

Abstract

PNEUMACRIT will provide a revolutionary multi sensor wearable imaging system that will inform lung function diagnosis for infants and children with conditions that can lead to respiratory problems. Although respiratory support, especially mechanical ventilation, can improve their survival, it may also cause severe injury to the vulnerable lungs, resulting in chronic pulmonary morbidity lasting into adulthood. PNEUMACRIT has the potential to provide early detection of respiratory failure in infants, by providing a low-cost monitoring system, which will also facilitate optimisation of the respiratory support. This will provide both immediate benefits and decrease the risk of patients developing long-term respiratory disorders. PNEUMACRIT pursues breakthroughs in analytical measurement, microsystems embedded in flexible printable wearable materials, signal processing, and organic devices, to produce multi-parameter clinical measurements obtained from the data produced from electrical impedance tomography (EIT), Electrocardiogram (ECG) and apnoea monitoring. EIT is a non-radiative, inexpensive technique that uses small electrical currents to produce cross sectional images of the body that can facilitate real time dynamic monitoring of lung aeration, and recent studies have shown that it is effective in monitoring aeration in preterm babies in a clinical setting. However, to maximise its diagnostics potential, this EIT information need to be combined with other non-invasive measures. Advances in electrode technologies within the project will enable multi-site recordings, without the need for physical interconnection and integrated power supplies, opening the door to a new generation of diagnostic wearables. Such monitoring is crucial because each year millions of babies across the world suffer from respiratory failure due to immaturity of the lung or infectious diseases. In addition, standard lung function tests are not suitable for use with babies and young children until they are old enough to actively co-operate with instructions (~age 7 years). Therefore, PNEMACRIT could, in future, provide valuable lung function information to this age group as well.

Planned Impact

At present there is no multi-sensor imaging modality suitable for continuous non-assisted monitoring of infants' lung physiology. The overall benefit of healthcare interventions in respiratory function in infants and children is currently limited by assumptions that respiratory support results in homogeneous aeration and ventilation of the lung. However, this is often not the case, resulting in inappropriate interventions with acute and lifelong impacts on health and wellbeing as the damage persists into adulthood.
This project will significantly decrease respiratory related treatment damages in infants and children and establish more effective treatment schemes through the use of a new medical device based on electrical impedance tomography (EIT), combined with ECG and apnoea in the form of a wearable system . It will provide real time information regarding the patient's condition by defining the nature, inhomogeneity and severity of persisting lung disorders We believe this will significantly advance early detection and monitoring of lung problems in the neonatal and paediatric patient population worldwide. It will thus have immense impact across a wide range of stakeholders as detailed Below.

Excellent research: This technology will provide new approaches to creating wearables for the care and intervention of infants and children.
Impacts on the economy: Clearly any advance in the diagnosis and therapeutic intervention of infants and children will have significant impact in terms of national savings. Further, large-scale advancement of the technology would make it affordable in the developing world and will be of interest to W.H.O. The proposed research will lead to a new product or a range of products the manufacture of which will create new jobs (and possibly new companies), ultimately leading to wealth creation and reinforcing the UK's position as a leading country in healthcare technologies.
Impacts on the public sector / policy: Enabling early access interventions for respiratory related treatment will improve patient safety and treatment quality for the most vulnerable neonatal and paediatric patient population. Timely diagnosis will allow clinicians to intervene at an early stage and reduce mortality. This project will impact on service delivery policy helping to ensure availability of seamless access to integrated packages of interventions through an optimal mixture of health centre and hospital-based care.

Environmental / social advances: Due to the timeliness and health impact of the project, we will seek to attract national media updates and interviews for further dissemination of the work to the wider public.

Skilled people / leadership: The project will produce researchers with the multidisciplinary skills and expertise to tackle challenges within healthcare. The project will produce researchers with the multidisciplinary skills and expertise to tackle challenges within healthcare. The combination of materials, electronics, design, modelling, data capture and analysis are an attractive skill set applicable across a wide range of industries, including engineering and clinical sciences, and our staff will be well positioned to make major contributions in these areas. Those with a background in engineering will gain good appreciation of the possibilities of EIT, while those with a background of related fields, will gain a good appreciation of the solutions that engineering can provide and the associated practicalities.

Publications

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De Gelidi S (2021) Thoracic shape changes in newborns due to their position. in Scientific reports

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Seifnaraghi N (2021) Model Selection Based Algorithm in Neonatal Chest EIT in IEEE Transactions on Biomedical Engineering

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Rahal M (2022) High Frame Rate Electrical Impedance Tomography System for Monitoring of Regional Lung Ventilation. in Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference

 
Description The effect of body shape of the infants on the quality of the images produced and how it can be improved.
The development of a new wearable electrode belt that has been accessed by clinical users in Finland and found to be easy to apply to babies.
We have also undertaken successful measurements on 20 babies which show the system can provide high quality data for lung function and guild clinical interventions.
Exploitation Route A greater understanding of lung function of infant. This can be used on adults and we how to use the information in the clinical management of Covid patients.
Sectors Education

Electronics

Healthcare

Manufacturing

including Industrial Biotechology

Pharmaceuticals and Medical Biotechnology

 
Description We are undertaking MHRA approval for clinical use and developed a spin out company. Developing an application for a programme grant to develop multi sensors capability for monitoring neonates. Created new microelectronics systems comparable with the electrode belt, reduce the power requirements and size of the monitor system. We have also developed a sensing system to monitor the shape of the babies.
First Year Of Impact 2023
Sector Electronics,Healthcare,Manufacturing, including Industrial Biotechology
 
Description KCH 
Organisation King's College Hospital
Country United Kingdom 
Sector Hospitals 
PI Contribution The development of a new lung imaging system for the real time monitoring of the lung.
Collaborator Contribution Assisting with MHRA approval for adults
Impact Patent application PCT/GB2024/050180: Wearable device for use in electrical impedance tomography (EIT), to a kit comprising the device, to an EIT hub, to an apparatus for performing EIT, to various methods of manufacturing such a wearable device, and to use on a laboratory animal of a wearable device.
Start Year 2022
 
Description PEL 
Organisation Printed Electronics Ltd
Country United Kingdom 
Sector Private 
PI Contribution We collaborated on the development of novel wearable printed electrode arrays that can be manufactured at scale and low cost using their expertise and networks. We have developed arrays for both adults and neonates, both of which are now in their second iteration. We have filed a joint patent with PEL for these devices. Patent no. PCT/GB2024/050180 PEL have benefitted from this collaboration through: provision of manufacturing services; joint development of intellectual property; substantive work in the medical device sector to add to their portfolio of activity and expertise.
Collaborator Contribution PEL became an Industrial partner in 2018 supporting a variety of ongoing grant applications to date. They were formal industrial partners on: a) PNEUMACRIT: Preterm Neonate / neonatal Embedded Universal Microelectronic wearable Acquisition for Cardio-Respiratory Intensive Therapy [EP/T001240/1, EP/T004908/1, EP/T001259/1] b) CoRLEIT, Covid Regional Lung EIT [EP/V044036/1]; They manufactured our 'Shape belts', providing expertise on flexible printed circuit boards as part of EU H2020 CRADL https://cradlproject.org . [ Thoracic shape changes in newborns due to their position - de Gelidi, et. Al. Nature - Scientific Reports volume 11, Article number: 4446 (2021) ]
Impact We have filed a joint patent with PEL for these devices. Patent no. PCT/GB2024/050180
Start Year 2018
 
Description Sapien 
Organisation University of Oulu
Country Finland 
Sector Academic/University 
PI Contribution Development of a new imaging system for neonates.
Collaborator Contribution Dr Merja Kallio, MD, PhD, Consultant Paediatric Cardiologist and clinical researcher in PEDEGO Research Unit, University of Oulu and Oulu University Hospital, Finland ( recently a study of 20 babies was undertaken.
Impact PCT/GB2024/050180: Wearable device for use in electrical impedance tomography (EIT), to a kit comprising the device, to an EIT hub, to an apparatus for performing EIT, to various methods of manufacturing such a wearable device, and to use on a laboratory animal of a wearable device.
Start Year 2022
 
Title APPARATUS AND METHOD FOR ESTIMATING SHAPE 
Description An apparatus (480) for use in estimating the shape of a body part of a subject, which apparatus (480) comprises: a string of sensors (481) for positioning adjacent the body part so that the string of sensors substantially conforms with the shape of the body part, or at least a part of it, the string of sensors comprising at least one bend sensor and at least one stretch sensor (482) arranged end to end such that, in use, the at least one bend sensor lies adjacent a first region of the body part and the at least one stretch sensor (482) lies adjacent a second region of the body part, wherein the magnitude of a curvature of the first region of the body part is greater than the magnitude of a curvature of the second region of the body part. 
IP Reference WO2015025113 
Protection Patent application published
Year Protection Granted 2015
Licensed No
Impact Considerable improvement in clinical image quality
 
Title PNEUMACRIT imaging system 
Description We are seek translation funding and are setting up a Spin out. We have test the device in Finland and have to other trials ready to start at Glasgow children's hospital and KCH. 
Type Diagnostic Tool - Imaging
Current Stage Of Development Refinement. Clinical
Year Development Stage Completed 2024
Development Status Actively seeking support
Impact Too early to detail at present. 
 
Company Name Sapien Medical 
Description — 
Year Established 2023 
Impact Sapien Medical is a pre-revenue medtech company and has not been functioning long enough to produce impacts.