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Wearable Electronics for Effective Lung Monitoring

Periodic Reporting for period 2 - WELMO (Wearable Electronics for Effective Lung Monitoring)

Reporting period: 2020-01-01 to 2021-06-30

The diagnosis, monitoring and treatment of lung diseases depend on the availability of medical products {stethoscopes, spirometers, plethysmographs, X-ray, CT, MRI & electrical impedance tomography (EIT)} that are monitoring the lung disease progression and treatment. Such medical products are placed inside hospitals, labs, special care units and healthcare professionals’ sites, requiring patients to have regular visits to assess their status and receive therapy treatments.
However, such examination methods are not portable (with the exception of stethoscopes and simple spirometers) and allow a momentary patient assessment. Short-term trends in disease development, either deterioration or improvement, are not accessible. Up to now, continuous, wearable and real-time monitoring, especially in remote settings (e.g. patients’ home) is not available. Other medical devices, especially the radiological ones, are massive, expensive, requiring specialized personnel, increasing the radiation load on the patient. Moreover, the fusion of both visual and sound information, is difficult, leaving their interpretation on the healthcare profession’s experience.
WELMO with the adoption of Application-Specific-Integrated-Circuits (ASIC) will be prototyped and demonstrated for Electrical Impedance tomography (EIT) and for lung sounds. The incorporation of low-cost and power electronics will enable for the first time the combination of both visual & sound information enabling the systematic, accurate and real-time evaluation of respiratory conditions. The collected signals can be securely stored and processed, towards revealing linkages with specific clinical outcomes.
WELMO comfortable vest is enabling the effective and accurate monitoring of the lungs, through the collection, fusion and interpretation of sound and image signals with innovative algorithms.
According to EUROSTAT, there are 382.000+ deaths in the EU-28 from respiratory diseases, (7.7 % of all deaths). 235+ million people world-wide suffer from asthma (WHO). 40 billion Euros are wasted annually across EU through lost productivity due to employee absenteeism related to COPD & asthma.
WELMO holistic solution is expected to have a radical impact:
By continuously monitoring lung function with novel methods of signal acquisition of respiratory patients
By providing physicians with enhanced awareness of their patient's health status and enable early identification of disease exacerbations
By minimizing the healthcare associated costs due to earlier detection of disease deterioration and the resulting fewer hospitalizations
It will be one of the first applications of effective lung imaging, giving insights to patients to understand their disease
WELMO targets to the development of a high-usable, easy-to-wear, machine-washable wearable that will enable the efficient & accurate real-time monitoring of the lungs. Main Objectives are:
To develop and produce miniaturized and low-power sensors
To use smart-garments and cabling: enabling the integration of all sensors in a single wearable
To align with relevant standards regarding developed electronics
To perform real-time acquisition of sensor data accelerating the decision-making process
To design and develop algorithms for the lung sound signal analysis
To develop a Decision Support System to perform accurate assessment of respiratory function deficits & to assist, even not EIT-expert, in timely detection of lung abnormalities
To link measured signals with certain lung functions and clinical conditions
To develop a set of secure apps for enabling the dynamic presentation of the results
Work performed
Internal quality & management procedures were followed
Design and development of the system architecture
5 circuit architectures for Discrete components sensors developed and evaluated
1st version of the digital board and the housing of the master sensor are designed
Design and implementation of the layout of the ASIC & of the conductive cable to interconnect the sensors & the first vest prototype
Ergonomics and functional tests
Wearability and acceptability by end-users validated
Research in EIT features and signal analysis
Data collection for the training & validation of the algorithms.
Development of algorithms for classification and detection of wheezes and crackles & EIT reconstruction and feature extraction algorithms
Continuation of efforts within the Medical Wearables Cluster
Remote Lab testing and optimization of performance
Necessary documentation for the committees submission
Recruitment of healthy subjects (Male and Female)
WELMO brand identity was developed and the value proposition along with the KERs of the WELMO analyzed
Main results
User & System requirements & architecture defined
Prototypes with ASIC & discrete components architecture produced and evaluated
Delivery of the master sensor (digital board and housing) & a reliable conductive cabling & the vest prototype
Optimization of the WELMO algorithms and subcomponents
The patient association ''Lungs of Life'' participated in the development of the vest design.
Teleconference with 6 other coordinators with Medical Wearables related EU funded projects
Authorization from clinical trial pilot sites granted
IPR and exploitation routes defined
5 papers published
Lung function of patients with chronic lung diseases is monitored using spirometry. This method is not capable of assessing lung function on a regional level. EIT can determine lung function regionally within the chest cross-section. It can detect increased inhomogeneity of lung ventilation associated with the underlying disease and its deterioration during disease worsening. The challenge in the setup and operation of EIT instruments is in the connection of the sensors and electrodes (16+ sensors are needed). The current technology is not ready for this due to the cabling. In WELMO, we will exemplify the power of cooperative sensors technology which will record EIT movies and lung sound maps integrated to a comfortable, easy-to-wear, machine-washable vest. The comfort of the sensor vest will be increased thanks to a further miniaturization of the sensors (via ASIC development) with simple cabling (only two wires, instead of 1-2 cables per sensor compared with the competition).
EIT is provides early feedback on the exacerbation of the lung disease leading to earlier initiation of therapy and possibly prevention of hospitalisation. EIT might be able to reliably monitor patients with lung diseases even during spontaneous breathing without performing the forced manoeuvres compared with conventional spirometry. For the first time both visual and sound information are fused in real time for lung monitoring enabling accurate evaluation of respiratory condition at lung-regional level through EIT methodology.
Impact
Cost effective intervention to tackle the absenteeism and/or work impairment due to lung related diseases
Lower cost for health services since early detection reduces exacerbation and hospitalization days
Continuously monitoring of lung function through a wearable improves the QoL of patients
Physicians will have access to (lung-regional level) rich information of their patients
Lung imaging insights can be provided to patients for a better engagement and understanding of their respiratory disease enhancing self-management
The DSS will analyze automatically the recordings providing a combined analysis of the results
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