Ultra-Long-Term-EEG Monitoring (ULTEEM) Systems: Towards User-Friendly Out-of-Hospital Recordings of Electrical Brain Signals in Epilepsy.

Epilepsy is characterized by the occurrence of epileptic events, ranging from brief bursts of interictal epileptiform brain activity to their most dramatic manifestation as clinically overt bilateral tonic-clonic seizures. Epileptic events are often modulated in a patient-specific way, for example by sleep. But they also reveal temporal patterns not only on ultra- and circadian, but also on multidien scales. Thus, to accurately track the dynamics of epilepsy and to thereby enable and improve personalized diagnostics and therapies, user-friendly systems for long-term out-of-hospital recordings of electrical brain signals are needed. Here, we present two wearable devices, namely ULTEEM and ULTEEMNite, to address this unmet need. We demonstrate how the usability concerns of the patients and the signal quality requirements of the clinicians have been incorporated in the design. Upon testbench verification of the devices, ULTEEM was successfully benchmarked against a reference EEG device in a pilot clinical study. ULTEEMNite was shown to record typical macro- and micro-sleep EEG characteristics in a proof-of-concept study. We conclude by discussing how these devices can be further improved and become particularly useful for a better understanding of the relationships between sleep, epilepsy, and neurodegeneration.

Remotely Powered Two-Wire Cooperative Sensors for Biopotential Imaging Wearables.

Biopotential imaging (e.g., ECGi, EEGi, EMGi) processes multiple potential signals, each requiring an electrode applied to the body's skin. Conventional approaches based on individual wiring of each electrode are not suitable for wearable systems. Cooperative sensors solve the wiring problem since they consist of active (dry) electrodes connected by a two-wire parallel bus that can be implemented, for example, as a textile spacer with both sides made conductive. As a result, the cumbersome wiring of the classical star arrangement is replaced by a seamless solution. Previous work has shown that potential reference, current return, synchronization, and data transfer functions can all be implemented on a two-wire parallel bus while keeping the noise of the measured biopotentials within the limits specified by medical standards. We present the addition of the power supply function to the two-wire bus. Two approaches are discussed. One of them has been implemented with commercially available components and the other with an ASIC. Initial experimental results show that both approaches are feasible, but the ASIC approach better addresses medical safety concerns and offers other advantages, such as lower power consumption, more sensors on the two-wire bus, and smaller size.

Split electrodes for electrical-conductivity-based tissue discrimination.

This work presents a method to minimize the inadvertent cutting of tissues in surgeries involving bone drilling. We present electrical impedance measurements as an assistive technology to image-guided surgery to achieve online guidance. Proposed concept is to identify and localize the landmarks via impedance measurements and then use this information to superimpose the estimated drilling trajectory on the offline maps obtained by pre-operative imaging. To this end., we propose an asymmetric electrode geometry., split electrodes., capable of distinguishing impedance variations as a function of rotation angle. The feasibility of the proposed approach is verified with numerical analysis. A probe with stainless steel electrodes has been fabricated and tested with a technical phantom. Although the results are impacted by a non-ideality in the phantom., we could show that the variation of impedance as a function of rotation angle can be used to localize the regions with different impedivities. Clinical Relevance- Presented approach may be used to minimize the inadvertent cutting of tissues in surgeries involving bone drilling.

A Wearable Stethoscope for Long-Term Ambulatory Respiratory Health Monitoring.

Lung sounds acquired by stethoscopes are extensively used in diagnosing and differentiating respiratory diseases. Although an extensive know-how has been built to interpret these sounds and identify diseases associated with certain patterns, its effective use is limited to individual experience of practitioners. This user-dependency manifests itself as a factor impeding the digital transformation of this valuable diagnostic tool, which can improve patient outcomes by continuous long-term respiratory monitoring under real-life conditions. Particularly patients suffering from respiratory diseases with progressive nature, such as chronic obstructive pulmonary diseases, are expected to benefit from long-term monitoring. Recently, the COVID-19 pandemic has also shown the lack of respiratory monitoring systems which are ready to deploy in operational conditions while requiring minimal patient education. To address particularly the latter subject, in this article, we present a sound acquisition module which can be integrated into a dedicated garment; thus, minimizing the role of the patient for positioning the stethoscope and applying the appropriate pressure. We have implemented a diaphragm-less acousto-electric transducer by stacking a silicone rubber and a piezoelectric film to capture thoracic sounds with minimum attenuation. Furthermore, we benchmarked our device with an electronic stethoscope widely used in clinical practice to quantify its performance.

Multimodal remote chest monitoring system with wearable sensors: a validation study in healthy subjects.

OBJECTIVE: Development of wearable medical technology for remote monitoring of patients suffering from chronic lung diseases may improve the care, therapy and outcome of these patients. APPROACH: A multimodal system using wearable sensors for the acquisition of multiple biosignals (electrical bioimpedance of the chest for electrical impedance tomography and respiratory rate assessment, peripheral oxygen saturation, chest sounds, electrocardiography for heart rate measurement, body activity, and posture) was developed and validated in a prospective, monocentric study on 50 healthy subjects. The subjects were studied under different types of ventilation (tidal and deep breathing, forced full expiration maneuver) and during increased body activity and posture changes. The major goals were to assess the functionality by determining the presence and plausibility of the signals, comfort of wearing and safety of the vest. MAIN RESULTS: All intended signals were recorded. Streaming of selected signals and wireless download of complete data sets were functional. Electrical impedance tomography recordings revealed good to excellent quality of detection of ventilation-related impedance changes in 34 out of 50 participants. Respiratory and heart rates were reliably detected and generally in physiological ranges. Peripheral oxygen saturation values were unphysiologically low. The chest sound recordings did not show waveforms allowing meaningful analysis of lung sounds. Body activity and posture were correctly identified. The comfort of wearing and the vest properties were positively rated. No adverse events occurred. SIGNIFICANCE: Albeit the full functionality of the current vest design was not established, the study confirmed the feasibility of remote functional chest monitoring with a marked increase in clinically relevant information compared to existing systems.

Wearable Sensors for Frequency-Multiplexed EIT and Multilead ECG Data Acquisition.

This paper presents a wearable sensor architecture for frequency-multiplexed electrical impedance tomography (EIT) and synchronous multilead electrocardiogram (ECG) data acquisition. The system is based on a novel electronic sensing architecture, called cooperative sensors, that significantly reduces the cabling complexity and enables flexible EIT stimulation and measurement patterns. The cooperative-sensor architecture was initially designed for ECG and has been extended for multichannel bioimpedance measurement. This approach allows for an adjustable EIT stimulation pattern via frequency-division multiplexing. This paper also shows a calibration procedure as well as EIT system noise performance assessment. Preliminary measurements on a healthy volunteer showed the ability of the wearable system to measure EIT data synchronously with multilead ECG. Ventilation-related and heartbeat-related EIT images were reconstructed, demonstrating the feasibility of the proposed architecture for noninvasive cardiovascular monitoring.

Two-Wire Bus Combining Full Duplex Body-Sensor Network and Multilead Biopotential Measurements.

Classical approaches to make high-quality measurements of biopotential signals require the use of shielded or multiwire cables connecting the electrodes to a central unit in a star arrangement. As a consequence, increasing the number of leads increases cabling and connector complexity, which is not only limiting the patient comfort but is also anticipated as the main limiting factor to future miniaturization and cost reduction of tomorrow's wearables. We have recently introduced a novel sensing architecture that significantly reduces the cabling complexity by eliminating shielded or multiwire cables and by allowing simple connectors, thanks to a bus arrangement. In this architecture, electrodes are replaced by so-called cooperative sensors that require synchronous operation for systems larger than two sensors. This paper presents a novel full duplex body-sensor network based on a simple two-wire bus that combines biopotential measurements, synchronization, and gathering of data in a single cooperative sensor with a throughput up to 2 Mb/s. When compared to others, the suggested approach is advantageous as it keeps the cabling complexity at its minimum and does not require every sensor to be equipped with wireless communication capabilities. First experimental measurements demonstrated the reliability of the approach for a wearable 12-lead electrocardiogram monitoring system tested in real-life scenario.

Clinical validation of LTMS-S: A wearable system for vital signs monitoring.

LTMS-S is a new wearable system for the monitoring of several physiological signals--including a two-lead electrocardiogram (ECG)--and parameters, such as the heart rate, the breathing rate, the peripheral oxygen saturation (SpO2), the core body temperature (CBT), and the physical activity. All signals are measured using only three sensors embedded within a vest. The sensors are standalone with their own rechargeable battery, memory, wireless communication and with an autonomy exceeding 24 hours. This paper presents the results of the clinical validation of the LTMS-S system.

Synchronization and communication of cooperative sensors.

Cooperative sensors are an emerging technology consisting of autonomous sensor units working in concert to measure physiological signals requiring distant sensing points, such as biopotential (e.g., ECG) or bioimpedance (e.g., EIT). Their advantage with respect to the state-of-the-art technology is that they do not require shielded and even insulated cables to measure best quality biopotential or bioimpedance signals. Moreover, as all sensors are simply connected to a single electrical connection (which can be for instance a conductive vest) there is no connecting limitation to the miniaturization of the system or to its extension to large numbers of sensors. This results in an increase of wearability and comfort, as well as in a decrease of costs and integration challenges. However, cooperative sensors must communicate to be synchronized and to centralize the data. This paper presents possible communication strategies and focuses on the implementation of one of them that is particularly well suited for biopotential and bioimpedance measurements.

WELCOME ­ innovative integrated care platform using wearable sensing and smart cloud computing for COPD patients with comorbidities.

We propose WELCOME, an innovative integrated care platform using wearable sensors and smart cloud computing for Chronic Obstructive Pulmonary Disease (COPD) patients with co-morbidities. WELCOME aims to bring about a change in the reactive nature of the management of chronic diseases and its comorbidities, in particular through the development of a patient centred and proactive approach to COPD management. The aim of WELCOME is to support healthcare services to give early detection of complications (potentially reducing hospitalisations) and the prevention and mitigation of comorbidities (Heart Failure, Diabetes, Anxiety and Depression). The system incorporates patient hub, where it interacts with the patient via a light vest including a large number of non-invasive chest sensors for monitoring various relevant parameters. In addition, interactive applications to monitor and manage diabetes, anxiety and lifestyle issues will be provided to the patient. Informal carers will also be supported in dealing with their patients. On the other hand, welcome smart cloud platform is the heart of the proposed system where all the medical records and the monitoring data are managed and processed via the decision support system. Healthcare professionals will be able to securely access the WELCOME applications to monitor and manage the patient's conditions and respond to alerts on personalized level.

Chest pulse-wave velocity: a novel approach to assess arterial stiffness.

Pulse-wave velocity (PWV) is considered as the gold-standard method to assess arterial stiffness, an independent predictor of cardiovascular morbidity and mortality. Current available devices that measure PWV need to be operated by skilled medical staff, thus, reducing the potential use of PWV in the ambulatory setting. In this paper, we present a new technique allowing continuous, unsupervised measurements of pulse transit times (PTT) in central arteries by means of a chest sensor. This technique relies on measuring the propagation time of pressure pulses from their genesis in the left ventricle to their later arrival at the cutaneous vasculature on the sternum. Combined thoracic impedance cardiography and phonocardiography are used to detect the opening of the aortic valve, from which a pre-ejection period (PEP) value is estimated. Multichannel reflective photoplethysmography at the sternum is used to detect the distal pulse-arrival time (PAT). A PTT value is then calculated as PTT = PAT - PEP. After optimizing the parameters of the chest PTT calculation algorithm on a nine-subject cohort, a prospective validation study involving 31 normo- and hypertensive subjects was performed. 1/chest PTT correlated very well with the COMPLIOR carotid to femoral PWV (r = 0.88, p < 10 (-9)). Finally, an empirical method to map chest PTT values onto chest PWV values is explored.

Parametric estimation of pulse arrival time: a robust approach to pulse wave velocity.

Pulse wave velocity (PWV) is a surrogate of arterial stiffness and represents a non-invasive marker of cardiovascular risk. The non-invasive measurement of PWV requires tracking the arrival time of pressure pulses recorded in vivo, commonly referred to as pulse arrival time (PAT). In the state of the art, PAT is estimated by identifying a characteristic point of the pressure pulse waveform. This paper demonstrates that for ambulatory scenarios, where signal-to-noise ratios are below 10 dB, the performance in terms of repeatability of PAT measurements through characteristic points identification degrades drastically. Hence, we introduce a novel family of PAT estimators based on the parametric modeling of the anacrotic phase of a pressure pulse. In particular, we propose a parametric PAT estimator (TANH) that depicts high correlation with the Complior(R) characteristic point D1 (CC = 0.99), increases noise robustness and reduces by a five-fold factor the number of heartbeats required to obtain reliable PAT measurements.

Getting rid of the wires and connectors in physiological monitoring.

One of the main limitations towards an easy-touse, comfortable, and reliable product for physiological monitoring comes from wires and associated connectors. Wireless solutions for data transmission are more and more common in every domain, but for biopotential and impedance measurements, at least one galvanic line will always be needed. This paper describes a new technology that can make possible the measurement of biopotentials and body impedances with high quality standard using only one wire. As this wire requires neither shield nor isolation, one can imagine a conductive garment that simply connects several sensors distributed over the body. From the user point of view, the product would be 'cableless'.

Continuous monitoring of coordinated cardiovascular responses.

The continuous separate monitoring of cardiac and vascular functions provide important insights on cardiovascular regulation. In the last years several attempts have failed at demonstrating the feasibility of using Pulse Wave Velocity as a surrogate indicator of arterial blood pressure. Upon the hypothesis that the cause of PWV unreliability is vasomotor activity, in this paper we develop an extended model of lumped arterial tree that copes with changes in vessels diameter. The benefit of this approach is twofold: on the one hand one might correct the effects of vasomotor activity on the estimation of arterial blood pressure on the basis of PWV, and on the other hand one obtains continuous non-invasive estimations of Cardiac Output and Total Peripheral Resistance.

Combination of multiple light paths in pulse oximetry: the finger ring example.

When pulse oximetry is required at other body locations than the finger tip new strategies for optical setups and signal handling are required. In this paper we present a combination of short and long light paths that succeeded in resolving the problems associated to the development of a finger ring SpO2 sensor.