Pain detection with bioimpedance methodology from 3-dimensional exploration of nociception in a postoperative observational trial

Although the measurement of dielectric properties of the skin is a long-known tool for assessing the changes caused by nociception, the frequency modulated response has not been considered yet. However, for a rigorous characterization of the biological tissue during noxious stimulation, the bioimpedance needs to be analyzed over time as well as over frequency. The 3-dimensional analysis of nociception, including bioimpedance, time, and frequency changes, is provided by ANSPEC-PRO device. The objective of this observational trial is the validation of the new pain monitor, named as ANSPEC-PRO. After ethics committee approval and informed consent, 26 patients were monitored during the postoperative recovery period: 13 patients with the in-house developed prototype ANSPEC-PRO and 13 with the commercial device MEDSTORM. At every 7 min, the pain intensity was measured using the index of Anspec-pro or Medstorm and the 0-10 numeric rating scale (NRS), pre-surgery for 14 min and post-anesthesia for 140 min. Non-significant differences were reported for specificity-sensitivity analysis between ANSPEC-PRO (AUC = 0.49) and MEDSTORM (AUC = 0.52) measured indexes. A statistically significant positive linear relationship was observed between Anspec-pro index and NRS (r(2) = 0.15, p < 0.01). Hence, we have obtained a validation of the prototype Anspec-pro which performs equally well as the commercial device under similar conditions

A bioimpedance-based monitor for real-time detection and identification of secondary brain injury

Secondary brain injury impacts patient prognosis and can lead to long-term morbidity and mortality in cases of trauma. Continuous monitoring of secondary injury in acute clinical settings is primarily limited to intracranial pressure (ICP); however, ICP is unable to identify essential underlying etiologies of injury needed to guide treatment (e.g. immediate surgical intervention vs medical management). Here we show that a novel intracranial bioimpedance monitor (BIM) can detect onset of secondary injury, differentiate focal (e.g. hemorrhage) from global (e.g. edema) events, identify underlying etiology and provide localization of an intracranial mass effect. We found in an in vivo porcine model that the BIM detected changes in intracranial volume down to 0.38 mL, differentiated high impedance (e.g. ischemic) from low impedance (e.g. hemorrhagic) injuries (p \u3c 0.001), separated focal from global events (p \u3c 0.001) and provided coarse ‘imaging’ through localization of the mass effect. This work presents for the first time the full design, development, characterization and successful implementation of an intracranial bioimpedance monitor. This BIM technology could be further translated to clinical pathologies including but not limited to traumatic brain injury, intracerebral hemorrhage, stroke, hydrocephalus and post-surgical monitoring

Implantable intracardiac bioimpedance system

textAn implantable intracardiac bioimpedance system has been designed to measure the real and imaginary parts of impedance in a dynamic cardiac setting. The system is broken into two parts: an implantable wireless device and a desktop base station. This measurement is performed using both tetrapolar and tripolar electrode configurations where a 20 kHz current field is applied to the intracardiac blood pool and myocardium. Epochs of discrete voltage samples from the resulting electric field are analyzed using a digital signal processing algorithm to generate impedance measurements. Measurements are then wirelessly transmitted from the implantable device to a base station where advanced signal processing algorithms are applied and the data is plotted in real-time. The final system measures 485 impedance samples/sec, consumes 50 mA when active, and has a percent of measurement error less than 1% for the intracardiac bioimpedance range. The device has been extensively tested to ensure the quality of measurements required for future human use. Instrument design, calibration, verification, experimentation, and modeling are the primary topics of this thesis. Moving forward, the system will be used in studies where dynamic bioimpedance signals measured in the right and left ventricles of the heart will be used to derive stroke volume.Electrical and Computer Engineerin

Smart Bioimpedance Spectroscopy Device for Body Composition Estimation

The purpose of this work is to describe a first approach to a smart bioimpedance spectroscopy device for its application to the estimation of body composition. The proposed device is capable of carrying out bioimpedance measurements in multiple configurable frequencies, processing the data to obtain the modulus and the bioimpedance phase in each of the frequencies, and transmitting the processed information wirelessly. Another novelty of this work is a new algorithm for the identification of Cole model parameters, which is the basis of body composition estimation through bioimpedance spectroscopy analysis. Against other proposals, the main advantages of the proposed method are its robustness against parasitic effects by employing an extended version of Cole model with phase delay and three dispersions, its simplicity and low computational load. The results obtained in a validation study with respiratory patients show the accuracy and feasibility of the proposed technology for bioimpedance measurements. The precision and validity of the algorithm was also proven in a validation study with peritoneal dialysis patients. The proposed method was the most accurate compared with other existing algorithms. Moreover, in those cases affected by parasitic effects the proposed algorithm provided better approximations to the bioimpedance values than a reference device.Ministerio de Economía y Competitividad (Instituto de Salud Carlos III) PI15/00306Junta de Andalucía PIN-0394-2017Unión Europea "FRAIL

Study and development of a novel radio frequency electromedical device for the treatment of peri-implantitis: experimental performance analysis, modelling of the electromagnetic interaction with tissues and in vitro and in vivo evaluation

La peri-implantite (PI) è una grave patologia che interessa tessuti peri-implantari molli e duri. Ad oggi, la prevenzione è l’unico mezzo per contrastarla. Recentemente, è stata sperimentata una terapia basata sulla somministrazione di corrente elettrica a radio frequenza (successo: 81%). Il trattamento è stato simulato numericamente, fornendo le distribuzioni di corrente (EC) e campo elettrico (EF) nei tessuti: l’effetto anti-infiammatorio è attribuibile alla EC, quello di rigenerazione ossea al EF. Sono state considerate le misure di bioimpedenza (BM) per individuare le infiammazioni; numericamente si sono osservati cambiamenti nel modulo di impedenza del 4-20% (secondo diversi parametri), anche più alti sperimentalmente (35% infiammazione, 56% PI). Le BM permettono quindi di identificare il tessuto da trattare. Per la ripetibilità, sono state considerate radici di denti naturali, numericamente e sperimentalmente; l’ordine di grandezza è lo stesso (qualche kΩ), anche se ci sono differenze legate alle condizioni di misura. La variabilità intra-soggetto è il 10% in uno stesso giorno, fino al 26% in giorni diversi; quella inter-soggetto è più alta. La sicurezza elettrica è stata attentamente esaminata e si sono individuate le direttive applicabili (IEC 60601-1, 60601-1-2 and 60601-2-2). Sono stati fatti test in vitro per valutare l’effetto della terapia sulla vitalità cellulare: non c’è un significativo aumento della necrosi (vitalità: 85% test, 94% controlli), l’effetto negativo principale è l’apoptosi. Sono stati numericamente indagati possibili effetti termici: non sono stati individuati riscaldamenti nocivi dei tessuti. Si è progettato un nuovo dispositivo (PeriCare®) per trattare la PI, con parti diagnostica (BM) e terapeutica. Si stanno progettando elettrodi specifici e realizzando il prototipo. Si sta compilando il fascicolo tecnico e pianificando i test di conformità, in vista della certificazione. Il dispositivo medico dovrebbe entrare nel mercato entro l’anno.Peri-implantitis is a severe disease affecting hard and soft peri-implant tissues. At present, prevention is the only means to contrast it. Recently, a therapy based on the administration of radio frequency electric current was experimented (success rate: 81%). The treatment was numerically simulated, providing the electric current (EC) and field (EF) distributions in peri-implant tissues: the anti-inflammatory effect can be associated to EC, the bone regeneration to the EF. Bioimpedance measurements (BM) were investigated to detect inflammation; changes in the measured impedance modulus are equal to 4-20% (depending on different parameters) from numerical results, also more evident experimentally (35% inflammation, 56% peri-implantitis). So, BM could allow to detect the tissue to be treated. To evaluate the repeatability, natural tooth roots were numerically and experimentally measured; the order of magnitude is the same (some kΩ), even if there are differences probably due to the measurement conditions. Intra-subject variability was of 10% in the same day, but up to 26% in different days; inter-subject variability was higher. The electrical safety was accurately taken into account. The applicable directives were individuated (IEC 60601-1, 60601-1-2 and 60601-2-2). In vitro tests were carried out to evaluate the effect of the therapy on cell vitality: there is not a significant increase in necrosis (vitality: 85% tests, 94% controls), the main negative effect is apoptosis. Possible thermal effects were numerically investigated: no dangerous tissue heating was observed. A new device for the peri-implantitis treatment, PeriCare®, was designed, with diagnostic (BM) and therapeutic parts. Proper electrodes are being designed and the prototype is being realized. The technical file is being compiled and the conformity verification tests are being planned towards the certification process. Hopefully, the medical device will be placed into the market within this year

A Feasibility Study of the Suitability of an AD5933-based Spectrometer for EBI Applications

Projecte final de carrera realitzat en col.laboració amb University of BoräsElectrical Bioimpedance (EBI) measurements have proven their validity in several medical applications like body composition analysis and detection of melanoma among others. The successful application of EBI technology on the field of medicine has lead the way for applications in the field of personal healthcare and body performance in the field of sports. Due to the widespread use of the EBI technology and rising of new EBI applications requiring system portability or even suitable to wear, the manufacturer Analog devices has introduced in the market the first integrated system dedicated to measure EBI, the impedance network analyzer AD5933. The availability of this EBI spectrometer device opens up new horizons for the integration of the measurement systems to meet the demands of new EBI applications and allowing the development of portable and even wearable measurement systems. This project is focused on the AD5933 impedance network analyzer, and it aims to identify the EBI applications in which, the use of an AD5933 device is suitable. To adapt the AD5933 device for biomedical measurements an Analog Front-End (AFE) has been used to enable the system for 4-electrodes measurements. In order to evaluate the performance of AD5933 with the AFE, experimental measurements on electrical equivalent models have been taken with the AD5933+4E-AFE system and the EBI spectrometer Impedimed SFB7. The obtained impedance spectral data have been used to estimate the values of the equivalent circuit under measurement and the estimated values have been mutually compared in terms of estimation accuracy

Time Stamp – A Novel Time-to-Digital Demodulation Method for Bioimpedance Implant Applications

Bioimpedance analysis is a noninvasive and inexpensive technology used to investigate the electrical properties of biological tissues. The analysis requires demodulation to extract the real and imaginary parts of the impedance. Conventional systems use complex architectures such as I-Q demodulation. In this paper, a very simple alternative time-to-digital demodulation method or ‘time stamp’ is proposed. It employs only three comparators to identify or stamp in the time domain, the crossing points of the excitation signal, and the measured signal. In a CMOS proof of concept design, the accuracy of impedance magnitude and phase is 97.06% and 98.81% respectively over a bandwidth of 10 kHz to 500 kHz. The effect of fractional-N synthesis is analysed for the counter-based zero crossing phase detector obtaining a finer phase resolution (0.51˚ at 500 kHz) using a counter clock frequency ( fclk = 12.5 MHz). Because of its circuit simplicity and ease of transmitting the time stamps, the method is very suited to implantable devices requiring low area and power consumption

Development of a Novel Medical Device for Mucositis and Peri-Implantitis Treatment

In spite of all the developments in dental implantology techniques, peri-implant diseases are frequent (prevalence up to 80% and 56% of subjects for mucositis and peri-implantitis, respectively) and there is an urgency for an effective treatment strategy. This paper presents an innovative electromedical device for the electromagnetic treatment of mucositis and peri-implantitis diseases. This device is also equipped with a measurement part for bioimpedance, which reflects the health conditions of a tissue, thus allowing clinicians to objectively detect impaired areas and to monitor the severity of the disease, evaluate the treatment efficacy, and adjust it accordingly. The design of the device was realized considering literature data, clinical evidence, numerical simulation results, and electromagnetic compatibility (EMC) pre-compliance tests, involving both clinicians and engineers, to better understand all the needs and translate them into design requirements. The reported system is being tested in more than 50 dental offices since 2019, providing efficient treatments for mucositis and peri-implantitis, with success rates of approximately 98% and 80%, respectively