Methods for the metrological characterization of wearable devices for the measurement of physiological signals: state of the art and future challenges.

Wearable devices are rapidly spreading in many different application fields and with diverse measurement accuracy targets. However, data on their metrological characterization are very often missing or obtained with non-standardized methods, hence resulting in barely comparable results. The aim of this review paper is to discuss the existing methods for the metrological characterization of wearable sensors exploited for the measurement of physiological signals, highlighting the room for research still available in this field. Furthermore, as a case study, the authors report a customized method they have tuned for the validation of wireless electrocardiographic monitors. The literature provides a plethora of test/validation procedures, but there is no shared consensus on test parameters (e.g. test population size, test protocol, output parameters of validation procedure, etc.); on the other hand, manufacturers rarely provide measurement accuracy values and, even when they do, the test protocol and data processing pipelines are generally not disclosed. Given the increasing interest and demand of wearable sensors also for medical and diagnostic purposes, the metrological performance of such devices should be always considered, to be able to adequately interpret the results and always deliver them associated with the related measurement accuracy.•The sensor metrological performance should be always properly considered.•There are no standard methods for wearable sensors metrological characterization.•It is important to define rigorous test protocols, easily tunable for specific target applications.

Bioimpedance measurements in dentistry to detect inflammation: numerical modelling and experimental results.

Bioimpedance measurements represent an advantageous method to evaluate the physio-pathological conditions of biological tissues and their use is spreading in different application fields, from the evaluation of body composition to the vital signs monitoring, passing through the individuation of cancer tissues and the detection of different substances (e.g. glucose measurements in people affected by diabetes). In fact, tissues electric properties vary with their conditions; for example, electrical conductivity increases when there is an inflammatory process, because of the presence of oedema, hyperaemia and infiltration. Inflammatory phenomena are frequent in dentistry, in diseases like periodontitis and peri-implantitis; however, at present the diagnosis is mainly done with the naked eye, by observing the gingiva redness and swelling. OBJECTIVE: The aim of this work is to prove the feasibility of the inflammation detection by means of bioimpedance measurements. APPROACH: Both numerical simulations and preliminary experimental measurements provide significant outcomes in differentiating between healthy and inflamed tissues. MAIN RESULTS: Percentage differences in the impedance modulus equal to 4-20% (numerical simulations) and 35-56% (experimental measurements), respectively, depending on the considered conditions (e.g. electrodes characteristics and inflammation severity), were found. SIGNIFICANCE: Such a measure could be integrated in electromedical devices designed, for example, for the therapy of peri-implantitis, in order to personalise the therapeutic dose in terms of intensity and duration and focusing it on the impaired area, minimising the effects on the surrounding tissues.

Features of the non-contact carotid pressure waveform: Cardiac and vascular dynamics during rebreathing.

This report amplifies and extends prior descriptions of the use of laser Doppler vibrometry (LDV) as a method for assessing cardiovascular activity, on a non-contact basis. A rebreathing task (n = 35 healthy individuals) was used to elicit multiple effects associated with changes in autonomic drive as well as blood gases including hypercapnia. The LDV pulse was obtained from two sites overlying the carotid artery, separated by 40 mm. A robust pulse signal was obtained from both sites, in accord with the well-described changes in carotid diameter over the blood pressure cycle. Emphasis was placed on extracting timing measures from the LDV pulse, which could serve as surrogate measures of pulse wave velocity (PWV) and the associated arterial stiffness. For validation purposes, a standard measure of pulse transit time (PTT) to the radial artery was obtained using a tonometric sensor. Two key measures of timing were extracted from the LDV pulse. One involved the transit time along the 40 mm distance separating the two LDV measurement sites. A second measure involved the timing of a late feature of the LDV pulse contour, which was interpreted as reflection wave latency and thus a measure of round-trip travel time. Both LDV measures agreed with the conventional PTT measure, in disclosing increased PWV during periods of active rebreathing. These results thus provide additional evidence that measures based on the non-contact LDV technique might provide surrogate measures for those obtained using conventional, more obtrusive assessment methods that require attached sensors.

Photoelastic sphenoscopic analysis of crystals.

Birefringent crystals are at the basis of various devices used in many fields, from high energy physics to biomedical imaging for cancer detection. Since crystals are the main elements of those devices, a great attention is paid on their quality and properties. Here, we present a methodology for the photoelastic analysis of birefringent crystals, based on a modified polariscope. Polariscopes using conoscopic observation are used to evaluate crystals residual stresses in a precise but time consuming way; in our methodology, the light beam shape, which impinges on the crystal surface, has been changed from a solid cone (conoscopy) to a wedge (sphenoscopy). Since the polarized and coherent light is focused on a line rather than on a spot, this allows a faster analysis which leads to the observation, at a glance, of a spatial distribution of stress along a line. Three samples of lead tungstate crystals have been observed using this technique, and the obtained results are compared with the conoscopic observation. The samples have been tested both in unloaded condition and in a loaded configuration induced by means of a four points bending device, which allows to induce a known stress distribution in the crystal. The obtained results confirm, in a reliable manner, the sensitivity of the methodology to the crystal structure and stress.

An innovative therapy for peri-implantitis based on radio frequency electric current: numerical simulation results and clinical evidence.

Peri-implantitis is a severe inflammatory pathology that affects soit and hard tissues surrounding dental implants. Nowadays, only prevention is effective to contrast peri-implantitis, but, in recent years, there is the clinical evidence of the efficiency of a therapy based on the application of radio frequency electric current, reporting that 81% of the cases (66 implants, 46 patients) were successfully treated. The aim of this paper is to present the therapy mechanism, exploring the distribution of the electric currents in normal and pathologic tissues. A 3D numerical FEM model of tooth root with a dental implant screwed in the alveolar bone has been realized and the therapy has been simulated in COMSOL Multiphysics® environment. Results show that the electric current is focused in the inflamed zone around the implant, due to the fact that its conductivity is higher than the healthy tissue one. Moreover, by means of a movable return electrode, the electric current and field lines can be guided in the most inflamed area, limiting the interference on healthy tissues and improving the therapy in the area of interest. In conclusion, it can be stated that this innovative therapy would make a personalized therapy for peri-implantitis possible, also through impedance measurements, allowing the clinician to evaluate the tissue inflammation state.

Indirect measurement of the carotid arterial pressure from vibrocardiographic signal: Calibration of the waveform and comparison with photoplethysmographic signal.

The detection of arterial Blood Pressure waveform provides important information about the subject health status. Laser Doppler Vibrometry (LDV) is a non-contact technique with high sensitivity able to detect mechanical movements of the arterial wall; several previous studies have shown that LDV is able to characterize cardiac activity. Photoplethysmogram (PPG) quantifies the digital volume artery pulse, which has been demonstrated to be closely related to the pressure signal measured by an arterial tonometer. In this paper, an indirect measurement of carotid arterial pressure by means of LDV is presented. Moreover, a comparison between LDV and PPG is conducted in order to estimate the time interval between opening and closing of the aortic valve, that is the Left Ventricular Ejection Time (LVET). Results show an average reduction of around 20% of the systolic pressure derived from LDV signal measured over the carotid artery with respect to the systolic pressure measured at brachial level (i.e. peripheral pressure value). Finally, the comparison between LDV and PPG in the estimation of LVET shows a mean percentage deviation <;10%. So, in conclusion, it can be stated that LDV technique has the potential of providing a displacement waveform that, adequately calibrated, can furnish significant information about pressure waveform.

A photoelastic measurement system for residual stress analysis in scintillating crystals by conoscopic imaging.

The assessment of the stress state of scintillating crystals is an important issue for producers as well as users of such materials, because residual stress may arise during growth process. In this paper, a measurement system, based on the use of a photoelastic, conoscopic optical setup, is proposed for the assessment of stress state in scintillating crystals. Local stress values can be measured on the crystal in order to observe their spatial distribution. With the proposed system, it is possible to vary the dimensions of the inspected measurement volume. It has been validated with reference to a known stress state induced in a birefringent crystal sample and it has been tested for the case of loaded and unloaded samples, showing sub-millimetric spatial resolution and stress uncertainty ≤0.25 MPa. The proposed measurement system is a valid method for the inspection of scintillating crystals required by producers and users of such materials.

Laser doppler myography (LDMi): A novel non-contact measurement method for the muscle activity.

BACKGROUND AND AIMS: Electromyography (EMG) is considered the gold-standard for the evaluation of muscle activity. Transversal and dimensional changes of the muscle, during muscle activity, generate vibrational phenomena which can be measured by Laser Doppler Vibrometry (LDVi). There is a relationship between muscle contraction and vibrational activity, therefore, some information on fundamental muscle parameters can be assessed without contact with LDVi. In this paper, we explore the possibility to relate the EMG signal causing the muscle contraction and the vibrational activity also measureable on the muscle. A novel non-contact measurement method - Laser Doppler myography (LDMi) - aiming to measure the vibrational behavior of muscle during contraction, is presented herein. Correlations with some parameters normally measured with EMG are reported. MATERIALS AND METHODS: The proposed method has been compared with standard superficial EMG (sEMG). Signals produced with sEMG and laser Doppler myography have been simultaneously acquired and processed to test correlations on a population of 20 healthy volunteers. Tests have been carried out on the flexor carpi ulnaris and the tibialis anterior muscles (left and right). RESULTS: RESULTS show that it is possible to measure: The timing of muscle activation (max differences: 440 ms), the amplitude of the signals acquired during activation respect to the signals during rest (S/N), the correlation between the S/N of the sEMG and LDMi signals at different levels of force (P> 0.89), and to assess muscle fatigue. CONCLUSIONS: LDMi is a valid measurement technique for the assessment of muscle activity and fatigue. It is a non-contact method and this characteristic could suggest its use together with low level laser therapy pre-, intra- and post-LLLT sessions to evaluate the efficacy and effects of the treatments without the need for invasive electrodes.

An optical measurement method for the simultaneous assessment of respiration and heart rates in preterm infants.

Many conventional medical monitoring devices, while not technically invasive, are nevertheless obtrusive insofar as they require contact with the patient. This obtrusiveness sometimes poses problems in daily clinical practice. The need for contact with electrodes or transducers is particularly relevant in the case of patients recovering in intensive care units where continuous monitoring is required, in turn requiring continuous direct transducer contact for prolonged periods. Among the many physiological parameters commonly acquired, the respiratory and the cardiac rates of the patients are of primary importance. Typically these two parameters are measured respectively using spirometry and electrocardiography (ECG), both involving obtrusive measurement systems requiring contact with the patient with an air conduit and electrodes. This paper presents an optical measurement method for the simultaneous assessment of respiration and heart rates based on the measurement of the chest wall movements, associated with inspiratory/expiratory activities of the lungs and by the mechanical pumping action of the heart. The measurement method has been adapted for use with preterm infants and it has been applied to 55 patients recovering in a Neonatal Intensive Care Unit. The method is based on the use of a laser Doppler vibrometer (LDVi) pointed at the left, ventral thoracic surface of the patient. LDVi-based measures of respiration and heart rate have been simultaneously acquired for each patient, in parallel with the same quantities acquired using conventional reference instrumentation (flow-meter and ECG) for comparison purposes. Results show that for respiration rate, differences with respect to the spirometer data are <3%, while for the cardiac rate they are <6% with respect to ECG data. The method proposed in this paper has the advantage of requiring no contact with the patient. Moreover, it supports, by means of a single instrument, the simultaneous measurement of respiration and heart rates, thus reducing the burden of the number of electrodes, transducers, and other instrumentation that must be applied to the patient--a consideration that is particularly important in the Neonatal Intensive Care Unit. In addition to the measurement of respiration rate, we also describe the sensitivity of the LDVi method in detecting key respiration events (irregular inspiration/expiration cycles, apneas, and hiccups) which are relevant to clinical monitoring.

Fibre-reinforced composite crowns luted to implant abutments via electroformed primary copings: an in vitro retention study.

AIM: The aim of this study was to investigate the retention values and mode of failure of metal crowns and fibre-reinforced composite crowns. METHODS: Seventy-five implants and the corresponding abutments were used. After the galvanic copings were fabricated, the specimens were distributed into three groups: in group A traditional metal crowns were realized, whereas in groups B and C fibre-reinforced composite crowns were made. In group B the same resin based cement used in group A was employed for luting the fibre-reinforced composite crowns to the galvanic copings, while in group C a dedicated self-adhesive composite cement was used. All galvanic coping/crown assemblies were cemented onto abutments with Panavia 21 cement. Specimens were subjected to a pull-out test; median retentive values and standard deviations were calculated. RESULTS: All samples in the group A showed separation at the abutment-galvanic cap interface. All samples in the group B showed decementation at galvanic cap-crown interface. In 13 samples of the group C the decementation occurred at the abutment-galvanic cap interface and in 12 samples of this group the decementation occurred at the galvanic cap-crown interface. The mean retention value was 659.1 N±162.9 for group A, 304.7 N±101.4 for B and 635.4 N±155.9 for C. Differences between groups A/B and B/C are statistically significant (t-student test, P<0.01), while is not statistically different between groups A/C. CONCLUSION: When a self-adhesive composite cement is used, fibre-reinforced composite single crowns and conventional metal crowns show similar retentive performance.

Fiber-reinforced composite inlay fixed partial dentures: the influence of restorative materials and abutment design on stress distribution investigated by finite element model.

AIM: Fiber-reinforced composite may be successful used to fabricate inlay fixed partial dentures. This study used a finite element model to investigate three-dimensional stress distribution in a 3-unit fiber-reinforced composite fixed partial denture, and compared three types of fiber and three abutment configurations. METHODS: A finite element model of a 3-unit fixed partial denture was used to investigate stress distribution in three different fiber-reinforced composite systems (1) Ribbond Triaxial plus Sinfony; 2) EverStick plus Sinfony; 3) Vectris Pontic/Frame plus Sinfony) and in three different abutment configurations (minimal distal-occlusal and mesial-occlusal preparation; extensive distal-occlusal and mesial-occlusal preparation; mesial-occlusal-distal preparation of both abutment teeth). Maximum load of 196 N was applied at the center of the occlusal and buccal surfaces of the pontic. Stress distribution was calculated in the tooth/restoration complex and in the abutment preparation. RESULTS: When a vertical load was applied, no substantial differences between stress amount in the molar and in the premolar connectors was found. When a lateral load was applied, the stress was greater in the premolar connector than in the molar connector. In all designs investigated, stress was concentrated at the cervical margins of the proximal boxes adjacent to the pontic; no stress concentrated at the occlusal box preparation surface. CONCLUSIONS: Within the limitations of this study, the results suggest that different fiber-reinforced composite systems show similar pattern of stress distribution. Stress concentrates at the connector areas and in the prepared teeth. Peak stress is at the cervical margin of the boxes adjacent to the pontic.

Identification of cardiac events by optical Vibrocardiograpy: comparison with Phonocardiography.

Laser Doppler vibrometry has been recently applied for non-contact monitoring of the cardiac activity, both in terms of cardiac rate and heart rate variability, measuring the velocity of the skin surface of the chest wall and the neck (optical Vibrocardiography, VCG). To go further insight in the analysis of VCG recordings, in this study authors have compared heart sounds by digital Phonocardiography (PCG) with the motion of the skin on the chest wall by optical VCG, the final aim being the identification of some events of cardiac mechanics in the VCG signals. PCG and VCG traces were synchronously recorded on 10 healthy subjects, along with ECG. To reach this goal, multiresolution analysis together with Hilbert transforms for envelope calculation on PCG and VCG have been applied, temporal and morphological features were extracted from the signals. Data collection and signal processing allowed us to identify some events of cardiac mechanics, correlating the heart sounds relative to the closure of the mitral valve, and the following closure of the aortic and pulmonary valve with characteristic deflections identifiable on VCG traces.

Time-resolved PIV technique for high temporal resolution measurement of mechanical prosthetic aortic valve fluid dynamics.

Prosthetic heart valves (PHVs) have been used to replace diseased native valves for more than five decades. Among these, mechanical PHVs are the most frequently implanted. Unfortunately, these devices still do not achieve ideal behavior and lead to many complications, many of which are related to fluid mechanics. The fluid dynamics of mechanical PHVs are particularly complex and the fine-scale characteristics of such flows call for very accurate experimental techniques. Adequate temporal resolution can be reached by applying time-resolved PIV, a high-resolution dynamic technique which is able to capture detailed chronological changes in the velocity field. The aim of this experimental study is to investigate the evolution of the flow field in a detailed time domain of a commercial bileaflet PHV in a mock-loop mimicking unsteady conditions, by means of time-resolved 2D Particle Image Velocimetry (PIV). The investigated flow field corresponded to the region immediately downstream of the valve plane. Spatial resolution as in "standard" PIV analysis of prosthetic valve fluid dynamics was used. The combination of a Nd:YLF high-repetition-rate double-cavity laser with a high frame rate CMOS camera allowed a detailed, highly temporally resolved acquisition (up to 10000 fps depending on the resolution) of the flow downstream of the PHV. Features that were observed include the non-homogeneity and unsteadiness of the phenomenon and the presence of large-scale vortices within the field, especially in the wake of the valve leaflets. Furthermore, we observed that highly temporally cycle-resolved analysis allowed the different behaviors exhibited by the bileaflet valve at closure to be captured in different acquired cardiac cycles. By accurately capturing hemodynamically relevant time scales of motion, time-resolved PIV characterization can realistically be expected to help designers in improving PHV performance and in furnishing comprehensive validation with experimental data on fluid dynamics numeric modelling.

Fractal characterisation of boundary irregularity in skin pigmented lesions.

A growing literature shows researcher's interest in fractal analysis, arising from its ability to describe and characterise quantitatively the complexity of several tumour profiles. The aim of the work was to investigate the fractal properties of skin pigmented lesion boundaries. Although melanoma is one of the most aggressive tumours, early detection and a high rate of diagnostic accuracy, followed by timely excision, can allow complete recovery in melanoma patients. A modified approach to fractal dimension estimation was performed that was able to consider, in a data fit procedure, the range in which lesions show fractal properties. Identification of this zone is the most important step towards a correct fractal analysis procedure. The method was checked against a known fractal dimension object (Koch's curve) with an error of 0.007. The fractal dimension was estimated in 110 skin pigmented lesions and showed a significantly increasing linear regression (p < 0.05), from common naevi to naevi with dysplasia to melanomas. This result is important for screening, as it can inform the decision to excise precociously malignant lesions or to avoid unnecessary removal of benign ones. The limitations of the method are discussed.

Self-mixing feedback in a laser diode for intra-arterial optical blood velocimetry.

Intra-arterial measurements of the velocity and the average flow of red-blood cells were investigated by means of a fiber-coupled laser Doppler velocimeter based on the self-mixing effect. The velocity of the red cells was calculated from the frequency of the signal that occurs when light, scattered back from a moving object in front of a fiber into a laser-diode cavity, interferes with the laser cavity's proper mode. These fluctuations occur at the Doppler frequency. The signal was obtained from the photodiode that is present in the laser diode's housing. Temperature control and stabilization of the diode cavity were introduced to reduce the light-intensity fluctuation that is due to mode hopping of the diode. The velocimeter was calibrated with a rotating disk covered with white paper (nonlinearity of 2.6% for velocities up to 0.4 m/s) and tested in vitro as a fluid velocimeter. The velocimeter was used in in vivo tests on the iliac artery of a 35-kg pig and on the arteria pulmonaris of a healthy calf. The optical fiber was placed in the iliac artery by a basket catheter 4 cm proximal to the bifurcation of the femoral artery. The average arterial blood flow velocity of the red cells were measured upstream and downstream. A special cleaving procedure for the fiber tip in downstream measurement is reported. Blood-velocity measurement is compared with values generated by an ultrasound flowmeter, and a difference of less than 9% is found.

Design and development of an electro-optic measurement system for 3-D topographic surveys: application to skin nevoid lesions.

OBJECTIVE: The authors designed and developed a system for the measurement of skin lesions geometrical proprieties. The measured characteristics can be of extreme importance in order to provide elements for the early diagnosis of melanoma. SUMMARY BACKGROUND DATA: Actually, medical experience and prevention are the only instruments for melanoma diagnosis. Some studies have been conducted with thermocameras and with ecography and photoacoustics spectrography. METHODS: A scanning laser-based measurement system for non-contact shape measurement has been designed and tested. The system measurement characteristics have been studied to assure an accurate reconstruction of skin lesion surface characteristics. The laser sensor is fixed on a motorized system that scans the lesion surface. All the controls on the scanning system and on the recording of data have been automated and are software-controlled. RESULTS: Full success in the measurement and reconstruction of the skin lesions characteristics has been reached. An accuracy of 0.03 mm has been obtained with the system. Measurements of the height and perimeter of many suspected lesions have been performed. CONCLUSIONS: The research reported in this work has demonstrated the applicability and usefulness of the proposed method by means of an in-vitro prototype-version measurement system. The possibility of surveying the shape of skin lesions by means of a non-contact electro-optic measurement plays an important role in the objective evaluation of in vivo pigmented suspected nevoid lesions (melanoma). Next steps include the study of a possible correlation between topographic elements and histological tests and the possibility of controlling suspected lesions employing this technique both in the diagnostic and the follow-up phases.

Teeth mobility measurement: a laser vibrometry approach.

OBJECTIVE: This work presents a new technique based on the assessment of the mobility degree through the application of dynamic loads and the measurement of the tooth displacement with a laser Doppler vibrometer. SUMMARY BACKGROUND DATA: Measurements of the mobility degree have been made, up to now, by the application of static loads and the measurement of the consequent displacement. The results obtained with the measurement technique proposed by Muhlemann (1967) have been validated by O'Leary et al. (1964) and by Persson and Sweson (1980). This approach, however, has not been clinically disseminated both because of the high cost of the equipment and, above all, because of the difficulty in performing the measurements. METHODS: The ratio between the maximum of the tooth displacement and the input force peak has been considered as the mobility degree index. Dynamic loads have been applied and measured on teeth, with a small hammer and a load cell. The consequent displacement of tooth has been measured with a Laser Doppler vibrometer that allows easy to use and versatile noncontact measurements with high accuracy and sensitivity (< 0.1 mm/sec). RESULTS: An introductory in vitro study has been carried out on real teeth extracted and mounted on structures with different-stiffness silicone cast (stiffness of the support is one of the parameters responsible for teeth mobility), in order to evaluate the technique. An in vivo study has also been carried out on different teeth of a healthy patient. It is possible to observe the agreement between the O'Leary results and ones obtained in this work. The practicality of the procedure has also been demonstrated. CONCLUSIONS: Good correspondence between data available in literature and results obtained has been demonstrated. The use of the technique here proposed could allow having a deeper knowledge of the behavior of the periodontal teeth system: the tooth mobility under dynamic loads. With this new technique, it will be possible to quickly measure a pathological mobility of the tooth, before it becomes evident and problematic.