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  • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
  • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
  • A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing
  • A61B5/1135—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing by monitoring thoracic expansion
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• • G—PHYSICS
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  • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
  • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

• the present invention relates to a wearable device for continuous the monitoring of the respiratory rate and to the corresponding method.
• Respiratory rate is a fundamental factor of prognosis that provides important information on the health of a person.
• the aim of the present invention is to provide a wearable device for continuous monitoring of the respiratory rate that will ensure reliable measurement .
• Another aim is to provide a device that will ensure a measurement free from errors .
• a wearable device for continuous monitoring of the respiratory rate of a patient comprising three inertial sensors, a first inertial sensor being positioned on the abdomen, a second inertial sensor being positioned on the thorax, and a third inertial reference sensor being positioned on a part of the body not subject to respiratory movements, integral with respect to the torso.
• Each inertial sensor comprises: an accelerometer, a magnetometer, and a gyroscope.
• Each inertial sensor comprises a microprocessor connected to said accelerometer, magnetometer, and gyroscope.
• Said microprocessor is connected to a transmitter and is configured for processing said signals and for supplying to said transmitter a signal represented by a quaternion that describes the orientation of said three inertial sensors with respect to the Earth's reference system.
• a receiver connected to a control centre is configured for receiving the abdominal quaternion of the first inertial sensor, the thoracic quaternion of the second inertial sensor, and the reference quaternion of the third inertial sensor and for sending them to said control centre.
• Said control centre is configured for processing the quaternions received in such a way that the abdominal quaternion and the thoracic quaternion will be referenced to the reference quaternion, said control centre comprising a band-pass adaptive filter, which filters the signals represented by the abdominal quaternion and the thoracic quaternion to eliminate the residual components linked to the movements of the patient.
• the control centre is configured for calculating the respiratory rate from the signals represented by the filtered abdominal quaternion and the filtered thoracic quaternion.
• a method for continuous monitoring of the respiratory rate of a patient comprises the steps of: positioning a first inertial sensor on the abdomen; positioning a second inertial sensor on the thorax; positioning a third inertial reference sensor on a part of the body not subject to respiratory movements, where each inertial sensor comprises an accelerometer, a magnetometer, and a gyroscope, as well as a microprocessor, which receives the signals from said accelerometer, magnetometer, and gyroscope, and where each of said microprocessors processes said signals and supplies a signal represented by a quaternion that describes the orientation of said three inertial sensors with respect to the Earth's reference system; sending a first quaternion representing the spatial orientation of said first sensor to a control centre, sending a second quaternion representing the spatial orientation of said second sensor to said control centre, and sending a third quaternion representing the spatial orientation of said third sensor to said control centre; referencing the orientation of said
• the system according to the present invention exploits the presence of a reference unit that is set in an area of the body not subject to respiratory movement (e.g., the coccyx).
• the inertial units positioned on the thorax and abdomen will detect a movement consisting of a respiratory component and an extra-respiratory component (e.g., when walking) .
• the data recorded by the thoracic and abdominal units will be referenced to the reference unit with an operation of vector product between quaternions. In this way, the orientation of the thoracic and abdominal units wi l l be referenced no longer to the Earth ' s reference system but to that of the reference unit .
• an adaptive filter to be applied to the thoracic and abdominal units that will exclude the frequencies involved in walking detected by the reference unit.
• the presence of the reference unit hence solves the problem linked to the use of the device that is moving.
• the presence of two units on the thoraco-abdominal wall, one on the thorax and one on the abdomen makes it possible to consider the two degrees of freedom characteristic of the thoraco-abdominal wall.
• Figure 1 is a schematic illustration of a dummy wearing a wearable device for continuous monitoring of respiratory rate, according to the present invention
• Figure 2 is a schematic illustration of a sensor of a wearable device for continuous monitoring of respiratory rate, according to the present invention
• Figure 3 is a schematic illustration of a receiver of a wearable device for continuous monitoring of respiratory rate, according to the present invention
• Figure 4 is a schematic illustration of a flowchart of the operations carried out for continuous monitoring of respiratory rate, according to the present invention.
• Figure 5 is a schematic illustration of a container of a wearable device for continuous monitoring of respiratory rate, according to the present invention.
• a wearable device for continuous monitoring of respiratory rate comprises three inertial units 10, 11, and 12, each made up of an accelerometer, a gyroscope, and a magnetometer.
• a unit 11 is positioned on the abdomen 13 and a unit 10 on the thorax 14 for recording the movements of the thoraco-abdominal wall divided into the thoracic and abdominal contributions, respectively.
• the third unit 12 is positioned on a part of the body not subject to respiratory movements, but fixed with respect to the torso, and functions as reference for the other two units. This is particularly important in semi-static conditions (patient in a wheel chair) and dynamic conditions (for example, when walking) for extrapolating the movement information linked to breathing alone.
• the modular configuration described moreover enables modification of the number of units according to the need and to the conditions of the subject, for example, to exclude the reference unit in static conditions, or else to add further sensors for collecting data or for further references.
• Each inertial unit 10-13 comprises a sensor 20 made up of three units .
• the first is a classic triaxial accelerometer that identifies its position with respect to the Earth (by measuring gravity) or its acceleration in 3D space.
• the second is a triaxial magnetometer, which can identify the direction of the strongest magnetic force, generally used for detecting the magnetic North.
• the third is a triaxial gyroscope, which can measure rotation and torsion.
• the sensor is, for example, the one that uses the component LSM9DS0 marketed by
• Each inertial unit 10-13 also comprises a microprocessor 21, for example of the iOS Pro mini type or else of the ATMEGA 328p type marketed by the company Atmel, which receives the signals coming from the sensor 20 and supplies them to a transmitter 22, for example, of the Bluetooth type, model BL600 marketed by the company Laird.
• a microprocessor 21 for example of the iOS Pro mini type or else of the ATMEGA 328p type marketed by the company Atmel, which receives the signals coming from the sensor 20 and supplies them to a transmitter 22, for example, of the Bluetooth type, model BL600 marketed by the company Laird.
• Each inertial unit 10-13 is supplied by a battery 23.
• All the components are contained in a container 25, of small dimensions, which can be applied to the body of the patient.
• Each inertial unit 10-13 comprises a hooking element 27 that can be connected to the clip present on the adhesive electrode 26.
• the container 25 is provided with three hooking elements 28 to be connected to three adhesive electrodes set close to one another on the body of the patient .
• the transmitter 22 sends the data received to a receiver 30, for example of the BL620 type, which in turn is connected to a control centre 31, which may be a computer or a tablet or a smartphone that record the data, process them, and display them on their screens.
• a control centre 31 which may be a computer or a tablet or a smartphone that record the data, process them, and display them on their screens.
• the transmitter 22 of the unit 10 and of the unit 11 sends the data received from the sensors to the third unit 12, which in this case comprises also a receiver, and the latter sends the data of the three units to the control centre 31.
• the third unit 12 may moreover comprise a memory for storing the data, which in this case could even not be sent to the control centre 31.
• the microprocessor 21 of each inertial unit 10, 11, and 12 sends at pre-set instants a cyclic command to the sensor 20 and receives the measured signals of the accelerometer (ax, ay, az) , the magnetometer (mx, my, mz) , and the gyroscope (gx, gy» gz) ⁇
• the microprocessor 21 processes the data received and supplies at output a quaternion that describes the orientation, instant by instant
• the quaternions thus calculated are then sent by the transmitter 22 to the receiver 30 at a frequency of 10 Hz.
• the receiver 30 receives the data from the three inertial units 10-12.
• the data of the three units of the sensor are each delayed by 5 s and are re-synchronized in a subsequent step.
• the control centre 31 manages the connection between the units in an alternating way clocked by precise timings, this enabling synchronization of the data coming from the various units .
• orientations of the abdominal unit 40 an ⁇ ⁇ thoracic unit (j ⁇ ) 41 will then be referenced to the reference unit 42 ⁇ y means of an operation of vector product between quaternions and will supply a quaternion 43 for the abdominal part A .
• each quaternion thus obtained (abdominal quaternion, thoracic quaternion) all contain, to a different extent, respiratory information.
• PCA principal-component analysis
• the first component of the PCA which gathers the majority of the respiratory information, is selected for the abdomen and the thorax and is used for subsequent processing operations.
• PCA is a statistical procedure based upon orthogonal transformation, which, starting from a set of possible correlated variables, supplies a set of linearly non-correlated variables called principal components.
• the characteristic of this transformation is that the first principal component represents the maximum variability of the data, and each of the subsequent components presents in turn the maximum possible variation under the constraint that it is orthogonal to (i.e., not correlated with) the previous component. Consequently, the principal component 45 for the abdomen and the principal component 46 for the thorax are calculated.
• the signals of the principal components 45 and 46 are filtered with a filter of a notch type to eliminate the residual components linked to the movements of the patient, detected on the reference unit (during walking or running) .
• the notch filter is set so as to be centred on the frequency of the peak of the spectrum calculated on the signal of the third quaternion.
• the residual movement is not of a repetitive type and hence cannot be eliminated with a notch filter, it is possible to intervene upstream of the principal-component analysis, removing from the signals 43 and 44 the signal baselines calculated with a moving-average filter (with a window of variable size depending upon the signal of the third quaternion, i.e., upon the activity of the subject) .
• the principal components, filtered or not filtered with the notch filter are then each applied to a FIR filter, 47 and 48, respectively, of the Savitzky-Golay type, for example of the third order.
• This filter is based upon local least-square polynomial approximation and is able to reduce the noise in the signal without modifying the form and height of the peaks of the waveforms .
• the lower of these two threshold frequencies is selected as final threshold frequency 50.
• the power spectral densities 51 and 52, of the two, thoracic and abdominal, signals are calculated with the Welch method (using a Hamming window of 300 samples with overlap of 50 samples) .
• the maximum peak after the threshold frequency that has previously been determined is selected, and the corresponding frequency is the desired central frequency (fcentr) for the band-pass filter downstream.
• the peak frequency represents the main frequency of the respiratory signal .
• the cutoff frequencies 53 and 54 of the two filters (of the first-order Butterworth type) that are to be used are now determined by applying +- 0.4 Hz.
• OLP fcentr + 0-
• WH p max(0.05,(f centr - 0.4)) Applied to the band-pass filter 55 for the thoracic signal and to the band-pass filter 56 for the abdominal signal are the calculated filter frequency limits 53 and 54 at the principal component 45 for the abdomen and at the principal component 46 for the thorax.
• the passband of the filters 55 and 56 is comprised between 0.05 and 2 Hz.
• the band-pass filters 55 and 56 enable elimination from both signals of the residual components linked to the movements of the patient.
• the filter is of the adaptive type to eliminate the components of movement, whicfcf may differ from one patient to another and in particular according to the different motor activities of one patient or another.
• a filter of the Savitzky- Golay type 60 and 61 is again applied, with which the points 62 of maximum and minimum on both of the abdominal and thoracic signals, which identify the points of end of expiration and end of inspiration, are determined.
• the thoracic and abdominal signals may be added together to obtain a total signal.
• the parameters of the Savitzky-Golay filter, and the (time and amplitude) thresholds used for determination of maxima and minima are optimized on the basis of the central frequency fcentr , determined for the abdomen 52 and for the thorax 53.
• the parameters of interest are estimated 63 on the basis of the points of end of expiration and end of inspiration: respiratory rate, inspiratory time, and expiratory time, for the abdomen, the thorax, and the total signal.
• the total respiration time Ttot is calculated as the distance between two minima.
• the inspiration time Ti is calculated as time between one minimum and the next maximum.
• the expiration time T e is calculated as time between one maximum and the next minimum.
• the respiration frequency is calculated as reciprocal of the total time T to t .
• the values are recorded and displayed on the screen.

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