A multifunctional system for measuring BIO-signals in real time for assessing the condition of the muscle under study

Abstract

Multifunctional system for real-time measurement of bio-signals for assessing the condition of the muscle under examination, based on visualization of the time waveforms of the measured bio-signals EMG, MMG, BIOZ and muscle vibration signals it containing electrodes E1 (1), E2 (2), E3 (3), E4 (4), ER (5) and a microphone MIC (6) together with a three-coordinate accelerometer AKC (7) placed on a flexible Kinesio tape attached to the muscle under test, the outputs of which are connected to inputs (22, 23, 28) UPS Signal Processing System (10), and whose digital output (29) is connected to the input (30 ) of the Measurement Management Processor PZP (11), whose output (31) is connected to the input (32) of the two-way radio data transmission channel KRA1(12), whereby the UPS (10), PZP (11) and KRA1(12) circuits constitute an integrated MAD Data Acquisition Module (9) installed on the patient outside the examined muscle, while the output (33) of the KRA1 radio transmission channel (12) is connected by radio to the input (34) of the two-way radio channel KRB1 (14), the output (25) of which is connected to the input (36) of the Data Processing Processor PPD (17), which in turn transmits measurement data by cable from the output (42) or by radio to the input (43) of the Diagnostic Computer KD (19), for visualization of the time waveforms of the measured bio-signals.

Description

[0001] A multifunctional system for measuring bio-signals in real time to assess the condition of the tested muscle.

[0002] The object of the invention is a multifunctional system for measuring bio-signals in real time for assessing the condition of the muscle under examination, using sensors that receive bio- signals generated by the muscle, placed on a Kinesio tape installed on the muscle.

[0003] In the rehabilitation processes of patients and the training processes of sortie players, it is necessary to assess the state of muscles both at rest and during exercise by patients and players. Measurements of known bio-signals such as EMG, MMG and muscle bio-impedance change signal (BIOZ) are performed separately and sequentially , and then analyzed in non-real time. This results, losing some of the information related to the correlation of the visualized time waveforms of these bio-signals, which would be beneficial for assessing the state of the muscle during exercise by the patient or athlete.

[0004] The first need for the simultaneous measurement of the aforementioned bio-signals in near real time, is the desire to prevent injuries by preventing local overload of muscle fibers and by selecting optimal training parameters. Another need is to monitor the load of athletes (in real time and on the move), which is particularly important in professional sports, as it allows to rotate the lineup for long games, or to set tactics for individual starts.

[0005] Simultaneous measurement of the aforementioned bio-signals is necessary for assessing rehabilitation progress and adjusting exercises and loads, based on ongoing diagnosis of the muscle's condition. There is also a demand in terms of knowledge of possible injury resulting from overloading of a particular muscle part as a result of training / movement, which requires real-time measurement, ratherthan by the diagnostician under static conditions.

[0006] In case of minor muscle injuries or as a preventive measure, the so-called elastic Kinesio tape is applied. For this reason, there is a need to solve the problem of simultaneous examination of the state of the muscle, that is, taking measurements of bio-signals with the application of Kinesio tape on the examined muscle. The object of the invention responds to the needs of users, i.e.: coaches, physiotherapists, as well as athletes and people who do not engage in sports professionally, but significantly engage in training, especially sports that strain the body such as triathlon, cross- fit, strength sports.

[0007] The purpose of the invention is to make it possible to diagnose the state of the muscle during the patient's exercise on the basis of simultaneous visualization and recording of the time waveforms of bio-signals : EMG, MMG, bio-impedance and muscle vibration.

[0008] This can be accomplished by integrating multiple sensors with Kinesio elastic tape installed on the muscle under study and receiving and processing bio-signals from these sensors in a data acquisition system installed on the patient under study and transmitting these measurement data via radio to a computer for visualization.

[0009] In the known solutions of measuring systems for muscle parameters, independent wire connections are used to individual sensors, attached to the muscle under study separately. These wires are connected to the measurement data acquisition system and further transmitted via cable or radio to a computer performing data visualization.

[0010] A well-known instrument solution with a wide range of applications is BIOPAC's MP-150 instrument. The BIO-PAC system is an extensive desktop system, enabling the BIOPAC MP 150 variant to sequentially record and visualize many types of bio-signals: ECG (Electrocardiogram), EDA (Electrodermal Activity Impedance- BIOZ), EEG (Electroencephalogram) , EMG (Electromyogram), EOG / Eye Movement, Laser Doppler flow measurement. The MP 150 system is designed to conduct examinations on patients in a static position or with exercises limited by the length of the sensor cables. The system requires selecting one or two types of examinations and installing the appropriate set of sensors on the patient.

[0011] The system consists of a set of electrodes and sensors installed on the patient under study and connected by cables to a 16-channel data acquisition block via an interface block. The received bio-signals from the electrodes or sensors, usually in analog form, are transmitted to a standard computer (Windows system), where they are visualized on the screen and both the measurement data and their calculated statistical characteristics are archived for later analysis. Graphical as well as numerical representation of these data can be used in other analysis programs. The MP150 system can additionally visualize the results of statistical analysis (e.g. rms, mean value, median) and frequency domain analysis (FFT, spectrum, heart rate measurement).

[0012] The acquisition block has 16 analog inputs, the signals from which are processed into 16- bit digital words. For analog input signals, only two channels of measurement data are issued simultaneously in digital form to a computer. The output measurement data is sent via a USB Ethernet cable with a maximum length of 100m to the system computer.

[0013] The MP-150 system can be retrofitted with miniature BIO-NOMAD transmitter blocks (6x4x2 cm, weight 54 g) installed on the patient under study, wired to a sensor (e.g., an electrode), receiving two selected bio-signals during exercise or movement (walking, running, etc.). The transmitter block has a built-in battery to ensure operation without external power. Measurement data transmission in the 2.4 GHz band is provided for direct line-of-sight at a maximum distance of 10 m from the BIO-NOMAD receiver (4x11x19 cm), attached by wire to the acquisition block. The set of these blocks includes 12 types for receiving various bio-signals, including dual-channel reception for one or a combination of selected measurements: ECG, EEG, EGG, EMG, EOG, EDA (BIOZ).

[0014] When using the BIOPAC MP 150, after selecting two simultaneous measurements, there is a need to install the corresponding sensors on the muscle under study, which is not possible for all combinations of measurements.

[0015] The SBF7 instrument is a device consisting of a touch-screen block containing complete signal processing for the four-electrode bio-impedance spectroscopy method and a set of cables with electrodes installed on the patient under study . The instrument has one measurement channel, which in bio-impedance spectroscopy mode is tuned sequentially to 256 frequencies between 4 kHz and 1000 kHz. The instrument displays on the screen the measured measurement data and calculated: waveform of bio-impedance module, graph of resistance as a function of reactance, characteristic frequencies, body composition parameters ( TBW, ECF, ICF, FFM,FM). The block has a power supply from internal rechargeable batteries. The disadvantages of these well-known systems are the limitation to only two types of measurements using electrodes installed on the tested muscle and one type of measurement , when another sensor is used, for example, a gas pedal or a microphone. In addition, a significant difficulty for the user of these well-known devices is the need to set up electrodes on the patient each time. In addition, these well-known devices require for testing of exercising patients the use of independent measurement data transmitters for each type of measurement, which makes transition time from one measurement to another long and requires the interruption of exercise, in order to install a new set with measurement data transmitter.

[0016] There are a number of patents describing system solutions for measuring bio-signals and transmitting measurement data, but they are limited to selected types of measurements, which distinguishes them from the system that is the subject of the invention.

[0017] Patent WO2012089221A1 includes a system consisting of a mechanical inductor placed on the muscle to be tested and receiving sensor systems and a radio communication system for transmitting radio data, but it is limited to only one type of measurement that is, the elastography of the muscle. The system solution that is the subject of the invention is completely different from that described in patent WO2012089221A1.

[0018] Patent W02014122011A1, on the other hand, describes a mechanical exciter system and a receiving system with an accelerometer as a sensor for reading the bio-signal of the muscle response. This circuit also provides only one type of bio-signal measurement. The system that is the subject of the invention does not use a mechanical exciter system.

[0019] Patent CN109222909A claims a system for monitoring a patient's posture that develops appropriate alarm signals in the event of improper posture, based on bio-signals from three sensors placed on the patient: a 9-axis sensor, a miniature microphone for pulse measurement and a myographic sensor. The sensors are placed in separate modules on different parts of the patient's body. The first module is placed on the patient's head, for example, and contains a 9- axis motion sensor. The second module is placed on the patient's chest and provides ECG , pulse measurement and respiration detection. The third sensor is placed on the patient's limbs, for example, and measures EMG and MMG myographs. All modules are equipped with Bluetooth connectivity for transmitting measurement data to smart devices like smartphones and computers.

[0020] On the basis of the transmitted measurement data, an assessment of the correctness of the patient's posture is worked out and, in the event of its abnormality, alarm sound signals are produced. The system described in this patent has a different architecture the system of the invention and a completely different layer of application of measurement results.

[0021] Patent CN110639191A describes a system for evaluating the ability of a patient's body to exercise, comprising: a unit for measuring the acidity of saliva, a unit for measuring the thermal radiation of the body, a unit for measuring the bio-electrical activity of the body, a unit for measuring the physical index of the body, a unit for recording the subjective evaluation of the patient's condition under examination, a unit for measuring the physiological index of the patient (at least measuring myography and EEG), a unit for measuring the bio-chemical index of the patient, a unit for measuring the mechanical properties of the muscle and the activity parameters of the blood circulation system. Also claimed is a method of using this system to determine the achievement of a critical point during patient exercise . The patent claims do not state the links in the system associated with the use of EMG measurement, nor do they describe the means or methods for transmitting measurement data. It follows that there is no infringement of the claims of patent CN110639191A by the solution of the system that is the subject of the invention.

[0022] Patent US2020113485A1 describes a device for detecting and analyzing an artificially induced neuromuscular response within a patient's limb and, on the basis of sensors installed on the tested limb, producing MMG bio-signals, transmitted after pre-processing to a computer system via radio. The limitation of this device is the measurement and analysis of only one type of bio-signal (EMG), which in many cases is not sufficient for a comprehensive assessment of the state of the muscle.

[0023] In the system that is the subject of the invention, several parameters of the muscle state (EMG, MMG, Bioimpedance) are measured and the movement of the limb in space is recorded, with the raw measurement data being filtered before being sent by radio for further processing in the Diagnostic Computer. In contrast, in the system described in the patent US2020113485A1 raw MMG measurement data is transmitted by radio when the occurrence of a response to mechanical stimulation of the muscle is detected in the received signal. The architecture of the system of the invention is different from that described in patent US2020113485A1, in that each set of sensors placed on the Kinesio tape forming a Measurement Tape, is wired to a Data Acquisition Module (MAD) containing a measurement data processing unit that formats the post-processed data into packets of digital data transmitted by radio. Each successive Measurement Belt is connected to the next MAD, and the measurement data is transmitted via a separate radio channel, while in the solution according to patent US2020113485A1, data is first received from all sensors by a single processor forming data packets for transmission via radio.

[0024] The purpose of the invention is to eliminate the above-mentioned shortcomings, which will make it possible to simultaneously conduct various types of measurements , in which both electrodes and an accelerometer and microphone are used as sensors. In addition, it will be obtained both a shorter time of installing sensors on the tested muscle and the possibility of simultaneously conducting multiple types of measurements while the patient is exercising.

[0025] The essence of the invention is that a set of five measuring electrodes, as well as a microphone and an accelerometer, are placed on a flexible Kinesio tape installed on the muscle under test and connected by wire to a data acquisition system installed on the patient at a certain distance from the muscle under test, which processes the received bio-signals into measurement data sent by radio link through a receiving system to a computer that performs visualization of the bio-signal time waveforms and the calculated measurement data.

[0026] A schematic of the multifunctional system for measuring bio-signals in near real time for assessing the condition of the muscle under study is shown in Fig.l.

[0027] To obtain bio-signals, a Measurement Tape (8) is used, which is an elastic Kinesio tape applied to the muscle under test, on which electrodes (1, 2, 3, 4, 5) are installed, as well as a Microphone (6) and a three-coordinate Accelerometer (7). Electrode (5) is a reference electrode, placed outside the muscle area to be tested, and is used to achieve suppression of unwanted interference. Electrodes (2, 3) are receiving electrodes for the EMG signal or the signal for bioimpedance (BIOZ) measurement, depending on the type of measurement. Electrodes (1, 4) are electrodes that deliver the excitation current to the muscle when measuring the BIOZ. A microphone (7) and a three-coordinate accelerometer (8) generate bio-signals representing the oscillations of the stimulated muscle by self-mediated contraction (MMG) or mechanical shock.

[0028] The outputs of all sensors, that is, electrodes (1,2, 3, 4, 5 ) and the output of the microphone (6), as well as the output of the three-coordinate accelerometer (7), are connected to the inputs of the Signal Processing System (10) , which receives bio-signals and processes them into digital form and then performs filtering and transmission in the form of digital packets to the Measurement Management Processor (11) . The digital output (29) of the circuit (10) is connected to the input (30) of the Processor (11) and the Radio Channel (12). The circuits (10, 11, 12) together with the rechargeable battery (13) are placed in a single housing to form the Data Acquisition Module (9), which is connected by a wire harness to the Measurement Tape (8j. The Module (9) is installed outside the muscle under test , for example, on the belt of the patient under test.

[0029] The output (33) of the circuit (12) is connected by radio to the input (34) of the Radio Channel circuit (14) in the Data Preparation Circuit (18) block, the output (35) of which is connected to the input (36) of the Data Processing Processor (17). The Measurement Data Preparation Circuit (18) consists of N radio channels (14, 15, 16) and the Data Processing Processor (17) to which they are connected. N modules (MAD) can be attached to the circuit (17) along with N Measurement Tapes (TP). The chip (18) is connected by cable link or local WiFi network to the Diagnostic Computer (19), on whose screen the time waveforms of the measured bio-signals are visualized.

[0030] The operation of the system that is the subject of the invention is managed from a menu on the screen of the Diagnostic Computer (19), from which the types of measurements and visualization of bio-signal time waveforms are selected. The basic type of operation is simultaneous measurement of EMG and MMG bio-signals with periodic measurement of bioimpedance (BIOZ) , which is a slowly varying waveform during the patient's exercise. Below is described the operation of the system for the example of testing only one muscle, that is, installed one measuring tape working with one MAD module.

[0031] When EMG is measured, the received analog signal through electrodes E2 (2) and E3 (3) is amplified and frequency filtered in the UPS circuit (10) , and then converted to digital form. The digital EMG signal is passed to the PZP circuit (11), which collects the all received bio-signals and forms measurement data packets into appropriate formats, transmitted to the two-way radio transmission channel KRAI (12). The sent measurement data are received in the two-way radio channel KRB1 (14), from which they are transmitted to the data processing unit PPD (17), which from the received data forms digital packets sent to the Diagnostic Computer KD (19) , for registration of these data and their visualization. At the same time, commands, selected from a menu on the screen of the Diagnostic Computer KD (19), controlling the selection of the type of measurement, are sent to the MAD (9, 20, 21) on this radio channel.

[0032] Similarly, when measuring bio-signal, electrodes E2 (2) and E3 (3) receive the muscle response signal to current stimulation by electrodes El (1) and E4 (4). The received bio-signal from the electrodes is subjected to amplification and frequency filtering in the UPS system (10), and then, after processing into digital form, sent on, analogous to the EMG bio-signal measurement data. The next two digital signals from the MIC microphone (6) and the AKC accelerometer (7) are also sent to the UPS system (10), where, after frequency filtering, similarly to the EMG signal, they are sent to the PZP processor (11), where measurement data packets containing the data of all measurement signals , that is : EMG, MMG, BIOZ, muscle vibration based on the signals from (MIC (6), AKC (7)) are produced.

[0033] These combined measurement data sent by radio are received by the UPD system

[0034] (18) and sent to the KD Diagnostician's Computer (19), where they are selected for visualization on the screen, where they can be displayed together in the appropriate screen windows or selected some for visualization and observation. A diagnostician with appropriate qualifications, on the basis of the visualized time waveforms of the selected bio-signals, performs the procedure for assessing the condition of the muscle under examination.

Claims

Patent claims1. Multifunctional system for real-time measurement of bio-signals for assessing the condition of the muscle under examination, based on visualization of the time waveforms of the measured bio-signals EMG, MMG, BIOZ and muscle vibration signals, characterized by the following, that it contains electrodes El (1), E2 (2), E3 (3), E4 (4), ER (5) and a microphone MIC (6) together with a three-coordinate accelerometer AKC (7) placed on a flexible Kinesio tape attached to the muscle under test, the outputs of which are connected to inputs (22, 23 , > 28 ) UPS Signal Processing System (10), and whose digital output (29) is connected to the input (30 ) of the Measurement Management Processor PZP (11), whose output (31) is connected to the input (32) of the two-way radio data transmission channel KRAI (12), whereby the UPS (10), PZP (11) and KRAI (12) circuits constitute an integrated MAD Data Acquisition Module (9) installed on the patient outside the examined muscle, while the output (33) of the KRAI radio transmission channel(12) is connected by radio to the input (34) of the two-way radio channel KRB1 (14), the output (25) of which is connected to the input (36) of the Data Processing Processor PPD (17), which in turn transmits measurement data by cable from the output (42) or by radio to the input (43) of the Diagnostic Computer KD (19), for visualization of the time waveforms of the measured bio-signals.

2. Arrangement according to claim 1, characterized in that there are attached to theMeasuring Data Preparation Arrangement UPD (18), N measuring blocks consisting of Measuring Tapes TP1 ...TPN, each of which is attached to a different muscle under test, and which Measuring Tapes TP1 ...TPN are connected to individual Data Acquisition Modules MAD1...MADN, connected by radio to successive bidirectional measuring data transmission channels KRB1. KRBN.