WO2020232706A1 - Procédé et dispositif de mesure de fluide corporel et de ses changements et de mesure de changements de débit sanguin - Google Patents

Procédé et dispositif de mesure de fluide corporel et de ses changements et de mesure de changements de débit sanguin Download PDF

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Publication number
WO2020232706A1
WO2020232706A1 PCT/CN2019/088167 CN2019088167W WO2020232706A1 WO 2020232706 A1 WO2020232706 A1 WO 2020232706A1 CN 2019088167 W CN2019088167 W CN 2019088167W WO 2020232706 A1 WO2020232706 A1 WO 2020232706A1
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signal
human
ofdm
division multiplexing
parameters
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PCT/CN2019/088167
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English (en)
Chinese (zh)
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易成
王翎
何碧霞
谢鹏
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麦层移动健康管理有限公司
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Priority to PCT/CN2019/088167 priority Critical patent/WO2020232706A1/fr
Publication of WO2020232706A1 publication Critical patent/WO2020232706A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition

Definitions

  • the present invention relates to the medical field, specifically, to a non-invasive technology for detecting the electrical characteristics of biological tissues, and more specifically, but not as a limitation, to the measurement of blood flow and body fluid levels.
  • Bioimpedance and bioreactor measurements have been widely explored as non-invasive methods for measuring blood flow and body fluid levels. These techniques are widely accepted in the medical field, but they have some disadvantages, and the measured values are frequency dependent. When taking measurements, some people will produce different frequency selective interference or noise compared to others. Frequency selectivity defects can cause poor measurement results for some people. Even if the body or tissue is considered to be conductive and capacitive (conductor and non-conductor), the characteristics of the tissue are frequency dependent. As the frequency changes, the overall conductance and capacitance of the tissue may not be linear.
  • tissue can be divided into conductors and non-conductors.
  • Conductors can be measured by conductivity (reverse of resistance)
  • non-conductors can be measured by capacitance. Any changes in tissue will be represented by changes in conductance and capacitance. The above-mentioned electrical characteristic information can be monitored to realize the detection of the body state.
  • the invention overcomes the shortcomings of using single-frequency alternating current to measure bioimpedance and bioreactor in the existing method and device, and then calculating body fluid and cardiac output and related parameters.
  • the present invention provides a non-invasive device and method for simultaneously measuring the amplitude and phase of impedance of a local body or tissue in a wide frequency range to calculate the relevant parameters of body fluid and blood flow, wherein the above parameters can be used for Realize remote monitoring of human body status.
  • the alternating current of orthogonal frequency division multiplexing (OFDM) symbols is generated by using inverse fast Fourier transform (IFFT) technology.
  • IFFT inverse fast Fourier transform
  • IFFT is an implementation method of Orthogonal Frequency Division Multiplexing (OFDM) technology. All the frequency signals are orthogonal to each other.
  • the sequence length is usually a power of 2, for example, the sequence length of the N signal is 2 N.
  • the sequence can then be converted to a longer sequence, but transmitted in the same time period, which is called upscaling.
  • the present invention uses upscaling to reduce quantization noise.
  • the sequence may be stored in a memory, and the contents of the memory may be continuously or periodically pumped out by a digital controller or generated in a real-time form from a digital processor.
  • the sequence is converted into an analog current signal by a digital-to-analog converter (DAC) at a fixed rate.
  • DAC digital-to-analog converter
  • the clock rate of the digital-to-analog converter is preferably 100 KHz to 50 MHz. A higher clock rate will reduce quantization errors or produce analog waveform distortion. As a result, the analog signal has multiple alternating currents of different frequencies.
  • the multiple alternating currents are injected into the human or animal body through the electrodes and form a loop with external electronic components.
  • currents pass through the body, they are modulated by body tissues and changes in tissues.
  • the sampled electrical and biological signals will be amplified and converted into digital signals (A/D), and then processed by a computer processor.
  • the analog-to-digital conversion rate also known as the sampling rate, is preferably between 100KHz and 4MHz.
  • the sampled electrical signal is segmented into the same time period as the transmission sequence (injection signal) period, that is, orthogonal frequency division multiplexing (OFDM) symbol period.
  • OFDM orthogonal frequency division multiplexing
  • the sampled electrical signal can be synchronized according to the injection (transmission) signal to obtain a synchronized sampling signal with the same time period.
  • the length of the transmission sequence and the reception sequence (synchronized sampling signal) do not have to be the same, but the time period must be the same and synchronized.
  • the fast Fourier transform technique is used to demodulate the synchronous sampling signal. All signals of different frequencies are extracted. Since the phase of the injected signal is known, they can be subtracted from the extracted signal.
  • the transmission equation of the instrument system can also be estimated offline, just like a regular radio frequency (RF) equipment calibration. Therefore, the system amplitude and phase response can also be subtracted from the extracted signal. The final amplitude and phase will represent the tissue modulation, which provides physiological information.
  • RF radio frequency
  • the final signal is usually complex.
  • This plural signal provides human/animal organization information.
  • Process the complex signal such as low-pass filtering to remove high frequency noise.
  • the cut-off frequency is usually around 10 Hz. A higher cutoff frequency will bring more details of the waveform, but it usually requires a higher signal-to-noise ratio (SNR).
  • the present invention has an adaptive low-pass filter.
  • relevant information is extracted to calculate body fluid and blood flow parameters from different frequency signals.
  • the result is frequency compensated.
  • the equation coefficients for calculating physiological parameters are different. You can also check the cross relationship of the results from different frequency currents. In order to obtain better results, the same physiological parameters from different frequency signals can be summed with different weights.
  • ECG electronic electrocardiogram
  • Commonly calculated physiological parameters include, but are not limited to, heart rate (HR), left ventricular ejection time (LVET), stroke volume (SV), stroke index (SI), cardiac output (CO), cardiac index (CI) , Pleural fluid level (TFC), velocity index (VI), total vascular resistance (TVR) and acceleration index (ACI).
  • HR heart rate
  • LVET left ventricular ejection time
  • SV stroke volume
  • SI stroke index
  • CO cardiac output
  • CI cardiac index
  • TFC Pleural fluid level
  • VI velocity index
  • TVR total vascular resistance
  • ACI acceleration index
  • the present invention also provides a system for monitoring human or animal hemodynamics, including body fluids and blood flow.
  • the system includes a generator that generates alternating currents of multiple frequencies; an electrical converter that can transmit the generated alternating current to the human or animal body and can sense voltage changes in the human or animal body; multiple sense amplifiers, connected Cables or wire bundles between the electrical converter and the generator, and between the electrical converter and the sense amplifier; signal processing unit, which can be a single computer or multiple computers; processing software and connecting people or animals and systems HMI.
  • the computer can be remote, and the person (doctor) can remotely observe the system work in real-time mode.
  • the present invention uses multi-frequency orthogonal alternating stimuli (current) to measure impedance and reactance, which can represent changes in tissue from more aspects, so that the measurement results are more consistent and accurate.
  • the present invention can compensate for frequency dependence by measuring the impedance and reactance of multiple frequencies of the body or tissue at the same time, or can find the dependent cross relationship, and measure body fluid and blood flow more accurately.
  • the present invention uses the technical characteristics of Orthogonal Frequency Division Multiplexing (OFDM) to preset the amplitude and phase as anti-distortion to offset the system distortion, thereby obtaining more accurate measurement results.
  • OFDM Orthogonal Frequency Division Multiplexing
  • Figure 1 is an embodiment of the terminal system of the present invention
  • Figure 2 is an example of a structural diagram of the terminal system of the present invention.
  • Figure 3 is a schematic diagram of an example of the present invention.
  • Figure 4 is an example of the internal structure diagram of the system of the present invention.
  • Figure 5 is an example of a transmission waveform diagram of the present invention.
  • Fig. 6 is an example of a spectrum diagram of a received signal according to the present invention.
  • Fig. 7 is a schematic diagram of testing pure resistance network of the present invention.
  • 8A and 8B are examples of frequency response graphs measured from a pure resistance network without correction of the present invention.
  • 9A and 9B are examples of frequency response graphs measured from a pure resistance network corrected by the present invention.
  • FIG. 10 is an example of demodulated impedance cardiogram (ICG) of the present invention.
  • Fig. 11 is an example of phase graphs of different frequencies of the present invention.
  • Figure 12 is an example of the impedance amplitude and phase change diagram of the present invention.
  • Fig. 13 is another example of the impedance amplitude and phase change diagram of the present invention.
  • Figure 1 shows the mechanism of the terminal system on the human or animal body.
  • the human or animal body “1" has electrodes or contacts "A"-"D" that connect the human or animal body to the system.
  • the different arrangements of electrodes have Different focus and measurement points.
  • the electrodes are mainly placed on the chest, along the aorta.
  • other electrode arrangements on the chest or other parts of the body can be selected by ordinary technicians.
  • the signal generator "2" For the terminal system itself, the signal generator “2" generates a wideband signal with multiple frequency components, that is, orthogonal frequency division multiplexing (OFDM) symbols.
  • the system also includes a signal detector "3", a signal processor "4", and Wire or cable “5"-”8” connecting one or more elements “2"-"4" to human or animal body “1". Wires or cables transmit the generated signal to the electrodes or contacts "A” and “D", and the electrodes "A” and “D” are arranged so that the generated signal can pass through the relevant artery.
  • the electrodes "A” and “D” are connected to the chest through which several aorta pass. The signal flow is transmitted along the radial direction of the blood flow or artery.
  • the generated signal is transmitted from “A” to “D” or from “D” to “A” in the human or animal body "1".
  • the signal detector “3" collects biological signals from the electrodes “B” and “C” through wires or cables "7” and “8".
  • the signal processor "4" controls and coordinates the signal generator “2” and the signal detector "3".
  • the signal processor "4" also processes the signals received from the electrodes "B” and “C” and extracts biological information from the processed signals.
  • multiple alternating currents of different frequencies generated by the IFFT technology are synchronously converted into digital sequences in the time domain on all complete sinusoidal cycles of different frequencies. All the frequency signals are orthogonal to each other. The signal can then be up-converted to a longer sequence, but transmitted in the same time period.
  • the sequence may be stored in a memory, which may be continuously or periodically output by a digital controller or generated in real-time from a digital processor.
  • the sequence is converted into an analog current signal by a digital-to-analog converter at a fixed rate.
  • the clock rate of the digital-to-analog converter is 100 KHz to 10 MHz. A higher clock rate will reduce quantization error or analog waveform distortion.
  • Alternating Current Figure 5 shows the transmission waveform in the digital domain.
  • the DAC clock frequency is 3.353MHz, has 16 bits, and is superimposed with multiple sine waves.
  • the multiple alternating currents are injected into the human or animal body through the electrodes and form a loop with external electronic components.
  • currents pass through the body, they are modulated by body tissues and changes in tissues.
  • a sampling signal is acquired, which can be synchronized according to the injection (transmission) signal and has the same time period.
  • Figure 6 shows the frequency spectrum of the received signal (synchronized sampling signal) in an embodiment, the frequencies are 13.6KHz, 32.3KHz, 72.5KHz, 95.5KHz, 115.6KHz, 135.7KHz, 160.1KHz, 203.2KHz, 279.3KHz and 348.2 KHz.
  • the ADC sampling rate is 718KHz and has 24 bits.
  • the transmission sequence (injection signal) and the reception sequence (synchronization sampling signal) do not have to be the same length, but the time period must be the same and synchronized. Then, the fast Fourier transform technique is used to demodulate the sampled signal sequence. All signals of different frequencies are extracted. Since the amplitude and phase of the injected signal are known, they can be subtracted from the extracted signal. The system amplitude and phase response of the device can also be subtracted from the extracted signal, or corrected by the distortion of the injected signal to eliminate system interference. The final amplitude and phase will represent the tissue modulation, which brings physiological information. Due to modulation in humans or animals, the signal is usually complex. This complex signal provides information about humans or animals.
  • the cutoff frequency is usually around 10 Hz. A higher cutoff frequency will bring more details of the waveform, but it usually requires a higher signal-to-noise ratio (SNR).
  • SNR signal-to-noise ratio
  • an adaptive low-pass filter is used in the embodiment of the present invention.
  • relevant information is extracted to calculate body fluid and blood flow parameters from different frequency signals. The result is frequency compensated. The equation coefficients for calculating physiological parameters are different. You can also check the cross relationship of the results from different frequency currents. In order to obtain better results, the same physiological parameters from different frequency signals can be summed with different weights.
  • ECG electronic electrocardiogram
  • the terminal system shown in Figure 2 is also called an acquisition system.
  • the signal generator “9” can work in the time and frequency domains.
  • the figure also shows the digital-to-analog converter “10", the analog amplifiers “11” and “14”, the broadband current pump “12”, and the analog-to-digital converter. "15” and digital signal processor (DSP) "16".
  • DSP digital signal processor
  • the system not only obtains signals, but also sends excitation currents to human or animal bodies and tissues.
  • the signal generator “9” that can work in both the time domain and the frequency domain generates multi-frequency signals.
  • the signal is an orthogonal frequency division multiplexing (OFDM) symbol composed of the sum of multiple sine or cosine waves.
  • OFDM orthogonal frequency division multiplexing
  • a signal In the frequency domain, a signal is the sum of multiple frequency "tones". It can use IFFT technology to convert frequency "tones” into orthogonal frequency division multiplexing (OFDM) symbols with multiple sinusoidal signals in the time domain.
  • the generated digital sinusoidal signal is converted into an analog signal through the digital-analog converter "10", which is amplified by the analog amplifier "11” to drive the broadband current pump "12” for impedance conversion.
  • the current pump "12” converts a broadband single-ended voltage signal into a broadband differential current signal. Starting from the current pump "12", a multi-frequency sine wave small current enters the body through the contacts "A" and "D". Human or animal body as a complex medium will modulate the current in transmission.
  • Fig. 3 shows the working principle of the computer system of the present invention.
  • the excitation signal is sent out through the path "17", and the modulation signal and other biological signals from the human or animal body can be obtained from the path "18".
  • the terminal system “19” performs some preprocessing work, including but not limited to the functions in the examples such as demodulation and filtering.
  • the terminal system “19” can also have its own man-machine interface.
  • the terminal system “19” sends the intermediate results to the local computer "20", where all final processing (such as parameter calculation, feature extraction, data analysis) is completed.
  • the remote computer "21” using the software of the present invention can obtain all information from the local computer "20” in real time or offline.
  • the results and data can be stored in the database server "22" anywhere, and can be restored from the local computer "20” and the remote computer "21".
  • "23" refers to the communication between the local host "20" and the terminal system "19".
  • Figure 4 shows the terminal system or acquisition system, which includes a micro-processing system "24” (which may include one or more ARM processors).
  • the communication between the micro-processing system and peripheral components can be realized through the field programmable gate array (FPGA) "25".
  • FPGA field programmable gate array
  • the data is sent to the FPGA and stored through the micro-processing system, and then the FPGA can send the data to the digital-to-analog converter (DAC) "26", and then the data is converted into an analog current signal to input AC current to the human or animal body.
  • DAC digital-to-analog converter
  • preamplifiers choose to obtain analog signals from human or animal systems. Perform basic impedance transformation.
  • the signal is input to two different amplifiers, one is the impedance cardiogram (ICG) amplifier "27” and the other is the electrocardiogram (ECG) amplifier "28".
  • the ECG amplifier "28” can be directly connected to the microprocessor system because the microprocessor system (ARM) "24” has an analog-to-digital converter.
  • the ICG signal is digitized by a 24-bit analog-to-digital converter (ADC) "29”, and then transmitted to the FPGA "25" through the high-speed serial peripheral interface (SPI) bus.
  • ADC analog-to-digital converter
  • SPI serial peripheral interface
  • the FPGA "25” repackages the digital signal, and the signal passes The other SPI bus is input to the micro-processing system "24", which is demodulated by the micro-processing system "24".
  • Figure 10 shows that the demodulated ICG signal in an embodiment corresponds to frequencies of 18.7KHz, 33.0KHX, 47.4KHz, 68.9KHz and 94.8KHz, respectively.
  • the ECG signal calculated from the received frequency spectrum has 5 waveforms. Each ICG signal is calculated from one of 5 frequencies.
  • the heart cycle is clearly shown here.
  • Figures 12-13 respectively show the impedance amplitude (ICG) and phase (reactance) changes obtained through different human bodies in an embodiment, where the Y-axis is the average value and the peak-to-peak value is normalized to 1 (no unit ).
  • Fig. 7 is a diagram of testing a pure resistance network according to the present invention, which is used to evaluate the non-linearity and missing parts in the system through frequency response.
  • the OFDM generator transmits current to the resistor network through the excitation electrodes "TX1" and "TX2".
  • the receiving electrodes "RX1" and “RX2" take out the voltage signal.
  • FIGS. 8A and 8B are examples of frequency response graphs measured from a pure resistance network without correction of the present invention.
  • the frequency response graph of the phase or amplitude should be two horizontal straight lines.
  • the phase or amplitude frequency response graph is two non-horizontal lines, indicating that the system is not a linear system. If the amplitude and phase of these different frequencies are reversed (also known as the anti-distortion amount) and put into the transmitted multi-frequency signal, that is, the amplitude and phase of the corresponding frequency in the transmitted signal are reversed by the same amount, that is Anti-distortion.
  • phase and amplitude frequency response diagram of the pure resistance network will be two horizontal lines. This kind of system correction processing is aimed at the injected (transmitted) signal, and there is no need to make similar corrections at the signal receiving end.
  • FIGS. 9A and 9B are examples of frequency response graphs measured from a pure resistance network corrected by the present invention.
  • the same amount of inverse amplitude and inverse phase is added to the output signal, which is called every The correction factor of the amplitude and phase of the frequency can get the detection result of the approximate linear system.
  • the phase and amplitude curves of the corrected measurement frequency response are very close to the horizontal line. Using the corrected system to implement the measurement method provided by the present invention can improve the accuracy.
  • the present invention can also provide a method and system for monitoring human or animal hemodynamics, including the detection of body fluids and blood flow, and the method includes simultaneous Generate multiple synchronous alternating currents (AC) of multiple frequencies (frequency range from 10KHz to 1MHz), that is, orthogonal frequency division multiplexing (OFDM) symbol currents, transmit the generated currents to human or animal bodies, and sense
  • AC Generate multiple synchronous alternating currents
  • OFDM orthogonal frequency division multiplexing
  • the present invention can also provide a system/method for operating the extracted different information to obtain parameters related to human hemodynamics.
  • the present invention can also provide a system/method for changing the frequency and the number of frequencies, and the amplitude and phase of AC current.
  • the present invention can also provide a system/method for detecting the frequency dependence of human tissue and organ characteristics such as conductivity and permittivity.
  • the present invention can also provide a system/method for estimating the relationship between frequency dependence and organ or tissue characteristics.
  • the present invention can also provide a system/method for calculating hemodynamic parameters based on frequency-dependent conductance and permittivity values. These parameters include but are not limited to stroke volume (SV), cardiac output (CO), left ventricular ejection time (LVET), pre-ejection period (PEP), pleural fluid level (TFC), acceleration index (ACI), Speed Index (VI), Heart Rate (HR), Systemic Vascular Resistance (SVR) and Left Heart Work (LCW).
  • SV stroke volume
  • CO cardiac output
  • LVET left ventricular ejection time
  • PEP pre-ejection period
  • TFC pleural fluid level
  • ACI acceleration index
  • VI Speed Index
  • HR Heart Rate
  • SVR Systemic Vascular Resistance
  • LCW Left Heart Work
  • the entire specification refers to human or animal bodies, and the device and method of the present invention are equally applicable to both types.
  • different kinds of parameters are mentioned, the characteristics of which may be identified according to the output of the system and/or according to the method.
  • the calculation of independent parameters from the signal at a single frequency is known.
  • the use of multiple frequencies and multiple corresponding signals can produce the better results discussed above.

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  • Health & Medical Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
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Abstract

La présente invention concerne un procédé et un système de mesure de fluide corporel et de débit sanguin dans des corps humains ou animaux en utilisant un courant de marquage par multiplexage en répartition orthogonale de fréquence (OFDM). Le procédé consiste à déterminer des changements de résistance et de réactance multi-fréquence des tissus, et à calculer des paramètres de fluide corporel, de débit sanguin et physiologiques associés. En mesurant simultanément la résistance et la réactance du corps ou des tissus à de multiples fréquences, la dépendance vis-à-vis de la fréquence peut être compensée ou la relation croisée de la dépendance peut être trouvée de sorte que le fluide corporel et le débit sanguin peuvent être mesurés de manière plus précise.
PCT/CN2019/088167 2019-05-23 2019-05-23 Procédé et dispositif de mesure de fluide corporel et de ses changements et de mesure de changements de débit sanguin WO2020232706A1 (fr)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1244779A (zh) * 1995-04-20 2000-02-16 麦克考股份有限公司 非侵入地确定血球比率的方法和设备
CN101848677A (zh) * 2007-09-26 2010-09-29 麦德托尼克公司 生理信号的频率选择监视
US8994536B2 (en) * 2009-02-25 2015-03-31 Xanthia Global Limited Wireless physiology monitor
CN104783792A (zh) * 2014-01-21 2015-07-22 三星电子株式会社 测量生物阻抗的设备和方法
US20160234669A1 (en) * 1999-08-09 2016-08-11 Kamilo Feher Heart Rate Sensor and Medical Diagnostics Wireless Devices
CN106377259A (zh) * 2016-08-30 2017-02-08 苏州品诺维新医疗科技有限公司 一种血液状态检测装置及获取阻抗变化值的方法
US20170172514A1 (en) * 2015-12-18 2017-06-22 Samsung Electronics Co., Ltd. Method and apparatus for processing biosignal

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1244779A (zh) * 1995-04-20 2000-02-16 麦克考股份有限公司 非侵入地确定血球比率的方法和设备
US20160234669A1 (en) * 1999-08-09 2016-08-11 Kamilo Feher Heart Rate Sensor and Medical Diagnostics Wireless Devices
CN101848677A (zh) * 2007-09-26 2010-09-29 麦德托尼克公司 生理信号的频率选择监视
US8994536B2 (en) * 2009-02-25 2015-03-31 Xanthia Global Limited Wireless physiology monitor
CN104783792A (zh) * 2014-01-21 2015-07-22 三星电子株式会社 测量生物阻抗的设备和方法
US20170172514A1 (en) * 2015-12-18 2017-06-22 Samsung Electronics Co., Ltd. Method and apparatus for processing biosignal
CN106377259A (zh) * 2016-08-30 2017-02-08 苏州品诺维新医疗科技有限公司 一种血液状态检测装置及获取阻抗变化值的方法

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