WO2020067505A1 - 呼吸数計測装置 - Google Patents
呼吸数計測装置 Download PDFInfo
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- WO2020067505A1 WO2020067505A1 PCT/JP2019/038359 JP2019038359W WO2020067505A1 WO 2020067505 A1 WO2020067505 A1 WO 2020067505A1 JP 2019038359 W JP2019038359 W JP 2019038359W WO 2020067505 A1 WO2020067505 A1 WO 2020067505A1
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- 230000029058 respiratory gaseous exchange Effects 0.000 title claims abstract description 85
- 238000005259 measurement Methods 0.000 title abstract description 9
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims abstract description 106
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Definitions
- the present disclosure relates to a respiratory rate measuring device used for a pressure fluctuation adsorption type oxygen concentrator.
- oxygen therapy has been used as one of patients for respiratory diseases such as asthma and obstructive chronic lung disease. This is a therapy in which a patient inhales oxygen gas or oxygen-enriched gas.
- home oxygen therapy HET: Home Oxygen Therapy
- QOL quality of life
- the oxygen concentrator is a device that condenses and discharges about 21% of oxygen present in the air.
- a pressure fluctuation adsorption type hereinafter, PSA type: Pressure : Swing Adsorption
- PSA type Pressure : Swing Adsorption
- the PSA type oxygen concentrator air is taken into an adsorption column filled with an adsorbent for selectively adsorbing nitrogen gas, and an adsorption step of pressurizing the interior of the adsorption column and adsorbing nitrogen gas to the adsorbent is performed.
- the desorption step of reducing the pressure and discharging the adsorbed nitrogen gas out of the system is repeated.
- concentrated oxygen gas is generated, and the oxygen concentrator can continuously provide the patient with high-concentration oxygen gas.
- the method of reducing the pressure in the adsorption cylinder to an atmospheric pressure or lower may be referred to as VPSA or VSA instead of PSA, but the basic principle is the same as PSA. Unify with the name of.
- COPD chronic obstructive pulmonary disease
- COPD COPD
- oxygen therapy respiratory information of a patient, particularly a change in respiratory rate, is a very useful information source for grasping a patient's condition.
- the respiratory rate can also be measured by using a belly band, etc., but in order to grasp the long-term changes in the patient's condition, the patient must always or regularly wear the belly band. There is a burden on the patient. On the other hand, in general, patients receiving home oxygen therapy often require regular use for at least several hours a day. If the oxygen concentrator has a built-in or attached respiratory rate measuring device, the respiratory rate measuring device can reliably confirm changes in the condition during use of the oxygen concentrator without imposing an additional burden on the patient. it can. Respiratory rate measuring devices are very useful.
- a fine differential pressure sensor for measuring respiration is attached between the oxygen concentrator and the cannula worn by the patient.
- Patent Documents 2 and 4 disclose that a respiratory rate and the like can be calculated from a respiratory pattern, but do not describe a specific method.
- Patent Literature 3 stores the timing at which the pressure waveform changes from falling to rising, counting the respiratory rate at the interval, and multiplying a predetermined detection level rate from the pressure amplitude to exceed the threshold. A method of determining that breathing is performed only when is shown.
- Patent Document 5 discloses a method of calculating a respiratory rate by FFT (Fast Fourier Transform) processing or TDS processing.
- FFT Fast Fourier Transform
- Patent Document 6 discloses a method in which the pressure fluctuation of the oxygen concentrator itself is measured in advance, stored, and subtracted from the detected pressure waveform.
- the waveform data measured every 100 milliseconds (ms) is sent as it is, for example, and the data amount becomes enormous, and analysis may take time.
- the method of sending the calculated respiratory data as it is has a drawback that when a respiratory waveform is disturbed due to noise or body movement, a peak value due to the disturb is detected as respiration.
- the respiratory waveform varies greatly depending on the condition of the patient using the subject, the state of the patient at the time of activity or at bedtime, and the respiratory waveform varies greatly from patient to patient. It is difficult to determine a breath by uniformly setting a threshold for determining a breath.
- the FFT requires a large amount of calculation, and if the data section used for the calculation is made short, an accurate respiratory cycle cannot be calculated. If the data section is made too long, a slight difference in the respiratory interval between breaths may occur. This makes it difficult to obtain the peak of the respiratory cycle.
- the TDS process has problems due to the effects of noise and body movement, changes in breathing due to the state of the patient, and differences in the breathing state of each individual patient.
- the purpose of the respiratory rate measuring device is to solve the above-mentioned problem, and it is used together with the PSA type oxygen concentrator to improve the respiratory rate measuring accuracy.
- the respiratory rate measuring device is connected to a patient, and is a pressure-concentration adsorption type oxygen concentrating device that condenses oxygen in the air by periodically repeating pressurization and depressurization.
- a detection unit that detects the pressure in the pipe and / or the gas flow rate in the pipe that supplies the gas to the patient, and outputs the pressure data and / or the gas flow rate data, and performs the patient respiration based on the pressure data and / or the gas flow rate data.
- the estimating unit estimates the respiratory rate using a waveform indicating at least 10 seconds or more of patient respiratory information data.
- the estimating unit uses a peak of the autocorrelation coefficient exceeding a predetermined threshold value for estimating the respiratory rate.
- the threshold value is 0.3 or more and 0.7 or less.
- the respiratory rate measuring device outputs, when a peak of an autocorrelation coefficient exceeding a predetermined threshold value cannot be obtained, a message indicating that calculation was not possible.
- the calculation unit is configured to perform a periodic pressure change and / or a periodic pressure change of the oxygen-enriched gas generated by the operation of the oxygen concentrator based on the pressure data and / or the gas flow rate data.
- the respiratory rate measuring device further includes a storage unit that stores the fluctuation value data measured in advance, and the calculation unit removes the fluctuation value data from the pressure data and / or the previous gas flow rate data. By doing so, it is preferable to extract patient respiration information data.
- the respiratory rate measuring device is used together with the PSA type oxygen concentrating device, and can improve the measuring accuracy of the respiratory rate without imposing an additional burden on the patient.
- PSA oxygen concentrator A configuration of a PSA type oxygen concentrator, which is an example of a pressure fluctuation adsorption type oxygen concentrator used together with the respiratory rate measuring device according to one aspect of the embodiment, will be described.
- FIG. 1 is a diagram showing an example of a schematic configuration of a PSA-type oxygen concentrator.
- the PSA-type oxygen concentrator 1 has an oxygen generator 11 that takes in air A from outside the PSA-type oxygen concentrator 1 and generates a concentrated oxygen gas.
- Air A taken into the oxygen generation unit 11 from outside the PSA type oxygen device is compressed by the compressor 111 and sent to the adsorption column 113 via the first switching valve 112.
- the first switching valve 112 sends compressed air to the adsorption cylinder 113 by communicating any one of the adsorption cylinders 113 with the compressor 111, and opens the other adsorption cylinders to the atmosphere.
- the adsorption column 113 is filled with an adsorbent for selectively adsorbing nitrogen gas.
- the compressed air that has passed through the adsorption cylinder 113 has a reduced nitrogen gas concentration and becomes concentrated oxygen gas.
- the concentrated oxygen gas is stored in the concentrated oxygen buffer tank 115 via the second switching valve 114.
- the second switching valve 114 connects or disconnects any one of the plurality of adsorption cylinders 113 with the concentrated oxygen buffer tank 115.
- the oxygen generation unit 11 allows the compressor 111 to communicate with one of the plurality of adsorption cylinders 113 by the first switching valve 112, and connects the adsorption cylinder 113 and the concentrated oxygen buffer tank 115 which communicate with the compressor 111 by the second switching valve 114. Communicate. Therefore, the compressed oxygen buffer tank 115 is communicated with the compressor 111 and any one of the plurality of adsorption cylinders 113, and the generated concentrated oxygen gas is supplied to the concentrated oxygen buffer tank 115.
- the adsorption cylinder 113 that is not in communication with the compressor 111 is opened to the atmosphere via the first switching valve 112 in a state where the adsorption cylinder 113 is shut off from the concentrated oxygen buffer tank 115 by the second switching valve 114.
- the pressure in the adsorption cylinder 113 is reduced, and the nitrogen gas adsorbed by the adsorbent is discharged to the outside of the PSA type oxygen concentrator 1.
- Opening / closing of the first switching valve 112 and the second switching valve 114 is controlled by, for example, a microcomputer unit in a respiratory rate measurement device (not shown).
- the microcomputer unit can acquire the timing of switching between pressurization and depressurization in the adsorption cylinder 113.
- the respiratory rate measuring device may be installed inside the oxygen concentrating device 1 or may be installed outside the oxygen concentrating device 1 separately from the oxygen concentrating device 1.
- the oxygen concentrator 1 may include an oxygen concentration controller that controls the oxygen concentration process including the opening and closing processes of the first and second switching valves.
- the microcomputer unit can obtain the timing of switching between pressurization and depressurization in the adsorption cylinder 113 from the oxygen concentration control unit.
- the PSA type oxygen concentrator 1 may be connected to any two or more of the plurality of adsorption columns 113 other than the above-described basic configuration.
- the PSA-type oxygen concentrator 1 includes a pressure equalizing step for equalizing the pressure of each adsorption column and a purging step for returning a part of the generated oxygen-enriched gas to one of the adsorption columns 113. It may have additional steps.
- the compressed air is released from the compressor 111 by the first switching valve 112 and released to the atmosphere.
- the adsorption cylinder 113 that has been released to the atmosphere is connected to the compressor 111 by the first switching valve 112, and shifts to the process of oxygen compression.
- the plurality of adsorption cylinders 113 alternately repeat compression and release to the atmosphere by the first switching valve 112, so that the concentrated oxygen gas can be continuously supplied.
- the oxygen flow rate of the concentrated oxygen gas whose pressure has been adjusted by the oxygen generation unit 11 is controlled by an oxygen flow rate control unit 12 including a control valve 121 and a flow meter 122. Supplied to Either the control valve 121 or the flow meter 122 in the oxygen flow control unit 12 may be provided upstream of the flow path, and the oxygen flow control unit 12 may include other components.
- the PSA-type oxygen concentrator 1 may have a switchable fixed orifice for switching the flow rate instead of the flow meter 122 and the control valve 121.
- the PSA-type oxygen concentrator 1 may use a flow meter that can be visually observed such as a rotameter as the flow meter 122, and may use a method of adjusting the flow rate by manual operation using a manual flow rate adjusting valve instead of the control valve 121. Alternatively, other flow control methods may be used.
- the PSA-type oxygen concentrator 1 may be configured without the humidifier 101.
- FIG. 2 is a diagram showing an example of a schematic configuration of a respiratory rate measuring device.
- Oxygen generated by the PSA-type oxygen concentrator 1 is supplied to the patient's nasal cavity via a pipe 2 connected to the PSA-type oxygen concentrator 1 and a nasal cannula 3 connected to the pipe 2.
- the patient is constantly breathing even during oxygen inhalation, and a pressure change caused by the patient's breathing is transmitted to the nasal cannula 3, the pipe 2, and the PSA-type oxygen concentrator 1.
- the respiratory rate measuring device 4 is connected to the pipe 2 serving as the oxygen supply path in order to acquire the respiratory pressure of the patient.
- the pipe indicates the pipe including all the pipes between the humidifier 101 (or the oxygen flow controller 12 when the PSA-type oxygen concentrator 1 does not include the humidifier 101) and the nasal cannula 3; May be connected to any position of the pipe.
- Part or all of the respiratory rate measuring device 4 may be installed inside the PSA type oxygen concentrating device 1 or may be installed outside.
- the pressure fluctuation added to the respiratory rate measuring device 4 is accompanied by the pressure increase and decrease during the generation of the concentrated oxygen gas. It was found that pressure fluctuations were included.
- the amplitude of the pressure fluctuation generated during the generation of the concentrated oxygen gas is larger than the amplitude of the respiratory pressure, and the amplitude of the respiratory pressure also decreases due to the pressure loss caused by passing through the oxygen flow path. It is difficult to directly measure a patient's respiratory pressure waveform.
- the respiratory rate measuring device 4 has a microcomputer unit 7 connected to the pressure sensor 6 and having a calculating unit and an estimating unit.
- the pressure sensor 6 is preferably a slight differential pressure sensor.
- the respiratory rate measuring device 4 includes a display unit 8 that displays the measured respiratory rate, for example, a liquid crystal display.
- the display unit 8 is connected to the microcomputer unit 7 and is controlled by the microcomputer unit 7.
- the respiratory rate measuring device 4 is electrically connected to, for example, a pressure sensor 6, preferably a slight differential pressure sensor 6, as a detecting unit that detects and outputs the pressure in the pipe. And a microcomputer unit 7.
- the respiratory rate measuring device 4 may have a pressure smoothing unit including a volume connected to the minute differential pressure sensor 6 and an orifice 5 connecting between the pipe and the volume. The reason for providing the pressure smoothing unit is as follows.
- the respiratory pressure of a patient is usually about ⁇ 10 to 100 Pa, it is preferable to use a sensor having a range of about ⁇ 100 Pa as the fine differential pressure sensor 6 in order to obtain the respiratory pressure with the respiratory rate measuring device 4.
- a supply pressure due to the supply of oxygen is constantly generated.
- a supply pressure due to the supply of oxygen is about 300 Pa even at 1 LPM (liter per minute). Therefore, if one end of the small differential pressure sensor 6 is connected to the oxygen supply path as described above with the other end of the small differential pressure sensor being open to the atmosphere, the measurement range of the small differential pressure sensor 6 will be exceeded. Therefore, it is preferable to apply the pressure after passing through the orifice 5 to the other end of the small differential pressure sensor 6 to acquire the pressure including the breathing information of the patient within the measurement range of the small differential pressure sensor 6.
- a pressure that does not exceed the measurement range of the fine differential pressure sensor 6 is applied to the other end of the fine differential pressure sensor 6, and the method is not limited to the example of the present embodiment.
- the other end of the fine differential pressure sensor 6 may be open to the atmosphere as long as the measurement range of the fine differential pressure sensor 6 is larger than the supply pressure by the oxygen supply and the resolution is at a level capable of detecting the pressure fluctuation accompanying the patient's breathing.
- a pressure sensor for measuring a gauge pressure or an absolute pressure may be used instead of the fine differential pressure sensor 6.
- the respiratory rate measuring device 4 may use a flow rate sensor instead of the pressure sensor 6.
- the respiration rate measuring device 4 may have both the pressure sensor 6 and the flow sensor.
- the pressure sensor 6 and / or the flow sensor detects the pressure in the pipe and / or the gas flow rate in the pipe including the respiration information of the patient in the pipe 2 and outputs the pressure data and / or the gas flow rate data in the pipe. Department.
- FIG. 3 is a diagram illustrating an example of a configuration block of the microcomputer unit 7.
- the microcomputer unit 7 having the calculating unit 722 and the estimating unit 723 is connected to the pressure sensor 6, preferably the minute differential pressure sensor 6.
- the calculating unit 722 and the estimating unit 723 receive the in-pipe pressure data and / or the in-pipe gas flow rate data including the breathing information of the patient detected by the slight differential pressure sensor 6 serving as the detection unit, and execute the processing described below. To obtain the patient's breathing information.
- the microcomputer unit 7 may be the same microcomputer as the processing unit that processes the oxygen generation function and the display / user interface function of the oxygen concentrator, or may be separated. If they are separated, the switching timing of the cycle T of the PSA is obtained from the microcomputer that processes the oxygen generation function, and is used for calculation.
- the microcomputer unit 7 includes a storage unit 71 and a processing unit 72.
- the storage unit 71 includes one or a plurality of semiconductor memories. For example, it has at least one of a nonvolatile memory such as a RAM, a flash memory, an EPROM, and an EEPROM.
- the storage unit 71 stores a driver program, an operating system program, an application program, data, and the like used for processing by the processing unit 72.
- the storage unit 71 stores, as a driver program, a device driver program for controlling the small differential pressure sensor 6 and the like as the detection unit.
- the computer program may be installed in the storage unit 71 from a computer-readable portable recording medium such as a CD-ROM or a DVD-ROM using a known setup program or the like.
- the program may be downloaded from a program server or the like and installed.
- the storage unit 71 may temporarily store temporary data relating to a predetermined process.
- the storage unit 71 stores a threshold 711, a fluctuation value data file 712, and the like used for estimating a respiratory rate.
- the processing unit 72 includes one or more processors and their peripheral circuits.
- the processing unit 72 controls the overall operation of the respiratory rate measuring device 4 as a whole, and is, for example, an MCU (Micro Control Unit).
- MCU Micro Control Unit
- the processing unit 72 executes processing based on programs (such as an operating system program, a driver program, and an application program) stored in the storage unit 71.
- the processing unit 72 may execute a plurality of programs (such as application programs) in parallel.
- the processing unit 72 includes a detection data acquisition unit 721, a calculation unit 722, an estimation unit 723, a respiration rate output unit 724, and the like.
- processing unit 72 may be implemented in the microcomputer unit 7 as independent integrated circuits, circuit modules, microprocessors, or firmware.
- Continuous flow 5 LPM data groups acquired when an extension tube is connected 20 m downstream of the respiratory rate measuring device 4 are shown in FIGS. 4, 5 and 6.
- the continuous flow is one of the concentrated oxygen gas supply methods, and is a method of continuously supplying a constant flow of concentrated oxygen gas.
- FIG. 4 is a diagram showing pressure data including respiratory information of a patient and PSA pressure data of the PSA type oxygen concentrator 1 when a continuous flow of 5 LPM and an extension tube are connected by 20 m.
- FIG. 5 is a view showing PSA pressure data of the PSA type oxygen concentrator 1 when there is no patient respiration when the continuous flow is 5 LPM and the extension tube is connected to 20 m, or after the respiratory component is removed.
- the PSA pressure by the PSA type oxygen concentrator is a periodic pressure change accompanying the cycle of the adsorption cylinder of the PSA type oxygen concentrator 1 generated when oxygen is generated by the PSA type oxygen concentrator 1 described above.
- the cycle of the PSA pressure waveform coincides with the adsorption cylinder switching cycle of the PSA oxygen concentrator 1.
- FIG. 6 is a diagram showing the result of performing difference processing on the components of FIG. 4 from the components of FIG. 4 by software.
- the difference processing is processing for calculating the difference between the two data at an arbitrary time.
- the respiratory rate measuring device 4 can remove the PSA pressure component and detect the respiratory pressure of the patient's respiratory model.
- the respiratory rate measuring apparatus 4 allows the patient to breathe even under the condition that the oxygen is continuously inhaled from the PSA type oxygen concentrator 1 through the nasal cannula and the extension tube 20 m at 5 LPM. Information can be obtained.
- the method of removing the fluctuation value data such as the PSA pressure component and extracting the patient respiration information data is described in Patent Document 6 by measuring, storing and detecting the pressure fluctuation of the oxygen concentrator itself in advance.
- a method of subtracting from a pressure waveform or a method of subtracting a measured value in real time may be used.
- the calculating unit 722 determines that the pressure at a certain time t is equal to the flow rate value Y (t). , Y (t) and Y (t ⁇ T), Y (t ⁇ 2T),..., Y (t ⁇ nT) (n is a predetermined integer) X (t) ) Is calculated to extract respiratory information.
- the original respiratory waveform from which the PSA pressure component has been removed can be reproduced well.
- FIG. 7 is a conceptual diagram of the arithmetic processing according to the present embodiment.
- (I) is a respiratory waveform
- (II) is a model waveform of a PSA waveform.
- T is the cycle of the PSA waveform, which coincides with the switching cycle of the suction cylinder.
- (III) is a waveform obtained by adding (I) and (II), and corresponds to the pressure measured in the piping.
- (IV) is obtained by dividing (III) for each cycle T and superimposing them. As long as the respiratory cycle and the PSA cycle do not completely match, the respiratory waveform appears randomly in the waveform cut at the cycle T.
- (V) is the result of averaging the waveforms superimposed in (IV).
- fluctuation value data X (t) indicating a periodic pressure change and / or flow rate change of the oxygen-enriched gas generated by the operation of the PSA-type oxygen concentrator.
- V are estimated by superposition and averaging
- a simple moving average for five periods is used, where T is one period.
- (VI) is a waveform obtained by subtracting (V) from the last T portion of the waveform of (III). It can be seen that the original respiratory waveform (I) has been accurately reproduced.
- the method of selecting T may be T from the time when one of the plurality of adsorption cylinders starts communicating with the compressor to the time when another adsorption cylinder switches to the state communicating with the compressor.
- the method of selecting T is defined as T from the time when the state in which one adsorber is in communication with the compressor starts, the time when the other adsorber is in communication with the compressor, and the time when the first adsorber is switched to the state in which it communicates with the compressor again Is also good. Further, as another example, T may be selected as a multiple of each switching time.
- X (t) is the value after the averaging process at time t
- Y (t) is the measured value of the pressure at time t.
- a i is a weighting coefficient in the weighted average, and an arbitrary real number can be selected.
- n and a i an averaging process with faster convergence, such as a FIR (Finite Impulse Response) filter, is also possible.
- equation (1) appears to be simply an equation for numerically calculating the time average of Y (t).
- T is selected to be a sufficiently small value with respect to the fluctuation period of Y (t), whereas in the present embodiment, it is important to select T based on the adsorption / desorption period of the PSA process. is there.
- This is not a simple averaging process of the measured value Y (t) but a waveform of Y (t) over the period T as one unit, which is traced back by an integral multiple of T. It means taking the average value.
- the average value of the waveform it is possible to accurately estimate the PSA pressure having a characteristic that appears periodically at intervals of T.
- the method of measuring pressure was shown as a respiratory rate measurement unit.However, since the flow rate flowing through the piping changes in accordance with the fluctuation of pressure, a method of measuring flow rate instead of pressure may also be used. Can be. Further, a method in which the pressure value and the flow rate value are combined or switched depending on the operating conditions and environmental conditions of the device can be used.
- the respiration information obtained by the arithmetic processing is so-called raw data that represents real-time information of respiration such as pressure and flow rate as a waveform.
- This data may be recorded or transmitted as it is, but the data amount becomes enormous and the analysis takes time. Therefore, it is desirable to automatically calculate, record, and / or transmit the respiratory rate data inside the respiratory rate measuring device 4.
- the respirable waveform that can be detected has many noise components due to pressure fluctuations due to airflow and swaying of the cannula.
- the peak detection for calculating the timing at which the pressure changes from falling to rising or the method for detecting the timing at which the pressure becomes equal to or greater than the threshold value cannot properly calculate the respiratory cycle and respiratory rate.
- the respiratory waveforms to be counted appear as peaks represented by a1, a2, and a3 in the figure and valleys that appear immediately after the peaks, and the other portions are noise components. Even if an attempt is made to detect this peak as the timing at which the pressure changes from rising to falling, it is highly likely that part b in the figure will be detected.
- the autocorrelation coefficient between the original waveform and the waveform shifted by a time ⁇ t from the original waveform is obtained, and ⁇ t is changed so that the autocorrelation coefficient becomes a peak. It has been found that the respiration rate can be detected with high detection power by obtaining.
- the inventor has found a respiration rate estimating method for estimating a respiration rate per predetermined time from patient respiration information.
- the autocorrelation coefficient R can be calculated by the following formula.
- ⁇ t is the amount of time shift
- t 0 is the data acquisition interval
- n is the number of data used for one calculation of the autocorrelation coefficient
- f (t) is the patient respiration information data at time t.
- n values are obtained at intervals of t 0 .
- ⁇ and ⁇ are the average value and the standard deviation of f (t), but in the actual calculation, the average and the standard deviation of the acquired n values of f (t) may be used.
- the calculation method of the autocorrelation coefficient of the present embodiment is an example, and another calculation method of the autocorrelation coefficient may be used.
- the autocorrelation coefficient R calculated in this embodiment includes a normalization coefficient , The value is defined in the range of -1.0 to +1.0.
- a waveform in which it was difficult to determine a respiratory cycle by threshold or peak detection in raw patient respiratory information data can easily obtain a respiratory cycle by obtaining an autocorrelation coefficient. I understand.
- the data section of f (t) used for calculating the autocorrelation coefficient is determined from the range of the respiratory cycle to be calculated. As a result of intensive studies by the inventor, it has been found that the data section of f (t) needs to be at least twice the minimum respiratory cycle to be calculated.
- the threshold value of the autocorrelation coefficient for determining the peak of the autocorrelation coefficient needs to be set to at least 0.3 or more, preferably between 0.3 and 0.7. . At lower thresholds, the possibility of erroneous determination of an accidental increase in autocorrelation value due to noise or disturbance of the baseline as a peak increases, and at higher threshold values, the increase in autocorrelation value due to the respiratory cycle can be overlooked. Turned out to be high.
- the respiration rate is calculated as the reciprocal of the respiration interval of the value of ⁇ t when the autocorrelation coefficient is equal to or more than a certain value and takes a peak value.
- ⁇ t at the point P1 of the first peak is the respiratory interval
- dividing one minute by the respiratory interval is the respiratory rate per minute.
- ⁇ Depending on the respiratory waveform, there may be a plurality of peaks having a value equal to or more than a certain value as shown in FIG. 8, but the peak P2 on the right side is a double cycle peak that appears when ⁇ t is shifted by a plurality of breaths.
- the leftmost that is, the peak P1 having the smallest ⁇ t, which is estimated to correspond to the basic cycle of respiration, should be used.
- the information on the respiratory rate can be automatically and accurately calculated from the respiratory waveform acquired by the respiratory rate measuring unit connected to the concentrator.
- the estimation unit 723 calculates the respiration rate. The accuracy can be further improved by not performing. The determination on the presence or absence of breathing is not tested on the determination based on the variance of the patient respiration information data f (t), and another determination method may be used.
- the variance ⁇ 2 of the patient respiration information data f (t) is calculated by the following equation.
- n is the number of data used for one calculation of the autocorrelation coefficient
- f (t) is the value of the patient respiration information data at time t.
- ⁇ and ⁇ 2 are the average value and variance of f (t).
- the threshold for dispersion determination in the case of a PSA-type oxygen concentrator is: When the respiratory rate is less than 8: ⁇ 2 ⁇ 18 (Pa 2 ) For breathing rate 8-10: ⁇ 2 ⁇ 18 (Pa 2 ) When the respiratory rate is 11 or more: ⁇ 2 ⁇ 7 (Pa 2 )
- the value may vary depending on the oxygen supply device used. Since there are variations depending on parameters such as the respiratory rate, the threshold value for the dispersion determination needs to be appropriately set depending on the oxygen supply device used.
- FIG. 9 is a flowchart illustrating an example of a process for extracting patient respiration information data.
- the process of extracting the patient respiration information data shown in FIG. 9 is executed by the microcomputer unit 7 according to a computer program stored in the storage unit 71 in advance.
- the detection data acquisition unit 721 acquires pressure data Y (t) from the pressure sensor 6, which is a detection unit (ST101).
- Arithmetic unit 722 calculates an average value X (t) for n cycles of Y (t) (ST102).
- Arithmetic unit 722 extracts patient respiration information data f (t) by calculating the difference between Y (t) and X (t) (ST103).
- the arithmetic unit 722 When using the PSA pressure fluctuation measured and stored in advance, the arithmetic unit 722 does not perform the processing of ST102, and after the processing of ST101, calculates the difference between Y (t) and the PSA pressure fluctuation measured and stored in advance as ST103. Extracts patient respiration information data f (t).
- the process of estimating the respiratory rate is repeatedly performed. For example, every time n pieces of measurement data of the pressure Y (t) are acquired at intervals of t 0 , the patient respiratory information data f (t ) Is extracted and updated.
- the patient respiration information data f (t) may be extracted and updated at predetermined intervals.
- FIG. 10 is a flowchart illustrating an example of a process of estimating a respiratory rate based on patient respiratory information data.
- the processing for estimating the respiratory rate shown in FIG. 10 is executed by the microcomputer unit 7 according to a computer program stored in the storage unit 71 in advance.
- the estimating unit 723 calculates an average value ⁇ and a standard deviation ⁇ of the patient respiration information data f (t) (ST201).
- the estimating unit 723 determines whether or not the variance ⁇ 2, which is the square of the standard deviation ⁇ , is equal to or greater than a predetermined threshold TH D (ST202). If the variance ⁇ 2 is less than the threshold value TH D (ST202: NO), the respiratory rate output unit 724 outputs a message indicating that calculation was not possible (ST213), and ends the process.
- the estimating unit 723 sets the time ⁇ t to zero (0) as the time shift amount (ST203).
- the estimating unit 723 increments the data acquisition interval t 0 at time ⁇ t (ST204). Estimating section 723 calculates autocorrelation coefficient R ( ⁇ t) at time ⁇ t of patient respiration information data f (t) (ST205). Estimating section 723 writes calculated autocorrelation coefficient R ( ⁇ t) to storage section 71 (ST206). Estimating section 723 determines whether or not time ⁇ t has reached nt 0 (ST207). When the time ⁇ t has not reached nt 0 , the process returns to ST203, and the estimating unit 723 repeats the process (ST207: NO).
- estimation section 723 reads out autocorrelation coefficient R ( ⁇ t) stored in storage section 71 (ST208).
- the estimating unit 723 compares the read autocorrelation coefficients R ( ⁇ t), and determines whether there is a maximum autocorrelation coefficient Max (R ( ⁇ t)), that is, whether there is a peak autocorrelation coefficient R ( ⁇ t). Is determined (ST209). Specifically, it is determined whether Max (R ( ⁇ t)) is equal to or greater than a predetermined threshold TH C.
- the estimating unit 723 determines the maximum autocorrelation coefficient Max (R ( ⁇ t)).
- the time ⁇ t is set as a breathing interval (ST210). Further, estimation section 723 estimates the respiration rate from respiration interval ⁇ t (ST211). Respiratory rate output section 724 outputs a respiratory rate signal (ST212), and the process ends. For example, the display unit 8 to which the respiratory rate signal is input displays the respiratory rate.
- the respiratory rate output unit 724 When the maximum autocorrelation coefficient Max (R ( ⁇ t)) is less than the predetermined threshold TH C (ST209: NO), the respiratory rate output unit 724 outputs a message indicating that calculation was not possible (ST213). , And the process ends. While the respiratory rate measuring device 4 is operating, the process of estimating the respiratory rate is repeatedly performed, and the respiratory rate measuring device 4 can update the respiratory rate and display it on the display unit 8. The display on the display unit 8 may be performed at predetermined intervals.
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Abstract
Description
実施形態の一側面に係る呼吸数計測装置と共に使用される、圧力変動吸着方式の酸素濃縮装置の一例である、PSA式酸素濃縮装置の構成を説明する。
本発明に係る呼吸数計測装置の概略構成の一例を説明する。
図3は、マイコン部7の構成ブロックの一例を示す図である。
図2に示す構成を用いて鼻カニューラ3から患者呼吸モデルの呼吸圧を印加し、呼吸情報を取得したデータを用いて、本実施形態で行われる処理の原理について説明する。
ある一定の閾値以上をピークとして判断する方法であっても、閾値をXとして設定した場合は、a2のような低いピークが検出できなくなる可能性があり、Yに設定した場合は、ノイズ成分bをピークとして検出してしまう可能性がある。本例では3呼吸分程度しか波形を示していないが、実際の波形ではここで示した以上にピークやノイズ成分の高さがばらつく可能性があり、ピークを確実にとらえ、ノイズを確実に除去できる閾値の設定は極めて困難である。
1分当たりの呼吸数(bpm)=60秒÷(ピーク点のステップ数×サンプリング時間)
呼吸数8未満の場合 :σ2≧18(Pa2)
呼吸数8~10の場合:σ2≧18(Pa2)
呼吸数11以上の場合:σ2≧7(Pa2)
であるが、使用する酸素供給装置によりに値が異なる可能性がある。呼吸数等のパラメーターによりばらつきがあるので、分散判定の閾値は使用する酸素供給装置により適切に設定する必要がある。
2 配管
3 鼻カニューラ
4 呼吸数計測装置
5 オリフィス
6 圧力センサ
7 マイコン部
71 記憶部
72 処理部
721 検知データ取得部
722 演算部
723 推定部
724 呼吸数出力部
8 表示部
Claims (7)
- 患者と接続され、且つ、加圧・減圧を周期的に繰り返すことで空気中の酸素を濃縮する圧力変動吸着方式の酸素濃縮装置から酸素濃縮ガスを患者に供給する配管内の管内圧力及び/又は管内気体流量を検知して、圧力データ及び/又は気体流量データを出力する検知部と、
前記圧力データ及び/又は前記気体流量データに基づいて、患者呼吸情報データを抽出する演算部と、
前記患者呼吸情報データに基づいて所定時間当たりの呼吸数を推定する推定部と、を有し、
前記推定部は、時間Δtを変化させながら、前記患者呼吸情報データと、前記患者呼吸情報データから前記時間Δtだけずらしたデータとの自己相関係数を求め、前記自己相関係数がピークとなる時間Δtを呼吸間隔として、前記呼吸数を推定する、
ことを特徴とする呼吸数計測装置。 - 前記推定部は、少なくとも10秒以上の前記患者呼吸情報データを示す波形を用いて、前記呼吸数を推定する、請求項1に記載の呼吸数計測装置。
- 前記推定部は、所定の閾値を超えた前記自己相関係数のピークを前記呼吸数の推定に利用する、請求項1又は2に記載の呼吸数計測装置。
- 前記閾値は、0.3以上且つ0.7以下の値である、請求項3に記載の呼吸数計測装置。
- 前記所定の閾値を超えた前記自己相関係数のピークを取得できない場合、計算不能であった旨を出力する、請求項1~4の何れか一項に記載の呼吸数計測装置。
- 前記演算部は、前記圧力データ及び/又は前記気体流量データに基づいて、酸素濃縮装置の動作により発生する前記酸素濃縮ガスの周期的な圧力変化及び/又は流量変化を示す変動値データを推定し、前記変動値データを前記圧力データ及び/又は前記気体流量データから除去することによって、前記患者呼吸情報データを抽出する、請求項1~5の何れか一項に記載の呼吸数計測装置。
- 予め測定した前記変動値データを記憶する記憶部を更に有し、
前記演算部は、前記変動値データを前記圧力データ及び/又は前記気体流量データから除去することによって、前記患者呼吸情報データを抽出する、請求項1~5の何れか一項に記載の呼吸数計測装置。
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EP19867937.5A EP3858409B1 (en) | 2018-09-28 | 2019-09-27 | Respiration rate measurement device |
US17/279,215 US20220031986A1 (en) | 2018-09-28 | 2019-09-27 | Respiratory rate measurement device |
CN201980063693.XA CN112739403B (zh) | 2018-09-28 | 2019-09-27 | 呼吸次数计测装置 |
JP2020549479A JP7055217B2 (ja) | 2018-09-28 | 2019-09-27 | 呼吸数計測装置 |
KR1020217009195A KR102526829B1 (ko) | 2018-09-28 | 2019-09-27 | 호흡수 계측 장치 |
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EP (1) | EP3858409B1 (ja) |
JP (1) | JP7055217B2 (ja) |
KR (1) | KR102526829B1 (ja) |
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WO (1) | WO2020067505A1 (ja) |
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- 2019-09-27 KR KR1020217009195A patent/KR102526829B1/ko active IP Right Grant
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Also Published As
Publication number | Publication date |
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KR102526829B1 (ko) | 2023-04-27 |
EP3858409B1 (en) | 2024-05-08 |
EP3858409A4 (en) | 2022-06-29 |
US20220031986A1 (en) | 2022-02-03 |
CN112739403A (zh) | 2021-04-30 |
EP3858409A1 (en) | 2021-08-04 |
CN112739403B (zh) | 2024-04-30 |
JPWO2020067505A1 (ja) | 2021-05-20 |
JP7055217B2 (ja) | 2022-04-15 |
KR20210047936A (ko) | 2021-04-30 |
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