WO2021085043A1 - 血圧計、血圧測定方法、およびプログラム - Google Patents

血圧計、血圧測定方法、およびプログラム Download PDF

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Publication number
WO2021085043A1
WO2021085043A1 PCT/JP2020/037774 JP2020037774W WO2021085043A1 WO 2021085043 A1 WO2021085043 A1 WO 2021085043A1 JP 2020037774 W JP2020037774 W JP 2020037774W WO 2021085043 A1 WO2021085043 A1 WO 2021085043A1
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Prior art keywords
blood pressure
pressure measurement
schedule
nighttime
sphygmomanometer
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PCT/JP2020/037774
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English (en)
French (fr)
Japanese (ja)
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新吾 山下
幸哉 澤野井
美佳 江副
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オムロンヘルスケア株式会社
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Publication of WO2021085043A1 publication Critical patent/WO2021085043A1/ja

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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
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/022—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers

Definitions

  • the present invention relates to a sphygmomanometer, and more particularly to a sphygmomanometer having a nighttime (sleeping) blood pressure measurement mode.
  • the present invention also relates to a blood pressure measuring method for measuring blood pressure by such a sphygmomanometer.
  • the present invention also relates to a program for causing a computer to execute such a blood pressure measuring method.
  • Non-Patent Document 1 Guidelines for Use of 24-Hour Sphygmomanometer (ABPM) Standard (2010 revised edition)).
  • an object of the present invention is to provide a sphygmomanometer and a blood pressure measurement method capable of reducing the frequency of blood pressure measurement while acquiring necessary blood pressure value data when performing nocturnal blood pressure measurement.
  • Another object of the present invention is to provide a program for causing a computer to execute such a blood pressure measuring method.
  • the present inventor has noted that nighttime blood pressure fluctuation patterns are classified into dipper type, extreme-dipper type, non-dipper type, and riser type (riser type).
  • Non-Patent Document 1 Guidelines for Use of 24-Hour Blood Pressure Monitor (ABPM) Standards (2010 revised edition)).
  • the dipper type is a type in which the blood pressure at night gradually decreases by 10% to 20% as compared with the average blood pressure during the day, reaches a minimum before dawn, and then gradually increases (normal type).
  • the extreme dipper type is a type that shows an excessive decrease in blood pressure of 20% or more at night as compared with the dipper type.
  • the non-dipper type is a type in which the decrease in blood pressure at night is less than 10% as compared with the dipper type.
  • the riser type is a type in which the blood pressure rises at night (the average blood pressure at night rises more than the average blood pressure during the day).
  • the blood pressure at night rises more than the average blood pressure during the day.
  • the blood pressure in the time zone when the blood pressure is the minimum at night is important.
  • the non-dipper type and riser type it is considered that the blood pressure in some time zones throughout the night is important.
  • the sphygmomanometer of this disclosure is A sphygmomanometer that measures blood pressure by temporarily pressing the subject's area to be measured with a blood pressure measurement cuff. It has a nighttime blood pressure measurement mode that automatically starts blood pressure measurement according to a predetermined schedule. In the nocturnal blood pressure measurement mode, a blood pressure measurement unit that automatically starts blood pressure measurement according to the schedule and measures the blood pressure when the blood pressure measurement cuff is in the pressurization process or the depressurization process.
  • It has a storage unit that can store the measured blood pressure value, and further A storage processing unit that performs data storage processing in which the blood pressure measurement unit measures the blood pressure in the nighttime blood pressure measurement mode for a plurality of days according to the schedule, and the measured blood pressure values are sequentially stored in the storage unit.
  • the blood pressure value stored in the storage unit is statistically processed over the plurality of days to determine which type of the plurality of predetermined types of the nighttime blood pressure fluctuation pattern is classified.
  • the schedule is reset by resetting the schedule of the night blood pressure measurement mode so as to reduce the measurement frequency after the plurality of days according to the type of the determined night blood pressure fluctuation pattern. It is characterized by having a part.
  • the "schedule” defines the start time of blood pressure measurement (usually takes about 1 to 2 minutes).
  • the "time interval” (described later) of blood pressure measurement according to a schedule means the interval between the start time of a certain blood pressure measurement and the next start time, and is synonymous with a cycle.
  • Statistical processing typically refers to a process of averaging blood pressure values acquired for each of the same time zones over a plurality of days for each of the same time zones to obtain an average value for each time zone. ..
  • the length of the "time zone” can be arbitrarily set, such as 30 minutes and 1 hour.
  • the “same time zone” may be the “same time”.
  • the “predetermined types” are typically dippers as described in Non-Patent Document 1 (Guidelines for the Use of 24-Hour Blood Pressure Monitors (ABPM) Standards (2010 Revised Edition)). Refers to the type, extreme dipper type, non-dipper type, and riser type.
  • “Reducing the frequency of measurements” and “resetting” the schedule typically mean that blood pressure measurements are typically performed only during the time of day when blood pressure is minimal and / or the above data accumulation. This means that the time interval of the measurement after the plurality of days is longer than the time interval of the measurement on the plurality of days to be processed.
  • the accumulation processing unit causes the blood pressure measuring unit to measure the blood pressure of a certain subject in the nighttime blood pressure measuring mode according to the schedule for a plurality of days, and sequentially stores the measured blood pressure values in the storage unit. Performs data storage processing to be stored in.
  • the statistical processing unit statistically processes the blood pressure values stored in the storage unit over the plurality of days for the subject, and classifies the subject into any of a plurality of types in which the nighttime blood pressure fluctuation pattern is predetermined. Decide if it will be done. For example, the blood pressure values acquired for each of the same time zones over a plurality of days are averaged for each of the same time zones, and the average value for each time zone is obtained.
  • the schedule resetting unit sets the schedule of the nighttime blood pressure measurement mode for the subject so as to reduce the measurement frequency after the plurality of days according to the type of the determined nighttime blood pressure fluctuation pattern. Perform the process of resetting.
  • the blood pressure measurement is limited to the time zone in which the nighttime blood pressure is the minimum, or the measurement time interval on the plurality of days subject to the data accumulation processing is compared with the time interval of the measurement on the plurality of days. The time interval for subsequent measurements can be lengthened. Therefore, when performing nighttime blood pressure measurement, the frequency of blood pressure measurement can be reduced while acquiring necessary blood pressure value data.
  • the above predetermined types are The dipper type, in which the blood pressure at night decreases from 10% to less than 20% of the average blood pressure during the day, shows the minimum at a certain time, and then increases. Extreme dipper type, in which the blood pressure at night decreases to 20% or more of the average blood pressure during the day, shows the minimum at a certain time, and then increases.
  • the non-dipper type in which the blood pressure at night decreases from zero to less than 10% of the average blood pressure during the day, shows the minimum at a certain time, and then increases. It is characterized by four types, a riser type in which the average blood pressure at night is higher than the average blood pressure in the daytime.
  • the nighttime blood pressure fluctuation pattern of the subject can be appropriately classified in accordance with Non-Patent Document 1 (Guidelines for Use of 24-Hour Blood Pressure Monitor (ABPM) Criteria (2010 revised edition)). ..
  • the schedule resetting unit uses the nighttime blood pressure as the schedule of the nighttime blood pressure measurement mode after the plurality of days. It is characterized in that the time corresponding to the time zone indicating the minimum is set.
  • the schedule resetting unit performs the nighttime blood pressure after the plurality of days. As the schedule of the measurement mode, a time corresponding to the time zone in which the blood pressure at night shows the minimum is set.
  • the determined nighttime blood pressure fluctuation pattern is the dipper type or the extreme dipper type
  • the schedule of the nighttime blood pressure measurement mode is limited to the time corresponding to the time zone in which the nighttime blood pressure is the minimum, the frequency of blood pressure measurement can be reduced to once per night. This makes it possible to reduce the number of times the subject's sleep is disturbed after the plurality of days.
  • the schedule of the nighttime blood pressure measurement mode is set to the first time interval.
  • the schedule resetting unit sets the schedule of the nighttime blood pressure measurement mode after the plurality of days to the first one. It is characterized by switching to a second time interval that is longer than the time interval.
  • the schedule resetting unit uses the nighttime blood pressure after the plurality of days.
  • the schedule of the measurement mode is switched to a second time interval that is longer than the first time interval. For example, if the first time interval is a 30-minute interval, the second time interval is set to be a 2-hour interval.
  • the determined nighttime blood pressure fluctuation pattern is the non-dipper type or the riser type
  • the number of measurements after the plurality of days can be reduced as compared with the number of measurements on the plurality of days that are the targets of the data storage process. This makes it possible to reduce the number of times the subject's sleep is disturbed after the plurality of days.
  • the storage processing unit Upon receiving a predetermined start instruction, the storage processing unit starts the data storage processing and starts the data storage process. As soon as the data storage process is completed, the control unit is provided to continuously execute the process from the statistical processing by the statistical processing unit to the process of resetting the schedule by the schedule resetting unit.
  • the "predetermined start instruction” is, for example, an operation in which a user (mainly a subject) turns on a switch mounted on the sphygmomanometer, or wireless communication from the outside of the sphygmomanometer to the sphygmomanometer. Refers to operations such as inputting a processing start signal.
  • the above schedule is automatically reset. Therefore, it is convenient for the user because it does not substantially require the trouble of resetting the above schedule of the nighttime blood pressure measurement mode.
  • the accumulation processing unit causes the blood pressure measurement unit to measure the blood pressure in the nighttime blood pressure measurement mode at the same time zone every day in the nighttime blood pressure measurement mode, and sequentially stores the measured blood pressure values in the storage unit.
  • the statistical processing unit is characterized in that, as the statistical processing, the blood pressure values acquired every day for the same time zone over the same week are averaged for each of the same time zones, and the average value for each time zone is obtained. To do.
  • the accumulation processing unit causes the blood pressure measuring unit to measure the blood pressure at the same time zone every day according to the schedule in the nighttime blood pressure measuring mode for the above one week, and the measured blood pressure value. Are sequentially stored in the above storage unit.
  • the statistical processing unit averages the blood pressure values acquired every day for the same time zone over the same week, and obtains the average value for each time zone. If the average value for each time zone over a week is obtained, the average value for each time zone can be appropriately grasped from the experience of the present inventor, even if there is some variation from day to day.
  • the subject since the subject usually lives for one week as a life cycle, the daily variation in the blood pressure value of the subject is appropriately reflected in the average value for each time zone. As a result, the nighttime blood pressure fluctuation pattern of the subject can be appropriately grasped according to how the average value for each time zone changes throughout the night.
  • the sphygmomanometer of one embodiment is characterized in that the measured site is the wrist.
  • the blood pressure monitor of this embodiment is a type that presses the wrist as the measurement site, it is expected that the degree of disturbing the sleep of the subject is less than that of the type that presses the upper arm (Imai et al). ., “Development and evaluation of a home nocturnal blood pressure monitoring system using a wrist-cuff device”, Blood Pressure Monitoring 2018, 23, P318-326). Therefore, this sphygmomanometer is suitable for nighttime (sleeping) blood pressure measurement.
  • the main body is characterized by incorporating the blood pressure measuring unit, the storage unit, the accumulation processing unit, the statistical processing unit, and the schedule resetting unit.
  • the "blood pressure measuring unit” drives and controls, for example, a pump that supplies a pressurizing fluid to the blood pressure measuring cuff, a valve that exhausts the fluid from the blood pressure measuring cuff, and these pumps / valves. Contains elements.
  • the sphygmomanometer of this embodiment can be integrally and compactly configured. Therefore, the handling by the user becomes convenient.
  • the blood pressure measurement method of this disclosure is It is a blood pressure measurement method for a sphygmomanometer that measures blood pressure by temporarily pressing the area to be measured by a blood pressure measurement cuff.
  • the above blood pressure monitor It has a nighttime blood pressure measurement mode that automatically starts blood pressure measurement according to a predetermined schedule.
  • a blood pressure measurement unit that automatically starts blood pressure measurement according to the schedule and measures the blood pressure when the blood pressure measurement cuff is in the pressurization process or the depressurization process.
  • the above blood pressure measurement method is For a certain subject, a data storage process was performed in which the blood pressure measuring unit was made to measure the blood pressure according to the schedule in the nighttime blood pressure measuring mode for a plurality of days, and the measured blood pressure values were sequentially stored in the storage unit. For the subject, the blood pressure values stored in the storage unit over the plurality of days are statistically processed to determine which type of the plurality of predetermined types of the nighttime blood pressure fluctuation pattern is classified. , The subject is characterized in that the process of resetting the schedule of the nighttime blood pressure measurement mode is performed so as to reduce the measurement frequency after the plurality of days according to the type of the nighttime blood pressure fluctuation pattern determined. And.
  • the blood pressure measuring method of the present disclosure the blood pressure is measured only during the time period when the blood pressure at night is the minimum, or compared with the number of measurements on the plurality of days subject to the data accumulation processing. , The number of measurements after the above-mentioned plurality of days can be reduced. Therefore, when performing nighttime blood pressure measurement, the frequency of blood pressure measurement can be reduced while acquiring necessary blood pressure value data.
  • this disclosed program is a program for causing a computer to execute the above blood pressure measurement method.
  • the above blood pressure measurement method can be carried out by causing a computer to execute the program of this disclosure.
  • such a blood pressure measurement method can be executed by a computer.
  • FIG. 7A is a diagram showing the passage of time of the cuff pressure PC accompanying the blood pressure measurement.
  • FIG. 7B is a diagram showing the time passage of the pulse wave signal SM accompanying the blood pressure measurement.
  • FIG. 7C is a diagram showing an envelope ENV set for a sequence of pulse wave amplitudes formed by the pulse wave signal SM. It is a figure explaining the method of the blood pressure calculation in a nocturnal blood pressure measurement mode. It is a figure which illustrates four types which can classify a nocturnal blood pressure fluctuation pattern.
  • the above blood pressure monitor it is a figure which shows the process flow of the time examination mode which resets the schedule of the nighttime blood pressure measurement according to the type of the nighttime blood pressure fluctuation pattern of a subject. It is a figure explaining the mode of resetting the schedule of the nighttime blood pressure measurement for each type of the nighttime blood pressure fluctuation pattern of a subject in the said blood pressure monitor.
  • FIG. 1 shows the appearance of the wrist type sphygmomanometer 100 according to the embodiment of the present invention.
  • the sphygmomanometer 100 is roughly divided into a blood pressure measuring cuff 20 to be attached to the left wrist 90 (see FIG. 3 described later) as a measurement site, and a main body 10 integrally attached to the cuff 20. ing.
  • the cuff 20 is a general one for a wrist-type sphygmomanometer, and has an elongated band-like shape so as to surround the left wrist 90 along the circumferential direction.
  • the cuff 20 contains a fluid bag 22 (see FIG. 2) for pressing the left wrist 90.
  • a carla having appropriate flexibility may be provided in the cuff 20.
  • the main body 10 is integrally attached to a portion substantially in the center of the strip-shaped cuff 20 in the longitudinal direction.
  • the portion to which the main body 10 is attached is planned to correspond to the palm side surface (palm side surface) 90a of the left wrist 90 in the mounted state.
  • the main body 10 has a flat, substantially rectangular parallelepiped shape along the outer peripheral surface of the cuff 20.
  • the main body 10 is formed to be small and thin so as not to interfere with the sleep of the user (in this example, the subject; the same applies hereinafter). Further, the corners of the main body 10 are rounded (the corners are rounded).
  • a display 50 forming a display screen and an operation unit 52 for inputting an instruction from the user are input. And are provided.
  • the display 50 is composed of an LCD (Liquid Crystal Display) and displays predetermined information according to a control signal from a CPU (Central Processing Unit) 110 described later.
  • the systolic blood pressure (unit: mmHg), the diastolic blood pressure (unit: mmHg), and the pulse rate (unit: beat / minute) are displayed.
  • the display 50 may consist of an organic EL (ElectroLuminescence) display or may include an LED (Light Emitting Diode).
  • the operation unit 52 inputs an operation signal according to an instruction by the user to the CPU 110 described later.
  • the operation unit 52 includes a measurement switch 52A for receiving a blood pressure measurement instruction by the user and a night measurement switch 52B for receiving an instruction to switch the mode between the normal blood pressure measurement mode and the nighttime blood pressure measurement mode.
  • the time inspection mode switch 52C for receiving an instruction to execute the processing of the time inspection mode is included.
  • the "normal blood pressure measurement mode” means a mode in which, when a blood pressure measurement instruction is input by the measurement switch 52A, the blood pressure is measured in response to the blood pressure measurement instruction.
  • the "nighttime blood pressure measurement mode” means a mode in which blood pressure measurement is automatically started according to a predetermined schedule so that the user can measure the blood pressure value during sleep.
  • the predetermined schedule refers to a plan for measuring at a fixed time such as 1:00, 2:00, or 3:00 at midnight, or a plan for measuring once every two hours after the night measurement switch 52B is pressed.
  • the “time test mode” means a mode in which the process of resetting the schedule of the nighttime blood pressure measurement mode is performed according to the type of the nighttime blood pressure fluctuation pattern of the subject.
  • the measurement switch 52A, the night measurement switch 52B, and the time inspection mode switch 52C are all momentary type (self-recovery type) switches, and are turned on only while they are pressed down. When released, it returns to the off state.
  • the measurement switch 52A When the measurement switch 52A is pressed down while the sphygmomanometer 100 is in the normal blood pressure measurement mode, it means a blood pressure measurement instruction, and the cuff 20 temporarily presses the area to be measured (left wrist 90). Blood pressure measurements are performed by the metric method.
  • the measurement switch 52A When the measurement switch 52A is pressed down again during blood pressure measurement (for example, while pressurizing the cuff 20), it means an instruction to stop blood pressure measurement, and blood pressure measurement is stopped immediately.
  • the night measurement switch 52B is pressed down while the sphygmomanometer 100 is in the normal blood pressure measurement mode, it means an instruction to shift to the night blood pressure measurement mode, and the sphygmomanometer 100 measures the night blood pressure from the normal blood pressure measurement mode. Move to mode. In the nocturnal blood pressure measurement mode, as described above, blood pressure measurement by the oscillometric method is automatically started according to a predetermined schedule. If the night measurement switch 52B is pressed again while the sphygmomanometer 100 is in the nighttime blood pressure measurement mode, it means an instruction to stop the nighttime blood pressure measurement mode, and the sphygmomanometer 100 shifts from the nighttime blood pressure measurement mode to the normal blood pressure measurement mode. To do.
  • the user may instruct blood pressure measurement by interruption by pressing the measurement switch 52A, in addition to the predetermined schedule.
  • the blood pressure measurement is temporarily performed by the cuff 20 in response to the interrupted blood pressure measurement instruction, and the blood pressure measurement is performed by the oscillometric method.
  • time test mode switch 52C When the time test mode switch 52C is pressed while the sphygmomanometer 100 is powered on (ie, while in normal blood pressure measurement mode or nocturnal blood pressure measurement mode), it initiates to turn on time test mode. Means instructions. The processing of the time inspection mode will be described in detail later. A part of the time test mode processing (data storage processing described later) is executed in the background of the nighttime blood pressure measurement mode. If the time inspection mode switch 52C is pressed down again while the time inspection mode is on, it means an instruction to turn off the time inspection mode, and the time inspection mode is turned off.
  • FIG. 2 shows the block configuration of the sphygmomanometer 100.
  • the cuff 20 includes a fluid bag 22 for pressing the left wrist 90 as a measurement site as described above.
  • the fluid bag 22 and the main body 10 are connected by an air pipe 39 so that the fluid can flow.
  • the main body 10 includes a CPU 110 as a control unit, a memory 51 as a storage unit, a power supply unit 53, a pressure sensor 31, a pump 32, and a valve 33. And is installed. Further, the main body 10 includes an A / D conversion circuit 310 that converts the output of the pressure sensor 31 from an analog signal to a digital signal, a pump drive circuit 320 that drives the pump 32, and a valve drive circuit 330 that drives the valve 33. It is installed.
  • the pressure sensor 31, the pump 32, and the valve 33 are commonly connected to the fluid bag 22 through the air pipe 39 so that the fluid can flow.
  • the memory 51 stores a program for controlling the sphygmomanometer 100, data used for controlling the sphygmomanometer 100, setting data for setting various functions of the sphygmomanometer 100, data of blood pressure value measurement results, and the like.
  • the memory 51 is used as a work memory or the like when a program is executed.
  • the memory 51 stores an algorithm for the sitting position and an algorithm for the supine position as an algorithm for calculating blood pressure by the oscillometric method.
  • the “sitting position” means that a user 80 who wears a sphygmomanometer 100 on his left wrist 90 sits on a chair 97 or the like, puts his left elbow on a table 98, and puts his left wrist 90 on his trunk.
  • by raising it diagonally forward (hands up, elbows down) it means a posture in which the left wrist 90 (and sphygmomanometer 100) is maintained at the height level of the heart 81.
  • This posture is recommended to improve the accuracy of blood pressure measurement because the height difference between the left wrist 90 of the user 80 and the heart 81 can be eliminated.
  • a user 80 wearing a sphygmomanometer 100 on the left wrist 90 is placed on a horizontal floor surface 99 or the like with the left elbow extended along the trunk. It means lying on his back.
  • the height difference ⁇ H between the left wrist 90 (and the sphygmomanometer 100) of the user 80 and the heart 81 occurs (the height of the heart 81 is higher than the height of the left wrist 90), so that the blood pressure measurement value is measured. There will be a gap.
  • the blood pressure measurement value may deviate due to the bending and stretching of the left elbow. There is also sex.
  • a blood pressure calculation algorithm for measuring the blood pressure in the recumbent position is used as opposed to the blood pressure calculation algorithm for measuring the blood pressure in the sitting position. It is desirable to change.
  • the memory 51 stores an algorithm for the sitting position and an algorithm for the supine position as an algorithm for calculating blood pressure by the oscillometric method. The specific method of calculating blood pressure using these algorithms will be described later.
  • the memory 51 includes a time inspection mode flag 51A composed of a non-volatile semiconductor storage element. If the time inspection mode flag 51A is set, it indicates that the time inspection mode is on, while if the time inspection mode flag 51A is not set, it indicates that the time inspection mode is off. The time test mode flag 51A is set or not set regardless of whether the blood pressure monitor 100 is turned on or off, unless otherwise switched.
  • the CPU 110 shown in FIG. 2 controls the operation of the entire sphygmomanometer 100. Specifically, the CPU 110 acts as a pressure control unit according to a program for controlling the sphygmomanometer 100 stored in the memory 51, and drives the pump 32 and the valve 33 in response to an operation signal from the operation unit 52. Take control. Further, the CPU 110 functions as a blood pressure measuring unit, calculates a blood pressure value by using an algorithm for calculating blood pressure by an oscillometric method, and controls a display 50 and a memory 51.
  • the power supply unit 53 includes a secondary battery, a CPU 110, a pressure sensor 31, a pump 32, a valve 33, a display 50, a memory 51, an A / D conversion circuit 310, a pump drive circuit 320, and a valve drive circuit 330. Power is supplied to each part of.
  • the pump 32 supplies air as a fluid to the fluid bag 22 through the air pipe 39 in order to pressurize the pressure (cuff pressure) in the fluid bag 22 contained in the cuff 20.
  • the valve 33 is opened and closed to discharge the air from the fluid bag 22 through the air pipe 39 or to fill the fluid bag 22 with air to control the cuff pressure.
  • the pump drive circuit 320 drives the pump 32 based on a control signal given from the CPU 110.
  • the valve drive circuit 330 opens and closes the valve 33 based on a control signal given from the CPU 110.
  • the pressure sensor 31 and the A / D conversion circuit 310 function as a pressure detection unit that detects the pressure of the cuff.
  • the pressure sensor 31 is a piezoresistive pressure sensor in this example, and outputs the pressure (cuff pressure) in the fluid bag 22 contained in the cuff 20 as an electric resistance due to the piezoresistive effect through the air pipe 39.
  • the A / D conversion circuit 310 converts the output (electrical resistance) of the pressure sensor 31 from an analog signal to a digital signal and outputs it to the CPU 110.
  • the CPU 110 acts as an oscillating circuit that oscillates at a frequency corresponding to the electrical resistance from the pressure sensor 31, and acquires a signal representing the cuff pressure according to the oscillating frequency.
  • FIG. 5 shows an operation flow when a user measures blood pressure with a sphygmomanometer 100 in a normal blood pressure measurement mode.
  • the measurement switch 52A is continuously pressed for, for example, 3 seconds or more in the power-off state, the power is turned on and the normal blood pressure measurement mode is set by default. Further, it is assumed that the time inspection mode flag 51A is not set (therefore, the time inspection mode is off).
  • step S2 of FIG. 5 when the user presses down the measurement switch 52A provided on the main body 10 and inputs a blood pressure measurement instruction, the CPU 110 initializes the pressure sensor 31 (step S2). Specifically, the CPU 110 initializes the processing memory area, turns off (stops) the pump 32, and adjusts the pressure sensor 31 to 0 mmHg (atmospheric pressure is set to 0 mmHg) with the valve 33 open. )I do.
  • the CPU 110 closes the valve 33 via the valve drive circuit 330 (step S3), and then turns on (starts) the pump 32 via the pump drive circuit 320 to form the cuff 20 (fluid bag 22). Pressurization is started (step S4).
  • the CPU 110 is the pressure inside the fluid bag 22 as shown in FIG. 7A based on the output of the pressure sensor 31 while supplying air from the pump 32 to the fluid bag 22 through the air pipe 39.
  • Cuff pressure Controls the pressurization speed of the PC.
  • step S5 of FIG. 5 the CPU 110 acts as a blood pressure measuring unit, and the pulse wave signal SM (variable component due to the pulse wave included in the output of the pressure sensor 31) acquired at this time (FIG. 7 (FIG. 7). Based on (B)), an attempt is made to calculate the blood pressure value (maximum blood pressure (systolic blood pressure) and diastolic blood pressure (diastolic blood pressure)) using the sitting algorithm stored in the memory 51.
  • the blood pressure value maximum blood pressure (systolic blood pressure) and diastolic blood pressure (diastolic blood pressure)
  • step S6 if the blood pressure value cannot be calculated yet due to lack of data (No in step S6), the cuff pressure PC reaches the upper limit pressure (for safety, for example, 300 mmHg is predetermined). Unless otherwise specified, the processes of steps S4 to S6 are repeated.
  • the CPU 110 calculates the blood pressure value as follows. That is, with respect to the sequence of pulse wave amplitudes (peak to peak) formed by the pulse wave signal SM shown in FIG. 7 (B) obtained from the cuff pressure PC when the cuff 20 is in the pressurizing process, FIG. 7
  • the envelope ENV as shown in (C) is set. Along with this, it sets the maximum value AmpMax envelope ENV, predetermined ratio alpha dia for loci, two threshold level THD1, Ths1 of alpha sys.
  • THS1 ⁇ sys ⁇ AmpMax.
  • the cuff pressure PCs at the time when the envelope ENV crossed those threshold levels THD1 and THS1 are the diastolic blood pressure (diastolic blood pressure) BPdia1 and the systolic blood pressure (systolic blood pressure), respectively. Calculated as BPsys1.
  • step S6 the CPU 110 turns off the pump 32 (step S7), opens the valve 33 (step S8), and enters the cuff 20 (fluid bag 22). Controls the exhaust of air.
  • the CPU 110 counts the pulse waves obtained from the cuff pressure PC while repeating the processes of steps S4 to S6, and calculates the pulse rate (unit: beat / minute).
  • the CPU 110 displays the calculated blood pressure value and pulse rate on the display 50 (step S9), and controls to save the data such as the blood pressure value and the pulse rate in the memory 51.
  • FIG. 6 shows an operation flow when the user measures blood pressure in the nighttime blood pressure measurement mode with the sphygmomanometer 100.
  • the sphygmomanometer 100 is assumed to be in the normal blood pressure measurement mode. Further, it is assumed that the time inspection mode flag 51A is not set (therefore, the time inspection mode is off).
  • step S11 of FIG. 6 when the user presses down the nighttime measurement switch 52B provided on the main body 10, the sphygmomanometer 100 shifts from the normal blood pressure measurement mode to the nighttime blood pressure measurement mode.
  • a schedule for measuring once every hour for example, from the time when the nighttime measurement switch 52B is pressed until, for example, 7:00 am is set. It should be noted that the schedule is not limited to this, and even if a schedule for measuring on time such as 7:00 am, 1:00 am, 2:00 pm, and 3:00 am is set after the nighttime measurement switch 52B is pressed. Good.
  • the CPU 110 determines whether or not the measurement time is determined by the schedule (in the nighttime blood pressure measurement mode). If it is not the measurement time specified in the schedule (No in step S12), wait for the measurement time specified in the schedule to be reached.
  • the CPU 110 starts blood pressure measurement in the same manner as in steps S2 to S4 of FIG. 5, as shown in steps S13 to S15 of FIG. That is, the CPU 110 first initializes the pressure sensor 31 (step S13).
  • the CPU 110 closes the valve 33 via the valve drive circuit 330 (step S14), and then turns on (starts) the pump 32 via the pump drive circuit 320 to form the cuff 20 (fluid bag 22). Pressurization is started (step S15). At this time, the CPU 110 controls the pressurizing speed of the cuff pressure PC in the same manner as shown in FIG. 7A.
  • step S16 of FIG. 6 the CPU 110 acts as a blood pressure measuring unit, and the pulse wave signal SM (variable component due to the pulse wave included in the output of the pressure sensor 31) acquired at this time (FIG. 7 (FIG. 7). Based on (similar to that shown in B)), an attempt is made to calculate blood pressure values (maximum blood pressure (systolic blood pressure) and diastolic blood pressure (diastolic blood pressure)) using an algorithm for the supine position.
  • blood pressure values maximum blood pressure (systolic blood pressure) and diastolic blood pressure (diastolic blood pressure)
  • step S17 if the blood pressure value cannot be calculated yet due to lack of data (No in step S17), the cuff pressure PC reaches the upper limit pressure (for safety, for example, 300 mmHg is predetermined). Unless otherwise specified, the processes of steps S15 to S17 are repeated.
  • the CPU 110 calculates the blood pressure value as follows. That is, the envelope ENV as shown in FIG. 8 with respect to the sequence of pulse wave amplitudes (peak to peak) formed by the pulse wave signal SM obtained from the cuff pressure PC when the cuff 20 is in the pressurizing process. (Similar to that shown in FIG. 7C) is set.
  • the user In the nocturnal blood pressure measurement mode, the user is usually expected to be in the supine position. Therefore, by using the algorithm for the supine position, the blood pressure values (maximum blood pressure and diastolic blood pressure) can be calculated stably and accurately.
  • step S17 When the blood pressure value (current blood pressure value) can be calculated in this way (Yes in step S17), the CPU 110 turns off the pump 32 (step S18), opens the valve 33 (step S19), and cuffs 20 (step S19). Control is performed to exhaust the air in the fluid bag 22).
  • the CPU 110 counts the pulse waves obtained from the cuff pressure PC while repeating the processes of steps S15 to S17, and calculates the pulse rate (unit: beat / minute).
  • the CPU 110 displays the calculated blood pressure value and pulse rate on the display 50 (step S20), and controls to save the data such as the blood pressure value and the pulse rate in the memory 51.
  • step S21 the CPU 110 determines whether or not all the blood pressure measurements defined in the above schedule are completed.
  • the process returns to step S12. Then, it waits for the next measurement time determined in the above schedule (No in step S12).
  • step S12 the CPU 110 repeats the processes of steps S13 to S20. Further, in step S21, the CPU 110 determines whether or not all the blood pressure measurements defined in the above schedule have been completed. When all the blood pressure measurements defined in the above schedule are completed (“finished” in step S21), the CPU 110 ends the nighttime blood pressure measurement mode.
  • the dipper type in the dipper type, the blood pressure at night drops from 10% to less than 20% of the average blood pressure during the day, and for a certain period of time. It is a type that rises after showing the minimum in the band.
  • the extreme dipper type is a type in which the blood pressure at night decreases until the amount of decrease becomes 20% or more of the average blood pressure in the daytime, shows the minimum in a certain time zone, and then increases.
  • the non-dipper type is a type in which the blood pressure at night decreases from zero to less than 10% of the average blood pressure during the day, shows the minimum at a certain time zone, and then increases.
  • the riser type is a type in which the average blood pressure at night rises higher than the average blood pressure during the day.
  • the above dipper type and the above extreme dipper type it is considered important to measure the blood pressure in the time zone when the nighttime blood pressure is the minimum from the viewpoint of grasping the diurnal variation of blood pressure. Further, regarding the non-dipper type and the riser type, it is considered important to comprehensively measure the blood pressure at night from the viewpoint of grasping the diurnal variation of blood pressure.
  • the time test mode process for nighttime blood pressure measurement as shown in FIG. 10 is executed.
  • the sphygmomanometer 100 is turned on and is in the normal blood pressure measurement mode (or nocturnal blood pressure measurement mode).
  • the CPU 110 sets the time inspection mode flag 51A (see FIG. 2) accordingly.
  • the time inspection mode is turned on (started).
  • step S32 the CPU 110 acts as an accumulation processing unit and starts data accumulation processing for the subject over a plurality of days (one week in this example).
  • the schedule of the nighttime blood pressure measurement mode is set every day for one week (the period during which the data accumulation process is performed) immediately after the time test mode is turned on, for example, at 22:00 pm. It is set every 30 minutes as the first time interval from to about 6 o'clock in the early morning. Alternatively, it may be set every hour.
  • the time is represented along the horizontal axis, and one blood pressure measurement is represented by one vertical bar P.
  • the CPU 110 operates the sphygmomanometer 100 according to the flow shown in FIG. 6 in the nighttime blood pressure measurement mode every day for the week to measure the blood pressure. Then, the CPU 110 sequentially stores the measured blood pressure values in the memory 51 (data storage process).
  • the CPU 110 acts as a statistical processing unit, and the blood pressure value stored in the memory 51 for the subject over the above one week is stored. Statistical processing is performed to determine which of the above four types the nocturnal blood pressure fluctuation pattern is classified into.
  • the CPU 110 averages the blood pressure values acquired for each of the same time zones every day for the above one week, and obtains the average value for each time zone. ..
  • a nighttime blood pressure fluctuation pattern similar to that shown from 22:00 pm to 6:00 am in FIG. 9 can be obtained.
  • the average value for each time zone over a week is obtained, even if there is some variation from day to day, the average value for each time zone can be appropriately grasped from the experience of the present inventor.
  • the daily variation in the blood pressure value of the subject is appropriately reflected in the average value for each time zone.
  • the nighttime blood pressure fluctuation pattern of the subject can be appropriately grasped according to how the average value for each time zone changes throughout the night.
  • the CPU 110 determines which type of the nighttime blood pressure fluctuation pattern of the subject is classified into a dipper type, an extreme dipper type, a non-dipper type, and a riser type. Specifically, first, it is classified into dipper type, extreme dipper type, and non-dipper type according to whether the nighttime blood pressure is lower than the daytime blood pressure average or the nighttime blood pressure (average) is higher than the daytime blood pressure average. It is roughly divided into whether it is classified as a riser type or a riser type. Then, depending on how much the minimum value of blood pressure at night corresponds to the average blood pressure during the day, it is determined whether it is classified into a dipper type, an extreme dipper type, or a non-dipper type. Thereby, it is possible to smoothly determine which type of the nighttime blood pressure fluctuation pattern of the subject is classified into the dipper type, the extreme dipper type, the non-dipper type, and the riser type.
  • the nighttime blood pressure fluctuation pattern of the subject can be appropriately classified in accordance with Non-Patent Document 1 (Guidelines for Use of 24-Hour Blood Pressure Monitor (ABPM) Standard (Revised 2010)).
  • Non-Patent Document 1 Guidelines for Use of 24-Hour Blood Pressure Monitor (ABPM) Standard (Revised 2010)
  • the CPU 110 acts as a schedule resetting unit to measure the measurement frequency of the subject after one week according to the type of the determined nighttime blood pressure fluctuation pattern.
  • the process of resetting the schedule of the nighttime blood pressure measurement mode is performed so as to reduce the amount.
  • the determined nighttime blood pressure fluctuation pattern is a dipper type or an extreme dipper type
  • the time zone in which the nighttime blood pressure is the minimum is from 0:00 am to 0:30 am.
  • the CPU 110 sets the time corresponding to the time zone in which the nighttime blood pressure is the minimum, as shown in the upper part and the middle upper part of FIG. 11B, as the above schedule of the nighttime blood pressure measurement mode after the above one week. It is set to midnight.
  • the reason for this is that for the dipper type or the extreme dipper type, as described above, it is important to measure the blood pressure during the time period when the nighttime blood pressure is the minimum from the viewpoint of grasping the diurnal variation of blood pressure. This is because it is considered.
  • the schedule of the nighttime blood pressure measurement mode is set to the time corresponding to the time zone in which the nighttime blood pressure is the minimum (in the above example, midnight).
  • the frequency of blood pressure measurement can be reduced to once per night. This makes it possible to reduce the number of times the subject's sleep is disturbed after the above one week.
  • the CPU 110 uses the first time interval as the schedule of the nighttime blood pressure measurement mode after the one week.
  • the second time interval is switched to a longer time interval (30 minute interval) as shown in FIG. 11 (A).
  • midnight which is the time two hours after the start of sleep
  • 2:00 am and 4:00 am are set at 2-hour intervals as the second time interval from 0:00 am.
  • 11B, 23:00 which is the time one hour after the start of sleep, is set as the above schedule of the nighttime blood pressure measurement mode after the above one week, and the second 2:00 am is set with a time interval of 3 hours, and 4:00 am is set with a second time interval of 2 hours.
  • the reason for this is that for the non-dipper type and the riser type, it is considered important to comprehensively measure the blood pressure at night from the viewpoint of grasping the diurnal variation of blood pressure as described above. is there.
  • the determined nighttime blood pressure fluctuation pattern is the non-dipper type or the riser type, it is possible to acquire important (that is, necessary) blood pressure value data for the subject.
  • the number of measurements after one week can be reduced as compared with the number of measurements in the one week (17 times per night in the example of FIG. 11A), which is the target of the data storage process. For example, in the examples in the lower middle and lower rows of FIG. 11B, the number is reduced to 3 times per night. This makes it possible to reduce the number of times the subject's sleep is disturbed after the plurality of days.
  • the blood pressure is measured only in the time zone when the blood pressure at night is the minimum, or the measurement in the above one week which is the target of the data accumulation process (step S32 in FIG. 10). It is possible to lengthen the time interval of the measurement after one week as compared with the time interval of. Therefore, when performing nighttime blood pressure measurement, the frequency of blood pressure measurement can be reduced while acquiring necessary blood pressure value data.
  • the period for the data storage process is not limited to the above-mentioned one week, and may be, for example, two weeks or three weeks.
  • step S35 of FIG. 10 the CPU 110 sets the time inspection mode flag 51A (see FIG. 2) and turns off (ends) the time inspection mode.
  • the CPU 110 performs the data storage process (step S32). ) Is started, and as soon as the data accumulation process is completed, the statistical process (step S33) to the process of resetting the schedule (step S34) are continuously executed. As a result, the above schedule is automatically reset. Therefore, it is convenient for the user because it does not substantially require the trouble of resetting the above schedule of the nighttime blood pressure measurement mode.
  • the sphygmomanometer 100 is a type that presses the wrist as the measurement site (the left wrist 90 is used in the above example, but the right wrist may also be used), the blood pressure monitor 100 is compared with the type that presses the upper arm. It is expected that the degree of disturbing the sleep of the user (subject) is small (Imai et al., “Development and evaluation of a home nocturnal blood pressure monitoring system using a wrist-cuff device”, Blood Pressure Monitoring 2018, 23, P318. -326). Therefore, this sphygmomanometer 100 is suitable for nighttime blood pressure measurement.
  • this sphygmomanometer 100 is integrally and compactly configured as a wrist-type sphygmomanometer, it is convenient for the user to handle.
  • the blood pressure is calculated in the process of pressurizing the cuff 20 (fluid bag 22), but the present invention is not limited to this. Blood pressure may be calculated in the process of depressurizing the cuff 20.
  • the blood pressure measurement instruction, the transition instruction to the night blood pressure measurement mode, and the time inspection are performed by the measurement switch 52A, the night measurement switch 52B, and the time inspection mode switch 52C as the operation unit provided in the main body 10, respectively.
  • I have entered a mode start instruction, but it is not limited to this.
  • a communication unit capable of wireless communication is mounted on the main body 10, and a blood pressure measurement instruction, a transition instruction to the nighttime blood pressure measurement mode, and a time inspection are performed from a smartphone or the like existing outside the sphygmomanometer 100 via this communication unit. You may enter a mode start instruction.
  • the main body 10 is provided integrally with the cuff 20, but the present invention is not limited to this.
  • the main body 10 may be configured as a separate body from the cuff 20 and may be connected to the cuff 20 (fluid bag 22) so that fluid can flow through a flexible air tube.
  • the above-mentioned blood pressure measurement method (particularly, the operation flow of FIGS. 5, 6 and 10) is used as software (computer program) for non-temporary (compact disc), DVD (digital universal disc), flash memory and the like. Data may be recorded on a recording medium that can store data in non-transitory).
  • a substantial computer device such as a personal computer, a PDA (Personal Digital Assistance), or a smartphone, the above-mentioned blood pressure measurement method can be applied to those computer devices. Can be executed.

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PCT/JP2020/037774 2019-10-29 2020-10-05 血圧計、血圧測定方法、およびプログラム WO2021085043A1 (ja)

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Citations (3)

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Publication number Priority date Publication date Assignee Title
JP2009149691A (ja) * 2001-03-13 2009-07-09 Penwest Pharmaceuticals Co 時間治療（ｃｈｒｏｎｏｔｈｅｒａｐｅｕｔｉｃ）投与形態
WO2012018029A1 (ja) * 2010-08-06 2012-02-09 株式会社オムシー 血圧測定装置
US20160342764A1 (en) * 2015-05-19 2016-11-24 Universidad De Vigo System, computer-implemented method and computer program product for individualized multiple-disease quantitative risk assessment

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JP3668843B2 (ja) * 2001-08-27 2005-07-06 オムロンヘルスケア株式会社 電子血圧計および血圧測定データ処理システム
US8428965B2 (en) * 2009-08-05 2013-04-23 Universidade De Vigo System for clinical research and clinical management of cardiovascular risk using ambulatory blood pressure monitoring and actigraphy
JP6597790B2 (ja) * 2015-11-17 2019-10-30 株式会社村田製作所 脈波伝播時間計測装置、及び、生体状態推定装置
JP6863665B2 (ja) * 2018-01-10 2021-04-21 オムロンヘルスケア株式会社 血圧リスク分析装置及び血圧リスク分析方法

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Publication number Priority date Publication date Assignee Title
JP2009149691A (ja) * 2001-03-13 2009-07-09 Penwest Pharmaceuticals Co 時間治療（ｃｈｒｏｎｏｔｈｅｒａｐｅｕｔｉｃ）投与形態
WO2012018029A1 (ja) * 2010-08-06 2012-02-09 株式会社オムシー 血圧測定装置
US20160342764A1 (en) * 2015-05-19 2016-11-24 Universidad De Vigo System, computer-implemented method and computer program product for individualized multiple-disease quantitative risk assessment

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